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Annual Report 2024

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Annual Report 2024

Reference: ECHA-25-R-03-EN ISBN: 978-92-9468-469-1 ISSN: 2600-0849 Cat. Number: ED-01-25-003-EN-N DOI: 10.2823/7460332 Publ.date: April 2025 Language: EN © European Chemicals Agency, 2025

Cover page © European Chemicals Agency

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P.O. Box 400, FI-00121 Helsinki, Finland

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Annual Report 2024

Table of Contents TABLE OF CONTENTS .................................................................................................. 3 LIST OF ACRONYMS .................................................................................................... 5 MANAGEMENT BOARD ANALYSIS AND ASSESSMENT .................................................. 8 FOREWORD ............................................................................................................... 13 EXECUTIVE SUMMARY .............................................................................................. 15 PART I. ACHIEVEMENTS OF THE YEAR ...................................................................... 20 Dossier preparation ................................................................................................................. 20 Dossier submission and processing ............................................................................................ 21 Identification and prioritisation of substances and groups of substances .......................................... 23 Evaluation ............................................................................................................................. 24 Authorisation .......................................................................................................................... 26 Restrictions ............................................................................................................................ 28 Classification and labelling ........................................................................................................ 30 Data management and dissemination ........................................................................................ 33 Promotion of alternatives to animal testing ................................................................................. 35 Biocides ................................................................................................................................. 37 Contribution to EU Environmental policy ..................................................................................... 39 Tasks under grant, cooperation and service-level agreements ....................................................... 44 Governance and Enablers ......................................................................................................... 47

PART II. MANAGEMENT ............................................................................................ 61 Management Board ................................................................................................................. 61 Major developments ................................................................................................................ 61 Budgetary and financial management ........................................................................................ 62 Delegation and sub-delegation of the powers of budget implementation to agency’s Staff .................. 62 Human Resources (HR) management ......................................................................................... 62 Strategy for efficiency gains ..................................................................................................... 62 Assessment of audit and retrospective evaluation results during the reporting year .......................... 63 Follow up of recommendations and action plans for audits and evaluations ...................................... 66 Follow up of observations from the Discharge authority ................................................................ 66 Environment management ....................................................................................................... 67 Assessment by management .................................................................................................... 69

PART III. ASSESSMENT OF THE EFFECTIVENESS OF THE INTERNAL CONTROL SYSTEMS ........................................................................................................................... 70

Effectiveness of internal control system ...................................................................................... 70 Conclusions of the assessment of the internal control systems ....................................................... 75 Statement of the manager in charge of risk management and internal control ................................. 77

PART IV. MANAGEMENT ASSURANCE ........................................................................ 78 Review of the elements supporting assurance ............................................................................. 78 Reservations .......................................................................................................................... 78

PART V. DECLARATION OF ASSURANCE .................................................................... 79 Declaration of assurance by the Authorising Officer ...................................................................... 79

ANNEXES .................................................................................................................. 80 Annex I - Key indicators ........................................................................................................... 81 Annex II - Budget implementation reports and statistics on financial management ........................... 82 Revenue .............................................................................................................................. 82 REACH/CLP Revenue .............................................................................................................. 83 BPR Revenue ........................................................................................................................ 83 Environmental Policy Revenue ................................................................................................. 84 Expenditure .......................................................................................................................... 86

Annex III – Organisational chart ............................................................................................... 94

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Annex IV - Establishment plan and additional information on human resources management ............. 95 Annex V – Human and financial resources by activity .................................................................. 100 Annex VI – Contribution, grant and service-level agreements ....................................................... 101 Annex VII - Environment management...................................................................................... 102

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List of acronyms Acronym Description

AD Administrator

AI Artificial Intelligence

APCRA Accelerating the Pace of Chemical Risk Assessment

ARN Assessment of regulatory needs

ASO Accredited Stakeholder Organisation

AST Assistant

BAT Best Available Technique

BEF BPR-EN-FORCE (Forum- coordinated BPR enforcement project)

BoA Board of Appeal

BPC Biocidal Products Committee

BPR Biocidal Products Regulation

BPRS BPR Subgroup of the Forum

BREF Best Available Techniques Reference documents

C&L Classification and labelling

CA Contract agent

Chesar Chemical Safety Assessment and Reporting tool

CLH Harmonised classification and labelling

CLP Classification, labelling and packaging (and the respective Regulation)

CoIAC Conflict of Interest Advisory Committee

COM European Commission

CoRAP Community rolling action plan

CSS Chemicals Strategy for Sustainability of the Commission

DG DIGIT Directorate General for Informatics

DG EMPL Directorate General for Employment, Social Affairs and Inclusion

DG GROW Directorate General for Internal Market, Industry, Entrepreneurship and SMEs

DG NEAR Directorate General for Neighbourhood and Enlargement Negotiations

DG RTD Directorate General for Research

Acronym Description

and Innovation

DNA Designated national authorities

DoI Declaration of Interests

DWD Drinking Water Directive

EAP Environmental Action Programme

EC European Commission

ECA European Court of Auditors

ECDC European Centre for Disease Control

ECHA European Chemicals Agency

eChemPortal OECD Global Portal to Information on Chemical Substances

ED Endocrine disruptor

EDPS European Data Protection Supervisor

EEA European Environment Agency

EFSA European Food Safety Authority

EFTA European Free Trade Association

ELV End-of-Life Vehicle

EMA European Medicines Agency

EMAS EU Eco-Management and Audit Scheme

EMS Environmental management system

eMSCA Evaluating Member State competent authority

ENVI European Parliament's Committee on Environment, Public Health and Food Safety

EUAN EU Agencies Network

EUCLEF European Chemicals Legislation Finder

EUON European Union Observatory for Nanomaterials

EU-OSHA European Agency for Safety and Health at Work

Forum Forum for Exchange of Information on Enforcement

FTE Full-time equivalent

FWC Framework contract

GIME Groupe Interinstitutionnel de Management Environnemental (Interinstitutional Group for

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Acronym Description

Environmental Management)

GLP Good Laboratory Practice

GN EUAN Greening Network

GPP Green Public Procurement

HelpNet Network of national BPR, CLP and REACH helpdesks

HR Human resources

IAC Internal Audit Capability of ECHA

IAS Internal Audit Service of the Commission

ICT Information communications technology

IED Industrial Emissions Directive 2010/75/EU

IMS Integrated Management System

IPA Instrument for Pre-Accession Assistance

IRS Integrated Regulatory Strategy

ISO International Organisation for Standardisation

IT Information technology

IUCLID International Uniform Chemical Information Database

JEAP Joint Evaluation Action Plan

JRC Joint Research Centre

KPI Key Performance Indicators

MB Management Board

MCCP Medium-chain chlorinated paraffins

MS Member State

MSC Member State Committee

MSCA Member State competent authority

NAM New approach methodologies

NGO Non-governmental organization

NEA National enforcement authority

NeRSAP Network of REACH SEA and Analysis of Alternatives practitioners

OECD Organisation for Economic Co- operation and Development

OEL Occupational exposure limit

OHT OECD Harmonised Template

OSOA One Substance, One Assessment

PAH Polycyclic aromatic hydrocarbons

PARC Partnership for the Assessment of

Acronym Description

Risks of Chemicals

PBT Persistent, bioaccumulative and toxic

PCN Poison Centre Notifications

PDN Performance Development Network

PFAS Per- and polyfluoroalkyl substances

PFCA Perfluorocarboxylic acids

PIC Rotterdam Convention on the prior informed consent procedure (and the respective Regulation)

PMT Persistent, mobile and toxic

POP Persistent organic pollutant

POPRC Persistent Organic Pollutants Review Committee

POPs Persistent organic pollutants (and the respective Regulation)

PPORD Product and Process Oriented Research and Development

PPP Plant protection products

QSAR Quantitative Structure-Activity Relationship

R4BP Register for Biocidal Products

RAC Committee for Risk Assessment

REACH Registration, evaluation, authorisation and restriction of chemicals (and the respective Regulation)

REACH-IT Central IT system providing support for REACH

REF REACH-EN-FORCE (Forum- coordinated REACH enforcement project)

RoP Rules of Procedure

SCBTH Serious Cross-Borders Threats to Health

SCIP Database for information on Substances of Concern In articles as such or in complex objects (Products)

SEAC Committee Socio-economic Analysis Committee

SEV Substance Evaluation

SLA Service Level Agreement

SME Small and medium-sized enterprises

SNE Seconded national expert

SPC Summary of product

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Acronym Description

characteristics

SVHC Substance of very high concern

SWACHE Surveys on Willingness-to-Pay to Avoid Negative Chemicals- Related Health Effects

TA Temporary agent

UNEP United Nations Environment Programme

UFI Unique Formula Identifier

UN GHS United Nations Globally Harmonised System of classification and labelling of chemicals

UWWT Urban Wastewater Treatment Directive 91/271/EEC

vPvB Very persistent and very bioaccumulative

vPvM Very persistent and very mobile

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Annual Report 2024

Management Board analysis and assessment The Management Board welcomes the Annual Report 2024, fulfilling the requirements of the REACH Regulation (General Report)1 and those of the ECHA Financial Regulation (Consolidated Annual Activity Report)2.

We consider that this report provides a comprehensive account of the activities carried out by ECHA during 2024, the performance of the Agency against the expected inputs, outputs and outcomes defined in the Single Programming Document 2024-20263. It also represents a fair overview of the evolution of ECHA’s budget, staffing, management, and its internal management system strategy and framework.

This assessment is based on our analysis of all parts of the report, including the activities carried out, achievements, financial information, results of audits, retrospective evaluations, and the assessment of the internal control system, as well as the risks related to ECHA’s activities together with the corresponding mitigating measures.

Achievements of the year

2024 was the first year of implementing the ECHA Strategy 2024-2028. We consider that the performance and quality of the outputs in 2024 were high, as shown in Part I of the Annual Report.

In assessing4 the Consolidated Annual Activity Report of the Authorising Officer for 2024, we:

1. Acknowledge the performance of the ECHA committees in delivering opinions to the Commission, and note, in this context, the enhanced Member State focus on increasing the capacity of the Committees. RAC and SEAC have made steady progress in the complex PFAS restriction assessment, with clear updates provided to interested parties throughout the process

2. Welcome the conclusion of the Joint Evaluation Action Plan and the review and new objectives of the Integrated Regulatory Strategy (IRS), shifting the focus towards moving substances to risk management.

3. Welcome the continued outreach efforts to Member States, including via bilateral engagements of the Executive Director, and the organisation of a meeting of Heads of Chemical Authorities.

4. Note the 5-year IT transformation plan and the ongoing review of the data management approach, including a data governance model and look forward to receiving information about their implementation and about the overall IT preparation to onboard new tasks.

5. Acknowledge the launch of the first version of the ECHA Chem portal, the new system for making information on chemicals publicly available and encourage the secretariat to develop it further.

Based on the periodical reporting and the Annual Report 2024 prepared by the secretariat, the

1 Article 78(a) of the REACH Regulation. 2 Article 48 of ECHA’s Financial Regulation. 3 https://echa.europa.eu/documents/10162/58005821/final_mb_31_2023_echa_spd_2024- 2026_en.pdf/49a5ffa2-10e8-327b-b1d4-743758851514?t=1706552312333 4 Assessment pursuant to Article 48(1) of the Agency’s Financial Regulation.

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Board makes the following observations:

1. ECHA continued preparing for the full implementation of the Drinking Water Directive, however, the implementation of the provisions for notification and application systems have been delayed by one year by the legislator.

2. The committee's capacities and competence remain a point of great concern, especially regarding the implementation of new tasks.

3. ECHA continued preparing opinions on the approval and renewal of biocidal active substances and Union authorisations of biocidal products. However, the progress with the Review Programme of existing active substances continued to be limited. The overall progress of the Review Programme is now at 50%.

4. ECHA continued to provide support to the Forum, including by training a higher than estimated number of national trainers and inspectors, which is important for the continued improvement of harmonised enforcement of chemicals legislation across the EU.

Management

• The 10 recommendations the Management Board provided for 2024 as part of the assessment of the 2023 Annual Report have been implemented or are in progress.

• 178 outputs were delivered out of the planned 200. The challenges in delivering some of the outputs were mostly related to lack of external input, revised timing of legislative proposals, technical or resourcing issues and the need for task reprioritisation.

Budgetary and financial management

• We welcome the excellent performance of ECHA in implementing its budget with 99.5% of commitment rate and 0.5% of cancelled payment appropriation rate, with processing 99.8% of payments within legal deadlines, while keeping the strict segregation between its funding sources and operating in an environment of fluctuating and challenging to predict fee income.

Human resources management

• We commend ECHA for having maintained a high rate of filling its establishment plan posts (97.2%) and the strong focus on staff wellbeing, diversity and inclusion.

• We note the gender imbalance (30% female, 70% male) at the middle and senior management levels.

• We welcome that ECHA adopted and started to implement the People and Organisational Strategy 2024-2028.

• We take note of the outcome of the Retrospective evaluation of ECHA’s HR strategy 2019- 2023, including that ECHA compares with other ENVI agencies as the Agency with the lowest proportion of its HR staff to total staff and the lowest proportion of “neutral staff” to total staff, which includes posts in horizontal services, such as finance, procurement, quality management, linguistics etc.

Audit and retrospective evaluation results and follow-up on recommendations

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• Assurance has been provided by the Internal Audit Capability (IAC) on audits, follow-up audits and the implementation of the recommendations, as well as appropriate information from the secretariat on the retrospective evaluations. The audits and evaluations planned for 2024 were all completed.

• The European Court of Auditors adopted a positive opinion regarding the 2023 annual accounts, with no reservation or observation. We welcome that there are no pending observations or recommendations.

• The European Parliament, as the Discharge Authority, granted discharge to the Executive Director with respect to ECHA’s 2022 budget, including the decision on the closure of the 2022 accounts. The secretariat duly provided replies to the Discharge Authority’s observations and the implementation of the six recommendations is on track.

• The Internal Audit Service (IAS) of the Commission did not conduct any audit in ECHA in 2024. There are no pending recommendations from past IAS audits.

Internal control framework and Integrated Management System

• We consider that the internal control framework remains effective and functioning.

• ECHA’s Integrated Management System Strategy and Framework has demonstrated its effectiveness in achieving the Agency’s strategic goals and priorities in 2024.

• ECHA obtained recertification of the Agency’s International Organisation for Standardisation (ISO) 9001:2015 and 14001:2015 and EU Eco-Management and Audit Scheme (EMAS). Guidelines for the implementation of the ISO 20121:2012 standard on event sustainability management systems were developed and issued during 2024.

Organisational risk management

• We highlight the importance of the continued development and application of the organisational Risk Management Policy, including via training and awareness raising.

• We found the regular updates on the risk register, including the continued specific reporting on the IT-security related risks, pertinent.

• We note that appropriate measures are in place to identify, monitor and manage risks threatening the achievement of ECHA’s objectives. The secretariat regularly signalled significant risks and control issues to the Management Board, including as part of the Executive Director reporting, as well as the updates to the Agency Risk Register.

• We welcome the investments and efforts to meet cybersecurity regulation5 requirements, and we note the low number of cybersecurity incidents. We call for continued focus on this area.

Management Assurance

The Management Board takes note of the systems in place to support the Executive Director’s declaration of assurance and takes note of the declaration of assurance of the Executive Director. Based on the information in the Section II, no significant weaknesses or gaps that may threaten the achievement of ECHA’s objectives were identified.

5 Regulation (EU, Euratom) 2023/2841.

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The Board takes note of the fact that no reservations were made.

Recommendations for the secretariat for 2025

Based on our assessment, the Management Board requests particular emphasis in 2025 on the following actions, without prejudice to the implementation of the Single Programming Document 2025-2027:

1. Take appropriate actions to maintain the committees’ ability to deliver transparent, independent and high-quality scientific outputs for existing and new tasks: Continue supporting the work of the committees to further enhance the Committees competence and working structures including increasing their capacity. In this context, keep in focus the continued facilitation of the preparation of the RAC/SEAC opinion on the UPFAS dossier.

2. Continue closely following the legislative process concerning ECHA’s new tasks and support the decision-makers with technical-scientific input, as required. Prepare for the implementation of new tasks, according to the (timing of) availability of resources and timely signal issues and risks to the Management Board.

3. Maintain focus on engaging and building trusted relationships with key European institutional stakeholders, as well as with Member State partners and engage with other stakeholders. Continue providing clear and accessible information about ECHA’s mandate and chemical safety to all stakeholders.

4. Continue the support to Member States competent authorities for biocidal products, with a view to accelerating the progress with the Review Programme of existing active substances.

5. Fine-tune the activity-based budgeting of the Agency as it will be crucial in the future against the background of tasks assigned to the Agency deriving from many pieces of legislation.

6. Update the Management Board on the actions implemented in follow up to the organisational review of ECHA, given its importance in addressing the evolving nature and increasing complexity of ECHA’s tasks and mandate.

7. Implement the refocused IRS objectives: maintain a good knowledge about the chemicals in ECHA’s databases and shift the focus to deliver risk management outcomes for (groups of) substances.

8. Continue supporting the implementation of the revised CLP regulation, including for the introduction of new hazard classes, grouping and read-across approaches, including in the run-up to the first implementation deadline.

Acknowledgments

The members of the Management Board express their appreciation to ECHA staff, members of ECHA bodies and the Agency’s partners, in particular Member States, for their commitment and achievements in 2024.

Conclusion

In assessing the Annual Report 2024, the Management Board concludes that the overall performance of ECHA is in line with the objectives included in the Agency’s Single Programming

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Annual Report 2024

Document 2024-2026 and ECHA made good progress in delivering its Strategy 2024-2028.

Based on the above observations, the Management Board requests that the Annual Report 2024 be forwarded to the Member States, the Court of Auditors, the Commission, the European Parliament, the European Economic and Social Committee and the Council.

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Annual Report 2024

Foreword

Dr Sharon McGuinness

Executive Director

I am pleased to present the Agency’s annual report for 2024, the first under our Strategy Statement 2024-2028. We delivered the legal mandate across the wide range of chemical legislation under our remit and met the objectives of our work programme 2024.

With our goal to be a trusted chemicals agency, we continued our commitment to delivering transparent, independent, and high-quality scientific advice, opinions, and decisions across REACH, CLP, Biocides and other legislative areas. In all legislative areas, we also delivered significant levels of support and advice to the Commission, Member States, industry and other stakeholders.

The members of our scientific committees are central to our ability to deliver opinions and decisions. In this regard, having the appropriate capacity and competence within our committees is essential. We have put more focus on increasing capacity in relation to the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC). This focus included engaging with Member States with a view to increasing nominations as well as measures, such as revised remuneration for specific tasks. Together with the Commission, ECHA also wrote to Member State authorities asking them to nominate, as applicable, the two experts to the scientific committees. Having full capacity of our committees is not only important for current tasks under REACH and CLP, but also for new tasks such as drinking water and batteries. We have seen increased Member State focus on ensuring capacity for our committees and ended the year with 80% membership in RAC and 55% in SEAC. To ensure our committees are sustainable in the future, ECHA also contributed to the Commission’s preparatory work to strengthen governance and streamline operations with the future ECHA Basic Regulation, and we look forward to seeing a proposal in 2025.

In 2024, we completed reviews of the Integrated Regulatory Strategy (IRS) and the Joint Evaluation Action Plan (JEAP), which were two significant initiatives under our 2018-2023 strategic plan. As a result of these reviews, we have concluded the Joint Evaluation Action Plan and revised the Integrated Regulatory Strategy. The findings and recommendations arising from these reviews will inform our future focus on risk management activities.

Throughout the year, we prepared for implementation of new or changing legislative tasks. We commenced implementing legislation tasks in relation to Drinking Water, Batteries, Serious Cross Border Threats to Health and Industrial Emissions. In anticipation of the publication of the revised CLP Regulation, we updated and published the tools and the CLP guidance on criteria for new hazard classes. We also supported the Commission in relation to

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Annual Report 2024

their work on the various legislative packages under One Substance, One Assessment (OSOA) as it made its way through the co-decision process.

We also continued delivering on our legal obligations under the Biocidal Products Regulation (BPR), however, the low number of completed assessment reports for biocidal active substances submitted by Member States continued. We remain committed to working together with the Member States and the Commission to address this issue with the Review Programme for existing active substances.

Communicating and engaging with all stakeholders, EU institutions, EU agencies, Member States, industry and other stakeholders is necessary to deliver our legal mandate and our vision of chemical safety through science, collaboration and knowledge. In 2024, we put increased emphasis on these areas. We also worked closely with other EU Agencies, including the European Medicines Agency (EMA), the European Food Safety Authority (EFSA), the European Environment Agency (EEA) and the European Centre for Disease Control (ECDC). This work included signing the One Health Framework of action between our agencies. This collaborative work is important for delivering existing tasks and will become even more important as we implement the future tasks under the OSOA approach.

With our new strategic priority to support SMEs, we prepared an engagement plan which we will implement in the coming years. To increase awareness and transparency of the chemicals data we have and make it widely available to industry and interested parties, we launched a new dissemination tool, ECHA CHEM and will continue to increase information available on it over the coming years.

Delivering our current and future legal mandate and our strategic vision and goals requires an organisation that has the necessary people and systems in place to meet increasing demands and expectations. In 2024, we took steps to ensure our organisation, our data and IT will all be fit for the future. On IT, we finalised a 5-year IT transformation plan, which foresees four portals based on the specific tasks and needs of different groups – industry, authorities, ECHA and the public – built on modular enterprise architecture. Coupled with this IT focus, we are also reviewing our approach on data management, with the first step taken in 2024 to confirm a data governance model.

In line with ECHA’s priority to ‘Ensure that our organisational model is ready to support delivery of our current and future mandate’, ECHA undertook an organisational review in 2024. The organisational review was conducted to address the evolving nature and increasing complexity of ECHA’s tasks and mandate and meet our strategic goals and vision. The recommendations, which addressed ways of working, strategic prioritisation and organisational structure will be addressed in 2025.

I would like, in conclusion, to express my thanks to the Management Board for their support and collaboration throughout the course of 2024. A particular note of thanks and appreciation also to ECHA’s management team and all the staff for their dedication and commitment in delivering our 2024 Work Programme.

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Annual Report 2024

Executive summary ECHA’s achievements in 2024 reflect a strong commitment to our strategic goals and priorities, as well as our vision of chemical safety through science, collaboration and knowledge. We continued to progress and implement our existing legal mandate and also commenced implementation of several new tasks. Our role continues to expand, and in 2024, we supported decision makers as they prepared for the introduction of further new regulatory tasks for the Agency. Throughout the year, we collaborated closely with our many stakeholders, including Member States, the Commission, EU agencies, industry and NGOs. This engagement ensures we can deliver transparent, independent and high-quality scientific opinions and decisions and ensure duty holders meet their legal obligations. While much has been achieved in 2024, the Agency continues to face challenges, which will need to be addressed over the coming period. However, we also took steps to address how the Agency can tackle several of these challenges by modifying our ways or working in the future.

Strategic Goal - a Trusted Chemicals Agency

As the EU Chemicals Agency, we work continuously to be trusted and reliable as we implement chemical regulations and protect health and the environment through our work on chemical safety. A key priority for the Agency is to deliver transparent, independent and high-quality scientific opinions and decisions as required under our legal mandate. Under REACH and CLP, our committees delivered opinions to the Commission on applications for authorisation of 55 uses of substances, a restriction proposal on creosote, as well as adopting 56 opinions on harmonised classification and labelling proposals. We also added two entries to the Candidate List, bringing the total to 242 entries in the end of 20246. Also under REACH, we published the investigation report on brominated flame retardants and continued to make progress on the PFAS restriction opinion making throughout the year.

Following the introduction of the revised CLP Regulation, we updated and published guidance to include the new hazard classes. This updated guidance was a significant collaborative achievement by experts from ECHA, Member States, industry and non-governmental organisations.

In relation to biocides, we submitted to the Commission 15 opinions on active substances, 17 opinions on Union authorisations along with 20 opinions on administrative changes of a Union Authorisation, 15 opinions on same biocidal products of a Union Authorisation and eight opinions on classification of changes of biocidal products.

In other legislative tasks, we delivered four opinions on Occupational Exposure Limits (OELs) and updated the draft scientific dossier (Annex D POPS proposal) for Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5) and Dodecamethylcyclohexasiloxane (D6) based on new available information. We also conducted a screening exercise to identify substances that could meet the POP criteria, with the aim of identifying a new candidate for an EU proposal.

As we aim to enhance decision and policy making through optimal use of data, we initiated the implementation of our new data management approach and established a Data Governance Office to manage and oversee all our regulatory data. We also took measures, such as initiating a new Chemical Identifiers Management System to manage the inherent differences between regulatory contexts and prepare the Agency to onboard new tasks. Early in 2024, we launched the ECHA CHEM platform, which enables public access to critical chemical safety information.

6 Five additional entries were added in January 2025, bringing the current total to 247 entries.

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Annual Report 2024

The Integrated Regulatory Strategy, which was a cornerstone of our strategic efforts from 2019 to 2023 was reviewed, as was the Joint Evaluation Action Plan. These reviews were completed as we prepared for a new phase in future REACH evaluation and risk management activities. Key drivers for IRS in the future will be to maintain a good knowledge about the chemicals in our databases and shift the focus to delivering risk management outcomes for (groups of) substances. In 2024, we concluded the systematic screening of high production volume chemicals, marking the culmination of the previous five year’s IRS work. We successfully concluded the actions under the Joint Evaluation Action Plan and refocussed our efforts away from compliance checks to conclude follow-up of dossiers after draft decisions on compliance checks.

Strategic Goal - Respond to Emerging Challenges and Changes in Our Legal Landscape

In 2024, we demonstrated our agility in addressing emerging challenges and legislative changes. We continued the planning and implementation of new tasks that have arrived at the Agency in recent years, such as Batteries, Drinking Water Directive and Serious Cross Border Threats to Health. Preparations were carried out on relevant aspects such as technical, scientific and stakeholder engagement. In addition to ensuring the Agency is ready for these new tasks, we also must ensure that our scientific committees, Risk Assessment Committee (RAC) and Socio- Economic Analysis Committee (SEAC) are preparing. In the case of the Drinking Water Directive, a RAC Working Group has been established, and work is progressing on developing procedures for dealing with applications in the future. We commenced developments in our IT systems to be able to deal with future tasks under the DWD. In this context, we have agreed that IT development for the DWD will be the pilot for our future IT systems. In delivering these new tasks, we need to engage with many new stakeholders and throughout the year, we held several workshops and meetings with them.

In support of the Chemicals Strategy for Sustainability (CSS), we provided support and inputs to the Council, European Parliament and Commission in relation to the Commission legislative proposal on One Substance One Assessment (OSOA). This proposal will see several regulatory tasks be reattributed to ECHA as well as the introduction of a Common Data Platform, where the Agency will play a lead role. We developed, as required under the CSS and the mandate of the 8th Environmental Action Programme, an indicator framework for chemicals with EEA and the Commission and produced a joint synthesis report on this framework with EEA.

Strategic Goal - Communicate and Engage

Efforts to improve communication and engagement with stakeholders were central to our operations in 2024. A widely attended ECHA conference was organised, as well as a meeting of Member States' Heads of Chemicals Authorities. We launched a new External Communications Strategy and Stakeholder Engagement Approach to foster stronger relationships with Member States, industry, and stakeholders representing workers, the public and the environment. This includes clearer messaging on chemical risks, regulatory processes, and upcoming legislative changes. An action plan was agreed to step up our efforts to support SMEs and will be implemented over the next years. The number of followers across ECHA's social media channels continued to grow (by 21%, to over 130 000 in 2024), as well as our website visitors, growing by over a million in 2024 to almost 5.5 million.

We further strengthened our collaboration with peer agencies (EFSA, EMA, EEA and ECDC), including by conducting joint initiatives in scientific-technical areas and institutional engagement. We signed the One Health framework of action with these agencies and presented our work to the Environment Committee of the European Parliament. To further ensure consistency in our methodologies, we delivered jointly with EFSA a guidance on risk assessment on bees from the use of biocides, and cooperated with EFSA, EMA and ECDC on a report to address anti-fungal resistance, that was endorsed by the BPC. The IUCLID platform cooperation with EFSA on Plant Protection Products continued in 2024, with the agreement to start expanding IUCLID for Food Contact Materials.

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Annual Report 2024

Strategic Goal - Lead on Chemical Knowledge and Expertise

We continued our commitment on promoting New Approach Methodologies (NAMs) in 2024 through a range of measures. For example, we contracted a collaborative consortium of researchers to conduct scientific studies on the reliability and relevance of NAMs as alternatives to animal testing and to promote the use of such methods in the future. The contract will run for six years and has a total value of EUR 4.2 million in funding. These projects will investigate the application of omics in regulatory contexts to enhance read-across and grouping methodologies; explore potential alternatives to current aquatic toxicity testing involving the use of fish; and examine the use of in vitro toxicokinetics to support hazard assessment. We further strengthened our interactions with stakeholders and EU Agencies and worked closely with the European Commission to support development of a roadmap to phase out animal testing.

We proactively contributed to expanding scientific and technical competence and knowledge on chemical safety through our work in PARC (Partnership for the Assessment of Risks from Chemicals). A key achievement in relation to PARC has been the publication of our updated report on Key Areas of Regulatory Challenge, which provides details on research needs on chemical safety.

In support of the Commission’s international efforts, we participated in a wide range of OECD (Organisation for Economic Co-operation and Development) activities, ranging from development of non-animal methods to completing the development of the QSAR toolbox. We also supported the Commission in the UN Sub-Committee of Experts on the Globally Harmonised System for Classification and Labelling of Chemicals (GHS). We delivered support to pre- candidate countries and hosted several IPA countries in meetings and trainings in capacity building efforts on communication and enforcement.

Strategic goal - Invest in Our People and Organisational Excellence

We continued the focus on investing in our people and organisational development through implementing actions under our People and Organisational Strategy 2024-2028, our Wellbeing Action Plan and our Diversity and Inclusion Action Plan. At the end of 2024, our staffing plan was filled at 97.2%. A review of ECHA’s organisation was completed to take account of the new strategy and our expanding legal mandate. The recommendations, which addressed ways of working, strategic prioritisation and organisational structure will be addressed in 2025.

We initiated a pilot on optimising use of our office building and conference centre, to plan and test new ways of working. In 2024, we continued to successfully organise meeting services for approximately 400 events and official meetings, with 36 600 participants joining online and a further 5 300 visitors in person.

We effectively managed our financing through close monitoring of uncertain fee income development. On the final budget size of EUR 126.6 million, the Agency reached a 99.5% commitment rate and 87.0% payment rate, exceeding the targets set. The European Court of Auditors gave a clean audit opinion on ECHA's annual accounts for 2023.

The ongoing transformation of our IT infrastructure and data management systems further exemplifies our commitment to enhancing ECHA's organisational excellence. A five-year IT vision and plan was agreed and implementation commenced with the IT systems needed for the Drinking Water Directive, which will be the first to be considered under our new approach. As part of our continued efforts to improve and innovate, we have also established a horizontal working group on Artificial Intelligence (AI). This group has created guidelines for the safe use of AI, assessed several use cases and proposed several pilots, which will be commenced in 2025.

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Annual Report 2024

Current and future challenges

Notwithstanding all our achievements and successes in 2024, there are still areas where the Agency has challenges now and in the future.

The first such challenge is in relation to the sustainability and workability of our scientific committees, the RAC and SEAC. Although these committees have delivered significant levels of opinions in 2024, with the continued work required to meet existing tasks, such as concluding the PFAS dossier as well as prepare for new tasks under the DWD and harmonised classifications of new hazards (endocrine disruptors etc), they continue to be under pressure. Efforts have been taken by the secretariat and the Management Board to address workability. For example, this year, the MB agreed to increase the payments for REACH restriction rapporteur work in RAC and SEAC. Through active engagement with Member States throughout the year, there has been an increase in numbers of nominations, and we ended the year with 80% membership in RAC and 55% in SEAC. While this is welcomed, Member States are still asked to nominate the full number of experts to the committees. It is hoped that the Commission proposal for an ECHA Basic Regulation, which is planned for 2025, will introduce measures to address workability and sustainability of the committees. However, as such measures are unlikely to be in place for several years, interim measures will be needed if the committees are to meet new tasks on DWD from 2026 onwards. The Agency, together with the Commission and Member States, will continue to review the work of the Committees to ensure that it can meet its existing and future tasks.

The significant work on the PFAS dossier has also put pressure on our committees during 2024 and the Agency has taken steps to provide additional supports to the Rapporteurs and will continue to do so until the opinion making is concluded. We have also added additional resources in the Secretariat Ensuring the integrity of the opinion making process so that we can deliver a final opinion that is independent, transparent and of high-quality, was and will remain the Agency’s main focus.

Since 2019, the Agency has focussed on the compliance check process, which has meant that there are backlogs in other areas of dossier evaluation. With the conclusion of the Joint Evaluation Action Plan, the focus has now shifted to conclude follow-up of dossiers after draft decisions on compliance checks as well as examining testing proposals. With this change of focus, we aim to reduce the backlogs over the coming period. Support from the Commission, Member States and registrants will be important in helping us address this matter.

After a peak number of applications for authorisation in the past years, mainly for the use of hexavalent chromium substances, the number of applications significantly decreased in 2024, with 43 applications and review reports received (covering 57 uses). As the total number of applications received has been higher than the capacity of the scientific committees, they continue to work steadily to process the applications in their opinion making. In line with the Commission approach to address the high levels of authorisation applications for hexavalent chromium substances, ECHA progressed the development of a restriction proposal on hexavalent chromium, for which the assessment in the committees will start in 2025. However, until such time as a restriction proposal on these substances is agreed and enters info force, ECHA will have to continue to prioritise applications in line with the capacity of the committees.

We also continued delivering on our legal obligations under the Biocidal Products Regulation, however, the low number of completed assessment reports for biocidal active substances submitted by Member States continued. We remain committed to working together with the Member States and the Commission to address this issue with the Review Programme for existing active substances.

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Annual Report 2024

While every effort is being made to prepare in advance for implementing new tasks, challenges remain as resources for new tasks will usually only be made available to ECHA when the legislative proposal is finalised. As many of the new tasks, requires significant preparatory work from IT systems development to committee procedures to stakeholder guidance and support, the Agency has to complete its preparations in sometimes very short timeframes. Prioritisation of our preparatory work may have impacts on existing tasks, though the Agency will seek to keep such impacts to a minimum.

Finally, as the Agency mandate expands and as technology rapidly evolves, the Agency needs to ensure its IT and data management systems are modernised and user focussed. The development of the Agency’s long term IT vision and plan is a step in the right direction; however, it will require intense activity and resources over the coming period to ensure we are ready to meet new tasks such as Drinking Water as well as meet stakeholder expectations and demands. The Agency will use the organisational review recommendations to address these challenges where possible. However, to fully address all our challenges, ECHA will need inputs from external parties such as the Commission, Member States and stakeholders.

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Annual Report 2024

Part I. Achievements of the year

Dossier preparation7

Objective 1: Companies supported on inquiries and data sharing.

Main Outputs Execution Status

Inquiries and disputes on data sharing are handled in line with legal requirements and timelines.

We successfully handled inquiries and disputes over data sharing according to legal requirements and timelines, ensuring a smooth process for all parties involved. We managed a record number of inquiries, with a 14% increase compared to previous years, and ensured that the process ran smoothly. We also continued to support companies with the tools and guidance they need to successfully register and update their information.

Yes

Indicators Estimate Actual

Inquiries received and concluded 4 800 5491

Objective 2: Harmonised IT tools are available to support the transparent sharing of harmonised data between industry and regulatory authorities.

Main Outputs Execution Status

Promotion of IUCLID as the international harmonised format for chemical data continued.

We hosted, for the first time, a joint meeting with OECD on IUCLID and the eChemPortal. As more international authorities adopt IUCLID as the reference implementation of the OECD Harmonised Templates8 (OHTs), there is a greater need to monitor and review how IUCLID data is being exchanged and made available for publication. This joint meeting contributed to better understanding of how to best manage our data and tools globally (OECD) and take stock of the challenges faced internationally in exchanging and managing data.

Yes

IUCLID updated to incorporate existing, new and changing regulatory requirements.

We made important updates to the International Uniform Chemical Information Database (IUCLID) to meet new EU and international regulatory requirements. This

Yes

7 This section covers only REACH registration dossier preparation. The support to the preparation of other REACH and CLP dossiers are covered by the relevant sections. 8 https://www.oecd.org/en/topics/sub-issues/assessment-of-chemicals/harmonised- templates.html#:~:text=The%20OECD%20Harmonised%20Templates%20(OHTs)%20are

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Annual Report 2024

included new formats, validation, and filtering rules to make sure the database stays aligned with different regulatory needs.

IUCLID progressively updated to support the needs of OECD and international partners.

We updated IUCLID as required and also promoted it as the standard for chemical data worldwide.

Yes

Scientific contribution made to development of the OECD harmonised test guidelines relevant for the EU information requirements.

We contributed to development of the OECD test guideline programmes in key areas by actively participating in the expert group meetings and consultations.

Yes

Indicators

N/A

Dossier submission and processing Objective 1: Access to market for duty holders continues to be streamlined and predictable.

Main Outputs Execution Status

REACH registration dossiers (initial and updates) processed.

We ensured the timely processing of all dossiers submitted by industry under REACH and CLP. In 2024, we saw a significant increase in C&L notifications compared to the previous year, far exceeding our initial estimate. This surge was primarily driven by a few companies, submitting large volumes of notifications, and/or using system-to-system submission.

Yes

PPORD notifications processed, and data analysed to identify and monitor innovation and new chemicals trends.

PPORD notifications were monitored and analysed to track innovation trends and new chemical developments.

Yes

Completeness checks including manual verifications performed, invoices issued, and confidentiality requests assessed.

All submitted registrations were completeness checked, with one third undergoing manual checks. In 2024, fewer dossiers were submitted than expected, and the submitted data was more complete than in previous years. As a result, the actual number of registrations failing the first technical completeness check was significantly lower than estimated based on previous years, with 669 failures compared to the expected 1 300.

An appeal on a completeness check decision was dismissed, reinforcing ECHA’s implementation approach, which includes manual checks of part of the information.

Yes

Clear and timely feedback provided to companies on how to successfully

We updated the dossier preparation manuals and reviewed failure messages to further

Yes

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Annual Report 2024

complete their submissions. improve the support to companies that submit information to ECHA.

The verification of the size of SME companies which registered after the last registration deadline continued and the time lag between submission and beginning of the verification further reduced.

ECHA performed over 400 companies size verifications and reduced delays between submission and verification to further streamline the process. We also provided input to the European Commission to shift SME verification to an “ex-ante” approach, which will enhance process predictability and efficiency.

Yes

Tools and processes for invalidation of registrations developed further for different circumstances, such as the implementation of EU sanctions.

ECHA developed tools and procedures to address various invalidation scenarios, including invalidation of registrations and implementation of EU sanctions. For the revocation of non-existing companies and the invalidation process, we improved the process, gaining efficiency and ensuring consistency.

Yes

Preparations commenced, as necessary, for the adaptations stemming from the revision of the REACH Regulation.

The Commission’s work on revising the REACH Regulation is ongoing. ECHA anticipates a proposal for a revised Regulation in 2025 and will work closely with the Commission to provide input and support the development and implementation of the proposal.

No

Indicators Estimate Actual

Number of PPORD notifications received 240 238

Number of C&L notifications received 35 000 168990

Number of Registration dossiers received (incl. updates) 15 000 13 470

Number of SME companies verified for their status 400 408

Registrations stopped for manual verification at technical completeness check

5 100 4 206

Number of registrations failing first technical completeness check 1 300 669

Number of confidentiality assessments concluded 220 241

Number of revocations or invalidations concluded 150 126

Objective 2: Submission activities are user-focussed, streamlined and adaptable.

Main Outputs Execution Status

ECHA’s submission systems transformation plan commenced.

Progress was made on how to simplify the systems used by companies to submit their dossiers towards an Industry portal that will offer a single-entry point with increased user- friendliness and consistency. We initiated this transformation plan by focusing on drinking water submissions under DWD.

Yes

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Annual Report 2024

Indicators

N/A

Identification and prioritisation of substances and groups of substances Objective 1: Prioritisation of regulatory action on individual substance and/or groups of substances.

Main Outputs Execution Status

Workshop organised with the Member States and stakeholders to review the Integrated Regulatory Strategy and actions on the coordinated identification and prioritisation of substances and groups of substances identified.

We discussed and developed new objectives for the IRS in conjunction with the Commission and Member States to ensure that the approach meets current and future challenges. Key drivers for the IRS in the future include the need to maintain a good knowledge about the chemicals in our databases and shifting the focus to deliver risk management outcomes for (groups of) substances.

We also continued strengthening co-operation across regulatory frameworks and with sister agencies, especially EFSA and more recently EMA, as this is essential to support information sharing and consistency of regulatory outcomes. We explored synergies between collaboration platforms such as RIME+ and the ‘One substance, one assessment framework’.

Yes

Groups of substances identified for authorities to select for CLH and restriction processes.

We supported authorities in identifying (groups of) substances that require risk management through shortlisting (groups of) substances considered as good candidates for CLH, restriction, or other risk management options. CLH cases were short-listed and presented to Member States at the RiME+ meetings.

Yes

Results from the group assessment reports, on request of the Commission, used to update the restriction roadmap.

We identified candidates for the Restrictions Roadmap by screening assessment of regulatory needs (ARN) cases. These suggestions were submitted to the Commission, which incorporated the proposals into the updated Restrictions Roadmap.

Yes

Progress report on the Integrated Regulatory Strategy published.

In 2024, we concluded the systematic screening of high production volume chemicals, marking the culmination of a five- year effort to group and assess nearly all high- tonnage substances in our database.

We published the final IRS report, which takes

Yes

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Annual Report 2024

stock of the progress achieved over the last five years and outlines future plans.

Indicators Estimate Actual

Number of groups of substances for which a preliminary conclusion on potential regulatory follow up was drawn or further clarified

40 47

Evaluation9 Objective 1: Dossier evaluation is efficient, transparent and scientifically and legally robust.

Main Outputs Execution Status

Follow-up actions to the 2023 review of Joint Evaluation Action Plan completed. A proposal for a new approach to compliance check developed.

In 2024, we successfully concluded the Joint Evaluation Action Plan (JEAP), which aimed to ensure compliance of registration dossiers and reviewed the outcomes together with the Commission, Member States and stakeholders.

Yes

Evaluation targets and indicators delivered.

The 2024 annual evaluation targets were met. Collaborative efforts with Member States showed strong alignment, with less than 10% of draft decisions discussed by the Member State Committee (following proposals for amendment by Member States). This enabled a high throughput of cases.

Yes

Testing proposals examined within the legal deadlines.

In 2024, testing proposals were not consistently examined within the legal deadlines, which apply only to non-phase-in substances. This was due to prioritising decisions with a backlog in follow up and testing proposal evaluations - a focus, which will persist in the coming years. While significant efforts were made to address pending evaluations and follow-up actions, the focus on backlog reduction meant that some testing proposals were not processed within the expected timelines.

To identify challenges in the process, we performed an audit, which provides insight on the issues and resulted in several recommendations, which will be addressed in 2025. The findings and recommendations will be shared with the Commission and further analysed to ensure improvements are implemented effectively.

No

9 Title VI of Regulation (EC) No 1907/2006

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Annual Report 2024

Information submitted in response to ECHA evaluation decisions examined without delay and conclusions communicated to the Commission and Member State competent authorities.

Follow-up actions were conducted to verify that any updated information provided in response to evaluation decisions addressed the requested requirements.

Yes

National enforcement authorities informed in case of non-compliance with the decision and follow-up decisions drafted where appropriate.

We kept national enforcement authorities informed in cases of non-compliance with decisions, and drafted follow-up decisions where appropriate.

Yes

Updated recommendations to registrants stemming from evaluation published and communicated.

We published regular updates to the website and communicated recommendations directly to registrants as needed.

Yes

Support to the Commission provided in relation to the CSS and the REACH revision (Evaluation and the annexes on information requirements).

The Commission’s work on revising the REACH Regulation is ongoing. ECHA anticipates a proposal for a revised Regulation in 2025 and will work closely with the Commission to provide input and support the development and implementation of the proposal.

No

Targeted study audits requested in case a concern about compliance with principles of Good Laboratory Practice is identified by ECHA or a Member State.

We requested two GLP study audits based on concern and three GLP study audits based on random selection.

Yes

Regulatory advice provided to registrants and other interested parties on information requirements and on dossier and substance evaluation processes.

We provided regulatory advice to registrants and other interested parties on information requirements and the evaluation processes for dossiers and substances through guidance, helpdesk and direct interactions with registrants.

Yes

Indicators Estimate Actual

Compliance checks concluded: draft decisions or no action 250 251

Final decisions on dossier evaluation (testing proposals and compliance checks)

250 300

Number of substances for which a conclusion was reached in the follow-up to dossier evaluation

250 219

Objective 2: Substance Evaluation by Member States becomes more efficient and effective.

Main Outputs Execution Status

Updates of the CoRAP proposed to the MSC for substances where substance evaluation is the most appropriate tool to generate further hazard information.

The CoRAP list was updated with 25 substances for evaluation by 12 Member States, and during the year conclusions were reached for 19 substances.

Yes

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Annual Report 2024

Member States advised and supported in achieving substance evaluation conclusions as fast as possible.

We provided continuous support to evaluating MSCAs on their open substance evaluation cases. Based on eMSCAs' feedback, MSCAs expressed high level of appreciation with this support.

Yes

The appropriate regulatory risk management measures and initiatives adopted by Member States.

An initial analysis of follow-up regulatory risk management measures and initiatives proposed by eMSCAs as an outcome of substance evaluation has been conducted and will be communicated to ECHA stakeholders in 2025. Evaluations during the year led to key regulatory actions, including harmonised classification and labelling, identification of substances of very high concern (SVHC), and restrictions.

Yes

Number of substance evaluation cases currently opened reduced further.

10 new evaluation cases were opened while 19 substances evaluation cases were concluded. This led to a c.a. 10% decrease in the number of open SEV cases in 2024. Eight substance evaluation decisions (six draft decisions and three final decisions) were issued, requesting data to address concerns regarding endocrine disruption, PBT/vPvB, or mutagenicity. The number of final decisions was lower than anticipated, reflecting the gap between the original ambition of ECHA and Member State authorities, and the complexities emerging at the time of implementation.

Yes

Indicators Estimate Actual

Substance evaluation final decisions issued 10 3

Number of substances for which a conclusion was reached in substance evaluation

25 19

Authorisation10 Objective 1: Substances of very high concern identified, controlled and progressively replaced.

Main Outputs Execution Status

Substances of very high concern identified and included in the Candidate List.

Two entries were added to the Candidate List, bringing the total in 2024 to 242 entries. These substances were found to have either very persistent and very bioaccumulative properties, or were shown to be persistent, bioaccumulative and toxic, or displayed negative effects on reproduction, or had

Yes

10 Title VII of Regulation (EC) No 1907/2006

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Annual Report 2024

endocrine disrupting properties for the environment. In addition, an existing entry was updated to reflect that it is an endocrine disruptor to the environment based both on its intrinsic properties and when it contains an impurity at ≥ 0.1% w/w. The total number of new entries was lower than the initial estimate, reflecting the gap between the intentions communicated by the dossier submitters, and the ability to implement the dossiers, through the drafting and decision- making phase, in time.

Applications for authorisation processed and progressed in line with agreed approach.

After a peak number of applications for authorisation in the past years, mainly for the use of hexavalent chromium substances, the number of applications significantly decreased in 2024, with 43 applications and review reports received (covering 57 uses). As the total number of applications received has been higher than the capacity of the scientific committees, they continue to work steadily to process the applications in their opinion making (see objective 2 below).

In 2024, the actual number of downstream user notifications of authorised uses of SVHCs provided by companies was lower than estimated (766 actual compared to 3000 estimated). Estimating a figure for such notifications is very difficult in any given year, hence the discrepancy.

Yes

Indicators Estimate Actual

Number of new entries in the Candidate List 15 211

Applications and review reports for authorisation received (number of uses)

40-60 57

Number of downstream user notifications of authorised uses of SVHCs 3 000 766

Objective 2: Opinions of the Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) are timely and fit-for purpose.

Main Outputs Execution Status

Opinions on applications for authorisation delivered to Commission.

The scientific Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) delivered opinions on applications for authorisation of 55 uses of substances.

Yes

11 See respective output above.

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Annual Report 2024

Participation in workshops and network meetings facilitated as necessary, to develop methodologies and enhance the capacity of Member States and companies to carry out analysis of alternatives and socio-economic analysis with view of finding viable alternatives.

We actively participated in key networks and meetings such as the Network of REACH SEA and Analysis of Alternatives Practitioners (NeRSAP), the OECD Working Party on Risk Management and related workshop on safer alternatives, as well as various environmental and human health economists networks. In support to substitution, we focused on maintaining ECHA's dedicated webpages, including its online training module, and in following the developments of the Commission’s substitution-related studies.

Yes

Indicators Estimate Actual

Number of RAC and SEAC opinions adopted on applications for authorisation (number of uses)

40 55

Restrictions12 Objective 1: Commission supported in the implementation of the Restrictions Roadmap.

Main Outputs Execution Status

Annex XV dossiers proposing restrictions and/or investigations developed for 2-3 substances or groups of substances from the restriction roadmap at the request of the Commission.

The requested investigation report on Aromatic Brominated Flame-retardants, covering 60 substances, was finalised and published. The restriction dossier on chromium (VI) substances, originally due to be completed in 2024, was delayed as the Commission requested ECHA to expand the scope and therefore the timeline for the submission of this dossier was postponed to April 2025.

No

Screening reports for 2-3 substances under Article 69(2) prepared.

We delivered 4 screening reports, analysing whether there is a need for restricting the use in articles for substances subject to authorisation (Art.69.2).

Yes

Indicators Estimate Actual

Restriction proposals or investigation/screening reports developed 5 5

12 Title VIII of Regulation (EC) No 1907/2006

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Annual Report 2024

Objective 2: Opinions of the Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) are timely, robust and fit-for-purpose.

Main Outputs Execution Status

Robust opinions on restrictions delivered to the Commission.

The opinion of the scientific committees (RAC and SEAC) on the restriction dossier for creosote was delivered to the European Commission.

The committees made progress in evaluating the PFAS restriction dossier that was submitted by five countries in 2023. They arrived at provisional conclusions on hazards and on eight sectors and uses of PFAS and will continue the evaluation in 2025 based on the work of the dossier submitters.

Yes

Methodologies related to socio- economic analysis developed and explained to create a fit-for-purpose toolbox, including the valuation of various health and environmental endpoints in collaboration with the OECD and in line with the Commission’s Better Regulation guidelines.

We maintained our involvement in methodological development-related activities, including the valuation of five human health-related endpoints (hypothyroidism, hypertension, non-fatal cancer, skin sensitisation, and miscarriage) under the OECD SWACHE project. We also actively contributed to the first steps of a similar project for environmental endpoints (OECD SACRE).

Yes

Indicators Estimate Actual

Number of RAC and SEAC opinions on restriction proposals 1 1

Objective 3: Commission supported in their decision-making tasks.

Main Outputs Execution Status

Case-specific support provided to Commission in the decision-making phase of the restriction process.

At the request of the Commission, we provided support in the decision-making phase related to four restriction proposals: PFAS in fire-fighting foams, PAH in clay targets, skin sensitisers and lead in shooting and fishing.

Yes

General and specific guidance to aid the implementation of Annex XVII restriction entries (e.g., Formaldehyde) delivered to the Commission.

The guideline on the Formaldehyde restriction was developed in 2024 as mandated by the Commission. Incorporation of the Commission's suggestions was ongoing at year end. The guideline is expected to be submitted to the Commission in the first quarter of 2025 and subsequently published on the ECHA website.

No

General and specific technical support to aid the implementation of Annex XVII restriction entries (e.g., microplastics), delivered to the

We supported the Commission in developing guidance on the microplastics restriction and in developing a microplastics reporting system as part of the implementation of that

Yes

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Annual Report 2024

Commission. restriction. A proposal for implementing these requirements was agreed with the Commission and will be made available in 2025.

Indicators Estimate Actual

Number of cases in decision making where support is provided 4 4

Number of reports 1 0

Number of Annex XVII entries where implementation support is provided

1 1

Classification and labelling13 Objective 1: Opinions of the Committee for Risk Assessment (RAC) are timely and fit-for purpose.

Main Outputs Execution Status

CLH dossiers, including individual and groups of industrial chemicals from the outcome of identification and prioritisation processed in line with legal requirements.

60 dossiers with proposals for harmonised classification were received and 56 opinions on harmonised classification by RAC were adopted.

Yes

All harmonised PPP and biocides dossiers processed in line with legal requirements.

All harmonised PPP and biocides dossiers were processed within the legal deadlines.

Yes

Joint Commission, EFSA and ECHA efforts to encourage the timely submission of PPP and biocide dossiers completed.

Alignment on this objective was not prioritised for completion.

No

Indicators Estimate Actual

Proposals for harmonised classification and labelling 50 60

Number of RAC opinions on proposals for harmonised classification and labelling

50 56

Objective 2: Member States, Commission services and duty holders supported to fulfil their legal obligations.

Main Outputs Execution Status

Guidance made available and updated as necessary.

We continued supporting the European Commission in the review of the CLP Regulation, which was published in late 2024. Guidance and support on CLP were updated to

Yes

13 Regulation (EC) 1272/2008

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Annual Report 2024

include the new hazard classes. This was a significant collaborative achievement delivered under tight deadlines by experts from ECHA, EU Member States, EU level non- governmental organisations and others, with input from an extensive stakeholder consultation.

Decisions made on requests to use an alternative chemical name in line with legal requirements.

We received 20 requests to use an alternative chemical name, a lower number compared to previous years. All requests were processed in accordance with legal requirements.

Yes

Scientific and technical support provided to the Commission in the context of the further development of the United Nations Globally Harmonised System of classification and labelling of chemicals (UNGHS), and in particular including advice on:

• the new hazard classes and criteria for endocrine disruptors; PBT, vPvB, PMT, vPvM; neurotoxicity and immunotoxicity; terrestrial toxicity in GHS.

• the implementation of revisions 8, 9 and 10 of UNGHS.

• the work of selected GHS working groups, notably the working group on the use of non-animal testing methods for classification.

We provided regular support to the Commission in the context of the United Nations’ Globally Harmonised System of classification and labelling of chemicals (UN GHS).

Yes

Scientific and technical support provided to the Commission in the implementation of the revisions of the CLP regulation and the UNEP GHS project in African countries.

We provided support to the Commission in the implementation of the revisions of the CLP regulation and the UNEP GHS project in African countries.

Yes

Indicators Estimate Actual

Decisions made on requests to use an alternative chemical name (Art 24 CLP)

40 20

Objective 3: Up-to-date information on the classifications for chemicals, both harmonised and non-harmonised, publicly available.

Main Outputs Execution Status

First version of the new C&L inventory launched as part of ECHA’s new public data availability

The delays in setting up the new public cloud IT environments and infrastructure resulted in the launch of the C&L inventory being

No

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Annual Report 2024

system. The new version will take into account the changes in the revised CLP regulation.

postponed from November 2024 to Q2 2025.

Tools and support materials were updated to take account of the review of the CLP Regulation.

Indicators

N/A

Objective 4: Structured, high quality and consistent information for the EU poison centre scheme is timely available across Europe.

Main Outputs Execution Status

Notification portal and system-to- system submission channel maintained and adapted to meet the requirements stemming from the revision of the CLP Regulation and changes with IUCLID.

We maintained and successfully adapted the notification portal and system-to-system submission channel to meet the requirements stemming from the revision of the CLP Regulation and changes with IUCLID.

Yes

Actions to address issues with misuse of UFIs identified and delivered in conjunction with MS Competent and Enforcement Authorities.

We began addressing the misuse of UFIs and finalised an information package aimed at helping companies avoid misuse which will be published in 2025. Additional input from Member States and Appointed Bodies on UFI misuse was sought for further investigation.

No

PCN activities promoted and support provided to companies and Member States following the entry into force of the notification obligation for mixtures with industrial uses of 1 January 2024 and in view of the end of the transition period on 1 January 2025, as well as with regard to adaptations stemming from the revision of the CLP Regulation.

We provided ongoing support to companies and Member States following the entry into force of the notification obligation for mixtures with industrial uses. Appointed Bodies and Poison Centres regularly used the PCN central database to perform their duties under Article 45, Annex VIII. The number of poison centre notifications viewed by national authorities in the PCN central database exceeded our estimate, with 22,775 views compared to the anticipated 15,000.

Yes

Indicators Estimate Actual

Poison centre notifications received and made available to Appointed Bodies and Poison Centres

2 to 3 million

3 148 898

Poison centre notifications viewed by national authorities in the PCN central database

15 000 22 775

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Annual Report 2024

Objective 5: ECHA advice, processes and tools, resulting from the revision of CLP, updated and communicated.

Main Outputs Execution Status

Guidance and support on CLP updated to include the new hazard classes.

Guidance and support on CLP were updated to include the new hazard classes and published by year end.

Yes

Guidance to support CLH for groups of substances.

We continued assisting Member States in developing dossiers for Harmonised Classification for 10 groups of substances that originated from the chemical universe screening. This included ad-hoc support requested by three Member States and preparing a shortlist of seven group CLH candidates presented to the RiME+ meeting.

Yes

Support mechanisms for Member States in the preparation of CLH dossiers including for the new hazard classes established, including the clarification how the PBT and ED expert groups can support the work.

We provided advice to various relevant fora on the role of the Expert Groups and how to receive support.

Yes

Data submission formats and tools adapted to the requirements of the revised CLP regulation.

We successfully adapted data submission formats and tools to the requirements of the revised CLP regulation.

Yes

Indicators

N/A

Data management and dissemination Objective 1: Regulatory processes performed by relevant actors based on robust data and IT systems.

Main Outputs Execution Status

Data governance to support regulatory data consistency, coherence, transparency and reporting across regulations consolidated.

We initiated the implementation of our new data management approach and established a Data Governance Office responsible for managing our regulatory data. This work will continue and will be further shaped to support regulatory data consistency, coherence and transparency.

Yes

Interact Portal (including ACT) maintained with due consideration of process and users’ requirements.

We maintained and further developed the Interact Portal, including ACT, which introduced enhanced functionalities were introduced such as a tracking list for ACT and email notifications.

Yes

Case management capabilities further developed to onboard new

First versions of the core case management modules (task, process, case, and portal)

Yes

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Annual Report 2024

tasks and increase efficiency of existing regulatory processes.

were set up. These modules will be used in the delivery of the IT solution to support the Drinking Water Directive process as part of our IT Transformation. These and then they will be further applied in other regulatory processes in the future.

Chemical identifiers data management reviewed to increase its efficiency and effectiveness.

We initiated implementation of a new Chemicals Identifiers Management System to manage the inherent differences between regulatory contexts and prepare the Agency to onboard new tasks.

Yes

Tools to search, extract and analyse data maintained and accessible to authorities and industry.

We maintained and made accessible to authorities and industry tools to search, extract, and analyse data.

Yes

Data analysis services completed upon request from EU institutions or Member States.

Our data services supported the Commission and Member States on scientific data analysis. This included assisting the Commission with the revision of the EU UWWT (Urban Wastewater Treatment Directive 91/271/EEC); providing information on substances in electronic devices to support Member States regulatory work; supporting the preparation of ECHA investigation report on aromatic brominated flame retardants, which will aid the Commission in deciding on the scope and need for further regulatory action.

Yes

Indicators Estimate Actual

Number of data provision and analysis requests 70 61

Objective 2: Transparent and public access to data submitted under different regulations as well as progress on regulatory activities made available.

Main Outputs Execution Status

First version of ECHA’s new public data availability system launched, including hazard, use and classification data from registration dossiers.

The first version of the new system for making information on chemicals publicly available, ECHA CHEM, went live in Q1 2024, covering information from registration dossiers.

Yes

New solution for dissemination of regulatory data integrated into ECHA’s new data availability system.

Further extension of the scope of ECHA CHEM had to be postponed to 2025, due to delays encountered with the set-up of the new cloud- based IT infrastructure and the need to address an unforeseen IT incident affecting the publication of information from registration dossiers.

No

OECD Global Portal to Information on Chemical Substances (eChemPortal) maintained and

The OECD eChemPortal was maintained as planned, but the data refresh to ECHA’s dissemination website was not completed due

No

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Annual Report 2024

synchronised with ECHA’s dissemination website.

to the transition to ECHA CHEM, the new ECHA dissemination website. The refresh will be aligned with the new system going forward.

Indicators

N/A

Promotion of alternatives to animal testing Objective 1: Industry generates hazard data using non-animal testing methods and new approaches.

Main Outputs Execution Status

Development of the QSAR toolbox to integrate new information (for example, metabolites, biocides or data from pharmaceuticals) and models further developed.

Two versions of the QSAR Toolbox were released in 2024. Key achievements include the full implementation of Meta Map, compatibility with the latest IUCLID version, and the integration of new databases.

Yes

Data available for download (REACH studies results and pharmaceutical industry data contribution) expanded to be used for NAMs development and/or avoiding unnecessary animal testing.

This output was not achieved due to the change in technology for the dissemination of registration dossiers, transitioning to the new ECHA CHEM platform. As a result, no updates were made in 2024.

No

Predictive models to support prioritisation and scientific decision making further implemented.

Due to budget constraints, further deployment of modules could not be achieved.

No

Application of the OECD QSAR Assessment Framework supported.

We provided all necessary support for the application of the OECD QSAR Assessment Framework.

Yes

Indicators

N/A

Objective 2: ECHA information and advice on alternatives to animal testing provided to policy makers and stakeholders.

Main Outputs Execution Status

OECD activities related to further development of alternatives and integration of regulatory relevant alternatives in test guidelines supported.

We finalised drafting the OECD Guidance for Omics Sampling.

Yes

Development of high throughput NAMs in cooperation with ECHA’s

We also rolled out our own projects to reduce reliance on animal testing while maintaining

Yes

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Annual Report 2024

international partners progressed. protection of human health and environment. For example, we contracted a collaborative consortium of researchers to conduct scientific studies on the reliability and relevance of New Approach Methodologies (NAMs) as alternatives to animal testing and to promote the use of such methods in the future. The contract will run for six years and has a total value of EUR 4.2 million in funding. These projects will investigate the application of omics in regulatory contexts to enhance read- across and grouping methodologies; explore potential alternatives to current aquatic toxicity testing involving the use of fish; and examine the use of in vitro toxicokinetics to support hazard assessment.

We also supported a case study under the Risk Hunter research consortia. The case study aimed at classifying substances as toxic (STOT RE classification) or non-toxic (NOAEL ≥ 1000 mg/kg bw) using bio-spider sequencing.

International collaboration towards the identification and acceptance of alternatives in regulatory frameworks (e.g., with US and Canada within the APCRA initiative (Accelerating the Pace of Chemical Risk Assessment)) maintained.

We invested in international activities, particularly Accelerating the Pace of Chemical Risk Assessment (APCRA), Partnership for the Assessment of Risks from Chemicals (PARC) and Organisation for Economic Co-operation and Development (OECD) activities and finalised a number of case studies with them. For example, a case study for systemic toxicity, characterisation of the uncertainty for high throughput toxicokinetic, and analysis of the toxicological concordance between animal and human data.

We worked closely with the European Commission to support development of a roadmap to phase out animal testing.

Yes

Indicators

N/A

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Annual Report 2024

Biocides14 Objective 1: Active substance and Union authorisation opinions are timely and of high quality.

Main Outputs Execution Status

Opinions on the approval and renewals of active substances and on Union authorisation of biocidal products prepared.

We finalised 15 opinions on active substances and one opinion on a review of the approval of an active substance. The overall progress of the active substances Review Programme is now at 50%. We delivered 17 opinions on Union authorisations as well as 8 opinions following Art. 75(1)(g) requests from the Commission.

Yes

Opinions on Union authorisation of same biocidal products and on administrative changes of the Union authorisations prepared.

We delivered 15 opinions on Union authorisations of same biocidal products, as well as 20 opinions on administrative changes of Union authorisations.

Yes

Opinions on minor changes and major changes of the Union authorisations prepared.

We delivered four opinions on minor changes of Union Authorisations, and one opinion on a major change of a Union Authorisation. Additionally, we finalised eight opinions on classification of changes of biocidal products.

Yes

Cooperation with EFSA further advanced to implement the basis and mechanisms for alignment of evaluation of common substances (one substance, one assessment).

We continued to collaborate with other agencies. With EFSA we developed consistent guidance documents, such as on risk assessment for pollinators.

We also cooperated with EFSA, EMA and ECDC, on a report to address anti-fungal resistance (Aspergillus) that was endorsed by BPC.

Yes

List of frequently used sentences in the SPCs updated and translated in all the EU official languages.

The list of frequently used sentences in the SPCs is updated every two years. It was updated and translated into all EU official languages in 2023. It will be updated again in 2025.

Yes

Assessments of applications for technical equivalence, inclusion in the Article 95 BPR list and classification for of changes performed.

Decisions on technical equivalence (32) and inclusion in Art. 95 list remained a sustained output, as in previous years, contributing to the total amount of work involved in implementing the Biocidal Products Regulation.

Yes

Indicators Estimate Actual

Number of opinions on active substances [approval & renewal] 15 15

Number of opinions on Union authorisation of biocidal products 20 17

Number of opinions on Union authorisation and related processes: 35 40

14 Regulation (EU) No 528/2012

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Annual Report 2024

same biocidal products, administrative, minor and major changes.

Number of technical equivalence application assessments 30 32

Objective 2: Member States and Commission supported to facilitate biocides processes and accelerate the Review Programme.

Main Outputs Execution Status

Regulatory, procedural and technical support provided to the competent authorities of the Member States (MSCAs) in the evaluation and BPC opinion forming on the approval of active substances, including also on measures defined in connection with the prolongation of the Review Programme, and on Union authorisation of biocidal products.

We provided regulatory, procedural and technical support to MCSAs. We also took additional steps to improve the implementation of the Biocidal Products Regulation, for instance, by improving the part of BPC opinions on analysis of alternatives and exclusion derogation criteria, improving the consultation practice for analysis of alternatives and inclusion of derogation criteria.

We provided secretariat support to the Coordination Group, assisting Member States in resolving disagreements during mutual recognition of biocidal products authorisations and in reaching agreements on horizontal topics to prevent future disagreements.

We further improved working procedures, such as the active substance renewal procedures, as well as on the renewal of Union authorisations (working procedure, SPC linguistic review, criteria for full evaluation, guidelines for submission of applications). A recommended approach to address in situ active substances was endorsed by the Commission and Member States.

Yes

Contribution made to MSCAs capacity building by providing training and scientific-technical advice, including also on endocrine- disrupting substances and analysis of alternatives.

We organised information sessions and a campaign for direct support to Member States in requesting endocrine disruptors (ED) data for all pending cases by June 2024. This is a prerequisite to obtain all necessary ED data by the end of 2026 and conclude the evaluation accordingly.

In the annual survey, the EU biocides authorities expressed a very high level of satisfaction with the work of ECHA, increasing from 84% to 95%.

Yes

BPC opinions requested by the Commission pursuant to Articles 38, 15(2) and 75(1)(g) of the BPR prepared.

We delivered 10 opinions following requests from the Commission according to Articles 15, 38 and 75(1)(g).

Yes

Guidance developed and maintained aiming for alignment as far as EU Regulations allow.

Several guidance documents were developed or updated including the guidance on risk assessment for pollinators; practical guide for letters of access; update of efficacy guidance;

Yes

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Annual Report 2024

guidance to reduce exposure of cats to pyrethroids; endorsement of approach to address in situ substances.

Support to the development of an easily accessible and structured overview of ECHA guidance documents and relevant policy documents provided.

We delivered a solution to easily identify and access relevant documents.

Yes

Indicators Estimate Actual

Satisfaction of authority actors Positive trend 95 %

Number of opinions on Article 15, Article 38 and Article 75(1)(g) requests

10 10

Objective 3: Biocides IT tools integrated with other ECHA regulatory IT systems.

Main Outputs Execution Status

Specialised Biocides IT tools integrated with ECHA IT systems.

We adapted IUCLID to integrate the preparation of the summaries of biocidal product characteristics (SPCs). The previous ‘SPC Editor’ was discontinued.

Yes

Development continued for the Register for Biocidal Products (R4BP 3) and other IT support tools (e.g., Chesar platform).

R4BP 3 was maintained and improved through two major releases. Progress was made in aligning it further with ECHA target modular architecture. We continued collecting user information and exchanging through the BPR IT user group.

Yes

Transition of evaluation dossiers into IUCLID format for active substances and Union authorisation cases initiated.

We made good progress in developing the first set of IUCLID quality rules for applications of active substance approval.

Yes

Indicators

N/A

Contribution to EU Environmental policy Objective 1: international trade of chemicals listed under the Rotterdam Convention and the PIC regulation facilitated and managed.

Main Outputs Execution Status

Received export notifications processed.

We received 10,448 export notifications and successfully processed all of them.

Yes

Support provided to EU MS DNAs and the Commission, including the management of explicit consent

We provided support to EU MS DNAs and the Commission, including the management of explicit consent requests, to allow companies

Yes

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Annual Report 2024

requests, to allow companies to export these chemicals in accordance with the EU’s international commitments.

to export these chemicals in accordance with the EU’s international commitments.

Support to companies (via the helpdesk) and non-EU Authorities provided.

Support was provided as requested. Yes

Fifth biannual report on the exchange of information under the PIC Regulation (Art. 20) published.

The report was published in October 2024. Yes

Annual report on PIC exports and imports (Art. 10) published.

The annual report published, showed that EU chemical exports under PIC remained at similar levels to previous years.

Yes

Support provided to the Commission with the EU contribution to the Rotterdam Convention implementation.

We provided support to the Commission with the EU contribution to the Rotterdam Convention Implementation.

Yes

Support provided to the Commission in the continuous improvement of the efficient implementation of the PIC Regulation, including any follow- ups to ECHA’s third “report on the implementation of the PIC Regulation”, and providing input to the Commission in the evaluation and follow-up of the PIC Regulation.

We continued providing support to the Commission on improving the efficient implementation of the PIC Regulation, including follow-ups to ECHA’s third report on its implementation. We also contributed input to the Commission for the evaluation and follow-up of the regulation.

Yes

Indicators Estimate Actual

Export notifications processed 11 000 10 448

Share of notifications validated by ECHA 90 % 94 %

Support provided to PIC duty holders (importers and exporters) 250 253

Objective 2: European Commission supported in the implementation of the Stockholm Convention and the POP Regulation.

Main outputs Execution Status

Scientific dossiers drafted for a new EU proposal to list a potential POP substance under the Stockholm Convention on Persistent Organic Pollutants.

We updated the draft scientific dossier (Annex D proposal) for Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5) and Dodecamethylcyclohexasiloxane (D6) based on new available information. At the European Commission’s request, we conducted a screening exercise to identify substances that could meet the POP criteria, with the aim of identifying a new candidate for an EU proposal. We presented the screening results at the POP Competent Authorities Expert Group meeting in November 2024.

Yes

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Annual Report 2024

Technical and scientific support provided as required to the Commission for the listing process.

Under the EU Persistent Organic Pollutants (POPs) Regulation, we provided technical and scientific support to the Commission for discussions at the 20th meeting of the POPs Review Committee (POPRC-20). We actively participated in discussions related to the addendum for the risk management evaluations of Medium-chain Chlorinated Paraffins (MCCPs), chlorpyrifos and long-chain PFCAs. All substances (MCCPs, chlorpyrifos and long-chain PFCAs) were recommended for listing under Annex A of the Stockholm Convention, with specific exemptions. The Committee also agreed that polybrominated dibenzo-p-dioxins and dibenzofurans and mixed polybrominated/chlorinated dibenzo-p- dioxins and dibenzofurans met the screening criteria in Annex D to the Convention.

Yes

The reporting system for the implementation of the POP regulation maintained and the Union Overview report based on the Member States reports updated. These outputs will be delivered in line with resource constraints.

The Union Overview report was updated in February 2024.

Yes

Indicators Estimate Actual

Number of scientific dossiers drafted for the identification of new substances as Persistent Organic Pollutants

1 1

Support provided to various stakeholders 50 70

Scientific and technical support provided to the Commission, EU and non-EU CAs

10 35

Objective 3: Substances of very high Concern In Products (SCIP) database maintained.

Main outputs Execution Status

Notification portal and the public SCIP database maintained.

We successfully maintained the Notification portal and the public SCIP database, ensuring continuous operation and accessibility throughout the year.

Yes

Support provided to EU suppliers of articles to submit the required information to ECHA.

We provided ongoing support to EU suppliers of articles, assisting them in submitting the required information to ECHA in a timely and efficient manner.

Yes

Indicators Estimate Actual

Successful SCIP notifications received (incl. updates) 8-12 million 12 257 502

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Annual Report 2024

Objective 4: Implementation plan for ECHA’s role under of Article 11 of the revised Drinking Water Directive in place.

Main outputs Execution Status

Technical and scientific support to the Commission provided on drafting and adopting the Implementing and Delegated acts.

We continued our preparatory work to ensure readiness of the entry into operation of the directive’s provisions relevant for ECHA’s role. We prepared scientific guidance for the potential applicants and held a webinar on the new obligations under the directive.

Yes

Internal operational procedures and working instructions for handling the applications to be submitted from 2025 onwards established.

We continued to work on setting up the process and the IT tools needed to ensure smooth and timely handling of notifications and applications as well as delivery of the opinions under Art. 11 of the directive. The implementation of the provisions for notification and application systems have been delayed by one year by the legislator.

Accordingly, the implementation of the related tools and procedures have been slightly deprioritised during 2024. This work will continue in 2025.

No

Procedures for opinion forming by RAC and the Working Group developed and implemented.

No

IT tools for the reception, processing and dissemination of applications, including the adaptation of IUCLID to the specific needs of the DWD process, developed and implemented.

No

Objective 5: an accessible and transparent evidence base to support the monitoring, measuring and reporting on chemicals.

Main outputs Execution Status

Relevant indicators developed that are based on accessible and transparent evidence and enable the monitoring, measuring and reporting on chemicals.

ECHA indicators and signals were developed in time for publication in the dashboard

Yes

Public version of the indicator framework prepared and published jointly with EEA and the Commission.

Under the 8th Environmental Action Programme (EAP), we developed the indicator framework jointly between Commission, ECHA and EEA. The final framework was published on the EEA website.

Yes

Joint synthesis report, offering policy-relevant messaging on the trends observed in the chemicals indicators prepared.

The joint synthesis report was prepared and published on the EEA website together with the framework in April 2024.

Yes

Objective 6: implementation of the Batteries Regulation.

Main outputs Execution Status

First part of the study completed, detailing the identification and engagement with all main batteries’ stakeholders, including waste

As 2024 was the first year of implementation of the ECHA tasks under the Batteries Regulation, the first phase of the scoping study was only launched and is expected to be

No

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Annual Report 2024

batteries, the investigation on the possibility to amend current restrictions (under ELV Directive) for Mercury, Cadmium and Lead in batteries in Annex I of the Batteries regulation and the foundation for the second part of the scoping study.

concluded in Q2 2025.

In preparation for this new task, the multi- annual work plan for implementing the batteries regulation at ECHA (implementation plan) was approved.

The first phase of the scoping study was launched in 2024 and is expected to be concluded in Q2 2025.

Workshop with all relevant stakeholders organised and follow- up actions implemented as necessary.

Two workshops were organised with relevant stakeholders in April and October 2024. The follow-up actions were fed into the scoping study development and onboarding of batteries restrictions work at ECHA.

Yes

Objective 7: preparation for the implementation of the Water Framework, Groundwater and Environmental Quality Standards (EQS) Directives.

Main outputs Execution Status

Technical and scientific support provided to the Commission in assessing changes proposed by Council and EP and any new drafts prepared.

In addition to support provided to the Commission on request, we set up cooperation with Commission, EEA and JRC to ensure smooth hand over of tasks, as well as following as observers some of the working group meetings of the Commission with relevant stakeholders.

Yes

Setup of internal operational procedures and working instructions for implementation of the tasks established.

The legislative process was delayed in 2024 and therefore the readiness for entry into operation on ECHA side was delayed accordingly. The focus in 2024 was on developing further understanding of the tasks, to identify the necessary expertise needed within the secretariat and in the RAC/SEAC committees.

No

Objective 8: further development of Best Available Techniques Reference (BREF) documents under the Industrial Emissions Directive supported.

Main outputs Execution Status

Expert and relevant input on chemicals provided to the JRC and IED Forum provided.

ECHA received a formal role in 2024 under the Industrial Emissions Directive. We supported the initiation of a new Best Available Techniques (BAT) reference documents (BREF) on ore mining, by providing information from ECHA’s chemical databases to assist in the identification of relevant input chemicals and potential Key Environmental Issues.

Yes

Assistance given to the BREF development and chemical risks are

We supported EU-BRITE with ad hoc consultations e.g., on ongoing BREFs, inclusion of chemical management systems in

Yes

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Annual Report 2024

addressed as appropriate. BAT-C (Best Available Technique Conclusion) documents and feedback on potential Guidance development.

Workplan for the further development of the Chemical Management Systems methodology (to prioritise chemicals for prevention/control of emissions from industrial installations) developed and agreed.

This output was deprioritised in 2024 to enable ECHA to shift focus to supporting the BREF process.

No

Tasks under grant, cooperation and service-level agreements Objective 1: EUON database on nanomaterials on the EU market available and updated.

Main Outputs Execution Status

Specific data gaps in the public knowledge about nanomaterials via the commissioning of external studies addressed.

Two studies were completed, and two new ones were launched, in accordance with the EUON work plan.

Yes

Database updated as necessary with new or changing regulatory or scientific information.

The EUON was updated with new content such as study reports and Nanopinions.

An evaluation of the functioning of the EUON was also performed providing insights and recommendations on the further development of EUON including its integration in the future Common data platform of chemicals as proposed by the Commission.

Yes

EUON promoted via different channels to increase its outreach to a wide variety of audiences.

Social media campaigns were delivered and found to be an effective tool to direct users to EUON.

Yes

Indicators Estimate Actual

All traffic to EUON websites 130 000 182 285

Objective 2: EUCLEF database on EU chemicals legislation available and updated.

Main Outputs Execution Status

EUCLEF maintained and updated. Information on regulatory obligations on chemicals was maintained and regulatory changes reflected.

Yes

EUCLEF promoted wider to increase the utility of the service for the target audience, with a particular focus on SMEs.

Information on regulatory obligations on chemicals was promoted especially towards SMEs as per the agreement with Commission

Yes

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Annual Report 2024

Advice provided via the EUCLEF helpdesk.

The outsourced EUCLEF helpdesk continued to provide timely support to customers.

Yes

Indicators Estimate Actual

All traffic to EUCLEF pages15 400 000 439 924

Objective 3: Opinions of the Risk Assessment Committee (RAC) on OELs delivered to the Commission.

Main Outputs Execution Status

SLA requests processed to agreed timelines.

Five new requests for setting occupational exposure limits were received under the 2024 contribution agreement with the Commission:

• N-(Hydroxymethyl)acrylamide (NMA) • Ethylene dibromide or 1,2-

Dibromoethane (EDB) • Anthraquinone • 1,3-Propanesultone • Oximes (butanone oxime and acetone

oxime)

The RAC opinions for these substances must be adopted by 30 April 2026.

Yes

Five RAC opinions completed and delivered to the Commission.

The RAC opinions on scientific evaluations of occupational exposure limits (OELs) for four of the five substances agreed for 2023 were adopted. The five substances included:

• Boron and its compounds • 1,3-Butadiene • 1,2-Dihydroxybenzene (Pyrocatechol) • Silicon carbide fibres

Exceptionally discussions on the fifth substance, Bisphenol A (BPA) (and other Bisphenols), were not completed with the RAC opinion scheduled to be adopted in 2025.

No

Indicators Estimate Actual

Number of OEL requests received under SLA 5 5

Number of RAC opinions on OELs completed 5 4

Number of scoping documents 1 0

15 Traffic aggregated for all the EUCLEF pages, including EUCLEF main landing page, Information for Chemicals (EUCLEF subset) and EUCLEF Legislation Lists for substances.

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Annual Report 2024

Objective 4: IPA grant implemented fully in support of EU candidate and pre-candidate countries on chemicals management.

Main Outputs Execution Status

Support actions as agreed in the IPA grant agreement for 2023-June 2026 implemented.

We delivered support to pre-candidate countries with the implementation of the chemicals acquis. IPA countries attended several relevant meetings and trainings including capacity building on enforcement and communication.

Yes

Indicators

N/A

Objective 5: IUCLID platform cooperation on Plant Protection Products (PPP) between EFSA and ECHA continued.

Main Outputs Execution Status

Submitted dossiers processed and made available to EFSA.

ECHA continued to support EFSA Industry access to ECHA Cloud Services and consolidated PPP submission processes.

Yes

Applicability of IUCLID to other food regulated products (e.g., Food Contact Materials and synergies with Drinking Water Directive and Feed additives) reviewed and assessed.

ECHA and EFSA discussed and agreed on the IUCLID requirements for Food Contact Material (IUCLID format). The implementation of the agreed requirements in IUCLID will start in 2025.

Yes

Support provided to EFSA with the use of IUCLID data tools for the extraction, search and upload of data.

ECHA delivered to EFSA several updates of the IUCLID data tools, and supported EFSA contractor with curating and populating data (e.g. on food toxicity) in EFSA IUCLID database.

Yes

Indicators

N/A

Objective 6: Input provided to research activities in support of current and future regulatory challenges

Main Outputs Execution Status

Framework developed with clear decision criteria to enable transparent decision making for the prioritisation of activities within PARC.

As a co-leader of Task 2.1 ‘Priority setting’ under PARC, ECHA’s experts reviewed 46 projects, mainly related to hazard, exposure and risk assessment methodologies.

Yes

Development of annual work plans supported and steered to ensure

We actively participated in PARC projects addressing data gaps, for example, on

Yes

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Annual Report 2024

identified EU priorities and knowledge gaps in the area of chemical risk assessment appropriately considered.

immunotoxicity and development of innovative methods on different hazard endpoints (e.g. developmental neurotoxicity).

We have further updated the regulatory research needs in our document called ‘Key Areas of Regulatory Challenge’ (KARC). The second version of this KARC report was launched during a joint webinar together with the EEA and EFSA (European Food Safety Authority) in June. These updated research needs serve as an important source of inspiration feeding into the key priorities for future research projects for the last three years of PARC.

We presented these research needs in various scientific fora (e.g., ECETOC- LRI Scoping meeting, Workshop Future chemical Risk Assessment and Management at University of Gothenburg, Helsinki Chemical Forum, etc.).

Advice and steer provided to the development and implementation of a rapid response mechanism to allow national and European policy makers to submit requests for specific information to the PARC Consortium outside of the formal timeframes.

We have submitted together with the European Environmental Agency (EEA) an urgent request to generate exposure data on a phthalate of concern via the Rapid Response Mechanism.

Yes

Indicators

N/A

Governance and Enablers Objective 1: A level playing field for economic operators through harmonised enforcement.

Main Outputs Execution Status

Reports on five Forum-coordinated REACH and BPR enforcement projects prepared, published and communicated. Reports include REACH and POP Restrictions (REF- 10), REACH safety data sheets (REF-11), control of REACH for imports (REF-12), online sales (REF- 13), BPR approved substances in biocidal products containing non- approved/approved active substances (BEF-2) and control of SPC and SDS for biocides (BEF-3).

All anticipated enforcement projects went through the different phases without delays. Reports and findings were published and communicated.

Yes

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Annual Report 2024

Subject matter of next REACH project (REF-14) agreed and steps taken to implement actions.

The classification and labelling of mixtures in products was agreed as the next Forum project (REF-14) and will commence in 2027.

Yes

Best practice enhanced by maintaining the Forum and BPRS Manuals of Conclusions on practical enforcement issues and running Forum pilot projects on PFCA (Perfluoroalkyl carboxylic acids) and related substances and poison centre notifications.

Updates to Manuals of Conclusions were made on a regular basis. Pilot projects (PFCAs in cosmetics, PCN notifications, bridging principles) progressed according to plans.

Yes

Advice on enforceability on all submitted proposals for restrictions delivered and published.

Advice was delivered. Yes

Process revised for delivering the Forum advice.

Process was revised, reviewed and accepted by the Forum.

Yes

New version of the compendium of analytical methods prepared.

A new draft version was made available. Yes

Four trainings for national trainers and inspectors developed and delivered.

Trainings took place, with some 730 participants, which was much higher than estimated.

Yes

Forum’s input provided on the Commission’s views on enforcement related topics under the CSS/REACH revision and the impact of any proposed legislative changes on the operation of the Forum reviewed.

The Commission’s work on revising the REACH Regulation is ongoing. ECHA anticipates a proposal for a revised Regulation in 2025 and will work closely with the Commission to provide input and support the development and implementation of the proposal.

No

Indicators Estimate Actual

Number of enforcement trainers trained by the Forum 200 730

Number of enforcement projects ongoing 5 9

Objective 2: Board of Appeal16 decisions are adopted without undue delay and are of high quality.

Main Outputs Execution Status

Appeals brought against decisions of the Agency, according to procedural requirements, processed and decided.

In 2024, eight appeal cases were received, and 14 appeal cases were closed.

Yes

Communication to parties and the public about appeal decisions completed.

Section on the Board of Appeal on the ECHA website was revised to make it easier for stakeholders to find decisions and other information on appeals.

Yes

16 Art. 90 of Regulation (EC) No 1907/2006 and Art. 77 of Regulation (EU) No 528/2012

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Annual Report 2024

Support provided to the Secretariat in defence of Board of Appeal decisions when challenged before the EU Courts.

Staff of the Registry supported the Secretariat in representing ECHA in two cases before the General Court.

Yes

Contributions provided to ECHA’s input for the review of the REACH Regulation.

The Registry and the Board of Appeal provided input to the secretariat, as required, with regard to processes within the competence of the Board.

Yes

Indicators Estimate Actual

Appeals submitted REACH 12 8

Appeals submitted BPR 2 0

Appeals concluded REACH 12 11

Appeals concluded BPR 2 2

Objective 3: ECHA's Governance aligns with strategy and adapts to the changing organisational and institutional landscape.

Main Outputs Execution Status

Four Management Board meetings with related subgroups and an external assessment of the Board organised.

Five Management Board meetings were organised, including one extraordinary meeting. The Management Board decided to conduct a self-evaluation17 without external support, which was run between April and August 2024.

Due to the extraordinary Board meeting scheduled, and in agreement with the Chair, the timelines for providing documentation were shortened. This is reflected in the fact that the relevant indicator achievement rate is 83% instead of 95%.

Yes

All statutory documents required by legislation in the area of planning and reporting are prepared and adopted on time.

All statutory reports were approved by the Management Board in line with regulatory requirements and timelines.

Yes

Regular reports on ECHA’s activities provided to the Management Board.

ECHA fulfilled its 2024 obligations, including a Management Board exercise to improve clarity of plans and reports and better linking strategy implementation to outputs and indicators.

Yes

Quality, internal control and risk management frameworks are implemented.

ECHA maintained its ISO 9001:2015 and 14001:2015 certifications and further developed its risk management framework, with a focus on training and awareness

Yes

17https://echa.europa.eu/documents/10162/74925298/final_mb_08_2024_mb_self_evaluation_2024_plan_en.pdf/845 faa2d-7da8-341f-6481-3b4a3b34cb37?t=1713184329505

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Annual Report 2024

raising.

Agency-wide audit and evaluation plan implemented.

The audit and evaluation plan was implemented with one additional evaluation conducted upon request by the Commission (EUON). The number of audit findings (11 see below) includes important and very important findings. There were no critical findings in 2024.

Yes

Actions foreseen in policies related to independence, transparency, fraud-prevention and data protection implemented.

Actions completed included a mandatory all- staff e-learning, with a focus on conflict-of- interest prevention and relations with interest groups; the Management Board received an annual refresher on ethics.

The focus of data protection actions concerned procured IT licences and software, the specific privacy risks involved with the migration of data to public cloud and the roll-out of the first AI pilot projects.

Yes

The Agency’s organisational model reviewed.

A review of ECHA’s organisation was completed to take account of the new strategy and our expanding legal mandate. The recommendations, which addressed ways of working, strategic prioritisation and organisational structure will be addressed in 2025.

Yes

Interactions with Member States authorities organised, both through bilaterals and networks (Heads of Chemicals authorities meeting).

There was increased engagement again in 2024 with the Member States partners highlighted by 12 bilateral engagements at the level of the Executive Director and a network meeting with the heads of Member States’ chemical authorities, organised in Q1 2024. These efforts significantly exceeded the corresponding indicator.

Yes

ECHA’s collaboration with other EU agencies, Commission services and international bodies is deepened. Review of corresponding agreements launched and revised as needed.

ECHA’s overall collaboration with Institutions and other EU agencies was deepened, as shown by the collaborative actions and outputs presented in the respective activities. A review of the agreements with third countries and EU agencies was conducted, with the implementation of resulting revisions planned to start in 2025.

Yes

JRC-ECHA collaboration agreement concluded.

The revision of the JRC-ECHA collaboration agreement18 was concluded in Q3 2024.

Yes

Regular and structural dialogue with ECHA’s institutional partners maintained and further developed in aftermath of the 2024 European elections. Opportunities for joint engagement with other EU/ENVI

Regular engagements took place with the institutional partners, via bilateral meetings or participation institutional events (22 engagements at high level). New stakeholders for the 2024-2029 policy cycle were mapped and contacts established.

Yes

18https://echa.europa.eu/documents/10162/17206/collaboration_agreement_between_jrc_and_echa_en.pdf/c750cf63 -e9b2-40de-a109-c72a24098952

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agencies investigated. These efforts significantly exceeded the corresponding indicator, also due to increased stakeholders’ interest in engaging with the Agency.

The five ENVI agencies (ECHA, EMA, EEA, EFSA, ECDC) jointly introduced their work to the new European Parliament’s ENVI committee in December 2024.

Increased Brussels presence for institutional liaison purposes.

The institutional liaison presence in Brussels was increased (ca 9 extended missions).

Yes

Indicators Estimate Actual

Number of Management Board plenary MB meetings 4 5

% of documents provided on time as required by RoP 95 83

Percentage of statutory documents adopted on time 100 100

Number of major findings during internal and external audits, no reservations in Court of Auditor observations

0 11

Discharge granted Y Y

Number of breaches of trust or disciplinary procedure initiated for conflict-of-interest management.

0 0

Number of high-level meetings conducted with Member States and European Union institutions

12/12 34

Number of meetings conducted with international organisations and third countries (besides IPA and OECD)

12 11

Objective 4: ECHA’s communication is effective, transparent, targeted and timely.

Main Outputs Execution Status

New Communications Strategy implemented.

A new External Communications Strategy and Stakeholder Engagement Approach were developed and implemented in support of ECHA’s new strategy.

Yes

Relations with relevant media outlets improved and expanded.

Contacts with media were managed efficiently and effectively. Highlights for the year included contacts around the Helsinki Chemicals Forum (HCF) as well as engagement with EUObserver, Deutsche Welle, Euronews, Euractiv, ChemicalWatch and Politico. Visits from Finnish and Swedish environmental journalists were also hosted.

Yes

Number of social media followers increased.

The number of followers across ECHA's social media channels - LinkedIn, X, Facebook, YouTube - increased by 21% from 110,500 at 31 December 2023 to 132, 257 at 31 December 2024.

Yes

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ECHA website improved as a key communications channel to all stakeholders.

We concentrated on stabilising and maintaining the website. However, it suffered a number of outages throughout the year due to its aging technology and complicated structure. The future development of the website will form part of the Public Portal element of ECHA’s longer term IT Transformation Project.

Yes

Biannual meetings of the Member States Competent Authorities Communicators Network held and activities reported.

Two meetings of the network were held (May, September). Working with Member States, we have increased participation during the course of the year with feedback received being overwhelmingly positive.

Yes

Internal Communications Strategy developed and implemented.

ECHA finalised its Internal Communications Strategy to support ECHA’s strategic goal of investing in people and organisational excellence.

Yes

Consistent staff use of ECHANet ECHANet continued to be the main source of information for staff on relevant work- related issues.

Yes

Continue cooperation on communications alignment with sister Agencies and MS.

This work was facilitated through three workstreams:

- the Member State Communicators Network – which met twice in 2024;

- ECHA's role in the ENVI Agencies Heads of Comms informal network which met monthly to ensure coordinated actions and share relevant information and experience; and

- ECHA's active participation in the broader EU Agencies Heads of Communications & Information Network.

In addition to the identified workstreams, ECHA was also active in the:

- One Health project with colleagues in the other ENVI agencies;

- ENVI Instagram account (weekly basis);

- ICOP on Stakeholder Engagement (ENVI Agencies) including a physical workshop in November.

Yes

Indicators Estimate Actual

Share of neutral and positive coverage of ECHA >85 % 98 %

Website unique visitors/traffic to web content 4.2 M 5 449 176

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Growth in social media followers 120 K 134 52719

Unique staff visits to ECHAnet 2.1 M 1 021 66820

Objective 5: Open and transparent engagement with all stakeholders.

Main Outputs Execution Status

New stakeholder engagement approach implemented.

The new engagement approach has been rolled out across the organisation. This approach has been used to map stakeholders relevant for new tasks i.e. Batteries. An internal Customer Relationship Management (CRM) pilot was launched in October, which will report on progress in early 2025.

Yes

ECHA Conference 2024 delivered and positively received.

A first post-pandemic in-person conference under the theme of Shaping Tomorrow was organised, which saw 300 participants join in Helsinki with excellent feedback on content and format.

Yes

NGO Dialogues and Accredited Stakeholder Organisations introductory sessions held.

Biannual dialogues with non-governmental organisations (NGOs) and three introductory sessions for Accredited Stakeholder Organisations (ASOs) were organised.

Yes

Launch Stakeholder Perception Survey – to provide benchmark for future annual indicators.

The survey project was initiated and prepared in October for launch in early 2025. The results will feed into ECHA’s future stakeholder interactions, development of KPIs etc.

Yes

Preparation of Eurobarometer survey question(s).

We provided input to DG ENV in the preparation of its 2024 Eurobarometer Survey which resulted in the inclusion of specific questions on chemicals relevant for ECHA.

Yes

Indicators Estimate Actual

ECHA engagements with stakeholders21 200 113

ECHA Conference survey results Positive 4.422

19 The projected growth in 2024 was 8.5%. The majority of new followers were gained on LinkedIn, as a result of a combination of organic growth and successful paid campaigns aimed at attracting new followers. 20 The number of visits to pages by staff was less than half (1.02m) of the projected figure of 2.1m. The initial high level in Q1 reflects the update of information on the site and the need for staff to check and review which was reflected as visits. Continued monitoring of the number of visitors will be undertaken to determine the disparity between projections and actual visits. 21 The recording of stakeholder interactions is still in its developmental phase with the recorded figures for 2024 indicating those meetings undertaken by senior management and the Communications Unit. The figure is expected to differ in 2025 when reporting is extended following the CRM pilot. 22 Participant rating from the post-event feedback survey, on a scale 1-5.

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Objective 6: Companies, and in particular SMEs, have the necessary advice to meet legal obligations.

Main Outputs Execution Status

Questions are timely and effectively answered.

45000 questions were answered by the network of national helpdesks, with more than 9000 answered by ECHA.

Yes

Topics of broad interest/relevance discussed and agreed among all national helpdesks for harmonised advice.

New FAQs and Q&As were published and increased efforts were taken to engage and cooperate with the national helpdesks and other environment agencies.

Yes

Preparations initiated to support companies following the revised regulations under the CSS, e.g., CLP and REACH regulations.

The ECHA helpdesk received and answered questions on the new tasks were picked up by the Helpdesk. The national Helpdesks were informed by the Commission and the European Parliament on the CLP revision.

Yes

Regular contacts with SME to understand and address better their specific needs established.

An action plan was agreed to step up our efforts to support SMEs and will be implemented over the next years.

Yes

Indicators Estimate Actual

Number of helpdesk questions answered (across all our legal basis) 10 000 9 330

Objective 7: Compliance with legal requirements related to finances, human resources, procurement, intellectual property and access to documents.

Main Outputs Execution Status

ECHA’s contributions in legal proceedings made within deadlines.

All ECHA contributions in legal proceedings were made within deadlines in seven proceedings in front of the European Court, in eight cases in front of the Board of Appeal and in 18 cases in national courts.

Yes

Legal review, advice and training provided to ensure sound decisions on access to documents.

We provided legal review, advice and training to ensure sound decisions on access to documents. We observed an increase in access to documents requests. Many requests were also considerably larger in scope than in earlier years.

Yes

ECHA’s trademarks kept up to date. ECHA’s trademarks were all kept up to date. Yes

Indicators Estimate Actual

Access to documents requests received and concluded 100 145

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Objective 8: IT operations are efficient, secure and of high quality.

Main Outputs Execution Status

The refresh of end-of-life administrative tooling continued.

Progress for this refresh was delivered as planned in the scope of management information systems.

Yes

The replacement framework contracts for Management Information Systems and for managed IT Workplace Services established.

The new Management Information Systems contract was established and awarded as planned. The transition to the new IT Workplace Services was successfully completed.

Yes

A target architecture and roadmap of the administrative/support tooling to increase staff productivity and better support ECHA strategy prepared.

A target architecture and roadmap was prepared. The deliverable will be revised regularly to incorporate future changes.

Yes

New Cybersecurity and Information Security regulations adopted, and implementation continued.

Investments and efforts to meet cybersecurity regulation requirements continued successfully, with a low number of cybersecurity incidents. All but one incident was categorized as low or medium level. The more significant incident, related to a third- party software vulnerability, was professionally managed, minimizing impact and ensuring no ECHA data or systems were compromised.

Yes

User satisfaction surveys completed and indicating a high level of satisfaction.

The survey took place in November demonstrating high level of satisfaction among the users.

Yes

Indicators Estimate Actual

Average availability of key systems >98 % 100 %

High impact security incidents23 <2 0

Objective 9: IT functions and business processes transformed, modernised and enhanced.

Main Outputs Execution Status

First solution following the new modular target architecture published (DWD).

We focused on laying the foundation of the modular architecture on which the capabilities for supporting DWD regulatory obligations are expected to be deployed. Significant work was delivered also for producing a solid understanding of the information flows and the operational and business capabilities required to fulfil the DWD deadlines for 2025.

No

23 Number of successful cyberattacks with very high impact for ECHA (e.g. resulting to loss, leakage, tampering of important data, systems unavailability).

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Plans to transition to public cloud infrastructure and services followed.

As part of ECHA’s IT transformation plans, a project to migrate the agency’s IT assets to public cloud infrastructure was started. This migration will provide access to modern technologies and capabilities, such as AI, and long-term efficiencies across the IT delivery process.

Yes

Data provision services of the organization maintained.

Service maintained and delivered according to the plans.

Yes

A coherent data catalogue of data products and assets with their respective stewardship produced.

First data catalogue is available. Stewards appointed for most urgent data product. The work on this topic will continue in 2025.

Yes

Long term (5 years) IT vision, plan and roadmap adopted and implementation started.

A five-year IT plan, outlining the vision, priorities, and approach for the new architecture, was developed and endorsed.

ECHA systems achieved a 100% availability rate, surpassing the 98% target, ensuring a high level of service.

ECHA’s internal horizontal working group for Artificial Intelligence created guidelines for the safe use of AI, assessed potential AI use cases, proposed several pilots, and coordinated AI initiatives.

Yes

New refined and more agile IT governance model developed.

A model was developed, which will be first piloted and refined during 2025 under the IT Transformation Plans.

Yes

First version of ECHA wide design system for improving the development process and alignment between solutions developed.

Investments in user experience continued, resulting in the first version of the ECHA Design System—a comprehensive set of guidelines, components, and tools to maintain consistency in digital product design and development.

Yes

The target enterprise architecture adopted, and implementation started to improve tooling for regulatory processes for internal and authority users.

Work on regulatory process tooling area progressed according to the enterprise architecture vision. The goal is to replace the existing fragmented application landscape with a regulatory-agnostic modular architecture, capable of serving all current and future regulatory tasks of the agency.

Yes

Indicators Estimate Actual

Long-term (5 years) IT vision, plan and roadmap adopted Yes

Objective 10: ECHA’s budget is implemented in accordance with the objectives set in the Programming Document and the Financial Regulation.

Main Outputs Execution Status

Annual budget prepared and We effectively managed our financing through Yes

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implemented in accordance with the objectives set in the Programming Document and the Financial Regulation.

close monitoring of uncertain fee income development. On the final budget size of EUR 126.6 million, the Agency reached a 99.5% commitment rate and 87.0% payment rate, exceeding the targets set. Comprehensive details on ECHA’s budget management in 2024 can be found in Part II and Annex II of this report.

Annual accounts prepared and implemented for ECHA’s Management Board and the relevant EU institutions, in accordance with the requirements of the Financial Regulation.

The annual accounts were prepared in a timely manner, with a clean audit opinion attained. The European Court of Auditors gave a clean audit opinion on ECHA's annual accounts for 2023.

Yes

Procurement and contracting activities implemented in accordance with the objectives set in the Programming Document and the Financial Regulation.

The 2024 procurement plan was presented, adopted and revised by the Management Board and relevant actions implemented.

Yes

Regular reports provided to the Commission partner DGs on the evolution of fee income and budget implementation.

Monthly reports were provided to, and continuous communication took place with, the Commission partner DGs.

We also conducted and delivered a study on costing of its fee-related services, as requested by the Commission.

Yes

Regular contacts maintained with the Commission partner DGs to agree ways of handling any shortfall or surplus arising during the financial year.

Two amending budgets were agreed with the Commission partner DGs and presented for adoption by the Management Board.

Yes

Annual evolution of the transfer of a proportion of fees to Members States reported.

Annual report presented to the Management Board Subgroup on Finance, Audit and Risks.

Yes

Indicators Estimate Actual

Level of budget implementation: Commitment rate. >95 % 99.5%

Level of budget implementation: Cancelled payment appropriation rate (including carry-forward)

<5 % 0.5 %

Processing of payments within legal deadlines >99 % 99.8 %

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Objective 11: Attract, develop and retain competent and committed staff to implement ECHA’s mandate, purpose and vision.

Main Outputs Execution Status

Actions under ECHA’s People and Organisational Strategy 2024-2028 implemented.

We adopted ECHA’s People and Organisational Strategy 2024-2028 that supports the Agency in delivering on its Strategy for the same period, in line with its goal to invest in people and organisational excellence and the two related priorities to develop and empower people for success and to create optimal ways of working for the Agency, its bodies, people and the environment. Key deliverables from the first year of implementation included the following:

• In the area of attracting and selecting people; we adopted a selection plan based on a robust gap analysis with a view to both existing and upcoming tasks for the Agency, the onboarding of new selection tools and the further investment in employer branding through participation in different job fairs.

• With respect to a positive people experience and engagement, we ensured career development opportunities for staff through regular career enhancement calls; our mental health working group delivered meaningful campaigns and staff cohesion was supported through several staff events, including our first corporate day after the pandemic.

• People development was further promoted through a dedicated learning and development plan that addressed current and future needs, paving the way for onboarding new tasks allotted to the Agency. We also adopted a new policy on capacity building with external partners and initiated a pilot project thereunder.

• Finally, we supported the organisation’s ongoing development through the conduct of an organisational review exercise and dedicated contribution to the Agency’s AI working group.

At the end of 2024, all KPI’s in the area of HR were met and the staffing plan filled at 97.2%.

Yes

ECHA’s Wellbeing Action Plan 2023- 2024 implemented in conjunction with ECHA’s Joint Committee for Health and Wellbeing.

See under objective 12 below. Yes

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Annual Report 2024

ECHA’s Diversity and Inclusion Action Plan 2023-2024 implemented.

We implemented our 2024 action plan which included general awareness raising around key Diversity and Inclusion topics through events, articles and training. To support the specific focus on gender balance at management level we onboarded management representatives to our internal D&I Working Group, discussed best practices and challenges in fostering a diverse and inclusive work environment with the Management Team, and delivered training courses on unconscious bias to managers and team leaders. A slight increase is observed in the representation of women in middle and senior management compared to 2023. Nationality balance of ECHA staff is comparable to 2023 with Finns representing nearly a third of all staff.

Yes

Regular communication with ECHA’s Staff Committee to maintain a healthy working culture and positive relations and dialogue.

Regular meetings between management and the Executive Director were held with the Staff Committee. Elections were also successfully held for a new staff committee in December.

Yes

Indicators Estimate Actual

Turnover of Temporary Agents <5 % 1.5%

Turnover of Contract Agents <10 % 0.8%

Percentage of Establishment Plan posts filled 95 % 97.2%

Objective 12: A safe, productive and healthy physical work environment for staff and guests.

Main Outputs Execution Status

ECHA’s Wellbeing Action Plan 2023- 2024 implemented in conjunction with ECHA’s Joint Committee for Health and Wellbeing.

ECHA’s Wellbeing Action Plan 2023- 2024 was progressed, by the Agency’s Joint Committee for Health and Wellbeing and numerous implementation measures were undertaken throughout the year.

Following up on a 2023 analysis on optimising the use of our office building and Conference centre, a pilot project was initiate, to plan for testing new ways of working.

Yes

ECHA’s Environmental Work Programme 2023-2025 implemented.

We successfully organised meeting services for approximately 400 events and official meetings, with 36 600 participants joining online through Webex, and approximately 5 300 visitors hosted in person in our premises.

Against this backdrop, we also continued to work towards our aim to reduce CO2 emissions from both staff travel and building operations. Our 2023-2025 environmental

Yes

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work programme was coordinated and monitored effectively (more information in Part II and Annex VII).

Actions related to ECHA’s ISO 14001:2015 and EMAS certifications co-ordinated.

We obtained recertification of the Agency’s International Organisation for Standardisation (ISO) 14001:2015 and EU Eco-Management and Audit Scheme (EMAS) until 2027. Guidelines for the implementation of the ISO 20121:2012 standard on event sustainability management systems were developed and issued during 2024.

Yes

Indicators

N/A

Objective 13: Implement the Regulation on Serious Cross-border Threats to Health (SCBTH).

Main Outputs Execution Status

Internal procedures in place to enable delivery on the tasks allocated.

The preparation of internal procedures was started in 2024 and will be concluded in 2025.

No

Approach confirmed and co- ordinated with Commission and other agencies.

Agreement was signed in November 2024. A contribution agreement with the Commission was concluded setting the basis for ECHA’s preparation to deliver on this new task. ECHA participated for the first time in simulation exercises with other EU and national bodies to increase EU preparedness for SCBTH.

Yes

Indicators

N/A

Objective 14: Support development and implementation of new legal requirements.

Main Outputs Execution Status

Contribution provided to Commission’s work on CSS implementation and REACH revision.

ECHA provided input, as requested, to ongoing legislative processes with impact on ECHA’s tasks executed, in particular in the context of the ‘one substance, one assessment’ (OSOA) package.

Yes

Indicators

N/A

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Part II. Management Management Board

The Management Board (MB) provides strategic direction and governance to ECHA to enable the Agency to deliver on its purpose and vision and meet the expectations of its stakeholders.

In 2024, the MB saw changes in its leadership, with the election of its new Chair, Sofia Zisi (Greece) in September and its new Deputy-Chair, Per Ängquist (Sweden) in December. As part of its commitment to continuous improvement, the MB conducted a self-evaluation in 2024, reviewing its own processes, decision-making and governance. The self-evaluation resulted in a few targeted improvement actions, without any major change in the MB’s way of working24.

With a view to ensuring the workability of ECHA’s committees, the MB decided in 2024 to increase the payments for REACH restriction rapporteur work in RAC and SEAC. Regarding the Board of Appeal (BoA), the MB decided in December 2024 to transition the ECHA BoA to an ad hoc structure, composed of members appointed by the MB, based on a list proposed by the Commission, who will not be staff members of ECHA.

During 2024, the MB continued closely monitoring the legislative and policy developments with an impact on ECHA’s mandate and resourcing, including the new tasks assigned to ECHA. It also continuously oversaw the risk management processes, including regularly reviewing the Agency Risk Register and specific reporting on IT security, as well as obtaining assurance that risks are properly identified, assessed, and mitigated.

The MB adopted all documents required by law in line with the applicable rules and regulations. In its capacity of Appointing Authority, the MB took the necessary decisions in all staff matters for the functions reporting directly to it (Executive Director, members of the Board of Appeal), including the annual performance appraisals.

Major developments

Following the 2024 elections, the EU set new political priorities focusing on sustainable prosperity, security, and social fairness. ECHA closely monitored these evolving priorities and engaged with stakeholders to ensure clarity and readiness for necessary changes. As an EU decentralised agency, ECHA is also expected to reduce administrative burdens, foster competitiveness, and maintain high standards of health and environmental protection. Throughout 2024, ECHA supported decision-makers in negotiations on the One Substance, One Assessment package, which bring significant new tasks. Anticipating the future ECHA Basic Regulation, ECHA contributed to the Commission’s preparatory work to strengthen governance and streamline operations. Additionally, ECHA tracked political developments related to the simplification of REACH and clarification of PFAS regulations, preparing to provide scientific- technical input as needed. Amid resource constraints, ECHA focused on enhancing internal competence and capacity, collaborating with Member States to address gaps and align with the EU’s vision for a sustainable future.

In 2024 ECHA started the implementation of its new Strategy 2024-2028, which, according to the perception of its Management is on a good path, well communicated to staff with values well lived up to and upheld. In line with ECHA’s priority to ‘Ensure that our organisational model is ready to support delivery of our current and future mandate’, ECHA undertook an organisational review in 2024. The organisational review was conducted to address the evolving nature and

24 MB/M/04/2024 final: https://echa.europa.eu/documents/10162/91846726/mb_m_04_2024_minutes_mb75_en.pdf/9b697143-04ee-8717- 92b6-a85fe469420c?t=1734527244500.

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increasing complexity of ECHA’s tasks and mandate, necessitating a strategic approach to optimise performance and integrate new responsibilities. Following the last review in 2018, which led to structural changes effective from January 2019, it became clear that further adjustments were needed to ECHA’s ways of working and organisation, underpinned by internal and external feedback. The recommendations, which addressed ways of working, strategic prioritisation and organisational structure will be addressed in 2025.

Budgetary and financial management

Financial management

ECHA effectively managed its financing in 2024, by closely monitoring the development of fee income and the overall financing position. By the end of the year, the financial operations reached a 99.5 % commitment rate and 87.0 % payment rate, notably exceeding the targets set. The European Court of Auditors gave a clean audit opinion on ECHA's annual accounts for 2023 and carried out the first part of its audit for the financial year 2024 under a new audit team.

Details on ECHA’s budget information and management in 2024 can be found in Annex II.

Delegation and sub-delegation of the powers of budget implementation to agency’s Staff

ECHA maintains a system of operational and financial delegations as part of its Integrated Management System, which allows to effectively manage delegations and sub-delegations, taking into account the risk level of the particular process.

Human Resources (HR) management

Human resources management

In 2024, ECHA adopted and started to implement the People and Organisational Strategy 2024- 2029. Our joint efforts in running selection procedures efficiently and investing in employer branding led to a high rate of filled establishment plan posts (97.2 %) with a low Temporary Agent turnover (1.5 %) rate. We maintained a strong focus on staff wellbeing through delivery on our respective action plan, in close cooperation with ECHA’s Joint Committee on Health and Wellbeing. In addition, the Diversity and Inclusion Action Plan was further implemented.

Strategy for efficiency gains

ECHA’s Integrated Management System Strategy and Framework has demonstrated its effectiveness in achieving the Agency’s strategic goals and priorities throughout 2024. The results of the annual benchmarking exercise (full results available in Annex IV) conducted in accordance with the Commission’s requirements indicate efficiency gains in the Agency’s administration. The results show a decrease of 2.6% in the staff involved in administrative support and coordination and increase of 2.1% and 0.5% in the staff involved in operational and neutral tasks, respectively.

In the realm of IT, ECHA continued the development of its new enterprise architecture throughout 2024. This approach focuses on streamlining business solutions through modular architecture, enabling faster adoption of new regulatory processes. The governance of ECHA's IT portfolio was also revamped, to further accelerate the transition towards the target architecture.

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Additionally, ECHA continued its efforts to digitalise its administrative processes in 2024. As a concrete example of this work, the Agency completed the incorporation of electronic signatures to document workflows through the implementation of EU Sign, a qualified electronic signature tool developed by DG DIGIT. This tool allows electronic signature of all documents signed by the Agency, reducing both paper and postal costs as well as time spent by relevant actors to process original documents, thus gaining efficiency.

Assessment of audit and retrospective evaluation results during the reporting year

Retrospective evaluations

In 2024, ECHA performed the following retrospective evaluations following the criteria and methodology as stipulated in the Better Regulation Guidelines25 :

• Retrospective evaluation of ECHA’s HR strategy 2019-2023. Upon request of the Management Board, this ex-post evaluation analysed the degree of effectiveness, relevance, efficiency, proportionality, coherence, added value and sustainability of the ECHA’s HR strategy. The lessons learnt will be used for the implementation plan of the current People and Organisational strategy.

Main highlights from the evaluation are presented below:

It could be overall concluded that the objectives of the HR Strategy have been achieved to a large extent. The HR strategy has contributed to developing ECHA’s competence base for current and future tasks, building a high performing and flexible environment, promoting staff engagement by facilitating career development and enhancing management and leadership capabilities. It could also be concluded that ECHA’s HR strategy has brought added value to ECHA in alignment to ECHA’s long term strategy 2019-2023.

ECHA’s competence map is well used in various HR processes, such as identifying competence gaps and training needs. The use of the competence map across ECHA and in the resource planning and allocation exercise could be further strengthened.

Following the challenges of the pandemic, ECHA has progressed towards creating a more flexible work environment and better work-life balance.

Staff engagement has been promoted in various ways, with a high use of internal career development opportunities throughout the years, decrease in the interims’ support and developing an employer brand for ECHA.

Management and leadership capabilities have overall improved over the years via coaching, training and other management practices, which is visible in the trends of the Staff survey with regards to trust in Senior management and job motivation. Employer image, diversity and inclusion have also a very good perception by staff. Fair rewarding of staff however is an area where further efforts are needed. ECHA’s HR Unit has taken actions on increasing the transparency of the reclassification process, however it cannot yet be judged if those actions have been effective.

Despite the complexities and legislative constraints, ECHA has been able to achieve certain level of synergies and efficiencies in its HR services and overall in its horizontal activities. ECHA compares with other ENVI agencies as the Agency with the

25 http://ec.europa.eu/smart-regulation/guidelines/tool_42_en.htm

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lowest proportion of its HR staff to total staff and the lowest proportion of “neutral staff” to total staff, which includes posts in horizontal services, such as finance, procurement, quality management, linguistics etc. Maintaining such a low proportion of HR and overall horizontal services staff however bears the risk of decrease in the staff wellbeing and ECHA not being able to manage the increasing workload.

• Second interim retrospective evaluation of European Union Observatory for Nanomaterials (EUON). Upon request of the Commission, this second interim ex-post evaluation analysed the degree of effectiveness, relevance, efficiency, proportionality, coherence, added value and sustainability of EUON. A comparison with the results from the previous evaluation of EUON in 2019 was made and the trends followed to conclude on the developments from 2019 until 2024. The lessons learnt will be used by the Commission to decide on the future of EUON. The evaluation is available on the EUON webpage26.

Internal Audit Service (IAS)

The Internal Audit Service (IAS) of the Commission did not conduct audits in 2024 at ECHA. IAS has closed all pending actions from earlier audits.

Internal Audit Capability (IAC)

The Internal Audit Capacity (IAC) conducted four assurance audits (one finalised in January 2025) with the objective of assessing and providing reasonable assurance on the regularity and the quality of internal control systems applied as well as efficiency and effectiveness of the processes.

The audit “Helpnet” resulted in three important recommendations:

• Establish long term planning to anticipate and prepare for the future challenges of the national helpdesks and to ensure that Helpnet members are systematically consulted on the critical areas necessitating EU-level harmonisation.

• Establish indicators to assess efficiency and effectiveness of the Helpnet activity.

• Continue to activate and engage the Helpnet members.

The audit “Quality and reliability of data in ECHA reporting” resulted in one very important recommendation:

• Use the clarified definitions for indicators in a consistent way in all reports. To enhance audit trail of the data source and calculation of the main indicators and figures in the Annual activity report, add to the ECHA-level indicator table a link to the data source and instructions how to retrieve the data. Keep the data source (report) at least for the main data in annual corporate reports to ensure an audit trail (follow the good practice for financial data by the Finance Unit).

And two important recommendations:

• To comply with ECHA’s Integrated management system strategy and framework and to establish clear responsibilities and accountability for numerical correctness, consider ways how to

o assign designated staff member to a reporting task o document validation of the most relevant data in ECHA's main corporate reports.

26 View article - European Observatory for Nanomaterials: https://euon.echa.europa.eu/view-article/- /journal_content/title/new-report-evaluates-the-performance-of-euon

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• Develop further indicators and corporate reporting

The audit “Testing proposal examination process under Dossier Evaluation” resulted in one very important recommendation:

• Inform the Commission of the current limitations and unclarities of the legal text to support its improvement in the context of the foreseen revision of REACH.

Improve the testing proposal examination process.

Provide a transparent overview of the status of the testing proposal examination process including compliance with the legal deadline.

Continue to analyse the reasons for the backlog TPs and to identify types of TPs where agreed principles by ECHA management and Member States Committee would help to conclude TPs.

Calculate the needed resources to improve the TPE process (see also recommendation 5 for specific expertise) and remove the backlog of pending TPEs and aim to assign sufficient resources to remove the backlog.

And four important recommendations:

• Develop further measures to ensure consistency in the Testing proposal examination. Consider how to improve the monitoring and reporting of the cases. Review IUCLID and submission process, including guidance to clarify the process (after changes to the legal text).

• Improve communication on the Testing proposal examination process to stakeholders.

• Identify and collect indicators and statistics to assess efficiency and effectiveness of the Testing proposal examination process.

• Ensure the TPE team has the necessary access to expertise on: o Read-across assessment o regulatory/ policy issues with complicated TPs o access to PBT and ED networks for consultation

The audit “Environmental management” did not result in any critical, very important or important recommendations.

The Agency follows up these recommendations with corresponding actions.

For earlier audits, the Internal Audit Capability conducted two follow-up audits (one finalised in February 2025) to verify the implementation of the action plans, concluding that 1 very important and 1 important action are still being implemented.

European Court of Auditors (ECA)

In their statement of assurance27, the European Court of Auditors (ECA) concluded that the accounts of the Agency for the financial year 2023 present fairly, in all material respects the financial position of the Agency at 31 December 2023, the results of its operations, its cash flows, and the changes in net assets for the year then ended, in accordance with its Financial Regulation and with accounting rules adopted by the Commission’s accounting officer. These are based on internationally accepted accounting standards for the public sector.

The revenue and payments underlying the accounts for the year were also legal in all material

27 https://www.eca.europa.eu/ECAPublications/SAR-AGENCIES-2023/SAR-AGENCIES-2023_EN.pdf

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aspects.

The Court did not make any observations regarding the financial year 2023 and there are no observations open from previous years either.

Follow up of recommendations and action plans for audits and evaluations

The follow up of the retrospective evaluations from 2023 and namely ECHA’s financial model, ECHA’s Committees28 (RAC, SEAC and MSC) and ECHA’s Board of Appeal29 show that many of the recommendations are in progress. For RAC and SEAC in particular the actions taken to increase the capacity of the Committee, such as increasing the rapporteurs’ payment rate in June 2024, have proved to be effective30. Some of the recommendations are linked to potential legislative changes which may be introduced with the Commission’s announced proposal for an ECHA Basic Regulation.

The follow-up of the evaluations performed in previous years showed that most of the recommendations on the retrospective evaluations have been implemented. The follow up includes the following evaluations performed in the last three years: SCIP database (Substances of Concern In articles as such or in complex objects (Products) established under the Waste Framework Directive (WFD))31, EU Chemicals Legislation Finder (EUCLEF) and the EU Observatory for Nanomaterials (EUON).

Follow up of recommendations issued following investigations by the European Anti-Fraud Office (OLAF)

N/A

Follow up of observations from the Discharge authority

In accordance with Article 262 of the Financial Regulation and Article 107 of the Financial Framework Regulation and the Financial Regulation of the European Chemicals Agency (ECHA), the Executive Director of ECHA shall take all appropriate steps to act on the observations accompanying the European Parliament's discharge decision and on the comments accompanying the recommendation for discharge adopted by the Council, and at the request of the Discharge Authority, report on the measures taken in the light of those observations and comments.

ECHA’s follow up report of the discharge32 provides an overview of the relevant observations and recommendations from the European Parliament discharge33 of 11 April 2024 for the financial year 2022.

In summary, there were six recommendations from the European Parliament, whose

28 https://echa.europa.eu/documents/10162/17086/retrospective_evaluation_of_committees_report_en.pdf/e491f353- 1e6e-8616-8990-48db2fed0056?t=1695807929141 29 file://echa/data/users/u09175/Roaming%20Profile/Downloads/ex_post_evaluation_board_appeal_en%20(6).pdf 30https://echa.europa.eu/documents/10162/74925298/final_mb_07_2024_decision_transfer_fees_ms_en.pdf/6eb9f27 3-3bf8-3cb8-d5f7-97f33003789a?t=1718633914154 31 SCIP retrospective evaluation: https://echa.europa.eu/documents/10162/6205986/scip_evaluation_report_en.pdf/2c677149-e876-f2b1-0ba7- 3daca0a419ef?t=1665556373094 32 ECHA discharge follow up 2022: https://echa.sharepoint.com/sites/1203/120301/Forms/AllItems.aspx?id=%2Fsites%2F1203%2F120301%2F12%2E0 3%2E01%2E02%20MB%20Meetings%2F2024%2FMB75_26-27_Sept%2F02_Docs%2FAPC%2E01_Follow- up_discharge_2022_recommendations_MB_29_2024%2Epdf&parent=%2Fsites%2F1203%2F120301%2F12%2E03%2 E01%2E02%20MB%20Meeting 33 https://oeil.secure.europarl.europa.eu/oeil/en/document-summary?id=1782930

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implementation is either ongoing or completed.

Environment management

Environmental and sustainability management

The 2024 objectives for environmental management at ECHA aimed at improving ECHA’s environmental performance as laid down in ECHA’s environmental policy (POL-0022) and to pave the way towards achieving climate neutrality by 2030. This was achieved through the implementation of ECHA’s environmental work-programme and by actively promoting sustainability with our environmental management system (EMS).

ECHA’s strategy is embedded in ECHA’s EMS where we aim to be a trusted chemicals agency, we respond to emerging challenges and changes in our legal landscape, and we actively communicate and engage with our stakeholders. Improvements and innovation in ECHA’s EMS are achieved through monitoring and verification, through process and legislative updates and by learning about developments with our stakeholders, particularly with other EU Institutions and Agencies.

Environmental objectives and indicators

Environmental Objectives 2023-25 (Benchmark year: 2019)

Target Result in 2024

Achieved

Building CO2 emissions 20% 75 % decrease Yes

Travel (meeting participants) CO2 emissions 50% 42 % decrease No

Travel (staff missions) CO2 emissions 50% 56 % decrease Yes

Through the continuous monitoring, reporting and verification of ECHA’s EMS, the CO2 reduction targets for staff travel and building emissions were met. The emissions target related to travel of meeting participants attending ECHA’s Committees was not met in 2024. This is primarily the result of the increased demand for in-person meetings to meet business needs, with this risk highlighted in the EMS audit report by the IAC. Nonetheless, it is considered that a 42% reduction, in a context of increasing business demands, is noteworthy. In addition, to partly mitigate the environmental impact of ECHA’s Committees, guidelines for sustainable meetings were issued in 2024 with a view to future ISO certification.

Furthermore, ECHA identified two environmental indicators that contribute to the Agency’s CO2 footprint. Whilst including new indicators increases ECHA’s total carbon footprint, it allows us to be comprehensive and transparent in our reporting which enables the Agency to better manage how we will mitigate our impact on the environment. The two new indicators related to emissions generated through hotel nights from ECHA staff travel, and the impact of teleworking were added to the calculation and reporting of our carbon footprint.

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ECHA’s EMS it is subject to regular audits to ensure that it performs according to our objectives. In addition to the assurance audit of ECHA Environmental management system conducted by ECHA’s IAC, four other audits took place in 2024: the ISO 14001 certification Audit, the EMAS Verification audit and two internal audits. The audits did not identify any non-conformities or critical, very important or important recommendations, and ECHA’s ISO certificate and EMAS registration were both renewed.

ECHA made progress in 2024 on greener and more sustainable procurement, when we strengthened the minimum environmental requirements that companies must meet to deliver IT services and now request evidence of compliance with the relevant standards.

Achieving climate neutrality

To achieve carbon neutrality by 2030, ECHA will need to compensate the unavoidable residual greenhouse gases (GHG) emissions. Planning for this this began in 2024 against the legislative provisions of the forthcoming CRCF Regulation, when ECHA initiated a pilot project on carbon removals. The CRCF will provide the legal certainty to purchase carbon credits through certified carbon removal schemes. Working with DG CLIMA and Finnish Centre for Economic Development, Transport and Environment the pilot project will allow ECHA to explore the possibility to compensate part of the Agency’s residual emissions using a responsible scheme, whilst avoiding reputational damage.

Communicating with stakeholders

Finally, to promote and implement ECHA’s environmental objectives, over 30 training and internal communications activities were undertaken during 2024 to promote climate awareness actions such as Earth Day, EU Green week and the Baltic Sea Day.

Within the EU Institutional landscape, ECHA published the EU Agencies’ Network “Charter on greenhouse gases (GHG) reduction and responsible environmental management”, which reflects ECHA’s environmental policy and objectives. To ensure good cooperation, communication and knowledge sharing throughout the year with our EU partners, ECHA participated to 10 events virtually. The events were organised by external stakeholders such as the Groupe Interinstitutionnel de Management Environmental (GIME) and the EUAN Greening Network (GN).

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EU Institutional information sessions and ad-hoc meetings

ICTAC & GN Joint meeting on EMAS GN Lecture on EIT Climate KIC PDN Meeting on sustainability reporting GN & NAPO Diversity and Inclusion in sustainability GN EMAS DE Advisory Board: Sustainability reporting under the CSRD GN Carbon compensation: Presentation by Climeworks and DG CLIMA GN Annual plenary meeting with external speakers: Vice-chair ICCP, DG

HR - GIME chair, COMM & ECHA. GN EMAS related good practice GIME Climate neutrality of the EU Institutions (ECHA presentation) - Twice.

Assessment by management

Based on the information in the Section II, no significant weaknesses or gaps that may threaten the achievement of ECHA’s objectives were identified. An overall conclusion taking into account the findings from the internal control assessment is available in Part III.

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Part III. Assessment of the effectiveness of the internal control systems Effectiveness of internal control system

Compliance and performance of ECHA under the Integrated Management System Strategy and Framework

The purpose of the annual internal controls assessment is to give reasonable assurance that ECHA’s management system is functioning, continuously improved, and that the objectives set out in Article 30 of the ECHA Financial regulation are met, namely: (I) effectiveness, efficiency and economy of operations; (ii) reliability of reporting; (iii) safeguarding of assets and information; (iv) prevention, detection, correction and follow-up of fraud and irregularities; and (v) adequate management of risks relating to the legality and regularity of the underlying transactions.

The reference for the assessment is ECHA’s Integrated Management System Strategy and Framework, (POL-0001) which supplements the financial regulation and aligns with the principles and guidelines set out by the European Commission (in the areas of internal control and programming) and with the ISO 9001:2015 and ISO 14001:2015 standards.

The assessment is based on a wide range of sources, such as internal and external audits, retrospective evaluations, risks, non-conformities, complaints, appeals, financial, operational, IT, environmental and HR reports, complemented with insights from self-assessments of managers, staff and stakeholders’ surveys. Internal control surveys were conducted to capture the self-assessment of Directors and Heads of Units with regard to the functioning of the ECHA’s management system. Stakeholders’ input was captured in the stakeholders survey and various retrospective evaluations and audits. Staff perception was captured in the staff survey (latest from 2023) and other internal reports and events. All sources mentioned above were analysed and triangulated to derive conclusions.

Following the recommendations from the IAS audit on ‘Budget preparation, monitoring and reporting’ in 2023, ECHA analysed the whole exceptions register. The detailed conclusions from the analysis of the exceptions register as well as the trend between 2023 and 2024 are available in the internal controls assessment for the year 2024.

For 2024, the assessment confirms that the Integrated Management System (IMS) is effective and functioning as intended. All directors and most middle managers agree that management commits to the core principles. Also, most of the detailed components are fully present and functioning (8 out of 12), while areas identified for improvement are not considered major, or critical, deficiencies of the whole IMS or about the objectives of Article 30 of the ECHA Financial Regulation. Details of the assessment are available in the next section. Improvement work is either ongoing or planned for 2025.

In terms of costing the controls, the Agency follows the definition in the General Financial Regulation34 of the EU, according to which ‘control’ means ‘any measure taken to provide reasonable assurance regarding the effectiveness, efficiency and economy of operations, the reliability of reporting, the safeguarding of assets and information, the prevention and detection and correction of fraud and irregularities and their follow-up, and the adequate management of the risks relating to the legality and regularity of the underlying transactions, taking into account

34 Financial Regulation applicable to the general budget of the Union: https://op.europa.eu/en/publication-detail/- /publication/e9488da5-d66f-11e8-9424-01aa75ed71a1

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the multiannual character of programmes as well as the nature of the payments concerned’.

Controls may involve various checks, as well as the implementation of any policies and procedures to achieve the objectives. Based on an approximation of the resources deployed in the units responsible for governance, human resources and financial management, as well as the average salary costs, the cost of controls as a percentage of the total budget are estimated to be around 2.8 % which is lower than the previous year, when the percentage was 3.4%.

The summary from the internal controls assessment as per the principles and characteristics of each component is covered in the next section below.

Risk management

Risk management is an integral part of ECHA’s Integrated Management System. The risks, that were identified as possibly jeopardising the achievement of the objectives defined in the Programming Document, were followed up regularly and a more detailed assessment was carried out every four months during the year. In 2024, ECHA further developed the implementation of the internal framework for addressing risk management in ECHA through the introduction of directorate-level risk registers. Regular updates were given to the Management Board and specific reporting continued on the IT-security related risks.

Transparency, accountability and integrity

Throughout 2024, the Agency lived up to its values of transparency and integrity, ensuring continued public and stakeholder trust in the impartiality and objectivity of ECHA’s work.

The decision-making processes of the Agency are designed to be clear, open and to ensure a balanced outcome based on a reasoned scientific approach. Information on the intentions of ECHA and the Member States – for example, to look into substances or create dossiers – is available online, so companies have access to the data they need to make informed business decisions.

Accredited stakeholder organisations may participate in scientific meetings as observers, except where confidential business information requires sessions to be closed. This gives them a chance to witness the debate and decision-making process and, where appropriate, express their views. Where consultations take place, the comments received are discussed and addressed. The reflections, minority opinions and conclusions of ECHA’s scientific committees are recorded in opinions and minutes, and these are published online.

ECHA maintains the world's largest regulatory database on chemicals. The database provides transparent information on the chemicals used in Europe today. In early 2024 ECHA launched ECHA CHEM, which is ECHA’s new public chemicals database launched. Initially, it includes data that companies have submitted in their REACH registrations. Over the coming years, ECHA will gradually transfer the data it makes publicly available from their current location (Search for chemicals) to ECHA CHEM.

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Prevention of conflicts of interest

Based on a thorough risk assessment of its activities, the Agency has identified the processes and sub-processes that require conflicts of interest to be managed. Conflict of interest checks are performed for more than 30 processes, sub-processes or process steps, including the main operational processes of the Agency.

In all these processes, a review of the annual declarations of interest is performed by the process owner each time a task is assigned to a staff member, while for some sensitive processes this is complemented with a case-specific declaration of no interest by the staff member.

If there is a potential conflict, the case is assigned to a different staff member. The approach is documented in detailed work instructions and guidance is available for those managing the interests to help them deal with individual cases. As a result, no cases of actual conflicts of interest among ECHA staff, affecting the output of the Agency were identified in 2024.

For the ECHA bodies, all members are assessed against the generic exclusion criteria agreed upon by the Management Board, at the time of their appointment. Once they take up their function, their annual declarations of interest are reviewed by the respective Chair and published on ECHA’s website.

Before each meeting of an ECHA body, specific declarations for items on the agenda are collected and documented in publicly available minutes together with the mitigating measures imposed. As most of the members of ECHA’s bodies are Member State public officials, the majority of the conflicts of interest declared by the members concerned involvement in preparing dossiers submitted by their Member State competent authority. In all such cases, the members concerned were not allowed to participate in the voting on such dossiers.

Post-employment

Members of staff must notify new occupational activities for the first two years after leaving the service of the Agency. ECHA can forbid the new activity or impose conditions.

In 2024, sixteen (16) staff members left ECHA: four (4) of them went to work for another EU institution, body or Agency. One (1) staff member moved to a national public administration or international organisation. Three (3) staff members moved to the private sector or started self- employment and, in one (1) of these cases, the Agency deemed it necessary to impose specific conditions due to the nature of the occupational activity or the role of the individual within their new occupation.

In the remaining eight (8) cases, ECHA has not (yet) been informed about a new occupational activity, as the departure was due to retirement, termination of contract or death of a staff member. None of these cases concerned a member of senior management.

An overview of the post-employment decisions of all former senior managers is published on ECHA’s website, including their names, date of departure, positions, their foreseen new occupational activities, and the outcomes of ECHA’s assessments35.

No breaches of trust or disciplinary procedure were initiated for conflict-of-interest management.

Conflict of Interest Advisory Committee

The Conflicts of Interest Advisory Committee (CoIAC) is an advisory body in the context of

35 https://echa.europa.eu/documents/10162/13559/post-employment_senior_managers_en.pdf/8567fc1f-1631-05fe- eceb-8817a0e110d1

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ECHA’s Procedure on Prevention and Management of Potential Conflicts of Interest. The Committee is available to the Management Board, the Committees, the Forum and the Executive Director for advice on matters related to potential conflicts of interest of ECHA staff or members of the Agency’s bodies.

The Committee comprises three members: Per Ängquist, appointed by the Management Board from among its members, Madeleine Healy, a Senior Compliance Expert from the Single Resolution Board, appointed as an external expert, and Minna Heikkilä, Head of ECHA’s Legal Affairs Unit as Chairperson. The external expert was newly appointed in 2024, following a public call for expression of interest. Three alternate external experts were also appointed at the same time.

In 2024, the CoIAC delivered five opinions. On 12 March 2024 the CoIAC advised on the prospective activity of a recently retired former Head of Unit of ECHA. The CoIAC did not find any reason justifying objections to this activity. On 9 April 2024 the CoIAC gave its advice to the Executive Director concerning an analysis of ECHA’s Policy on Prevention of Conflict of Interests and implementing rules with a view to the expanding role and mandates of the Committees and the actors involved around the Committee work. In July 2024, the CoIAC further advised on the application of the Policy in the context of the selection and appointment of the co-opted members for the Committees for Risk Assessment (RAC) and for Socio-economic Analysis (SEAC).

On 29 November 2024, the CoIAC convened for its annual meeting where two further requests for advice from the Executive Director and from the Chair of the Management Board were discussed. These related to the appointment of members of the RAC and to the perception of conflicts related to public procurement. The advice in both cases was further discussed and concluded in written procedure on 9 December 2024.

Ex-post controls

In line with the Procedure on Prevention and Management of potential Conflicts of Interest, ECHA may undertake ex-post controls to guarantee the effectiveness of the procedure.

A sample check on 11 annual declarations (DoI) submitted by the chairpersons of the ECHA bodies and expert groups revealed that all of them were in place, accurate and sufficiently complete to allow for effective conflict of interest prevention and management. However, while the internal DoI tool for submitting and verifying the annual declarations of interest of the ECHA staff contained an updated DoI for the four chairpersons of the MSC, RAC, SEAC and BPC, on the ECHA website an older and outdated version of this declaration was made publicly available. This however did not undermine the process of verifying conflicts of interest, as an up-to-date DoI was available for that purpose, but it did not give stakeholders a transparent view on the DoI as required.

In addition, ECHA’s Internal Audit Capability took sample checks during her audit of the testing proposal process to verify that conflict of interest checks were performed for ECHA colleagues for 2 testing proposal dossier examinations. It was confirmed that indeed such checks are systematically made for all testing proposal dossiers.

Fraud prevention

By design, the Agency’s internal control systems contain fraud prevention, with an emphasis on critical areas such as financial transactions, procurement and selections.

ECHA’s Code of Good Administrative Behaviour36 is well communicated to all staff members.

36 https://echa.europa.eu/documents/10162/13559/code_of_good_administrative_behaviour_en.pdf/a4aa94f7-f631- 43d6-8c28-77a10a0d0720

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Management Board decision 30/2009 of 23 April 2009 stipulates the terms and conditions for internal investigations in relation to the prevention of fraud, corruption, and any illegal activity detrimental to the Communities’ interests.

Guidelines for whistleblowers were first adopted in 2015 and updated in September 2018. Through these guidelines, ECHA ensures that its employees can always highlight any action which goes against the public interest.

The ECHA Anti-Fraud Strategy37 was revised by the ECHA Management Board in December 2022 and includes a focus on maintaining and further developing the anti-fraud culture in the Agency and regularly reviewing key policies and procedures. In autumn 2024 a mandatory all-staff e- learning was organised, with a focus on conflict of interest prevention and relations with interest groups, while also the Management Board members received an annual refresher on ethics.

Data protection

The Data Protection Officer is an independent function within the Agency, who advises the Agency and staff on compliance with privacy laws and regulations. He keeps the required records of processing operations centrally and acts as the liaison with the European Data Protection Supervisor.

In 2024, the focus areas of support concerned the regular review of data protection aspects of procured IT licences and software, the specific privacy risks involved with the migration of ECHA data to public cloud and the roll-out of the first AI pilot projects. Actions have also been taken in the context of one data protection related complaint and nine personal data breaches that occurred in ECHA and involving ECHA staff and/or stakeholders. Two of those personal data breaches were communicated to the European Data Protection Supervisor (EDPS), as legally required due to the risks to the rights and freedoms of the persons concerned. The first incident concerned personal data being published unredacted on the biocides dissemination website, while the second incident concerned the unauthorised disclosure of personal information due to a software bug in a new version of ECHA CHEM. The latter incident has also been reported to CERT-EU as an information security incident (more details on that incident are available under “Security and business continuity” below). As required, these cases were recorded and reported, and appropriate mitigating measures were agreed with process owners to prevent potential occurrence in the future.

Security and business continuity

Regarding cybersecurity the new EU regulation was adopted in December 2023 laying out several legal obligations. Implementation of the legal obligations has been ongoing in 2024 and will continue into 2025 and beyond. An initial maturity assessment has been conducted and an initial cybersecurity review and action plan prepared.

A risk assessment for the ICT environment has been conducted, with periodic follow up during the 2024 quarterly reporting cycle with a focus on risks that are medium likelihood and impact or higher.

Cybersecurity principles have been established and eight essential maturity assessments as mandated by the cybersecurity regulation have been conducted. In addition, regarding data protection various impact assessments were performed.

37 https://echa.europa.eu/documents/10162/10709201/final_mb_47_2022_annex1_anti-fraud-strategy_2023- 2026_en.pdf/c42eb6f4-1d61-5be9-83a4-3f4af5ee6b4e

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"Red Teaming" exercise conducted proposing several immediate, mid-term and long-term security improvements. Public Cloud security assessments were conducted, evaluating the security of ECHA’s cloud infrastructure and security risk.

Cybersecurity awareness campaign was continued with several Cybersecurity Awareness trainings provided in 2024 as follows: “GDPR – The 7 Principles of Data Protection”, “GDPR – Accountability and Compliance”, “What is Processing – Global Privacy”, “GDPR – What is Sensitive Personal Data”.

In June 2024, ECHA experienced a data breach incident. A new version of the application ECHA CHEM was deployed with a software bug, that allowed non-public information to be disseminated to the public. The error was noticed early August, and as the first action the application was shutdown. Investigation proved that the problem covered 680 registrations belonging to 291 legal entities i.e. companies, which were duly informed. The leaked dossiers were removed and after thorough testing the public access was restored 25th August. The corrected new version of the application was deployed successfully in late November. The case was also reported regularly to CERT-EU, where the final report was sent in January 2025.

The ECHA CHEM incident is not classified as a “High Impact Security Incident” because it was not caused by a cyberattack.

Conclusions of the assessment of the internal control systems

Component Conclusion

Governance

1.1 Purpose and vision

The implementation of ECHA’s new strategy is on a good path, however more efforts may be needed so that staff could link their work to the strategy. Stakeholders have an overall good understanding of ECHA’s role, aims and activities. The difference in the commitment of Directors and Heads of Units to the new strategy may bear risks for its successful implementation.

1.2 Values and behaviours

The principle is present and functioning. New values have been communicated and upheld in 2024. More efforts are needed to exemplify “innovation” and to further increase the transparency towards communicating decisions and information to stakeholders. Awareness raising efforts on dealing with sensitive topics need to remain high.

1.3 Management responsibility

The Integrated Management System is functioning, and management and staff are committed to its continual improvement. The overall management perception of ECHA’s delegation and empowering staff has improved. The quality assurance officers' satisfaction with the organisation of the Integrated Management system has improved as well. Areas for attention include the clarity in roles, responsibilities and accountabilities, minimising bureaucracy and ensuring sustainability in the day-to-day operations.

1.4 People (Human Resources)

ECHA has competent and highly qualified staff, and there is a management commitment to enhance staff and competence development. Areas of attention include the mapping of competence needs in particular with regards to the new tasks, the length of the selection procedures, the effective communication around the performance appraisal exercise and the adequate resourcing of HR and horizontal services.

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1.5 Stakeholders and partners

ECHA has invested lots of efforts in improving its stakeholders’ engagement approach in 2024 thus addressing effectively all weaknesses as identified in the Stakeholders’ audit. Some actions have already led to positive results in terms of increased stakeholders’ commitment. Stakeholders are overall satisfied with the support and services of ECHA, but request ECHA to put further efforts into timely and approachable communication and more visibility of how their input is taken into account. The roles and responsibilities with regards to the oversight of the stakeholders’ repository is an area for attention.

Strategy, planning and risk management

2.1 Goals planning and resource allocation

In 2024, ECHA started the implementation of its new strategy which is considered to be on a good path and well communicated. Watch out areas are linked to the unclarity in the formulation of negative priorities, allocation of resources in line with priorities, linking initiatives with strategic priorities, and developing indicators with their respective consistent definitions to serve the Management decision making.

2.2 Risk management

ECHA has put lots of efforts to strengthen its corporate risk management increasing the level of engagement of management and MB involvement. ECHA’s overall low risk appetite may become a hurdle towards the process improvements efforts of the Agency and implementing the value of the innovation. Areas for attention include the clarity of roles and responsibilities with regards to the consolidation and oversight of Units and Directorates risks, the different practices around project risk management and the inconsistency in performing cost-risk-benefit analysis and analysis of options when starting new projects.

Operations and operational structure

3.1 Activity management

The activity and process management is a strength for ECHA and allows synergies. The optimisation of some regulatory activities, like Biocides, is limited by the legal constraints within which they are required to operate. Areas for attention include the potential risk of overdependence on few contractors and the weaknesses in tracking the overall contractors’ performance.

3.2 Information and data management

ECHA has been able to find some synergies and reuse some of its existing platforms for new tasks. Stakeholders' satisfaction with ECHA’s website is overall high. Roles and responsibilities between IT and operational directorates need to be better defined. Areas for attention refer to the timeliness and completeness of incident reporting, as well as the increased risk of personal data breaches. The gap between the existing overall positive IT indicators and the low perception of management on the efficiency, security and reliability of IT systems is also a warning.

3.3 Change management

ECHA overall responds to changes flexibly whilst ensuring continuity of operations and changes foreseen with the Better Regulation may provide further agility. At the moment, ECHA’s organisational structure may be sometimes rigid and preventing innovation. Specific consideration should be paid to the prerequisites (including the legislative ones) for maintaining a flexible and agile management system in view of the changing stakeholders’ requirements and the onboarding of new tasks.

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Evaluation and improvement

4.1 Performance management

The adequacy of corporate metrics is currently being addressed, taking into account the balance between quantitative and qualitative indicators and the data expectations of the different stakeholders groups. No critical gaps were found from the analysis of non-conformities, complaints and exceptions register. Attention is required in the area of data management with the need to build more tailor – made and consistent reports that add more value to Management decision – making.

4.2 Assessments, audits, and evaluations

ECHA has adequate tools in their disposal to oversee the effectiveness, adequacy, and suitability of the Agency’s Integrated Management System through assessments, audits, and evaluations. There is a need to systematically discuss learnings from mistakes, have less cumbersome follow up audits and better integrate ex-post controls.

Statement of the manager in charge of risk management and internal control I, the undersigned,

Shay O’MALLEY

Director of Resources

In my capacity as manager in charge of risk management and internal control, I declare that in accordance with ECHA’s Internal Control Framework, I have reported my advice and recommendations on the overall state of internal control in the Agency to the Executive Director. I hereby certify that the information provided in the present Annual Report and in its annexes is, to the best of my knowledge, accurate, reliable and complete. Done in Helsinki, on 5 March 2025

signed

Shay O’MALLEY

Director of Resources

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Part IV. Management assurance Review of the elements supporting assurance The Authorising Officer performed an assessment of the effectiveness and efficiency of the internal control system, acknowledging that the system, based on ECHA’s Integrated Management Strategy and Framework, is functioning well. The assessment considered a broad range of input and fed into the Management Review 2024, where senior management of the Agency reflected on the strengths, weaknesses, risks and opportunities of the management system. No significant weaknesses that may have a potential impact on the declaration of assurance of the Authorising Officer were identified and reported in any of the relevant parts as set out in the present report. Reservations Not applicable

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Part V. Declaration of assurance

Declaration of assurance by the Authorising Officer

I, the undersigned,

Dr Sharon McGuinness

Executive Director of the European Chemicals Agency

In my capacity as Authorising Officer,

Declare that the information contained in this report gives a true and fair view,

State that I have reasonable assurance that the resources assigned to the activities described in this report have been used for their intended purpose and in accordance with the principles of sound financial management, and that the control procedures put in place give the necessary guarantees concerning the legality and regularity of the underlying transactions,

This reasonable assurance is based on my own judgement and on the information at my disposal, such as the results of the self-assessment, ex post controls, the work of the Internal Audit Capability, the recommendations of the Internal Audit Service and the lessons learnt from the reports of the Court of Auditors38 for years prior to the year of this declaration,

Confirm that I am not aware of anything not reported here which could harm the interests of the Agency.

Done in Helsinki, on 21 March 2025

signed

Dr Sharon McGuinness

Executive Director

38 With regard to the implementation of EU legislation and the fee regulations under the Agency’s remit, this assurance has to be limited to the field of competences of the Agency. Since ECHA’s mandate does not include controls or inspections at national level, it cannot be confirmed that only registered or authorised substances and products, for which a fee has been paid to the Agency, are circulating on the EU market.

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Annexes

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Annex I - Key indicators

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Annex II - Budget implementation reports and statistics on financial management

Budget overview

The initially budgeted total payment appropriations for the Agency’s expenditure in 2024, as concluded by the Management Board in December 2023, amounted to EUR 127.9 million, including c. EUR 0.8 million for the separately budgeted other tasks (“Contribution Agreements and SLAs” in the table below). During the year, two budget amendments were approved by the Management Board, primarily for the following reasons: a) incorporating the agreed amounts to be collected under the Contribution Agreements and SLAs (EUR 1.32 million increase), b) excluding the EU contribution (and EFTA contribution) relating to the water protection legislation, due to delay in its adoption (EUR 1.65 million decrease), c) incorporating the additional EU contribution reinforcement, concluded centrally for all EU Agencies following the adjustment in salaries (EUR 0.98 million increase), and d) adjusting the fee income and bank interest income (EUR 0.15 million net increase). The final total expenditure, concluded in the 2nd amending budget in November 2024, amounted to EUR 128.7 million, including EUR 2.1 million for the separately budgeted Contribution Agreements and SLAs.

Revenue Initial voted budget Amending budgets Final voted budget Total revenue 127 918 559 794 107 128 712 666

Expenditure Initial voted budget Amending budgets Final voted budget Commitment appropriations 127 955 559 530 848 128 486 407

Payment appropriations 127 918 559 794 107 128 712 666

Revenue

The budget funding of ECHA in 2024 consisted of the following (amounts in EUR):

Description Initial voted

Budget 2024

Amendments 2024

Final voted Budget 2024

Entitlements established

2024

Revenue received

2024 Fees and charges from Registrations & Updates 24 751 025 1 159 645 25 910 670 26 201 769 26 201 769 Fees and charges from Authorisations 2 970 000 (1 195 000) 1 775 000 1 707 126 1 707 126 Fees SME Administration 700 000 - 700 000 617 358 617 358 Fees and charges from CLP 90 500 - 90 500 66 500 66 500 Fees and charges from appeals - 12 556 12 556 29 298 29 298 Total REACH Fees & Charges Income 28 511 525 (22 799) 28 488 726 28 622 051 28 622 051

Fees relating to Biocidal Active Substances 712 975 (250 000) 462 975 570 500 570 500 Fees for Union Authorisation of Biocidal products 2 346 851 220 000 2 566 851 2 789 000 2 789 000 Miscellaneous fees 2 566 000 30 000 2 596 000 2 322 300 2 322 300 Fees and charges from appeals 0 2 500 2 500 5 000 5 000 Total BPR Fee & Charges Income 5 625 826 2 500 5 628 326 5 686 800 5 686 800

REACH EU Contribution 73 971 000 835 000 74 806 000 74 806 000 74 806 000 BPR EU Contribution 7 745 000 86 585 7 831 585 7 831 585 7 831 585 ENV EU Contribution 6 931 688 (1 540 460) 5 391 228 5 391 228 5 391 228 EFTA Contribution – REACH 2 499 040 - 2 499 040 2 499 040 2 499 040 EFTA Contribution – BPR 227 286 - 227 286 227 287 227 287 Confederation of Switzerland Contribution – BPR 346 201 - 346 201 346 201 346 201 EFTA Contribution – ENV 246 281 (55 148) 191 133 191 133 191 133 Total EU and other Contributions 91 966 496 (674 023) 91 292 473 91 292 475 91 292 475

Contribution Agreement EUON - - - 619 000 619 000 Contribution Agreement EUCLEF - - - 1 053 400 1 053 400 Contribution Agreement OELs - 975 000 975 000 975 000 975 000 Contribution Agreement SCBTH - - - 520 000 520 000 SLA with EFSA 784 712 345 000 1 129 712 1 129 712 1 129 712

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Annual Report 2024

Total Contribution Agreements and SLAs 784 712 1 320 000 2 104 712 4 297 112 4 297 112

Bank Interest Income 1 030 000 168 429 1 198 429 1 440 219 1 440 219 Other income – miscellaneous - - - 47 760 48 781 Total Administrative Operations Income 1 030 000 168 429 1 198 429 1 487 979 1 489 000

Total 127 918 559 794 107 128 712 666 131 386 416 131 387 437

REACH/CLP Revenue

A) REACH/CLP Fees and Charges

ECHA is financed through fees paid by industry and by an EU balancing contribution, in accordance with the REACH Regulation (No 1907/2006). The fees and charges collected by ECHA are determined by the REACH Fee Regulation and by the decisions of the Management Board.

Due to the one-off nature of REACH fees and their dependence on strategic decisions of the chemical industry players, there is high uncertainty as to their amount and timing.

The budgetary revenue from REACH fees and charges in 2024, in terms of cash received, amounted to EUR 28.59 million (EUR 30.90 million in 2023). In addition, EUR 0.03 million (EUR 0.03 million in 2023) was recorded in relation to REACH appeal fees39 giving a total of fees and charges of EUR 28.62 million (EUR 30.93 million in 2023).

Broken down by fee category, ECHA collected a total of EUR 26.20 million from REACH Registrations and Updates fees (EUR 26.68 million in 2023), EUR 1.71 million from Applications for Authorisation (EUR 3.30 million in 2023) and EUR 0.07 million from CLP fees (EUR 0.10 million in 2023). The additional registration fee income that was generated through the SME company size verification process (which is included in the REACH registrations and updates income) amounted to EUR 0.36 million in 2024 (EUR 0.52 million in 2023). On top of the additional registration fees, the Agency generated EUR 0.62 million in administrative charges (EUR 0.82 million in 2023) levied on companies who were deemed non-eligible for the granted SME fee rebates.

B) REACH/CLP Contributions from the General Budget of the EU

During 2024, the Agency received an EU balancing contribution for REACH/CLP of EUR 74.81 million (EUR 66.81 million in 2023) and a European Free Trade Association (EFTA) contribution of EUR 2.50 million (EUR 2.00 million in 2023).

BPR Revenue

A) BPR Fees and Charges

In accordance with the Biocidal Products Regulation (BPR, No 528/2012), ECHA is financed through fees paid by industry and a balancing EU contribution. The biocide fees and charges collected by ECHA are determined by the Biocidal Products Regulation and the BPR Fees and Charges Regulation. The budgetary revenue from biocidal product fees and charges for 2024, in terms of cash received, amounted to EUR 5.69 million (EUR 2.79 million in 2023). The significant increase in the collected BPR fee income relates primarily to the significantly increased number of Union Authorisation applications, for single products and for product family, received in 2024 compared to 2023 (25 applications in 2024 vs. 6 applications in 2023).

39 Income from appeal fees is recognised by ECHA only when a case has been decided and the Board of Appeal rules that the fee should not be refunded to the applicant.

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B) BPR Contributions from the General Budget of the EU

During 2024, the Agency received an EU balancing contribution of EUR 7.83 million (EUR 9.56 million in 2023) and an EFTA contribution of EUR 0.23 million (EUR 0.19 million in 2023). In addition, the Agency received a contribution from the Confederation of Switzerland of EUR 0.35 million (EUR 0.38 million in 2023). Environmental Policy Revenue In accordance with the Prior Informed Consent (PIC) Regulation (EU) No 649/2012, Persistent Organic Pollutants (POPs) Regulation (EU)2019/2021, Waste Framework Directive (SCIP) (EU) 2018/851 amending Directive 2008/98/EC, the revised Drinking Water Directive (DWD) Directive (EU) 2020/2184, the 8th Environmental Action Programme (8th EAP), the Batteries Regulation and the Industrial Emissions Directive (IED), ECHA is fully financed through an EU contribution for these activities. In 2024, the EU contribution amounted to EUR 1.31 million for PIC (EUR 1.22 million in 2023), EUR 0.31 million for POPs (EUR 0.29 million in 2023), EUR 1.09 million for SCIP (EUR 1.34 million in 2023), EUR 1.24 million for DWD (EUR 1.72 million in 2023), EUR 0.34 million for 8th EAP (EUR 0.33 million in 2023), EUR 0.48 million for the Batteries Regulation (new task in 2024) and EUR 0.62 million for IED (new task in 2024), totalling EUR 5.39 million (EUR 4.91 million in 2023). Furthermore, in 2024, the Agency received an EFTA contribution of EUR 0.19 million (EUR 0.14 million in 2023) in total for the above tasks. Contribution Agreements and Service Level Agreements The Agency has signed contribution agreements with the European Commission to implement the European Union Observatory for Nanomaterials (EUON) and the European Union Chemicals Legislation Finder (EUCLEF). ECHA has also signed a Service Level Agreement with the European Commission to provide opinions for occupational exposure limits (OELs). Additionally, the Agency has signed a Service Level Agreement with the European Food Safety Authority (EFSA) for developing and implementing IUCLID software solutions for plant protection products. Finally, in 2024, the Agency signed a contribution agreement with the European Commission for the implementation of tasks under the Serious Cross-Border Threats to Health (SCBTH), to carry out and deliver public health risk assessments on chemical incidents. In 2024, ECHA received an amount of EUR 4.30 million in aggregate for implementing these tasks. It is to be noted that the Agency has also signed a Service Level Agreement with the European Commission for work with respect to the Instrument for Pre-Accession Assistance (IPA), for which no additional funding was collected during 2024. Other miscellaneous income The table below shows the other miscellaneous income received by the Agency in 2024 and 2023 (amounts in EUR).

Description Revenue received

2024

Revenue received

2023

Bank Interest income 1 440 219 930 573 Legal recoveries - 50 791 Late interest income 3 425 6 176 Recoveries from other EU agencies 43 092 57 456 Other recoveries 2 264 14 052 Other income - miscellaneous 48 781 128 475 Total Administrative Operations Income 1 489 000 1 059 048

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Annual Report 2024

Fee Invoicing In accordance with Article 71 of the Agency’s Financial Regulation, the number of debit notes issued, and their global amount shall be provided in the Agency’s report on budgetary and financial management. In addition, where fees and charges are entirely determined by legislation or decisions of the Management Board, the Authorising Officer may abstain from issuing recovery orders and directly draw up debit notes after having established the amount receivable. Where the Agency uses a separate invoicing system, the Accounting Officer shall regularly, and at least on a monthly basis, enter the accumulated sum of fees and charges received into the accounts. The Agency uses a separate invoicing and debtors’ system for daily transactions related to fee income, namely the REACHIT (for REACH/CLP fees and charges) and REACH-NG (for Biocidal Products fees and charges) invoicing modules. The invoices raised and the payments received are recorded in the central accounting system on a monthly basis.

A) REACH Fees and Charges

The total net invoiced by the Agency in 2024 amounted to EUR 28.46 million (EUR 31.01 million in 2023 and EUR 33.02 million in 2022). The table below depicts the breakdown of the net invoiced REACH fees during the years 2022-2024.

REACH 2024 2023 2022

Description No of Invoices EUR No of

Invoices EUR No of Invoices EUR

Invoices issued 5 670 30 915 187 5 743 33 510 775 6 579 35 011 416 Credit Notes 150 (1 998 717) 131 (1 790 613) 494 (1 628 744) Unpaid 76 (455 495) 136 (710 941) 111 (364 332) Considered paid 14 (259) 14 (259) 17 (842)

Net Invoiced 28 460 716 31 008 962 33 017 498

Write offs - - 5 (87 682) 13 (238 488)

On 31 December 2024, the amount to be recovered for REACH fees and charges, before any year- end accounting adjustments, stood at EUR 1.89 million relating to 274 open invoices (on 31 December 2023, the amount to be recovered for REACH fees and charges, before any year end accounting adjustment, stood at EUR 2.05 million relating to 266 open invoices).

B) Biocidal Products Fees and Charges

The total net invoiced by the Agency in 2024 amounted to EUR 5.98 million (EUR 2.88 million in 2023 and EUR 6.80 million in 2022). The table below depicts the breakdown of the net invoiced BPR fees during the year.

BPR 2024 2023 2022

Description No of Invoices EUR No of

Invoices EUR No of Invoices EUR

Invoices issued 1 098 6 599 900 608 3 618 500 1 201 8 232 100 Credit Notes 56 (603 600) 51 (589 500) 103 (1 347 000) Unpaid 15 (17 000) 14 (149 500) 37 (81 400) Considered paid - - - - 3 (95)

Net Invoiced 5 979 500 2 879 500 6 803 605

On 31 December 2024, the amount to be recovered for Biocidal product fees and charges before any year end accounting adjustments, stood at EUR 0.48 million relating to 72 open invoices (on

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Annual Report 2024

31 December 2023, the amount to be recovered for BPR fees and charges, before any year end accounting adjustment, stood at EUR 0.18 million relating to 24 open invoices). Expenditure ECHA’s expenditure budget consists of commitment appropriations (CA) and payment appropriations (PA). The initial CAs totalled EUR 127.2 million and the initial PAs totalled EUR 127.1 million, while the figure concluded in the final budget is EUR 126.4 million for CAs and EUR 126.6 million for PAs. These commitment and payment appropriations consist of C1 funds only, i.e. excluding the R0 funds ("Contribution Agreements and SLAs") of EUR 0.8 million from initial Budget and EUR 2.1 million from final budget.

Budget expenditure includes payments made during the year and the carry-over of budgetary appropriations. Summary of the execution of appropriations per title and a more detailed breakdown is provided in the ‘Statistics on Financial Management and Budget (Expenditure)’ section below. Changes and implementation of the commitment appropriations for 2024 (C1) The initially adopted budget for the Agency in 2024 was EUR 127.2 million and the overall net decrease during the year, including 26 transfers and two amending budgets, was c. EUR 0.8 million, to arrive at EUR 126.4 million as the final budget.

The final executed amount totalled EUR 125.8 million corresponding to an execution rate of 99.5 % for the appropriations. Carry over of appropriations to 2025 The commitment and payment appropriations carried over to 2025 totals EUR 15.9 million, corresponding to 12.6 % of the committed amount.

The carry-over of staff related expenditure, budgeted in Title 1, was insignificant and mainly relates to the commitments for training and interim services.

In Title 2, covering the Agency’s infrastructure, the carry-over totalled EUR 3.4 million, stemming mainly from commitments related to ECHA’s IT services.

The operational expenditure required to implement the Work Programme for the different regulations is budgeted in Title 3 for REACH and CLP, in Title 4 for Biocides, and in Title 5 for the Environmental Policy (PIC, POPs, Waste Framework Directive (SCIP), Drinking Water Directive, the 8th Environmental Action Programme, Batteries Regulation and Industrial Emissions Directive). The carry-over in operational titles totalled EUR 12.2 million and is mostly related to IT development projects.

The relatively high level of carry-overs stems from the contracting cycle caused largely by the uncertainty in the fee income. In the past years, ECHA has had to wait late in the year before signing the contracts to make sure sufficient funds will be available, and at the same time, has had to sometimes frontload certain projects when the income has exceeded the estimates. This had led to a situation where, during the first part of the year, the focus has been on implementing the projects carried over and new projects are only commenced during the second half and sometimes even during the last quarter of the year.

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Annual Report 2024

Implementation of the appropriations carried over from 2023 (C8) The amount carried over from 2023 totalled EUR 14.4 million and the finally executed amount was EUR 14.3 million, corresponding to 99.4 %. The cancelled 0.6 % relates mostly to meetings that took place at the end of 2023, where the actual costs were lower than anticipated, and lower than anticipated costs for legal services related to debt collection of administrative charges in Title 3. Late interest payments During the year 2024, ECHA did not pay late interest for commercial invoices. Procurement procedures During 2024 budget implementation:

• ECHA signed a total 368 contracts and purchase orders40. • 282 were specific contracts and orders under existing framework contracts (FWC) and 86

were contracts resulting from new tendering procedures. • ECHA concluded 9 new FWCs:

o for management standard certification services, o for methodological developments and data generation for the assessment and

building of sets of nanoforms (NAMs), o for scientific and technical support work related to hazard assessment and

identification (4 lots), o for support on the POP dossier for D4, D5 and D6, o for support to risk management work under REACH and other legislations

(restriction support), o for interim services, o for canteen and catering services, o for travel services, o for office supplies.

ECHA also signed multiannual contracts for banking services and the info desk and established a Dynamic Purchasing System (DPS) for IT services. ECHA joined 8 inter-institutional FWCs:

• for thematic communication services (COM), • for impact assessment, evaluation, studies in communications (COM), • for digital communication and social media (COM), • for data protection advice, consultancy and related services II (EBA), • for engagement and community management services (EFSA), • for learning and development services for staff on general skills, resilience & wellbeing

(EPSO), • for EU IPR management and annuities & renewal services (JRC) • for legal advice services in respect of EU intellectual property rights (JRC).

A total of 20 contracts were signed following negotiated procedures without prior publication, based on the relevant rules of the Financial Regulation (Annex 1–11.1):

• 13 for legal services • 7 (for technical reasons) for specific scientific expertise, for subscriptions to scientific

40 This number also includes amendments with budgetary commitment.

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Annual Report 2024

database and professional journals, as well as for specialised software.

In 2024, the performance of the suppliers of the Agency was satisfactory overall and in accordance with the terms of the contracts, with few exceptions, which were successfully addressed by ECHA. Preliminary market consultation in the form of questionnaires to be filled in by potential tenderers continues being an established practice in ECHA, before launching procurement. Green Public Procurement (GPP) remains a priority and an integral part of the Agency’s management system and was extended beyond technical equipment also to apply to tenderers providing human labour-based services/expert services (DPS for IT services). Furthermore, ECHA used demonstration of social responsibility as part of the financial award criterion in the new FWC for interim services. The introduction of Qualified Electronic Signature for all Authorising Officers directly in EasySign workflow tool has brought significant efficiencies to signing contracts. Through the NAPO network the procurement team joined an expert group to analyse possibilities, limitations and legality of using artificial intelligence in procurement procedures. ECHA continued relying on IT tools (e.g., Cloudia for the DPS, PPMT) in its procurement and contract processes. The annual list of contractors is published by ECHA by 30 June of each year for the previous year on ECHA’s website 41. Acts of delegation and sub delegation For the purposes of the budget implementation, and in line with Article 41(1) of ECHA’s Financial Regulation, the Executive Director as the Authorising Officer of the Agency has delegated financial powers to the directors for the budget lines which they are responsible for, in line with their activities.

In accordance with Article 41(2), the directors have further sub-delegated financial powers to the heads of unit of their directorates.

For efficiency reasons, the Executive Director has also delegated financial powers to authorise payments below EUR 8 000 to staff in the Finance Unit.

41 https://echa.europa.eu/view-article/-/journal_content/title/annual-list-of-awarded-contracts

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Annual Report 2024

Statistics on Financial Management and Budget (Expenditure)

Budget 2024: Breakdown and changes in commitment appropriations and implementation of the appropriations for the current year (C1) per Title* (EUR)

Title Description Budget 2024 (1)

Transfers / amendments

(2)

Final Available

Commitment Appropriations

(3)

Executed Commitment

Amount (4)

% Committed

(4)/(3)

Final Available Payment

Appropriations (5)

Executed Payment Amount

(6)

% Paid

(6)/(5)

Carried over RAL (C8)

(7)

Carried over %

(7)/(4)

Cancelled (3)-(4)

A-1 STAFF 83 470 319 -161 235 83 309 084 83 077 124 99.7% 83 309 084 82 825 344 99.4% 251 781 0.3% 231 960

A-2 BUILDING. EQUIPMENT AND MISCELL OPER EXPEND 19 375 816 2 748 784 22 124 600 22 105 259 99.9% 22 124 600 18 720 102 84.6% 3 385 157 15.3% 19 341

B0-3 OPERATIONAL EXPENDITURE - REACH/CLP 18 936 545 -2 437 833 16 498 712 16 217 153 98.3% 16 724 971 7 240 868 43.3% 9 178 319 56.6% 281 559

B0-4 OPERATIONAL EXPENDITURE - BIOCIDES 2 609 929 -124 718 2 485 211 2 441 849 98.3% 2 485 211 884 206 35.6% 1 557 644 63.8% 43 362

B0-5 OPERATIONAL EXPENDITURE - ENVIRONMENTAL POLICY 2 778 238 -814 150 1 964 088 1 958 107 99.7% 1 964 088 475 451 24.2% 1 482 657 75.7% 5 981

127 170 847 -789 152 126 381 695 125 799 492 99.5% 126 607 954 110 145 970 87.0% 15 855 557 12.6% 582 203

*Note: As ECHA operates with both differentiated (multi-annual) and non-differentiated (annual) budget lines, the funds reserved for commitments (commitment appropriations) do not equal the funds reserved for payments (payment appropriations). The results for the administrative titles 1 and 2 are combined for all three regulations.

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Annual Report 2024

Budget 2024: Breakdown and changes in commitment appropriations and implementation of the appropriations for the current year (C1) per Regulation and Title (EUR)

REACH/CLP

Title Description Budget 2024 (1)

Transfers / amendments

(2)

Final Available

Commitment Appropriations

(3)

Executed Commitment

Amount (4)

% Committed

(4)/(3)

Final Available Payment

Appropriations (5)

Executed Payment Amount

(6)

% Paid

(6)/(5)

Carried over

RAL (C8) (7)

Carried over %

(7)/(4)

Cancelled (3)-(4)

A-1 STAFF 70 761 345 1 081 796 71 497 541 71 315 955 99.7% 71 497 541 71 099 811 99.4% 216 144 0.3% 181 586

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND 16 120 675 1 974 979 18 441 254 18 425 175 99.9% 18 441 254 15 575 125 84.5% 2 850 051 15.5% 16 079

B0-3 OPERATIONAL EXPENDITURE - REACH/CLP 18 936 545 -2 437 833 16 498 712 16 217 153 98.3% 16 724 971 7 240 868 43.3% 9 178 319 56.6% 281 559

105 818 565 618 942 106 437 507 105 958 283 99.5% 106 663 766 93 915 804 88.0% 12 244 513 11.6% 479 224

BIOCIDES

Title Description Budget 2024 (1)

Transfers / amendments

(2)

Final Available

Commitment Appropriations

(3)

Executed Commitment

Amount (4)

% Committed

(4)/(3)

Final Available Payment

Appropriations (5)

Executed Payment Amount

(6)

% Paid

(6)/(5)

Carried over

RAL (C8) (7)

Carried over %

(7)/(4)

Cancelled (3)-(4)

A-1 STAFF 9 255 539 -21 813 9 213 776 9 204 749 99.9% 9 213 776 9 181 950 99.7% 22 799 0.2% 9 027

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND 2 208 845 270 616 2 499 411 2 497 199 99.9% 2 499 411 2 134 092 85.4% 363 108 14.5% 2 212

B0-4 OPERATIONAL EXPENDITURE - BIOCIDES 2 609 929 -124 718 2 485 211 2 441 849 98.3% 2 485 211 884 206 35.6% 1 557 644 63.8% 43 362

14 074 313 124 085 14 198 398 14 143 797 99.6% 14 198 398 12 200 247 85.9% 1 943 550 13.7% 54 601

ENVIRONMENTAL POLICY

Title Description Budget 2024 (1)

Transfers / amendments

(2)

Final Available

Commitment Appropriations

(3)

Executed Commitment

Amount (4)

% Committed

(4)/(3)

Final Available Payment

Appropriations (5)

Executed Payment Amount

(6)

% Paid

(6)/(5)

Carried over

RAL (C8) (7)

Carried over %

(7)/(4)

Cancelled (3)-(4)

A-1 STAFF 3 453 435 -846 218 2 597 767 2 556 421 98.4% 2 597 767 2 543 582 97.9% 12 838 0.5% 41 346

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND 1 046 296 128 189 1 183 935 1 182 884 99.9% 1 183 935 1 010 885 85.4% 171 998 14.5% 1 051

B0-5 OPERATIONAL EXPENDITURE - ENVIRONMENTAL POLICY 2 778 238 -814 150 1 964 088 1 958 107 99.7% 1 964 088 475 451 24.2% 1 482 657 75.7% 5 981

7 277 969 -1 532 179 5 745 790 5 697 412 99.2% 5 745 790 4 029 918 70.1% 1 667 493 29.3% 48 378

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Annual Report 2024

Budget 2024: Implementation of differentiated appropriations (EUR)

Budget line Available

commitment appropriations

Commitments made %

Available payment

appropriations

Payments made %

B3-111 Substance evaluation and Rapporteurs (Multiannual) 618 894 617 815 99.83% 838 152 814 001 97.12%

B3-801 Cooperation with international organisations for IT programs 502 300 500 015 99.55% 509 301 505 864 99.33%

Total 1 121 194 1 117 830 c.100% 1 347 453 1 319 865 97.95%

Out of the total available commitment appropriations of EUR 1 562 595, the amount of EUR 891 719 is stemming from commitments made in earlier financial years. The available commitment appropriations for 2024 totalled EUR 1 121 194 out of which EUR 1 117 830 (c.100%) were committed.

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Annual Report 2024

Budget 2024: Implementation of assigned revenue (C4, C5, R0) (EUR)

Title Description FS Commitments Appropriations

Commitments Established Com % Payments

Appropriations Payments Executed Pay%

Carried over commitment

appropriations

Carried over payment

appropriations

A-1 STAFF C4 43 602 0 0.0% 43 602 0 0.0% 43 602 43 602

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND C4 3 425 0 0.0% 3 425 0 0.0% 3 425 3 425

B0-3 OPERATIONAL EXPENDITURE - REACH/CLP C4 1 243 0 0.0% 1 243 0 0.0% 1 243 1 243

C4 48 270 0 0.0% 48 270 0 0.0% 48 270 48 270

Title Description FS Commitments Appropriations

Commitments Established Com % Payments

Appropriations Payments Executed Pay%

Carried over commitment

appropriations

Carried over payment

appropriations

A-1 STAFF C5 20 345 20 345 100.0% 20 345 20 345 100.0% 0 0

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND C5 6 176 6 176 100.0% 6 176 6 176 100.0% 0 0

B0-3 OPERATIONAL EXPENDITURE - REACH/CLP C5 29 477 28 009 95.0% 29 477 25 791 87.5% 0 2 219

B0-4 OPERATIONAL EXPENDITURE - BIOCIDES C5 153 153 100.0% 153 153 100.0% 0 0 C5 56 150 54 682 97.4% 56 150 52 464 93.4% 0 2 219

BL Description FS Commitments Appropriations

Commitments Established Com % Payments

Appropriations Payments Executed Pay%

Carried over commitment

appropriations

Carried over payment

appropriations

B6-000 IPA programme R0 472 488 185 892 39.3% 472 488 185 732 39.3% 286 596 286 756

B6-010 EUON R0 1 513 432 844 452 55.8% 1 513 432 578 167 38.2% 668 981 935 266

B6-011 EUCLEF R0 3 280 552 1 607 166 49.0% 3 280 552 981 274 29.9% 1 673 385 2 299 277

B6-020 Occupational exposure limits R0 1 560 820 950 210 60.9% 1 560 820 818 365 52.4% 610 610 742 455

B6-021 Further development of IUCLID (w/ third parties) R0 1 898 451 1 600 758 84.3% 1 898 451 1 198 843 63.1% 297 693 699 608

B6-022 Support to cross-border threats to health (SCBTH) R0 520 000 0.0% 520 000 0.0% 520 000 520 000

R0 9 245 744 5 188 479 56.1% 9 245 744 3 762 381 40.7% 4 057 265 5 483 362

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Annual Report 2024

Budget 2024: Implementation of the appropriations carried forward from previous year (C8) Per Title (EUR)

Title Description Carried Forward from 2023 Paid Cancelled % Cancelled

A-1 STAFF 296 082 290 902 5 180 1.7%

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND 2 606 583 2 595 821 10 762 0.4%

B0-3 OPERATIONAL EXPENDITURE - REACH/CLP 8 610 244 8 556 134 54 110 0.6%

B0-4 OPERATIONAL EXPENDITURE - BIOCIDES 1 269 456 1 256 830 12 626 1.0%

B0-5 OPERATIONAL EXPENDITURE - ENVIRONMENTAL POLICY 1 588 521 1 586 926 1 595 0.1%

14 370 886 14 286 613 84 273 0.6%

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Annual Report 2024

Annex III – Organisational chart

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Annual Report 2024

Annex IV - Establishment plan and additional information on human resources management

Last establishment plan adopted

Category and grade

Establishment plan in voted EU Budget 2024 Posts filled 31 December 202442

TA TA REACH/

Biocides ENV TOTAL REACH/

Biocides ENV TOTAL CLP CLP

AD 15 0 0

AD 14 6 6 3 3

AD 13 13 1 14 4 4

AD 12 12 2 14 11 1 12

AD 11 30 1 31 17 1 18

AD 10 41 5 46 46 6 52

AD 9 60 10 1 71 41 7 1 49

AD 8 52 9 61 60 7 67

AD 7 53 9 6 68 48 4 1 53

AD 6 27 5 10 42 41 9 4 54

AD 5 16 1 17 32 6 4 42

Total AD 310 43 17 370 303 41 10 354

AST 11 0 0

AST 10 0 0

AST 9 3 3 0

AST 8 8 8 6 6

AST 7 10 1 2 13 12 12

AST 6 18 1 19 18 1 1 20

AST 5 26 3 2 31 17 2 19

AST 4 16 3 2 21 10 4 3 17

AST 3 10 1 11 13 2 15

AST 2 3 3 14 2 16

AST 1 0 0

Total AST 94 9 6 109 90 9 6 105

AST/SC 6 0 0

AST/SC 5 0 0

AST/SC 4 0 0

AST/SC 3 0 0

AST/SC 2 0 0

AST/SC 1 0 0

TOTAL AD+AST 404 52 11 467 393 50 16 459

CA CA

42 Under recruitment (included in figures): REACH: 2 TAs

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estimated need of FTEs 2024 posts filled 31 December 202443

REACH/ Biocides ENV Other

tasks TOTAL REACH/

Biocides ENV Other tasks TOTAL

CLP CLP

CA FG IV 27 7 12 13 59 18 6 5 9 38

CA FG III 53 6 3 1 63 57 6 6 4 73

CA FG II 17 2 0.5 19.5 19 2 21

CA FG I 0 0 TOTAL 97 15 15 14.5 141.5 94 14 11 13 132

Percentage of posts filled on 31 December 2024

REACH/ CLP Biocides ENV

TA posts 97.28% 96.15% 69.57%44

CA posts 96.91% 93.33% 73.33%

Geographical and gender balance (as per 31 December 2024)45

Nationality TA CA OVERALL

% Male Female Total Male Female Total Sum

1 AT Austrian 3 4 7 0 0 0 7 1.2%

2 BE Belgian 11 10 21 2 1 3 24 4.1%

3 BG Bulgarian 1 9 10 3 4 7 17 2.9%

4 CY Cypriot 0 0 0 1 0 1 1 0.2%

5 CZ Czech 0 3 3 1 0 1 4 0.7%

6 DE German 17 7 24 0 0 0 24 4.1%

7 DK Danish 1 1 2 0 0 0 2 0.3%

8 EE Estonian 0 6 6 1 0 1 7 1.2%

9 ES Spanish 18 12 30 5 4 9 39 6.6%

10 FI Finnish 57 87 144 15 31 46 190 32.3%

11 FR French 20 15 35 3 7 10 45 7.7%

12 GR Greek 15 7 22 4 6 10 32 5.4%

13 HR Croatian 0 0 0 0 2 2 2 0.3%

14 HU Hungarian 2 7 9 0 4 4 13 2.2%

15 IE Irish 10 7 17 0 1 1 18 3.1%

16 IS Iceland 0 0 0 0 0 0 0 0.0%

17 IT Italian 23 18 41 6 5 11 52 8.8%

18 LI Liechtenstein 1 0 1 0 0 0 1 0.2%

19 LT Lithuanian 1 6 7 0 0 0 7 1.2%

20 LU Luxembourger 0 0 0 0 0 0 0 0.0%

21 LV Latvian 2 5 7 0 1 1 8 1.4%

22 MT Maltese 0 3 3 0 0 0 3 0.5%

23 NL Dutch 9 5 14 3 1 4 18 3.1%

43 Under recruitment (included in figures): BIOCIDES: 1 CA. 44 The posts related to the Water directives (3 TAs and 4 CAs) were expected to come to ECHA during 2024 and were foreseen in the Authorised budget. However, the posts were not received in 2024. This negatively affects the 'posts filled' ratio. 45 Data in the table includes statutory staff in place on the indicated date. Posts under recruitment are not included.

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24 NO Norwegian 0 1 1 0 0 0 1 0.2%

25 PL Polish 8 10 18 1 2 3 21 3.6%

26 PT Portuguese 6 7 13 0 2 2 15 2.6%

27 RO Romanian 3 5 8 2 8 10 18 3.1%

28 SE Swedish 3 2 5 1 0 1 6 1.0%

29 SI Slovenian 3 3 6 1 1 2 8 1.4%

30 SK Slovakian 1 2 3 0 2 2 5 0.9%

31 Other Other 0 0 0 0 0 0 0 0.0% TOTAL 215 242 457 49 82 131 588 100.0%

Middle and senior management – gender and nationality overview46

NATIONALITY MALE FEMALE TOTAL %

BE Belgian 2 0 2 5.9%

DE German 2 0 2 5.9%

ES Spanish 2 1 3 8.8%

FI Finnish 3 4 7 20.6%

FR French 3 1 4 11.8%

GR Greek 1 0 1 2.9%

IE Irish 4 2 6 17.6%

IT Italian 2 0 2 5.9%

MT Maltese 0 1 1 2.9%

NL Dutch 2 0 2 5.9%

PT Portuguese 1 0 1 2.9%

RO Romanian 0 1 1 2.9%

SE Swedish 1 0 1 2.9%

SI Slovenian 1 0 1 2.9%

Total OVERALL 24 10 34 100%

Results of the screening / benchmarking exercise

Key functions

Type of contract (official, TA or CA)

Function group, grade

of recruitment

(or bottom of grade bracket if published with such

Indication whether the function is dedicated to

administrative support or operations subject to

definitions used in screening methodology

Core functions

Executive Director TA – 5+5

years AD 14 Management-Operations

Deputy Executive Director

TA – 5+5 years +

indefinite

AD 14 Management-Operations

Director (Head of Directorate) (Level 2) TA – 5+5 AD 12 Management-Operations

46 Data in the table includes statutory staff in place on the indicated date. Posts under recruitment are not included.

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Annual Report 2024

Key functions

Type of contract (official, TA or CA)

Function group, grade

of recruitment

(or bottom of grade bracket if published with such

Indication whether the function is dedicated to

administrative support or operations subject to

definitions used in screening methodology

years + indefinite

Head of Unit (Level 3)

TA – 5+5 years +

indefinite

AD 9 Operations/Administration

Administrator

TA – 5+5 years +

indefinite

AD 5 and higher

depending on profile

Operations/Administration

Administration

Head of Administration (Head of Directorate) (Level 2)

TA – 5+5 years +

indefinite

AD 12 Management- Administration

Head of Human Resources (Level 3)

TA – 5+5 years +

indefinite

AD 9 Administration

Head of Finance (Level 3)

TA – 5+5 years +

indefinite

AD 9 Administration

Head of Communications (Level 3)

TA – 5+5 years +

indefinite

AD 9 Administration

Head of IT (Level 3)

TA – 5+5 years +

indefinite

AD 9 Administration

Assistant

TA - 5+5 years +

indefinite

AST 1 and higher

depending on profile, up to

AST 4

Operations/Administration

Special functions

ECHA Committee Chair TA - 5+5 years +

indefinite AD 10 Operations

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Annual Report 2024

Key functions

Type of contract (official, TA or CA)

Function group, grade

of recruitment

(or bottom of grade bracket if published with such

Indication whether the function is dedicated to

administrative support or operations subject to

definitions used in screening methodology

Board of Appeal Chair TA – 5+5

years AD 12 Operations

Data Protection Officer

TA - 5+5 years +

indefinite

AD 6 Administration

Accounting Officer

TA - 5+5 years +

indefinite

AD 8 Administration

Internal Auditor

TA - 5+5 years +

indefinite

AD 10 Administration

Benchmarking against previous results

ECHA undertook the benchmarking (job screening) exercise in 2024, in accordance with the Commission’s requirements. The 2024 results indicate a decrease of 2.6% in the percentage of administrative support and coordination staff, an increase of 2.1% in the percentage of the operational staff and an increase of 0.5% in the percentage of neutral staff in comparison to 2023.

Job Type (sub) category 2023 (numbers in %) 2024 (numbers in %)

Administrative support and Coordination 14.8 12.2

Administrative Support 12.1 9.6

Coordination 2.8 2.6

Operational 81.6 83.7

Top level Operational Coordination 2.5 2.4

Programme management and Implementation 56.1 61.9

Evaluation & Impact assessment 3.2 2.3

General operational 19.8 17.1

Neutral 3.6 4.1

Finance/ Control 3.6 4.1

Linguistics 0.0 0.0

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Annual Report 2024

Annex V – Human and financial resources by activity

Work Programme activity

Actual consumption of

the human resources

Executed budget 2024

1.1 Dossier preparation 26 6 929 896 1.2 Dossier submission and processing 34 8 480 661 1.3 Identification and prioritisation of substances and groups of substances

41 10 115 816

1.4 Evaluation 86 16 784 194 1.5 Authorisation 29 6 132 956 1.6 Restrictions 30 6 318 755 1.7 Classification and labelling 33 6 517 743 1.8 Data management and dissemination 29 10 540 388 1.9 Promotion of alternatives to animal testing 4 1 316 944 2. Biocides 50 11 183 632 3. Environmental policy 25 4 841 570 4. Tasks under grant, cooperation and service-level agreements

18 5 188 479

Governance and enablers 194 36 636 938

Overall TOTAL 599 130 987 971

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Annual Report 2024

Annex VI – Contribution, grant and service-level agreements

General information Financial and HR impacts

Actual or expected date of

signature

Total amount Duration Counterpart Short

description

2023 2024

Grant agreements

1. IPA 20.12.2022 675 103 42 months

Commission DG NEAR

Amount Number of CA 1.5 1.5

Number of SNEs - -

Amount Number of CA 1.5 1.5

Number of SNEs - -

Contribution agreements

1. EUCLEF 10.12.2021 5 829 200 5 years (2021- 2025)

Commission DG GROW

Amount Number of CA 0 0

Number of SNEs - -

2. EUON 09.12.2021 3 066 000 5 years (2021- 2025)

Commission DG GROW

Amount Number of CA 3 3

Number of SNEs

3. SCBTH 15.11.2024 520 000 3 years (2025- 2027)

Commission

DG SANTE

Amount Number of CA 0 0

Number of SNEs - -

Amount Number of CA 3 3

Number of SNEs - -

Service-level agreements

1. IUCLID for EFSA

26.03.2021 Annual fee of 784 712 plus project cost

N/A EFSA

Amount Number of CA 4 4

Number of SNEs - -

2. OEL 23.02.2022 195 000 per opinion

18-24 months per case

Commission DG EMPL

Amount Number of CA 4 4

Number of SNEs - -

Total service-level agreements

Amount Number of CA 8 8

Number of SNEs - -

TOTAL (contribution agreements and SLAs) Amount Number of CA 12.5 12.5

Number of SNEs

- -

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Annual Report 2024

Annex VII - Environment management Context of the Agency and its environmental management strategy ECHA implements the EU’s chemicals legislation to protect health and the environment. Our work also contributes to a well-functioning internal market, innovation and the competitiveness of Europe’s chemicals industry. Through ECHA’s work, better knowledge and regulation of harmful chemicals helps to protect workers, consumers and the environment, makes recycling easier, and encourages industry to develop safer alternatives. ECHA has an environmental policy which commits ECHA to continually improve its environmental performance. ECHA supports the political priorities of the EU, as enshrined in the European Green Deal and the EUAN Strategy 2021-2027. To this end, ECHA has pledged to climate-neutral by 2030. Finally, ECHA’s environmental objectives are fully aligned with the “Charter on greenhouse gases (GHG) reduction and responsible environmental management”, adopted by the Head of EU Agencies in February 2024, which set additional ambitious objectives to achieve Carbon Neutrality by 2030. Overview of the Agency's environmental management system ECHA established an Environmental Management System (EMS) in 2015 - part of the Agency’s integrated management system - which aims to deliver on ECHA’s strategy, vision, goals and objectives. ECHA’s environmental objectives, targets and actions reflect our commitment to incorporating sustainability measures within all areas of our activities. This is implemented through our multi-annual environmental work programme (2023-2025) and the internal follow- up of actions and reporting of progress. In 2024, ECHA was recertified under ISO 14001:2015 standard (Environmental Management System) and ECHA’s EMAS registration was renewed and extended until 2027.

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Annual Report 2024

Environmental aspects, indicators and targets

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Annual Report 2024

Actions taken to improve and communicate environmental performance 2024 was the second year of ECHA’s updated multi-annual Environmental Work Programme (2023-2025) which maintained the previous objectives and introduced new actions and targets.

Goal Multi-annual work programme

Actions implemented in 2024

F1 Inform and involve all staff in greening ECHA.

Green communications plan, training and info sessions. Continue ECHA’s active participation in the Greening Network of the EU Agencies.

Promoted over 30 staff information campaigns. Participated at 9 GIME and EUAN GN meetings. Published the EUAN “Charter on greenhouse gases (GHG) reduction and responsible environmental management on ECHA’s website.

F1 Inform and involve all staff in greening ECHA.

Continue to develop ECHA’s sustainability reporting in all areas (for example, energy and climate).

Began developing a pilot project on carbon capture to begin CO2 offsetting under the EU carbon removals and carbon farming certification framework.

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Annual Report 2024

F1 Inform and involve all staff in greening ECHA.

Continue to develop ECHA’s sustainability reporting in all areas (for example, energy and climate).

Communicated the outcomes and improvement areas of the 2024 ISO, EMAS, Internal Audit (under the IAC) and 2 specific internal audits (under the EMAS Regulation) of its Environmental Management System.

F3 Strengthen green public procurement (GPP).

Develop and apply a GPP checklist for procurement.

Further strengthened environmental and sustainability standards into ECHA procurement (including the canteen services) and introduced Environmental Certification requirements for ICT services.

F4 Improve sustainability of events.

Introduce relevant guidelines for sustainable meeting organisation.

Introduced relevant guidelines for sustainable meeting organisation.

F6 Extend scope of ECHA’s carbon footprint.

Establish baseline and reduction targets for CO2 emissions from teleworking, waste and hotel nights.

Reviewed the scope of ECHA’s CO2 footprint and included CO2 emissions from teleworking and hotels nights related staff travel in order to ensure a comprehensive overview and to avoid reporting gaps and reputational damage which will be included in future environmental reports.

EUROPEAN CHEMICALS AGENCY P.O. BOX 400, FI-00121 HELSINKI, FINLAND ECHA.EUROPA.EU

1 (1) D(2025)0362 Helsinki, 28 April 2025 SMG/gsr

P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | echa.europa.eu

To the Permanent Representations of the EU Member States Per email only Subject: Annual Report 2024 of the European Chemicals Agency

Your Excellency,

Please find attached herewith the Annual Report 2024 of the European Chemicals Agency (ECHA). This Annual Report covers the period from 1 January 2024 to 31 December 2024. The report is prepared pursuant to Article 83(3) of the REACH Regulation and Article 48 of ECHA’s Financial Regulation. It consolidates the requirements of the REACH General Report and the Consolidated Annual Activity Report (CAAR) under ECHA’s Financial Regulation. The Annual Report 2024 will be available on our website (https://echa.europa.eu/plans-and- reports) and contains the Management Board’s (MB) assessment of said report. Should you or your services have any questions related to this Annual Report, please do not hesitate to contact me.

Yours sincerely, Dr Sharon McGuinness Executive Director Enclosure: Annual Report 2024 of the European Chemicals Agency

Cc.: Sofia Zisi, Chair of the ECHA Management Board

Annual Report 2024

Disclaimer

The European Chemicals Agency is not responsible for the use that may be made of the information contained in this document.

Europe Direct is a service to help you find answers to your questions about the European Union.

Freephone number (*):

00 800 6 7 8 9 10 11 (*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed.

More information on the European Union is available on the Internet (http://europa.eu).

Annual Report 2024

Reference: ECHA-25-R-03-EN ISBN: 978-92-9468-469-1 ISSN: 2600-0849 Cat. Number: ED-01-25-003-EN-N DOI: 10.2823/7460332 Publ.date: April 2025 Language: EN © European Chemicals Agency, 2025

Cover page © European Chemicals Agency

If you have questions or comments in relation to this document, please send them (quote the reference and issue date) using the information request form. The information request form can be accessed via the Contact ECHA page at: http://echa.europa.eu/contact

European Chemicals Agency

P.O. Box 400, FI-00121 Helsinki, Finland

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Annual Report 2024

Table of Contents TABLE OF CONTENTS .................................................................................................. 3 LIST OF ACRONYMS .................................................................................................... 5 MANAGEMENT BOARD ANALYSIS AND ASSESSMENT .................................................. 8 FOREWORD ............................................................................................................... 13 EXECUTIVE SUMMARY .............................................................................................. 15 PART I. ACHIEVEMENTS OF THE YEAR ...................................................................... 20 Dossier preparation ................................................................................................................. 20 Dossier submission and processing ............................................................................................ 21 Identification and prioritisation of substances and groups of substances .......................................... 23 Evaluation ............................................................................................................................. 24 Authorisation .......................................................................................................................... 26 Restrictions ............................................................................................................................ 28 Classification and labelling ........................................................................................................ 30 Data management and dissemination ........................................................................................ 33 Promotion of alternatives to animal testing ................................................................................. 35 Biocides ................................................................................................................................. 37 Contribution to EU Environmental policy ..................................................................................... 39 Tasks under grant, cooperation and service-level agreements ....................................................... 44 Governance and Enablers ......................................................................................................... 47

PART II. MANAGEMENT ............................................................................................ 61 Management Board ................................................................................................................. 61 Major developments ................................................................................................................ 61 Budgetary and financial management ........................................................................................ 62 Delegation and sub-delegation of the powers of budget implementation to agency’s Staff .................. 62 Human Resources (HR) management ......................................................................................... 62 Strategy for efficiency gains ..................................................................................................... 62 Assessment of audit and retrospective evaluation results during the reporting year .......................... 63 Follow up of recommendations and action plans for audits and evaluations ...................................... 66 Follow up of observations from the Discharge authority ................................................................ 66 Environment management ....................................................................................................... 67 Assessment by management .................................................................................................... 69

PART III. ASSESSMENT OF THE EFFECTIVENESS OF THE INTERNAL CONTROL SYSTEMS ........................................................................................................................... 70

Effectiveness of internal control system ...................................................................................... 70 Conclusions of the assessment of the internal control systems ....................................................... 75 Statement of the manager in charge of risk management and internal control ................................. 77

PART IV. MANAGEMENT ASSURANCE ........................................................................ 78 Review of the elements supporting assurance ............................................................................. 78 Reservations .......................................................................................................................... 78

PART V. DECLARATION OF ASSURANCE .................................................................... 79 Declaration of assurance by the Authorising Officer ...................................................................... 79

ANNEXES .................................................................................................................. 80 Annex I - Key indicators ........................................................................................................... 81 Annex II - Budget implementation reports and statistics on financial management ........................... 82 Revenue .............................................................................................................................. 82 REACH/CLP Revenue .............................................................................................................. 83 BPR Revenue ........................................................................................................................ 83 Environmental Policy Revenue ................................................................................................. 84 Expenditure .......................................................................................................................... 86

Annex III – Organisational chart ............................................................................................... 94

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Annual Report 2024

Annex IV - Establishment plan and additional information on human resources management ............. 95 Annex V – Human and financial resources by activity .................................................................. 100 Annex VI – Contribution, grant and service-level agreements ....................................................... 101 Annex VII - Environment management...................................................................................... 102

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Annual Report 2024

List of acronyms Acronym Description

AD Administrator

AI Artificial Intelligence

APCRA Accelerating the Pace of Chemical Risk Assessment

ARN Assessment of regulatory needs

ASO Accredited Stakeholder Organisation

AST Assistant

BAT Best Available Technique

BEF BPR-EN-FORCE (Forum- coordinated BPR enforcement project)

BoA Board of Appeal

BPC Biocidal Products Committee

BPR Biocidal Products Regulation

BPRS BPR Subgroup of the Forum

BREF Best Available Techniques Reference documents

C&L Classification and labelling

CA Contract agent

Chesar Chemical Safety Assessment and Reporting tool

CLH Harmonised classification and labelling

CLP Classification, labelling and packaging (and the respective Regulation)

CoIAC Conflict of Interest Advisory Committee

COM European Commission

CoRAP Community rolling action plan

CSS Chemicals Strategy for Sustainability of the Commission

DG DIGIT Directorate General for Informatics

DG EMPL Directorate General for Employment, Social Affairs and Inclusion

DG GROW Directorate General for Internal Market, Industry, Entrepreneurship and SMEs

DG NEAR Directorate General for Neighbourhood and Enlargement Negotiations

DG RTD Directorate General for Research

Acronym Description

and Innovation

DNA Designated national authorities

DoI Declaration of Interests

DWD Drinking Water Directive

EAP Environmental Action Programme

EC European Commission

ECA European Court of Auditors

ECDC European Centre for Disease Control

ECHA European Chemicals Agency

eChemPortal OECD Global Portal to Information on Chemical Substances

ED Endocrine disruptor

EDPS European Data Protection Supervisor

EEA European Environment Agency

EFSA European Food Safety Authority

EFTA European Free Trade Association

ELV End-of-Life Vehicle

EMA European Medicines Agency

EMAS EU Eco-Management and Audit Scheme

EMS Environmental management system

eMSCA Evaluating Member State competent authority

ENVI European Parliament's Committee on Environment, Public Health and Food Safety

EUAN EU Agencies Network

EUCLEF European Chemicals Legislation Finder

EUON European Union Observatory for Nanomaterials

EU-OSHA European Agency for Safety and Health at Work

Forum Forum for Exchange of Information on Enforcement

FTE Full-time equivalent

FWC Framework contract

GIME Groupe Interinstitutionnel de Management Environnemental (Interinstitutional Group for

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Annual Report 2024

Acronym Description

Environmental Management)

GLP Good Laboratory Practice

GN EUAN Greening Network

GPP Green Public Procurement

HelpNet Network of national BPR, CLP and REACH helpdesks

HR Human resources

IAC Internal Audit Capability of ECHA

IAS Internal Audit Service of the Commission

ICT Information communications technology

IED Industrial Emissions Directive 2010/75/EU

IMS Integrated Management System

IPA Instrument for Pre-Accession Assistance

IRS Integrated Regulatory Strategy

ISO International Organisation for Standardisation

IT Information technology

IUCLID International Uniform Chemical Information Database

JEAP Joint Evaluation Action Plan

JRC Joint Research Centre

KPI Key Performance Indicators

MB Management Board

MCCP Medium-chain chlorinated paraffins

MS Member State

MSC Member State Committee

MSCA Member State competent authority

NAM New approach methodologies

NGO Non-governmental organization

NEA National enforcement authority

NeRSAP Network of REACH SEA and Analysis of Alternatives practitioners

OECD Organisation for Economic Co- operation and Development

OEL Occupational exposure limit

OHT OECD Harmonised Template

OSOA One Substance, One Assessment

PAH Polycyclic aromatic hydrocarbons

PARC Partnership for the Assessment of

Acronym Description

Risks of Chemicals

PBT Persistent, bioaccumulative and toxic

PCN Poison Centre Notifications

PDN Performance Development Network

PFAS Per- and polyfluoroalkyl substances

PFCA Perfluorocarboxylic acids

PIC Rotterdam Convention on the prior informed consent procedure (and the respective Regulation)

PMT Persistent, mobile and toxic

POP Persistent organic pollutant

POPRC Persistent Organic Pollutants Review Committee

POPs Persistent organic pollutants (and the respective Regulation)

PPORD Product and Process Oriented Research and Development

PPP Plant protection products

QSAR Quantitative Structure-Activity Relationship

R4BP Register for Biocidal Products

RAC Committee for Risk Assessment

REACH Registration, evaluation, authorisation and restriction of chemicals (and the respective Regulation)

REACH-IT Central IT system providing support for REACH

REF REACH-EN-FORCE (Forum- coordinated REACH enforcement project)

RoP Rules of Procedure

SCBTH Serious Cross-Borders Threats to Health

SCIP Database for information on Substances of Concern In articles as such or in complex objects (Products)

SEAC Committee Socio-economic Analysis Committee

SEV Substance Evaluation

SLA Service Level Agreement

SME Small and medium-sized enterprises

SNE Seconded national expert

SPC Summary of product

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Annual Report 2024

Acronym Description

characteristics

SVHC Substance of very high concern

SWACHE Surveys on Willingness-to-Pay to Avoid Negative Chemicals- Related Health Effects

TA Temporary agent

UNEP United Nations Environment Programme

UFI Unique Formula Identifier

UN GHS United Nations Globally Harmonised System of classification and labelling of chemicals

UWWT Urban Wastewater Treatment Directive 91/271/EEC

vPvB Very persistent and very bioaccumulative

vPvM Very persistent and very mobile

8

Annual Report 2024

Management Board analysis and assessment The Management Board welcomes the Annual Report 2024, fulfilling the requirements of the REACH Regulation (General Report)1 and those of the ECHA Financial Regulation (Consolidated Annual Activity Report)2.

We consider that this report provides a comprehensive account of the activities carried out by ECHA during 2024, the performance of the Agency against the expected inputs, outputs and outcomes defined in the Single Programming Document 2024-20263. It also represents a fair overview of the evolution of ECHA’s budget, staffing, management, and its internal management system strategy and framework.

This assessment is based on our analysis of all parts of the report, including the activities carried out, achievements, financial information, results of audits, retrospective evaluations, and the assessment of the internal control system, as well as the risks related to ECHA’s activities together with the corresponding mitigating measures.

Achievements of the year

2024 was the first year of implementing the ECHA Strategy 2024-2028. We consider that the performance and quality of the outputs in 2024 were high, as shown in Part I of the Annual Report.

In assessing4 the Consolidated Annual Activity Report of the Authorising Officer for 2024, we:

1. Acknowledge the performance of the ECHA committees in delivering opinions to the Commission, and note, in this context, the enhanced Member State focus on increasing the capacity of the Committees. RAC and SEAC have made steady progress in the complex PFAS restriction assessment, with clear updates provided to interested parties throughout the process

2. Welcome the conclusion of the Joint Evaluation Action Plan and the review and new objectives of the Integrated Regulatory Strategy (IRS), shifting the focus towards moving substances to risk management.

3. Welcome the continued outreach efforts to Member States, including via bilateral engagements of the Executive Director, and the organisation of a meeting of Heads of Chemical Authorities.

4. Note the 5-year IT transformation plan and the ongoing review of the data management approach, including a data governance model and look forward to receiving information about their implementation and about the overall IT preparation to onboard new tasks.

5. Acknowledge the launch of the first version of the ECHA Chem portal, the new system for making information on chemicals publicly available and encourage the secretariat to develop it further.

Based on the periodical reporting and the Annual Report 2024 prepared by the secretariat, the

1 Article 78(a) of the REACH Regulation. 2 Article 48 of ECHA’s Financial Regulation. 3 https://echa.europa.eu/documents/10162/58005821/final_mb_31_2023_echa_spd_2024- 2026_en.pdf/49a5ffa2-10e8-327b-b1d4-743758851514?t=1706552312333 4 Assessment pursuant to Article 48(1) of the Agency’s Financial Regulation.

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Annual Report 2024

Board makes the following observations:

1. ECHA continued preparing for the full implementation of the Drinking Water Directive, however, the implementation of the provisions for notification and application systems have been delayed by one year by the legislator.

2. The committee's capacities and competence remain a point of great concern, especially regarding the implementation of new tasks.

3. ECHA continued preparing opinions on the approval and renewal of biocidal active substances and Union authorisations of biocidal products. However, the progress with the Review Programme of existing active substances continued to be limited. The overall progress of the Review Programme is now at 50%.

4. ECHA continued to provide support to the Forum, including by training a higher than estimated number of national trainers and inspectors, which is important for the continued improvement of harmonised enforcement of chemicals legislation across the EU.

Management

• The 10 recommendations the Management Board provided for 2024 as part of the assessment of the 2023 Annual Report have been implemented or are in progress.

• 178 outputs were delivered out of the planned 200. The challenges in delivering some of the outputs were mostly related to lack of external input, revised timing of legislative proposals, technical or resourcing issues and the need for task reprioritisation.

Budgetary and financial management

• We welcome the excellent performance of ECHA in implementing its budget with 99.5% of commitment rate and 0.5% of cancelled payment appropriation rate, with processing 99.8% of payments within legal deadlines, while keeping the strict segregation between its funding sources and operating in an environment of fluctuating and challenging to predict fee income.

Human resources management

• We commend ECHA for having maintained a high rate of filling its establishment plan posts (97.2%) and the strong focus on staff wellbeing, diversity and inclusion.

• We note the gender imbalance (30% female, 70% male) at the middle and senior management levels.

• We welcome that ECHA adopted and started to implement the People and Organisational Strategy 2024-2028.

• We take note of the outcome of the Retrospective evaluation of ECHA’s HR strategy 2019- 2023, including that ECHA compares with other ENVI agencies as the Agency with the lowest proportion of its HR staff to total staff and the lowest proportion of “neutral staff” to total staff, which includes posts in horizontal services, such as finance, procurement, quality management, linguistics etc.

Audit and retrospective evaluation results and follow-up on recommendations

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Annual Report 2024

• Assurance has been provided by the Internal Audit Capability (IAC) on audits, follow-up audits and the implementation of the recommendations, as well as appropriate information from the secretariat on the retrospective evaluations. The audits and evaluations planned for 2024 were all completed.

• The European Court of Auditors adopted a positive opinion regarding the 2023 annual accounts, with no reservation or observation. We welcome that there are no pending observations or recommendations.

• The European Parliament, as the Discharge Authority, granted discharge to the Executive Director with respect to ECHA’s 2022 budget, including the decision on the closure of the 2022 accounts. The secretariat duly provided replies to the Discharge Authority’s observations and the implementation of the six recommendations is on track.

• The Internal Audit Service (IAS) of the Commission did not conduct any audit in ECHA in 2024. There are no pending recommendations from past IAS audits.

Internal control framework and Integrated Management System

• We consider that the internal control framework remains effective and functioning.

• ECHA’s Integrated Management System Strategy and Framework has demonstrated its effectiveness in achieving the Agency’s strategic goals and priorities in 2024.

• ECHA obtained recertification of the Agency’s International Organisation for Standardisation (ISO) 9001:2015 and 14001:2015 and EU Eco-Management and Audit Scheme (EMAS). Guidelines for the implementation of the ISO 20121:2012 standard on event sustainability management systems were developed and issued during 2024.

Organisational risk management

• We highlight the importance of the continued development and application of the organisational Risk Management Policy, including via training and awareness raising.

• We found the regular updates on the risk register, including the continued specific reporting on the IT-security related risks, pertinent.

• We note that appropriate measures are in place to identify, monitor and manage risks threatening the achievement of ECHA’s objectives. The secretariat regularly signalled significant risks and control issues to the Management Board, including as part of the Executive Director reporting, as well as the updates to the Agency Risk Register.

• We welcome the investments and efforts to meet cybersecurity regulation5 requirements, and we note the low number of cybersecurity incidents. We call for continued focus on this area.

Management Assurance

The Management Board takes note of the systems in place to support the Executive Director’s declaration of assurance and takes note of the declaration of assurance of the Executive Director. Based on the information in the Section II, no significant weaknesses or gaps that may threaten the achievement of ECHA’s objectives were identified.

5 Regulation (EU, Euratom) 2023/2841.

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Annual Report 2024

The Board takes note of the fact that no reservations were made.

Recommendations for the secretariat for 2025

Based on our assessment, the Management Board requests particular emphasis in 2025 on the following actions, without prejudice to the implementation of the Single Programming Document 2025-2027:

1. Take appropriate actions to maintain the committees’ ability to deliver transparent, independent and high-quality scientific outputs for existing and new tasks: Continue supporting the work of the committees to further enhance the Committees competence and working structures including increasing their capacity. In this context, keep in focus the continued facilitation of the preparation of the RAC/SEAC opinion on the UPFAS dossier.

2. Continue closely following the legislative process concerning ECHA’s new tasks and support the decision-makers with technical-scientific input, as required. Prepare for the implementation of new tasks, according to the (timing of) availability of resources and timely signal issues and risks to the Management Board.

3. Maintain focus on engaging and building trusted relationships with key European institutional stakeholders, as well as with Member State partners and engage with other stakeholders. Continue providing clear and accessible information about ECHA’s mandate and chemical safety to all stakeholders.

4. Continue the support to Member States competent authorities for biocidal products, with a view to accelerating the progress with the Review Programme of existing active substances.

5. Fine-tune the activity-based budgeting of the Agency as it will be crucial in the future against the background of tasks assigned to the Agency deriving from many pieces of legislation.

6. Update the Management Board on the actions implemented in follow up to the organisational review of ECHA, given its importance in addressing the evolving nature and increasing complexity of ECHA’s tasks and mandate.

7. Implement the refocused IRS objectives: maintain a good knowledge about the chemicals in ECHA’s databases and shift the focus to deliver risk management outcomes for (groups of) substances.

8. Continue supporting the implementation of the revised CLP regulation, including for the introduction of new hazard classes, grouping and read-across approaches, including in the run-up to the first implementation deadline.

Acknowledgments

The members of the Management Board express their appreciation to ECHA staff, members of ECHA bodies and the Agency’s partners, in particular Member States, for their commitment and achievements in 2024.

Conclusion

In assessing the Annual Report 2024, the Management Board concludes that the overall performance of ECHA is in line with the objectives included in the Agency’s Single Programming

12

Annual Report 2024

Document 2024-2026 and ECHA made good progress in delivering its Strategy 2024-2028.

Based on the above observations, the Management Board requests that the Annual Report 2024 be forwarded to the Member States, the Court of Auditors, the Commission, the European Parliament, the European Economic and Social Committee and the Council.

13

Annual Report 2024

Foreword

Dr Sharon McGuinness

Executive Director

I am pleased to present the Agency’s annual report for 2024, the first under our Strategy Statement 2024-2028. We delivered the legal mandate across the wide range of chemical legislation under our remit and met the objectives of our work programme 2024.

With our goal to be a trusted chemicals agency, we continued our commitment to delivering transparent, independent, and high-quality scientific advice, opinions, and decisions across REACH, CLP, Biocides and other legislative areas. In all legislative areas, we also delivered significant levels of support and advice to the Commission, Member States, industry and other stakeholders.

The members of our scientific committees are central to our ability to deliver opinions and decisions. In this regard, having the appropriate capacity and competence within our committees is essential. We have put more focus on increasing capacity in relation to the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC). This focus included engaging with Member States with a view to increasing nominations as well as measures, such as revised remuneration for specific tasks. Together with the Commission, ECHA also wrote to Member State authorities asking them to nominate, as applicable, the two experts to the scientific committees. Having full capacity of our committees is not only important for current tasks under REACH and CLP, but also for new tasks such as drinking water and batteries. We have seen increased Member State focus on ensuring capacity for our committees and ended the year with 80% membership in RAC and 55% in SEAC. To ensure our committees are sustainable in the future, ECHA also contributed to the Commission’s preparatory work to strengthen governance and streamline operations with the future ECHA Basic Regulation, and we look forward to seeing a proposal in 2025.

In 2024, we completed reviews of the Integrated Regulatory Strategy (IRS) and the Joint Evaluation Action Plan (JEAP), which were two significant initiatives under our 2018-2023 strategic plan. As a result of these reviews, we have concluded the Joint Evaluation Action Plan and revised the Integrated Regulatory Strategy. The findings and recommendations arising from these reviews will inform our future focus on risk management activities.

Throughout the year, we prepared for implementation of new or changing legislative tasks. We commenced implementing legislation tasks in relation to Drinking Water, Batteries, Serious Cross Border Threats to Health and Industrial Emissions. In anticipation of the publication of the revised CLP Regulation, we updated and published the tools and the CLP guidance on criteria for new hazard classes. We also supported the Commission in relation to

14

Annual Report 2024

their work on the various legislative packages under One Substance, One Assessment (OSOA) as it made its way through the co-decision process.

We also continued delivering on our legal obligations under the Biocidal Products Regulation (BPR), however, the low number of completed assessment reports for biocidal active substances submitted by Member States continued. We remain committed to working together with the Member States and the Commission to address this issue with the Review Programme for existing active substances.

Communicating and engaging with all stakeholders, EU institutions, EU agencies, Member States, industry and other stakeholders is necessary to deliver our legal mandate and our vision of chemical safety through science, collaboration and knowledge. In 2024, we put increased emphasis on these areas. We also worked closely with other EU Agencies, including the European Medicines Agency (EMA), the European Food Safety Authority (EFSA), the European Environment Agency (EEA) and the European Centre for Disease Control (ECDC). This work included signing the One Health Framework of action between our agencies. This collaborative work is important for delivering existing tasks and will become even more important as we implement the future tasks under the OSOA approach.

With our new strategic priority to support SMEs, we prepared an engagement plan which we will implement in the coming years. To increase awareness and transparency of the chemicals data we have and make it widely available to industry and interested parties, we launched a new dissemination tool, ECHA CHEM and will continue to increase information available on it over the coming years.

Delivering our current and future legal mandate and our strategic vision and goals requires an organisation that has the necessary people and systems in place to meet increasing demands and expectations. In 2024, we took steps to ensure our organisation, our data and IT will all be fit for the future. On IT, we finalised a 5-year IT transformation plan, which foresees four portals based on the specific tasks and needs of different groups – industry, authorities, ECHA and the public – built on modular enterprise architecture. Coupled with this IT focus, we are also reviewing our approach on data management, with the first step taken in 2024 to confirm a data governance model.

In line with ECHA’s priority to ‘Ensure that our organisational model is ready to support delivery of our current and future mandate’, ECHA undertook an organisational review in 2024. The organisational review was conducted to address the evolving nature and increasing complexity of ECHA’s tasks and mandate and meet our strategic goals and vision. The recommendations, which addressed ways of working, strategic prioritisation and organisational structure will be addressed in 2025.

I would like, in conclusion, to express my thanks to the Management Board for their support and collaboration throughout the course of 2024. A particular note of thanks and appreciation also to ECHA’s management team and all the staff for their dedication and commitment in delivering our 2024 Work Programme.

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Annual Report 2024

Executive summary ECHA’s achievements in 2024 reflect a strong commitment to our strategic goals and priorities, as well as our vision of chemical safety through science, collaboration and knowledge. We continued to progress and implement our existing legal mandate and also commenced implementation of several new tasks. Our role continues to expand, and in 2024, we supported decision makers as they prepared for the introduction of further new regulatory tasks for the Agency. Throughout the year, we collaborated closely with our many stakeholders, including Member States, the Commission, EU agencies, industry and NGOs. This engagement ensures we can deliver transparent, independent and high-quality scientific opinions and decisions and ensure duty holders meet their legal obligations. While much has been achieved in 2024, the Agency continues to face challenges, which will need to be addressed over the coming period. However, we also took steps to address how the Agency can tackle several of these challenges by modifying our ways or working in the future.

Strategic Goal - a Trusted Chemicals Agency

As the EU Chemicals Agency, we work continuously to be trusted and reliable as we implement chemical regulations and protect health and the environment through our work on chemical safety. A key priority for the Agency is to deliver transparent, independent and high-quality scientific opinions and decisions as required under our legal mandate. Under REACH and CLP, our committees delivered opinions to the Commission on applications for authorisation of 55 uses of substances, a restriction proposal on creosote, as well as adopting 56 opinions on harmonised classification and labelling proposals. We also added two entries to the Candidate List, bringing the total to 242 entries in the end of 20246. Also under REACH, we published the investigation report on brominated flame retardants and continued to make progress on the PFAS restriction opinion making throughout the year.

Following the introduction of the revised CLP Regulation, we updated and published guidance to include the new hazard classes. This updated guidance was a significant collaborative achievement by experts from ECHA, Member States, industry and non-governmental organisations.

In relation to biocides, we submitted to the Commission 15 opinions on active substances, 17 opinions on Union authorisations along with 20 opinions on administrative changes of a Union Authorisation, 15 opinions on same biocidal products of a Union Authorisation and eight opinions on classification of changes of biocidal products.

In other legislative tasks, we delivered four opinions on Occupational Exposure Limits (OELs) and updated the draft scientific dossier (Annex D POPS proposal) for Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5) and Dodecamethylcyclohexasiloxane (D6) based on new available information. We also conducted a screening exercise to identify substances that could meet the POP criteria, with the aim of identifying a new candidate for an EU proposal.

As we aim to enhance decision and policy making through optimal use of data, we initiated the implementation of our new data management approach and established a Data Governance Office to manage and oversee all our regulatory data. We also took measures, such as initiating a new Chemical Identifiers Management System to manage the inherent differences between regulatory contexts and prepare the Agency to onboard new tasks. Early in 2024, we launched the ECHA CHEM platform, which enables public access to critical chemical safety information.

6 Five additional entries were added in January 2025, bringing the current total to 247 entries.

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Annual Report 2024

The Integrated Regulatory Strategy, which was a cornerstone of our strategic efforts from 2019 to 2023 was reviewed, as was the Joint Evaluation Action Plan. These reviews were completed as we prepared for a new phase in future REACH evaluation and risk management activities. Key drivers for IRS in the future will be to maintain a good knowledge about the chemicals in our databases and shift the focus to delivering risk management outcomes for (groups of) substances. In 2024, we concluded the systematic screening of high production volume chemicals, marking the culmination of the previous five year’s IRS work. We successfully concluded the actions under the Joint Evaluation Action Plan and refocussed our efforts away from compliance checks to conclude follow-up of dossiers after draft decisions on compliance checks.

Strategic Goal - Respond to Emerging Challenges and Changes in Our Legal Landscape

In 2024, we demonstrated our agility in addressing emerging challenges and legislative changes. We continued the planning and implementation of new tasks that have arrived at the Agency in recent years, such as Batteries, Drinking Water Directive and Serious Cross Border Threats to Health. Preparations were carried out on relevant aspects such as technical, scientific and stakeholder engagement. In addition to ensuring the Agency is ready for these new tasks, we also must ensure that our scientific committees, Risk Assessment Committee (RAC) and Socio- Economic Analysis Committee (SEAC) are preparing. In the case of the Drinking Water Directive, a RAC Working Group has been established, and work is progressing on developing procedures for dealing with applications in the future. We commenced developments in our IT systems to be able to deal with future tasks under the DWD. In this context, we have agreed that IT development for the DWD will be the pilot for our future IT systems. In delivering these new tasks, we need to engage with many new stakeholders and throughout the year, we held several workshops and meetings with them.

In support of the Chemicals Strategy for Sustainability (CSS), we provided support and inputs to the Council, European Parliament and Commission in relation to the Commission legislative proposal on One Substance One Assessment (OSOA). This proposal will see several regulatory tasks be reattributed to ECHA as well as the introduction of a Common Data Platform, where the Agency will play a lead role. We developed, as required under the CSS and the mandate of the 8th Environmental Action Programme, an indicator framework for chemicals with EEA and the Commission and produced a joint synthesis report on this framework with EEA.

Strategic Goal - Communicate and Engage

Efforts to improve communication and engagement with stakeholders were central to our operations in 2024. A widely attended ECHA conference was organised, as well as a meeting of Member States' Heads of Chemicals Authorities. We launched a new External Communications Strategy and Stakeholder Engagement Approach to foster stronger relationships with Member States, industry, and stakeholders representing workers, the public and the environment. This includes clearer messaging on chemical risks, regulatory processes, and upcoming legislative changes. An action plan was agreed to step up our efforts to support SMEs and will be implemented over the next years. The number of followers across ECHA's social media channels continued to grow (by 21%, to over 130 000 in 2024), as well as our website visitors, growing by over a million in 2024 to almost 5.5 million.

We further strengthened our collaboration with peer agencies (EFSA, EMA, EEA and ECDC), including by conducting joint initiatives in scientific-technical areas and institutional engagement. We signed the One Health framework of action with these agencies and presented our work to the Environment Committee of the European Parliament. To further ensure consistency in our methodologies, we delivered jointly with EFSA a guidance on risk assessment on bees from the use of biocides, and cooperated with EFSA, EMA and ECDC on a report to address anti-fungal resistance, that was endorsed by the BPC. The IUCLID platform cooperation with EFSA on Plant Protection Products continued in 2024, with the agreement to start expanding IUCLID for Food Contact Materials.

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Annual Report 2024

Strategic Goal - Lead on Chemical Knowledge and Expertise

We continued our commitment on promoting New Approach Methodologies (NAMs) in 2024 through a range of measures. For example, we contracted a collaborative consortium of researchers to conduct scientific studies on the reliability and relevance of NAMs as alternatives to animal testing and to promote the use of such methods in the future. The contract will run for six years and has a total value of EUR 4.2 million in funding. These projects will investigate the application of omics in regulatory contexts to enhance read-across and grouping methodologies; explore potential alternatives to current aquatic toxicity testing involving the use of fish; and examine the use of in vitro toxicokinetics to support hazard assessment. We further strengthened our interactions with stakeholders and EU Agencies and worked closely with the European Commission to support development of a roadmap to phase out animal testing.

We proactively contributed to expanding scientific and technical competence and knowledge on chemical safety through our work in PARC (Partnership for the Assessment of Risks from Chemicals). A key achievement in relation to PARC has been the publication of our updated report on Key Areas of Regulatory Challenge, which provides details on research needs on chemical safety.

In support of the Commission’s international efforts, we participated in a wide range of OECD (Organisation for Economic Co-operation and Development) activities, ranging from development of non-animal methods to completing the development of the QSAR toolbox. We also supported the Commission in the UN Sub-Committee of Experts on the Globally Harmonised System for Classification and Labelling of Chemicals (GHS). We delivered support to pre- candidate countries and hosted several IPA countries in meetings and trainings in capacity building efforts on communication and enforcement.

Strategic goal - Invest in Our People and Organisational Excellence

We continued the focus on investing in our people and organisational development through implementing actions under our People and Organisational Strategy 2024-2028, our Wellbeing Action Plan and our Diversity and Inclusion Action Plan. At the end of 2024, our staffing plan was filled at 97.2%. A review of ECHA’s organisation was completed to take account of the new strategy and our expanding legal mandate. The recommendations, which addressed ways of working, strategic prioritisation and organisational structure will be addressed in 2025.

We initiated a pilot on optimising use of our office building and conference centre, to plan and test new ways of working. In 2024, we continued to successfully organise meeting services for approximately 400 events and official meetings, with 36 600 participants joining online and a further 5 300 visitors in person.

We effectively managed our financing through close monitoring of uncertain fee income development. On the final budget size of EUR 126.6 million, the Agency reached a 99.5% commitment rate and 87.0% payment rate, exceeding the targets set. The European Court of Auditors gave a clean audit opinion on ECHA's annual accounts for 2023.

The ongoing transformation of our IT infrastructure and data management systems further exemplifies our commitment to enhancing ECHA's organisational excellence. A five-year IT vision and plan was agreed and implementation commenced with the IT systems needed for the Drinking Water Directive, which will be the first to be considered under our new approach. As part of our continued efforts to improve and innovate, we have also established a horizontal working group on Artificial Intelligence (AI). This group has created guidelines for the safe use of AI, assessed several use cases and proposed several pilots, which will be commenced in 2025.

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Annual Report 2024

Current and future challenges

Notwithstanding all our achievements and successes in 2024, there are still areas where the Agency has challenges now and in the future.

The first such challenge is in relation to the sustainability and workability of our scientific committees, the RAC and SEAC. Although these committees have delivered significant levels of opinions in 2024, with the continued work required to meet existing tasks, such as concluding the PFAS dossier as well as prepare for new tasks under the DWD and harmonised classifications of new hazards (endocrine disruptors etc), they continue to be under pressure. Efforts have been taken by the secretariat and the Management Board to address workability. For example, this year, the MB agreed to increase the payments for REACH restriction rapporteur work in RAC and SEAC. Through active engagement with Member States throughout the year, there has been an increase in numbers of nominations, and we ended the year with 80% membership in RAC and 55% in SEAC. While this is welcomed, Member States are still asked to nominate the full number of experts to the committees. It is hoped that the Commission proposal for an ECHA Basic Regulation, which is planned for 2025, will introduce measures to address workability and sustainability of the committees. However, as such measures are unlikely to be in place for several years, interim measures will be needed if the committees are to meet new tasks on DWD from 2026 onwards. The Agency, together with the Commission and Member States, will continue to review the work of the Committees to ensure that it can meet its existing and future tasks.

The significant work on the PFAS dossier has also put pressure on our committees during 2024 and the Agency has taken steps to provide additional supports to the Rapporteurs and will continue to do so until the opinion making is concluded. We have also added additional resources in the Secretariat Ensuring the integrity of the opinion making process so that we can deliver a final opinion that is independent, transparent and of high-quality, was and will remain the Agency’s main focus.

Since 2019, the Agency has focussed on the compliance check process, which has meant that there are backlogs in other areas of dossier evaluation. With the conclusion of the Joint Evaluation Action Plan, the focus has now shifted to conclude follow-up of dossiers after draft decisions on compliance checks as well as examining testing proposals. With this change of focus, we aim to reduce the backlogs over the coming period. Support from the Commission, Member States and registrants will be important in helping us address this matter.

After a peak number of applications for authorisation in the past years, mainly for the use of hexavalent chromium substances, the number of applications significantly decreased in 2024, with 43 applications and review reports received (covering 57 uses). As the total number of applications received has been higher than the capacity of the scientific committees, they continue to work steadily to process the applications in their opinion making. In line with the Commission approach to address the high levels of authorisation applications for hexavalent chromium substances, ECHA progressed the development of a restriction proposal on hexavalent chromium, for which the assessment in the committees will start in 2025. However, until such time as a restriction proposal on these substances is agreed and enters info force, ECHA will have to continue to prioritise applications in line with the capacity of the committees.

We also continued delivering on our legal obligations under the Biocidal Products Regulation, however, the low number of completed assessment reports for biocidal active substances submitted by Member States continued. We remain committed to working together with the Member States and the Commission to address this issue with the Review Programme for existing active substances.

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Annual Report 2024

While every effort is being made to prepare in advance for implementing new tasks, challenges remain as resources for new tasks will usually only be made available to ECHA when the legislative proposal is finalised. As many of the new tasks, requires significant preparatory work from IT systems development to committee procedures to stakeholder guidance and support, the Agency has to complete its preparations in sometimes very short timeframes. Prioritisation of our preparatory work may have impacts on existing tasks, though the Agency will seek to keep such impacts to a minimum.

Finally, as the Agency mandate expands and as technology rapidly evolves, the Agency needs to ensure its IT and data management systems are modernised and user focussed. The development of the Agency’s long term IT vision and plan is a step in the right direction; however, it will require intense activity and resources over the coming period to ensure we are ready to meet new tasks such as Drinking Water as well as meet stakeholder expectations and demands. The Agency will use the organisational review recommendations to address these challenges where possible. However, to fully address all our challenges, ECHA will need inputs from external parties such as the Commission, Member States and stakeholders.

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Annual Report 2024

Part I. Achievements of the year

Dossier preparation7

Objective 1: Companies supported on inquiries and data sharing.

Main Outputs Execution Status

Inquiries and disputes on data sharing are handled in line with legal requirements and timelines.

We successfully handled inquiries and disputes over data sharing according to legal requirements and timelines, ensuring a smooth process for all parties involved. We managed a record number of inquiries, with a 14% increase compared to previous years, and ensured that the process ran smoothly. We also continued to support companies with the tools and guidance they need to successfully register and update their information.

Yes

Indicators Estimate Actual

Inquiries received and concluded 4 800 5491

Objective 2: Harmonised IT tools are available to support the transparent sharing of harmonised data between industry and regulatory authorities.

Main Outputs Execution Status

Promotion of IUCLID as the international harmonised format for chemical data continued.

We hosted, for the first time, a joint meeting with OECD on IUCLID and the eChemPortal. As more international authorities adopt IUCLID as the reference implementation of the OECD Harmonised Templates8 (OHTs), there is a greater need to monitor and review how IUCLID data is being exchanged and made available for publication. This joint meeting contributed to better understanding of how to best manage our data and tools globally (OECD) and take stock of the challenges faced internationally in exchanging and managing data.

Yes

IUCLID updated to incorporate existing, new and changing regulatory requirements.

We made important updates to the International Uniform Chemical Information Database (IUCLID) to meet new EU and international regulatory requirements. This

Yes

7 This section covers only REACH registration dossier preparation. The support to the preparation of other REACH and CLP dossiers are covered by the relevant sections. 8 https://www.oecd.org/en/topics/sub-issues/assessment-of-chemicals/harmonised- templates.html#:~:text=The%20OECD%20Harmonised%20Templates%20(OHTs)%20are

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Annual Report 2024

included new formats, validation, and filtering rules to make sure the database stays aligned with different regulatory needs.

IUCLID progressively updated to support the needs of OECD and international partners.

We updated IUCLID as required and also promoted it as the standard for chemical data worldwide.

Yes

Scientific contribution made to development of the OECD harmonised test guidelines relevant for the EU information requirements.

We contributed to development of the OECD test guideline programmes in key areas by actively participating in the expert group meetings and consultations.

Yes

Indicators

N/A

Dossier submission and processing Objective 1: Access to market for duty holders continues to be streamlined and predictable.

Main Outputs Execution Status

REACH registration dossiers (initial and updates) processed.

We ensured the timely processing of all dossiers submitted by industry under REACH and CLP. In 2024, we saw a significant increase in C&L notifications compared to the previous year, far exceeding our initial estimate. This surge was primarily driven by a few companies, submitting large volumes of notifications, and/or using system-to-system submission.

Yes

PPORD notifications processed, and data analysed to identify and monitor innovation and new chemicals trends.

PPORD notifications were monitored and analysed to track innovation trends and new chemical developments.

Yes

Completeness checks including manual verifications performed, invoices issued, and confidentiality requests assessed.

All submitted registrations were completeness checked, with one third undergoing manual checks. In 2024, fewer dossiers were submitted than expected, and the submitted data was more complete than in previous years. As a result, the actual number of registrations failing the first technical completeness check was significantly lower than estimated based on previous years, with 669 failures compared to the expected 1 300.

An appeal on a completeness check decision was dismissed, reinforcing ECHA’s implementation approach, which includes manual checks of part of the information.

Yes

Clear and timely feedback provided to companies on how to successfully

We updated the dossier preparation manuals and reviewed failure messages to further

Yes

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Annual Report 2024

complete their submissions. improve the support to companies that submit information to ECHA.

The verification of the size of SME companies which registered after the last registration deadline continued and the time lag between submission and beginning of the verification further reduced.

ECHA performed over 400 companies size verifications and reduced delays between submission and verification to further streamline the process. We also provided input to the European Commission to shift SME verification to an “ex-ante” approach, which will enhance process predictability and efficiency.

Yes

Tools and processes for invalidation of registrations developed further for different circumstances, such as the implementation of EU sanctions.

ECHA developed tools and procedures to address various invalidation scenarios, including invalidation of registrations and implementation of EU sanctions. For the revocation of non-existing companies and the invalidation process, we improved the process, gaining efficiency and ensuring consistency.

Yes

Preparations commenced, as necessary, for the adaptations stemming from the revision of the REACH Regulation.

The Commission’s work on revising the REACH Regulation is ongoing. ECHA anticipates a proposal for a revised Regulation in 2025 and will work closely with the Commission to provide input and support the development and implementation of the proposal.

No

Indicators Estimate Actual

Number of PPORD notifications received 240 238

Number of C&L notifications received 35 000 168990

Number of Registration dossiers received (incl. updates) 15 000 13 470

Number of SME companies verified for their status 400 408

Registrations stopped for manual verification at technical completeness check

5 100 4 206

Number of registrations failing first technical completeness check 1 300 669

Number of confidentiality assessments concluded 220 241

Number of revocations or invalidations concluded 150 126

Objective 2: Submission activities are user-focussed, streamlined and adaptable.

Main Outputs Execution Status

ECHA’s submission systems transformation plan commenced.

Progress was made on how to simplify the systems used by companies to submit their dossiers towards an Industry portal that will offer a single-entry point with increased user- friendliness and consistency. We initiated this transformation plan by focusing on drinking water submissions under DWD.

Yes

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Annual Report 2024

Indicators

N/A

Identification and prioritisation of substances and groups of substances Objective 1: Prioritisation of regulatory action on individual substance and/or groups of substances.

Main Outputs Execution Status

Workshop organised with the Member States and stakeholders to review the Integrated Regulatory Strategy and actions on the coordinated identification and prioritisation of substances and groups of substances identified.

We discussed and developed new objectives for the IRS in conjunction with the Commission and Member States to ensure that the approach meets current and future challenges. Key drivers for the IRS in the future include the need to maintain a good knowledge about the chemicals in our databases and shifting the focus to deliver risk management outcomes for (groups of) substances.

We also continued strengthening co-operation across regulatory frameworks and with sister agencies, especially EFSA and more recently EMA, as this is essential to support information sharing and consistency of regulatory outcomes. We explored synergies between collaboration platforms such as RIME+ and the ‘One substance, one assessment framework’.

Yes

Groups of substances identified for authorities to select for CLH and restriction processes.

We supported authorities in identifying (groups of) substances that require risk management through shortlisting (groups of) substances considered as good candidates for CLH, restriction, or other risk management options. CLH cases were short-listed and presented to Member States at the RiME+ meetings.

Yes

Results from the group assessment reports, on request of the Commission, used to update the restriction roadmap.

We identified candidates for the Restrictions Roadmap by screening assessment of regulatory needs (ARN) cases. These suggestions were submitted to the Commission, which incorporated the proposals into the updated Restrictions Roadmap.

Yes

Progress report on the Integrated Regulatory Strategy published.

In 2024, we concluded the systematic screening of high production volume chemicals, marking the culmination of a five- year effort to group and assess nearly all high- tonnage substances in our database.

We published the final IRS report, which takes

Yes

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Annual Report 2024

stock of the progress achieved over the last five years and outlines future plans.

Indicators Estimate Actual

Number of groups of substances for which a preliminary conclusion on potential regulatory follow up was drawn or further clarified

40 47

Evaluation9 Objective 1: Dossier evaluation is efficient, transparent and scientifically and legally robust.

Main Outputs Execution Status

Follow-up actions to the 2023 review of Joint Evaluation Action Plan completed. A proposal for a new approach to compliance check developed.

In 2024, we successfully concluded the Joint Evaluation Action Plan (JEAP), which aimed to ensure compliance of registration dossiers and reviewed the outcomes together with the Commission, Member States and stakeholders.

Yes

Evaluation targets and indicators delivered.

The 2024 annual evaluation targets were met. Collaborative efforts with Member States showed strong alignment, with less than 10% of draft decisions discussed by the Member State Committee (following proposals for amendment by Member States). This enabled a high throughput of cases.

Yes

Testing proposals examined within the legal deadlines.

In 2024, testing proposals were not consistently examined within the legal deadlines, which apply only to non-phase-in substances. This was due to prioritising decisions with a backlog in follow up and testing proposal evaluations - a focus, which will persist in the coming years. While significant efforts were made to address pending evaluations and follow-up actions, the focus on backlog reduction meant that some testing proposals were not processed within the expected timelines.

To identify challenges in the process, we performed an audit, which provides insight on the issues and resulted in several recommendations, which will be addressed in 2025. The findings and recommendations will be shared with the Commission and further analysed to ensure improvements are implemented effectively.

No

9 Title VI of Regulation (EC) No 1907/2006

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Annual Report 2024

Information submitted in response to ECHA evaluation decisions examined without delay and conclusions communicated to the Commission and Member State competent authorities.

Follow-up actions were conducted to verify that any updated information provided in response to evaluation decisions addressed the requested requirements.

Yes

National enforcement authorities informed in case of non-compliance with the decision and follow-up decisions drafted where appropriate.

We kept national enforcement authorities informed in cases of non-compliance with decisions, and drafted follow-up decisions where appropriate.

Yes

Updated recommendations to registrants stemming from evaluation published and communicated.

We published regular updates to the website and communicated recommendations directly to registrants as needed.

Yes

Support to the Commission provided in relation to the CSS and the REACH revision (Evaluation and the annexes on information requirements).

The Commission’s work on revising the REACH Regulation is ongoing. ECHA anticipates a proposal for a revised Regulation in 2025 and will work closely with the Commission to provide input and support the development and implementation of the proposal.

No

Targeted study audits requested in case a concern about compliance with principles of Good Laboratory Practice is identified by ECHA or a Member State.

We requested two GLP study audits based on concern and three GLP study audits based on random selection.

Yes

Regulatory advice provided to registrants and other interested parties on information requirements and on dossier and substance evaluation processes.

We provided regulatory advice to registrants and other interested parties on information requirements and the evaluation processes for dossiers and substances through guidance, helpdesk and direct interactions with registrants.

Yes

Indicators Estimate Actual

Compliance checks concluded: draft decisions or no action 250 251

Final decisions on dossier evaluation (testing proposals and compliance checks)

250 300

Number of substances for which a conclusion was reached in the follow-up to dossier evaluation

250 219

Objective 2: Substance Evaluation by Member States becomes more efficient and effective.

Main Outputs Execution Status

Updates of the CoRAP proposed to the MSC for substances where substance evaluation is the most appropriate tool to generate further hazard information.

The CoRAP list was updated with 25 substances for evaluation by 12 Member States, and during the year conclusions were reached for 19 substances.

Yes

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Annual Report 2024

Member States advised and supported in achieving substance evaluation conclusions as fast as possible.

We provided continuous support to evaluating MSCAs on their open substance evaluation cases. Based on eMSCAs' feedback, MSCAs expressed high level of appreciation with this support.

Yes

The appropriate regulatory risk management measures and initiatives adopted by Member States.

An initial analysis of follow-up regulatory risk management measures and initiatives proposed by eMSCAs as an outcome of substance evaluation has been conducted and will be communicated to ECHA stakeholders in 2025. Evaluations during the year led to key regulatory actions, including harmonised classification and labelling, identification of substances of very high concern (SVHC), and restrictions.

Yes

Number of substance evaluation cases currently opened reduced further.

10 new evaluation cases were opened while 19 substances evaluation cases were concluded. This led to a c.a. 10% decrease in the number of open SEV cases in 2024. Eight substance evaluation decisions (six draft decisions and three final decisions) were issued, requesting data to address concerns regarding endocrine disruption, PBT/vPvB, or mutagenicity. The number of final decisions was lower than anticipated, reflecting the gap between the original ambition of ECHA and Member State authorities, and the complexities emerging at the time of implementation.

Yes

Indicators Estimate Actual

Substance evaluation final decisions issued 10 3

Number of substances for which a conclusion was reached in substance evaluation

25 19

Authorisation10 Objective 1: Substances of very high concern identified, controlled and progressively replaced.

Main Outputs Execution Status

Substances of very high concern identified and included in the Candidate List.

Two entries were added to the Candidate List, bringing the total in 2024 to 242 entries. These substances were found to have either very persistent and very bioaccumulative properties, or were shown to be persistent, bioaccumulative and toxic, or displayed negative effects on reproduction, or had

Yes

10 Title VII of Regulation (EC) No 1907/2006

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Annual Report 2024

endocrine disrupting properties for the environment. In addition, an existing entry was updated to reflect that it is an endocrine disruptor to the environment based both on its intrinsic properties and when it contains an impurity at ≥ 0.1% w/w. The total number of new entries was lower than the initial estimate, reflecting the gap between the intentions communicated by the dossier submitters, and the ability to implement the dossiers, through the drafting and decision- making phase, in time.

Applications for authorisation processed and progressed in line with agreed approach.

After a peak number of applications for authorisation in the past years, mainly for the use of hexavalent chromium substances, the number of applications significantly decreased in 2024, with 43 applications and review reports received (covering 57 uses). As the total number of applications received has been higher than the capacity of the scientific committees, they continue to work steadily to process the applications in their opinion making (see objective 2 below).

In 2024, the actual number of downstream user notifications of authorised uses of SVHCs provided by companies was lower than estimated (766 actual compared to 3000 estimated). Estimating a figure for such notifications is very difficult in any given year, hence the discrepancy.

Yes

Indicators Estimate Actual

Number of new entries in the Candidate List 15 211

Applications and review reports for authorisation received (number of uses)

40-60 57

Number of downstream user notifications of authorised uses of SVHCs 3 000 766

Objective 2: Opinions of the Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) are timely and fit-for purpose.

Main Outputs Execution Status

Opinions on applications for authorisation delivered to Commission.

The scientific Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) delivered opinions on applications for authorisation of 55 uses of substances.

Yes

11 See respective output above.

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Participation in workshops and network meetings facilitated as necessary, to develop methodologies and enhance the capacity of Member States and companies to carry out analysis of alternatives and socio-economic analysis with view of finding viable alternatives.

We actively participated in key networks and meetings such as the Network of REACH SEA and Analysis of Alternatives Practitioners (NeRSAP), the OECD Working Party on Risk Management and related workshop on safer alternatives, as well as various environmental and human health economists networks. In support to substitution, we focused on maintaining ECHA's dedicated webpages, including its online training module, and in following the developments of the Commission’s substitution-related studies.

Yes

Indicators Estimate Actual

Number of RAC and SEAC opinions adopted on applications for authorisation (number of uses)

40 55

Restrictions12 Objective 1: Commission supported in the implementation of the Restrictions Roadmap.

Main Outputs Execution Status

Annex XV dossiers proposing restrictions and/or investigations developed for 2-3 substances or groups of substances from the restriction roadmap at the request of the Commission.

The requested investigation report on Aromatic Brominated Flame-retardants, covering 60 substances, was finalised and published. The restriction dossier on chromium (VI) substances, originally due to be completed in 2024, was delayed as the Commission requested ECHA to expand the scope and therefore the timeline for the submission of this dossier was postponed to April 2025.

No

Screening reports for 2-3 substances under Article 69(2) prepared.

We delivered 4 screening reports, analysing whether there is a need for restricting the use in articles for substances subject to authorisation (Art.69.2).

Yes

Indicators Estimate Actual

Restriction proposals or investigation/screening reports developed 5 5

12 Title VIII of Regulation (EC) No 1907/2006

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Annual Report 2024

Objective 2: Opinions of the Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) are timely, robust and fit-for-purpose.

Main Outputs Execution Status

Robust opinions on restrictions delivered to the Commission.

The opinion of the scientific committees (RAC and SEAC) on the restriction dossier for creosote was delivered to the European Commission.

The committees made progress in evaluating the PFAS restriction dossier that was submitted by five countries in 2023. They arrived at provisional conclusions on hazards and on eight sectors and uses of PFAS and will continue the evaluation in 2025 based on the work of the dossier submitters.

Yes

Methodologies related to socio- economic analysis developed and explained to create a fit-for-purpose toolbox, including the valuation of various health and environmental endpoints in collaboration with the OECD and in line with the Commission’s Better Regulation guidelines.

We maintained our involvement in methodological development-related activities, including the valuation of five human health-related endpoints (hypothyroidism, hypertension, non-fatal cancer, skin sensitisation, and miscarriage) under the OECD SWACHE project. We also actively contributed to the first steps of a similar project for environmental endpoints (OECD SACRE).

Yes

Indicators Estimate Actual

Number of RAC and SEAC opinions on restriction proposals 1 1

Objective 3: Commission supported in their decision-making tasks.

Main Outputs Execution Status

Case-specific support provided to Commission in the decision-making phase of the restriction process.

At the request of the Commission, we provided support in the decision-making phase related to four restriction proposals: PFAS in fire-fighting foams, PAH in clay targets, skin sensitisers and lead in shooting and fishing.

Yes

General and specific guidance to aid the implementation of Annex XVII restriction entries (e.g., Formaldehyde) delivered to the Commission.

The guideline on the Formaldehyde restriction was developed in 2024 as mandated by the Commission. Incorporation of the Commission's suggestions was ongoing at year end. The guideline is expected to be submitted to the Commission in the first quarter of 2025 and subsequently published on the ECHA website.

No

General and specific technical support to aid the implementation of Annex XVII restriction entries (e.g., microplastics), delivered to the

We supported the Commission in developing guidance on the microplastics restriction and in developing a microplastics reporting system as part of the implementation of that

Yes

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Annual Report 2024

Commission. restriction. A proposal for implementing these requirements was agreed with the Commission and will be made available in 2025.

Indicators Estimate Actual

Number of cases in decision making where support is provided 4 4

Number of reports 1 0

Number of Annex XVII entries where implementation support is provided

1 1

Classification and labelling13 Objective 1: Opinions of the Committee for Risk Assessment (RAC) are timely and fit-for purpose.

Main Outputs Execution Status

CLH dossiers, including individual and groups of industrial chemicals from the outcome of identification and prioritisation processed in line with legal requirements.

60 dossiers with proposals for harmonised classification were received and 56 opinions on harmonised classification by RAC were adopted.

Yes

All harmonised PPP and biocides dossiers processed in line with legal requirements.

All harmonised PPP and biocides dossiers were processed within the legal deadlines.

Yes

Joint Commission, EFSA and ECHA efforts to encourage the timely submission of PPP and biocide dossiers completed.

Alignment on this objective was not prioritised for completion.

No

Indicators Estimate Actual

Proposals for harmonised classification and labelling 50 60

Number of RAC opinions on proposals for harmonised classification and labelling

50 56

Objective 2: Member States, Commission services and duty holders supported to fulfil their legal obligations.

Main Outputs Execution Status

Guidance made available and updated as necessary.

We continued supporting the European Commission in the review of the CLP Regulation, which was published in late 2024. Guidance and support on CLP were updated to

Yes

13 Regulation (EC) 1272/2008

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include the new hazard classes. This was a significant collaborative achievement delivered under tight deadlines by experts from ECHA, EU Member States, EU level non- governmental organisations and others, with input from an extensive stakeholder consultation.

Decisions made on requests to use an alternative chemical name in line with legal requirements.

We received 20 requests to use an alternative chemical name, a lower number compared to previous years. All requests were processed in accordance with legal requirements.

Yes

Scientific and technical support provided to the Commission in the context of the further development of the United Nations Globally Harmonised System of classification and labelling of chemicals (UNGHS), and in particular including advice on:

• the new hazard classes and criteria for endocrine disruptors; PBT, vPvB, PMT, vPvM; neurotoxicity and immunotoxicity; terrestrial toxicity in GHS.

• the implementation of revisions 8, 9 and 10 of UNGHS.

• the work of selected GHS working groups, notably the working group on the use of non-animal testing methods for classification.

We provided regular support to the Commission in the context of the United Nations’ Globally Harmonised System of classification and labelling of chemicals (UN GHS).

Yes

Scientific and technical support provided to the Commission in the implementation of the revisions of the CLP regulation and the UNEP GHS project in African countries.

We provided support to the Commission in the implementation of the revisions of the CLP regulation and the UNEP GHS project in African countries.

Yes

Indicators Estimate Actual

Decisions made on requests to use an alternative chemical name (Art 24 CLP)

40 20

Objective 3: Up-to-date information on the classifications for chemicals, both harmonised and non-harmonised, publicly available.

Main Outputs Execution Status

First version of the new C&L inventory launched as part of ECHA’s new public data availability

The delays in setting up the new public cloud IT environments and infrastructure resulted in the launch of the C&L inventory being

No

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Annual Report 2024

system. The new version will take into account the changes in the revised CLP regulation.

postponed from November 2024 to Q2 2025.

Tools and support materials were updated to take account of the review of the CLP Regulation.

Indicators

N/A

Objective 4: Structured, high quality and consistent information for the EU poison centre scheme is timely available across Europe.

Main Outputs Execution Status

Notification portal and system-to- system submission channel maintained and adapted to meet the requirements stemming from the revision of the CLP Regulation and changes with IUCLID.

We maintained and successfully adapted the notification portal and system-to-system submission channel to meet the requirements stemming from the revision of the CLP Regulation and changes with IUCLID.

Yes

Actions to address issues with misuse of UFIs identified and delivered in conjunction with MS Competent and Enforcement Authorities.

We began addressing the misuse of UFIs and finalised an information package aimed at helping companies avoid misuse which will be published in 2025. Additional input from Member States and Appointed Bodies on UFI misuse was sought for further investigation.

No

PCN activities promoted and support provided to companies and Member States following the entry into force of the notification obligation for mixtures with industrial uses of 1 January 2024 and in view of the end of the transition period on 1 January 2025, as well as with regard to adaptations stemming from the revision of the CLP Regulation.

We provided ongoing support to companies and Member States following the entry into force of the notification obligation for mixtures with industrial uses. Appointed Bodies and Poison Centres regularly used the PCN central database to perform their duties under Article 45, Annex VIII. The number of poison centre notifications viewed by national authorities in the PCN central database exceeded our estimate, with 22,775 views compared to the anticipated 15,000.

Yes

Indicators Estimate Actual

Poison centre notifications received and made available to Appointed Bodies and Poison Centres

2 to 3 million

3 148 898

Poison centre notifications viewed by national authorities in the PCN central database

15 000 22 775

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Annual Report 2024

Objective 5: ECHA advice, processes and tools, resulting from the revision of CLP, updated and communicated.

Main Outputs Execution Status

Guidance and support on CLP updated to include the new hazard classes.

Guidance and support on CLP were updated to include the new hazard classes and published by year end.

Yes

Guidance to support CLH for groups of substances.

We continued assisting Member States in developing dossiers for Harmonised Classification for 10 groups of substances that originated from the chemical universe screening. This included ad-hoc support requested by three Member States and preparing a shortlist of seven group CLH candidates presented to the RiME+ meeting.

Yes

Support mechanisms for Member States in the preparation of CLH dossiers including for the new hazard classes established, including the clarification how the PBT and ED expert groups can support the work.

We provided advice to various relevant fora on the role of the Expert Groups and how to receive support.

Yes

Data submission formats and tools adapted to the requirements of the revised CLP regulation.

We successfully adapted data submission formats and tools to the requirements of the revised CLP regulation.

Yes

Indicators

N/A

Data management and dissemination Objective 1: Regulatory processes performed by relevant actors based on robust data and IT systems.

Main Outputs Execution Status

Data governance to support regulatory data consistency, coherence, transparency and reporting across regulations consolidated.

We initiated the implementation of our new data management approach and established a Data Governance Office responsible for managing our regulatory data. This work will continue and will be further shaped to support regulatory data consistency, coherence and transparency.

Yes

Interact Portal (including ACT) maintained with due consideration of process and users’ requirements.

We maintained and further developed the Interact Portal, including ACT, which introduced enhanced functionalities were introduced such as a tracking list for ACT and email notifications.

Yes

Case management capabilities further developed to onboard new

First versions of the core case management modules (task, process, case, and portal)

Yes

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Annual Report 2024

tasks and increase efficiency of existing regulatory processes.

were set up. These modules will be used in the delivery of the IT solution to support the Drinking Water Directive process as part of our IT Transformation. These and then they will be further applied in other regulatory processes in the future.

Chemical identifiers data management reviewed to increase its efficiency and effectiveness.

We initiated implementation of a new Chemicals Identifiers Management System to manage the inherent differences between regulatory contexts and prepare the Agency to onboard new tasks.

Yes

Tools to search, extract and analyse data maintained and accessible to authorities and industry.

We maintained and made accessible to authorities and industry tools to search, extract, and analyse data.

Yes

Data analysis services completed upon request from EU institutions or Member States.

Our data services supported the Commission and Member States on scientific data analysis. This included assisting the Commission with the revision of the EU UWWT (Urban Wastewater Treatment Directive 91/271/EEC); providing information on substances in electronic devices to support Member States regulatory work; supporting the preparation of ECHA investigation report on aromatic brominated flame retardants, which will aid the Commission in deciding on the scope and need for further regulatory action.

Yes

Indicators Estimate Actual

Number of data provision and analysis requests 70 61

Objective 2: Transparent and public access to data submitted under different regulations as well as progress on regulatory activities made available.

Main Outputs Execution Status

First version of ECHA’s new public data availability system launched, including hazard, use and classification data from registration dossiers.

The first version of the new system for making information on chemicals publicly available, ECHA CHEM, went live in Q1 2024, covering information from registration dossiers.

Yes

New solution for dissemination of regulatory data integrated into ECHA’s new data availability system.

Further extension of the scope of ECHA CHEM had to be postponed to 2025, due to delays encountered with the set-up of the new cloud- based IT infrastructure and the need to address an unforeseen IT incident affecting the publication of information from registration dossiers.

No

OECD Global Portal to Information on Chemical Substances (eChemPortal) maintained and

The OECD eChemPortal was maintained as planned, but the data refresh to ECHA’s dissemination website was not completed due

No

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Annual Report 2024

synchronised with ECHA’s dissemination website.

to the transition to ECHA CHEM, the new ECHA dissemination website. The refresh will be aligned with the new system going forward.

Indicators

N/A

Promotion of alternatives to animal testing Objective 1: Industry generates hazard data using non-animal testing methods and new approaches.

Main Outputs Execution Status

Development of the QSAR toolbox to integrate new information (for example, metabolites, biocides or data from pharmaceuticals) and models further developed.

Two versions of the QSAR Toolbox were released in 2024. Key achievements include the full implementation of Meta Map, compatibility with the latest IUCLID version, and the integration of new databases.

Yes

Data available for download (REACH studies results and pharmaceutical industry data contribution) expanded to be used for NAMs development and/or avoiding unnecessary animal testing.

This output was not achieved due to the change in technology for the dissemination of registration dossiers, transitioning to the new ECHA CHEM platform. As a result, no updates were made in 2024.

No

Predictive models to support prioritisation and scientific decision making further implemented.

Due to budget constraints, further deployment of modules could not be achieved.

No

Application of the OECD QSAR Assessment Framework supported.

We provided all necessary support for the application of the OECD QSAR Assessment Framework.

Yes

Indicators

N/A

Objective 2: ECHA information and advice on alternatives to animal testing provided to policy makers and stakeholders.

Main Outputs Execution Status

OECD activities related to further development of alternatives and integration of regulatory relevant alternatives in test guidelines supported.

We finalised drafting the OECD Guidance for Omics Sampling.

Yes

Development of high throughput NAMs in cooperation with ECHA’s

We also rolled out our own projects to reduce reliance on animal testing while maintaining

Yes

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Annual Report 2024

international partners progressed. protection of human health and environment. For example, we contracted a collaborative consortium of researchers to conduct scientific studies on the reliability and relevance of New Approach Methodologies (NAMs) as alternatives to animal testing and to promote the use of such methods in the future. The contract will run for six years and has a total value of EUR 4.2 million in funding. These projects will investigate the application of omics in regulatory contexts to enhance read- across and grouping methodologies; explore potential alternatives to current aquatic toxicity testing involving the use of fish; and examine the use of in vitro toxicokinetics to support hazard assessment.

We also supported a case study under the Risk Hunter research consortia. The case study aimed at classifying substances as toxic (STOT RE classification) or non-toxic (NOAEL ≥ 1000 mg/kg bw) using bio-spider sequencing.

International collaboration towards the identification and acceptance of alternatives in regulatory frameworks (e.g., with US and Canada within the APCRA initiative (Accelerating the Pace of Chemical Risk Assessment)) maintained.

We invested in international activities, particularly Accelerating the Pace of Chemical Risk Assessment (APCRA), Partnership for the Assessment of Risks from Chemicals (PARC) and Organisation for Economic Co-operation and Development (OECD) activities and finalised a number of case studies with them. For example, a case study for systemic toxicity, characterisation of the uncertainty for high throughput toxicokinetic, and analysis of the toxicological concordance between animal and human data.

We worked closely with the European Commission to support development of a roadmap to phase out animal testing.

Yes

Indicators

N/A

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Annual Report 2024

Biocides14 Objective 1: Active substance and Union authorisation opinions are timely and of high quality.

Main Outputs Execution Status

Opinions on the approval and renewals of active substances and on Union authorisation of biocidal products prepared.

We finalised 15 opinions on active substances and one opinion on a review of the approval of an active substance. The overall progress of the active substances Review Programme is now at 50%. We delivered 17 opinions on Union authorisations as well as 8 opinions following Art. 75(1)(g) requests from the Commission.

Yes

Opinions on Union authorisation of same biocidal products and on administrative changes of the Union authorisations prepared.

We delivered 15 opinions on Union authorisations of same biocidal products, as well as 20 opinions on administrative changes of Union authorisations.

Yes

Opinions on minor changes and major changes of the Union authorisations prepared.

We delivered four opinions on minor changes of Union Authorisations, and one opinion on a major change of a Union Authorisation. Additionally, we finalised eight opinions on classification of changes of biocidal products.

Yes

Cooperation with EFSA further advanced to implement the basis and mechanisms for alignment of evaluation of common substances (one substance, one assessment).

We continued to collaborate with other agencies. With EFSA we developed consistent guidance documents, such as on risk assessment for pollinators.

We also cooperated with EFSA, EMA and ECDC, on a report to address anti-fungal resistance (Aspergillus) that was endorsed by BPC.

Yes

List of frequently used sentences in the SPCs updated and translated in all the EU official languages.

The list of frequently used sentences in the SPCs is updated every two years. It was updated and translated into all EU official languages in 2023. It will be updated again in 2025.

Yes

Assessments of applications for technical equivalence, inclusion in the Article 95 BPR list and classification for of changes performed.

Decisions on technical equivalence (32) and inclusion in Art. 95 list remained a sustained output, as in previous years, contributing to the total amount of work involved in implementing the Biocidal Products Regulation.

Yes

Indicators Estimate Actual

Number of opinions on active substances [approval & renewal] 15 15

Number of opinions on Union authorisation of biocidal products 20 17

Number of opinions on Union authorisation and related processes: 35 40

14 Regulation (EU) No 528/2012

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Annual Report 2024

same biocidal products, administrative, minor and major changes.

Number of technical equivalence application assessments 30 32

Objective 2: Member States and Commission supported to facilitate biocides processes and accelerate the Review Programme.

Main Outputs Execution Status

Regulatory, procedural and technical support provided to the competent authorities of the Member States (MSCAs) in the evaluation and BPC opinion forming on the approval of active substances, including also on measures defined in connection with the prolongation of the Review Programme, and on Union authorisation of biocidal products.

We provided regulatory, procedural and technical support to MCSAs. We also took additional steps to improve the implementation of the Biocidal Products Regulation, for instance, by improving the part of BPC opinions on analysis of alternatives and exclusion derogation criteria, improving the consultation practice for analysis of alternatives and inclusion of derogation criteria.

We provided secretariat support to the Coordination Group, assisting Member States in resolving disagreements during mutual recognition of biocidal products authorisations and in reaching agreements on horizontal topics to prevent future disagreements.

We further improved working procedures, such as the active substance renewal procedures, as well as on the renewal of Union authorisations (working procedure, SPC linguistic review, criteria for full evaluation, guidelines for submission of applications). A recommended approach to address in situ active substances was endorsed by the Commission and Member States.

Yes

Contribution made to MSCAs capacity building by providing training and scientific-technical advice, including also on endocrine- disrupting substances and analysis of alternatives.

We organised information sessions and a campaign for direct support to Member States in requesting endocrine disruptors (ED) data for all pending cases by June 2024. This is a prerequisite to obtain all necessary ED data by the end of 2026 and conclude the evaluation accordingly.

In the annual survey, the EU biocides authorities expressed a very high level of satisfaction with the work of ECHA, increasing from 84% to 95%.

Yes

BPC opinions requested by the Commission pursuant to Articles 38, 15(2) and 75(1)(g) of the BPR prepared.

We delivered 10 opinions following requests from the Commission according to Articles 15, 38 and 75(1)(g).

Yes

Guidance developed and maintained aiming for alignment as far as EU Regulations allow.

Several guidance documents were developed or updated including the guidance on risk assessment for pollinators; practical guide for letters of access; update of efficacy guidance;

Yes

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Annual Report 2024

guidance to reduce exposure of cats to pyrethroids; endorsement of approach to address in situ substances.

Support to the development of an easily accessible and structured overview of ECHA guidance documents and relevant policy documents provided.

We delivered a solution to easily identify and access relevant documents.

Yes

Indicators Estimate Actual

Satisfaction of authority actors Positive trend 95 %

Number of opinions on Article 15, Article 38 and Article 75(1)(g) requests

10 10

Objective 3: Biocides IT tools integrated with other ECHA regulatory IT systems.

Main Outputs Execution Status

Specialised Biocides IT tools integrated with ECHA IT systems.

We adapted IUCLID to integrate the preparation of the summaries of biocidal product characteristics (SPCs). The previous ‘SPC Editor’ was discontinued.

Yes

Development continued for the Register for Biocidal Products (R4BP 3) and other IT support tools (e.g., Chesar platform).

R4BP 3 was maintained and improved through two major releases. Progress was made in aligning it further with ECHA target modular architecture. We continued collecting user information and exchanging through the BPR IT user group.

Yes

Transition of evaluation dossiers into IUCLID format for active substances and Union authorisation cases initiated.

We made good progress in developing the first set of IUCLID quality rules for applications of active substance approval.

Yes

Indicators

N/A

Contribution to EU Environmental policy Objective 1: international trade of chemicals listed under the Rotterdam Convention and the PIC regulation facilitated and managed.

Main Outputs Execution Status

Received export notifications processed.

We received 10,448 export notifications and successfully processed all of them.

Yes

Support provided to EU MS DNAs and the Commission, including the management of explicit consent

We provided support to EU MS DNAs and the Commission, including the management of explicit consent requests, to allow companies

Yes

40

Annual Report 2024

requests, to allow companies to export these chemicals in accordance with the EU’s international commitments.

to export these chemicals in accordance with the EU’s international commitments.

Support to companies (via the helpdesk) and non-EU Authorities provided.

Support was provided as requested. Yes

Fifth biannual report on the exchange of information under the PIC Regulation (Art. 20) published.

The report was published in October 2024. Yes

Annual report on PIC exports and imports (Art. 10) published.

The annual report published, showed that EU chemical exports under PIC remained at similar levels to previous years.

Yes

Support provided to the Commission with the EU contribution to the Rotterdam Convention implementation.

We provided support to the Commission with the EU contribution to the Rotterdam Convention Implementation.

Yes

Support provided to the Commission in the continuous improvement of the efficient implementation of the PIC Regulation, including any follow- ups to ECHA’s third “report on the implementation of the PIC Regulation”, and providing input to the Commission in the evaluation and follow-up of the PIC Regulation.

We continued providing support to the Commission on improving the efficient implementation of the PIC Regulation, including follow-ups to ECHA’s third report on its implementation. We also contributed input to the Commission for the evaluation and follow-up of the regulation.

Yes

Indicators Estimate Actual

Export notifications processed 11 000 10 448

Share of notifications validated by ECHA 90 % 94 %

Support provided to PIC duty holders (importers and exporters) 250 253

Objective 2: European Commission supported in the implementation of the Stockholm Convention and the POP Regulation.

Main outputs Execution Status

Scientific dossiers drafted for a new EU proposal to list a potential POP substance under the Stockholm Convention on Persistent Organic Pollutants.

We updated the draft scientific dossier (Annex D proposal) for Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5) and Dodecamethylcyclohexasiloxane (D6) based on new available information. At the European Commission’s request, we conducted a screening exercise to identify substances that could meet the POP criteria, with the aim of identifying a new candidate for an EU proposal. We presented the screening results at the POP Competent Authorities Expert Group meeting in November 2024.

Yes

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Annual Report 2024

Technical and scientific support provided as required to the Commission for the listing process.

Under the EU Persistent Organic Pollutants (POPs) Regulation, we provided technical and scientific support to the Commission for discussions at the 20th meeting of the POPs Review Committee (POPRC-20). We actively participated in discussions related to the addendum for the risk management evaluations of Medium-chain Chlorinated Paraffins (MCCPs), chlorpyrifos and long-chain PFCAs. All substances (MCCPs, chlorpyrifos and long-chain PFCAs) were recommended for listing under Annex A of the Stockholm Convention, with specific exemptions. The Committee also agreed that polybrominated dibenzo-p-dioxins and dibenzofurans and mixed polybrominated/chlorinated dibenzo-p- dioxins and dibenzofurans met the screening criteria in Annex D to the Convention.

Yes

The reporting system for the implementation of the POP regulation maintained and the Union Overview report based on the Member States reports updated. These outputs will be delivered in line with resource constraints.

The Union Overview report was updated in February 2024.

Yes

Indicators Estimate Actual

Number of scientific dossiers drafted for the identification of new substances as Persistent Organic Pollutants

1 1

Support provided to various stakeholders 50 70

Scientific and technical support provided to the Commission, EU and non-EU CAs

10 35

Objective 3: Substances of very high Concern In Products (SCIP) database maintained.

Main outputs Execution Status

Notification portal and the public SCIP database maintained.

We successfully maintained the Notification portal and the public SCIP database, ensuring continuous operation and accessibility throughout the year.

Yes

Support provided to EU suppliers of articles to submit the required information to ECHA.

We provided ongoing support to EU suppliers of articles, assisting them in submitting the required information to ECHA in a timely and efficient manner.

Yes

Indicators Estimate Actual

Successful SCIP notifications received (incl. updates) 8-12 million 12 257 502

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Annual Report 2024

Objective 4: Implementation plan for ECHA’s role under of Article 11 of the revised Drinking Water Directive in place.

Main outputs Execution Status

Technical and scientific support to the Commission provided on drafting and adopting the Implementing and Delegated acts.

We continued our preparatory work to ensure readiness of the entry into operation of the directive’s provisions relevant for ECHA’s role. We prepared scientific guidance for the potential applicants and held a webinar on the new obligations under the directive.

Yes

Internal operational procedures and working instructions for handling the applications to be submitted from 2025 onwards established.

We continued to work on setting up the process and the IT tools needed to ensure smooth and timely handling of notifications and applications as well as delivery of the opinions under Art. 11 of the directive. The implementation of the provisions for notification and application systems have been delayed by one year by the legislator.

Accordingly, the implementation of the related tools and procedures have been slightly deprioritised during 2024. This work will continue in 2025.

No

Procedures for opinion forming by RAC and the Working Group developed and implemented.

No

IT tools for the reception, processing and dissemination of applications, including the adaptation of IUCLID to the specific needs of the DWD process, developed and implemented.

No

Objective 5: an accessible and transparent evidence base to support the monitoring, measuring and reporting on chemicals.

Main outputs Execution Status

Relevant indicators developed that are based on accessible and transparent evidence and enable the monitoring, measuring and reporting on chemicals.

ECHA indicators and signals were developed in time for publication in the dashboard

Yes

Public version of the indicator framework prepared and published jointly with EEA and the Commission.

Under the 8th Environmental Action Programme (EAP), we developed the indicator framework jointly between Commission, ECHA and EEA. The final framework was published on the EEA website.

Yes

Joint synthesis report, offering policy-relevant messaging on the trends observed in the chemicals indicators prepared.

The joint synthesis report was prepared and published on the EEA website together with the framework in April 2024.

Yes

Objective 6: implementation of the Batteries Regulation.

Main outputs Execution Status

First part of the study completed, detailing the identification and engagement with all main batteries’ stakeholders, including waste

As 2024 was the first year of implementation of the ECHA tasks under the Batteries Regulation, the first phase of the scoping study was only launched and is expected to be

No

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Annual Report 2024

batteries, the investigation on the possibility to amend current restrictions (under ELV Directive) for Mercury, Cadmium and Lead in batteries in Annex I of the Batteries regulation and the foundation for the second part of the scoping study.

concluded in Q2 2025.

In preparation for this new task, the multi- annual work plan for implementing the batteries regulation at ECHA (implementation plan) was approved.

The first phase of the scoping study was launched in 2024 and is expected to be concluded in Q2 2025.

Workshop with all relevant stakeholders organised and follow- up actions implemented as necessary.

Two workshops were organised with relevant stakeholders in April and October 2024. The follow-up actions were fed into the scoping study development and onboarding of batteries restrictions work at ECHA.

Yes

Objective 7: preparation for the implementation of the Water Framework, Groundwater and Environmental Quality Standards (EQS) Directives.

Main outputs Execution Status

Technical and scientific support provided to the Commission in assessing changes proposed by Council and EP and any new drafts prepared.

In addition to support provided to the Commission on request, we set up cooperation with Commission, EEA and JRC to ensure smooth hand over of tasks, as well as following as observers some of the working group meetings of the Commission with relevant stakeholders.

Yes

Setup of internal operational procedures and working instructions for implementation of the tasks established.

The legislative process was delayed in 2024 and therefore the readiness for entry into operation on ECHA side was delayed accordingly. The focus in 2024 was on developing further understanding of the tasks, to identify the necessary expertise needed within the secretariat and in the RAC/SEAC committees.

No

Objective 8: further development of Best Available Techniques Reference (BREF) documents under the Industrial Emissions Directive supported.

Main outputs Execution Status

Expert and relevant input on chemicals provided to the JRC and IED Forum provided.

ECHA received a formal role in 2024 under the Industrial Emissions Directive. We supported the initiation of a new Best Available Techniques (BAT) reference documents (BREF) on ore mining, by providing information from ECHA’s chemical databases to assist in the identification of relevant input chemicals and potential Key Environmental Issues.

Yes

Assistance given to the BREF development and chemical risks are

We supported EU-BRITE with ad hoc consultations e.g., on ongoing BREFs, inclusion of chemical management systems in

Yes

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Annual Report 2024

addressed as appropriate. BAT-C (Best Available Technique Conclusion) documents and feedback on potential Guidance development.

Workplan for the further development of the Chemical Management Systems methodology (to prioritise chemicals for prevention/control of emissions from industrial installations) developed and agreed.

This output was deprioritised in 2024 to enable ECHA to shift focus to supporting the BREF process.

No

Tasks under grant, cooperation and service-level agreements Objective 1: EUON database on nanomaterials on the EU market available and updated.

Main Outputs Execution Status

Specific data gaps in the public knowledge about nanomaterials via the commissioning of external studies addressed.

Two studies were completed, and two new ones were launched, in accordance with the EUON work plan.

Yes

Database updated as necessary with new or changing regulatory or scientific information.

The EUON was updated with new content such as study reports and Nanopinions.

An evaluation of the functioning of the EUON was also performed providing insights and recommendations on the further development of EUON including its integration in the future Common data platform of chemicals as proposed by the Commission.

Yes

EUON promoted via different channels to increase its outreach to a wide variety of audiences.

Social media campaigns were delivered and found to be an effective tool to direct users to EUON.

Yes

Indicators Estimate Actual

All traffic to EUON websites 130 000 182 285

Objective 2: EUCLEF database on EU chemicals legislation available and updated.

Main Outputs Execution Status

EUCLEF maintained and updated. Information on regulatory obligations on chemicals was maintained and regulatory changes reflected.

Yes

EUCLEF promoted wider to increase the utility of the service for the target audience, with a particular focus on SMEs.

Information on regulatory obligations on chemicals was promoted especially towards SMEs as per the agreement with Commission

Yes

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Annual Report 2024

Advice provided via the EUCLEF helpdesk.

The outsourced EUCLEF helpdesk continued to provide timely support to customers.

Yes

Indicators Estimate Actual

All traffic to EUCLEF pages15 400 000 439 924

Objective 3: Opinions of the Risk Assessment Committee (RAC) on OELs delivered to the Commission.

Main Outputs Execution Status

SLA requests processed to agreed timelines.

Five new requests for setting occupational exposure limits were received under the 2024 contribution agreement with the Commission:

• N-(Hydroxymethyl)acrylamide (NMA) • Ethylene dibromide or 1,2-

Dibromoethane (EDB) • Anthraquinone • 1,3-Propanesultone • Oximes (butanone oxime and acetone

oxime)

The RAC opinions for these substances must be adopted by 30 April 2026.

Yes

Five RAC opinions completed and delivered to the Commission.

The RAC opinions on scientific evaluations of occupational exposure limits (OELs) for four of the five substances agreed for 2023 were adopted. The five substances included:

• Boron and its compounds • 1,3-Butadiene • 1,2-Dihydroxybenzene (Pyrocatechol) • Silicon carbide fibres

Exceptionally discussions on the fifth substance, Bisphenol A (BPA) (and other Bisphenols), were not completed with the RAC opinion scheduled to be adopted in 2025.

No

Indicators Estimate Actual

Number of OEL requests received under SLA 5 5

Number of RAC opinions on OELs completed 5 4

Number of scoping documents 1 0

15 Traffic aggregated for all the EUCLEF pages, including EUCLEF main landing page, Information for Chemicals (EUCLEF subset) and EUCLEF Legislation Lists for substances.

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Annual Report 2024

Objective 4: IPA grant implemented fully in support of EU candidate and pre-candidate countries on chemicals management.

Main Outputs Execution Status

Support actions as agreed in the IPA grant agreement for 2023-June 2026 implemented.

We delivered support to pre-candidate countries with the implementation of the chemicals acquis. IPA countries attended several relevant meetings and trainings including capacity building on enforcement and communication.

Yes

Indicators

N/A

Objective 5: IUCLID platform cooperation on Plant Protection Products (PPP) between EFSA and ECHA continued.

Main Outputs Execution Status

Submitted dossiers processed and made available to EFSA.

ECHA continued to support EFSA Industry access to ECHA Cloud Services and consolidated PPP submission processes.

Yes

Applicability of IUCLID to other food regulated products (e.g., Food Contact Materials and synergies with Drinking Water Directive and Feed additives) reviewed and assessed.

ECHA and EFSA discussed and agreed on the IUCLID requirements for Food Contact Material (IUCLID format). The implementation of the agreed requirements in IUCLID will start in 2025.

Yes

Support provided to EFSA with the use of IUCLID data tools for the extraction, search and upload of data.

ECHA delivered to EFSA several updates of the IUCLID data tools, and supported EFSA contractor with curating and populating data (e.g. on food toxicity) in EFSA IUCLID database.

Yes

Indicators

N/A

Objective 6: Input provided to research activities in support of current and future regulatory challenges

Main Outputs Execution Status

Framework developed with clear decision criteria to enable transparent decision making for the prioritisation of activities within PARC.

As a co-leader of Task 2.1 ‘Priority setting’ under PARC, ECHA’s experts reviewed 46 projects, mainly related to hazard, exposure and risk assessment methodologies.

Yes

Development of annual work plans supported and steered to ensure

We actively participated in PARC projects addressing data gaps, for example, on

Yes

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Annual Report 2024

identified EU priorities and knowledge gaps in the area of chemical risk assessment appropriately considered.

immunotoxicity and development of innovative methods on different hazard endpoints (e.g. developmental neurotoxicity).

We have further updated the regulatory research needs in our document called ‘Key Areas of Regulatory Challenge’ (KARC). The second version of this KARC report was launched during a joint webinar together with the EEA and EFSA (European Food Safety Authority) in June. These updated research needs serve as an important source of inspiration feeding into the key priorities for future research projects for the last three years of PARC.

We presented these research needs in various scientific fora (e.g., ECETOC- LRI Scoping meeting, Workshop Future chemical Risk Assessment and Management at University of Gothenburg, Helsinki Chemical Forum, etc.).

Advice and steer provided to the development and implementation of a rapid response mechanism to allow national and European policy makers to submit requests for specific information to the PARC Consortium outside of the formal timeframes.

We have submitted together with the European Environmental Agency (EEA) an urgent request to generate exposure data on a phthalate of concern via the Rapid Response Mechanism.

Yes

Indicators

N/A

Governance and Enablers Objective 1: A level playing field for economic operators through harmonised enforcement.

Main Outputs Execution Status

Reports on five Forum-coordinated REACH and BPR enforcement projects prepared, published and communicated. Reports include REACH and POP Restrictions (REF- 10), REACH safety data sheets (REF-11), control of REACH for imports (REF-12), online sales (REF- 13), BPR approved substances in biocidal products containing non- approved/approved active substances (BEF-2) and control of SPC and SDS for biocides (BEF-3).

All anticipated enforcement projects went through the different phases without delays. Reports and findings were published and communicated.

Yes

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Annual Report 2024

Subject matter of next REACH project (REF-14) agreed and steps taken to implement actions.

The classification and labelling of mixtures in products was agreed as the next Forum project (REF-14) and will commence in 2027.

Yes

Best practice enhanced by maintaining the Forum and BPRS Manuals of Conclusions on practical enforcement issues and running Forum pilot projects on PFCA (Perfluoroalkyl carboxylic acids) and related substances and poison centre notifications.

Updates to Manuals of Conclusions were made on a regular basis. Pilot projects (PFCAs in cosmetics, PCN notifications, bridging principles) progressed according to plans.

Yes

Advice on enforceability on all submitted proposals for restrictions delivered and published.

Advice was delivered. Yes

Process revised for delivering the Forum advice.

Process was revised, reviewed and accepted by the Forum.

Yes

New version of the compendium of analytical methods prepared.

A new draft version was made available. Yes

Four trainings for national trainers and inspectors developed and delivered.

Trainings took place, with some 730 participants, which was much higher than estimated.

Yes

Forum’s input provided on the Commission’s views on enforcement related topics under the CSS/REACH revision and the impact of any proposed legislative changes on the operation of the Forum reviewed.

The Commission’s work on revising the REACH Regulation is ongoing. ECHA anticipates a proposal for a revised Regulation in 2025 and will work closely with the Commission to provide input and support the development and implementation of the proposal.

No

Indicators Estimate Actual

Number of enforcement trainers trained by the Forum 200 730

Number of enforcement projects ongoing 5 9

Objective 2: Board of Appeal16 decisions are adopted without undue delay and are of high quality.

Main Outputs Execution Status

Appeals brought against decisions of the Agency, according to procedural requirements, processed and decided.

In 2024, eight appeal cases were received, and 14 appeal cases were closed.

Yes

Communication to parties and the public about appeal decisions completed.

Section on the Board of Appeal on the ECHA website was revised to make it easier for stakeholders to find decisions and other information on appeals.

Yes

16 Art. 90 of Regulation (EC) No 1907/2006 and Art. 77 of Regulation (EU) No 528/2012

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Annual Report 2024

Support provided to the Secretariat in defence of Board of Appeal decisions when challenged before the EU Courts.

Staff of the Registry supported the Secretariat in representing ECHA in two cases before the General Court.

Yes

Contributions provided to ECHA’s input for the review of the REACH Regulation.

The Registry and the Board of Appeal provided input to the secretariat, as required, with regard to processes within the competence of the Board.

Yes

Indicators Estimate Actual

Appeals submitted REACH 12 8

Appeals submitted BPR 2 0

Appeals concluded REACH 12 11

Appeals concluded BPR 2 2

Objective 3: ECHA's Governance aligns with strategy and adapts to the changing organisational and institutional landscape.

Main Outputs Execution Status

Four Management Board meetings with related subgroups and an external assessment of the Board organised.

Five Management Board meetings were organised, including one extraordinary meeting. The Management Board decided to conduct a self-evaluation17 without external support, which was run between April and August 2024.

Due to the extraordinary Board meeting scheduled, and in agreement with the Chair, the timelines for providing documentation were shortened. This is reflected in the fact that the relevant indicator achievement rate is 83% instead of 95%.

Yes

All statutory documents required by legislation in the area of planning and reporting are prepared and adopted on time.

All statutory reports were approved by the Management Board in line with regulatory requirements and timelines.

Yes

Regular reports on ECHA’s activities provided to the Management Board.

ECHA fulfilled its 2024 obligations, including a Management Board exercise to improve clarity of plans and reports and better linking strategy implementation to outputs and indicators.

Yes

Quality, internal control and risk management frameworks are implemented.

ECHA maintained its ISO 9001:2015 and 14001:2015 certifications and further developed its risk management framework, with a focus on training and awareness

Yes

17https://echa.europa.eu/documents/10162/74925298/final_mb_08_2024_mb_self_evaluation_2024_plan_en.pdf/845 faa2d-7da8-341f-6481-3b4a3b34cb37?t=1713184329505

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Annual Report 2024

raising.

Agency-wide audit and evaluation plan implemented.

The audit and evaluation plan was implemented with one additional evaluation conducted upon request by the Commission (EUON). The number of audit findings (11 see below) includes important and very important findings. There were no critical findings in 2024.

Yes

Actions foreseen in policies related to independence, transparency, fraud-prevention and data protection implemented.

Actions completed included a mandatory all- staff e-learning, with a focus on conflict-of- interest prevention and relations with interest groups; the Management Board received an annual refresher on ethics.

The focus of data protection actions concerned procured IT licences and software, the specific privacy risks involved with the migration of data to public cloud and the roll-out of the first AI pilot projects.

Yes

The Agency’s organisational model reviewed.

A review of ECHA’s organisation was completed to take account of the new strategy and our expanding legal mandate. The recommendations, which addressed ways of working, strategic prioritisation and organisational structure will be addressed in 2025.

Yes

Interactions with Member States authorities organised, both through bilaterals and networks (Heads of Chemicals authorities meeting).

There was increased engagement again in 2024 with the Member States partners highlighted by 12 bilateral engagements at the level of the Executive Director and a network meeting with the heads of Member States’ chemical authorities, organised in Q1 2024. These efforts significantly exceeded the corresponding indicator.

Yes

ECHA’s collaboration with other EU agencies, Commission services and international bodies is deepened. Review of corresponding agreements launched and revised as needed.

ECHA’s overall collaboration with Institutions and other EU agencies was deepened, as shown by the collaborative actions and outputs presented in the respective activities. A review of the agreements with third countries and EU agencies was conducted, with the implementation of resulting revisions planned to start in 2025.

Yes

JRC-ECHA collaboration agreement concluded.

The revision of the JRC-ECHA collaboration agreement18 was concluded in Q3 2024.

Yes

Regular and structural dialogue with ECHA’s institutional partners maintained and further developed in aftermath of the 2024 European elections. Opportunities for joint engagement with other EU/ENVI

Regular engagements took place with the institutional partners, via bilateral meetings or participation institutional events (22 engagements at high level). New stakeholders for the 2024-2029 policy cycle were mapped and contacts established.

Yes

18https://echa.europa.eu/documents/10162/17206/collaboration_agreement_between_jrc_and_echa_en.pdf/c750cf63 -e9b2-40de-a109-c72a24098952

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Annual Report 2024

agencies investigated. These efforts significantly exceeded the corresponding indicator, also due to increased stakeholders’ interest in engaging with the Agency.

The five ENVI agencies (ECHA, EMA, EEA, EFSA, ECDC) jointly introduced their work to the new European Parliament’s ENVI committee in December 2024.

Increased Brussels presence for institutional liaison purposes.

The institutional liaison presence in Brussels was increased (ca 9 extended missions).

Yes

Indicators Estimate Actual

Number of Management Board plenary MB meetings 4 5

% of documents provided on time as required by RoP 95 83

Percentage of statutory documents adopted on time 100 100

Number of major findings during internal and external audits, no reservations in Court of Auditor observations

0 11

Discharge granted Y Y

Number of breaches of trust or disciplinary procedure initiated for conflict-of-interest management.

0 0

Number of high-level meetings conducted with Member States and European Union institutions

12/12 34

Number of meetings conducted with international organisations and third countries (besides IPA and OECD)

12 11

Objective 4: ECHA’s communication is effective, transparent, targeted and timely.

Main Outputs Execution Status

New Communications Strategy implemented.

A new External Communications Strategy and Stakeholder Engagement Approach were developed and implemented in support of ECHA’s new strategy.

Yes

Relations with relevant media outlets improved and expanded.

Contacts with media were managed efficiently and effectively. Highlights for the year included contacts around the Helsinki Chemicals Forum (HCF) as well as engagement with EUObserver, Deutsche Welle, Euronews, Euractiv, ChemicalWatch and Politico. Visits from Finnish and Swedish environmental journalists were also hosted.

Yes

Number of social media followers increased.

The number of followers across ECHA's social media channels - LinkedIn, X, Facebook, YouTube - increased by 21% from 110,500 at 31 December 2023 to 132, 257 at 31 December 2024.

Yes

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Annual Report 2024

ECHA website improved as a key communications channel to all stakeholders.

We concentrated on stabilising and maintaining the website. However, it suffered a number of outages throughout the year due to its aging technology and complicated structure. The future development of the website will form part of the Public Portal element of ECHA’s longer term IT Transformation Project.

Yes

Biannual meetings of the Member States Competent Authorities Communicators Network held and activities reported.

Two meetings of the network were held (May, September). Working with Member States, we have increased participation during the course of the year with feedback received being overwhelmingly positive.

Yes

Internal Communications Strategy developed and implemented.

ECHA finalised its Internal Communications Strategy to support ECHA’s strategic goal of investing in people and organisational excellence.

Yes

Consistent staff use of ECHANet ECHANet continued to be the main source of information for staff on relevant work- related issues.

Yes

Continue cooperation on communications alignment with sister Agencies and MS.

This work was facilitated through three workstreams:

- the Member State Communicators Network – which met twice in 2024;

- ECHA's role in the ENVI Agencies Heads of Comms informal network which met monthly to ensure coordinated actions and share relevant information and experience; and

- ECHA's active participation in the broader EU Agencies Heads of Communications & Information Network.

In addition to the identified workstreams, ECHA was also active in the:

- One Health project with colleagues in the other ENVI agencies;

- ENVI Instagram account (weekly basis);

- ICOP on Stakeholder Engagement (ENVI Agencies) including a physical workshop in November.

Yes

Indicators Estimate Actual

Share of neutral and positive coverage of ECHA >85 % 98 %

Website unique visitors/traffic to web content 4.2 M 5 449 176

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Annual Report 2024

Growth in social media followers 120 K 134 52719

Unique staff visits to ECHAnet 2.1 M 1 021 66820

Objective 5: Open and transparent engagement with all stakeholders.

Main Outputs Execution Status

New stakeholder engagement approach implemented.

The new engagement approach has been rolled out across the organisation. This approach has been used to map stakeholders relevant for new tasks i.e. Batteries. An internal Customer Relationship Management (CRM) pilot was launched in October, which will report on progress in early 2025.

Yes

ECHA Conference 2024 delivered and positively received.

A first post-pandemic in-person conference under the theme of Shaping Tomorrow was organised, which saw 300 participants join in Helsinki with excellent feedback on content and format.

Yes

NGO Dialogues and Accredited Stakeholder Organisations introductory sessions held.

Biannual dialogues with non-governmental organisations (NGOs) and three introductory sessions for Accredited Stakeholder Organisations (ASOs) were organised.

Yes

Launch Stakeholder Perception Survey – to provide benchmark for future annual indicators.

The survey project was initiated and prepared in October for launch in early 2025. The results will feed into ECHA’s future stakeholder interactions, development of KPIs etc.

Yes

Preparation of Eurobarometer survey question(s).

We provided input to DG ENV in the preparation of its 2024 Eurobarometer Survey which resulted in the inclusion of specific questions on chemicals relevant for ECHA.

Yes

Indicators Estimate Actual

ECHA engagements with stakeholders21 200 113

ECHA Conference survey results Positive 4.422

19 The projected growth in 2024 was 8.5%. The majority of new followers were gained on LinkedIn, as a result of a combination of organic growth and successful paid campaigns aimed at attracting new followers. 20 The number of visits to pages by staff was less than half (1.02m) of the projected figure of 2.1m. The initial high level in Q1 reflects the update of information on the site and the need for staff to check and review which was reflected as visits. Continued monitoring of the number of visitors will be undertaken to determine the disparity between projections and actual visits. 21 The recording of stakeholder interactions is still in its developmental phase with the recorded figures for 2024 indicating those meetings undertaken by senior management and the Communications Unit. The figure is expected to differ in 2025 when reporting is extended following the CRM pilot. 22 Participant rating from the post-event feedback survey, on a scale 1-5.

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Annual Report 2024

Objective 6: Companies, and in particular SMEs, have the necessary advice to meet legal obligations.

Main Outputs Execution Status

Questions are timely and effectively answered.

45000 questions were answered by the network of national helpdesks, with more than 9000 answered by ECHA.

Yes

Topics of broad interest/relevance discussed and agreed among all national helpdesks for harmonised advice.

New FAQs and Q&As were published and increased efforts were taken to engage and cooperate with the national helpdesks and other environment agencies.

Yes

Preparations initiated to support companies following the revised regulations under the CSS, e.g., CLP and REACH regulations.

The ECHA helpdesk received and answered questions on the new tasks were picked up by the Helpdesk. The national Helpdesks were informed by the Commission and the European Parliament on the CLP revision.

Yes

Regular contacts with SME to understand and address better their specific needs established.

An action plan was agreed to step up our efforts to support SMEs and will be implemented over the next years.

Yes

Indicators Estimate Actual

Number of helpdesk questions answered (across all our legal basis) 10 000 9 330

Objective 7: Compliance with legal requirements related to finances, human resources, procurement, intellectual property and access to documents.

Main Outputs Execution Status

ECHA’s contributions in legal proceedings made within deadlines.

All ECHA contributions in legal proceedings were made within deadlines in seven proceedings in front of the European Court, in eight cases in front of the Board of Appeal and in 18 cases in national courts.

Yes

Legal review, advice and training provided to ensure sound decisions on access to documents.

We provided legal review, advice and training to ensure sound decisions on access to documents. We observed an increase in access to documents requests. Many requests were also considerably larger in scope than in earlier years.

Yes

ECHA’s trademarks kept up to date. ECHA’s trademarks were all kept up to date. Yes

Indicators Estimate Actual

Access to documents requests received and concluded 100 145

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Annual Report 2024

Objective 8: IT operations are efficient, secure and of high quality.

Main Outputs Execution Status

The refresh of end-of-life administrative tooling continued.

Progress for this refresh was delivered as planned in the scope of management information systems.

Yes

The replacement framework contracts for Management Information Systems and for managed IT Workplace Services established.

The new Management Information Systems contract was established and awarded as planned. The transition to the new IT Workplace Services was successfully completed.

Yes

A target architecture and roadmap of the administrative/support tooling to increase staff productivity and better support ECHA strategy prepared.

A target architecture and roadmap was prepared. The deliverable will be revised regularly to incorporate future changes.

Yes

New Cybersecurity and Information Security regulations adopted, and implementation continued.

Investments and efforts to meet cybersecurity regulation requirements continued successfully, with a low number of cybersecurity incidents. All but one incident was categorized as low or medium level. The more significant incident, related to a third- party software vulnerability, was professionally managed, minimizing impact and ensuring no ECHA data or systems were compromised.

Yes

User satisfaction surveys completed and indicating a high level of satisfaction.

The survey took place in November demonstrating high level of satisfaction among the users.

Yes

Indicators Estimate Actual

Average availability of key systems >98 % 100 %

High impact security incidents23 <2 0

Objective 9: IT functions and business processes transformed, modernised and enhanced.

Main Outputs Execution Status

First solution following the new modular target architecture published (DWD).

We focused on laying the foundation of the modular architecture on which the capabilities for supporting DWD regulatory obligations are expected to be deployed. Significant work was delivered also for producing a solid understanding of the information flows and the operational and business capabilities required to fulfil the DWD deadlines for 2025.

No

23 Number of successful cyberattacks with very high impact for ECHA (e.g. resulting to loss, leakage, tampering of important data, systems unavailability).

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Annual Report 2024

Plans to transition to public cloud infrastructure and services followed.

As part of ECHA’s IT transformation plans, a project to migrate the agency’s IT assets to public cloud infrastructure was started. This migration will provide access to modern technologies and capabilities, such as AI, and long-term efficiencies across the IT delivery process.

Yes

Data provision services of the organization maintained.

Service maintained and delivered according to the plans.

Yes

A coherent data catalogue of data products and assets with their respective stewardship produced.

First data catalogue is available. Stewards appointed for most urgent data product. The work on this topic will continue in 2025.

Yes

Long term (5 years) IT vision, plan and roadmap adopted and implementation started.

A five-year IT plan, outlining the vision, priorities, and approach for the new architecture, was developed and endorsed.

ECHA systems achieved a 100% availability rate, surpassing the 98% target, ensuring a high level of service.

ECHA’s internal horizontal working group for Artificial Intelligence created guidelines for the safe use of AI, assessed potential AI use cases, proposed several pilots, and coordinated AI initiatives.

Yes

New refined and more agile IT governance model developed.

A model was developed, which will be first piloted and refined during 2025 under the IT Transformation Plans.

Yes

First version of ECHA wide design system for improving the development process and alignment between solutions developed.

Investments in user experience continued, resulting in the first version of the ECHA Design System—a comprehensive set of guidelines, components, and tools to maintain consistency in digital product design and development.

Yes

The target enterprise architecture adopted, and implementation started to improve tooling for regulatory processes for internal and authority users.

Work on regulatory process tooling area progressed according to the enterprise architecture vision. The goal is to replace the existing fragmented application landscape with a regulatory-agnostic modular architecture, capable of serving all current and future regulatory tasks of the agency.

Yes

Indicators Estimate Actual

Long-term (5 years) IT vision, plan and roadmap adopted Yes

Objective 10: ECHA’s budget is implemented in accordance with the objectives set in the Programming Document and the Financial Regulation.

Main Outputs Execution Status

Annual budget prepared and We effectively managed our financing through Yes

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Annual Report 2024

implemented in accordance with the objectives set in the Programming Document and the Financial Regulation.

close monitoring of uncertain fee income development. On the final budget size of EUR 126.6 million, the Agency reached a 99.5% commitment rate and 87.0% payment rate, exceeding the targets set. Comprehensive details on ECHA’s budget management in 2024 can be found in Part II and Annex II of this report.

Annual accounts prepared and implemented for ECHA’s Management Board and the relevant EU institutions, in accordance with the requirements of the Financial Regulation.

The annual accounts were prepared in a timely manner, with a clean audit opinion attained. The European Court of Auditors gave a clean audit opinion on ECHA's annual accounts for 2023.

Yes

Procurement and contracting activities implemented in accordance with the objectives set in the Programming Document and the Financial Regulation.

The 2024 procurement plan was presented, adopted and revised by the Management Board and relevant actions implemented.

Yes

Regular reports provided to the Commission partner DGs on the evolution of fee income and budget implementation.

Monthly reports were provided to, and continuous communication took place with, the Commission partner DGs.

We also conducted and delivered a study on costing of its fee-related services, as requested by the Commission.

Yes

Regular contacts maintained with the Commission partner DGs to agree ways of handling any shortfall or surplus arising during the financial year.

Two amending budgets were agreed with the Commission partner DGs and presented for adoption by the Management Board.

Yes

Annual evolution of the transfer of a proportion of fees to Members States reported.

Annual report presented to the Management Board Subgroup on Finance, Audit and Risks.

Yes

Indicators Estimate Actual

Level of budget implementation: Commitment rate. >95 % 99.5%

Level of budget implementation: Cancelled payment appropriation rate (including carry-forward)

<5 % 0.5 %

Processing of payments within legal deadlines >99 % 99.8 %

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Annual Report 2024

Objective 11: Attract, develop and retain competent and committed staff to implement ECHA’s mandate, purpose and vision.

Main Outputs Execution Status

Actions under ECHA’s People and Organisational Strategy 2024-2028 implemented.

We adopted ECHA’s People and Organisational Strategy 2024-2028 that supports the Agency in delivering on its Strategy for the same period, in line with its goal to invest in people and organisational excellence and the two related priorities to develop and empower people for success and to create optimal ways of working for the Agency, its bodies, people and the environment. Key deliverables from the first year of implementation included the following:

• In the area of attracting and selecting people; we adopted a selection plan based on a robust gap analysis with a view to both existing and upcoming tasks for the Agency, the onboarding of new selection tools and the further investment in employer branding through participation in different job fairs.

• With respect to a positive people experience and engagement, we ensured career development opportunities for staff through regular career enhancement calls; our mental health working group delivered meaningful campaigns and staff cohesion was supported through several staff events, including our first corporate day after the pandemic.

• People development was further promoted through a dedicated learning and development plan that addressed current and future needs, paving the way for onboarding new tasks allotted to the Agency. We also adopted a new policy on capacity building with external partners and initiated a pilot project thereunder.

• Finally, we supported the organisation’s ongoing development through the conduct of an organisational review exercise and dedicated contribution to the Agency’s AI working group.

At the end of 2024, all KPI’s in the area of HR were met and the staffing plan filled at 97.2%.

Yes

ECHA’s Wellbeing Action Plan 2023- 2024 implemented in conjunction with ECHA’s Joint Committee for Health and Wellbeing.

See under objective 12 below. Yes

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Annual Report 2024

ECHA’s Diversity and Inclusion Action Plan 2023-2024 implemented.

We implemented our 2024 action plan which included general awareness raising around key Diversity and Inclusion topics through events, articles and training. To support the specific focus on gender balance at management level we onboarded management representatives to our internal D&I Working Group, discussed best practices and challenges in fostering a diverse and inclusive work environment with the Management Team, and delivered training courses on unconscious bias to managers and team leaders. A slight increase is observed in the representation of women in middle and senior management compared to 2023. Nationality balance of ECHA staff is comparable to 2023 with Finns representing nearly a third of all staff.

Yes

Regular communication with ECHA’s Staff Committee to maintain a healthy working culture and positive relations and dialogue.

Regular meetings between management and the Executive Director were held with the Staff Committee. Elections were also successfully held for a new staff committee in December.

Yes

Indicators Estimate Actual

Turnover of Temporary Agents <5 % 1.5%

Turnover of Contract Agents <10 % 0.8%

Percentage of Establishment Plan posts filled 95 % 97.2%

Objective 12: A safe, productive and healthy physical work environment for staff and guests.

Main Outputs Execution Status

ECHA’s Wellbeing Action Plan 2023- 2024 implemented in conjunction with ECHA’s Joint Committee for Health and Wellbeing.

ECHA’s Wellbeing Action Plan 2023- 2024 was progressed, by the Agency’s Joint Committee for Health and Wellbeing and numerous implementation measures were undertaken throughout the year.

Following up on a 2023 analysis on optimising the use of our office building and Conference centre, a pilot project was initiate, to plan for testing new ways of working.

Yes

ECHA’s Environmental Work Programme 2023-2025 implemented.

We successfully organised meeting services for approximately 400 events and official meetings, with 36 600 participants joining online through Webex, and approximately 5 300 visitors hosted in person in our premises.

Against this backdrop, we also continued to work towards our aim to reduce CO2 emissions from both staff travel and building operations. Our 2023-2025 environmental

Yes

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work programme was coordinated and monitored effectively (more information in Part II and Annex VII).

Actions related to ECHA’s ISO 14001:2015 and EMAS certifications co-ordinated.

We obtained recertification of the Agency’s International Organisation for Standardisation (ISO) 14001:2015 and EU Eco-Management and Audit Scheme (EMAS) until 2027. Guidelines for the implementation of the ISO 20121:2012 standard on event sustainability management systems were developed and issued during 2024.

Yes

Indicators

N/A

Objective 13: Implement the Regulation on Serious Cross-border Threats to Health (SCBTH).

Main Outputs Execution Status

Internal procedures in place to enable delivery on the tasks allocated.

The preparation of internal procedures was started in 2024 and will be concluded in 2025.

No

Approach confirmed and co- ordinated with Commission and other agencies.

Agreement was signed in November 2024. A contribution agreement with the Commission was concluded setting the basis for ECHA’s preparation to deliver on this new task. ECHA participated for the first time in simulation exercises with other EU and national bodies to increase EU preparedness for SCBTH.

Yes

Indicators

N/A

Objective 14: Support development and implementation of new legal requirements.

Main Outputs Execution Status

Contribution provided to Commission’s work on CSS implementation and REACH revision.

ECHA provided input, as requested, to ongoing legislative processes with impact on ECHA’s tasks executed, in particular in the context of the ‘one substance, one assessment’ (OSOA) package.

Yes

Indicators

N/A

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Part II. Management Management Board

The Management Board (MB) provides strategic direction and governance to ECHA to enable the Agency to deliver on its purpose and vision and meet the expectations of its stakeholders.

In 2024, the MB saw changes in its leadership, with the election of its new Chair, Sofia Zisi (Greece) in September and its new Deputy-Chair, Per Ängquist (Sweden) in December. As part of its commitment to continuous improvement, the MB conducted a self-evaluation in 2024, reviewing its own processes, decision-making and governance. The self-evaluation resulted in a few targeted improvement actions, without any major change in the MB’s way of working24.

With a view to ensuring the workability of ECHA’s committees, the MB decided in 2024 to increase the payments for REACH restriction rapporteur work in RAC and SEAC. Regarding the Board of Appeal (BoA), the MB decided in December 2024 to transition the ECHA BoA to an ad hoc structure, composed of members appointed by the MB, based on a list proposed by the Commission, who will not be staff members of ECHA.

During 2024, the MB continued closely monitoring the legislative and policy developments with an impact on ECHA’s mandate and resourcing, including the new tasks assigned to ECHA. It also continuously oversaw the risk management processes, including regularly reviewing the Agency Risk Register and specific reporting on IT security, as well as obtaining assurance that risks are properly identified, assessed, and mitigated.

The MB adopted all documents required by law in line with the applicable rules and regulations. In its capacity of Appointing Authority, the MB took the necessary decisions in all staff matters for the functions reporting directly to it (Executive Director, members of the Board of Appeal), including the annual performance appraisals.

Major developments

Following the 2024 elections, the EU set new political priorities focusing on sustainable prosperity, security, and social fairness. ECHA closely monitored these evolving priorities and engaged with stakeholders to ensure clarity and readiness for necessary changes. As an EU decentralised agency, ECHA is also expected to reduce administrative burdens, foster competitiveness, and maintain high standards of health and environmental protection. Throughout 2024, ECHA supported decision-makers in negotiations on the One Substance, One Assessment package, which bring significant new tasks. Anticipating the future ECHA Basic Regulation, ECHA contributed to the Commission’s preparatory work to strengthen governance and streamline operations. Additionally, ECHA tracked political developments related to the simplification of REACH and clarification of PFAS regulations, preparing to provide scientific- technical input as needed. Amid resource constraints, ECHA focused on enhancing internal competence and capacity, collaborating with Member States to address gaps and align with the EU’s vision for a sustainable future.

In 2024 ECHA started the implementation of its new Strategy 2024-2028, which, according to the perception of its Management is on a good path, well communicated to staff with values well lived up to and upheld. In line with ECHA’s priority to ‘Ensure that our organisational model is ready to support delivery of our current and future mandate’, ECHA undertook an organisational review in 2024. The organisational review was conducted to address the evolving nature and

24 MB/M/04/2024 final: https://echa.europa.eu/documents/10162/91846726/mb_m_04_2024_minutes_mb75_en.pdf/9b697143-04ee-8717- 92b6-a85fe469420c?t=1734527244500.

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increasing complexity of ECHA’s tasks and mandate, necessitating a strategic approach to optimise performance and integrate new responsibilities. Following the last review in 2018, which led to structural changes effective from January 2019, it became clear that further adjustments were needed to ECHA’s ways of working and organisation, underpinned by internal and external feedback. The recommendations, which addressed ways of working, strategic prioritisation and organisational structure will be addressed in 2025.

Budgetary and financial management

Financial management

ECHA effectively managed its financing in 2024, by closely monitoring the development of fee income and the overall financing position. By the end of the year, the financial operations reached a 99.5 % commitment rate and 87.0 % payment rate, notably exceeding the targets set. The European Court of Auditors gave a clean audit opinion on ECHA's annual accounts for 2023 and carried out the first part of its audit for the financial year 2024 under a new audit team.

Details on ECHA’s budget information and management in 2024 can be found in Annex II.

Delegation and sub-delegation of the powers of budget implementation to agency’s Staff

ECHA maintains a system of operational and financial delegations as part of its Integrated Management System, which allows to effectively manage delegations and sub-delegations, taking into account the risk level of the particular process.

Human Resources (HR) management

Human resources management

In 2024, ECHA adopted and started to implement the People and Organisational Strategy 2024- 2029. Our joint efforts in running selection procedures efficiently and investing in employer branding led to a high rate of filled establishment plan posts (97.2 %) with a low Temporary Agent turnover (1.5 %) rate. We maintained a strong focus on staff wellbeing through delivery on our respective action plan, in close cooperation with ECHA’s Joint Committee on Health and Wellbeing. In addition, the Diversity and Inclusion Action Plan was further implemented.

Strategy for efficiency gains

ECHA’s Integrated Management System Strategy and Framework has demonstrated its effectiveness in achieving the Agency’s strategic goals and priorities throughout 2024. The results of the annual benchmarking exercise (full results available in Annex IV) conducted in accordance with the Commission’s requirements indicate efficiency gains in the Agency’s administration. The results show a decrease of 2.6% in the staff involved in administrative support and coordination and increase of 2.1% and 0.5% in the staff involved in operational and neutral tasks, respectively.

In the realm of IT, ECHA continued the development of its new enterprise architecture throughout 2024. This approach focuses on streamlining business solutions through modular architecture, enabling faster adoption of new regulatory processes. The governance of ECHA's IT portfolio was also revamped, to further accelerate the transition towards the target architecture.

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Additionally, ECHA continued its efforts to digitalise its administrative processes in 2024. As a concrete example of this work, the Agency completed the incorporation of electronic signatures to document workflows through the implementation of EU Sign, a qualified electronic signature tool developed by DG DIGIT. This tool allows electronic signature of all documents signed by the Agency, reducing both paper and postal costs as well as time spent by relevant actors to process original documents, thus gaining efficiency.

Assessment of audit and retrospective evaluation results during the reporting year

Retrospective evaluations

In 2024, ECHA performed the following retrospective evaluations following the criteria and methodology as stipulated in the Better Regulation Guidelines25 :

• Retrospective evaluation of ECHA’s HR strategy 2019-2023. Upon request of the Management Board, this ex-post evaluation analysed the degree of effectiveness, relevance, efficiency, proportionality, coherence, added value and sustainability of the ECHA’s HR strategy. The lessons learnt will be used for the implementation plan of the current People and Organisational strategy.

Main highlights from the evaluation are presented below:

It could be overall concluded that the objectives of the HR Strategy have been achieved to a large extent. The HR strategy has contributed to developing ECHA’s competence base for current and future tasks, building a high performing and flexible environment, promoting staff engagement by facilitating career development and enhancing management and leadership capabilities. It could also be concluded that ECHA’s HR strategy has brought added value to ECHA in alignment to ECHA’s long term strategy 2019-2023.

ECHA’s competence map is well used in various HR processes, such as identifying competence gaps and training needs. The use of the competence map across ECHA and in the resource planning and allocation exercise could be further strengthened.

Following the challenges of the pandemic, ECHA has progressed towards creating a more flexible work environment and better work-life balance.

Staff engagement has been promoted in various ways, with a high use of internal career development opportunities throughout the years, decrease in the interims’ support and developing an employer brand for ECHA.

Management and leadership capabilities have overall improved over the years via coaching, training and other management practices, which is visible in the trends of the Staff survey with regards to trust in Senior management and job motivation. Employer image, diversity and inclusion have also a very good perception by staff. Fair rewarding of staff however is an area where further efforts are needed. ECHA’s HR Unit has taken actions on increasing the transparency of the reclassification process, however it cannot yet be judged if those actions have been effective.

Despite the complexities and legislative constraints, ECHA has been able to achieve certain level of synergies and efficiencies in its HR services and overall in its horizontal activities. ECHA compares with other ENVI agencies as the Agency with the

25 http://ec.europa.eu/smart-regulation/guidelines/tool_42_en.htm

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lowest proportion of its HR staff to total staff and the lowest proportion of “neutral staff” to total staff, which includes posts in horizontal services, such as finance, procurement, quality management, linguistics etc. Maintaining such a low proportion of HR and overall horizontal services staff however bears the risk of decrease in the staff wellbeing and ECHA not being able to manage the increasing workload.

• Second interim retrospective evaluation of European Union Observatory for Nanomaterials (EUON). Upon request of the Commission, this second interim ex-post evaluation analysed the degree of effectiveness, relevance, efficiency, proportionality, coherence, added value and sustainability of EUON. A comparison with the results from the previous evaluation of EUON in 2019 was made and the trends followed to conclude on the developments from 2019 until 2024. The lessons learnt will be used by the Commission to decide on the future of EUON. The evaluation is available on the EUON webpage26.

Internal Audit Service (IAS)

The Internal Audit Service (IAS) of the Commission did not conduct audits in 2024 at ECHA. IAS has closed all pending actions from earlier audits.

Internal Audit Capability (IAC)

The Internal Audit Capacity (IAC) conducted four assurance audits (one finalised in January 2025) with the objective of assessing and providing reasonable assurance on the regularity and the quality of internal control systems applied as well as efficiency and effectiveness of the processes.

The audit “Helpnet” resulted in three important recommendations:

• Establish long term planning to anticipate and prepare for the future challenges of the national helpdesks and to ensure that Helpnet members are systematically consulted on the critical areas necessitating EU-level harmonisation.

• Establish indicators to assess efficiency and effectiveness of the Helpnet activity.

• Continue to activate and engage the Helpnet members.

The audit “Quality and reliability of data in ECHA reporting” resulted in one very important recommendation:

• Use the clarified definitions for indicators in a consistent way in all reports. To enhance audit trail of the data source and calculation of the main indicators and figures in the Annual activity report, add to the ECHA-level indicator table a link to the data source and instructions how to retrieve the data. Keep the data source (report) at least for the main data in annual corporate reports to ensure an audit trail (follow the good practice for financial data by the Finance Unit).

And two important recommendations:

• To comply with ECHA’s Integrated management system strategy and framework and to establish clear responsibilities and accountability for numerical correctness, consider ways how to

o assign designated staff member to a reporting task o document validation of the most relevant data in ECHA's main corporate reports.

26 View article - European Observatory for Nanomaterials: https://euon.echa.europa.eu/view-article/- /journal_content/title/new-report-evaluates-the-performance-of-euon

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• Develop further indicators and corporate reporting

The audit “Testing proposal examination process under Dossier Evaluation” resulted in one very important recommendation:

• Inform the Commission of the current limitations and unclarities of the legal text to support its improvement in the context of the foreseen revision of REACH.

Improve the testing proposal examination process.

Provide a transparent overview of the status of the testing proposal examination process including compliance with the legal deadline.

Continue to analyse the reasons for the backlog TPs and to identify types of TPs where agreed principles by ECHA management and Member States Committee would help to conclude TPs.

Calculate the needed resources to improve the TPE process (see also recommendation 5 for specific expertise) and remove the backlog of pending TPEs and aim to assign sufficient resources to remove the backlog.

And four important recommendations:

• Develop further measures to ensure consistency in the Testing proposal examination. Consider how to improve the monitoring and reporting of the cases. Review IUCLID and submission process, including guidance to clarify the process (after changes to the legal text).

• Improve communication on the Testing proposal examination process to stakeholders.

• Identify and collect indicators and statistics to assess efficiency and effectiveness of the Testing proposal examination process.

• Ensure the TPE team has the necessary access to expertise on: o Read-across assessment o regulatory/ policy issues with complicated TPs o access to PBT and ED networks for consultation

The audit “Environmental management” did not result in any critical, very important or important recommendations.

The Agency follows up these recommendations with corresponding actions.

For earlier audits, the Internal Audit Capability conducted two follow-up audits (one finalised in February 2025) to verify the implementation of the action plans, concluding that 1 very important and 1 important action are still being implemented.

European Court of Auditors (ECA)

In their statement of assurance27, the European Court of Auditors (ECA) concluded that the accounts of the Agency for the financial year 2023 present fairly, in all material respects the financial position of the Agency at 31 December 2023, the results of its operations, its cash flows, and the changes in net assets for the year then ended, in accordance with its Financial Regulation and with accounting rules adopted by the Commission’s accounting officer. These are based on internationally accepted accounting standards for the public sector.

The revenue and payments underlying the accounts for the year were also legal in all material

27 https://www.eca.europa.eu/ECAPublications/SAR-AGENCIES-2023/SAR-AGENCIES-2023_EN.pdf

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aspects.

The Court did not make any observations regarding the financial year 2023 and there are no observations open from previous years either.

Follow up of recommendations and action plans for audits and evaluations

The follow up of the retrospective evaluations from 2023 and namely ECHA’s financial model, ECHA’s Committees28 (RAC, SEAC and MSC) and ECHA’s Board of Appeal29 show that many of the recommendations are in progress. For RAC and SEAC in particular the actions taken to increase the capacity of the Committee, such as increasing the rapporteurs’ payment rate in June 2024, have proved to be effective30. Some of the recommendations are linked to potential legislative changes which may be introduced with the Commission’s announced proposal for an ECHA Basic Regulation.

The follow-up of the evaluations performed in previous years showed that most of the recommendations on the retrospective evaluations have been implemented. The follow up includes the following evaluations performed in the last three years: SCIP database (Substances of Concern In articles as such or in complex objects (Products) established under the Waste Framework Directive (WFD))31, EU Chemicals Legislation Finder (EUCLEF) and the EU Observatory for Nanomaterials (EUON).

Follow up of recommendations issued following investigations by the European Anti-Fraud Office (OLAF)

N/A

Follow up of observations from the Discharge authority

In accordance with Article 262 of the Financial Regulation and Article 107 of the Financial Framework Regulation and the Financial Regulation of the European Chemicals Agency (ECHA), the Executive Director of ECHA shall take all appropriate steps to act on the observations accompanying the European Parliament's discharge decision and on the comments accompanying the recommendation for discharge adopted by the Council, and at the request of the Discharge Authority, report on the measures taken in the light of those observations and comments.

ECHA’s follow up report of the discharge32 provides an overview of the relevant observations and recommendations from the European Parliament discharge33 of 11 April 2024 for the financial year 2022.

In summary, there were six recommendations from the European Parliament, whose

28 https://echa.europa.eu/documents/10162/17086/retrospective_evaluation_of_committees_report_en.pdf/e491f353- 1e6e-8616-8990-48db2fed0056?t=1695807929141 29 file://echa/data/users/u09175/Roaming%20Profile/Downloads/ex_post_evaluation_board_appeal_en%20(6).pdf 30https://echa.europa.eu/documents/10162/74925298/final_mb_07_2024_decision_transfer_fees_ms_en.pdf/6eb9f27 3-3bf8-3cb8-d5f7-97f33003789a?t=1718633914154 31 SCIP retrospective evaluation: https://echa.europa.eu/documents/10162/6205986/scip_evaluation_report_en.pdf/2c677149-e876-f2b1-0ba7- 3daca0a419ef?t=1665556373094 32 ECHA discharge follow up 2022: https://echa.sharepoint.com/sites/1203/120301/Forms/AllItems.aspx?id=%2Fsites%2F1203%2F120301%2F12%2E0 3%2E01%2E02%20MB%20Meetings%2F2024%2FMB75_26-27_Sept%2F02_Docs%2FAPC%2E01_Follow- up_discharge_2022_recommendations_MB_29_2024%2Epdf&parent=%2Fsites%2F1203%2F120301%2F12%2E03%2 E01%2E02%20MB%20Meeting 33 https://oeil.secure.europarl.europa.eu/oeil/en/document-summary?id=1782930

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implementation is either ongoing or completed.

Environment management

Environmental and sustainability management

The 2024 objectives for environmental management at ECHA aimed at improving ECHA’s environmental performance as laid down in ECHA’s environmental policy (POL-0022) and to pave the way towards achieving climate neutrality by 2030. This was achieved through the implementation of ECHA’s environmental work-programme and by actively promoting sustainability with our environmental management system (EMS).

ECHA’s strategy is embedded in ECHA’s EMS where we aim to be a trusted chemicals agency, we respond to emerging challenges and changes in our legal landscape, and we actively communicate and engage with our stakeholders. Improvements and innovation in ECHA’s EMS are achieved through monitoring and verification, through process and legislative updates and by learning about developments with our stakeholders, particularly with other EU Institutions and Agencies.

Environmental objectives and indicators

Environmental Objectives 2023-25 (Benchmark year: 2019)

Target Result in 2024

Achieved

Building CO2 emissions 20% 75 % decrease Yes

Travel (meeting participants) CO2 emissions 50% 42 % decrease No

Travel (staff missions) CO2 emissions 50% 56 % decrease Yes

Through the continuous monitoring, reporting and verification of ECHA’s EMS, the CO2 reduction targets for staff travel and building emissions were met. The emissions target related to travel of meeting participants attending ECHA’s Committees was not met in 2024. This is primarily the result of the increased demand for in-person meetings to meet business needs, with this risk highlighted in the EMS audit report by the IAC. Nonetheless, it is considered that a 42% reduction, in a context of increasing business demands, is noteworthy. In addition, to partly mitigate the environmental impact of ECHA’s Committees, guidelines for sustainable meetings were issued in 2024 with a view to future ISO certification.

Furthermore, ECHA identified two environmental indicators that contribute to the Agency’s CO2 footprint. Whilst including new indicators increases ECHA’s total carbon footprint, it allows us to be comprehensive and transparent in our reporting which enables the Agency to better manage how we will mitigate our impact on the environment. The two new indicators related to emissions generated through hotel nights from ECHA staff travel, and the impact of teleworking were added to the calculation and reporting of our carbon footprint.

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ECHA’s EMS it is subject to regular audits to ensure that it performs according to our objectives. In addition to the assurance audit of ECHA Environmental management system conducted by ECHA’s IAC, four other audits took place in 2024: the ISO 14001 certification Audit, the EMAS Verification audit and two internal audits. The audits did not identify any non-conformities or critical, very important or important recommendations, and ECHA’s ISO certificate and EMAS registration were both renewed.

ECHA made progress in 2024 on greener and more sustainable procurement, when we strengthened the minimum environmental requirements that companies must meet to deliver IT services and now request evidence of compliance with the relevant standards.

Achieving climate neutrality

To achieve carbon neutrality by 2030, ECHA will need to compensate the unavoidable residual greenhouse gases (GHG) emissions. Planning for this this began in 2024 against the legislative provisions of the forthcoming CRCF Regulation, when ECHA initiated a pilot project on carbon removals. The CRCF will provide the legal certainty to purchase carbon credits through certified carbon removal schemes. Working with DG CLIMA and Finnish Centre for Economic Development, Transport and Environment the pilot project will allow ECHA to explore the possibility to compensate part of the Agency’s residual emissions using a responsible scheme, whilst avoiding reputational damage.

Communicating with stakeholders

Finally, to promote and implement ECHA’s environmental objectives, over 30 training and internal communications activities were undertaken during 2024 to promote climate awareness actions such as Earth Day, EU Green week and the Baltic Sea Day.

Within the EU Institutional landscape, ECHA published the EU Agencies’ Network “Charter on greenhouse gases (GHG) reduction and responsible environmental management”, which reflects ECHA’s environmental policy and objectives. To ensure good cooperation, communication and knowledge sharing throughout the year with our EU partners, ECHA participated to 10 events virtually. The events were organised by external stakeholders such as the Groupe Interinstitutionnel de Management Environmental (GIME) and the EUAN Greening Network (GN).

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EU Institutional information sessions and ad-hoc meetings

ICTAC & GN Joint meeting on EMAS GN Lecture on EIT Climate KIC PDN Meeting on sustainability reporting GN & NAPO Diversity and Inclusion in sustainability GN EMAS DE Advisory Board: Sustainability reporting under the CSRD GN Carbon compensation: Presentation by Climeworks and DG CLIMA GN Annual plenary meeting with external speakers: Vice-chair ICCP, DG

HR - GIME chair, COMM & ECHA. GN EMAS related good practice GIME Climate neutrality of the EU Institutions (ECHA presentation) - Twice.

Assessment by management

Based on the information in the Section II, no significant weaknesses or gaps that may threaten the achievement of ECHA’s objectives were identified. An overall conclusion taking into account the findings from the internal control assessment is available in Part III.

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Part III. Assessment of the effectiveness of the internal control systems Effectiveness of internal control system

Compliance and performance of ECHA under the Integrated Management System Strategy and Framework

The purpose of the annual internal controls assessment is to give reasonable assurance that ECHA’s management system is functioning, continuously improved, and that the objectives set out in Article 30 of the ECHA Financial regulation are met, namely: (I) effectiveness, efficiency and economy of operations; (ii) reliability of reporting; (iii) safeguarding of assets and information; (iv) prevention, detection, correction and follow-up of fraud and irregularities; and (v) adequate management of risks relating to the legality and regularity of the underlying transactions.

The reference for the assessment is ECHA’s Integrated Management System Strategy and Framework, (POL-0001) which supplements the financial regulation and aligns with the principles and guidelines set out by the European Commission (in the areas of internal control and programming) and with the ISO 9001:2015 and ISO 14001:2015 standards.

The assessment is based on a wide range of sources, such as internal and external audits, retrospective evaluations, risks, non-conformities, complaints, appeals, financial, operational, IT, environmental and HR reports, complemented with insights from self-assessments of managers, staff and stakeholders’ surveys. Internal control surveys were conducted to capture the self-assessment of Directors and Heads of Units with regard to the functioning of the ECHA’s management system. Stakeholders’ input was captured in the stakeholders survey and various retrospective evaluations and audits. Staff perception was captured in the staff survey (latest from 2023) and other internal reports and events. All sources mentioned above were analysed and triangulated to derive conclusions.

Following the recommendations from the IAS audit on ‘Budget preparation, monitoring and reporting’ in 2023, ECHA analysed the whole exceptions register. The detailed conclusions from the analysis of the exceptions register as well as the trend between 2023 and 2024 are available in the internal controls assessment for the year 2024.

For 2024, the assessment confirms that the Integrated Management System (IMS) is effective and functioning as intended. All directors and most middle managers agree that management commits to the core principles. Also, most of the detailed components are fully present and functioning (8 out of 12), while areas identified for improvement are not considered major, or critical, deficiencies of the whole IMS or about the objectives of Article 30 of the ECHA Financial Regulation. Details of the assessment are available in the next section. Improvement work is either ongoing or planned for 2025.

In terms of costing the controls, the Agency follows the definition in the General Financial Regulation34 of the EU, according to which ‘control’ means ‘any measure taken to provide reasonable assurance regarding the effectiveness, efficiency and economy of operations, the reliability of reporting, the safeguarding of assets and information, the prevention and detection and correction of fraud and irregularities and their follow-up, and the adequate management of the risks relating to the legality and regularity of the underlying transactions, taking into account

34 Financial Regulation applicable to the general budget of the Union: https://op.europa.eu/en/publication-detail/- /publication/e9488da5-d66f-11e8-9424-01aa75ed71a1

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the multiannual character of programmes as well as the nature of the payments concerned’.

Controls may involve various checks, as well as the implementation of any policies and procedures to achieve the objectives. Based on an approximation of the resources deployed in the units responsible for governance, human resources and financial management, as well as the average salary costs, the cost of controls as a percentage of the total budget are estimated to be around 2.8 % which is lower than the previous year, when the percentage was 3.4%.

The summary from the internal controls assessment as per the principles and characteristics of each component is covered in the next section below.

Risk management

Risk management is an integral part of ECHA’s Integrated Management System. The risks, that were identified as possibly jeopardising the achievement of the objectives defined in the Programming Document, were followed up regularly and a more detailed assessment was carried out every four months during the year. In 2024, ECHA further developed the implementation of the internal framework for addressing risk management in ECHA through the introduction of directorate-level risk registers. Regular updates were given to the Management Board and specific reporting continued on the IT-security related risks.

Transparency, accountability and integrity

Throughout 2024, the Agency lived up to its values of transparency and integrity, ensuring continued public and stakeholder trust in the impartiality and objectivity of ECHA’s work.

The decision-making processes of the Agency are designed to be clear, open and to ensure a balanced outcome based on a reasoned scientific approach. Information on the intentions of ECHA and the Member States – for example, to look into substances or create dossiers – is available online, so companies have access to the data they need to make informed business decisions.

Accredited stakeholder organisations may participate in scientific meetings as observers, except where confidential business information requires sessions to be closed. This gives them a chance to witness the debate and decision-making process and, where appropriate, express their views. Where consultations take place, the comments received are discussed and addressed. The reflections, minority opinions and conclusions of ECHA’s scientific committees are recorded in opinions and minutes, and these are published online.

ECHA maintains the world's largest regulatory database on chemicals. The database provides transparent information on the chemicals used in Europe today. In early 2024 ECHA launched ECHA CHEM, which is ECHA’s new public chemicals database launched. Initially, it includes data that companies have submitted in their REACH registrations. Over the coming years, ECHA will gradually transfer the data it makes publicly available from their current location (Search for chemicals) to ECHA CHEM.

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Prevention of conflicts of interest

Based on a thorough risk assessment of its activities, the Agency has identified the processes and sub-processes that require conflicts of interest to be managed. Conflict of interest checks are performed for more than 30 processes, sub-processes or process steps, including the main operational processes of the Agency.

In all these processes, a review of the annual declarations of interest is performed by the process owner each time a task is assigned to a staff member, while for some sensitive processes this is complemented with a case-specific declaration of no interest by the staff member.

If there is a potential conflict, the case is assigned to a different staff member. The approach is documented in detailed work instructions and guidance is available for those managing the interests to help them deal with individual cases. As a result, no cases of actual conflicts of interest among ECHA staff, affecting the output of the Agency were identified in 2024.

For the ECHA bodies, all members are assessed against the generic exclusion criteria agreed upon by the Management Board, at the time of their appointment. Once they take up their function, their annual declarations of interest are reviewed by the respective Chair and published on ECHA’s website.

Before each meeting of an ECHA body, specific declarations for items on the agenda are collected and documented in publicly available minutes together with the mitigating measures imposed. As most of the members of ECHA’s bodies are Member State public officials, the majority of the conflicts of interest declared by the members concerned involvement in preparing dossiers submitted by their Member State competent authority. In all such cases, the members concerned were not allowed to participate in the voting on such dossiers.

Post-employment

Members of staff must notify new occupational activities for the first two years after leaving the service of the Agency. ECHA can forbid the new activity or impose conditions.

In 2024, sixteen (16) staff members left ECHA: four (4) of them went to work for another EU institution, body or Agency. One (1) staff member moved to a national public administration or international organisation. Three (3) staff members moved to the private sector or started self- employment and, in one (1) of these cases, the Agency deemed it necessary to impose specific conditions due to the nature of the occupational activity or the role of the individual within their new occupation.

In the remaining eight (8) cases, ECHA has not (yet) been informed about a new occupational activity, as the departure was due to retirement, termination of contract or death of a staff member. None of these cases concerned a member of senior management.

An overview of the post-employment decisions of all former senior managers is published on ECHA’s website, including their names, date of departure, positions, their foreseen new occupational activities, and the outcomes of ECHA’s assessments35.

No breaches of trust or disciplinary procedure were initiated for conflict-of-interest management.

Conflict of Interest Advisory Committee

The Conflicts of Interest Advisory Committee (CoIAC) is an advisory body in the context of

35 https://echa.europa.eu/documents/10162/13559/post-employment_senior_managers_en.pdf/8567fc1f-1631-05fe- eceb-8817a0e110d1

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ECHA’s Procedure on Prevention and Management of Potential Conflicts of Interest. The Committee is available to the Management Board, the Committees, the Forum and the Executive Director for advice on matters related to potential conflicts of interest of ECHA staff or members of the Agency’s bodies.

The Committee comprises three members: Per Ängquist, appointed by the Management Board from among its members, Madeleine Healy, a Senior Compliance Expert from the Single Resolution Board, appointed as an external expert, and Minna Heikkilä, Head of ECHA’s Legal Affairs Unit as Chairperson. The external expert was newly appointed in 2024, following a public call for expression of interest. Three alternate external experts were also appointed at the same time.

In 2024, the CoIAC delivered five opinions. On 12 March 2024 the CoIAC advised on the prospective activity of a recently retired former Head of Unit of ECHA. The CoIAC did not find any reason justifying objections to this activity. On 9 April 2024 the CoIAC gave its advice to the Executive Director concerning an analysis of ECHA’s Policy on Prevention of Conflict of Interests and implementing rules with a view to the expanding role and mandates of the Committees and the actors involved around the Committee work. In July 2024, the CoIAC further advised on the application of the Policy in the context of the selection and appointment of the co-opted members for the Committees for Risk Assessment (RAC) and for Socio-economic Analysis (SEAC).

On 29 November 2024, the CoIAC convened for its annual meeting where two further requests for advice from the Executive Director and from the Chair of the Management Board were discussed. These related to the appointment of members of the RAC and to the perception of conflicts related to public procurement. The advice in both cases was further discussed and concluded in written procedure on 9 December 2024.

Ex-post controls

In line with the Procedure on Prevention and Management of potential Conflicts of Interest, ECHA may undertake ex-post controls to guarantee the effectiveness of the procedure.

A sample check on 11 annual declarations (DoI) submitted by the chairpersons of the ECHA bodies and expert groups revealed that all of them were in place, accurate and sufficiently complete to allow for effective conflict of interest prevention and management. However, while the internal DoI tool for submitting and verifying the annual declarations of interest of the ECHA staff contained an updated DoI for the four chairpersons of the MSC, RAC, SEAC and BPC, on the ECHA website an older and outdated version of this declaration was made publicly available. This however did not undermine the process of verifying conflicts of interest, as an up-to-date DoI was available for that purpose, but it did not give stakeholders a transparent view on the DoI as required.

In addition, ECHA’s Internal Audit Capability took sample checks during her audit of the testing proposal process to verify that conflict of interest checks were performed for ECHA colleagues for 2 testing proposal dossier examinations. It was confirmed that indeed such checks are systematically made for all testing proposal dossiers.

Fraud prevention

By design, the Agency’s internal control systems contain fraud prevention, with an emphasis on critical areas such as financial transactions, procurement and selections.

ECHA’s Code of Good Administrative Behaviour36 is well communicated to all staff members.

36 https://echa.europa.eu/documents/10162/13559/code_of_good_administrative_behaviour_en.pdf/a4aa94f7-f631- 43d6-8c28-77a10a0d0720

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Management Board decision 30/2009 of 23 April 2009 stipulates the terms and conditions for internal investigations in relation to the prevention of fraud, corruption, and any illegal activity detrimental to the Communities’ interests.

Guidelines for whistleblowers were first adopted in 2015 and updated in September 2018. Through these guidelines, ECHA ensures that its employees can always highlight any action which goes against the public interest.

The ECHA Anti-Fraud Strategy37 was revised by the ECHA Management Board in December 2022 and includes a focus on maintaining and further developing the anti-fraud culture in the Agency and regularly reviewing key policies and procedures. In autumn 2024 a mandatory all-staff e- learning was organised, with a focus on conflict of interest prevention and relations with interest groups, while also the Management Board members received an annual refresher on ethics.

Data protection

The Data Protection Officer is an independent function within the Agency, who advises the Agency and staff on compliance with privacy laws and regulations. He keeps the required records of processing operations centrally and acts as the liaison with the European Data Protection Supervisor.

In 2024, the focus areas of support concerned the regular review of data protection aspects of procured IT licences and software, the specific privacy risks involved with the migration of ECHA data to public cloud and the roll-out of the first AI pilot projects. Actions have also been taken in the context of one data protection related complaint and nine personal data breaches that occurred in ECHA and involving ECHA staff and/or stakeholders. Two of those personal data breaches were communicated to the European Data Protection Supervisor (EDPS), as legally required due to the risks to the rights and freedoms of the persons concerned. The first incident concerned personal data being published unredacted on the biocides dissemination website, while the second incident concerned the unauthorised disclosure of personal information due to a software bug in a new version of ECHA CHEM. The latter incident has also been reported to CERT-EU as an information security incident (more details on that incident are available under “Security and business continuity” below). As required, these cases were recorded and reported, and appropriate mitigating measures were agreed with process owners to prevent potential occurrence in the future.

Security and business continuity

Regarding cybersecurity the new EU regulation was adopted in December 2023 laying out several legal obligations. Implementation of the legal obligations has been ongoing in 2024 and will continue into 2025 and beyond. An initial maturity assessment has been conducted and an initial cybersecurity review and action plan prepared.

A risk assessment for the ICT environment has been conducted, with periodic follow up during the 2024 quarterly reporting cycle with a focus on risks that are medium likelihood and impact or higher.

Cybersecurity principles have been established and eight essential maturity assessments as mandated by the cybersecurity regulation have been conducted. In addition, regarding data protection various impact assessments were performed.

37 https://echa.europa.eu/documents/10162/10709201/final_mb_47_2022_annex1_anti-fraud-strategy_2023- 2026_en.pdf/c42eb6f4-1d61-5be9-83a4-3f4af5ee6b4e

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"Red Teaming" exercise conducted proposing several immediate, mid-term and long-term security improvements. Public Cloud security assessments were conducted, evaluating the security of ECHA’s cloud infrastructure and security risk.

Cybersecurity awareness campaign was continued with several Cybersecurity Awareness trainings provided in 2024 as follows: “GDPR – The 7 Principles of Data Protection”, “GDPR – Accountability and Compliance”, “What is Processing – Global Privacy”, “GDPR – What is Sensitive Personal Data”.

In June 2024, ECHA experienced a data breach incident. A new version of the application ECHA CHEM was deployed with a software bug, that allowed non-public information to be disseminated to the public. The error was noticed early August, and as the first action the application was shutdown. Investigation proved that the problem covered 680 registrations belonging to 291 legal entities i.e. companies, which were duly informed. The leaked dossiers were removed and after thorough testing the public access was restored 25th August. The corrected new version of the application was deployed successfully in late November. The case was also reported regularly to CERT-EU, where the final report was sent in January 2025.

The ECHA CHEM incident is not classified as a “High Impact Security Incident” because it was not caused by a cyberattack.

Conclusions of the assessment of the internal control systems

Component Conclusion

Governance

1.1 Purpose and vision

The implementation of ECHA’s new strategy is on a good path, however more efforts may be needed so that staff could link their work to the strategy. Stakeholders have an overall good understanding of ECHA’s role, aims and activities. The difference in the commitment of Directors and Heads of Units to the new strategy may bear risks for its successful implementation.

1.2 Values and behaviours

The principle is present and functioning. New values have been communicated and upheld in 2024. More efforts are needed to exemplify “innovation” and to further increase the transparency towards communicating decisions and information to stakeholders. Awareness raising efforts on dealing with sensitive topics need to remain high.

1.3 Management responsibility

The Integrated Management System is functioning, and management and staff are committed to its continual improvement. The overall management perception of ECHA’s delegation and empowering staff has improved. The quality assurance officers' satisfaction with the organisation of the Integrated Management system has improved as well. Areas for attention include the clarity in roles, responsibilities and accountabilities, minimising bureaucracy and ensuring sustainability in the day-to-day operations.

1.4 People (Human Resources)

ECHA has competent and highly qualified staff, and there is a management commitment to enhance staff and competence development. Areas of attention include the mapping of competence needs in particular with regards to the new tasks, the length of the selection procedures, the effective communication around the performance appraisal exercise and the adequate resourcing of HR and horizontal services.

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1.5 Stakeholders and partners

ECHA has invested lots of efforts in improving its stakeholders’ engagement approach in 2024 thus addressing effectively all weaknesses as identified in the Stakeholders’ audit. Some actions have already led to positive results in terms of increased stakeholders’ commitment. Stakeholders are overall satisfied with the support and services of ECHA, but request ECHA to put further efforts into timely and approachable communication and more visibility of how their input is taken into account. The roles and responsibilities with regards to the oversight of the stakeholders’ repository is an area for attention.

Strategy, planning and risk management

2.1 Goals planning and resource allocation

In 2024, ECHA started the implementation of its new strategy which is considered to be on a good path and well communicated. Watch out areas are linked to the unclarity in the formulation of negative priorities, allocation of resources in line with priorities, linking initiatives with strategic priorities, and developing indicators with their respective consistent definitions to serve the Management decision making.

2.2 Risk management

ECHA has put lots of efforts to strengthen its corporate risk management increasing the level of engagement of management and MB involvement. ECHA’s overall low risk appetite may become a hurdle towards the process improvements efforts of the Agency and implementing the value of the innovation. Areas for attention include the clarity of roles and responsibilities with regards to the consolidation and oversight of Units and Directorates risks, the different practices around project risk management and the inconsistency in performing cost-risk-benefit analysis and analysis of options when starting new projects.

Operations and operational structure

3.1 Activity management

The activity and process management is a strength for ECHA and allows synergies. The optimisation of some regulatory activities, like Biocides, is limited by the legal constraints within which they are required to operate. Areas for attention include the potential risk of overdependence on few contractors and the weaknesses in tracking the overall contractors’ performance.

3.2 Information and data management

ECHA has been able to find some synergies and reuse some of its existing platforms for new tasks. Stakeholders' satisfaction with ECHA’s website is overall high. Roles and responsibilities between IT and operational directorates need to be better defined. Areas for attention refer to the timeliness and completeness of incident reporting, as well as the increased risk of personal data breaches. The gap between the existing overall positive IT indicators and the low perception of management on the efficiency, security and reliability of IT systems is also a warning.

3.3 Change management

ECHA overall responds to changes flexibly whilst ensuring continuity of operations and changes foreseen with the Better Regulation may provide further agility. At the moment, ECHA’s organisational structure may be sometimes rigid and preventing innovation. Specific consideration should be paid to the prerequisites (including the legislative ones) for maintaining a flexible and agile management system in view of the changing stakeholders’ requirements and the onboarding of new tasks.

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Evaluation and improvement

4.1 Performance management

The adequacy of corporate metrics is currently being addressed, taking into account the balance between quantitative and qualitative indicators and the data expectations of the different stakeholders groups. No critical gaps were found from the analysis of non-conformities, complaints and exceptions register. Attention is required in the area of data management with the need to build more tailor – made and consistent reports that add more value to Management decision – making.

4.2 Assessments, audits, and evaluations

ECHA has adequate tools in their disposal to oversee the effectiveness, adequacy, and suitability of the Agency’s Integrated Management System through assessments, audits, and evaluations. There is a need to systematically discuss learnings from mistakes, have less cumbersome follow up audits and better integrate ex-post controls.

Statement of the manager in charge of risk management and internal control I, the undersigned,

Shay O’MALLEY

Director of Resources

In my capacity as manager in charge of risk management and internal control, I declare that in accordance with ECHA’s Internal Control Framework, I have reported my advice and recommendations on the overall state of internal control in the Agency to the Executive Director. I hereby certify that the information provided in the present Annual Report and in its annexes is, to the best of my knowledge, accurate, reliable and complete. Done in Helsinki, on 5 March 2025

signed

Shay O’MALLEY

Director of Resources

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Part IV. Management assurance Review of the elements supporting assurance The Authorising Officer performed an assessment of the effectiveness and efficiency of the internal control system, acknowledging that the system, based on ECHA’s Integrated Management Strategy and Framework, is functioning well. The assessment considered a broad range of input and fed into the Management Review 2024, where senior management of the Agency reflected on the strengths, weaknesses, risks and opportunities of the management system. No significant weaknesses that may have a potential impact on the declaration of assurance of the Authorising Officer were identified and reported in any of the relevant parts as set out in the present report. Reservations Not applicable

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Part V. Declaration of assurance

Declaration of assurance by the Authorising Officer

I, the undersigned,

Dr Sharon McGuinness

Executive Director of the European Chemicals Agency

In my capacity as Authorising Officer,

Declare that the information contained in this report gives a true and fair view,

State that I have reasonable assurance that the resources assigned to the activities described in this report have been used for their intended purpose and in accordance with the principles of sound financial management, and that the control procedures put in place give the necessary guarantees concerning the legality and regularity of the underlying transactions,

This reasonable assurance is based on my own judgement and on the information at my disposal, such as the results of the self-assessment, ex post controls, the work of the Internal Audit Capability, the recommendations of the Internal Audit Service and the lessons learnt from the reports of the Court of Auditors38 for years prior to the year of this declaration,

Confirm that I am not aware of anything not reported here which could harm the interests of the Agency.

Done in Helsinki, on 21 March 2025

signed

Dr Sharon McGuinness

Executive Director

38 With regard to the implementation of EU legislation and the fee regulations under the Agency’s remit, this assurance has to be limited to the field of competences of the Agency. Since ECHA’s mandate does not include controls or inspections at national level, it cannot be confirmed that only registered or authorised substances and products, for which a fee has been paid to the Agency, are circulating on the EU market.

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Annexes

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Annex I - Key indicators

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Annex II - Budget implementation reports and statistics on financial management

Budget overview

The initially budgeted total payment appropriations for the Agency’s expenditure in 2024, as concluded by the Management Board in December 2023, amounted to EUR 127.9 million, including c. EUR 0.8 million for the separately budgeted other tasks (“Contribution Agreements and SLAs” in the table below). During the year, two budget amendments were approved by the Management Board, primarily for the following reasons: a) incorporating the agreed amounts to be collected under the Contribution Agreements and SLAs (EUR 1.32 million increase), b) excluding the EU contribution (and EFTA contribution) relating to the water protection legislation, due to delay in its adoption (EUR 1.65 million decrease), c) incorporating the additional EU contribution reinforcement, concluded centrally for all EU Agencies following the adjustment in salaries (EUR 0.98 million increase), and d) adjusting the fee income and bank interest income (EUR 0.15 million net increase). The final total expenditure, concluded in the 2nd amending budget in November 2024, amounted to EUR 128.7 million, including EUR 2.1 million for the separately budgeted Contribution Agreements and SLAs.

Revenue Initial voted budget Amending budgets Final voted budget Total revenue 127 918 559 794 107 128 712 666

Expenditure Initial voted budget Amending budgets Final voted budget Commitment appropriations 127 955 559 530 848 128 486 407

Payment appropriations 127 918 559 794 107 128 712 666

Revenue

The budget funding of ECHA in 2024 consisted of the following (amounts in EUR):

Description Initial voted

Budget 2024

Amendments 2024

Final voted Budget 2024

Entitlements established

2024

Revenue received

2024 Fees and charges from Registrations & Updates 24 751 025 1 159 645 25 910 670 26 201 769 26 201 769 Fees and charges from Authorisations 2 970 000 (1 195 000) 1 775 000 1 707 126 1 707 126 Fees SME Administration 700 000 - 700 000 617 358 617 358 Fees and charges from CLP 90 500 - 90 500 66 500 66 500 Fees and charges from appeals - 12 556 12 556 29 298 29 298 Total REACH Fees & Charges Income 28 511 525 (22 799) 28 488 726 28 622 051 28 622 051

Fees relating to Biocidal Active Substances 712 975 (250 000) 462 975 570 500 570 500 Fees for Union Authorisation of Biocidal products 2 346 851 220 000 2 566 851 2 789 000 2 789 000 Miscellaneous fees 2 566 000 30 000 2 596 000 2 322 300 2 322 300 Fees and charges from appeals 0 2 500 2 500 5 000 5 000 Total BPR Fee & Charges Income 5 625 826 2 500 5 628 326 5 686 800 5 686 800

REACH EU Contribution 73 971 000 835 000 74 806 000 74 806 000 74 806 000 BPR EU Contribution 7 745 000 86 585 7 831 585 7 831 585 7 831 585 ENV EU Contribution 6 931 688 (1 540 460) 5 391 228 5 391 228 5 391 228 EFTA Contribution – REACH 2 499 040 - 2 499 040 2 499 040 2 499 040 EFTA Contribution – BPR 227 286 - 227 286 227 287 227 287 Confederation of Switzerland Contribution – BPR 346 201 - 346 201 346 201 346 201 EFTA Contribution – ENV 246 281 (55 148) 191 133 191 133 191 133 Total EU and other Contributions 91 966 496 (674 023) 91 292 473 91 292 475 91 292 475

Contribution Agreement EUON - - - 619 000 619 000 Contribution Agreement EUCLEF - - - 1 053 400 1 053 400 Contribution Agreement OELs - 975 000 975 000 975 000 975 000 Contribution Agreement SCBTH - - - 520 000 520 000 SLA with EFSA 784 712 345 000 1 129 712 1 129 712 1 129 712

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Total Contribution Agreements and SLAs 784 712 1 320 000 2 104 712 4 297 112 4 297 112

Bank Interest Income 1 030 000 168 429 1 198 429 1 440 219 1 440 219 Other income – miscellaneous - - - 47 760 48 781 Total Administrative Operations Income 1 030 000 168 429 1 198 429 1 487 979 1 489 000

Total 127 918 559 794 107 128 712 666 131 386 416 131 387 437

REACH/CLP Revenue

A) REACH/CLP Fees and Charges

ECHA is financed through fees paid by industry and by an EU balancing contribution, in accordance with the REACH Regulation (No 1907/2006). The fees and charges collected by ECHA are determined by the REACH Fee Regulation and by the decisions of the Management Board.

Due to the one-off nature of REACH fees and their dependence on strategic decisions of the chemical industry players, there is high uncertainty as to their amount and timing.

The budgetary revenue from REACH fees and charges in 2024, in terms of cash received, amounted to EUR 28.59 million (EUR 30.90 million in 2023). In addition, EUR 0.03 million (EUR 0.03 million in 2023) was recorded in relation to REACH appeal fees39 giving a total of fees and charges of EUR 28.62 million (EUR 30.93 million in 2023).

Broken down by fee category, ECHA collected a total of EUR 26.20 million from REACH Registrations and Updates fees (EUR 26.68 million in 2023), EUR 1.71 million from Applications for Authorisation (EUR 3.30 million in 2023) and EUR 0.07 million from CLP fees (EUR 0.10 million in 2023). The additional registration fee income that was generated through the SME company size verification process (which is included in the REACH registrations and updates income) amounted to EUR 0.36 million in 2024 (EUR 0.52 million in 2023). On top of the additional registration fees, the Agency generated EUR 0.62 million in administrative charges (EUR 0.82 million in 2023) levied on companies who were deemed non-eligible for the granted SME fee rebates.

B) REACH/CLP Contributions from the General Budget of the EU

During 2024, the Agency received an EU balancing contribution for REACH/CLP of EUR 74.81 million (EUR 66.81 million in 2023) and a European Free Trade Association (EFTA) contribution of EUR 2.50 million (EUR 2.00 million in 2023).

BPR Revenue

A) BPR Fees and Charges

In accordance with the Biocidal Products Regulation (BPR, No 528/2012), ECHA is financed through fees paid by industry and a balancing EU contribution. The biocide fees and charges collected by ECHA are determined by the Biocidal Products Regulation and the BPR Fees and Charges Regulation. The budgetary revenue from biocidal product fees and charges for 2024, in terms of cash received, amounted to EUR 5.69 million (EUR 2.79 million in 2023). The significant increase in the collected BPR fee income relates primarily to the significantly increased number of Union Authorisation applications, for single products and for product family, received in 2024 compared to 2023 (25 applications in 2024 vs. 6 applications in 2023).

39 Income from appeal fees is recognised by ECHA only when a case has been decided and the Board of Appeal rules that the fee should not be refunded to the applicant.

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B) BPR Contributions from the General Budget of the EU

During 2024, the Agency received an EU balancing contribution of EUR 7.83 million (EUR 9.56 million in 2023) and an EFTA contribution of EUR 0.23 million (EUR 0.19 million in 2023). In addition, the Agency received a contribution from the Confederation of Switzerland of EUR 0.35 million (EUR 0.38 million in 2023). Environmental Policy Revenue In accordance with the Prior Informed Consent (PIC) Regulation (EU) No 649/2012, Persistent Organic Pollutants (POPs) Regulation (EU)2019/2021, Waste Framework Directive (SCIP) (EU) 2018/851 amending Directive 2008/98/EC, the revised Drinking Water Directive (DWD) Directive (EU) 2020/2184, the 8th Environmental Action Programme (8th EAP), the Batteries Regulation and the Industrial Emissions Directive (IED), ECHA is fully financed through an EU contribution for these activities. In 2024, the EU contribution amounted to EUR 1.31 million for PIC (EUR 1.22 million in 2023), EUR 0.31 million for POPs (EUR 0.29 million in 2023), EUR 1.09 million for SCIP (EUR 1.34 million in 2023), EUR 1.24 million for DWD (EUR 1.72 million in 2023), EUR 0.34 million for 8th EAP (EUR 0.33 million in 2023), EUR 0.48 million for the Batteries Regulation (new task in 2024) and EUR 0.62 million for IED (new task in 2024), totalling EUR 5.39 million (EUR 4.91 million in 2023). Furthermore, in 2024, the Agency received an EFTA contribution of EUR 0.19 million (EUR 0.14 million in 2023) in total for the above tasks. Contribution Agreements and Service Level Agreements The Agency has signed contribution agreements with the European Commission to implement the European Union Observatory for Nanomaterials (EUON) and the European Union Chemicals Legislation Finder (EUCLEF). ECHA has also signed a Service Level Agreement with the European Commission to provide opinions for occupational exposure limits (OELs). Additionally, the Agency has signed a Service Level Agreement with the European Food Safety Authority (EFSA) for developing and implementing IUCLID software solutions for plant protection products. Finally, in 2024, the Agency signed a contribution agreement with the European Commission for the implementation of tasks under the Serious Cross-Border Threats to Health (SCBTH), to carry out and deliver public health risk assessments on chemical incidents. In 2024, ECHA received an amount of EUR 4.30 million in aggregate for implementing these tasks. It is to be noted that the Agency has also signed a Service Level Agreement with the European Commission for work with respect to the Instrument for Pre-Accession Assistance (IPA), for which no additional funding was collected during 2024. Other miscellaneous income The table below shows the other miscellaneous income received by the Agency in 2024 and 2023 (amounts in EUR).

Description Revenue received

2024

Revenue received

2023

Bank Interest income 1 440 219 930 573 Legal recoveries - 50 791 Late interest income 3 425 6 176 Recoveries from other EU agencies 43 092 57 456 Other recoveries 2 264 14 052 Other income - miscellaneous 48 781 128 475 Total Administrative Operations Income 1 489 000 1 059 048

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Fee Invoicing In accordance with Article 71 of the Agency’s Financial Regulation, the number of debit notes issued, and their global amount shall be provided in the Agency’s report on budgetary and financial management. In addition, where fees and charges are entirely determined by legislation or decisions of the Management Board, the Authorising Officer may abstain from issuing recovery orders and directly draw up debit notes after having established the amount receivable. Where the Agency uses a separate invoicing system, the Accounting Officer shall regularly, and at least on a monthly basis, enter the accumulated sum of fees and charges received into the accounts. The Agency uses a separate invoicing and debtors’ system for daily transactions related to fee income, namely the REACHIT (for REACH/CLP fees and charges) and REACH-NG (for Biocidal Products fees and charges) invoicing modules. The invoices raised and the payments received are recorded in the central accounting system on a monthly basis.

A) REACH Fees and Charges

The total net invoiced by the Agency in 2024 amounted to EUR 28.46 million (EUR 31.01 million in 2023 and EUR 33.02 million in 2022). The table below depicts the breakdown of the net invoiced REACH fees during the years 2022-2024.

REACH 2024 2023 2022

Description No of Invoices EUR No of

Invoices EUR No of Invoices EUR

Invoices issued 5 670 30 915 187 5 743 33 510 775 6 579 35 011 416 Credit Notes 150 (1 998 717) 131 (1 790 613) 494 (1 628 744) Unpaid 76 (455 495) 136 (710 941) 111 (364 332) Considered paid 14 (259) 14 (259) 17 (842)

Net Invoiced 28 460 716 31 008 962 33 017 498

Write offs - - 5 (87 682) 13 (238 488)

On 31 December 2024, the amount to be recovered for REACH fees and charges, before any year- end accounting adjustments, stood at EUR 1.89 million relating to 274 open invoices (on 31 December 2023, the amount to be recovered for REACH fees and charges, before any year end accounting adjustment, stood at EUR 2.05 million relating to 266 open invoices).

B) Biocidal Products Fees and Charges

The total net invoiced by the Agency in 2024 amounted to EUR 5.98 million (EUR 2.88 million in 2023 and EUR 6.80 million in 2022). The table below depicts the breakdown of the net invoiced BPR fees during the year.

BPR 2024 2023 2022

Description No of Invoices EUR No of

Invoices EUR No of Invoices EUR

Invoices issued 1 098 6 599 900 608 3 618 500 1 201 8 232 100 Credit Notes 56 (603 600) 51 (589 500) 103 (1 347 000) Unpaid 15 (17 000) 14 (149 500) 37 (81 400) Considered paid - - - - 3 (95)

Net Invoiced 5 979 500 2 879 500 6 803 605

On 31 December 2024, the amount to be recovered for Biocidal product fees and charges before any year end accounting adjustments, stood at EUR 0.48 million relating to 72 open invoices (on

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31 December 2023, the amount to be recovered for BPR fees and charges, before any year end accounting adjustment, stood at EUR 0.18 million relating to 24 open invoices). Expenditure ECHA’s expenditure budget consists of commitment appropriations (CA) and payment appropriations (PA). The initial CAs totalled EUR 127.2 million and the initial PAs totalled EUR 127.1 million, while the figure concluded in the final budget is EUR 126.4 million for CAs and EUR 126.6 million for PAs. These commitment and payment appropriations consist of C1 funds only, i.e. excluding the R0 funds ("Contribution Agreements and SLAs") of EUR 0.8 million from initial Budget and EUR 2.1 million from final budget.

Budget expenditure includes payments made during the year and the carry-over of budgetary appropriations. Summary of the execution of appropriations per title and a more detailed breakdown is provided in the ‘Statistics on Financial Management and Budget (Expenditure)’ section below. Changes and implementation of the commitment appropriations for 2024 (C1) The initially adopted budget for the Agency in 2024 was EUR 127.2 million and the overall net decrease during the year, including 26 transfers and two amending budgets, was c. EUR 0.8 million, to arrive at EUR 126.4 million as the final budget.

The final executed amount totalled EUR 125.8 million corresponding to an execution rate of 99.5 % for the appropriations. Carry over of appropriations to 2025 The commitment and payment appropriations carried over to 2025 totals EUR 15.9 million, corresponding to 12.6 % of the committed amount.

The carry-over of staff related expenditure, budgeted in Title 1, was insignificant and mainly relates to the commitments for training and interim services.

In Title 2, covering the Agency’s infrastructure, the carry-over totalled EUR 3.4 million, stemming mainly from commitments related to ECHA’s IT services.

The operational expenditure required to implement the Work Programme for the different regulations is budgeted in Title 3 for REACH and CLP, in Title 4 for Biocides, and in Title 5 for the Environmental Policy (PIC, POPs, Waste Framework Directive (SCIP), Drinking Water Directive, the 8th Environmental Action Programme, Batteries Regulation and Industrial Emissions Directive). The carry-over in operational titles totalled EUR 12.2 million and is mostly related to IT development projects.

The relatively high level of carry-overs stems from the contracting cycle caused largely by the uncertainty in the fee income. In the past years, ECHA has had to wait late in the year before signing the contracts to make sure sufficient funds will be available, and at the same time, has had to sometimes frontload certain projects when the income has exceeded the estimates. This had led to a situation where, during the first part of the year, the focus has been on implementing the projects carried over and new projects are only commenced during the second half and sometimes even during the last quarter of the year.

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Implementation of the appropriations carried over from 2023 (C8) The amount carried over from 2023 totalled EUR 14.4 million and the finally executed amount was EUR 14.3 million, corresponding to 99.4 %. The cancelled 0.6 % relates mostly to meetings that took place at the end of 2023, where the actual costs were lower than anticipated, and lower than anticipated costs for legal services related to debt collection of administrative charges in Title 3. Late interest payments During the year 2024, ECHA did not pay late interest for commercial invoices. Procurement procedures During 2024 budget implementation:

• ECHA signed a total 368 contracts and purchase orders40. • 282 were specific contracts and orders under existing framework contracts (FWC) and 86

were contracts resulting from new tendering procedures. • ECHA concluded 9 new FWCs:

o for management standard certification services, o for methodological developments and data generation for the assessment and

building of sets of nanoforms (NAMs), o for scientific and technical support work related to hazard assessment and

identification (4 lots), o for support on the POP dossier for D4, D5 and D6, o for support to risk management work under REACH and other legislations

(restriction support), o for interim services, o for canteen and catering services, o for travel services, o for office supplies.

ECHA also signed multiannual contracts for banking services and the info desk and established a Dynamic Purchasing System (DPS) for IT services. ECHA joined 8 inter-institutional FWCs:

• for thematic communication services (COM), • for impact assessment, evaluation, studies in communications (COM), • for digital communication and social media (COM), • for data protection advice, consultancy and related services II (EBA), • for engagement and community management services (EFSA), • for learning and development services for staff on general skills, resilience & wellbeing

(EPSO), • for EU IPR management and annuities & renewal services (JRC) • for legal advice services in respect of EU intellectual property rights (JRC).

A total of 20 contracts were signed following negotiated procedures without prior publication, based on the relevant rules of the Financial Regulation (Annex 1–11.1):

• 13 for legal services • 7 (for technical reasons) for specific scientific expertise, for subscriptions to scientific

40 This number also includes amendments with budgetary commitment.

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database and professional journals, as well as for specialised software.

In 2024, the performance of the suppliers of the Agency was satisfactory overall and in accordance with the terms of the contracts, with few exceptions, which were successfully addressed by ECHA. Preliminary market consultation in the form of questionnaires to be filled in by potential tenderers continues being an established practice in ECHA, before launching procurement. Green Public Procurement (GPP) remains a priority and an integral part of the Agency’s management system and was extended beyond technical equipment also to apply to tenderers providing human labour-based services/expert services (DPS for IT services). Furthermore, ECHA used demonstration of social responsibility as part of the financial award criterion in the new FWC for interim services. The introduction of Qualified Electronic Signature for all Authorising Officers directly in EasySign workflow tool has brought significant efficiencies to signing contracts. Through the NAPO network the procurement team joined an expert group to analyse possibilities, limitations and legality of using artificial intelligence in procurement procedures. ECHA continued relying on IT tools (e.g., Cloudia for the DPS, PPMT) in its procurement and contract processes. The annual list of contractors is published by ECHA by 30 June of each year for the previous year on ECHA’s website 41. Acts of delegation and sub delegation For the purposes of the budget implementation, and in line with Article 41(1) of ECHA’s Financial Regulation, the Executive Director as the Authorising Officer of the Agency has delegated financial powers to the directors for the budget lines which they are responsible for, in line with their activities.

In accordance with Article 41(2), the directors have further sub-delegated financial powers to the heads of unit of their directorates.

For efficiency reasons, the Executive Director has also delegated financial powers to authorise payments below EUR 8 000 to staff in the Finance Unit.

41 https://echa.europa.eu/view-article/-/journal_content/title/annual-list-of-awarded-contracts

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Statistics on Financial Management and Budget (Expenditure)

Budget 2024: Breakdown and changes in commitment appropriations and implementation of the appropriations for the current year (C1) per Title* (EUR)

Title Description Budget 2024 (1)

Transfers / amendments

(2)

Final Available

Commitment Appropriations

(3)

Executed Commitment

Amount (4)

% Committed

(4)/(3)

Final Available Payment

Appropriations (5)

Executed Payment Amount

(6)

% Paid

(6)/(5)

Carried over RAL (C8)

(7)

Carried over %

(7)/(4)

Cancelled (3)-(4)

A-1 STAFF 83 470 319 -161 235 83 309 084 83 077 124 99.7% 83 309 084 82 825 344 99.4% 251 781 0.3% 231 960

A-2 BUILDING. EQUIPMENT AND MISCELL OPER EXPEND 19 375 816 2 748 784 22 124 600 22 105 259 99.9% 22 124 600 18 720 102 84.6% 3 385 157 15.3% 19 341

B0-3 OPERATIONAL EXPENDITURE - REACH/CLP 18 936 545 -2 437 833 16 498 712 16 217 153 98.3% 16 724 971 7 240 868 43.3% 9 178 319 56.6% 281 559

B0-4 OPERATIONAL EXPENDITURE - BIOCIDES 2 609 929 -124 718 2 485 211 2 441 849 98.3% 2 485 211 884 206 35.6% 1 557 644 63.8% 43 362

B0-5 OPERATIONAL EXPENDITURE - ENVIRONMENTAL POLICY 2 778 238 -814 150 1 964 088 1 958 107 99.7% 1 964 088 475 451 24.2% 1 482 657 75.7% 5 981

127 170 847 -789 152 126 381 695 125 799 492 99.5% 126 607 954 110 145 970 87.0% 15 855 557 12.6% 582 203

*Note: As ECHA operates with both differentiated (multi-annual) and non-differentiated (annual) budget lines, the funds reserved for commitments (commitment appropriations) do not equal the funds reserved for payments (payment appropriations). The results for the administrative titles 1 and 2 are combined for all three regulations.

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Budget 2024: Breakdown and changes in commitment appropriations and implementation of the appropriations for the current year (C1) per Regulation and Title (EUR)

REACH/CLP

Title Description Budget 2024 (1)

Transfers / amendments

(2)

Final Available

Commitment Appropriations

(3)

Executed Commitment

Amount (4)

% Committed

(4)/(3)

Final Available Payment

Appropriations (5)

Executed Payment Amount

(6)

% Paid

(6)/(5)

Carried over

RAL (C8) (7)

Carried over %

(7)/(4)

Cancelled (3)-(4)

A-1 STAFF 70 761 345 1 081 796 71 497 541 71 315 955 99.7% 71 497 541 71 099 811 99.4% 216 144 0.3% 181 586

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND 16 120 675 1 974 979 18 441 254 18 425 175 99.9% 18 441 254 15 575 125 84.5% 2 850 051 15.5% 16 079

B0-3 OPERATIONAL EXPENDITURE - REACH/CLP 18 936 545 -2 437 833 16 498 712 16 217 153 98.3% 16 724 971 7 240 868 43.3% 9 178 319 56.6% 281 559

105 818 565 618 942 106 437 507 105 958 283 99.5% 106 663 766 93 915 804 88.0% 12 244 513 11.6% 479 224

BIOCIDES

Title Description Budget 2024 (1)

Transfers / amendments

(2)

Final Available

Commitment Appropriations

(3)

Executed Commitment

Amount (4)

% Committed

(4)/(3)

Final Available Payment

Appropriations (5)

Executed Payment Amount

(6)

% Paid

(6)/(5)

Carried over

RAL (C8) (7)

Carried over %

(7)/(4)

Cancelled (3)-(4)

A-1 STAFF 9 255 539 -21 813 9 213 776 9 204 749 99.9% 9 213 776 9 181 950 99.7% 22 799 0.2% 9 027

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND 2 208 845 270 616 2 499 411 2 497 199 99.9% 2 499 411 2 134 092 85.4% 363 108 14.5% 2 212

B0-4 OPERATIONAL EXPENDITURE - BIOCIDES 2 609 929 -124 718 2 485 211 2 441 849 98.3% 2 485 211 884 206 35.6% 1 557 644 63.8% 43 362

14 074 313 124 085 14 198 398 14 143 797 99.6% 14 198 398 12 200 247 85.9% 1 943 550 13.7% 54 601

ENVIRONMENTAL POLICY

Title Description Budget 2024 (1)

Transfers / amendments

(2)

Final Available

Commitment Appropriations

(3)

Executed Commitment

Amount (4)

% Committed

(4)/(3)

Final Available Payment

Appropriations (5)

Executed Payment Amount

(6)

% Paid

(6)/(5)

Carried over

RAL (C8) (7)

Carried over %

(7)/(4)

Cancelled (3)-(4)

A-1 STAFF 3 453 435 -846 218 2 597 767 2 556 421 98.4% 2 597 767 2 543 582 97.9% 12 838 0.5% 41 346

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND 1 046 296 128 189 1 183 935 1 182 884 99.9% 1 183 935 1 010 885 85.4% 171 998 14.5% 1 051

B0-5 OPERATIONAL EXPENDITURE - ENVIRONMENTAL POLICY 2 778 238 -814 150 1 964 088 1 958 107 99.7% 1 964 088 475 451 24.2% 1 482 657 75.7% 5 981

7 277 969 -1 532 179 5 745 790 5 697 412 99.2% 5 745 790 4 029 918 70.1% 1 667 493 29.3% 48 378

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Budget 2024: Implementation of differentiated appropriations (EUR)

Budget line Available

commitment appropriations

Commitments made %

Available payment

appropriations

Payments made %

B3-111 Substance evaluation and Rapporteurs (Multiannual) 618 894 617 815 99.83% 838 152 814 001 97.12%

B3-801 Cooperation with international organisations for IT programs 502 300 500 015 99.55% 509 301 505 864 99.33%

Total 1 121 194 1 117 830 c.100% 1 347 453 1 319 865 97.95%

Out of the total available commitment appropriations of EUR 1 562 595, the amount of EUR 891 719 is stemming from commitments made in earlier financial years. The available commitment appropriations for 2024 totalled EUR 1 121 194 out of which EUR 1 117 830 (c.100%) were committed.

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Budget 2024: Implementation of assigned revenue (C4, C5, R0) (EUR)

Title Description FS Commitments Appropriations

Commitments Established Com % Payments

Appropriations Payments Executed Pay%

Carried over commitment

appropriations

Carried over payment

appropriations

A-1 STAFF C4 43 602 0 0.0% 43 602 0 0.0% 43 602 43 602

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND C4 3 425 0 0.0% 3 425 0 0.0% 3 425 3 425

B0-3 OPERATIONAL EXPENDITURE - REACH/CLP C4 1 243 0 0.0% 1 243 0 0.0% 1 243 1 243

C4 48 270 0 0.0% 48 270 0 0.0% 48 270 48 270

Title Description FS Commitments Appropriations

Commitments Established Com % Payments

Appropriations Payments Executed Pay%

Carried over commitment

appropriations

Carried over payment

appropriations

A-1 STAFF C5 20 345 20 345 100.0% 20 345 20 345 100.0% 0 0

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND C5 6 176 6 176 100.0% 6 176 6 176 100.0% 0 0

B0-3 OPERATIONAL EXPENDITURE - REACH/CLP C5 29 477 28 009 95.0% 29 477 25 791 87.5% 0 2 219

B0-4 OPERATIONAL EXPENDITURE - BIOCIDES C5 153 153 100.0% 153 153 100.0% 0 0 C5 56 150 54 682 97.4% 56 150 52 464 93.4% 0 2 219

BL Description FS Commitments Appropriations

Commitments Established Com % Payments

Appropriations Payments Executed Pay%

Carried over commitment

appropriations

Carried over payment

appropriations

B6-000 IPA programme R0 472 488 185 892 39.3% 472 488 185 732 39.3% 286 596 286 756

B6-010 EUON R0 1 513 432 844 452 55.8% 1 513 432 578 167 38.2% 668 981 935 266

B6-011 EUCLEF R0 3 280 552 1 607 166 49.0% 3 280 552 981 274 29.9% 1 673 385 2 299 277

B6-020 Occupational exposure limits R0 1 560 820 950 210 60.9% 1 560 820 818 365 52.4% 610 610 742 455

B6-021 Further development of IUCLID (w/ third parties) R0 1 898 451 1 600 758 84.3% 1 898 451 1 198 843 63.1% 297 693 699 608

B6-022 Support to cross-border threats to health (SCBTH) R0 520 000 0.0% 520 000 0.0% 520 000 520 000

R0 9 245 744 5 188 479 56.1% 9 245 744 3 762 381 40.7% 4 057 265 5 483 362

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Annual Report 2024

Budget 2024: Implementation of the appropriations carried forward from previous year (C8) Per Title (EUR)

Title Description Carried Forward from 2023 Paid Cancelled % Cancelled

A-1 STAFF 296 082 290 902 5 180 1.7%

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND 2 606 583 2 595 821 10 762 0.4%

B0-3 OPERATIONAL EXPENDITURE - REACH/CLP 8 610 244 8 556 134 54 110 0.6%

B0-4 OPERATIONAL EXPENDITURE - BIOCIDES 1 269 456 1 256 830 12 626 1.0%

B0-5 OPERATIONAL EXPENDITURE - ENVIRONMENTAL POLICY 1 588 521 1 586 926 1 595 0.1%

14 370 886 14 286 613 84 273 0.6%

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Annual Report 2024

Annex III – Organisational chart

95

Annual Report 2024

Annex IV - Establishment plan and additional information on human resources management

Last establishment plan adopted

Category and grade

Establishment plan in voted EU Budget 2024 Posts filled 31 December 202442

TA TA REACH/

Biocides ENV TOTAL REACH/

Biocides ENV TOTAL CLP CLP

AD 15 0 0

AD 14 6 6 3 3

AD 13 13 1 14 4 4

AD 12 12 2 14 11 1 12

AD 11 30 1 31 17 1 18

AD 10 41 5 46 46 6 52

AD 9 60 10 1 71 41 7 1 49

AD 8 52 9 61 60 7 67

AD 7 53 9 6 68 48 4 1 53

AD 6 27 5 10 42 41 9 4 54

AD 5 16 1 17 32 6 4 42

Total AD 310 43 17 370 303 41 10 354

AST 11 0 0

AST 10 0 0

AST 9 3 3 0

AST 8 8 8 6 6

AST 7 10 1 2 13 12 12

AST 6 18 1 19 18 1 1 20

AST 5 26 3 2 31 17 2 19

AST 4 16 3 2 21 10 4 3 17

AST 3 10 1 11 13 2 15

AST 2 3 3 14 2 16

AST 1 0 0

Total AST 94 9 6 109 90 9 6 105

AST/SC 6 0 0

AST/SC 5 0 0

AST/SC 4 0 0

AST/SC 3 0 0

AST/SC 2 0 0

AST/SC 1 0 0

TOTAL AD+AST 404 52 11 467 393 50 16 459

CA CA

42 Under recruitment (included in figures): REACH: 2 TAs

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Annual Report 2024

estimated need of FTEs 2024 posts filled 31 December 202443

REACH/ Biocides ENV Other

tasks TOTAL REACH/

Biocides ENV Other tasks TOTAL

CLP CLP

CA FG IV 27 7 12 13 59 18 6 5 9 38

CA FG III 53 6 3 1 63 57 6 6 4 73

CA FG II 17 2 0.5 19.5 19 2 21

CA FG I 0 0 TOTAL 97 15 15 14.5 141.5 94 14 11 13 132

Percentage of posts filled on 31 December 2024

REACH/ CLP Biocides ENV

TA posts 97.28% 96.15% 69.57%44

CA posts 96.91% 93.33% 73.33%

Geographical and gender balance (as per 31 December 2024)45

Nationality TA CA OVERALL

% Male Female Total Male Female Total Sum

1 AT Austrian 3 4 7 0 0 0 7 1.2%

2 BE Belgian 11 10 21 2 1 3 24 4.1%

3 BG Bulgarian 1 9 10 3 4 7 17 2.9%

4 CY Cypriot 0 0 0 1 0 1 1 0.2%

5 CZ Czech 0 3 3 1 0 1 4 0.7%

6 DE German 17 7 24 0 0 0 24 4.1%

7 DK Danish 1 1 2 0 0 0 2 0.3%

8 EE Estonian 0 6 6 1 0 1 7 1.2%

9 ES Spanish 18 12 30 5 4 9 39 6.6%

10 FI Finnish 57 87 144 15 31 46 190 32.3%

11 FR French 20 15 35 3 7 10 45 7.7%

12 GR Greek 15 7 22 4 6 10 32 5.4%

13 HR Croatian 0 0 0 0 2 2 2 0.3%

14 HU Hungarian 2 7 9 0 4 4 13 2.2%

15 IE Irish 10 7 17 0 1 1 18 3.1%

16 IS Iceland 0 0 0 0 0 0 0 0.0%

17 IT Italian 23 18 41 6 5 11 52 8.8%

18 LI Liechtenstein 1 0 1 0 0 0 1 0.2%

19 LT Lithuanian 1 6 7 0 0 0 7 1.2%

20 LU Luxembourger 0 0 0 0 0 0 0 0.0%

21 LV Latvian 2 5 7 0 1 1 8 1.4%

22 MT Maltese 0 3 3 0 0 0 3 0.5%

23 NL Dutch 9 5 14 3 1 4 18 3.1%

43 Under recruitment (included in figures): BIOCIDES: 1 CA. 44 The posts related to the Water directives (3 TAs and 4 CAs) were expected to come to ECHA during 2024 and were foreseen in the Authorised budget. However, the posts were not received in 2024. This negatively affects the 'posts filled' ratio. 45 Data in the table includes statutory staff in place on the indicated date. Posts under recruitment are not included.

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24 NO Norwegian 0 1 1 0 0 0 1 0.2%

25 PL Polish 8 10 18 1 2 3 21 3.6%

26 PT Portuguese 6 7 13 0 2 2 15 2.6%

27 RO Romanian 3 5 8 2 8 10 18 3.1%

28 SE Swedish 3 2 5 1 0 1 6 1.0%

29 SI Slovenian 3 3 6 1 1 2 8 1.4%

30 SK Slovakian 1 2 3 0 2 2 5 0.9%

31 Other Other 0 0 0 0 0 0 0 0.0% TOTAL 215 242 457 49 82 131 588 100.0%

Middle and senior management – gender and nationality overview46

NATIONALITY MALE FEMALE TOTAL %

BE Belgian 2 0 2 5.9%

DE German 2 0 2 5.9%

ES Spanish 2 1 3 8.8%

FI Finnish 3 4 7 20.6%

FR French 3 1 4 11.8%

GR Greek 1 0 1 2.9%

IE Irish 4 2 6 17.6%

IT Italian 2 0 2 5.9%

MT Maltese 0 1 1 2.9%

NL Dutch 2 0 2 5.9%

PT Portuguese 1 0 1 2.9%

RO Romanian 0 1 1 2.9%

SE Swedish 1 0 1 2.9%

SI Slovenian 1 0 1 2.9%

Total OVERALL 24 10 34 100%

Results of the screening / benchmarking exercise

Key functions

Type of contract (official, TA or CA)

Function group, grade

of recruitment

(or bottom of grade bracket if published with such

Indication whether the function is dedicated to

administrative support or operations subject to

definitions used in screening methodology

Core functions

Executive Director TA – 5+5

years AD 14 Management-Operations

Deputy Executive Director

TA – 5+5 years +

indefinite

AD 14 Management-Operations

Director (Head of Directorate) (Level 2) TA – 5+5 AD 12 Management-Operations

46 Data in the table includes statutory staff in place on the indicated date. Posts under recruitment are not included.

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Annual Report 2024

Key functions

Type of contract (official, TA or CA)

Function group, grade

of recruitment

(or bottom of grade bracket if published with such

Indication whether the function is dedicated to

administrative support or operations subject to

definitions used in screening methodology

years + indefinite

Head of Unit (Level 3)

TA – 5+5 years +

indefinite

AD 9 Operations/Administration

Administrator

TA – 5+5 years +

indefinite

AD 5 and higher

depending on profile

Operations/Administration

Administration

Head of Administration (Head of Directorate) (Level 2)

TA – 5+5 years +

indefinite

AD 12 Management- Administration

Head of Human Resources (Level 3)

TA – 5+5 years +

indefinite

AD 9 Administration

Head of Finance (Level 3)

TA – 5+5 years +

indefinite

AD 9 Administration

Head of Communications (Level 3)

TA – 5+5 years +

indefinite

AD 9 Administration

Head of IT (Level 3)

TA – 5+5 years +

indefinite

AD 9 Administration

Assistant

TA - 5+5 years +

indefinite

AST 1 and higher

depending on profile, up to

AST 4

Operations/Administration

Special functions

ECHA Committee Chair TA - 5+5 years +

indefinite AD 10 Operations

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Annual Report 2024

Key functions

Type of contract (official, TA or CA)

Function group, grade

of recruitment

(or bottom of grade bracket if published with such

Indication whether the function is dedicated to

administrative support or operations subject to

definitions used in screening methodology

Board of Appeal Chair TA – 5+5

years AD 12 Operations

Data Protection Officer

TA - 5+5 years +

indefinite

AD 6 Administration

Accounting Officer

TA - 5+5 years +

indefinite

AD 8 Administration

Internal Auditor

TA - 5+5 years +

indefinite

AD 10 Administration

Benchmarking against previous results

ECHA undertook the benchmarking (job screening) exercise in 2024, in accordance with the Commission’s requirements. The 2024 results indicate a decrease of 2.6% in the percentage of administrative support and coordination staff, an increase of 2.1% in the percentage of the operational staff and an increase of 0.5% in the percentage of neutral staff in comparison to 2023.

Job Type (sub) category 2023 (numbers in %) 2024 (numbers in %)

Administrative support and Coordination 14.8 12.2

Administrative Support 12.1 9.6

Coordination 2.8 2.6

Operational 81.6 83.7

Top level Operational Coordination 2.5 2.4

Programme management and Implementation 56.1 61.9

Evaluation & Impact assessment 3.2 2.3

General operational 19.8 17.1

Neutral 3.6 4.1

Finance/ Control 3.6 4.1

Linguistics 0.0 0.0

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Annual Report 2024

Annex V – Human and financial resources by activity

Work Programme activity

Actual consumption of

the human resources

Executed budget 2024

1.1 Dossier preparation 26 6 929 896 1.2 Dossier submission and processing 34 8 480 661 1.3 Identification and prioritisation of substances and groups of substances

41 10 115 816

1.4 Evaluation 86 16 784 194 1.5 Authorisation 29 6 132 956 1.6 Restrictions 30 6 318 755 1.7 Classification and labelling 33 6 517 743 1.8 Data management and dissemination 29 10 540 388 1.9 Promotion of alternatives to animal testing 4 1 316 944 2. Biocides 50 11 183 632 3. Environmental policy 25 4 841 570 4. Tasks under grant, cooperation and service-level agreements

18 5 188 479

Governance and enablers 194 36 636 938

Overall TOTAL 599 130 987 971

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Annual Report 2024

Annex VI – Contribution, grant and service-level agreements

General information Financial and HR impacts

Actual or expected date of

signature

Total amount Duration Counterpart Short

description

2023 2024

Grant agreements

1. IPA 20.12.2022 675 103 42 months

Commission DG NEAR

Amount Number of CA 1.5 1.5

Number of SNEs - -

Amount Number of CA 1.5 1.5

Number of SNEs - -

Contribution agreements

1. EUCLEF 10.12.2021 5 829 200 5 years (2021- 2025)

Commission DG GROW

Amount Number of CA 0 0

Number of SNEs - -

2. EUON 09.12.2021 3 066 000 5 years (2021- 2025)

Commission DG GROW

Amount Number of CA 3 3

Number of SNEs

3. SCBTH 15.11.2024 520 000 3 years (2025- 2027)

Commission

DG SANTE

Amount Number of CA 0 0

Number of SNEs - -

Amount Number of CA 3 3

Number of SNEs - -

Service-level agreements

1. IUCLID for EFSA

26.03.2021 Annual fee of 784 712 plus project cost

N/A EFSA

Amount Number of CA 4 4

Number of SNEs - -

2. OEL 23.02.2022 195 000 per opinion

18-24 months per case

Commission DG EMPL

Amount Number of CA 4 4

Number of SNEs - -

Total service-level agreements

Amount Number of CA 8 8

Number of SNEs - -

TOTAL (contribution agreements and SLAs) Amount Number of CA 12.5 12.5

Number of SNEs

- -

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Annual Report 2024

Annex VII - Environment management Context of the Agency and its environmental management strategy ECHA implements the EU’s chemicals legislation to protect health and the environment. Our work also contributes to a well-functioning internal market, innovation and the competitiveness of Europe’s chemicals industry. Through ECHA’s work, better knowledge and regulation of harmful chemicals helps to protect workers, consumers and the environment, makes recycling easier, and encourages industry to develop safer alternatives. ECHA has an environmental policy which commits ECHA to continually improve its environmental performance. ECHA supports the political priorities of the EU, as enshrined in the European Green Deal and the EUAN Strategy 2021-2027. To this end, ECHA has pledged to climate-neutral by 2030. Finally, ECHA’s environmental objectives are fully aligned with the “Charter on greenhouse gases (GHG) reduction and responsible environmental management”, adopted by the Head of EU Agencies in February 2024, which set additional ambitious objectives to achieve Carbon Neutrality by 2030. Overview of the Agency's environmental management system ECHA established an Environmental Management System (EMS) in 2015 - part of the Agency’s integrated management system - which aims to deliver on ECHA’s strategy, vision, goals and objectives. ECHA’s environmental objectives, targets and actions reflect our commitment to incorporating sustainability measures within all areas of our activities. This is implemented through our multi-annual environmental work programme (2023-2025) and the internal follow- up of actions and reporting of progress. In 2024, ECHA was recertified under ISO 14001:2015 standard (Environmental Management System) and ECHA’s EMAS registration was renewed and extended until 2027.

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Annual Report 2024

Environmental aspects, indicators and targets

104

Annual Report 2024

Actions taken to improve and communicate environmental performance 2024 was the second year of ECHA’s updated multi-annual Environmental Work Programme (2023-2025) which maintained the previous objectives and introduced new actions and targets.

Goal Multi-annual work programme

Actions implemented in 2024

F1 Inform and involve all staff in greening ECHA.

Green communications plan, training and info sessions. Continue ECHA’s active participation in the Greening Network of the EU Agencies.

Promoted over 30 staff information campaigns. Participated at 9 GIME and EUAN GN meetings. Published the EUAN “Charter on greenhouse gases (GHG) reduction and responsible environmental management on ECHA’s website.

F1 Inform and involve all staff in greening ECHA.

Continue to develop ECHA’s sustainability reporting in all areas (for example, energy and climate).

Began developing a pilot project on carbon capture to begin CO2 offsetting under the EU carbon removals and carbon farming certification framework.

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Annual Report 2024

F1 Inform and involve all staff in greening ECHA.

Continue to develop ECHA’s sustainability reporting in all areas (for example, energy and climate).

Communicated the outcomes and improvement areas of the 2024 ISO, EMAS, Internal Audit (under the IAC) and 2 specific internal audits (under the EMAS Regulation) of its Environmental Management System.

F3 Strengthen green public procurement (GPP).

Develop and apply a GPP checklist for procurement.

Further strengthened environmental and sustainability standards into ECHA procurement (including the canteen services) and introduced Environmental Certification requirements for ICT services.

F4 Improve sustainability of events.

Introduce relevant guidelines for sustainable meeting organisation.

Introduced relevant guidelines for sustainable meeting organisation.

F6 Extend scope of ECHA’s carbon footprint.

Establish baseline and reduction targets for CO2 emissions from teleworking, waste and hotel nights.

Reviewed the scope of ECHA’s CO2 footprint and included CO2 emissions from teleworking and hotels nights related staff travel in order to ensure a comprehensive overview and to avoid reporting gaps and reputational damage which will be included in future environmental reports.

EUROPEAN CHEMICALS AGENCY P.O. BOX 400, FI-00121 HELSINKI, FINLAND ECHA.EUROPA.EU

1 (1) D(2025)0362 Helsinki, 28 April 2025 SMG/gsr

P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | echa.europa.eu

To the Permanent Representations of the EU Member States Per email only Subject: Annual Report 2024 of the European Chemicals Agency

Your Excellency,

Please find attached herewith the Annual Report 2024 of the European Chemicals Agency (ECHA). This Annual Report covers the period from 1 January 2024 to 31 December 2024. The report is prepared pursuant to Article 83(3) of the REACH Regulation and Article 48 of ECHA’s Financial Regulation. It consolidates the requirements of the REACH General Report and the Consolidated Annual Activity Report (CAAR) under ECHA’s Financial Regulation. The Annual Report 2024 will be available on our website (https://echa.europa.eu/plans-and- reports) and contains the Management Board’s (MB) assessment of said report. Should you or your services have any questions related to this Annual Report, please do not hesitate to contact me.

Yours sincerely, Dr Sharon McGuinness Executive Director Enclosure: Annual Report 2024 of the European Chemicals Agency

Cc.: Sofia Zisi, Chair of the ECHA Management Board