Kiri

1 (1)

D(2024)0359

Helsinki, 22 April 2024 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 2023 of the European Chemicals Agency

Your Excellency,

Please find attached herewith the Annual Report 2023 of the European Chemicals Agency

(ECHA).

This Annual Report covers the period from 1 January 2023 to 31 December 2023. 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 2023 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 2023 of the European Chemicals Agency

1 (1)

D(2024)0359

Helsinki, 22 April 2024 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 2023 of the European Chemicals Agency

Your Excellency,

Please find attached herewith the Annual Report 2023 of the European Chemicals Agency

(ECHA).

This Annual Report covers the period from 1 January 2023 to 31 December 2023. 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 2023 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 2023 of the European Chemicals Agency

Annual Report 2023

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 2023

Reference: ECHA-24-R-03-EN ISBN: 978-92-9468-355-7

ISSN: 2600-0849 Cat. Number: ED-BF-24-001-EN-N

DOI: 10.2823/25240 Publ.date: April 2024

Language: EN

© European Chemicals Agency, 2024

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

3

Annual Report 2023

Table of Contents

TABLE OF CONTENTS .................................................................................................. 3

LIST OF ACRONYMS .................................................................................................... 5

MANAGEMENT BOARD ANALYSIS AND ASSESSMENT .................................................. 8 Achievements of the year ........................................................................................................... 8 Management ............................................................................................................................ 9 Budgetary and financial management .......................................................................................... 9 Human resources management ................................................................................................... 9 Audit and retrospective evaluation results and follow-up on recommendations ................................... 9 Internal control framework and Integrated Management System ...................................................... 9 Organisational risk management ............................................................................................... 10 Management Assurance ........................................................................................................... 10 Recommendations for the secretariat for 2024 ............................................................................ 10 Acknowledgments ................................................................................................................... 11 Conclusion ............................................................................................................................. 11

FOREWORD ............................................................................................................... 12

EXECUTIVE SUMMARY .............................................................................................. 14

PART I. ACHIEVEMENTS OF THE YEAR ...................................................................... 19 Dossier preparation ................................................................................................................. 19 Dossier submission and processing ............................................................................................ 20 Identification and prioritisation .................................................................................................. 22 Evaluation ............................................................................................................................. 23 Authorisation .......................................................................................................................... 25 Restrictions ............................................................................................................................ 26 Classification and labelling ........................................................................................................ 28 Safe and sustainable use of chemicals ........................................................................................ 30 Data management and dissemination ........................................................................................ 31 Promotion of alternatives to animal testing ................................................................................. 32 Biocides ................................................................................................................................. 33 Prior informed consent ............................................................................................................. 36 Persistent organic pollutants ..................................................................................................... 37 Waste Framework Directive ...................................................................................................... 38 Drinking Water Directive .......................................................................................................... 39 Support to the 8th Environmental Action Programme of the EU ....................................................... 40 EU Observatory for Nanomaterials ............................................................................................. 40 EU Chemicals Legislation Finder ................................................................................................ 41 Support to occupational health legislation ................................................................................... 41 Instrument for Pre-Accession Assistance (IPA) ............................................................................ 42 Support to other legislation ...................................................................................................... 43 IUCLID for EFSA ..................................................................................................................... 43 Partnership for the Assessment of Risk from Chemicals (PARC) ...................................................... 44 Support to Forum ................................................................................................................... 45 Board of Appeal ...................................................................................................................... 46 Management .......................................................................................................................... 47 ICT 50 Financial Resources ................................................................................................................. 51 Human Resources ................................................................................................................... 52 Corporate Services .................................................................................................................. 53

PART II. MANAGEMENT ............................................................................................ 55 Management Board ................................................................................................................. 55 Major developments ................................................................................................................ 55 Budgetary and financial management ........................................................................................ 56 Delegation and sub-delegation of the powers of budget implementation to agency’s Staff .................. 56 Human Resources (HR) management ......................................................................................... 56

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Annual Report 2023

Strategy for efficiency gains ..................................................................................................... 57 Assessment of audit and retrospective evaluation results during the reporting year .......................... 57 Follow up of recommendations and action plans for audits and evaluations ...................................... 59 Follow up of observations from the Discharge authority ................................................................ 59 Environment management ....................................................................................................... 60 Assessment by management .................................................................................................... 61

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

........................................................................................................................... 62 Effectiveness of internal control system ...................................................................................... 62 Conclusions of assessment internal control systems ..................................................................... 67 Statement of the manager in charge of risk management and internal control ................................. 69

PART IV. MANAGEMENT ASSURANCE ........................................................................ 70 Review of the elements supporting assurance ............................................................................. 70 Reservations .......................................................................................................................... 70

PART V. DECLARATION OF ASSURANCE .................................................................... 71 Declaration of assurance by the Authorising Officer ...................................................................... 71

APPENDICES ............................................................................................................. 72 Appendix I - Key indicators ...................................................................................................... 73 Appendix II - Budget implementation reports and statistics on financial management ....................... 74 Appendix III – Organisational chart ........................................................................................... 84 Appendix IV - Establishment plan and additional information on human resources management ......... 85 Appendix V – Human and financial resources by activity ............................................................... 90 Appendix VI – Contribution, grant and service-level agreements .................................................... 91 Annex VII - Environment management....................................................................................... 92

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Annual Report 2023

List of acronyms

Acronym Description

AD Administrator

APCRA Accelerating the Pace of Chemical Risk Assessment

ARN Assessment of regulatory needs

ASO Accredited Stakeholder Organisation

AST Assistant

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

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

CCH Compliance check

CCS Chemicals Strategy for Sustainability of the Commission

CEFIC Conseil Européen des Fédérations de l'Industrie Chimique

CEOS Conditions of Employment of

Other Servants of the European Union

Chesar Chemical Safety Assessment and

Reporting tool

CLH Harmonised classification and labelling

CLP Classification, labelling and

packaging (and the respective Regulation)

CMD Carcinogens and Mutagens

Directive 2004/37/EC

CMR Carcinogenic, mutagenic or toxic to reproduction

CoIAC Conflict of Interest Advisory Committee

COM European Commission

CoRAP Community rolling action plan

CSA Chemical safety assessment

CSR Chemical safety report

CSS Chemicals Strategy for

Sustainability of the Commission

DEC Discharge procedure

Acronym Description

2021/2157(DEC)

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

and Innovation

DNA Designated national authorities

DNEL Derived no-effect level

DPP Digital Product Passports

DU Downstream user

DWD Drinking Water Directive

EAP Environmental Action Programme

EC European Commission

ECA European Court of Auditors

ECETOC TRA European Centre for

Ecotoxicology and Toxicology of Chemicals Targeted Risk Assessment

ECHA European Chemicals Agency

eChemPortal OECD Global Portal to Information on Chemical Substances

ED Endocrine disruptor

EEA European Economic Area

EFSA European Food Safety Authority

EFTA European Free Trade Association

EMA European Medicines Agency

EMAS EU Eco-Management and Audit

Scheme

EMCDDA European Monitoring Centre for Drugs and Drug Addiction

EMS Environmental management system

US EPA United States Environmental Protection Agency

ERR Exposure-risk relationship

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Annual Report 2023

Acronym Description

ES Exposure scenario

EU European Union

EUCLEF European Chemicals Legislation

Finder

EUON European Union Observatory for Nanomaterials

EUSES European Union System for Evaluation of Substances

Forum Forum for Exchange of

Information on Enforcement

FRA Final regulatory action

FTE Full-time equivalent

FWC Framework contract

GIME Groupe Interinstitutionnel de Management Environnemental (Interinstitutional Group for

Environmental Management)

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

IR Information requirements

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

MFF Multiannual Financial Framework

MISA Metals and Inorganics Sectoral

Approach

Acronym Description

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

NONS Notification of New Substances

Odyssey ECHA’s tool to support evaluation tasks

OECD Organisation for Economic Co- operation and Development

OEL Occupational exposure limit

OSH Occupational safety and health

PACT Public activities coordination tool

PAH Polycyclic aromatic hydrocarbons

PARC Partnership for the Assessment of Risks of Chemicals

PBT Persistent, bioaccumulative and toxic

PCN Poison Centre Notifications

PFAS Per- and polyfluoroalkyl substances

PFCA Perfluorocarboxylic acids

PFOS Perfluorooctanesulfonic acid

PIC Rotterdam Convention on the

prior informed consent procedure (and the respective Regulation)

PMT Persistent, mobile and toxic

POP Persistent organic pollutants

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

PVC Polyvinyl chloride

QSAR Quantitative Structure-Activity Relationship

R4BP Register for Biocidal Products

RAC Committee for Risk Assessment

REACH Registration, evaluation,

authorisation and restriction of

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Annual Report 2023

Acronym Description

chemicals (and the respective Regulation)

REACH-IT Central IT system providing

support for REACH

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

project)

DG RTD Directorate-General for Research and Innovation

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

SLA Service Level Agreement

SME Small and medium-sized

enterprises

SNE Seconded national expert

SON Security Officers Network

SPC Summary of product

characteristics

SVHC Substance of very high concern

TA Temporary agent

TP Testing proposal

Acronym Description

UNEP United Nations Environment Programme

UNGHS United Nations Globally

Harmonised System of classification and labelling of chemicals

UVCB Substance of Unknown or Variable composition, Complex reaction products or Biological

materials

vPvB Very persistent and very bioaccumulative

WFD Waste Framework Directive

WP Work programme

1S1A One substance one assessment

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Annual Report 2023

Management Board analysis and

assessment

The Management Board welcomes the Annual Report 2023, combining the reports prepared

according to 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 2023, the performance of the Agency against the expected inputs, outputs, outcomes, and the impacts defined in the Programming Document 2023-20263. 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

We consider that the performance and quality of the outputs in 2023 were high, as shown in

Part I of the Annual Report.

In assessing4 the Consolidated Annual Activity Report of the Authorising Officer for 2023, we:

• Emphasize the importance of the ECHA Strategy adopted in December 2023, in providing

direction and priorities for ECHA in implementing its evolving mandate.

• Commend the secretariat and all ECHA bodies for being prepared for and having started

to implement new or expanded legal mandates.

• Welcome that ECHA made progress with the Integrated Regulatory Strategy, including

identification of (groups of) substances that are candidates for regulatory risk management measures, addressed the key actions from the Joint Evaluation Action Plan

and started the review of its outcomes.

• Acknowledge the significant support provided to the European Commission in the

implementation of the Chemicals Strategy for Sustainability (CSS).

• Express concern regarding the membership of the ECHA scientific Committees, which

poses a risk of not meeting legal deadlines and targets in operational areas that are

dependent on the Committees outputs.

• Acknowledge and support the efforts of all contributors in facilitating the preparation of

the RAC/SEAC opinion on the Annex XV report for the UPFAS restriction, given its unique

complexity and size.

• Acknowledge that the number of opinions that the Biocidal Products Committee (BPC) was in a position to deliver in 2023 was well below estimated numbers due to significantly

less submissions by the Member States of evaluation dossiers both for active substances

and Union authorisations.

1 Article 78(a) of the REACH Regulation. 2 Article 48 of ECHA’s Financial Regulation. 3 https://echa.europa.eu/documents/10162/17623970/final_mb_41_2022_echa_pd_2023-2026_en.pdf 4 Assessment pursuant to Article 48(1) of the Agency’s Financial Regulation.

9

Annual Report 2023

• Acknowledge the efforts in promoting alternatives to animal testing, and in clarifying the

opportunities and challenges in moving away from animal testing for the regulatory

assessment of chemicals.

• Welcome the increased clarity in the way the secretariat reports to the Management

Board.

• Note that ECHA defined 179 specific outputs for 2023 and accomplished 154 out of these

during the year. In addition, 23 actions are in progress and 2 not done.

Based on the periodical reporting and the Annual Report 2023 prepared by the secretariat, the

Board makes the following observations:

Management

• The 10 recommendations the Management Board provided for 2023 as part of the

assessment of the 2022 Annual Report have been implemented or are in progress.

Budgetary and financial management

• We welcome the outstanding performance of ECHA in implementing its budget with 99%

of commitment rate and 1% of cancelled payment appropriation rate, 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 and the strong focus on staff wellbeing, diversity and inclusion.

Audit and retrospective evaluation results and follow-up on recommendations

• We received adequate information from, and assurance 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 European Court of Auditors adopted a positive opinion regarding the 2022 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 2021 budget, including the decision on the closure of the

2021 accounts. The secretariat duly provided replies to the Discharge Authority’s

observations and the implementation of the recommendations is on track.

• The Internal Audit Service (IAS) of the Commission conducted an audit on ‘Budget

preparation, monitoring and reporting’. The audit did not result in any critical or very important recommendations. The audit identified two improvement areas, classified as

important, on resource allocation and the exceptions register.

Internal control framework and Integrated Management System

• The internal control framework remains effective and functioning as intended. Areas

identified for improvement are not considered major or critical and relate to areas such

as performance management and stakeholder engagement.

• We welcome that the Integrated Management System Strategy and Framework was

revised in 2023, to align it with the new ECHA Strategy 2024-2028.

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Annual Report 2023

• ECHA’s ISO 9001:2015 and 14001:2015 quality certificates were renewed with no non-

conformities found in the re-certification audit, and EMAS (Eco-Management and Audit

Scheme) registration maintained.

Organisational risk management

• We welcome the development of the new organisational Risk Management Policy, which

includes a dedicated role for a Chief Risk Officer. 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 that no high impact IT/cyber security incidents took place in 2023 and that

ECHA is ready to implement the new EU regulation on cybersecurity for Union Institutions,

Bodies, Offices and Agencies.

Management Assurance

The 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.

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

Recommendations for the secretariat for 2024

Based on our assessment, the Management Board requests particular emphasis in 2024 on the following actions, without prejudice to the implementation of the Single Programming Document

2024-2026:

1. Actively continue engaging with Member State partners and stakeholders.

2. Take appropriate actions to maintain the ECHA Committees' ability to deliver transparent,

independent and high-quality outputs, including attention on ensuring the necessary level

of competence, expertise and working structures.

3. Follow up on the results of the Integrated Regulatory Strategy (IRS), including promoting and facilitating the uptake of regulatory measures by Member States and further refining

the performance indicators and targets for grouping.

4. Maintain efforts to bring to the Management Board timely and sufficient information on

the implementation of current and potential new tasks, including impacts, synergies,

efficiency gains, challenges and risks, including the sustainability of ECHA's Committees.

5. Support the preparation of the RAC/SEAC opinion on the UPFAS dossier to ensure the

delivery of a transparent, independent and high-quality opinion in an appropriate

timeframe.

6. Support the implementation of the new hazard classes in the CLP regulation.

7. Improve and facilitate cooperation with other Agencies and Commission Directorates

General to promote issues of common interest.

8. Maintain efforts in providing fit-for-purpose support to Member State Competent

Authorities for biocidal products, with a view to achieving progress with the Review

Programme for existing active substances.

9. Review the costing of ECHA activities and assess whether the services delivered to duty

11

Annual Report 2023

holders are fully charged.

10. Maintain strong focus on staff wellbeing, diversity and inclusion.

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 2023.

Conclusion

In assessing the Annual Report 2023, the Management Board concludes that the overall

performance of ECHA is in line with the objectives included in the Agency’s Programming

Document 2023-2026.

Based on the above observations, the Management Board requests that the Annual Report 2023 be forwarded to the Member States, the Court of Auditors, the Commission, the European

Parliament, the European Economic and Social Committee and the Council.

12

Annual Report 2023

Foreword

Dr Sharon McGuinness

Executive Director

I am pleased to present the Agency’s annual report for

2023. This is the final report under ECHA’s Strategic Plan 2019-2023, and it shows that we have delivered the

actions and performance metrics set out in our Work

Programme for 2023.

We continued to deliver our legal mandate across the wide

range of chemical legislation under our remit. With respect to the REACH and CLP Regulations, our two scientific

committees (Risk Assessment Committee and Socio- Economic Analysis Committee) delivered six opinions on

restriction dossiers, 58 opinions on uses of substances in authorisation applications and 42 opinions on proposals for

harmonised classification and labelling. The Biocidal Products Committee (BPC) adopted 13 opinions for active

substance approvals and renewals as well as 10 opinions

on Union authorisations.

We continued the prioritisation of efforts on promoting

alternatives to animal testing and held a collaborative workshop with all stakeholders to discuss how collectively

we can work to promote and move to using alternatives to

animal testing.

Support and input to the Commission on the Chemicals Strategy for Sustainability (CSS) was high on our agenda

for 2023. We actively supported the decision-making

process for the revised CLP Regulation and have already commenced work in preparation for its implementation.

We also worked closely with the Commission to assist them in their considerations for the revision of the REACH

Regulation and the Basic Regulation. While the anticipated publication of the REACH revision did not materialise as

expected in 2023, we remain ready to support the Commission’s proposal for a future revision. We also

continue to support the Commission in relation to their

work on the various legislative packages under One Substance, One Assessment as well as the Basic

Regulation. This year also saw us commence work on implementation of the new regulatory tasks given to the

Agency under the Drinking Water Directive, the Batteries Regulation, and the Serious Cross-Border Threats to

Health Regulation.

While we have delivered on our mandate and Work

Programme obligations, we also recognise that some

issues continue to challenge. For instance, a recurring challenge was the low number of draft assessment reports

for biocidal active substances and this year also a lower number of Union authorisation applications for biocidal

products evaluated and submitted by Member States.

Another area of challenge is the ability to fully resource

and sustain membership in our scientific committees. This poses a risk of not meeting legal deadlines and targets in

operational areas that are dependent on input by

Committee members. We recognise that Member States

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Annual Report 2023

are finding it increasingly difficult to find experts with the

right competencies and who can commit to the ever- increasing workload. Together with the Commission and

the Management Board, we have looked at ways to encourage and increase membership and participation.

One first step was to review the current payments for

member’s rapporteur work together with the Management Board. Over the course of 2023, we emphasised the

importance of a Basic Regulation for ECHA to enable us, and our committees deliver on existing and future tasks,

and we hope that such a regulation will be forthcoming in

the near term.

As this was my first full year as Executive Director, I spent time getting to meet ECHA’s staff, partners and

stakeholders. These included colleagues in the

Commission, the EU Agencies, Member States, industry stakeholder groups and civil society organisations. As an

Agency, we rely on close engagement and collaboration with these groups in our delivery of our legal mandate. I

look forward to continuing my visits to the remaining Member States in 2024 as their current and future

collaboration with ECHA is key for successful delivery of

existing and future tasks.

While 2023 was the final year of our Strategic Plan 2019-

2023, it was also the year that our Management Board adopted our new Strategy Statement 2024-2028. I would

like to thank the members of the Management Board and all ECHA’s staff for their support and active participation in

the development of this new strategy. I look forward to working with them and our stakeholders in the coming

period to implement our vision of chemical safety through

science, collaboration, and knowledge.

Finally, I would like to express my thanks to the

Management Board for their support and collaboration as I settled into my first year. 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

2023 Work Programme.

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Annual Report 2023

Executive summary

With 2023 the last year of our strategic plan 2019-2023, we concluded the delivery of our strategic objectives and performed the planned activities specified in our Work Programme. This

year also saw us commence work on implementation of the new regulatory tasks assigned to

the Agency under the Drinking Water Directive, the Batteries Regulation and the Serious Cross- Border Threats to Health Regulation. We also continued to deliver our legal mandate across the

wide range of chemical legislation under our remit.

Two key deliverables under our strategic plan were the Integrated Regulatory Strategy (IRS)

and the Joint Evaluation Action Plan (JEAP) and these are relevant to both the REACH and CLP regulations. Identification and prioritisation of substances and groups of substances for risk

management actions is central to our Integrated Regulatory Strategy. In 2023, we made further strides in understanding the data on substances in our database with some 92% of substances

registered above 100 tonnes now assessed.

Another important aspect of the IRS is to identify substances or groups of substances for which generation of data under dossier or substance evaluation may be needed. These substances are

considered under the JEAP, which sets targets for checking the compliance of registration dossiers. In 2023, we performed 301 compliance checks under dossier evaluation. With the

conclusion of our strategic plan in 2023, reviews of both the IRS and JEAP took place, the outcomes of which will be used to determine the next steps for implementation of our new

strategic goals and priorities.

In substance evaluation, the Community rolling action plan (CoRAP) update for 2023-2025 was

agreed by the Member State Committee (MSC) and published with 24 substances for evaluation

by 12 Member States. Conclusions were also reached for 26 substances while 6 substance evaluation decisions were issued requesting data to address concerns regarding endocrine

disruption, PBT/vPvB, and mutagenicity.

Risk management actions under REACH and CLP in 2023 included the delivery of six opinions on

restrictions dossiers as well as 42 opinions on proposals for harmonised classification and labelling. These opinions were delivered by the Committee for Risk Assessment (RAC) and the

Committee for Socio-Economic Analysis (SEAC).

One of the restriction opinions covered the use of PFAS in firefighting foams. Early in 2023, we

also received the restriction dossier on per- and polyfluoroalkyl substances (PFAS) by the five

Member States (Germany, the Netherlands, Sweden, Denmark and Norway), and by year end had concluded the initial public consultation and screening of the more than 5600 comments

received. We will continue to progress this dossier through the RAC and SEAC in the course of 2024. We also received a mandate from the European Commission to prepare a restriction

dossier by 2024 for chromium (VI) substances, which are covered in the growing number of authorisation applications currently being received. ECHA also completed several investigative

and screening reports, including reports on Polyvinyl chloride (PVC) and additives and on

substances that are carcinogenic, mutagenic or toxic to reproduction (CMRs) in childcare articles.

Other risk management actions taken in 2023 were the addition of a further 11 substances to

the Candidate List for Authorisation, bringing the total number of substances of very high concern entries to 235. We also submitted eight substances under the 11th Recommendation for

inclusion of substances to the Authorisation List to the European Commission. We saw an increase in the number of authorisation applications mainly for the use of chromium (VI)

substances. The total numbers of applications and review reports received was 100 and our scientific committees RAC and SEAC delivered opinions on applications for authorisation of 58

uses of substances.

15

Annual Report 2023

In 2023, we processed 13 749 registration dossiers and completed 416 SME company size

verifications. Our Helpdesk answered 9200 questions, while the combined total of queries answered by Member State and European Economic Area country helpdesks was approximately

45000. While we continued to receive many questions on registration, we also saw queries on PFAS, authorisation of chromates and were seeing queries on the new legislative tasks that the

Agency has been assigned. In furtherance of public availability of data, we devoted significant

time to the development of our new data dissemination platform, ECHA Chem, which is scheduled to be launched in 2024. This work is the start of efforts in transforming the way we

provide and make data available.

The Biocidal Products Committee (BPC) adopted 13 opinions for active substance approval and

renewal, while for Union authorisations, 10 opinions were adopted in 2023. We continue to observe that estimates from Member States on submission of active substance dossiers are not

met and nor are estimates of applications for Union authorisation. This is a worrying trend and requires renewed efforts by Member States to meet their ongoing regulatory obligations. We

were pleased to have delivered the pollinators guidance and make progress in the move to use

IUCLID for biocides dossiers.

We continued the prioritisation of efforts on promoting alternatives to animal testing in the year.

We held a collaborative workshop with all stakeholders to discuss how collectively we can work to promote and move to using alternatives to animal testing. We published our fifth report on

the use of alternatives to testing on animals for the REACH Regulation and highlighted the opportunities and challenges in moving away from animal testing for the regulatory assessment

of chemicals.

We processed 10857 notifications under the Prior Informed Consent Regulation (PIC) with many

of these related to the inclusion of benzene as the first substance in substance entry. In 2023,

we published the three-years report on the operation of the PIC Regulation (Article 22 report) and provided the recommendations made in the report to the Commission’s evaluation of the

PIC Regulation. A key recommendation was the need to review the extent of which information is made publicly available in any future legislation as access to document (ATD) requests are

increasing in relation to PIC.

In addition to the above regulatory areas, we continued to deliver on specific tasks in relation to

environmental legislation or service level agreements with the Commission. For instance, we prepared a draft scientific dossier (Annex D proposal) for three substances in support of the

Commission implementation of the Stockholm Convention. We continued to provide support

under the Industrial Emissions Directive (IED) and followed closely the decision making for the revision of this legislation as it will formalise ECHA’s role in this support work. We also delivered

five opinions from the RAC on Occupational Exposure Limits (OELs) in fulfilment of our support to the Commission’s Directorate General for Employment, Social Affairs and Inclusion (DG

EMPL). We concluded a new contribution agreement for the period 2023-2026 with the

Commission to continue providing support and training to pre-accessing countries.

Support and input to the Commission on the Chemicals Strategy for Sustainability (CSS) remained a high priority for us in 2023. We supported the Commission before and during the

decision making on the revised CLP Regulation and have already commenced work in preparation

for its implementation. We worked together with the European Environment Agency (EEA) under the 8th Environmental Action Programme (EAP), in establishing a new framework of indicators

aimed at monitoring the drivers and impacts of chemical pollution and assessing the

effectiveness of the chemical legislation. This framework will be published in 2024.

As noted already, we commenced work on the implementation of the new legislative tasks related to Drinking Water, Batteries and Serious Cross-Border Threats to Health. We supported

the Commission in developing the implementing and delegated acts necessary for the operation of the Drinking Water Directive (DWD). As tasks under the DWD will eventually come under the

RAC work area, we have already established a Working Group under RAC to commence

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Annual Report 2023

preparations for this new task by the committee. Our implementation planning for the tasks

under the Batteries Regulation got underway with the publication of the legislation in August

2023. First tasks are expected to be delivered in 2025.

Significant levels of support and advice were provided to the Commission services to assist them in their considerations for the revision of the REACH Regulation and the ECHA Basic Regulation.

While the anticipated publication of the REACH revision did not materialise as expected in 2023,

we are ready to continue to support the Commission on a future revision.

The Commission’s one substance, one assessment (1S1A) approach under the CSS was also an

area where ECHA provided significant levels of input and advice. We were pleased to see that the legislative package to support 1S1A was published by year end. This package covered not

only reattribution of tasks to ECHA but also a data regulation establishing a common EU data platform. We look forward to working with the Commission and decision makers in 2024 to

progress this legislation.

As an agency that relies on science to develop our opinions and decisions, we worked closely

with the research community to ensure that regulatory science needs are communicated and

understood. In this regard, we continued to engage with the Partnership for the Assessment of Risks from Chemicals (PARC), an EU-wide research and innovation programme focused on

developing next-generation chemical risk assessment to protect health and the environment. A key achievement for ECHA in 2023 was the publication of a report, Key Areas of Regulatory

Challenge, which clearly set out areas where the research community could direct future

research efforts.

Engagement and collaboration with stakeholders are fundamental to how we work. We continued to collaborate closely with EU agencies, particularly those with an environmental and health

focus. Our close collaboration with the European Food Safety Authority (EFSA), to assess the

safety of substances and develop consistent views across regulatory frameworks, including for areas such as biocides and pesticides, remained a focus in 2023. We have, as mentioned, worked

closely with the European Environment Agency (EEA) to build a joint framework of indicators that will help to track the progress and impact of the CSS implementation and chemicals

legislation.

We received increased requests in 2023 to join our Accredited Stakeholder Organisation (ASO)

list. We expect increased stakeholder requests to the ASO list to continue especially with our wider our legal mandate, which will bring in many new stakeholders who may not have previously

worked with us. We developed a new stakeholder engagement approach, which together with

our new communications strategy for 2024-2028 will enable us to continue to build strong

engagement and communication channels and networks.

One of the key stakeholder groups for ECHA is our Member State colleagues, whom we work closely with daily in many different fora, for example, through our Management Board, our

scientific committees, our Forum on Enforcement, Member State Communications Network, HelpNet and expert working groups. In 2023, we renewed our engagements directly with the

Member States through visits to Member States so that we heard first-hand the views and requests of national authorities. Member States’ full and active participation in all our committees

is essential for delivery of opinions and decisions. Throughout the year, we kept a focus on

facilitating sufficient nominations to the RAC and SEAC as well as ensuring that we can keep the members already involved. In these efforts, our Management Board and Commission colleagues

engaged closely with us.

We are pleased to report that our legal, governance and management obligations for 2023 were

all met. Our financial and HR key performance indicators were met and exceeded in many instances. We had no significant findings in any financial or other audits completed. We

maintained our International Organisation for Standardisation (ISO) 9001:2015; 14001:2015 and EU Eco-Management and Audit Scheme (EMAS) certifications. We also successfully

17

Annual Report 2023

organised meeting services for 640 events and official meetings, hosted 5000 visitors in person

and 32,800 online. We continued to work to reduce CO2 emissions and in 2023 remained in line

with our targets.

Our Management Board led the successful development of our new Strategy Statement for 2024- 2028. This Statement was developed in close collaboration with our staff as well as Member

States, Commission and stakeholders and we look forward to implementing it over the coming

years.

While the year saw many deliverables and achievements, we also wish to note a number of areas

that continue to challenge.

A major challenge again this year was the low number of draft assessment reports for biocidal

active substances submitted by Member States. This is detrimental to completing the evaluation of all existing active substances in the Review Programme by the end of 2024 as required by the

Biocidal Products Regulation. While ECHA has and will continue to make efforts to support the Member States to make further progress, the reality is that Member States are not prioritising

this work and many lack the capacity or resources to deliver in the near future.

Our scientific committees are a key component in delivering transparent, independent and high- quality opinions, and decisions. These committees rely heavily on the participation, commitment,

and expertise of members from the Member States. Keeping current members in the RAC and SEAC active and engaged was an ongoing effort in 2023. One aspect to ensure committee

sustainability was to review the current payments for member’s rapporteur work together with the Management Board. We hope these measures will encourage uptake across the members in

the future. Notwithstanding these efforts, the number of members in the RAC and SEAC is falling as Member States find it harder to find nominees with the relevant experience and competence.

This poses a risk of not meeting legal deadlines and targets in operational areas that are

dependent on input by Committee members. In 2023, we worked closely with the Commission on how we can ensure a sustainable future for the committees, especially considering new tasks

that have already been assigned or could be assigned because of published legislative proposals. The future ECHA Basic Regulation is an important means to achieve long term sustainability and

competence for our scientific committees and ECHA has and will continue to emphasise that this

Regulation is needed as soon as possible.

Another challenge is posed by the high number of authorisation applications significantly exceeding our capacity to deliver opinions. ECHA is closely monitoring the incoming applications

and planning and phasing the opinion making. The European Commission has requested ECHA

to prepare a restriction on chromium VI substances that may in time lead to a more efficient and timely management of the risks of these substances, while maintaining a level playing field for

the operations in the industrial sectors involved.

In 2023, we commenced implementation of new legislation and new tasks. These efforts will

continue over the coming years and will increase as proposals coming through the co-decision process will be finalised. Balancing implementation of new requirements while continuing to

deliver a full regulatory programme will be a key area of focus in the coming period. ECHA’s staff are fully committed to implementing these new tasks and we will be looking to work in close

collaboration with our EU institutional partners, the Member States and other stakeholders to

support us in delivering what is required.

With the publication of the ‘one substance one assessment’ legislative package at the end of

2023, we now can see the extent of the work required by all agencies to align their opinions and decisions across different scientific committees. We also welcome the introduction of new hazard

classifications in the CLP Regulation, which will help further alignment. However, the achievement of full alignment may continue to be a challenge in the absence of changes in other

legislation.

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Annual Report 2023

As our Strategic Plan 2019-2023 is concluded, we are reviewing some of the initiatives that

supported its delivery, for example, the IRS and JEAP. These reviews have commenced in 2023. We need to determine how best to use the data in our databases to ensure that the appropriate

risk management action is taken by the relevant parties, be that harmonised classification, authorisation or restriction. However, we also need to consider how we integrate additional risk

management actions coming from new legislation into our thinking. Furthermore, while ECHA

can analyse and provide information to the Commission and Member States, we do not have the legal basis to take action directly ourselves. Therefore, we need to have closer cooperation and

engagement with the Commission and Member States to align on identification and prioritisation on appropriate risk management actions. The new Strategy Statement 2024-2028 identifies this

as a priority, and we look forward to collaborating with all parties in this regard.

Further details on achievements and metrics are available in the following sections.

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Annual Report 2023

Part I. Achievements of the year

Dossier preparation

Highlights

In 2023, we continued to provide companies with the tools and support they need to successfully

register and update their registration information. We successfully managed the inquiry process

and took decisions on the data sharing requests. We updated the International Uniform Chemical Information Database (IUCLID) to incorporate new regulatory requirements at EU or

international level. We contributed to development of the Organisation for Economic Co- operation and Development (OECD) test guideline programmes in key areas by actively

participating in the expert group meetings and consultations.

We continued development of the Chemical Safety Assessment and Reporting tool (Chesar) to

support both REACH and Biocides. The platform will fully integrate the European Union System for Evaluation of Substances (EUSES) models for environmental assessment, as well as the

European Centre for Ecotoxicology and Toxicology of Chemicals' Targeted Risk Assessment

(ECETOC TRA) models for workers and consumers. It will help companies to perform their chemical safety assessments and generate chemical safety reports under REACH. For biocides,

it will enable users to carry out environmental risks assessments for active substances and biocidal products. Integration of models for risk assessment in the platform brought a few

technical challenges which lead to delays and prevented from launching in 2023 as originally

planned.

The ECHA helpdesk answered 9200 questions in 2023. Intensive cooperation with the national helpdesks continued and they replied to 45000 questions, with a growing number of questions

outside the original regulations in scope REACH, CLP and BPR. Most questions were on dossier

preparation, the per- and polyfluoroalkyl substances (PFAS) restriction and chromates authorisation. The network of national helpdesks (HelpNet) held 26 meetings including dedicated

workshops on REACH and CLP, approving four new or revised FAQs.

Two campaigns to address companies that were not in compliance with the update obligations

for their registration dossiers were concluded during the year: one on compliance with harmonised classifications and one on compliance with authorisation obligations for substances

in Annex XIV.

Main outputs

O1 Companies are supported in inquiries and in sharing their data across the EU, helping to

reduce registration costs and to avoid unnecessary testing.

Inquiries and disputes on data sharing are handled. Yes

O2 Harmonised IT tools and advice ensure consistency of risk management and safety information, thus promoting exchange across and between industry and regulatory

authorities.

ECHA continues to lead the development of IUCLID and its promotion as the

international harmonised format for chemical data. Yes

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Annual Report 2023

IUCLID is progressively maintained to incorporate regulatory requirements,

such as changes resulting from the amendment of REACH Annexes, other technical and scientific progress under REACH and CLP, or requirements from

our OECD international partners.

Yes

ECHA contributes to the development of the OECD harmonised test guidelines

relevant for the EU information requirements. Yes

The unified CHESAR-EUSES platform is released, facilitating improved

exposure assessments for both REACH and BPR. On-going

Questions are timely and effectively answered; a number of topics are

discussed and agreed among all national helpdesks for harmonised advice. Yes

In support of the Commission implementing regulation on registration updates, a second campaign in collaboration with the national enforcement authorities

is organised on cases of potential breach of the update obligation.

Yes

Indicators Estimate Actual

O1 Effective working time for processing inquiries 0.3 person day 0.3 person day

Inquiries received and concluded 4 200 4 835

Dossier submission and processing

Highlights

In 2023, ECHA processed 13 749 registration dossiers with 5 883 invoices generated.

Completeness check was performed on all dossiers, with around 30 % of these checks completed with the manual verification, a similar number compared to 2022. The completeness check rules

were updated to address the revised REACH Annex VI-XI information requirements under the Commission-ECHA Joint Action Plan. ECHA put in place support actions and no major deviations

were found in terms of incomplete submissions.

Over 400 companies submitted as SMEs went through the company size verification process to ensure that they were rightly benefitting from reduced fees. We provided advice to the

Commission to support a review of this process into an ex-ante approach. The time between

submission and SME verification continued to reduce this year.

The invalidation of registrations continued tackling non-existing companies, or companies

subject to restrictive measures due to the war in Ukraine.

ECHA’s submission systems’ vision for the future was developed and the work towards a single Industry portal was kicked off including the setup of a user group for discussions with companies

and information sessions for authorities.

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Annual Report 2023

Main outputs

O1 Access to market for duty holders continues to be fast and predictable and data comes

in a way that supports subsequent regulatory work.

The flow of registration dossiers (initial and updates) is processed; completeness checks are performed, including manual verifications, invoices are issued, and

confidentiality requests are assessed. Clear and timely feedback is provided to

companies on how to successfully complete their submissions.

Yes

ECHA verifies the size of companies that registered in 2018 and previous

deadlines and continues the initiation and verification of the size of SME companies which registered after the last registration deadline; the time gap

of ca. 4.5 years between submission and beginning of the verification

continues to be reduced.

Yes

Tools and processes for invalidation of registrations are further developed for

different circumstances, such as the implementation of EU sanctions. Yes

PPORD notifications are processed and indications for innovation and new

kind of substances are monitored. Yes

As part of the development of a registration obligation for certain polymers,

ECHA supports the Commission in the development of a registration process, including a notification step, and the following regulatory activities, and starts

preparations for the necessary changes in relevant IT tools.

Yes

O2 Submission activities are built in a streamlined way to facilitate their long-term

functioning.

Develop a vision paper for the future of ECHA’s submission systems and

commence implementation. Yes

Indicators Estimate Actual

O1 Number of PPORD notifications received 340 235

Number of C&L notifications received 33 000 43 933

Number of Registration dossiers received (incl.

updates) 16 000 13 749

Number of SME companies verified for their status 400 416

Effective working time for processing a registration

dossier (first submission)

0.50 – 0.60

person days

0.45 person

days

Registrations stopped for manual verification at

technical completeness check 5 900 4 721

Number of registrations failing first technical

completeness check 1 600 1 035

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Annual Report 2023

Identification and prioritisation

Highlights

In 2023, we continued screening structurally similar substances individually or in groups. We screened 61 groups rather than the initially estimated 70 groups. However, the actual number of substances

screened is higher than initially planned. Overall, we screened around 1380 substances and identified

that 320 may eventually be or are already considered for risk management actions; around 280 require data generation to confirm the suspected hazard; and about 540 substances do not need further

regulatory risk management as they are considered low hazard, have low exposure potential or there

are already sufficient risk management measures in place.

By the end of 2023, we assessed 92 % of substances registered above 100 tonnes; less than

400 high-tonnage substances remained to be assessed.

We continued to publish the reports on the assessment of regulatory needs (ARN) for groups of

substances, providing transparency to our work and supporting the work of our stakeholders.

We liaised with our industry stakeholders to provide further clarity on the content and scope of

the ARN reports, including holding a well-attended webinar. To improve clarity, we updated the

template and format of the reports based on the feedback received.

An internal review of our integrated regulatory strategy was initiated which will feed into a

workshop with our stakeholders in spring 2024.

Main outputs

O1 ECHA, Member States and Commission services can perform risk management processes

and evaluation activities related to hazardous chemicals more effectively and efficiently, based on grouping of chemicals and their assessments and supported by ECHA’s

expertise and tools.

Complete the assessment for 70 new groups of chemicals to support the needs of the main regulatory processes (evaluation, restrictions,

authorisations and harmonised classification).

Yes

Support the annual update of the restriction roadmap based on the outcomes

of the group assessments results. Yes

Publish the annual report on the implementation of the Integrated Regulatory

Strategy. Yes

Prepare the publication of the assessments of regulatory needs for groups of

substances. Yes

Update information through Chemical Universe engine to show the progress

with assessing groups of substances. Yes

Indicators Estimate Actual

O1 Number of substances registered above 100 t/y in the unassigned region of the chemical universe for which a

conclusion on potential regulatory follow up was drawn

250 156

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Annual Report 2023

Number of groups of substances for which the

assessment of regulatory needs is carried out 70 61

Evaluation

Highlights

The REACH Evaluation Action Plan sets targets for checking the compliance of registration dossiers submitted to ECHA. A minimum of 20% of registrations for substances registered in

quantities of 100 tonnes or more per year need to be checked for compliance, with a similar

percentage for substances in tonnage bands less than 100 tonnes per year.

In 2023, ECHA carried out 301 full compliance checks and 104 testing proposal examinations, covering 367 unique substances. With these outputs we addressed the key actions from the Joint

Evaluation Action Plan (JEAP). ECHA has started a review of the outcomes of the JEAP, and the review will continue together with the Commission and stakeholders at the beginning of 2024

(originally planned for 2023).

Collaboration with the Member State competent authorities was effective and showed good alignment as only 9% of the draft decisions were discussed by the Member State Committee (following proposals

for amendment). Follow-up actions were conducted to verify that any updated information provided

in response to evaluation decisions addressed what was requested.

An analysis revealed that around 19 % of completed dossier evaluation cases were considered for further regulatory action (harmonised classification and labelling (CLH), endocrine disruptor

(ED), and persistent, bioaccumulative and toxic (PBT) assessment or substance evaluation). The most frequent outcome by far was the consideration of a CLH process, particularly for

reproductive toxicity concerns.

We also put greater focus on those decisions where there is a backlog in follow up and testing proposal evaluations. The increased focus on clearing this backlog will continue in the coming

years.

In substance evaluation, the Community rolling action plan (CoRAP) update for 2023-2025 was

published in March. The list was updated with 24 substances for evaluation by 12 Member States. A conclusion was reached for 26 substances. Some of the regulatory follow-up actions at EU

level included harmonised classification and labelling (20), identification as a substance of very high concern (10) and restriction (12). In 2023, 6 substance evaluation decisions were issued

requesting data to address concerns regarding endocrine disruption, PBT/vPvB, and

mutagenicity.

Main outputs

O1 Dossier evaluation is efficient, transparent and scientifically and legally robust.

Deliver the outputs in line with the objectives from the Joint Evaluation Action

Plan, including 300 compliance checks concluded as draft decision or no

action.

Yes

Organise - jointly with the Commission - a mid-term review of the achievements of the Joint Evaluation Action Plan (including screening,

grouping and evaluation of chemicals), considering the impact of changes

arising from the REACH and CLP reviews.

On-going

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Annual Report 2023

Examine testing proposals within the legal deadlines striving for zero

proposals that are not handled in time. On-going

The information submitted in response to ECHA evaluation decisions is

examined without delay and conclusions communicated to the Commission

and Member State competent authorities.

On-going

The national enforcement authorities are informed in case of non-compliance

with the decision and follow-up decisions are drafted where appropriate Yes

Report on the progress made in (both dossier and substance) evaluation as

part of the annual report on the Integrated Regulatory Strategy and publish annually the updated recommendations to registrants stemming from

evaluation.

Yes

Contribute to the Caracal sub-groups and other fora in support of the

Commission in their policy activities, in accordance with the REACH Evaluation

Joint Action Plan.

Yes

Support the Commission in CSS relevant activities. It includes the review of

the Evaluation title in REACH and the annexes on information requirements. Yes

Request targeted study audits in case a concern about compliance with

principles of good laboratory practice is identified by ECHA or a Member State. Yes

Publish the report on the scientific and technical review of the received

extended one-generation reproductive toxicity studies in collaboration with

the Member State Competent Authorities.

Yes

Provide regulatory advice to registrants and other interested parties on

information requirements and on dossier and substance evaluation processes. Yes

O2 For Substance Evaluation Member States are supported to conclude as fast as possible,

in a scientifically and legally robust manner, enabling the initiation of appropriate

regulatory risk management measures.

Propose updates of the CoRAP to the MSC with substances for which

substance evaluation is the most appropriate tool to generate further hazard

information.

Yes

Support Member States in achieving substance evaluation conclusions as fast as possible. Encourage that appropriate regulatory risk management

measures and initiatives are taken up by Member states.

Yes

Keep reducing the number of substance evaluation cases currently opened. Yes

Indicators Estimate Actual

O1 Compliance checks concluded: draft decisions or no

action

300 301

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Annual Report 2023

Final decisions on dossier evaluation (testing

proposals and compliance checks) 300 367

Number of substances for which a conclusion was

reached in the follow-up to dossier evaluation 200 202

O2 Substance evaluation final decisions issued 10 6

Number of substances for which a conclusion was

reached in substance evaluation

25 26

Authorisation

Highlights

In 2023 eleven substances were added to the Candidate List, bringing the total to 235 entries.

These substances were found to have either very persistent and very bio accumulative properties, or were shown to be persistent, mobile and toxic, or displayed negative effects on

reproduction. Other reasons for inclusion were the carcinogenic properties or endocrine

disrupting potential of these substances.

In 2023, we submitted to the European Commission the 11th recommendation for inclusion of

substances to the Authorisation List. It recommended to add eight substances, including lead. The inclusion of lead generated many comments from the stakeholders, related to the best

timing, its combination with other ongoing or planned regulatory activities as well as the expected workload for industry and authorities at the next stage. This recommendation brought

lead metal to the same regulatory stage as other lead compounds with similar uses already

recommended for inclusion to the Authorisation List.

The number of applications for authorisation increased, mainly for the use of hexavalent

chromium substances. In total we received just over one hundred applications and review reports for authorisation. The scientific committees, RAC and SEAC, delivered opinions on applications

for authorisation of 58 uses of substances. To manage the gap between applications received and opinions delivered, we monitored closely the incoming applications and planned and phased

the opinion making process. The European Commission requested ECHA to prepare a restriction dossier for chromium (VI) substances, to be delivered in 2024. In view of the widespread use of

these substances, this may lead to a more efficient and timely management of the risks of these substances, while maintaining a level playing field for the operations in the industrial sectors

involved.

We contributed to the Authorisation Taskforce that was set up in 2023 by the European Commission to discuss the operation and streamlining of the authorisation process under REACH,

also in view of the judgement of the European Court of Justice on the ‘Chemservice’ case.

Main outputs

O1 Substances of very high concern are properly controlled and progressively replaced by

suitable alternatives.

Identification of substances of very high concern and inclusion in the Candidate

List Yes

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Annual Report 2023

Prioritise the chemicals on the Candidate List and propose to the MSC the ones

to be included in the 11th Annex XIV recommendation to the Commission for

inclusion in the Authorisation List.

Yes

Provide web-based training to stakeholders on analysis of alternatives and

informed substitution of substances subject to regulatory risk management. Yes

O2 Opinions of the Committees for Risk Assessment (RAC) and Socio-Economic Analysis

(SEAC) on applications for authorisations are timely and fit-for purpose.

Develop and implement - jointly with the Commission - an agreed approach to deal with the anticipated significant increase in the number of authorisation

applications.

Yes

Hold workshops and network meetings to develop methodologies and to

enhance the capacity of Member States and companies to carry out analysis of alternatives and socio-economic analysis with view of finding viable

alternatives.

Yes

Indicators Estimate Actual

O1 Number of new entries in the Candidate List 15 11

Recommendation for inclusion of substances in the

authorisation list 1 1

Applications and review reports for authorisation

received (number of uses) 100-140 102

Number of downstream user notifications of

authorised uses of SVHCs 3 000 2 742

O2 Number of RAC and SEAC opinions adopted on

applications for authorisation (number of uses) 60 58

Effective working time of ECHA staff per opinion

38-46 person

days

39 person

days

Restrictions

Highlights

We continued to deliver high impact restrictions dossiers and investigation reports. In 2023, we

produced three restriction investigation reports and five screening reports (art.69.2) including reports on Polyvinyl chloride (PVC) and additives as well as on substances that are carcinogenic,

mutagenic or toxic to reproduction (CMRs) in childcare articles. Our scientific committees (RAC and SEAC) delivered six opinions on restrictions dossiers for regulatory decision making,

including opinions on medium-chained chlorinated paraffins (MCCPs) and on per- and polyfluoroalkyl substances (PFAS) in fire-fighting foams. Furthermore, we received the restriction

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Annual Report 2023

dossier on universal PFAS from five dossier submitter countries and handled the publication,

consultation and screened the 5,642 comments received in a record two months’ time to facilitate the further process. There were no Commission mandates received requiring delivery

of Annex XV reports in 2023.

Furthermore, we continued to contribute to the development of scientific methodologies for

regulatory assessments on the valuation of various health and environmental endpoints for

socio-economic analysis together with OECD countries.

The implementation plan for the new tasks allocated to the Agency by the EU Batteries

Regulation was developed this year and initial steps were taken to prepare for the first phase of

the study on relevant substances and the recruitment of staff.

Main outputs

O1 Support the Commission in the implementation of the Restrictions Roadmap by

developing timely fit-for-purpose restrictions dossiers.

Annex XV reports proposing restrictions developed for 2-3 substances from the

restriction roadmap at the request of the Commission per year (e.g., flame

retardants, ortho-phthalates).

No

The investigative reports requested by the Commission related to risks of PVC

and substances in PVC, CMR substances in childcare articles, and PAHs in rubber granules used on children’s playgrounds prepared according to the

deadlines agreed with the Commission.

Yes

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

O2 Opinions of the Committees for Risk Assessment (RAC) and Socio-Economic Analysis

(SEAC) on restrictions are timely and fit for purpose.

Deliver restriction opinions, including for the use of lead in outdoor shooting

and fishing, BPA+ in articles, chloroalkanes (C14-C17) and PFASs in firefighting

foams.

Yes

Develop methodologies related to socio-economic analysis to create a fit-for- purpose toolbox, including i.a., the valuation of various health and

environmental endpoints in OECD. The Commission’s Better Regulation

guidelines are taken into account.

Yes

O3 Opinions of the Committees for Risk Assessment (RAC) and Socio-Economic Analysis

(SEAC) on restrictions are timely and fit for purpose.

Batteries restrictions implementation plan Yes

Indicators Estimate Actual

O1 Restriction proposals or investigation/screening

reports developed

5 8

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Annual Report 2023

O2 Number of RAC and SEAC opinions on restriction

proposals

6 5

Effective working time of ECHA staff per opinion

(ECHA dossier)

220 – 330

person days

227 person

days

Effective working time of ECHA staff per opinion

(Member State dossier)

200 – 300

person days

193 person

days

Classification and labelling

Highlights

We supported the Commission in the review of the CLP Regulation. After its adoption, we started the update of the tools and CLP guidance. Proposals for harmonised classification of 45

substances were brought to the Risk Assessment Committee. We started to support the Member States to develop the dossier for proposed Harmonised Classification for two groups of

substances originated from the chemical universe screening.

As part of our new public chemicals database (see activity Data management and dissemination), we worked on a redesign of the Classification and labelling inventory that is expected to be

launched in autumn 2024. Our preparatory work in 2023 took into account the proposed changes

in the CLP regulation.

We received 4,748,401 Poison Centre Notifications (more than in 2022). The compliance deadline of 1 January 2024 for mixtures with industrial uses was met without major problems

for submitters with the appropriate support in place.

We supported the European Commission in the context of the United Nations Globally

Harmonised System of classification and labelling of chemicals (UN GHS) and in the

implementation of the United Nations Environment Programme (UNEP) project to pilot the

implementation of GHS in four African countries.

Main outputs

O1 Opinions of the Committee for Risk Assessment (RAC) are timely and fit-for purpose

Process incoming CLH dossiers, including industrial chemicals from the outcome of identification and prioritisation (based on the grouping approach)

while continuing to process a high number of PPP and Biocides dossiers resulting from the joint Commission, EFSA and ECHA efforts to encourage

timely submission of dossiers.

Yes

Undertake pilot projects with the relevant RAC subgroup for a number of identified groups of substances to improve the usability of grouping information

for the purpose of CLH proposals.

Yes

O2 Up-to-date information on the classifications for chemicals is publicly available in a user- friendly format, also for those substances for which no harmonisation at EU level has

taken place yet

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Annual Report 2023

As part of the creation of ECHA’s new public data availability system, design

and develop the new C&L Inventory, taking into account the changes in the

revised CLP regulation.

On-going

O3 Member States, Commission services and duty holders have the support they need to

fulfil their obligations, with a specific focus to ensure the readiness for the

implementation of the planned CLP 2.0

Closely monitor the progress of the legislative process and, according to the

expected entry in force, deliver an internal roadmap for the implementation of the planned legislative changes to the CLP Regulation including ECHA’s role in

the CLH process.

Yes

Start implementation of guidance updates, teams and systems for the entry in

force of the revised CLP processes. Yes

Provide scientific and technical support to the Commission in the context of the

further development of the United Nations Globally Harmonised System of

classification and labelling of chemicals (UNGHS), including:

o related to new hazard classes and criteria to fully address

environmental toxicity, persistency, mobility and bioaccumulation; and to introduce endocrine disruptors, persistent, mobile, toxic, very

persistent and very mobile substances as categories of substances of

very high concern.

o for the implementation of revisions 8, 9 and 10 of UNGHS. This

implementation should start in spring 2023 at the very latest.

o to the work of selected GHS working groups, notably the working group

on the use of non-animal testing methods for classification.

On-going

Provide scientific and technical support to the Commission in its

implementation of the Chemicals Strategy for Sustainability in the context of the revisions of the CLP regulation and to the UNEP-GHS project in African

countries.

Yes

O4 Structured, high quality and consistent information for the EU poison centre scheme is

timely available across Europe

Maintain the notification portal and system-to-system submission channel and

keep it aligned with IUCLID. Yes

Conclude the development of the searchable central database, to be used by

the national appointed bodies and Poison Centres, based on the Commission’s mandate and the feedback from national authorities on the use of the

database.

Yes

Continue the promotion of the PCN activities, in preparation for the next

compliance date of 1 January 2024 for mixtures with industrial uses. Yes

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Annual Report 2023

Indicators Estimate Actual

O1 Proposals for harmonised classification and labelling 60 45

Number of RAC opinions on proposals for

harmonised classification and labelling 50 42

Effective working time for processing RAC opinions Approx. 40-55

person days

37.4 person

days

O3 Decisions made on requests to use an alternative

chemical name (Art 24 CLP) 40 26

O4 Poison centre notifications received and made

available to Appointed Bodies and Poison Centres

2 million 4.4 million

Poison centre notifications viewed by national

authorities in the PCN central database

10 000 23 804

Safe and sustainable use of chemicals

Highlights

Our work on safe and sustainable use of chemicals focused on providing technical and scientific support and guidance to companies. We also continued developing tools to support chemical

safety assessment at company level (e.g., CHESAR) and ensured basic maintenance of industry-

developed use maps.

We also continued to support the European Commission in testing its framework for safe and sustainable by design, by providing a priority list of substances of very high concern which could

be considered as candidates for testing the framework.

Main outputs

O1 Registrants perform an effective chemical safety assessment, demonstrating (i) safe use

to the authorities via the registration and (ii) delivering safe use advice for inclusion in

the safety data sheets

Provide maintenance and ensure dissemination of tools developed to support

industry work. Yes

Support the Commission in developing case studies and testing the framework

and criteria for Safe and Sustainable by design. Yes

Indicators Estimate Actual

O1 N/A

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Annual Report 2023

Data management and dissemination

Highlights

During 2023, ECHA data services supported the Commission work on preparing several legislative packages including REACH and CLP review or the Directive 2004/37/EC on the

protection of workers from the risks related to exposure to CMR substances at work. We also

supported the Member States with data relevant for preparing their restrictions proposals. Tools that allow users to search, convert and manage their chemicals data in IUCLID format were

further developed and we supported our key stakeholders such as EFSA and Member States in

their use.

Data management has a central role in improving the consistency and integration of the EU regulatory system on chemicals. In 2023, we initiated a review of our data management

approach and established a Data Governance Office responsible for managing our regulatory

data. This work will further support regulatory data consistency, coherence and transparency.

During 2023, the first version of ECHA's new public chemicals database, ECHA CHEM, was

developed, leaving it ready for launch in January 2024. The development of this new public database involved extensive engagement with our stakeholders to ensure it would meet the user

needs. The new database has IUCLID as a central building block and is designed on a modular platform to ensure a stable and high-performing system that will enable efficient onboarding of

new datasets in the future, as well as a starting point for a future EU common data platform on

chemicals.

The OECD eChem portal was maintained and developed with new datasets coming from REACH

Registrations.

Main outputs

O1 The regulatory processes performed by ECHA, Member States and Commission are

efficiently supported and monitored.

Deliver a plan to consolidate data management and guarantee regulatory data

consistency, coherence, transparency and reporting. On-going

Deliver the necessary features to optimise the Interact Portal with due

consideration of process and users’ requirements. Yes

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

Tools to search, extract and analyse data in registration dossiers made

available to other authorities and industry. Yes

Develop tools and methodologies to convert legacy toxicity data to IUCLID

harmonised templates in collaboration with other Authorities and industry. Yes

O2 Data submitted to ECHA under different regulations is publicly available in user friendly

ways and progress of ECHA’s regulatory activities is transparent.

Deliver the first prototype of ECHA’s new public data availability system based on IUCLID, including hazard and classification and labelling data, and

supporting the preparedness for the EU Common Data Platform.

Yes

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Annual Report 2023

Deliver a plan to develop the new solution for dissemination of regulatory data

and proceed with its integration into ECHA’s new data availability system. Yes

Further develop IUCLID as a key building block, considering the future EU

common data platform on chemicals and bearing in mind the OECD intentions

for a Global Chemicals Knowledge Base.

Yes

OECD Global Portal to Information on Chemical Substances (eChemPortal) is

maintained and synchronised with ECHA’s dissemination website. Yes

Indicators Estimate Actual

O1 Description and number of data requests Internal: 50

External: 20

Internal:77

External:13

O2 Number of user page views for published

information on chemicals 48 million 50 million

Promotion of alternatives to animal testing

Highlights

In 2023, we intensified our activities to promote alternatives to animal testing. We invested in

many international activities, particularly APCRA (Accelerating the Pace of Chemical Risk Assessment), PARC (Partnership for the Assessment of Risks from Chemicals) and OECD

(Organisation for Economic Co-operation and Development) to enhance regulatory knowledge on how we can protect health and the environment and reduce our reliance on animal testing.

We also increased the access to toxicity data, aiming to support research and development within

the wider regulatory and scientific community.

We published the fifth report on the use of alternatives to testing on animals for the REACH

Regulation. The report shed light on opportunities and challenges associated with moving away

from animal testing in the regulatory assessment of chemicals.

We strengthened our interactions with stakeholders and worked closely with the European Commission and international partners to support the development and uptake of alternatives

that are suitable for regulatory purposes.

We organised a workshop to further explore new approach methodologies and work towards an

animal testing-free regulatory system for industrial chemicals. The event brought together

regulators, policy makers, scientists and stakeholders (industry, animal welfare NGOs, environmental NGOs) to discuss the state of the art and research needs for phasing out animal

testing. The workshop supported the efforts at EU level to work towards development of a EU

roadmap for fully replacing animal testing in the risk assessment of industrial chemicals.

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Annual Report 2023

Main outputs

O1 Industry generates hazard data using non-animal testing methods and new approaches,

wherever appropriate, to fulfil the REACH information requirements.

Invest in further development of the QSAR toolbox to integrate new information (for example, metabolites, biocides or data from pharmaceuticals)

and models.

Yes

Expand data available for download (REACH studies results and pharmaceutical industry data contribution) that can be used for NAMs development and/or

avoiding unnecessary animal testing.

Yes

Further implement predictive models to support substance grouping,

prioritisation and scientific decision making. Yes

O2 ECHA plays a proactive role towards the public and policy makers to provide clear, timely and sufficient information on alternatives to animal testing in a regulatory context, within

ECHA’s role and mandate.

Organise an external workshop on new approach methodologies (NAMs) to contribute to EU efforts towards building an EU roadmap for replacement of

animal testing.

Yes

Publish the fifth report on the use of alternatives to testing on animals for the

REACH Regulation (117.3). Yes

Contribute to OECD activities related to further development of alternatives

and integration of regulatory relevant alternatives in the OECD test guidelines. Yes

Further develop high throughput NAMs in cooperation with ECHA’s international

partners. Yes

Collaborate at international level 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).

Yes

Indicators Estimate Actual

O1 N/A

Biocides

Highlights

The number of opinions that the Biocidal Products Committee (BPC) was in a position to deliver in 2023 was well below the estimated numbers due to significantly less submissions by the

Member States of evaluation dossiers both for active substances and Union authorisations (UA). While we observed a decrease in numbers of UA applications this year, we also noted that these

cover product families and therefore dossiers tend to be larger and more complex. In response to technical scientific questions from the Commission, the BPC developed opinions on

alternatives to active substances and the comparative assessment of anticoagulant substances

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Annual Report 2023

used to control infestations of rodents, as well as on technical aspects of disagreements arising

in the mutual recognition of biocidal products authorisations. On request of the Commission, we also reviewed the work of the BPC with respect to analysis of available alternatives and socio-

economic aspects related to potential non-approval of certain active substances.

We continued providing support to Member States under the Active Substance Action Plan. This

included the organisation of two information sessions with Member States to discuss and share

their best practices on active substance approval and renewal. Furthermore, we provided regulatory and scientific advice and allowed Member States to increase competence in areas

such as genotoxicity and endocrine disruptors.

We also continued to provide the secretariat of the Coordination Group, assisting Member States

in the resolution of disagreements arising during mutual recognition of biocidal products authorisations and in reaching agreements on horizontal topics which may help preventing

certain future disagreements. This allowed for a reduction in the number of Art. 38 requests compared to what was initially foreseen. In the regular and ad-hoc meetings (19 in total), an

increasing number of disagreements were discussed together with the endorsement of key

specific procedures.

Regarding Union authorisations, we established a working procedure for processing applications

for minor changes, which allows the swift evaluation of the first such cases. Additionally, several critical working procedures were improved and streamlined, including the procedure for

processing application for major changes and for the linguistic review of the SPC translations.

Within the scope of one-substance-one-assessment, ECHA continued to collaborate with EFSA

on common guidance documents, such as on the impact of water treatment processes on residues of active substances in drinking water. Furthermore, we introduced alignment

mechanisms, such as identifying common substances early in advance and connecting and

supporting the evaluating Member States across regulations. We also established an engagement procedure on inviting experts to meetings of working groups and of the BPC. The

experience gained helped in defining collaboration practices with other EU agencies, in particular EFSA. In close collaboration with EFSA, we finalised the guidance for the assessment of risk to

bees from the use of biocides as our contribution to maintain biodiversity.

We have established an IT vision for biocides that sets the direction towards further integration of

the tools, ensuring structured data and increased data availability as well as efficiency gains for all stakeholders. The first implementation steps in the transfer of biocides information to IUCLID format,

based on a roadmap agreed with Member States, were a major advancement in this regard.

Main outputs

O1 Provide timely fit-for-purpose opinions, including means for improved consideration of

cross-regulations consistency, on active substance and Union authorisation applications.

Prepare ECHA’s opinions on the approval of active substances and on Union

authorisation of biocidal products. Yes

Prepare ECHA’s opinions on Union authorisation of same biocidal products and

on administrative and minor changes to Union authorisations. Yes

Cooperate with EFSA and within ECHA to interlink guidance documents and put

in place means to improve synergies and alignment, with focus on the

evaluation of common substances.

Yes

Update of the list of frequently used sentences in the SPCs translated in all the

EU official languages. Yes

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Annual Report 2023

Perform assessments of applications for technical equivalence, inclusion in the

Article 95 BPR list and classification for changes. Yes

O2 Provide support to Member States and Commission to facilitate biocides processes and

accelerate the Review Programme.

Providing regulatory, procedural and technical support to the MSCAs in the

evaluation and BPC opinion forming on the approval of active substances, with specific effort to progress with the Review Programme, and on Union

authorisation of biocidal products.

Yes

Contribute to the MSCAs capacity building by providing training and scientific-

technical advice. Yes

Support the MSCAs in their work on potential endocrine-disrupting substances. Yes

Prepare the BPC opinions requested by the Commission pursuant to Article 38

of the BPR on scientific and technical questions. Yes

Providing technical and scientific support to the Commission under Article

15(2) and 75(1)(g) of the BPR on general and case specific issues relevant for

the implementation of the BPR.

Yes

Provide training to stakeholders on analysis of alternatives and informed

substitution of substances. Yes

Develop and maintain guidance and provide support to the development of an

easily accessible, structured overview of ECHA guidance documents and

relevant policy documents.

Yes

Engage with stakeholders in different fora such as the BPC and its Working

Groups, organisation of biocides stakeholders’ day, etc. Yes

Dossiers submitted by industry to ECHA are timely processed and feedback

given as appropriate. Yes

O3 Continuing the integration of the biocides IT tools with the ECHA IT systems

Integrate, where feasible, specialised Biocides IT tools with ECHA IT systems. Yes

Continue developing the Register for Biocidal Products (R4BP 3). Yes

Continue developing the IT support tools (ECHA Act and Interact). Yes

Finalise the introduction of the biocides’ environmental exposure scenarios in

the CHESAR platform (see REACH activity Dossier preparation). On-going

Move the SPC Editor into a IUCLID based solution.

On-going

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Annual Report 2023

Promote and initiate the enhancement of structured data availability in IUCLID

for Annex II and III BPR information requirements. Yes

Propose and support a campaign on the IUCLID dossier filling for active

substances and Union authorisation cases. Yes

Indicators Estimate Actual

O1 Number of opinions on active substances [approval

& renewal]

28 13

Number of opinions on Union authorisation of

biocidal products

31 10

Number of opinions on Union authorisations sub- processes: same biocidal products, administrative

and minor changes

52 21

Number of technical equivalence application

assessments 30 32

O2 Satisfaction of authority actors Establishment of

baseline 84 %

Number of opinions on Article 15, Article 38 and

Article 75(1)(g) requests 20 7

O3 User satisfaction of ECHA IT tools (e.g., R4BP, SPC

editor, Interact)

Establishing baseline with

BPR user group

90%

Prior informed consent

Highlights

The reception and processing of PIC notifications experienced an increase in volumes compared

with previous years. A total of 10 857 notifications were processed in 2023 which represents 97% of the annual forecast (11 200) and is +8% compared to the number of notifications

processed in 2022 (10 072)). This increase was mainly due to the addition of benzene, being the first ‘substance in substance’ entry in the list of substances subject to PIC notification

obligations. ECHA continued to devote significant efforts to support all involved parties with these

obligations.

In terms of reporting, the usual annual report on exports and imports subject to Rotterdam

convention was published. In addition, we published the three-years report on the operation of the PIC Regulation (‘article 22 report’). Its conclusions input to the Commission’s ongoing

evaluation of the PIC Regulation, as some changes in legal provisions could facilitate the implementation, in particular the extent of the information that is made publicly available. This

was important as the increasing number of Access to documents requests showed public interest

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Annual Report 2023

in this information. In this context, we hosted an information session to exchange experiences

among Member States with the access to documents under PIC.

We continued to support the Commission in the implementation of the Rotterdam Convention

including participation in the 11th Conference of the Parties.

Main outputs

O1 Companies and Authorities in the EU and third countries can effectively manage the

international trade of chemicals listed under the Rotterdam Convention and the PIC

regulation.

Process effectively the received number of notifications allowing companies to export these chemicals in accordance with the EU’s international commitments;

execute related tasks such as stakeholder support.

Yes

Prepare the tri-annual report on the operation of the PIC Regulation (2020-

2022). Yes

O2 The Commission and other Authorities receive fit-for-purpose support in the context of

PIC implementation and UN Rotterdam Convention.

Produce and publish the annual report on PIC exports and imports. Yes

Support the Commission with the EU contribution to the Rotterdam convention

implementation. Yes

Indicators Estimate Actual

O1 Export notifications processed 11 200 10 857

Share of notifications validated/accepted by ECHA 90 % 96 %

Support provided to PIC duty holders (importers

and exporters) 250 245

O2 Scientific and technical support provided to the

Commission, EU and non-EU DNAs 3 600 3 570

Persistent organic pollutants

Highlights

At the European Commission’s request and linked to ECHA’s scientific support to the Commission in identifying new POP substances, we prepared in 2023 a draft scientific dossier (Annex D

proposal) for Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5) and

Dodecamethylcyclohexasiloxane (D6).

We provided technical and scientific support to the Commission for discussions at the 19th

meeting of the POPs Review Committee (POPRC-19). At this meeting in October 2023, the risk

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Annual Report 2023

profile for chlorpyrifos, an organophosphate pesticide, was adopted as was the risk management

evaluations for Medium-chain chlorinated paraffins (MCCPs) and long-chain perfluorocarboxylic acids and related compounds (LC-PFCAs). Both substances were recommended for listing under

Annex A (elimination) of the Stockholm Convention, with specific exemptions. Nevertheless, the POPRC agreed that further information on the scope of the chemical identity of MCCPs for the

purpose of its listing under the Convention is required, which would be subject to further

discussion at POPRC-20.

In addition, ECHA reviewed and commented on the POPRC document on long-range

environmental transport which had been finalised in October 2023. This document is equivalent

to a guidance on how to assess the long-range environmental properties of substances.

The Union Overview report detailing the implementation of the POPs Regulation in the EU was updated in May and December 2023. The report provides information on various aspects of POPs,

such as manufacturing, market placement, stockpiling, enforcement actions and releases of POPs

into the environment.

Finally, ECHA supported the European Commission in the following activities linked to the POPs:

revising the document for the notification of articles use for submission to the Stockholm Convention, gathering UV-328 information to support the specific exemptions in the EU POPs

Regulation (investigation report under Article 69(2)) and contributing to the amendment of the

PFOS entry of the POPs Regulation.

Main outputs

O1 Prepare and support processing of the technical dossiers that the European Commission

uses when proposing to list a substance as a POP in the Stockholm Convention, review the technical dossiers submitted by other parties and support the implementation of POP

Regulation.

Draft scientific dossiers for a new EU proposal to list a potential POP substance under the Stockholm Convention on Persistent Organic Pollutants and provide

further support to the Commission for the listing process.

Yes

Maintain and develop where possible within the resource constraints the

reporting system for the implementation of the POP Regulation and update the

Union Overview report based on the Member States reports regularly.

Yes

Indicators Estimate Actual

O1 Number of scientific dossiers drafted for the

identification of new substances as Persistent

Organic Pollutants

1 1

Support provided to various stakeholders 50 55

Scientific and technical support provided to the

Commission, EU and non-EU Cas 10 14

Waste Framework Directive

Highlights

The reception of notifications of SVHCs present in articles on the EU market continued in 2023

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Annual Report 2023

including corresponding support to duty holders. The total number of notifications received in

2023 is 10 653 336. The resulting Database for information on Substances of Concern In articles (SCIP database), making this information public, was maintained.

Main outputs

O1 Maintain a database on the presence of Candidate List substances in articles.

Maintain the notification portal and disseminate the SCIP database information. Yes

Provide support to duty holders to allow EU suppliers of articles to submit the

required information to ECHA. Yes

Indicators Estimate Actual

O1 Successful SCIP notifications received (incl.

updates)

8-12 million 10.6 million

Drinking Water Directive

Highlights

With the revision of the Drinking Water Directive, ECHA assumed new responsibilities related to setting up and maintaining European positive lists of substances that are authorised to be used

for the manufacturing of materials coming into contact with drinking water.

We provided support to the European Commission for drafting and smooth adoption of the

implementing and delegated acts related to the adoption of the EU positive list, information requirements for materials in contact with drinking water and the process for submission and

inclusion of substances on the EU positive list. The acts were successfully agreed through

Comitology by the end of 2023.

We also worked to develop guidance and tools necessary to support applicants and set up a RAC

working group to ensure overall readiness for entry into operation in 2025.

Main outputs

O1 Ensure the readiness for the implementation of Article 11 of DWD (2025) (including development of the delegated acts, delivery of the tools and processes for submission,

accordance check and opinion forming, including setting up of a working group attached

to RAC).

Provide technical and scientific support to the Commission in drafting and

adopting the Implementing and Delegated acts. Yes

Clarify the likely number of applications to be expected in period 2025-2028

through engagement with stakeholders. Yes

Setup internal operational procedures and working instructions for handling

the applications to be submitted from 2025 onwards. On-going

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Annual Report 2023

Set up a Working Group associated to RAC and start developing procedures for

opinion forming. On-going

Finalise the DWD IT solution, including the adaptation of IUCLID to the specific

needs of the DWD process. On-going

Develop guidance documents for the applicants.

On-going

Indicators Estimate Actual

O1 N/A

Support to the 8th Environmental Action Programme of the

EU

Highlights

In 2023, we worked further with EEA towards creating the first version of the framework and prepared to publish the relevant indicator dashboard. We also worked to develop a common

report with joint messages on the EU progress towards the policy objectives of the CSS. The

report accompanies the CSS indicator dashboard and is expected to be published in early 2024.

Main outputs

O1 Ensure a sound, accessible and transparent evidence base to support the monitoring,

measuring and reporting on chemicals

Implement indicators based on ECHA’s data in ECHA's data platforms,

according to the plan agreed with the Commission and EEA. Yes

Develop the public version of the indicator framework jointly with EEA and the

Commission. Yes

Together with EEA develop a joint synthesis report, offering policy-relevant

messaging on the trends observed in the chemicals indicators Yes

Indicators Estimate Actual

O1 N/A

EU Observatory for Nanomaterials

Highlights

During 2023, EUON continued to produce and publish new and updated content regarding the markets and safety of nanomaterials. In the beginning of the year, the NanoData knowledgebase

was refreshed with updated information about nanomaterials on the EU market. The EUON also commissioned new studies on topics of general interest and published regular ‘Nanopinions’ on

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Annual Report 2023

current matters related to nanomaterials.

Main outputs

O1 Provide better access to information on nanomaterials on the EU market, their uses and

safety aspects, and related research activities.

Continue to fulfil specific data gaps in the public knowledge about

nanomaterials via the commissioning of external studies. Yes

Continue to promote the EUON via different channels to increase its outreach

to a wide variety of audiences. Yes

Indicators Estimate Actual

O1 All traffic to EUON websites 125 000 186 084

EU Chemicals Legislation Finder

Highlights

EUCLEF continued to provide up-to-date information on EU chemicals legislation throughout the

year. A new framework contract for the data provision feeding EUCLEF was put in place ensuring

its continuation.

Main outputs

O1 Improve transparency for the public and the business environment for EU companies

and SMEs in particular, with regard to access to information on legislation applicable to

a given substance.

Continue to operate EUCLEF and maintain updated the pieces of legislation in

the scope of the service. Yes

Continue to promote EUCLEF via different channels to increase the utility of the

service for its target audiences. Yes

Run the corresponding helpdesk. Yes

Indicators Estimate Actual

O1 Number of data updates on EUCLEF pieces of legislation 4-6 5

All traffic to EUCLEF pages 350 000 395 000

Support to occupational health legislation

Highlights

In 2023 ECHA continued supporting the Directorate General for Employment, Social Affairs and

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Annual Report 2023

Inclusion (DG EMPL), through Service Level Agreements, in providing five opinions from the RAC

on Occupational Exposure Limits (OELs). These OELs were values set by authorities at EU and national levels that help employers protect their workers’ health from possible risks when using

chemicals at work and limit exposure to harmful chemicals in the air of a workplace. All RAC opinions were made in advance to the contractual deadlines set and covered the following

substances: 1,2-dichloropropane, 1,2,3-trichloropropane, 2-chloro-1,3-butadiene

(chloroprene), 2,3-epoxypropyl methacrylate (glycidyl methacrylate) and Nitrosamines.

ECHA’s website was updated in 2023 to host a repository of substances, for which the

recommendations and opinions relating to the toxicological evaluations of substances affecting the health of workers were adopted by the Scientific Committee on Occupational Exposure Limits

(SCOEL) - Recommendations of the SCOEL - ECHA (europa.eu).

Five new requests for setting occupational exposure limits were received under the 2023

contribution agreement with the Commission: 1,3-butadiene, Boron and its compounds, Bisphenol A, Silicon carbide fibres, Pyrocatechol. RAC opinions for these substances will be

adopted by 23 February 2025.

Main outputs

O1 Opinions of the Risk Assessment Committee (RAC) on OELs to the Commission are timely

and fit-for purpose.

6 RAC opinions per year Yes

Indicators Estimate Actual

O1 Number of OEL requests received under SLA 5 5

Number of RAC opinions on OELs completed 6 5

Number of scoping documents 0 0

Instrument for Pre-Accession Assistance (IPA)

Highlights

We continued supporting the pre-accessing countries to the EU under a new contribution agreement with the Commission for 2023-2026. The focus of this support remained on training

on the EU chemicals legislation and related IT tools. Quarterly bilateral meetings were held with

beneficiaries to make sure topics and mechanisms to provide information and support are in line

with their priorities.

Main outputs

O1 Enhance the readiness of EU (pre)candidate countries to assume their role in their path

towards EU membership in the area of EU legislation for chemical management.

Implement support actions as agreed in the IPA grant agreement for 2023-25

Yes

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Annual Report 2023

Indicators Estimate Actual

O1 N/A

Support to other legislation

Highlights

In 2023, we provided input to the review of some Best Available Techniques Reference

documents (BREF) under the Industrial Emissions Directive and prepared for the formal onboarding of tasks under the upcoming revision of the Industrial Emissions Directive foreseen

to be adopted in spring 2024. We contributed to the workshop organised by the European Integrated Pollution Prevention and Control Bureau (EIPPCB), whose aim was to clarify with

stakeholders the main priorities and approaches for further development of the Chemical

Management System.

We worked with the Commission to determine the appropriate structure for ECHA to deliver on the new tasks received under the Serious Cross-Borders Threats to Health (SCBTH) Regulation.

We also participated in the discussions with the other Agencies involved in the SCBTH regulation

to share experiences and align approaches.

Main outputs

O1 Promote and support the use of the REACH/CLP data and expertise under other EU

regulatory schemes

Sustaining active input to the review of the Best Available Techniques

Reference documents (BREF) under the Industrial Emissions Directive. Yes

At Commission’s request, prepare for the onboarding of additional tasks under the upcoming revision of the Industrial Emissions Directive in relation to risk

assessment methodology in the Chemical Management System framework.

On-going

O2 Establish a readiness structure within ECHA for delivering rapid risk assessments in

case of cross-border threats to health

Agree on a process for delivering the risk assessments with the Commission.

On-going

Indicators Estimate Actual

O1 N/A

IUCLID for EFSA

Highlights

In 2023, we continued to provide support for the integration of IUCLID into the EFSA IT infrastructure by facilitating the publication of IUCLID data and assessing the implementation of

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Annual Report 2023

data analysis tools. Data Uploader was successfully used by EFSA to upload OpenFoodTox to

IUCLID format. Assessment on the use of Text analytics and Data extractor will be completed in

2024.

Main outputs

O1 Maintain cooperation between EFSA and ECHA and effective operation of the IUCLID

platform.

Assess applicability of IUCLID to other food regulated products (e.g., Food

Contact Materials and synergies with Drinking Water Directive). Yes

Submission portal is enhanced to automate the handling of large PPP

submissions. Yes

Assess the implementation of data analysis tools.

On-going

Continue support to EFSA to perform its regulatory work. Estimate resources and compensation mechanisms. Execution of the Service Level Agreement

for implementation of agreed scope and regular service accordingly.

Yes

Indicators Estimate Actual

O1 N/A

Partnership for the Assessment of Risk from Chemicals (PARC)

Highlights

As a co-leader of Task 2.1 ‘Priority setting’ under PARC, ECHA’s experts reviewed 34 projects,

mainly related to hazard, exposure and risk assessment methodologies.

We also developed with the partners of Task 2.1 the process for a Rapid Response Mechanism

(RRM) to submit project requests for specific information (e.g., urgent needs on hazardous chemicals). Furthermore, we actively participated in PARC projects addressing data gaps, for

example, on bisphenol alternatives and development of innovative methods on different hazard

endpoints (e.g., developmental neurotoxicity)

To better communicate ECHA’s research needs to the scientific community, we started to map key areas of regulatory challenge. The identified key areas of regulatory challenge were

formulated as an ‘evolving research and development agenda’ aiming to support and inspire researchers. The report was published during a joint webinar together with the European

Environmental Agency and the European Food Safety Authority in June. These research needs

will be updated and refined as the scientific areas evolve and key regulatory challenges develop. ECHA presented its research needs in various scientific fora (e.g., Joint Policy Session organised

by DG RTD, at Eurotox 2023) and via relevant communication channels (e.g., ECHA Safer

Chemicals podcast).

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Annual Report 2023

Main outputs

O1 Ensure, together with EFSA and EEA, that the research activities will support current regulatory challenges and new areas identified in the Commission’s Chemicals Strategy

for Sustainability.

Steer the development and implementation of a prioritisation strategy

(including surveys, interviews and workshops on regulatory needs with EU

and national regulatory bodies) based on the initial work done during the

PARC proposal development phase.

Yes

Contribute to the development of a framework with clear decision criteria to enable transparent decision making for the prioritisation of activities within

PARC.

Yes

Support the development of annual work plans by steering the process of

review of the projects submitted, ensuring identified EU priorities and knowledge gaps in the area of chemical risk assessment are appropriately

considered in the process.

Yes

Steer for the development and implement 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.

Yes

Indicators Estimate Actual

O1 N/A

Support to Forum

Highlights

We continued supporting the Forum of enforcement authorities, with a focus on the preparation, execution and reporting for the Forum-coordinated REACH and BPR enforcement projects. Three

projects were under preparation (imports, online sales and SPCs for biocides), two under execution (safety data sheets and PFCAs in cosmetics) and four under reporting (authorisation,

restrictions in products, biocides and classification of mixtures).

We provided advice on enforceability aspects of seven restrictions proposals to enhance their

regulatory process and future implementation including the restriction on the universal PFAS and

on CMR on childcare articles.

210 REACH and 630 BPR inspectors were trained via the train the trainers approach that supports

the harmonisation of EU enforcement of chemicals regulations.

We provided support to the Commission as input to the preparation of legislative proposals in

the context of the CSS ambition towards zero tolerance for non-compliance.

Henrik Hedlund (SE) was appointed as the new Forum chair and Helmut de Vos (BE) as the new

BPRS chair.

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Annual Report 2023

Main outputs

O1 An equal level playing field for economic operators is promoted in the EU through

harmonised enforcement

Prepare, execute, report and follow up on five Forum-coordinated REACH and BPR enforcement projects on: REACH authorisation (REF-9), REACH and POP

Restrictions (REF-10), REACH safety data sheets (REF-11), control of REACH

for imports (REF-12), BPR approved substances in biocidal products (BEF-2) and select the subjects of next REACH and BPR coordinated projects (REF-13

and BEF-3).

Yes

Establish best practice in enforcement by maintaining the Forum and BPRS

Manuals of Conclusions on practical enforcement issues and running four Forum pilot projects on exemption from registration for recovered

substances, classification of mixtures and poison centre notifications.

On-going

Deliver timely advice on enforceability on all submitted proposals for

restrictions and revise the process for delivering the Forum advice. Yes

Develop and deliver four trainings for national trainers and inspectors. Yes

Contribute and facilitate Forum’s input on the Commission’s ideas on enhanced enforcement of chemicals legislation on imports, on European Audit

Capacity for enforcement and other enforcement topics under the

CSS/REACH revision.

On-going

Indicators Estimate Actual

O1 Number of enforcement trainers trained by the

Forum

200 840

Board of Appeal

Highlights

In 2023, the Board of Appeal adopted 15 final decisions, all under REACH. In those decisions it addressed important aspects such as the interpretation of REACH information requirements and

the possibility for ECHA to revoke registrations. 10 cases (two under BPR) remained pending at

the end of the reporting period.

The General Court confirmed three decisions of the Board of Appeal which were adopted in previous years. Most notably, the Court confirmed the decisions in which the Board of Appeal

examined the relationship between REACH and the Cosmetics Regulation.

Main outputs

O1 Increase the efficiency of the Board of Appeal procedures, while continuing to ensure

their quality.

Process and decide on appeals brought against decisions of the Agency,

according to procedural requirements. Yes

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Annual Report 2023

Communicate to parties and the general public about appeal decisions. Yes

Defend appeal decisions when challenged before the EU Courts, together with

the Secretariat. Yes

Contribute to ECHA’s input for the review of the REACH Regulation. Yes

Prepare and adopt a code of conduct applicable to members of the Board of

Appeal who are Agency staff members. Yes

Indicators Estimate Actual

O1 Appeals submitted REACH 12 10

Appeals submitted BPR 2 2

Appeals concluded REACH 12 14

Appeals concluded BPR 2 1

Management

Highlights

ECHA continued to meet its governance and management obligations during 2023. All

deliverables regarding annual reports, planning and budget requirements were done within the

required timelines. With our new Executive Director, several governance and management changes and initiatives were completed. Our new Strategy Statement for the period 2024-2028

was developed and finalised. The development process involved significant staff and Management Board engagement and consultation. We also developed a new risk management

policy, risk register and procedure. To ensure even greater levels of transparency to the Management Board, the Executive Director introduced a new ED report that is presented at each

meeting. Discussions continued with the Management Board on ensuring our planning and other documents are clear, concise, and accessible to our stakeholders and partners. Further efforts

on transparency included a new quarterly report to the Management Board as well as a review

and update of our Conflicts of Interest policy.

We supported Commission colleagues in their policy development work under the Chemicals

Strategy for Sustainability including our joint efforts on alternatives to animal testing. This facilitated the establishment of structured contacts around specific files. Due to this focus,

drafting a Memorandum of Understanding with Commission services was de-prioritised. Although the REACH revision and ECHA Basic Regulation were not published in 2023, we provided

significant support to these. We aim to continue the dialogue with the Commission on the Basic Regulation in 2024 given it is a priority us. We also paid particular attention to increasing our

engagement with the Member States and institutional partners. This involved meetings with the

European Parliament and EU agencies as well as several Member States visits initiated by the

Executive Director, which will continue in 2024.

Following a successful audit, ECHA maintained its ISO 9001:2015 certification. We also completed several successful audits and evaluations and ensured the necessary follow-up was

completed on their main recommendations. Outside of the day-to-day legal activities, ECHA defended its own decisions at the European Court of Justice and the Board of Appeal. We also

supported the Commission at the European Court of Justice in risk management and biocides

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Annual Report 2023

related cases. Altogether more than 50 cases were pending at different stages during the year,

and the judgments received were predominantly very positive, confirming the position of ECHA.

We expect the level of litigation to continue similar or higher in the next years.

Our key focus was in communicating and engaging with our stakeholders and partners and will continue under the new strategy. As our legal mandate is widened, we will also be increasing

our stakeholder and partner contacts in the EU, Member States, industry, and civil society

organisations. We have resumed the organisation of regular NGO dialogues. We received increased requests for our Accredited Stakeholder Organisation (ASO) list in 2023 and we expect

this to continue into 2024 and beyond. To help us prepare for the increased levels of engagement envisaged in our new strategy and new tasks, we completed our new stakeholder engagement

approach and drafted our new communications strategy for the period 2024-2028. Both will be

finalised and rolled out in 2024.

ECHA’s communications activities in 2023 focused on supporting the organisation in presenting its work clearly and transparently, across the range of its activities to its different internal and

external stakeholder audiences. Key initiatives included the introduction of the Executive

Director, the promotion of ECHA’s work on new alternative methodologies and key areas of

regulatory challenge, the proposed universal restriction on PFAS amongst many others.

We continued to broaden our use of digital communications channels focusing, in addition to the website, on the development of our social media channels which are reaching a growing

community, podcasts, audiovisual products and supporting stakeholder interaction through

information and training webinars.

Main outputs

O1 ECHA’s (multi-)annual planning provides clear direction that is aligned with its mandate

and developing EU policies, while facilitating the efficient integration of new tasks

Adopt a multi-annual work programme (Strategic Plan) and associated

objectives for integration in the Programming Document Yes

Develop and implement a project portfolio management mechanism to provide continued effective support to the implementation of the

Commission’s Chemicals Strategy for Sustainability.

Yes

Develop and implement a project portfolio management mechanism to

facilitate the integration of new regulatory tasks and changes to ECHA’s

governance structures.

Yes

O2 The management bodies are in the position to drive performance and ensure

compliance of ECHA.

Adopt and publish the Programming Document, including (multi-)annual work

programme and budget in line with the Commission guidelines. Yes

Prepare and take the decisions statutorily required from the management

bodies, including the Management Board, within the applicable deadlines. Yes

Monitor performance through monthly and quarterly reporting to the Management Board and address issues through mitigating actions; and report

the overall status and achievements through the annual report published by

end of April each year.

Yes

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Annual Report 2023

Timely reporting on measures taken in the light of the observations

accompanying the annual discharge from the EU budget authority. Yes

Prepare and implement the corporate audit and evaluation plan, in

consultation with the Management Board, with regular status reports and

appropriate follow-up actions.

Yes

Maintain the ISO 9001:2015 certification. Yes

Review ECHA’s Policy for the Prevention and Management of Conflicts of

Interest. Yes

Defend ECHA’s interests in legal proceedings and ensure legal advice to its

operations and on issues relating to financial interests, human resources,

procurement, intellectual property and access to documents.

Yes

O3 ECHA addresses the individual circumstances and needs of its institutional partners and

is aligned with EU priorities.

The Executive Director has a regular exchange of views with the European

Parliament’s Committee for Environment, Public Health and Food Safety and

maintains regular contacts with its liaison MEP and other MEPs.

Yes

Organise regular bilateral interactions with Member States authorities. Yes

Propose a draft Memorandum of Understanding on mutual expectations with

the Commission services. No

O4 Stakeholders and general audiences are aware of ECHA’s activities and impact and

easily obtain the information they need from the Agency.

Implementation of 2023 Communications Action Plan to support the Work

Programme. Yes

Organise the biennial ECHA Conference.

On-going

Maintain and further develop the ECHA websites as key communication

channels to provide accurate, relevant and up to date information to

stakeholders.

On-going

Adopt a revised, cooperative approach for stakeholder engagement to support the implementation of the new multi-annual work programme

(Strategic Plan) and clarify ECHA’s work to key audiences in view the Agency’s evolving role under the Chemicals Strategy for Sustainability and

implement related actions.

On-going

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Annual Report 2023

Indicators Estimate Actual

O2 Areas where audits and evaluations results (including prevention of conflicts of interest and

fraud) have been considered in future strategic

decisions.

5 5

O4 Combined neutral and positive feedback monitored

in media publications

>90 % 96 %

Website unique visitors/traffic to the web content 4.2 million 5.8 million

ICT

Highlights

During the year 2023 ECHA embarked on the transformative ECHA IT 3.0 Journey, which has a

primary focus on IT resilience, scalability and delivery capabilities.

ECHA systems maintained an availability rate of 99%, surpassing the target of 98%, ensuring

good level of service delivery internally and towards all stakeholders. By keeping the focus on

IT security and business continuity, and implementing the agency’s cybersecurity policy, the Agency avoided major cybersecurity incidents, and maintained the high standards of defences

against evolving threats.

In 2023, we made progress in implementing a modular and reusable IT architecture, aligning

with the Target Enterprise Architecture vision established in 2022. Our modular approach ensures flexibility and adaptability, laying the groundwork for improved tooling support for

regulatory processes. Following the same architecture prescriptions, a new version of ECHA's dissemination platform was designed and implemented. This revamp enhanced accessibility and

scalability, ensuring seamless access to critical information for all stakeholders.

Our ongoing refresh of administrative tooling ensured optimal performance, allowing us to keep pace with technological advancements and streamline workflows. The potential of artificial

intelligence (AI) was also recognised, and a horizontal working group was established to

identifying opportunities and setting guidelines for AI-related initiatives.

Main outputs

O1 Improve the resilience and scalability of the IT product and services portfolio in order to

improve the efficiency and cost effectiveness in absorbing a growing mandate (CSS,

1S1A, new tasks etc).

The target enterprise architecture is adopted, and implementation is started

to improve tooling for regulatory processes for internal and authority users. On-going

O2 Further develop the capability of the IT function to deliver through more effective

organisational processes, refined architecture and leverage of new technologies.

Implement the cybersecurity policy adopted in 2022. Yes

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Annual Report 2023

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

The implementation of the roadmap for the future of the ICT infrastructure

towards the public cloud begins. On-going

Services continue to be run at the required level of quality, in an efficient and

cost-effective manner, by continuously investing in evolving the tools and

practices.

Yes

The preparation and establishment of replacement framework contracts for Management Information Systems, Enterprise Content Management and for

Managed IT Workplace Services.

Yes

Indicators Estimate Actual

O1 Average availability of key systems >98 % 99 %

O2 High impact security incidents <3 0

Financial Resources

Highlights

We effectively managed our financing in 2023 through close monitoring of uncertain fee income development. On the final budget size of EUR 123.3 million, the Agency reached a 99%

commitment rate and 87% payment rate, exceeding the targets set. The European Court of

Auditors gave a clean audit opinion on ECHA's annual accounts for 2022 and their first audit

mission on the financial year 2023 concluded without any preliminary findings.

We continued supporting the Commission in its design of a sustainable and more predictable financing model and a simpler budget structure. Details on ECHA’s budget information and

management in 2023 can be found in Part II and Appendix II of this report.

Main outputs

O1 ECHA’s budget is implemented in line with the objectives set in the Programming Document, with a high degree of implementation and in line with the Financial

Regulation.

Prepare and implement ECHA’s budget in line with the objectives set in the Programming Document and the rules and deadlines set in the Financial

Regulation.

Yes

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

Prepare and present the annual accounts to the Management Board and

Institutions in line with the rules and deadlines set in the Financial Regulation. Yes

Prepare and implement procurement and contracting activities in line with

the objectives set in the Programming Document and the rules and deadlines

set in the Financial Regulation.

Yes

Provide data and analysis to the Commission to support achieving a stable

and predictable financing model for ECHA, with a more flexible budget Yes

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Annual Report 2023

allocation.

Provide regular reports to the Commission partner services and the

Management Board’s Sub-group on Finance, Audit and Risk, on the evolution of fee income, actual budget implementation, including revenue and

expenditure estimates for the future.

Yes

Maintain regular contacts with the Commission’s partner DGs’ financial

services to discuss ways of handling any shortfall or surplus during the budget

year.

Yes

Monitor and report annually on the evolution of the transfer of a proportion of fees to Member States, propose improvements thereto, as necessary, and

prepare updates to the related transfer amounts per country when the

Commission country coefficients are updated.

Yes

Implement further efficiency measures, including the automation of

electronic signature to contracts, further digitalisation of the financial workflows, streamlining the procurement process by onboarding PPMT (that

provides a single platform access to all eProcurement tools) and further

promotion of electronic invoicing.

Yes

Indicators Estimate Actual

O1 Level of budget implementation: commitment rate

and cancelled payment appropriation rate

(including carry-forward)

Min. 95 %

and max. 5 %

respectively

99 % and

1 %

Processing of payments within legal deadlines No less

than 99 %

99 %

Human Resources

Highlights

During 2023, we continued to build our organisational capability to support the delivery of ECHA’s

Work Programme. The annual staff turnover rate was within target, while vacancies were

promptly filled leading to a high 96.8 % of establishment plan posts filled. Our biennial staff engagement survey showed high levels of commitment and engagement and confirmed ECHA’s

recognition as one of Finland’s most inspiring workplaces.

2023 was the final year of the existing HR Strategy and actions on priority areas were all

delivered. Technical competencies were successfully reviewed and updated with a view to preparing for new tasks. Learning and development priorities were actively addressed and

delivered to build and maintain critical competence in key areas, including management and leadership capabilities. ECHA continued to provide its staff with career development

opportunities through regular career enhancement calls, an internal mentorship programme and

career coaching addressing individual needs. The attractiveness of ECHA as an employer was promoted with our strategic partners, at both international and at host country level. We also

revamped the organisation’s presence in social media to further enhance our attractiveness as

an employer.

Finally, we consulted all our staff and the Staff Committee in the development of the new People and Organisational Strategy for the period 2024–2028. This key document will support the

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Annual Report 2023

organisation in achieving its purpose, vision and goals as contained in ECHA’s new Strategy

Statement 2024-2028.

Main outputs

O1 ECHA attracts, develops and retains competent and committed staff to implement its

current and future mandate.

Develop a new human resources framework, in line with the new ECHA multi-

annual work programme (Strategic Plan), addressing core topics such as competence development, recruitment, inclusiveness, gender balance and

career development.

Yes

Implement ECHA’s Wellbeing Action Plan 2023-2024 with the support of

ECHA’s Corporate Services Unit and the Agency’s Joint Committee for Health

and Wellbeing.

Yes

Provide competence development activities to ensure continuous capacity building of staff, including exploring joint training initiatives with peer

Agencies.

Yes

Ensure regular communication with ECHA’s Staff Committee to maintain a

healthy working culture and positive relations and dialogue. Yes

Implement ECHA’s Diversity and Inclusion Action Plan 2023-2024 to advance diversity (including gender balance) in the management team and at

organisational level.

Yes

Indicators Estimate Actual

O1 Turnover of Temporary Agents <5 % 1.1 %

Turnover of Contract Agents <10 % 4.6 %

Percentage of Establishment Plan posts filled 95 % 96.8 %

Corporate Services

Highlights

During 2023, we continued to adapt to the hybrid working environment and an external

consultant conducted an analysis on optimising the use of our office building and Conference centre. In 2023, ECHA maintained its International Organisation for Standardisation (ISO)

14001:2015 and EU Eco-Management and Audit Scheme (EMAS) certifications, as well as

business continuity and security while closely monitoring the geopolitical situation with local authorities. Our new environmental work programme 2023-2025 was coordinated and monitored

effectively (more information can be found in Part II and Appendix VII).

We successfully organised meeting services for 640 events and official meetings, with 32 800

participants joining online through Webex, and hosted approximately 5 000 visitors to our premises. We also continued to work towards our aim to reduce CO2 emissions from both staff

travel and building operations. A feasibility study of ISO 20121:2012 standard on event

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Annual Report 2023

sustainability management systems was concluded and based on this study, we will aim to

implement this standard during 2024.

We launched and concluded a significant number of procurement procedures in 2023, including

several new 4-year service contracts (for example, cleaning, security and reception services contracts). We also provided the facilities, support in safety and access management for two

European Agencies who organised an official event at ECHA. 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.

Main outputs

O1 ECHA provides a safe and healthy physical work environment for staff and guests that

facilitates optimal Agency-wide performance.

Conduct an analysis on optimising the use of ECHA’s office building and

Conference Centre, including related service delivery options. Yes

Implement ECHA’s Wellbeing Action Plan 2023-2024 with the support of

ECHA’s Human Resources Unit and the Agency’s Joint Committee for Health

and Wellbeing.

Yes

Coordinate and monitor implementation of ECHA’s Environmental Work

Programme 2023-2025. Yes

Conduct staff awareness-raising activities in carbon neutrality. Yes

Indicators Estimate Actual

O1 Examine the feasibility of obtaining a relevant certification to confirm, and improve, the

sustainability of ECHA’s event-related activities.

Completed Completed

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Annual Report 2023

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

2023, eight new Board members were appointed. A number of significant decisions were taken by the MB including the development of ECHA’s strategy for 2024-2028, approving the new

policy for managing corporate risks and revising ECHA’s conflict of interest policy.

The MB led the strategy development process via its dedicated subgroup, in close collaboration

with the Executive Director. The MB assessed the evolution of ECHA’s external environment, took stock of the achievements of the previous strategy period and gathered input from ECHA

staff and the Agency’s key stakeholder groups. The final Strategy Statement 2024-2028 was

adopted in December 2023.

In June 2023, the MB adopted ECHA’s revised conflict of interest policy to strengthen the

monitoring of compliance with post-employment duties by former staff members. The policy also provides guidelines for Member States to ensure the independence of their services provided to

ECHA and clarifies the duties applicable to staff and to external contributors.

In September 2023, the MB adopted the Agency’s new framework for identifying, assessing, and

managing risks to reduce the likelihood of negative impacts on ECHA’s objectives and ensure that risk management is integrated into the decision-making process. Regular reports on risks

related to IT security were provided to the MB as well as risks arising from legal obligations not

being met due to committee capacity constraints or the size and complexity of dossiers.

With a view to resources and work programming, the MB was regularly updated on pending and

upcoming Commission initiatives with an impact on ECHA’s mandate and/or resourcing, as well

as on ECHA’s technical input to the Commission’s preparatory work.

The MB adopted all statutorily required documents 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 probationary period and annual performance appraisal, as well as renewal

of mandates.

Major developments

In 2023, the MB led ECHA’s strategy development process via its dedicated subgroup, in close

collaboration with the new Executive Director. The Strategy Statement 2024-2028 was adopted in December 2023, and it provides the framework for ECHA to deliver on its existing wide legal

mandate, build on its expertise and experience, collaborate with its stakeholders and partners,

implement new tasks and support the ambition of the EU policy goals on chemicals.

During 2023, ECHA continued to support the implementation of the Chemicals Strategy for Sustainability (CSS) as requested by the Commission. For instance, we provided scientific and

technical input to the Commission during the trilogues with the European Parliament and the

Council on the CLP Regulation revision, until a provisional agreement was reached at the end of 2023. In addition, ECHA provided technical input to the Commission during the preparation of

the legal proposals for the revision of the Groundwater, Water Framework and Environmental Quality Standards Directives, the revision of the End-of-Life Vehicles (ELV) and Restriction of

Hazardous Substances in electrical and electronic equipment (RoHS) Directives, as well as the

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Annual Report 2023

revision of the Toys Safety, Persistent Organic Pollutants (POPs) and Medical Devices

Regulations, among others. For all these the Commission put forward legal proposals, reattributing scientific and technical tasks to the Agency. In addition, the Commission published

a legal proposal to establish a Common Data Platform, which includes a number of “data-related” new tasks for ECHA, such as the development of an EU Common Data Platform for Chemicals, a

new repository of reference values, the extension of the Public Activities Coordination Tool

(PACT), the hosting of the Information Platform for Chemical Monitoring (IPCHEM), a new database of study notification, a new Early Warning Framework and the establishment of an EU

data generation mechanism. For two newly adopted legislations, the Batteries Regulation and the Regulation on Serious Cross-Border Threats to Health, ECHA commenced our implementation

plans with a view to become operational in 2024.

ECHA supported the Commission in its conceptual work on the future ECHA Basic Regulation. In

this context, ECHA delivered five retrospective evaluations on ECHA’s financial model, Committees (RAC, SEAC and MSC) and the Board of Appeal. Main recommendations on ECHA’s

financial model referred to ex-ante verifications for SMEs and a potential reserve fund, which

are expected to further enhance the flexibility and agility of ECHA’s management system, if implemented. Among the main recommendations of the evaluation of the committees were

increasing the number of coopted members, reconsidering the payment schemes for rapporteurs, considering alternative legislative structures for ECHA to get the needed expertise

and assigning a more active regulatory role for ECHA for some processes. These recommendations are expected to increase the flexibility for ECHA in attracting and keeping the

right expertise for rapporteurs, relieve the Committees’ workload and ultimately speed up the

opinion making process.

Budgetary and financial management

Financial management

ECHA effectively managed its financing in 2023, closely monitoring fee income development and

reaching a 99 % commitment rate and 87 % payment rate, exceeding the targets set. The European Court of Auditors gave a clean audit opinion on ECHA's annual accounts for 2022 and

their first audit mission on the financial year 2023 concluded without any preliminary findings.

Details on ECHA’s budget information and management in 2023 can be found in Appendix II.

Delegation and sub-delegation of the powers of budget implementation to

agency’s Staff

ECHA has 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

ECHA continued to implement its 2019-2023 Human Resources (HR) Strategy and had a high

rate of filled establishment plan posts (96.8 %) with a low Temporary Agent turnover (1.1 %) 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. Finally, the

Diversity and Inclusion Action Plan was further implemented, and our efforts were recognised

through the award of a Certificate of Excellence from the Network of EU Agencies.

ECHA’s biennial staff engagement survey was conducted by ECHA’s independent service partner in the spring of 2023. The results are above benchmark levels and show high employee

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Annual Report 2023

engagement level. The service provider characterised ECHA as an inspiring workplace where

business is developed together with employees. The results of the staff survey, together with

the rest data sources, are analysed in the internal controls assessment (see Section III).

Strategy for efficiency gains

In the recently released draft discharge report for the financial year 20225, the European

Parliament commends ECHA for its strategy for efficiency gains, stating that the Agency’s strategy focuses on achieving added value through performance-based governance, alongside

the development of new tools that enhance Planning and Reporting processes. These tools, designed to be more user-friendly, offer better reporting capabilities, and save time for the entire

staff. In terms of efficiency gains, the discharge report also observes that the Agency also started an infrastructure capacity optimisation exercise to minimise any excess capacity in the IT

infrastructure and the Agency was able to reduce the usage by roughly 25 %.

With regard to ECHA’s efficiency efforts in the area of IT management, in 2023 the Agency

continued the process of organising its IT portfolio in modules, which allows a composable

architecture and further enables synergies between activities and legislations.

According to the 2023 staff survey, 42 % of respondents fully agree and 44 % tend to agree

that their units operate efficiently, pointing to a perception of ECHA as an efficient organisation.

As part of its efficiency initiatives, in 2023 the Agency prioritised the adoption of the PEPPOL

platform for invoice exchange. This initiative ensures secure and timely transactions, benefitting both public and private sector entities within and outside the EU. The use of this platform has

streamlined the recording of debit notes in the Agency’s accounting system, handling an average of 2000 commercial invoices annually. Furthermore, to expedite financial transactions, the

Finance unit now possesses the authority to approve payments below EUR 8,000. Approximately

75 % of invoice-based payments and 100 % of cost-claims, such as meeting participant reimbursements, are processed within the Finance unit, freeing up time for middle and senior

management to focus on strategic priorities.

Another significant change occurred with the implementation of the new hybrid working

arrangement as of 1 September 2023. This approach replaced the previous structural teleworking request system, resulting in around 82 % decrease in teleworking requests during

Q4 2023 compared to Q4 2022. The adoption of hybrid teleworking arrangement brought several tangible benefits. It has reduced the administrative burden for both staff and managers (two

approval workflows per year instead of weekly or monthly) and reinforced flexibility and trust

between staff and managers. This new approach is expected to lead to increased staff

engagement and commitment.

Assessment of audit and retrospective evaluation results during the reporting year

Retrospective (ex-post) evaluations

In 2023, ECHA performed the following retrospective evaluations following the criteria and

methodology as stipulated in the Better Regulation Guidelines6 :

• Retrospective evaluation of ECHA’s Committees, and namely: the Committee for Risk

Assessment (RAC), the Committee for Socio-economic Analysis (SEAC) and the Member

5 https://www.europarl.europa.eu/doceo/document/CONT-PR-753516_EN.pdf 6 http://ec.europa.eu/smart-regulation/guidelines/tool_42_en.htm

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Annual Report 2023

State Committee (MSC)7. Upon request of the services of the European Commission, this

ex-post evaluation analysed the degree of effectiveness, relevance, efficiency, proportionality, coherence, added value and sustainability of the Committees established

by the REACH Regulation. The results will be used to support the Commission’s work on improving the governance of ECHA, for which the Chemicals Strategy for Sustainability

(CSS) foresees the establishment of a self-standing basic regulation. Some process

results may be used by the Commission in a possible future REACH revision.

• Retrospective evaluation of ECHA’s Board of Appeal8. The objective of this evaluation was

to analyse the degree of effectiveness, efficiency, proportionality, coherence, added value, relevance, and sustainability of the Board of Appeal (BoA), with the results

supporting the European Commission’s work on the Basic Regulation for ECHA.

• Retrospective evaluation of ECHA’s financial model, including its REACH/CLP and Biocides

fee income trends, and their predictability and stability throughout the years. A comparison with other agencies’ models was covered to allow for conclusions on the

proportionality of ECHA’s model. The costs, risks and benefits associated with the model

for ECHA, and its main stakeholders were also captured in the analysis. The results of the retrospective evaluation can be used to support the Commission’s announced proposal

for an ECHA Basic Regulation.

Internal Audit Service (IAS)

The Internal Audit Service (IAS) of the Commission conducted an audit on ‘Budget preparation,

monitoring and reporting’. The audit did not result in any critical or very important recommendations. The audit identified two improvement areas, classified as important, on

resource allocation and the exceptions register.

Internal Audit Capability (IAC)

The Internal Audit Capacity (IAC) conducted one assurance audit 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 Follow-up to Dossier Evaluation process.

The audit resulted in one very important recommendation:

• Provide a holistic overview and monitor dossier evaluation process (compliance checks

and testing proposals) from start to end by e.g., preparing analysis on annual trends on

status of Final decisions (closed, in follow-up evaluation, in enforcement).

and three important recommendations:

• To support efficient and effective enforcement of the Failure to respond cases: o Inform National enforcement authorities of the priority cases according to the

ECHA’s strategy and Integrated Regulatory Strategy o Continue cooperation with the National enforcement authorities.

• Complete the existing calculations on resource needs to deal with the accumulated

backlog and the scenarios for the future. Agree on the need to allocate resources to additional tasks such as restructuring and simplifying the Follow-up to Dossier Evaluation

process, IT development.

• To reinforce assessment of the regulatory risk management measures as a Follow-up to

Dossier evaluation outcome clarify if Follow-up to Dossier evaluation team needs

7 https://echa.europa.eu/documents/10162/17086/retrospective_evaluation_of_committees_report_en.pdf/e491f353-

1e6e-8616-8990-48db2fed0056?t=1695807929141 8 file://echa/data/users/u09175/Roaming%20Profile/Downloads/ex_post_evaluation_board_appeal_en%20(6).pdf

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Annual Report 2023

additional support.

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 2024) to verify the implementation of the action plans, concluding that two very

important and four important actions are still being implemented.

European Court of Auditors (ECA)

In their statement of assurance9, the European Court of Auditors (ECA) concluded that the accounts of the Agency for the financial year 2022 present fairly, in all material respects the

financial position of the Agency at 31 December 2022, 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.

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

aspects.

The Court did not make any observations regarding the financial year 2022 and there are no

observations open from previous years either.

Follow up of recommendations and action plans for audits and evaluations

Follow up of recommendations and action plans for audits and evaluations

▪ The follow-up of the evaluations performed in previous years showed that most of the recommendations on the retrospective evaluations, such as those concerning the SCIP

database (Substances of Concern In articles as such or in complex objects (Products) established under the Waste Framework Directive (WFD))10, EU Chemicals Legislation

Finder (EUCLEF), the EU Observatory for Nanomaterials (EUON), Cloud services and Portal Dashboard for national enforcement authorities (PD-NEA) and Portal Dashboard for

Member State competent authorities (PD-MSCA) have been implemented.

▪ The follow up of the retrospective evaluation on the functioning of ECHA’s Integrated

Management System (performed in 2019) showed progress in areas such as further integration of internal control and quality, simplification of IMS processes, aiming to ensure

proportionality between costs, risks and benefits at process level and promotion of staff empowerment.

Follow up of recommendations issued following investigations by the

European Anti-Fraud Office (OLAF)

N/A

Follow up of observations from the Discharge authority

For the discharge 2022, the Secretariat of the European Parliament Committee on Budgetary

Control asked all EU Decentralised Agencies for a follow-up report to the 2021 budgetary

discharge to be submitted by 15 September 2023.

9 https://www.eca.europa.eu/en/publications/SAR-AGENCIES-2022 10 https://echa.europa.eu/documents/10162/6205986/scip_evaluation_report_en.pdf/2c677149-e876-f2b1-0ba7-

3daca0a419ef?t=1665556373094

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Annual Report 2023

The report11 provides an overview of the relevant observations and recommendations from the

European Parliament Resolution12 of 10 May 2023 on discharge in respect of the implementation of the budget of ECHA for the financial year 2021, together with the measures ECHA has taken

in light of these.

On 10 May 2023, the European Parliament also adopted the resolution on discharge in respect

of the implementation of the budget of the EU agencies for the financial year 2021: performance,

financial management and control (2022/2134(DEC)). This resolution is a horizontal report containing recommendations and observations that accompanied the individual 2021 discharge

reports for each of the Agencies and Joint Undertakings. The follow-up actions to these recommendations, where a collective response was prepared by the EU Agencies Network, will

be presented in a separate report being prepared by the Agency holding the Chairing role of the EU Agencies' Network. ECHA has contributed to this report by providing information in relation

to its own actions.

In summary, there were nine recommendations from the European Parliament, out of which six

have been implemented.

Environment management

Environmental and sustainability management

To sustainably use resources and maintain sound environmental practices, ECHA has integrated

environmental management into its systems. In 2023, the Agency was recertified under both the EU Eco-Management and Audit Scheme (EMAS) and International Organisation for

Standardisation (ISO) 14001, which both confirm that ECHA evaluates, reports and improves its environmental performance. These certifications are central to realising our vision of becoming

an Agency with net-zero greenhouse gas emissions by 2030, as stated in our climate neutrality

pledge.

ECHA’s Environmental Work Programme (EWP) 2023-2025 outlines our goals, actions, and

objectives for reducing the consumption of natural resources, cutting down waste, and minimising our carbon footprint. Overall, ECHA’s total CO2 consumption was within the annual

target of the 2023-2025 environmental work programme. This was made possible with the collective effort of all ECHA staff, who limited their work travel by respecting the limits set for

total CO2 through the mission quota system introduced in 2023.

Environmental Objectives 2023-25

(Benchmark year: 2019)

Result in 2023

Building CO2 emissions reduction of 20% 61 %* decrease

Travel (meeting participants) CO2 emissions reduction of 75% 73 % decrease

Travel (staff missions) CO2 emissions reduction of 50% 70 % decrease

*Adjusted to 2022 CO2 emission factors

Actions of the EWP implemented in 2023 included the strengthening sustainability criteria and

monitoring for Green Public Procurement (GPP), the development and implementation of an

11 ECHA_2021_Discharge_report_follow-up.docx (europa.eu) 12 TA (europa.eu)

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Internal Audit methodology of the ECHA Environmental Management system (EMS) and the

review of the scope of CO2 related to ECHA’s activities. Finally, to promote and implement ECHA’s environmental objectives, over 30 communications activities were undertaken during

2023 to promote international, EU, national and ECHA climate awareness actions such as Earth Day, EU Green week and the Baltic Sea Day. ECHA was also active in inter-institutional activities

and participates in the Groupe Interinstitutionnel de Management Environnemental (GIME) and

European Union Agency Network (EUAN) Greening Network to exchange best practice on

environmental management among the EU institutions and Agencies.

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 Section IV.

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Annual Report 2023

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. Following the recommendations from the IAS audit on ‘Budget

preparation, monitoring and reporting’, ECHA also sampled and analysed the whole exceptions register. The detailed conclusions from the sampling and analysis of all those sources are

available in the internal controls assessment for the year 2023.

Internal control surveys were conducted to capture the self-assessment of Directors, Heads of Units and Management board members with regard to the functioning of the ECHA’s

management system. Staff members’ perception was also analysed as part of the annual staff survey 2023 and stakeholders’ input was captured in the media report and various retrospective

evaluations. Interviews were also conducted to deepen the analysis in the areas with low scores. The data on perception together with the other sources mentioned above were analysed and

triangulated to derive conclusions.

For 2023, the assessment confirms that the 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 (9 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.

Performance management, and stakeholder engagement are the main areas of attention as a

result of the internal controls assessment 2023 (details are available in the next section).

Improvement work is either ongoing or planned for 2024.

In terms of costing the controls, the Agency follows the definition in the General Financial Regulation13 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

13 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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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

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 3.4 % which is lower than the previous year, when the percentage was 3.7%.

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 2023, ECHA appointed a Chief Risk Officer and ECHA’s

Management Board adopted a new organisational Risk Management Policy. ECHA also developed a new Risk Management Procedure, together with implementing a revised internal framework

for addressing risk management in ECHA. Regular updates were given to the Management Board

and specific reporting continued on the IT-security related risks.

Transparency, accountability and integrity

Throughout 2023, the Agency lived up to its values of transparency and independence, 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 three layers: a simple Infocard aimed at consumers, a more detailed Brief Profile for professionals and the non-confidential

source data submitted by industry to ECHA.

During 2023, ECHA published a IUCLID dataset for 528 approved pharmaceuticals, including

results from animal studies and human data. The availability of this new data supports the development of alternatives to animal testing. In addition, a pilot project led by the European

Federation of Pharmaceutical Industries and Associations (EFPIA), and supported by ECHA, has

made an updated set of archived data from unpublished chemical tests available on the IUCLID website. The database contains now altogether information about the hazard properties of 94

substances from 517 tests.

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Annual Report 2023

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 of 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 2023. However, one issue was identified within a process where an external service provider contributed to the

Agency’s outputs. The provider had failed to declare that one of its experts was at the same time and on the same topic also advising a private entity potentially affected by ECHA’s work.

Immediately after detecting this potential for a conflict of interest, ECHA took the necessary mitigating measures, including terminating the contract in question and re-evaluating all of the

outputs produced by the external service provider in this file, to fully exclude any undue influencing. Improvements were also made to the procurement process to avoid any similar

situations in the future.

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 considered to not be in a position to participate in the voting on such dossiers.

Policy update

ECHA’s Management Board adopted in June 2023 changes to ECHA’s procedures for prevention

and management of potential conflicts of interest. Based on recommendations issued by the European Parliament as discharge authority, the European Ombudsman and the European Court

of Auditors, ECHA introduced additional measures to strengthen the monitoring of compliance

with post-employment duties by former ECHA staff members. It also converted the existing individual Memoranda of Understanding between ECHA and Member State Competent Authorities

(for ensuring the independence of Member State services to be provided to ECHA) into the format of a single document with guidelines for Member States, in order to streamline the process.

Finally, it separated the duties applicable to ECHA staff from those applicable to members of

ECHA bodies into two self-standing procedures under an overarching policy document.

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 2023, twenty-five (25) staff members left ECHA: six (6) of them went to work for another EU institution, body or Agency. Four (4) staff members moved to a national public administration

or international organisation. Eight (8) staff members moved to the private sector or started

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Annual Report 2023

self-employment and, in seven (7) 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 seven (7) cases, ECHA has not (yet) been informed about a new occupational activity, as the departure was due to retirement, permanent invalidity 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 assessments14.

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

Conflict of Interest Advisory Committee

The Conflict of Interest Advisory Committee (CoIAC) is an advisory body in the context of 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: Mr Per Ängquist, appointed by the Management

Board of ECHA (he has succeeded Ms Judite Dipane whose mandate in Management Board and CoIAC expired end of May), Mr Julio Bacio Terracino from the OECD ethics department, appointed

as an external expert, and Ms Minna Heikkilä, Head of ECHA’s Legal Affairs Unit as Chairperson.

On 31 May 2023, the CoIAC convened for its annual meeting where it took the opportunity of the change in its composition but also of the presence of the ECHA’s new Executive Director to

recapitulate and discuss the past ten years of advice given by the CoIAC.

The CoIAC further received a request for advice from the Executive Director concerning analysis

of ECHA’s CoI prevention policy and implementing rules with a view to the expanding role and mandates of the ECHA Committees and the actors involved around the Committee work. The

CoIAC agreed to base its advice on an analysis of the new and amended policy to be adopted in June 2023, and it held a number of interviews with Chairs of ECHA’s Committees as well as

Working Groups. The final advice will be delivered in 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 12annual declarations submitted by the members of the ECHA Board of Appeal revealed that all of them were in place, publicly available and sufficiently complete to

allow for effective conflict of interest prevention and management. However, while there is a duty for an annual update, for 1 declaration more than 21 months had expired since the latest

update. While the Board of Appeal confirmed that the annual renewal process was ongoing also for this alternate member, they were reminded of the importance of the prescribed 12-month

time limits to allow accurate assessments of potential conflict of interest situations.

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

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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 Behaviour15 is well communicated to all staff members.

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 Strategy16 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 2023 a mandatory all-staff ethics

training was organised, with a focus on dealing appropriately and effectively with lobbyists.

Data protection

The Data Protection Officer is an independent function within the Agency, who advises the units

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 2023, the focus areas of support concerned contractual arrangements for IT solutions procured by the Agency, as well as an in-depth assessment of the privacy risks associated with

ECHA’s project of migrating its data to the public cloud. Actions have also been taken in the context of two data protection related complaints and three personal data breaches that occurred

in ECHA and involving ECHA staff and/or stakeholders.

As required, these cases were recorded and reported, and appropriate mitigating measures were

agreed with process owners to avoid repeats in the future.

Security and business continuity

During 2023, separate training sessions on security for service providers in ECHA’s premises as

well as numerous unit/directorate fire-safety and evacuation walk throughs were organised.

Based on a scheduled fire safety inspection the agency’s Emergency Rescue Plan was updated and communicated to the Helsinki Rescue Authorities. ECHA’s emergency procedures were

audited as part of the ISO-audit and as part of the EMAS verification of ECHA’s environmental

statement.

Radiation safety training was organised for ECHA’s Radiation Safety Officer by the STUK organisation. ECHA’s business continuity organisation was reviewed and updated in 2023 to

better reflect the needs of the organisation. The agency has maintained and updated its physical security and safety equipment, in accordance with legal requirements and with due consideration

to best practice throughout the year and continuously monitors its geopolitical operating

environment.

15

https://echa.europa.eu/documents/10162/13559/code_of_good_administrative_behaviour_en.pdf/a4aa9

4f7-f631-43d6-8c28-77a10a0d0720 16 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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Annual Report 2023

Co-operation and security briefings with Commission´s Representation in Helsinki, the Helsinki

police and other local authorities on security and safety matters continued during year 2023. Finally, the Agency received one request for support from the EU Agencies Security Network

related to security management.

Regarding cybersecurity the new EU regulation on cybersecurity for Union Institutions, Bodies,

Offices and Agencies was adopted in December 2023. Preparations for the new legal obligations

were made and implementation will follow in 2024 and beyond. This includes cybersecurity risk- management, governance and control framework, maturity assessment, risk-management

measures and cybersecurity plan.

Public cloud services were being put in place the cybersecurity and resilience and continuity

arrangements were put in place. In addition, regarding data protection various impact

assessments were performed.

Cybersecurity awareness campaign was continued with two more mandatory courses for ECHA staff as well as phishing simulation exercises and European Cybersecurity Month "Be Smarter

than a Hacker" in October 2023.

Although the Cybersecurity service of the Union Institutions, Bodies, Offices and Agencies (CERT-EU) reported unprecedented rise of cybersecurity incidents in the second half of 2023,

cybersecurity of ECHA infrastructure and data, including hybrid working practice, was maintained

and no high impact security incidents were encountered in ECHA.

Conclusions of assessment internal control systems

Component Conclusion

Governance

1.1 Mission and vision

ECHA’s purpose, vision and values were reviewed in the context of the new ECHA strategy in 2023 building on input from staff, MB members and via them

stakeholders.

1.2 Ethical and organisational values

The principle is present and functioning. ECHA is perceived as a transparent organisation. Values have been updated in 2023 in consultation with staff and MB and reflect ECHA’s new tone at the top and strategy 2024 -2028. Awareness raising

efforts on dealing with sensitive topics need to remain high.

1.3 Management responsibility

The Integrated management system is functioning, and management committed to its continual improvement and flexibility. The overall management perception of

ECHA’s ability to support effective decision-making at the right level is neutral towards positive for senior management. The overall perception of the efficiency of decision-making is positive among staff. The decreasing allocation of resources in

the area of quality, internal control, internal audits and process improvements at ECHA is impacting the support to the work of the QAO network.

1.4 Human Resources

ECHA has competent and highly qualified staff, and there is Management commitment to enhance staff and competence development. There is a need for

improvement in the areas of identifying competence gaps and assessing staff performance in an objective, equal and transparent way.

1.5 Stakeholders and partners engagement

ECHA is well committed to its stakeholders and their needs. In 2023 there was a new

Communications’ strategy and a stakeholder methodology developed and efforts were made towards identification, classification and prioritisation of stakeholders. However, it cannot yet be concluded that the actions taken have been effective in

handling the deficiencies as identified in the IAC audit in 2022 since the strategy has not yet been implemented and there is work ongoing under the new stakeholders’ approach. It will be beneficial to ensure stakeholder contacts are transparently

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Annual Report 2023

shared in the organisation and tailor made to the Agency’s strategic and operational goals.

Strategy, planning and risk management

2.1 Priorities planning

and resource allocation

In 2023, Management Board adopted ECHA’s new strategy and the SPD for 2024- 2026 where it defined ECHA’s strategic and operational priorities and their implementation. ECHA demonstrates commitment to stakeholders, priorities and

objectives, which is demonstrated in the new strategic statement. The resources allocation based on strategic goals, including in horizontal services, is an area for improvement.

2.2 Risk management

The corporate level risk exercise is well established. MB involvement and establishment of clear roles and responsibilities with the new risk policy in 2023 is a positive development. Process-level risk management is less structured, and controls

are partly perceived as disproportionate or as removed without prior risk assessment. Different indications exist for the cost-benefit ratio of horizontal functions. No overall analysis is available.

Operations and operational structure

3.1 Activity

management

The activity and process management enables synergies. Efforts were made in 2023 to define the outcomes, expected performance, efficiency, and impact of activities, however, biggest part of this work will take place in 2024 in alignment with the

implementation of ECHA’s new strategy. There are control mechanisms in place to manage suppliers and contracts at ECHA. The Agency may benefit from an overall systematic analysis of how and if the risk of overdependence has materialised in the

different activities of ECHA, together with a consideration of the costs, risks and

benefits of the dependency versus the transition to new potential contractors. Awareness raising around management of contractual risks and strengthening

ECHA’s negotiating power may target contract managers and process owners in the operational units.

3.2 Information and data management

ECHA aims at effective, efficient, integrated information, communication, and data

solutions. The level of IT has remained adequate, despite the increased number of security threats. There is ongoing work with regard to improving the overall efficiency of the IT systems and the systematic involvement of stakeholders in the development

of IT products and services. Measuring the efficiency and economy of ECHA’s IT initiatives, i.e. around re-using existing IT platforms and tools will be beneficial.

3.3 Change management

ECHA overall responds to changes flexibly whilst ensuring continuity of operations.

Changes to ECHA’s financial model are expected to further enhance the flexibility and agility of the system. Specific consideration should be paid to the prerequisites (including the legislative ones) for maintaining a flexible and agile management system in the future in view of the changing stakeholders’ requirements and the

onboarding of new tasks.

Evaluation and improvement

4.1 Performance management

The structures ensure overall reliability of reporting, accuracy, completeness, and timeliness of data. 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 consistent reports and avoid manual interventions. The adequacy of corporate metrics will need to be addressed, taking

into account the balance between quantitative and qualitative indicators, such as stories, and the data needs of the different stakeholder groups.

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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 improve the communication around the Management Review topics and to ensure that cost-risk-benefit analysis is performed

when new initiatives are started.

Statement of the manager in charge of risk management and internal control

We, the undersigned,

Shay O’MALLEY And Frank BÜCHLER

Director of Resources Head of Unit Governance,

Strategy and Relations

In our capacities as manager in charge of risk management and internal control, we declare that

in accordance with ECHA’s Internal Control Framework, we have reported our advice and

recommendations on the overall state of internal control in the Agency to the Executive Director.

We hereby certify that the information provided in the present Annual Report and in its annexes is, to the best of our knowledge, accurate, reliable and complete.

Done at Helsinki, on 12 March 2024

signed signed

Shay O’MALLEY And Frank BÜCHLER

Director of Resources Head of Unit Governance,

Strategy and Relations

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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 will feed into the Management Review 2024, where senior management of the Agency gets together to reflect on the strengths, weaknesses, risks and opportunities of the

management system. Based on this retrospective assessment, the Senior Management agrees on the priorities and actions to take in 2024. 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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Annual Report 2023

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 Auditors17 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 at Helsinki, on 22 March 2024

signed

Dr Sharon McGuinness

Executive Director

17 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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Annual Report 2023

Appendices

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Annual Report 2023

Appendix I - Key indicators

WP Activity Indicator Estimate

2023 (PD) Actual Progress

1.1 Dossier preparation Inquiries received and concluded 4200 4835 115%

1.2 Dossier submission and processing Number of SME companies verified for their status 400 416 104%

1.3 Identification and prioritisation Number of substances registered above 100 t/y in the unassigned region of the chemical

universe for which a conclusion on potential regulatory follow-up was drawn 250 156 62%

1.3 Identification and prioritisation Number of groups of substances for which the assessment of regulatory needs is carried out 70 61 87%

1.4 Evaluation Compliance checks concluded: draft decisions or no action 300 301 100%

1.4 Evaluation Final decisions on dossier evaluation (testing proposals and compliance checks) 300 367 122%

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

evaluation 200 202 101%

1.4 Evaluation Substance evaluation final decisions issued 10 6 60%

1.4 Evaluation Number of substances for which a conclusion was reached in substance evaluation 25 26 104%

1.5 Authorisation Number of new entries in the Candidate List 15 8 53%

1.5 Authorisation Number of RAC & SEAC opinions adopted on applications for authorisation (number of uses) 60 58 97%

1.6 Restrictions Number of RAC & SEAC opinions on restriction proposals 6 5 83%

1.6 Restrictions Restriction proposals or investigation/screening reports developed 5 8 160%

1.7 Classification and Labelling Number of RAC opinions on proposals for harmonised classification and labelling 50 42 84%

1.7 Classification and Labelling Decisions made on requests to use an alternative chemical name (CLP Article 24) 40 26 65%

1.7 Classification and Labelling Poison centre notifications (millions) received and made available to Appointed Bodies and

Poison Centres 2 4.4 220%

2. Biocides Number of opinions on active substances [approval & renewal] 28 13 46%

2. Biocides Number of opinions on Article 15, Article 38 and Article 75(1)(g) requests 20 7 35%

2. Biocides Number of opinions on Union authorisation of biocidal products 31 10 32%

2. Biocides Number of opinions on Union authorisations subprocesses (same biocidal products,

administrative and minor changes) 52 21 40%

2. Biocides Number of technical equivalence application assessments 30 32 107%

3.1 PIC – prior informed consent Export notifications processed 11200 10857 97%

4.2 EU Chemicals Legislation Finder Number of data updates on EUCLEF pieces of legislation 4 5 125%

4.3 Support to occupational health legislationNumber of RAC opinions on OELs completed 6 6 100%

5.2 Board of Appeal Appeals concluded under REACH 12 14 117%

5.2 Board of Appeal Appeals concluded under BPR 2 1 50%

5.4 ICT Average availability of key Systems >98% 99.96% 99.96%

5.5 Financial resources Commitment rate 95% 99.20% 99.20%

5.6 Human resources Percentage of Establishment Plan posts filled 95% 96.80% 96.80%

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Annual Report 2023

Appendix II - Budget implementation reports and statistics on financial

management

Budget overview

The initially budgeted total payment appropriations for the Agency’s expenditure in 2023, as concluded by the Management Board in December 2022, amounted to EUR 117.7 million. In

addition the budget included c. EUR 0.8 million for the separately budgeted Other tasks

(“Contribution Agreements and SLAs” in the table below), and the final total expenditure, concluded in the amending budget in September 2023, amounted to EUR 118.0 million. The

budget for the Other tasks was increased by EUR 4.5 million.

Revenue Initial voted budget Amending budgets Final voted budget

Total revenue 117 724 442 249 258 117 973 700

Expenditure Initial voted budget Amending budgets Final voted budget

Commitment appropriations 117 756 974 265 505 118 022 479

Payment appropriations 117 724 442 249 258 117 973 700

Revenue

The budget funding of ECHA in 2023 consisted of the following (amounts in EUR):

Description

Initial voted

Budget

2023

Budget

Amendment

s 2023

Final voted

Budget 2023

Entitlements

established

2023

Revenue

received

2023

Fees and charges from Registrations & Updates 23 413 785 2 744 690 26 158 475 26 680 580 26 680 580

Fees and charges from Authorisations 2 932 200 200 000 3 132 200 3 297 666 3 297 666

Fees SME Administration 814 500 (114 500) 700 000 817 549 817 549

Fees and charges from CLP 90 500 - 90 500 100 600 100 600

Fees and charges from Appeals - 26 309 26 309 33 484 33 484

Total REACH Fees & Charges Income 27 250 985 2 856 499 30 107 484 30 929 879 30 929 879

Fees relating to Biocidal Active Substances 705 712 (452 579) 253 133 236 500 236 500

Fees for Union Authorisation of Biocidal products 1 430 884 (442 982) 987 902 922 200 922 200

Miscellaneous fees 2 494 878 (735 913) 1 758 965 1 631 700 1 631 700

Fees and charges from Appeals - - - 2 500 2 500

Total BPR Fee & Charges Income 4 631 474 (1 631 474) 3 000 000 2 792 900 2 792 900

REACH EU Contribution 70 711 023 (3 900 000) 66 811 023 66 811 023 66 811 023

BPR EU Contribution 7 556 055 2 000 000 9 556 055 9 556 055 9 556 055

ENV EU Contribution 4 907 490 - 4 907 490 4 907 490 4 907 490

EFTA Contribution - REACH 2 003 016 - 2 003 016 2 003 016 2 003 016

EFTA Contribution - BPR 190 924 - 190 924 190 924 190 924.00

Confederation of Switzerland Contribution - BPR 333 222 49 233 382 455 382 455 382 455.00

EFTA Contribution - ENV 140 253 - 140 253 140 253 140 253

Total EU and other Contributions 85 841 983 (1 850 767) 83 991 216 83 991 216 83 991 216

Contribution Agreement EUON - 609 000 609 000 614 000 614 000

Contribution Agreement EUCLEF - 1 519 000 1 519 000 1 053 400 1 053 400

Contribution Agreement IPA - 641 348 641 348 641 348 641 348

Contribution Agreement OELs - 975 000 975 000 975 000 975 000

SLA with EFSA 784 712 777 380 1 562 092 1 562 092 1 562 092

Total Contribution Agreements and SLAs 784 712 4 521 728 5 306 440 4 845 840 4 845 840

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Annual Report 2023

Description

Initial voted

Budget

2023

Budget

Amendment

s 2023

Final voted

Budget 2023

Entitlements

established

2023

Revenue

received

2023

Bank Interest Income - 875 000 875 000 930 573 930 573

Other income - miscellaneous - - - 96 067 128 475

Total Administrative Operations Income - 875 000 875 000 1 026 640 1 059 048

Total 118 509 154 4 770 986 123 280 140 123 586 475 123 618 883

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 2023, in terms of cash received,

amounted to EUR 30.90 million (EUR 33.36 million in 2022). In addition, EUR 0.03 million (EUR 0.03 million in 2022) was recorded in relation to REACH appeal fees18 giving a total of fees and

charges of EUR 30.93 million (EUR 33.40 million in 2022).

Broken down by fee category, ECHA collected a total of EUR 26.68 million from REACH

Registrations and Updates fees (EUR 29.72 million in 2022). Furthermore, the Agency collected

in 2023 EUR 3.30 million from Applications for Authorisation (EUR 2.78 million in 2022) and EUR 0.10 million from CLP fees (EUR 0.07 million in 2022). 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 0.52 million in 2023 (EUR 0.52

million in 2022). On top of the additional registration fees, the Agency generated EUR 0.82 million in administrative charges (EUR 0.79 million in 2022) 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 2023, the Agency received an EU balancing contribution for REACH/CLP of EUR 66.81

million (EUR 64.22 million in 2022) and a European Free Trade Association (EFTA) contribution

of EUR 2.00 million (EUR 1.61 million in 2022).

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, the Fees and Charges Regulation and by the decisions of the Management Board. The budgetary revenue from biocidal

product fees and charges for 2023, in terms of cash received, amounted to EUR 2.79 million (EUR 6.76 million in 2022). The significant decrease in the collected BPR fee income relates

primarily to the significantly reduced number of Union Authorisation applications, for single products and for product family, received in 2023 compared to 2022 (6 applications in 2023 vs.

42 applications in 2022).

18 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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Annual Report 2023

B) BPR Contributions from the General Budget of the EU

During 2023, the Agency received an EU balancing contribution of EUR 9.56 million (EUR 7.10

million in 2022) and an EFTA contribution of EUR 0.19 million (EUR 0.20 million in 2022). In addition, the Agency received a contribution from the Confederation of Switzerland of EUR 0.38

million (EUR 0.31 million in 2022).

Environmental directives and international conventions 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, and the 8th Environmental Action Programme (8th EAP), ECHA is fully financed through an EU contribution for these activities. In 2023, the EU contribution amounted to EUR

1.22 million for PIC (EUR 1.16 million in 2022), EUR 0.29 million for POPs (EUR 0.20 million in 2022), EUR 1.34 million for SCIP (EUR 1.49 million in 2022), EUR 1.72 million for DWD (EUR

1.52 million in 2022), and EUR 0.33 million for 8th EAP (EUR 0.33 million in 2022), totalling EUR 4.91 million (EUR 4.73 million in 2022). Furthermore, in 2023, the Agency received an EFTA

contribution of EUR 0.14 million (EUR 0.12 million in 2022) 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), as well as for work with respect to the Instrument for Pre-Accession

Assistance (IPA). 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. In 2023,

ECHA received an amount of EUR 4.85 million in aggregate for implementing these tasks (EUR

4.54 million in 2022).

Other miscellaneous income from Administrative operations

The table below shows the other miscellaneous income received by the Agency in 2023 (amounts

in EUR).

Description Entitlements

established 2023

Revenue received

2023

Bank Interest income 930 573 930 573

Legal recoveries 65 918 32 489

Late interest income 11 299 11 299

Recoveries from other EU agencies 28 728 28 728

Other recoveries 1 662 1 662

Other income - miscellaneous 96 067 128 475

Total Administrative Operations Income 1 026 640 1 059 048

Fee Invoicing (other information in accordance with Article 71 of FR)

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

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Annual Report 2023

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 REACH IT (REACH/CLP fees and charges) and REACH-NG (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 2023 amounted to EUR 31.01 million (EUR 33.02 million in 2022 and EUR 26.63 million in 2021). The table below depicts the breakdown of the net

invoiced REACH fees during the years 2021-2023.

REACH 2023 2022 2021

Description No of

Invoices EUR

No of Invoices

EUR No of

Invoices EUR

Invoices issued 5 743 33 510 775 6 579 35 011 416 6 588 28 295 673 Credit Notes 131 (1 790 613) 494 (1 628 744) 215 (1 161 459) Unpaid 136 (710 941) 111 (364 332) 118 (505 526) Considered paid 14 (259) 17 (842) 29 (488)

Net Invoiced 31 008 962 33 017 498 26 628 200

Write offs 5 (87 682) 13 (238 488) 29 (458 573)

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

31 December 2022, the amount to be recovered for REACH fees and charges, before any year

end accounting adjustment, stood at EUR 1.95 million relating to 290 open invoices).

B) Biocidal Products Fees and Charges

The total net invoiced by the Agency in 2023 amounted to EUR 2.88 million (EUR 6.80 million in 2022 and EUR 3.00 million in 2021). The table below depicts the breakdown of the net invoiced

BPR fees during the year.

BPR 2023 2022 2021

Description No of

Invoices EUR

No of Invoices

EUR No of

Invoices EUR

Invoices issued 608 3 618 500 1 201 8 232 100 730 3 383 700 Credit Notes 51 (589 500) 103 (1 347 000) 39 (363 700) Unpaid 14 (149 500) 37 (81 400) 14 (13 700) Considered paid - - 3 (95) 2 (110)

Net Invoiced 2 879 500 6 803 605 3 006 190

On 31 December 2023, the amount to be recovered for Biocidal product fees and charges before any year end accounting adjustments, stood at EUR 0.18 million relating to 24 open invoices (on

31 December 2022, the amount to be recovered for BPR fees and charges, before any year end

accounting adjustment, stood at EUR 0.10 million relating to 18 open invoices).

Expenditure

ECHA’s expenditure budget consists of commitment appropriations (CA) and payment appropriations (PA). The initial CAs totalled EUR 117.8 million and the initial PAs totalled EUR

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Annual Report 2023

117.7 million, while the figure concluded in the final budget is EUR 118.0 million for CAs and

EUR 118.0 million for PAs. These commitment and payment appropriations consist of C1 funds.

Budget expenditure includes payments made during the year and the carry-over of budgetary

appropriations. The following paragraphs and the tables provided in the Statistics on Financial Management and Budget (Expenditure) summarise the execution of appropriations per title while

a more detailed breakdown is provided in Appendix I.

Changes and implementation of the commitment appropriations for the current year

(C1)

The initially adopted budget for the Agency in 2023 was EUR 117.7 million and the overall net increase during the year, including 22 transfers and three amending budgets, was EUR 0.3

million, to arrive at EUR 118.0 million as the final budget.

The main reason for the increase in the budget was the positive fee income development, which

allowed, for instance, accelerating some IT investments.

The final executed amount totalled EUR 117.2 million corresponding to an execution rate of 99.3

% for the appropriations.

Carry over of appropriations to 2024

The commitment and payment appropriations carried over to 2024 totals EUR 14.4 million,

corresponding to 12.0 % 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 2.6 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 Directives and International Conventions (PIC, POPs, Waste Framework Directive

(SCIP), Drinking Water Directive and the 8th Environmental Action Programme). The carry-over

in operational titles totalled EUR 11.5 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.

Implementation of the appropriations carried over from 2022 (C8)

The amount carried over from 2022 totalled EUR 15.6 million and the finally executed amount was EUR 15.4 million, corresponding to 99 %. The cancelled 1 % relates mostly to IT projects

in Title 2 and lower than anticipated costs for legal services related to debt collection of

administrative charges.

Late interest payments

During the year 2023, ECHA did not pay late interest for commercial invoices.

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Annual Report 2023

Procurement procedures

During 2023 budget implementation, ECHA signed 337 contracts and purchase orders19. Out of the 337 signed contracts, 276 were specific contracts and orders under framework contracts

(FWC) and 61 were contracts resulting from tendering procedures. Out of the 61 contracts resulting from procurement, ECHA concluded four new FWCs: for managed IT workplace

services, for consultancy on IT User Experience, for New Approach Methodologies (NAMS), and for the EU Chemicals Legislation Finder (EUCLEF) and led the procurement to establish two

interagency FWCs for standard management certification services and for interim services to be

signed in early 2024. ECHA also signed three multiannual contracts: for security and reception services, for cleaning services, and for the Cloudia e-procurement platform. ECHA also joined

seven inter-institutional FWCs: for event management and related communication services (DG RTD), for audits and controls (DG BUDG), for leadership and management skills (EPSO), for

learning and development (DG HR), for attracting and sourcing of candidates (EMA), for HR consultancy services (DG HR) and for Microsoft high-level services (DIGIT), and two DPS of

DIGIT for Software (SIDE III) and Telecommunication Services.

A total of 11 contracts were signed following negotiated procedures without prior publication

based on the relevant rules of the Financial Regulation (Annex 1–11.1), eight of which refer to

legal services; and three for technical reasons for subscriptions to a scientific database and professional journals, as well as for specialised software. Furthermore, there were two IT FWC

ceiling increases that had been foreseen in the specifications of the original procurement

procedure.

In 2023, the performance of the suppliers of the Agency was satisfactory overall and in accordance with the terms of the contracts, with very 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.

ECHA continued relying on and adopting suitable IT tools (e.g., Cloudia, PPMT) in its procurement

and contract processes, and undertook the revision work of its overall and sectoral procurement strategy, which included participating in a 4-month specialised training delivered by the KEINO

Academy of the central purchasing body (Hansel) in Finland. Theannual list of contractors is

published by ECHA by 30 June of each year for the previous year on ECHA’s website 20.

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) of ECHA’s Financial Regulation, 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.

19 This number also includes amendments with budgetary commitment. 20 https://echa.europa.eu/view-article/-/journal_content/title/annual-list-of-awarded-contracts

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Annual Report 2023

Statistics on Financial Management and Budget (Expenditure)

Budget 2023: Breakdown and changes in commitment appropriations and implementation of the appropriations for the

current year (C1) per Title21 (EUR)

Title Description Budget 2023

(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 79 708 220 145 217 79 853 437 79 574 605 99.7% 79 853 437 79 278 523 99.3% 296 082 0.4% 278 832

A-2 BUILDING. EQUIPMENT AND MISCELL OPER

EXPEND 17 067 482 -62 455 17 005 027 16 970 489 99.8% 17 005 027 14 363 906 84.5% 2 606 583 15.4% 34 538

B0-3 OPERATIONAL EXPENDITURE - REACH/CLP 16 645 769 -264 219 16 381 550 15 964 264 97.5% 16 332 771 7 308 895 44.7% 8 607 206 53.9% 417 286

B0-4 OPERATIONAL EXPENDITURE - BIOCIDES 1 898 690 440 346 2 339 036 2 245 984 96.0% 2 339 036 976 720 41.8% 1 269 264 56.5% 93 052

B0-5 OPERATIONAL EXPENDITURE - ENVIRONMENTAL DIRECTIVES AND

INTERNATIONAL CONVENTIONS

2 436 813 6 616 2 443 429 2 420 319 99.1% 2 443 429 831 865 34.0% 1 588 454 65.6% 23 110

117 756 974 265 505 118 022 479 117 175 661 99.3% 117 973 700 102 759 909 87.1% 14 367 589 12.3% 846 818

21 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.

81

Annual Report 2023

Budget 2023: 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 2023 (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 68 878 569 -28 350 68 850 219 68 656 483 99.7% 68 850 219 68 405 623 99.4% 250 860 0.4% 193 736

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND

14 473 218 -54 685 14 418 533 14 389 257 99.8% 14 418 533 12 178 875 84.5% 2 210 382 15.4% 29 276

B0-3 OPERATIONAL EXPENDITURE - REACH/CLP

16 645 769 -264 219 16 381 550 15 964 264 97.5% 16 332 771 7 308 895 44.7% 8 607 206 53.9% 417 286

99 997 556 -347 254 99 650 302 99 010 004 99.4% 99 601 523 87 893 392 88.2% 11 068 448 11.2% 640 298

BIOCIDES

Title Description Budget 2023 (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 8 833 154 93 345 8 926 499 8 868 065 99.3% 8 926 499 8 837 326 99.0% 30 739 0.3% 58 434

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND

1 979 831 -5 932 1 973 899 1 969 887 99.8% 1 973 899 1 667 524 84.5% 302 364 15.3% 4 012

B0-4 OPERATIONAL EXPENDITURE - BIOCIDES

1 898 690 440 346 2 339 036 2 245 984 96.0% 2 339 036 976 720 41.8% 1 269 264 56.5% 93 052

12 711 675 527 759 13 239 434 13 083 937 98.8% 13 239 434 11 481 570 86.7% 1 602 367 12.2% 155 497

ENVIRONMENTAL DIRECTIVES AND INTERNATIONAL CONVENTIONS

Title Description Budget 2023 (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 1 996 497 80 222 2 076 719 2 050 056 98.7% 2 076 719 2 035 573 98.0% 14 483 0.7% 26 663

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND

614 433 -1 838 612 595 611 344 99.8% 612 595 517 507 84.5% 93 837 15.3% 1 251

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Annual Report 2023

B0-5

OPERATIONAL EXPENDITURE - ENVIRONMENTAL DIRECTIVES AND INTERNATIONAL CONVENTIONS

2 436 813 6 616 2 443 429 2 420 319 99.1% 2 443 429 831 865 34.0% 1 588 454 65.6% 23 110

5 047 743 85 000 5 132 743 5 081 720 99.0% 5 132 743 3 384 946 65.9% 1 696 774 33.4% 51 023

Budget 2023: Implementation of differentiated appropriations (EUR)

Budget line

Available

commitment

appropriations

Commitments

made %

Available

payment

appropriations

Payments

made %

B3-111 Substance evaluation and Rapporteurs (Multiannual) 910 363 909 694 99.93% 771 664 771 618 99.99%

B3-801 Cooperation with international organisations for IT

programs 610 000 609 982 c.100% 699 920 699 894 c.100%

Total 1 520 363 1 519 676 c.100% 1 471 584 1 471 512 c.100%

Out of the total available commitment appropriations of EUR 2 672 838, the amount of EUR 1 152 475 is stemming from commitments made

in earlier financial years. The available commitment appropriations for 2023 totalled EUR 1 520 363 out of which EUR 1 519 676 (c.100%) were committed.

Budget 2023: 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 59 171 38 827 66% 59 171 38 827 66% 20 345 20 345

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND C4 6 176 0 0% 6 176 0 0% 6 176 6 176

B0-3 OPERATIONAL EXPENDITURE - REACH/CLP C4 32 839 3 362 10% 32 839 1 939 6% 29 477 30 900

B0-4OPERATIONAL EXPENDITURE - BIOCIDESC460645375%60626143%153345

B0-5 OPERATIONAL EXPENDITURE - ENV C4 159 159 100% 159 92 58% 0 67

C4 98 951 42 801 43% 98 951 41 119 42% 56 150 57 832

Title Description FS Commitments Appropriations

Commitments Established

Com %

Payments Appropriations

Payments Executed

Pay% Carried over commitment

appropriations

Carried over payment

appropriations

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Annual Report 2023

A-1 STAFF C5 28 728 28 728 100% 28 728 28 728 100% 0 0

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND C5 11 299 11 299 100% 11 299 11 299 100% 0 0

B0-3 OPERATIONAL EXPENDITURE - REACH/CLP C5 33 043 21 384 65% 33 043 19 769 60% 0 1 615

B0-4 OPERATIONAL EXPENDITURE - BIOCIDES C5 852 852 100% 852 852 100% 0 0

C5 73 922 62 263 84% 73 922 60 648 82% 0 1 615

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 644 465 189 377 29% 644 465 171 977 27% 455 088 472 488

B6-010 EUON R0 1 544 900 855 341 55% 1 544 900 648 055 42% 689 559 896 844

B6-011 EUCLEF R0 3 338 602 1 532 088 46% 3 338 602 1 012 758 30% 1 806 514 2 325 845

B6-020 Occupational exposure limits R0 1 591 105 1 030 206 65% 1 591 105 889 623 56% 560 899 701 483

B6-021 Further development of IUCLID (w/ third parties) R0 2 517 055 2 114 362 84% 2 517 055 1 748 316 69% 402 693 768 739

R0 9 636 128 5 721 375 59% 9 636 128 4 470 729 46% 3 914 753 5 165 399

Budget 2023: Implementation of the appropriations carried forward from previous year (C8) Per Title (EUR)

Title Description Carried Forward from

2022 Paid Cancelled % Cancelled

A-1 STAFF 196 707 192 366 4 342 2%

A-2 BUILDING. EQUIPMENT AND MISCELL. OPER EXPEND 1 761 736 1 723 707 38 029 2%

B0-3 OPERATIONAL EXPENDITURE - REACH/CLP 10 147 612 10 040 092 107 521 1%

B0-4 OPERATIONAL EXPENDITURE - BIOCIDES 1 929 864 1 922 169 7 696 0%

B0-5 OPERATIONAL EXPENDITURE - ENVIRONMENTAL DIRECTIVES AND

INTERNATIONAL CONVENTIONS 1 519 288 1 513 877 5 411 0%

15 555 208 15 392 209 162 999 1%

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Annual Report 2023

Appendix III – Organisational chart

85

Annual Report 2023

Appendix IV - Establishment plan and additional information on human

resources management

Last establishment plan adopted

Category

and

grade

Establishment plan in voted EU Budget 2023 Posts filled 31 December 2023*

TA TA

REACH/ Biocides ENV TOTAL

REACH/ Biocides ENV TOTAL

CLP CLP

AD 15 0 0

AD 14 6 6 2 2

AD 13 13 1 14 4 4

AD 12 12 2 14 9 1 10

AD 11 30 1 31 18 18

AD 10 41 5 46 42 5 47

AD 9 60 10 1 71 41 7 1 49

AD 8 52 9 61 64 7 71

AD 7 53 9 1 63 44 7 1 52

AD 6 27 5 3 35 47 9 56

AD 5 16 1 17 27 6 3 36

Total

AD 310 43 5 358 298 42 5 345

AST 11 0 0

AST 10 0 0

AST 9 3 3 0

AST 8 8 8 5 5

AST 7 10 1 2 13 12 12

AST 6 18 1 19 16 1 17

AST 5 26 3 2 31 22 2 1 25

AST 4 16 3 2 21 8 2 3 13

AST 3 10 1 11 11 3 14

AST 2 3 3 18 1 2 21

AST 1 0 0

Total

AST 94 9 6 109 92 9 6 107

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 11 467 390 51 11 452

CA CA

estimated need of FTEs 2023 posts filled 31 December 202322

REACH/ Biocides ENV

Other

tasks TOTAL

REACH/ Biocides ENV

Other

tasks TOTAL

CLP CLP

CA FG IV 27 7 8 13 55 20 5 6 10 41

CA FG III 53 6 2 1 62 59 6 4 4 73

CA FG II 17 2 0 0.5 19.5 16 2 18

CA FG I 0 0

22 Under external recruitment (included in figures): REACH: 2 TAs and 2 CAs; BIOCIDES: 1CA

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Annual Report 2023

TOTAL 97 15 10 14.5 136.5 95 13 10 14 132

Percentage of posts filled on 31 December 2023

REACH/ CLP Biocides ENV

TA posts 96.53% 98.08% 100.00%

CA posts 97.94% 86.67% 100.00%

Geographical and gender balance (as per 31 December 2023)23

Nationality

TA CA OVERALL

% Male Female Total Male Female Total Sum

1 AT Austrian 2 4 6 0 0 0 6 1.0%

2 BE Belgian 12 10 22 2 1 3 25 4.3%

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 0.8%

6 DE German 16 9 25 1 0 1 26 4.5%

7 DK Danish 1 1 2 0 0 0 2 0.4%

8 EE Estonian 0 6 6 1 0 1 7 1.2%

9 ES Spanish 16 12 28 6 5 11 39 6.7%

10 FI Finnish 59 85 144 15 30 45 189 32.6%

11 FR French 20 15 35 2 6 8 43 7.4%

12 GR Greek 14 6 20 6 6 12 32 5.5%

13 HR Croatian 0 0 0 0 1 1 1 0.2%

14 HU Hungarian 2 6 8 0 4 4 12 2.1%

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 25 18 43 5 2 7 50 8.6%

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 1 5 6 1 1 2 8 1.4%

22 MT Maltese 0 3 3 0 0 0 3 0.5%

23 NL Dutch 9 5 14 2 1 3 17 2.9%

24 NO Norwegian 0 1 1 0 0 0 1 0.2%

25 PL Polish 8 9 17 1 3 4 21 3.6%

26 PT Portuguese 5 7 12 0 2 2 14 2.4%

27 RO Romanian 2 5 7 3 7 10 17 2.9%

28 SE Swedish 3 1 4 1 0 1 5 0.9%

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 212 238 450 52 77 129 579 100.0%

23 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 2023

Middle and senior management – gender and nationality overview24

NATIONALITY MALE FEMALE TOTAL %

BE Belgian 2 0 2 6.1%

DE German 2 0 2 6.1%

ES Spanish 2 1 3 9.1%

FI Finnish 3 4 7 21.2%

FR French 3 0 3 9.1%

GR Greek 1 0 1 3.0%

IE Irish 4 2 6 18.2%

IT Italian 2 0 2 6.1%

NL Dutch 2 0 2 6.1%

MT Maltese 0 1 1 3.0%

PT Portuguese 1 0 1 3.0%

RO Romanian 0 1 1 3.0%

SE Swedish 1 0 1 3.0%

SI Slovenian 1 0 1 3.0%

Total OVERALL 24 9 33 100%

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

bracket)

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

years +

indefinite

AD 12

Management-Operations

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

Operations/Administration

24 Data in the table includes statutory staff in place on the indicated date. Posts under recruitment are not included.

88

Annual Report 2023

Key functions

Type of

contract

(official,

TA or CA)

Function

group, grade

of

recruitment

(or bottom of

grade bracket

if published

with such

bracket)

Indication whether the

function is dedicated to

administrative support or

operations subject to

definitions used in

screening methodology

profile

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 or Board of Appeal Chair

TA - 5+5

years +

indefinite

AD 10 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 AD 10 Administration

89

Annual Report 2023

Key functions

Type of

contract

(official,

TA or CA)

Function

group, grade

of

recruitment

(or bottom of

grade bracket

if published

with such

bracket)

Indication whether the

function is dedicated to

administrative support or

operations subject to

definitions used in

screening methodology

years +

indefinite

Benchmarking against previous results

ECHA undertook the benchmarking (job screening) exercise in 2023, in accordance with the

Commission’s requirements. The 2023 results indicate an increase of 0.3% in the percentage of

administrative support and coordination staff, an increase of 0.2% in the percentage of the operational staff and a decrease of 0.5% in the percentage of neutral staff in comparison to

2022.

Job Type (sub) category 2022 2023

Administrative support and Coordination 14.5 14.8

Administrative Support 11.7 12.1

Coordination 2.8 2.8

Operational 81.4 81.6

Top level Operational Coordination 2.6 2.5

Programme management and

Implementation 57 56.1

Evaluation & Impact assessment 3.4 3.2

General operational 18.6 19.8

Neutral 4.1 3.6

Finance/ Control 4.0 3.6

Linguistics 0.1 0.0

90

Annual Report 2023

Appendix V – Human and financial resources by activity

WP activity

Actual consumption of

the human resources

Executed budget 2023

1.1 Dossier preparation 29 7 595 644

1.2 Dossier submission and processing 34 8 375 567

1.3 Identification and prioritisation 55 12 739 439

1.4 Evaluation 91 16 617 743

1.5 Authorisation 26 5 549 010

1.6 Restrictions 29 6 137 817

1.7 Classification and labelling 33 6 399 609

1.8 Safe and sustainable use of chemicals 1 202 710

1.9 Data management and dissemination 23 6 800 546

1.10 Promotion of alternatives to animal testing 6 2 454 907

2. Biocides 56 10 213 821

3.1 Prior Informed Consent 7 1 598 449

3.2 Persistent organic pollutants 1 218 104

3.3 Waste Framework Directive 4 968 043

3.4 Drinking Water Directive 7 1 263 755

3.5 8th Environmental Action Programme 1 313 731

4.1 EU Observatory for Nanomaterials 3 855 341

4.2 EU Chemicals Legislation Finder 1 1 532 088

4.3 Support to Occupational health legislation 6 1 030 206

4.4 Instrument for Pre-Accession assistance (IPA) 1 189 377

4.5 Support to other legislation 1

4.6 IUCLID for EFSA 4 2 114 362

4.7 Partnership for the Assessment of Risk from

Chemicals 2

Governance and enablers 169 29 726 767

Overall TOTAL 590 122 897 036

91

Annual Report 2023

Appendix 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

2022 2023

Grant agreements

1. IPA 20.12.2022 675 103 42

months

Commission

DG NEAR

Amount

Number of

CA 1 1.5

Number of

SNEs - -

Amount

Number

of CA 1 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 - -

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 12.5

Number

of SNEs

--

92

Annual Report 2023

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, and ECHA has pledged to be climate-neutral by 2030.

Overview of the Agency's environmental management system

ECHA has put in place a quality and environmental management system, aligned to its strategy,

which commits to incorporating sustainability measures within the internal follow-up of actions and reporting.

To achieve climate neutrality, ECHA has set objectives, targets and actions which are described

its environmental work programme which was renewed in 2023 to cover the period up to 2025.

In 2023, ECHA was recertified under ISO 14001:2015 standard (Environmental Management

System) and ECHA’s 2022 Environmental Statement was successfully registered under EMAS.

Environmental aspects, indicators and targets

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Annual Report 2023

94

Annual Report 2023

Actions to improve and communicate environmental performance

In support of the ISO 14001:2015 environmental re-certification and EMAS registration, which includes additional planning and reporting on ECHA’s environmental performance, the Agency

has established a dedicated team for Environmental Compliance and Sustainability whose role is to facilitate the implementation the actions identified in ECHA’s Environmental Work Programme.

2023 was the first year of ECHA’s updated multi-annual Environmental Work Programme (2023- 2025) which maintained the previous objectives and introduced new actions and targets. In 2023

ECHA:

- reduced CO2 emissions from travel (staff missions) - strengthened environmental and sustainability standards into ECHA procurement

(including the canteen services). - adapted the programming in building management systems and improving automation

of technology.

- promoted over 30 staff information campaigns and environmental initiatives at local, national, EU and international levels of interest.

- reduced waste volume and the amount of landfill waste by leasing ICT equipment with sustainability requirements in the contract and recycling used equipment (mobile

phones for Ukraine). - reviewed the scope of ECHA’s CO2 footprint to ensure a comprehensive overview and to

avoid gaps and reputational damage which will be included in future environmental reports.

- took preparatory actions to implement a pilot project on carbon capture to begin CO2

offsetting under the forthcoming EU carbon certification Regulation. - developed and implemented an Internal Audit Methodology for its Environmental

Management System in cooperation with the European Environment Agency.

EUROPEAN CHEMICALS AGENCY

P.O. BOX 400, FI-00121 HELSINKI, FINLAND

ECHA.EUROPA.EU

Annual Report 2023

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 2023

Reference: ECHA-24-R-03-EN ISBN: 978-92-9468-355-7

ISSN: 2600-0849 Cat. Number: ED-BF-24-001-EN-N

DOI: 10.2823/25240 Publ.date: April 2024

Language: EN

© European Chemicals Agency, 2024

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

3

Annual Report 2023

Table of Contents

TABLE OF CONTENTS .................................................................................................. 3

LIST OF ACRONYMS .................................................................................................... 5

MANAGEMENT BOARD ANALYSIS AND ASSESSMENT .................................................. 8 Achievements of the year ........................................................................................................... 8 Management ............................................................................................................................ 9 Budgetary and financial management .......................................................................................... 9 Human resources management ................................................................................................... 9 Audit and retrospective evaluation results and follow-up on recommendations ................................... 9 Internal control framework and Integrated Management System ...................................................... 9 Organisational risk management ............................................................................................... 10 Management Assurance ........................................................................................................... 10 Recommendations for the secretariat for 2024 ............................................................................ 10 Acknowledgments ................................................................................................................... 11 Conclusion ............................................................................................................................. 11

FOREWORD ............................................................................................................... 12

EXECUTIVE SUMMARY .............................................................................................. 14

PART I. ACHIEVEMENTS OF THE YEAR ...................................................................... 19 Dossier preparation ................................................................................................................. 19 Dossier submission and processing ............................................................................................ 20 Identification and prioritisation .................................................................................................. 22 Evaluation ............................................................................................................................. 23 Authorisation .......................................................................................................................... 25 Restrictions ............................................................................................................................ 26 Classification and labelling ........................................................................................................ 28 Safe and sustainable use of chemicals ........................................................................................ 30 Data management and dissemination ........................................................................................ 31 Promotion of alternatives to animal testing ................................................................................. 32 Biocides ................................................................................................................................. 33 Prior informed consent ............................................................................................................. 36 Persistent organic pollutants ..................................................................................................... 37 Waste Framework Directive ...................................................................................................... 38 Drinking Water Directive .......................................................................................................... 39 Support to the 8th Environmental Action Programme of the EU ....................................................... 40 EU Observatory for Nanomaterials ............................................................................................. 40 EU Chemicals Legislation Finder ................................................................................................ 41 Support to occupational health legislation ................................................................................... 41 Instrument for Pre-Accession Assistance (IPA) ............................................................................ 42 Support to other legislation ...................................................................................................... 43 IUCLID for EFSA ..................................................................................................................... 43 Partnership for the Assessment of Risk from Chemicals (PARC) ...................................................... 44 Support to Forum ................................................................................................................... 45 Board of Appeal ...................................................................................................................... 46 Management .......................................................................................................................... 47 ICT 50 Financial Resources ................................................................................................................. 51 Human Resources ................................................................................................................... 52 Corporate Services .................................................................................................................. 53

PART II. MANAGEMENT ............................................................................................ 55 Management Board ................................................................................................................. 55 Major developments ................................................................................................................ 55 Budgetary and financial management ........................................................................................ 56 Delegation and sub-delegation of the powers of budget implementation to agency’s Staff .................. 56 Human Resources (HR) management ......................................................................................... 56

4

Annual Report 2023

Strategy for efficiency gains ..................................................................................................... 57 Assessment of audit and retrospective evaluation results during the reporting year .......................... 57 Follow up of recommendations and action plans for audits and evaluations ...................................... 59 Follow up of observations from the Discharge authority ................................................................ 59 Environment management ....................................................................................................... 60 Assessment by management .................................................................................................... 61

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

........................................................................................................................... 62 Effectiveness of internal control system ...................................................................................... 62 Conclusions of assessment internal control systems ..................................................................... 67 Statement of the manager in charge of risk management and internal control ................................. 69

PART IV. MANAGEMENT ASSURANCE ........................................................................ 70 Review of the elements supporting assurance ............................................................................. 70 Reservations .......................................................................................................................... 70

PART V. DECLARATION OF ASSURANCE .................................................................... 71 Declaration of assurance by the Authorising Officer ...................................................................... 71

APPENDICES ............................................................................................................. 72 Appendix I - Key indicators ...................................................................................................... 73 Appendix II - Budget implementation reports and statistics on financial management ....................... 74 Appendix III – Organisational chart ........................................................................................... 84 Appendix IV - Establishment plan and additional information on human resources management ......... 85 Appendix V – Human and financial resources by activity ............................................................... 90 Appendix VI – Contribution, grant and service-level agreements .................................................... 91 Annex VII - Environment management....................................................................................... 92

5

Annual Report 2023

List of acronyms

Acronym Description

AD Administrator

APCRA Accelerating the Pace of Chemical Risk Assessment

ARN Assessment of regulatory needs

ASO Accredited Stakeholder Organisation

AST Assistant

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

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

CCH Compliance check

CCS Chemicals Strategy for Sustainability of the Commission

CEFIC Conseil Européen des Fédérations de l'Industrie Chimique

CEOS Conditions of Employment of

Other Servants of the European Union

Chesar Chemical Safety Assessment and

Reporting tool

CLH Harmonised classification and labelling

CLP Classification, labelling and

packaging (and the respective Regulation)

CMD Carcinogens and Mutagens

Directive 2004/37/EC

CMR Carcinogenic, mutagenic or toxic to reproduction

CoIAC Conflict of Interest Advisory Committee

COM European Commission

CoRAP Community rolling action plan

CSA Chemical safety assessment

CSR Chemical safety report

CSS Chemicals Strategy for

Sustainability of the Commission

DEC Discharge procedure

Acronym Description

2021/2157(DEC)

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

and Innovation

DNA Designated national authorities

DNEL Derived no-effect level

DPP Digital Product Passports

DU Downstream user

DWD Drinking Water Directive

EAP Environmental Action Programme

EC European Commission

ECA European Court of Auditors

ECETOC TRA European Centre for

Ecotoxicology and Toxicology of Chemicals Targeted Risk Assessment

ECHA European Chemicals Agency

eChemPortal OECD Global Portal to Information on Chemical Substances

ED Endocrine disruptor

EEA European Economic Area

EFSA European Food Safety Authority

EFTA European Free Trade Association

EMA European Medicines Agency

EMAS EU Eco-Management and Audit

Scheme

EMCDDA European Monitoring Centre for Drugs and Drug Addiction

EMS Environmental management system

US EPA United States Environmental Protection Agency

ERR Exposure-risk relationship

6

Annual Report 2023

Acronym Description

ES Exposure scenario

EU European Union

EUCLEF European Chemicals Legislation

Finder

EUON European Union Observatory for Nanomaterials

EUSES European Union System for Evaluation of Substances

Forum Forum for Exchange of

Information on Enforcement

FRA Final regulatory action

FTE Full-time equivalent

FWC Framework contract

GIME Groupe Interinstitutionnel de Management Environnemental (Interinstitutional Group for

Environmental Management)

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

IR Information requirements

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

MFF Multiannual Financial Framework

MISA Metals and Inorganics Sectoral

Approach

Acronym Description

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

NONS Notification of New Substances

Odyssey ECHA’s tool to support evaluation tasks

OECD Organisation for Economic Co- operation and Development

OEL Occupational exposure limit

OSH Occupational safety and health

PACT Public activities coordination tool

PAH Polycyclic aromatic hydrocarbons

PARC Partnership for the Assessment of Risks of Chemicals

PBT Persistent, bioaccumulative and toxic

PCN Poison Centre Notifications

PFAS Per- and polyfluoroalkyl substances

PFCA Perfluorocarboxylic acids

PFOS Perfluorooctanesulfonic acid

PIC Rotterdam Convention on the

prior informed consent procedure (and the respective Regulation)

PMT Persistent, mobile and toxic

POP Persistent organic pollutants

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

PVC Polyvinyl chloride

QSAR Quantitative Structure-Activity Relationship

R4BP Register for Biocidal Products

RAC Committee for Risk Assessment

REACH Registration, evaluation,

authorisation and restriction of

7

Annual Report 2023

Acronym Description

chemicals (and the respective Regulation)

REACH-IT Central IT system providing

support for REACH

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

project)

DG RTD Directorate-General for Research and Innovation

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

SLA Service Level Agreement

SME Small and medium-sized

enterprises

SNE Seconded national expert

SON Security Officers Network

SPC Summary of product

characteristics

SVHC Substance of very high concern

TA Temporary agent

TP Testing proposal

Acronym Description

UNEP United Nations Environment Programme

UNGHS United Nations Globally

Harmonised System of classification and labelling of chemicals

UVCB Substance of Unknown or Variable composition, Complex reaction products or Biological

materials

vPvB Very persistent and very bioaccumulative

WFD Waste Framework Directive

WP Work programme

1S1A One substance one assessment

8

Annual Report 2023

Management Board analysis and

assessment

The Management Board welcomes the Annual Report 2023, combining the reports prepared

according to 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 2023, the performance of the Agency against the expected inputs, outputs, outcomes, and the impacts defined in the Programming Document 2023-20263. 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

We consider that the performance and quality of the outputs in 2023 were high, as shown in

Part I of the Annual Report.

In assessing4 the Consolidated Annual Activity Report of the Authorising Officer for 2023, we:

• Emphasize the importance of the ECHA Strategy adopted in December 2023, in providing

direction and priorities for ECHA in implementing its evolving mandate.

• Commend the secretariat and all ECHA bodies for being prepared for and having started

to implement new or expanded legal mandates.

• Welcome that ECHA made progress with the Integrated Regulatory Strategy, including

identification of (groups of) substances that are candidates for regulatory risk management measures, addressed the key actions from the Joint Evaluation Action Plan

and started the review of its outcomes.

• Acknowledge the significant support provided to the European Commission in the

implementation of the Chemicals Strategy for Sustainability (CSS).

• Express concern regarding the membership of the ECHA scientific Committees, which

poses a risk of not meeting legal deadlines and targets in operational areas that are

dependent on the Committees outputs.

• Acknowledge and support the efforts of all contributors in facilitating the preparation of

the RAC/SEAC opinion on the Annex XV report for the UPFAS restriction, given its unique

complexity and size.

• Acknowledge that the number of opinions that the Biocidal Products Committee (BPC) was in a position to deliver in 2023 was well below estimated numbers due to significantly

less submissions by the Member States of evaluation dossiers both for active substances

and Union authorisations.

1 Article 78(a) of the REACH Regulation. 2 Article 48 of ECHA’s Financial Regulation. 3 https://echa.europa.eu/documents/10162/17623970/final_mb_41_2022_echa_pd_2023-2026_en.pdf 4 Assessment pursuant to Article 48(1) of the Agency’s Financial Regulation.

9

Annual Report 2023

• Acknowledge the efforts in promoting alternatives to animal testing, and in clarifying the

opportunities and challenges in moving away from animal testing for the regulatory

assessment of chemicals.

• Welcome the increased clarity in the way the secretariat reports to the Management

Board.

• Note that ECHA defined 179 specific outputs for 2023 and accomplished 154 out of these

during the year. In addition, 23 actions are in progress and 2 not done.

Based on the periodical reporting and the Annual Report 2023 prepared by the secretariat, the

Board makes the following observations:

Management

• The 10 recommendations the Management Board provided for 2023 as part of the

assessment of the 2022 Annual Report have been implemented or are in progress.

Budgetary and financial management

• We welcome the outstanding performance of ECHA in implementing its budget with 99%

of commitment rate and 1% of cancelled payment appropriation rate, 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 and the strong focus on staff wellbeing, diversity and inclusion.

Audit and retrospective evaluation results and follow-up on recommendations

• We received adequate information from, and assurance 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 European Court of Auditors adopted a positive opinion regarding the 2022 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 2021 budget, including the decision on the closure of the

2021 accounts. The secretariat duly provided replies to the Discharge Authority’s

observations and the implementation of the recommendations is on track.

• The Internal Audit Service (IAS) of the Commission conducted an audit on ‘Budget

preparation, monitoring and reporting’. The audit did not result in any critical or very important recommendations. The audit identified two improvement areas, classified as

important, on resource allocation and the exceptions register.

Internal control framework and Integrated Management System

• The internal control framework remains effective and functioning as intended. Areas

identified for improvement are not considered major or critical and relate to areas such

as performance management and stakeholder engagement.

• We welcome that the Integrated Management System Strategy and Framework was

revised in 2023, to align it with the new ECHA Strategy 2024-2028.

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Annual Report 2023

• ECHA’s ISO 9001:2015 and 14001:2015 quality certificates were renewed with no non-

conformities found in the re-certification audit, and EMAS (Eco-Management and Audit

Scheme) registration maintained.

Organisational risk management

• We welcome the development of the new organisational Risk Management Policy, which

includes a dedicated role for a Chief Risk Officer. 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 that no high impact IT/cyber security incidents took place in 2023 and that

ECHA is ready to implement the new EU regulation on cybersecurity for Union Institutions,

Bodies, Offices and Agencies.

Management Assurance

The 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.

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

Recommendations for the secretariat for 2024

Based on our assessment, the Management Board requests particular emphasis in 2024 on the following actions, without prejudice to the implementation of the Single Programming Document

2024-2026:

1. Actively continue engaging with Member State partners and stakeholders.

2. Take appropriate actions to maintain the ECHA Committees' ability to deliver transparent,

independent and high-quality outputs, including attention on ensuring the necessary level

of competence, expertise and working structures.

3. Follow up on the results of the Integrated Regulatory Strategy (IRS), including promoting and facilitating the uptake of regulatory measures by Member States and further refining

the performance indicators and targets for grouping.

4. Maintain efforts to bring to the Management Board timely and sufficient information on

the implementation of current and potential new tasks, including impacts, synergies,

efficiency gains, challenges and risks, including the sustainability of ECHA's Committees.

5. Support the preparation of the RAC/SEAC opinion on the UPFAS dossier to ensure the

delivery of a transparent, independent and high-quality opinion in an appropriate

timeframe.

6. Support the implementation of the new hazard classes in the CLP regulation.

7. Improve and facilitate cooperation with other Agencies and Commission Directorates

General to promote issues of common interest.

8. Maintain efforts in providing fit-for-purpose support to Member State Competent

Authorities for biocidal products, with a view to achieving progress with the Review

Programme for existing active substances.

9. Review the costing of ECHA activities and assess whether the services delivered to duty

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Annual Report 2023

holders are fully charged.

10. Maintain strong focus on staff wellbeing, diversity and inclusion.

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 2023.

Conclusion

In assessing the Annual Report 2023, the Management Board concludes that the overall

performance of ECHA is in line with the objectives included in the Agency’s Programming

Document 2023-2026.

Based on the above observations, the Management Board requests that the Annual Report 2023 be forwarded to the Member States, the Court of Auditors, the Commission, the European

Parliament, the European Economic and Social Committee and the Council.

12

Annual Report 2023

Foreword

Dr Sharon McGuinness

Executive Director

I am pleased to present the Agency’s annual report for

2023. This is the final report under ECHA’s Strategic Plan 2019-2023, and it shows that we have delivered the

actions and performance metrics set out in our Work

Programme for 2023.

We continued to deliver our legal mandate across the wide

range of chemical legislation under our remit. With respect to the REACH and CLP Regulations, our two scientific

committees (Risk Assessment Committee and Socio- Economic Analysis Committee) delivered six opinions on

restriction dossiers, 58 opinions on uses of substances in authorisation applications and 42 opinions on proposals for

harmonised classification and labelling. The Biocidal Products Committee (BPC) adopted 13 opinions for active

substance approvals and renewals as well as 10 opinions

on Union authorisations.

We continued the prioritisation of efforts on promoting

alternatives to animal testing and held a collaborative workshop with all stakeholders to discuss how collectively

we can work to promote and move to using alternatives to

animal testing.

Support and input to the Commission on the Chemicals Strategy for Sustainability (CSS) was high on our agenda

for 2023. We actively supported the decision-making

process for the revised CLP Regulation and have already commenced work in preparation for its implementation.

We also worked closely with the Commission to assist them in their considerations for the revision of the REACH

Regulation and the Basic Regulation. While the anticipated publication of the REACH revision did not materialise as

expected in 2023, we remain ready to support the Commission’s proposal for a future revision. We also

continue to support the Commission in relation to their

work on the various legislative packages under One Substance, One Assessment as well as the Basic

Regulation. This year also saw us commence work on implementation of the new regulatory tasks given to the

Agency under the Drinking Water Directive, the Batteries Regulation, and the Serious Cross-Border Threats to

Health Regulation.

While we have delivered on our mandate and Work

Programme obligations, we also recognise that some

issues continue to challenge. For instance, a recurring challenge was the low number of draft assessment reports

for biocidal active substances and this year also a lower number of Union authorisation applications for biocidal

products evaluated and submitted by Member States.

Another area of challenge is the ability to fully resource

and sustain membership in our scientific committees. This poses a risk of not meeting legal deadlines and targets in

operational areas that are dependent on input by

Committee members. We recognise that Member States

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Annual Report 2023

are finding it increasingly difficult to find experts with the

right competencies and who can commit to the ever- increasing workload. Together with the Commission and

the Management Board, we have looked at ways to encourage and increase membership and participation.

One first step was to review the current payments for

member’s rapporteur work together with the Management Board. Over the course of 2023, we emphasised the

importance of a Basic Regulation for ECHA to enable us, and our committees deliver on existing and future tasks,

and we hope that such a regulation will be forthcoming in

the near term.

As this was my first full year as Executive Director, I spent time getting to meet ECHA’s staff, partners and

stakeholders. These included colleagues in the

Commission, the EU Agencies, Member States, industry stakeholder groups and civil society organisations. As an

Agency, we rely on close engagement and collaboration with these groups in our delivery of our legal mandate. I

look forward to continuing my visits to the remaining Member States in 2024 as their current and future

collaboration with ECHA is key for successful delivery of

existing and future tasks.

While 2023 was the final year of our Strategic Plan 2019-

2023, it was also the year that our Management Board adopted our new Strategy Statement 2024-2028. I would

like to thank the members of the Management Board and all ECHA’s staff for their support and active participation in

the development of this new strategy. I look forward to working with them and our stakeholders in the coming

period to implement our vision of chemical safety through

science, collaboration, and knowledge.

Finally, I would like to express my thanks to the

Management Board for their support and collaboration as I settled into my first year. 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

2023 Work Programme.

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Annual Report 2023

Executive summary

With 2023 the last year of our strategic plan 2019-2023, we concluded the delivery of our strategic objectives and performed the planned activities specified in our Work Programme. This

year also saw us commence work on implementation of the new regulatory tasks assigned to

the Agency under the Drinking Water Directive, the Batteries Regulation and the Serious Cross- Border Threats to Health Regulation. We also continued to deliver our legal mandate across the

wide range of chemical legislation under our remit.

Two key deliverables under our strategic plan were the Integrated Regulatory Strategy (IRS)

and the Joint Evaluation Action Plan (JEAP) and these are relevant to both the REACH and CLP regulations. Identification and prioritisation of substances and groups of substances for risk

management actions is central to our Integrated Regulatory Strategy. In 2023, we made further strides in understanding the data on substances in our database with some 92% of substances

registered above 100 tonnes now assessed.

Another important aspect of the IRS is to identify substances or groups of substances for which generation of data under dossier or substance evaluation may be needed. These substances are

considered under the JEAP, which sets targets for checking the compliance of registration dossiers. In 2023, we performed 301 compliance checks under dossier evaluation. With the

conclusion of our strategic plan in 2023, reviews of both the IRS and JEAP took place, the outcomes of which will be used to determine the next steps for implementation of our new

strategic goals and priorities.

In substance evaluation, the Community rolling action plan (CoRAP) update for 2023-2025 was

agreed by the Member State Committee (MSC) and published with 24 substances for evaluation

by 12 Member States. Conclusions were also reached for 26 substances while 6 substance evaluation decisions were issued requesting data to address concerns regarding endocrine

disruption, PBT/vPvB, and mutagenicity.

Risk management actions under REACH and CLP in 2023 included the delivery of six opinions on

restrictions dossiers as well as 42 opinions on proposals for harmonised classification and labelling. These opinions were delivered by the Committee for Risk Assessment (RAC) and the

Committee for Socio-Economic Analysis (SEAC).

One of the restriction opinions covered the use of PFAS in firefighting foams. Early in 2023, we

also received the restriction dossier on per- and polyfluoroalkyl substances (PFAS) by the five

Member States (Germany, the Netherlands, Sweden, Denmark and Norway), and by year end had concluded the initial public consultation and screening of the more than 5600 comments

received. We will continue to progress this dossier through the RAC and SEAC in the course of 2024. We also received a mandate from the European Commission to prepare a restriction

dossier by 2024 for chromium (VI) substances, which are covered in the growing number of authorisation applications currently being received. ECHA also completed several investigative

and screening reports, including reports on Polyvinyl chloride (PVC) and additives and on

substances that are carcinogenic, mutagenic or toxic to reproduction (CMRs) in childcare articles.

Other risk management actions taken in 2023 were the addition of a further 11 substances to

the Candidate List for Authorisation, bringing the total number of substances of very high concern entries to 235. We also submitted eight substances under the 11th Recommendation for

inclusion of substances to the Authorisation List to the European Commission. We saw an increase in the number of authorisation applications mainly for the use of chromium (VI)

substances. The total numbers of applications and review reports received was 100 and our scientific committees RAC and SEAC delivered opinions on applications for authorisation of 58

uses of substances.

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Annual Report 2023

In 2023, we processed 13 749 registration dossiers and completed 416 SME company size

verifications. Our Helpdesk answered 9200 questions, while the combined total of queries answered by Member State and European Economic Area country helpdesks was approximately

45000. While we continued to receive many questions on registration, we also saw queries on PFAS, authorisation of chromates and were seeing queries on the new legislative tasks that the

Agency has been assigned. In furtherance of public availability of data, we devoted significant

time to the development of our new data dissemination platform, ECHA Chem, which is scheduled to be launched in 2024. This work is the start of efforts in transforming the way we

provide and make data available.

The Biocidal Products Committee (BPC) adopted 13 opinions for active substance approval and

renewal, while for Union authorisations, 10 opinions were adopted in 2023. We continue to observe that estimates from Member States on submission of active substance dossiers are not

met and nor are estimates of applications for Union authorisation. This is a worrying trend and requires renewed efforts by Member States to meet their ongoing regulatory obligations. We

were pleased to have delivered the pollinators guidance and make progress in the move to use

IUCLID for biocides dossiers.

We continued the prioritisation of efforts on promoting alternatives to animal testing in the year.

We held a collaborative workshop with all stakeholders to discuss how collectively we can work to promote and move to using alternatives to animal testing. We published our fifth report on

the use of alternatives to testing on animals for the REACH Regulation and highlighted the opportunities and challenges in moving away from animal testing for the regulatory assessment

of chemicals.

We processed 10857 notifications under the Prior Informed Consent Regulation (PIC) with many

of these related to the inclusion of benzene as the first substance in substance entry. In 2023,

we published the three-years report on the operation of the PIC Regulation (Article 22 report) and provided the recommendations made in the report to the Commission’s evaluation of the

PIC Regulation. A key recommendation was the need to review the extent of which information is made publicly available in any future legislation as access to document (ATD) requests are

increasing in relation to PIC.

In addition to the above regulatory areas, we continued to deliver on specific tasks in relation to

environmental legislation or service level agreements with the Commission. For instance, we prepared a draft scientific dossier (Annex D proposal) for three substances in support of the

Commission implementation of the Stockholm Convention. We continued to provide support

under the Industrial Emissions Directive (IED) and followed closely the decision making for the revision of this legislation as it will formalise ECHA’s role in this support work. We also delivered

five opinions from the RAC on Occupational Exposure Limits (OELs) in fulfilment of our support to the Commission’s Directorate General for Employment, Social Affairs and Inclusion (DG

EMPL). We concluded a new contribution agreement for the period 2023-2026 with the

Commission to continue providing support and training to pre-accessing countries.

Support and input to the Commission on the Chemicals Strategy for Sustainability (CSS) remained a high priority for us in 2023. We supported the Commission before and during the

decision making on the revised CLP Regulation and have already commenced work in preparation

for its implementation. We worked together with the European Environment Agency (EEA) under the 8th Environmental Action Programme (EAP), in establishing a new framework of indicators

aimed at monitoring the drivers and impacts of chemical pollution and assessing the

effectiveness of the chemical legislation. This framework will be published in 2024.

As noted already, we commenced work on the implementation of the new legislative tasks related to Drinking Water, Batteries and Serious Cross-Border Threats to Health. We supported

the Commission in developing the implementing and delegated acts necessary for the operation of the Drinking Water Directive (DWD). As tasks under the DWD will eventually come under the

RAC work area, we have already established a Working Group under RAC to commence

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Annual Report 2023

preparations for this new task by the committee. Our implementation planning for the tasks

under the Batteries Regulation got underway with the publication of the legislation in August

2023. First tasks are expected to be delivered in 2025.

Significant levels of support and advice were provided to the Commission services to assist them in their considerations for the revision of the REACH Regulation and the ECHA Basic Regulation.

While the anticipated publication of the REACH revision did not materialise as expected in 2023,

we are ready to continue to support the Commission on a future revision.

The Commission’s one substance, one assessment (1S1A) approach under the CSS was also an

area where ECHA provided significant levels of input and advice. We were pleased to see that the legislative package to support 1S1A was published by year end. This package covered not

only reattribution of tasks to ECHA but also a data regulation establishing a common EU data platform. We look forward to working with the Commission and decision makers in 2024 to

progress this legislation.

As an agency that relies on science to develop our opinions and decisions, we worked closely

with the research community to ensure that regulatory science needs are communicated and

understood. In this regard, we continued to engage with the Partnership for the Assessment of Risks from Chemicals (PARC), an EU-wide research and innovation programme focused on

developing next-generation chemical risk assessment to protect health and the environment. A key achievement for ECHA in 2023 was the publication of a report, Key Areas of Regulatory

Challenge, which clearly set out areas where the research community could direct future

research efforts.

Engagement and collaboration with stakeholders are fundamental to how we work. We continued to collaborate closely with EU agencies, particularly those with an environmental and health

focus. Our close collaboration with the European Food Safety Authority (EFSA), to assess the

safety of substances and develop consistent views across regulatory frameworks, including for areas such as biocides and pesticides, remained a focus in 2023. We have, as mentioned, worked

closely with the European Environment Agency (EEA) to build a joint framework of indicators that will help to track the progress and impact of the CSS implementation and chemicals

legislation.

We received increased requests in 2023 to join our Accredited Stakeholder Organisation (ASO)

list. We expect increased stakeholder requests to the ASO list to continue especially with our wider our legal mandate, which will bring in many new stakeholders who may not have previously

worked with us. We developed a new stakeholder engagement approach, which together with

our new communications strategy for 2024-2028 will enable us to continue to build strong

engagement and communication channels and networks.

One of the key stakeholder groups for ECHA is our Member State colleagues, whom we work closely with daily in many different fora, for example, through our Management Board, our

scientific committees, our Forum on Enforcement, Member State Communications Network, HelpNet and expert working groups. In 2023, we renewed our engagements directly with the

Member States through visits to Member States so that we heard first-hand the views and requests of national authorities. Member States’ full and active participation in all our committees

is essential for delivery of opinions and decisions. Throughout the year, we kept a focus on

facilitating sufficient nominations to the RAC and SEAC as well as ensuring that we can keep the members already involved. In these efforts, our Management Board and Commission colleagues

engaged closely with us.

We are pleased to report that our legal, governance and management obligations for 2023 were

all met. Our financial and HR key performance indicators were met and exceeded in many instances. We had no significant findings in any financial or other audits completed. We

maintained our International Organisation for Standardisation (ISO) 9001:2015; 14001:2015 and EU Eco-Management and Audit Scheme (EMAS) certifications. We also successfully

17

Annual Report 2023

organised meeting services for 640 events and official meetings, hosted 5000 visitors in person

and 32,800 online. We continued to work to reduce CO2 emissions and in 2023 remained in line

with our targets.

Our Management Board led the successful development of our new Strategy Statement for 2024- 2028. This Statement was developed in close collaboration with our staff as well as Member

States, Commission and stakeholders and we look forward to implementing it over the coming

years.

While the year saw many deliverables and achievements, we also wish to note a number of areas

that continue to challenge.

A major challenge again this year was the low number of draft assessment reports for biocidal

active substances submitted by Member States. This is detrimental to completing the evaluation of all existing active substances in the Review Programme by the end of 2024 as required by the

Biocidal Products Regulation. While ECHA has and will continue to make efforts to support the Member States to make further progress, the reality is that Member States are not prioritising

this work and many lack the capacity or resources to deliver in the near future.

Our scientific committees are a key component in delivering transparent, independent and high- quality opinions, and decisions. These committees rely heavily on the participation, commitment,

and expertise of members from the Member States. Keeping current members in the RAC and SEAC active and engaged was an ongoing effort in 2023. One aspect to ensure committee

sustainability was to review the current payments for member’s rapporteur work together with the Management Board. We hope these measures will encourage uptake across the members in

the future. Notwithstanding these efforts, the number of members in the RAC and SEAC is falling as Member States find it harder to find nominees with the relevant experience and competence.

This poses a risk of not meeting legal deadlines and targets in operational areas that are

dependent on input by Committee members. In 2023, we worked closely with the Commission on how we can ensure a sustainable future for the committees, especially considering new tasks

that have already been assigned or could be assigned because of published legislative proposals. The future ECHA Basic Regulation is an important means to achieve long term sustainability and

competence for our scientific committees and ECHA has and will continue to emphasise that this

Regulation is needed as soon as possible.

Another challenge is posed by the high number of authorisation applications significantly exceeding our capacity to deliver opinions. ECHA is closely monitoring the incoming applications

and planning and phasing the opinion making. The European Commission has requested ECHA

to prepare a restriction on chromium VI substances that may in time lead to a more efficient and timely management of the risks of these substances, while maintaining a level playing field for

the operations in the industrial sectors involved.

In 2023, we commenced implementation of new legislation and new tasks. These efforts will

continue over the coming years and will increase as proposals coming through the co-decision process will be finalised. Balancing implementation of new requirements while continuing to

deliver a full regulatory programme will be a key area of focus in the coming period. ECHA’s staff are fully committed to implementing these new tasks and we will be looking to work in close

collaboration with our EU institutional partners, the Member States and other stakeholders to

support us in delivering what is required.

With the publication of the ‘one substance one assessment’ legislative package at the end of

2023, we now can see the extent of the work required by all agencies to align their opinions and decisions across different scientific committees. We also welcome the introduction of new hazard

classifications in the CLP Regulation, which will help further alignment. However, the achievement of full alignment may continue to be a challenge in the absence of changes in other

legislation.

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Annual Report 2023

As our Strategic Plan 2019-2023 is concluded, we are reviewing some of the initiatives that

supported its delivery, for example, the IRS and JEAP. These reviews have commenced in 2023. We need to determine how best to use the data in our databases to ensure that the appropriate

risk management action is taken by the relevant parties, be that harmonised classification, authorisation or restriction. However, we also need to consider how we integrate additional risk

management actions coming from new legislation into our thinking. Furthermore, while ECHA

can analyse and provide information to the Commission and Member States, we do not have the legal basis to take action directly ourselves. Therefore, we need to have closer cooperation and

engagement with the Commission and Member States to align on identification and prioritisation on appropriate risk management actions. The new Strategy Statement 2024-2028 identifies this

as a priority, and we look forward to collaborating with all parties in this regard.

Further details on achievements and metrics are available in the following sections.

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Annual Report 2023

Part I. Achievements of the year

Dossier preparation

Highlights

In 2023, we continued to provide companies with the tools and support they need to successfully

register and update their registration information. We successfully managed the inquiry process

and took decisions on the data sharing requests. We updated the International Uniform Chemical Information Database (IUCLID) to incorporate new regulatory requirements at EU or

international level. We contributed to development of the Organisation for Economic Co- operation and Development (OECD) test guideline programmes in key areas by actively

participating in the expert group meetings and consultations.

We continued development of the Chemical Safety Assessment and Reporting tool (Chesar) to

support both REACH and Biocides. The platform will fully integrate the European Union System for Evaluation of Substances (EUSES) models for environmental assessment, as well as the

European Centre for Ecotoxicology and Toxicology of Chemicals' Targeted Risk Assessment

(ECETOC TRA) models for workers and consumers. It will help companies to perform their chemical safety assessments and generate chemical safety reports under REACH. For biocides,

it will enable users to carry out environmental risks assessments for active substances and biocidal products. Integration of models for risk assessment in the platform brought a few

technical challenges which lead to delays and prevented from launching in 2023 as originally

planned.

The ECHA helpdesk answered 9200 questions in 2023. Intensive cooperation with the national helpdesks continued and they replied to 45000 questions, with a growing number of questions

outside the original regulations in scope REACH, CLP and BPR. Most questions were on dossier

preparation, the per- and polyfluoroalkyl substances (PFAS) restriction and chromates authorisation. The network of national helpdesks (HelpNet) held 26 meetings including dedicated

workshops on REACH and CLP, approving four new or revised FAQs.

Two campaigns to address companies that were not in compliance with the update obligations

for their registration dossiers were concluded during the year: one on compliance with harmonised classifications and one on compliance with authorisation obligations for substances

in Annex XIV.

Main outputs

O1 Companies are supported in inquiries and in sharing their data across the EU, helping to

reduce registration costs and to avoid unnecessary testing.

Inquiries and disputes on data sharing are handled. Yes

O2 Harmonised IT tools and advice ensure consistency of risk management and safety information, thus promoting exchange across and between industry and regulatory

authorities.

ECHA continues to lead the development of IUCLID and its promotion as the

international harmonised format for chemical data. Yes

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Annual Report 2023

IUCLID is progressively maintained to incorporate regulatory requirements,

such as changes resulting from the amendment of REACH Annexes, other technical and scientific progress under REACH and CLP, or requirements from

our OECD international partners.

Yes

ECHA contributes to the development of the OECD harmonised test guidelines

relevant for the EU information requirements. Yes

The unified CHESAR-EUSES platform is released, facilitating improved

exposure assessments for both REACH and BPR. On-going

Questions are timely and effectively answered; a number of topics are

discussed and agreed among all national helpdesks for harmonised advice. Yes

In support of the Commission implementing regulation on registration updates, a second campaign in collaboration with the national enforcement authorities

is organised on cases of potential breach of the update obligation.

Yes

Indicators Estimate Actual

O1 Effective working time for processing inquiries 0.3 person day 0.3 person day

Inquiries received and concluded 4 200 4 835

Dossier submission and processing

Highlights

In 2023, ECHA processed 13 749 registration dossiers with 5 883 invoices generated.

Completeness check was performed on all dossiers, with around 30 % of these checks completed with the manual verification, a similar number compared to 2022. The completeness check rules

were updated to address the revised REACH Annex VI-XI information requirements under the Commission-ECHA Joint Action Plan. ECHA put in place support actions and no major deviations

were found in terms of incomplete submissions.

Over 400 companies submitted as SMEs went through the company size verification process to ensure that they were rightly benefitting from reduced fees. We provided advice to the

Commission to support a review of this process into an ex-ante approach. The time between

submission and SME verification continued to reduce this year.

The invalidation of registrations continued tackling non-existing companies, or companies

subject to restrictive measures due to the war in Ukraine.

ECHA’s submission systems’ vision for the future was developed and the work towards a single Industry portal was kicked off including the setup of a user group for discussions with companies

and information sessions for authorities.

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Annual Report 2023

Main outputs

O1 Access to market for duty holders continues to be fast and predictable and data comes

in a way that supports subsequent regulatory work.

The flow of registration dossiers (initial and updates) is processed; completeness checks are performed, including manual verifications, invoices are issued, and

confidentiality requests are assessed. Clear and timely feedback is provided to

companies on how to successfully complete their submissions.

Yes

ECHA verifies the size of companies that registered in 2018 and previous

deadlines and continues the initiation and verification of the size of SME companies which registered after the last registration deadline; the time gap

of ca. 4.5 years between submission and beginning of the verification

continues to be reduced.

Yes

Tools and processes for invalidation of registrations are further developed for

different circumstances, such as the implementation of EU sanctions. Yes

PPORD notifications are processed and indications for innovation and new

kind of substances are monitored. Yes

As part of the development of a registration obligation for certain polymers,

ECHA supports the Commission in the development of a registration process, including a notification step, and the following regulatory activities, and starts

preparations for the necessary changes in relevant IT tools.

Yes

O2 Submission activities are built in a streamlined way to facilitate their long-term

functioning.

Develop a vision paper for the future of ECHA’s submission systems and

commence implementation. Yes

Indicators Estimate Actual

O1 Number of PPORD notifications received 340 235

Number of C&L notifications received 33 000 43 933

Number of Registration dossiers received (incl.

updates) 16 000 13 749

Number of SME companies verified for their status 400 416

Effective working time for processing a registration

dossier (first submission)

0.50 – 0.60

person days

0.45 person

days

Registrations stopped for manual verification at

technical completeness check 5 900 4 721

Number of registrations failing first technical

completeness check 1 600 1 035

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Annual Report 2023

Identification and prioritisation

Highlights

In 2023, we continued screening structurally similar substances individually or in groups. We screened 61 groups rather than the initially estimated 70 groups. However, the actual number of substances

screened is higher than initially planned. Overall, we screened around 1380 substances and identified

that 320 may eventually be or are already considered for risk management actions; around 280 require data generation to confirm the suspected hazard; and about 540 substances do not need further

regulatory risk management as they are considered low hazard, have low exposure potential or there

are already sufficient risk management measures in place.

By the end of 2023, we assessed 92 % of substances registered above 100 tonnes; less than

400 high-tonnage substances remained to be assessed.

We continued to publish the reports on the assessment of regulatory needs (ARN) for groups of

substances, providing transparency to our work and supporting the work of our stakeholders.

We liaised with our industry stakeholders to provide further clarity on the content and scope of

the ARN reports, including holding a well-attended webinar. To improve clarity, we updated the

template and format of the reports based on the feedback received.

An internal review of our integrated regulatory strategy was initiated which will feed into a

workshop with our stakeholders in spring 2024.

Main outputs

O1 ECHA, Member States and Commission services can perform risk management processes

and evaluation activities related to hazardous chemicals more effectively and efficiently, based on grouping of chemicals and their assessments and supported by ECHA’s

expertise and tools.

Complete the assessment for 70 new groups of chemicals to support the needs of the main regulatory processes (evaluation, restrictions,

authorisations and harmonised classification).

Yes

Support the annual update of the restriction roadmap based on the outcomes

of the group assessments results. Yes

Publish the annual report on the implementation of the Integrated Regulatory

Strategy. Yes

Prepare the publication of the assessments of regulatory needs for groups of

substances. Yes

Update information through Chemical Universe engine to show the progress

with assessing groups of substances. Yes

Indicators Estimate Actual

O1 Number of substances registered above 100 t/y in the unassigned region of the chemical universe for which a

conclusion on potential regulatory follow up was drawn

250 156

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Annual Report 2023

Number of groups of substances for which the

assessment of regulatory needs is carried out 70 61

Evaluation

Highlights

The REACH Evaluation Action Plan sets targets for checking the compliance of registration dossiers submitted to ECHA. A minimum of 20% of registrations for substances registered in

quantities of 100 tonnes or more per year need to be checked for compliance, with a similar

percentage for substances in tonnage bands less than 100 tonnes per year.

In 2023, ECHA carried out 301 full compliance checks and 104 testing proposal examinations, covering 367 unique substances. With these outputs we addressed the key actions from the Joint

Evaluation Action Plan (JEAP). ECHA has started a review of the outcomes of the JEAP, and the review will continue together with the Commission and stakeholders at the beginning of 2024

(originally planned for 2023).

Collaboration with the Member State competent authorities was effective and showed good alignment as only 9% of the draft decisions were discussed by the Member State Committee (following proposals

for amendment). Follow-up actions were conducted to verify that any updated information provided

in response to evaluation decisions addressed what was requested.

An analysis revealed that around 19 % of completed dossier evaluation cases were considered for further regulatory action (harmonised classification and labelling (CLH), endocrine disruptor

(ED), and persistent, bioaccumulative and toxic (PBT) assessment or substance evaluation). The most frequent outcome by far was the consideration of a CLH process, particularly for

reproductive toxicity concerns.

We also put greater focus on those decisions where there is a backlog in follow up and testing proposal evaluations. The increased focus on clearing this backlog will continue in the coming

years.

In substance evaluation, the Community rolling action plan (CoRAP) update for 2023-2025 was

published in March. The list was updated with 24 substances for evaluation by 12 Member States. A conclusion was reached for 26 substances. Some of the regulatory follow-up actions at EU

level included harmonised classification and labelling (20), identification as a substance of very high concern (10) and restriction (12). In 2023, 6 substance evaluation decisions were issued

requesting data to address concerns regarding endocrine disruption, PBT/vPvB, and

mutagenicity.

Main outputs

O1 Dossier evaluation is efficient, transparent and scientifically and legally robust.

Deliver the outputs in line with the objectives from the Joint Evaluation Action

Plan, including 300 compliance checks concluded as draft decision or no

action.

Yes

Organise - jointly with the Commission - a mid-term review of the achievements of the Joint Evaluation Action Plan (including screening,

grouping and evaluation of chemicals), considering the impact of changes

arising from the REACH and CLP reviews.

On-going

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Annual Report 2023

Examine testing proposals within the legal deadlines striving for zero

proposals that are not handled in time. On-going

The information submitted in response to ECHA evaluation decisions is

examined without delay and conclusions communicated to the Commission

and Member State competent authorities.

On-going

The national enforcement authorities are informed in case of non-compliance

with the decision and follow-up decisions are drafted where appropriate Yes

Report on the progress made in (both dossier and substance) evaluation as

part of the annual report on the Integrated Regulatory Strategy and publish annually the updated recommendations to registrants stemming from

evaluation.

Yes

Contribute to the Caracal sub-groups and other fora in support of the

Commission in their policy activities, in accordance with the REACH Evaluation

Joint Action Plan.

Yes

Support the Commission in CSS relevant activities. It includes the review of

the Evaluation title in REACH and the annexes on information requirements. Yes

Request targeted study audits in case a concern about compliance with

principles of good laboratory practice is identified by ECHA or a Member State. Yes

Publish the report on the scientific and technical review of the received

extended one-generation reproductive toxicity studies in collaboration with

the Member State Competent Authorities.

Yes

Provide regulatory advice to registrants and other interested parties on

information requirements and on dossier and substance evaluation processes. Yes

O2 For Substance Evaluation Member States are supported to conclude as fast as possible,

in a scientifically and legally robust manner, enabling the initiation of appropriate

regulatory risk management measures.

Propose updates of the CoRAP to the MSC with substances for which

substance evaluation is the most appropriate tool to generate further hazard

information.

Yes

Support Member States in achieving substance evaluation conclusions as fast as possible. Encourage that appropriate regulatory risk management

measures and initiatives are taken up by Member states.

Yes

Keep reducing the number of substance evaluation cases currently opened. Yes

Indicators Estimate Actual

O1 Compliance checks concluded: draft decisions or no

action

300 301

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Annual Report 2023

Final decisions on dossier evaluation (testing

proposals and compliance checks) 300 367

Number of substances for which a conclusion was

reached in the follow-up to dossier evaluation 200 202

O2 Substance evaluation final decisions issued 10 6

Number of substances for which a conclusion was

reached in substance evaluation

25 26

Authorisation

Highlights

In 2023 eleven substances were added to the Candidate List, bringing the total to 235 entries.

These substances were found to have either very persistent and very bio accumulative properties, or were shown to be persistent, mobile and toxic, or displayed negative effects on

reproduction. Other reasons for inclusion were the carcinogenic properties or endocrine

disrupting potential of these substances.

In 2023, we submitted to the European Commission the 11th recommendation for inclusion of

substances to the Authorisation List. It recommended to add eight substances, including lead. The inclusion of lead generated many comments from the stakeholders, related to the best

timing, its combination with other ongoing or planned regulatory activities as well as the expected workload for industry and authorities at the next stage. This recommendation brought

lead metal to the same regulatory stage as other lead compounds with similar uses already

recommended for inclusion to the Authorisation List.

The number of applications for authorisation increased, mainly for the use of hexavalent

chromium substances. In total we received just over one hundred applications and review reports for authorisation. The scientific committees, RAC and SEAC, delivered opinions on applications

for authorisation of 58 uses of substances. To manage the gap between applications received and opinions delivered, we monitored closely the incoming applications and planned and phased

the opinion making process. The European Commission requested ECHA to prepare a restriction dossier for chromium (VI) substances, to be delivered in 2024. In view of the widespread use of

these substances, this may lead to a more efficient and timely management of the risks of these substances, while maintaining a level playing field for the operations in the industrial sectors

involved.

We contributed to the Authorisation Taskforce that was set up in 2023 by the European Commission to discuss the operation and streamlining of the authorisation process under REACH,

also in view of the judgement of the European Court of Justice on the ‘Chemservice’ case.

Main outputs

O1 Substances of very high concern are properly controlled and progressively replaced by

suitable alternatives.

Identification of substances of very high concern and inclusion in the Candidate

List Yes

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Annual Report 2023

Prioritise the chemicals on the Candidate List and propose to the MSC the ones

to be included in the 11th Annex XIV recommendation to the Commission for

inclusion in the Authorisation List.

Yes

Provide web-based training to stakeholders on analysis of alternatives and

informed substitution of substances subject to regulatory risk management. Yes

O2 Opinions of the Committees for Risk Assessment (RAC) and Socio-Economic Analysis

(SEAC) on applications for authorisations are timely and fit-for purpose.

Develop and implement - jointly with the Commission - an agreed approach to deal with the anticipated significant increase in the number of authorisation

applications.

Yes

Hold workshops and network meetings to develop methodologies and to

enhance the capacity of Member States and companies to carry out analysis of alternatives and socio-economic analysis with view of finding viable

alternatives.

Yes

Indicators Estimate Actual

O1 Number of new entries in the Candidate List 15 11

Recommendation for inclusion of substances in the

authorisation list 1 1

Applications and review reports for authorisation

received (number of uses) 100-140 102

Number of downstream user notifications of

authorised uses of SVHCs 3 000 2 742

O2 Number of RAC and SEAC opinions adopted on

applications for authorisation (number of uses) 60 58

Effective working time of ECHA staff per opinion

38-46 person

days

39 person

days

Restrictions

Highlights

We continued to deliver high impact restrictions dossiers and investigation reports. In 2023, we

produced three restriction investigation reports and five screening reports (art.69.2) including reports on Polyvinyl chloride (PVC) and additives as well as on substances that are carcinogenic,

mutagenic or toxic to reproduction (CMRs) in childcare articles. Our scientific committees (RAC and SEAC) delivered six opinions on restrictions dossiers for regulatory decision making,

including opinions on medium-chained chlorinated paraffins (MCCPs) and on per- and polyfluoroalkyl substances (PFAS) in fire-fighting foams. Furthermore, we received the restriction

27

Annual Report 2023

dossier on universal PFAS from five dossier submitter countries and handled the publication,

consultation and screened the 5,642 comments received in a record two months’ time to facilitate the further process. There were no Commission mandates received requiring delivery

of Annex XV reports in 2023.

Furthermore, we continued to contribute to the development of scientific methodologies for

regulatory assessments on the valuation of various health and environmental endpoints for

socio-economic analysis together with OECD countries.

The implementation plan for the new tasks allocated to the Agency by the EU Batteries

Regulation was developed this year and initial steps were taken to prepare for the first phase of

the study on relevant substances and the recruitment of staff.

Main outputs

O1 Support the Commission in the implementation of the Restrictions Roadmap by

developing timely fit-for-purpose restrictions dossiers.

Annex XV reports proposing restrictions developed for 2-3 substances from the

restriction roadmap at the request of the Commission per year (e.g., flame

retardants, ortho-phthalates).

No

The investigative reports requested by the Commission related to risks of PVC

and substances in PVC, CMR substances in childcare articles, and PAHs in rubber granules used on children’s playgrounds prepared according to the

deadlines agreed with the Commission.

Yes

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

O2 Opinions of the Committees for Risk Assessment (RAC) and Socio-Economic Analysis

(SEAC) on restrictions are timely and fit for purpose.

Deliver restriction opinions, including for the use of lead in outdoor shooting

and fishing, BPA+ in articles, chloroalkanes (C14-C17) and PFASs in firefighting

foams.

Yes

Develop methodologies related to socio-economic analysis to create a fit-for- purpose toolbox, including i.a., the valuation of various health and

environmental endpoints in OECD. The Commission’s Better Regulation

guidelines are taken into account.

Yes

O3 Opinions of the Committees for Risk Assessment (RAC) and Socio-Economic Analysis

(SEAC) on restrictions are timely and fit for purpose.

Batteries restrictions implementation plan Yes

Indicators Estimate Actual

O1 Restriction proposals or investigation/screening

reports developed

5 8

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Annual Report 2023

O2 Number of RAC and SEAC opinions on restriction

proposals

6 5

Effective working time of ECHA staff per opinion

(ECHA dossier)

220 – 330

person days

227 person

days

Effective working time of ECHA staff per opinion

(Member State dossier)

200 – 300

person days

193 person

days

Classification and labelling

Highlights

We supported the Commission in the review of the CLP Regulation. After its adoption, we started the update of the tools and CLP guidance. Proposals for harmonised classification of 45

substances were brought to the Risk Assessment Committee. We started to support the Member States to develop the dossier for proposed Harmonised Classification for two groups of

substances originated from the chemical universe screening.

As part of our new public chemicals database (see activity Data management and dissemination), we worked on a redesign of the Classification and labelling inventory that is expected to be

launched in autumn 2024. Our preparatory work in 2023 took into account the proposed changes

in the CLP regulation.

We received 4,748,401 Poison Centre Notifications (more than in 2022). The compliance deadline of 1 January 2024 for mixtures with industrial uses was met without major problems

for submitters with the appropriate support in place.

We supported the European Commission in the context of the United Nations Globally

Harmonised System of classification and labelling of chemicals (UN GHS) and in the

implementation of the United Nations Environment Programme (UNEP) project to pilot the

implementation of GHS in four African countries.

Main outputs

O1 Opinions of the Committee for Risk Assessment (RAC) are timely and fit-for purpose

Process incoming CLH dossiers, including industrial chemicals from the outcome of identification and prioritisation (based on the grouping approach)

while continuing to process a high number of PPP and Biocides dossiers resulting from the joint Commission, EFSA and ECHA efforts to encourage

timely submission of dossiers.

Yes

Undertake pilot projects with the relevant RAC subgroup for a number of identified groups of substances to improve the usability of grouping information

for the purpose of CLH proposals.

Yes

O2 Up-to-date information on the classifications for chemicals is publicly available in a user- friendly format, also for those substances for which no harmonisation at EU level has

taken place yet

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Annual Report 2023

As part of the creation of ECHA’s new public data availability system, design

and develop the new C&L Inventory, taking into account the changes in the

revised CLP regulation.

On-going

O3 Member States, Commission services and duty holders have the support they need to

fulfil their obligations, with a specific focus to ensure the readiness for the

implementation of the planned CLP 2.0

Closely monitor the progress of the legislative process and, according to the

expected entry in force, deliver an internal roadmap for the implementation of the planned legislative changes to the CLP Regulation including ECHA’s role in

the CLH process.

Yes

Start implementation of guidance updates, teams and systems for the entry in

force of the revised CLP processes. Yes

Provide scientific and technical support to the Commission in the context of the

further development of the United Nations Globally Harmonised System of

classification and labelling of chemicals (UNGHS), including:

o related to new hazard classes and criteria to fully address

environmental toxicity, persistency, mobility and bioaccumulation; and to introduce endocrine disruptors, persistent, mobile, toxic, very

persistent and very mobile substances as categories of substances of

very high concern.

o for the implementation of revisions 8, 9 and 10 of UNGHS. This

implementation should start in spring 2023 at the very latest.

o to the work of selected GHS working groups, notably the working group

on the use of non-animal testing methods for classification.

On-going

Provide scientific and technical support to the Commission in its

implementation of the Chemicals Strategy for Sustainability in the context of the revisions of the CLP regulation and to the UNEP-GHS project in African

countries.

Yes

O4 Structured, high quality and consistent information for the EU poison centre scheme is

timely available across Europe

Maintain the notification portal and system-to-system submission channel and

keep it aligned with IUCLID. Yes

Conclude the development of the searchable central database, to be used by

the national appointed bodies and Poison Centres, based on the Commission’s mandate and the feedback from national authorities on the use of the

database.

Yes

Continue the promotion of the PCN activities, in preparation for the next

compliance date of 1 January 2024 for mixtures with industrial uses. Yes

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Annual Report 2023

Indicators Estimate Actual

O1 Proposals for harmonised classification and labelling 60 45

Number of RAC opinions on proposals for

harmonised classification and labelling 50 42

Effective working time for processing RAC opinions Approx. 40-55

person days

37.4 person

days

O3 Decisions made on requests to use an alternative

chemical name (Art 24 CLP) 40 26

O4 Poison centre notifications received and made

available to Appointed Bodies and Poison Centres

2 million 4.4 million

Poison centre notifications viewed by national

authorities in the PCN central database

10 000 23 804

Safe and sustainable use of chemicals

Highlights

Our work on safe and sustainable use of chemicals focused on providing technical and scientific support and guidance to companies. We also continued developing tools to support chemical

safety assessment at company level (e.g., CHESAR) and ensured basic maintenance of industry-

developed use maps.

We also continued to support the European Commission in testing its framework for safe and sustainable by design, by providing a priority list of substances of very high concern which could

be considered as candidates for testing the framework.

Main outputs

O1 Registrants perform an effective chemical safety assessment, demonstrating (i) safe use

to the authorities via the registration and (ii) delivering safe use advice for inclusion in

the safety data sheets

Provide maintenance and ensure dissemination of tools developed to support

industry work. Yes

Support the Commission in developing case studies and testing the framework

and criteria for Safe and Sustainable by design. Yes

Indicators Estimate Actual

O1 N/A

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Annual Report 2023

Data management and dissemination

Highlights

During 2023, ECHA data services supported the Commission work on preparing several legislative packages including REACH and CLP review or the Directive 2004/37/EC on the

protection of workers from the risks related to exposure to CMR substances at work. We also

supported the Member States with data relevant for preparing their restrictions proposals. Tools that allow users to search, convert and manage their chemicals data in IUCLID format were

further developed and we supported our key stakeholders such as EFSA and Member States in

their use.

Data management has a central role in improving the consistency and integration of the EU regulatory system on chemicals. In 2023, we initiated a review of our data management

approach and established a Data Governance Office responsible for managing our regulatory

data. This work will further support regulatory data consistency, coherence and transparency.

During 2023, the first version of ECHA's new public chemicals database, ECHA CHEM, was

developed, leaving it ready for launch in January 2024. The development of this new public database involved extensive engagement with our stakeholders to ensure it would meet the user

needs. The new database has IUCLID as a central building block and is designed on a modular platform to ensure a stable and high-performing system that will enable efficient onboarding of

new datasets in the future, as well as a starting point for a future EU common data platform on

chemicals.

The OECD eChem portal was maintained and developed with new datasets coming from REACH

Registrations.

Main outputs

O1 The regulatory processes performed by ECHA, Member States and Commission are

efficiently supported and monitored.

Deliver a plan to consolidate data management and guarantee regulatory data

consistency, coherence, transparency and reporting. On-going

Deliver the necessary features to optimise the Interact Portal with due

consideration of process and users’ requirements. Yes

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

Tools to search, extract and analyse data in registration dossiers made

available to other authorities and industry. Yes

Develop tools and methodologies to convert legacy toxicity data to IUCLID

harmonised templates in collaboration with other Authorities and industry. Yes

O2 Data submitted to ECHA under different regulations is publicly available in user friendly

ways and progress of ECHA’s regulatory activities is transparent.

Deliver the first prototype of ECHA’s new public data availability system based on IUCLID, including hazard and classification and labelling data, and

supporting the preparedness for the EU Common Data Platform.

Yes

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Annual Report 2023

Deliver a plan to develop the new solution for dissemination of regulatory data

and proceed with its integration into ECHA’s new data availability system. Yes

Further develop IUCLID as a key building block, considering the future EU

common data platform on chemicals and bearing in mind the OECD intentions

for a Global Chemicals Knowledge Base.

Yes

OECD Global Portal to Information on Chemical Substances (eChemPortal) is

maintained and synchronised with ECHA’s dissemination website. Yes

Indicators Estimate Actual

O1 Description and number of data requests Internal: 50

External: 20

Internal:77

External:13

O2 Number of user page views for published

information on chemicals 48 million 50 million

Promotion of alternatives to animal testing

Highlights

In 2023, we intensified our activities to promote alternatives to animal testing. We invested in

many international activities, particularly APCRA (Accelerating the Pace of Chemical Risk Assessment), PARC (Partnership for the Assessment of Risks from Chemicals) and OECD

(Organisation for Economic Co-operation and Development) to enhance regulatory knowledge on how we can protect health and the environment and reduce our reliance on animal testing.

We also increased the access to toxicity data, aiming to support research and development within

the wider regulatory and scientific community.

We published the fifth report on the use of alternatives to testing on animals for the REACH

Regulation. The report shed light on opportunities and challenges associated with moving away

from animal testing in the regulatory assessment of chemicals.

We strengthened our interactions with stakeholders and worked closely with the European Commission and international partners to support the development and uptake of alternatives

that are suitable for regulatory purposes.

We organised a workshop to further explore new approach methodologies and work towards an

animal testing-free regulatory system for industrial chemicals. The event brought together

regulators, policy makers, scientists and stakeholders (industry, animal welfare NGOs, environmental NGOs) to discuss the state of the art and research needs for phasing out animal

testing. The workshop supported the efforts at EU level to work towards development of a EU

roadmap for fully replacing animal testing in the risk assessment of industrial chemicals.

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Annual Report 2023

Main outputs

O1 Industry generates hazard data using non-animal testing methods and new approaches,

wherever appropriate, to fulfil the REACH information requirements.

Invest in further development of the QSAR toolbox to integrate new information (for example, metabolites, biocides or data from pharmaceuticals)

and models.

Yes

Expand data available for download (REACH studies results and pharmaceutical industry data contribution) that can be used for NAMs development and/or

avoiding unnecessary animal testing.

Yes

Further implement predictive models to support substance grouping,

prioritisation and scientific decision making. Yes

O2 ECHA plays a proactive role towards the public and policy makers to provide clear, timely and sufficient information on alternatives to animal testing in a regulatory context, within

ECHA’s role and mandate.

Organise an external workshop on new approach methodologies (NAMs) to contribute to EU efforts towards building an EU roadmap for replacement of

animal testing.

Yes

Publish the fifth report on the use of alternatives to testing on animals for the

REACH Regulation (117.3). Yes

Contribute to OECD activities related to further development of alternatives

and integration of regulatory relevant alternatives in the OECD test guidelines. Yes

Further develop high throughput NAMs in cooperation with ECHA’s international

partners. Yes

Collaborate at international level 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).

Yes

Indicators Estimate Actual

O1 N/A

Biocides

Highlights

The number of opinions that the Biocidal Products Committee (BPC) was in a position to deliver in 2023 was well below the estimated numbers due to significantly less submissions by the

Member States of evaluation dossiers both for active substances and Union authorisations (UA). While we observed a decrease in numbers of UA applications this year, we also noted that these

cover product families and therefore dossiers tend to be larger and more complex. In response to technical scientific questions from the Commission, the BPC developed opinions on

alternatives to active substances and the comparative assessment of anticoagulant substances

34

Annual Report 2023

used to control infestations of rodents, as well as on technical aspects of disagreements arising

in the mutual recognition of biocidal products authorisations. On request of the Commission, we also reviewed the work of the BPC with respect to analysis of available alternatives and socio-

economic aspects related to potential non-approval of certain active substances.

We continued providing support to Member States under the Active Substance Action Plan. This

included the organisation of two information sessions with Member States to discuss and share

their best practices on active substance approval and renewal. Furthermore, we provided regulatory and scientific advice and allowed Member States to increase competence in areas

such as genotoxicity and endocrine disruptors.

We also continued to provide the secretariat of the Coordination Group, assisting Member States

in the resolution of disagreements arising during mutual recognition of biocidal products authorisations and in reaching agreements on horizontal topics which may help preventing

certain future disagreements. This allowed for a reduction in the number of Art. 38 requests compared to what was initially foreseen. In the regular and ad-hoc meetings (19 in total), an

increasing number of disagreements were discussed together with the endorsement of key

specific procedures.

Regarding Union authorisations, we established a working procedure for processing applications

for minor changes, which allows the swift evaluation of the first such cases. Additionally, several critical working procedures were improved and streamlined, including the procedure for

processing application for major changes and for the linguistic review of the SPC translations.

Within the scope of one-substance-one-assessment, ECHA continued to collaborate with EFSA

on common guidance documents, such as on the impact of water treatment processes on residues of active substances in drinking water. Furthermore, we introduced alignment

mechanisms, such as identifying common substances early in advance and connecting and

supporting the evaluating Member States across regulations. We also established an engagement procedure on inviting experts to meetings of working groups and of the BPC. The

experience gained helped in defining collaboration practices with other EU agencies, in particular EFSA. In close collaboration with EFSA, we finalised the guidance for the assessment of risk to

bees from the use of biocides as our contribution to maintain biodiversity.

We have established an IT vision for biocides that sets the direction towards further integration of

the tools, ensuring structured data and increased data availability as well as efficiency gains for all stakeholders. The first implementation steps in the transfer of biocides information to IUCLID format,

based on a roadmap agreed with Member States, were a major advancement in this regard.

Main outputs

O1 Provide timely fit-for-purpose opinions, including means for improved consideration of

cross-regulations consistency, on active substance and Union authorisation applications.

Prepare ECHA’s opinions on the approval of active substances and on Union

authorisation of biocidal products. Yes

Prepare ECHA’s opinions on Union authorisation of same biocidal products and

on administrative and minor changes to Union authorisations. Yes

Cooperate with EFSA and within ECHA to interlink guidance documents and put

in place means to improve synergies and alignment, with focus on the

evaluation of common substances.

Yes

Update of the list of frequently used sentences in the SPCs translated in all the

EU official languages. Yes

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Annual Report 2023

Perform assessments of applications for technical equivalence, inclusion in the

Article 95 BPR list and classification for changes. Yes

O2 Provide support to Member States and Commission to facilitate biocides processes and

accelerate the Review Programme.

Providing regulatory, procedural and technical support to the MSCAs in the

evaluation and BPC opinion forming on the approval of active substances, with specific effort to progress with the Review Programme, and on Union

authorisation of biocidal products.

Yes

Contribute to the MSCAs capacity building by providing training and scientific-

technical advice. Yes

Support the MSCAs in their work on potential endocrine-disrupting substances. Yes

Prepare the BPC opinions requested by the Commission pursuant to Article 38

of the BPR on scientific and technical questions. Yes

Providing technical and scientific support to the Commission under Article

15(2) and 75(1)(g) of the BPR on general and case specific issues relevant for

the implementation of the BPR.

Yes

Provide training to stakeholders on analysis of alternatives and informed

substitution of substances. Yes

Develop and maintain guidance and provide support to the development of an

easily accessible, structured overview of ECHA guidance documents and

relevant policy documents.

Yes

Engage with stakeholders in different fora such as the BPC and its Working

Groups, organisation of biocides stakeholders’ day, etc. Yes

Dossiers submitted by industry to ECHA are timely processed and feedback

given as appropriate. Yes

O3 Continuing the integration of the biocides IT tools with the ECHA IT systems

Integrate, where feasible, specialised Biocides IT tools with ECHA IT systems. Yes

Continue developing the Register for Biocidal Products (R4BP 3). Yes

Continue developing the IT support tools (ECHA Act and Interact). Yes

Finalise the introduction of the biocides’ environmental exposure scenarios in

the CHESAR platform (see REACH activity Dossier preparation). On-going

Move the SPC Editor into a IUCLID based solution.

On-going

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Annual Report 2023

Promote and initiate the enhancement of structured data availability in IUCLID

for Annex II and III BPR information requirements. Yes

Propose and support a campaign on the IUCLID dossier filling for active

substances and Union authorisation cases. Yes

Indicators Estimate Actual

O1 Number of opinions on active substances [approval

& renewal]

28 13

Number of opinions on Union authorisation of

biocidal products

31 10

Number of opinions on Union authorisations sub- processes: same biocidal products, administrative

and minor changes

52 21

Number of technical equivalence application

assessments 30 32

O2 Satisfaction of authority actors Establishment of

baseline 84 %

Number of opinions on Article 15, Article 38 and

Article 75(1)(g) requests 20 7

O3 User satisfaction of ECHA IT tools (e.g., R4BP, SPC

editor, Interact)

Establishing baseline with

BPR user group

90%

Prior informed consent

Highlights

The reception and processing of PIC notifications experienced an increase in volumes compared

with previous years. A total of 10 857 notifications were processed in 2023 which represents 97% of the annual forecast (11 200) and is +8% compared to the number of notifications

processed in 2022 (10 072)). This increase was mainly due to the addition of benzene, being the first ‘substance in substance’ entry in the list of substances subject to PIC notification

obligations. ECHA continued to devote significant efforts to support all involved parties with these

obligations.

In terms of reporting, the usual annual report on exports and imports subject to Rotterdam

convention was published. In addition, we published the three-years report on the operation of the PIC Regulation (‘article 22 report’). Its conclusions input to the Commission’s ongoing

evaluation of the PIC Regulation, as some changes in legal provisions could facilitate the implementation, in particular the extent of the information that is made publicly available. This

was important as the increasing number of Access to documents requests showed public interest

37

Annual Report 2023

in this information. In this context, we hosted an information session to exchange experiences

among Member States with the access to documents under PIC.

We continued to support the Commission in the implementation of the Rotterdam Convention

including participation in the 11th Conference of the Parties.

Main outputs

O1 Companies and Authorities in the EU and third countries can effectively manage the

international trade of chemicals listed under the Rotterdam Convention and the PIC

regulation.

Process effectively the received number of notifications allowing companies to export these chemicals in accordance with the EU’s international commitments;

execute related tasks such as stakeholder support.

Yes

Prepare the tri-annual report on the operation of the PIC Regulation (2020-

2022). Yes

O2 The Commission and other Authorities receive fit-for-purpose support in the context of

PIC implementation and UN Rotterdam Convention.

Produce and publish the annual report on PIC exports and imports. Yes

Support the Commission with the EU contribution to the Rotterdam convention

implementation. Yes

Indicators Estimate Actual

O1 Export notifications processed 11 200 10 857

Share of notifications validated/accepted by ECHA 90 % 96 %

Support provided to PIC duty holders (importers

and exporters) 250 245

O2 Scientific and technical support provided to the

Commission, EU and non-EU DNAs 3 600 3 570

Persistent organic pollutants

Highlights

At the European Commission’s request and linked to ECHA’s scientific support to the Commission in identifying new POP substances, we prepared in 2023 a draft scientific dossier (Annex D

proposal) for Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5) and

Dodecamethylcyclohexasiloxane (D6).

We provided technical and scientific support to the Commission for discussions at the 19th

meeting of the POPs Review Committee (POPRC-19). At this meeting in October 2023, the risk

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Annual Report 2023

profile for chlorpyrifos, an organophosphate pesticide, was adopted as was the risk management

evaluations for Medium-chain chlorinated paraffins (MCCPs) and long-chain perfluorocarboxylic acids and related compounds (LC-PFCAs). Both substances were recommended for listing under

Annex A (elimination) of the Stockholm Convention, with specific exemptions. Nevertheless, the POPRC agreed that further information on the scope of the chemical identity of MCCPs for the

purpose of its listing under the Convention is required, which would be subject to further

discussion at POPRC-20.

In addition, ECHA reviewed and commented on the POPRC document on long-range

environmental transport which had been finalised in October 2023. This document is equivalent

to a guidance on how to assess the long-range environmental properties of substances.

The Union Overview report detailing the implementation of the POPs Regulation in the EU was updated in May and December 2023. The report provides information on various aspects of POPs,

such as manufacturing, market placement, stockpiling, enforcement actions and releases of POPs

into the environment.

Finally, ECHA supported the European Commission in the following activities linked to the POPs:

revising the document for the notification of articles use for submission to the Stockholm Convention, gathering UV-328 information to support the specific exemptions in the EU POPs

Regulation (investigation report under Article 69(2)) and contributing to the amendment of the

PFOS entry of the POPs Regulation.

Main outputs

O1 Prepare and support processing of the technical dossiers that the European Commission

uses when proposing to list a substance as a POP in the Stockholm Convention, review the technical dossiers submitted by other parties and support the implementation of POP

Regulation.

Draft scientific dossiers for a new EU proposal to list a potential POP substance under the Stockholm Convention on Persistent Organic Pollutants and provide

further support to the Commission for the listing process.

Yes

Maintain and develop where possible within the resource constraints the

reporting system for the implementation of the POP Regulation and update the

Union Overview report based on the Member States reports regularly.

Yes

Indicators Estimate Actual

O1 Number of scientific dossiers drafted for the

identification of new substances as Persistent

Organic Pollutants

1 1

Support provided to various stakeholders 50 55

Scientific and technical support provided to the

Commission, EU and non-EU Cas 10 14

Waste Framework Directive

Highlights

The reception of notifications of SVHCs present in articles on the EU market continued in 2023

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Annual Report 2023

including corresponding support to duty holders. The total number of notifications received in

2023 is 10 653 336. The resulting Database for information on Substances of Concern In articles (SCIP database), making this information public, was maintained.

Main outputs

O1 Maintain a database on the presence of Candidate List substances in articles.

Maintain the notification portal and disseminate the SCIP database information. Yes

Provide support to duty holders to allow EU suppliers of articles to submit the

required information to ECHA. Yes

Indicators Estimate Actual

O1 Successful SCIP notifications received (incl.

updates)

8-12 million 10.6 million

Drinking Water Directive

Highlights

With the revision of the Drinking Water Directive, ECHA assumed new responsibilities related to setting up and maintaining European positive lists of substances that are authorised to be used

for the manufacturing of materials coming into contact with drinking water.

We provided support to the European Commission for drafting and smooth adoption of the

implementing and delegated acts related to the adoption of the EU positive list, information requirements for materials in contact with drinking water and the process for submission and

inclusion of substances on the EU positive list. The acts were successfully agreed through

Comitology by the end of 2023.

We also worked to develop guidance and tools necessary to support applicants and set up a RAC

working group to ensure overall readiness for entry into operation in 2025.

Main outputs

O1 Ensure the readiness for the implementation of Article 11 of DWD (2025) (including development of the delegated acts, delivery of the tools and processes for submission,

accordance check and opinion forming, including setting up of a working group attached

to RAC).

Provide technical and scientific support to the Commission in drafting and

adopting the Implementing and Delegated acts. Yes

Clarify the likely number of applications to be expected in period 2025-2028

through engagement with stakeholders. Yes

Setup internal operational procedures and working instructions for handling

the applications to be submitted from 2025 onwards. On-going

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Annual Report 2023

Set up a Working Group associated to RAC and start developing procedures for

opinion forming. On-going

Finalise the DWD IT solution, including the adaptation of IUCLID to the specific

needs of the DWD process. On-going

Develop guidance documents for the applicants.

On-going

Indicators Estimate Actual

O1 N/A

Support to the 8th Environmental Action Programme of the

EU

Highlights

In 2023, we worked further with EEA towards creating the first version of the framework and prepared to publish the relevant indicator dashboard. We also worked to develop a common

report with joint messages on the EU progress towards the policy objectives of the CSS. The

report accompanies the CSS indicator dashboard and is expected to be published in early 2024.

Main outputs

O1 Ensure a sound, accessible and transparent evidence base to support the monitoring,

measuring and reporting on chemicals

Implement indicators based on ECHA’s data in ECHA's data platforms,

according to the plan agreed with the Commission and EEA. Yes

Develop the public version of the indicator framework jointly with EEA and the

Commission. Yes

Together with EEA develop a joint synthesis report, offering policy-relevant

messaging on the trends observed in the chemicals indicators Yes

Indicators Estimate Actual

O1 N/A

EU Observatory for Nanomaterials

Highlights

During 2023, EUON continued to produce and publish new and updated content regarding the markets and safety of nanomaterials. In the beginning of the year, the NanoData knowledgebase

was refreshed with updated information about nanomaterials on the EU market. The EUON also commissioned new studies on topics of general interest and published regular ‘Nanopinions’ on

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Annual Report 2023

current matters related to nanomaterials.

Main outputs

O1 Provide better access to information on nanomaterials on the EU market, their uses and

safety aspects, and related research activities.

Continue to fulfil specific data gaps in the public knowledge about

nanomaterials via the commissioning of external studies. Yes

Continue to promote the EUON via different channels to increase its outreach

to a wide variety of audiences. Yes

Indicators Estimate Actual

O1 All traffic to EUON websites 125 000 186 084

EU Chemicals Legislation Finder

Highlights

EUCLEF continued to provide up-to-date information on EU chemicals legislation throughout the

year. A new framework contract for the data provision feeding EUCLEF was put in place ensuring

its continuation.

Main outputs

O1 Improve transparency for the public and the business environment for EU companies

and SMEs in particular, with regard to access to information on legislation applicable to

a given substance.

Continue to operate EUCLEF and maintain updated the pieces of legislation in

the scope of the service. Yes

Continue to promote EUCLEF via different channels to increase the utility of the

service for its target audiences. Yes

Run the corresponding helpdesk. Yes

Indicators Estimate Actual

O1 Number of data updates on EUCLEF pieces of legislation 4-6 5

All traffic to EUCLEF pages 350 000 395 000

Support to occupational health legislation

Highlights

In 2023 ECHA continued supporting the Directorate General for Employment, Social Affairs and

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Annual Report 2023

Inclusion (DG EMPL), through Service Level Agreements, in providing five opinions from the RAC

on Occupational Exposure Limits (OELs). These OELs were values set by authorities at EU and national levels that help employers protect their workers’ health from possible risks when using

chemicals at work and limit exposure to harmful chemicals in the air of a workplace. All RAC opinions were made in advance to the contractual deadlines set and covered the following

substances: 1,2-dichloropropane, 1,2,3-trichloropropane, 2-chloro-1,3-butadiene

(chloroprene), 2,3-epoxypropyl methacrylate (glycidyl methacrylate) and Nitrosamines.

ECHA’s website was updated in 2023 to host a repository of substances, for which the

recommendations and opinions relating to the toxicological evaluations of substances affecting the health of workers were adopted by the Scientific Committee on Occupational Exposure Limits

(SCOEL) - Recommendations of the SCOEL - ECHA (europa.eu).

Five new requests for setting occupational exposure limits were received under the 2023

contribution agreement with the Commission: 1,3-butadiene, Boron and its compounds, Bisphenol A, Silicon carbide fibres, Pyrocatechol. RAC opinions for these substances will be

adopted by 23 February 2025.

Main outputs

O1 Opinions of the Risk Assessment Committee (RAC) on OELs to the Commission are timely

and fit-for purpose.

6 RAC opinions per year Yes

Indicators Estimate Actual

O1 Number of OEL requests received under SLA 5 5

Number of RAC opinions on OELs completed 6 5

Number of scoping documents 0 0

Instrument for Pre-Accession Assistance (IPA)

Highlights

We continued supporting the pre-accessing countries to the EU under a new contribution agreement with the Commission for 2023-2026. The focus of this support remained on training

on the EU chemicals legislation and related IT tools. Quarterly bilateral meetings were held with

beneficiaries to make sure topics and mechanisms to provide information and support are in line

with their priorities.

Main outputs

O1 Enhance the readiness of EU (pre)candidate countries to assume their role in their path

towards EU membership in the area of EU legislation for chemical management.

Implement support actions as agreed in the IPA grant agreement for 2023-25

Yes

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Annual Report 2023

Indicators Estimate Actual

O1 N/A

Support to other legislation

Highlights

In 2023, we provided input to the review of some Best Available Techniques Reference

documents (BREF) under the Industrial Emissions Directive and prepared for the formal onboarding of tasks under the upcoming revision of the Industrial Emissions Directive foreseen

to be adopted in spring 2024. We contributed to the workshop organised by the European Integrated Pollution Prevention and Control Bureau (EIPPCB), whose aim was to clarify with

stakeholders the main priorities and approaches for further development of the Chemical

Management System.

We worked with the Commission to determine the appropriate structure for ECHA to deliver on the new tasks received under the Serious Cross-Borders Threats to Health (SCBTH) Regulation.

We also participated in the discussions with the other Agencies involved in the SCBTH regulation

to share experiences and align approaches.

Main outputs

O1 Promote and support the use of the REACH/CLP data and expertise under other EU

regulatory schemes

Sustaining active input to the review of the Best Available Techniques

Reference documents (BREF) under the Industrial Emissions Directive. Yes

At Commission’s request, prepare for the onboarding of additional tasks under the upcoming revision of the Industrial Emissions Directive in relation to risk

assessment methodology in the Chemical Management System framework.

On-going

O2 Establish a readiness structure within ECHA for delivering rapid risk assessments in

case of cross-border threats to health

Agree on a process for delivering the risk assessments with the Commission.

On-going

Indicators Estimate Actual

O1 N/A

IUCLID for EFSA

Highlights

In 2023, we continued to provide support for the integration of IUCLID into the EFSA IT infrastructure by facilitating the publication of IUCLID data and assessing the implementation of

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Annual Report 2023

data analysis tools. Data Uploader was successfully used by EFSA to upload OpenFoodTox to

IUCLID format. Assessment on the use of Text analytics and Data extractor will be completed in

2024.

Main outputs

O1 Maintain cooperation between EFSA and ECHA and effective operation of the IUCLID

platform.

Assess applicability of IUCLID to other food regulated products (e.g., Food

Contact Materials and synergies with Drinking Water Directive). Yes

Submission portal is enhanced to automate the handling of large PPP

submissions. Yes

Assess the implementation of data analysis tools.

On-going

Continue support to EFSA to perform its regulatory work. Estimate resources and compensation mechanisms. Execution of the Service Level Agreement

for implementation of agreed scope and regular service accordingly.

Yes

Indicators Estimate Actual

O1 N/A

Partnership for the Assessment of Risk from Chemicals (PARC)

Highlights

As a co-leader of Task 2.1 ‘Priority setting’ under PARC, ECHA’s experts reviewed 34 projects,

mainly related to hazard, exposure and risk assessment methodologies.

We also developed with the partners of Task 2.1 the process for a Rapid Response Mechanism

(RRM) to submit project requests for specific information (e.g., urgent needs on hazardous chemicals). Furthermore, we actively participated in PARC projects addressing data gaps, for

example, on bisphenol alternatives and development of innovative methods on different hazard

endpoints (e.g., developmental neurotoxicity)

To better communicate ECHA’s research needs to the scientific community, we started to map key areas of regulatory challenge. The identified key areas of regulatory challenge were

formulated as an ‘evolving research and development agenda’ aiming to support and inspire researchers. The report was published during a joint webinar together with the European

Environmental Agency and the European Food Safety Authority in June. These research needs

will be updated and refined as the scientific areas evolve and key regulatory challenges develop. ECHA presented its research needs in various scientific fora (e.g., Joint Policy Session organised

by DG RTD, at Eurotox 2023) and via relevant communication channels (e.g., ECHA Safer

Chemicals podcast).

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Annual Report 2023

Main outputs

O1 Ensure, together with EFSA and EEA, that the research activities will support current regulatory challenges and new areas identified in the Commission’s Chemicals Strategy

for Sustainability.

Steer the development and implementation of a prioritisation strategy

(including surveys, interviews and workshops on regulatory needs with EU

and national regulatory bodies) based on the initial work done during the

PARC proposal development phase.

Yes

Contribute to the development of a framework with clear decision criteria to enable transparent decision making for the prioritisation of activities within

PARC.

Yes

Support the development of annual work plans by steering the process of

review of the projects submitted, ensuring identified EU priorities and knowledge gaps in the area of chemical risk assessment are appropriately

considered in the process.

Yes

Steer for the development and implement 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.

Yes

Indicators Estimate Actual

O1 N/A

Support to Forum

Highlights

We continued supporting the Forum of enforcement authorities, with a focus on the preparation, execution and reporting for the Forum-coordinated REACH and BPR enforcement projects. Three

projects were under preparation (imports, online sales and SPCs for biocides), two under execution (safety data sheets and PFCAs in cosmetics) and four under reporting (authorisation,

restrictions in products, biocides and classification of mixtures).

We provided advice on enforceability aspects of seven restrictions proposals to enhance their

regulatory process and future implementation including the restriction on the universal PFAS and

on CMR on childcare articles.

210 REACH and 630 BPR inspectors were trained via the train the trainers approach that supports

the harmonisation of EU enforcement of chemicals regulations.

We provided support to the Commission as input to the preparation of legislative proposals in

the context of the CSS ambition towards zero tolerance for non-compliance.

Henrik Hedlund (SE) was appointed as the new Forum chair and Helmut de Vos (BE) as the new

BPRS chair.

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Annual Report 2023

Main outputs

O1 An equal level playing field for economic operators is promoted in the EU through

harmonised enforcement

Prepare, execute, report and follow up on five Forum-coordinated REACH and BPR enforcement projects on: REACH authorisation (REF-9), REACH and POP

Restrictions (REF-10), REACH safety data sheets (REF-11), control of REACH

for imports (REF-12), BPR approved substances in biocidal products (BEF-2) and select the subjects of next REACH and BPR coordinated projects (REF-13

and BEF-3).

Yes

Establish best practice in enforcement by maintaining the Forum and BPRS

Manuals of Conclusions on practical enforcement issues and running four Forum pilot projects on exemption from registration for recovered

substances, classification of mixtures and poison centre notifications.

On-going

Deliver timely advice on enforceability on all submitted proposals for

restrictions and revise the process for delivering the Forum advice. Yes

Develop and deliver four trainings for national trainers and inspectors. Yes

Contribute and facilitate Forum’s input on the Commission’s ideas on enhanced enforcement of chemicals legislation on imports, on European Audit

Capacity for enforcement and other enforcement topics under the

CSS/REACH revision.

On-going

Indicators Estimate Actual

O1 Number of enforcement trainers trained by the

Forum

200 840

Board of Appeal

Highlights

In 2023, the Board of Appeal adopted 15 final decisions, all under REACH. In those decisions it addressed important aspects such as the interpretation of REACH information requirements and

the possibility for ECHA to revoke registrations. 10 cases (two under BPR) remained pending at

the end of the reporting period.

The General Court confirmed three decisions of the Board of Appeal which were adopted in previous years. Most notably, the Court confirmed the decisions in which the Board of Appeal

examined the relationship between REACH and the Cosmetics Regulation.

Main outputs

O1 Increase the efficiency of the Board of Appeal procedures, while continuing to ensure

their quality.

Process and decide on appeals brought against decisions of the Agency,

according to procedural requirements. Yes

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Annual Report 2023

Communicate to parties and the general public about appeal decisions. Yes

Defend appeal decisions when challenged before the EU Courts, together with

the Secretariat. Yes

Contribute to ECHA’s input for the review of the REACH Regulation. Yes

Prepare and adopt a code of conduct applicable to members of the Board of

Appeal who are Agency staff members. Yes

Indicators Estimate Actual

O1 Appeals submitted REACH 12 10

Appeals submitted BPR 2 2

Appeals concluded REACH 12 14

Appeals concluded BPR 2 1

Management

Highlights

ECHA continued to meet its governance and management obligations during 2023. All

deliverables regarding annual reports, planning and budget requirements were done within the

required timelines. With our new Executive Director, several governance and management changes and initiatives were completed. Our new Strategy Statement for the period 2024-2028

was developed and finalised. The development process involved significant staff and Management Board engagement and consultation. We also developed a new risk management

policy, risk register and procedure. To ensure even greater levels of transparency to the Management Board, the Executive Director introduced a new ED report that is presented at each

meeting. Discussions continued with the Management Board on ensuring our planning and other documents are clear, concise, and accessible to our stakeholders and partners. Further efforts

on transparency included a new quarterly report to the Management Board as well as a review

and update of our Conflicts of Interest policy.

We supported Commission colleagues in their policy development work under the Chemicals

Strategy for Sustainability including our joint efforts on alternatives to animal testing. This facilitated the establishment of structured contacts around specific files. Due to this focus,

drafting a Memorandum of Understanding with Commission services was de-prioritised. Although the REACH revision and ECHA Basic Regulation were not published in 2023, we provided

significant support to these. We aim to continue the dialogue with the Commission on the Basic Regulation in 2024 given it is a priority us. We also paid particular attention to increasing our

engagement with the Member States and institutional partners. This involved meetings with the

European Parliament and EU agencies as well as several Member States visits initiated by the

Executive Director, which will continue in 2024.

Following a successful audit, ECHA maintained its ISO 9001:2015 certification. We also completed several successful audits and evaluations and ensured the necessary follow-up was

completed on their main recommendations. Outside of the day-to-day legal activities, ECHA defended its own decisions at the European Court of Justice and the Board of Appeal. We also

supported the Commission at the European Court of Justice in risk management and biocides

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Annual Report 2023

related cases. Altogether more than 50 cases were pending at different stages during the year,

and the judgments received were predominantly very positive, confirming the position of ECHA.

We expect the level of litigation to continue similar or higher in the next years.

Our key focus was in communicating and engaging with our stakeholders and partners and will continue under the new strategy. As our legal mandate is widened, we will also be increasing

our stakeholder and partner contacts in the EU, Member States, industry, and civil society

organisations. We have resumed the organisation of regular NGO dialogues. We received increased requests for our Accredited Stakeholder Organisation (ASO) list in 2023 and we expect

this to continue into 2024 and beyond. To help us prepare for the increased levels of engagement envisaged in our new strategy and new tasks, we completed our new stakeholder engagement

approach and drafted our new communications strategy for the period 2024-2028. Both will be

finalised and rolled out in 2024.

ECHA’s communications activities in 2023 focused on supporting the organisation in presenting its work clearly and transparently, across the range of its activities to its different internal and

external stakeholder audiences. Key initiatives included the introduction of the Executive

Director, the promotion of ECHA’s work on new alternative methodologies and key areas of

regulatory challenge, the proposed universal restriction on PFAS amongst many others.

We continued to broaden our use of digital communications channels focusing, in addition to the website, on the development of our social media channels which are reaching a growing

community, podcasts, audiovisual products and supporting stakeholder interaction through

information and training webinars.

Main outputs

O1 ECHA’s (multi-)annual planning provides clear direction that is aligned with its mandate

and developing EU policies, while facilitating the efficient integration of new tasks

Adopt a multi-annual work programme (Strategic Plan) and associated

objectives for integration in the Programming Document Yes

Develop and implement a project portfolio management mechanism to provide continued effective support to the implementation of the

Commission’s Chemicals Strategy for Sustainability.

Yes

Develop and implement a project portfolio management mechanism to

facilitate the integration of new regulatory tasks and changes to ECHA’s

governance structures.

Yes

O2 The management bodies are in the position to drive performance and ensure

compliance of ECHA.

Adopt and publish the Programming Document, including (multi-)annual work

programme and budget in line with the Commission guidelines. Yes

Prepare and take the decisions statutorily required from the management

bodies, including the Management Board, within the applicable deadlines. Yes

Monitor performance through monthly and quarterly reporting to the Management Board and address issues through mitigating actions; and report

the overall status and achievements through the annual report published by

end of April each year.

Yes

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Annual Report 2023

Timely reporting on measures taken in the light of the observations

accompanying the annual discharge from the EU budget authority. Yes

Prepare and implement the corporate audit and evaluation plan, in

consultation with the Management Board, with regular status reports and

appropriate follow-up actions.

Yes

Maintain the ISO 9001:2015 certification. Yes

Review ECHA’s Policy for the Prevention and Management of Conflicts of

Interest. Yes

Defend ECHA’s interests in legal proceedings and ensure legal advice to its

operations and on issues relating to financial interests, human resources,

procurement, intellectual property and access to documents.

Yes

O3 ECHA addresses the individual circumstances and needs of its institutional partners and

is aligned with EU priorities.

The Executive Director has a regular exchange of views with the European

Parliament’s Committee for Environment, Public Health and Food Safety and

maintains regular contacts with its liaison MEP and other MEPs.

Yes

Organise regular bilateral interactions with Member States authorities. Yes

Propose a draft Memorandum of Understanding on mutual expectations with

the Commission services. No

O4 Stakeholders and general audiences are aware of ECHA’s activities and impact and

easily obtain the information they need from the Agency.

Implementation of 2023 Communications Action Plan to support the Work

Programme. Yes

Organise the biennial ECHA Conference.

On-going

Maintain and further develop the ECHA websites as key communication

channels to provide accurate, relevant and up to date information to

stakeholders.

On-going

Adopt a revised, cooperative approach for stakeholder engagement to support the implementation of the new multi-annual work programme

(Strategic Plan) and clarify ECHA’s work to key audiences in view the Agency’s evolving role under the Chemicals Strategy for Sustainability and

implement related actions.

On-going

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Annual Report 2023

Indicators Estimate Actual

O2 Areas where audits and evaluations results (including prevention of conflicts of interest and

fraud) have been considered in future strategic

decisions.

5 5

O4 Combined neutral and positive feedback monitored

in media publications

>90 % 96 %

Website unique visitors/traffic to the web content 4.2 million 5.8 million

ICT

Highlights

During the year 2023 ECHA embarked on the transformative ECHA IT 3.0 Journey, which has a

primary focus on IT resilience, scalability and delivery capabilities.

ECHA systems maintained an availability rate of 99%, surpassing the target of 98%, ensuring

good level of service delivery internally and towards all stakeholders. By keeping the focus on

IT security and business continuity, and implementing the agency’s cybersecurity policy, the Agency avoided major cybersecurity incidents, and maintained the high standards of defences

against evolving threats.

In 2023, we made progress in implementing a modular and reusable IT architecture, aligning

with the Target Enterprise Architecture vision established in 2022. Our modular approach ensures flexibility and adaptability, laying the groundwork for improved tooling support for

regulatory processes. Following the same architecture prescriptions, a new version of ECHA's dissemination platform was designed and implemented. This revamp enhanced accessibility and

scalability, ensuring seamless access to critical information for all stakeholders.

Our ongoing refresh of administrative tooling ensured optimal performance, allowing us to keep pace with technological advancements and streamline workflows. The potential of artificial

intelligence (AI) was also recognised, and a horizontal working group was established to

identifying opportunities and setting guidelines for AI-related initiatives.

Main outputs

O1 Improve the resilience and scalability of the IT product and services portfolio in order to

improve the efficiency and cost effectiveness in absorbing a growing mandate (CSS,

1S1A, new tasks etc).

The target enterprise architecture is adopted, and implementation is started

to improve tooling for regulatory processes for internal and authority users. On-going

O2 Further develop the capability of the IT function to deliver through more effective

organisational processes, refined architecture and leverage of new technologies.

Implement the cybersecurity policy adopted in 2022. Yes

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Annual Report 2023

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

The implementation of the roadmap for the future of the ICT infrastructure

towards the public cloud begins. On-going

Services continue to be run at the required level of quality, in an efficient and

cost-effective manner, by continuously investing in evolving the tools and

practices.

Yes

The preparation and establishment of replacement framework contracts for Management Information Systems, Enterprise Content Management and for

Managed IT Workplace Services.

Yes

Indicators Estimate Actual

O1 Average availability of key systems >98 % 99 %

O2 High impact security incidents <3 0

Financial Resources

Highlights

We effectively managed our financing in 2023 through close monitoring of uncertain fee income development. On the final budget size of EUR 123.3 million, the Agency reached a 99%

commitment rate and 87% payment rate, exceeding the targets set. The European Court of

Auditors gave a clean audit opinion on ECHA's annual accounts for 2022 and their first audit

mission on the financial year 2023 concluded without any preliminary findings.

We continued supporting the Commission in its design of a sustainable and more predictable financing model and a simpler budget structure. Details on ECHA’s budget information and

management in 2023 can be found in Part II and Appendix II of this report.

Main outputs

O1 ECHA’s budget is implemented in line with the objectives set in the Programming Document, with a high degree of implementation and in line with the Financial

Regulation.

Prepare and implement ECHA’s budget in line with the objectives set in the Programming Document and the rules and deadlines set in the Financial

Regulation.

Yes

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

Prepare and present the annual accounts to the Management Board and

Institutions in line with the rules and deadlines set in the Financial Regulation. Yes

Prepare and implement procurement and contracting activities in line with

the objectives set in the Programming Document and the rules and deadlines

set in the Financial Regulation.

Yes

Provide data and analysis to the Commission to support achieving a stable

and predictable financing model for ECHA, with a more flexible budget Yes

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Annual Report 2023

allocation.

Provide regular reports to the Commission partner services and the

Management Board’s Sub-group on Finance, Audit and Risk, on the evolution of fee income, actual budget implementation, including revenue and

expenditure estimates for the future.

Yes

Maintain regular contacts with the Commission’s partner DGs’ financial

services to discuss ways of handling any shortfall or surplus during the budget

year.

Yes

Monitor and report annually on the evolution of the transfer of a proportion of fees to Member States, propose improvements thereto, as necessary, and

prepare updates to the related transfer amounts per country when the

Commission country coefficients are updated.

Yes

Implement further efficiency measures, including the automation of

electronic signature to contracts, further digitalisation of the financial workflows, streamlining the procurement process by onboarding PPMT (that

provides a single platform access to all eProcurement tools) and further

promotion of electronic invoicing.

Yes

Indicators Estimate Actual

O1 Level of budget implementation: commitment rate

and cancelled payment appropriation rate

(including carry-forward)

Min. 95 %

and max. 5 %

respectively

99 % and

1 %

Processing of payments within legal deadlines No less

than 99 %

99 %

Human Resources

Highlights

During 2023, we continued to build our organisational capability to support the delivery of ECHA’s

Work Programme. The annual staff turnover rate was within target, while vacancies were

promptly filled leading to a high 96.8 % of establishment plan posts filled. Our biennial staff engagement survey showed high levels of commitment and engagement and confirmed ECHA’s

recognition as one of Finland’s most inspiring workplaces.

2023 was the final year of the existing HR Strategy and actions on priority areas were all

delivered. Technical competencies were successfully reviewed and updated with a view to preparing for new tasks. Learning and development priorities were actively addressed and

delivered to build and maintain critical competence in key areas, including management and leadership capabilities. ECHA continued to provide its staff with career development

opportunities through regular career enhancement calls, an internal mentorship programme and

career coaching addressing individual needs. The attractiveness of ECHA as an employer was promoted with our strategic partners, at both international and at host country level. We also

revamped the organisation’s presence in social media to further enhance our attractiveness as

an employer.

Finally, we consulted all our staff and the Staff Committee in the development of the new People and Organisational Strategy for the period 2024–2028. This key document will support the

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Annual Report 2023

organisation in achieving its purpose, vision and goals as contained in ECHA’s new Strategy

Statement 2024-2028.

Main outputs

O1 ECHA attracts, develops and retains competent and committed staff to implement its

current and future mandate.

Develop a new human resources framework, in line with the new ECHA multi-

annual work programme (Strategic Plan), addressing core topics such as competence development, recruitment, inclusiveness, gender balance and

career development.

Yes

Implement ECHA’s Wellbeing Action Plan 2023-2024 with the support of

ECHA’s Corporate Services Unit and the Agency’s Joint Committee for Health

and Wellbeing.

Yes

Provide competence development activities to ensure continuous capacity building of staff, including exploring joint training initiatives with peer

Agencies.

Yes

Ensure regular communication with ECHA’s Staff Committee to maintain a

healthy working culture and positive relations and dialogue. Yes

Implement ECHA’s Diversity and Inclusion Action Plan 2023-2024 to advance diversity (including gender balance) in the management team and at

organisational level.

Yes

Indicators Estimate Actual

O1 Turnover of Temporary Agents <5 % 1.1 %

Turnover of Contract Agents <10 % 4.6 %

Percentage of Establishment Plan posts filled 95 % 96.8 %

Corporate Services

Highlights

During 2023, we continued to adapt to the hybrid working environment and an external

consultant conducted an analysis on optimising the use of our office building and Conference centre. In 2023, ECHA maintained its International Organisation for Standardisation (ISO)

14001:2015 and EU Eco-Management and Audit Scheme (EMAS) certifications, as well as

business continuity and security while closely monitoring the geopolitical situation with local authorities. Our new environmental work programme 2023-2025 was coordinated and monitored

effectively (more information can be found in Part II and Appendix VII).

We successfully organised meeting services for 640 events and official meetings, with 32 800

participants joining online through Webex, and hosted approximately 5 000 visitors to our premises. We also continued to work towards our aim to reduce CO2 emissions from both staff

travel and building operations. A feasibility study of ISO 20121:2012 standard on event

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sustainability management systems was concluded and based on this study, we will aim to

implement this standard during 2024.

We launched and concluded a significant number of procurement procedures in 2023, including

several new 4-year service contracts (for example, cleaning, security and reception services contracts). We also provided the facilities, support in safety and access management for two

European Agencies who organised an official event at ECHA. 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.

Main outputs

O1 ECHA provides a safe and healthy physical work environment for staff and guests that

facilitates optimal Agency-wide performance.

Conduct an analysis on optimising the use of ECHA’s office building and

Conference Centre, including related service delivery options. Yes

Implement ECHA’s Wellbeing Action Plan 2023-2024 with the support of

ECHA’s Human Resources Unit and the Agency’s Joint Committee for Health

and Wellbeing.

Yes

Coordinate and monitor implementation of ECHA’s Environmental Work

Programme 2023-2025. Yes

Conduct staff awareness-raising activities in carbon neutrality. Yes

Indicators Estimate Actual

O1 Examine the feasibility of obtaining a relevant certification to confirm, and improve, the

sustainability of ECHA’s event-related activities.

Completed Completed

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Annual Report 2023

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

2023, eight new Board members were appointed. A number of significant decisions were taken by the MB including the development of ECHA’s strategy for 2024-2028, approving the new

policy for managing corporate risks and revising ECHA’s conflict of interest policy.

The MB led the strategy development process via its dedicated subgroup, in close collaboration

with the Executive Director. The MB assessed the evolution of ECHA’s external environment, took stock of the achievements of the previous strategy period and gathered input from ECHA

staff and the Agency’s key stakeholder groups. The final Strategy Statement 2024-2028 was

adopted in December 2023.

In June 2023, the MB adopted ECHA’s revised conflict of interest policy to strengthen the

monitoring of compliance with post-employment duties by former staff members. The policy also provides guidelines for Member States to ensure the independence of their services provided to

ECHA and clarifies the duties applicable to staff and to external contributors.

In September 2023, the MB adopted the Agency’s new framework for identifying, assessing, and

managing risks to reduce the likelihood of negative impacts on ECHA’s objectives and ensure that risk management is integrated into the decision-making process. Regular reports on risks

related to IT security were provided to the MB as well as risks arising from legal obligations not

being met due to committee capacity constraints or the size and complexity of dossiers.

With a view to resources and work programming, the MB was regularly updated on pending and

upcoming Commission initiatives with an impact on ECHA’s mandate and/or resourcing, as well

as on ECHA’s technical input to the Commission’s preparatory work.

The MB adopted all statutorily required documents 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 probationary period and annual performance appraisal, as well as renewal

of mandates.

Major developments

In 2023, the MB led ECHA’s strategy development process via its dedicated subgroup, in close

collaboration with the new Executive Director. The Strategy Statement 2024-2028 was adopted in December 2023, and it provides the framework for ECHA to deliver on its existing wide legal

mandate, build on its expertise and experience, collaborate with its stakeholders and partners,

implement new tasks and support the ambition of the EU policy goals on chemicals.

During 2023, ECHA continued to support the implementation of the Chemicals Strategy for Sustainability (CSS) as requested by the Commission. For instance, we provided scientific and

technical input to the Commission during the trilogues with the European Parliament and the

Council on the CLP Regulation revision, until a provisional agreement was reached at the end of 2023. In addition, ECHA provided technical input to the Commission during the preparation of

the legal proposals for the revision of the Groundwater, Water Framework and Environmental Quality Standards Directives, the revision of the End-of-Life Vehicles (ELV) and Restriction of

Hazardous Substances in electrical and electronic equipment (RoHS) Directives, as well as the

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Annual Report 2023

revision of the Toys Safety, Persistent Organic Pollutants (POPs) and Medical Devices

Regulations, among others. For all these the Commission put forward legal proposals, reattributing scientific and technical tasks to the Agency. In addition, the Commission published

a legal proposal to establish a Common Data Platform, which includes a number of “data-related” new tasks for ECHA, such as the development of an EU Common Data Platform for Chemicals, a

new repository of reference values, the extension of the Public Activities Coordination Tool

(PACT), the hosting of the Information Platform for Chemical Monitoring (IPCHEM), a new database of study notification, a new Early Warning Framework and the establishment of an EU

data generation mechanism. For two newly adopted legislations, the Batteries Regulation and the Regulation on Serious Cross-Border Threats to Health, ECHA commenced our implementation

plans with a view to become operational in 2024.

ECHA supported the Commission in its conceptual work on the future ECHA Basic Regulation. In

this context, ECHA delivered five retrospective evaluations on ECHA’s financial model, Committees (RAC, SEAC and MSC) and the Board of Appeal. Main recommendations on ECHA’s

financial model referred to ex-ante verifications for SMEs and a potential reserve fund, which

are expected to further enhance the flexibility and agility of ECHA’s management system, if implemented. Among the main recommendations of the evaluation of the committees were

increasing the number of coopted members, reconsidering the payment schemes for rapporteurs, considering alternative legislative structures for ECHA to get the needed expertise

and assigning a more active regulatory role for ECHA for some processes. These recommendations are expected to increase the flexibility for ECHA in attracting and keeping the

right expertise for rapporteurs, relieve the Committees’ workload and ultimately speed up the

opinion making process.

Budgetary and financial management

Financial management

ECHA effectively managed its financing in 2023, closely monitoring fee income development and

reaching a 99 % commitment rate and 87 % payment rate, exceeding the targets set. The European Court of Auditors gave a clean audit opinion on ECHA's annual accounts for 2022 and

their first audit mission on the financial year 2023 concluded without any preliminary findings.

Details on ECHA’s budget information and management in 2023 can be found in Appendix II.

Delegation and sub-delegation of the powers of budget implementation to

agency’s Staff

ECHA has 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

ECHA continued to implement its 2019-2023 Human Resources (HR) Strategy and had a high

rate of filled establishment plan posts (96.8 %) with a low Temporary Agent turnover (1.1 %) 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. Finally, the

Diversity and Inclusion Action Plan was further implemented, and our efforts were recognised

through the award of a Certificate of Excellence from the Network of EU Agencies.

ECHA’s biennial staff engagement survey was conducted by ECHA’s independent service partner in the spring of 2023. The results are above benchmark levels and show high employee

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engagement level. The service provider characterised ECHA as an inspiring workplace where

business is developed together with employees. The results of the staff survey, together with

the rest data sources, are analysed in the internal controls assessment (see Section III).

Strategy for efficiency gains

In the recently released draft discharge report for the financial year 20225, the European

Parliament commends ECHA for its strategy for efficiency gains, stating that the Agency’s strategy focuses on achieving added value through performance-based governance, alongside

the development of new tools that enhance Planning and Reporting processes. These tools, designed to be more user-friendly, offer better reporting capabilities, and save time for the entire

staff. In terms of efficiency gains, the discharge report also observes that the Agency also started an infrastructure capacity optimisation exercise to minimise any excess capacity in the IT

infrastructure and the Agency was able to reduce the usage by roughly 25 %.

With regard to ECHA’s efficiency efforts in the area of IT management, in 2023 the Agency

continued the process of organising its IT portfolio in modules, which allows a composable

architecture and further enables synergies between activities and legislations.

According to the 2023 staff survey, 42 % of respondents fully agree and 44 % tend to agree

that their units operate efficiently, pointing to a perception of ECHA as an efficient organisation.

As part of its efficiency initiatives, in 2023 the Agency prioritised the adoption of the PEPPOL

platform for invoice exchange. This initiative ensures secure and timely transactions, benefitting both public and private sector entities within and outside the EU. The use of this platform has

streamlined the recording of debit notes in the Agency’s accounting system, handling an average of 2000 commercial invoices annually. Furthermore, to expedite financial transactions, the

Finance unit now possesses the authority to approve payments below EUR 8,000. Approximately

75 % of invoice-based payments and 100 % of cost-claims, such as meeting participant reimbursements, are processed within the Finance unit, freeing up time for middle and senior

management to focus on strategic priorities.

Another significant change occurred with the implementation of the new hybrid working

arrangement as of 1 September 2023. This approach replaced the previous structural teleworking request system, resulting in around 82 % decrease in teleworking requests during

Q4 2023 compared to Q4 2022. The adoption of hybrid teleworking arrangement brought several tangible benefits. It has reduced the administrative burden for both staff and managers (two

approval workflows per year instead of weekly or monthly) and reinforced flexibility and trust

between staff and managers. This new approach is expected to lead to increased staff

engagement and commitment.

Assessment of audit and retrospective evaluation results during the reporting year

Retrospective (ex-post) evaluations

In 2023, ECHA performed the following retrospective evaluations following the criteria and

methodology as stipulated in the Better Regulation Guidelines6 :

• Retrospective evaluation of ECHA’s Committees, and namely: the Committee for Risk

Assessment (RAC), the Committee for Socio-economic Analysis (SEAC) and the Member

5 https://www.europarl.europa.eu/doceo/document/CONT-PR-753516_EN.pdf 6 http://ec.europa.eu/smart-regulation/guidelines/tool_42_en.htm

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State Committee (MSC)7. Upon request of the services of the European Commission, this

ex-post evaluation analysed the degree of effectiveness, relevance, efficiency, proportionality, coherence, added value and sustainability of the Committees established

by the REACH Regulation. The results will be used to support the Commission’s work on improving the governance of ECHA, for which the Chemicals Strategy for Sustainability

(CSS) foresees the establishment of a self-standing basic regulation. Some process

results may be used by the Commission in a possible future REACH revision.

• Retrospective evaluation of ECHA’s Board of Appeal8. The objective of this evaluation was

to analyse the degree of effectiveness, efficiency, proportionality, coherence, added value, relevance, and sustainability of the Board of Appeal (BoA), with the results

supporting the European Commission’s work on the Basic Regulation for ECHA.

• Retrospective evaluation of ECHA’s financial model, including its REACH/CLP and Biocides

fee income trends, and their predictability and stability throughout the years. A comparison with other agencies’ models was covered to allow for conclusions on the

proportionality of ECHA’s model. The costs, risks and benefits associated with the model

for ECHA, and its main stakeholders were also captured in the analysis. The results of the retrospective evaluation can be used to support the Commission’s announced proposal

for an ECHA Basic Regulation.

Internal Audit Service (IAS)

The Internal Audit Service (IAS) of the Commission conducted an audit on ‘Budget preparation,

monitoring and reporting’. The audit did not result in any critical or very important recommendations. The audit identified two improvement areas, classified as important, on

resource allocation and the exceptions register.

Internal Audit Capability (IAC)

The Internal Audit Capacity (IAC) conducted one assurance audit 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 Follow-up to Dossier Evaluation process.

The audit resulted in one very important recommendation:

• Provide a holistic overview and monitor dossier evaluation process (compliance checks

and testing proposals) from start to end by e.g., preparing analysis on annual trends on

status of Final decisions (closed, in follow-up evaluation, in enforcement).

and three important recommendations:

• To support efficient and effective enforcement of the Failure to respond cases: o Inform National enforcement authorities of the priority cases according to the

ECHA’s strategy and Integrated Regulatory Strategy o Continue cooperation with the National enforcement authorities.

• Complete the existing calculations on resource needs to deal with the accumulated

backlog and the scenarios for the future. Agree on the need to allocate resources to additional tasks such as restructuring and simplifying the Follow-up to Dossier Evaluation

process, IT development.

• To reinforce assessment of the regulatory risk management measures as a Follow-up to

Dossier evaluation outcome clarify if Follow-up to Dossier evaluation team needs

7 https://echa.europa.eu/documents/10162/17086/retrospective_evaluation_of_committees_report_en.pdf/e491f353-

1e6e-8616-8990-48db2fed0056?t=1695807929141 8 file://echa/data/users/u09175/Roaming%20Profile/Downloads/ex_post_evaluation_board_appeal_en%20(6).pdf

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Annual Report 2023

additional support.

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 2024) to verify the implementation of the action plans, concluding that two very

important and four important actions are still being implemented.

European Court of Auditors (ECA)

In their statement of assurance9, the European Court of Auditors (ECA) concluded that the accounts of the Agency for the financial year 2022 present fairly, in all material respects the

financial position of the Agency at 31 December 2022, 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.

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

aspects.

The Court did not make any observations regarding the financial year 2022 and there are no

observations open from previous years either.

Follow up of recommendations and action plans for audits and evaluations

Follow up of recommendations and action plans for audits and evaluations

▪ The follow-up of the evaluations performed in previous years showed that most of the recommendations on the retrospective evaluations, such as those concerning the SCIP

database (Substances of Concern In articles as such or in complex objects (Products) established under the Waste Framework Directive (WFD))10, EU Chemicals Legislation

Finder (EUCLEF), the EU Observatory for Nanomaterials (EUON), Cloud services and Portal Dashboard for national enforcement authorities (PD-NEA) and Portal Dashboard for

Member State competent authorities (PD-MSCA) have been implemented.

▪ The follow up of the retrospective evaluation on the functioning of ECHA’s Integrated

Management System (performed in 2019) showed progress in areas such as further integration of internal control and quality, simplification of IMS processes, aiming to ensure

proportionality between costs, risks and benefits at process level and promotion of staff empowerment.

Follow up of recommendations issued following investigations by the

European Anti-Fraud Office (OLAF)

N/A

Follow up of observations from the Discharge authority

For the discharge 2022, the Secretariat of the European Parliament Committee on Budgetary

Control asked all EU Decentralised Agencies for a follow-up report to the 2021 budgetary

discharge to be submitted by 15 September 2023.

9 https://www.eca.europa.eu/en/publications/SAR-AGENCIES-2022 10 https://echa.europa.eu/documents/10162/6205986/scip_evaluation_report_en.pdf/2c677149-e876-f2b1-0ba7-

3daca0a419ef?t=1665556373094

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Annual Report 2023

The report11 provides an overview of the relevant observations and recommendations from the

European Parliament Resolution12 of 10 May 2023 on discharge in respect of the implementation of the budget of ECHA for the financial year 2021, together with the measures ECHA has taken

in light of these.

On 10 May 2023, the European Parliament also adopted the resolution on discharge in respect

of the implementation of the budget of the EU agencies for the financial year 2021: performance,

financial management and control (2022/2134(DEC)). This resolution is a horizontal report containing recommendations and observations that accompanied the individual 2021 discharge

reports for each of the Agencies and Joint Undertakings. The follow-up actions to these recommendations, where a collective response was prepared by the EU Agencies Network, will

be presented in a separate report being prepared by the Agency holding the Chairing role of the EU Agencies' Network. ECHA has contributed to this report by providing information in relation

to its own actions.

In summary, there were nine recommendations from the European Parliament, out of which six

have been implemented.

Environment management

Environmental and sustainability management

To sustainably use resources and maintain sound environmental practices, ECHA has integrated

environmental management into its systems. In 2023, the Agency was recertified under both the EU Eco-Management and Audit Scheme (EMAS) and International Organisation for

Standardisation (ISO) 14001, which both confirm that ECHA evaluates, reports and improves its environmental performance. These certifications are central to realising our vision of becoming

an Agency with net-zero greenhouse gas emissions by 2030, as stated in our climate neutrality

pledge.

ECHA’s Environmental Work Programme (EWP) 2023-2025 outlines our goals, actions, and

objectives for reducing the consumption of natural resources, cutting down waste, and minimising our carbon footprint. Overall, ECHA’s total CO2 consumption was within the annual

target of the 2023-2025 environmental work programme. This was made possible with the collective effort of all ECHA staff, who limited their work travel by respecting the limits set for

total CO2 through the mission quota system introduced in 2023.

Environmental Objectives 2023-25

(Benchmark year: 2019)

Result in 2023

Building CO2 emissions reduction of 20% 61 %* decrease

Travel (meeting participants) CO2 emissions reduction of 75% 73 % decrease

Travel (staff missions) CO2 emissions reduction of 50% 70 % decrease

*Adjusted to 2022 CO2 emission factors

Actions of the EWP implemented in 2023 included the strengthening sustainability criteria and

monitoring for Green Public Procurement (GPP), the development and implementation of an

11 ECHA_2021_Discharge_report_follow-up.docx (europa.eu) 12 TA (europa.eu)

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Annual Report 2023

Internal Audit methodology of the ECHA Environmental Management system (EMS) and the

review of the scope of CO2 related to ECHA’s activities. Finally, to promote and implement ECHA’s environmental objectives, over 30 communications activities were undertaken during

2023 to promote international, EU, national and ECHA climate awareness actions such as Earth Day, EU Green week and the Baltic Sea Day. ECHA was also active in inter-institutional activities

and participates in the Groupe Interinstitutionnel de Management Environnemental (GIME) and

European Union Agency Network (EUAN) Greening Network to exchange best practice on

environmental management among the EU institutions and Agencies.

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 Section IV.

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Annual Report 2023

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. Following the recommendations from the IAS audit on ‘Budget

preparation, monitoring and reporting’, ECHA also sampled and analysed the whole exceptions register. The detailed conclusions from the sampling and analysis of all those sources are

available in the internal controls assessment for the year 2023.

Internal control surveys were conducted to capture the self-assessment of Directors, Heads of Units and Management board members with regard to the functioning of the ECHA’s

management system. Staff members’ perception was also analysed as part of the annual staff survey 2023 and stakeholders’ input was captured in the media report and various retrospective

evaluations. Interviews were also conducted to deepen the analysis in the areas with low scores. The data on perception together with the other sources mentioned above were analysed and

triangulated to derive conclusions.

For 2023, the assessment confirms that the 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 (9 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.

Performance management, and stakeholder engagement are the main areas of attention as a

result of the internal controls assessment 2023 (details are available in the next section).

Improvement work is either ongoing or planned for 2024.

In terms of costing the controls, the Agency follows the definition in the General Financial Regulation13 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

13 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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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

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 3.4 % which is lower than the previous year, when the percentage was 3.7%.

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 2023, ECHA appointed a Chief Risk Officer and ECHA’s

Management Board adopted a new organisational Risk Management Policy. ECHA also developed a new Risk Management Procedure, together with implementing a revised internal framework

for addressing risk management in ECHA. Regular updates were given to the Management Board

and specific reporting continued on the IT-security related risks.

Transparency, accountability and integrity

Throughout 2023, the Agency lived up to its values of transparency and independence, 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 three layers: a simple Infocard aimed at consumers, a more detailed Brief Profile for professionals and the non-confidential

source data submitted by industry to ECHA.

During 2023, ECHA published a IUCLID dataset for 528 approved pharmaceuticals, including

results from animal studies and human data. The availability of this new data supports the development of alternatives to animal testing. In addition, a pilot project led by the European

Federation of Pharmaceutical Industries and Associations (EFPIA), and supported by ECHA, has

made an updated set of archived data from unpublished chemical tests available on the IUCLID website. The database contains now altogether information about the hazard properties of 94

substances from 517 tests.

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Annual Report 2023

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 of 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 2023. However, one issue was identified within a process where an external service provider contributed to the

Agency’s outputs. The provider had failed to declare that one of its experts was at the same time and on the same topic also advising a private entity potentially affected by ECHA’s work.

Immediately after detecting this potential for a conflict of interest, ECHA took the necessary mitigating measures, including terminating the contract in question and re-evaluating all of the

outputs produced by the external service provider in this file, to fully exclude any undue influencing. Improvements were also made to the procurement process to avoid any similar

situations in the future.

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 considered to not be in a position to participate in the voting on such dossiers.

Policy update

ECHA’s Management Board adopted in June 2023 changes to ECHA’s procedures for prevention

and management of potential conflicts of interest. Based on recommendations issued by the European Parliament as discharge authority, the European Ombudsman and the European Court

of Auditors, ECHA introduced additional measures to strengthen the monitoring of compliance

with post-employment duties by former ECHA staff members. It also converted the existing individual Memoranda of Understanding between ECHA and Member State Competent Authorities

(for ensuring the independence of Member State services to be provided to ECHA) into the format of a single document with guidelines for Member States, in order to streamline the process.

Finally, it separated the duties applicable to ECHA staff from those applicable to members of

ECHA bodies into two self-standing procedures under an overarching policy document.

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 2023, twenty-five (25) staff members left ECHA: six (6) of them went to work for another EU institution, body or Agency. Four (4) staff members moved to a national public administration

or international organisation. Eight (8) staff members moved to the private sector or started

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Annual Report 2023

self-employment and, in seven (7) 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 seven (7) cases, ECHA has not (yet) been informed about a new occupational activity, as the departure was due to retirement, permanent invalidity 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 assessments14.

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

Conflict of Interest Advisory Committee

The Conflict of Interest Advisory Committee (CoIAC) is an advisory body in the context of 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: Mr Per Ängquist, appointed by the Management

Board of ECHA (he has succeeded Ms Judite Dipane whose mandate in Management Board and CoIAC expired end of May), Mr Julio Bacio Terracino from the OECD ethics department, appointed

as an external expert, and Ms Minna Heikkilä, Head of ECHA’s Legal Affairs Unit as Chairperson.

On 31 May 2023, the CoIAC convened for its annual meeting where it took the opportunity of the change in its composition but also of the presence of the ECHA’s new Executive Director to

recapitulate and discuss the past ten years of advice given by the CoIAC.

The CoIAC further received a request for advice from the Executive Director concerning analysis

of ECHA’s CoI prevention policy and implementing rules with a view to the expanding role and mandates of the ECHA Committees and the actors involved around the Committee work. The

CoIAC agreed to base its advice on an analysis of the new and amended policy to be adopted in June 2023, and it held a number of interviews with Chairs of ECHA’s Committees as well as

Working Groups. The final advice will be delivered in 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 12annual declarations submitted by the members of the ECHA Board of Appeal revealed that all of them were in place, publicly available and sufficiently complete to

allow for effective conflict of interest prevention and management. However, while there is a duty for an annual update, for 1 declaration more than 21 months had expired since the latest

update. While the Board of Appeal confirmed that the annual renewal process was ongoing also for this alternate member, they were reminded of the importance of the prescribed 12-month

time limits to allow accurate assessments of potential conflict of interest situations.

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

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Annual Report 2023

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 Behaviour15 is well communicated to all staff members.

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 Strategy16 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 2023 a mandatory all-staff ethics

training was organised, with a focus on dealing appropriately and effectively with lobbyists.

Data protection

The Data Protection Officer is an independent function within the Agency, who advises the units

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 2023, the focus areas of support concerned contractual arrangements for IT solutions procured by the Agency, as well as an in-depth assessment of the privacy risks associated with

ECHA’s project of migrating its data to the public cloud. Actions have also been taken in the context of two data protection related complaints and three personal data breaches that occurred

in ECHA and involving ECHA staff and/or stakeholders.

As required, these cases were recorded and reported, and appropriate mitigating measures were

agreed with process owners to avoid repeats in the future.

Security and business continuity

During 2023, separate training sessions on security for service providers in ECHA’s premises as

well as numerous unit/directorate fire-safety and evacuation walk throughs were organised.

Based on a scheduled fire safety inspection the agency’s Emergency Rescue Plan was updated and communicated to the Helsinki Rescue Authorities. ECHA’s emergency procedures were

audited as part of the ISO-audit and as part of the EMAS verification of ECHA’s environmental

statement.

Radiation safety training was organised for ECHA’s Radiation Safety Officer by the STUK organisation. ECHA’s business continuity organisation was reviewed and updated in 2023 to

better reflect the needs of the organisation. The agency has maintained and updated its physical security and safety equipment, in accordance with legal requirements and with due consideration

to best practice throughout the year and continuously monitors its geopolitical operating

environment.

15

https://echa.europa.eu/documents/10162/13559/code_of_good_administrative_behaviour_en.pdf/a4aa9

4f7-f631-43d6-8c28-77a10a0d0720 16 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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Annual Report 2023

Co-operation and security briefings with Commission´s Representation in Helsinki, the Helsinki

police and other local authorities on security and safety matters continued during year 2023. Finally, the Agency received one request for support from the EU Agencies Security Network

related to security management.

Regarding cybersecurity the new EU regulation on cybersecurity for Union Institutions, Bodies,

Offices and Agencies was adopted in December 2023. Preparations for the new legal obligations

were made and implementation will follow in 2024 and beyond. This includes cybersecurity risk- management, governance and control framework, maturity assessment, risk-management

measures and cybersecurity plan.

Public cloud services were being put in place the cybersecurity and resilience and continuity

arrangements were put in place. In addition, regarding data protection various impact

assessments were performed.

Cybersecurity awareness campaign was continued with two more mandatory courses for ECHA staff as well as phishing simulation exercises and European Cybersecurity Month "Be Smarter

than a Hacker" in October 2023.

Although the Cybersecurity service of the Union Institutions, Bodies, Offices and Agencies (CERT-EU) reported unprecedented rise of cybersecurity incidents in the second half of 2023,

cybersecurity of ECHA infrastructure and data, including hybrid working practice, was maintained

and no high impact security incidents were encountered in ECHA.

Conclusions of assessment internal control systems

Component Conclusion

Governance

1.1 Mission and vision

ECHA’s purpose, vision and values were reviewed in the context of the new ECHA strategy in 2023 building on input from staff, MB members and via them

stakeholders.

1.2 Ethical and organisational values

The principle is present and functioning. ECHA is perceived as a transparent organisation. Values have been updated in 2023 in consultation with staff and MB and reflect ECHA’s new tone at the top and strategy 2024 -2028. Awareness raising

efforts on dealing with sensitive topics need to remain high.

1.3 Management responsibility

The Integrated management system is functioning, and management committed to its continual improvement and flexibility. The overall management perception of

ECHA’s ability to support effective decision-making at the right level is neutral towards positive for senior management. The overall perception of the efficiency of decision-making is positive among staff. The decreasing allocation of resources in

the area of quality, internal control, internal audits and process improvements at ECHA is impacting the support to the work of the QAO network.

1.4 Human Resources

ECHA has competent and highly qualified staff, and there is Management commitment to enhance staff and competence development. There is a need for

improvement in the areas of identifying competence gaps and assessing staff performance in an objective, equal and transparent way.

1.5 Stakeholders and partners engagement

ECHA is well committed to its stakeholders and their needs. In 2023 there was a new

Communications’ strategy and a stakeholder methodology developed and efforts were made towards identification, classification and prioritisation of stakeholders. However, it cannot yet be concluded that the actions taken have been effective in

handling the deficiencies as identified in the IAC audit in 2022 since the strategy has not yet been implemented and there is work ongoing under the new stakeholders’ approach. It will be beneficial to ensure stakeholder contacts are transparently

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Annual Report 2023

shared in the organisation and tailor made to the Agency’s strategic and operational goals.

Strategy, planning and risk management

2.1 Priorities planning

and resource allocation

In 2023, Management Board adopted ECHA’s new strategy and the SPD for 2024- 2026 where it defined ECHA’s strategic and operational priorities and their implementation. ECHA demonstrates commitment to stakeholders, priorities and

objectives, which is demonstrated in the new strategic statement. The resources allocation based on strategic goals, including in horizontal services, is an area for improvement.

2.2 Risk management

The corporate level risk exercise is well established. MB involvement and establishment of clear roles and responsibilities with the new risk policy in 2023 is a positive development. Process-level risk management is less structured, and controls

are partly perceived as disproportionate or as removed without prior risk assessment. Different indications exist for the cost-benefit ratio of horizontal functions. No overall analysis is available.

Operations and operational structure

3.1 Activity

management

The activity and process management enables synergies. Efforts were made in 2023 to define the outcomes, expected performance, efficiency, and impact of activities, however, biggest part of this work will take place in 2024 in alignment with the

implementation of ECHA’s new strategy. There are control mechanisms in place to manage suppliers and contracts at ECHA. The Agency may benefit from an overall systematic analysis of how and if the risk of overdependence has materialised in the

different activities of ECHA, together with a consideration of the costs, risks and

benefits of the dependency versus the transition to new potential contractors. Awareness raising around management of contractual risks and strengthening

ECHA’s negotiating power may target contract managers and process owners in the operational units.

3.2 Information and data management

ECHA aims at effective, efficient, integrated information, communication, and data

solutions. The level of IT has remained adequate, despite the increased number of security threats. There is ongoing work with regard to improving the overall efficiency of the IT systems and the systematic involvement of stakeholders in the development

of IT products and services. Measuring the efficiency and economy of ECHA’s IT initiatives, i.e. around re-using existing IT platforms and tools will be beneficial.

3.3 Change management

ECHA overall responds to changes flexibly whilst ensuring continuity of operations.

Changes to ECHA’s financial model are expected to further enhance the flexibility and agility of the system. Specific consideration should be paid to the prerequisites (including the legislative ones) for maintaining a flexible and agile management system in the future in view of the changing stakeholders’ requirements and the

onboarding of new tasks.

Evaluation and improvement

4.1 Performance management

The structures ensure overall reliability of reporting, accuracy, completeness, and timeliness of data. 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 consistent reports and avoid manual interventions. The adequacy of corporate metrics will need to be addressed, taking

into account the balance between quantitative and qualitative indicators, such as stories, and the data needs of the different stakeholder groups.

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Annual Report 2023

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 improve the communication around the Management Review topics and to ensure that cost-risk-benefit analysis is performed

when new initiatives are started.

Statement of the manager in charge of risk management and internal control

We, the undersigned,

Shay O’MALLEY And Frank BÜCHLER

Director of Resources Head of Unit Governance,

Strategy and Relations

In our capacities as manager in charge of risk management and internal control, we declare that

in accordance with ECHA’s Internal Control Framework, we have reported our advice and

recommendations on the overall state of internal control in the Agency to the Executive Director.

We hereby certify that the information provided in the present Annual Report and in its annexes is, to the best of our knowledge, accurate, reliable and complete.

Done at Helsinki, on 12 March 2024

signed signed

Shay O’MALLEY And Frank BÜCHLER

Director of Resources Head of Unit Governance,

Strategy and Relations

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Annual Report 2023

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 will feed into the Management Review 2024, where senior management of the Agency gets together to reflect on the strengths, weaknesses, risks and opportunities of the

management system. Based on this retrospective assessment, the Senior Management agrees on the priorities and actions to take in 2024. 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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Annual Report 2023

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 Auditors17 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 at Helsinki, on 22 March 2024

signed

Dr Sharon McGuinness

Executive Director

17 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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Annual Report 2023

Appendices

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Annual Report 2023

Appendix I - Key indicators

WP Activity Indicator Estimate

2023 (PD) Actual Progress

1.1 Dossier preparation Inquiries received and concluded 4200 4835 115%

1.2 Dossier submission and processing Number of SME companies verified for their status 400 416 104%

1.3 Identification and prioritisation Number of substances registered above 100 t/y in the unassigned region of the chemical

universe for which a conclusion on potential regulatory follow-up was drawn 250 156 62%

1.3 Identification and prioritisation Number of groups of substances for which the assessment of regulatory needs is carried out 70 61 87%

1.4 Evaluation Compliance checks concluded: draft decisions or no action 300 301 100%

1.4 Evaluation Final decisions on dossier evaluation (testing proposals and compliance checks) 300 367 122%

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

evaluation 200 202 101%

1.4 Evaluation Substance evaluation final decisions issued 10 6 60%

1.4 Evaluation Number of substances for which a conclusion was reached in substance evaluation 25 26 104%

1.5 Authorisation Number of new entries in the Candidate List 15 8 53%

1.5 Authorisation Number of RAC & SEAC opinions adopted on applications for authorisation (number of uses) 60 58 97%

1.6 Restrictions Number of RAC & SEAC opinions on restriction proposals 6 5 83%

1.6 Restrictions Restriction proposals or investigation/screening reports developed 5 8 160%

1.7 Classification and Labelling Number of RAC opinions on proposals for harmonised classification and labelling 50 42 84%

1.7 Classification and Labelling Decisions made on requests to use an alternative chemical name (CLP Article 24) 40 26 65%

1.7 Classification and Labelling Poison centre notifications (millions) received and made available to Appointed Bodies and

Poison Centres 2 4.4 220%

2. Biocides Number of opinions on active substances [approval & renewal] 28 13 46%

2. Biocides Number of opinions on Article 15, Article 38 and Article 75(1)(g) requests 20 7 35%

2. Biocides Number of opinions on Union authorisation of biocidal products 31 10 32%

2. Biocides Number of opinions on Union authorisations subprocesses (same biocidal products,

administrative and minor changes) 52 21 40%

2. Biocides Number of technical equivalence application assessments 30 32 107%

3.1 PIC – prior informed consent Export notifications processed 11200 10857 97%

4.2 EU Chemicals Legislation Finder Number of data updates on EUCLEF pieces of legislation 4 5 125%

4.3 Support to occupational health legislationNumber of RAC opinions on OELs completed 6 6 100%

5.2 Board of Appeal Appeals concluded under REACH 12 14 117%

5.2 Board of Appeal Appeals concluded under BPR 2 1 50%

5.4 ICT Average availability of key Systems >98% 99.96% 99.96%

5.5 Financial resources Commitment rate 95% 99.20% 99.20%

5.6 Human resources Percentage of Establishment Plan posts filled 95% 96.80% 96.80%

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Annual Report 2023

Appendix II - Budget implementation reports and statistics on financial

management

Budget overview

The initially budgeted total payment appropriations for the Agency’s expenditure in 2023, as concluded by the Management Board in December 2022, amounted to EUR 117.7 million. In

addition the budget included c. EUR 0.8 million for the separately budgeted Other tasks

(“Contribution Agreements and SLAs” in the table below), and the final total expenditure, concluded in the amending budget in September 2023, amounted to EUR 118.0 million. The

budget for the Other tasks was increased by EUR 4.5 million.

Revenue Initial voted budget Amending budgets Final voted budget

Total revenue 117 724 442 249 258 117 973 700

Expenditure Initial voted budget Amending budgets Final voted budget

Commitment appropriations 117 756 974 265 505 118 022 479

Payment appropriations 117 724 442 249 258 117 973 700

Revenue

The budget funding of ECHA in 2023 consisted of the following (amounts in EUR):

Description

Initial voted

Budget

2023

Budget

Amendment

s 2023

Final voted

Budget 2023

Entitlements

established

2023

Revenue

received

2023

Fees and charges from Registrations & Updates 23 413 785 2 744 690 26 158 475 26 680 580 26 680 580

Fees and charges from Authorisations 2 932 200 200 000 3 132 200 3 297 666 3 297 666

Fees SME Administration 814 500 (114 500) 700 000 817 549 817 549

Fees and charges from CLP 90 500 - 90 500 100 600 100 600

Fees and charges from Appeals - 26 309 26 309 33 484 33 484

Total REACH Fees & Charges Income 27 250 985 2 856 499 30 107 484 30 929 879 30 929 879

Fees relating to Biocidal Active Substances 705 712 (452 579) 253 133 236 500 236 500

Fees for Union Authorisation of Biocidal products 1 430 884 (442 982) 987 902 922 200 922 200

Miscellaneous fees 2 494 878 (735 913) 1 758 965 1 631 700 1 631 700

Fees and charges from Appeals - - - 2 500 2 500

Total BPR Fee & Charges Income 4 631 474 (1 631 474) 3 000 000 2 792 900 2 792 900

REACH EU Contribution 70 711 023 (3 900 000) 66 811 023 66 811 023 66 811 023

BPR EU Contribution 7 556 055 2 000 000 9 556 055 9 556 055 9 556 055

ENV EU Contribution 4 907 490 - 4 907 490 4 907 490 4 907 490

EFTA Contribution - REACH 2 003 016 - 2 003 016 2 003 016 2 003 016

EFTA Contribution - BPR 190 924 - 190 924 190 924 190 924.00

Confederation of Switzerland Contribution - BPR 333 222 49 233 382 455 382 455 382 455.00

EFTA Contribution - ENV 140 253 - 140 253 140 253 140 253

Total EU and other Contributions 85 841 983 (1 850 767) 83 991 216 83 991 216 83 991 216

Contribution Agreement EUON - 609 000 609 000 614 000 614 000

Contribution Agreement EUCLEF - 1 519 000 1 519 000 1 053 400 1 053 400

Contribution Agreement IPA - 641 348 641 348 641 348 641 348

Contribution Agreement OELs - 975 000 975 000 975 000 975 000

SLA with EFSA 784 712 777 380 1 562 092 1 562 092 1 562 092

Total Contribution Agreements and SLAs 784 712 4 521 728 5 306 440 4 845 840 4 845 840

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Annual Report 2023

Description

Initial voted

Budget

2023

Budget

Amendment

s 2023

Final voted

Budget 2023

Entitlements

established

2023

Revenue

received

2023

Bank Interest Income - 875 000 875 000 930 573 930 573

Other income - miscellaneous - - - 96 067 128 475

Total Administrative Operations Income - 875 000 875 000 1 026 640 1 059 048

Total 118 509 154 4 770 986 123 280 140 123 586 475 123 618 883

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 2023, in terms of cash received,

amounted to EUR 30.90 million (EUR 33.36 million in 2022). In addition, EUR 0.03 million (EUR 0.03 million in 2022) was recorded in relation to REACH appeal fees18 giving a total of fees and

charges of EUR 30.93 million (EUR 33.40 million in 2022).

Broken down by fee category, ECHA collected a total of EUR 26.68 million from REACH

Registrations and Updates fees (EUR 29.72 million in 2022). Furthermore, the Agency collected

in 2023 EUR 3.30 million from Applications for Authorisation (EUR 2.78 million in 2022) and EUR 0.10 million from CLP fees (EUR 0.07 million in 2022). 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 0.52 million in 2023 (EUR 0.52

million in 2022). On top of the additional registration fees, the Agency generated EUR 0.82 million in administrative charges (EUR 0.79 million in 2022) 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 2023, the Agency received an EU balancing contribution for REACH/CLP of EUR 66.81

million (EUR 64.22 million in 2022) and a European Free Trade Association (EFTA) contribution

of EUR 2.00 million (EUR 1.61 million in 2022).

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, the Fees and Charges Regulation and by the decisions of the Management Board. The budgetary revenue from biocidal

product fees and charges for 2023, in terms of cash received, amounted to EUR 2.79 million (EUR 6.76 million in 2022). The significant decrease in the collected BPR fee income relates

primarily to the significantly reduced number of Union Authorisation applications, for single products and for product family, received in 2023 compared to 2022 (6 applications in 2023 vs.

42 applications in 2022).

18 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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Annual Report 2023

B) BPR Contributions from the General Budget of the EU

During 2023, the Agency received an EU balancing contribution of EUR 9.56 million (EUR 7.10

million in 2022) and an EFTA contribution of EUR 0.19 million (EUR 0.20 million in 2022). In addition, the Agency received a contribution from the Confederation of Switzerland of EUR 0.38

million (EUR 0.31 million in 2022).

Environmental directives and international conventions 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, and the 8th Environmental Action Programme (8th EAP), ECHA is fully financed through an EU contribution for these activities. In 2023, the EU contribution amounted to EUR

1.22 million for PIC (EUR 1.16 million in 2022), EUR 0.29 million for POPs (EUR 0.20 million in 2022), EUR 1.34 million for SCIP (EUR 1.49 million in 2022), EUR 1.72 million for DWD (EUR

1.52 million in 2022), and EUR 0.33 million for 8th EAP (EUR 0.33 million in 2022), totalling EUR 4.91 million (EUR 4.73 million in 2022). Furthermore, in 2023, the Agency received an EFTA

contribution of EUR 0.14 million (EUR 0.12 million in 2022) 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), as well as for work with respect to the Instrument for Pre-Accession

Assistance (IPA). 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. In 2023,

ECHA received an amount of EUR 4.85 million in aggregate for implementing these tasks (EUR

4.54 million in 2022).

Other miscellaneous income from Administrative operations

The table below shows the other miscellaneous income received by the Agency in 2023 (amounts

in EUR).

Description Entitlements

established 2023

Revenue received

2023

Bank Interest income 930 573 930 573

Legal recoveries 65 918 32 489

Late interest income 11 299 11 299

Recoveries from other EU agencies 28 728 28 728

Other recoveries 1 662 1 662

Other income - miscellaneous 96 067 128 475

Total Administrative Operations Income 1 026 640 1 059 048

Fee Invoicing (other information in accordance with Article 71 of FR)

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

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Annual Report 2023

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 REACH IT (REACH/CLP fees and charges) and REACH-NG (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 2023 amounted to EUR 31.01 million (EUR 33.02 million in 2022 and EUR 26.63 million in 2021). The table below depicts the breakdown of the net

invoiced REACH fees during the years 2021-2023.

REACH 2023 2022 2021

Description No of

Invoices EUR

No of Invoices

EUR No of

Invoices EUR

Invoices issued 5 743 33 510 775 6 579 35 011 416 6 588 28 295 673 Credit Notes 131 (1 790 613) 494 (1 628 744) 215 (1 161 459) Unpaid 136 (710 941) 111 (364 332) 118 (505 526) Considered paid 14 (259) 17 (842) 29 (488)

Net Invoiced 31 008 962 33 017 498 26 628 200