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EUROPEAN COMMISSION

Brussels, 7.12.2023

COM(2023) 779 final

2023/0453 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

establishing a common data platform on chemicals, laying down rules to ensure that the

data contained in it are findable, accessible, interoperable and reusable and establishing

a monitoring and outlook framework for chemicals

(Text with EEA relevance)

{SWD(2023) 855 final}

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EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

Chemicals are everywhere in our daily lives and they play a fundamental role in most of our

activities. They form part of virtually every product we use for our well-being, the products

we use to protect our health and security, and the innovative solutions to meet new challenges.

However, some chemicals can also cause harm to human health and the environment. Certain

chemicals can cause cancers, affect the immune, respiratory, endocrine, reproductive and

cardiovascular systems, and increase our vulnerability to disease. Exposure to these harmful

chemicals is therefore a threat to human health. In addition, chemical pollution of the

environment is one of the key drivers putting the earth at risk1, affecting and amplifying

planetary crises such as climate change, degradation of ecosystems and loss of biodiversity.

Examples of these effects are the negative effects chemicals have on pollinators, insects,

aquatic ecosystems, and on the bird population.

The European Union has developed a comprehensive regulatory framework for chemicals.

The aim is to provide a high level of protection of human health and the environment from the

adverse effects of harmful chemicals and to support the efficient functioning of the internal

market for chemicals while promoting the competitiveness and innovation of EU industry. A

fitness check of the most relevant chemicals legislation (excluding REACH)2 assessed over

40 pieces of legislation. It concluded that overall, the EU chemicals regulatory framework

delivers results as intended and is fit for purpose. However, it found a number of significant

weaknesses that prevent the framework from achieving its full potential. If not rapidly

addressed, the framework will struggle to cope effectively with the risks posed by existing

and new chemicals.

The EU chemicals regulatory framework has the overall objective to provide high-level

protection of human health and the environment from exposure to harmful chemicals. The

risk management processes introduced by each piece of legislation draw heavily from

scientific and technical assessments of chemicals’ properties, their uses, exposure and risks

and of the socio-economic consequences of the risk management measures planned.

To prevent harm caused by harmful chemicals, it is also essential to be able to identify as

early as possible any emerging chemical risks and to anticipate unforeseen consequences

related to the use of chemicals and their release into the environment. This requires having

information on early warning signals.

It is essential to assess the environmental impacts generated by chemicals along their entire

life cycle in order to conserve our natural resources, protect ecosystems and people, and to

live within the limits of our planet. To evaluate several categories of impact, such as climate

change and resource use, we need access to robust and high-quality information. Armed with

this information, we can guide the design, development and production of chemicals and the

1 Rockström, J. et al., Planetary Boundaries: Exploring the Safe Operating Space for Humanity. Ecology

and Society, 2009. 2 Fitness Check of the most relevant chemical legislation (excluding REACH)

(europa.eu).

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products for which they are used that provide a desirable function or service while being safe

and sustainable. Moreover, making available information on the sustainability of chemicals

could trigger demand for chemicals with lower environmental impacts, which would have a

direct benefit for health and the environment.

Building on the findings of the fitness check, the Commission committed in the European

Green Deal3 to present a chemicals strategy for sustainability4 (‘the strategy’). As part of this

work, it committed to start using the ‘one substance, one assessment’ approach to improve the

efficiency, effectiveness, coherence and transparency of issuing safety assessments of

chemicals across different pieces of EU legislation.

The one substance, one assessment approach focuses on the main factors influencing the

efficiency, effectiveness, coherence and transparency of safety assessments. It covers:

– Initiation of chemicals safety assessments. This means synchronising and

coordinating the initiation or triggering of assessments and assessing groups of

substances instead of assessing substances individually, to the extent possible.

– Attribution of tasks. This involves a clear allocation of responsibilities to bodies

performing assessments, making good use of available expertise and resources, as

well as ensuring the good cooperation between the parties involved.

– Information. Ensuring that information on chemicals is easily findable, accessible,

interoperable, secure, of high quality, and can be shared and reused to ensure that

assessors have access to all available data without technical or administrative burden.

– Methodologies. The methods used for the assessments are coherent and, to the extent

possible, harmonised.

– Transparency. Ensuring a high level of transparency in performing assessments, as

well as in the underlying scientific data and information on chemicals.

To enable the design, production and use of chemicals that are safe and sustainable by design,

and throughout their life cycle, the strategy announced that the Commission would develop

criteria for chemicals that are ‘safe and sustainable by design’5. To that end, a comprehensive

assessment of both safety and sustainability throughout the whole life cycle of chemicals is

required.

To strengthen the science-policy interface, the strategy announced that the Commission would

develop an early warning and action system for chemicals to ensure that EU policies address

emerging chemical risks as soon as identified by monitoring and research. It also announced

that the Commission would develop a framework of indicators to monitor the drivers and

impacts of chemical pollution and to measure the effectiveness of chemicals legislation.

3 The European Green Deal. COM (2019) 640 final. 4 The Chemicals Strategy for Sustainability. COM (2020) 667 final.

5 Commission Recommendation of 8.12.2022 establishing a European assessment framework for ‘safe

and sustainable by design’ chemicals and material, C(2022) 8854 final.

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The EU action plan entitled Towards Zero Pollution for Air, Water and Soil6 (‘the EU Zero

Pollution action plan’) contributed to the strategy’s objectives by committing to developing an

integrated zero pollution monitoring and outlook framework. It also consolidated the roles of

the European Environment Agency and the Commission’s Joint Research Centre in close

collaboration with the European Chemicals Agency, the European Food Safety Authority, the

European Maritime Safety Agency and other agencies as the EU’s knowledge centres of

excellence in the zero pollution monitoring and outlook framework.

In addition, the EU action plan and the proposal for a regulation on establishing a framework

for setting ecodesign requirements for sustainable products7 emphasise the commitment to

ensure that chemicals and materials are as safe and sustainable as possible by design and

during their life cycle, so that material cycles are non-toxic.

To fulfil the commitment to start using the one substance, one assessment approach and in

order to collate relevant information on the safety and sustainability of chemicals and on early

warning signals for chemicals risks, this proposal aims to:

– develop a common data platform bringing together chemicals data from multiple

sources, including environmental sustainability-related data;

– ensure that information contained in the common data platform is secure, of high

quality, findable, accessible, interoperable and re-usable;

– enable the commissioning of testing and monitoring of substances as part of the

regulatory framework when further information is considered necessary;

– keep records of studies commissioned or carried out by businesses in a chemicals

regulatory context and set up an early warning system for emerging chemical risks.

– establish a monitoring and outlook framework for chemicals

• Consistency with existing policy provisions in the policy area

The proposal complements the body of EU law governing chemicals. In addition, it

complements or is consistent with several specific legal provisions under specific chemicals-

related legislations.

The proposed provisions on setting up a common data platform on chemicals and dedicated

services provided by that platform complement existing provisions on databases, repositories

or platforms containing chemicals-related information issued under specific pieces of

legislation. The common data platform will centralise and consolidate data on chemicals at

EU level in one centrally accessible IT infrastructure. The proposed provisions also build on a

6 Communications from the Commission to the European Parliament, the Council, the European Economic and

Social Committee and the Committee of the Regions: Pathway to a Healthy Planet for All EU Action Plan:

‘Towards Zero Pollution for Air, Water and Soil’. COM (2021) 400 final.

7 The EU Action Plan and the Proposal for a Regulation on establishing a framework for setting ecodesign

requirements for sustainable products. COM (2022) 142 final.

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project initiated by the European Parliament to assess the feasibility of consolidating the data

on chemicals collected by EU institutions, bodies and agencies.

The proposed provisions related to the service under the common data platform on regulatory

information will integrate existing practices on disseminating regulatory process information

by the European Chemicals Agency (ECHA) and European Food Safety Authority (EFSA),

notably the Public Activities Coordination Tool8 and Open EFSA9. The provisions are

consistent with the proposals made to revise Regulation (EC) No 1272/200810 on

classification, labelling and packaging of substances and mixtures and the proposal for a

directive amending Directive 2000/60/EC11 establishing a framework for Community action

in the field of water policy, Directive 2006/118/EC12 on the protection of groundwater against

pollution and deterioration and Directive 2013/39/EU13 as regards priority substances in the

field of water policy, which oblige authorities to inform the European Chemicals Agency on

regulatory processes they intend to start or have started.

The proposed provisions on using standard formats and controlled vocabularies by EU

agencies are consistent with and complementary to provisions under:

– Regulation (EC) No 1907/200614 concerning the Registration, Evaluation,

Authorisation and Restriction of Chemicals (REACH), establishing a European

Chemicals Agency (Articles 77 and 111);

– Regulation (EU) 528/2012 concerning the making available on the market and use of

biocidal products (Articles 76 and 79);

– Commission Implementing Regulation (EU) 2021/42815 adopting standard data

formats for the submission of applications for the approval or the amendment to the

8 PACT - Public Activities Coordination Tool - ECHA (europa.eu)

9 Open EFSA (europa.eu)

10 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on

classification, labelling and packaging of substances and mixtures, amending and repealing Directives

67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, p. 1 11 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a

framework for Community action in the field of water policy. OJ L 327, 22.12.2000, p. 1 12 Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the

protection of groundwater against pollution and deterioration. OJ L 372, 27.12.2006, p. 19 13 Directive 2013/39/EU of the European Parliament and of the Council of 12 August 2013 amending

Directives 2000/60/EC and 2008/105/EC as regards priority substances in the field of water policy Text with

EEA relevance. OJ L 226, 24.8.2013, p. 1 14 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing

a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No

793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and

Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. OJ L 396 30.12.2006, p. 1.

15 Commission Implementing Regulation (EU) 2021/428 of 10 March 2021 adopting standard data formats for

the submission of applications for the approval or the amendment to the conditions of approval of active

substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council.

OJ L 84 11.3.2021, p. 25 – 26.

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conditions of approval of active substances, as provided for in Regulation (EC) No

1107/200916 (Articles 1 and 2);

– Regulation (EC) No 178/200217 laying down the general principles and requirements

of food law, establishing the European Food Safety Authority and laying down

procedures in matters of food safety (Articles 39f) and

– Council Regulation (EEC) No 1210/9018 on the establishment of the European

Environment Agency and the European Environment Information and Observation

Network (Annex A).

The proposed provisions on the use by authorities of information contained in the common

data platform complement existing reuse provisions. They aim to align with EU policies on

data and therefore give consistent and transparent expectations on the reuse of data compiled

under different pieces of legislation.

The proposed provisions on the notification of studies commissioned or carried out by

business operators are consistent with a similar notification obligation stipulated in Article

32b of Regulation (EC) No 178/2002 for studies commissioned or carried out by business

operators to support an application or notification in food-related areas.

The proposed provisions on creating a data generation mechanism build upon Article 32 of

Regulation (EC) No 178/2002, which states that the European Food Safety Authority shall

commission scientific studies necessary for the performance of its mission.

The proposed provisions on creating a database on environmental sustainability-related

information is complementary to Article 19a of Directive (EU) 2022/246419 setting the

reporting requirements needed to understand an undertaking’s impacts on sustainability

matters, and the information needed to understand how sustainability matters affect the

undertakings’ development, performance and market position and are relevant to the proposed

Ecodesign Regulation20. The aim of the Ecodesign Regulation is, among others, to create

harmonised reporting obligations for environmental sustainability information along the value

chain.

This proposal is closely linked to, and part of the same ‘one substance, one assessment’

legislative package, as the proposal as regards the re-attribution of scientific and technical

16 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21

October 2009 concerning the placing of plant protection products on the market and

repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309.24.11.2009, p. 1. 17 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28

January 2002 laying down the general principles and requirements of food law,

establishing the European Food Safety Authority and laying down procedures in

matters of food safety. OJ L 031 1.2.2002, p. 1. 18 Council Regulation (EEC) No 1210/90 of 7 May 1990 on the establishment of the European

Environment Agency and the European environment information and observation network. OJ L 120

11.5.1990, p. 1.

19 The Directive (EU) 2022/2464 - Corporate Sustainability Reporting Directive ("CSRD"). OJ L 322,

16.12.2022, p. 15–80. 20 Commission proposal for a Regulation of the European Parliament and of the Council establishing a

framework for setting ecodesign requirements for sustainable products and repealing Directive

2009/125/EC (Ecodesign Regulation). COM (2022) 142 final

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tasks and improving cooperation among Union agencies in the area of chemicals. That

proposed regulation makes targeted amendments to the allocation of tasks under Directive

2011/65/EU21 on the restriction of the use of certain hazardous substances in electrical and

electronic equipment, Regulation (EU) 2019/102122 on persistent organic pollutants and

Regulation (EU) 2017/74523 on medical devices. The proposal also amends Regulation (EC)

No 401/200924 establishing the European Environmental Agency and Regulation (EC) No

178/2002 laying down the general principles and requirements of general food law,

establishing the European Food Safety Authority and laying down procedures in matters of

food safety. The aim is to ensure good cooperation between EU agencies on all aspects

affecting coherence and efficiency of assessment of chemicals (such as methodology

development, data exchange and solving divergences in scientific output).

This proposal also relates to the proposal for a regulation on the European Chemicals Agency.

This may include provisions on methodologies and cooperation between EU agencies.

• Consistency with other Union policies

The regulation aims to consolidate the data on chemicals in a central IT infrastructure and to

ensure that that information is secure, of high quality, findable, accessible, interoperable and

re-usable to the extent possible. Data considered publicly available under related specific

Union acts and contained in the infrastructure will be accessible by the public. Member State

competent authorities, EU agencies and the European Commission will have access to all data

contained in the infrastructure. This availability of data will ensure the detection of early

warning signals on emerging chemical risks and facilitate the generation of further scientific

chemicals data when necessary. This should help build up a broad knowledge base and enable

more coherent assessments across different pieces of EU legislation to underpin evidence-

based, transparent and inclusive policy making. This proposal is therefore consistent with the

objective of Better Regulation.

The proposal also contributes to the objectives of EU data and digital policies by promoting

interoperability and machine readability of the chemicals information collected under EU law

on chemicals under the scope of this Regulation, of environmental sustainability-related data

for chemicals - including data on resources, emissions and relevant by-products - and of

information on early warning signals for emerging chemical risks. It builds on existing legal

instruments on data governance, such as the Data Act16 and Data Governance Act17. It lays

21 Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction

of the use of certain hazardous substances in electrical and electronic equipment (recast). OJ L 174,

1.7.2011, p. 88 22 Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on

persistent organic pollutants (recast). OJ L 169, 25.6.2019, p. 45 23 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical

devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No

1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. OJ L 117, 5.5.2017, p. 1 24 Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the

European Environment Agency and the European Environment Information and Observation Network.

OJ L 126, 21.5.2009, p. 13

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down specific rules governing data on chemicals and setting conditions for accessing and

reusing this data to better protect human health and the environment.

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis

This proposal has its legal basis in Article 114 of the Treaty on the Functioning of the

European Union. The measures laid out in this proposal pursue a better-informed, more robust

scientific decision-making in the EU that would allow to achieve a high level of protection of

human health and the environment. The common data platform on chemicals will give

broader access to and encourage the use by public authorities in the performance of regulatory

functions and fulfilment of their missions of data on chemicals in the environment and on the

presence and risk of chemicals in humans. In addition, the proposal will improve the

functioning and effectiveness of the governance of the internal market for chemicals as the

common data platform will provide information on planned, ongoing and completed

regulatory processes on chemicals as well as information on legal obligations under Union

acts on chemicals. This information will increase predictability for business operators.

• Subsidiarity (for non-exclusive competence)

The aim of providing a high level of protection of human health and the environment and of

contributing to coherent safety assessments to that end applies to all EU Member States,

though the extent of chemicals risks may vary between countries and regions. The

environmental impacts of harmful substances have no boundaries.

In order to address the problem of chemicals data being scattered among different EU

agencies, Commission departments and at Member State level the availability of information

at EU level needs to be improved. The ultimate objective regarding information availability

and information sharing is to collate all data on chemicals centrally in an accessible location,

which by definition requires action at EU level. The same logic applies to the other objectives

relating to incomplete knowledge bases: to improve the uptake of peer-reviewed published

scientific information, to create a data generation mechanism for the European Chemicals

Agency and to create an early warning system for chemical risks.

• Proportionality

This initiative does not go beyond what is necessary to achieve the set objectives.

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The accompanying staff working document25 assesses the impacts of the proposed provisions.

A more detailed estimate of the impacts of creating the common data platform on chemicals

and related actions (such as setting standard formats and controlled vocabularies) in particular

is given in the staff working document26 accompanying the proposal for a regulation as

regards the re-attribution of scientific and technical tasks and improving cooperation among

Union agencies in the area of on chemicals to the EU agencies.

The proposal does not create any new data requirements. Economic operators and laboratories

will experience some administrative burden linked to the requirement to submit a notification

when a study is intended to be commissioned or carried out. It has been estimated that it will

only take 30 minutes to submit one notification. The information requirements under existing

EU chemicals legislation continue to apply. This proposal streamlines information flows and

centralises the data collected under current EU legislation. This will make it easier for

assessment authorities to find and access information and broaden the evidence base for their

existing tasks. In the longer term, this will improve coherence between scientific assessments

at EU level and will enable better, more informed and more efficient policy choices. This will

have a knock-on benefit for citizens, industry and the environment.

The proposal aims to strike a balance between giving public authorities access to data and

allowing them to use that data for the purpose of human health and environmental protection,

while preserving business incentives to innovate, and preserve their competitiveness on the

internal market by providing operators with comprehensive information and data relevant to

fulfilling their obligations and allowing them to monitor developments in chemicals

production and use.

• Choice of the instrument

The proposed instrument is a legislative proposal for a regulation of the European Parliament

and the Council. This regulation will set direct requirements for all operators, EU agencies

and bodies within the scope of this Regulation, thus providing the legal certainty and scope

needed to enforce a fully integrated market across the EU. A regulation also ensures that the

obligations are implemented at the same time and in the same way in all 27 Member States.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER

CONSULTATIONS AND IMPACT ASSESSMENTS

• Ex-post evaluations/fitness checks of existing legislation

The Commission carried out a fitness check of the most relevant pieces of legislation

governing chemicals, assessing over 40 pieces of legislation in 201927. It concluded that,

25 SWD (2023) 855 26 SWD (2023) 850 27 Fitness Check of the most relevant chemical legislation (excluding REACH)

(europa.eu)

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overall, the legislation was delivering the results intended and is fit for purpose, but a number

of significant weaknesses prevent the legislation from achieving its full potential. It identified

shortcomings across pieces of legislation in terms of the coherence of safety assessments,

efficiency of the underlying technical and scientific work and the coherence of transparency

rules. These shortcomings can lead to inconsistency and incoherence in safety assessments,

slow procedures, inefficient use of resources, unnecessary burden, (perceived) lack of

transparency and occasional quality issues of scientific advice. It also showed significant

potential for streamlining the technical and scientific work through EU agencies that would

improve the efficiency of chemicals legislation. It would also improve the quality of

assessments and give stakeholders and the general public greater predictability.

This proposal directly tackles the problems and opportunities identified in the fitness check.

• Stakeholder consultations

The Commission published a call for evidence for this initiative on the website ‘Have your

say’28 on 19 July 2022. The public and stakeholders were invited to provide feedback by 16

August 2022. In total, the Commission received 68 submissions from the following categories

of respondents:

– business associations (35%),

– NGOs (16%),

– individual companies (15%),

– EU citizens (12%),

– public authorities (9%),

– others (4%),

– non-EU citizens (3%),

– academic/research institutions (3%), and

– trade unions (3%).

The Commission held an extensive discussion with representatives of Member States and EU

Agencies at three meetings of the Expert Group on One Substance, One Assessment29. The

meetings were held on 29 September 2021, 2-3 June 2022 and 30 March 2023.

The Commission also informed and consulted stakeholders during the online information

session on One Substance, One Assessment held on 1 June 2022. Around 800 participants

attended.

The proposal was underpinned by a study30, which used a combination of tools and methods

to collect views and data from different stakeholder groups. It involved:

28 Chemical safety – better access to chemicals data for safety assessments (europa.eu). 29 Register of Commission expert groups and other similar entities (europa.eu)

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– an online questionnaire targeting Member States yielding 15 responses;

– an online questionnaire targeting academia, industry and NGOs, yielding 65

responses;

– 14 interviews conducted with Commission departments and EU agencies;

– three online workshops for all stakeholders on 15 November 2022, 19 January 2023

and 27 February 2023, attended by 44, 72 and 61 participants, respectively.

Feedback on the establishment of a common data platform on chemicals

Generally, the consultation process revealed broad support for creating a common data

platform on chemicals. Several public authorities stated that national authorities and EU

agencies should make more data available and claimed that public authorities should have

unrestricted access to all data in the platform. Industry emphasised the importance of

maintaining the confidentiality of information shared and used. NGOs advocated for the

general public to have full transparency of data on chemicals. Some NGOs stated that

obstacles related to intellectual property rights and confidentiality should be removed to

enable broader access to and reuse of information.

Feedback on options related to data formats

Several business associations emphasised that data formats should be developed in

consultation with stakeholders and should take account of existing initiatives. Academics

mainly highlighted that it would be essential for them to have all data available for bulk

download in a common format without the need for new software. They highlighted the

importance of reporting values for a given parameter in a consistent manner and in a constant

unit. Several Member States reported that they support the principle to use the same data

formats and tools for different pieces of legislation and data holders as much as possible.

However, the use of standard data formats should not increase the burden on industry or delay

regulatory processes. One Member State found coordination with the OECD essential. Use

should be made of OECD harmonised templates. Another Member State proposed moving

from human readable to FAIR and highly granular data, to facilitate readability and use.

Feedback on controlled vocabularies

The majority of the feedback received related to examples of different pieces of legislation

using different terms for the same concept. To remedy this, EU agencies agreed on the benefit

of using a controlled vocabulary. Industry associations indicated that stakeholders should be

involved in developing controlled vocabularies and they should build on existing initiatives.

EU agencies, industry and Member States agreed that it was not possible to harmonise

substance identifiers. EU agencies raised the idea to work towards a common set of

identifiers, which can be used for all chemicals data sets. Sector-specific identifiers could be

30 Study on streamlining chemicals data flows, increasing data interoperability, dissemination, re-use, and

the use of all available data, and on the establishment of a data generation mechanism for the purpose of

safety assessments in the context of the European chemicals regulatory framework (to be published).

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used in addition. Data sets should also be linked to the regulatory context in which they were

generated, so that regulators could identify the specific substance definition. Several Member

States indicated that in addition to substance identifiers, information on the purity of a

substance is similarly important. They considered it necessary to find common definitions for

‘substance’, ‘constituent’, ‘component’, ‘impurity’, ‘substance identity’, ‘intrinsic property’ to

ensure that different datasets generated under different regulatory frameworks are

interoperable. They strongly recommended involving the OECD in this work.

Feedback on transparency and reuse

Academics indicated that it may not be necessary to disseminate more data than is currently

made available to the general public. But scientific experts from academia need to have access

to more data in order to ensure that the public is protected sufficiently from any harm caused

by chemicals. They noted that currently, the main legal obstacles to accessing information are

confidential business information and lack of access to full industry study reports. They

supported the suggestion to harmonise transparency rules across the chemicals regulatory

framework. NGOs called for better data access to enable them to perform analyses and find

potentially harmful and under-regulated substances. They suggested limiting confidentiality

claims to a minimum and applying fees to prevent default claims.

One NGO highlighted that the system that eventually will be set up must enable independent

scientists to scrutinise industry studies, to ensure that adverse effects or indicators of adverse

effects are not overlooked. Today, only summaries of the studies are available. In cases of

controversy, it is in the public interest and important to provide access to the raw data for

independent parties, on a confidential basis. Industry representatives welcomed the

dissemination of assessment reports but highlighted the danger of disclosing proprietary and

confidential business information that could undermine competitiveness and innovation. They

suggested limiting transparency to chemicals already on the market and ensuring fair sharing

of costs involved in generating test data. One industry sector expressed concerns that

undifferentiated dissemination of data could facilitate counterfeiting and pose a risk to human

health. Industry also suggested using a disclaimer prior to providing access to data in order to

clarify the legal situation and ownership and protect against misuse. One company expressed

support for the originator principle.

On the subject of the use of information, some data providers expressed concern about how

their data will be interpreted or used. While industry generally accepted the need for

authorities to use data for legal purposes, they highlighted the obstacles of fair cost-sharing

mechanisms, unfair competition, inappropriate use of data, and compromised data generation

and sharing. There was a certain perceived risk that data could be used inappropriately, as

tests are designed for specific purposes and specific chemicals. One industry association

welcomed the suggestion that data reuse should not be used to fill data gaps in regulatory

files.

Stakeholder feedback on creating a data generation mechanism

On this aspect, several Member States, business associations, companies, NGOs, and one

university voiced different opinions on the scope of a data generation mechanism. The views

ranged from using the mechanism ‘only in exceptional cases’, to ‘solve doubts or unclarities

in specific dossiers’, for ‘targeted and specific data requests’, to ‘broad scope’ and ‘all testing

of chemicals’. The university, several business associations and an individual expert also

emphasised the need to avoid overlap with existing systems. Existing data should be

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evaluated before new data are generated. One EU agency and a Member State emphasised

that data generation should be relevant for several Member States. One EU agency, one

university and a Member State also stressed the importance of following existing principles

and obligations, such as the precautionary principle, the polluter pays principle or specific

obligations for companies (such as to monitor the real-life fate and effects of their

substances).

Several Member States and business associations indicated that a data generation mechanism

should not be used to fill data gaps in files or to bypass difficulties in regulatory processes

where the data request is in the scope of such processes. An NGO pointed out that a data

generation mechanism could exclude data on substances covered in existing chemicals and

chemical product regulations, and instead focus on low tonnage substances and substances

with reduced information requirements under the REACH Regulation. Alternatively, a

Member State suggested using a data generation mechanism to identify new chemicals for

monitoring and to assess future regulatory needs. Another Member State emphasised the need

for provisions authorising the conduct of vertebrate animal tests as a last resort only.

Several Member States indicated that all bodies involved in regulatory safety assessments

should be allowed to make study requests under a data generation mechanism. Academics

claimed that academia should also be able to submit study requests. Some Member States and

a research consortium stressed the need to be able to generate (bio)monitoring data.

Comments from a Member State, several business associations, and a university on the budget

included the need for due reflection on the polluter pays principle. They also indicated that it

would be difficult to fund the data generation mechanism through industry fees, as it would be

difficult to allocate them fairly.

Feedback on the requirement to notify studies commissioned or carried out by business

operators

For the most part, respondents agreed that a study notification requirement would greatly limit

the scope to hide study results relevant to a given regulatory process. Industry stakeholders

were generally against the proposal to extend the notification mechanism that already exists

under general food legislation to the rest of the chemicals sector while NGO and academia

respondents were generally in favour.

Industry stakeholders also underlined the compliance cost implications and highlighted the

need for proportionate action. Some Member States and EU agencies reported that a

notification requirement would bring several indirect benefits related to information on

progress throughout the regulatory process (decisions taken by the applicant, planning future

workload). Several business associations expressed concern that a notification requirement

would increase the administrative burden. In addition, they stated that notifications should

ensure confidentiality and protect research and development work. A few business

associations stated that the notifications can hinder competitiveness because a co-notification

requirement would only apply to laboratories located in the European Union.

• Impact assessment

The fitness check of all chemical legislation (excluding REACH) already assessed and

concluded on most of the challenges and risks addressed through this initiative. Moreover, for

most of the proposed provisions in this initiative the options were of a more technical or legal

EN 13 EN

implementation nature rather than policy options. While the Commission therefore did not

carry out a formal impact assessment for this proposal, the study supporting the initiative did

assess impacts - quantitatively or qualitatively - where relevant and possible.

Overall, this proposal is expected to contribute to an improvement of the efficiency,

coherence, quality and transparency of chemicals assessments under EU legislation as well as

to the early identification of emerging chemicals risks. It will therefore improve the protection

of human health and the environment from chemicals, for the benefit of Member State

authorities, stakeholders and citizens. In addition, the initiative simplifies access to chemicals

information for everyone (citizens, industry, national authorities, EU agencies, the

Commission) thus increasing transparency. Moreover, it will improve predictability and thus

the possibility for the industry, national authorities and EU agencies to plan – and where

relevant coordinate – their activities:

• Bringing together chemicals data in one common data platform will increase

findability and simplify access, which is beneficial for all users. The platform will

operationalise the ambition of the one-substance one-assessment approach,

supporting quality and mutual coherence of chemicals assessments. The use of

standard formats and controlled vocabularies will enhance interoperability of

information, thus increasing its findability. In addition, information across regulatory

dossiers will be easier to compare. An increased findability and comparability will in

turn reduce administrative burden for risk assessors, which include national

administrations, and have a positive impact on the effectiveness, efficiency and

coherence of chemical safety assessments.

• Trough the extended utility of shared information in the common data platform, this

proposal will help minimise potential duplication of efforts and optimise data

generation strategies. With an increased volume and transparency of data on

chemical properties and supported by adequate context data that enables the

responsible use of that chemicals data, compliance with and enforcement of existing

obligations should be facilitated.

• Building on integrated access and services the common data platform is expected to

provide additional insight into effective risk management measures and to facilitate

the search for safe and sustainable alternatives, leading to improvements in the

protection of human health and the environment.

• Bringing together chemicals data and being allowed to use it will increase the

knowledge base for scientific assessments and opinions, thus improving their

robustness. This will in turn increase the acceptance by society of conclusions and

regulatory decisions. Knowing through the notification of studies that all studies

have been considered in an assessment further strengthens the trust of citizens in

regulatory decisions.

• A dedicated service in the common data platform related to information on

regulatory processes planned or ongoing by the Commission, EU agencies and

Member States will improve the coordination of activities, which in turn will allow

better planning for the authorities and agencies involved, thus increasing efficiency.

That information will also allow better predictability and planning for industry,

facilitating receipt of comprehensive but also consistent input to the activities, where

required. It will be easier for industry but also other stakeholders to know when and

how to contribute to regulatory processes.

EN 14 EN

• A dedicated service in the common data platform related to obligations under EU

legal acts on chemicals will be very valuable for industry, and in particular for SMEs

and microenterprises, to easily get an overview of their legal obligations, which will

give them certainty on what exactly their duties are. Acting with such full knowledge

in turn supports compliance and correspondingly reduces burden on national

authorities.

• The establishment of a monitoring and outlook framework including an early

warning and action system for emerging chemical risks will allow to shorten the

reaction time between early signals of risks and regulatory measures to reduce those

risks, and as such will lead to an improved protection of human health and the

environment.

• The establishment of a data generation mechanism allows the commissioning of

studies when there are no legal provisions to obtain them. This will contribute to the

creation of a complete knowledge base.

The establishment and operation of the platform will not impose any costs on industry.

Economic operators will continue to be bound by their existing legal obligations. Economic

operators and laboratories will experience some administrative burden linked to the

requirement to submit a notification when a study is intended to be commissioned or carried

out. Quantified costs associated with the notification obligation are set out in the staff working

document31 accompanying this proposal.

The establishment of the platform will be associated with significant costs for the EU

agencies, but they should principally be seen as investment in technical progress within the

data economy, enhancing the value of existing and future data. The task requires the

adaptation and expansion of existing data structures and IT systems as well as the

development of new ones, principally on the ECHA’s side, but also on the side of other EU

agencies as data source owners who are to prepare datasets for integration in the platform.

These costs have been quantified and assessed in detail in cooperation with the agencies

concerned. They are set out in the staff working document32 accompanying the proposal for a

regulation as regards the (re-)attribution of scientific and technical tasks and improving

cooperation among Union agencies in the area of chemicals.

• Regulatory fitness and simplification

The proposed centralisation of chemicals data and widening of the knowledge base on

chemicals will improve the coherence, efficiency and effectiveness of the legal framework as

a whole, and especially of chemical safety assessments.

The proposal will generate added value in terms of improving scientific consistency between

different pieces of legislation and the scientific quality and robustness of safety assessments.

It will significantly improve transparency and the inclusiveness of the processes to regulate

31 SWD (2023) 855 32 SWD (2023) 850

EN 15 EN

chemicals. Setting standard data formats and controlled vocabularies will also facilitate

digitalisation and the interoperability of data and will ensure that data are machine readable.

The initiative is expected to have only a limited impact on small, medium and micro

enterprises. The only new requirement for business operators that this initiative proposes to

bring in is the obligation to notify when a study is commissioned or carried out. It is estimated

that it will take around 30 minutes to submit one notification.

• Fundamental rights

The proposal has no implications on the protection of fundamental rights.

4. BUDGETARY IMPLICATIONS

The budgetary implications of this proposal are covered by the wider assessment of budgetary

needs for the one substance, one assessment package. This includes the current proposal and

the proposal for a regulation amending Regulations (EC) No 178/2002, (EC) No 401/2009,

EU 2017/745 and (EU) 2019/1021 of the European Parliament and of the Council as regards

the re-attribution of scientific and technical tasks and improving cooperation among Union

agencies in the area of chemicals. The Commission drew up a financial statement when

preparing the second proposal showing the budgetary implications and the human and

administrative resources required. The overall package will have budgetary implications for

the Commission, the European Chemicals Agency (ECHA), the European Environment

Agency (EEA), the European Food Safety Authority (EFSA) and the European Medicine

Agency (EMA) in terms of the human and administrative resources required.

The table below gives an overview of the additional resource needs for the activities covered

by the current proposal.

Full time equivalent staff per year Operational costs (in EUR 1 000)

Y1 Y2 Y3 Y1 Y2 Y3

TA CA TA CA TA CA

ECHA 7 8 9 10 9 10 0 5 076 7 023

EEA 3 2 3 2 3 2 0 766 684

EFSA 0 5 0 5 0 5 670 670 670

EMA 0 3 0 3 0 3 100 100 100

EU OSHA 0 0 0 0 0 0 0 0 0

JRC 0 0 0 0 0 0 180 180 180

SUM 10 18 12 20 12 20 950 6 792 8 657

Y = year; TA = temporary agent; CA = contract agent

5. OTHER ELEMENTS

An implementation and monitoring plan for creating a common data platform is documented

in the project initiation document (used also to underpin the assessment of impacts in the

accompanying staff working document). It outlines the steps involved, the governance setup

and population of the platform by the different data providers with datasets identified for a

EN 16 EN

minimum viable product. The Commission will closely monitor progress through interim

outputs until the go-live version of the platform within 36 months after the regulation enters

into force. The platform governance envisions regular reporting on its operations including

the effectiveness of work on interoperability i.e. integrating individual chemical datasets.

The common data platform itself will enable users to monitor associated activities such as the

early warning system and the application of a data generation mechanism. The same applies

to chemical indicators, expected to contribute to the 8th environmental action plan monitoring

framework33. The standing expert group on one substance-one assessment is expected to

continuously monitor progress on interoperability, on the reuse of data and on the utility of

the common data platform and its products.

• Detailed explanation of the specific provisions of the proposal

Chapter I, General Issues, lays out the scope and definitions applicable to this Regulation. The

core aim of this Regulation is to increase the effectiveness, efficiency and coherence of

chemicals assessments, thus contributing to the protection of human health and the

environment. The Regulation targets key actors broadly referred to as authorities. These

include the European Commission, the European Agency for Safety and Health at Work

(‘EU-OSHA’), the European Chemicals Agency (‘ECHA’), the European Environment

Agency (‘EEA’), the European Food Safety Authority (‘EFSA’), the European Medicines

Agency (‘EMA’), and Member State authorities.

Chapter II, Information System and Platforms, comprises 11 provisions that provide for the

setup by the ECHA of a common data platform on chemicals providing access to chemicals-

related data. Such chemicals-related data comprises:

• physico-chemical, hazard, use, exposure safety, risk, occurrence, emissions and

manufacturing process-related data and information on chemical substances, on their

own, or in mixtures or articles, generated or submitted under EU chemicals

legislation;

• Environmental sustainability related data and information, including climate change

related information;

• information on legal obligations, academic studies and chemicals-related data not

generated in an EU regulatory context but as part of EU, national or international

programmes or research activities;

• data and information on reference values;

• data and information from study notifications;

• information related to regulatory processes under the Union acts listed in Annex III

to this Regulation, as well as any data on applicable legal obligations under the EU

legislation listed in Annex I; and

33 8th Environmental Action Plan (EAP) monitoring framework. COM (2022) 357 final.

EN 17 EN

• data and information supporting the implementation of this Regulation such as

standard formats and controlled vocabularies.

The proposal creates an obligation to ensure that chemicals-related data of the type explained

above held by these agencies or the Commission is included in the common data platform.

Documents relating to authorities’ internal work or decision-making processes need not be

included in the common data platform, unless explicitly required so.

For medicinal active substances, only data on relevant substances needs to be included.

Relevant active substances are substances that are not only covered by medicines legislation,

but also have a relevance for other chemicals legislation, or environmental or health policies.

These include dual-use active substances as well as other active substances with particular

persistent, bio-accumulative and toxic properties or with a known high level of residues in the

environment.

This Chapter provides for a platform steering committee to be set up and for the Commission

to decide on a governance scheme for the common data platform to support and steer the

platform’s operation and evolution. It also defines the data flows that will feed into the

common data platform, to enable the ECHA to collect and make data available through the

platform. It proposes to streamline monitoring and hazard data on chemicals to ensure that the

relevant EU agency hosts the right monitoring and hazard data in line with their field of

expertise and mandate. As the collection of human biomonitoring data can mean processing

personal data, the proposal includes a provision to authorise the lawful processing of that data

by the EEA. The existing IPCHEM will be integrated into the common data platform

gradually to prevent any service disruptions.

Seven building blocks making up dedicated services are set up as part of the common data

platform. They include an information platform on chemical monitoring, a repository of

reference values, a database of study notifications, a database with information on regulatory

processes, a database with information on applicable legal obligations, a repository of

standard formats and controlled vocabularies and a database on environmental sustainability-

related information, including climate change relevant data. Individual provisions cover each

service, including specific obligations applicable to the bodies involved in providing the

service.

Chapter III, Data Formats and Controlled Vocabularies, comprises two provisions. These

provisions aim to enable users to find the data (discoverability), and for chemicals-related

information to be interoperable and accessible. It places obligations on the Commission and

EU agencies to specify formats and controlled vocabularies and make them available free of

charge on the common data platform on chemicals. It also sets an obligation to resolve any

divergence on standard formats or controlled vocabularies between the establishing parties.

Chapter IV, Data use and Confidentiality, comprises two provisions laying down rights for

access to information in the common data platform and use rights for authorities to use data in

the common data platform. It differentiates access rights to distinguish between rights for

authorities and the general public to access information. Authorities may use the data

contained in the common data platform. Conditions apply to the use of the data, including the

need to respect the confidentiality regime of the originating legislation under which the data

was submitted.

Chapter V, Monitoring and Outlook Framework for Chemicals, comprises three independent,

yet closely related provisions creating a monitoring framework for chemicals and chemical

risks. It places obligations on Union agencies to set up a dashboard of indicators to monitor

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the impacts of chemical pollution and measure the effectiveness of chemicals legislation. It

also places obligations on agencies to help set up and operate an early warning and action

system for emerging chemical risks. It establishes an observatory function compiling and

publicly disseminating information on the properties, uses and market presence of selected

chemicals, with an initial focus on nanomaterials, covering the previously established

European Observatory for Nanomaterials (EUON). It places obligations on the Commission

to select relevant chemicals or groups of chemicals and gives the possibility to the ECHA to

then use the data in the common data platform and generate new data, as appropriate,

including by using the data generation mechanism. The aim of this Chapter is to set out a

comprehensive and useful monitoring and outlook framework on chemicals to feed into and

underpin actions and policymaking on chemicals.

Chapter VI establishes the 'Data generation mechanism', enabling the ECHA to commission

studies in the form of testing or monitoring. The objective is to support the implementation

and evaluation of EU chemicals legislation within its mandate and to help support and

develop EU chemicals policy. It sets conditions for and qualifiers to the provision to

commission scientific studies, including ensuring that they do not duplicate existing studies,

maintaining the burden of proof on duty holders under the respective EU legislations, and

making it mandatory for the ECHA and the EFSA to cooperate on the planning and

commissioning of studies under the current proposal and under Article 32 of Regulation (EC)

No 178/2002. The mechanism could feed into regulatory processes where data are lacking, to

verify the effectiveness of legal measures and to generate additional data to provide evidence

in exceptional cases of serious controversy on a specific substance or file. This will contribute

to a more effective and robust knowledge base on chemicals and to building public trust in

scientific assessments.

Chapter VII, Notification of Studies, lays out obligations for business operators to notify

information on studies to the database of study notifications, part of the common data

platform, when they commission studies to fulfil the obligations under legislation listed in

Annex I to this Regulation. The obligation is placed both on industry and on the laboratories

and testing facilities commissioning or intending to carry out such studies. The ECHA has the

task of managing the database of study notifications. Study notification information is only

transferred to the common data platform once a corresponding regulatory dossier is submitted

where applicable, and once relevant confidentiality assessments have been completed. The

aim of this Chapter is to strengthen transparency in the chemicals sector and to ensure that all

available data are included in a dossier supporting a regulatory process. As a result, the

Authorities can be informed when a study is planned in the context of a regulatory processes

under the legislation governing the chemicals industry.

Chapter VIII, Delegated Powers, empowers the Commission to amend the annexes to this

Regulation to update the provisions to any new EU legislation of relevance.

Chapter IX, Enforcement, sets out provisions for enforcing the obligations on private parties

and lays down provisions for the Member States on reporting and setting penalties.

EN 19 EN

2023/0453 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

establishing a common data platform on chemicals, laying down rules to ensure that the

data contained in it are findable, accessible, interoperable and reusable and establishing

a monitoring and outlook framework for chemicals

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN,

Having regard to the Treaty on the Functioning of the European Union, and in particular

Article 114(1) thereof.

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee,

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) The European Green Deal34 sets a high ambition for enabling the transition towards a

toxic-free environment and zero pollution. The Chemicals Strategy for Sustainability35

is a crucial delivery of this zero-pollution ambition and introduces the ‘one substance,

one assessment’ approach, which aims to improve the efficiency, effectiveness,

coherence, and transparency of safety assessments of chemicals across Union

legislation. According to that Strategy, ‘safe and sustainable by design’ criteria should

be developed to enable the production and use of chemicals that are safe and

sustainable throughout their entire lifecycle. The Strategy also sets out that the

interaction between scientific developments and policy-making should be strengthened

by means of an early warning system for chemicals to ensure that Union policies

address emerging chemical risks as soon as these are identified by monitoring and

research, and that a framework of indicators should be developed to monitor the

drivers and impacts of chemical pollution and to measure the effectiveness of

chemicals legislation. This Regulation aims to implement these objectives.

34 Communication from the Commission to the European Parliament, the European Council, the Council,

the European Economic and Social Committee and the Committee of the Regions, The European Green

Deal, COM (2019) 640 final. 35 Communication from the Commission to the European Parliament, the Council, the European

Economic and Social Committee and the Committee of the Regions, Chemicals Strategy for

Sustainability Towards a Toxic-Free Environment, COM (2020) 667 final,

EN 20 EN

(2) The main objective of this Regulation is to increase the level of protection of the

environment and human health from the risks arising from hazardous chemicals, as

well as to facilitate the functioning of the internal market for chemicals. For that

purpose, this Regulation should establish a common data platform data on chemicals

(‘the common data platform’), to be managed by the European Chemicals Agency

(‘ECHA’). The common data platform is a digital infrastructure that brings together

chemicals data and information generated under the Union chemicals acquis. This

Regulation should also establish dedicated services within the common data platform

and lay down rules on the accessibility and usability of the data contained in that

platform. This Regulation aims to create a common knowledge base on chemicals

available to authorities to enable better, complete, coherent and robust scientific

assessments of chemicals and their impacts and to ensure the best use of existing

information for the purpose of the implementation and the development of Union

legislation on chemicals. Moreover, the Regulation aims to provide a one-stop-shop on

chemicals data and information in the Union accessible to the general public and, thus,

to increase the predictability and the transparency of regulatory processes on

chemicals, as well as to strengthen public trust in the robustness of scientific decision-

making.

(3) Under Decision (EU) 2022/591 of the European Parliament and of the Council36,

harnessing the potential of digital and data technologies to support environmental

policy, including by delivering real-time data where possible and information on the

state of ecosystems, while increasing efforts to minimise the environmental footprint

of these technologies and ensuring transparency, authenticity, interoperability and

public accessibility of the data and information is a long-term priority objective. Data

and information on chemicals are therefore essential for the proper development and

implementation of a Union environmental policy, and specifically of a chemicals

policy.

(4) In its communication of 19 February 2020 on a European strategy for data37, the

Commission described its vision of a common European data space and highlighted

the need for the development of sectoral data spaces in strategic areas, since not all

sectors of the economy and society are moving at the same speed. This Regulation

aims therefore to build a data space for chemicals by establishing a common data

platform on chemicals (‘common data platform’), which is also part of the Green Deal

data space, as referred to in the European strategy for data. Furthermore, in that

strategy, the Commission highlighted several issues concerning the availability of data

for the public good, including data availability, data infrastructures and governance,

interoperability, as well as the lack of adequate sharing of data between public

authorities. This Regulation aims to increase data availability on chemicals by

requiring the relevant Union agencies to make data available for integration in the

common data platform on chemicals, to promote interoperability of that data by

providing for the establishment of standard formats and controlled vocabularies, as

36 Decision (EU) 2022/591 of the European Parliament and of the Council of 6 April 2022 on a General

Union Environment Action Programme to 2030 (OJ L 114, 12.4.2022, p. 22). 37 Communication from the Commission to the European Parliament, The Council, The European

Economic and Social Committee and the Committee of the Regions, A European strategy for data,

COM/2020/66 final.

EN 21 EN

well as to facilitate data exchange and use by public authorities to enable them to

effectively carry out their regulatory and policy developing tasks.

(5) This Regulation also aims to implement into the chemicals sector the principles laid

out in the proposal for an Interoperable Europe Act38 by strengthening the cross-border

interoperability of network and information systems used to provide or manage public

services on chemicals in the Union. This Regulation will contribute to increased cross-

border data flows for truly European digital services and broaden the access to

publicly available chemicals data for utilisation in other sectors’ applications.

(6) Business operators and Members States’ competent authorities are required by various

Union acts to submit data and information to a multitude of Union agencies, as well as

to the Commission in specific cases. This generates a fragmentation of data and

information on chemicals, which are held under various data sharing and use

conditions and in different formats. Such fragmentation prevents public authorities, as

well as the general public, from having a clear overview of what information is

available on individual chemicals or groups of chemicals, of where and how

information can be accessed and whether it can be used. This increases the likelihood

of inconsistency between various assessments of the same chemical required by

various Union acts on chemicals and of damaging the general public’s trust in the

scientific grounds for Union decisions on chemicals. In order to ensure that data on

chemicals is easily findable, accessible, interoperable and usable, the ECHA should

establish a common data platform on chemicals. The common data platform on

chemicals should serve as a single point of reference and as a broadened and shared

evidence base to enable the efficient delivery of coherent hazard and risk assessments

of chemicals across various Union acts on chemicals, as well as to enable the timely

identification of emerging chemical risks and the drivers and impact of chemical

pollution.

(7) The common data platform should contain chemicals-related data and information

held by relevant Union agencies or the Commission generated or submitted as part of

the implementation of Union chemicals legislation listed in Annex I. This includes, for

instance, all regulatory dossiers or applications submitted to the relevant Union

agencies, but also chemicals data on occurrence of chemicals submitted by Member

States to Union agencies or the Commission in compliance with their reporting

obligations. The common data platform should also include chemicals data and

information generated as part of Union, national or international programmes or

research activities related to chemicals, where this data and information is held by the

Commission or one of the relevant agencies.

(8) Due to the different nature of the risk and hazard assessments performed under Union

acts on medicinal products, when compared to those performed under the main Union

acts on chemicals, for medicinal products, only chemicals data related to

environmental risk assessments for human and veterinary medicines, non-clinical

studies for human medicines and maximum residue limit values the European

Medicines Agency (‘EMA’) holds, as well as specific reference values, should be

38 Proposal for a Regulation of the European Parliament and of the Council laying down measures for a

high level of public sector interoperability across the Union (Interoperable Europe Act) COM(2022)

720 final.

EN 22 EN

included in the common data platform. For medicinal active substances, only data on

relevant substances should be included. These concern active substances covered by

the medicines legislation and also used for other applications regulated by other Union

legislation identified in this Regulation, as well as other active substances with

particular persistent, bio-accumulative and toxic properties or with a known high level

of residues in the environment.

(9) These data should also be limited to data submitted to the EMA in the context of the

relevant procedures that are finalised or submitted after the entry into force of this

Regulation. At a later stage, it should also be possible to include in the common data

platform, where relevant, data the EMA holds on procedures concluded before the

entry into force of this Regulation.

(10) Due to the sensitivity of the information on the exact chemical composition of

mixtures placed on the market and classified as hazardous on the basis of their health

or physical effects, submitted to the bodies appointed by the Member States under

Article 45 of Regulation (EC) No 1272/2008 of the European Parliament and the

Council39, that information should not be included in the common data platform.

Likewise, due to the commercial sensitiveness of data and information on final

cosmetic products, the information related to cosmetic products notified to the

Cosmetic Product Notification Portal under Article 13 of Regulation (EC) No

1223/200940 of the European Parliament and of the Council should not be included in

the common data platform either. However, chemicals data and information on

individual chemical ingredients of cosmetic products should be included in the

common data platform.

(11) To safeguard the ability of the European Commission, of the Union agencies working

on chemicals and of the competent Member State authorities (hereinafter ‘the

Authorities’), to carry out their tasks, documents with chemicals data relating to their

internal work or decision-making should in principle not be included in the common

data platform.

(12) In order to respond to the needs of the digital economy and to ensure a high level of

protection of the environment and human health, it is necessary to lay down a

harmonised framework specifying who is entitled to access and use the chemicals data

contained in the common data platform, under which conditions, on what basis, and

for which purposes. The Authorities that are entrusted with regulatory tasks related to

chemicals should be allowed and encouraged to use the chemicals data and

information contained in the common data platform to effectively fulfil their

regulatory duties and tasks, in order to improve the effectiveness, efficiency, and

coherence of chemicals-related assessments as well as the development of Union

chemicals policies.

39 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on

classification, labelling and packaging of substances and mixtures, amending and repealing Directives

67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p.

1). 40 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009

on cosmetic products (OJ L 342, 22.12.2009, p. 59).

EN 23 EN

(13) Chemicals data and information generated as a result of obligations set by Union acts

on chemicals may be protected by confidentiality claims on confidential business

information. The public dissemination of such data may affect the commercial interest

of private parties. To ensure legal certainty for duty holders and to protect their

legitimate expectations, as well as to ensure industry’s competitiveness on the internal

market, the ECHA, as a manager of the common data platform, should grant

differentiated access rights to the data and information contained in the common data

platform. To this end, the Authorities should have full access to all chemicals data and

information contained in the common data platform, including access to confidential

information, while business operators and the general public should have restricted

access to that data and information, which does not include access to confidential

information.

(14) When using data contained in the common data platform, the Authorities should

respect the originator principle. Under this principle, the confidentiality marking of

chemicals data as done by the originator and as correspondingly indicated by the

Agency when it provides that data to the common data platform should be respected

by the Authorities using that data or information to perform their regulatory functions

or fulfil their tasks.

(15) To ensure the protection of legitimate expectations of duty holders when generating or

submitting data or information under the Union acts listed in Annex I, as well as to

protect the confidentiality of that information when used by the Authorities,

exceptional grounds for disclosing confidential information laid down in the Union

acts listed in Annex I should apply only to the disclosure of the data and information

submitted or generated in compliance with those acts. For example, under Article

39(4) of Regulation (EC) No 178/2002 of the European Parliament and of the

Council41, where urgent action is essential to protect human health, animal health or

the environment, such as in emergency situations, the European Food Safety Authority

(‘EFSA’) may disclose information previously considered confidential under that

Regulation and the EFSA is required to make public information, previously

considered confidential, that forms part of conclusions of scientific outputs of the

EFSA and relates to foreseeable effects on human health, animal health or the

environment. Likewise, Article 118 of Regulation (EC) No 1907/2006 of the European

Parliament and of the Council42 provides for the possibility for the ECHA to disclose

confidential information submitted to it under that Regulation if urgent action is

essential to protect human health, safety or the environment, such as in emergency

situations.

41 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying

down the general principles and requirements of food law, establishing the European Food Safety

Authority and laying down procedures in matters of food safety (General Food Law) (OJ L 031

1.2.2002, p. 1). 42 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),

establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council

Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council

Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and

2000/21/EC (OJ L 396 30.12.2006, p. 1).

EN 24 EN

(16) Taking into account that the Agencies would be required to store scientific data, which

includes confidential and personal data, it is necessary to ensure that such storage is

carried out in accordance with a high level of security of information systems and that

access to confidential data is auditable.

(17) While the ECHA should identify and develop the technical functionalities of the

common data platform in stages, certain dedicated services should be defined by this

Regulation. As such, the common data platform should, in addition to providing

access to chemicals-related data made available by the Agencies and the Commission,

provide access to the chemicals data and information made available through its

dedicated services. These dedicated services should be integrated into the common

data platform and consist of the existing Information Platform for Chemical

Monitoring (‘IPCHEM’), a repository of reference values, a database of study

notifications, a database with information on regulatory processes, a database with

information on applicable legal obligations, a repository of standard formats and

controlled vocabularies, a database on environmental sustainability related data, as

well as a dashboard of indicators on chemicals.

(18) The Commission should adopt an implementation plan identifying initial datasets to be

made accessible via the platform and the timeline for their integration, informed by the

preparatory work of the Commission and the Agencies43. The Commission should set

up a governance scheme to support and steer the common data platform’s operation

and evolution covering the organisation of work structures and coordination between

ECHA and data providers, required rules, formats and vocabularies for data

integration, and maintain a rolling implementation plan to ensure the progress in

identification and integration of new datasets and services for inclusion. The

governance scheme should be adopted and updated as necessary by the Commission,

after consultation with a newly established platform steering committee composed of

representatives from Union agencies and the Commission. In order to ensure uniform

conditions for the implementation of the obligations to establish an implementation

plan and a governance scheme, implementing powers should be conferred on the

Commission.

(19) The common data platform should serve the widest possible community, with the

ability to address new use cases, incorporate new relevant datasets, develop new

functionalities, and respond to developing tools and applications.

(20) In order to bring together all relevant chemicals data and information in the common

data platform, the Commission and Union agencies – notably the European Agency

for Safety and Health at Work (‘EU-OSHA’), the ECHA, the European Environment

Agency (‘EEA’), the EFSA, and the EMA (‘the Agencies’), should act as data

providers and make available any such relevant data they have or hold to the ECHA

for integration in the common data platform. The Agencies, including the ECHA itself

when making its own data available, should provide the necessary standard metadata,

contextual information and relevant mapping to the platform’s structure, and respect

rules on standard formats and controlled vocabularies where available.

43 European Union Common Data Platform on Chemicals Project Initiation Document, v1.1 endorsed by

the One Substance One Assessment Interservice Group 27 February 2023.

EN 25 EN

(21) To ensure that an adequate knowledge base on chemicals is available through the

common data platform, the Commission should be able to request the Agencies to

host, maintain and make available, via the common data platform, data generated as

part of Union, national or international programmes or research activities beyond the

data already flowing to the Agencies as part of the obligations under the Union acts

listed in Annex I. The Commission should make such requests to the Agencies in

accordance with their mandates and allocated tasks.

(22) Some types of data are currently not within the mandate of any of the Agencies. In

order to ensure clarity of responsibilities of the Agencies and efficient management of

chemicals data, the Agencies should be required to host, maintain and provide specific

data types to the common data platform. To this end, the ECHA should host and be a

data provider to the common data platform for workplace monitoring data, and the

EEA should host and be a data provider to the common data platform for data on

indoor air quality and environment monitoring data, as well as data on concentrations

of chemicals in human matrices such as blood or urine (‘human biomonitoring data’).

(23) To improve the uptake of academic data and to expand the knowledge base for

chemicals safety assessments and environmental sustainability impacts of chemicals,

researchers or research consortia funded by Union framework programmes should

make available, in line with the ‘as open as possible, as closed as necessary’ principle,

any human biomonitoring data they collect or generate resulting from research and

development programmes to the EEA and any environmental sustainability data on

chemicals or materials they collect or generate to the ECHA.

(24) The EEA, as the agency responsible for monitoring data and information on chemicals

in the environment, should also be responsible for collecting, hosting, and maintaining

human biomonitoring data. To the extent that human biomonitoring data constitutes a

special category of personal data, namely, health data, the EEA should process that

data only where the processing is necessary for reasons of substantial public interest,

as required by Article 10(2)(g) of the Regulation (EU) No 2018/1725 of the European

Parliament and of the Council44. This Regulation lays down the cases where there is

such substantial public interest in processing human biomonitoring data: namely,

where the EEA processes that data to assess the impact of chemicals on human health

and the environment, to monitor time and spatial trends in exposure, to develop health

risk and impact indicators, to monitor the impact of regulatory intervention, and to

support regulatory risk assessments.

(25) In order to ensure that appropriate safeguards are in place to secure the protection of

this sensitive type of personal data, the EEA should only provide anonymised human

biomonitoring data to the ECHA for integration in IPCHEM and the common data

platform. IPCHEM, currently operated by the Commission, gathers occurrence data on

chemicals in different media, including water, soil, indoor and outdoor air, biota, food

and feed, humans, and products. In order to take advantage of the integration of

various information systems and to ensure that occurrence data on chemicals is made

available for use together with the other chemicals data, the ECHA should take over

44 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the

protection of natural persons with regard to the processing of personal data by the Union institutions,

bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No

45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

EN 26 EN

from the Commission the operation of IPCHEM and integrate it in the common data

platform as one of its main dedicated services.

(26) In order to prevent disruption to the existing operation and functioning of the

IPCHEM, the ECHA should integrate the IPCHEM in the common data platform

together with the data present in IPCHEM at the moment of integration. At the same

time, in order to enable optimal hosting and management of occurrence data on

chemicals, the Commission should also transfer the data present in IPCHEM to the

ECHA, the EEA or the EFSA for hosting and future updating in accordance with their

respective mandates. In order to ensure that the ECHA takes over from the

Commission the operation of the IPCHEM, integrates it into the common data

platform and takes over the initial data sets and sets up adequate data flows, it is

necessary to allow the ECHA an appropriate period of time to carry out these actions,

of up to 3 years from the date of entry into force of this Regulation.

(27) In order to promote the use and harmonisation of reference values among risk

assessors and risk managers across different Union acts and to facilitate compliance

with, and enforcement of, regulatory reference values, the ECHA should establish and

maintain a repository of reference values established or adopted under the Union acts

listed in Annexes I and II The Agencies should provide the ECHA with reference

values they hold or establish as part of their activities. In addition, the ECHA should

regularly screen Union acts for reference values adopted under them. To facilitate

automatic access of the general public to up-to-date reference values, the ECHA

should integrate the repository of reference values in the common data platform as a

dedicated service, include in that repository all reference values together with the

relevant context data it has received or retrieved and ensure that those values and that

context data are machine readable.

(28) In order to increase transparency, as well as to enable Authorities to have complete

prior knowledge of studies commissioned by business operators, irrespective of

whether such studies are carried out by the business operator itself or are outsourced,

business operators and laboratories should notify to a database of study notifications

established and managed by the ECHA the studies on chemicals they commission for

compliance with regulatory requirements under the Union acts listed in Annex I. For

this purpose, the ECHA should establish and manage a database of study notifications,

as a dedicated service of the common data platform, to store the information related to

those studies. In order to allow business operators and laboratories sufficient time to

prepare the notifications of studies, the obligation to notify studies should only start to

apply two years after the date of entry into force of this Regulation.

(29) Under Regulation (EC) No 178/2002 of the European Parliament and of the Council,

business operators and laboratories are obliged to notify to the database of study

notifications established and managed by the EFSA the studies they commission to

support an application or notification in relation to which Union law contains

provisions for the EFSA to provide a scientific output. To avoid overburdening

business operators and laboratories, they should therefore not be required to also

notify those studies to the database of study notifications established and managed by

the ECHA under this Regulation.

(30) To ensure the coherence between those two study notification mechanisms, as well as

to ensure certainty for business operators submitting notifications, the rules on the

public dissemination of study notifications should, where relevant, correspond in that

the notifications should only be made available through the common data platform

EN 27 EN

once a corresponding registration, application, notification or other relevant regulatory

dossier was submitted to the relevant Union or national institution and a decision on

the confidentiality of the data contained in that regulatory dossier was taken by that

Union or national institution. In addition, in order to facilitate compliance with the

requirement to notify a study, the ECHA and the EFSA should cooperate to ensure a

common approach for the identification of notified information in order to facilitate

the traceability of studies notified to their respective databases.

(31) While the study notification obligation established in this Regulation should apply in

the context of all the Union acts on chemicals listed in Annex I, the various relevant

data collection and safety assessment processes under those acts may vary widely

procedurally. The overarching aim of the database of study notifications established

under this Regulation should be to bring together information on studies on chemicals

being commissioned by business operators, such as to enable a centralised and

complete overview of the studies being performed to support regulatory compliance

under Union acts on chemicals as listed in Annex I. On the basis of this objective and

considering the fact that assessment procedures under Union acts on chemicals in

Annex I may vary widely, it would be beyond the scope and aim of this Regulation to

amend existing assessment processes set under those Union acts listed in Annex I by

imposing additional conditions leading to potential market access consequences not

foreseen in those Union acts. Consequently, it is not appropriate to introduce in this

Regulation the consequences associated non-compliance with the study notification

obligation as laid out in Article 32b of Regulation (EC) No 178/2002 of the European

Parliament and of the Council.

(32) Nevertheless, to ensure compliance with the study notification obligation laid down in

this Regulation, and to cater to the specificities of individual assessment processes,

where existing, Member States should lay down rules on penalties applicable to the

infringement of that obligation and take all necessary measures to ensure that those

rules are complied with. Those penalties should be effective, proportionate, and

dissuasive, since non-compliance with this Regulation could result in less robust

chemicals risk assessments, creating potential risks and consequently adverse effects

on human health and the environment.

(33) In order to facilitate enforcement by Member States, the Agencies responsible for

assessing and providing scientific output, including scientific opinions, on regulatory

dossiers containing studies subject to notification to ECHA should, where relevant,

cooperate and exchange information with the Member State enforcement authorities

on the compliance with the obligations laid out in Article 22.

(34) While Regulation (EC) No 178/2002 of the European Parliament and of the Council

also requires the consultation of stakeholders and the public following the notification

to the EFSA of studies commissioned for the purposes of the renewal of an

authorisation or approval, a similar requirement under this Regulation would lay a

disproportionate administrative burden on the ECHA, given the wide scope of the

studies that is to be notified under this Regulation.

(35) A mechanism related to study notifications exists in Regulation (EC) No 1907/2006 of

the European Parliament and of the Council. Where registrants are required to perform

studies to generate data in accordance with requirements in Annexes IX and X to that

Regulation, they must first submit a testing proposal to the ECHA in order to receive a

decision requiring them to perform a study. Such decision may also be issued as an

outcome of compliance check or substance evaluation under that Regulation. In order

EN 28 EN

to facilitate the transparency, traceability, and effective monitoring of studies

commissioned or carried out pursuant to a decision of the ECHA in accordance with

Articles 40, 41 or 46 of Regulation (EC) No 1907/2006 of the European Parliament

and of the Council, business operators should specify in their notifications of studies

under this Regulation that those studies are being commissioned or carried out in

compliance with those decisions.

(36) To strengthen the coordination and cooperation between the different bodies

performing chemicals assessments in the Union, and to promote an increased

transparency of chemicals assessments, the ECHA should establish and manage a

database with information on regulatory processes or activities that are planned,

ongoing or completed by Member States, the Commission and Agencies referred to in

the Union acts listed in Annex III to this Regulation and integrate it into the common

data platform for access by the authorities. The information on such regulatory

processes or activities should include at least the substance identity and the

identification, status and eventually the outcome of the regulatory process or activity.

That information should also be made available without undue delay and kept updated

through the assessment process. Once the process or activity has formally started, that

information should be shared also publicly on the common data platform.

(37) The existing ‘The EU Chemicals Legislation Finder’45 project managed by the ECHA

makes it easier to find and identify legal obligations related to the use of a specific

chemical. The project is especially helpful for small and medium sized enterprises in

identifying their legal obligations. To reinforce the supportive function of the project

for business operators, it should be established on a permanent basis and more Union

acts should be included in its scope. For this purpose, the ECHA should collect

information on the legal obligations deriving from the Union acts on chemicals listed

in Annex I to this Regulation and incorporate that information into the common data

platform as a dedicated service.

(38) In order to ensure the interoperability and comparability of chemicals data and to

facilitate their automatic and electronic exchange, the Agencies and the Commission

should store chemicals data in adequate and mutually coherent and interoperable

formats and use mutually coherent and interoperable controlled vocabularies. Some

Union acts listed in Annex I or II set procedures to establish or make available data

formats, in particular for the submission of chemicals data by business operators or

Member States. Where such procedures do not exist in the Union acts listed in Annex I

or II, the Agencies and the Commission should, where relevant, specify appropriate

formats for chemicals data they receive and store, avoiding the use of proprietary

standards while, as appropriate, using OECD or other internationally agreed formats,

making use of existing formats and ensuring interoperability with existing data

submission approaches.

(39) Likewise, the Agencies and the Commission should specify appropriate controlled

vocabularies for data they receive and store and, where relevant, integrate them in

submission software or formats. Moreover, in order to facilitate a smooth electronic

45 EU Chemicals Legislation Finder - ECHA (europa.eu), database managed by ECHA and funded by the

EU Programme for Competitiveness of Enterprises and Small and Medium-sized Enterprises

(COSME).

EN 29 EN

exchange of data through the common data platform, the Agencies and the

Commission should agree on the required formats and controlled vocabularies for

providing data to the common data platform. Whenever the Agencies or the

Commission set formats or controlled vocabularies, they should cooperate with each

other to ensure their coherence, consistency and interoperability. In order to ensure

uniform conditions for resolving divergences in data formats and controlled

vocabularies, implementing powers should be conferred on the Commission.

(40) In order to promote the interoperability of database systems on chemicals beyond the

common data platform, the ECHA should establish a repository of standard formats

and controlled vocabularies as part of the common data platform. The Agencies and

the Commission should make the formats and controlled vocabularies they set

available to the repository and the ECHA should make them available free of charge in

electronic formats for use by developers of database systems and the general public.

(41) The International Uniform Chemical Information Database (‘IUCLID’) is a software

application designed to record, store, maintain and exchange data on chemicals. The

ECHA develops and maintains the IUCLID software and the underlying format in

collaboration with the Organisation for Economic Cooperation and Development

(‘OECD’). The IUCLID implements all OECD-harmonised templates, which are

harmonised formats agreed at the OECD level to facilitate structured and consistent

documentation of test outputs and similar chemicals data. Since chemicals data is

being submitted to the ECHA in IUCLID under Union acts such as Regulations (EC)

No 1907/2006, (EC) No 1107/200946 and (EU) No 528/201247 of the European

Parliament and of the Council, the ECHA is closely involved in the continued

development of IUCLID, and IUCLID implements the standard formats agreed at the

OECD level, it is appropriate and necessary to require the Commission and the

Agencies to use IUCLID for the relevant parts of dossiers under specified Union acts

listed in Annex I when they make the data contained in those dossiers available to the

ECHA .

(42) To increase the availability and facilitate the use of information on the environmental

performance of chemicals throughout their lifecycle, and to enable a comprehensive

assessment of the impacts of chemicals on the environment, the Commission should

identify relevant data and information related to the environmental sustainability of

chemicals, including, where available, information on their impact on climate change,

for integration into the common data platform. Once the Commission has identified

the relevant existing datasets on environmental sustainability related data and has

designed the relevant related database functionalities, the ECHA should establish a

database on environmental sustainability-related data, collect the data as made

available by the Commission, the Agencies and, where relevant, by the researchers and

research consortia funded by Union framework programmes, and integrate the content

of that database into the common data platform as a dedicated service. In order to

ensure uniform conditions for the implementation of the obligation to identify relevant

46 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009

concerning the placing of plant protection products on the market and repealing Council Directives

79/117/EEC and 91/414/EEC (OJ L 309 24.11.2009, p. 1). 47 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012

concerning the making available on the market and use of biocidal products (OJ L 167 27.6.2012, p. 1).

EN 30 EN

environmental sustainability datasets, implementing powers should be conferred on

the Commission.

(43) To monitor the impacts on humans and the environment, including the climate, of

exposure to chemicals and to establish a knowledge base to measure the effectiveness

of chemicals legislation in protecting human health and the environment, the EEA and

the ECHA should jointly develop and regularly, at least every two years, update a set

of indicators and present it in the form of a dashboard. The EFSA, the EMA, the EU-

OSHA and the Commission shall regularly provide the EEA with any available data

falling within their mandate and relevant for the establishment of the indicators. The

EEA and the ECHA should integrate this dashboard of indicators into the common

data platform.

(44) To enable the identification and evaluation of emerging chemical risks, the EEA

should develop and compile information on early warning signals and draw up an

annual summary report to inform regulatory follow-up actions. In its work, the EEA

should include its own sources, targeted literature searches and make use of

information from national early warning systems. It should also include relevant

information made available by the related work of the ECHA, the EFSA, the EU-

OSHA, the EMA and their networks, such as the EFSA’s task of identifying and

collecting information on emerging risks under Regulation 178/2002. The EEA should

make the summary report and the underlying data available through the common data

platform, ensuring public access and its use for further action on existing and

emerging risks. In order to allow the EEA sufficient time to organise the collection of

early warning signals and to compile and analyse the initial information the EEA

should only deliver the first report six months after the end of the first calendar year

after entry into force of this Regulation. this Regulation sets a deadline for the first

report and associated data.

(45) In June 2017, at the Commission’ request, the ECHA set up the European Observatory

for Nanomaterials48 (‘EUON’), which collects existing data and information from

databases, registries and studies and generates new data through studies and surveys

on nanomaterials on the EU market.

(46) The ECHA should continue operating the EUON and transform it into an observatory

for specific chemicals with potential contribution to emerging chemical risks (‘the

observatory’), which should cover also other chemicals and innovative (rationally

designed complex ‘advanced’) materials selected by the Commission, using, as

appropriate, signals from the early warning and action system. One of the criteria for

selecting chemicals for the observatory should be their novelty and disruptive potential

that may contribute to an emerging chemical risk. Another criterion for that selection

should be the higher degree of uncertainty surrounding them and, due to less

regulatory experience regarding those chemicals, the resulting need for additional

scrutiny and transparency. The observatory should facilitate regulatory implementation

and responsible use of these chemicals by collecting, generating, and disseminating

48 Commission Staff Working Document – Impact assessment accompanying the document: Commission

implementing decision on a delegation agreement with the European Chemicals Agency on the

European Union Observatory for Nanomaterials and the European Union Chemical Legislation Finder

in the framework of the COSME program. SWD (2017) 138 final.

EN 31 EN

reliable information on selected chemicals’ properties, uses and market presence to the

general public.

(47) The observatory should not be regarded as a substitute for required risk management

action on any chemical in cases where a hazard or risk has been identified. In order to

provide for an efficient and consistent approach for the generation and dissemination

of all such additional information, the ECHA should oversee the work of the

observatory and make the regularly updated data and information it collects available

through the common data platform, or by means of other communication channels, as

appropriate. In order to ensure uniform conditions for the implementation of the

requirement to select chemicals to be included in the observatory, implementing

powers should be conferred on the Commission.

(48) Under Regulation (EC) No 178/2002, the EFSA is able to commission, in an open and

transparent manner, the scientific studies it needs to accomplish its mission, while

seeking to avoid duplication with Member States or Union research programmes. The

ECHA should also be able to commission studies to obtain adequate data and

information on chemicals within its mission, while maintaining the principle that the

burden to prove compliance with Union chemicals legislation remains on the duty

holder. Furthermore, the ECHA should commission such studies out of its own

initiative or at the request of the Commission, with the objective of supporting the

effective and efficient implementation and evaluation of Union acts on chemicals

within its mandate and contributing the development of a Union chemicals policy.

(49) In order to adjust the contents of Annexes I and III to technical and scientific progress

in the field of chemicals and to bring in the scope of this Regulation new Union acts

under which relevant chemicals data and information is generated or submitted, and,

where relevant, to expand the specific data types and reference values, listed in Annex

II, to be made available by the EMA through the common data platform, the power to

adopt acts in accordance with Article 290 of the Treaty on the Functioning of the

European Union should be delegated to the Commission in respect of amending

Annexes I, II and III. It is of particular importance that the Commission carry out

appropriate consultations during its preparatory work in relation to the amendment of

the Annexes by delegated act, including at expert level through the One-Substance

One-Assessment Expert Group, and that those consultations be conducted in

accordance with the principles laid down in the Interinstitutional Agreement on Better

Law-Making of 13 April 201649. In particular, to ensure equal participation in the

preparation of delegated acts, the European Parliament and the Council receive all

documents at the same time as Member States' experts, and their experts

systematically have access to meetings of Commission expert groups dealing with the

preparation of delegated acts.

(50) Since the objectives of this Regulation cannot be sufficiently achieved by the Member

States as Member States do not hold the data within the scope of this Regulation and

cannot establish a Union wide common data platform, but can rather, by reason of

chemicals data and information being hosted at Union level by the Agencies, be better

achieved at Union level, the Union may adopt measures, in accordance with the

principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In

49 OJ L 123, 12.5.2016, p. 1.

EN 32 EN

accordance with the principle of proportionality, as set out in that Article, this

Regulation does not go beyond what is necessary in order to achieve those objectives.

(51) The European Data Protection Supervisor was consulted in accordance with Article

42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council

and delivered an opinion on [OP: Please insert the date of the opinion of the EDPS].

HAVE ADOPTED THIS REGULATION:

Chapter I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

1. This Regulation aims to ensure the efficient delivery of coherent hazard and risk

assessments of chemicals where those assessments are required by Union legal acts, to

achieve a high level of protection of human health and the environment, to enable the

development and use of sustainable chemicals, to ensure the proper functioning of the

single market for chemicals, and to improve the Union’s citizens’ trust in the scientific

base for the decisions taken under Union legal acts on chemicals.

2. To achieve the objectives referred to in paragraph 1, this Regulation contains measures

to:

(a) bring together data and information on chemicals and ensure that data and

information are easily findable, accessible, interoperable and re-usable;

(b) keep records of studies commissioned or carried out by business operators in

the context of fulfilling their obligations set under Union chemicals legislation;

(c) establish the widest possible scientific base for the implementation and

development of Union legislation and policy on chemicals;

(d) establish an early warning and action system for emerging chemical risks.

3. The provisions laid down in this Regulation apply to chemicals data as laid out in

Article 3(2).

Article 2

Definitions

For the purpose of this Regulation, the following definitions shall apply:

1. ‘Agencies’ means the European Chemicals Agency (‘ECHA’), the European

Environment Agency (‘EEA’), the European Food Safety Authority (‘EFSA’) and the

European Medicines Agency (‘EMA’) and the European Agency for Safety and Health

at Work (‘EU-OSHA’);

2. ‘Authorities’ means the European Commission, the competent authorities of the

Member States as referred to in any of the Union acts listed in Annexes I and III, and

the Agencies, excluding their management boards;

3. ‘duty holder’ means a natural or legal person responsible for meeting obligations under

the Union acts listed in Annex I or II;

4. ‘business operators’ means duty holders which are private or public undertakings;

EN 33 EN

5. ‘human biomonitoring data’ means concentrations of chemicals measured in human

matrices such as blood or urine;

6. ‘reference value’ means an estimate of a maximum exposure to or emission level of a

chemical below which no or only acceptable adverse effects on human health or the

environment are expected, or below which risks related to the adverse effects on human

health or the environment are considered acceptable or tolerable;

7. ‘originator’ means the Commission, Agency, or Member State competent authority

responsible for confidentiality assessments under any Union act listed in Annex I or

Annex II;

8. ‘originating Union act’ means the Union act under which chemicals data and

information were generated or submitted;

9. ‘controlled vocabularies’ means standardised and organised arrangements of words and

phrases presented as lists of terms or as thesaurus and taxonomies with a hierarchical

structure of broader and narrower terms;

10. ‘chemicals data’ means any representation of facts or information relating to chemicals

and any compilation of such facts or information, including information on physico-

chemical properties, hazard properties, use, exposure, risk, occurrence, emissions and

manufacturing process of the chemicals, as well as environmental sustainability related

information, including climate change related information, on those chemicals,

regulatory process-related information on chemicals, standard formats, controlled

vocabularies, or any information on applicable legal obligations related to chemicals;

11. ‘environmental sustainability related data’ means any data relevant for the

environmental sustainability assessment of a chemical or material throughout its entire

life cycle, including:

(a) data on resources, including raw materials, water, energy, fossil fuels and land;

(b) data on emissions, including greenhouse gases, eutrophication-relevant

substances, dust and all other polluting substances; and

(c) data on by-products originating during the chemical’s life cycle that can be

used as resources for other production processes, including hydrogen and

carbon monoxide.

12. ‘personal data’ means personal data as defined in Article 4, point (1), of Regulation

(EU) 2016/679 of the European Parliament and of the Council and as defined in Article

3, point (16), of Regulation (EU) 2018/175 of the European Parliament and of the

Council;

13. ‘processing’ means processing as defined in Article 4, point (2), of Regulation (EU)

2016/679 of the European Parliament and of the Council and as defined in Article 3,

point (3), of Regulation (EU) 2018/175 of the European Parliament and of the Council;

14. ‘data controller’ means controller as defined in Article 4, point (7), of Regulation (EU)

2016/679 and as defined in Article 3, point (8), of Regulation (EU) 2018/175 of the

European Parliament and of the Council;

15. ‘interoperability’ means the ability of two or more data spaces or communication

networks, systems, products, applications or components to exchange and use data in

order to perform their functions.

Chapter II

INFORMATION SYSTEMS AND PLATFORMS

EN 34 EN

Article 3

Common Data Platform on Chemicals

1. The ECHA shall establish and manage a common data platform on chemicals (‘the

common data platform’).

2. The common data platform shall provide access to all chemicals data:

(a) generated or submitted as part of the implementation of the Union acts listed in

Annex I to this Regulation and held by the Agencies or the Commission;

(b) generated as part of Union, national or international programmes or research

activities in the sphere of chemicals and held by the ECHA, the EEA, the

EFSA, the EU-OSHA or the Commission;

(c) listed in Annex II and held by the EMA;

3. The following information shall not be included in the common data platform:

(a) the information referred to in Article 45 of Regulation (EC) No 1272/200850;

(b) the information related to cosmetic products and notified to the Cosmetic

Product Notification Portal under Article 13 of Regulation (EC) No

1223/200951 of the European Parliament and of the Council.

4. Documents relating to Authorities’ internal work or decision-making processes need

not be included in the common data platform, unless required under Article 10.

5. The common data platform shall provide the dedicated services identified in the

governance scheme referred to in Article 4(3) including:

(a) the Information Platform for Chemical Monitoring (‘IPCHEM’) referred to in

Article 7;

(b) the repository of reference values referred to in Article 8;

(c) the database of study notifications referred to in Article 9;

(d) information on regulatory processes referred to in Article 10;

(e) information on obligations under Union chemicals legislation referred to in

Article 11;

(f) the repository of standard formats and controlled vocabularies referred to in

Article 12;

(g) the database on environmental sustainability-related data referred to in Article

13.

6. The Authorities and the general public shall have access to the data contained in the

common data platform in accordance with Article 16.

50 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on

classification, labelling and packaging of substances and mixtures, amending and repealing Directives

67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p.

1). 51 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November on

cosmetic products (OJ L 342 22.12.2009, p. 59).

EN 35 EN

7. The data contained in the common data platform may be used in accordance with

Article 17.

8. The data contained in the common data platform shall be made available in standard

formats, where developed, and through controlled vocabularies where available.

9. The data contained in the common data platform shall be electronically accessible and

searchable. The ECHA shall take measures to ensure a high standard of security

appropriate to the security risks at stake for the storage of chemicals data in and

transmission of chemicals data to the common data platform. The ECHA shall design

the common data platform in a way that guarantees that any access to confidential data

is auditable.

10. The Commission or Agency under whose authority chemicals data is included in the

common data platform on chemicals shall remain responsible for handling any requests

for access to documents made under Regulation (EC) No 1049/200152.

11. The common data platform and its dedicated services shall be established by [OP:

please insert date: three years after the date of entry into force of this Regulation],

unless specified otherwise. The relevant datasets shall be integrated progressively into

the common data platform by [OP please insert date: ten years from the date of entry

into force of this Regulation] according to the implementation plan referred to in

Article 4 (1), first sentence. Upon integration of those datasets in the common data

platform, when the ECHA receives chemicals data in accordance with Article 5, it shall

make that data available through the common data platform without undue delay.

Article 4

Implementation plan and governance of the common data platform

1. By [OP please insert date: 6 months after the date of entry into force of this

Regulation] the Commission shall adopt and publish an implementation plan

identifying datasets for inclusion in the common data platform together with a timeline

for their inclusion by means of an implementing decision. Subsequent rolling

implementation plans shall be adopted in line with the governance scheme referred to

in paragraph 3.

2. The Commission shall, by means of an implementing decision, establish and manage a

platform steering committee, which shall include one representative from the ECHA,

one representative from the EEA, one representative from the EFSA, one

representative from the EMA, one representative from the EU-OSHA and five

representatives from the Commission.

3. The platform steering committee shall advise the Commission in the preparation of the

common data platform’s governance scheme.

4. The Commission shall adopt and publish the governance scheme referred to in

paragraph 3 and any revision thereof by means of an implementing decision

5. That governance scheme shall describe:

(a) the organisation of the main work structures supporting the development and

implementation of the common data platform;

52 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001

regarding public access to European Parliament, Council and Commission documents (. OJ L 145,

31.5.2001, p. 43).

EN 36 EN

(b) the preparation and adoption of rolling implementation plans for the common

data platform;

(c) the principles on data governance and the required standard formats, controlled

vocabularies and further conditions for the provision of information and

context data to the common data platform;

(d) the decision-making procedures for the development of new dedicated services

and the inclusion of new functionalities of the platform;

(e) any other rules or requirements necessary for the operation of the common data

platform such as the data update, archiving and deletion policy;

(f) the operation of the steering committee itself.

Article 5

Data flows for the purpose of the common data platform

1. At the Commission’s request, the Agencies shall host and maintain chemicals data

generated as part of Union, national or international legislation, programmes or

research activities, corresponding to their mandate and the type of data they already

hold.

2. Where the Commission or the Agencies hold data or information referred to in Article

3(2), they shall make that data available to the ECHA, in a standard format, where

available, together with the relevant context data as referred to in Article 4(4), point (c).

The Commission and the Agencies shall indicate whether that data or information is

made available to the public under the originating Union act.

3. The ECHA shall host and maintain occurrence data related to workplace monitoring.

4. The EEA shall host and maintain human biomonitoring data, occurrence data for the

environment and occurrence data related to indoor air quality.

5. Researchers or research consortia funded by Union framework programmes shall make

available to the EEA any human biomonitoring data they collect or generate from [OP

please insert: date of the entry into force of this Regulation].

6. Researchers or research consortia funded by Union framework programmes shall make

available to the ECHA any environmental sustainability data on chemicals or materials

they collect or generate from [OP please insert: date of the entry into force of this

Regulation].

7. The Commission and the Agencies shall provide the necessary technical cooperation to

the ECHA to enable the integration of the chemicals data provided in accordance with

paragraph 2 in the common data platform as well as its publication through that

platform.

8. For the purpose of paragraph 2, the Commission and the Agencies shall make

chemicals data available to the ECHA without undue delay after collection or receipt of

the data, after performance of validity and confidentiality assessments in accordance

with applicable rules and once the corresponding dataset has been integrated in the

common data platform.

9. The Commission and the Agencies shall ensure that data made available to the ECHA

shall be downloadable, machine readable and interoperable. They shall appropriately

curate and validate the data before providing them to the ECHA.

EN 37 EN

Article 6

Human biomonitoring data

1. The EEA shall collect, host, and maintain human biomonitoring data generated within

the territory of the EEA’s member and cooperating countries.

2. At the latest by [OP please insert date: 3 years after entry into force of this Regulation]

the Commission shall transfer any human biomonitoring data it holds to the EEA.

3. The EEA may process human biomonitoring data constituting personal data to support

the Commission in its policy making or to support the Agencies in fulfilling their

missions.

4. Human biomonitoring data constituting personal data may be processed by the EEA for

the following purposes:

(a) assessing the impact of chemicals on human health and the environment;

(b) monitoring time and spatial trends in exposure;

(c) developing health risk and impact indicators;

(d) monitoring the impact of regulatory intervention;

(e) supporting regulatory risk assessments.

5. The EEA shall make human biomonitoring data they hold or host publicly available in

anonymised form through the Information Platform for Chemical Monitoring.

6. The EEA shall act as data controller for the human biomonitoring personal data it holds

or hosts and processes for the purposes referred to in paragraph 2.

Article 7

Information Platform for Chemical Monitoring

1. The ECHA shall operate and maintain the Information Platform for Chemical

Monitoring containing occurrence data on chemicals across different media, including

water, soil, indoor air, outdoor air, biota, food and feed, humans, and products as part

of the common data platform.

2. At the latest by [OP please insert date: 3 years after the date of entry into force of this

Regulation], the Commission shall transfer the chemicals data contained in the

Information Platform for Chemical Monitoring at that moment to the ECHA for

integration in the common data platform.

3. At the latest by [OP please insert date: 3 years after entry into force of this

Regulation], the Commission shall transfer the chemicals data contained in the

Information Platform for Chemical Monitoring to the ECHA, the EEA or the EFSA for

hosting in accordance with the respective agencies’ mandate and in accordance with

Article 5.

4. After the completion of the transfer referred to in paragraph 3, where the Commission

or the Agencies host or hold occurrence data on chemicals and related chemicals data,

they shall make that data available to the ECHA without undue delay for integration in

the Information Platform for Chemical Monitoring.

5. The Commission and Agencies shall provide the necessary technical cooperation to the

ECHA to enable the integration and publication of occurrence data and related

chemicals data they host or hold through the common data platform.

EN 38 EN

6. The ECHA shall ensure that the data contained in the Information Platform for

Chemical Monitoring is machine readable and downloadable.

Article 8

Repository of reference values

1. The ECHA shall establish and manage a repository of reference values as part of the

common data platform.

2. The ECHA shall include any reference value adopted under Union acts listed in Annex

I or Annex II, Part 1, in the repository of reference values without undue delay.

3. For reference values not falling under paragraph 2, the Agencies holding or

establishing reference values as part of their activities under Union acts listed in Annex

I, or the reference values referred to in Annex II, Part 2, shall make those reference

values available to the ECHA, in the standard formats provided for in Article 14, where

developed, and without undue delay, for integration in the repository of reference

values.

4. For the purpose of paragraph 3, where reference values are included in a regulatory

dossier submitted to the Agencies, the Agencies shall share those reference values in

the standard formats with ECHA without undue delay and once relevant validity and

confidentiality assessments have been completed by the originator in accordance with

applicable rules.

5. The ECHA shall ensure that the data contained in the repository of reference values is

machine readable.

Article 9

Database of Study Notifications

1. The ECHA shall establish and operate a Database of Study Notifications by [OP please

insert date: two years after the date of entry into force of this Regulation].

2. The ECHA shall store in the Database of Study Notifications the data notified to it in

accordance with Article 22.

3. The ECHA shall integrate the data contained in the Database of Study Notifications in

the common data platform once a corresponding registration, application, notification

or other relevant regulatory dossier was submitted to the relevant Union or national

institution, agency, or body in accordance with corresponding Union law and after a

decision was taken by that Union or national institution, agency, or body on the

disclosure of the accompanying studies in accordance with the applicable rules on

confidentiality.

4. The EFSA shall make the data contained in the database referred to in Article 32b of

Regulation (EC) No 178/2002 available to the ECHA for integration in the common

data platform once it has received a corresponding application and after it has decided

on the disclosure of the accompanying studies in accordance with Articles 38 to 39e of

Regulation (EC) No 178/2002.

5. The ECHA and the EFSA shall cooperate to ensure a common approach for the

identification of information notified to them in accordance with Article 22 of this

Regulation and Article 32b of Regulation (EC) No 178/2002, respectively and facilitate

the traceability of the studies notified to their respective databases.

EN 39 EN

Article 10

Information on regulatory processes on chemicals

1. The ECHA shall establish and manage, as part of the common data platform, a new

database containing information on regulatory processes on individual substances or

groups of substances that are planned, ongoing or have been completed since the entry

into force of this Regulation by the Member States or the Union institutions, agencies

or committees referred to in the Union acts listed in Annex III.

2. Where Member State competent authorities as referred to in any of the Union acts

listed in Annex III hold the information referred to in paragraph 1, they shall make that

information available to the Union agency responsible under the respective Union act

listed in Annex III without undue delay.

3. Where the ECHA, EEA, EFSA, EU-OSHA or the Commission hold the information

referred to in paragraph 1, they shall make that information available to the ECHA for

integration in the common data platform in the standard formats provided for in Article

14 without undue delay and, where relevant, once the responsible agency or the

Commission has performed the validity assessment. For each regulatory process or

activity, at least the following information shall be included:

(a) substance identity;

(b) the Union act and the regulatory process under which the activity takes place;

(c) submitter or actor responsible for the regulatory process or activity;

(d) status of the regulatory process or activity;

(e) outcome of the regulatory process or activity, including, where applicable,

reports or opinions adopted;

(f) where applicable, date of intention to start the regulatory process or activity,

completion and latest update.

4. The information referred to in paragraph 3, points (a) to (f), on a specific regulatory

process or activity shall be made available to the public once that process or activity

has formally started.

Article 11

Information on the obligations under Union acts on chemicals

1. The ECHA shall establish and manage, as part of the common data platform, a

database with information on the provisions and legal obligations applicable to

chemicals under the Union acts listed in Annex I.

2. The ECHA shall update the information in the database on a regular basis and in

accordance with the governance scheme referred to in Article 4(3).

Article 12

Repository of standard formats and controlled vocabularies

1. The ECHA shall establish and manage as part of the common data platform a

repository of standard formats and controlled vocabularies.

EN 40 EN

2. Where standard data formats are established under the Union acts listed in Annexes I

and II, the ECHA shall include them in the common data platform.

3. Where the Commission or the Agencies specify a standard format or controlled

vocabulary in accordance with Articles 14 or 15, the Commission or the Agency shall

make it available to the ECHA without undue delay for integration in the common data

platform.

Article 13

Database on environmental sustainability related data

1. At the latest within three years after the publication of the decision referred to in

paragraph 4, the ECHA shall establish and manage, as part of the common data

platform, a database containing environmental sustainability related data.

2. Where the Commission or the Agencies host or hold environmental sustainability

related data in addition to the chemicals data already available in the common data

platform, they shall make that data available to the ECHA without undue delay once

the Commission or the Agency hosting or holding that data has completed, where

relevant, validity and confidentiality assessments. The Commission and the Agencies

shall provide the necessary technical cooperation to the ECHA to enable the integration

of environmental sustainability related data in the database on environmental

sustainability related data.

3. Where researchers or research consortia funded by Union framework programmes

make available to the ECHA, under Article 5(6), any environmental sustainability data

on chemicals or materials they collect or generate, the ECHA shall integrate the

relevant data in the database on environmental sustainability related data.

4. By [OP please insert date: three years after the date of entry into force of this

Regulation], the Commission shall adopt an implementing decision identifying existing

datasets on environmental sustainability related data, other than those referred to in

paragraph 2, for inclusion in the common data platform and shall design relevant

related database functionalities.

Chapter III

DATA FORMATS AND CONTROLLED VOCABULARIES

Article 14

Standard formats

1. Without prejudice to Union provisions providing for the development or making

available of data formats, the Commission and the Agencies shall specify, where

relevant, for the data referred to in Article 3 (2) and falling within their mandate,

standard formats and software packages and make them available free of charge

through the common data platform.

2. The standard formats referred to in paragraph 1 shall, to the extent possible:

(a) avoid the use of proprietary standards;

(b) re-use existing data formats or parts of them;

(c) use OECD or other internationally agreed formats;

(d) be coherent with other existing data formats;

EN 41 EN

(e) ensure interoperability with existing data submission approaches.

3. Those standard formats shall be interoperable with the common data platform and be

user-friendly.

4. The Commission and the Agencies shall exchange data contained in the common data

platform in the relevant standard format.

5. The Commission and the Agencies shall use the International Uniform Chemical

Information Database format (IUCLID) for making available to the ECHA for

integration in the common data platform the relevant parts of dossiers under the

following Union acts:

(a) Regulation (EC) No 1831/2003 of the European Parliament and of the

Council53;

(b) Regulation (EC) No 1935/2004 of the European Parliament and of the

Council54;

(c) Regulation (EC) No 1331/2008 of the European Parliament and of the

Council55;

(d) Regulation (EC) No 1332/2008 of the European Parliament and of the

Council56;

(e) Regulation (EC) No 1333/2008 of the European Parliament and of the

Council57;

(f) Regulation (EC) No 1334/2008 of the European Parliament and of the

Council58;

(g) Regulation (EC) No 1223/2009 of the European Parliament and of the Council 59;

(h) Commission Regulation (EU) No 234/201160;

53 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003

on additives for use in animal nutrition (OJ L 268 18.20.2003, p. 29). 54 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on

materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and

89/109/EEC (OJ L 338 13.11.2004, p. 4). 55 Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008

establishing a common authorisation procedure for food additives, food enzymes and food flavourings

(OJ L 354 31.12.2008. p. 1). 56 Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on

food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999,

Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97 (OJ L 354

31.12.2008, p. 7). 57 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on

food additives (OJ L 354 31.12.2008, p. 16). 58 Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on

flavourings and certain food ingredients with flavouring properties for use in and on foods and

amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008

and Directive 2000/13/EC (OJ L 354 31.12.2008, p. 34). 59 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009

on cosmetic products (OJ L 342 22.12.2009. p, 59).

EN 42 EN

(i) Directive 2009/48/EC of the European Parliament and of the Council.61

6. The Commission and the Agencies shall cooperate when setting standard formats to

ensure coherence with other formats and the interoperability of the standard formats

with the common data platform and with existing data submission approaches.

7. The Commission and the Agencies shall take the necessary and appropriate measures

to monitor and identify at an early stage any potential divergence between data formats

that could cause interoperability problems. If a divergence is identified, the Agencies

concerned shall cooperate to resolve it or, where the divergence is justified, explain the

underlying reasons. Where the Agencies concerned are not able to resolve that

divergence, they shall draw up a joint report and present it to the Commission. The

report shall clearly outline the reasons for the divergence, clarify any underlying

technical issue and make a proposal to remedy the divergence.

8. The Commission shall adopt an implementing decision to remedy the divergence.

Article 15

Controlled vocabularies

1. The Commission and the Agencies shall specify and regularly update controlled

vocabularies within their mandate for the data referred to in Article 3(2), where

relevant.

2. The Commission and the Agencies shall prioritise specifying controlled vocabularies

for the identification of chemicals and the characterisation of their forms.

3. Those controlled vocabularies shall:

(a) avoid the use of proprietary controlled vocabularies to the extent possible;

(b) re-use existing substance identifiers and controlled vocabularies or parts of

them to the extent possible;

(c) use OECD or other internationally agreed controlled vocabularies to the extent

possible;

(d) ensure coherence with other relevant controlled vocabularies including by

preparing alignment tables.

4. Those controlled vocabularies shall be interoperable with the common data platform.

5. Where controlled vocabularies are specified, the Commission and the Agencies shall:

(a) make them available free of charge through the common data platform and as

open datasets;

(b) integrate them in any submission software or template to be used by duty

holders under the Union acts listed in Annex I and referred to in Article 3(2);

and

60 Commission Regulation (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No

1331/2008 of the European Parliament and of the Council establishing a common authorisation

procedure for food additives, food enzymes and food flavourings (OJ L 064 11.3.2011, p. 15). 61 Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of

toys (OJ L 170 30.6.2009, p. 1).

EN 43 EN

(c) use them when exchanging data between them through the common data

platform.

6. The Commission and the Agencies shall cooperate with each other in setting the

controlled vocabularies.

7. The Commission and the Agencies shall take the necessary and appropriate measures

to monitor and identify at an early stage any potential divergence between controlled

vocabularies. If a divergence is identified, the Agencies concerned shall cooperate to

resolve it or, where the divergence is justified, explain the underlying reasons. Where

the Agencies concerned are not able to resolve that divergence, they shall draw up a

joint report and present it to the Commission. The report shall clearly outline the

reasons for the divergence, clarify any underlying technical issue and make a proposal

to remedy the divergence.

8. The Commission shall adopt an implementing decision to remedy the divergence.

Chapter IV

CHEMICALS DATA CONFIDENTIALITY AND USE

Article 16

Access rights and transparency

1. The Authorities shall have access to all the chemicals data contained in the common

data platform, including data which is deemed to be confidential under Article 5(2),

second sentence.

2. The Authorities shall take the necessary measures to ensure that information contained

in the common data platform marked as confidential in accordance with Article 5(2) is

not made public.

3. The general public shall have access to all the chemicals data contained in the common

data platform and considered as available to the public in accordance with the Union

act under which the data was generated or submitted.

Article 17

Use of chemicals data contained in the common data platform

1. The Authorities may use the chemicals data contained in the common data platform in

the performance of any of their activities, where those activities support the

development or implementation of chemicals legislation and policy.

2. Without prejudice to existing provisions enabling the sharing and use of chemicals data

under the Union acts listed in Annexes I and II, Authorities shall not use chemicals data

contained in the common data platform to fulfil any legal obligations of duty holders.

3. When using chemicals data contained in the common data platform that is deemed

confidential under Article 5(2), second sentence, the Authorities shall respect the

confidentiality of information data as marked by the originator and shall not disclose

that data to the public without the consent of the originator.

Chapter V

MONITORING AND OUTLOOK FRAMEWORK FOR CHEMICALS

EN 44 EN

Article 18

Framework of indicators

1. The EEA, in collaboration with the ECHA, the EFSA, the EMA, the EU-OSHA and

the Commission, shall establish, operate, and maintain a framework of indicators to

monitor the drivers and impacts of exposure to chemicals, measure the effectiveness of

chemicals legislation and measure the transition towards the production of safe and

sustainable chemicals.

2. The framework of indicators referred to in paragraph 1 shall be accessible in the form

of an indicator dashboard, which the EEA shall establish and which the ECHA shall

make available through the common data platform.

Article 19

Early warning and action system for emerging chemical risks

1. The EEA shall establish, operate and maintain a Union early warning system for

emerging chemical risks by [OP please insert date: one year after the date of entry into

force of this Regulation].

2. For the purpose of paragraph 1, the EEA shall compile early warning signals, which

shall include at least signals from:

(a) the EFSA’s emerging risks exchange network;

(b) existing national early warning systems;

(c) data that the EEA holds;

(d) targeted literature searches performed by the EEA;

(e) data made available by the ECHA, the EFSA, the EU-OSHA and the EMA in

accordance with paragraph 3.

The early warning signals compiled by the EEA under the first subparagraph may be

based on a positive identification of an emerging risk or on an uncertainty in the data

leading to a potential positive identification of an emerging risk.

3. The ECHA, the EFSA, the EU-OSHA and the EMA shall identify and gather relevant

available data on early warning signals from the field falling within their mandate and

provide this data to the EEA.

4. The EEA shall draw up an annual report, compiling and analysing the data on early

warning signals gathered in accordance with paragraphs 2 and 3. [The first report shall

be prepared by [OP: please insert date: 6 months after the end of the first calendar

year after entry into force of this Regulation]. The EEA shall present this report to the

Commission, relevant Union agencies and Member State competent authorities for

consideration of the need for regulatory or policy action related to the early warning

signals.

5. The EEA shall make all relevant data on early warning signals that it holds or hosts as

well as the report referred to in paragraph 4 available to the ECHA for integration in

the common data platform.

Article 20

Observatory for specific chemicals with potential contribution to emerging chemical

risks

EN 45 EN

1. The ECHA shall establish, operate and maintain an observatory for specific chemicals

that the Commission considers as requiring additional scrutiny. The observatory shall

include reliable information on the chemicals’ properties, safety aspects, uses and

market presence.

2. By [OP please insert date: 6 months after the date of entry into force of this

Regulation] the Commission shall adopt and publish a list of the selected chemicals by

means of an implementing decision. The Commission shall review the list of selected

chemicals regularly adopt any revision thereof by the same means.

3. The Commission shall select the chemicals referred to in paragraph 1 based on the

scientific and technical progress and using the signals of the early warning system

referred to in Article 19. The selection shall include potential contributors to new and

emerging chemical risks among innovative rationally designed materials with new or

enhanced properties or targeted or enhanced structural features at nanoscale.

4. For the purpose of operating the observatory referred to in paragraph 1, the ECHA

shall:

(a) make use of relevant datasets integrated in the common data platform, and

compile, analyse and curate further available data on selected chemicals or

classes of chemicals;

(b) commission studies and, where relevant, use the data generation mechanism

established under Article 21 to address knowledge gaps or significant

uncertainties;

(c) make compiled data publicly available through the common data platform or

other communication and outreach tools as appropriate, to facilitate informed

societal discussion and increase public awareness on the properties, use and

safety aspects of specific chemicals, and regularly update that information.

EN 46 EN

Chapter VI

DATA GENERATION MECHANISM

Article 21

Data generation mechanism

1. Using the best independent resources available, the ECHA may commission scientific

studies to support the implementation of Union acts on chemicals listed in Annex I

within its mandate and to contribute to the support, evaluation or development of a

Union chemicals policy.

2. The Commission may request the ECHA to commission the scientific studies referred

to in paragraph 1.

3. The ECHA shall only commission scientific studies when results cannot be obtained

through existing legal provisions or processes under Union legislation listed in Annex

I. It shall not commission studies with a predominant research objective.

4. The ECHA shall seek to avoid duplication with Member State or Union research or

implementation programmes.

5. The ECHA shall commission these scientific studies in an open and transparent

manner.

6. The ECHA and the EFSA shall closely cooperate with each other on the planning and

commissioning of scientific studies undertaken by the ECHA in accordance with

paragraph 1 and of studies undertaken by the EFSA in accordance with Article 32 of

Regulation (EC) No 178/2002.

7. The ECHA shall make the results of the scientific studies performed under this Article

available through the common data platform.

EN 47 EN

Chapter VII

NOTIFICATION OF STUDIES

Article 22

Notification of studies

1. Business operators shall notify to the Database of Study Notifications referred to in

Article 9, without undue delay, any studies on chemicals they commission to support

an application, notification or regulatory dossier notified or submitted to an Authority,

as well as any studies on chemicals on their own or in products they commission as

part of a risk or safety assessment , prior to placing on the market, under the Union acts

listed in Annex I. However, business operators shall not notify to the Database of Study

Notifications referred to in Article 9 studies that are to be notified under Article 32b of

Regulation (EC) No 178/2002.

2. For the purposes of paragraph 1, business operators shall notify to the Database of

Study Notifications referred to in Article 9 the title, scope, laboratory, or testing facility

carrying out the study, the intended starting and planned completion dates and, where

relevant, whether the study is commissioned to comply with a decision of the ECHA

pursuant to Articles 40, 41 or 46 of Regulation (EC) No 1907/2006.

3. Laboratories and testing facilities shall also, without undue delay, notify any study

commissioned by business operators to support a regulatory dossier on which an

Agency is required to provide a scientific output, including a scientific opinion, under

the Union acts listed in Annex I. However, laboratories and testing facilities shall not

notify to the Database of Study Notifications referred to in Article 9 studies that are to

be notified under Article 32b of Regulation (EC) No 178/2002.

4. For the purposes of paragraph 3, laboratories and testing facilities shall notify to the

Database of Study Notifications referred to in Article 9 the title, scope, intended

starting and planned completion dates of any test they carry out, as well as the name of

the business operator who commissioned the test.

5. Paragraphs 3 and 4 shall apply, mutatis mutandis, to laboratories and testing facilities

located in third countries insofar as set out in relevant agreements with those third

countries.

6. The obligations set under this article shall apply from [OP please insert date: 24

months after the date of entry into force of this Regulation].

7. The ECHA shall lay down the practical arrangements for implementing the provisions

of this Article.

EN 48 EN

Chapter VIII

DELEGATED POWERS

Article 23

Amendment of Annexes I, II and III

1. The Commission is empowered to adopt delegated acts in accordance with Article 24

to amend Annex I in order to adjust the content of that Annex to technical and

scientific progress in the field of chemicals or, where the development of Union

chemicals legislation so requires, to supplement that Annex by adding to it new Union

acts under which relevant chemicals data is generated or submitted.

2. The Commission is empowered to adopt delegated acts in accordance with Article 24

to amend Annex II by adding, where relevant, new categories of data types.

3. The Commission is empowered to adopt delegated acts in accordance with Article 24

to amend Annex III in order to adjust the content of that Annex to technical and

scientific and technical progress in the field of chemicals and, where the development

of Union chemicals legislation so requires, to supplement that Annex by adding to it

Union acts relevant for data on new regulatory processes on chemicals.

Article 24

Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the

conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 23 shall be conferred on the

Commission for a period of five years from [OP please insert: the date of the entry into

force of this Regulation]. The Commission shall draw up a report in respect of the

delegation of power not later than nine months before the end of the five-year period. The

delegation of power shall be tacitly extended for periods of an identical duration, unless

the European Parliament or the Council opposes such extension not later than three

months before the end of each five-year period.

3. The delegation of power referred to in Article 23 may be revoked at any time by the

European Parliament or by the Council. A decision to revoke shall put an end to the

delegation of the power specified in that decision. It shall take effect the day following the

publication of the decision in the Official Journal of the European Union or at a later date

specified therein. It shall not affect the validity of any delegated acts already in force.

4. Before adopting a delegated act, the Commission shall consult experts designated by each

Member State in accordance with the principles laid down in the Interinstitutional

Agreement of 13 April 2016 on Better Law-Making.

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the

European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 23 shall enter into force only if no objection

has been expressed either by the European Parliament or by the Council within a period of

three months of notification of that act to the European Parliament and to the Council or

if, before the expiry of that period, the European Parliament and the Council have both

informed the Commission that they will not object. That period shall be extended by three

months at the initiative of the European Parliament or of the Council.

Chapter IX

EN 49 EN

ENFORCEMENT AND PENALTIES

Article 25

Enforcement

The Agencies shall cooperate with Member States’ enforcement authorities and exchange

information on the compliance, by business operators and laboratories, with the obligation to

notify studies in accordance with Article 22.

Article 26

Penalties for non-compliance

1. Member States shall introduce penalties for non-compliance, by business operators and

laboratories, with the obligations laid out in Article 22 and shall take all necessary

measures to ensure that they are implemented. The penalties provided for shall be

effective, proportionate, and dissuasive.

2. Member States shall notify the Commission of those rules and of those measures by 30

June 2025 and shall notify to the Commission without delay any subsequent amendment

affecting them.

Article 27

Entry into force and application in time

This Regulation shall enter into force on the twentieth day following that of its publication in

the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

EN EN

EUROPEAN COMMISSION

Brussels, 7.12.2023

COM(2023) 779 final

ANNEXES 1 to 3

ANNEXES

to the

Proposal for a Regulation of the European Parliament and of the Council

establishing a common data platform on chemicals, laying down rules to ensure that the

data contained in it are findable, accessible, interoperable and reusable and establishing

a monitoring and outlook framework for chemicals

{SWD(2023) 855 final}

EN 1 EN

ANNEX I

UNION ACTS REFERRED TO IN ARTICLES 2, 3, 8, 11, 12, 15, 17, 21, 22 AND 23

Reference to each Union act listed herein should be understood also as reference to

all implementing and delegated acts adopted under that Union act, where relevant.

1. Council Directive 91/271/EEC of 21 May 1991 concerning urban wastewater

treatment (OJ L 135, 30.5.1991, p. 40)

2. Council Directive 91/676/EEC of 12 December 1991 concerning the protection of

waters against pollution caused by nitrates from agricultural sources (OJ L 375,

31.12.1991, p.1)

3. Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community

procedures for contaminants in food (OJ L 037, 13.2.1993, p.1)

4. European Parliament and Council Directive 94/62/EC of 20 December 1994 on

packaging and packaging waste

5. Council Directive 98/24/EC of 7 April 1998 on the protection of workers from the

risks related to chemical agents at work (fourteenth individual Directive within the

meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11)

6. Directive 2004/37/EC of the European Parliament and of the Council of 29 April

2004 on the protection of workers from the risks related to exposure to carcinogens or

mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of

Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p.50)

7. Directive 2000/53/EC of the European Parliament and of the Council of 18

September 2000 on end-of life vehicles (OJ L 269, 21.10.2000, p. 34)

8. Directive 2000/60/EC of the European Parliament and of the Council of 23 October

2000 establishing a framework for the Community action in the field of water

policy (OJ L 327, 22.12.2000, p.1)

9. Directive 2001/18/EC of the European Parliament and of the Council of 12 March

2001 on the deliberate release into the environment of genetically modified organisms

and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1)

10. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28

January 2002 laying down the general principles and requirements of food law,

establishing the European Food Safety Authority and laying down procedures in

matters of food safety (OJ L 031, 1.2.2002, p. 1)

11. Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002

on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10)

12. Directive 2002/46/EC on the approximation of the laws of the Member States relating

to food supplements (OJ L 183, 12.7.2002, p. 51)

13. Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22

September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1)

14. Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22

September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29)

15. Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10

November 2003 on smoke flavourings used or intended for use in or on foods (OJ L

309, 26.11.2003, p. 1)

16. Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29

April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139,

30.4.2004, p. 55)

EN 2 EN

17. Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31

March 2004 on detergents (OJ L 104, 8.4.2004, p. 1)

18. Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29

April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1)

19. Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27

October 2004 on materials and articles intended to come into contact with food and

repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4)

20. Directive 2004/107/EC of the European Parliament and of the Council of 15

December 2004 relating to arsenic, cadmium, mercury, nickel and polycyclic

aromatic hydrocarbons in ambient air (OJ L 023, 26.1.2005, p. 3)

21. Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23

February 2005 on maximum residue levels of pesticides in or on food and feed of

plant and animal origin and amending Council Directive 91/414/EEC (OJ L 070,

16.3.2005, p. 1)

22. Regulation (EC) No 166/2006 of the European Parliament and of the Council of 18

January 2006 concerning the establishment of a European Pollutant Release and

Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC

(OJ L 033, 4.2.2006, p. 1)

23. Directive 2006/118/EC of the European Parliament and of the Council of 12

December 2006 on the protection of groundwater against pollution and

deterioration (OJ L 372, 27.12.2006, p. 19)

24. Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18

December 2006 concerning the Registration, Evaluation, Authorisation and

Restriction of Chemicals (REACH), establishing a European Chemicals Agency,

amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93

and Commission Regulation (EC) No 1488/94 as well as Council Directive

76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC, and

2000/21/EC (OJ L 396, 30.12.2006, p. 1)

25. Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20

December 2006 on nutrition and health claims made on foods (OJ L 404, 30.12.2006,

p. 9)

26. Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20

December 2006 on the addition of vitamins and minerals and of certain other

substances to foods (OJ L 404, 30.12.2006, p. 26)

27. Directive 2007/2/EC of the European Parliament and of the Council of 14 March

2007 establishing an Infrastructure for Spatial Information in the European

Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1)

28. Regulation (EC) No 108/2008 of the European Parliament and of the Council of 15

January 2008 amending Regulation (EC) No 1925/2006 on the addition of vitamins

and minerals and of certain other substances to foods (OJ L 39, 13.2.2008, p. 11)

29. Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008

establishing a framework for community action in the field of marine environmental

policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19)

30. Directive 2008/50/EC of the European Parliament and of the Council of 21 May 2008

on ambient air quality and cleaner air for Europe (OJ L 152, 11.6.2008, p. 1)

31. Directive 2008/98/EC of the European Parliament and of the Council of 19 November

2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3)

32. Directive 2008/105/EC of the European Parliament and of the Council of 16

December 2008 on environmental quality standards in the field of water policy,

amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC,

EN 3 EN

84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the

European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84)

33. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16

December 2008 on classification, labelling and packaging of chemicals of substances

and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and

amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1)

34. Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16

December 2008 establishing a common authorisation procedure for food additives,

food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1)

35. Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16

December 2008 on food enzymes and amending Council Directive 83/417/EEC,

Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive

2001/112/EC, and Regulation (EC) No 258/97 (OJ L 354, 31.12.2008, p.7)

36. Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16

December 2008 on food additives (OJ L 354, 31.12.2008, p. 16)

37. Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16

December 2008 on flavourings and certain food ingredients with flavouring

properties for use in and on foods and amending Council Regulation (EEC) No

1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive

2000/13/EC (OJ L 354, 31.12.2008, p. 34)

38. Directive 2009/125/EC of the European Parliament and of the Council of 21 October

2009 establishing a framework for the setting of ecodesign requirements for energy-

related products

39. Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23

April 2009 on the European Environment Agency and the European Environment

Information and Observation Network (OJ L 126, 21.5.2009, p. 13)

40. Directive 2009/32/EC of the European Parliament and of the Council of 23 April

2009 on the approximation of the laws of the Member States on extraction solvents

used in the production of foodstuffs and food ingredients (OJ L 141, 6.6.2009, p. 3)

41. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009

on the safety of toys (OJ L 170, 30.6.2009, p. 1)

42. Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21

October 2009 laying down health rules as regards animal by-products and derived

products not intended for human consumption and repealing Regulation (EC) No

1774/2002 (OJ L 300, 14.11.2009, p. 1)

43. Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21

October 2009 concerning the placing of plant protection products on the market and

repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p.

1)

44. Directive 2009/128/EC of the European Parliament and of the Council of 21 October

2009 establishing a framework for Community action to achieve the sustainable use

of pesticides (OJ L 309, 24.11.2009, p. 71)

45. Directive 2009/148/EC of the European Parliament and of the Council of 30

November 2009 on the protection of workers from the risks related to exposure to

asbestos at work (OJ L 330, 16.12.2009, p. 28)

46. Regulation (EC) No 1221/2009 of the European Parliament and of the Council of 25

November 2009 on the voluntary participation by organisations in a Community eco-

management and audit scheme (EMAS), repealing Regulation (EC) No 761/2001 and

Commission Decisions 2001/681/EC and 2006/193/EC (OJ L 342, 22.12.2009, p. 1)

47. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30

November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59)

EN 4 EN

48. Directive 2010/75/EU of the European Parliament and of the Council of 24

November 2010 on industrial emissions (integrated pollution prevention and control)

(OJ L 334, 17.12.2010, p. 17)

49. Regulation (EC) No 66/210 of the European Parliament and of the Council of 25

November 2009 on the EU Ecolabel (OJ L 027, 30.1.2010, p. 1)

50. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011

on the restriction of the use of certain hazardous substances in electrical and

electronic equipment (OJ L 174, 1.7.2011, p. 88)

51. Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25

October 2011 on the provision of food information to consumers, amending

Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament

and of the Council, and repealing Commission Directive 87/250/EEC, Council

Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of

the European Parliament and of the Council, Commission Directives 2002/67/EC and

2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p.

18)

52. Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22

May 2012 concerning the making available on the market and use of biocidal

products (OJ L 167, 27.6.2012, p. 1)

53. Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012

on the control of major-accident hazards involving dangerous substances, amending

and subsequently repealing Council Directive 96/82/EC (OJ L 197, 24.7.2012, p. 1)

54. Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012

on waste electrical and electronic equipment (WEEE) (OJ L 197, 24.7.2012, p. 38)

55. Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4

July 2012 concerning the import and export of hazardous chemicals (OJ L 201,

27.7.2012, p. 60)

56. Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12

June 2013 on food intended for infants and young children, food for special medical

purposes, and total diet replacement for weight control and repealing Council

Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC

and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the

Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L

181, 29.6.2013, p. 35)

57. Directive 2014/28/EU of the European Parliament and of the Council of 26 February

2014 on the harmonisation of the laws of the Member States relating to the making

available on the market and supervision of explosives for civil uses (OJ L 96,

29.3.2014, p. 1)

58. Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014

on the approximation of the laws, regulations and administrative provisions of the

Member States concerning the manufacture, presentation and sale of tobacco and

related products and repealing Directive 2001/37/EC (OJ L 127, 29.4.2014, p. 1)

59. Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16

April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) No

842/2006 (OJ L 150, 20.5.2014, p. 195)

60. Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25

November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the

European Parliament and of the Council and repealing Regulation (EC) No 258/97 of

the European Parliament and of the Council and Commission Regulation (EC) No

1852/2001 (OJ L 327, 11.12.2015, p. 1)

EN 5 EN

61. Directive (EU) 2016/2284 of the European Parliament and of the Council of 14

December 2016 on the reduction of national emissions of certain atmospheric

pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ

L 344, 17.12.2016, p. 1)

62. Regulation (EU) 2017/625 of the European Parliament and of the Council of 15

March 2017 on official controls and other official activities performed to ensure the

application of food and feed law, rules on animal health and welfare, plant health and

plant protection products, amending Regulations (EC) No 999/2001, (EC) No

396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No

652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the

Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council

Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and

repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European

Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC,

90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision

92/438/EEC (Official Controls Regulation) (OJ L 095, 7.4.2017, p. 1)

63. Regulation (EU) 2017/745 of the European Parliament and of the Council on medical

devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and

Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and

93/42/EEC (OJ L 117, 5.5.2017, p. 1)

64. Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May

2017 on mercury, and repealing Regulation (EC) No 1102/2008 (OJ L 137,

24.5.2017, p. 1)

65. Regulation (EU) 2019/4 of the European Parliament and of the Council of 11

December 2018 on the manufacture, placing on the market and use of medicated feed,

amending Regulation (EC) No 183/2005 of the European Parliament and of the

Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1).

66. Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June

2019 laying down rules on the making available on the market of EU fertilising

products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and

repealing Regulation (EC) No 2003/2003 (OJ L 170, 25.6.2019, p. 1)

67. Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June

2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p. 45)

68. Directive (EU) 2020/2184 of the European Parliament and of the Council of 16

December 2020 on the quality of water intended for human consumption (OJ L 435,

23.12.2020, p. 1)

69. Regulation (EU) …/… of the European Parliament and of the Council on nature

restoration (OJ …/ELI: … [OP: please add number and publication reference].

70. Regulation (EU) …/… of the European Parliament and of the Council concerning

batteries and waste batteries, repealing Directive 2006/66/EC and amending

Regulation (EU) No 2019/1020 (OJ …/ELI: … [OP: please add number and

publication reference].

EN 6 EN

ANNEX II

UNION ACTS REFERRED TO IN ARTICLES 2, 3, 12, 17 AND 23 AND REFERENCE VALUES

REFERRED TO IN ARTICLE 8

Part 1 - Specific data on relevant active substances to be identified in accordance with Article

4(5)(b) falling under the scope of this Regulation for the purposes of Article 3 for human and

veterinary medicinal products

1. Non-clinical safety data, including data related to environmental risk assessments,

compiled pursuant to Directive 2001/83/EC of the European Parliament and of the

Council1 and Regulation (EC) No 726/2004 of the European Parliament and of the

Council2;

2. Data related to environmental risk assessments, compiled pursuant to Regulation (EU)

2019/6 of the European Parliament and of the Council3; and

3. Maximum residue levels data compiled pursuant to Regulation (EC) No 470/2009 of

the European Parliament and of the Council4.

These data shall be limited to data submitted to the EMA in the context of the relevant

procedures that are concluded after the date of entry into force of this Regulation. Where

relevant, the data held by the EMA resulting from procedures concluded before the entry into

force of this Regulation may also be considered for inclusion into the common data platform.

Part 2 - Reference values to be included in the repository of reference values following

Article 8(3)

1. Predicted no effect concentrations derived as part of the environmental risk assessment

under Directive 2001/83/EC of the European Parliament and of the Council, Regulation

(EC) No 726/2004 of the European Parliament and of the Council and Regulation (EU)

2019/6 of the European Parliament and of the Council.

These data shall be limited to data submitted to the EMA in the context of the relevant

procedures that are concluded after the date of entry into force of this Regulation. Where

relevant, data held by the EMA resulting from procedures concluded before the date of entry

into force of this Regulation shall also be considered for inclusion into the common data

platform.

1 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the

Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). 2 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying

down Union procedures for the authorisation and supervision of medicinal products for human use and

establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). 3 Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on

veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43). 4 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying

down Community procedures for the establishment of residue limits of pharmacologically active

substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and

amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC)

No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

EN 7 EN

ANNEX III

UNION ACTS REFERRED TO IN ARTICLES 2, 10 AND 23

Reference to each Union act listed herein should be understood also as reference to

all implementing and delegated acts adopted under that Union act, where relevant.

1. Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community

procedures for contaminants in food (OJ L 037, 13.2.1993, p.1)

2. European Parliament and Council Directive 94/62/EC of 20 December 1994 on

packaging and packaging waste

3. Directive 2004/37/EC of the European Parliament and of the Council of 29 April

2004 on the protection of workers from the risks related to exposure to carcinogens or

mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of

Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p.50)

4. Council Directive 98/24/EC of 7 April 1998 on the protection of workers from the

risks related to chemical agents at work (fourteenth individual Directive within the

meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11)

5. Directive 2000/53/EC of the European Parliament and of the Council of 18

September 2000 on end-of life vehicles (OJ L 269, 21.10.2000, p. 34)

6. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28

January 2002 laying down the general principles and requirements of food law,

establishing the European Food Safety Authority and laying down procedures in

matters of food safety (OJ L 031, 1.2.2002, p. 1)

7. Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002

on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10)

8. Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22

September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29)

9. Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27

October 2004 on materials and articles intended to come into contact with food and

repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4)

10. Directive 2004/107/EC of the European Parliament and of the Council of 15

December 2004 relating to arsenic, cadmium, mercury, nickel and polycyclic

aromatic hydrocarbons in ambient air (OJ L 023, 26.1.2005, p. 3)

11. Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23

February 2005 on maximum residue levels of pesticides in or on food and feed of

plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70,

16.3.2005, p. 1)

12. Directive 2006/118/EC of the European Parliament and of the Council of 12

December 2006 on the protection of groundwater against pollution and deterioration

(OJ L 372, 27.12.2006, p. 19)

13. Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18

December 2006 concerning the Registration, Evaluation, Authorisation and

Restriction of Chemicals (REACH), establishing a European Chemicals Agency,

amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93

and Commission Regulation (EC) No 1488/94 as well as Council Directive

76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC, and

2000/21/EC (OJ L 396, 30.12.2006, p. 1)

EN 8 EN

14. Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012

on waste electrical and electronic equipment (WEEE) (OJ L 197, 24.7.2012, p. 38)

15. Directive 2008/105/EC of the European Parliament and of the Council of 16

December 2008 on environmental quality standards in the field of water policy,

amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC,

84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the

European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84)

16. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16

December 2008 on classification, labelling and packaging of chemicals of substances

and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and

amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1)

17. Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16

December 2008 establishing a common authorisation procedure for food additives,

food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1)

18. Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16

December 2008 on food enzymes and amending Council Directive 83/417/EEC,

Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive

2001/112/EC, and Regulation (EC) No 258/97 (OJ L 354, 31.12.2008, p.7)

19. Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16

December 2008 on food additives (OJ L 354, 31.12.2008, p. 16)

20. Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16

December 2008 on flavourings and certain food ingredients with flavouring

properties for use in and on foods and amending Council Regulation (EEC) No

1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive

2000/13/EC (OJ L 354, 31.12.2008, p. 34)

21. Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16

December 2008 establishing a common authorisation procedure for food additives,

food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1)

22. Directive 2009/32/EC of the European Parliament and of the Council of 23 April

2009 on the approximation of the laws of the Member States on extraction solvents

used in the production of foodstuffs and food ingredients (OJ L 141, 6.6.2009, p. 3)

23. Directive 2009/125/EC of the European Parliament and of the Council of 21 October

2009 establishing a framework for the setting of ecodesign requirements for energy-

related products

24. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009

on the safety of toys (OJ L 170, 30.6.2009, p. 1)

25. Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16

September 2009 on substances that deplete the ozone layer (OJ L 286, 31.10.2009, p.

1)

26. Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21

October 2009 concerning the placing of plant protection products on the market and

repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p.

1)

27. Directive 2009/148/EC of the European Parliament and of the Council of 30

November 2009 on the protection of workers from the risks related to exposure to

asbestos at work (OJ L 330, 16.12.2009, p. 28)

28. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30

November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59)

29. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011

on the restriction of the use of certain hazardous substances in electrical and

electronic equipment (OJ L 174, 1.7.2011, p. 88)

EN 9 EN

30. Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22

May 2012 concerning the making available on the market and use of biocidal

products (OJ L 167, 27.6.2012, p. 1)

31. Regulation (EU) 2019/4 of the European Parliament and of the Council of 11

December 2018 on the manufacture, placing on the market and use of medicated feed,

amending Regulation (EC) No 183/2005 of the European Parliament and of the

Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1).

32. Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June

2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p. 45)

33. Directive (EU) 2020/2184 of the European Parliament and of the Council of 16

December 2020 on the quality of water intended for human consumption (OJ L 435,

23.12.2020, p. 1)

34. Regulation (EU) …/… of the European Parliament and of the Council concerning

batteries and waste batteries, repealing Directive 2006/66/EC and amending

Regulation (EU) No 2019/1020 (OJ …/ELI: … [OP: please add number and

publication reference].

    Resolutsiooni liik: Riigikantselei resolutsioon Viide: Sotsiaalministeerium /  / ; Riigikantselei /  / 2-5/24-00159

Resolutsiooni teema: Kemikaalide "Üks aine, üks hindamine" algatused

Adressaat: Sotsiaalministeerium Ülesanne: Tulenevalt Riigikogu kodu- ja töökorra seaduse § 152` lg 1 p 2 ning Vabariigi Valitsuse reglemendi § 3 lg 4 palun valmistada ette Vabariigi Valitsuse seisukoha ja otsuse eelnõu järgnevate algatuste kohta, kaasates seejuures olulisi huvigruppe ja osapooli: - Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals, COM(2023) 779; - Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2011/65/EU of the European Parliament and of the Council as regards the re- attribution of scientific and technical tasks to the European Chemicals Agency, COM(2023) 781; - Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals, COM(2023) 783.

EISi toimiku nr: 23-0512

Tähtaeg: 04.03.2024

Adressaat: Justiitsministeerium, Kliimaministeerium, Regionaal- ja Põllumajandusministeerium Ülesanne: Palun esitada oma sisend Sotsiaalministeeriumile seisukohtade kujundamiseks antud eelnõude kohta (eelnõude infosüsteemi (EIS) kaudu).

Tähtaeg: 19.02.2024

Lisainfo: Eelnõu on kavas arutada valitsuse 14.03.2024 istungil ja Vabariigi Valitsuse reglemendi § 6 lg 6 kohaselt sellele eelneval nädalal (06.03.2024) EL koordinatsioonikogus. Esialgsed materjalid EL koordinatsioonikoguks palume esitada hiljemalt 04.03.2024.

Kinnitaja: Merli Vahar, Euroopa Liidu asjade direktori asetäitja Kinnitamise kuupäev: 26.01.2024 Resolutsiooni koostaja: Elen Nurme [email protected], 693 5201      

25.01.2024

Kemikaalide "Üks aine, üks hindamine" algatused

Otsuse ettepanek koordinatsioonikogule

Kujundada seisukoht

Kaasvastutaja sisendi tähtpäev 19.02.2024

KOKi esitamise tähtpäev 06.03.2024

VV esitamise tähtpäev 14.03.2024

Vastutav ministeerium: Sotsiaalministeerium;

Kaasvastutajad: Kliimaministeerium, Regionaal- ja Põllumajandusministeerium, Justiitsministeerium.

Seisukoha valitsusse toomise alus ja põhjendus

Algatuse reguleerimisala nõuab vastavalt Eesti Vabariigi põhiseadusele seaduse või Riigikogu otsuse vastuvõtmist, muutmist või kehtetuks tunnistamist (RKKTS § 152¹ lg 1 p 1);

Seisukoha võtmist peab oluliseks peaminister või minister (VVS § 20¹ lg 2);

Sisukokkuvõte Algatuste paketiga luuakse EL tasandil kemikaalide andmeplatvorm ning täpsustatakse EL agentuuride vahelist ülesannete jaotust ja protseduure kemikaalide hindamisel „one substance, one assessment“ põhimõttest lähtuvalt, mis võeti suunaks 2020. aastal avaldatud EL kemikaalistrateegias.

Algatuse eesmärk on rakendada kemikaalide hindamisel "üks aine, üks hindamine" põhimõtet ehk muuta kemikaalide ohutuse hindamist erinevates valdkondlikes EL õigusaktides efektiivsemaks, mõjusamaks, koherentsemaks ja läbipaistvamaks.

1. Ühe määruse eelnõuga (COM(2023) 779) luuakse ühtne andmeplatvorm ja reeglid andmete leitavuse, ligipääsu, koostalitlusvõimelisuse ja taaskasutatavuse kohta, samuti luuakse kemikaalide seire- ja vaatlusraamistik.

2. Teise määruse eelnõuga (COM(2023) 783 nn Omnibus) muudetakse nelja õigusakti, et ümber jaotada kemikaalide hindamist puudutavaid teaduslikke ja tehnilisi ülesandeid ja erinevate EL ametite koostööd parandada (muudetakse toiduohutuse üldmäärust (EÜ) 178/2002, Euroopa Keskkonnaameti ja Euroopa keskkonnateabe- ja -vaatlusvõrgu kohast määrust (EÜ) nr 401/2009, meditsiiniseadmete määrust (EL)

2017/745 ja püsivate orgaaniliste saasteainete määrust (EL) 2019/1021).

3. Direktiivi eelnõuga (COM(2023) 781) muudetakse elektri- ja elektroonikaseadmetes ohtlike ainete kasutamise piiramise kohta käivat direktiivi (2011/65/EL) samuti eesmärgiga anda ülesanded Euroopa Kemikaaliametile ja kaasata selle teaduslikud komiteed seoses ainete tehniliste ja teaduslike hindamistega.

Kas EL algatus reguleerib karistusi või haldustrahve? Jah, määruse eelnõu COM(2023) 779 artiklis 26 on kohustus liikmesriikidele sätestada karistused ettevõtjatele ja laboritele, kes ei täida sama määruse eelnõus artiklis 22 sätestatud kohustust esitada andmeplatvormile andmeid. Komisjonile tuleb karistusmeetmetest teavitada hiljemalt 30.06.25.

Kas nähakse ette uue asutuse loomine (järelevalvelised või muud asutused)? Ei

Kas lahenduse rakendamine vajab IT-arendusi? Jah, lahendus vajab IT- rakenduste väljatöötamist EL tasandil. Riigisiseselt ei ole vaja IT arendusi teha, sest andmevahetus ja andmeedastuse kohustus puudutab EL ametiasutusi ning ettevõtjaid ja laboreid. Samas tagatakse riikide pädevatele asutustele ligipääs andmeplatvormil olevatele kemikaalide andmetele, samuti peavad riikide pädevad asutused võtma kõik vajalikud meetmed, et konfidentsiaalne info ei oleks kättesaadav avalikkusele.

Eesmärgid

1.Eesmärk - Määruse eelnõu COM(2023) 779: Parandada kemikaalide ohustusalase info kättesaadavust ja taaskasutust luues EL tasandil ühtse kemikaalide andmeplatvormi, kuhu integreeritakse andmed praegu erinevate valdkondlike õigusaktide alusel nõutud kemikaalide ohutushinnangute kohta. Eesmärk on suurendada järjepidevust sama kemikaali või kemikaalide rühma kohta erinevate EL ametite poolt kogutavas infos või tehtud ohutuse hinnangutes.

Andmeplatvormi peab looma Euroopa Kemikaaliamet ECHA ning sinna kantakse andmed erinevate liidu õigusaktide rakendamise raames loodud ja esitatud ning EL ametite hallatavad andmed, samuti liidu programmide või teadustegevuse käigus loodud ECHA, EEA, EFSA, EU- OSHA või Euroopa Komisjoni hallatavad andmed ning ravimite ja veterinaarravimite ohutus- ja keskkonnariskihindamisega seotud EMA hallatavad andmed. Platvormi osaks on varase hoiatuse süsteem, mille peab looma Euroopa Keskkonnaamet (EEA) ning mis peab hõlmama mh ka ohuteatisi olemasolevatest riiklikest varase hoiatuse süsteemidest. Riskipotentsiaaliga kemikaalide jälgimiseks luuakse ECHA poolt eraldi vaatlussüsteem.

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2.Eesmärk - Määruse eelnõu COM(2023) 783 (nn omnibus määrus): Muuta kemikaalide ohutuse hindamisega seotud vastutuse jaotust selgemaks, koostööd paremaks ning pädevuse ja ressursikasutust efektiivsemaks. Jaotada ümber olemasolevad tööülesanded ja seada uusi tööülesandeid EL ametitele seonduvalt kemikaalide ohutusalase hindamisega.

Eesmärgi saavutamiseks tehakse muudatused mitmes valdkondlikus EL õigusaktis, mis sätestavad menetlusi või reegleid kemikaalide ohutuse hindamisega seoses. Muudatused puudutavad EL ametite vastutuse jaotust hindamiste, sh tehnilise ja teadusliku töö tegemisel, ametite omavahelist koostööd ning andmete kõrget teaduslikku kvaliteeti, protseduuride läbipaistvust ja kaasavust. Muudatusi tehakse toiduohutuse üldmääruses, meditsiiniseadmete määruses, püsivate orgaaniliste saasteainete määruses ning EEA ja keskkonnateabe- ja -vaatlusvõrgu määruses.

3.Eesmärk - Direktiivi eelnõu COM(2023) 781: Ühtlustada elektri- ja elektroonikaseadmetes ohtlike ainete kasutamise piirangute menetlused teiste kemikaalide hindamist puudutavate õigusaktide nõuetega ja saavutada parem seostatavus kemikaaliregulatsiooniga.

Parandatakse kooskõla kemikaalide registreerimist, hindamist, autoriseerimist ja piiramist reguleeriva (REACH) määrusega, andes ülesanded Euroopa Kemikaaliametile (ECHA) ja selle teaduslike komiteede kaasamiseks elektri- ja elektroonikaseadmete direktiivis (RoHS) kasutamispiirangu all olevate ainete nimekirja muutmise ning erandite taotlemise protseduurides. Elektri- ja elektroonikaseadmetes piirangualuste ainete nimekirja ülevaatamise ja muutmise kriteeriumina lisatakse ka koherentsus muude kemikaalide valdkonna õigusaktidega, samuti täpsustatakse erandi taotlemise menetlust, milles komisjoni asemel saab juhtrolli ECHA. Teiseks täpsustatakse teatud spetsiifilistes tehnilistes rakendustes piirangualuste ainete kasutamiseks ettevõtjatele antavate erandite taotlemise protseduuri, mille puhul samuti saab piirangutoimiku koostamise ülesande ECHA.

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