Explanatory Memorandum to COM(2023)779 - 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 - Main contents

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dossier	COM(2023)779 - Common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, ...
source	COM(2023)779
date	07-12-2023

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 risk ¹, 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 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 Deal ³ to present a chemicals strategy for sustainability ⁴ (‘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:
- establish a monitoring and outlook framework for chemicals
The proposed provisions on using standard formats and controlled vocabularies by EU agencies are consistent with and complementary to provisions under:

1. 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.

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 products ⁷ 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.

2. - 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 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 Tool ⁸ and Open EFSA ⁹. The provisions are consistent with the proposals made to revise Regulation (EC) No 1272/2008 ¹⁰ on classification, labelling and packaging of substances and mixtures and the proposal for a directive amending Directive 2000/60/EC ¹¹ establishing a framework for Community action in the field of water policy, Directive 2006/118/EC ¹² on the protection of groundwater against pollution and deterioration and Directive 2013/39/EU ¹³ 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.

3. The proposed provisions on using standard formats and controlled vocabularies by EU agencies are consistent with and complementary to provisions under:

- Regulation (EC) No 1907/2006 ¹⁴ 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) 2021/428 ¹⁵ 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 ¹⁶ (Articles 1 and 2);

- Regulation (EC) No 178/2002 ¹⁷ 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) 2022/2464 ¹⁹ 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 Regulation ²⁰. 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 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/EU ²¹ on the restriction of the use of certain hazardous substances in electrical and electronic equipment, Regulation (EU) 2019/1021 ²² on persistent organic pollutants and Regulation (EU) 2017/745 ²³ on medical devices. The proposal also amends Regulation (EC) No 401/2009 ²⁴ 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 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.

The accompanying staff working document ²⁵ 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 document ²⁶ 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 2019 ²⁷. It concluded that, 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 Assessment ²⁹. 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 study ³⁰, which used a combination of tools and methods to collect views and data from different stakeholder groups. It involved:

- 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 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 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 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.

- 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 document ³¹ 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 document ³² 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 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 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 framework ³³. 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

- 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 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.

Please note

Contents

1.

The one substance, one assessment approach focuses on the main factors influencing the efficiency, effectiveness, coherence and transparency of safety assessments. It covers:

2.

- establish a monitoring and outlook framework for chemicals

3.

The proposed provisions on using standard formats and controlled vocabularies by EU agencies are consistent with and complementary to provisions under: