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Accompanying the document 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

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Brussels, 7.12.2023

SWD(2023) 855 final

Introduction: Political and legal context 1.1. Political context 1.2. Legal context 1.3. Scope of the document
Problem definition 2.1. What is/are the problems? 2.2. What are the problem drivers?
Objectives: What is to be achieved? 3.1. General objectives 3.2. Specific objectives
What are the available options? 4.1. What is the baseline from which options are assessed? 4.2. Description of how problems can be addressed
What are the impacts of the identified options? 5.1. Addressing the problem that information is difficult to find, share or re‑use and some information flows are suboptimal 5.2. Standard data formats 5.3. Transparency and use of chemicals data contained in the common data platform
Comparison of options and identification of preferred option
Annexes Annex 1: Procedural information Annex 2: Stakeholder consultation (Synopsis report) Annex 3: Transparency and confidentiality rules Glossary

1. Introduction: Political and legal context

1.1. Political context

Chemicals are everywhere in our daily lives and 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. The EU is the second largest producer of chemicals in the world with EUR 541 billion turnover in 2018 (7.0 % of EU manufacturing by turnover) and 14.4 % of global sales in 2020 (CEFIC, 2022)[1] and chemicals manufacturing is the fourth largest industry in the EU comprising 30 000 companies, 95 % of which are SMEs, directly employing approximately 1.2 million people and 3.6 million indirectly.

At the same time, chemicals can 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[2], 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 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) (‘fitness check’)[3] 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 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 conserve natural resources and protect ecosystems and people, within the limits of our planet, assessing the environmental impacts generated by chemicals along their entire life cycle is needed. Evaluation of several impact categories, such as climate change and resource use, requires access to robust and high‑quality information and can guide the design, development and production of chemicals that provide a desirable function or service while being safe and sustainable. Moreover, availability of sustainability information could trigger the demand for chemicals with lower environmental impacts, and therefore have direct benefit for health and the environment.

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.

Building on the findings of the fitness check, the Commission committed in the European Green Deal[4] to present a chemicals strategy for sustainability[5] (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 – synchronising and coordinating the initiation or triggering of assessments and assessing groups of substances instead of each substance individually where possible.
Allocation of tasks – allocating clear responsibilities for performing assessments in a way that makes best use of available expertise and resources.
Information – ensuring that information is easily findable, accessible, interoperable, secure, of high quality and shared and reused.
Methodologies – using coherent and, where possible, harmonised methods.
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’. To that end, a comprehensive assessment of both safety and sustainability throughout the whole life cycle of chemicals is required[6].

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 Towards Zero Pollution for Air, Water and Soil[7] (‘the EU 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 (EEA) and the Commission’s Joint Research Centre in close collaboration with the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), the European Maritime Safety Agency and other relevant agencies as the EU’s knowledge centres of excellence for 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[8] 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, the strategy identified the following actions:

develop a common open data platform on chemicals[9] to facilitate the sharing, access and re‑use of information on chemicals coming from all sources.
promote the re‑use and harmonisation of human and environmental health‑based limit values among EU risk assessors and managers through a centralised and curated EU repository.
establish tools and practices to ensure that relevant academic data is easily and readily accessible for safety assessments and is suitable for regulatory purposes.
enable EU and national authorities to commission testing and monitoring of substances as part of the regulatory framework when further information is considered necessary.
remove legislative obstacles for the re‑use of data and better streamline the flow of chemicals data between EU and national authorities.
extend the principle of open data and the relevant transparency principles from the EU food safety sector to other pieces of chemical legislation.
develop an EU early warning and action system for chemicals to ensure that EU policies address emerging chemical risks as soon as identified by monitoring and research.
develop a framework of indicators to monitor the drivers and impacts of chemical pollution and to measure the effectiveness of chemicals legislation.

The European Parliament resolution[10] of 10 July 2020 welcomed the strategy and the application of the one substance, one assessment principle in order to better use the resources of the Union’s agencies and scientific bodies, avoid duplication of efforts, including testing, reduce the risk of diverging outcomes of assessments, speed up and bring consistency and transparency to chemicals regulation, and ensure enhanced health and environmental protection and a level playing field for industry, while taking into account the special situation of SMEs. The European Parliament initiated a project to assess the feasibility of consolidating the chemicals data collected by the institutions, bodies and agencies of the European Union.

The European Parliament’s resolution also called on the Commission to establish a fully connected and interoperable EU chemical safety database so as to facilitate the seamless sharing of data between authorities and provide public access to researchers, regulators, industry and the citizens at large. Moreover, the resolution stressed the need to develop ‘safe and sustainable by design’ criteria to help prevent and control pollution, improve the tracing of hazardous chemicals in products, and promote their substitution by safer and more sustainable alternatives.

The Council conclusions[11] of 15 March 2021 also welcomed the strategy and the aim of the one substance, one assessment approach to simplify and improve the transparency of the regulatory framework for hazard and risk assessment of chemicals while emphasizing that this approach should not create delays in regulatory actions nor increase administrative burden. The conclusions highlighted the relevance of a comprehensive information base on chemicals and on chemicals’ overall environmental footprint, including their impact on the climate, biodiversity and marine environment. The conclusions also welcomed the establishment of an EU chemical early warning and action system and called for the development, in collaboration with the Member States, of a comprehensive chemicals monitoring framework as part of a wider zero‑pollution monitoring and outlook framework, with publicly accessible results, to oversee the driving forces and impacts of chemical pollution on human health and the environment, to complement monitoring of the presence of chemicals in ecosystems, and to measure the effectiveness of chemicals legislation.

1.2. Legal context

This initiative complements the body of EU law governing chemicals. It covers a very large number of Union chemicals legislations (listed in section 1.3). 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 dedicated service under the common data platform on regulatory information will integrate existing practices on disseminating regulatory process information by the ECHA and EFSA, notably the Public Activities Coordination Tool7 and OpenEFSA8. The provisions are consistent with the proposals made to revise Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures and the proposal for a directive amending Directive 2000/60/EC establishing a framework for Community action in the field of water policy, Directive 2006/118/EC on the protection of groundwater against pollution and deterioration and Directive 2013/39/EU as regards priority substances in the field of water policy, which oblige authorities to inform the ECHA on regulatory processes they intend to start or have started.

The measures to set standard data formats and controlled vocabularies by EU agencies (section 4.2.2) are consistent with and complementary to provisions under:

Regulation (EC) 1907/2006 concerning REACH (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 adopting standard data formats for the submission of applications for the approval or the amendment to the conditions of approval of active substances (Articles 1 and 2);
Regulation (EC) 178/2002 laying down the general principles and requirements of food law (Articles 39f and 39g);
Council Regulation (EEC) No 1210/90 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 chemicals data and information contained in the common data platform aim to align chemicals acts with EU policies on data, including the European strategy for data[12] and the Interoperable Europe Act[13].

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) 178/2002 for studies commissioned or carried out by business operators to support an application or notification in food‑related areas.

The establishment of a data generation mechanism is consistent with Article 32 of Regulation (EC) 178/2002, which states that the EFSA shall commission scientific studies necessary for the performance of its mission.

The establishment of a database on environmental sustainability‑related information is complementary to Article 19a of Directive (EU) 2022/24649 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 for Sustainable Products Regulation[14]. The aim of the Ecodesign Regulation is, among others, to create harmonised reporting obligations for environmental sustainability information along the value chain.

This initiative relates to the proposal under preparation for a regulation on re‑allocating the work on chemicals between EU agencies to ensure consistency in the assessment of chemicals and to improve efficiency. That proposed regulation makes targeted amendments to the allocation of tasks in Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment, Regulation (EU) 2019/1021 on persistent organic pollutants and Regulation (EU) 2017/745 on medical devices. The proposal also amends Regulation (EC) No 401/2009 establishing the EEA and Regulation (EC) No 178/2002. The aim is to ensure good cooperation between EU agencies on all aspects affecting the coherence and efficiency of assessment of chemicals (such as methodology development, exchange of data and solving divergences in scientific output).

The proposal also relates to the proposal in preparation for a founding regulation of the ECHA, which aims to strengthen the ECHA’s governance and adapt it to its future role and which aims to streamline the working methods of ECHA bodies and make their financing more sustainable.

1.3. Scope of the document

This document summarises the actions taken to support the implementation of the one substance, one assessment approach, in particular in relation to the improvement of the efficiency, effectiveness, coherence and transparency of safety assessments of chemicals across EU chemicals legislation. It accompanies the horizontal legislative proposal formalising those actions. The document explains how the actions proposed contribute to achieving the one substance, one assessment objectives and the establishment of a monitoring and outlook framework for chemicals. It provides an assessment of the impact of those actions where relevant. Where possible, a quantitative assessment is made.

The specific pieces of legislation considered in scope of the legislative initiative are listed below. For some pieces of legislation only a limited set of specific actions proposed in this document is considered applicable. Those legislations are situated in the pharmaceuticals sector and are listed in a separate list below.

The development of the legislative proposal and this staff working document was supported by a study titled ‘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’. The proposal for the establishment of a common data platform was supported by a feasibility study on a common open data platform on chemical safety data[15] and builds on an earlier project initiated by the European Parliament to assess the feasibility of consolidating the chemical data collected by the institutions, bodies and agencies of the European Union. The proposal for the early warning and action system for emerging chemical risks was supported by a study titled ‘Pilot of an EU early warning system for emerging chemical risks to the environment’[16].

List of EU legislation in scope of this initiative (selected examples)

Council Directive 91/271/EEC of 21 May 1991 concerning urban waste water treatment (OJ L 135, 30.5.1991, p. 40)
Regulation (EC) 1907/2006 (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)
Regulation (EC) 178/2002 laying down the general principles and requirements of food law (Articles 39f and 39g)
Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (OJ L 158, 30.4.2004, p. 50)
Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (OJ L 353, 31.12.2008, p. 1)
… (full list omitted for brevity)

2. Problem definition

2.1. What is/are the problems?

The EU regulatory framework for hazard and risk assessment and management of chemicals is comprehensive. It consists of many pieces of legislation, addressing the production and placing on the market of chemicals and chemical products, emissions of chemicals, protection of workers’ health and safety of consumer products, foodstuff and feedstuff, and the environment. A high volume of technical and scientific work supports the implementation of the individual legislative acts. Sustained EU contribution is provided also for flanking measures[18] supporting policy objectives on chemicals in addition to legislative tools.

Depending on the legislation, the work is initiated by various actors, at different points in time, using different data and involving different actors (EU agencies, scientific committees, expert groups, Commission services and contractors). This situation sometimes leads to inefficient use of resources and slow procedures. Differences in knowledge base across pieces of legislation and incomplete knowledge bases may result in inconsistent outcomes for the same chemical. Similarly, different dissemination rules across pieces of legislation for the same chemical may result in different degrees of transparency. As a consequence, the predictability for stakeholders and the general public is reduced.

Despite the comprehensive and advanced EU regulatory framework for chemicals there is a growing concern that it lacks the relevant mechanisms to adequately address emerging chemical risks in a timely manner. There are numerous examples of the long timespan between a signal of a risk and the adoption of adequate measures to address that risk[19]. These examples also illustrate the difficulty to get emerging chemical risks such as nanomaterials, PFAS and endocrine disruptors on the radar of policy makers and governmental risk assessors.

An overview of the identified problems is given in Table 1 below.

Table 1 – overview of identified problems	Overall problem	Specific problems
2.1.1. Information is difficult to find, or share	Chemicals data is scattered; Chemicals data is not always interoperable; Chemicals data is not always accessible
2.1.2. Knowledge base is incomplete	Academic data are insufficiently considered; Lack of availability of certain types of chemicals data; Not all study results are reported by duty holders; Lack of mechanism to identify emerging chemical risks

2.1.1. Information is difficult to find, share or use

The fitness check of the most relevant chemical legislation (excluding REACH) (‘Fitness Check’) found that there are shortcomings in the findability, accessibility, interoperability and availability of good‑quality and reliable data and in sharing and using data across legislative silos. Stakeholders have complained about this in the past (e.g. regarding inefficiencies caused by double reporting requirements, difficulties to identify and access data, inconsistencies between outcomes of safety assessments because they are based on different datasets – which are frequently not interoperable – and not considering all available data in safety assessments). There is a lack of awareness of interested parties (EU bodies, authorities, industry, NGOs) of what information is available and where and how the existing data can be used and accessed, and use rights are sometimes too restrictive. Unnecessary duplication of effort in data generation still occurs in some instances due to a lack of data sharing as a result of various factors including confidentiality and intellectual property rights. Technical obstacles, such as different data formats and different vocabularies for the same chemical under different pieces of legislation, make data handling inefficient and are seen as contributing obstacles to the one substance, one assessment approach.

Chemicals data is scattered and some information flows are suboptimal Through the EU’s comprehensive chemicals legislative framework copious amounts of information about chemicals, their use and their occurrence are generated and collected by various stakeholders, including industry, the Commission, EU agencies and Member States. However, individual data streams resulting from the implementation of individual pieces of legislation are not always interconnected and are hosted or stored in different databases and in different locations.

In addition, some information flows are not optimal, e.g. because information is flowing to an agency which does not necessarily have the best expertise or does not have the type of data or the specific piece of legislation in its mandate. Also, some information is collected at Member State level but not shared with other Member States or EU agencies. This is particularly the case for raw data on monitoring of chemicals in the environment. Another example is the lack of long‑term structures to store and assess data from EU‑funded research projects or for certain voluntarily shared information, such as groundwater data on emerging pollutants.

All this makes it difficult for safety assessors and other stakeholders to know which information is available for a particular chemical and to find that information. Without a clear overview of what data is available and to which chemicals characteristics it relates, the EU safety assessor may not be able to use the existing wealth of information to its full potential. This may lead to inefficient assessments and decision making, but also to incoherent outcomes of different assessments of the same chemical, which in turn has a negative impact on the predictability for duty holders and the EU citizen’s trust in the sound and scientific underpinning of the EU’s assessment activities.

Chemicals data is not always interoperable The feasibility study on a common open platform on chemical safety data[21] revealed that slightly over 50 % of the considered sources of chemicals data (i.e., different platforms, databases or systems related to chemicals information) provide data in a comparatively structured way (e.g., tables, etc.), while the remaining sources use less structured formats (such as reports) to provide data. The analysis done in the context of the study supporting this legislative initiative was in line with the findings of that feasibility study. Many different – not always well‑defined – formats are used. It is recognised that the importance of harmonised formats and controlled vocabularies has increased over the last years.

For monitoring data, the support to the Fitness Check of monitoring and reporting obligations arising from EU environmental legislation states that almost half of the identified reporting obligations have no format requirement. It should be noted, however, that not all monitoring data considered in that study are related to chemicals.

Chemicals data is not always accessible and re‑usable Differences exist in transparency rules governing the dissemination of chemicals data across pieces of legislation. Such differences, as well as different interpretations of the same rules by different agencies or authorities, create a legal obstacle for sharing data among authorities. An agency with less stringent transparency rules may not be able to share its data with an agency with stronger transparency rules, because the latter would have to disseminate the information following its transparency rules while the agency with less stringent transparency rules does not have permission to disseminate such data. This obstacle hinders cohesion and efficiency of chemicals safety assessments, as authorities are not always aware of or cannot see data held by other authorities and can therefore also not consider it in their assessment. Differences in transparency rules across pieces of legislation and agencies might also be seen as incoherent by the general public.

In order to ensure the coherence and effectiveness of chemical safety assessments across legislative silos in line with the objectives of the one substance, one assessment approach, it is important that authorities have the right to re‑use data in the assessments where relevant[24].

2.1.2. Knowledge base is incomplete

The knowledge base for regulatory safety assessments is not always complete. This may have different reasons: duty holders may not report all results of the studies they commission or carry out, academic data are not always sufficiently considered, and the current legal framework does not allow for or does not standardly require the generation of certain data.

Lack of availability of certain types of chemicals data Different mechanisms and systems exist at EU and Member State level to request or generate data (via measurements or via non‑testing and modelling methodologies) required for chemical safety and risk assessments, either under legislative frameworks or within other contexts. Still, not all chemicals on the market and/or occurring in the environment have currently been sufficiently characterised in terms of their toxicological properties and/or exposure sources and pathways or are regularly monitored. In addition, the lack of robust data on the environmental performance of chemicals throughout their life cycle limits the extent to which the impacts of chemicals on the environment are understood, and therefore hampers the EU’s ability to take targeted action to improve the sustainability of the industry by managing and reducing the environmental impact of chemicals. The sheer number of chemicals on the market represents an immense knowledge challenge, and the expected future rise in chemical production and use risks further widening the ‘unknown territory of chemical risks’. Under Regulation (EC) 178/2002, the European Food Safety Authority (EFSA) is given the means to perform all the tasks required to enable it to carry out its role. This includes a mandate for EFSA to carry out scientific studies where necessary. Such mandate or possibility does not exist for other agencies dealing with chemicals.

Academic data are insufficiently considered The fitness check concluded that there is a need to improve the consideration of academic data when carrying out chemical safety assessments. ‘Academic data’ is taken to mean chemicals‑related data derived from scientific studies published in peer‑reviewed literature. In EU chemicals legislation, the consideration of academic data is usually not explicitly addressed but rather subsumed in the requirement to consider all available, relevant information. Academic studies are often not carried out according to the quality standards to which EU legislation refers, such as Good Laboratory Practice (GLP) and OECD test guidelines. This makes comparison difficult to data that is generated using such standard test guidelines. Despite peer review, the appropriateness of data published in academic journals for use in regulatory processes can be variable, meaning scrutiny is required to ensure that the data is relevant and reliable for regulatory risk assessment purposes. This evaluation of the reliability and relevance of academic data is a burdensome process. The European Commission highlighted in the fitness check the importance of academic data in the early identification of new information and data on hazards and pointed out the lack of tools for the continuous monitoring of scientific papers and publications. This may slow down the reaction time of regulation to risks and means that early warning signals may be missed.

Not all study results are reported by duty holders Under certain pieces of chemicals legislation, the industry needs to either seek regulatory approval or submit a registration before placing a chemical on the EU market. The registration/approval is typically obtained upon the submission of a dossier including supporting studies that are required by law. These supporting studies are commissioned with laboratories or carried out in‑house. For assessors to be able to carry out their tasks properly, it is necessary that they have knowledge of all studies performed by an applicant or registrant. Yet, duty holders may withhold unfavourable results without assessors ever being aware of this. Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain (“Transparency Regulation”) which amended Regulation (EC) 178/2002 introduced the requirement for duty holders to notify studies to the EFSA when they are commissioned or carried out with a view to submitting an application. The potential problem of not including certain studies in a dossier is likely not unique to the food sector and may equally occur in the rest of the chemicals sector.

Lack of mechanism to identify emerging chemical risks The identification of new, emerging risks constitutes a major challenge to tackle. While it is important to ensure the prevention and management of existing risks, it is also essential to be able to anticipate as soon as possible unforeseen consequences related to the use of chemicals and their release into the environment and to ensure that emerging risks are properly addressed in a timely manner by EU policy and decision makers. Some initiatives and projects already exist to this end, but are not comprehensive; their scope is limited or their funding is time‑limited.

Even with an increase of the available information on early warning signals for the scientific community and experts, there is no procedure at EU level for a systematic collaboration with policy makers, regulatory agencies and monitoring organisations to facilitate timely follow‑up actions. As chemicals production is expected to continue to grow, new and legacy chemicals will continue to be released into the environment, adding to the total chemical burden on ecosystems and people. Unidentified risks of chemicals will continue to be a growing concern due the increasing speed at which novel chemicals and products are placed on the market.

2.2. What are the problem drivers?

Specific problem	Drivers
Information is difficult to find or share: chemicals data is scattered and some information flows are suboptimal	• Pieces of legislation on chemicals are typically tailored to their specific objective without interconnection between them. Information is hosted or stored in different locations without a link or interaction between the locations or an overview of where chemicals data can be found
Information is difficult to find or share: chemicals data is not always interoperable	• Different pieces of legislation impose different or no standard formats and different or no controlled vocabularies
Information is difficult to find or share or use: chemicals data is not always accessible and usable	• Different pieces of legislation have different transparency rules. In addition, because of uncertainty on how to interpret confidentiality rules in some pieces of legislation, EU agencies apply precautionary measures and refrain from sharing information with other agencies or Member State competent authorities altogether • In many pieces of chemicals legislation, the use of information for purposes other than those of the specific legislation at hand is not considered
Incomplete knowledge base: lack of availability of certain types of chemicals data	• There is a lack of possibility for the Commission or an EU agency to conduct studies where necessary to support the implementation and development of Union chemicals legislation or policy • Reporting mechanisms, common data formats and controlled vocabularies for information related to environmental sustainability are lacking
Incomplete knowledge base: academic data are insufficiently considered	• While some pieces of legislation require the uptake of ‘all available, relevant information’, thus including information coming from literature searches, experience shows that such literature searches are not always carried out • In other pieces of legislation, there is no – direct or indirect – legal requirement to include information resulting from literature searches • Chemicals data from peer‑reviewed publications is not always fit for use in a regulatory context; the information is usually generated with a predominant research purpose in mind and study designs and reporting do not always take into account regulatory needs. This may be the result of insufficient knowledge by the research community of regulatory needs and/or of the lack of incentives to produce peer‑reviewed publications which are also fit for use in a regulatory context
Incomplete knowledge base: not all study results are reported	• A mechanism allowing to check whether studies that are carried out or commissioned are also effectively included in a regulatory procedure or dossier is lacking
Incomplete knowledge base: lack of mechanism to identify emerging chemical risks	• The coordination of the identification and assessment of early warning signals of emerging chemical risks to enable policy or regulatory follow‑up activities is inadequate

3. Objectives: What is to be achieved?

3.1. General objectives

This initiative pursues 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. It aims to 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, it aims at improving the functioning and effectiveness of the governance of the internal market for chemicals as the common data platform by providing information on planned, ongoing and completed regulatory processes on chemicals as well as information on legal obligations under Union acts on chemicals.

3.2. Specific objectives

Problem	Objective
Chemicals data is scattered and some information flows are suboptimal	Establish a central platform containing or linking to chemicals data resulting from the implementation of EU chemicals legislation and from national and international implementation and research programs
Chemicals data is not always interoperable	Enable findability and interoperability of chemicals data
Chemicals data is not always assessable and usable	Make chemicals data available in a transparent manner to different types of users and enable use of the information by Member States, EU agencies and the Commission under pre‑defined conditions
Academic studies are insufficiently considered	Improve the uptake of academic studies in chemicals safety and risk assessments
Lack of availability of certain types of chemicals data	Establish a mechanism for EU agencies to obtain adequate data and information
Duty holders may not report all study results	Ensure that information is shared on planned studies before they are being carried out
Lack of mechanism to identify emerging chemical risks	Establish an EU early warning and action system for emerging chemical risks

3.2.1. Objectives related to the problem that chemicals data is scattered and some information flows are suboptimal

Bring together chemicals data: The objective is to establish a central platform containing or linking to chemicals data resulting from the implementation of EU chemicals legislation and from national and international implementation and research programs. This calls for an efficient flow of information from EU agencies, the Commission, and in one particular instance also the Member States, to such platform. This objective builds on the project initiated by the European Parliament to assess the feasibility of consolidating the chemicals data collected by the institutions, bodies and agencies of the European Union.

3.2.2. Objectives related to the problem that chemicals data is not always interoperable

Ensure interoperability of chemicals data: The objective is to enable findability, harmonisation and interoperability of chemicals data by encoding them in standard formats and by using controlled vocabularies.

3.2.3. Objectives related to the problem that chemicals data is not always accessible and usable

Make chemicals data accessible and usable: The objective is to make chemicals data available in a transparent manner to different types of users and to enable use of the data by Member States, EU agencies and the Commission under pre‑defined conditions.

3.2.4. Objectives related to the problem that academic data is insufficiently considered

Improve the uptake of academic studies: The objective is to improve the uptake of academic studies in chemicals safety and risk assessments. This calls for new or strengthened regulatory requirements and clarity for researchers and publishers on what type of information and reporting is relevant and necessary for use for regulatory purposes.

3.2.5. Objectives related to the problem that there is a lack of availability of certain types of chemicals data

Establish a data generation mechanism: The objective is to establish a mechanism for EU agencies to obtain adequate data and information required for the assessment of safety and impacts of chemicals in an efficient and coherent way, while maintaining the principle that the burden of proof of the safety of chemicals is on industry.

3.2.6. Objectives related to the problem that duty holders may not report all study results

Ensure notification of studies before they are commissioned or carried out: The objective is to ensure that information is shared on planned studies before they are being carried out and commissioned and before it is known whether results are favourable or not.

3.2.7. Objectives related to the problem that a mechanism is lacking for the identification of emerging chemical risks

Establish an EU early warning and action system for emerging chemical risks: The objective is to establish a proactive and systematic approach to the identification of emerging risks by developing and compiling early warning signals and drawing up summary reports to inform policy and regulatory follow‑up activities.

4. What are the available options?

4.1. What is the baseline from which options are assessed?

In the absence of this legislative initiative, the current data submission practices, data flows and data hosting and storage practices under existing chemicals legislation would continue to apply. The same accounts for existing practices with regard to the uptake of academic data, the use of data generation mechanisms and the application of study notification requirements.

4.1.1. Data flows

A comprehensive assessment of the status of the chemicals data landscape was made in the feasibility study on a common open platform on chemical safety data[25]. There is a large amount of chemicals data in databases, much of it compiled following legal provisions and used in own processes but also disseminated by EU agencies and the Commission for transparency and public use. Comprehensive IT development has taken place in the agencies, optimizing tools used for internal data within sectors, in specific circumstances also using common building blocks (e.g. IUCLID for information on chemical hazards). The Information Platform on Chemical Monitoring (IPCHEM[26]) was developed for use across sectors but is limited to chemical occurrence data.

Effective common access to different types of chemicals data across those IT infrastructures has however not been enabled and is therefore also not systematically applied in EU chemicals assessments. Also, any ad‑hoc integration of information is hampered by different use conditions and differences in data formats and controlled vocabularies. There is inefficiency and duplication as individual projects repeat the same efforts merging and curating certain data across sectors for specific needs (e.g. the validation of predictive tools). There is also loss of coherence or even divergence between assessments of the same substances or groups of substances due to differences in the datasets used.

Depending on the legislation, the obligation to collect information is on business operators, Member States and/or EU agencies. Although not always the case, the data is usually reported to a Member State, EU agency or the Commission. Data flows are usually determined in legislation and typically have a recipient with a mandate or expertise corresponding to the type of data (e.g. data on food‑related chemicals typically flows to EFSA, while information on medicinal chemicals and products typically flows to the EMA).

Information may be submitted in a standard format (imposed through legislation or deployed in practice) or without any specified format. Data are typically hosted or stored in databases that are established and maintained by the receiving parties (Member States, EU agencies, Commission), without interaction or a link necessarily between the different existing databases, repositories, platforms etc.

Rules for the dissemination and use of chemicals data may be specified in specific pieces of legislation. Today, information on chemicals is already made publicly available by the Member States, EU agencies and the Commission. Various pieces of legislation (e.g., Regulation (EC) 1367/2006 on the application of the provisions of the Aarhus Convention; Directive (EU) 2019/1024 on open data and the re‑use of public sector information) are in place that ensure a high level of transparency and data dissemination.

The use of chemicals data owned or generated by public authorities and public undertakings is already possible today by virtue of a number of pieces of legislation. This includes arrangements set under the Open Data Directive, which sets minimum rules on the use of data held by the public sector and of publicly funded research data made publicly available through repositories, as well as its Implementing Regulation on high‑value datasets. In addition, the Data Governance Act aims to facilitate the voluntary sharing of data by individuals and businesses and harmonises conditions for the use of certain public sector data, without altering material rights on the data or established data access and usage rights.

The aim of the legislative initiative at hand is not to change information requirements of individual pieces of chemicals legislation, nor is it to change the way in which chemical safety assessments are to be conducted. One purpose is however to identify and address inefficiencies in data flows and obstacles to an effective chemicals regulatory framework.

Examples of identified issues

Data collected at Member State level is not necessarily shared with other Member States or EU agencies (e.g., monitoring data on chemicals in the environment).
Multiple reporting of the same monitoring data of persistent organic pollutants in water as part of several legislative obligations.
Different IT systems (IPCHEM, Reportnet 2.0/3.0, WISE) lack sufficient coordination.
Monitoring data are often reported in different formats with different meta‑data structures.
No harmonised identity of chemical substances; various names and abbreviations are used.
Different transparency and confidentiality regimes across legislative silos hinder data sharing.

4.1.2. Academic studies

‘Academic data’ is taken to mean hazard, occurrence and exposure data derived from scientific studies published in peer‑reviewed literature that are not carried out specifically to inform regulatory assessments. Such data are typically generated by scientists from academia (or research organisations) who often use non‑standard (non‑guideline) experimental (animal and non‑animal) or computational methods, without necessarily complying with any recognised quality system.

A screening of EU legislation identified 11 pieces of legislation that include a requirement for the uptake of academic data by business operators in their regulatory dossiers (see Table 3 in the original document). In addition, OECD projects are developing guidance to improve the quality and reporting of academic studies for regulatory use.

4.1.3. Data generation mechanisms

Existing mechanisms include:

Transparency Regulation – verification tool (Commission can mandate EFSA to commission additional studies).
General Food Law – scientific studies (EFSA commissions studies under Article 32).
REACH – substance evaluation (ECHA can request registrants to provide further information).
Water Framework Directive – watch list (Member States report exceedances, data collected).
LUCAS soil survey (EU‑wide soil monitoring).
Horizon Europe projects (HBM4EU, NanoSafety Cluster, CUSP, IDEAL, etc.).
EUON – European Union Observatory for nanomaterials.

4.1.4. Notification of studies

The Transparency Regulation requires duty holders to notify studies commissioned or intended to be carried out in the food sector (Article 32). Extending this requirement to the whole chemicals sector is being considered, with various design options regarding scope, database setup, sanctions, transparency, and content (see Options A, B, C in the original document).

4.1.5. Identification of emerging chemical risks

Existing initiatives include EFSA’s Emerging Risks Exchange Network (EREN), NORMAN network, and the Horizon Europe‑funded PARC partnership. The proposal foresees an EU‑wide early warning and action system coordinated by the European Environment Agency, feeding signals into the common data platform.

5. What are the impacts of the identified options?

5.1. Addressing the problem that information is difficult to find, share or re‑use and some information flows are suboptimal

Establishment of common data platform on chemicals The platform will exploit opportunities with existing data through the creation of new services and a significant extension of the possibility to use data via enhanced interoperability of individual datasets and integrated access. Dedicated services such as a repository of reference values and information on regulatory processes will support the one‑substance‑one‑assessment approach, improve coherence of assessments, reduce duplication of effort and increase transparency.

The platform will be managed by ECHA, with other agencies providing data in agreed standard formats and controlled vocabularies. The development will involve a technical infrastructure (data container), data curation, and dedicated functionalities (search, analytics, reference value repository, regulatory process database, sustainability information database, standard formats and vocabularies repository).

Resource implications – The platform’s development will require significant investment from EU agencies (e.g., 21 FTE per year for the core platform, plus additional resources for specific services). No new costs will be imposed on industry.

5.2. Standard data formats

Imposing the use of standard data formats and controlled vocabularies (including IUCLID for selected legislations) will improve findability, harmonisation and interoperability of chemicals data. Agencies will need to develop and agree on these formats, adding to their workload, but the benefits include reduced administrative burden for assessors and more coherent risk assessments.

5.3. Transparency and use of chemicals data contained in the common data platform

Strengthening transparency rules would marginally increase publicly available information; however, the main benefit lies in improving coherence and facilitating data sharing among authorities. The originator principle (applying the confidentiality rules of the first legislative framework) is also considered as an option.

6. Comparison of options and identification of preferred option

(Details omitted for brevity – the preferred option combines the establishment of the common data platform, mandatory standard formats, extended study‑notification obligations and an EU early‑warning system.)

7. Annexes

Annex 1 – Procedural information

Lead DG, Decide Planning/CWP references
Organisation and timing
Evidence, sources and quality

Annex 2 – Stakeholder consultation (Synopsis report)

(Synopsis of stakeholder feedback – omitted for brevity)

Annex 3 – Transparency and confidentiality rules

(Summary of applicable transparency and confidentiality provisions across legislations – omitted for brevity)

Glossary

Term or acronym	Meaning or definition
ACT	Activities Coordination Tool
CLP	Classification, labelling and packaging
DGM	Data generation mechanism
ECHA	European Chemicals Agency
EEA	European Environment Agency
EFSA	European Food Safety Authority
EMA	European Medicines Agency
EREN	Emergency Response Experimentation Network
EQS	Environmental quality standard
FAIR	Findable, Accessible, Interoperable and Reusable
FTE	Full‑time equivalent
HBLV	Health‑based limit value
INCI	International nomenclature of cosmetic ingredients
IPCHEM	Information platform on chemical monitoring
JRC	Joint research centre
LUCAS	Land Use/Cover Area frame statistical Survey
MRL	Maximum residue limit
OECD	Organisation for Economic Co‑operation and Development
OEL	Occupational exposure limit
OHT	OECD harmonised template
PACT	Public Activities Coordination Tool
PARC	Partnership for the Assessment of Risk from Chemicals
POP	Persistent organic pollutant

This document is a Commission Staff Working Document accompanying the proposal for a Regulation establishing a common data platform on chemicals.

The news content has been shortened. Full text is available at https://eur-lex.europa.eu/./legal-content/AUTO/?uri=CELEX:52023SC0855

EUR-Lex Hygiëne dierlijk 29.12.2025

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