Regulation (EU) 2025/2455 of the European Parliament and of the Council of 26 November 2025 establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114(1) thereof,

Having regard to the proposal from the European Commission,

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

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1) The communication of the Commission of 11 December 2019 on the European Green Deal sets high ambitions for enabling the transition towards a toxic-free environment and zero pollution. The strategy set out in the communication of the Commission of 14 October 2020 entitled ‘Chemicals Strategy for Sustainability Towards a Toxic-Free Environment’ (the ‘Strategy’) is a crucial step towards achieving zero-pollution and introduces the ‘one substance, one assessment’ approach, which aims to improve the efficiency, effectiveness, coherence and transparency of safety assessments of chemicals across Union legal acts. According to the Strategy, ‘safe and sustainable by design’ criteria should be developed to enable the production and use of chemicals that are safe and sustainable throughout their entire lifecycle. The Strategy also states that the interaction between scientific developments and policy-making should be strengthened by means of an early warning system for chemicals and groups of chemicals, to ensure that Union policies address emerging chemical risks as soon as they are identified by monitoring and research, and that a framework of indicators should be developed to monitor the drivers and impacts of chemical pollution and to measure the effectiveness of Union law on chemicals. This Regulation aims to implement those objectives.

(2) The main objective of this Regulation is to increase the level of protection of the environment and human health from the risks arising from chemicals, as well as to facilitate the functioning of the internal market for chemicals. For that purpose, this Regulation should establish a common data platform on chemicals (the ‘common data platform’), to be managed by the European Chemicals Agency (the ‘ECHA’). The common data platform is a digital infrastructure that brings together chemicals data and information generated under the Union chemicals acquis. This Regulation should also establish dedicated services within the common data platform and lay down rules on the transparency, accessibility and usability of the data contained in the platform. This Regulation aims to create a common knowledge base on chemicals, which would be available to risk assessors to enable better, complete, consistent and robust scientific assessments of chemicals and their impact and to ensure the best use of existing information for the purpose of the implementation and the development of Union legal acts and thereby contribute to the replacement and reduction of animal testing wherever possible. This Regulation aims to improve the integration of information from different sources and establish a cost-effective digital infrastructure, providing a one-stop-shop for chemicals data and information in the Union that is accessible to the public. This will increase the predictability and transparency of regulatory processes on chemicals and strengthen public trust in the robustness of scientific decision-making. By collecting and making available all data on chemicals in the Union, the data platform will also foster innovation and support the development of advanced tools, methods and models for chemicals assessments.

(3) Under Decision (EU) 2022/591 of the European Parliament and of the Council (3), harnessing the potential of digital and data technologies to support environmental policy, including by delivering real-time data, where possible, and information on the state of ecosystems, while increasing efforts to minimise the environmental footprint of those technologies and ensuring that the data and information are transparent, authentic, interoperable and publicly accessible is a long-term priority objective. Data and information on chemicals are therefore essential for the proper development and implementation of the Union’s environmental policy and specifically of its chemicals policy.

(4) In its communication of 19 February 2020 on a European strategy for data, the Commission described its vision of a common European data space and highlighted the need for the development of sectoral data spaces in strategic areas, since not all sectors of the economy and society are moving at the same speed. This Regulation therefore aims to build a data space for chemicals by establishing the common data platform, which is also part of the Green Deal data space, as referred to in the European strategy for data. Furthermore, in that strategy, the Commission highlighted several issues concerning the availability of data for the public good, including accessibility, data infrastructures and governance, interoperability, as well as the lack of adequate sharing of data between public authorities. This Regulation therefore aims to increase the availability of data on chemicals by requiring the Commission and the relevant Union agencies, namely the European Agency for Safety and Health at Work (‘EU-OSHA’), the ECHA, the European Environment Agency (the ‘EEA’), the European Food Safety Authority (the ‘EFSA’), and the European Medicines Agency (the ‘EMA’) (together the ‘Agencies’), to make data available for incorporation in the common data platform, to promote interoperability of those data by providing for the establishment of standard formats and controlled vocabularies, as well as to facilitate data exchange and use by public authorities enabling them to effectively carry out their regulatory and policy development tasks.

(5) This Regulation also aims to implement the principles laid out in the proposal for an Interoperable Europe Act in the chemicals sector by strengthening the cross-border interoperability of network and information systems used to provide or manage public services on chemicals in the Union. This Regulation will contribute to increasing cross-border data flows for truly European digital services and will broaden the access to publicly available chemicals data for utilisation in other sectors’ applications.

(6) Business operators and competent authorities of the Member States are required by various Union legal acts to submit data and information to a multitude of Union agencies, as well as to the Commission in specific cases. This generates a fragmentation of data and information on chemicals, which are held under various data sharing and use conditions as well as in different formats. Such fragmentation prevents public authorities, as well as the public, from having a clear overview of what information is available on individual chemicals or groups of chemicals, of where and how information can be accessed and whether it can be used. This increases the likelihood of inconsistency between various assessments of the same chemical required by various Union legal acts on chemicals, and of damaging the public’s trust in the scientific grounds for Union decisions on chemicals. In order to ensure that data on chemicals are easily findable, accessible, interoperable and reusable, the ECHA should establish the common data platform. The common data platform should serve as a single point of reference and as a broadened and shared evidence base to enable the efficient delivery of consistent hazard and risk assessments of chemicals across various Union legal acts on chemicals, as well as to enable the timely identification of emerging chemical risks and the drivers and impact of chemical pollution. Authorities should take the necessary measures to protect the confidentiality of data, including, where relevant, by means of physical and cybersecurity measures.

(7) Unless this Regulation specifies otherwise, the common data platform should contain, but not be limited to, all chemicals-related data and information held by the Agencies or the Commission and generated or submitted to them as part of the implementation of Union legal acts listed in Annex I. This includes, for instance, all regulatory dossiers or applications submitted to the Agencies, but also chemicals data on the occurrence of chemicals submitted by Member States to the Agencies or the Commission as well as chemicals data resulting from Member States’ implementation activities, in compliance with their reporting obligations. The common data platform should also include chemicals data and information generated as part of Union, national or international programmes or from research activities related to chemicals, where those data and that information are held by the Commission or one of the Agencies. In addition, the common data platform should allow for the incorporation of chemicals data provided on a voluntary basis by Member States and other parties, including national agencies and research institutes, as well as chemicals data resulting from international collaboration with third-country organisations and held by the Commission or one of the Agencies.

(8) While some medicinal products are also chemicals and are relevant to the objectives of this Regulation, the application and use of hazard and risk assessments performed on chemicals under Union law on medicinal products is different from the application and use of hazard and risk assessments performed under the main Union legal acts on chemicals. It is thus appropriate to adopt a stepwise approach and to include, as a first step and taking due account of the administrative burden for the EMA, only the chemicals data which have the highest added value. Under that first step, the data with the highest assessed added value are data on relevant active substances, which are considered to be active substances covered by Union legal acts on medicinal products listed in Annex I, Part 2, and also subject to regulatory processes under other Union legal acts listed in Annex I, Part 1, 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. The specific chemicals data to be included for those relevant active substances should include chemicals data related to environmental risk assessments carried out under Union law on medicinal products for human and veterinary use, non-clinical studies carried out under Union law on medicinal products for human use and maximum residue limit values and the chemicals data underlying their derivation that the EMA holds, as well as specific reference values.

(9) Taking due account of the administrative work for the EMA from the adaptation of such data to an appropriate format for incorporation in the common data platform, it is appropriate to adopt a stepwise approach and to include during the first stage only chemicals data for active substances which are submitted to the EMA in the context of the relevant procedures that are finalised after the entry into force of this Regulation. No later than six years after the entry into force of this Regulation, the EMA should also start incorporating chemicals data on active substances resulting from procedures concluded before the entry into force of this Regulation.

(10) Other chemicals data submitted or generated under Union legal acts on medicinal products could also be of relevance to chemicals regulatory areas, such as data related to other active substances contained in medicinal products, clinical data and data related to other substances contained in medicinal products besides active substances. Moreover, a relevant part of the medicinal data is held by the competent authorities of the Member States. No later than 6 years after the entry into force of this Regulation, the Commission should therefore assess, in consultation with Member States and the Agencies, whether such additional data should be included in the common data platform. That assessment should also take into account the relevance, the anticipated added value and the cost-benefit balance of incorporating the additional data.

(11) In order to add data to be made available by the EMA through the common data platform where relevant to support the achievement of the objectives of this Regulation, such as to ensure consistency and the efficient delivery of hazard and risk assessments of chemicals, or if, in view of scientific progress, there is new knowledge about the hazards or risks to the environment or human health, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of amending Article 3(3) of this Regulation.

(12) Due to the sensitivity of the information on the exact chemical composition of mixtures placed on the market and classified as hazardous on the basis of their health or physical effects, submitted to the bodies appointed by the Member States under Article 45 of Regulation (EC) No 1272/2008 of the European Parliament and the Council (4), that information should not be included in the common data platform. Likewise, due to the commercial sensitivity of data and information on final cosmetic products, the information related to cosmetic products notified to the Cosmetic Product Notification Portal under Article 13 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council (5) should not be included in the common data platform either. However, chemicals data and information on individual chemical ingredients of cosmetic products should be included in the common data platform.

(13) To safeguard the ability of the European Commission, of the Agencies and of the competent authorities of the Member States to carry out their tasks, documents with chemicals data relating to their internal work or decision-making should, in principle, not be included in the common data platform.

(14) In order to respond to the needs of the digital economy and to ensure a high level of protection of the environment and human health, it is necessary to lay down a harmonised framework granting access to the chemicals data contained in the common data platform. That framework should, as a general principle, grant the widest possible access to that chemicals data. It should also specify, where appropriate, who is entitled to access and use that chemicals data, under which conditions, on what basis, and for what purposes. The Authorities entrusted with regulatory tasks related to chemicals should be allowed and encouraged to use the chemicals data and information contained in the common data platform to fulfil their regulatory duties and tasks effectively, in order to improve the effectiveness, efficiency and consistency of chemicals-related assessments as well as the development of Union chemicals policies. Access to personal data should be limited to what is necessary for the purposes for which those data are processed by the Authorities.

(15) Chemicals data and information generated as a result of obligations laid down by Union legal acts on chemicals could contain commercially sensitive information or be protected under those Union legal acts by confidentiality claims on confidential business information. The public dissemination of such data could affect the commercial interests of private parties. To ensure legal certainty and predictability for duty holders and to protect their legitimate expectations, as well as to ensure the industry’s competitiveness on the internal market, the ECHA, as a manager of the common data platform, should grant differentiated access rights to the data and information contained in the common data platform. To that end, the Authorities should have full access to all chemicals data and information contained in the common data platform, also in machine-readable formats, including access to all confidential information and information that is not made available to the public. In contrast, other parties should not have access via the common data platform to confidential data or to data that are not made available to the public under the originating Union act as they could contain commercially sensitive information and the confidentiality of those data has not been assessed. Nevertheless, all parties should maintain the right to request access to any data contained in the common data platform in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council (6).

(16) When using data contained in the common data platform, the Authorities should respect the originator principle. Under that principle, the confidentiality marking of chemicals data as carried out by the originator and as correspondingly indicated by the relevant agency when it provides those data to the common data platform should be respected by the Authorities using those data to perform their regulatory functions or fulfil their tasks. The common data platform should also include terms and conditions of use of the data, including regarding intellectual property rights.

(17) To ensure the protection of legitimate expectations of duty holders when generating or submitting data or information under the Union legal acts listed in Annex I, as well as to protect the confidentiality of that information when used by the Authorities, exceptional grounds for disclosing confidential information laid down in those Union legal acts should apply only to the disclosure of the data and information submitted or generated in compliance with those legal acts. For example, under Article 39(4) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (7), where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the EFSA can disclose information previously considered confidential under that Regulation and the EFSA is required to make public information which was previously considered confidential where that information forms part of the conclusions of scientific outputs of the EFSA which relate to foreseeable effects on human health, animal health or the environment. Likewise, Article 118 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (8) provides for the possibility for the ECHA to disclose confidential information submitted to it under that Regulation if urgent action is essential to protect human health, safety or the environment, such as in emergency situations.

(18) When processing or disclosing personal data contained in the common data platform, the Agencies and the Commission should comply with Regulation (EU) 2018/1725 of the European Parliament and of the Council (9), and the competent authorities of the Member States should comply with Regulation (EU) 2016/679 of the European Parliament and of the Council (10).

(19) Given that the Agencies would be required to store scientific data which includes confidential and personal data, it is necessary to ensure that such storage is carried out in accordance with a high level of information system security and that access to confidential data is auditable.