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)

Without prejudice to paragraph 7 of this Article, where the Commission or any of the Agencies makes available to the ECHA, in accordance with Article 5(2), a registration, application, notification or other relevant regulatory dossier in the context of which a notification was submitted under Article 26, they shall indicate which elements of the study notifications are confidential when incorporated into the common data platform. Only the elements indicated as confidential in the corresponding application, notification or other relevant regulatory dossier, in accordance with the provisions on confidentiality under the originating Union act, shall be indicated as confidential in the study notification when incorporated into the common data platform.

Upon receipt by the ECHA, in accordance with Article 5(2), of a registration, application, notification or other relevant regulatory dossier in the context of which a notification was submitted under Article 26, the ECHA shall make the related notification information available to the public through the common data platform, and shall respect the confidentiality of the elements indicated confidential in accordance with paragraph 4 of this Article.

Authorities and national enforcement authorities shall have access to the data contained in the Database of Study Notifications before those data are incorporated into the common data platform.

When the EFSA receives an application under Regulation (EC) No 178/2002 and has decided on the disclosure of the studies accompanying that application in accordance with Articles 38 to 39e of Regulation (EC) No 178/2002, it shall make the data that are contained in the database referred to in Article 32b of Regulation (EC) No 178/2002 and that correspond to that application available to the ECHA for incorporation in the common data platform.

The ECHA and the EFSA shall cooperate to ensure a common approach for the identification of information notified to them in accordance with Article 26 of this Regulation and Article 32b of Regulation (EC) No 178/2002, respectively, and shall facilitate the traceability of the studies notified to their respective databases.

The ECHA shall establish and manage, as part of the common data platform, a new database containing information on regulatory processes and activities on individual chemicals or groups of chemicals that are planned, ongoing or have been completed since the entry into force of this Regulation by the Member States, the national agencies or the Union institutions, the ECHA, the EEA, the EFSA, EU-OSHA or committees referred to in the Union legal acts listed in Annex III.

Where competent authorities of the Member States as referred to in any of the Union legal acts listed in Annex III hold information as referred to in paragraph 1, they shall make that information available to the Union agency responsible under the respective Union legal act listed in Annex III without delay. For each regulatory process or activity, at least the following information shall be included:

Where the ECHA, the EEA, the EFSA, EU-OSHA or the Commission hold information as referred to in paragraph 1, they shall make that information available to the ECHA for incorporation in the common data platform in the standard formats provided for in Article 17 without delay and, where relevant, once the agency responsible or the Commission has carried out a validity assessment. When making that information available, at least the following information shall be included for each regulatory process or activity:

The information referred to in paragraph 3, points (a) to (f), on a specific regulatory process or activity shall be made available to the public once that process or activity has formally started.

The ECHA shall establish and manage, as part of the common data platform, a database containing data on chemicals in articles or products generated or submitted as part of the implementation of Union legal acts listed in Annex V. The Commission shall design relevant related database functionalities.

Where the Commission or one of the Agencies holds the data referred to in paragraph 1 of this Article, it shall make those data available to the ECHA for incorporation in the common data platform in the standard formats as referred to in Article 17, where available, without delay and, where relevant, once the agency responsible or the Commission has performed the validity assessment.

Where competent authorities of the Member States hold the data referred to in paragraph 1 of this Article, they may make those data available in the standard formats as referred to in Article 17, where available, to the agency responsible under the relevant Union legal act listed in Annex V, or to the ECHA in the absence of such agency, which may host the data.

The Commission and the Agencies shall provide the necessary technical cooperation to the ECHA to enable data on chemicals in articles or products to be incorporated into the database referred to in paragraph 1.

The ECHA shall establish and manage, as part of the common data platform, a database containing data on alternatives to substances of concern as defined in Article 2, point 27 of Regulation (EU) 2024/1781 of the European Parliament and of the Council (21) and to substances that meet the criteria for classification in hazard classes referred to in Article 2, point (27)(b), of that Regulation. Those data shall include data on alternative technologies or materials that do not require such substances.

Where the Commission or one of the Agencies holds data as referred to in paragraph 1, it shall make those data available to the ECHA for incorporation in the common data platform.

Where competent authorities of the Member States hold data as referred to in paragraph 1 of this Article, they may make those data available in the standard formats as referred to in Article 17, where available, to the agency responsible under the relevant Union legal act listed in Annex I or, in the absence of such agency, to the ECHA, which may host the data.

The ECHA shall facilitate the voluntary submission by interested parties of data as referred to in paragraph 1.

The ECHA shall establish and manage, as part of the common data platform, a database containing information on the provisions and legal obligations applicable to chemicals under the Union legal acts listed in Annex I, Part 1.

The ECHA shall update the information in the database referred to in paragraph 1 of this Article on a regular basis at least annually, and in accordance with the governance scheme referred to in Article 4(3).

The ECHA shall establish and manage, as part of the common data platform, a repository of standard formats and controlled vocabularies.

Where standard data formats are established under the Union legal acts listed in Annex I, the ECHA shall include them in the common data platform.

Where the Commission or one of the Agencies specifies a standard format or controlled vocabulary in accordance with Articles 17 or 18, it shall make it available to the ECHA without delay for incorporation in the common data platform.

By 2 January 2032, the ECHA shall establish, as part of the common data platform, a database that contains environmental sustainability-related data and that has functionalities designed in accordance with paragraph 4, which it shall manage.

Where the Commission or one of the Agencies hosts or holds environmental sustainability-related data, it shall make those data available to the ECHA without delay for incorporation in the database of environmental sustainability-related data once the Commission or the agency hosting or holding that data has completed, where relevant, validity and confidentiality assessments. In addition, Member States or other parties, including national agencies, research institutes and third country organisations may submit environmental sustainability-related data to the ECHA. The Commission and the Agencies shall provide the necessary technical cooperation to the ECHA to enable such data to be incorporated into the database of environmental sustainability-related data. The ECHA shall provide the necessary support to the Commission and the Agencies to facilitate the incorporation of such data.

Where, pursuant to Article 5(6), researchers or research consortia funded by Union framework programmes make any environmental sustainability-related data on chemicals or materials they collect or generate available to the ECHA, the ECHA shall incorporate those data into the database of environmental sustainability-related data.

By 2 January 2029, the Commission shall, in consultation with the Member States, design database functionalities and identify existing datasets of chemicals data on environmental sustainability-related data other than data as referred to in paragraph 2. Such data shall be hosted and maintained by the ECHA.

The Commission and the Agencies shall promote the development and use of tools and practices facilitating the uptake of peer-reviewed published research data in regulatory chemicals assessments, including practices to develop and use reporting standards for such data, and tools to search, screen and extract relevant peer-reviewed published research data.

Where the Commission or one of the Agencies engages in the development of the tools and practices referred to in paragraph 1, the Commission and the Agencies shall cooperate closely and provide assistance as appropriate.

Without prejudice to Union provisions on the development or making available of data formats, the Commission and the Agencies shall, where relevant, establish standard formats and software packages for the data referred to in Article 3(2) and (3) falling within their mandate and make them available free of charge through the common data platform.

The standard formats shall, to the extent possible:

The standard formats shall be interoperable with the common data platform and be user-friendly.

The Authorities or national agencies shall exchange data contained in the common data platform in the relevant standard format.

The Commission and the Agencies shall use the International Uniform Chemical Information Database format (IUCLID) for making the relevant parts of dossiers under the following Union legal acts available to the ECHA for incorporation in the common data platform:

The Commission and the Agencies shall cooperate when establishing standard formats to ensure they are consistent with other relevant formats and are interoperable with the common data platform and existing data submission procedures.

The Commission and the Agencies shall take the necessary and appropriate measures to monitor and identify at an early stage any potential divergence between data formats that could cause interoperability problems. If a divergence between data formats is identified, the Agencies concerned shall cooperate to resolve it or, where the divergence is justified, explain the underlying reasons. Where the Agencies concerned are not able to resolve the divergence, they shall draw up a joint report and present it to the Commission. The report shall clearly outline the reasons for the divergence, clarify any underlying technical issue and make a proposal to resolve the divergence.

The Commission shall adopt an implementing act to resolve the divergence referred to in paragraph 7.

The Commission and the Agencies shall establish and regularly update controlled vocabularies within their mandate for the data referred to in Article 3(2) and (3), where relevant.

The Commission and the Agencies shall prioritise establishing controlled vocabularies for the identification of chemicals and the characterisation of their forms.

In establishing controlled vocabularies the Commission and the Agencies shall:

The controlled vocabularies shall be interoperable with the common data platform.

Where controlled vocabularies are established, the Commission and the Agencies shall:

The Commission and the Agencies shall cooperate with each other in establishing controlled vocabularies.

The Commission and the Agencies shall take the necessary and appropriate measures to monitor and identify, at an early stage, any potential divergence between controlled vocabularies. If a divergence between controlled vocabularies is identified, the Agencies concerned shall cooperate to resolve it or, where the divergence is justified, explain the underlying reasons. Where the Agencies concerned are not able to resolve the divergence, they shall draw up a joint report and present it to the Commission. The report shall clearly outline the reasons for the divergence, clarify any underlying technical issue and make a proposal to resolve the divergence.

The Commission shall adopt an implementing act to resolve the divergence.

Without prejudice to Regulation (EC) No 1049/2001, the public shall have access to all the chemicals data contained in the common data platform, except data which are indicated in accordance with Article 5(2) of this Regulation as not being made available to the public under the originating Union act.

The Authorities shall have access to all the chemicals data contained in the common data platform, including data which are indicated in accordance with Article 5(2) as not being made available to the public under the originating Union act.

The Authorities shall take the necessary measures, including security measures, to ensure that information contained in the common data platform indicated in accordance with Article 5(2) as not being made available to the public under the originating Union act are not made available to the public.

The Authorities may use the chemicals data contained in the common data platform or in the Database of Study Notifications referred to in Article 9 in the performance of any of their activities, where those activities support the development, implementation or enforcement of Union law and policy.

Authorities shall not use chemicals data contained in the common data platform to fulfil any legal obligations of duty holders except for the assessment of the completeness of chemicals data submitted by duty holders or where existing provisions provide for the sharing and use of chemicals data under the Union legal acts listed in Annex I.

When using chemicals data contained in the common data platform that are indicated in accordance with Article 5(2) as not being made available to the public, the Authorities shall respect that indication and shall not make those data available to the public without the consent of the originator.

The EEA and the ECHA shall, in collaboration with the EFSA, the EMA, EU-OSHA and the Commission, and in consultation with the Member States, establish, manage and update as appropriate a framework of indicators to:

The framework of indicators shall, where meaningful and to the extent possible, include an aggregated territory-based risk indicator to monitor, as regards the exposure of populations to individual and multiple chemicals:

The framework of indicators shall be accessible in the form of an indicator dashboard, which the EEA shall establish and which the ECHA shall make available to the public through the common data platform.

By 2 January 2027, the EEA shall establish a Union early warning system for emerging chemical risks, which it shall manage.

For the purpose of paragraph 1, the EEA shall compile data on early warning signals, which shall include at least signals from:

The ECHA, the EFSA, EU-OSHA and the EMA shall identify and gather relevant available data on early warning signals from the fields falling within their respective mandates and provide those data to the EEA, including data obtained pursuant to this Regulation.

The EEA shall draw up an annual report, compiling and analysing the data on early warning signals gathered in accordance with paragraphs 2 and 3. The first report shall be prepared by 2 July 2027. The EEA shall present that report to the Authorities. Within nine months of the presentation of each annual report, the Authorities shall consider undertaking regulatory, policy or enforcement actions accordingly, and provide a justification if they decide not to proceed with any action.

The EEA shall make all data on early warning signals that it holds or hosts as well as the report referred to in paragraph 4 available to the ECHA for incorporation in the common data platform.

The ECHA shall establish and manage an observatory for specific chemicals or groups of chemicals that the Commission considers as requiring additional scrutiny. The observatory shall include reliable information on properties, safety aspects, uses and market presence of those chemicals.

The Commission shall select the chemicals for the purposes of the observatory referred to in paragraph 1on the basis of scientific and technical progress and using the signals of the early warning system referred to in Article 22. The selection shall include potential contributors to new and emerging chemical risks among innovative rationally designed materials with new or enhanced properties or targeted or enhanced structural features at nanoscale.

By 2 July 2026 the Commission shall adopt and publish a list of the chemicals selected pursuant to paragraph 2 by means of an implementing act. The Commission shall review the list regularly and adopt any revision thereof by the same means. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29.

For the purpose of operating the observatory referred to in paragraph 1, the ECHA shall:

Using the best independent resources available, the ECHA may commission scientific studies to:

Without prejudice to the obligations on duty holders under the Union legal acts listed in Annex I, Part 1, the Commission, in exceptional circumstances of serious controversy or conflicting results, may request the ECHA to commission scientific studies with the objective of verifying evidence used in its chemicals assessment process. Those studies may have a wider scope than the evidence subject to verification.

Upon request by the Commission, the ECHA shall commission scientific studies as referred to in paragraphs 1 and 2.

The ECHA shall only commission scientific studies where results cannot be obtained through existing legal provisions or processes under Union legal acts listed in Annex I, Part 1. It shall give priority to the use of validated non-animal methods, with animal testing on vertebrate animals to be used only as a last resort. It shall not commission studies with a predominant research objective.

The ECHA shall seek to avoid duplication with Member State or Union research or implementation programmes.

The ECHA shall commission scientific studies pursuant to this Article in an open and transparent manner, and only after it has consulted the Member States.

The ECHA and the EFSA shall closely cooperate with each other on the planning and commissioning of scientific studies undertaken by the ECHA in accordance with paragraphs 1, 2 and 3 of this Article and of studies undertaken by the EFSA in accordance with Article 32 of Regulation (EC) No 178/2002.

The ECHA may request a sample of a substance or mixture necessary for performing the scientific studies referred to in paragraphs 1, 2 and3 from a business operator manufacturing, importing, formulating or placing such substance or mixture on the market. In order to request a sample, the ECHA shall send a draft request to the business operator, explaining the request and specifying the quantity and form of the sample as well as the date by which the sample is to be provided. The ECHA may also ask the business operator to provide substance or mixture characterisation. The ECHA shall inform the business operator of its right to comment within 30 days of receipt of the request. Any such comment received shall be taken into account by the ECHA, which shall confirm or amend the request.

The ECHA shall make the results of the scientific studies performed under this Article available through the common data platform.

By 2 January 2030, the ECHA and the EFSA, in cooperation with the EEA, shall, in the context of the data generation mechanism referred to in Article 24, commission a Union-wide human biomonitoring study covering all Member States.

Member States shall cooperate with the ECHA, the EFSA and the EEA in the planning and organisation of the human biomonitoring study and provide the necessary technical assistance and administrative support to the parties contracted by the ECHA or the EFSA to perform the sampling in order to enable sampling in their territories and to ensure that the samples are sufficiently representative. The human biomonitoring study shall comply with ethical and confidentiality standards.

Business operators shall notify to the Database of Study Notifications referred to in Article 9 of this Regulation, without delay, any studies that generate chemicals data and that they commission to support an application, notification or regulatory dossier notified or submitted to an Authority, as well as any studies on chemicals on their own or in products that business operators commission as part of a risk or safety assessment under the Union legal acts listed in Annex I, Part 1, to this Regulation. However, business operators shall not notify to the Database of Study Notifications referred to in Article 9 of this Regulation studies that are to be notified under Article 32b of Regulation (EC) No 178/2002.

For the purposes of paragraph 1, business operators shall notify to the Database of Study Notifications referred to in Article 9 of this Regulation the identity of the chemicals concerned, title and scope of the study, the laboratory or testing facility carrying out the study, the intended starting and planned completion dates, and, where relevant, whether the study is commissioned to comply with a decision of the ECHA pursuant to Articles 40, 41 or 46 of Regulation (EC) No 1907/2006.

Laboratories and testing facilities shall, without delay, notify to the Database of Study Notifications referred to in Article 9 of this Regulation any information as referred to in paragraph 2 of this Article related to studies commissioned by business operators to support an application, notification or regulatory dossier notified or submitted to an Authority, as well as any studies on chemicals on their own or in products that they commission as part of a risk or safety assessment under the Union legal acts listed in Annex I, Part 1, to this Regulation. However, laboratories and testing facilities shall not notify to the Database of Study Notifications referred to in Article 9 of this Regulation studies that are to be notified under Article 32b of Regulation (EC) No 178/2002.

For the purposes of paragraph 3 of this Article, for each study, laboratories and testing facilities shall notify to the Database of Study Notifications referred to in Article 9 the identity of the chemicals concerned, the title and scope of the study, the intended start and completion date and the name of the business operator that commissioned the study.

Paragraphs 3 and 4 shall apply, mutatis mutandis, to laboratories and testing facilities located in third countries, insofar as set out in relevant agreements with those third countries.

The obligations laid down in paragraphs 1 to 5 shall apply from 2 November 2027.

Member States may provide for exemptions from the obligations laid down in paragraphs 1 to 5 of for studies conducted in the interests of defence.

The ECHA, in close cooperation with the EFSA and in consultation with stakeholders, shall lay down the practical arrangements for implementing this Article.

In order to ensure that Annex I lists all relevant Union legal acts pursuant to which chemicals data are generated or submitted to the Agencies or to the Commission, and in order to keep the common data platform up to date, as soon as new Union legal acts pursuant to which chemicals data are generated or submitted enter into force, or an existing Union legal act is amended to introduce provisions on the generation or submission of data, the Commission shall adopt delegated acts in accordance with Article 28 to amend Annex I by adding those Union legal acts to that Annex, where the Union legal act concerned did not amend Annex I accordingly.

The Commission is empowered to adopt delegated acts in accordance with Article 28 to amend Annex II to this Regulation by adding new reference values derived under Union law on medicinal products, taking into account advances in digitalisation and interoperability as well as the values’ relevance for other chemicals policy and regulatory areas.

In order to ensure that Annex III lists all Union legal acts pursuant to which regulatory processes on chemicals or groups of chemicals are undertaken by competent authorities of the Member States, the ECHA, the EEA, the EFSA, EU-OSHA or the Commission, and in order to keep the common data platform up to date, as soon as new Union legal acts pursuant to which new regulatory processes are established enter into force, or an existing Union legal act is amended to establish new regulatory processes, the Commission shall adopt delegated acts in accordance with Article 28 to amend Annex III by adding those Union legal acts to that Annex, where the Union legal act concerned did not amend Annex III accordingly.

The Commission shall adopt delegated acts in accordance with Article 28, where necessary to keep Annex V as complete as possible, and to keep the common data platform up to date, to amend Annex V by adding

The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

The power to adopt delegated acts referred to in Article 3(4) and Article 27 shall be conferred on the Commission for a period of five years from 1 January 2026. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each five-year period.

The delegation of power referred to in Article 3(4) and Article 27 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

A delegated act adopted pursuant to Article 3(4) or Article 27 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.

The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Member States shall introduce penalties for non-compliance by business operators and laboratories with the obligations laid down in Article 26, and shall take all necessary measures to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.

Member States shall notify the Commission of those rules and of those measures by 2 November 2027, and shall notify the Commission without delay of any subsequent amendment thereto.

No later than 2 January 2032, the Commission shall assess and adopt a report on the appropriateness and cost-benefit ratio of including in the common data platform the following chemicals data relating to medicinal products pursuant to Article 3(3):

No later than 2 January 2030, and taking into account the work done by the OECD on the generation, reporting and use of peer-reviewed published research data for regulatory assessments, the Commission shall assess whether to collaborate with scientific and academic publishers and operators of databases containing contents of peer-reviewed journals on:

Within two years of completing the human biomonitoring study referred to in Article 25, the Commission shall assess the appropriateness of requiring the ECHA and the EFSA, in cooperation with the EEA, to commission regular human biomonitoring studies, as well as the resources necessary for such studies and the practical arrangements for involving Member States in such studies.

By 2 January 2032, the Commission shall carry out a general review of this Regulation and present a report to the European Parliament and to the Council, accompanied, if appropriate, by a legislative proposal. The report shall assess the progress made on the implementation and functioning of the common data platform, whether this Regulation has achieved its objectives, in particular to make it easier to reuse data across the Union legal acts listed in Annex I, and the appropriateness of resource allocation to the Agencies and the Commission.