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) ANNEX I

Article 1

Subject matter and scope

1. This Regulation aims to ensure the efficient delivery of consistent hazard and risk assessments of chemicals where those assessments are required by Union legal acts, in order to achieve a high level of protection of human health and the environment, enable the development and use of safe and sustainable chemicals, ensure the proper functioning of the single market for chemicals, improve the Union’s citizens’ knowledge about, and trust in, the scientific basis for the decisions taken under Union legal acts on chemicals, and to contribute to the replacement and reduction of animal testing wherever possible.

1. To achieve the objectives referred to in paragraph 1, this Regulation lays down measures to:

(a)

bring together chemicals data and ensure that such data are easily findable accessible, interoperable and reusable;

(b)

keep records of studies commissioned by business operators in the context of fulfilling their obligations under Union law on chemicals;

(c)

establish the widest possible scientific basis for the implementation and development of Union law and policy related to chemicals;

(d)

establish an early warning and action system for emerging chemical risks.

1. This Regulation applies to chemicals data as referred to in Article 3(2) and (3).

Article 2

Definitions

For the purpose of this Regulation, the following definitions apply:

(1)

‘Agencies’ means the European Chemicals Agency (the ‘ECHA’), the European Environment Agency (the ‘EEA’), the European Food Safety Authority (the ‘EFSA’), the European Medicines Agency (the ‘EMA’) and the European Agency for Safety and Health at Work (‘EU-OSHA’);

(2)

‘Authorities’ means the Commission, the competent authorities of the Member States as referred to in any of the Union legal acts listed in Annexes I or III, and the Agencies, excluding their management boards;

(3)

‘duty holder’ means a natural or legal person responsible for meeting obligations under the Union legal acts listed in Annex I;

(4)

‘business operator’ means a duty holder which is a private or public undertaking;

(5)

‘human biomonitoring data’ means data on concentrations of chemicals measured in human matrices such as blood or urine;

(6)

‘reference value’ means an estimate of a maximum exposure level or emission level of a chemical below which no or only acceptable adverse effects on human health or the environment are expected, or below which risks related to adverse effects of that chemical on human health or the environment are considered acceptable or tolerable;

(7)

‘originator’ means the Commission or the agency or competent authority of a Member State responsible for confidentiality assessments under any Union legal act listed in Annex I;

(8)

‘originating Union act’ means the Union legal act pursuant to which chemicals data and information were generated or submitted;

(9)

‘controlled vocabularies’ means standardised and organised arrangements of words and phrases presented as lists of terms or as a thesaurus, and taxonomies with a hierarchical structure of broader and narrower terms;

(10)

‘chemicals data’ means any representation of facts or information relating to chemicals and any compilation of such facts or information, including information on physicochemical properties, hazard properties, use, exposure, risk, occurrence, emissions, fate and manufacturing process of chemicals, as well as environmental sustainability-related information on chemicals, including climate change-related information, regulatory process-related information on chemicals, data on alternatives to substances of concern, standard formats, controlled vocabularies, or any information on applicable legal obligations relating to chemicals;

(11)

‘environmental sustainability-related data’ means any data relevant for the environmental sustainability assessment of a chemical or material throughout its entire life cycle, including:

(a)

data on resources, including raw materials, water, energy, fossil fuels and land;

(b)

data on emissions, including of greenhouse gases, eutrophication-relevant substances, dust and all other polluting substances; and

(c)

data on by-products originating during the chemical’s life cycle that can be used as resources for other production processes, including hydrogen and carbon monoxide;

Article 3

Common data platform on chemicals

1. The ECHA shall establish and manage a common data platform on chemicals (the ‘common data platform’).

1. The common data platform shall provide access to all chemicals data:

(a)

generated or submitted as part of the implementation of the Union legal acts listed in Annex I and held by the Agencies or the Commission;

(b)

generated as part of Union, national or international programmes or from research activities in the field of chemicals and held by the ECHA, the EEA, the EFSA, EU-OSHA or the Commission;

(c)

provided on a voluntary basis by Member States or other parties, including national agencies, research institutes and third-country organisations, and held or accepted by the ECHA, the EEA, the EFSA, EU-OSHA or the Commission.

1. By way of derogation from paragraph 2, the common data platform shall provide access to chemicals data related to human and veterinary medicinal products as part of the implementation of the Union legal acts listed in Annex I, Part 2, only if such data:

(a)

are held by the EMA; and

(b)

relate to active substances:

(i)

that are subject to regulatory processes under other Union legal acts listed in Annex I, Part 1; or

(ii)

that have particular persistent, bio-accumulative and toxic properties; or

(iii)

for which a high level of residues has been identified in the environment; and

(c)

fall into at least one of the following categories:

(i)

non-clinical safety data, including data related to environmental risk assessments, compiled pursuant to Directive 2001/83/EC of the European Parliament and of the Council (17) and Regulation (EC) No 726/2004 of the European Parliament and of the Council (18); or

(ii)

data related to environmental risk assessments, compiled pursuant to Regulation (EU) 2019/6 of the European Parliament and of the Council (19); or

(iii)

maximum residue levels and the data from which they were derived, compiled pursuant to Regulation (EC) No 470/2009 of the European Parliament and of the Council (20).

1. The Commission is empowered to adopt delegated acts in accordance with Article 28 to amend:

(a)

paragraph 3, point (b), of this Article, by adding chemicals data relating to substances contained in medicinal products other than active substances or relating to active substances contained in medicinal products with properties other than those referred to in paragraph 3, point (b) (i) and (ii), of this Article, where relevant to the objectives of this Regulation or if, in view of scientific progress, there is new knowledge about the hazards or risks to the environment or human health;

(b)

paragraph 3, point (c), of this Article, by adding new categories of data types relevant to the objectives of this Regulation or, if, in view of scientific progress, there are new data on the hazard or risk to the environment or human health.

1. The following information shall not be included in the common data platform:

(a)

the information referred to in Article 45 of Regulation (EC) No 1272/2008;

Article 4

Implementation plan and governance of the common data platform

1. By 2 July 2026 the Commission shall by means of an implementing act adopt an implementation plan identifying datasets of chemicals data for inclusion in the common data platform together with a timeline for their inclusion. Subsequent implementation plans shall be adopted in line with the governance scheme adopted pursuant to paragraph 4.

1. The Commission shall, by means of an implementing act, establish and manage a platform steering committee, which shall include at least one representative from each of the Agencies and as many representatives from the Commission as from all of the Agencies combined.

1. The platform steering committee shall advise the Commission in the preparation of the common data platform’s governance scheme referred to in paragraph 4.

1. The Commission shall adopt and publish the governance scheme for the common data platform and any revision thereof by means of implementing acts.

In preparing the governance scheme, the Commission shall take into account the different levels of responsibility of the Commission and the Agencies in the management and operation of the common data platform.

1. The governance scheme for the common data platform shall describe:

(a)

the organisation of the main work structures supporting the development and implementation of the common data platform;

(b)

the preparation and adoption of implementation plans for the common data platform;

(c)

the principles on data governance and the required standard formats, controlled vocabularies and further conditions for the provision of information and context data to the common data platform;

(d)

the decision-making procedures for the development of new dedicated services and the inclusion of new functionalities of the common data platform;

(e)

any other rules or requirements necessary for the operation of the common data platform and the use of the data contained in it, such as the policy regarding data updating, archiving and deletion and the terms and conditions of use;

(f)

the operation and transparency obligations of the steering committee itself.

Article 5

Data flows for the purpose of the common data platform

1. At the Commission’s request, the Agencies shall host and maintain chemicals data generated as part of Union, national or international law, programmes or from research activities corresponding to their mandate and to the type of data they already hold. In addition, Agencies may, in accordance with their mandate, host and maintain chemicals data submitted to them by Member States or other parties, including national agencies, research institutes and third-country organisations.

1. Where the Commission or one of the Agencies holds data or information as referred to in Article 3(2) or (3), it shall make those data available to the ECHA, which shall incorporate them into the common data platform. The Commission and the Agencies shall provide the data or information to the ECHA in a standard format, where available, together with the relevant context data as referred to in Article 4(5), point (c). Where those data are or that information is not made available to the public under the originating Union act, the Commission and the Agencies shall so indicate.

1. The ECHA shall host and maintain occurrence data related to workplace monitoring, including occupational human biomonitoring data.

1. The EEA shall host and maintain human biomonitoring data, occurrence data for the environment and occurrence data related to indoor air quality.

1. From 1 January 2026, researchers or research consortia funded by Union framework programmes or national programmes shall make all human biomonitoring data they collect or generate available to the EEA. The EEA shall host that data. For human biomonitoring data constituting personal data, the EEA shall specify which type of data are to be made available to it.

1. From 1 January 2026, researchers or research consortia funded by Union framework programmes shall make all environmental sustainability-related data they collect or generate available to the ECHA. The ECHA shall host that data.

1. The Commission and the Agencies shall provide the necessary technical cooperation to the ECHA to enable the chemicals data provided in accordance with paragraph 2 to be incorporated into and published through the common data platform. The ECHA shall provide support to the Authorities and national agencies to facilitate the incorporation of the chemicals data provided in accordance with paragraph 2.

1. For the purpose of paragraph 2, the Commission and the Agencies shall make chemicals data that they have collected or received available to the ECHA without delay once they have performed validity and confidentiality assessments of the data in accordance with applicable rules and once they have incorporated the corresponding dataset into the common data platform.

1. The Authorities and national agencies shall ensure, when making data available to the ECHA, that such data are downloadable, machine readable and interoperable. They shall curate and validate the data in an appropriate manner before providing them to the ECHA.

Article 6

Human biomonitoring data

1. The EEA shall collect human biomonitoring data generated within the territory of the EEA’s member and cooperating countries. In the case of occupational human biomonitoring data, the EEA shall cooperate with the ECHA.

1. By 2 January 2029, the Commission shall transfer any human biomonitoring data it holds to the EEA.

1. The EEA shall process human biomonitoring data constituting personal data for the following purposes only:

(a)

assessing the impact of chemicals on human health and the environment;

(b)

monitoring time and spatial trends in exposure;

(c)

developing health risk and impact indicators;

(d)

monitoring the impact of regulatory intervention;

(e)

supporting regulatory risk assessments and regulatory risk management;

(f)

supporting policy making and the development of legislation;

(g)

facilitating the processing of human biomonitoring data by the Commission, the ECHA, the EFSA, the EMA, and EU-OSHA in accordance with paragraphs 4 to 8.

1. The Commission shall process human biomonitoring data constituting personal data for the following purposes only:

(a)

assessing the impact of chemicals on human health and the environment;

(b)

monitoring time and spatial trends in exposure;

(c)

developing health risk and impact indicators;

(d)

monitoring the impact of regulatory intervention;

(e)

assessing the need for regulatory action and prioritising such action;

(f)

performing regulatory risk assessment and regulatory risk management;

(g)

supporting policy making and the development of legislation, including by carrying out scientific research to that effect;

(h)

in the context of studies under the data generation mechanism referred to in Article 24 and the human biomonitoring study referred to in Article 25.

1. The ECHA shall process human biomonitoring data constituting personal data for the following purposes only:

(a)

assessing the impact of chemicals on human health and the environment;

(b)

monitoring time and spatial trends in exposure;

(c)

developing health risk and impact indicators;

(d)

monitoring the impact of regulatory intervention;

(e)

performing regulatory risk assessment and regulatory risk management;

(f)

in the context of studies under the data generation mechanism referred to in Article 24 and the human biomonitoring study referred to in Article 25;

(g)

assessing the need for regulatory action and prioritising such action;

(h)

supporting policy making and the development of legislation, including by carrying out scientific research to that effect;

(i)

facilitating the processing of human biomonitoring data by the Commission, the EEA, the EFSA, the EMA, and EU-OSHA in accordance with paragraphs 3, 4, 6 and 7.

1. The EFSA shall process human biomonitoring data constituting personal data for the following purposes only:

(a)

assessing the impact of chemicals on human health and the environment;

(b)

monitoring time and spatial trends in exposure;

(c)

developing health risk and impact indicators;

(d)

in the context of studies under the data generation mechanism referred to in Article 24 and the human biomonitoring study referred to in Article 25;

Article 7

Information Platform for Chemical Monitoring

1. The ECHA shall operate and maintain the IPCHEM containing occurrence data on chemicals across different media, including water, soil, indoor air, outdoor air, biota, food and feed, humans and products as part of the common data platform.

1. By 2 January 2029, the Commission shall transfer the chemicals data contained in the IPCHEM to the ECHA for incorporation in the common data platform.

1. By 2 January 2029, the Commission shall transfer the chemicals data contained in the IPCHEM to the ECHA, the EEA or the EFSA for hosting in accordance with the respective agency’s mandate and in accordance with Article 5.

1. After the completion of the transfer referred to in paragraph 3, where the Commission or one of the Agencies hosts or holds occurrence data on chemicals and related chemicals data, it shall make those data available to the ECHA without delay for incorporation in the IPCHEM.

1. The Commission and the Agencies shall cooperate at technical level with the ECHA to enable occurrence data on chemicals and related chemicals data they host or hold to be incorporated into and published on the common data platform.

1. The ECHA shall ensure that the data contained in the IPCHEM are machine readable and downloadable.

Article 8

Repository of reference values

1. The ECHA shall establish and manage a repository of reference values as part of the common data platform.

1. Without delay, the ECHA shall include any reference value adopted under Union legal acts listed in Annex I in the repository of reference values.

1. For reference values not adopted under Union legal acts listed in Annex I, the Agencies holding or establishing reference values as part of their activities under Union legal acts listed in Annex I, Part 1, or the reference values referred to in Annex II shall make those reference values available to the ECHA without delay, in the standard formats provided for in Article 17, where available, and for incorporation in the repository of reference values.

1. For the purposes of paragraph 3, where reference values are included in a regulatory dossier submitted to the Agencies, the Agencies shall share those reference values in the standard formats with the ECHA without delay once relevant validity and confidentiality assessments have been completed by the originator in accordance with applicable rules.

1. Without delay, the ECHA shall include in the repository of reference values any reference value it considers relevant that is generated as part of Union, national or international programmes or from research activities and made available to the ECHA in the standard formats as referred to in Article 17, where such a standard format has been developed.

1. The ECHA shall ensure that the data contained in the repository of reference values are machine readable.

Article 9

Database of Study Notifications

1. By 2 November 2027, the ECHA shall establish a Database of Study Notifications, which it shall manage.

1. The ECHA shall store the chemicals data notified to it in accordance with Article 26 in the Database of Study Notifications.

1. Data contained in the Database of Study Notifications shall be considered confidential and shall not be made public.

1. 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.

1. 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.

1. 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.

1. 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.

1. 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.

Article 10

Information on regulatory processes on chemicals

1. The ECHA shall establish and manage, as part of the common data platform, a new database containing information on regulatory processes 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.

1. 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:

(a)

the chemical identity;

(b)

the Union legal act and the regulatory process in the context of which the activity takes place;

(c)

the person or body responsible for the regulatory process or activity;

(d)

the status of the regulatory process or activity;

(e)

the outcome of the regulatory process or activity, including, where applicable, any reports or opinions adopted;

(f)

where applicable, the intended start date of the regulatory process or activity, and the date of completion and latest progress update.

1. 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:

(a)

the chemical identity;

(b)

the Union legal act and the regulatory process in the context of which the activity takes place;

(c)

the person or body responsible for the regulatory process or activity;

(d)

the status of the regulatory process or activity;

(e)

the outcome of the regulatory process or activity, including, where applicable, any reports or opinions adopted;

(f)

where applicable, the intended start date of the regulatory process or activity, and the date of completion and latest progress update.

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

Article 11

Data on chemicals in articles or products

1. 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.

1. 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.

1. 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.

1. 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.

Article 12

Data on alternatives to substances of concern

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.

1. 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.

1. 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.

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

Article 13

Information on the obligations under Union legal acts on chemicals

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.

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).

Article 14

Repository of standard formats and controlled vocabularies

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

1. 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.

1. 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.

Article 15

Database of environmental sustainability-related data

1. 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.

1. 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.

1. 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.

1. 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.

Article 16

Uptake of peer-reviewed published research data

1. 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.

1. 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.

CHAPTER III

STANDARD FORMATS AND CONTROLLED VOCABULARIES

Article 17

Standard formats

1. 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.

1. The standard formats shall, to the extent possible:

(a)

avoid the use of proprietary standards;

(b)

re-use existing data formats or parts thereof;

(c)

use OECD or other internationally agreed formats;

(d)

ensure consistency with other relevant data formats;

(e)

ensure interoperability with existing data submission procedures.

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

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

1. 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:

(a)

Regulation (EC) No 1831/2003 of the European Parliament and of the Council (22);

(b)

Regulation (EC) No 1935/2004 of the European Parliament and of the Council (23);

(c)

Regulation (EC) No 1331/2008 of the European Parliament and of the Council (24);

(d)

Regulation (EC) No 1332/2008 of the European Parliament and of the Council (25);

(e)

Regulation (EC) No 1333/2008 of the European Parliament and of the Council (26);

(f)

Regulation (EC) No 1334/2008 of the European Parliament and of the Council (27);

(g)

Regulation (EC) No 1223/2009;

(h)

Commission Regulation (EU) No 234/2011 (28);

(i)

Directive 2009/48/EC of the European Parliament and of the Council (29);

(j)

Regulation (EC) No 1107/2009;

(k)

Regulation (EC) No 396/2005 of the European Parliament and of the Council (30).

1. 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.

1. 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.

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

Article 18

Controlled vocabularies

1. 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.

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

1. In establishing controlled vocabularies the Commission and the Agencies shall:

(a)

avoid the use of proprietary controlled vocabularies to the extent possible;

(b)

re-use existing substance identifiers and controlled vocabularies or parts thereof to the extent possible;

(c)

use OECD or other internationally agreed controlled vocabularies to the extent possible;

(d)

ensure consistency with other relevant controlled vocabularies including by preparing alignment tables.

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

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

(a)

make them available free of charge through the common data platform as open datasets, supporting their re-use;

(b)

incorporate them in any submission software or template to be used by duty holders under the Union legal acts listed in Annex I, Part 1 and referred to in Article 3(2); and

(c)

use them when exchanging data through the common data platform.

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

1. 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.

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

CHAPTER IV

CHEMICALS DATA CONFIDENTIALITY AND USE

Article 19

Access rights and transparency

1. 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.

1. 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.

1. 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.

Article 20

Use of chemicals data contained in the common data platform

1. 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.

1. 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.

1. 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.

CHAPTER V

MONITORING AND OUTLOOK FRAMEWORK FOR CHEMICALS

Article 21

Framework of indicators

1. 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:

(a)

monitor chemical pollution throughout a chemical’s lifecycle, including emissions, occurrence and fate;

(b)

monitor the drivers and impacts of exposure to chemicals; and

(c)

measure the effectiveness of Union law on chemicals and the transition towards the production of safe and sustainable chemicals.

1. 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:

(a)

time and spatial trends in such exposure;

(b)

health risks associated with such exposure.

1. 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.

Article 22

Early warning and action system for emerging chemical risks

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

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

(a)

the EFSA’s emerging risks exchange network;

(b)

national early warning systems;

(c)

data that the EEA holds, including human biomonitoring data, and data from the framework of indicators as referred to in Article 21;

(d)

targeted literature searches performed by the EEA;

(e)

data made available by the ECHA, the EFSA, EU-OSHA and the EMA in accordance with paragraph 3;

(f)

relevant datasets from the EU dataset catalogue established pursuant to Article 79 of Regulation (EU) 2025/327;

(g)

relevant information resulting from the implementation of Union law.

The early warning signals compiled by the EEA pursuant to the first subparagraph may be based on a positive identification of an emerging risk or on an uncertainty in the data leading to a potential positive identification of an emerging risk.

1. 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.

1. 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.

1. 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.

Article 23

Observatory for specific chemicals with the potential to contribute to emerging chemical risks

1. 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.

1. 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.

1. 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.

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

(a)

make use of relevant chemicals data incorporated in the common data platform and compile, analyse and curate further available data on selected chemicals or classes of chemicals;

(b)

commission studies and, where relevant, use the data generation mechanism established under Article 24 to address knowledge gaps or significant uncertainties;

(c)

make compiled data available to the public through the common data platform or other communication and outreach tools, as appropriate, to facilitate the identification of potential further research needs or risk management measures, and to facilitate informed societal discussion and increase public awareness on the properties, use and safety aspects of specific chemicals, and regularly update those data.

CHAPTER VI

DATA GENERATION MECHANISM

Article 24

Data generation mechanism

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

(a)

support the implementation of Union legal acts on chemicals or groups of chemicals listed in Annex I, Part 1, within its mandate;

(b)

contribute to supporting, evaluating and developing Union chemicals policy;

(c)

investigate further emerging chemical risks identified in the report referred to in Article 22(4).

1. 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.

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

1. 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.

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

1. 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.

1. 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.

1. 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.

Where the ECHA confirms or amends the request, the business operator shall provide the requested sample free of charge to the ECHA or to any natural or legal person commissioned by the ECHA to perform the scientific study within the deadline set by the ECHA. The business operator may request the ECHA not to disclose certain characterisation information relating to the provided sample if the business operator demonstrates that the disclosure would undermine the protection of its commercial interests.

Article 25

Human biomonitoring study

1. 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.

1. 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.

CHAPTER VII

NOTIFICATION OF STUDIES

Article 26

Notification of studies

1. 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.

1. 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.

At the time a study is commissioned, business operators shall inform the laboratory or testing facility in which the study is carried out whether the study is subject to the notification obligation under this Article.

1. 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.

1. 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.

1. 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.

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

1. 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.

Article 27

Amendment of Annexes I, II, III and V

1. 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.

1. 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.

1. 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.

1. 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

(a)

any new Union legal act pursuant to which data on chemicals in articles or products are generated or submitted, as soon as it enters into force, unless it contains a provision adding that act to Annex V;

(b)

any existing Union legal act listed in Annex I which is amended in such a way that data on chemicals in articles or products are generated or submitted pursuant to it, as soon as the respective amending act enters into force, unless the amending act contains a provision adding that act to Annex V; or

(c)

any existing Union legal act listed in Annex I for which it has become apparent from further verification that data on chemicals in articles or products are generated or submitted pursuant to it.

Article 28

Exercise of the delegation

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

1. 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.

1. 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.

1. 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.

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

1. 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.

Article 29

Committee procedure

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

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

CHAPTER IX

ENFORCEMENT AND PENALTIES

Article 30

Cooperation on compliance

The Agencies shall cooperate with Member States’ enforcement authorities and exchange information on the compliance by business operators and laboratories with the obligation to notify studies in accordance with Article 26.

Article 31

Penalties for non-compliance

1. 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.

1. 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.

CHAPTER X

REVIEW AND ENTRY INTO FORCE

Article 32

Reports and review

1. 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):

(a)

new categories of data types;

(b)

chemicals data on substances other than active substances;

(c)

chemicals data on active substances that do not meet the criteria referred to in Article 3(3), point (b);

(d)

chemicals data collected and submitted under Union legal acts listed in Annex I, Part 2, and held by competent authorities of the Member States and not by the Agencies.

1. 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:

(a)

harmonised reporting of peer-reviewed published research data to scientific peer-reviewed journals; and

(b)

the use of tools to search, screen and extract peer-reviewed published research data relevant for chemicals assessments from databases containing content from peer-reviewed journals.

1. 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.

On the basis of that assessment the Commission may present a legislative proposal.

1. 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.

Article 33

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg, 26 November 2025.

For the European Parliament

The President

R. METSOLA

For the Council

The President

M. BJERRE

(1)

OJ C, C/2024/3381, 31.5.2024, ELI: http://data.europa.eu/eli/C/2024/3381/oj.

(2) Position of the European Parliament of 21 October 2025 (not yet published in the Official Journal) and decision of the Council of 13 November 2025.

(3) Decision (EU) 2022/591 of the European Parliament and of the Council of 6 April 2022 on a General Union Environment Action Programme to 2030 (OJ L 114, 12.4.2022, p. 22, ELI: http://data.europa.eu/eli/dec/2022/591/oj).

(4) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).

(5) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59, ELI: http://data.europa.eu/eli/reg/2009/1223/oj).

(6) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43, ELI: http://data.europa.eu/eli/reg/2001/1049/oj).

(7) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1, ELI: http://data.europa.eu/eli/reg/2002/178/oj).

(8) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).

(9) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39, ELI: http://data.europa.eu/eli/reg/2018/1725/oj).

(10) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/679/oj).