Common data platform on chemicals
1. The ECHA shall establish and manage a common data platform on chemicals (the ‘common data platform’).
2. 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.
3. 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 ) .
4. 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.
5. 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;
(b)
the information related to cosmetic products and notified to the Cosmetic Product Notification Portal under Article 13 of Regulation (EC) No 1223/2009.
6. Documents relating to Authorities’ internal work or decision-making processes need not be included in the common data platform, unless required to be included pursuant to Article 10.
7. The ECHA shall ensure that each chemical or material for which chemicals data are hosted on the common data platform is identified by a unique technical identifier that links all chemicals data on that chemical or material, and, where possible and available, by specifying its molecular structure by means of a chemical notation, without prejudice to any confidentiality requirements in the originating Union act.
8. The common data platform shall provide the dedicated services identified in the governance scheme referred to in Article 4(3) including:
(a)
the Information Platform for Chemical Monitoring (‘IPCHEM’), referred to in Article 7;
(b)
the repository of reference values, referred to in Article 8;
(c)
the Database of Study Notifications, referred to in Article 9;
(d)
the database containing information on regulatory processes, referred to in Article 10;
(e)
the database containing data on chemicals in articles or products, referred to in Article 11;
(f)
the database containing data on alternatives to substances of concern, referred to in Article 12;
(g)
the database containing information on obligations under Union law on chemicals, referred to in Article 13;
(h)
the repository of standard formats and controlled vocabularies, referred to in Article 14;
(i)
the database of environmental sustainability-related data, referred to in Article 15.
The common data platform shall contain appropriate background and explanatory information in order to make it easier for the Authorities and the public to use those data in an informed manner.
9. The Authorities and the public shall, in accordance with Article 19, have easy access, free of charge, to the data contained in the common data platform, as well as to any related context data as referred to in Article 4(5), point (c). Where the data were generated by the Authorities, the context data shall include an indication to that effect.
10. Article 20 shall apply to the use of the data contained in the common data platform by the Authorities.
11. The data contained in the common data platform shall be made available in standard format, and through controlled vocabularies, where available.
12. The data contained in the common data platform shall be electronically accessible and searchable. The ECHA shall take measures to ensure a high standard of security appropriate to the security risks arising from the storage of chemicals data in the common data platform. The relevant Agencies shall take measures in cooperation with the ECHA to ensure that chemicals data are transmitted securely to the common data platform. The ECHA shall design the common data platform in a way that guarantees that any access to confidential data is auditable.
13. The Commission or Agencies under whose authority chemicals data are included in the common data platform shall remain responsible for handling any requests for access to documents made under Regulation (EC) No 1049/2001.
14. The common data platform and its dedicated services shall be established by 2 January 2029, unless specified otherwise.
By 2 January 2029 the common data platform shall contain at least the datasets as set out in Annex IV.
Other relevant datasets, including chemicals data generated or submitted before 1 January 2026, shall be incorporated progressively into the common data platform by 2 January 2036 in accordance with the implementation plan referred to in Article 4(1). Chemicals data related to human and veterinary medicinal products, as specified in paragraph 3, points (a), (b) and (c), of this Article, resulting from procedures that were concluded before 1 January 2026, shall be incorporated progressively into the common data platform from 2 January 2032.
When the ECHA receives chemicals data in accordance with Article 5 belonging to a dataset which has already been incorporated, it shall make those data available through the common data platform within 90 days of receipt.
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.
2. 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.
3. The platform steering committee shall advise the Commission in the preparation of the common data platform’s governance scheme referred to in paragraph 4.
4. 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.
5. 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.
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.
2. 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.
3. The ECHA shall host and maintain occurrence data related to workplace monitoring, including occupational human biomonitoring data.
4. The EEA shall host and maintain human biomonitoring data, occurrence data for the environment and occurrence data related to indoor air quality.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. Without prejudice to Article 6(11), the Commission and the Agencies shall act as data controller for any personal data they provide to the ECHA for incorporation into the common data platform.
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.
2. By 2 January 2029, the Commission shall transfer any human biomonitoring data it holds to the EEA.
3. 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.
4. 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.
5. 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.
6. 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;
(e)
performing regulatory risk assessment and supporting regulatory risk management;
(f)
assessing the need for regulatory action and prioritising such action;
(g)
monitoring the impact of regulatory intervention;
(h)
supporting policy making and the development of legislation, including by carrying out scientific research to that effect.
7. The EMA 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)
performing regulatory risk assessment and supporting regulatory risk management;
(d)
assessing the need for regulatory action and prioritising such action;
(e)
monitoring the impact of regulatory intervention;
(f)
supporting policy making and the development of legislation, including by carrying out scientific research to that effect.
8. EU-OSHA 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)
monitoring the impact of regulatory intervention;
(d)
assessing the need for regulatory action and prioritising such action;
(e)
supporting regulatory risk assessment and regulatory risk management;
(f)
supporting policy making and the development of legislation, including by carrying out scientific research to that effect;
(g)
developing health risk and impact indicators.
9. Any processing of human biomonitoring data constituting personal data by the Agencies or the Commission for the purposes referred to in paragraphs 3 to 8 of this Article shall not entail the sharing of such data with third parties other than those within the meaning of Article 4, point (10) of Regulation (EU) 2016/679 and Article 3, point (14) of Regulation (EU) 2018/1725.
10. The EEA and the ECHA shall make human biomonitoring data they hold or host publicly available in anonymised form through the IPCHEM.
11. The Agencies and the Commission shall act as data controller for the human biomonitoring data constituting personal data they hold, host or process for the purposes referred to in paragraphs 3 to 8.
12. The EEA and the ECHA shall determine the storage period for the human biomonitoring data constituting personal data that they hold as well as the criteria used for that purpose, and shall review that period and those criteria.
13. For the purposes of this Article, human biomonitoring data include personal data collected before the entry into force of this Regulation in accordance with relevant data protection rules.
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.
2. 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.
3. 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.
4. 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.
5. 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.
6. The ECHA shall ensure that the data contained in the IPCHEM are machine readable and downloadable.
Repository of reference values
1. The ECHA shall establish and manage a repository of reference values as part of the common data platform.
2. Without delay, the ECHA shall include any reference value adopted under Union legal acts listed in Annex I in the repository of reference values.
3. 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.
4. 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.
5. 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.
6. The ECHA shall ensure that the data contained in the repository of reference values are machine readable.
Database of Study Notifications
1. By 2 November 2027, the ECHA shall establish a Database of Study Notifications, which it shall manage.
2. The ECHA shall store the chemicals data notified to it in accordance with Article 26 in the Database of Study Notifications.
3. Data contained in the Database of Study Notifications shall be considered confidential and shall not be made public.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
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.
2. 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.
3. 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.
4. 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.
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.
2. 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.
3. 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.
4. 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.
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.
2. 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.
3. 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.
4. The ECHA shall facilitate the voluntary submission by interested parties of data as referred to in paragraph 1.
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.
2. 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).
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.
2. 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.
3. 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.
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.
2. 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.
3. 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.
4. 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.
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.
2. 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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
