What changed between the adopted text of 1 Apr 2025 and the adopted text of 21 Oct 2025

Removed:Article 2 – paragraph 1 – point 10: 10. ‘chemicals data’ means any representation of facts or information relating to chemicals and any compilation of such facts or information, including information on physico-chemical properties, hazard properties, use, exposure, risk, occurrence, emissions, fate and manufacturing process of the chemicals, as well as environmental sustainability related information, including climate change related information, on those chemicals, regulatory process-related information on chemicals, information on the availability and suitability of alternatives, standard formats, controlled vocabularies, or any information on applicable legal obligations related to chemicals and the enforcement thereof;

Removed:Article 2 – paragraph 1 – point 11 a (new): 11a. 'research data' means any hazard, occurrence, exposure and fate data derived from scientific studies published in peer-reviewed literature that are not carried out specifically to inform regulatory assessments;

Removed:Article 2 – paragraph 1 – point 14 a (new): 14a. ‘data processor’ means a processor as defined in Article 4, point (8), of Regulation (EU) 2016/679 of the European Parliament and of the Council;

Removed:Article 3 – paragraph 2 – point b a (new): (ba) additional data provided on a voluntary basis by Member States, national agencies, research institutes or other parties;

Removed:Article 3 – paragraph 2 – point b b (new): (bb) generated in the context of academic research activities in the sphere of chemicals not covered in point (b) and voluntarily submitted to ECHA by a third party;

Removed:Article 3 – paragraph 4 a (new): 4a. Each chemical or material hosted on the common data platform shall be identified by a unique chemical identifier and a chemical notation specifying its molecular structure without prejudice to any confidentiality requirements in the original act or related legal obligations.

Removed:Article 3 – paragraph 5 – point d a (new): (da) information on chemicals in articles as referred to in Article 10a;

Removed:Article 3 – paragraph 5 – point d b (new): (db) information on safer alternatives to substances of concern as referred to in Article 10b;

Removed:Article 3 – paragraph 6: 6. The Authorities and the general public shall have easy access, free of charge, to the data contained in the common data platform in accordance with Article 16.

Removed:Article 3 – paragraph 9: 9. 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 at stake for the storage of chemicals data in the common data platform. Security measures shall be adopted by the relevant Agencies in cooperation with the ECHA to ensure safe transmission of chemical data 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.

Removed:Article 3 – paragraph 11: 11. The common data platform and its dedicated services shall be established by ... [OP: please insert date: three years after the date of entry into force of this Regulation], unless specified otherwise, and shall at least include the datasets set out in Annex IIIa. Further relevant datasets shall be integrated progressively into the common data platform by [OP please insert date: eight years from the date of entry into force of this Regulation] according to the implementation plan referred to in Article 4 (1), first sentence. Upon integration of those datasets in the common data platform, when the ECHA receives chemicals data in accordance with Article 5, it shall make that data available through the common data platform within a period of 30 days.

Removed:Article 4 – paragraph 1: 1. By [OP please insert date: 6 months after the date of entry into force of this Regulation] the Commission shall adopt an implementation plan identifying datasets of chemicals data for inclusion in the common data platform together with a timeline for their inclusion by means of implementing acts. Subsequent rolling implementation plans shall be adopted in line with the governance scheme referred to in paragraph 3.

Removed:Article 4 – paragraph 2: 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 Union agency required to submit chemicals data to the Platform, and as many representatives from the Commission as from all those Union agencies combined.

Removed:Article 4 – paragraph 4: 4. The Commission shall adopt and publish the governance scheme referred to in paragraph 3 and any revision thereof by means of implementing acts. / While setting up the governance scheme, the Commission shall consult the Agencies and shall take into account the different level of responsibilities of the Authorities in the management and operation of the common data platform.

Removed:Article 4 – paragraph 5 – point d a (new): (da) the organisation and operation of the mechanisms for cooperation and information exchange with databases and similar platforms in third countries and internationally;

Removed:Article 4 – paragraph 5 – point f: (f) the operation, reporting requirements and transparency obligations of the steering committee itself.

Removed:Article 5 – paragraph 1: 1. At the Commission’s request, the Agencies shall host and maintain chemicals data generated as part of Union, national or international legislation, programmes or research activities, corresponding to their mandate and the type of data they already hold. In addition, Agencies may host and maintain chemicals data in accordance with their mandate and chemicals data submitted to them by Member States, national agencies, research institutes or other parties.

Removed:Article 5 – paragraph 2: 2. Where the Commission or the Agencies hold data or information referred to in Article 3(2), they shall make that data available to the ECHA, in a standard format, where available, together with the relevant context data as referred to in Article 4(5), point (c). The Commission and the Agencies shall indicate whether the data or information included in the common data platform can be made available to the public or whether it is or they are deemed confidential in accordance with the provisions on confidentiality under the originating Union act.

Removed:Article 5 – paragraph 3: 3. The ECHA shall host and maintain occurrence data related to workplace monitoring, including occupational human biomonitoring data.

Removed:Article 5 – paragraph 5: 5. Researchers or research consortia funded by national or Union framework programmes shall make available to the EEA any human biomonitoring data they collect or generate from [OP please insert: date of the entry into force of this Regulation]. For human biomonitoring data constituting personal data, the EEA shall specify which type of data are to be made available to it.

Removed:Article 5 – paragraph 6: 6. Researchers or research consortia funded by national or Union framework programmes shall make available to the ECHA any environmental sustainability data on chemicals or materials they collect or generate from [OP please insert: date of the entry into force of this Regulation + 6 months].

Removed:Article 5 – paragraph 7: 7. The Authorities and national agencies shall provide the necessary technical cooperation to the ECHA to enable the integration of the chemicals data provided in accordance with paragraph 2 in the common data platform as well as its publication through that platform. The ECHA shall provide support to the Authorities and national agencies to facilitate the integration of the chemicals data provided in accordance with paragraph 2.

Removed:Article 5 – paragraph 8: 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 undue delay once they have performed validity and confidentiality assessments of the data in accordance with applicable rules and once they have integrated the corresponding dataset in the common data platform.

Removed:Article 5 – paragraph 9: 9. The Authorities and national agencies shall ensure that data made available to the ECHA shall be downloadable, machine readable and interoperable. They shall appropriately curate and validate the data before providing them to the ECHA.

Removed:Article 5 – paragraph 9 a (new): 9a. Notwithstanding provisions related to processing of human biomonitoring data constituting personal data set out in Article 6, the Commission or Agency under whose authority chemicals data are included in the common data platform on chemicals shall remain the data controller with regard to the personal data it provided.

Removed:Article 5 – paragraph 9 b (new): 9b. Notwithstanding provisions related to processing of occupational human biomonitoring data constituting personal data set out in Article 6, the ECHA shall act as data processor for any personal data included in the common data platform falling under the Authority of another Agency or the Commission.

Removed:Article 6 – paragraph 1: 1. The EEA shall collect, host, and maintain human biomonitoring data generated within the territory of the EEA’s member and cooperating countries, with the exception of occupational human biomonitoring data in accordance with Article 5(3).

Removed:Article 6 – paragraph 3: deleted

Removed:Article 6 – paragraph 4 – introductory part: 4. The EEA may process human biomonitoring data constituting personal data for the following purposes:

Removed:Article 6 – paragraph 4 – point e: (e) supporting regulatory risk assessments and management.

Removed:Article 6 – paragraph 4 – point e a (new): (ea) supporting policy making and legislative processes at Union level;

Removed:Article 6 – paragraph 4 – point e b (new): (eb) the creation of a 'chemicals exposure index' for each region in the Union, to provide an overview of the population's exposure to chemical substances and facilitate comparisons between different regions, geographical areas and Member States;

Removed:Article 6 – paragraph 4 – point e c (new): (ec) facilitating the processing by the Commission, the ECHA, the EFSA, the EMA, and the EU-OSHA in accordance with paragraphs 4a, 4b, 4c, 4d and 4e of this Article.

Removed:Article 6 – paragraph 4 a (new): 4a. The Commission may process human biomonitoring data constituting personal data for the following purposes only: / (a) scientific research aimed at policy making; / (b) assessing the impact of chemicals on human health and the environment; / (c) monitoring time and spatial trends in exposure; / (d) developing health risk and impact indicators; / (e) monitoring the impact of regulatory intervention; / (f) assessing the need for further regulatory action and prioritising such action; / (g) supporting regulatory risk assessment and risk management.

Removed:Article 6 – paragraph 4 b (new): 4b. The ECHA may process human biomonitoring data included in occurrence data related to workplace monitoring and which constitute personal data for the following purposes: / (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 assessment and management; / (f) evaluating and prioritising required regulatory action; / (g) performing assessments of chemicals; / (h) as part of the commissioning of studies under the data generation mechanism referred to in Article 21.

Removed:Article 6 – paragraph 4 c (new): 4c. The EFSA may process human biomonitoring data constituting personal data for the following purposes only: / (a) evaluating and prioritising required regulatory action; / (b) performing assessments of chemicals; / (c) supporting regulatory risk management.

Removed:Article 6 – paragraph 4 d (new): 4d. The EMA may process human biomonitoring data constituting personal data for the following purposes only: / (a) evaluating and prioritising required regulatory action; / (b) performing assessments of chemicals; / (c) supporting regulatory risk management.

Removed:Article 6 – paragraph 4 e (new): 4e. The EU-OSHA may process human biomonitoring data constituting personal data for the following purposes only: / (a) scientific research aimed at policy making; / (b) assessing the impact of chemicals on human health and the environment; / (c) monitoring time and spatial trends in exposure; / (d) monitoring the impact of regulatory intervention; / (e) assessing the need for further regulatory action and prioritising such action; / (f) supporting regulatory risk management.

Removed:Article 6 – paragraph 5: 5. The EEA and ECHA shall make human biomonitoring data they hold or host publicly available in anonymised form through the Information Platform for Chemical Monitoring.

Removed:Article 6 – paragraph 5 a (new): 5a. Any processing of human biomonitoring data constituting personal data by the EEA, the ECHA, the EFSA, the EMA, the EU-OSHA, or the Commission for the purposes referred to in paragraphs 4, 4a, 4b, 4c, 4d, and 4e shall not entail the sharing of such data with third parties.

Removed:Article 6 – paragraph 6: 6. The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission shall act as data controller for the human biomonitoring data constituting personal data they hold or host or process for the purposes referred to in paragraphs 4, 4a, 4b, 4c, 4d and 4e.

Removed:Article 6 – paragraph 6 a (new): 6a. The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission shall define the storage period, and carry out any review thereof, for the human biomonitoring data constituting personal data that they hold as well as the criteria used to define the storage period.

Removed:Article 6 – paragraph 6 b (new): 6b. The human biomonitoring data referred to in this Article include personal data lawfully collected before the entry into force of this Regulation.

Removed:Article 8 – paragraph 4 – subparagraph 1 a (new): The ECHA shall include in the repository of reference values, without undue delay, any reference value generated as part of Union, national or international programmes or research activities and made available to ECHA in the standard formats as referred to in Article 14, where such a standard format has been developed.

Removed:Article 9 – paragraph 1 a (new): 1a. The ECHA shall establish and operate a mechanism for cooperation and exchange of information with relevant third countries’ authorities for the exchange of studies notified or submitted by business operators to those authorities to support an application, notification or regulatory dossier for a chemical by ... [OP please insert date: two years after the date of entry into force of this Regulation].

Removed:Article 9 – paragraph 2: 2. The ECHA shall store in the Database of Study Notifications the data notified to it in accordance with Article 22 and the data obtained through the mechanism referred to in paragraph 1a of this Article.

Removed:Article 9 – paragraph 3: 3. Data contained in the Database of Study Notifications shall be considered confidential and shall not be made public.

Removed:Article 9 – paragraph 4 a (new): 4a. Without prejudice to paragraph 4, 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 22, it shall indicate which elements of the study notifications are confidential when included in the common data platform. Only those elements shall be indicated as confidential where the same element is 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.

Removed:Article 9 – paragraph 4 b (new): 4b. 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 22, the ECHA shall make the related notification information available through the common data platform, in accordance with the provisions on confidentiality under the originating Union act.

Removed:Article 9 – paragraph 4 c (new): 4c. Authorities and national enforcement authorities shall have access to the data contained in the Database of Study Notifications before those data are integrated in the common data platform.

Removed:Article 10 – paragraph 1: 1. The ECHA shall establish and manage, as part of the common data platform, a new database containing information on regulatory processes 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 or the Union institutions, agencies or committees referred to in the Union acts listed in Annex III.

Removed:Article 10 – paragraph 2: 2. Where Member State competent authorities as referred to in any of the Union acts listed in Annex III hold the information referred to in paragraph 1, they shall make that information available to the Union agency responsible under the respective Union act listed in Annex III without undue delay. For each regulatory process or activity, at least the following information shall be included:

Removed:Article 10 – paragraph 2 – point a (new): (a) chemical identity;

Removed:Article 10 – paragraph 2 – point b (new): (b) the Union act and the regulatory process under which the activity takes place;

Removed:Article 10 – paragraph 2 – point c (new): (c) the submitter or actor responsible for the regulatory process or activity;

Removed:Article 10 – paragraph 2 – point d (new): (d) the status of the regulatory process or activity;

Removed:Article 10 – paragraph 2 – point e (new): (e) the outcome of the regulatory process or activity, including, where applicable, the reports or opinions adopted;

Removed:Article 10 – paragraph 2 – point f (new): (f) where applicable, the intended date for starting the regulatory process or activity, and the date of its completion and latest update;

Removed:Article 10 – paragraph 2 – point g (new): (g) where applicable, whether the process or activity includes the use of animals in testing and for which endpoints.

Removed:Article 10 – paragraph 3 – point a: (a) chemical identity;