What changed between the draft committee report and the plenary report

Removed:Under OSOA, ECHA has the mandate to create a database covering all sectors of the chemical industry. At the same time, the EFSA and the Commission have a mandate to create a database on co-formulants in plant protection products as there is currently a lack of a single database for co-formulants. There should be clear communication between ECHA, EFSA and the Member States in order to align on the use of the ECHA database and avoid multiple and potentially diverging data being available on the different platforms existing both at the EU and MS level.

Added: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 5 – paragraph 3: Occurrence data related to workplace monitoring may include human biomonitoring data. Human biomonitoring data constituting personal data may be processed by the ECHA 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 assessments; / The ECHA shall make any human biomonitoring data they hold publicly available in anonymised form through the Common data platform.

Added: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:Workplace monitoring data can include human biomonitoring data (HBMD) as well. To account for the need for a specific legal basis for processing such data, this provision mirrors the provision setting this out for EEA with regard to the HBMD they will hold.

Added: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.

Change 7

Changed:Article 510 – paragraph 51: –1. subparagraphThe 1ECHA ashall (new):establish Memberand Statesmanage, shallas requirepart researchersof orthe researchcommon consortiadata fundedplatform, bya nationalnew programmesdatabase tocontaining makeinformation availableon toregulatory theprocesses EEAon anyindividual humanchemicals biomonitoringor datagroups theyof collectchemicals orthat generateare fromplanned, [OPongoing pleaseor insert:have datebeen ofcompleted since the entry into force of this Regulation +by 6the months].Member States or the Union institutions, agencies or committees referred to in the Union acts listed in Annex III.

Change 8

Removed:Considering the regulation’s objectives, including enhancing trust and widening the scientific base of chemical policies, the proposal does not fully exploit available scientific resources, notably the valuable insights from independent research (e.g. peer-reviewed studies from academia, but is limited to Union research in certain areas (eg. sustainability). In line with the Chemicals Strategy for Sustainability commitment to “establish tools and practices to ensure that relevant academic data is easily and readily accessible for safety assessments and is suitable for regulatory purposes” (p.17), it is suggested to widen the scope of research uptake to all research generating chemicals data and originating from national funding.

Added: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 5 – paragraph 6: 6. Researchers or research consortia funded by Union framework programmes shall make available to the ECHA any chemical data other than biomonitoring data, including environmental sustainability data on chemicals or materials they collect or generate from [OP please insert: date of the entry into force of this Regulation].

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

Removed:Alignment with the article 5.5 and its justification.

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

Removed:Article 5 – paragraph 6 – subparagraph 1 a (new): Member States shall require researchers or research consortia funded by national programmes, to make available to the ECHA any chemicals data other than biomonitoring data, including 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].

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

Removed:Alignment with the article 5.5 and its justification.

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

Removed:Article 5 – paragraph 8: 8. For the purpose of paragraph 2, the Commission and the Agencies shall make chemicals data available to the ECHA without undue delay after collection or receipt of the data submitted by duty holders in accordance with the implementation of Union acts listed in Annex I, after performance of validity and confidentiality assessments in accordance with applicable rules and once the corresponding dataset has been integrated in the common data platform.

Added: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:This provision aims at clarifying which data has to be made available to ECHA.

Added: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 8 – paragraph 2: 2. Once notified by the Authority responsible, the ECHA shall include any reference value adopted under Union acts listed in Annex I or Annex II, Part 1, in the repository of reference values without undue delay.

Added: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:This provision intends to clarify the misconception that ECHA should have the responsibility to proactively seek any reference value that is published.

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

Removed:Article 8 – paragraph 4 – subparagraph 1 a (new): The ECHA shall include in the repository of reference values 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.

Added:Article 10 – paragraph 3 – point f a (new): (fa) where applicable, whether the process or activity includes the use of animals in testing and for which endpoints.

Removed:Considering the regulation’s objectives, including enhancing trust and widening the scientific base of chemical policies, the proposal does not fully exploit available scientific resources, notably the valuable insights from independent research (e.g. peer-reviewed studies from academia, but is limited to Union research in certain areas (eg. sustainability). In line with the Chemicals Strategy for Sustainability commitment to “establish tools and practices to ensure that relevant academic data is easily and readily accessible for safety assessments and is suitable for regulatory purposes” (p.17), it is suggested to widen the scope of research uptake to all research generating chemicals data and originating from national funding.

Added:Article 10 – paragraph 4: 4. The information referred to in paragraph 3, points (a) to (fa), on a specific regulatory process or activity shall be made available to the public without undue delay.

Removed:Article 9 – paragraph 3: 3. The ECHA shall integrate the data contained in the Database of Study Notifications in the common data platform once a corresponding registration, application, notification or other relevant regulatory dossier was submitted to the relevant Union or national institution, agency, or body in accordance with corresponding Union law and after a decision was taken by that Union or national institution, agency, or body on the disclosure of the accompanying studies summaries in accordance with the applicable rules on confidentiality.

Added:Article 10 a (new): Article 10a / Information on chemicals in articles / 1. The ECHA shall establish and manage, as part of the common data platform, a database containing information on chemicals in articles generated or submitted as part of the implementation of Union chemicals legislation listed in Annex I. / That database shall integrate the information required under Article 9(1)(i) of Directive 2008/98/EC and to Article 14 of Regulation (EU) 2024/1781. / The Commission shall design relevant related database functionalities. / 2. Where Member State competent authorities as referred to in any of the Union acts listed in Annex I 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 I without undue delay. / 3. Where the ECHA, EEA, EFSA, EU-OSHA or the Commission hold the information referred to in paragraph 1, they shall make that information available to the ECHA for integration in the common data platform in the standard formats provided for in Article 14 without undue delay and, where relevant, once the responsible agency or the Commission has performed the validity assessment.

Removed:This provision aims at limiting the disclosing of studies to 'study summary’, with due respect to the protection of intellectual property rights of studies.

Added:Article 10 b (new): Article 10b / Information on safer alternatives to substances of concern / 1. The ECHA shall establish and manage, as part of the common data platform, a database containing information on safer alternatives to substances of concern as defined in Article 2(27) of Regulation (EU) 2024/1781 as well as substances that meet the criteria for classification in hazard classes referred to in Article 2(27)(b) of Regulation (EU) 2024/1781, including on materials not requiring such substances. The Commission shall design relevant related database functionalities. / 2. Where Member State competent authorities as referred to in any of the Union acts listed in Annex I 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 I without undue delay. / 3. Where the ECHA, EEA, EFSA, EU-OSHA or the Commission hold the information referred to in paragraph 1, they shall make that information available to the ECHA for integration in the common data platform in the standard formats provided for in Article 14 without undue delay and, where relevant, once the responsible agency or the Commission has performed the validity assessment. / 4. The ECHA shall encourage providers of safer alternatives to substances of concern, or of materials not requiring such substances, to identify them and to provide all relevant data.

Removed:Article 10 – paragraph 3 – introductory part: 3. Where the ECHA, EEA, EFSA, EU-OSHA or the Commission hold the information referred to in paragraph 1, they shall make that information available to the ECHA for integration in the common data platform in the standard formats provided for in Article 14 without undue delay and, where relevant, once the responsible agency or the Commission has performed the validity assessment.

Added:Article 11 – paragraph 2: 2. The ECHA shall update the information in the database on a regular basis, and at least annually, and in accordance with the governance scheme referred to in Article 4(3).

Removed:The data to be included will be determined by the format to be defined.

Added:Article 13 – paragraph 1: 1. At the latest within three years after the identification of datasets and design of database functionalities referred to in paragraph 4, the ECHA shall establish and manage, as part of the common data platform, a database containing environmental sustainability related data.

Removed:Article 10 – paragraph 3 – point a: deleted

Added:Article 13 – paragraph 2: 2. Where Authorities or national agencies host or hold environmental sustainability related data in addition to the chemicals data already available in the common data platform, they shall make that data available to the ECHA without undue delay once the Authority or national agency hosting or holding that data has completed, where relevant, validity and confidentiality assessments. Authorities and national agencies shall provide the necessary technical cooperation to the ECHA to enable the integration of environmental sustainability related data in the database on environmental sustainability related data. The ECHA shall provide the necessary support to the Authorities and national agencies to facilitate the integration of those data.

Removed:The data to be included will be determined by the format to be defined.

Added:Article 13 – paragraph 3: 3. Where researchers or research consortia funded by Union framework and national programmes make available to the ECHA, under Article 5(6), any environmental sustainability data on chemicals or materials they collect or generate, the ECHA shall integrate the relevant data in the database on environmental sustainability related data.

Removed:Article 10 – paragraph 3 – point b: deleted

Added:Article 13 – paragraph 4: 4. By ... [OP please insert date: three years after the date of entry into force of this Regulation], the Commission shall, in consultation with the Member States, identify existing datasets on environmental sustainability related data, other than those referred to in paragraph 2, for inclusion in the common data platform, request the ECHA to host and maintain them in accordance with Article 5(1) and shall design relevant related database functionalities.

Removed:The data to be included will be determined by the format to be defined.

Added:Article 14 – paragraph 4: 4. The Authorities or national agencies shall exchange data contained in the common data platform in the relevant standard format.

Removed:Article 10 – paragraph 3 – point c: deleted

Added:Article 14 – paragraph 5 – point i a (new): (ia) Regulation (EC) No 1107/2009 of the European Parliament and of the Council1a. / 1a Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

Removed:The data to be included will be determined by the format to be defined.

Added:Article 14 – paragraph 5 – point i b (new): (ib) Regulation (EC) No 396/2005 of the European Parliament and of the Council1b / 1b Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).

Removed:Article 10 – paragraph 3 – point d: deleted

Added:Article 14 – paragraph 8: 8. The Commission shall adopt an implementing act to remedy the divergence

Removed:The data to be included will be determined by the format to be defined.

Added:Article 15 – paragraph 5 – point a: (a) make them available free of charge through the common data platform as open datasets, supporting their re-use;

Removed:Article 10 – paragraph 3 – point e: deleted

Added:Article 15 – paragraph 8: 8. The Commission shall adopt an implementing act to remedy the divergence

Removed:The data to be included will be determined by the format to be defined.

Added:Article 15 a (new): Article 15a / Uptake of research data / 1. Researchers shall be able to submit publicly available research data on chemicals related to an entry in the common data platform. Research data shall be submitted in a format prescribed by the ECHA. / 2. By ... [OP: insert 18 months after the entry into force of this Regulation], the ECHA shall establish and maintain an online platform for the submission process referred to in paragraph 1. / 3. The ECHA shall assess the compliance of research data submitted through the portal referred to in paragraph 2 with the requirements set in the guidance referred to in paragraph 4. Where research data submitted are deemed to fulfil these requirements, the data shall be hosted on the common data platform together with the corresponding entry. / 4. By ... [OP: insert 12 months after the entry into force of this Regulation], the Commission shall publish guidance setting minimum quality and reporting requirements to improve the uptake of research data. / 5. In order to ensure that the research data are submitted in a uniform format, the Commission shall, by means of implementing acts, adopt a standard format for the submission of research data. / Those implementing acts shall be adopted by ... [OP: please insert the date = 12 months after the entry into force of this Regulation], in accordance with the examination procedure referred to in Article 24a(2).

Removed:Article 10 – paragraph 3 – point f: deleted

Removed:The data to be included will be determined by the format to be defined.

Removed:Article 10 a (new): Article 10a / Information on substances in articles and their alternatives / 1. The ECHA shall integrate, as part of the common data platform, a new database containing information on substances in articles and their alternatives generated or submitted as part of the implementation of Union chemicals legislation listed in Annex I. / This database shall integrate the information subject to paragraph 2 of Article 3, point (ca). / 2. Where Member State competent authorities as referred to in any of the Union acts listed in Annex I 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 I without undue delay. / 3. Where the ECHA, EEA, EFSA, EU-OSHA or the Commission hold the information referred to in paragraph 1, they shall make that information available to the ECHA for integration in the common data platform in the standard formats provided for in Article 14 without undue delay and, where relevant, once the responsible agency or the Commission has performed the validity assessment. / 4. The ECHA shall encourage providers of alternatives to identify them.