What changed between the draft committee report and the plenary report

Changed:Article 13 – paragraph 26: a6. new:The 2a.Authorities Theand scopethe ofgeneral toxicologicalpublic andshall ecotoxicologicalhave studieseasy isaccess, limitedfree of charge, to thatthe performeddata contained in accordancethe withcommon thedata Goodplatform Laboratoryin Practiceaccordance Directivewith 2004/10/EC.Article 16.

Removed:The Notification of Studies (Article 22) will introduce a new obligation while the proposed obligation for notification of studies commissioned by the industry will create a significant administrative burden. This burden on both the business operators, labs and subsequently on the ECHA and enforcement authorities should not be underestimated, taking into account the large number and diversity of legislative acts included in Annex I (70 legislation), as well as the vast amount of studies, measurements and analyses performed on a daily basis. It must therefore be proportionately scoped and focused on studies with an added value to the risk or regulatory management of chemicals. The GLP Directive 2004/10/EC provides a good starting point of the suitable scoping.

Added: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 2 – paragraph 1 – point 2: 2. ‘Authorities’ means, when they are entrusted with regulatory tasks related to chemicals, the European Commission, the competent authorities of the Member States as referred to in any of the Union acts listed in Annexes I and III, and the Agencies, excluding their management boards;

Added: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:This provision is aligned with recital (12) and with article 17, paragraph 1.

Added: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 2 – paragraph 1 – point 3: 3. ‘duty holder’ means a natural or legal person other than the Authorities responsible for meeting obligations under the Union acts listed in Annex I or II;

Added: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:The proposed definition of ''duty holder'' by the European Commission seems to include ECHA and COM. Therefore, this amendment helps to clarify the reference in Article 17.2.

Added: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 2 – paragraph 1 – point 4: 4. ‘business operators’ means duty holders which are private or public undertakings excluding Member States and Agencies;

Added: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:This amendment to the legal act aims at clarifying the definition of ‘business operators’, while allowing a clear distinction between ‘business operators’ and ‘duty holder’.

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

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 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 availability and suitability of alternatives, standard formats, controlled vocabularies, or any information on applicable legal obligations related to chemicals and the enforcement thereof;

Added: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:This provision aims to clarify that data on alternatives fall into the scope of this Regulation. Besides, an important objective of the proposed regulation is to “improve the Union’s citizens’ trust in the scientific base for the decisions taken under Union legal acts on chemicals”. Lack of enforcement as regards eg. imported products is a concerning topic for the public. Hence, given the role of enforcement with a view to improving citizens’ trust, the common data platform should provide structured access to the enforcement activities at the European and national levels and their outcomes. In addition, greater visibility of enforcement activities would facilitate consistency in the enforcement approaches of Member States and promote a level playing field on the internal market. While the term “chemicals data” as proposed in Article 2(10) is rather inclusive, comprising both scientific facts and e.g. regulatory process-related information, it is not clear if this covers enforcement/compliance data. Therefore, it should be clarified that this type of information is included.

Added: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 2 – paragraph 1 – point 11 – introductory part: 11. ‘environmental sustainability related data’ means any data relevant for the environmental sustainability assessment of a chemical throughout its entire life cycle, including:

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

Removed:This provision aims at keeping the focus on chemicals since this is the object of the Common Data Platform on Chemicals.

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

Added: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:This provision amends the definition with the aim of taking into account the terms 'data processor'.

Added: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 2 – paragraph 15 a (new): 15a. ‘study’ means research commissioned or carried out by business operators to support an application, notification or regulatory dossier intended to be notified or submitted to an Authority to comply with regulatory requirements under the Union acts listed in Annex I.

Added: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:This suggested amendment is proposed for clarity purposes. This amendment helps in clarifying what 'study' means.

Added: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 2 – paragraph 15 b (new): 15b. ‘study summary’ means a summary as defined in Article 3(29) of the Regulation (EC) No 1907/2006 of the European Parliament and of the Council.

Added: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:Since not all sectorial legislations listed in Annex I have provisions on confidentiality or on the access of the public to studies, this suggested amendments aims at defining the terms ‘study summary’ to use this terminology in particular in article 9, paragraph 3.

Added: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 3 – paragraph 2 – point a: (a) generated and submitted as part of the implementation of the Union acts listed in Annex I to this Regulation and held by the Agencies or the Commission;

Added: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:This amendment intends to align article 3, paragraph 2, with recital (7).

Added:Article 6 – paragraph 3: deleted

Removed:Article 3 – paragraph 2 - point c a (new): ca. generated under Regulation (EU) 2024/1781 and accessible through the web portal under Article 14 of that regulation.

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

Removed:There is an urgent need to improve data availability concerning substances in products and their alternatives (see the new proposed recital under Justification 2). When the Commission developed the OSOA package, they did not consider integrating information from the Digital Product Passport under the ESPR, as this information is stored decentrally and thus, technically, not held by an Agency or the Commission. Article 14 ESPR was not foreseen in the ESPR proposal but added later in the legislative procedure. The web portal creates an opportunity to fill a data gap under OSOA.

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

Removed:Article 3 – paragraph 3 – introductory part: 3. Notwithstanding Article 3, paragraph 2, the following information shall not be included in the common data platform:

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

Removed:This amendment intends to clarify that only data and information that has to be submitted to Agencies or the Commission will be included in the Common Data Platform on Chemicals, in line with recital (31) which indicates that “it would be beyond the scope and aim of this Regulation to amend existing assessment processes set under those Union acts listed in Annex I by imposing additional conditions leading to potential market access consequences not foreseen in those Union acts”.

Added: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 3 – paragraph 5 – point d a (new): (da) information on substances in products and their alternatives referred to in Article 10a;

Added: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:To be aligned with the recital 17.

Added: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 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. The ECHA shall design the common data platform in a way that guarantees that any access to confidential data is auditable.

Added: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 3 – paragraph 10: 10. The Commission or Agency under whose authority chemicals data is included in the common data platform on chemicals shall remain the data controller with regard to the personal data it provided and shall also remain responsible for handling any requests for access to documents made under Regulation (EC) No 1049/200119.

Added: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:This provision aims to include specifications on 'data controllers' under the EU's Data Protection Regulation.

Added: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 3 – paragraph 10 a (new): 10a. 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.

Added: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:This provision aims at clarifying ECHA's role and responsibilities of each participating authority for any personal data in the platform as recommended by the EDPS.

Added: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 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. The relevant datasets, referred in the Union acts listed in Annexes I and II to this Regulation, shall be integrated progressively into the common data platform by [OP please insert date: ten 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 without undue delay.

Added: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:This amendment provides more clarity on which chemicals data shall be included in the common data platform on chemicals and the reasons why they should be included. Only data currently made public under their corresponding EU act should also be made public on the common data platform on chemicals.

Added: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 4 – paragraph 2: 2. The Commission shall, by means of an implementing decision, establish and manage a platform steering committee.

Added: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:For flexibility reasons, the composition can be dealt with an implementing decision.

Added: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 4 – paragraph 5 – introductory part: 5. That governance scheme shall take into account the extent of involvement of the different parties in the management and operation of the common data platform and shall describe:

Added:Article 8 – paragraph 4 – subparagraph 1 (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:Any governance scheme should as far as possible strive to take into account the extent of involvement of the different parties in the management and operation of the common data platform.

Added: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 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). / Data from different existing platforms both at EU and Member States’ level shall be aligned with ECHA’s database, and where it concerns similar information or data, the existing platforms shall stipulate that the data available on those platforms become merged and harmonised with the data available on the ECHA database. / The Commission and the Agencies shall indicate whether that data or information can be made available to the public or they are deemed confidential in accordance with the provisions on confidentiality under the originating Union act.

Added: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:Whilst the proposal includes provisions protecting the confidentiality of some data shared, they need to be strengthened to ensure that the protection of confidential data granted under each corresponding EU act is not undermined by this proposal. Furthermore, in case of conflict between the provisions on confidentiality of this proposal and those laid in corresponding EU acts, the latter should prevail. In addition, the provision intends to correct the references to Articles 3 and 4.

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

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.

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.

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.

Removed:Data on substances in products (mixtures and articles in terms of REACH) are covered by the term “chemicals data” as proposed in Article 2(10), and so are data on alternatives to targeted substances. However, such data are scattered across different regulatory procedures, including from different legislations (e.g. RoHS, REACH). The proposal does not provide for the structured access to these important items, thereby not allowing targeted retrieval of relevant and actionable information, across legislations and procedures (e.g. all products linked with a specific substance, alternatives discussed in relation to a specific substance or use).

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

Removed:This amendment to the legal act aims at keeping the focus on chemicals as per the Platform's objective.

Removed:Article 14 – paragraph 5 a (new): 5a. This paragraph shall not apply to the Union acts listed in Annex II.

Removed:According to the Staff Working Document accompanying the Proposal, this may gradually be imposed on applicants – increasing administrative burden. IUCLID isn’t suitable for human and animal medicines and therefore for the EMA. This requirement would therefore increase administrative burden on both industry and EMA. It should not apply to the Union acts listed in Annex II.

Removed:Article 14 – paragraph 6: 6. The Commission and the Agencies shall cooperate when setting standard formats to ensure coherence with other formats and the interoperability of the standard formats with the common data platform and with existing data submission approaches. They shall also consult stakeholders.

Removed:Standard data formats and controlled vocabularies must be developed in consultation with stakeholders and especially the industry, as in the longer term, the formats and vocabularies set by the Agencies will also be used for the submission of data by the duty holders under the individual pieces of legislation.

Removed:Article 14 – paragraph 7: 7. 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. Stakeholders shall be consulted to ensure duty holders contribute to ensure optimal operability. If a divergence 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 that 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 remedy the divergence.

Removed:Stakeholders should be consulted, because, in the longer term, the formats and vocabularies set by the Agencies will be used also for the submission of data by the duty holders under the individual pieces of legislation, therefore affecting different interested parties.

Removed:Article 15 – paragraph 5 – point a: (a) make them available free of charge through the common data platform in a way that supports their re-use;

Removed:The amendment aims at clarifying that these vocabularies should be freely available and open for re-use. Open data does not necessarily mean data free of IPR restrictions.

Removed:Article 15 – paragraph 6: 6. The Commission and the Agencies shall cooperate with each other in setting the controlled vocabularies and shall consult stakeholders.

Removed:Stakeholders should be consulted, because, in the longer term, the formats and vocabularies set by the Agencies will be used also for the submission of data by the duty holders under the individual pieces of legislation, therefore affecting different interested parties.

Removed:Article 15 – paragraph 7: 7. 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. Stakeholders shall be consulted to ensure duty holders contribute to ensure optimal operability. If a divergence 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 that 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 remedy the divergence.

Removed:Stakeholders should be consulted, because, in the longer term, the formats and vocabularies set by the Agencies will be used also for the submission of data by the duty holders under the individual pieces of legislation, therefore affecting different interested parties.

Removed:Article 15 – paragraph 8: 8. The Commission shall adopt an implementing decision to remedy the divergence in cases where it is not justified.

Removed:There might be decisions where divergences will be justified.

Removed:This provision aims at providing further legal clarity and predictability.

Added:Article 16 – paragraph 2: 2. The Authorities shall take the necessary measures, including security measures, to ensure that information contained in the common data platform marked as confidential in accordance with Article 5(2), is not made available to the public.

Changed:Article 16 – paragraph 2:3: 2.3. The Authoritiespublic shall take the necessary measures, including securityhave measures,access to ensureall thatthe informationchemicals data contained in the common data platform marked as confidential in accordance with Article 5(2),except isdata notwhich madeare availablemarked to the public in accordance with the provisions onbe confidentialityconfidential under the originating UnionArticle act.5(2).

Removed:Whilst the proposal includes provisions protecting the confidentiality of some data shared, they need to be strengthened to ensure that the protection of confidential data granted under each corresponding EU act is not undermined by this proposal. Furthermore, in case of conflict between the provisions on confidentiality of this proposal and those laid in corresponding EU acts, the latter should prevail.

Added:Article 17 – paragraph 1: 1. The Authorities may use the chemicals data contained in the common data platform or in the Database of Study Notifications in the performance of any of their activities, where those activities support the development, implementation or enforcement of legislation and policy.

Removed:Article 16 – paragraph 3: 3. The general public shall only have access to the chemicals data contained in the common data platform considered as available to the public in accordance with the originating Union act.

Added:Article 17 – paragraph 2: 2. Without prejudice to existing provisions enabling the sharing and use of chemicals data under the Union acts listed in Annexes I and II, and to the possibility of identifying data gaps in the applications received from business operators, Authorities shall not use chemicals data contained in the common data platform to fulfil any legal obligations of duty holders.

Removed:The use of the defined term 'originating Union act' aims to better clarify the relevant reference.

Added:Article 17 – paragraph 3 a (new): 3a. The common data platform shall also include terms and conditions, particularly regarding the respect of intellectual property rights and other related rights.

Removed:Article 17 – paragraph 1: 1. The Authorities may use the chemicals data contained in the common data platform in the performance of any of their activities, where those activities support the development, implementation or enforcement of legislation and policy, in full transparency and in accordance with the consultation procedures stipulated in the relevant legislation.

Added:Article 18 – paragraph 1: 1. The EEA, in collaboration with the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission, shall, in consultation with Member States, establish, operate, maintain and update as appropriate a framework of indicators to monitor chemical pollution throughout the chemical’s lifecycle, including emissions, occurrence and fate, to monitor the drivers and impacts of exposure to chemicals, and to measure the effectiveness of chemicals legislation and the transition towards the production of safe and sustainable chemicals.

Removed:Lack of enforcement is a concerning topic for the public. Hence, given the role of enforcement with a view to improving citizens’ trust, the common data platform should provide structured access to the enforcement activities at the European and national levels and their outcomes. In addition, greater visibility of enforcement activities would facilitate consistency in the enforcement approaches of Member States and promote a level playing field on the internal market. While the term “chemicals data” as proposed in Article 2(10) is rather inclusive, comprising both scientific facts and e.g. regulatory process-related information, it is not clear if this covers enforcement/compliance data. Therefore, it should be clarified that this type of information is included. In addition, when the authorities intend to re-use the data for the secondary purposes (Article 17), it should be conducted in an open and transparent manner and in accordance with the consultation procedure stipulated in the relevant legislation. Each study is performed under the specific requirements and objectives of the concerned legislation. The validity and extent of the reuse of study outcomes for other purposes than the original objective needs to be carefully considered by taking the substance identity and limitation of applicability of each study into account.

Added:Article 18 – paragraph 1 a (new): 1a. The framework of indicators referred to in paragraph 1 shall include an aggregated territory-based risk indicator at different administrative levels as defined in Regulation (EC) No 1059/2003 to monitor time and spatial trends in exposure of populations to individual and multiple chemicals and health risks associated with such exposure and co-exposure.

Changed:Article 1718 – paragraph 32: a2. (new):The 3a.framework Unlessof otherwiseindicators specifiedreferred to in theparagraph Union1, actsand listedthe inaggregated Annexindicator I,referred theto datain sharingparagraph and1a, datashall protectionbe rulesaccessible in Articlethe 25form of Regulation (EC) Noan 1907/2006indicator shalldashboard, applywhich tothe anyEEA studyshall summariesestablish orand robustwhich summariesthe ofECHA studiesshall mademake available through the common data platform.

Removed:Data protection aspects are not explicitly included in the proposed Regulation but are vital to protect investments in new data by economic actors. The amendment seeks to align requirements in this Regulation with standard practices for data protection enshrined in the REACH Regulation.

Added:Article 19 – paragraph 2 – subparagraph 1 – point b: (b) national early warning systems;

Removed:Article 17 – paragraph 3 b (new): 3b. It shall be clearly mentioned on the common data platform, in particular for the attention of the general public, that the data may be owned by third parties and that any use of the data without prior approval from the data owner might infringe their rights. The common data platform shall also include terms and conditions, particularly regarding intellectual property rights and other related rights.

Added:Article 19 – paragraph 2 – subparagraph 1 – point c: (c) data that the EEA holds, including data from human biomonitoring as referred to in Article 6, and data from the framework of indicators and the aggregated indicator as referred to in Article 18;

Removed:This provision aims at ensuring that the general public understands that some data may be protected by intellectual property rights.

Added:Article 19 – paragraph 2 – subparagraph 1 – point e a (new): (ea) relevant datasets from the EU Datasets Catalogue established by Article 57 of Regulation (EU) …/… of the European Parliament and of the Council on the European Health Data Space ... [OP: please add number and publication reference];

Removed:Article 18 – paragraph 1 a (new): 1a. Stakeholders shall be consulted to help avoid unnecessary duplication of studies, within the EEA or beyond.

Added:Article 19 – paragraph 2 – subparagraph 1 – point e b (new): (eb) relevant information resulting from national enforcement programmes;

Removed:The Framework of Indicators (Article 18) should involve the stakeholder consultation in the process. Before new scientific studies are undertaken, it is important that all relevant information is taken into consideration, including on the methodologies of the study and to avoid potential duplication of work.

Added:Article 19 – paragraph 2 – subparagraph 1 – point e c (new): (ec) relevant data or information submitted by researchers.

Removed:The EEA should develop guidance for identification of emerging chemicals risks in cooperation with all relevant parties, based on current ECHA stakeholder practices. To ensure sufficient time for such a guidance document to be developed, there is a need to reconsider the timeline currently proposed in Article 19(4).

Added:Article 19 – paragraph 4: 4. 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 ... [OP: please insert date: 6 months after the end of the first calendar year after entry into force of this Regulation]. The EEA shall present this report to the Commission, relevant Union agencies and Member State competent authorities for consideration of the need for regulatory or policy action related to the early warning signals. Within six months of the presentation of the report, the Authorities shall undertake regulatory, policy or enforcement actions accordingly or provide justification if they decide not to proceed with any action related to any of the early warning signals identified by the report, including an assessment of the possible consequences of non-action.

Removed:Article 19 – paragraph 5: 5. The EEA shall make data on early warning signals that it holds or hosts and that led to a positive identification of an emerging risk as well as the report referred to in paragraph 4 available to the ECHA for integration in the common data platform. Data that did not lead to a positive identification of an emerging risk as described in Article 19, paragraph 2, shall not be included in the common data platform.

Added:Article 19 – paragraph 4 a (new): 4a. Where the data analysis indicates there is a risk that warrants urgent action, the EEA shall inform the authorities without undue delay.

Removed:This provision aims at ensuring that data is assessed or complemented with scientific evidence before being listed publicly in the Common Data Platform on Chemicals as early warnings to avoid confusion among the users.

Added:Article 19 – paragraph 5: 5. 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 integration in the common data platform.

Removed:Article 21 – paragraph 1: 1. Using the best resources available, the ECHA may commission scientific studies to support the implementation of Union acts on chemicals listed in Annex I within its mandate and to contribute to the support, evaluation or development of a Union chemicals policy.

Added:Article 19 – paragraph 5 a (new): 5a. The Commission shall take into account, where relevant, the emerging chemical risks identified, in accordance with this Article, in the strategic planning of R&I activities of Regulation (EU) 2021/6951a. / 1a Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013.

Removed:Article 21 – paragraph 2: 2. The Commission may request the ECHA to commission the scientific studies referred to in paragraph 1 and Article 20(4), point (b), of this Regulation.

Added:Article 20 – paragraph 1: 1. The ECHA shall establish, operate and maintain an observatory for specific chemicals or groups of chemicals that the Commission considers as requiring additional scrutiny. The observatory shall include reliable information on the chemicals’ properties, safety aspects, uses and market presence.

Removed:This amendment provides a better clarification.

Added:Article 20 – paragraph 2: 2. By ... [OP please insert date: 6 months after the date of entry into force of this Regulation] the Commission shall adopt and publish a list of the selected chemicals by means of an implementing act. The Commission shall review the list of selected chemicals regularly adopt any revision thereof by the same means.

Removed:Article 21 – paragraph 3: 3. The ECHA shall only commission scientific studies when results cannot be obtained through existing legal provisions or processes under Union legislation listed in Annex I. It shall not commission studies with a predominant research objective. Stakeholders shall be consulted in order to avoid unnecessary duplication of studies.

Added:Article 20 – paragraph 4 – point c: (c) make compiled data publicly available 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, to facilitate informed societal discussion and increase public awareness on the properties, use and safety aspects of specific chemicals, and regularly update that information.

Removed:The Data Generation Mechanism (Article 21) should involve the stakeholder consultation in the process. Before new scientific studies are undertaken, it is important that all relevant information is taken into consideration, including on the methodologies of the study and to avoid potential duplication of work.

Added:Article 21 – paragraph 1: 1. Using the best independent resources available, the ECHA may commission scientific studies to: / (a) support the implementation of Union acts on chemicals or groups of chemicals listed in Annex I within its mandate and to contribute to the support, evaluation or development of a Union chemicals policy; / (b) investigate further emerging chemical risks identified in the report referred to in Article 19(4) of this Regulation; / (c) conduct a Union-wide data sampling survey of human biomonitoring in collaboration with Member States.

Removed:Article 22 – paragraph 1: 1. Business operators shall notify to the Database of Study Notifications referred to in Article 9, within three months of the date of the commissioning, information referred to in paragraph 2 related to studies on chemicals they commission to support an application, notification or regulatory dossier notified or submitted to an Authority, under the Union acts listed in Annex I and where handling or holding of data is under the responsibility of EFSA and ECHA. / However, business operators shall not notify to the Database of Study Notifications referred to in Article 9 / (a) in case of studies that are to be notified under Article 32b of Regulation (EC) No 178/2002; / (b) when a valid justification for late or non-notification is provided by business operators. / The assessment of the validity of justifications for non-notifications shall be done by ECHA / (c) in case of studies under Articles 40, 41 and 46 of Regulation (EC) No 1907/2006 (REACH). They shall be excluded from the notification requirement, given that such studies are carried out in response to a request from the authority.

Added:Article 21 – paragraph 2: 2. The Commission may request the ECHA to commission the scientific studies referred to in paragraph 1 and Article 20(4), point (b), of this Regulation. Member States may request the Commission to request the ECHA to commission such scientific studies.

Removed:The notification mechanism should be related to Annex I Union acts implemented only by EFSA and ECHA. Similarly to the EFSA Transparency Regulation (Article 32b), the possibility to submit late notifications or non-notification of studies must be included in Article 22 of the proposal, where valid justification is provided. The assessment of the validity of any justifications will be done by ECHA (as EFSA already does pursuant to Article 21 of the EFSA Practical Arrangements, taking into consideration all relevant factual elements as well as any additional elements of justification or clarification).

Added:Article 21 – paragraph 3: 3. The ECHA shall only commission scientific studies when results cannot be obtained through existing legal provisions or processes under Union legislation listed in Annex I. It shall give priority to the use of non-animal methods, with animal testing on vertebrate animals used only as a last resort. It shall not commission studies with a predominant research objective. / ECHA shall consult the chemical data platform in order to avoid unnecessary duplication of studies.

Removed:In addition, to ensure proportionality and feasibility of the proposed Regulation, this provision seeks to link notification requirements to studies commissioned solely in the context of specific EU regulations.

Added:Article 21 – paragraph 3 a (new): 3a. The ECHA may request from a business operator a sample of a substance, where such sample is indispensable to perform the scientific study referred to in paragraph 1. The request shall be duly justified and any handling of the substance shall be in accordance with applicable confidentiality and data protection rules under relevant Union law. The relevant business operator shall, upon a request from the ECHA, provide the requested sample to the ECHA or to any body commissioned by the ECHA to perform the scientific study.

Removed:Prior to commissioning the studies, a testing proposal is submitted by the registrants to the authority, which already serves the objectives (see Recital 28) of the Article. Double notifications therefore need to be avoided to prevent increased administrative burdens. If necessary, the authorities who receive the relevant testing proposal should notify the studies to the database.

Added:Article 21 – paragraph 5: The ECHA shall publish, on its website, the proposal for the study it intends to commission.

Removed:Article 22 – paragraph 2: 2. For the purposes of paragraph 1, information to be notified by business operators to the Database of Study Notifications referred to in Article 9 shall be limited to the title, scope, 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. For medicinal products, notification is only required after the market authorisation application has been submitted.

Added:Article 21 – paragraph 6 a (new): 6a. Without prejudice to the obligation on applicants to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances of serious controversies or conflicting results, may request the ECHA to commission scientific studies with the objective of verifying evidence used in its hazard and risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification.

Removed:To ensure proportionality and feasibility of the proposed Regulation, this amendment seeks to define more clearly the boundaries of the information in scope of each notification. In addition, there is concern that the study notification obligation will result in the disclosure of business sensitive information and therefore, it is essential that confidentiality is protected for business operators and laboratories including information on laboratory or testing facility carrying out any studies, and the intended starting and completion dates.

Added:Article 21 – paragraph 6 b (new): 6b. Every five years, the ECHA, in cooperation with the EFSA, shall commission a Union-wide human biomonitoring study that covers all Member States.

Removed:Article 22 – paragraph 2 a (new): 2a. For the purpose of paragraphs 1 and 2, business operators may claim part of the information in paragraph 2 is confidential in accordance with the provisions on confidentiality under the originating Union act.

Added:Article 21 – paragraph 6 c (new): 6c. Member States shall cooperate with and support the ECHA and EFSA in the organisation of any human biomonitoring study within their territories, to ensure sampling and collection of the data, and adequate representativeness and quality of the data. The human biomonitoring studies shall adhere to ethical and confidentiality standards.

Removed:Sensitive data (e.g., for research and development, data sensitive under competition law, commercially valuable information) or confidential business information should be protected and excluded from the mandatory notification system. It is essential to maintain the protection of information as well as safeguard intellectual property rights. Data should be protected by the confidentiality as marked by the originator and not be disclosed to the public. No fee should be requested for the confidentiality claims, as fees were already paid by the business operator under the originating act, e.g. REACH.

Added:Article 22 – paragraph 1: 1. Business operators shall notify to the Database of Study Notifications referred to in Article 9, without delay, any information referred to in paragraph 2 related to any studies that generate data on chemicals which 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 they commission as part of a risk or safety assessment, under the Union acts listed in Annex I. / Business operators shall not notify to the Database of Study Notifications referred to in Article 9: / (a) in the case of studies that are to be notified under Article 32b of Regulation (EC) No 178/2002; / (b) scientific studies conducted only for research purposes that are not commissioned to support an application, notification or regulatory dossier notified or submitted to an Authority, or that are not part of a risk or safety assessment under the Union acts listed in Annex I. / Business operators shall provide a valid justification for the late notification of studies in accordance with this paragraph.

Changed:Article 22 – paragraph 3:2: 3.2. LaboratoriesFor andthe testingpurposes facilitiesof shallparagraph also,1, withinbusiness threeoperators monthsshall ofnotify to the dateDatabase of the commissioning, notifyStudy informationNotifications referred to in paragraph 2 related to studies commissioned by business operators to supportArticle a9 regulatorythe dossier,following underinformation: the Union actsidentity listedof inthe Annexchemicals Iconcerned, andtitle, wherescope, handlinglaboratory, or holding oftesting datafacility iscarrying underout the responsibility of EFSA andstudy, ECHA.the However,intended laboratoriesstarting and testingplanned facilitiescompletion shalldates, notand, notifywhere torelevant, whether the Databasestudy ofis Studycommissioned Notificationsto referredcomply towith ina Articledecision 9of studiesthe thatECHA arepursuant to beArticles notified40, under41 Articleor 32b46 of Regulation (EC) No 178/2002. The confidentiality of information on laboratories and testing facilities shall be respected.1907/2006.

Removed:The reference to 'which an Agency is required to provide a scientific input' is unclear and may trigger confusion for duty holders. In addition, the other amendments to the legal act help clarifying that it will not be the studies as such to be notified, but well the information listed in article 22, paragraph 2, in line with the scope of the proposal. To achieve the objective of transparency pursued by the proposal, it would be important to keep a proportionate level of studies notification.

Added:Article 22 – paragraph 3: 3. Laboratories and testing facilities shall also, without delay, notify any information referred to in paragraph 2 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 acts listed in Annex I. However, laboratories and testing facilities shall not notify to the Database of Study Notifications referred to in Article 9 studies that are to be notified under Article 32b of Regulation (EC) No 178/2002.

Changed:Article 22 – paragraph 4: 4. For the purposes of paragraph 3, information to be notified by laboratories and testing facilities shall notify to the Database of Study Notifications referred to in Article 9 the following information: the identity of the chemicals concerned, title, scope, intended starting and planned completion dates of any test they carry out, as well as the name of the business operator who commissioned the test.

Removed:To ensure proportionality and feasibility of the proposed Regulation, this provision seeks to define more clearly the boundaries of the information in scope of each notification.

Added:Article 22 – paragraph 6: 6. The obligations set under this article shall apply from [OP please insert date: 18 months after the date of entry into force of this Regulation].

Changed:Article 22 – paragraph 7: 7. The ECHA, in close cooperation with the EFSA and in consultation with stakeholders, shall lay down the practical arrangements for implementing the provisions of this Article.

Changed:Article 23 – paragraph 2: 2. The Commission is empowered to adopt delegated acts in accordance with Article 24 to amend Annex II by extending it to additional active substances, and by adding new categories of data typestypes, whilesubject respectingto the confidentialityoutcome of certainthe data.review in Article 26a(2).

Removed:Whilst there is the inclusion of some provisions on the protection of confidential information in the proposal, these provisions need to be strengthened to ensure that the protection of confidential information afforded under the applicable sector-specific legislation is not undermined.

Added:Article 24 a (new): Article 24a / Committee procedure / 1. The Commission shall be assisted by a Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/20111a. / 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. / 1a Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

Removed:Annex I – point 9: deleted

Added:Article 25 – title: Enforcement and cooperation on compliance

Removed:This regulation aims to bring together all data related to chemicals into on common data platform, therefore it is unclear why Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms is listed in Annex 1, as this legislation doesn’t cover chemicals but organisms.

Added:Article 26 a (new): Article 26a / Reports and review / 1. No later than … [OP: please insert 18 months after the entry into force of this Regulation], the Commission shall assess the workload and further needs of the Agencies, stemming from the additional tasks related to the inclusion of information on substances in products and information on alternatives, and the inclusion of information on medicinal products resulting from procedures concluded before the entry into force of this Regulation, and where appropriate, provide it with adequate further resources. / 2. No later than ... [OP: please insert the date: 4 years after the entry into force of this Regulation], the Commission shall assess the costs and benefits of extending the common data platform to additional medicinal active substances and of adding new categories of data types. / 3. No later than ... [OP: please insert the date: 4 years after the entry into force of this Regulation], the Commission shall assess the feasibility, in collaboration with scientific and academic publishers, of harmonised reporting and of enabling the integration of relevant contents from scientific journals and publications into the common data platform, in order to increase further the uptake of research data into the hazard and risk assessment of chemicals. / 4. No later than … [OP: please insert 4 years after the entry into force of this Regulation], the Commission shall report on the resources needed to address key areas of regulatory challenge. The Comm…

Removed:Annex I – point 65: deleted

Added:Annex I – point 70 a (new): 70a. Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC (OJ L, 2024/1781, 28.6.2024)

Removed:Regulation 2019/4 concerns a specific route of administration for products authorised by the EMA under (EU) 2019/6. No data is generated under 2019/4. Therefore, this regulation should not be included in Annexes 1 and 3.

Added:Annex II – Part 1 – subparagraph 2: These data shall be limited to data related to chemicals and materials used in medicinal products and submitted to the EMA in the context of the relevant procedures that are concluded after the date of entry into force of this Regulation. No later than ... [OP please insert date: eight years after the date of entry into force of this Regulation], the data held by the EMA resulting from procedures concluded before the entry into force of this Regulation shall be included into the common data platform.

Changed:Annex II – Part 12 – paragraphsubparagraph 2: These data shall be limited to data related to chemicals and materials used in pharmaceuticalsmedicinal products and submitted to the EMA in the context of the relevant procedures that are concluded after the date of entry into force of this Regulation. WhereNo relevant,later than ... [OP please insert date: eight years after the date of entry into force of this Regulation], the data held by the EMA resulting from procedures concluded before the entry into force of this Regulation may alsoshall be considered for inclusionincluded into the common data platform.

Removed:In the context of medicinal products, it appears that all products covered by Regulation 2019/6 shall comply with this draft Regulation, however, some medicines such as immunologicals (e.g. vaccines) don’t use chemicals, but organisms. This is beyond the scope of the Common Data Platform and therefore represent disproportionate administrative burden for these products.

Added:Annex III – point 34 a (new): 34a. Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC (OJ L, 2024/1781, 28.6.2024)

Removed:Annex II – Part 2 – paragraph 2: These data shall be limited to data related to chemicals used in pharmaceuticals and submitted to the EMA in the context of the relevant procedures that are concluded after the date of entry into force of this Regulation. Where relevant, data held by the EMA resulting from procedures concluded before the date of entry into force of this Regulation shall also be considered for inclusion into the common data platform.

Added:Annex III a (new): ANNEX IIIa / Datasets to be included at the date of establishment of the common data platform referred to in Article 3 / ECHA REACH: REACH registrations including Chemical Safety Reports (CSR). / ECHA Classification, Labelling and Packaging (CLP): classification and labelling (C&L) inventory. / ECHA Biocidal Products Regulation (BPR): biocidal active substance approval process data. / ECHA Prior Informed Consent (PIC): data on substances subject to PIC the Regulation. / ECHA Persistent Organic Pollutants (POP): (1) List of POPs; (2) List of substances proposed to be included in the POP list of the Stockholm Convention. / ECHA SCIP database: information on Substances of very high concern in articles as such or in complex objects (products) established under the Waste Framework Directive (WFD). / Commission data from the Digital Product Passport Webportal: information on substances of concern present in products · / EFSA OpenFoodTox: summary of all EFSA chemical risk assessments including chemical identifiers, critical endpoints, toxicological reference values and metadata from EFSA outputs. / EFSA Chemical Monitoring Data: chemical monitoring data for pesticides and veterinary medicinal product residues and contaminants data. The individual measurements of chemicals in food/feed and other materials sampled as part of official controls and enforcement activities. Measurements of chemicals in food and feed received from industry or other sources in response to a call for data. /…

Removed:To be in consistency with Annex II, Part 1, paragraph 1.

Removed:Annex III – point 31: deleted

Removed:Regulation 2019/4 is a regulation about a specific route of administration for products authorised by the EMA under (EU) 2019/6. No data is generated under 2019/4. Therefore, this regulation should not be included in Annexes 1 and 3.

Removed:Stakeholder engagement on the practical arrangements for implementing the provisions of this new obligation must be ensured, similarly to the interactions of EFSA with stakeholders during the implementation phase of the Transparency Regulation.

Added:Chapter VIII – title: DELEGATED POWERS AND COMMITTEE PROCEDURE

Changed:Article 19 – paragraph 3: 3. The ECHA, the EFSA, the EU-OSHA and the EMA shall identify and gather relevant available data obtained through theon early warning signals systemobtained establishedpursuant byto this Regulation or from the field falling within their mandate and provide this data to the EEA. The EEA shall develop guidance for identification of emerging chemicals risks in cooperation with ECHA, the EFSA, the EU-OSHA and the EMA and other relevant parties.