What changed between the draft committee report and the plenary report

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.