What changed between the draft committee report and the plenary report

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.

Change 16

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.

Change 17

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.

Change 18

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.

Change 19

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].

Change 20

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.

Change 21

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

Change 22

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).

Change 23

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.

Change 24

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.

Change 25

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.