What changed between the plenary report and the adopted text

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.

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).

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.

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.

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.

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.

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

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).

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).

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

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;

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

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).

Article 16 – paragraph 1: 1. The Authorities shall have access to all the chemicals data contained in the common data platform, including data which is marked as confidential under Article 5(2), second sentence.

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.

Article 16 – paragraph 3: 3. The public shall have access to all the chemicals data contained in the common data platform except data which are marked to be confidential under Article 5(2).

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.

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.

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.

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.

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.

Article 18 – paragraph 2: 2. The framework of indicators referred to in paragraph 1, and the aggregated indicator referred to in paragraph 1a, shall be accessible in the form of an indicator dashboard, which the EEA shall establish and which the ECHA shall make available through the common data platform.

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

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;

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];

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

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

Article 19 – paragraph 3: 3. The ECHA, the EFSA, the EU-OSHA and the EMA shall identify and gather relevant available data on early warning signals obtained pursuant to this Regulation or from the field falling within their mandate and provide this data to the EEA.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

Article 22 – paragraph 2: 2. For the purposes of paragraph 1, business operators shall notify to the Database of Study Notifications referred to in Article 9 the following information: the identity of the chemicals concerned, 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.

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.

Article 22 – paragraph 4: 4. For the purposes of paragraph 3, 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.

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].

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.

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 types, subject to the outcome of the review in Article 26a(2).

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).

Article 25 – title: Enforcement and cooperation on compliance

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…

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)

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.

Annex II – Part 2 – 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.

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)

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. /…