What changed between the draft committee report and the plenary report

Added:Recital 36 a (new): (36a) There are data gaps on the occurrence of hazardous and other harmful chemicals in articles on the Union market. In order to enhance visibility on the availability of data, and to promote research and development activities as regards safer alternatives, as well as the uptake of such alternatives, ECHA should establish and manage a repository of information on chemicals in articles generated or submitted under Union acts listed in Annex I. This database should integrate the information required under Article 9(1)(i) of Directive 2008/98/EC and the web portal under Article 14 of Regulation (EU) 2024/178. In addition, ECHA should also establish and manage a database collecting available information from Agencies, Member States and business operators 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.

Removed:Other agencies, and most importantly the EMA, should be included in the processing of human biomonitoring data, and health data. The EMA would then be able to provide the necessary context around certain data, when relevant.

Added:Recital 38: (38) In order to ensure chemicals data are easily findable within the database and to avoid duplicates, each chemical contained in the common data platform should be identified by a unique chemical identifier and a chemical notation specifying its molecular structure. In order to ensure the interoperability and comparability of chemicals data and to facilitate their automatic and electronic exchange, the Agencies and the Commission should store chemicals data in adequate and mutually coherent and interoperable formats and use mutually coherent and interoperable controlled vocabularies. Some Union acts listed in Annex I or II set procedures to establish or make available data formats, in particular for the submission of chemicals data by business operators or Member States. Where such procedures do not exist in the Union acts listed in Annex I or II, the Agencies and the Commission should, where relevant, specify appropriate formats for chemicals data they receive and store, avoiding the use of proprietary standards while, as appropriate, using OECD or other internationally agreed formats, making use of existing formats and ensuring interoperability with existing data submission approaches. When specifying such formats and controlled vocabularies, the Agencies and Commission should, where relevant, take into account input and contributions from Member States and stakeholders.

Removed:Recital 27: (27) In order to increase transparency of reference values among risk assessors and risk managers across different Union acts and to facilitate compliance with, and enforcement of, regulatory reference values, the ECHA should establish and maintain a repository of reference values established or adopted under the Union acts listed in Annexes I and II The Agencies should provide the ECHA with reference values they hold or establish as part of their activities. In addition, the ECHA should regularly screen Union acts for reference values adopted under them. To facilitate automatic access of the general public to up-to-date reference values, the ECHA should integrate the repository of reference values in the common data platform as a dedicated service, include in that repository all reference values together with the relevant context data it has received or retrieved and ensure that those values and that context data are machine readable.

Added:Recital 41 a (new): (41a) Independent research studies are often given comparatively low weight as evidence in hazard and risk assessment of chemicals, thus creating a gap between independent research and chemicals regulation and policy. It is necessary to provide structure and transparency in the evaluation of research data in order to increase their use in regulatory assessment of chemicals. The Commission should publish guidance setting minimum quality and reporting requirements to improve the uptake of research data.

Removed:The intention of this provision should be keeping sector-specific risk assessments (especially considering the animal testing ban in force for some sectors).

Added:Recital 42: (42) To increase the availability and facilitate the use of information on the environmental performance of chemicals throughout their lifecycle, and to enable a comprehensive assessment of the impacts of chemicals on the environment, the Commission should identify relevant data and information related to the environmental sustainability of chemicals, including, where available, information on their impact on climate change, for integration into the common data platform. Once the Commission has identified the relevant existing datasets of chemicals data on environmental sustainability related data and has designed the relevant related database functionalities, the ECHA should establish a database on environmental sustainability-related data, collect the data as made available by the Commission, the Agencies, national agencies, and, where relevant, by the researchers and research consortia funded by Union and national framework programmes, and integrate the content of that database into the common data platform as a dedicated service. In order to ensure uniform conditions for the implementation of the obligation to identify relevant environmental sustainability datasets, implementing powers should be conferred on the Commission.

Removed:Recital 28: (28) In order to increase transparency, as well as to enable Authorities to have complete prior knowledge of studies commissioned by business operators, irrespective of whether such studies are carried out by the business operator itself or are outsourced, business operators and laboratories should notify to a database of study notifications established and managed by the ECHA certain information related to the studies on chemicals they commission to support an application, notification or regulatory dossier intended to be notified or submitted to an authority for compliance with regulatory requirements under the Union acts listed in Annex I. For this purpose, the ECHA should establish and manage a database of study notifications, as a dedicated service of the common data platform, to store the information related to those studies. In order to allow business operators and laboratories sufficient time to prepare the notifications of studies, the obligation to notify studies should only start to apply two years after the date of entry into force of this Regulation.

Added:Recital 43: (43) To monitor the impacts on humans and the environment, including the climate, of exposure to chemicals and to establish a knowledge base to measure the effectiveness of chemicals legislation in protecting human health and the environment, the EEA, in collaboration with the Agencies, should jointly develop and regularly, at least every two years, update a set of indicators and present it in the form of a dashboard. In order to monitor the aggregated risk for territories associated with the impacts on humans and the environment, including on the climate, of exposure to chemicals and pollutants, the set of indicators should include an aggregated indicator for different territorial levels, developed in collaboration with the Joint Research Centre and drawing inspiration from its European wide vulnerability framework1a. The EEA should cross-reference the results of this indicator with other health and environment datasets, such as epidemiological data on occupational health, lifestyle factors, and socio-economic factors, in order to assess the impacts and risks of c cumulated risk factors on population at the territorial level. The Agencies and the Commission should regularly provide the EEA with any available data falling within their mandate and relevant for the establishment of the indicators. The EEA and the ECHA should integrate this dashboard of indicators into the common data platform.

Removed:For the purpose of clarity, this provision intends to align this recital with Article 22.

Added:Recital 44: (44) This Regulation should establish an early warning and action system as regards existing and emerging chemical risks. To enable the identification and evaluation of emerging chemical risks , the EEA should develop and compile information on early warning signals and draw up an annual summary report to inform regulatory and policy follow-up actions by authorities. In its work, the EEA should include its own sources, targeted literature searches and make use of information from national early warning systems. It should also include relevant information made available by the related work of the ECHA, the EFSA, the EU-OSHA, the EMA and their networks, such as the EFSA’s task of identifying and collecting information on emerging risks under Regulation 178/2002. The EEA should make the summary report and the underlying data available through the common data platform, ensuring public access and its use for further action on existing and emerging risks concerning chemicals, groups of chemicals, and cumulative exposure to chemicals. In order to allow the EEA sufficient time to organise the collection of early warning signals and to compile and analyse the initial information the EEA should only deliver the first report six months after the end of the first calendar year after entry into force of this Regulation. this Regulation sets a deadline for the first report and associated data. For any risk and warning signal identified by the report, the Authorities should consider underta…

Removed:Recital 28 a (new): (28a) Given the wide scope of Union acts listed in Annex I, when laying down the practical arrangements for implementing the study notification provisions, consideration should be given to proportionality to avoid the overburdening of business operators, laboratories and the ECHA.

Added:Recital 46: (46) The ECHA should continue operating the EUON and transform it into an observatory for specific chemicals and groups of chemicals with potential contribution to emerging chemical risks (‘the observatory’), which should cover also other chemicals and innovative (rationally designed complex ‘advanced’) materials selected by the Commission, using, as appropriate, signals from the early warning and action system. One of the criteria for selecting chemicals for the observatory should be their novelty and disruptive potential that may contribute to an emerging chemical risk. Another criterion for that selection should be the higher degree of uncertainty surrounding them and, due to less regulatory experience regarding those chemicals, the resulting need for additional scrutiny and transparency. The observatory should facilitate regulatory implementation and responsible use of these chemicals by collecting, generating, and disseminating reliable information on selected chemicals’ properties, uses and market presence to the general public.

Removed:The proposed obligation for notification of studies will create a significant administrative burden. This burden on both the business operators and subsequently on the ECHA should not be underestimated, taking into account the large number and diversity of legislative acts included in Annex I, 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.

Added:Recital 48: (48) Under Regulation (EC) No 178/2002, the EFSA is able to commission, in an open and transparent manner, the scientific studies it needs to accomplish its mission, while seeking to avoid duplication with Member States or Union research programmes. The ECHA should also be able to commission studies to obtain adequate data and information on chemicals and groups of chemicals within its mission, while maintaining the principle that the burden to prove compliance with Union chemicals legislation remains on the duty holder. Furthermore, the ECHA should commission such studies out of its own initiative or at the request of the Commission, with the objective of supporting the effective and efficient implementation and evaluation of Union acts on chemicals within its mandate and contributing the development of a Union chemicals policy. When obtaining a sample of a substance is a precondition for conducting the scientific studies, ECHA should be given the necessary sample by the business operator, upon request, and provided that applicable confidentiality and data protection under Union law is ensured. Whenever possible, information generated through studies commissioned by the ECHA should be generated by means other than animal tests.

Removed:Recital 31: (31) While the study notification obligation established in this Regulation should apply in the context of all the Union acts on chemicals listed in Annex I, the various relevant data collection and safety assessment processes under those acts may vary widely procedurally. The overarching aim of the database of study notifications established under this Regulation should be to bring together information on studies on chemicals being commissioned by business operators, such as to enable a centralised and complete overview of the studies being performed to support an application, notification or regulatory dossier intended to be notified or submitted to an Authority to ensure compliance under Union acts on chemicals as listed in Annex I. On the basis of this objective and considering the fact that assessment procedures under Union acts on chemicals in Annex I may vary widely, 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. Consequently, it is not appropriate to introduce in this Regulation the consequences associated non-compliance with the study notification obligation as laid out in Article 32b of Regulation (EC) No 178/2002 of the European Parliament and of the Council.

Added:Recital 48 a (new): (48a) To support the effective implementation and evaluation of Union acts on chemicals and to contribute to the development of a comprehensive Union chemicals policy, it is essential to conduct Union-wide human biomonitoring studies that provide high-quality and representative data at regular intervals. To support a resource-efficient approach, the ECHA and EFSA should cooperate closely in pooling resources and expertise for such studies. The Member States should cooperate with the Agencies to organise the human bio-monitoring in their respective territories, in terms of planning, coordination, collection and transmission of samples.

Removed:This provision intends to align this recital with article 22 for the purpose of clarity.

Added:Recital 48 b (new): (48b) In order to contribute to the overall objective of this Regulation to enable better, complete, coherent and robust scientific assessments of chemicals and their impacts, and to ensure the best use of existing information for the purpose of the implementation and the development of Union legislation on chemicals, this Regulation should require the Commission to draw up a report analysing how adequate the resources of the agencies are in relation to their current tasks and their new tasks under this Regulation, and a prospective view of the resources needed to address key areas of regulatory challenge in the future.

Removed:Recital 33: (33) In order to facilitate enforcement by Member States, the Agencies responsible for assessing and providing scientific output, including scientific opinions, on regulatory dossiers containing studies subject to notification to ECHA should, where relevant, cooperate and exchange information with the Member State enforcement authorities to help them to verify compliance with the obligations laid out in Article 22.

Added:Recital 48 c (new): (48c) As this Regulation expands the tasks and workload of the European Chemicals Agency, it should be provided with appropriate and stable resources, and stable governance of the scientific committees should be ensured. In this respect, it is appropriate that the Commission takes account of any developments and reflects the needs of the Agency to allow fulfilment of its tasks and potential.

Removed:This provision is in light of ECHA's limited resources and the limited possibility to verify compliance with these obligations.

Added:Article 1 – paragraph 1: 1. This Regulation aims to ensure the efficient delivery of coherent hazard and risk assessments of chemicals where those assessments are required by Union legal acts, to achieve a high level of protection of human health and the environment, to enable the development and use of safe and sustainable chemicals, to ensure the proper functioning of the single market for chemicals, and to improve the Union’s citizens’ knowledge of, and trust in, the scientific base for the decisions taken under Union legal acts on chemicals, and to contribute to the goal of phasing out animal testing wherever possible.

Removed:Recital 42: (42) To increase the availability and facilitate the use of information on the environmental performance of chemicals throughout their lifecycle, and to enable a comprehensive assessment of the impacts of chemicals on the environment, the Commission should identify relevant data and information related to the environmental sustainability of chemicals, including, where available, information on their impact on climate change, for integration into the common data platform. Once the Commission has identified the relevant existing datasets on environmental sustainability related data and has designed the relevant related database functionalities, the ECHA should establish a database on environmental sustainability-related data, collect the data as made available by the Commission, the Agencies and, where relevant, by the researchers and research consortia funded by Union and national framework programmes, and integrate the content of that database into the common data platform as a dedicated service. In order to ensure uniform conditions for the implementation of the obligation to identify relevant environmental sustainability datasets, implementing powers should be conferred on the Commission.

Added:Article 1 – paragraph 2 – point b a (new): (ba) keep records of data on studies obtained from relevant third countries through the mechanism referred to in Article 9(1a);

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 2 – paragraph 1 – point 2: 2. ‘Authorities’ means, the European Commission, the competent authorities of the Member States as referred to in any of the Union acts listed in Annexes I, II and III, and the Agencies, excluding their management boards;

Removed:Recital 44: (44) This regulation should establish an early warning and action system as regards existing and emerging chemical risks. To enable the identification and evaluation of emerging chemical risks, the EEA should develop and compile information on early warning signals and draw up an annual summary report to inform follow-up actions by authorities. In its work, the EEA should include its own sources, targeted literature searches and make use of information from national early warning systems. It should also include relevant information made available by the related work of the ECHA, the EFSA, the EU-OSHA, the EMA and their networks, such as the EFSA’s task of identifying and collecting information on emerging risks under Regulation 178/2002. The EEA should make the summary report and the underlying data available through the common data platform, ensuring public access and its use for further action on existing and emerging risks. In order to allow the EEA sufficient time to organise the collection of early warning signals and to compile and analyse the initial information the EEA should only deliver the first report six months after the end of the first calendar year after entry into force of this Regulation. this Regulation sets a deadline for the first report and associated data. For any risk and warning signal identified by the report, the authorities should consider undertaking regulatory, policy or enforcement actions and justify if they decide not to proceed with any actio…

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

Removed:The proposal does foresee the compilation and assessment of emerging risk signals, which are then presented to the Commission, Agencies and Member State Authorities in the form a report, for “consideration of the need for regulatory or policy action related to the early warning signals”. Enforcement activities should be expressly added to the scope, since signals may indicate non-compliance of industry with existing legal obligations. In addition, to instill trust in the system, presenting a report and leaving both the if and how of any follow-up activities to the full discretion of authorities is not sufficient. Instead, it is suggested that the named authorities should be obliged to react upon the report, explain which measures are planned and where reaction does not appear necessary, and justify any of the decisions to ensure minimum accountability of the regulatory bodies.

Added:Article 2 – paragraph 1 – point 11 a (new): 11a. 'research data' means any hazard, occurrence, exposure and fate data derived from scientific studies published in peer-reviewed literature that are not carried out specifically to inform regulatory assessments;

Removed:Article 1 – paragraph 1: 1. This Regulation aims to ensure the efficient delivery of coherent hazard and risk assessments of chemicals where those assessments are required to be submitted to Union Agencies or the Commission by Union legal acts listed in Annex I, to achieve a high level of protection of human health and the environment, to enable the development and use of sustainable chemicals, to ensure the proper functioning of the single market for chemicals, and to improve the Union’s citizens’ trust in the scientific base for the decisions taken under Union legal acts on chemicals.

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

Removed:This provision intends to clarify that only data and information that has to be submitted to Union 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 3 – paragraph 2 – point b a (new): (ba) additional data provided on a voluntary basis by Member States, national agencies, research institutes or other parties;

Removed:Article 1 – paragraph 2 – point a: (a) bring together existing data and information on chemicals and ensure that data and information are easily findable, accessible, interoperable and re-usable;

Added:Article 3 – paragraph 2 – point b b (new): (bb) generated in the context of academic research activities in the sphere of chemicals not covered in point (b) and voluntarily submitted to ECHA by a third party;

Removed:This provisions aims to clarify in the scope that this legislation applies to current and future data generated under the various chemical legislations in the EU, rather than introducing new data requirements, which is in the scope of the sector-specific legislation.

Added:Article 3 – paragraph 4 a (new): 4a. Each chemical or material hosted on the common data platform shall be identified by a unique chemical identifier and a chemical notation specifying its molecular structure without prejudice to any confidentiality requirements in the original act or related legal obligations.

Removed:Article 1 – paragraph 2 – point b: (b) keep records of studies commissioned or carried out by business operators in the context of fulfilling their obligations set under Union acts listed in Annex I, where those studies are commissioned 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 3 – paragraph 5 – point d a (new): (da) information on chemicals in articles as referred to in Article 10a;

Removed:This provision intends to clarify that only data and information that has to be submitted to Union 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 3 – paragraph 5 – point d b (new): (db) information on safer alternatives to substances of concern as referred to in Article 10b;

Change 5

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.

Change 6

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.