What changed between the draft committee report and the plenary report

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

9 unchanged paragraphs

on the proposal for a regulation of the European Parliament and of the Council establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals

(COM(2023)0779 – C90449/2023 – 2023/0453(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

– having regard to the Commission proposal to Parliament and the Council (COM(2023)0779),

– having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90449/2023),

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– having regard to the opinion of the European Economic and Social Committee of 20 March 2024,

– having regard to Rule 60 of its Rules of Procedure,

Changed:– having regard to the report of the Committee on the Environment, Public HealthClimate and Food Safety (A100000/2024),(A10-0018/2025),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Change 1

Added:Recital 1: (1) The European Green Deal1 sets a high ambition for enabling the transition towards a toxic-free environment and zero pollution. The Chemicals Strategy for Sustainability2 is a crucial delivery of this zero-pollution ambition and introduces the ‘one substance, one assessment’ approach, which aims to improve the efficiency, effectiveness, coherence, and transparency of safety assessments of chemicals across Union legislation. According to that Strategy, ‘safe and sustainable by design’ criteria should be developed to enable the production and use of chemicals that are safe and sustainable throughout their entire lifecycle. The Strategy also sets out that the interaction between scientific developments and policy-making should be strengthened by means of an early warning system for chemicals and groups of chemicals to ensure that Union policies address emerging chemical risks as soon as these are identified by monitoring and research, and that a framework of indicators should be developed to monitor the drivers and impacts of chemical pollution and to measure the effectiveness of chemicals legislation. This Regulation aims to implement these objectives.

Added:Recital 2: (2) The main objective of this Regulation is to increase the level of protection of the environment and human health from the risks arising from chemicals, as well as to facilitate the functioning of the internal market for chemicals. Improving the integration of information from different sources, and establishing a cost-effective digital infrastructure will improve the predictability and transparency of regulatory processes and result in a reduction of the administrative burden and overlaps. For that purpose, this Regulation should establish a common data platform data on chemicals (‘the common data platform’), to be managed by the European Chemicals Agency (‘ECHA’). The common data platform is a digital infrastructure that brings together chemicals data and information generated under the Union chemicals acquis. This Regulation should also establish dedicated services within the common data platform and lay down rules on the transparency, accessibility and usability of the data contained in that platform. This Regulation aims to create a common knowledge base on chemicals available to authorities 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 and thereby contribute to ensuring that testing on animals only takes place as a last resort. Moreover, the Regulation aims to provide a one-stop-shop …

Added:Recital 4: (4) In its communication of 19 February 2020 on a European strategy for data4 , the Commission described its vision of a common European data space and highlighted the need for the development of sectoral data spaces in strategic areas, since not all sectors of the economy and society are moving at the same speed. This Regulation aims therefore to build a data space for chemicals by establishing a common data platform on chemicals (‘common data platform’), which is also part of the Green Deal data space, as referred to in the European strategy for data. Furthermore, in that strategy, the Commission highlighted several issues concerning the availability of data for the public good, including data availability, data infrastructures and governance, interoperability, as well as the lack of adequate sharing of data between public authorities. This Regulation aims to increase data availability on chemicals by requiring the Commission and the relevant Union agencies to make data available for integration in the common data platform on chemicals, to promote interoperability of that data by providing for the establishment of standard formats and controlled vocabularies, as well as to facilitate data exchange and use by public authorities to enable them to effectively carry out their regulatory and policy developing tasks.

Recital 6: (6) Business operators and Members States’ competent authorities are required by various Union acts to submit data and information to a multitude of Union agencies, as well as to the Commission in specific cases. This generates a fragmentation of data and information on chemicals, which are held under various data sharing and use conditions and in different formats. Such fragmentation prevents public authorities, as well as the general public, from having a clear overview of what information is available on individual chemicals or groups of chemicals, of where and how information can be accessed and whether it can be used. This increases the likelihood of inconsistency between various assessments of the same chemical required by various Union acts on chemicals and of damaging the general public’s trust in the scientific grounds for Union decisions on chemicals. In order to ensure that data on chemicals is easily findable, accessible, interoperable and usable, the ECHA should establish a common data platform on chemicals. The common data platform on chemicals should serve as a single point of reference and as a broadened and shared evidence base to enable the efficient delivery of coherent hazard and risk assessments of chemicals across various Union acts on chemicals, as well as to enable the timely identification of emerging chemical risks and the drivers and impact of chemical pollution. Authorities should take the necessary measures to protect the confidentiality of data, …

Change 2

Removed:Whilst there is the inclusion of some provisions on the protection of confidential information, these provisions need to be strengthened to ensure that the protection of confidential information afforded under the applicable sector-specific legislation is not undermined by this proposal. Furthermore, in case of conflict between the provisions on confidentiality of this proposal and those laid in sector-specific legislation, the latter should prevail.

Added:Recital 7: (7) The common data platform should contain, but not be limited to, all chemicals-related data and information held by relevant Union agencies or the Commission generated or submitted to them as part of the implementation of Union chemicals legislation listed in Annex I, unless this Regulation specifies otherwise. This includes, for instance, all regulatory dossiers or applications submitted to the relevant Union agencies, but also chemicals data on occurrence of chemicals submitted by Member States to Union agencies or the Commission in compliance with their reporting obligations and enforcement activities. The common data platform should also include chemicals data and information generated as part of Union, national or international programmes or research activities related to chemicals, where this data and information is held by the Commission or one of the relevant agencies.

Removed:Recital 7: (7) The common data platform should contain chemicals-related data and information held by relevant Union agencies or the Commission generated and submitted to them as part of the implementation of Union chemicals legislation listed in Annex I. This includes, for instance, relevant dossiers submitted to the relevant Union agencies, but also chemicals data on occurrence of chemicals submitted by Member States to Union agencies or the Commission in compliance with their reporting obligations. The common data platform should also include chemicals data and information generated as part of Union, national or international programmes or research activities related to chemicals, where this data and information is held by the Commission or one of the relevant agencies.

Added:Recital 8: (8) Due to the different nature of the risk and hazard assessments performed under Union acts on medicinal products, when compared to those performed under the main Union acts on chemicals, for medicinal products, only chemicals data related to environmental risk assessments for human and veterinary medicines, non-clinical studies for human medicines and maximum residue limit values the European Medicines Agency (‘EMA’) holds, as well as specific reference values, should be included in the common data platform. For medicinal active substances, only data on relevant substances should be included. These concern active substances covered by the medicines legislation and also used for other applications regulated by other Union legislation identified in this Regulation, as well as other active substances with particular persistent, bio-accumulative and toxic properties or with a known high level of residues in the environment. The extension to further data categories or additional medicinal active substances should be assessed in the context of a review.

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”. The scope of the Data Regulation is broad but still covering those submissions that are relevant for the CDP. The difference between 'regulatory dossiers' and 'applications' may also cause confusion.

Added:Recital 9: (9) Taking due account of the administrative work for EMA coming from the adaptation of such data to an appropriate format for inclusion in the common data platform, it is appropriate to adopt a stepwise approach, and to include during the first stage only chemical data for active substances which are submitted to the EMA in the context of the relevant procedures that are finalised after the entry into force of this Regulation. No later than eight years after the entry into force of this regulation, EMA should also include the chemical data on active substances from procedures concluded before the entry into force of this Regulation.

Removed:Recital 8: (8) While some medicinal products are also chemicals and could fall under the objectives of this Regulation, the application and use of hazard and risk assessments performed on them under Union acts on medicinal products is different from the application and use of hazard and risk assessments performed under the main Union acts on chemicals. It is thus appropriate to adopt a stepwise approach and to include in the scope of this regulation at this stage, taking due account of the administrative burden for the European Medicines Agency (‘EMA’), only chemicals data with the highest added value. At this stage, data with the highest assessed added value are data on relevant active substances, which are considered to be active substances covered by Union legislation on medicinal products listed in Annex II, and also subject to regulatory procedures under other Union legislation listed in Annex I identified in this Regulation, as well as other active substances with particular persistent, bio-accumulative and toxic properties or with a known high level of residues in the environment. The specific chemicals data to be included for those relevant active substances should cover chemicals data related to environmental risk assessments carried out under Union legislation on medicinal products for human and veterinary use, non-clinical studies carried out under Union legislation on medicinal products for human use and maximum residue limit values and the chemicals data underlying their de…

Added:Recital 9 a (new): (9a) Active substances contained in medicinal products are covered by Annex II to this Regulation, but may also be regulated in legislation referred to in Annex I since active substances in medicinal products may also be used in applications that fall under Union legislation listed under Annex I. In order to protect the confidentiality of certain data, the provisions on confidentiality under the originating Union act apply.

Removed:Pharmaceutical data is not restricted only to the data referred to in Annex II and falls within scope of legislations listed under Annex I. In addition, as this Regulation aims to bring together all data related to chemicals into a common data platform and the Annexes include pieces of legislation covering products which are not chemicals, these products should explicitly be excluded from the scope of this Regulation.

Added:Recital 12: (12) In order to respond to the needs of the digital economy and to ensure a high level of protection of the environment and human health, it is necessary to lay down a harmonised framework, granting, as a general principle, the widest possible access to chemicals data and, where appropriate, specifying who is entitled to access and use the chemicals data contained in the common data platform, under which conditions, on what basis, and for which purposes. The Authorities that are entrusted with regulatory tasks related to chemicals should be allowed and encouraged to use the chemicals data and information contained in the common data platform to effectively fulfil their regulatory duties and tasks, in order to improve the effectiveness, efficiency, and coherence of chemicals-related assessments as well as the development of Union chemicals policies. Access to personal data should be limited to what is necessary in relation to the purposes for which those data are processed by the Authorities.

Removed:Recital 8 a (new): (8a) Chemicals contained in medicinal products are covered by Annex II to this Regulation, as well as Annex I since chemicals in medicinal products are also subject to regulatory procedures under the majority of other Union legislation listed under Annex I. In order to protect the confidentiality of certain data and to prevent any conflicts between legislative acts, the provisions from Directive 2001/83/EC of the European Parliament and the Council and Regulation (EC) 726/2004 of the European Parliament and the Council should always take precedence over this Regulation. This covers future implementation through delegating and/or implementing acts.

Added:Recital 14: (14) When using data contained in the common data platform, the Authorities should respect the originator principle. Under this principle, the confidentiality marking of chemicals data as done by the originator and as correspondingly indicated by the Agency when it provides that data to the common data platform should be respected by the Authorities using that data or information to perform their regulatory functions or fulfil their tasks. The common data platform should also include terms and conditions, particularly regarding the respect of intellectual property rights and other related rights.

Removed:The General Pharmaceutical Legislation rules governing general data protection provisions should take precedence over this legislation.

Added:Recital 17: (17) While the ECHA should identify and develop the technical functionalities of the common data platform in stages, certain dedicated services should be defined by this Regulation. As such, the common data platform should, in addition to providing access to chemicals-related data made available by the Agencies and the Commission, provide access to the chemicals data and information made available through its dedicated services. These dedicated services should be integrated into the common data platform and consist of the existing Information Platform for Chemical Monitoring (‘IPCHEM’), a repository of reference values, a database of study notifications, a database with information on regulatory processes, a database with information on applicable legal obligations, a repository of standard formats and controlled vocabularies, a database on environmental sustainability related data, a database on chemicals in articles, a database on safer alternatives to substances of concern, as well as a dashboard of indicators on chemicals.

Removed:Recital 9: (9) Considering the format of these data and the effort it would require to transform them into an appropriate format, for efficiency reasons, only data that are submitted to the EMA in the context of the relevant procedures that are finalised after the entry into force of this Regulation should be included in the common data platform.

Added:Recital 18: (18) The Commission should adopt an implementation plan identifying datasets of chemicals data to be made accessible via the platform and the timeline for their integration, informed by the preparatory work of the Commission and the Agencies10 . The Commission should set up a governance scheme to support and steer the common data platform’s operation and evolution covering the organisation of work structures and coordination between ECHA and data providers, required rules, formats and vocabularies for data integration, and maintain a rolling implementation plan to ensure the progress in identification and integration of new datasets of chemicals data and services for inclusion. The governance scheme should be adopted and updated as necessary by the Commission, after consultation with a newly established platform steering committee composed of representatives from Union agencies and the Commission. In order to ensure uniform conditions for the implementation of the obligations to establish an implementation plan and a governance scheme, implementing powers should be conferred on the Commission.

Removed:This recital takes into account how transforming the data would burden the EMA which is already under strained capacities. In addition, only data submitted after the entry into force of this Regulation should be added in the platform, as included former data retroactively would be too difficult and burdensome for the EMA.

Added:Recital 19: (19) The common data platform should serve the widest possible community, with the ability to address new use cases, incorporate new relevant datasets of chemicals data, develop new functionalities, and respond to developing tools and applications.

Change 3

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Change 4

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:Recital 22: (22) Some types of data are currently not within the mandate of any of the Agencies. In order to ensure clarity of responsibilities of the Agencies and efficient management of chemicals data, the Agencies should be required to host, maintain and provide specific data types to the common data platform. To this end, the ECHA should host and be a data provider to the common data platform for workplace monitoring data, including occupational human biomonitoring data, and the EEA should host and be a data provider to the common data platform for data on indoor air quality and environment monitoring data, as well as data on concentrations of chemicals in human matrices such as blood or urine (‘human biomonitoring data’).

Removed:Recital 12: (12) In order to respond to the needs of the digital economy and to ensure a high level of protection of the environment and human health, it is necessary to lay down a harmonised framework, granting as a general principle, the widest possible access to chemicals data and, where appropriate, specifying who is entitled to access and use the chemicals data contained in the common data platform, under which conditions, on what basis, and for which purposes. The Authorities that are entrusted with regulatory tasks related to chemicals should be allowed and encouraged to use the chemicals data and information contained in the common data platform to effectively fulfil their regulatory duties and tasks, in order to improve the effectiveness, efficiency, and coherence of chemicals-related assessments as well as the development of Union chemicals policies. Access to personal data should be limited to what is necessary in relation to the purposes for which those data are processed by the Authorities.

Added:Recital 23: (23) To improve the uptake of academic data and to expand the knowledge base for chemicals safety assessments and environmental sustainability impacts of chemicals, researchers or research consortia funded by national or Union framework programmes should make available, in line with the ‘as open as possible, as closed as necessary’ principle, any human biomonitoring data they collect or generate resulting from research and development programmes to the EEA and any environmental sustainability data, on chemicals or materials they collect or generate to the ECHA.

Removed:The Regulation's objective is to enhance trust and clarify the rule and its exemptions. With regards to access to personal data, whilst there is the inclusion of some provisions on the protection of confidential information, these provisions need to be strengthened to ensure that the protection of confidential information afforded under the applicable sector-specific legislation is not undermined by this proposal.

Added:Recital 24: (24) The EEA, as the agency responsible for monitoring data and information on chemicals in the environment, should also be responsible for collecting, hosting, and maintaining human biomonitoring data, with the exception of occupational human biomonitoring data, which should be collected, hosted and maintained by the ECHA.

Removed:Recital 13: (13) Chemicals data and information generated as a result of obligations set by Union acts on chemicals may be protected by confidentiality claims on confidential business information. The public dissemination of such data may affect the commercial interest of private parties. To ensure legal certainty for duty holders and to protect their legitimate expectations, as well as to ensure industry’s competitiveness on the internal market, the ECHA, as a manager of the common data platform, should grant differentiated access rights to the data and information contained in the common data platform. To this end, the Authorities should have full access to all chemicals data and information contained in the common data platform, including access to confidential information, while the general public, including business operators, should have restricted access to that data and information, which does not include access to confidential information.

Added:Recital 24 a (new): (24a) The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission should be able to process human biomonitoring data constituting personal data. Since human biomonitoring personal data constitute a special category of personal data, namely, health data, the EEA, the Commission, the ECHA, the EFSA, the EU-OSHA and the EMA should process those data only where the processing is necessary for reasons of substantial public interest, as laid down in Article 10(2)(g) and for scientific research as laid down in Article 10(2)(j) of Regulation (EU) No 2018/1725. The present Regulation lays down the cases where there is such substantial public interest in processing human biomonitoring data constituting personal data.

Removed:In the context of this proposal, the terms ‘general public’ refers to any users of the Common Data Platform on Chemicals, that is not an Authority, i.e., citizens, ‘business operators’, etc. In this respect and for the purpose of clarity, this amendment aims at replacing ‘business operators and the general public’ by ‘the general public, including business operators’.

Added:Recital 24 b (new): (24b) The inclusion of human biomonitoring data collected prior to the entry into force of this Regulation in the common data platform is necessary to ensure the completeness and quality of the human biomonitoring datasets for the purposes of this Regulation.

Removed:Recital 14: (14) When using data contained in the common data platform, the Authorities should respect the originator principle. Under this principle, the confidentiality marking of chemicals data as done by the originator and as correspondingly indicated by the Agency when it provides that data to the common data platform should be respected by the Authorities using that data or information to perform their regulatory functions or fulfil their tasks. A clear mention should be made on the common data platform, which indicates to the general public that the data may be owned by third parties and that any use of the data without prior approval from the data owner might infringe its rights. The common data platform should also include terms and conditions, including regarding intellectual property rights and other rights.

Added:Recital 27: (27) In order to promote the use and harmonisation 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. The ECHA should also include in the repository of reference values reference values that are generated through other programmes or research activities and that are made available to it.

Removed:This suggested amendment intends to highlight the importance of the protection of intellectual property rights.

Added: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 the studies on chemicals they commission for compliance with regulatory requirements under the Union acts listed in Annex I. Scientific studies that are 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 Union acts listed in Annex I, do not need to be notified. The ECHA should establish and manage a database of study notifications to store the information related to those studies. That database should be a separate database in which notification information is kept confidential. The ECHA, in cooperation with the relevant Agencies, should take the necessary measures to protect the safe transmission of chemicals data. 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 18 months after the date of entry into force of this Regulation. The ECHA should also set up a mechanism to cooperate with authorities in third countries…

Removed:Recital 17: (17) While the ECHA should identify and develop the technical functionalities of the common data platform in stages, certain dedicated services should be defined by this Regulation. As such, the common data platform should, in addition to providing access to chemicals-related data made available by the Agencies and the Commission, provide access to the chemicals data and information made available through its dedicated services. These dedicated services should be integrated into the common data platform and consist of the existing Information Platform for Chemical Monitoring (‘IPCHEM’), a repository of reference values, a database of study notifications, a database with information on regulatory processes, a database with information on applicable legal obligations, a repository of standard formats and controlled vocabularies, a database on environmental sustainability related data, a database on substances in articles and their alternatives, as well as a dashboard of indicators on chemicals.

Added:Recital 30: (30) To ensure the coherence between those two study notification mechanisms, as well as to ensure certainty for business operators submitting notifications, the rules on the public dissemination of study notifications should, where relevant, correspond in that the notifications should only be made available through the common data platform once a corresponding registration, application, notification or other relevant regulatory dossier was submitted to the relevant Union or national institution. In order to respect the confidentiality of relevant elements of study notifications when they are integrated in the common data platform, where the Commission or an Agency makes available to the ECHA the corresponding registration, application, notification or other relevant regulatory dossiers, it should also indicate which elements of the study notification are to be confidential when they will be included in the common data platform. Only those elements should be indicated as confidential where the same element is indicated as confidential in the corresponding application, notification or other relevant regulatory dossier in accordance with the provisions on confidentiality under the originating Union act. In order to facilitate compliance with the requirement to notify a study, the ECHA and the EFSA should cooperate to ensure a common approach for the identification of notified information in order to facilitate the traceability of studies notified to their respective databases. …

Removed:Data on substances in products (mixtures and articles in terms of REACH) are covered by the term “chemicals data” as proposed in Article 2(10), and so are data on alternatives to targeted substances. However, such data are scattered across different regulatory procedures, including from different legislations (e.g. RoHS, REACH). The proposal does not provide for the structured access to these important items, thereby not allowing targeted retrieval of relevant and actionable information, across legislations and procedures (e.g. all products linked with a specific substance, alternatives discussed in relation to a specific substance or use). Hence, to better contribute to the goals to achieve a high level of protection of human health and the environment, promote the circular economy, and to enable the development and use of sustainable chemicals, it is suggested that distinct services – within the meaning of Article 3(5) of the proposal – are established with all available data on substances in products and available data on alternatives. The additional costs linked with this service appear minimal.

Added: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, as well as any studies on chemicals on their own or in products they commission as part of a risk or safety assessment, to ensure compliance under the Union acts 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 with 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 t…

Removed:Recital 23: (23) To improve the uptake of academic data and to expand the knowledge base for chemicals safety assessments and environmental sustainability impacts of chemicals, researchers or research consortia funded by Union framework programmes should make available, in line with the ‘as open as possible, as closed as necessary’ principle, any human biomonitoring data they collect or generate resulting from research and development programmes to the EEA and any other chemicals, including environmental sustainability data on chemicals or materials they collect or generate to the ECHA. Member States should require researchers or research consortia funded by national framework programmes to make their data available to the EEA or to ECHA, as appropriate.

Added: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. Information on enforcement should be made public to enhance public trust in the effective implementation of Union law.

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:Recital 36: (36) To strengthen the coordination and cooperation between the different bodies performing chemicals assessments in the Union, and to promote an increased transparency of chemicals assessments, the ECHA should establish and manage a database with information on regulatory processes or activities that are planned, ongoing or completed by Member States, the Commission and Agencies referred to in the Union acts listed in Annex III to this Regulation and integrate it into the common data platform for access by the authorities. The information on such regulatory processes or activities should include at least the substance identity and the identification, status and eventually the outcome of the regulatory process, or activity, including whether it involves animal testing. That information should also be made available without undue delay and kept updated through the assessment process. Once the process or activity has formally started, that information should be shared also publicly on the common data platform.

Removed:Recital 24 a (new): (24a) The EEA, ECHA, EFSA, EMA and the Commission should be able to process human biomonitoring data constituting personal data. Since human biomonitoring personal data constitutes a special category of personal data, namely, health data, the EEA, the Commission, the ECHA, the EFSA and the EMA should process those data only where the processing is necessary for reasons of substantial public interest, as laid out in Article 10(2)(g) and for scientific research as laid out in Article 10(2)(j) of the Regulation (EU) No 2018/1725.