Common data platform on chemicals, establishing a monitoring and outlook framework for chemicals

Amendments tabled for the plenary sitting on this text, in their own numbering series. This is a different set from the committee amendments tracked elsewhere on AmendEU, and is not counted in any of the site’s amendment totals.

1. Amendment 1Proposal for a regulation · Recital 1
   Current text

   (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 d…

   Amendment

   (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 d…

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2. Amendment 2Proposal for a regulation · Recital 2
   Current text

   (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 hazardous chemicals, as well as to facilitate the functioning of the internal market for chemicals. 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 accessibilit…

   Amendment

   (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 platfo…

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3. Amendment 3Proposal for a regulation · Recital 4
   Current text

   (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…

   Amendment

   (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…

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4. Amendment 4Proposal for a regulation · Recital 6
   Current text

   (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 assess…

   Amendment

   (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 assess…

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5. Amendment 5Proposal for a regulation · Recital 7
   Current text

   (7) The common data platform should contain chemicals-related data and information held by relevant Union agencies or the Commission generated or submitted as part of the implementation of Union chemicals legislation listed in Annex I. 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. 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…

   Amendment

   (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 generate…

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6. Amendment 6Proposal for a regulation · Recital 8
   Current text

   (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 appl…

   Amendment

   (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 appl…

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7. Amendment 7Proposal for a regulation · Recital 9
   Current text

   (9) These data should also be limited to data submitted to the EMA in the context of the relevant procedures that are finalised or submitted after the entry into force of this Regulation. At a later stage, it should also be possible to include in the common data platform, where relevant, data the EMA holds on procedures concluded before the entry into force of this Regulation.

   Amendment

   (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.

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8. Amendment 8Proposal for a regulation · Recital 9 a (new)
   Amendment

   (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.

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9. Amendment 9Proposal for a regulation · Recital 12
   Current text

   (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 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 assessment…

   Amendment

   (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…

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10. Amendment 10Proposal for a regulation · Recital 14
    Current text

    (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.

    Amendment

    (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.

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11. Amendment 11Proposal for a regulation · Recital 17
    Current text

    (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 regula…

    Amendment

    (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 regula…

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12. Amendment 12Proposal for a regulation · Recital 18
    Current text

    (18) The Commission should adopt an implementation plan identifying initial datasets 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 and services for inclusion. The governance scheme should be adopted a…

    Amendment

    (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 governanc…

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13. Amendment 13Proposal for a regulation · Recital 19
    Current text

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

    Amendment

    (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.

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14. Amendment 14Proposal for a regulation · Recital 21
    Current text

    (21) To ensure that an adequate knowledge base on chemicals is available through the common data platform, the Commission should be able to request the Agencies to host, maintain and make available, via the common data platform, data generated as part of Union, national or international programmes or research activities beyond the data already flowing to the Agencies as part of the obligations under the Union acts listed in Annex I. The Commission should make such requests to the Agencies in accordance with their mandates and allocated tasks.

    Amendment

    (21) To ensure that an adequate knowledge base on chemicals is available through the common data platform, the Commission should be able to request the Agencies to host, maintain and make available, via the common data platform, chemicals data generated as part of Union, national or international programmes or research activities beyond the data already flowing to the Agencies as part of the obligations under the Union acts listed in Annex I or other obligations laid down in this Regulation. The Commission should make such requests to the Agencies in accordance with their mandates and allocated tasks. Other parties, such as Member States, national agencies, scientific bodies of Member States…

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15. Amendment 15Proposal for a regulation · Recital 22
    Current text

    (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, 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’).

    Amendment

    (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 (‘hum…

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16. Amendment 16Proposal for a regulation · Recital 23
    Current text

    (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 environmental sustainability data on chemicals or materials they collect or generate to the ECHA.

    Amendment

    (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.

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17. Amendment 17Proposal for a regulation · Recital 24
    Current text

    (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. To the extent that human biomonitoring data constitutes a special category of personal data, namely, health data, the EEA should process that data only where the processing is necessary for reasons of substantial public interest, as required by Article 10(2)(g) of the Regulation (EU) No 2018/1725 of the European Parliament and of the Council11 . This Regulation lays down the cases where there is such substantial public interest in processing human biomonitoring data: namely, where the EEA pro…

    Amendment

    (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. __________________ 11 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 2…

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18. Amendment 18Proposal for a regulation · Recital 24 a (new)
    Amendment

    (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 co…

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19. Amendment 19Proposal for a regulation · Recital 24 b (new)
    Amendment

    (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.

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20. Amendment 20Proposal for a regulation · Recital 27
    Current text

    (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…

    Amendment

    (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…

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21. Amendment 21Proposal for a regulation · Recital 28
    Current text

    (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. 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…

    Amendment

    (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…

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22. Amendment 22Proposal for a regulation · Recital 30
    Current text

    (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 and a decision on the confidentiality of the data contained in that regulatory dossier was taken by that Union or national institution. In addition, in order to facilitate compliance with the require…

    Amendment

    (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 ECH…

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23. Amendment 23Proposal for a regulation · Recital 31
    Current text

    (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 regulatory compliance under Union acts on chemicals as listed in Annex I. On the basis of this objective and considering the fact t…

    Amendment

    (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…

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24. Amendment 24Proposal for a regulation · Recital 33
    Current text

    (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 on the compliance with the obligations laid out in Article 22.

    Amendment

    (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.

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25. Amendment 25Proposal for a regulation · Recital 36
    Current text

    (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…

    Amendment

    (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…

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26. Amendment 26Proposal for a regulation · Recital 36 a (new)
    Amendment

    (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) 2024/1781. In addition, ECHA should also establish and manage a database collecting available…

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27. Amendment 27Proposal for a regulation · Recital 38
    Current text

    (38) 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…

    Amendment

    (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 part…

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28. Amendment 28Proposal for a regulation · Recital 41 a (new)
    Amendment

    (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.

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29. Amendment 29Proposal for a regulation · Recital 42
    Current text

    (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 environme…

    Amendment

    (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 dat…

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30. Amendment 30Proposal for a regulation · Recital 43
    Current text

    (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 and the ECHA should jointly develop and regularly, at least every two years, update a set of indicators and present it in the form of a dashboard. The EFSA, the EMA, the EU-OSHA and the Commission shall 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.

    Amendment

    (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, d…

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31. Amendment 31Proposal for a regulation · Recital 44
    Current text

    (44) 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 follow-up actions. 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…

    Amendment

    (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 a…

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32. Amendment 32Proposal for a regulation · Recital 46
    Current text

    (46) The ECHA should continue operating the EUON and transform it into an observatory for specific 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…

    Amendment

    (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 regulat…

    Excerpt — full text in the official PDF.
    official amendment document ↗
33. Amendment 33Proposal for a regulation · Recital 48
    Current text

    (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 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 e…

    Amendment

    (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 effici…

    Excerpt — full text in the official PDF.
    official amendment document ↗
34. Amendment 34Proposal for a regulation · Recital 48 a (new)
    Amendment

    (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.

    official amendment document ↗
35. Amendment 35Proposal for a regulation · Recital 48 b (new)
    Amendment

    (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.

    official amendment document ↗
36. Amendment 36Proposal for a regulation · Recital 48 c (new)
    Amendment

    (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.

    official amendment document ↗
37. Amendment 37Proposal for a regulation · Article 1 – paragraph 1
    Current text

    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 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.

    Amendment

    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.

    official amendment document ↗
38. Amendment 38Proposal for a regulation · Article 1 – paragraph 2 – point b a (new)
    Amendment

    (ba) keep records of data on studies obtained from relevant third countries through the mechanism referred to in Article 9(1a);

    official amendment document ↗
39. Amendment 39Proposal for a regulation · Article 2 – paragraph 1 – point 2
    Current text

    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 and III, and the Agencies, excluding their management boards;

    Amendment

    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;

    official amendment document ↗
40. Amendment 40Proposal for a regulation · Article 2 – paragraph 1 – point 10
    Current text

    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, standard formats, controlled vocabularies, or any information on applicable legal obligations related to chemicals;

    Amendment

    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;

    official amendment document ↗
41. Amendment 41Proposal for a regulation · Article 2 – paragraph 1 – point 11 a (new)
    Amendment

    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;

    official amendment document ↗
42. Amendment 42Proposal for a regulation · Article 2 – paragraph 1 – point 14 a (new)
    Amendment

    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;

    official amendment document ↗
43. Amendment 43Proposal for a regulation · Article 3 – paragraph 2 – point b a (new)
    Amendment

    (ba) additional data provided on a voluntary basis by Member States, national agencies, research institutes or other parties;

    official amendment document ↗
44. Amendment 44Proposal for a regulation · Article 3 – paragraph 2 – point b b (new)
    Amendment

    (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;

    official amendment document ↗
45. Amendment 45Proposal for a regulation · Article 3 – paragraph 4 a (new)
    Amendment

    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.

    official amendment document ↗
46. Amendment 46Proposal for a regulation · Article 3 – paragraph 5 – point d a (new)
    Amendment

    (da) information on chemicals in articles as referred to in Article 10a;

    official amendment document ↗
47. Amendment 47Proposal for a regulation · Article 3 – paragraph 5 – point d b (new)
    Amendment

    (db) information on safer alternatives to substances of concern as referred to in Article 10b;

    official amendment document ↗
48. Amendment 48Proposal for a regulation · Article 3 – paragraph 6
    Current text

    6. The Authorities and the general public shall have access to the data contained in the common data platform in accordance with Article 16.

    Amendment

    6. The Authorities and the general public shall have easy access, free of charge, to the data contained in the common data platform in accordance with Article 16.

    official amendment document ↗
49. Amendment 49Proposal for a regulation · Article 3 – paragraph 9
    Current text

    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 and transmission of chemicals 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.

    Amendment

    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.

    official amendment document ↗
50. Amendment 50Proposal for a regulation · Article 3 – paragraph 11
    Current text

    11. The common data platform and its dedicated services shall be established by [OP: please insert date: three years after the date of entry into force of this Regulation], unless specified otherwise. The relevant datasets shall be integrated progressively into the common data platform by [OP please insert date: ten years from the date of entry into force of this Regulation] according to the implementation plan referred to in Article 4 (1), first sentence. Upon integration of those datasets in the common data platform, when the ECHA receives chemicals data in accordance with Article 5, it shall make that data available through the common data platform without undue delay.

    Amendment

    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…

    Excerpt — full text in the official PDF.
    official amendment document ↗
51. Amendment 51Proposal for a regulation · Article 4 – paragraph 1
    Current text

    1. By [OP please insert date: 6 months after the date of entry into force of this Regulation] the Commission shall adopt and publish an implementation plan identifying datasets for inclusion in the common data platform together with a timeline for their inclusion by means of an implementing decision. Subsequent rolling implementation plans shall be adopted in line with the governance scheme referred to in paragraph 3.

    Amendment

    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.

    official amendment document ↗
52. Amendment 52Proposal for a regulation · Article 4 – paragraph 2
    Current text

    2. The Commission shall, by means of an implementing decision, establish and manage a platform steering committee, which shall include one representative from the ECHA, one representative from the EEA, one representative from the EFSA, one representative from the EMA, one representative from the EU-OSHA and five representatives from the Commission.

    Amendment

    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.

    official amendment document ↗
53. Amendment 53Proposal for a regulation · Article 4 – paragraph 4
    Current text

    4. The Commission shall adopt and publish the governance scheme referred to in paragraph 3 and any revision thereof by means of an implementing decision

    Amendment

    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.

    official amendment document ↗
54. Amendment 54Proposal for a regulation · Article 4 – paragraph 5 – point d a (new)
    Amendment

    (da) the organisation and operation of the mechanisms for cooperation and information exchange with databases and similar platforms in third countries and internationally;

    official amendment document ↗
55. Amendment 55Proposal for a regulation · Article 4 – paragraph 5 – point f
    Current text

    (f) the operation of the steering committee itself.

    Amendment

    (f) the operation, reporting requirements and transparency obligations of the steering committee itself.

    official amendment document ↗
56. Amendment 56Proposal for a regulation · Article 5 – paragraph 1
    Current text

    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.

    Amendment

    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.

    official amendment document ↗
57. Amendment 57Proposal for a regulation · Article 5 – paragraph 2
    Current text

    2. Where the Commission or the Agencies hold data or information referred to in Article 3(2), they shall make that data available to the ECHA, in a standard format, where available, together with the relevant context data as referred to in Article 4(4), point (c). The Commission and the Agencies shall indicate whether that data or information is made available to the public under the originating Union act.

    Amendment

    2. Where the Commission or the Agencies hold data or information referred to in Article 3(2), they shall make that data available to the ECHA, in a standard format, where available, together with the relevant context data as referred to in Article 4(5), point (c). The Commission and the Agencies shall indicate whether the data or information included in the common data platform can be made available to the public or whether it is or they are deemed confidential in accordance with the provisions on confidentiality under the originating Union act.

    official amendment document ↗
58. Amendment 58Proposal for a regulation · Article 5 – paragraph 3
    Current text

    3. The ECHA shall host and maintain occurrence data related to workplace monitoring.

    Amendment

    3. The ECHA shall host and maintain occurrence data related to workplace monitoring, including occupational human biomonitoring data.

    official amendment document ↗
59. Amendment 59Proposal for a regulation · Article 5 – paragraph 5
    Current text

    5. Researchers or research consortia funded by Union framework programmes shall make available to the EEA any human biomonitoring data they collect or generate from [OP please insert: date of the entry into force of this Regulation].

    Amendment

    5. Researchers or research consortia funded by national or Union framework programmes shall make available to the EEA any human biomonitoring data they collect or generate from [OP please insert: date of the entry into force of this Regulation]. For human biomonitoring data constituting personal data, the EEA shall specify which type of data are to be made available to it.

    official amendment document ↗
60. Amendment 60Proposal for a regulation · Article 5 – paragraph 6
    Current text

    6. Researchers or research consortia funded by Union framework programmes shall make available to the ECHA any environmental sustainability data on chemicals or materials they collect or generate from [OP please insert: date of the entry into force of this Regulation].

    Amendment

    6. Researchers or research consortia funded by national or Union framework programmes shall make available to the ECHA any environmental sustainability data on chemicals or materials they collect or generate from [OP please insert: date of the entry into force of this Regulation + 6 months].

    official amendment document ↗
61. Amendment 61Proposal for a regulation · Article 5 – paragraph 7
    Current text

    7. The Commission and the Agencies shall provide the necessary technical cooperation to the ECHA to enable the integration of the chemicals data provided in accordance with paragraph 2 in the common data platform as well as its publication through that platform.

    Amendment

    7. The Authorities and national agencies shall provide the necessary technical cooperation to the ECHA to enable the integration of the chemicals data provided in accordance with paragraph 2 in the common data platform as well as its publication through that platform. The ECHA shall provide support to the Authorities and national agencies to facilitate the integration of the chemicals data provided in accordance with paragraph 2.

    official amendment document ↗
62. Amendment 62Proposal for a regulation · Article 5 – paragraph 8
    Current text

    8. For the purpose of paragraph 2, the Commission and the Agencies shall make chemicals data available to the ECHA without undue delay after collection or receipt of the data, after performance of validity and confidentiality assessments in accordance with applicable rules and once the corresponding dataset has been integrated in the common data platform.

    Amendment

    8. For the purpose of paragraph 2, the Commission and the Agencies shall make chemicals data that they have collected or received available to the ECHA without undue delay once they have performed validity and confidentiality assessments of the data in accordance with applicable rules and once they have integrated the corresponding dataset in the common data platform.

    official amendment document ↗
63. Amendment 63Proposal for a regulation · Article 5 – paragraph 9
    Current text

    9. The Commission and the Agencies shall ensure that data made available to the ECHA shall be downloadable, machine readable and interoperable. They shall appropriately curate and validate the data before providing them to the ECHA.

    Amendment

    9. The Authorities and national agencies shall ensure that data made available to the ECHA shall be downloadable, machine readable and interoperable. They shall appropriately curate and validate the data before providing them to the ECHA.

    official amendment document ↗
64. Amendment 64Proposal for a regulation · Article 5 – paragraph 9 a (new)
    Amendment

    9a. Notwithstanding provisions related to processing of human biomonitoring data constituting personal data set out in Article 6, the Commission or Agency under whose authority chemicals data are included in the common data platform on chemicals shall remain the data controller with regard to the personal data it provided.

    official amendment document ↗
65. Amendment 65Proposal for a regulation · Article 5 – paragraph 9 b (new)
    Amendment

    9b. Notwithstanding provisions related to processing of occupational human biomonitoring data constituting personal data set out in Article 6, the ECHA shall act as data processor for any personal data included in the common data platform falling under the Authority of another Agency or the Commission.

    official amendment document ↗
66. Amendment 66Proposal for a regulation · Article 6 – paragraph 1
    Current text

    1. The EEA shall collect, host, and maintain human biomonitoring data generated within the territory of the EEA’s member and cooperating countries.

    Amendment

    1. The EEA shall collect, host, and maintain human biomonitoring data generated within the territory of the EEA’s member and cooperating countries, with the exception of occupational human biomonitoring data in accordance with Article 5(3).

    official amendment document ↗
67. Amendment 67Proposal for a regulation · Article 6 – paragraph 3
    Current text

    3. The EEA may process human biomonitoring data constituting personal data to support the Commission in its policy making or to support the Agencies in fulfilling their missions.

    Amendment

    deleted

    official amendment document ↗
68. Amendment 68Proposal for a regulation · Article 6 – paragraph 4 – introductory part
    Current text

    4. Human biomonitoring data constituting personal data may be processed by the EEA for the following purposes:

    Amendment

    4. The EEA may process human biomonitoring data constituting personal data for the following purposes:

    official amendment document ↗
69. Amendment 69Proposal for a regulation · Article 6 – paragraph 4 – point e
    Current text

    (e) supporting regulatory risk assessments.

    Amendment

    (e) supporting regulatory risk assessments and management.

    official amendment document ↗
70. Amendment 70Proposal for a regulation · Article 6 – paragraph 4 – point e a (new)
    Amendment

    (ea) supporting policy making and legislative processes at Union level;

    official amendment document ↗
71. Amendment 71Proposal for a regulation · Article 6 – paragraph 4 – point e b (new)
    Amendment

    (eb) the creation of a 'chemicals exposure index' for each region in the Union, to provide an overview of the population's exposure to chemical substances and facilitate comparisons between different regions, geographical areas and Member States;

    official amendment document ↗
72. Amendment 72Proposal for a regulation · Article 6 – paragraph 4 – point e c (new)
    Amendment

    (ec) facilitating the processing by the Commission, the ECHA, the EFSA, the EMA, and the EU-OSHA in accordance with paragraphs 4a, 4b, 4c, 4d and 4e of this Article.

    official amendment document ↗
73. Amendment 73Proposal for a regulation · Article 6 – paragraph 4 a (new)
    Amendment

    4a. The Commission may process human biomonitoring data constituting personal data for the following purposes only: (a) scientific research aimed at policy making; (b) assessing the impact of chemicals on human health and the environment; (c) monitoring time and spatial trends in exposure; (d) developing health risk and impact indicators; (e) monitoring the impact of regulatory intervention; (f) assessing the need for further regulatory action and prioritising such action; (g) supporting regulatory risk assessment and risk management.

    official amendment document ↗
74. Amendment 74Proposal for a regulation · Article 6 – paragraph 4 b (new)
    Amendment

    4b. The ECHA may process human biomonitoring data included in occurrence data related to workplace monitoring and which constitute personal data for the following purposes: (a) assessing the impact of chemicals on human health and the environment; (b) monitoring time and spatial trends in exposure; (c) developing health risk and impact indicators; (d) monitoring the impact of regulatory intervention; (e) supporting regulatory risk assessment and management; (f) evaluating and prioritising required regulatory action; (g) performing assessments of chemicals; (h) as part of the commissioning of studies under the data generation mechanism referred to in Article 21.

    official amendment document ↗
75. Amendment 75Proposal for a regulation · Article 6 – paragraph 4 c (new)
    Amendment

    4c. The EFSA may process human biomonitoring data constituting personal data for the following purposes only: (a) evaluating and prioritising required regulatory action; (b) performing assessments of chemicals; (c) supporting regulatory risk management.

    official amendment document ↗
76. Amendment 76Proposal for a regulation · Article 6 – paragraph 4 d (new)
    Amendment

    4d. The EMA may process human biomonitoring data constituting personal data for the following purposes only: (a) evaluating and prioritising required regulatory action; (b) performing assessments of chemicals; (c) supporting regulatory risk management.

    official amendment document ↗
77. Amendment 77Proposal for a regulation · Article 6 – paragraph 4 e (new)
    Amendment

    4e. The EU-OSHA may process human biomonitoring data constituting personal data for the following purposes only: (a) scientific research aimed at policy making; (b) assessing the impact of chemicals on human health and the environment; (c) monitoring time and spatial trends in exposure; (d) monitoring the impact of regulatory intervention; (e) assessing the need for further regulatory action and prioritising such action; (f) supporting regulatory risk management.

    official amendment document ↗
78. Amendment 78Proposal for a regulation · Article 6 – paragraph 5
    Current text

    5. The EEA shall make human biomonitoring data they hold or host publicly available in anonymised form through the Information Platform for Chemical Monitoring.

    Amendment

    5. The EEA and ECHA shall make human biomonitoring data they hold or host publicly available in anonymised form through the Information Platform for Chemical Monitoring.

    official amendment document ↗
79. Amendment 79Proposal for a regulation · Article 6 – paragraph 5 a (new)
    Amendment

    5a. Any processing of human biomonitoring data constituting personal data by the EEA, the ECHA, the EFSA, the EMA, the EU-OSHA, or the Commission for the purposes referred to in paragraphs 4, 4a, 4b, 4c, 4d, and 4e shall not entail the sharing of such data with third parties.

    official amendment document ↗
80. Amendment 80Proposal for a regulation · Article 6 – paragraph 6
    Current text

    6. The EEA shall act as data controller for the human biomonitoring personal data it holds or hosts and processes for the purposes referred to in paragraph 2.

    Amendment

    6. The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission shall act as data controller for the human biomonitoring data constituting personal data they hold or host or process for the purposes referred to in paragraphs 4, 4a, 4b, 4c, 4d and 4e.

    official amendment document ↗
81. Amendment 81Proposal for a regulation · Article 6 – paragraph 6 a (new)
    Amendment

    6a. The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission shall define the storage period, and carry out any review thereof, for the human biomonitoring data constituting personal data that they hold as well as the criteria used to define the storage period.

    official amendment document ↗
82. Amendment 82Proposal for a regulation · Article 6 – paragraph 6 b (new)
    Amendment

    6b. The human biomonitoring data referred to in this Article include personal data lawfully collected before the entry into force of this Regulation.

    official amendment document ↗
83. Amendment 83Proposal for a regulation · Article 8 – paragraph 4 – subparagraph 1 (new)
    Amendment

    The ECHA shall include in the repository of reference values, without undue delay, any reference value generated as part of Union, national or international programmes or research activities and made available to ECHA in the standard formats as referred to in Article 14, where such a standard format has been developed.

    official amendment document ↗
84. Amendment 84Proposal for a regulation · Article 9 – paragraph 1 a (new)
    Amendment

    1a. The ECHA shall establish and operate a mechanism for cooperation and exchange of information with relevant third countries’ authorities for the exchange of studies notified or submitted by business operators to those authorities to support an application, notification or regulatory dossier for a chemical by ... [OP please insert date: two years after the date of entry into force of this Regulation].

    official amendment document ↗
85. Amendment 85Proposal for a regulation · Article 9 – paragraph 2
    Current text

    2. The ECHA shall store in the Database of Study Notifications the data notified to it in accordance with Article 22.

    Amendment

    2. The ECHA shall store in the Database of Study Notifications the data notified to it in accordance with Article 22 and the data obtained through the mechanism referred to in paragraph 1a of this Article.

    official amendment document ↗
86. Amendment 86Proposal for a regulation · Article 9 – paragraph 3
    Current text

    3. The ECHA shall integrate the data contained in the Database of Study Notifications in the common data platform once a corresponding registration, application, notification or other relevant regulatory dossier was submitted to the relevant Union or national institution, agency, or body in accordance with corresponding Union law and after a decision was taken by that Union or national institution, agency, or body on the disclosure of the accompanying studies in accordance with the applicable rules on confidentiality.

    Amendment

    3. Data contained in the Database of Study Notifications shall be considered confidential and shall not be made public.

    official amendment document ↗
87. Amendment 87Proposal for a regulation · Article 9 – paragraph 4 a (new)
    Amendment

    4a. Without prejudice to paragraph 4, where the Commission or any of the Agencies makes available to the ECHA, in accordance with Article 5(2), a registration, application, notification or other relevant regulatory dossier in the context of which a notification was submitted under Article 22, it shall indicate which elements of the study notifications are confidential when included in the common data platform. Only those elements shall 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.

    official amendment document ↗
88. Amendment 88Proposal for a regulation · Article 9 – paragraph 4 b (new)
    Amendment

    4b. Upon receipt by the ECHA, in accordance with Article 5(2), of a registration, application, notification or other relevant regulatory dossier, in the context of which a notification was submitted under Article 22, the ECHA shall make the related notification information available through the common data platform, in accordance with the provisions on confidentiality under the originating Union act.

    official amendment document ↗
89. Amendment 89Proposal for a regulation · Article 9 – paragraph 4 c (new)
    Amendment

    4c. Authorities and national enforcement authorities shall have access to the data contained in the Database of Study Notifications before those data are integrated in the common data platform.

    official amendment document ↗
90. Amendment 90Proposal for a regulation · Article 10 – paragraph 1
    Current text

    1. The ECHA shall establish and manage, as part of the common data platform, a new database containing information on regulatory processes on individual substances or groups of substances that are planned, ongoing or have been completed since the entry into force of this Regulation by the Member States or the Union institutions, agencies or committees referred to in the Union acts listed in Annex III.

    Amendment

    1. The ECHA shall establish and manage, as part of the common data platform, a new database containing information on regulatory processes on individual chemicals or groups of chemicals that are planned, ongoing or have been completed since the entry into force of this Regulation by the Member States or the Union institutions, agencies or committees referred to in the Union acts listed in Annex III.

    official amendment document ↗
91. Amendment 91Proposal for a regulation · Article 10 – paragraph 2
    Current text

    2. Where Member State competent authorities as referred to in any of the Union acts listed in Annex III 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 III without undue delay.

    Amendment

    2. Where Member State competent authorities as referred to in any of the Union acts listed in Annex III 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 III without undue delay. For each regulatory process or activity, at least the following information shall be included:

    official amendment document ↗
92. Amendment 92Proposal for a regulation · Article 10 – paragraph 2 – point a (new)
    Amendment

    (a) chemical identity;

    official amendment document ↗
93. Amendment 93Proposal for a regulation · Article 10 – paragraph 2 – point b (new)
    Amendment

    (b) the Union act and the regulatory process under which the activity takes place;

    official amendment document ↗
94. Amendment 94Proposal for a regulation · Article 10 – paragraph 2 – point c (new)
    Amendment

    (c) the submitter or actor responsible for the regulatory process or activity;

    official amendment document ↗
95. Amendment 95Proposal for a regulation · Article 10 – paragraph 2 – point d (new)
    Amendment

    (d) the status of the regulatory process or activity;

    official amendment document ↗
96. Amendment 96Proposal for a regulation · Article 10 – paragraph 2 – point e (new)
    Amendment

    (e) the outcome of the regulatory process or activity, including, where applicable, the reports or opinions adopted;

    official amendment document ↗
97. Amendment 97Proposal for a regulation · Article 10 – paragraph 2 – point f (new)
    Amendment

    (f) where applicable, the intended date for starting the regulatory process or activity, and the date of its completion and latest update;

    official amendment document ↗
98. Amendment 98Proposal for a regulation · Article 10 – paragraph 2 – point g (new)
    Amendment

    (g) where applicable, whether the process or activity includes the use of animals in testing and for which endpoints.

    official amendment document ↗
99. Amendment 99Proposal for a regulation · Article 10 – paragraph 3 – point a
    Current text

    (a) substance identity;

    Amendment

    (a) chemical identity;

    official amendment document ↗
100. Amendment 100Proposal for a regulation · Article 10 – paragraph 3 – point f a (new)
     Amendment

     (fa) where applicable, whether the process or activity includes the use of animals in testing and for which endpoints.

     official amendment document ↗
101. Amendment 101Proposal for a regulation · Article 10 – paragraph 4
     Current text

     4. The information referred to in paragraph 3, points (a) to (f), on a specific regulatory process or activity shall be made available to the public once that process or activity has formally started.

     Amendment

     4. The information referred to in paragraph 3, points (a) to (fa), on a specific regulatory process or activity shall be made available to the public without undue delay.

     official amendment document ↗
102. Amendment 102Proposal for a regulation · Article 10 a (new)
     Amendment

     Article 10a Information on chemicals in articles 1. The ECHA shall establish and manage, as part of the common data platform, a database containing information on chemicals in articles generated or submitted as part of the implementation of Union chemicals legislation listed in Annex I. That database shall integrate the information required under Article 9(1)(i) of Directive 2008/98/EC and to Article 14 of Regulation (EU) 2024/1781. 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 availabl…

     Excerpt — full text in the official PDF.
     official amendment document ↗
103. Amendment 103Proposal for a regulation · Article 10 b (new)
     Amendment

     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 paragra…

     Excerpt — full text in the official PDF.
     official amendment document ↗
104. Amendment 104Proposal for a regulation · Article 11 – paragraph 2
     Current text

     2. The ECHA shall update the information in the database on a regular basis and in accordance with the governance scheme referred to in Article 4(3).

     Amendment

     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).

     official amendment document ↗
105. Amendment 105Proposal for a regulation · Article 13 – paragraph 1
     Current text

     1. At the latest within three years after the publication of the decision 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.

     Amendment

     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.

     official amendment document ↗
106. Amendment 106Proposal for a regulation · Article 13 – paragraph 2
     Current text

     2. Where the Commission or the 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 Commission or the Agency hosting or holding that data has completed, where relevant, validity and confidentiality assessments. The Commission and the 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.

     Amendment

     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…

     Excerpt — full text in the official PDF.
     official amendment document ↗
107. Amendment 107Proposal for a regulation · Article 13 – paragraph 3
     Current text

     3. Where researchers or research consortia funded by Union framework 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.

     Amendment

     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.

     official amendment document ↗
108. Amendment 108Proposal for a regulation · Article 13 – paragraph 4
     Current text

     4. By [OP please insert date: three years after the date of entry into force of this Regulation], the Commission shall adopt an implementing decision identifying existing datasets on environmental sustainability related data, other than those referred to in paragraph 2, for inclusion in the common data platform and shall design relevant related database functionalities.

     Amendment

     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.

     official amendment document ↗
109. Amendment 109Proposal for a regulation · Article 14 – paragraph 4
     Current text

     4. The Commission and the Agencies shall exchange data contained in the common data platform in the relevant standard format.

     Amendment

     4. The Authorities or national agencies shall exchange data contained in the common data platform in the relevant standard format.

     official amendment document ↗
110. Amendment 110Proposal for a regulation · Article 14 – paragraph 5 – point i a (new)
     Amendment

     (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).

     official amendment document ↗
111. Amendment 111Proposal for a regulation · Article 14 – paragraph 5 – point i b (new)
     Amendment

     (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).

     official amendment document ↗
112. Amendment 112Proposal for a regulation · Article 14 – paragraph 8
     Current text

     8. The Commission shall adopt an implementing decision to remedy the divergence.

     Amendment

     8. The Commission shall adopt an implementing act to remedy the divergence

     official amendment document ↗
113. Amendment 113Proposal for a regulation · Article 15 – paragraph 5 – point a
     Current text

     (a) make them available free of charge through the common data platform and as open datasets;

     Amendment

     (a) make them available free of charge through the common data platform as open datasets, supporting their re-use;

     official amendment document ↗
114. Amendment 114Proposal for a regulation · Article 15 – paragraph 8
     Current text

     8. The Commission shall adopt an implementing decision to remedy the divergence.

     Amendment

     8. The Commission shall adopt an implementing act to remedy the divergence

     official amendment document ↗
115. Amendment 115Proposal for a regulation · Article 15 a (new)
     Amendment

     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…

     Excerpt — full text in the official PDF.
     official amendment document ↗
116. Amendment 116Proposal for a regulation · Article 16 – paragraph 1
     Current text

     1. The Authorities shall have access to all the chemicals data contained in the common data platform, including data which is deemed to be confidential under Article 5(2), second sentence.

     Amendment

     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.

     official amendment document ↗
117. Amendment 117Proposal for a regulation · Article 16 – paragraph 2
     Current text

     2. The Authorities shall take the necessary measures to ensure that information contained in the common data platform marked as confidential in accordance with Article 5(2) is not made public.

     Amendment

     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.

     official amendment document ↗
118. Amendment 118Proposal for a regulation · Article 16 – paragraph 3
     Current text

     3. The general public shall have access to all the chemicals data contained in the common data platform and considered as available to the public in accordance with the Union act under which the data was generated or submitted.

     Amendment

     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).

     official amendment document ↗
119. Amendment 119Proposal for a regulation · Article 17 – paragraph 1
     Current text

     1. The Authorities may use the chemicals data contained in the common data platform in the performance of any of their activities, where those activities support the development or implementation of chemicals legislation and policy.

     Amendment

     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.

     official amendment document ↗
120. Amendment 120Proposal for a regulation · Article 17 – paragraph 2
     Current text

     2. Without prejudice to existing provisions enabling the sharing and use of chemicals data under the Union acts listed in Annexes I and II, Authorities shall not use chemicals data contained in the common data platform to fulfil any legal obligations of duty holders.

     Amendment

     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.

     official amendment document ↗
121. Amendment 121Proposal for a regulation · Article 17 – paragraph 3 a (new)
     Amendment

     3a. The common data platform shall also include terms and conditions, particularly regarding the respect of intellectual property rights and other related rights.

     official amendment document ↗
122. Amendment 122Proposal for a regulation · Article 18 – paragraph 1
     Current text

     1. The EEA, in collaboration with the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission, shall establish, operate, and maintain a framework of indicators to monitor the drivers and impacts of exposure to chemicals, measure the effectiveness of chemicals legislation and measure the transition towards the production of safe and sustainable chemicals.

     Amendment

     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.

     official amendment document ↗
123. Amendment 123Proposal for a regulation · Article 18 – paragraph 1 a (new)
     Amendment

     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.

     official amendment document ↗
124. Amendment 124Proposal for a regulation · Article 18 – paragraph 2
     Current text

     2. The framework of indicators referred to in paragraph 1 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.

     Amendment

     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.

     official amendment document ↗
125. Amendment 125Proposal for a regulation · Article 19 – paragraph 2 – subparagraph 1 – point b
     Current text

     (b) existing national early warning systems;

     Amendment

     (b) national early warning systems;

     official amendment document ↗
126. Amendment 126Proposal for a regulation · Article 19 – paragraph 2 – subparagraph 1 – point c
     Current text

     (c) data that the EEA holds;

     Amendment

     (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;

     official amendment document ↗
127. Amendment 127Proposal for a regulation · Article 19 – paragraph 2 – subparagraph 1 – point e a (new)
     Amendment

     (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];

     official amendment document ↗
128. Amendment 128Proposal for a regulation · Article 19 – paragraph 2 – subparagraph 1 – point e b (new)
     Amendment

     (eb) relevant information resulting from national enforcement programmes;

     official amendment document ↗
129. Amendment 129Proposal for a regulation · Article 19 – paragraph 2 – subparagraph 1 – point e c (new)
     Amendment

     (ec) relevant data or information submitted by researchers.

     official amendment document ↗
130. Amendment 130Proposal for a regulation · Article 19 – paragraph 3
     Current text

     3. The ECHA, the EFSA, the EU-OSHA and the EMA shall identify and gather relevant available data on early warning signals from the field falling within their mandate and provide this data to the EEA.

     Amendment

     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.

     official amendment document ↗
131. Amendment 131Proposal for a regulation · Article 19 – paragraph 4
     Current text

     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.

     Amendment

     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 d…

     Excerpt — full text in the official PDF.
     official amendment document ↗
132. Amendment 132Proposal for a regulation · Article 19 – paragraph 4 a (new)
     Amendment

     4a. Where the data analysis indicates there is a risk that warrants urgent action, the EEA shall inform the authorities without undue delay.

     official amendment document ↗
133. Amendment 133Proposal for a regulation · Article 19 – paragraph 5
     Current text

     5. The EEA shall make all relevant 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.

     Amendment

     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.

     official amendment document ↗
134. Amendment 134Proposal for a regulation · Article 19 – paragraph 5 a (new)
     Amendment

     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.

     official amendment document ↗
135. Amendment 135Proposal for a regulation · Article 20 – paragraph 1
     Current text

     1. The ECHA shall establish, operate and maintain an observatory for specific 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.

     Amendment

     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.

     official amendment document ↗
136. Amendment 136Proposal for a regulation · Article 20 – paragraph 2
     Current text

     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 decision. The Commission shall review the list of selected chemicals regularly adopt any revision thereof by the same means.

     Amendment

     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.

     official amendment document ↗
137. Amendment 137Proposal for a regulation · Article 20 – paragraph 4 – point c
     Current text

     (c) make compiled data publicly available through the common data platform or other communication and outreach tools as appropriate, to facilitate informed societal discussion and increase public awareness on the properties, use and safety aspects of specific chemicals, and regularly update that information.

     Amendment

     (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.

     official amendment document ↗
138. Amendment 138Proposal for a regulation · Article 21 – paragraph 1
     Current text

     1. Using the best independent resources available, the ECHA may commission scientific studies to support the implementation of Union acts on chemicals listed in Annex I within its mandate and to contribute to the support, evaluation or development of a Union chemicals policy.

     Amendment

     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.

     official amendment document ↗
139. Amendment 139Proposal for a regulation · Article 21 – paragraph 2
     Current text

     2. The Commission may request the ECHA to commission the scientific studies referred to in paragraph 1.

     Amendment

     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.

     official amendment document ↗
140. Amendment 140Proposal for a regulation · Article 21 – paragraph 3
     Current text

     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 not commission studies with a predominant research objective.

     Amendment

     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.

     official amendment document ↗
141. Amendment 141Proposal for a regulation · Article 21 – paragraph 3 a (new)
     Amendment

     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.

     official amendment document ↗
142. Amendment 142Proposal for a regulation · Article 21 – paragraph 5
     Current text

     5. The ECHA shall commission these scientific studies in an open and transparent manner.

     Amendment

     5. The ECHA shall commission these scientific studies in an open and transparent manner. The ECHA shall publish, on its website, the proposal for the study it intends to commission.

     official amendment document ↗
143. Amendment 143Proposal for a regulation · Article 21 – paragraph 6 a (new)
     Amendment

     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.

     official amendment document ↗
144. Amendment 144Proposal for a regulation · Article 21 – paragraph 6 b (new)
     Amendment

     6b. Every five years, the ECHA, in cooperation with the EFSA, shall commission a Union-wide human biomonitoring study that covers all Member States.

     official amendment document ↗
145. Amendment 145Proposal for a regulation · Article 21 – paragraph 6 c (new)
     Amendment

     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.

     official amendment document ↗
146. Amendment 146Proposal for a regulation · Article 22 – paragraph 1
     Current text

     1. Business operators shall notify to the Database of Study Notifications referred to in Article 9, without undue delay, any studies on chemicals 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 , prior to placing on the market, under the Union acts listed in Annex I. However, business operators 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.

     Amendment

     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…

     Excerpt — full text in the official PDF.
     official amendment document ↗
147. Amendment 147Proposal for a regulation · Article 22 – paragraph 2
     Current text

     2. For the purposes of paragraph 1, business operators shall notify to the Database of Study Notifications referred to in Article 9 the title, scope, laboratory, or testing facility carrying out the study, the intended starting and planned completion dates and, where relevant, whether the study is commissioned to comply with a decision of the ECHA pursuant to Articles 40, 41 or 46 of Regulation (EC) No 1907/2006.

     Amendment

     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.

     official amendment document ↗
148. Amendment 148Proposal for a regulation · Article 22 – paragraph 3
     Current text

     3. Laboratories and testing facilities shall also, without undue delay, notify any study commissioned by business operators to support a regulatory dossier on which an Agency is required to provide a scientific output, including a scientific opinion, 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.

     Amendment

     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.

     official amendment document ↗
149. Amendment 149Proposal for a regulation · Article 22 – paragraph 4
     Current text

     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 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.

     Amendment

     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.

     official amendment document ↗
150. Amendment 150Proposal for a regulation · Article 22 – paragraph 6
     Current text

     6. The obligations set under this article shall apply from [OP please insert date: 24 months after the date of entry into force of this Regulation].

     Amendment

     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].

     official amendment document ↗
151. Amendment 151Proposal for a regulation · Article 22 – paragraph 7
     Current text

     7. The ECHA shall lay down the practical arrangements for implementing the provisions of this Article.

     Amendment

     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.

     official amendment document ↗
152. Amendment 152Proposal for a regulation · Chapter VIII – title
     Current text

     VIII DELEGATED POWERS

     Amendment

     VIII DELEGATED POWERS AND COMMITTEE PROCEDURE

     official amendment document ↗
153. Amendment 153Proposal for a regulation · Article 23 – paragraph 2
     Current text

     2. The Commission is empowered to adopt delegated acts in accordance with Article 24 to amend Annex II by adding, where relevant, new categories of data types.

     Amendment

     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).

     official amendment document ↗
154. Amendment 154Proposal for a regulation · Article 24 a (new)
     Amendment

     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).

     official amendment document ↗
155. Amendment 155Proposal for a regulation · Article 25 – title
     Current text

     Enforcement

     Amendment

     Enforcement and cooperation on compliance

     official amendment document ↗
156. Amendment 156Proposal for a regulation · Article 26 a (new)
     Amendment

     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…

     Excerpt — full text in the official PDF.
     official amendment document ↗
157. Amendment 157Proposal for a regulation · Annex I – point 70 a (new)
     Amendment

     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)

     official amendment document ↗
158. Amendment 158Proposal for a regulation · Annex II – Part 1 – subparagraph 2
     Current text

     These data shall be limited to data submitted to the EMA in the context of the relevant procedures that are concluded after the date of entry into force of this Regulation. Where relevant, the data held by the EMA resulting from procedures concluded before the entry into force of this Regulation may also be considered for inclusion into the common data platform.

     Amendment

     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.

     official amendment document ↗
159. Amendment 159Proposal for a regulation · Annex II – Part 2 – subparagraph 2
     Current text

     These data shall be limited to data submitted to the EMA in the context of the relevant procedures that are concluded after the date of entry into force of this Regulation. Where relevant, data held by the EMA resulting from procedures concluded before the date of entry into force of this Regulation shall also be considered for inclusion into the common data platform.

     Amendment

     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.

     official amendment document ↗
160. Amendment 160Proposal for a regulation · Annex III – point 34 a (new)
     Amendment

     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)

     official amendment document ↗
161. Amendment 161Proposal for a regulation · Annex III a (new)
     Amendment

     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 suc…

     Excerpt — full text in the official PDF.
     official amendment document ↗
162. Amendment 162ENVIProposal for a regulation

     Replaces or inserts a longer passage — full text in the official document.

     official amendment document ↗