125 Amendments of Pierre JOUVET related to 2023/0453(COD)
Amendment 94 #
Proposal for a regulation
Recital 1
Recital 1
(1) The European Green Deal1 sets a high ambition for enabling the transition towards a toxic-free environment and zero pollution. The Chemicals Strategy for Sustainability2 is a crucial delivery of this zero-pollution ambition and introduces the ‘one substance, one assessment’ approach, which aims to improve the efficiency, effectiveness, coherence, and transparency of safety assessments of chemicals across Union legislation. According to that Strategy, ‘safe and sustainable by design’ criteria should be developed to enable the production and use of chemicals that are safe and sustainable throughout their entire lifecycle. The Strategy also sets out that the interaction between scientific developments and policy-making should be strengthened by means of an early warning system for chemicals and groups of chemicals to ensure that Union policies address emerging chemical risks as soon as these are identified by monitoring and research, and that a framework of indicators should be developed to monitor the drivers and impacts of chemical pollution and to measure the effectiveness of chemicals legislation. This Regulation aims to implement these objectives. _________________ 1 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM (2019) 640 final. 2 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Chemicals Strategy for Sustainability Towards a Toxic-Free Environment, COM (2020) 667 final,
Amendment 100 #
Proposal for a regulation
Recital 2
Recital 2
(2) The main objective of this Regulation is to increase the level of protection of the environment and human health from the risks arising from 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 transparency, accessibility, and usability of the data contained in that platform. This Regulation aims to create a common knowledge base on chemicals available to authorities to enable better, complete, coherent and robust scientific assessments of chemicals and their impacts and to ensure the best use of existing information for the purpose of the implementation and the development of Union legislation on chemicals. Moreover, the Regulation aims to provide a one-stop- shop on chemicals data and information in the Union accessible to the general public and, thus, to increase the predictability and the transparency of regulatory processes on chemicals, enable scrutiny by interested parties of data generated and used for regulatory purposes, as well as to strengthen public trust in the robustness of scientific decision-making.
Amendment 101 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2 a) People and other living organisms are exposed daily to a wide mix of chemicals originating and environmental stressors from various sources. However, the safety of chemicals in the EU is usually assessed through the evaluation of single chemicals without considering the combined exposure to multiple chemicals from different sources and over time. If some pieces of legislation require to assess the cumulative exposure to the same chemical from different sources, explicit requirements to take into account the impact of unintentional mixtures is generally lacking. The human exposome is a concept that provides a holistic view of human health and disease. It includes exposures from our diets, our lifestyles, and environmental factors, such as chemicals. This regulation should help gathering data on the impacts of the exposure to multiple chemicals and environmental factors to foster research on the human exposome and help to understand the causal pathways leading to common diseases such as cardiovascular disease, respiratory diseases, immunological disorders, mental health, and non-communicable diseases.
Amendment 102 #
Proposal for a regulation
Recital 4
Recital 4
(4) In its communication of 19 February 2020 on a European strategy for data4 , the Commission described its vision of a common European data space and highlighted the need for the development of sectoral data spaces in strategic areas, since not all sectors of the economy and society are moving at the same speed. This Regulation aims therefore to build a data space for chemicals by establishing a common data platform on chemicals (‘common data platform’), which is also part of the Green Deal data space, as referred to in the European strategy for data. Furthermore, in that strategy, the Commission highlighted several issues concerning the availability of data for the public good, including data availability, data infrastructures and governance, interoperability, as well as the lack of adequate sharing of data between public authorities. This Regulation aims to increase data availability on chemicals by requiring the relevant Union agencies and Member States' authorities to make data available for integration in the common data platform on chemicals, to promote interoperability of that data by providing for the establishment of standard formats and controlled vocabularies, as well as to facilitate data exchange and use by public authorities to enable them to effectively carry out their regulatory and policy developing tasks. _________________ 4 Communication from the Commission to the European Parliament, The Council, The European Economic and Social Committee and the Committee of the Regions, A European strategy for data, COM/2020/66 final.
Amendment 112 #
Proposal for a regulation
Recital 7
Recital 7
(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, exposure and fate of chemicals submitted by Member States to Union agencies or the Commission in compliance with their reporting obligations. The common data platform should also include chemicals data and information generated as part of Union, national or international programmes or research activities related to chemicals, where this data and information is held by the Commission or one of the relevant agencies.
Amendment 113 #
Proposal for a regulation
Recital 7
Recital 7
(7) The common data platform should contain all 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 this data and information is held by the Commission or one of the relevant agencies.
Amendment 117 #
Proposal for a regulation
Recital 8
Recital 8
(8) Due to the different nature of the risk and hazard assessments performed under Union acts on medicinal products, when compared to those performed under the main Union acts on chemicals, for medicinal products, only chemicals data related to environmental risk assessments for human and veterinary medicines, non- clinical studies for human medicines and maximum residue limit values the European Medicines Agency (‘EMA’) holds, as well as specific reference values, should be included in the common data platform. For medicinal active substances, only data on relevant substances should be included. These concern active substances covered by the medicines legislation and also used for other applications regulated by other Union legislation identified in this Regulation, as well as other active substances with particular persistent, bio-accumulative and toxic properties or with a known high level of residues in the environment.
Amendment 125 #
Proposal for a regulation
Recital 9
Recital 9
(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, and no later than 4 years after the entry into force of this Regulation, 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 129 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) Other chemicals data submitted or generated under Union legislation on medicinal products may also be of interest to chemicals regulatory areas, such as data related to other active substances contained in medicinal products, clinical data, data related to other substances contained in medicinal products besides active substances and data that is submitted to the EMA in the context of the relevant procedures that are finalised before the entry into force of this Regulation. Moreover, a relevant part of the medicinal data is held by the National Competent Authorities. At a later stage and no later than 5 years after the entry into force of this Regulation, the Commission should therefore assess, in close cooperation with Member States and the Agencies, whether such additional data should be included in the common data platform. This assessment should take also into account the relevancy, the anticipated added value as well as the cost-benefit balance of incorporating the additional data.
Amendment 145 #
Proposal for a regulation
Recital 17
Recital 17
(17) While the ECHA should identify and develop the technical functionalities of the common data platform in stages, certain dedicated services should be defined by this Regulation. As such, the common data platform should, in addition to providing access to chemicals-related data made available by the Agencies and the Commission, provide access to the chemicals data and information made available through its dedicated services. These dedicated services should be integrated into the common data platform and consist of the existing Information Platform for Chemical Monitoring (‘IPCHEM’), a repository of reference values, a database of study notifications, a database with information on regulatory processes, a database with information on applicable legal obligations, a repository of standard formats and controlled vocabularies, a database on environmental sustainability related data, a database on chemicals in products and their alternatives, as well as a dashboard of indicators on chemicals.
Amendment 146 #
Proposal for a regulation
Recital 18
Recital 18
(18) The Commission should adopt an implementation plan identifying initial 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, and required rules, formats and vocabularies for data integration, and maintain a rolling implementation plan to ensure the progress in identification and integration of new datasets of chemicals data and services for inclusion. The governance scheme should be adopted and updated as necessary by the Commission, after consultation with a newly established platform steering committee composed of representatives from Union agencies and the Commission. In order to ensure uniform conditions for the implementation of the obligations to establish an implementation plan and a governance scheme, implementing powers should be conferred on the Commission. _________________ 10 European Union Common Data Platform on Chemicals Project Initiation Document, v1.1 endorsed by the One Substance One Assessment Interservice Group 27 February 2023.
Amendment 148 #
Proposal for a regulation
Recital 19
Recital 19
(19) The common data platform should serve the widest possible community, with the ability to address new use cases, incorporate new relevant datasets, develop new functionalities, and respond to developing tools and applications. Other parties, such as Member States, scientific bodies of Member States or national authorities, academia, and civil society should be able to submit chemicals data to the Agencies or the Commission for hosting and maintenance.
Amendment 154 #
Proposal for a regulation
Recital 21
Recital 21
(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 legislation, 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 subject to this Regulation. The Commission should make such requests to the Agencies in accordance with their mandates and allocated tasks.
Amendment 155 #
Proposal for a regulation
Recital 23
Recital 23
(23) To improve the uptake of academic data and to expand the knowledge base for chemicals safety assessments and environmental sustainability impacts of chemicals, researchers or research consortia funded by Union framework programmes should make available, in line with the ‘as open as possible, as closed as necessary’ principle, any human biomonitoring data they collect or generate resulting from research and development programmes to the EEA and any environmental sustainability data on chemicals or materials they collect or generate to the ECHA. Member States should require researchers or research consortia funded by national framework programmes to make their data that is relevant for regulatory purposes available to the EEA or to ECHA.
Amendment 159 #
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23 a) Independent research studies are often given comparatively low weight as evidence in hazard and risk assessment of chemicals 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 a guidance setting minimum quality and reporting requirements to improve the uptake of research data.
Amendment 161 #
Proposal for a regulation
Recital 24
Recital 24
(24) The EEA, as the agency responsible for monitoring data and information on chemicals in the environment, should also be responsible for collecting, hosting, and maintaining human biomonitoring data. 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 processes that data to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure, to develop health risk and impact indicators, to monitor the impact of regulatory intervention, and to support regulatory risk assessments. _________________ 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, 21.11.2018, p. 39).
Amendment 163 #
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24 a) 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 constitutes 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 that data only where the processing is necessary for reasons of substantial public interest, as laid out in Article 10(2)(g) and for scientific research as laid out in Article 10(2)(j) of the Regulation (EU) No 2018/1725. The present Regulation lays down the cases where there is such substantial public interest in processing human biomonitoring data constituting personal data.
Amendment 166 #
Proposal for a regulation
Recital 24 b (new)
Recital 24 b (new)
(24 b) The EEA should be allowed to process human biomonitoring data to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure, to develop health risk and impact indicators, to monitor the impact of regulatory intervention, and to support regulatory risk assessments, risk management and policy making. The Commission should be allowed to process human biomonitoring data constituting personal data, notably for scientific research, to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure of populations to chemicals, to develop indicators on health risks associated to such exposure, as well as to measure the efficiency and effectiveness of regulatory measures in preventing exposure by analysing, for example, co-exposure to multiple chemicals for which data on co- occurrence of various chemicals per individual is necessary to observe common patterns and draw conclusions for populations, and supporting further risk assessments and risk management. The ECHA should also be allowed to act as a data processor for human biomonitoring data constituting personal data for the performance of assessments on chemicals, such as risk and safety assessments. Individual measurements of chemicals in human matrices may assist regulatory exposure and risk assessment, such as in the formulation of an opinion of the ECHA’s Risk Assessment Committee, and lead to recommendations of risk management measures. The EFSA and the EMA should also be allowed to act as a data processor for human biomonitoring data constituting personal data, notably to support the prioritisation of regulatory actions. The EU-OSHA should be allowed to process human biomonitoring data constituting personal data, notably for scientific research, to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure of populations to chemicals, as well as to measure the efficiency and effectiveness of regulatory measures in preventing exposure. Such data is also useful for the EFSA when conducting assessments of chemicals in food and for understanding the effectiveness of existing measures in preventing human contamination through the food and feed chains. When processing human biomonitoring data constituting personal data, the EEA, the ECHA, the EFSA, the EMA , the EU- OSHA, and the Commission should pay particular attention to compliance with Article 13 of Regulation (EU) No 2018/1725.
Amendment 168 #
Proposal for a regulation
Recital 24 c (new)
Recital 24 c (new)
(24 c) Human biomonitoring data collected prior to the coming into force of this Regulation is necessary to ensure the completeness, quality, and relevance of the human biomonitoring datasets for the purposes of guaranteeing the substantial public interests, and scientific research purposes as listed in this Regulation. Therefore, any such data gathered prior to the coming into force of this Regulation should be able to be processed by the EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission when this Regulation comes into force.
Amendment 170 #
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26 a) There are data gaps on the occurrence of hazardous and other harmful chemicals in products on the EU 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 maintain a repository of information on chemicals in products and their available alternatives generated under Union acts listed in Annex I. In addition, ECHA should integrate into the common data platform all chemicals data related to chemicals present in products or used in production processes and which is accessible through the web portal under Article 14 of Regulation (EU) 2024/178.
Amendment 171 #
Proposal for a regulation
Recital 27
Recital 27
(27) In order to promote the use and harmonisation of reference values among risk assessors and risk managers across different Union acts and to facilitate compliance with, and enforcement of, regulatory reference values, the ECHA should establish and maintain a repository of reference values established or adopted under the Union acts listed in Annexes I and II The Agencies should provide the ECHA with reference values they hold or establish as part of their activities. In addition, the ECHA should regularly screen Union acts for reference values adopted under them. To facilitate automatic access of the general public to up-to-date reference values, the ECHA should integrate the repository of reference values in the common data platform as a dedicated service, include in that repository all reference values together with the relevant context data it has received or retrieved and ensure that those values and that context data are machine readable. For a reference value for the carcinogenic effect of a chemical for which no maximum exposure level can be specified below which no harmful effects on human health are to be expected, the statistical cancer risk associated with that reference value should also be specified, if available.
Amendment 187 #
Proposal for a regulation
Recital 31
Recital 31
(31) While the study notification obligation established in this Regulation should apply in the context of all the Union acts on chemicals listed in Annex I, the various relevant data collection and safety assessment processes under those acts may vary widely procedurally. The overarching aim of the database of study notifications established under this Regulation should be to bring together information on studies on chemicals being commissioned by business operators, such as to enable a centralised and complete overview of the studies being performed to support regulatory compliance under Union acts on chemicals as listed in Annex I. On the basis of this objective and considering the fact that assessment procedures under Union acts on chemicals in Annex I may vary widely, it would be beyond the scope and aim of this Regulation to amend existing assessment processes set under those Union acts listed in Annex I by imposing additional conditions leading to potential market access consequences not foreseen in those Union acts. Consequently, it is not appropriate to introduce in this Regulation the consequences associated with non- compliance with the study notification obligation as laid out in Article 32b of Regulation (EC) No 178/2002 of the European Parliament and of the Council.
Amendment 202 #
Proposal for a regulation
Recital 38
Recital 38
(38) In order to ensure chemicals data are easily findable within the database and to avoid duplicates, each chemical contained in the common data platform shall be identified by a unique chemical identifier and a chemical notation specifying its molecular structure. In order to ensure the interoperability and comparability of chemicals data and to facilitate their automatic and electronic exchange, the Agencies and the Commission should store chemicals data in adequate and mutually coherent and interoperable formats and use mutually coherent and interoperable controlled vocabularies. Some Union acts listed in Annex I or II set procedures to establish or make available data formats, in particular for the submission of chemicals data by business operators or Member States. Where such procedures do not exist in the Union acts listed in Annex I or II, the Agencies and the Commission should, where relevant, specify appropriate formats for chemicals data they receive and store, avoiding the use of proprietary standards while, as appropriate, using OECD or other internationally agreed formats, making use of existing formats and ensuring interoperability with existing data submission approaches.
Amendment 206 #
Proposal for a regulation
Recital 41
Recital 41
(41) The International Uniform Chemical Information Database (‘IUCLID’) is a software application designed to record, store, maintain and exchange data on chemicals. The ECHA develops and maintains the IUCLID software and the underlying format in collaboration with the Organisation for Economic Cooperation and Development (‘OECD’). The IUCLID implements all OECD-harmonised templates, which are harmonised formats agreed at the OECD level to facilitate structured and consistent documentation of test outputs and similar chemicals data. Since chemicals data is being submitted to the ECHA in IUCLID under Union acts such as Regulations (EC) No 1907/2006, (EC) No 1107/200913 and (EU) No 528/201214 of the European Parliament and of the Council, the ECHA is closely involved in the continued development of IUCLID, and IUCLID implements the standard formats agreed at the OECD level, it is appropriate and necessary to require the Commission and the AgencAuthorities to use IUCLID for the relevant parts of dossiers under specified Union acts listed in Annex I when they make the data contained in those dossiers available to the ECHA . _________________ 13 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). 14 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167 27.6.2012, p. 1).
Amendment 207 #
Proposal for a regulation
Recital 42
Recital 42
(42) To increase the availability and facilitate the use of information on the environmental performance of chemicals throughout their lifecycle, and to enable a comprehensive assessment of the impacts of chemicals on the environment and health, the Commission should identify relevant data and information related to the environmental sustainability and health impacts 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 and health related data and has designed the relevant related database functionalities, the ECHA should establish a database on environmental sustainability- and health- related data, collect the data as made available by the Commission, the Agencies and, where relevant, by the researchers and research consortia funded by Union framework programmes, and integrate the content of that database into the common data platform as a dedicated service. In order to ensure uniform conditions for the implementation of the obligation to identify relevant environmental sustainability and health datasets of chemicals datasets, implementing powers should be conferred on the Commission.
Amendment 210 #
Proposal for a regulation
Recital 43
Recital 43
(43) To monitor the impacts on humans and the environment, including the climate, of exposure to chemicals and to establish a knowledge base to measure the effectiveness of chemicals legislation in protecting human health and the environment, the EEA and the ECHAAgencies 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- OSHAIn order to monitor the aggregated risk for territories associated to the impacts on humans and the environment, including the climate, of exposure to chemicals and pollutants, the Agencies should jointly develop and regularly, at least every two years, update an aggregated indicator at different territorial level, in collaboration with the Joint Research Centre and drawing inspiration from its European wide vulnerability framework1a. The EEA should cross-reference the results of this indicator with other health and environment datasets, such as epidemiological data on occupational health, life-style factors, and socio- economic factors, in order to assess the impacts and risks of cumulated risk factors on population at the territorial level. The Agencies 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 ECHAAgencies should integrate this dashboard of indicators into the common data platform. _________________ 1a Eklund, L.G., Sibilia, A., Salvi, A., Antofie, T., Rodomonti, D., Salari, S., Poljansek, K., Marzi, S., Gyenes, Z. and Corban, C., Towards a European wide vulnerability framework, Publications Office of the European Union, Luxembourg, 2023, doi:10.2760/353889, JRC118850.
Amendment 212 #
Proposal for a regulation
Recital 43 a (new)
Recital 43 a (new)
(43 a) In order to ensure the widest possible access to chemicals data and to improve trust in the implementation of this Regulation and Union policies on chemicals, and further acknowledging existing experience with citizen science approaches, natural or legal person should be able to submit substantiated concerns regarding impacts of chemicals on humans and the environment, such as peer-reviewed research results, or biomonitoring data. The authorities should assess submitted evidence and take action when they identify a concern. In line with commitments of the Union in relation to the Aarhus Convention, individuals submitting evidence should be equipped with procedural rights to ensure their concerns are appropriately taken into account.
Amendment 213 #
Proposal for a regulation
Recital 44
Recital 44
(44) This Regulation should establish an early warning and action system as regards existing and emerging chemical risks. To enable the identification and evaluation of emerging chemical risks, the EEA should develop and compile information on early warning signals and draw up an annual summary report to inform regulatory follow-up actions by authorities. In its work, the EEA should include its own sources, targeted literature searches and make use of information from national early warning systems. It should also include relevant information made available by the related work of the ECHA, the EFSA, the EU-OSHA, the EMA and their networks, such as the EFSA’s task of identifying and collecting information on emerging risks under Regulation 178/2002. The EEA should make the summary report and the underlying data available through the common data platform, ensuring public access and its use for further action on existing and emerging risks of chemicals, groups of chemicals, and cumulative exposure to chemicals. In order to allow the EEA sufficient time to organise the collection of early warning signals and to compile and analyse the initial information the EEA should only deliver the first report six months after the end of the first calendar year after entry into force of this Regulation. this Regulation sets a deadline for the first report and associated data. For any risk and warning signal identified by the report, the Authorities should consider undertaking regulatory, policy or enforcement actions and provide justification when they decide not to proceed with any action. Emerging chemicals risks identified in the early warning and action system should also be taken into account when setting priorities for the strategic planning of Horizon Europe.
Amendment 216 #
Proposal for a regulation
Recital 46
Recital 46
(46) The ECHA should continue operating the EUON and transform it into an observatory for specific chemicals, or groups of chemicals with potential contribution to emerging chemical risks (‘the observatory’), which should cover also other chemicals and innovative (rationally designed complex ‘advanced’) materials selected by the Commission, using, as appropriate, signals from the early warning and action system. One of the criteria for selecting chemicals for the observatory should be their novelty and disruptive potential that may contribute to an emerging chemical risk. Another criterion for that selection should be the higher degree of uncertainty surrounding them and, due to less regulatory experience regarding those chemicals, the resulting need for additional scrutiny and transparency. The observatory should facilitate regulatory implementation and responsible use of these chemicals by collecting, generating, and disseminating reliable information on selected chemicals’ properties, uses and market presence to the general public.
Amendment 220 #
Proposal for a regulation
Recital 48
Recital 48
(48) Under Regulation (EC) No 178/2002, the EFSA is able to commission, in an open and transparent manner, the scientific studies it needs to accomplish its mission, while seeking to avoid duplication with Member States or Union research programmes. The ECHA should also be able to commission studies to obtain adequate data and information on chemicals, groups of chemicals, and the risk of their cumulative exposure thereof, within its mission, while maintaining the principle that the burden to prove compliance with Union chemicals legislation remains on the duty holder. Furthermore, the ECHA should commission such studies out of its own initiative or at the request of the Commission, with the objective of supporting the effective and efficient implementation and evaluation of Union acts on chemicals within its mandate and contributing the development of a Union chemicals policy.
Amendment 221 #
Proposal for a regulation
Recital 48 a (new)
Recital 48 a (new)
(48 a) 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 the adequacy between the resources of the agencies and their current tasks, their new tasks under this Regulation, and a prospective view of the ressources needed to address key areas of regulatory challenge in the future. The Commission should also draw up a report on the impacts of cumulative exposure to chemicals on health and the environment, and analysing the efficacy of the current risk assessment of chemicals across Union legislation to adequately address the combination effect of chemical mixtures and to ensure a high level of protection of health and the environment.
Amendment 225 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation aims to ensure the efficient delivery of coherent hazard and risk assessments of chemicals where those assessments are required by Union legal acts, to achieve a high level of protection of human health and the environment, to enable the development and use of safe and sustainable chemicals, to ensure the proper functioning of the single market for chemicals, to enable scrutiny by interested parties of data generated and used for regulatory purposes, and to improve the Union’s citizens’ trust in the scientific base for the decisions taken under Union legal acts on chemicals.
Amendment 244 #
Proposal for a regulation
Article 2 – paragraph 1 – point 10
Article 2 – paragraph 1 – point 10
10. ‘chemicals data’ means any representation of facts or information relating to chemicals and any compilation of such facts or information, including information on physico-chemical properties, hazard properties, use, exposure, risk, occurrence, emissions, fate, and manufacturing process of the chemicals, as well as environmental sustainability related information, including climate change related information, on those chemicals, regulatory process-related information on chemicals, information on availability and suitability of alternatives, standard formats, controlled vocabularies, or any information on applicable legal obligations related to chemicals and the enforcement thereof;
Amendment 250 #
Proposal for a regulation
Article 2 – paragraph 1 – point 11 a (new)
Article 2 – paragraph 1 – point 11 a (new)
11 a. '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;
Amendment 256 #
Proposal for a regulation
Article 3 – paragraph 2 – point a
Article 3 – paragraph 2 – point a
(a) generated or submitted as part of the implementation of the Union acts listed in Annex I to this Regulation and held by the Agencies or, the Commission or Member States autorities ('the Authorities');
Amendment 259 #
Proposal for a regulation
Article 3 – paragraph 2 – point b
Article 3 – paragraph 2 – point b
(b) generated as part of Union, national or international programmes or research activities in the sphere of chemicals and held by the ECHA, the EEA, the EFSA, the EU-OSHA or the CommissionAuthorities;
Amendment 263 #
Proposal for a regulation
Article 3 – paragraph 2 – point c a (new)
Article 3 – paragraph 2 – point c a (new)
(c a) generated under Regulation (EU) 2024/1781 and accessible through the web portal under Article 14 of that regulation.
Amendment 268 #
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
Amendment 270 #
Proposal for a regulation
Article 3 – paragraph 4 a (new)
Article 3 – paragraph 4 a (new)
4 a. 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.
Amendment 272 #
Proposal for a regulation
Article 3 – paragraph 5 – point d a (new)
Article 3 – paragraph 5 – point d a (new)
(d a) information on chemicals in products and their alternatives referred to in Article 10a;
Amendment 274 #
Proposal for a regulation
Article 3 – paragraph 5 – point g
Article 3 – paragraph 5 – point g
(g) the database on environmental sustainability and health-related data referred to in Article 13.
Amendment 278 #
Proposal for a regulation
Article 3 – paragraph 6
Article 3 – paragraph 6
6. The Authorities and the general public shall have access free of charge to the data contained in the common data platform in accordance with Article 16.
Amendment 281 #
Proposal for a regulation
Article 3 – paragraph 11
Article 3 – paragraph 11
11. The common data platform and its dedicated services shall be established by [OP: please insert date: threone years after the date of entry into force of this Regulation], unless specified otherwise. The relevant datasets of chemicals data, including those generated or submitted before the entry into force of this Regulation, unless specified otherwise shall be integrated progressively into the common data platform by [OP please insert date: tensix 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 286 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. By [OP please insert date: 6 months after the date of entry into force of this Regulation] the Commission shall adopt and publish 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 an implementing decisionacts. Subsequent rolling implementation plans shall be adopted in line with the governance scheme referred to in paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2).
Amendment 288 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. The Commission shall, by means of an implementing decisionacts, 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. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2).
Amendment 290 #
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. The Commission shall adopt and publish the governance scheme referred to in paragraph 3 and any revision thereof by means of an implementing decisionimplementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2).
Amendment 297 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. At the Commission’s request, the Agencies shall host and maintain chemicals data generated as part of Union, national or international legislation, programmes or research activities, corresponding to their mandate and the type of data they already hold. The Agencies may host and maintain chemicals data corresponding to their mandate and submitted to them by Member States or other parties.
Amendment 307 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Where the Commission or the AgencAuthorities 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 AgencAuthorities shall indicate whether that data or information is made available to the publicconfidential in accordance with the provisions on confidentiality under the originating Union act.
Amendment 310 #
Proposal for a regulation
Article 5 – paragraph 5
Article 5 – paragraph 5
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]. For human biomonitoring data constituting personal data, the EEA shall specify which type of data shall be made available to it.
Amendment 313 #
Proposal for a regulation
Article 5 – paragraph 5 a (new)
Article 5 – paragraph 5 a (new)
5 a. Member States shall require researchers or research consortia funded by national programmes to 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 shall be made available to it.
Amendment 314 #
Proposal for a regulation
Article 5 – paragraph 6
Article 5 – paragraph 6
6. Researchers or research consortia funded by Union framework programmes shall make available to the ECHA any chemicals data other than biomonitoring data, including environmental sustainability and health-related data on chemicals or materials they collect or generate from [OP please insert: date of the entry into force of this Regulation].
Amendment 316 #
Proposal for a regulation
Article 5 – paragraph 6 a (new)
Article 5 – paragraph 6 a (new)
6 a. Member States shall require researchers or research consortia funded by national programmes, to make available to the ECHA any chemicals data relevant for regulatory purposes other than biomonitoring data, including environmental sustainability and health related data on chemicals or materials they collect or generate from [OP please insert: 6 months after the entry into force of this Regulation].
Amendment 318 #
Proposal for a regulation
Article 5 – paragraph 7
Article 5 – paragraph 7
7. The Commission and the AgencAuthorities 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 320 #
Proposal for a regulation
Article 5 – paragraph 8
Article 5 – paragraph 8
8. For the purpose of paragraph 2, the Commission and the AgencAuthorities 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 321 #
Proposal for a regulation
Article 5 – paragraph 9
Article 5 – paragraph 9
9. The Commission and the AgencAuthorities 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 323 #
Proposal for a regulation
Article 6 – paragraph 4 – introductory part
Article 6 – paragraph 4 – introductory part
4. HThe EEA may process human biomonitoring data constituting personal data may be processed by the EEA for the following purposes only:
Amendment 326 #
Proposal for a regulation
Article 6 – paragraph 4 – point e a (new)
Article 6 – paragraph 4 – point e a (new)
(e a) supporting regulatory risk management;
Amendment 327 #
Proposal for a regulation
Article 6 – paragraph 4 – point e b (new)
Article 6 – paragraph 4 – point e b (new)
(e b) supporting policy making and legislative processes at Union level;
Amendment 328 #
Proposal for a regulation
Article 6 – paragraph 4 – point e c (new)
Article 6 – paragraph 4 – point e c (new)
(e c) 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.
Amendment 329 #
Proposal for a regulation
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
4 a. 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 actions; (g) supporting regulatory risk assessment and risk management.
Amendment 330 #
Proposal for a regulation
Article 6 – paragraph 4 b (new)
Article 6 – paragraph 4 b (new)
4 b. The ECHA may process human biomonitoring data constituting personal data for the following purposes only: (a) evaluating and prioritising required regulatory actions; (b) performing assessments of chemicals; (c) supporting regulatory risk management; (d) as part of the commissioning of studies under the data generation mechanism referred to in Article 21.
Amendment 331 #
Proposal for a regulation
Article 6 – paragraph 4 c (new)
Article 6 – paragraph 4 c (new)
4 c. 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.
Amendment 332 #
Proposal for a regulation
Article 6 – paragraph 4 d (new)
Article 6 – paragraph 4 d (new)
4 d. 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.
Amendment 333 #
Proposal for a regulation
Article 6 – paragraph 4 e (new)
Article 6 – paragraph 4 e (new)
4 e. 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 actions; (f) supporting regulatory risk management.
Amendment 334 #
Proposal for a regulation
Article 6 – paragraph 4 f (new)
Article 6 – paragraph 4 f (new)
4 f. 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 paragraph 4, 4a, 4b, 4c, 4d, and 4e shall not entail the sharing of such data with third parties.
Amendment 335 #
Proposal for a regulation
Article 6 – paragraph 6
Article 6 – paragraph 6
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 ithey holds or hosts and or processes for the purposes referred to in paragraph 24, 4a, 4b, 4c, 4d and 4e.
Amendment 336 #
Proposal for a regulation
Article 6 – paragraph 6 a (new)
Article 6 – paragraph 6 a (new)
6 a. The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission shall define the storage period and any review thereof for the human biomonitoring data constituting personal data they hold as well as the criteria used to define the storage period.
Amendment 337 #
Proposal for a regulation
Article 6 – paragraph 6 b (new)
Article 6 – paragraph 6 b (new)
6 b. The human biomonitoring data referred to in this Article includes personal data lawfully collected before the entry into force of this Regulation.
Amendment 346 #
Proposal for a regulation
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
4 a. 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 it in the standard formats provided for in Article 14, where developed.
Amendment 350 #
Proposal for a regulation
Article 9 – paragraph 3 a (new)
Article 9 – paragraph 3 a (new)
3 a. Authorities and national enforcement authorities shall have access to the data contained in the Database of Study Notifications before that data is integrated in the common data platform.
Amendment 355 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. The ECHA shall establish and manage, as part of the common data platform, a new database containing information on regulatory processes on individual substancechemicals or groups of substancechemicals 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 357 #
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
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:
Amendment 359 #
Proposal for a regulation
Article 10 – paragraph 2 – point a (new)
Article 10 – paragraph 2 – point a (new)
(a) chemical identity;
Amendment 361 #
Proposal for a regulation
Article 10 – paragraph 2 – point b (new)
Article 10 – paragraph 2 – point b (new)
(b) the Union act and the regulatory process under which the activity takes place;
Amendment 363 #
Proposal for a regulation
Article 10 – paragraph 2 – point c (new)
Article 10 – paragraph 2 – point c (new)
(c) submitter or actor responsible for the regulatory process or activity;
Amendment 365 #
Proposal for a regulation
Article 10 – paragraph 2 – point d (new)
Article 10 – paragraph 2 – point d (new)
(d) status of the regulatory process or activity;
Amendment 367 #
Proposal for a regulation
Article 10 – paragraph 2 – point e (new)
Article 10 – paragraph 2 – point e (new)
(e) outcome of the regulatory process or activity, including, where applicable, reports or opinions adopted;
Amendment 369 #
Proposal for a regulation
Article 10 – paragraph 2 – point f (new)
Article 10 – paragraph 2 – point f (new)
(f) where applicable, date of intention to start the regulatory process or activity, completion and latest update.
Amendment 370 #
Proposal for a regulation
Article 10 – paragraph 3 – point a
Article 10 – paragraph 3 – point a
(a) substancechemical identity;
Amendment 376 #
Proposal for a regulation
Article 10 a (new)
Article 10 a (new)
Article 10a Information on chemicals in products and their alternatives 1. The ECHA shall establish and manage, as part of the common data platform, a new database containing information on chemicals in products and their alternatives generated or submitted as part of the implementation of Union chemicals legislation listed in Annex I. This database shall integrate the information subject to paragraph 2 of Article 3, point (ca). 2. Where Member State competent authorities as referred to in any of the Union acts listed in Annex I hold the information referred to in paragraph 1, they shall make that information available to the Union agency responsible under the respective Union act listed in Annex I without undue delay. 3. Where the ECHA, the EEA, the EFSA, the EU-OSHA or the Commission hold the information referred to in paragraph 1, they shall make that information available to the ECHA for integration in the common data platform in the standard formats provided for in Article 14 without undue delay and, where relevant, once the responsible agency or the Commission has performed the validity assessment. For each chemical in a product, where available, at least the following information shall be included: (a) chemical identity; (b) product uses identified; (c) uses for which available alternatives have been identified; (d) alternatives identified for each use; (e) available information on the suitability of alternatives; (f) available information on substitution plans and efforts for each use; 4. The ECHA shall encourage providers of alternatives referred to in paragraph 3 points (c) and (d) to identify themselves.
Amendment 382 #
Proposal for a regulation
Article 13 – title
Article 13 – title
Database on environmental sustainability and health related data
Amendment 385 #
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. At the latest within threOne 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 and health related data.
Amendment 388 #
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. Where the Commission or the AgencAuthorities host or hold environmental sustainability or health 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 AgencAuthority hosting or holding that data has completed, where relevant, validity and confidentiality assessments. The Commission and the AgencAuthorities shall provide the necessary technical cooperation to the ECHA to enable the integration of environmental sustainability related and health data in the database on environmental sustainability and health related data.
Amendment 393 #
Proposal for a regulation
Article 13 – paragraph 3 a (new)
Article 13 – paragraph 3 a (new)
3 a. The ECHA shall integrate the environmental sustainability or health related data on chemicals or materials, made available in accordance with Article 5(6a), in the database on environmental sustainability and health related data.
Amendment 396 #
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. By [OP please insert date: threone 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 398 #
Proposal for a regulation
Article 14 – paragraph 4
Article 14 – paragraph 4
4. The Commission and the AgencAuthorities shall exchange data contained in the common data platform in the relevant standard format.
Amendment 400 #
Proposal for a regulation
Article 14 – paragraph 5 – introductory part
Article 14 – paragraph 5 – introductory part
5. The Commission and the AgencAuthorities shall use the International Uniform Chemical Information Database format (IUCLID) for making available to the ECHA for integration in the common data platform the relevant parts of dossiers under the following Union acts:
Amendment 402 #
Proposal for a regulation
Article 14 – paragraph 5 – point i a (new)
Article 14 – paragraph 5 – point i a (new)
(i a) 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
Amendment 403 #
Proposal for a regulation
Article 14 – paragraph 5 – point i b (new)
Article 14 – paragraph 5 – point i b (new)
(i b) 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
Amendment 413 #
Proposal for a regulation
Article 15 a (new)
Article 15 a (new)
Article 15a Uptake of research data 1. Researchers shall be able to submit publicly available research data on chemicals related to an entry in the common data platform. Research data shall be submitted in a format prescribed by the ECHA. 2. By [OP: insert 18 months after the entry into force of this Regulation], the ECHA shall establish and maintain an online platform for the submission process referred to in paragraph 1. 3. The ECHA shall assess the compliance of research data submitted through the portal referred to in paragraph 2 with the requirements set in the guidance referred to in paragraph 4. Where research data submitted are deemed to fulfil these requirements, the data shall be hosted on the common data platform together with the corresponding entry. 4. By [OP: insert 12 months after the entry into force of this Regulation], the Commission shall publish a guidance setting minimum quality and reporting requirements to improve the uptake of research data. 5. In order to ensure a uniform format of the research data submitted, the Commission shall, by means of implementing acts, adopt a standard format for the submission of research data. Those implementing acts shall be adopted by [OP: please insert the date = 12 months after the entry into force of this Regulation], in accordance with the examination procedure referred to in Article 24a(2).
Amendment 424 #
Proposal for a regulation
Article 16 – paragraph 3
Article 16 – paragraph 3
3. The general public shall have access to all the chemicals data contained in the common data platform and considered as available to the publ, except data which in accordance with the Union act under which the data was generated or submitteds deemed to be confidential under Article 5(2), second sentence.
Amendment 427 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
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, or enforcement of chemicals legislation and policy.
Amendment 429 #
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
2. Without prejudice to existing provisions enabling the sharing and use of chemicals data under the Union acts listed in Annexes I and II, and to the possibility of identifying data gaps in the applications received from business operators, Authorities shall not use chemicals data contained in the common data platform to fulfil any legal obligations of duty holders.
Amendment 434 #
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. The EEA, in collaboration with the ECHA, the EFSA, the EMA, the EU- OSHA and the Commission, shall establish, operate, and maintain, and update as appropriate a framework of indicators to monitor chemical pollution along 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 measure the transition towards the production of safe and sustainable chemicals.
Amendment 437 #
Proposal for a regulation
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
1 a. The EEA, on the basis of the framework of indicators referred to in paragraph 1, as well as data from the database on environmental sustainability and health related data referred to in Article 13, the Union early warning system for emerging chemical risks referred to in Article 19, and human biomonitoring data shall establish, operate, maintain, and update as appropriate an aggregated territory-based risk indicator at different administrative levels (Country, NUTS2 and NUTS3) based on the Nomenclature of territorial units for statistics (NUTS) as defined in Regulation (EC) No 1059/200, to monitor time and spatial trends in exposure of populations to individual and multiple chemicals and health risks associated to such exposure and co-exposure. Where possible, the EEA shall cross- reference the results of the aggregated risk indicator with other health and environment datasets, including epidemiological data, to identify potential emerging risks for the purpose of Article 19.
Amendment 438 #
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. The framework of indicators referred to in paragraph 1, and the aggregated indicator referred to in paragraph 1a, shall be accessible in the form of an indicator dashboard, which the EEA shall establish and which the ECHA shall make available through the common data platform.
Amendment 440 #
Proposal for a regulation
Article 18 a (new)
Article 18 a (new)
Article 18a Substantiated concerns 1. Any natural or legal person, individually or in association, shall be entitled to submit to an Agency a substantiated concern regarding impacts of chemicals on humans and the environment, relating in particular to the properties, use, exposure, risk, occurrence and emissions of chemicals or groups of chemicals, and which is based on objective and verifiable information such as peer-reviewed studies, human biomonitoring data, or environmental monitoring data. 2. Where the concern does not correspond to the mandate of the Agency to which it is submitted, this Agency shall make it available to the authority or authorities with a corresponding mandate. 3. The authority or authorities with a mandate corresponding to the submitted concern shall diligently and impartially assess it and, where appropriate, take one or more of the following actions: (a) regulatory measures under Union legislation, including by imposing obligations on duty holders, such as to corroborate the evidence or mitigate any detrimental effects; (b) initiate or develop new policies addressing the concern submitted; (c) transfer the concern indicating a non- compliance to enforcement agencies. 4. The authority or authorities shall, within 6 months, inform the natural or legal persons referred to in paragraph 1 of any decision taken under paragraph 3, providing the reasons for such decision. 5. The ECHA shall publish an annual report compiling all substantiated concerns submitted under paragraph 1 and the information subject to paragraph 3. The report shall be integrated in the common data platform without undue delay.
Amendment 443 #
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 1 – point c
Article 19 – paragraph 2 – subparagraph 1 – point c
(c) data that the EEA holds, including data from the framework of indicators, and the aggregated indicator as referred to in Article 18;
Amendment 445 #
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 1 – point e a (new)
Article 19 – paragraph 2 – subparagraph 1 – point e a (new)
(e a) substantiated concerns submitted in accordance with Article 18a and made available by an Agency.
Amendment 449 #
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. The ECHA, the EFSA, the EU- OSHA and the EMA shall identify and gather relevant available data on early warning signals obtained in accordance with this Regulation or from the field falling within their mandate and provide this data to the EEA to host it.
Amendment 450 #
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
4. The EEA shall draw up an annual report, compiling and analysing the data on early warning signals gathered in accordance with paragraphs 2 and 3. [The first report shall be prepared by [OP: please insert date: 6 months after the end of the first calendar year after entry into force of this Regulation]. The EEA shall present this report to the Commission, relevant Union agencies and Member State competent authorities for consideration of the need for regulatory or policy action related to the early warning signals. Within six months of the presentation of the report, the Authorities shall consider undertaking regulatory, policy or enforcement actions accordingly or and justify if they decide not to proceed with any action related to any of the early warning signals identified by the report.
Amendment 454 #
Proposal for a regulation
Article 19 – paragraph 5
Article 19 – paragraph 5
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 457 #
Proposal for a regulation
Article 19 – paragraph 5 a (new)
Article 19 – paragraph 5 a (new)
5 a. Where the data analysis indicates there is a risk that warrants urgent action, the EEA shall inform the authorities without undue delay.
Amendment 458 #
Proposal for a regulation
Article 19 – paragraph 5 b (new)
Article 19 – paragraph 5 b (new)
5 b. The Commission shall take into account the emerging chemicals risks identified in accordance with this Article in the strategic planning of R&I activities of Regulation (EU) 2021/6951a, where relevant. _________________ 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
Amendment 459 #
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. The ECHA shall establish, operate and maintain an observatory for specific chemicals or group 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.
Amendment 461 #
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. By [OP please insert date: 6 months after the date of entry into force of this Regulation] the Commission shall adopt and publish a list of the selected chemicals by means of an implementing decisionacts. The Commission shall review the list of selected chemicals regularly adopt any revision thereof by the same means. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2).
Amendment 464 #
Proposal for a regulation
Article 20 – paragraph 4 – point c
Article 20 – paragraph 4 – point c
(c) make compiled data publicly available through the common data platform or other communication and outreach tools as appropriate, to facilitate the identification of potential further research needs or risk management measures, to facilitate informed societal discussion and increase public awareness on the properties, use and safety aspects of specific chemicals, and regularly update that information.
Amendment 467 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
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 468 #
Proposal for a regulation
Article 21 – paragraph 1 – point a (new)
Article 21 – paragraph 1 – point a (new)
(a) 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 469 #
Proposal for a regulation
Article 21 – paragraph 1 – point b (new)
Article 21 – paragraph 1 – point b (new)
(b) investigate further emerging chemical risks identified in the report referred to in Article 19(4) of this Regulation;
Amendment 470 #
Proposal for a regulation
Article 21 – paragraph 1 – point c (new)
Article 21 – paragraph 1 – point c (new)
(c) conduct Union-wide data sampling survey of human biomonitoring in collaboration with Member states.
Amendment 475 #
Proposal for a regulation
Article 21 – paragraph 3
Article 21 – paragraph 3
3. The ECHA shall only commission scientific studies when results cannot be obtained through existing legal provisions or processes under Union legislation listed in Annex I. It shall not commission studies with a predominant research objective.
Amendment 485 #
Proposal for a regulation
Article 21 – paragraph 6 a (new)
Article 21 – paragraph 6 a (new)
6 a. 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.
Amendment 491 #
Proposal for a regulation
Article 21 a (new)
Article 21 a (new)
Article 21a Centralised data generation mechanism 1. The Commission, the Agencies, and Member states competent authorities may submit request for studies to the Commission in accordance with the governance scheme referred to in Article 21b(4). A request for studies shall include, at the minimum, the following: (a) a rational for the request, summarizing the current knowledge and latest relevant findings; (b) a proposal for testing, including technical feasibility, the involvement of national or EU reference laboratories where necessary, and possibilities for appropriate sample acquisition; (c) a preliminary cost estimate; (d) an estimated timeline. 2. Using the best independent resources available, the Commission may commission scientific studies on the basis of request submitted in accordance with paragraph 1 to: (a) 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; (b) investigate further emerging chemical risks identified in the report referred to in Article 19(4) of this Regulation; (c) conduct Union-wide data sampling survey of human biomonitoring in collaboration with Member states. 2. The Commission may mandate the Agencies to commission the scientific studies referred to in paragraph 1, in accordance with the governance scheme referred to in Article 21b(4). 3. The Commission shall only commission scientific studies when results cannot be obtained through existing legal provisions or processes under Union legislation listed in Annex I. 4. The Commission shall seek to avoid duplication with Member State or Union research or implementation programmes. 5. The Commission shall commission these scientific studies in an open and transparent manner. 6. The Agencies shall closely cooperate with each other on the submission of requests for and planning of scientific studies undertaken in accordance with paragraph 1. 7. 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 Agencies 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. 8. The Commission shall make the results of the scientific studies performed under this Article available through the common data platform.
Amendment 493 #
Proposal for a regulation
Article 21 b (new)
Article 21 b (new)
Article21b Governance of the centralised data generation mechanism 1. The Commission shall establish and manage a centralised data generation mechanism. 2. The Commission shall prepare and adopt a governance scheme for the data generation mechanism, in collaboration with the Agencies. 3. The Commission shall publish the governance scheme referred to in paragraph 2 and any revision thereof by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2). 4. That governance scheme shall describe: (a) the organisation of the main work structures supporting the development and implementation of the data generation mechanism; (b) the centralised system for the submission of testing proposals, the eligibility check, and the assessment and submissions; (c) the decision-making process for approval and prioritisation of the requests; (d) the procedural steps and assignment of responsibilities at the execution stage of data generation. 5. The Commission may establish an expert working group for the purpose of point (c) of paragraph 4. The expert working group shall be composed of representatives from the Commission, Union agencies, and Member States.
Amendment 511 #
Proposal for a regulation
Article 22 – paragraph 2
Article 22 – paragraph 2
2. For the purposes of paragraph 1, business operators shall notify to the Database of Study Notifications referred to in Article 9 the identity of the chemical(s) 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.
Amendment 516 #
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
3. Laboratories and testing facilities shall also, without undue delay, notify any study commissioned by business operators to support an application, notification, or 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 517 #
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
4. For the purposes of paragraph 3, laboratories and testing facilities shall notify to the Database of Study Notifications referred to in Article 9 the identity of the chemical(s) 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.
Amendment 518 #
Proposal for a regulation
Article 22 – paragraph 5 a (new)
Article 22 – paragraph 5 a (new)
5 a. By ... [OP please insert date: 5 years after the date of entry into force of this Regulation], business operators shall notify to the Database of Study Notifications referred to in Article 9 any studies commissioned 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, for chemicals placed on the market before the entry into force of this Regulation, under the Union acts listed in Annex I. Subparagraph 1 shall only apply to chemicals placed on the market before the entry into force of this Regulation, under the Union acts listed in Annex I, and which are still authorised on the Union market by ... [OP please insert date: 5 years after the date of entry into force of this Regulation]. Studies notified in accordance with this paragraph shall only be included in the database for information and scientific purposes, and shall not, under any circumstances, have retroactive legal application.
Amendment 519 #
Proposal for a regulation
Article 22 – paragraph 6
Article 22 – paragraph 6
6. The obligations set under this article shall apply from [OP please insert date: 124 months after the date of entry into force of this Regulation].
Amendment 528 #
Proposal for a regulation
Chapter VII a (new)
Chapter VII a (new)
VII a Chapter VIIa ACCESS TO JUSTICE Article 22a Access to Justice 1. Any natural or legal person which has submitted substantiated concerns in accordance with Article 18a shall have access to an administrative or judicial procedure to review the procedural and substantive legality of the decisions, acts or omissions of the relevant authority under paragraph 3 of Article 18a. 2. Member States shall ensure access to administrative or judicial procedures to review their decisions, acts and omissions, in accordance with national law or practice. Decisions and omissions by the Commission shall be subject to review in accordance with Regulation EU (No) 1367/2006. 3. The procedures referred to in paragraph 2 shall be fair, equitable, timely and not prohibitively expensive while providing adequate and effective remedies, including injunctive relief where necessary. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.
Amendment 529 #
Proposal for a regulation
Chapter VIII – title
Chapter VIII – title
VIII DELEGATED AND IMPLEMENTING POWERS
Amendment 531 #
Proposal for a regulation
Article 24 a (new)
Article 24 a (new)
Article24a Committee procedure 1. The Commission shall be assisted by the Committee established by Article 133 of Regulation (EC) No 1907/2006. 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).
Amendment 533 #
Proposal for a regulation
Article 26 a (new)
Article 26 a (new)
Article26a Reports 1. By [OP: please insert date: 2 years after the end of the first calendar year after entry into force of this Regulation], the Commission shall draw up a report, analysing the adequacy between the resources of the agencies and their current tasks, their new tasks under this Regulation, and a prospective view of the resources needed to address key areas of regulatory challenge. The Commission shall present this report to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions. 2. By [OP: please insert date: 2 years after the end of the first calendar year after entry into force of this Regulation], the Commission shall draw up a report, compiling and analysing data on the impacts of cumulative exposure to chemicals on health and the environment, and analysing the efficacy of the current risk assessment of chemicals to adequately address the combination effect of chemical mixtures to ensure a high level of protection of health and the environment. The Commission shall present this report to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions.
Amendment 535 #
Proposal for a regulation
Article 26 b (new)
Article 26 b (new)
Article 26b Review 1. No later than ... [OP: please insert the date = 5 years after the date of application of this Regulation], the Commission shall carry out a review of this Regulation. This review shall assess in particular (a) the efficacy of the early warning and action mechanism (b) whether it is appropriate to include additional data into the common data platform. 2. No later than ... [OP: please insert the date = 2 years after the date of application of this Regulation], the Commission shall assess the feasibility, in collaboration with scientific and academic publishers, of harmonised reporting and of enabling the integration of relevant contents from scientific journals and publications into the common data platform, in order to increase further the uptake of research data into the hazard and risk assessment of chemicals. 3. The Commission shall present a report on the main findings of the evaluation under paragraph 1, to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions. The report shall assess whether this Regulation has contributed sufficiently to achieve its objectives, in particular to allow a better reuse of data across the Union acts referred to in Annex I. 4. Based on the findings of the assessment referred to in paragraph 2 and the report referred to in paragraph 3, the Commission may, as appropriate, submit legislative proposals to the European Parliament and to the Council in this regard.