79 Amendments of Catarina MARTINS related to 2023/0453(COD)
Amendment 92 #
Proposal for a regulation
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114(1), 168 and 191 thereof.
Amendment 93 #
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. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes3a establishes measures for the protection of animals used for scientific or educational purposes, making full replacement of animal testing its ultimate goal. According to the Strategy, safety testing and chemical risk assessment need to innovate in order to reduce dependency on animal testing but also to improve the quality, efficiency and speed of chemical hazard and risk assessments. 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, 3a Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes, OJ L 276, 20.10.2010, p. 33–79
Amendment 99 #
Proposal for a regulation
Recital 2
Recital 2
(2) The main objectives of this Regulation isare to increase the level of protection of the environment and human health from the risks arising from hazardous chemicals, to contribute to phasing out animal testing 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 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 and to contribute to ensuring animal testing takes place only as a last resort. 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, as well as to strengthen public trust in the robustness of scientific decision-making.
Amendment 103 #
Proposal for a regulation
Recital 6
Recital 6
(6) Business operators and Members States’ competent authorities are required by various Union acts to submit data and information to a multitude of Union agencies, as well as to the Commission in specific cases. This generates a fragmentation of data and information on chemicals, which are held under various data sharing and use conditions and in different formats. Such fragmentation prevents public authorities, as well as the general public, from having a clear overview of what information is available on individual chemicals or groups of chemicals, of where and how information can be accessed and whether it can be used. This increases the likelihood of inconsistency between various assessments of the same chemical required by various Union acts on chemicals and of damaging the general public’s trust in the scientific grounds for Union decisions on chemicals. In order to ensure that data on chemicals is easily findable, accessible, interoperable and usable, the ECHA should establish a common data platform on chemicals. The common data platform on chemicals should serve as a single point of reference and as a broadened and shared evidence base to enable the efficient delivery of coherent hazard and risk assessments of chemicals across various Union acts on chemicals, as well as to enable the timely identification of emerging chemical risks and the drivers and impact of chemical pollution. Where multiple studies exist for the same chemical, potentially generated to meet requirements across different regulatory frameworks, data from each study should be published in a harmonised format which facilitates rapid comparison and review.
Amendment 109 #
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 and occurence of chemicals in articles. The common data platform should also include chemicals data and information generated as part of Union, national or international programmes, enforcement actions or research activities related to chemicals, where this data and information is held by the Commission or one of the relevant agencies. For studies initiated after entry into force of this Regulation, the standard formats shall ensure publication of the date of commencement of studies and the name of the relevant GLP or equivalent compliance monitoring authority responsible for ensuring test facility compliance.
Amendment 115 #
Proposal for a regulation
Recital 8
Recital 8
Amendment 122 #
Proposal for a regulation
Recital 9
Recital 9
Amendment 130 #
Proposal for a regulation
Recital 10
Recital 10
Amendment 132 #
Proposal for a regulation
Recital 11
Recital 11
Amendment 133 #
Proposal for a regulation
Recital 12
Recital 12
(12) In order to respond to the needs of the digital economy and to ensure a high level of protection of the environment and human healthealth and a high level of transparency, it is necessary to lay down a harmonised framework, granting as a general principle, the widest possible access to chemicals data and, where appropriate and justified, 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 all of the chemicals data and information contained in the common data platform to effectively fulfil their regulatory duties and tasks, in order to improve the effectiveness, efficiency, and coherence of chemicals- related assessments as well as the development of Union chemicals policies.
Amendment 138 #
Proposal for a regulation
Recital 13
Recital 13
(13) Chemicals data and information generated as a result of obligations set by Union acts on chemicals may be protected by confidentiality claims on confidential business information. The public dissemination of such data may affect the commercial interest of private parties. To ensure legal certainty for duty holders and to protect their legitimate expectations, as well as to ensure industry’s competitiveness on the internal marketo ensure optimal transparency to the public as well as certainty for duty holders, the ECHA, as a manager of the common data platform, should grant differentiated access rights to the data and information contained in the common data platform, while prioritising transparency. To this end, the Authorities should have full access to all chemicals data and information contained in the common data platform, including access to confidential information, while business operators and the general public should have restricted access to that data and information, which does not include access to confidential informationle as much of the information as possible should be made public.
Amendment 141 #
Proposal for a regulation
Recital 15
Recital 15
(15) To ensure the protection of legitimate expectations of duty holders when generating or submitting data or information under the Union acts listed in Annex I, as well as to protect the confidentiality of that information when used by the Authorities, exceptional grounds for disclosing confidential information laid down in the Union acts listed in Annex I should apply only to the disclosure of the data and information submitted or generated in compliance with those actshealth and the environment, there may be exceptional grounds for disclosing confidential information laid down in the Union acts listed in Annex I. For example, under Article 39(4) of Regulation (EC) No 178/2002 of the European Parliament and of the Council8 , where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the European Food Safety Authority (‘EFSA’) may disclose information previously considered confidential under that Regulation and the EFSA is required to make public information, previously considered confidential, that forms part of conclusions of scientific outputs of the EFSA and relates to foreseeable effects on human health, animal health or the environment. Likewise, Article 118 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council9 provides for the possibility for the ECHA to disclose confidential information submitted to it under that Regulation if urgent action is essential to protect human health, safety or the environment, such as in emergency situations. These emergency provisions should apply to all information held in the common data platform. _________________ 8 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (General Food Law) (OJ L 031 1.2.2002, p. 1). 9 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396 30.12.2006, p. 1).
Amendment 142 #
Proposal for a regulation
Recital 16
Recital 16
(16) Taking into account that the Agencies would be required to store scientific data, which includes confidential and personal data, it is necessary to ensure that such storage is carried out in accordance with a high level of security of information systems and that confidentiality claims and access to confidential data isare auditable.
Amendment 143 #
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’) which should rapidly be elaborated to include all data on chemical substances in articles and on their alternatives, 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, as well as a dashboard of indicators on chemicals.
Amendment 151 #
Proposal for a regulation
Recital 20
Recital 20
(20) In order to bring together all relevant chemicals data and information in the common data platform, the Commission and Union agencies – notably the European Agency for Safety and Health at Work (‘EU-OSHA’), the ECHA, the European Environment Agency (‘EEA’), the EFSA, and the EMA (‘the Agencies’), should act as data providers and make available any such relevantchemical data they have or hold to the ECHA for integration in the common data platform. The Agencies, including the ECHA itself when making its own data available, should provide the necessary standard metadata, contextual information and relevant mapping to the platform’s structure, and respect rules on standard formats and controlled vocabularies where available.
Amendment 152 #
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, data generated as part of Union, national or international programmes, including monitoring and enforcement, 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. Other parties, such as Member States, academic institutes, scientific bodies of Member States or national authorities, should be able to offer chemicals data to the Agencies or the Commission for hosting and maintenance. In such case, it should be for the Agencies or the Commission, as the case may be, to decide whether to respond positively to the offer, and give justification in case the offer is refused.
Amendment 157 #
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 andand their environmental sustainability impacts of chemicals, researchers or research consortia, notably those funded by Union framework programmes should be required to make available, in line with the ‘as open as possible, as closed as necessary’ principle, any human biomonitoring data they collect or generate resulting from research and development programmes to the EEA and any other chemicals data, including environmental sustainability data on chemicals or materials they collect or generate to the ECHA.
Amendment 162 #
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 165 #
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24 a) The EEA, ECHA, EFSA, EMA and the Commission should be able to process human biomonitoring data constituting personal data. Since human biomonitoring personal data constitutes a special category of personal data, namely, health data, the EEA, the Commission, the ECHA, the EFSA and the EMA should process 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 167 #
Proposal for a regulation
Recital 24 b (new)
Recital 24 b (new)
(24 b) The EEA should be allowed to process 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, 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. Such data is also useful for 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 and the Commission should pay particular attention to compliance with Article 13 of Regulation (EU) No 2018/1725.
Amendment 169 #
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 and the Commission when this Regulation comes into force.
Amendment 177 #
Proposal for a regulation
Recital 28
Recital 28
(28) In order to increase transparency, as well as to enable Authorities to have complete prior knowledge of studies commissioned by business operators, irrespective of their purpose, results or 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 order to allow business operators and laboratories sufficient time to prepare the notifications of studies, the obligation to notify studies should only start to apply twoone years after the date of entry into force of this Regulation.
Amendment 183 #
Proposal for a regulation
Recital 31
Recital 31
Amendment 190 #
Proposal for a regulation
Recital 32
Recital 32
(32) Nevertheless, tTo ensure compliance with the study notification obligation laid down in this Regulation, and to cater to the specificities of individual assessment processes, where existing, Member States should lay down rules on penalties applicable to the infringement of that obligation and take all necessary measures to ensure that those rules are complied with. Those penalties should be effective, proportionate, and dissuasive, since non- compliance with this Regulation could result in less robust chemicals risk assessments, creating potential risks and consequently adverse effects on human health and the environment.
Amendment 194 #
Proposal for a regulation
Recital 33
Recital 33
(33) In order to facilitate enforcement by Member States, the Agencies responsible for assessing and providing scientific output, including scientific opinions, on regulatory dossiers containing studies subject to notification to ECHA should, where relevant, cooperate and exchange information with the Member State enforcement authorities on the compliance with the obligations laid out in Article 22 and ensure information on enforcement is made public.
Amendment 200 #
Proposal for a regulation
Recital 36
Recital 36
(36) To strengthen the coordination and cooperation between the different bodies performing chemicals assessments in the Union, and to promote an increased transparency of chemicals assessments and to promote the phasing out of animal tests, the ECHA should establish and manage a database with information on regulatory processes or activities that are planned, ongoing or completed by Member States, the Commission and Agencies referred to in the Union acts listed in Annex III to this Regulation and integrate it into the common data platform for access by the authorities. The information on such regulatory processes or activities should include at least the substance identity and the identification, status and eventually the outcome of the regulatory process or activity including any new requirement to conduct animal testing and the length of time each activity is expected to take. That information should also be made available without undue delay and kept updated through the assessment process. Once the process or activity has formally started, that information should be shared also publicly on the common data platform.
Amendment 204 #
Proposal for a regulation
Recital 38
Recital 38
(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 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. Such mutual coherence should be supported by the respective Agency’s efforts to ensure alignment across full study data, study reports and study summaries.
Amendment 208 #
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, the Commission should identify relevant data and information related to the environmental sustainability of chemicals, including, where available, information on their impact on climate change, for integration into the common data platform. Once the Commission has identified the relevant existing datasets on environmental sustainability related data and has designed the relevant related database functionalities, the ECHA should establish a database on environmental sustainability- related data, collect the data as made available by the Commission, the Agencies and Member States and, where relevant, by the researchers and research consortia funded by, in particular those funded by national and 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 datasets, implementing powers should be conferred on the Commission.
Amendment 211 #
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 and legislation on chemicals, and further acknowledging existing experience with citizen science approaches, individuals 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 be obliged to 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 214 #
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 and policy 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 through the common data platform, ensuring public access and its use for further action on existing and emerging risks of chemicals and groups of 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 justify if they decide not to proceed with any action.
Amendment 219 #
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 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. Where relevant and whenever possible, information generated through studies commissioned by the ECHA should be generated by means of non animal testing methods.
Amendment 227 #
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 sustainable and safe chemicals, to ensure the proper functioning of the single market for chemicals, to contribute to the goal of phasing out animal testing and to improve the Union’s citizens’ trust in the scientific base for the decisions taken under Union legal acts on chemicals.
Amendment 231 #
Proposal for a regulation
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) bring together data and information on chemicals and their alternative and ensure that data and information are easily findable, accessible, interoperable and re- usable;
Amendment 236 #
Proposal for a regulation
Article 1 – paragraph 2 – point b
Article 1 – paragraph 2 – point b
(b) keep records of all studies commissioned or carried out by business operators in the context of fulfilling their obligations set under Union chemicals legislation;
Amendment 238 #
Proposal for a regulation
Article 1 – paragraph 2 – point d a (new)
Article 1 – paragraph 2 – point d a (new)
(d a) foster innovations regarding advanced biologically-relevant tools, methods and models, and data analysis capacities.
Amendment 258 #
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 Commission;
Amendment 261 #
Proposal for a regulation
Article 3 – paragraph 2 – point c
Article 3 – paragraph 2 – point c
(c) listed in Annex II and held by the EMA;
Amendment 262 #
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 265 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
Amendment 269 #
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
Amendment 276 #
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, as well as any related context data as referred to in paragraph 5 of Article 4, point (c), including, where relevant, an indication whether the data was generated by Authorities.
Amendment 283 #
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: threewo 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: tenfive 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 294 #
Proposal for a regulation
Article 4 – paragraph 5 – point f
Article 4 – paragraph 5 – point f
(f) the operation, reporting requirements and transparency obligations of the steering committee itself.
Amendment 296 #
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. In addition, Agencies may host and maintain chemicals data according to their mandate and offered to them by Member States, research institutes or other parties.
Amendment 311 #
Proposal for a regulation
Article 5 – paragraph 5
Article 5 – paragraph 5
5. Researchers or research consortia, in particular those funded by Union or national 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 322 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. At the latest by [OP please insert date: 32 years after entry into force of this Regulation] the Commission shall transfer any human biomonitoring data it holds to the EEA.
Amendment 338 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. At the latest by [OP please insert date: 32 years after the date of entry into force of this Regulation], the Commission shall transfer the chemicals data contained in the Information Platform for Chemical Monitoring at that moment to the ECHA for integration in the common data platform.
Amendment 339 #
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. At the latest by [OP please insert date: 32 years after entry into force of this Regulation], the Commission shall transfer the chemicals data contained in the Information Platform for Chemical Monitoring to the ECHA, the EEA or the EFSA for hosting in accordance with the respective agencies’ mandate and in accordance with Article 5.
Amendment 347 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The ECHA shall establish and operate a Database of Study Notifications by [OP please insert date: twoone years after the date of entry into force of this Regulation].
Amendment 352 #
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 372 #
Proposal for a regulation
Article 10 – paragraph 3 – point f a (new)
Article 10 – paragraph 3 – point f a (new)
(f a) where applicable, whether animal testing is required and for which endpoint.
Amendment 374 #
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
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 once that process or activity has formally startedwithout delay.
Amendment 375 #
Proposal for a regulation
Article 10 – paragraph 4 a (new)
Article 10 – paragraph 4 a (new)
4 a. Any planned new test, in particular tests on animals, shall be notified in advance and the ECHA shall record the intention in the database. Furthermore, the ECHA shall record where new animal testing has been requested by an Agency for regulatory purposes. These records shall be made public without undue delay.
Amendment 384 #
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. At the latest within threewo 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 387 #
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. Where the Commission or, the Agencies or the Member States 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 and the Member States 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 389 #
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
3. Where researchers or research consortia, especially those funded by Union and national 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 without undue delay.
Amendment 395 #
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. By [OP please insert date: threewo 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 and 3, for inclusion in the common data platform and shall design relevant related database functionalitiesrequest the ECHA to host and maintain them in accordance with Article 5(1).
Amendment 397 #
Proposal for a regulation
Article 14 – paragraph 2 – point e a (new)
Article 14 – paragraph 2 – point e a (new)
(e a) increase transparency
Amendment 401 #
Proposal for a regulation
Article 14 – paragraph 5 – point i a (new)
Article 14 – paragraph 5 – point i a (new)
(i a) (j) 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).
Amendment 404 #
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 Council1a _________________ 1a 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).
Amendment 408 #
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The Commission and the Agencies shall cooperate when setting standard formats to ensure transparency and coherence with other formats and the interoperability of the standard formats with the common data platform and with existing data submission approaches.
Amendment 414 #
Proposal for a regulation
Article 16 – paragraph -1 (new)
Article 16 – paragraph -1 (new)
-1. The public shall have access to all the chemicals data contained in the common data platform.
Amendment 426 #
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 431 #
Proposal for a regulation
Article 17 – paragraph 3
Article 17 – paragraph 3
3. When using chemicals data contained in the common data platform that is deemed confidential under Article 5(2), second sentenceas provided for in paragraph 1, the Authorities shall respect the confidentiality of informationthat data as marked by the originator and shall not disclose that data to the public without the consent of the originator.
Amendment 435 #
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 a framework of indicatorsnd update as appropriate a framework of indicators to monitor chemical pollution along the chemical’s lifecycle, including emissions and occurrence, 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 439 #
Proposal for a regulation
Article 18 a (new)
Article 18 a (new)
Article18a 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 substances or groups of substances, 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. Any substantiated concern submitted under paragraph 1 and the information subject to paragraph 3 shall be made available to ECHA and compiled for publication in an annual report. The report shall be integrated in the common data platform without undue delay.
Amendment 444 #
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 as referred to in Article 18;
Amendment 446 #
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) relevant information resulting from national enforcement programmes
Amendment 447 #
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 1 – point e b (new)
Article 19 – paragraph 2 – subparagraph 1 – point e b (new)
(e b) relevant data or information submitted by researchers.
Amendment 452 #
Proposal for a regulation
Article 19 – paragraph 4 a (new)
Article 19 – paragraph 4 a (new)
4 a. Within two months after receipt of this report, the Commission, relevant Union agencies and Member State competent authorities shall publicly respond to the received early warning signals with the details and timeline of the undertaken or planned regulatory or policy action related to the early warning signals, or a justification of the lack of action.
Amendment 455 #
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 465 #
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 472 #
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 prioritise the use of non-animal methods, with animal tests only proposed as a last resort. Full justification for the need to perform any new test on animals shall be provided. It shall not commission studies with a predominant research objective.
Amendment 482 #
Proposal for a regulation
Article 21 – paragraph 6
Article 21 – paragraph 6
6. The ECHA, the EMA and the EFSA shall closely cooperate with each other on the planning and commissioning of scientific studies undertaken by the ECHA in accordance with paragraph 1 and of studies undertaken by the EFSA in accordance with Article 32 of Regulation (EC) No 178/2002 and studies undertaken by EMA. The agencies shall aim to avoid duplication and to ensure animal testing takes place only as a last resort and is fully justified.
Amendment 488 #
Proposal for a regulation
Article 21 – paragraph 7
Article 21 – paragraph 7
7. The ECHA shall make the results of the scientific studies performed under this Article available through the common data platform and shall, in advance, record the intention to perform new studies in accordance with Articles 9 and 10 of this Regulation.
Amendment 498 #
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. Business operators shall notify to the Database of Study Notifications referred to in Article 9, without undue delay, any studies onin one month from the date of the commissionning, any studies that generate data 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 hazard, risk or safety assessment , prior tor after the 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 509 #
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, relevant GLP or equivalent compliance monitoring authority responsible for ensuring test facility compliance 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 520 #
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 534 #
Proposal for a regulation
Article 26 a (new)
Article 26 a (new)
Article26a 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 and omissions, in accordance with national law or practice. Decisions and omissions by the Commission shall be subject to review in accordance with Title IV of 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.