47 Amendments of Martin HOJSÍK related to 2023/0453(COD)
Amendment 95 #
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 their groupings 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 98 #
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 and improve integration of information from different sources resulting in a reduction of the administrative burden and overlaps. For that purpose, this Regulation should establish a common data platform data on chemicals (‘the common data platform’), to be managed by the European Chemicals Agency (‘ECHA’). The common data platform is a digital infrastructure that brings together chemicals data and information generated under the Union chemicals acquis. This Regulation should also establish dedicated services within the common data platform and lay down rules on the 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, as well as to strengthen public trust in the robustness of scientific decision-making.
Amendment 106 #
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. Authorities should continue to take the necessary measures to protect the confidentiality of data, including, where relevant, by cybersecurity measures.
Amendment 114 #
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 128 #
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 stageProgressively, 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 144 #
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 substances in articles and their available alternatives, as well as a dashboard of indicators on chemicals.
Amendment 153 #
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 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, scientific bodies of Member States or national authorities, should be able to offer chemicals data to the Agencies or the Commission. 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, taking into account the format appropriate for the inclusion in the common data platform.
Amendment 158 #
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 national and Union framework programmes should make available, in line with the ‘as open as possible, as closed as necessary’ principle, any human biomonitoring data they collect or generate resulting from research and development programmes to the EEA and any environmental sustainability data on chemicals or materials they collect or generate to the ECHA.
Amendment 160 #
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23 a) To support a resource-efficient approach, the ECHA and EFSA, which were mandated to carry out scientific studies within the Regulation (EC) No 178/2002, should cooperate closely in pooling resources and expertise on EU- wide human biomonitoring studies. The Member States should cooperate with the Agencies to organise the monitoring in their respective territories, in terms of planning, coordination, collection and transmission of samples.
Amendment 175 #
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 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 two years after the date of entry into force of this Regulation. The ECHA should also develop guidance for duty holders to facilitate the implementation of the notification obligation, including information as regards the type of studies requiring notification.
Amendment 195 #
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 onto help them verify the compliance with the obligations laid out in Article 22.
Amendment 209 #
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, where relevant, by the researchers and research consortia 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 215 #
Proposal for a regulation
Recital 44
Recital 44
(44) To enable the identification and evaluation of emerging chemical riskrisks of chemicals and their groupings, the EEA should develop and compile information on early warning signals and draw up an annual summary report to inform regulatory follow-up actions. In its work, the EEA should include its own sources, targeted literature searches and make use of information from national early warning systems. It should also include relevant information made available by the related work of the ECHA, the EFSA, the EU- OSHA, the EMA and their networks, such as the EFSA’s task of identifying and collecting information on emerging risks under Regulation 178/2002. The EEA should make the summary report and the underlying data available through the common data platform, ensuring public access and its use for further action on existing and emerging risks. In order to allow the EEA sufficient time to organise the collection of early warning signals and to compile and analyse the initial information the EEA should only deliver the first report six months after the end of the first calendar year after entry into force of this Regulation. this Regulation sets a deadline for the first report and associated data.
Amendment 217 #
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. When a sample of a substance is precondition to conduct the scientific studies, ECHA should be given the necessary sample from the business operator, upon request, and provided that applicable confidentiality and data protection under Union law is ensured. Whenever possible, information generated through studies commissioned by the ECHA should be generated by means other than vertebrate animal tests
Amendment 222 #
Proposal for a regulation
Recital 48 a (new)
Recital 48 a (new)
(48 a) As this Regulation expands the tasks and workload of the European Chemicals Agency, it shall be provided with appropriate and stable resources and stable governance of the scientific committees should be ensured. In this respect, it is appropriate that the Commission takes account of any developments and reflects needs of the Agency to allow fullfillment of its tasks and potential.
Amendment 228 #
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, and to improve the Union’s citizens’ trust in the scientific base for the decisions taken under Union legal acts on chemicals.
Amendment 233 #
Proposal for a regulation
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) bring together all data and information on chemicals and ensure that data and information are easily findable, accessible, interoperable and re-usable;
Amendment 243 #
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 and manufacturing process of the chemicals, information on availability of sustainable alternatives, as well as environmental sustainability related information, including climate change related information, on those chemicals, regulatory process-related information on chemicals, standard formats, controlled vocabularies, or any information on applicable legal obligations related to chemicals, including information related to enforcement activities;
Amendment 251 #
Proposal for a regulation
Article 2 – paragraph 1 – point 14 a (new)
Article 2 – paragraph 1 – point 14 a (new)
14 a. ‘data processor’ means processor as defined in Article 4, point (8), of Regulation (EU) 2016/679 of the European Parliament and of the Council;
Amendment 254 #
Proposal for a regulation
Article 2 – paragraph 1 – point 15 a (new)
Article 2 – paragraph 1 – point 15 a (new)
15 a. ‘the public’ means one or more natural or legal persons, and associations, organisations or groups of such persons.
Amendment 264 #
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 275 #
Proposal for a regulation
Article 3 – paragraph 5 – point g a (new)
Article 3 – paragraph 5 – point g a (new)
(g a) information on substances in products and their alternatives referred to in Article 10a.
Amendment 277 #
Proposal for a regulation
Article 3 – paragraph 6
Article 3 – paragraph 6
6. The Authorities and the general public shall have easy access, free of charge, to the data contained in the common data platform in accordance with Article 16.
Amendment 279 #
Proposal for a regulation
Article 3 – paragraph 9
Article 3 – paragraph 9
9. The data contained in the common data platform shall be electronically accessible and searchable. The ECHA shall take measures to ensure a high standard of security appropriate to the security risks at stake for the storage of chemicals data in andthe common data platform. Safety measures shall be adopted by the relevant Agencies to ensure safe transmission of chemicals data to the common data platform. The ECHA shall design the common data platform in a way that guarantees that any access to confidential data is auditable.
Amendment 280 #
Proposal for a regulation
Article 3 – paragraph 10 a (new)
Article 3 – paragraph 10 a (new)
10 a. The ECHA shall act as data processor for any personal data included in the common data platform falling under the authority of another Agency or the Commission.
Amendment 298 #
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 or other parties.
Amendment 304 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Where the Commission or the Agencies hold data or information referred to in Article 3(2), they shall make that data available to the ECHA, in a standard format, where available, together with the relevant context data as referred to in Article 4(4), point (c). The Commission and the Agencies shall indicate whether that data or information is made available to the public or confidential in accordance with the provisions on confidentiality under the originating Union act.
Amendment 309 #
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. The ECHA shall host and maintain occurrence data related to workplace monitoring, including human biomonitoring data. Human biomonitoring data constituting personal data may be processed by the ECHA for the following purposes: (a) assessing the impact of chemicals on human health and the environment; (b) monitoring time and spatial trends in exposure; (c) developing health risk and impact indicators; (d) monitoring the impact of regulatory intervention; (e) supporting regulatory risk assessments; The ECHA shall make any human biomonitoring data they hold publicly available in anonymised form through the Common data platform.
Amendment 312 #
Proposal for a regulation
Article 5 – paragraph 5
Article 5 – paragraph 5
5. Researchers or research consortia funded by national and Union framework programmes shall make available to the EEA any human biomonitoring data they collect or generate from [OP please insert: date of the entry into force of this Regulation].
Amendment 315 #
Proposal for a regulation
Article 5 – paragraph 6
Article 5 – paragraph 6
6. Researchers or research consortia funded by national and Union framework programmes shall make available to the ECHA any environmental sustainability data on chemicals or materials they collect or generate from [OP please insert: date of the entry into force of this Regulation].
Amendment 324 #
Proposal for a regulation
Article 6 – paragraph 4 – point e
Article 6 – paragraph 4 – point e
(e) supporting regulatory risk assessments and management.
Amendment 343 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. TUpon notification by the responsible Authority, the ECHA shall include any reference value adopted under Union acts listed in Annex I or Annex II, Part 1, in the repository of reference values without undue delay.
Amendment 345 #
Proposal for a regulation
Article 8 – paragraph 3 a (new)
Article 8 – paragraph 3 a (new)
3 a. Upon the submission of reference values by researchers or research consortia funded by Union framework or national programmes to the ECHA in accordance with Article 14, the ECHA shall include those in the repository.
Amendment 351 #
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 377 #
Proposal for a regulation
Article 10 a (new)
Article 10 a (new)
Article10a Information on substances in articles and their alternatives 1. The ECHA shall establish and operate, as part of the common data platform, a new database containing information on substances in products and their alternatives generated or submitted as part of the implementation of Union chemicals legislation listed in Annex I. This database shall also 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, EEA, EFSA, 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. 4. The ECHA shall encourage providers of alternatives referred to in this Article to identify themselves. 5. The database shall include, where available, following information and shall be user-friendly: (a) substance identity; (b) sector of use; (c) alternatives identified for each use; (d) technical function; (e) material article category ;
Amendment 390 #
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
3. Where researchers or research consortia funded by Union framework and national programmes make available to the ECHA, under Article 5(6), any environmental sustainability data on chemicals or materials they collect or generate, the ECHA shall integrate the relevant data in the database on environmental sustainability related data.
Amendment 409 #
Proposal for a regulation
Article 15 – paragraph 5 – point a
Article 15 – paragraph 5 – point a
(a) make them available free of charge through the common data platform and as open datasetsto facilitate their re-use;
Amendment 425 #
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 public in accordance with the Union act under which the data was generated or submittedoriginating Union act.
Amendment 428 #
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 430 #
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 466 #
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, informed societal discussion and increase public awareness on the properties, use and safety aspects of specific chemicals, and regularly update that information.
Amendment 471 #
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
2. The Commission may request the ECHA to commission the scientific studies referred to in paragraph 1 and Article 20(4), point (b) of this Regulation.
Amendment 484 #
Proposal for a regulation
Article 21 – paragraph 6 a (new)
Article 21 – paragraph 6 a (new)
6 a. The ECHA may request from a business operator a sample of substance that is indispensable to perform the scientific study referred to in paragraph 1. The request shall be duly justified and any handling of the substance shall be in accordance with applicable confidentiality and data protection rules under relevant Union law. The relevant business operator shall, upon a request from the ECHA, provide sample of substance to perform the scientific study. The obligation shall not result in costs for the business operator.
Amendment 489 #
Proposal for a regulation
Article 21 – paragraph 7 a (new)
Article 21 – paragraph 7 a (new)
7 a. If a scientific study commissioned according to paragraph 1 or 2 is a human biomonitoring study, Member States shall coordinate with and support the ECHA and EFSA, as mandated under the Regulation (EC) No 178/2002, in organisation of the human biomonitoring activities within their territories, to ensure sampling and collection of the data, adequate representativeness and quality of the data. The EU-wide human biomonitoring shall cover all Member States and adhere to ethical and confidentiality standards.
Amendment 502 #
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 on chemicals they commission to support an application, notification or regulatory dossier notified or submitted to an Authority, as well as any studies on chemicals on their own or in products they commission as part of a risk or safety assessment , prior to placing on the market, under the Union acts listed in Annex I. However, bBusiness 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 523 #
Proposal for a regulation
Article 22 – paragraph 7
Article 22 – paragraph 7
7. The ECHA shall, in consultation with EFSA, lay down the practical arrangements for implementing the provisions of this Article.
Amendment 536 #
Proposal for a regulation
Article 27 a (new)
Article 27 a (new)
Article27a Review No later than … [OP: please insert 1 year after the entry into force of this Regulation], the Commission shall assess workload and further needs of the European Chemicals Agency, stemming among others from the additional tasks related to the establishment of database of information on substances in products and their available alternatives, and where appropriate, provide it with adequate further resources.