66 Amendments of Beatrice TIMGREN related to 2023/0453(COD)
Amendment 96 #
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 chemical while ensuring proportionality and reducing unnecessary burdens on economic operators. By modernising the integration of information and establishing a cost- effective digital infrastructure, this Regulation seeks to facilitate the internal market for chemicals and improve the predictability and transparency of regulatory processes. 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 108 #
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 prioritise and protect the confidentiality of data and sensitive information while facilitating efficient data sharing.
Amendment 111 #
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 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.focus on consolidating data directly related to regulatory purposes, excluding broader research or international program data unless explicitly required by Union legislation
Amendment 119 #
Proposal for a regulation
Recital 8
Recital 8
(8) Due to the differenstinct nature of the risk and hazard assessments performed under Union acts on medicinal products, wthen compared to those performed under the main Union acts on chemicals, for medicinal products, onlymon data platform should include only essential chemicals data related to environmental risk assessments for human and veterinary medicines, non- clinical studies for human medicines and and specific maximum residue limit values held by 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 applicationswith cross-sectoral relevance—those also regulated byunder other Union legislation identified in this Regulation, as well as other active substances with particular—should be included. Data on other active substances should be limited to those with confirmed persistent, bio- accumulative, and toxic properties or with a known high level of residues ia significant impact on the environment.
Amendment 124 #
Proposal for a regulation
Recital 9
Recital 9
(9) These data should also be limited to essential chemicals data submitted to the EMA in the context of the relevant procedures that are finalised or submitted after the entry into force of this Regulation. At a later stage, it should also be possible to include in the common data platform, where relevant, data the EMA holds on procedures concluded before the entry into force of this RegulationThe inclusion of data on earlier procedures finalised before the entry into force of this Regulation should be considered only for substances with persistent, bio-accumulative, and toxic properties or substances with significant environmental impact, where such inclusion is deemed necessary for coherence and interoperability within the common data platform.
Amendment 136 #
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 health, it is necessary to lay down a harmonised framework specifying who is entitled to access and use the chemicals data contained in the common data platform, under which conditions, on what basis, and for which purposes. The Authorities that are entrusted with regulatory tasks related to chemicals should be allowed and encouraged to use the chemicals data and information contained in the common data platform to effectively fulfil their regulatory duties and tasks, in order to improve the effectiveness, efficiency, and coherence of chemicals-related assessments as well as the development of Union chemicals policuse the platform to fulfil their regulatory duties efficiently and cost-effectively. Provisions ensuring proportionality and minimised administrative burdens should guide the access and use framework, ensuring balance between robust regulatory oversight and economic competitiveness. Access to personal data should be limited to what is necessary in relation to the purposes for which this data is processed by the Authorities.
Amendment 139 #
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 protect the competitiveness of Union industries, ensure legal certainty for duty holders, and to protect their legitimate expectations, as well as to ensure industry’s competitiveness on the internal marketuphold legitimate commercial interests, 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 platformensure that access rights are differentiated based on the sensitivity and confidentiality of the information. 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 information.
Amendment 147 #
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18 a) When exercising implementing powers, and in the cases in which Regulation (EU) No. 182/2011 does not apply, the Commission should, as part of its preparatory work, take into account views of Member States.
Amendment 149 #
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 chemicals datasets, develop new functionalities, and respond to developing tools and applications.
Amendment 172 #
Proposal for a regulation
Recital 27 a (new)
Recital 27 a (new)
(27 a) Given the wide scope of Union acts listed in Annex I, when laying down the practical arrangements for implementing the study notification provisions, consideration should be given to proportionality to avoid the overburdening of business operators, laboratories and the ECHA.
Amendment 173 #
Proposal for a regulation
Recital 28
Recital 28
Amendment 180 #
Proposal for a regulation
Recital 29
Recital 29
Amendment 181 #
Proposal for a regulation
Recital 30
Recital 30
Amendment 184 #
Proposal for a regulation
Recital 31
Recital 31
Amendment 189 #
Proposal for a regulation
Recital 32
Recital 32
Amendment 191 #
Proposal for a regulation
Recital 33
Recital 33
Amendment 197 #
Proposal for a regulation
Recital 34
Recital 34
Amendment 199 #
Proposal for a regulation
Recital 35
Recital 35
Amendment 203 #
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. When specifying such formats and controlled vocabularies, the Agencies and Commission should, where relevant, take into account input and contributions from Member States and stakeholders.
Amendment 229 #
Proposal for a regulation
Article 1 – paragraph 2 – introductory part
Article 1 – paragraph 2 – introductory part
2. To achieve the objectives referred to in paragraph 1, this Regulation contains targeted measures to:
Amendment 232 #
Proposal for a regulation
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) bring togetherconsolidate existing essential data and information on chemicals and ensure that data and information are easily findable, accessible, interoperable and re- usable;
Amendment 235 #
Proposal for a regulation
Article 1 – paragraph 2 – point b
Article 1 – paragraph 2 – point b
(b) keep records of studies commissioned or carried out by business operators in the context of fulfilling their obligations set under Union chemicals legislationas required under existing Union chemicals legislation, ensuring no additional obligations or market access conditions are imposed beyond those already set out in the relevant acts;
Amendment 239 #
Proposal for a regulation
Article 1 – paragraph 3
Article 1 – paragraph 3
3. The provisions laid down in this Regulation apply only to chemicals data as laid out in Article 3(2)explicitly referenced under the Union acts listed in Annex I.
Amendment 240 #
Proposal for a regulation
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
2. ‘Authorities’ means the European Commission, the competent authorities of the Member States as referred to in any of the Union acts listed in Annexes I and III, and the Agencies, excluding their management boardsAnnex I, and the Agencies, only insofar as they perform tasks directly under the Union acts listed in Annex I;
Amendment 241 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
3. ‘dDuty holder’ means a natural or legal person directly responsible for meeting obligations under the Union acts listed in Annex I or IIfulfilling specific obligations under Annex I-listed Union acts;
Amendment 242 #
Proposal for a regulation
Article 2 – paragraph 1 – point 10
Article 2 – paragraph 1 – point 10
10. ‘chemicals data’ means any representation of facts factual or regulatory information relating to chemicals and any compilation of such facts or information, including information onsubmitted or generated under Union acts listed in Annex I, specifically concerning chemicals’ physico-chemical properties, hazard properties, use, exposure, risk, occurrence, emissions and manufacturing process of the chemicals, as well as environmental sustainability related information, including climate change related information, on those chemicals, regulatory process-related information on chemicals, standard formats, controlled vocabularies, or any information on applicable legal obligations related to chemicaland use, as well as regulatory process-related information. Environmental sustainability data is included only where explicitly required by Annex I-listed acts;
Amendment 245 #
Proposal for a regulation
Article 2 – paragraph 1 – point 11 – introductory part
Article 2 – paragraph 1 – point 11 – introductory part
11. ‘environmental sustainability related data’ means any data relevantdata explicitly generated or required under Annex I- listed Union acts for the environmental sustainability assessment of a chemical or material throughout its entire life cycle, including, limited to:
Amendment 247 #
Proposal for a regulation
Article 2 – paragraph 1 – point 11 – point a
Article 2 – paragraph 1 – point 11 – point a
(a) data on resources, including raw materials, water, energy, fossil fuels and l and emissions relevant to the assessment of the chemical under applicable Union legislation; and;
Amendment 248 #
Proposal for a regulation
Article 2 – paragraph 1 – point 11 – point b
Article 2 – paragraph 1 – point 11 – point b
(b) data on emissions, including greenhouse gases, eutrophication-relevant substances, dust and all other polluting substances; andby-products explicitly identified in regulatory submissions;
Amendment 249 #
Proposal for a regulation
Article 2 – paragraph 1 – point 11 – point c
Article 2 – paragraph 1 – point 11 – point c
Amendment 252 #
Proposal for a regulation
Article 2 – paragraph 1 – point 15
Article 2 – paragraph 1 – point 15
15. ‘interoperability’ means the ability of two or more data spaces or communication networks, systems, products, applications or components to exchange and use data in order to perform their functions.;
Amendment 253 #
Proposal for a regulation
Article 2 – paragraph 1 – point 15 a (new)
Article 2 – paragraph 1 – point 15 a (new)
15 a. ‘Study’ means research conducted or commissioned by business operators for the purpose of preparing an application, notification, or regulatory dossier to be submitted to an Authority in compliance with the regulatory requirements of the Union acts specified in Annex I.
Amendment 255 #
Proposal for a regulation
Article 3 – paragraph 2 – introductory part
Article 3 – paragraph 2 – introductory part
2. The common data platform shall provide access to essentiall chemicals data:
Amendment 257 #
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 specific obligations under the Union acts listed in Annex I to this Regulation and held by the Agencies or the Commission;
Amendment 260 #
Proposal for a regulation
Article 3 – paragraph 2 – point c
Article 3 – paragraph 2 – point c
Amendment 266 #
Proposal for a regulation
Article 3 – paragraph 3 – point b a (new)
Article 3 – paragraph 3 – point b a (new)
(b a) data not explicitly required for hazard or risk assessment purposes;
Amendment 267 #
Proposal for a regulation
Article 3 – paragraph 3 – point b b (new)
Article 3 – paragraph 3 – point b b (new)
(b b) information submitted to the Agencies or Commission prior to [a specific cutoff date].
Amendment 271 #
Proposal for a regulation
Article 3 – paragraph 5 – introductory part
Article 3 – paragraph 5 – introductory part
5. The common data platform shall provide the dedicatedfollowing essential services, as identified in the governance scheme referred to in Article 4(3) including:
Amendment 273 #
Proposal for a regulation
Article 3 – paragraph 5 – point g
Article 3 – paragraph 5 – point g
Amendment 284 #
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: threfive 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: ten15 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 287 #
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 chemicals datasets for inclusion in the common data platform together with a timeline for their inclusion by means of an implementing decision. Subsequent rolling implementation plans shall be adopted in line with the governance scheme referred to in paragraph 3.
Amendment 291 #
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 decision. Stakeholders shall be consulted before decisions on implementation plans and governance are taken.
Amendment 302 #
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 iscan be made available to the public or they are deemed confidential in accordance with the provisions on confidentiality under the originating Union act.
Amendment 319 #
Proposal for a regulation
Article 5 – paragraph 8
Article 5 – paragraph 8
8. For the purpose of paragraph 2, the Commission and the Agencies shall make chemicals data referred to in Annex I 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 342 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. TOnce notified by the Authority responsible, the ECHA shall establish and manage a repository of reference values as part of the common data platform.
Amendment 344 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. 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 348 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The ECHA shall store in the Database of Study Notifications the data notified to it in accordance with Article 22only chemical data submitted to it under Annex I-listed Union acts where such data are part of registrations, applications, or notifications required under Union law.
Amendment 353 #
Proposal for a regulation
Article 9 – paragraph 5
Article 9 – paragraph 5
5. The ECHA and the EFSA shall cooperate to ensure a common approach for the identification of information notifisubmitted to them in accordance with Article 22 of this Regulation and Article 32b of Regulation (EC) No 178/2002, respectivelytheir respective mandates under Annex I-listed Union acts and facilitate the traceability of the studies notifiincluded toin their respective databases.
Amendment 380 #
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
2. Where standard data formats are established under the Union acts listed in Annexes I and I I, the ECHA shall include them in the common data platform.
Amendment 383 #
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. At the latest within threfive 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 391 #
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
3. Where researchers or research consortia funded by Union framework programmes make available to the ECHA, under Article 5(6), any environmental sustainability data on chemicals or materials they collect or generate, the ECHA shall integrate the relevant data in the database on environmental sustainability related data.
Amendment 394 #
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. By [OP please insert date: three years after the date of entry into force of this Regulation], the Commission shall adopt an implementing decision, in consultation with Member States, 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 399 #
Proposal for a regulation
Article 14 – paragraph 5 – introductory part
Article 14 – paragraph 5 – introductory part
5. The Commission and the Agencies 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 listed in Annex I:
Amendment 407 #
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 coherence with other formats and the interoperability of the standard formats with the common data platform and with existing data submission approaches. They shall also consult stakeholders.
Amendment 412 #
Proposal for a regulation
Article 15 – paragraph 6
Article 15 – paragraph 6
6. The Commission and the Agencies shall cooperate with each other in setting the controlled vocabularies and will consult stakeholders.
Amendment 420 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. The Authorities shall take the necessary measures, including security measures, to ensure that information contained in the common data platform marked as confidential in accordance with Article 5(2) is not mad, second sentence, is not made available to the public.
Amendment 423 #
Proposal for a regulation
Article 16 – paragraph 3
Article 16 – paragraph 3
3. The general public shall only have access to all the chemicals data contained in the common data platform and considered as available to the public in accordance with the Union act under which the data was generated or submitted.
Amendment 436 #
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, in consultation with Member States, operate, and maintain a framework of indicators to monitor the drivers and impacts of exposure to chemicals, measure the effectiveness of chemicals legislation and measure the transition towards the production of safe and sustainable chemicals.
Amendment 479 #
Proposal for a regulation
Article 21 – paragraph 5
Article 21 – paragraph 5
5. The ECHA shall commission these scientific studies in an open and transparent manner and after a consultation of stakeholders and the public on the intended studies.
Amendment 494 #
Proposal for a regulation
Article 22
Article 22
Amendment 532 #
Proposal for a regulation
Article 25 – title
Article 25 – title
Amendment 537 #
Proposal for a regulation
Annex I – point 9
Annex I – point 9
Amendment 538 #
Proposal for a regulation
Annex I – point 29
Annex I – point 29
Amendment 539 #
Proposal for a regulation
Annex I – point 65
Annex I – point 65
Amendment 543 #
Proposal for a regulation
Annex III – point 21
Annex III – point 21
Amendment 544 #
Proposal for a regulation
Annex III – point 31
Annex III – point 31