54 Amendments of Jutta PAULUS related to 2023/0453(COD)
Amendment 97 #
Proposal for a regulation
Recital 2
Recital 2
(2) The main objective of this Regulation is to increase the level of protection of the environment and human health from the risks arising from hazardous chemicals, as well as to facilitate the functioning of the internal market for chemicals. For that purpose, this Regulation should establish a common data platform data on chemicals (‘the common data platform’), to be managed by the European Chemicals Agency (‘ECHA’). The common data platform is a digital infrastructure that brings together chemicals data and information generated under the Union chemicals acquis. This Regulation should also establish dedicated services within the common data platform and lay down rules on the 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 chemicalsand thereby contribute to ensuring that testing on vertebrate animals only takes place 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 data of, and regulatory processes on chemicals, as well as to strengthen public trust in the robustness of scientific decision-making. When reference is made to chemicals, this should be understood as including groups of chemicals.
Amendment 110 #
Proposal for a regulation
Recital 7
Recital 7
(7) The common data platform should contain, but not be limited to, all chemicals-related data and information held by relevant Union agencies or the Commission generated or submitted as part of the implementation of Union chemicals legislation listed in Annex I, unless this Regulation specifies otherwise. This includes, for instance, all regulatory dossiers or applications submitted to the relevant Union agencies, but also chemicals data on occurrence of chemicals submitted by Member States to Union agencies or the Commission in compliance with their reporting obligations. 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 118 #
Proposal for a regulation
Recital 8
Recital 8
(8) Due toespite the different nature of the risk and hazard assessments performed under Union acts on medicinal products, when compared to those performed under the main Union acts on chemicals, for medicinal products, only chemicals data related to human health and environmental risk assessments for human and veterinary medicines, non- clinical studies for human medicines and maximum residue limit values the European Medicines Agency (‘EMA’) holds, as well as specific reference values, should be included in the common data platform. For medicinal active substances, only data on relevant substances should be included. These concern active substances covered by the medicines legislation and also used for other applications regulated by other Union legislation identified in this Regulation, as well as other active substances with particular persistent, bio-accumulative and toxic properties or with a known high level of residues in the environment.
Amendment 123 #
Proposal for a regulation
Recital 9
Recital 9
(9) TGiven the overall number of authorised medicines and the comparatively low number of annual new procedures, these data should alsonot be limited to data submitted to the EMA in the context of the relevant procedures that are finalised or submitted after the entry into force of this Regulation. At a later stage, it should also be possible to include in the common data platform, where relevant, data the EMA holds on procedures concluded before the entry into force of this RegulationData to be submitted to the EMA in the context of the relevant procedures that are finalised or submitted after the entry into force of this Regulation should be included by the date of establishment of the common data platform. Data on procedures concluded before the entry into force of this Regulation should be included as part of the five-year implementation period after establishment of the database.
Amendment 140 #
Proposal for a regulation
Recital 14
Recital 14
(14) When using data contained in the common data platform, the Authorities should respect the originator principle. Under this principle, the confidentiality marking of chemicals data as done by the originator and as correspondingly indicated by the Agency when it provides that data to the common data platform should be respected by the Authorities using that data or information to perform their regulatory functions or fulfil their tasks. Where relevant, a clear mention should be made on the common data platform, which indicates to the general public and business operators that data is owned by third parties and that any commercial use of the data without prior approval from the data owner might infringe its rights. The common data platform should also include relevant terms and conditions, including regarding intellectual property rights and other rights.
Amendment 156 #
Proposal for a regulation
Recital 23
Recital 23
(23) To improve the uptake of academic data and to expand the knowledge base for chemicals safety assessments and environmental sustainability impacts of chemicals, researchers or research consortia funded by Union framework programmes should make available, in line with the ‘as open as possible, as closed as necessary’ principle, any human biomonitoring data they collect or generate resulting from research and development programmes to the EEA and any other data on chemicals, including environmental sustainability data on chemicals or materials they collect or generate to the ECHA. Member States should require researchers or research consortia funded by national framework programmes to make their data available to the EEA or to ECHA, as appropriate.
Amendment 178 #
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28 a) To avoid uncertainties for business operators resulting from the existence of two databases of study notifications, managed by ECHA and EFSA respectively, the practical arrangements laid down by ECHA for implementing the provisions on notification of studies should as much as possible be aligned with the related EFSA’s practical arrangements.
Amendment 186 #
Proposal for a regulation
Recital 31
Recital 31
(31) While the study notification obligation established in this Regulation should apply in the context of all the Union acts on chemicals listed in Annex I, the various relevant data collection and safety assessment processes under those acts may vary widely procedurally. The overarching aim of the database of study notifications established under this Regulation should be to bring together information on studies on chemicals being commissioned by business operators, such as to enable a centralised and complete overview of the studies being performed to support regulatory compliance under Union acts on chemicals as listed in Annex I and to avoid animal testing wherever possible. On the basis of this objective and considering the fact that assessment procedures under Union acts on chemicals in Annex I may vary widely, it would be beyond the scope and aim of this Regulation to amend existing assessment processes set under those Union acts listed in Annex I by imposing additional conditions leading to potential market access consequences not foreseen in those Union acts. Consequently, it is not appropriate to introduce in this Regulation the consequences associated non- compliance with the study notification obligation as laid out in Article 32b of Regulation (EC) No 178/2002 of the European Parliament and of the Council.
Amendment 193 #
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. Information on enforcement should be made public to enhance public trust in the effective implementation of Union law.
Amendment 201 #
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, 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 whether it involves animal testing. 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 205 #
Proposal for a regulation
Recital 41
Recital 41
(41) The International Uniform Chemical Information Database (‘IUCLID’) is a software application designed to record, store, maintain and exchange data on chemicals. The ECHA develops and maintains the IUCLID software and the underlying format in collaboration with the Organisation for Economic Cooperation and Development (‘OECD’). The IUCLID implements all OECD-harmonised templates, which are harmonised formats agreed at the OECD level to facilitate structured and consistent documentation of test outputs and similar chemicals data. Since chemicals data is being submitted to the ECHA in IUCLID under Union acts such as Regulations (EC) No 1907/2006, (EC) No 1107/200913 and (EU) No 528/201214 of the European Parliament and of the Council, the ECHA is closely involved in the continued development of IUCLID, and IUCLID implements the standard formats agreed at the OECD level, it is appropriate and necessary to require the Commission and the Agencies to use IUCLID for the relevant parts of dossiers under specified Union acts listed in Annex I when they make the data contained in those dossiers available to the ECHA . In light of its expertise and responsibility in IUCLID software, as well as the establishment and operation of the Common Data Platform, it is appropriate for ECHA to furnish precise guidelines and adequate technical and IT support to ensure that the competent authorities are able to comply with their obligation to submit the relevant sections of the dossiers. _________________ 13 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309 24.11.2009, p. 1). 14 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167 27.6.2012, p. 1).
Amendment 218 #
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. If a sample of a substance is needed to conduct scientific studies, the ECHA should have the authority to request the business operator to provide the necessary sample.
Amendment 223 #
Proposal for a regulation
Recital 49 a (new)
Recital 49 a (new)
(49 a) To support the effective implementation and evaluation of Union acts on chemicals and to contribute to the development of a comprehensive Union chemicals policy, it is essential to conduct EU-wide human biomonitoring studies that provide high-quality and representative data at regular intervals.
Amendment 226 #
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’ knowledge of, and trust in, the scientific base for the decisions taken under Union legal acts on chemicals, and to help move away from animal testing wherever possible.
Amendment 282 #
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: three years after the date of entry into force of this Regulation], unless specified otherwise. T, and shall at least include the datasets as set out in Annex IIIa. Further relevant datasets shall be integrated progressively into the common data platform by [OP please insert date: teneight 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 289 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. The Commission shall, by means of an implementing decision, establish and manage a platform steering committee, which shall include at least one representative from the ECHA, one representative from the EEA, one representative from the EFSA, oneeach Union agency required to submit chemicals data to the Platform, and as many representatives from the EMA, one representative from the EU-OSHA and five representatives from the CommissionCommission as from all Union agencies combined.
Amendment 305 #
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 publicconfidential in accordance with the provisions on confidentiality under the originating Union act.
Amendment 317 #
Proposal for a regulation
Article 5 – paragraph 7
Article 5 – paragraph 7
7. The Commission and the Agencies shall provide the necessary technical cooperation to the ECHA to enable the integration of the chemicals data provided in accordance with paragraph 2 in the common data platform as well as its publication through that platform. The ECHA shall provide the necessary support to the Commission and the agencies to facilitate the integration of the chemicals data provided in accordance with paragraph 2.
Amendment 354 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. The ECHA shall establish and manage, as part of the common data platform, a new database containing information on regulatory processes on individual substances or groups of substances that are planned, ongoing or have been completed since the entry into force of this Regulation by the Member States or the Union institutions, agencies or committees referred to in the Union acts listed in Annex III. This shall include information on regulatory processes involving animal tests.
Amendment 356 #
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Where Member State competent authorities as referred to in any of the Union acts listed in Annex III hold the information referred to in paragraph 1, they shall make that information available to the Union agency responsible under the respective Union act listed in Annex III without undue delay. For each regulatory process or activity, the following information shall at least be transmitted:
Amendment 358 #
Proposal for a regulation
Article 10 – paragraph 2 – point a (new)
Article 10 – paragraph 2 – point a (new)
(a) the substance identity;
Amendment 360 #
Proposal for a regulation
Article 10 – paragraph 2 – point b (new)
Article 10 – paragraph 2 – point b (new)
(b) the Union act and the regulatory process under which the activity takes place;
Amendment 362 #
Proposal for a regulation
Article 10 – paragraph 2 – point c (new)
Article 10 – paragraph 2 – point c (new)
(c) submitter or actor responsible for the regulatory process or activity;
Amendment 364 #
Proposal for a regulation
Article 10 – paragraph 2 – point d (new)
Article 10 – paragraph 2 – point d (new)
(d) status of the regulatory process or activity;
Amendment 366 #
Proposal for a regulation
Article 10 – paragraph 2 – point e (new)
Article 10 – paragraph 2 – point e (new)
(e) where applicable, outcome of the regulatory process or activity, including reports or opinions adopted;
Amendment 368 #
Proposal for a regulation
Article 10 – paragraph 2 – point f (new)
Article 10 – paragraph 2 – point f (new)
(f) where applicable, date of intention to start the regulatory process or activity, completion and latest update.
Amendment 371 #
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 the activity includes use of animals in testing and for which endpoints.
Amendment 373 #
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 started.
Amendment 378 #
Proposal for a regulation
Article 10 a (new)
Article 10 a (new)
Article 10a Information on substances in articles and their alternatives 1. The ECHA shall integrate, as part of the common data platform, a new database containing information on substances in articles and their alternatives generated or submitted as part of the implementation of Union chemicals legislation listed in Annex I. This database shall integrate at least the information subject to Article 9(1)(i) of Directive 2008/98/EC and of Article 14 of Regulation (EU) 2024/1781. 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 to identify them and to provide all relevant data. (For SCIP data base, see herehttps://echa.europa.eu/scip)
Amendment 379 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. The ECHA shall update the information in the database on a regular basis, at least annually, and in accordance with the governance scheme referred to in Article 4(3).
Amendment 386 #
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. Where the Commission or the Agencies host or hold environmental sustainability related data in addition to the chemicals data already available in the common data platform, they shall make that data available to the ECHA without undue delay once the Commission or the Agency hosting or holding that data has completed, where relevant, validity and confidentiality assessments. The Commission and the Agencies shall provide the necessary technical cooperation to the ECHA to enable the integration of environmental sustainability related data in the database on environmental sustainability related data. The ECHA shall ensure the necessary support to the Commission and the agencies to facilitate the integration of these data.
Amendment 416 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The Authorities, scientific committees, and agencies which have rights and obligations in social security issues, shall have access to all the chemicals data contained in the common data platform, including data which is deemed to be confidential under Article 5(2), second sentence.
Amendment 422 #
Proposal for a regulation
Article 16 – paragraph 3
Article 16 – paragraph 3
3. The general public shall have access to all the chemicals data contained in the common data platform and considered as available to the publ, except data which in accordance with the Union act under which the data was generated or submitteds marked to be confidential under Article 5(2), second sentence.
Amendment 432 #
Proposal for a regulation
Article 17 – paragraph 3 a (new)
Article 17 – paragraph 3 a (new)
3 a. It shall be clearly mentioned on the common data platform, for the attention of the general public and business operators, where relevant, that the data is owned by a third party and that any commercial use of the data without prior approval from the data owner might infringe their rights. The common data platform shall also include terms and conditions, particularly regarding intellectual property rights and other related rights.
Amendment 433 #
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 indicators, in consultation with Member States, establish, operate, maintain and update as appropriate an indicative 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, and to measure the effectiveness of chemicals legislation and measure the transition towards the production of safe and sustainable chemicals.
Amendment 441 #
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 1 – point b
Article 19 – paragraph 2 – subparagraph 1 – point b
(b) existing national early warning systems;
Amendment 442 #
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 human biomonitoring as referred to in Article 6 and data from the framework of indicators as referred to in Article 18;
Amendment 451 #
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
4. The EEA shall draw up an annual report, compiling and analysing the data on early warning signals gathered in accordance with paragraphs 2 and 3. [The first report shall be prepared by [OP: please insert date: 6 months after the end of the first calendar year after entry into force of this Regulation]. The EEA shall present this report to the Commission, relevant Union agencies and Member SAuthorities. The Authorities shall undertatke competent authorities for consideration of the need for regulatory or policy action related to the early warning signalsenforcement, regulatory or policy action necessary to address the emerging risks in a timely manner. They shall justify if they decide not to proceed with any action related to the early warning signals, including an assessment of the costs of non-action.
Amendment 456 #
Proposal for a regulation
Article 19 – paragraph 5 a (new)
Article 19 – paragraph 5 a (new)
5 a. If the data analysis indicates that there is a risk that has to be tackled urgently, the EEA shall inform the authorities without undue delay.
Amendment 460 #
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. The ECHA shall establish, operate and maintain an observatory for specific chemicals that the Commission considers as requiring additional scrutiny. The observatory shall include reliable information on the chemicals’ properties, safety aspects, uses and market presence.
Amendment 462 #
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. By [OP please insert date: 6 months after the date of entry into force of this Regulation] the CommissionECHA shall adopt and publish a list of the selected chemicals by means of an implementing decision. The Commission. The ECHA shall review the list of selected chemicals regularly adopt any revision thereof by the same meansnd at least annually.
Amendment 463 #
Proposal for a regulation
Article 20 – paragraph 3
Article 20 – paragraph 3
3. The CommissionECHA shall select the chemicals referred to in paragraph 1 based on the scientific and technical progress and using the signals of the early warning system referred to in Article 19. The selection shall include potential contributors to new and emerging chemical risks among innovative rationally designed materials with new or enhanced properties or targeted or enhanced structural features at nanoscale.
Amendment 473 #
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 give priority to the use of non-animal methods, with animal testing on vertebrate animals only as a last resort. It shall not commission studies with a predominant research objective.
Amendment 474 #
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 or if data is incomplete or restricted to certain sectors. It shall not commission studies with a predominant research objective.
Amendment 476 #
Proposal for a regulation
Article 21 – paragraph 3 a (new)
Article 21 – paragraph 3 a (new)
3 a. The ECHA may request business operators to provide samples of substances necessary for performing the scientific studies referred to in paragraph 1. Business operators shall, upon request by the ECHA, provide the requested sample free of charge to the ECHA or to any body commissioned by the ECHA to perform the scientific study.
Amendment 486 #
Proposal for a regulation
Article 21 – paragraph 6 a (new)
Article 21 – paragraph 6 a (new)
6 a. Every three years, the ECHA, in cooperation with the EFSA, shall commission an EU-wide human biomonitoring study to assess the exposure of humans to relevant chemicals. Member States shall cooperate with the ECHA and the EFSA in the planning and organization of the study. Member States shall collect the samples in their territories and ensure that the data is representative and of good quality and submit the data to the ECHA.
Amendment 499 #
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 delayin one month from the date of commissioning, any studies on chemicals they commission to support an application, notification or regulatory dossier notified or submitted to an Authority, as well as any studies on chemicals on their own or in products they commission as part of a risk or safety assessment , prior to placing on the market, under the Union acts listed in Annex I. However, business operators shall not notify to the Database of Study Notifications referred to in Article 9 studies that are to be notified under Article 32b of Regulation (EC) No 178/2002.
Amendment 522 #
Proposal for a regulation
Article 22 – paragraph 7
Article 22 – paragraph 7
7. The ECHA, in close cooperation with the EFSA, shall lay down the practical arrangements for implementing the provisions of this Article.
Amendment 540 #
Proposal for a regulation
Annex I – point 70 a (new)
Annex I – point 70 a (new)
70 a. Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC (OJ L, 2024/1781, 28.6.2024)
Amendment 541 #
Proposal for a regulation
Annex II – Part 1 – paragraph 1
Annex II – Part 1 – paragraph 1
Amendment 542 #
Proposal for a regulation
Annex II – Part 2 – paragraph 1
Annex II – Part 2 – paragraph 1
Amendment 545 #
Proposal for a regulation
Annex III – point 34 a (new)
Annex III – point 34 a (new)
34 a. Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC (OJ L, 2024/1781, 28.6.2024)
Amendment 546 #
Proposal for a regulation
Annex III b (new)
Annex III b (new)
Datasets to be included at the date of establishment of the common data platform referred to in Article 3 o ECHA REACH: REACH registrations including Chemical Safety Reports (CSR). o ECHA Classification, Labelling and Packaging (CLP): Classification and labelling (C&L) inventory. o ECHA Biocidal Products Regulation (BPR): Biocidal active substance approval process data. o ECHA Prior Informed Consent (PIC): Data on substances subject to PIC the Regulation. o ECHA Persistent Organic Pollutants (POP): 1) List of POPs; 2) List of substances proposed to be included in the POP list of the Stockholm Convention. o EFSA OpenFoodTox: Summary of all EFSA chemical risk assessments including chemical identifiers, critical endpoints, toxicological reference values and metadata from EFSA outputs. o EFSA Chemical Monitoring Data: Chemical monitoring data for pesticides and veterinary medicinal product residues and contaminants data. The individual measurements of chemicals in food/feed and other materials sampled as part of official controls and enforcement activities. Measurements of chemicals in food and feed received from industry or other sources in response to call for data. o EFSA OpenEFSA: All information related to EFSA's scientific work. Tracking of the risk assessment process from receipt of dossier to adoption of the opinion. Information available includes status of assessments, dossiers and studies, meeting agendas and minutes, information on experts (DOIs), public consultations). o EFSA EU_PPP Agency IUCLID: IUCLID dossiers submitted by applicants (industry) under Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. o EEA Air Quality: Air quality data from a wide range of sources including current status of Europe’s air quality through five different air pollutants (European Air Quality Index), latest measurements from Europe's air quality monitoring network and Statistics for air pollutants calculated from officially-verified country data for years until ‘X-2’. o EEA Waterbase Water Quality: Time series of concentrations of nutrients, organic matter, hazardous substances and other chemicals in rivers, lakes, groundwater, transitional, coastal and marine waters. Records reported under the Water Framework Directive Watch List for chemicals in surface waters. o EEA Waterbase emissions: Time series of emissions of nutrients and hazardous substances to water, reported by EEA member countries and cooperating countries. Data on yearly riverine input loads to transitional, coastal and marine waters. o EEA Industrial emissions: Data reported by Member States in the scope of the E-PRTR Regulation and Industrial Emissions Directive. o EEA National Emission reductions Commitments (NEC) Directive emission inventory data: Data on emissions of air pollutants. o EMA human medicinal products data (environmental risk assessment and non- clinical safety data) o EMA veterinary medicinal products (environmental risk assessment and maximum residue limit (MRL) values and MRL assessment data)
Amendment 547 #
Proposal for a regulation
Annex II – Part 1 – introduction
Annex II – Part 1 – introduction
Specific data on relevant active substances to be identified in accordance with Article 4(5)(b) falling under the scope of this Regulation for the purposes of Article 3 for human and veterinary medicinal products