33 Amendments of Pietro FIOCCHI related to 2023/0453(COD)
Amendment 104 #
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 take the necessary measures to protect the confidentiality of data, including, where relevant, by means of physical and cybersecurity measures.
Amendment 116 #
Proposal for a regulation
Recital 8
Recital 8
(8) Due to the different nature of the risk and hazardWhile some medicinal products are also chemicals and could present an interest for the objectives of this Regulation, the application and use of hazard and risk assessments performed on them under Union acts on medicinal products, when compared to those performed under the main Union acts on chemicals, for medicinal products, only chemicals data rel is different from the application and use of hazard and risk assessments performed under the main Union acts on chemicals. It is thus appropriated to environmental risk assessments for human and veterinary medicines, non- clinical studies for human medicines and maximum residue limit values the European Medicines Agency (‘EMA’) holds, as well as specific reference values, should be included in the common data platform. For medicinal active substances, onlyadopt a stepwise approach and to include at this stage, taking due account of the administrative burden for the European Medicines Agency (‘EMA’), only chemicals data with the highest added value. At this stage, data with highest assessed added value is data on relevant active substances should be included. These concern active substances covered by the medicines legislation and also used for other applications regulated by, which are considered to be active substances covered by Union legislation on medicinal products listed in Annex II, and also subject to regulatory procedures under other Union legislation listed in Annex I 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. The specific chemicals data to be included for those relevant active substances should cover chemicals data related to environmental risk assessments carried out under Union legislation on medicinal products for human and veterinary use, non-clinical studies carried out under Union legislation on medicinal products for human use and maximum residue limit values and the chemicals data underlying their derivation that the EMA holds, as well as specific reference values.
Amendment 120 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8 a) Chemicals contained in medicinal products are covered by Annex II of this Regulation, as well as Annex I since chemicals in medicinal products are also subject to regulatory procedures under the majority of other Union legislation listed under Annex I. In order to protect the confidentiality of certain data and to prevent any conflicts between legislative acts, the provisions from Directive 2001/83/EC of the European Parliament and the Council and Regulation (EC) 726/2004 of the European Parliament and the Council should always take precedence over this Regulation. This covers future implementation through delegating and/or implementing acts.
Amendment 126 #
Proposal for a regulation
Recital 9
Recital 9
(9) These data should also be limited to dataConsidering the format this data is in and the effort it would require to transform it into an appropriate format, for efficiency reasons, only data that is 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 should be included in the common data platform, where relevant, data the EMA holds on procedures concluded before the entry into force of this Regulation.
Amendment 134 #
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 policies. 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 150 #
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 relevant 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. The quality control of data and completeness checks of data submissions should be carried out by the originator in accordance with the originating Union act under which the data was submitted or generated.
Amendment 164 #
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 176 #
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 certain information related to the studies on chemicals they commission to support an application, notification or regulatory dossier intended to be notified or submitted to an authority 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.
Amendment 224 #
Proposal for a regulation
Recital 51 a (new)
Recital 51 a (new)
(51 a) By XXX/before implementation of this regulation, the Commission shall carry out an impact assessment on the “one substance one assessment” initiative to ensure that possible impacts on businesses are duly considered and that businesses are involved in the initiative since its beginning.
Amendment 234 #
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 legislationacts listed in Annex I, where those studies are commissioned to support an application, notification or regulatory dossier intended to be notified or submitted to an Authority to comply with regulatory requirements under the Union acts listed in Annex I;
Amendment 237 #
Proposal for a regulation
Article 1 – paragraph 2 – point c
Article 1 – paragraph 2 – point c
(c) establish the widest possible scientific base for the implementation and development of Union legislation and policy on chemicals taking into account the different sectorial risk assessment;
Amendment 246 #
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 relevant for the environmental sustainability assessment of a chemical or material throughout its entire life cycle, including:
Amendment 299 #
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 under the originating Union actconfidential in accordance with the provisions on confidentiality under the originating Union act. Where the originating Union act does not contain confidentiality provisions, the Commission shall, by means of an implementing decision, establish interim confidentiality provisions under this Regulation. Such implementing decision shall be adopted, in consultation with stakeholders, within 12 months of the date of entry into force of this Regulation.
Amendment 306 #
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 349 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The ECHA shall integrate the data contained in the Database of Study Notifications in the common data platform once a corresponding registration, application, notification or other relevant regulatory dossier was submitted to the relevant Union or national institution, agency, or body in accordance with corresponding Union law and after a decision was taken by that Union or national institution, agency, or body on the disclosure of the accompanying studies summary in accordance with the applicable rules on confidentiality.
Amendment 392 #
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 406 #
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 410 #
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. The Commission and the Agencies shall cooperate with each other in setting the controlled vocabularies and will consult stakeholders
Amendment 418 #
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 made public, second sentence, is not made available to the public in accordance with the provisions on confidentiality under the originating Union act.
Amendment 448 #
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. The ECHA, the EFSA, the EU- OSHA and the EMA shall identify and gather relevant available data on early warning signals from the field falling within their mandate and provide this data to the EEA. The EEA shall develop guidance for identification of emerging chemicals risks in cooperation with ECHA, the EFSA, the EU-OSHA and the EMA and other relevant parties.
Amendment 453 #
Proposal for a regulation
Article 19 – paragraph 5
Article 19 – paragraph 5
5. The EEA shall make all relevantconfirmed 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. To avoid confusion, data that is not a positive identification of an emerging risk as described in article 19(3) will not be included in the common data platform.
Amendment 477 #
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. ECHA are to request industry to provide comments on the studies commissioned by ECHA, including comments on testing protocol and methodology.
Amendment 480 #
Proposal for a regulation
Article 21 – paragraph 5 a (new)
Article 21 – paragraph 5 a (new)
5 a. ECHA shall publish, on its website, the study identified to commission along with the relevant justification, the study protocol, and the financing mechanism. A public consultation shall run for 60 days for interested stakeholders to comment.
Amendment 483 #
Proposal for a regulation
Article 21 – paragraph 6
Article 21 – paragraph 6
6. The ECHA, 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.
Amendment 487 #
Proposal for a regulation
Article 21 – paragraph 6 a (new)
Article 21 – paragraph 6 a (new)
6 a. Interested stakeholders can appeal the decision to commission the study before the Board of Appeal.
Amendment 497 #
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 three months of the date of the 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. The confidentiality of information on business operators will be respected.
Amendment 500 #
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, anyinformation referred to in article 22(2) related to 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. Business operators shall provide a valid justification for the non- notification of studies in accordance with this paragraph.
Amendment 510 #
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 title, scope, laboratory, or testing facility carrying out the study, the intended starting and planned completion dates and, where relevant, whether the study is commissioned to comply with a decision of the ECHA pursuant to Articles 40, 41 or 46 of Regulation (EC) No 1907/2006. For medicinal products, notification is only required after the market authorisation application has been submitted.
Amendment 513 #
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
3. Laboratories and testing facilities shall also, without undue delayin three months of the date of the commissioning, notify any study commissioned by business operators to support a regulatory dossier on which an Agency is required to provide a scientific output, including a scientific opinion, under the Union acts listed in Annex I. However, laboratories and testing facilities shall not notify to the Database of Study Notifications referred to in Article 9 studies that are to be notified under Article 32b of Regulation (EC) No 178/2002. The confidentiality of information on laboratories and testing facilities will be respected.
Amendment 515 #
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
3. Laboratories and testing facilities shall also, without undue delay, notify anyinformation referred to in article 22(2) related to studyies commissioned by business operators to support a regulatory dossier on which an Agency is required to provide a scientific output, including a scientific opinion, under the Union acts listed in Annex I. However, laboratories and testing facilities shall not notify to the Database of Study Notifications referred to in Article 9 studies that are to be notified under Article 32b of Regulation (EC) No 178/2002.
Amendment 521 #
Proposal for a regulation
Article 22 – paragraph 7
Article 22 – paragraph 7
7. The ECHA shall lay down the practical arrangements for implementing the provisions of this Article, and engage business operators where relevant.
Amendment 527 #
Proposal for a regulation
Article 22 – paragraph 7 a (new)
Article 22 – paragraph 7 a (new)
7 a. The obligations set under this article shall not apply to substances manufactured, imported or used in Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD).
Amendment 530 #
Proposal for a regulation
Article 23 – paragraph 2
Article 23 – paragraph 2
2. The Commission is empowered to adopt delegated acts in accordance with Article 24 to amend Annex II by adding, where relevantrespecting the confidentiality of certain data, new categories of data types.