2023/0453(COD) Common data platform on chemicals, establishing a monitoring and outlook framework for chemicals
Lead committee dossier:
Progress: Awaiting committee decision
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | ENVI |
TSIODRAS Dimitris ( EPP)
|
CLERGEAU Christophe ( S&D),
TIMGREN Beatrice ( ECR),
HOJSÍK Martin ( Renew),
PAULUS Jutta ( Greens/EFA),
HAZEKAMP Anja ( The Left)
|
| Former Responsible Committee | ENVI |
SPYRAKI Maria ( EPP)
|
|
| Former Committee Opinion | BUDG | ||
| Former Committee Opinion | ITRE | ||
| Committee for budgetary assessment | BUDG |
Lead committee dossier:
Legal Basis:
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Legal Basis:
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Events
2024/12/05
European Parliament - Amendments tabled in committee
Documents
2024/12/04
European Parliament - Amendments tabled in committee
Documents
2024/12/04
European Parliament - Amendments tabled in committee
Documents
2024/11/13
EP - Committee referral announced in Parliament, 1st reading
2024/10/28
European Parliament - Committee draft report
Documents
2024/08/07
EP - TSIODRAS Dimitris (EPP) appointed as rapporteur in ENVI
2024/04/22
CZ_SENATE - Contribution
Documents
2024/04/12
IT_CHAMBER - Contribution
Documents
2024/03/20
Economic and Social Committee: opinion, report - ESC
Documents
2024/03/15
EP - SPYRAKI Maria (EPP) appointed as rapporteur in ENVI
2024/02/29
EP - Committee referral announced in Parliament, 1st reading
2023/12/07
European Commission - Document attached to the procedure
Documents
2023/12/07
European Commission - Legislative proposal
Details
PURPOSE: to establish a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals.
PROPOSED ACT: Regulation of the European Parliament and of the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: the European Green Deal sets a high ambition for enabling the transition towards a toxic-free environment and zero pollution. The Chemicals Strategy for Sustainability 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 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.
CONTENT: the Commission is presenting this draft Regulation which aims to implement the above-mentioned objectives.
Subject matter and scope
The proposed Regulation aims to ensure the efficient delivery of coherent hazard and risk assessments of chemicals where those assessments are required by Union legal acts, to achieve a high level of protection of human health and the environment, to enable the development and use of sustainable 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.
To achieve the objectives, this proposal contains measures to:
- bring together data and information on chemicals and ensure that data and information are easily findable, accessible, interoperable and re-usable;
- keep records of studies commissioned or carried out by business operators in the context of fulfilling their obligations set under Union chemicals legislation;
- establish the widest possible scientific base for the implementation and development of Union legislation and policy on chemicals;
- establish an early warning and action system for emerging chemical risks.
Common data platform on chemicals
The proposal aims to establish a common data platform on chemicals to be managed by the European Chemicals Agency (ECHA). The common data platform is a digital infrastructure that brings together data on chemicals and information generated under the EU chemicals acquis and held by EU agencies, namely ECHA, the European Environment Agency (EEA), the European Food Safety Authority (EFSA), the European Medicines Agency (EMA) and the European Agency for Safety and Health at Work (EU-OSHA). This includes data on hazards, physico-chemical properties, presence in the environment, emissions, uses, environmental sustainability of chemical substances and current regulatory procedures.
The proposal creates an obligation to ensure that data on chemicals held by these agencies or by the Commission is included in the common data platform. The common data platform will centralise and consolidate data on chemicals at EU level in one centrally accessible IT infrastructure.
The proposed Regulation will also establish dedicated services within the common data platform and lay down rules on the accessibility and usability of the data contained in this platform . It aims to create a common knowledge base on chemicals available to authorities to enable better, comprehensive, consistent and robust scientific assessments of chemicals and their impacts, as well as to ensure the best use of existing information for the implementation and development of EU chemicals legislation.
In addition, the proposed Regulation aims to provide a one-stop-shop on chemicals data and information in the Union accessible to the 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.
Legislative proposal
Documents
2023/12/07
EC - Legislative proposal published
Details
PURPOSE: to establish a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals.
PROPOSED ACT: Regulation of the European Parliament and of the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: the European Green Deal sets a high ambition for enabling the transition towards a toxic-free environment and zero pollution. The Chemicals Strategy for Sustainability 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 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.
CONTENT: the Commission is presenting this draft Regulation which aims to implement the above-mentioned objectives.
Subject matter and scope
The proposed Regulation aims to ensure the efficient delivery of coherent hazard and risk assessments of chemicals where those assessments are required by Union legal acts, to achieve a high level of protection of human health and the environment, to enable the development and use of sustainable 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.
To achieve the objectives, this proposal contains measures to:
- bring together data and information on chemicals and ensure that data and information are easily findable, accessible, interoperable and re-usable;
- keep records of studies commissioned or carried out by business operators in the context of fulfilling their obligations set under Union chemicals legislation;
- establish the widest possible scientific base for the implementation and development of Union legislation and policy on chemicals;
- establish an early warning and action system for emerging chemical risks.
Common data platform on chemicals
The proposal aims to establish a common data platform on chemicals to be managed by the European Chemicals Agency (ECHA). The common data platform is a digital infrastructure that brings together data on chemicals and information generated under the EU chemicals acquis and held by EU agencies, namely ECHA, the European Environment Agency (EEA), the European Food Safety Authority (EFSA), the European Medicines Agency (EMA) and the European Agency for Safety and Health at Work (EU-OSHA). This includes data on hazards, physico-chemical properties, presence in the environment, emissions, uses, environmental sustainability of chemical substances and current regulatory procedures.
The proposal creates an obligation to ensure that data on chemicals held by these agencies or by the Commission is included in the common data platform. The common data platform will centralise and consolidate data on chemicals at EU level in one centrally accessible IT infrastructure.
The proposed Regulation will also establish dedicated services within the common data platform and lay down rules on the accessibility and usability of the data contained in this platform . It aims to create a common knowledge base on chemicals available to authorities to enable better, comprehensive, consistent and robust scientific assessments of chemicals and their impacts, as well as to ensure the best use of existing information for the implementation and development of EU chemicals legislation.
In addition, the proposed Regulation aims to provide a one-stop-shop on chemicals data and information in the Union accessible to the 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.
Legislative proposal
Documents
Documents
- Amendments tabled in committee: PE766.765
- Amendments tabled in committee: PE766.784
- Amendments tabled in committee: PE766.686
- Committee draft report: PE763.255
- Contribution: COM(2023)0779
- Contribution: COM(2023)0779
- ESC: CES5710/2023
- Document attached to the procedure: Go to the pageEur-Lex
- Document attached to the procedure: SWD(2023)0855
- Legislative proposal: COM(2023)0779
- Legislative proposal: Go to the pageEur-Lex
- Legislative proposal published: COM(2023)0779
- Legislative proposal published: Go to the page Eur-Lex
- Committee draft report: PE763.255
- Amendments tabled in committee: PE766.784
- Amendments tabled in committee: PE766.686
- Amendments tabled in committee: PE766.765
- Document attached to the procedure: Go to the pageEur-Lex SWD(2023)0855
- Legislative proposal: COM(2023)0779 Go to the pageEur-Lex
- Contribution: COM(2023)0779
- Contribution: COM(2023)0779
- ESC: CES5710/2023
| Amendments | Dossier |
| 457 |
2023/0453(COD)
2024/12/05
ENVI
457 amendments...
Amendment 100 #
Proposal for a regulation 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
Amendment 101 #
Proposal for a regulation Recital 2 a (new) (2 a) People and other living organisms are exposed daily to a wide mix of chemicals originating and environmental stressors from various sources. However, the safety of chemicals in the EU is usually assessed through the evaluation of single chemicals without considering the combined exposure to multiple chemicals from different sources and over time. If some pieces of legislation require to assess the cumulative exposure to the same chemical from different sources, explicit requirements to take into account the impact of unintentional mixtures is generally lacking. The human exposome is a concept that provides a holistic view of human health and disease. It includes exposures from our diets, our lifestyles, and environmental factors, such as chemicals. This regulation should help gathering data on the impacts of the exposure to multiple chemicals and environmental factors to foster research on the human exposome and help to understand the causal pathways leading to common diseases such as cardiovascular disease, respiratory diseases, immunological disorders, mental health, and non-communicable diseases.
Amendment 102 #
Proposal for a regulation Recital 4 (4) In its communication of 19 February 2020 on a European strategy for data4 , the Commission described its vision of a common European data space and highlighted the need for the development of sectoral data spaces in strategic areas, since not all sectors of the economy and society are moving at the same speed. This Regulation aims therefore to build a data space for chemicals by establishing a common data platform on chemicals (‘common data platform’), which is also part of the Green Deal data space, as referred to in the European strategy for data. Furthermore, in that strategy, the Commission highlighted several issues concerning the availability of data for the public good, including data availability, data infrastructures and governance, interoperability, as well as the lack of adequate sharing of data between public authorities. This Regulation aims to increase data availability on chemicals by requiring the relevant Union agencies and Member States' authorities to make data available for integration in the common data platform on chemicals, to promote interoperability of that data by providing for the establishment of standard formats and controlled vocabularies, as well as to facilitate data exchange and use by public authorities to enable them to effectively carry out their regulatory and policy developing tasks.
Amendment 103 #
Proposal for a regulation Recital 6 (6) Business operators and Members States’ competent authorities are required by various Union acts to submit data and information to a multitude of Union agencies, as well as to the Commission in specific cases. This generates a fragmentation of data and information on chemicals, which are held under various data sharing and use conditions and in different formats. Such fragmentation prevents public authorities, as well as the general public, from having a clear overview of what information is available on individual chemicals or groups of chemicals, of where and how information can be accessed and whether it can be used. This increases the likelihood of inconsistency between various assessments of the same chemical required by various Union acts on chemicals and of damaging the general public’s trust in the scientific grounds for Union decisions on chemicals. In order to ensure that data on chemicals is easily findable, accessible, interoperable and usable, the ECHA should establish a common data platform on chemicals. The common data platform on chemicals should serve as a single point of reference and as a broadened and shared evidence base to enable the efficient delivery of coherent hazard and risk assessments of chemicals across various Union acts on chemicals, as well as to enable the timely identification of emerging chemical risks and the drivers and impact of chemical pollution. Where multiple studies exist for the same chemical, potentially generated to meet requirements across different regulatory frameworks, data from each study should be published in a harmonised format which facilitates rapid comparison and review.
Amendment 104 #
Proposal for a regulation 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 105 #
Proposal for a regulation 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 106 #
Proposal for a regulation 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 107 #
Proposal for a regulation 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. Union agencies are required to make every effort to protect the data they hold, in particular where there is a cybersecurity risk.
Amendment 108 #
Proposal for a regulation 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 109 #
Proposal for a regulation Recital 7 (7) The common data platform should contain all chemicals-related data and information
Amendment 110 #
Proposal for a regulation 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
Amendment 111 #
Proposal for a regulation 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
Amendment 112 #
Proposal for a regulation 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, exposure and fate 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 113 #
Proposal for a regulation 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 114 #
Proposal for a regulation 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 115 #
Proposal for a regulation Recital 8 Amendment 116 #
Proposal for a regulation Recital 8 (8)
Amendment 117 #
Proposal for a regulation Recital 8 (8) Due to 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 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.
Amendment 118 #
Proposal for a regulation Recital 8 (8) D
Amendment 119 #
Proposal for a regulation Recital 8 (8) Due to the di
Amendment 120 #
Proposal for a regulation 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 121 #
Proposal for a regulation Recital 8 a (new) (8 a) Chemicals contained in medicinal products are covered by Annex II to 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 122 #
Proposal for a regulation Recital 9 Amendment 123 #
Proposal for a regulation Recital 9 (9)
Amendment 124 #
Proposal for a regulation Recital 9 (9) These data should
Amendment 125 #
Proposal for a regulation 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 stage, and no later than 4 years after the entry into force of this Regulation, 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 126 #
Proposal for a regulation Recital 9 (9)
Amendment 127 #
Proposal for a regulation 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.
Amendment 128 #
Proposal for a regulation 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.
Amendment 129 #
Proposal for a regulation Recital 9 a (new) (9 a) Other chemicals data submitted or generated under Union legislation on medicinal products may also be of interest to chemicals regulatory areas, such as data related to other active substances contained in medicinal products, clinical data, data related to other substances contained in medicinal products besides active substances and data that is submitted to the EMA in the context of the relevant procedures that are finalised before the entry into force of this Regulation. Moreover, a relevant part of the medicinal data is held by the National Competent Authorities. At a later stage and no later than 5 years after the entry into force of this Regulation, the Commission should therefore assess, in close cooperation with Member States and the Agencies, whether such additional data should be included in the common data platform. This assessment should take also into account the relevancy, the anticipated added value as well as the cost-benefit balance of incorporating the additional data.
Amendment 130 #
Proposal for a regulation Recital 10 Amendment 131 #
Proposal for a regulation Recital 10 (10) Due to the sensitivity of the information on the exact chemical composition of mixtures placed on the market and classified as hazardous on the basis of their health or physical effects, submitted to the bodies appointed by the Member States under Article 45 of Regulation (EC) No 1272/2008 of the European Parliament and the Council6 , that information should not be included in the common data platform. Likewise, due to the commercial sensitiveness of data and information on final cosmetic products, the information related to cosmetic products notified to the Cosmetic Product Notification Portal under Article 13 of Regulation (EC) No 1223/20097 of the European Parliament and of the Council should not be included in the common data platform either. However, chemicals data and information on individual chemical ingredients of cosmetic products should be included in the common data platform.
Amendment 132 #
Proposal for a regulation Recital 11 Amendment 133 #
Proposal for a regulation 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 h
Amendment 134 #
Proposal for a regulation 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 135 #
Proposal for a regulation 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. The Authorities should give limited access to personal data in accordance with the purposes for which the data is used.
Amendment 136 #
Proposal for a regulation 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
Amendment 137 #
Proposal for a regulation Recital 13 (13) Chemicals data and information generated as a result of obligations set by Union acts on chemicals may be protected by confidentiality claims on confidential business information. The public dissemination of such data may affect the commercial interest of private parties. To ensure legal certainty for duty holders and to protect their legitimate expectations, as well as to ensure industry’s competitiveness on the internal market, the ECHA, as a manager of the common data platform, should grant differentiated access rights to the data and information contained in the common data platform. 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. Where Union law requires that commercial or industrial information be kept confidential to protect a legitimate economic interest, that confidentiality should be safeguarded.
Amendment 138 #
Proposal for a regulation 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. T
Amendment 139 #
Proposal for a regulation 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
Amendment 140 #
Proposal for a regulation 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 141 #
Proposal for a regulation Recital 15 (15) To ensure the protection of
Amendment 142 #
Proposal for a regulation Recital 16 (16) Taking into account that the Agencies would be required to store scientific data, which includes confidential and personal data, it is necessary to ensure that such storage is carried out in accordance with a high level of security of information systems and that confidentiality claims and access to confidential data
Amendment 143 #
Proposal for a regulation Recital 17 (17) While the ECHA should identify and develop the technical functionalities of the common data platform in stages, certain dedicated services should be defined by this Regulation. As such, the common data platform should, in addition to providing access to chemicals-related data made available by the Agencies and the Commission, provide access to the chemicals data and information made available through its dedicated services. These dedicated services should be integrated into the common data platform and consist of the existing Information Platform for Chemical Monitoring (‘IPCHEM’) which should rapidly be elaborated to include all data on chemical substances in articles and on their alternatives, a repository of reference values, a database of study notifications, a database with information on regulatory processes, a database with information on applicable legal obligations, a repository of standard formats and controlled vocabularies, a database on environmental sustainability related data, as well as a dashboard of indicators on chemicals.
Amendment 144 #
Proposal for a regulation 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 145 #
Proposal for a regulation 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 chemicals in products and their alternatives, as well as a dashboard of indicators on chemicals.
Amendment 146 #
Proposal for a regulation Recital 18 (18) The Commission should adopt an implementation plan identifying initial datasets of chemicals data to be made accessible via the platform and the timeline for their integration, informed by the preparatory work of the Commission and the Agencies10 . The Commission should set up a governance scheme to support and steer the common data platform’s operation and evolution covering the organisation of work structures and coordination between ECHA and data providers, and required rules, formats and vocabularies for data integration, and maintain a rolling implementation plan to ensure the progress in identification and integration of new datasets of chemicals data and services for inclusion. The governance scheme should be adopted and updated as necessary by the Commission, after consultation with a newly established platform steering committee composed of representatives from Union agencies and the Commission. In order to ensure uniform conditions for the implementation of the obligations to establish an implementation plan and a governance scheme, implementing powers should be conferred on the Commission. _________________ 10 European Union Common Data Platform on Chemicals Project Initiation Document, v1.1 endorsed by the One Substance One Assessment Interservice Group 27 February 2023.
Amendment 147 #
Proposal for a regulation 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 148 #
Proposal for a regulation Recital 19 (19) The common data platform should serve the widest possible community, with the ability to address new use cases, incorporate new relevant datasets, develop new functionalities, and respond to developing tools and applications. Other parties, such as Member States, scientific bodies of Member States or national authorities, academia, and civil society should be able to submit chemicals data to the Agencies or the Commission for hosting and maintenance.
Amendment 149 #
Proposal for a regulation 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 data
Amendment 150 #
Proposal for a regulation 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 151 #
Proposal for a regulation 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
Amendment 152 #
Proposal for a regulation Recital 21 (21) To ensure that an adequate knowledge base on chemicals is available through the common data platform, the Commission should be able to request the Agencies to host, maintain and make available, via the common data platform, data generated as part of Union, national or international programmes, including monitoring and enforcement, or research activities beyond the data already flowing to the Agencies as part of the obligations under the Union acts listed in Annex I. The Commission should make such requests to the Agencies in accordance with their mandates and allocated tasks. Other parties, such as Member States, academic institutes, scientific bodies of Member States or national authorities, should be able to offer chemicals data to the Agencies or the Commission for hosting and maintenance. In such case, it should be for the Agencies or the Commission, as the case may be, to decide whether to respond positively to the offer, and give justification in case the offer is refused.
Amendment 153 #
Proposal for a regulation 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 154 #
Proposal for a regulation 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, chemicals data generated as part of Union, national or international legislation, 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 or other obligations subject to this Regulation. The Commission should make such requests to the Agencies in accordance with their mandates and allocated tasks.
Amendment 155 #
Proposal for a regulation 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 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 that is relevant for regulatory purposes available to the EEA or to ECHA.
Amendment 156 #
Proposal for a regulation Recital 23 (23) To improve the uptake of academic data and to expand the knowledge base for
Amendment 157 #
Proposal for a regulation Recital 23 (23) To improve the uptake of academic data and to expand the knowledge base for chemicals
Amendment 158 #
Proposal for a regulation 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 159 #
Proposal for a regulation Recital 23 a (new) (23 a) Independent research studies are often given comparatively low weight as evidence in hazard and risk assessment of chemicals creating a gap between independent research and chemicals regulation and policy. It is necessary to provide structure and transparency in the evaluation of research data in order to increase their use in regulatory assessment of chemicals. The Commission should publish a guidance setting minimum quality and reporting requirements to improve the uptake of research data.
Amendment 160 #
Proposal for a regulation 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 161 #
Proposal for a regulation Recital 24 (24) The EEA, as the agency responsible for monitoring data and information on chemicals in the environment, should also be responsible for collecting, hosting, and maintaining human biomonitoring data.
Amendment 162 #
Proposal for a regulation Recital 24 (24) The EEA, as the agency responsible for monitoring data and information on chemicals in the environment, should also be responsible for collecting, hosting, and maintaining human biomonitoring data.
Amendment 163 #
Proposal for a regulation Recital 24 a (new) (24 a) The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA 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, the EU-OSHA 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 164 #
Proposal for a regulation 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 165 #
Proposal for a regulation 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 166 #
Proposal for a regulation Recital 24 b (new) (24 b) The EEA should be allowed to process human biomonitoring data to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure, to develop health risk and impact indicators, to monitor the impact of regulatory intervention, and to support regulatory risk assessments, risk management and policy making. The Commission should be allowed to process human biomonitoring data constituting personal data, notably for scientific research, to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure of populations to chemicals, to develop indicators on health risks associated to such exposure, as well as to measure the efficiency and effectiveness of regulatory measures in preventing exposure by analysing, for example, co-exposure to multiple chemicals for which data on co- occurrence of various chemicals per individual is necessary to observe common patterns and draw conclusions for populations, and supporting further risk assessments and risk management. The ECHA should also be allowed to act as a data processor for human biomonitoring data constituting personal data for the performance of assessments on chemicals, such as risk and safety assessments. Individual measurements of chemicals in human matrices may assist regulatory exposure and risk assessment, such as in the formulation of an opinion of the ECHA’s Risk Assessment Committee, and lead to recommendations of risk management measures. The EFSA and the EMA should also be allowed to act as a data processor for human biomonitoring data constituting personal data, notably to support the prioritisation of regulatory actions. The EU-OSHA should be allowed to process human biomonitoring data constituting personal data, notably for scientific research, to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure of populations to chemicals, as well as to measure the efficiency and effectiveness of regulatory measures in preventing exposure. Such data is also useful for the EFSA when conducting assessments of chemicals in food and for understanding the effectiveness of existing measures in preventing human contamination through the food and feed chains. When processing human biomonitoring data constituting personal data, the EEA, the ECHA, the EFSA, the EMA , the EU- OSHA, and the Commission should pay particular attention to compliance with Article 13 of Regulation (EU) No 2018/1725.
Amendment 167 #
Proposal for a regulation Recital 24 b (new) (24 b) The EEA should be allowed to process that data to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure, to develop health risk and impact indicators, to monitor the impact of regulatory intervention, and to support regulatory risk assessments, risk management and policy making. The Commission should be allowed to process human biomonitoring data constituting personal data, notably for scientific research, to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure of populations to chemicals, to develop indicators on health risks associated to such exposure, as well as to measure the efficiency and effectiveness of regulatory measures in preventing exposure by analysing, for example, co-exposure to multiple chemicals for which data on co- occurrence of various chemicals per individual is necessary to observe common patterns and draw conclusions for populations, and supporting further risk assessments and risk management. The ECHA should also be allowed to act as a data processor for human biomonitoring data constituting personal data for the performance of assessments on chemicals, such as risk and safety assessments. Individual measurements of chemicals in human matrices may assist regulatory exposure and risk assessment, such as in the formulation of an opinion of the ECHA’s Risk Assessment Committee, and lead to recommendations of risk management measures. The EFSA and the EMA should also be allowed to act as a data processor for human biomonitoring data constituting personal data, notably to support the prioritisation of regulatory actions. Such data is also useful for EFSA when conducting assessments of chemicals in food and for understanding the effectiveness of existing measures in preventing human contamination through the food and feed chains. When processing human biomonitoring data constituting personal data, the EEA, the ECHA, the EFSA, the EMA and the Commission should pay particular attention to compliance with Article 13 of Regulation (EU) No 2018/1725.
Amendment 168 #
Proposal for a regulation Recital 24 c (new) (24 c) Human biomonitoring data collected prior to the coming into force of this Regulation is necessary to ensure the completeness, quality, and relevance of the human biomonitoring datasets for the purposes of guaranteeing the substantial public interests, and scientific research purposes as listed in this Regulation. Therefore, any such data gathered prior to the coming into force of this Regulation should be able to be processed by the EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission when this Regulation comes into force.
Amendment 169 #
Proposal for a regulation Recital 24 c (new) (24 c) Human biomonitoring data collected prior to the coming into force of this Regulation is necessary to ensure the completeness, quality, and relevance of the human biomonitoring datasets for the purposes of guaranteeing the substantial public interests, and scientific research purposes as listed in this Regulation. Therefore, any such data gathered prior to the coming into force of this Regulation should be able to be processed by the EEA, the ECHA, the EFSA, the EMA and the Commission when this Regulation comes into force.
Amendment 170 #
Proposal for a regulation Recital 26 a (new) (26 a) There are data gaps on the occurrence of hazardous and other harmful chemicals in products on the EU market. In order to enhance visibility on the availability of data, and to promote research and development activities as regards safer alternatives, as well as the uptake of such alternatives, ECHA should establish and maintain a repository of information on chemicals in products and their available alternatives generated under Union acts listed in Annex I. In addition, ECHA should integrate into the common data platform all chemicals data related to chemicals present in products or used in production processes and which is accessible through the web portal under Article 14 of Regulation (EU) 2024/178.
Amendment 171 #
Proposal for a regulation Recital 27 (27) In order to promote the use and harmonisation of reference values among risk assessors and risk managers across different Union acts and to facilitate compliance with, and enforcement of, regulatory reference values, the ECHA should establish and maintain a repository of reference values established or adopted under the Union acts listed in Annexes I and II The Agencies should provide the ECHA with reference values they hold or establish as part of their activities. In addition, the ECHA should regularly screen Union acts for reference values adopted under them. To facilitate automatic access of the general public to up-to-date reference values, the ECHA should integrate the repository of reference values in the common data platform as a dedicated service, include in that repository all reference values together with the relevant context data it has received or retrieved and ensure that those values and that context data are machine readable. For a reference value for the carcinogenic effect of a chemical for which no maximum exposure level can be specified below which no harmful effects on human health are to be expected, the statistical cancer risk associated with that reference value should also be specified, if available.
Amendment 172 #
Proposal for a regulation 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 Amendment 174 #
Proposal for a regulation Recital 28 Amendment 175 #
Proposal for a regulation 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 176 #
Proposal for a regulation 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,
Amendment 177 #
Proposal for a regulation Recital 28 (28) In order to increase transparency, as well as to enable Authorities to have complete prior knowledge of studies commissioned by business operators, irrespective of their purpose, results or of whether such studies are carried out by the business operator itself or are outsourced, business operators and laboratories should notify to a database of study notifications established and managed by the ECHA the studies on chemicals they commission for compliance with regulatory requirements under the Union acts listed in Annex I. For this purpose, the ECHA should establish and manage a database of study notifications, as a dedicated service of the common data platform, to store the information related to those studies. In order to allow business operators and laboratories sufficient time to prepare the notifications of studies, the obligation to notify studies should only start to apply
Amendment 178 #
Proposal for a regulation 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 179 #
Proposal for a regulation Recital 29 Amendment 180 #
Proposal for a regulation Recital 29 Amendment 181 #
Proposal for a regulation Recital 30 Amendment 182 #
Proposal for a regulation Recital 30 Amendment 183 #
Proposal for a regulation Recital 31 Amendment 184 #
Proposal for a regulation Recital 31 Amendment 185 #
Proposal for a regulation Recital 31 Amendment 186 #
Proposal for a regulation 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 187 #
Proposal for a regulation 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. 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 with 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 188 #
Proposal for a regulation Recital 32 Amendment 189 #
Proposal for a regulation Recital 32 Amendment 190 #
Proposal for a regulation Recital 32 (32)
Amendment 191 #
Proposal for a regulation Recital 33 Amendment 192 #
Proposal for a regulation Recital 33 Amendment 193 #
Proposal for a regulation 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 194 #
Proposal for a regulation Recital 33 (33) In order to facilitate enforcement by Member States, the Agencies responsible for assessing and providing scientific output, including scientific opinions, on regulatory dossiers containing studies subject to notification to ECHA should, where relevant, cooperate and exchange information with the Member State enforcement authorities on the compliance with the obligations laid out in Article 22 and ensure information on enforcement is made public.
Amendment 195 #
Proposal for a regulation 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
Amendment 196 #
Proposal for a regulation Recital 34 Amendment 197 #
Proposal for a regulation Recital 34 Amendment 198 #
Proposal for a regulation Recital 35 Amendment 199 #
Proposal for a regulation Recital 35 Amendment 200 #
Proposal for a regulation Recital 36 (36) To strengthen the coordination and cooperation between the different bodies performing chemicals assessments in the Union, and to promote an increased transparency of chemicals assessments and to promote the phasing out of animal tests, the ECHA should establish and manage a database with information on regulatory processes or activities that are planned, ongoing or completed by Member States, the Commission and Agencies referred to in the Union acts listed in Annex III to this Regulation and integrate it into the common data platform for access by the authorities. The information on such regulatory processes or activities should include at least the substance identity and the identification, status and eventually the outcome of the regulatory process or activity including any new requirement to conduct animal testing and the length of time each activity is expected to take. That information should also be made available without undue delay and kept updated through the assessment process. Once the process or activity has formally started, that information should be shared also publicly on the common data platform.
Amendment 201 #
Proposal for a regulation 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 202 #
Proposal for a regulation Recital 38 (38) In order to ensure chemicals data are easily findable within the database and to avoid duplicates, each chemical contained in the common data platform shall be identified by a unique chemical identifier and a chemical notation specifying its molecular structure. 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.
Amendment 203 #
Proposal for a regulation 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 204 #
Proposal for a regulation Recital 38 (38) In order to ensure the interoperability and comparability of chemicals data and to facilitate their automatic and electronic exchange, the Agencies and the Commission should store chemicals data in adequate and mutually coherent and interoperable formats and use mutually coherent and interoperable controlled vocabularies. Some Union acts listed in Annex I or II set procedures to establish or make available data formats, in particular for the submission of chemicals data by business operators or Member States. Where such procedures do not exist in the Union acts listed in Annex I or II, the Agencies and the Commission should, where relevant, specify appropriate formats for chemicals data they receive and store, avoiding the use of proprietary standards while, as appropriate, using OECD or other internationally agreed formats, making use of existing formats and ensuring interoperability with existing data submission approaches. Such mutual coherence should be supported by the respective Agency’s efforts to ensure alignment across full study data, study reports and study summaries.
Amendment 205 #
Proposal for a regulation 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 .
Amendment 206 #
Proposal for a regulation 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
Amendment 207 #
Proposal for a regulation 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 and health, the Commission should identify relevant data and information related to the environmental sustainability and health impacts 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 of chemicals data on environmental sustainability and health related data and has designed the relevant related database functionalities, the ECHA should establish a database on environmental sustainability
Amendment 208 #
Proposal for a regulation Recital 42 (42) To increase the availability and facilitate the use of information on the environmental performance of chemicals throughout their lifecycle, and to enable a comprehensive assessment of the impacts of chemicals on the environment, the Commission should identify relevant data and information related to the environmental sustainability of chemicals, including, where available, information on their impact on climate change, for integration into the common data platform. Once the Commission has identified the relevant existing datasets on environmental sustainability related data and has designed the relevant related database functionalities, the ECHA should establish a database on environmental sustainability- related data, collect the data as made available by the Commission, the Agencies and Member States and, where relevant, by the researchers and research consortia
Amendment 209 #
Proposal for a regulation 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 210 #
Proposal for a regulation Recital 43 (43) To monitor the impacts on humans and the environment, including the climate, of exposure to chemicals and to establish a knowledge base to measure the effectiveness of chemicals legislation in protecting human health and the environment, the
Amendment 211 #
Proposal for a regulation Recital 43 a (new) (43 a) In order to ensure the widest possible access to chemicals data and to improve trust in the implementation of this Regulation and Union policies and legislation on chemicals, and further acknowledging existing experience with citizen science approaches, individuals should be able to submit substantiated concerns regarding impacts of chemicals on humans and the environment, such as peer-reviewed research results, or biomonitoring data. The authorities should be obliged to assess submitted evidence and take action when they identify a concern. In line with commitments of the Union in relation to the Aarhus Convention, individuals submitting evidence should be equipped with procedural rights to ensure their concerns are appropriately taken into account.
Amendment 212 #
Proposal for a regulation Recital 43 a (new) (43 a) In order to ensure the widest possible access to chemicals data and to improve trust in the implementation of this Regulation and Union policies on chemicals, and further acknowledging existing experience with citizen science approaches, natural or legal person should be able to submit substantiated concerns regarding impacts of chemicals on humans and the environment, such as peer-reviewed research results, or biomonitoring data. The authorities should assess submitted evidence and take action when they identify a concern. In line with commitments of the Union in relation to the Aarhus Convention, individuals submitting evidence should be equipped with procedural rights to ensure their concerns are appropriately taken into account.
Amendment 213 #
Proposal for a regulation Recital 44 (44) This Regulation should establish an early warning and action system as regards existing and emerging chemical risks. To enable the identification and evaluation of emerging chemical risks, the EEA should develop and compile information on early warning signals and draw up an annual summary report to inform regulatory follow-up actions by authorities. In its work, the EEA should include its own sources, targeted literature searches and make use of information from national early warning systems. It should also include relevant information made available by the related work of the ECHA, the EFSA, the EU-OSHA, the EMA and their networks, such as the EFSA’s task of identifying and collecting information on emerging risks under Regulation 178/2002. The EEA should make the summary report and the underlying data available through the common data platform, ensuring public access and its use for further action on existing and emerging risks of chemicals, groups of chemicals, and cumulative exposure to chemicals. In order to allow the EEA sufficient time to organise the collection of early warning signals and to compile and analyse the initial information the EEA should only deliver the first report six months after the end of the first calendar year after entry into force of this Regulation. this Regulation sets a deadline for the first report and associated data. For any risk and warning signal identified by the report, the Authorities should consider undertaking regulatory, policy or enforcement actions and provide justification when they decide not to proceed with any action. Emerging chemicals risks identified in the early warning and action system should also be taken into account when setting priorities for the strategic planning of Horizon Europe.
Amendment 214 #
Proposal for a regulation Recital 44 (44) This regulation should establish an early warning and action system as regards existing and emerging chemical risks. To enable the identification and evaluation of emerging chemical risks, the EEA should develop and compile information on early warning signals and draw up an annual summary report to inform regulatory and policy follow-up actions. In its work, the EEA should include its own sources, targeted literature searches and make use of information from national early warning systems. It should also include relevant information made available by the related work of the ECHA, the EFSA, the EU-OSHA, the EMA and their networks, such as the EFSA’s task of identifying and collecting information on emerging risks under Regulation 178/2002. The EEA should make the summary report and the underlying data available through the common data platform, ensuring public access and its use for further action on existing and emerging risks of chemicals and groups of chemicals. In order to allow the EEA sufficient time to organise the collection of early warning signals and to compile and analyse the initial information the EEA should only deliver the first report six months after the end of the first calendar year after entry into force of this Regulation. this Regulation sets a deadline for the first report and associated data. For any risk and warning signal identified by the report, the authorities should consider undertaking regulatory, policy or enforcement actions and justify if they decide not to proceed with any action.
Amendment 215 #
Proposal for a regulation Recital 44 (44) To enable the identification and evaluation of emerging
Amendment 216 #
Proposal for a regulation Recital 46 (46) The ECHA should continue operating the EUON and transform it into an observatory for specific chemicals, or groups of chemicals with potential contribution to emerging chemical risks (‘the observatory’), which should cover also other chemicals and innovative (rationally designed complex ‘advanced’) materials selected by the Commission, using, as appropriate, signals from the early warning and action system. One of the criteria for selecting chemicals for the observatory should be their novelty and disruptive potential that may contribute to an emerging chemical risk. Another criterion for that selection should be the higher degree of uncertainty surrounding them and, due to less regulatory experience regarding those chemicals, the resulting need for additional scrutiny and transparency. The observatory should facilitate regulatory implementation and responsible use of these chemicals by collecting, generating, and disseminating reliable information on selected chemicals’ properties, uses and market presence to the general public.
Amendment 217 #
Proposal for a regulation 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 218 #
Proposal for a regulation 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 219 #
Proposal for a regulation Recital 48 (48) Under Regulation (EC) No 178/2002, the EFSA is able to commission, in an open and transparent manner, the scientific studies it needs to accomplish its mission, while seeking to avoid duplication with Member States or Union research programmes. The ECHA should also be able to commission studies to obtain adequate data and information on chemicals within its mission, while maintaining the principle that the burden to prove compliance with Union chemicals legislation remains on the duty holder. Furthermore, the ECHA should commission such studies out of its own initiative or at the request of the Commission, with the objective of supporting the effective and efficient implementation and evaluation of Union acts on chemicals within its mandate and contributing the development of a Union chemicals policy. Where relevant and whenever possible, information generated through studies commissioned by the ECHA should be generated by means of non animal testing methods.
Amendment 220 #
Proposal for a regulation 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, groups of chemicals, and the risk of their cumulative exposure thereof, 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.
Amendment 221 #
Proposal for a regulation Recital 48 a (new) (48 a) In order to contribute to the overall objective of this Regulation 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, this Regulation should require the Commission to draw up a report analysing the adequacy between the resources of the agencies and their current tasks, their new tasks under this Regulation, and a prospective view of the ressources needed to address key areas of regulatory challenge in the future. The Commission should also draw up a report on the impacts of cumulative exposure to chemicals on health and the environment, and analysing the efficacy of the current risk assessment of chemicals across Union legislation to adequately address the combination effect of chemical mixtures and to ensure a high level of protection of health and the environment.
Amendment 222 #
Proposal for a regulation 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 223 #
Proposal for a regulation 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 224 #
Proposal for a regulation 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 225 #
Proposal for a regulation 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, to enable scrutiny by interested parties of data generated and used for regulatory purposes, and to improve the Union’s citizens’ trust in the scientific base for the decisions taken under Union legal acts on chemicals.
Amendment 226 #
Proposal for a regulation 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,
Amendment 227 #
Proposal for a regulation 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
Amendment 228 #
Proposal for a regulation 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 229 #
Proposal for a regulation Article 1 – paragraph 2 – introductory part 2. To achieve the objectives referred to in paragraph 1, this Regulation contains targeted measures to:
Amendment 230 #
Proposal for a regulation Article 1 – paragraph 2 – point a (a) bring together data and information on chemicals and ensure that data and information are easily findable, accessible, interoperable and re-usable for all categories of users;
Amendment 231 #
Proposal for a regulation Article 1 – paragraph 2 – point a (a) bring together data and information on chemicals and their alternative and ensure that data and information are easily findable, accessible, interoperable and re- usable;
Amendment 232 #
Proposal for a regulation Article 1 – paragraph 2 – point a (a)
Amendment 233 #
Proposal for a regulation 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 234 #
Proposal for a regulation Article 1 – paragraph 2 – point b (b) keep records of studies commissioned
Amendment 235 #
Proposal for a regulation Article 1 – paragraph 2 – point b (b) keep records of studies commissioned or carried out by business operators
Amendment 236 #
Proposal for a regulation Article 1 – paragraph 2 – point b (b) keep records of all studies commissioned or carried out by business operators
Amendment 237 #
Proposal for a regulation 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 238 #
Proposal for a regulation Article 1 – paragraph 2 – point d a (new) (d a) foster innovations regarding advanced biologically-relevant tools, methods and models, and data analysis capacities.
Amendment 239 #
Proposal for a regulation Article 1 – paragraph 3 3. The provisions laid down in this Regulation apply only to chemicals data
Amendment 240 #
Proposal for a regulation Article 2 – paragraph 1 – point 2 2. ‘Authorities’ means the European Commission, the competent authorities of the Member States
Amendment 241 #
Proposal for a regulation Article 2 – paragraph 1 – point 3 3. ‘
Amendment 242 #
Proposal for a regulation Article 2 – paragraph 1 – point 10 10. ‘chemicals data’ means
Amendment 243 #
Proposal for a regulation 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 244 #
Proposal for a regulation 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, fate, 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, information on availability and suitability of alternatives, standard formats, controlled vocabularies, or any information on applicable legal obligations related to chemicals and the enforcement thereof;
Amendment 245 #
Proposal for a regulation Article 2 – paragraph 1 – point 11 – introductory part 11. ‘environmental sustainability related data’ means
Amendment 246 #
Proposal for a regulation 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
Amendment 247 #
Proposal for a regulation Article 2 – paragraph 1 – point 11 – point a (a) data on resources
Amendment 248 #
Proposal for a regulation Article 2 – paragraph 1 – point 11 – point b (b)
Amendment 249 #
Proposal for a regulation Article 2 – paragraph 1 – point 11 – point c Amendment 250 #
Proposal for a regulation Article 2 – paragraph 1 – point 11 a (new) 11 a. 'research data' means any hazard, occurrence, exposure, and fate data derived from scientific studies published in peer-reviewed literature that are not carried out specifically to inform regulatory assessments;
Amendment 251 #
Proposal for a regulation 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 252 #
Proposal for a regulation 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) 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 254 #
Proposal for a regulation 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 255 #
Proposal for a regulation Article 3 – paragraph 2 – introductory part 2. The common data platform shall provide access to essentia
Amendment 256 #
Proposal for a regulation Article 3 – paragraph 2 – point a (a) generated or submitted as part of the implementation of the Union acts listed in Annex I to this Regulation and held by the Agencies
Amendment 257 #
Proposal for a regulation 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
Amendment 258 #
Proposal for a regulation Article 3 – paragraph 2 – point b (b) generated as part of Union, national or international programmes or research activities in the sphere of chemicals
Amendment 259 #
Proposal for a regulation Article 3 – paragraph 2 – point b (b) generated as part of Union, national or international programmes or research activities in the sphere of chemicals and held by the
Amendment 260 #
Proposal for a regulation Article 3 – paragraph 2 – point c Amendment 261 #
Proposal for a regulation Article 3 – paragraph 2 – point c (c)
Amendment 262 #
Proposal for a regulation 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 263 #
Proposal for a regulation 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 264 #
Proposal for a regulation Article 3 – paragraph 2 – point c a (new) (c a) generated under Regulation (EU) 2024/1781 and accessible through the web portal under article 14 of that Regulation.
Amendment 265 #
Proposal for a regulation Article 3 – paragraph 3 Amendment 266 #
Proposal for a regulation 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) (b b) information submitted to the Agencies or Commission prior to [a specific cutoff date].
Amendment 268 #
Proposal for a regulation Article 3 – paragraph 4 Amendment 269 #
Proposal for a regulation Article 3 – paragraph 4 Amendment 270 #
Proposal for a regulation Article 3 – paragraph 4 a (new) 4 a. Each chemical or material hosted on the common data platform shall be identified by a unique chemical identifier and a chemical notation specifying its molecular structure.
Amendment 271 #
Proposal for a regulation Article 3 – paragraph 5 – introductory part 5. The common data platform shall provide the
Amendment 272 #
Proposal for a regulation Article 3 – paragraph 5 – point d a (new) (d a) information on chemicals in products and their alternatives referred to in Article 10a;
Amendment 273 #
Proposal for a regulation Article 3 – paragraph 5 – point g Amendment 274 #
Proposal for a regulation Article 3 – paragraph 5 – point g (g) the database on environmental sustainability and health-related data referred to in Article 13.
Amendment 275 #
Proposal for a regulation Article 3 – paragraph 5 – point g a (new) (g a) information on substances in products and their alternatives referred to in Article 10a.
Amendment 276 #
Proposal for a regulation Article 3 – paragraph 6 6. The Authorities and the general public shall have access free of charge to the data contained in the common data platform in accordance with Article 16, as well as any related context data as referred to in paragraph 5 of Article 4, point (c), including, where relevant, an indication whether the data was generated by Authorities.
Amendment 277 #
Proposal for a regulation 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 278 #
Proposal for a regulation Article 3 – paragraph 6 6. The Authorities and the general public shall have access free of charge to the data contained in the common data platform in accordance with Article 16.
Amendment 279 #
Proposal for a regulation 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
Amendment 280 #
Proposal for a regulation 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 281 #
Proposal for a regulation Article 3 – paragraph 11 11. The common data platform and its dedicated services shall be established by [OP: please insert date:
Amendment 282 #
Proposal for a regulation 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
Amendment 283 #
Proposal for a regulation Article 3 – paragraph 11 11. The common data platform and its dedicated services shall be established by [OP: please insert date: t
Amendment 284 #
Proposal for a regulation Article 3 – paragraph 11 11. The common data platform and its dedicated services shall be established by [OP: please insert date:
Amendment 285 #
Proposal for a regulation Article 3 – paragraph 11 11. The common data platform and its dedicated services shall be established by [OP:
Amendment 286 #
Proposal for a regulation 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
Amendment 287 #
Proposal for a regulation 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 data
Amendment 288 #
Proposal for a regulation Article 4 – paragraph 2 2. The Commission shall, by means of
Amendment 289 #
Proposal for a regulation 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
Amendment 290 #
Proposal for a regulation 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
Amendment 291 #
Proposal for a regulation 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 292 #
Proposal for a regulation 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 after consulting stakeholders, when appropriate.
Amendment 293 #
Proposal for a regulation Article 4 – paragraph 5 – point d (d) the decision-making procedures for the development of new dedicated services and the inclusion of new functionalities of the platform, including mechanisms for cooperation and information exchange with databases and similar platforms in third countries and internationally;
Amendment 294 #
Proposal for a regulation Article 4 – paragraph 5 – point f (f) the operation, reporting requirements and transparency obligations of the steering committee itself.
Amendment 295 #
Proposal for a regulation Article 4 – paragraph 5 a (new) 5a. The Commission shall report annually to the European Parliament and to the Council on the progress made on the implementation and functioning of the common data platform, including information on its use by different categories of users and its impact on environmental and public health policies.
Amendment 296 #
Proposal for a regulation Article 5 – paragraph 1 1. At the Commission’s request, the Agencies shall host and maintain chemicals data generated as part of Union, national or international legislation, programmes or research activities, corresponding to their mandate and the type of data they already hold. In addition, Agencies may host and maintain chemicals data according to their mandate and offered to them by Member States, research institutes or other parties.
Amendment 297 #
Proposal for a regulation 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. The Agencies may host and maintain chemicals data corresponding to their mandate and submitted to them by Member States or other parties.
Amendment 298 #
Proposal for a regulation 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 299 #
Proposal for a regulation 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
Amendment 300 #
Proposal for a regulation 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(
Amendment 301 #
Proposal for a regulation 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
Amendment 302 #
Proposal for a regulation 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
Amendment 303 #
Proposal for a regulation 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 they are deemed confidential in accordance with the provisions on confidentiality under the originating Union act.
Amendment 304 #
Proposal for a regulation 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 305 #
Proposal for a regulation 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
Amendment 306 #
Proposal for a regulation 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
Amendment 307 #
Proposal for a regulation Article 5 – paragraph 2 2. Where the
Amendment 308 #
Proposal for a regulation 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
Amendment 309 #
Proposal for a regulation 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 310 #
Proposal for a regulation Article 5 – paragraph 5 5. Researchers or research consortia funded by 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]. For human biomonitoring data constituting personal data, the EEA shall specify which type of data shall be made available to it.
Amendment 311 #
Proposal for a regulation Article 5 – paragraph 5 5. Researchers or research consortia, in particular those funded by Union or national framework programmes shall make available to the EEA any human biomonitoring data they collect or generate from [OP please insert: date of the entry into force of this Regulation].
Amendment 312 #
Proposal for a regulation 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 313 #
Proposal for a regulation Article 5 – paragraph 5 a (new) 5 a. Member States shall require researchers or research consortia funded by national programmes to 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]. For human biomonitoring data constituting personal data, the EEA shall specify which type of data shall be made available to it.
Amendment 314 #
Proposal for a regulation Article 5 – paragraph 6 6. Researchers or research consortia funded by Union framework programmes shall make available to the ECHA any chemicals data other than biomonitoring data, including environmental sustainability and health-related data on chemicals or materials 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 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 316 #
Proposal for a regulation Article 5 – paragraph 6 a (new) 6 a. Member States shall require researchers or research consortia funded by national programmes, to make available to the ECHA any chemicals data relevant for regulatory purposes other than biomonitoring data, including environmental sustainability and health related data on chemicals or materials they collect or generate from [OP please insert: 6 months after the entry into force of this Regulation].
Amendment 317 #
Proposal for a regulation 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 318 #
Proposal for a regulation Article 5 – paragraph 7 7. The
Amendment 319 #
Proposal for a regulation 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 320 #
Proposal for a regulation Article 5 – paragraph 8 8. For the purpose of paragraph 2, the
Amendment 321 #
Proposal for a regulation Article 5 – paragraph 9 9. The
Amendment 322 #
Proposal for a regulation Article 6 – paragraph 2 2. At the latest by [OP please insert date:
Amendment 323 #
Proposal for a regulation Article 6 – paragraph 4 – introductory part 4.
Amendment 324 #
Proposal for a regulation Article 6 – paragraph 4 – point e (e) supporting regulatory risk assessments and management.
Amendment 325 #
Proposal for a regulation Article 6 – paragraph 4 – point e a (new) (ea) Creation of a 'chemicals exposure index' for each region in the EU, to provide an overview of the population's exposure to chemical substances and facilitate comparisons between different regions, geographical areas and Member States.
Amendment 326 #
Proposal for a regulation Article 6 – paragraph 4 – point e a (new) (e a) supporting regulatory risk management;
Amendment 327 #
Proposal for a regulation Article 6 – paragraph 4 – point e b (new) (e b) supporting policy making and legislative processes at Union level;
Amendment 328 #
Proposal for a regulation Article 6 – paragraph 4 – point e c (new) (e c) facilitating the processing by the Commission, the ECHA, the EFSA, the EMA, and the EU-OSHA in accordance with paragraphs 4a, 4b, 4c, 4d and 4e of this article.
Amendment 329 #
Proposal for a regulation Article 6 – paragraph 4 a (new) 4 a. The Commission may process human biomonitoring data constituting personal data for the following purposes only: (a) scientific research aimed at policy making; (b) assessing the impact of chemicals on human health and the environment; (c) monitoring time and spatial trends in exposure; (d) developing health risk and impact indicators; (e) monitoring the impact of regulatory intervention; (f) assessing the need for further regulatory action and prioritising such actions; (g) supporting regulatory risk assessment and risk management.
Amendment 330 #
Proposal for a regulation Article 6 – paragraph 4 b (new) 4 b. The ECHA may process human biomonitoring data constituting personal data for the following purposes only: (a) evaluating and prioritising required regulatory actions; (b) performing assessments of chemicals; (c) supporting regulatory risk management; (d) as part of the commissioning of studies under the data generation mechanism referred to in Article 21.
Amendment 331 #
Proposal for a regulation Article 6 – paragraph 4 c (new) 4 c. The EFSA may process human biomonitoring data constituting personal data for the following purposes only: (a) evaluating and prioritising required regulatory action; (b) performing assessments of chemicals; (c) supporting regulatory risk management.
Amendment 332 #
Proposal for a regulation Article 6 – paragraph 4 d (new) 4 d. The EMA may process human biomonitoring data constituting personal data for the following purposes only: (a) evaluating and prioritising required regulatory action; (b) performing assessments of chemicals; (c) supporting regulatory risk management.
Amendment 333 #
Proposal for a regulation Article 6 – paragraph 4 e (new) 4 e. The EU-OSHA may process human biomonitoring data constituting personal data for the following purposes only: (a) scientific research aimed at policy making; (b) assessing the impact of chemicals on human health and the environment; (c) monitoring time and spatial trends in exposure; (d) monitoring the impact of regulatory intervention; (e) assessing the need for further regulatory action and prioritising such actions; (f) supporting regulatory risk management.
Amendment 334 #
Proposal for a regulation Article 6 – paragraph 4 f (new) 4 f. Any processing of human biomonitoring data constituting personal data by the EEA, the ECHA, the EFSA, the EMA, the EU-OSHA, or the Commission for the purposes referred to in paragraph 4, 4a, 4b, 4c, 4d, and 4e shall not entail the sharing of such data with third parties.
Amendment 335 #
Proposal for a regulation Article 6 – paragraph 6 6. The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission shall act as data controller for the human biomonitoring data constituting personal data
Amendment 336 #
Proposal for a regulation Article 6 – paragraph 6 a (new) 6 a. The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission shall define the storage period and any review thereof for the human biomonitoring data constituting personal data they hold as well as the criteria used to define the storage period.
Amendment 337 #
Proposal for a regulation Article 6 – paragraph 6 b (new) 6 b. The human biomonitoring data referred to in this Article includes personal data lawfully collected before the entry into force of this Regulation.
Amendment 338 #
Proposal for a regulation Article 7 – paragraph 2 2. At the latest by [OP please insert date:
Amendment 339 #
Proposal for a regulation Article 7 – paragraph 3 3. At the latest by [OP please insert date:
Amendment 340 #
Proposal for a regulation Article 7 – paragraph 4 4. After the completion of the transfer referred to in paragraph 3, where the Commission or the Agencies host or hold occurrence data on chemicals and related chemicals data, they shall make that data available to the ECHA with
Amendment 341 #
Proposal for a regulation Article 7 – paragraph 6 a (new) 6a. The ECHA shall take into consideration research projects such as HBM4EU when integrating the results of human biomonitoring into the Information Platform for Chemical Monitoring, and shall regularly update the statistics on exposure of the population to chemical substances of interest.
Amendment 342 #
Proposal for a regulation Article 8 – paragraph 1 1.
Amendment 343 #
Proposal for a regulation Article 8 – paragraph 2 2.
Amendment 344 #
Proposal for a regulation Article 8 – paragraph 2 2. The ECHA shall include any reference value adopted under Union acts listed in Annex I
Amendment 345 #
Proposal for a regulation 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 346 #
Proposal for a regulation Article 8 – paragraph 4 a (new) 4 a. The ECHA shall include in the repository of reference values without undue delay any reference value generated as part of Union, national or international programmes or research activities and made available to it in the standard formats provided for in Article 14, where developed.
Amendment 347 #
Proposal for a regulation Article 9 – paragraph 1 1. The ECHA shall establish and operate a Database of Study Notifications by [OP please insert date:
Amendment 348 #
Proposal for a regulation Article 9 – paragraph 2 2. The ECHA shall store in the Database of Study Notifications
Amendment 349 #
Proposal for a regulation 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 350 #
Proposal for a regulation 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 351 #
Proposal for a regulation 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 352 #
Proposal for a regulation 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 353 #
Proposal for a regulation Article 9 – paragraph 5 5. The ECHA and the EFSA shall cooperate to ensure a common approach for the identification of information
Amendment 354 #
Proposal for a regulation 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 355 #
Proposal for a regulation 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
Amendment 356 #
Proposal for a regulation 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 357 #
Proposal for a regulation 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, at least the following information shall be included:
Amendment 358 #
Proposal for a regulation Article 10 – paragraph 2 – point a (new) (a) the substance identity;
Amendment 359 #
Proposal for a regulation Article 10 – paragraph 2 – point a (new) (a) chemical identity;
Amendment 360 #
Proposal for a regulation Article 10 – paragraph 2 – point b (new) (b) the Union act and the regulatory process under which the activity takes place;
Amendment 361 #
Proposal for a regulation 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) (c) submitter or actor responsible for the regulatory process or activity;
Amendment 363 #
Proposal for a regulation 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) (d) status of the regulatory process or activity;
Amendment 365 #
Proposal for a regulation 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) (e) where applicable, outcome of the regulatory process or activity, including reports or opinions adopted;
Amendment 367 #
Proposal for a regulation Article 10 – paragraph 2 – point e (new) (e) outcome of the regulatory process or activity, including, where applicable, reports or opinions adopted;
Amendment 368 #
Proposal for a regulation 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 369 #
Proposal for a regulation 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 370 #
Proposal for a regulation Article 10 – paragraph 3 – point a (a)
Amendment 371 #
Proposal for a regulation 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 372 #
Proposal for a regulation Article 10 – paragraph 3 – point f a (new) (f a) where applicable, whether animal testing is required and for which endpoint.
Amendment 373 #
Proposal for a regulation 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
Amendment 374 #
Proposal for a regulation 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
Amendment 375 #
Proposal for a regulation Article 10 – paragraph 4 a (new) 4 a. Any planned new test, in particular tests on animals, shall be notified in advance and the ECHA shall record the intention in the database. Furthermore, the ECHA shall record where new animal testing has been requested by an Agency for regulatory purposes. These records shall be made public without undue delay.
Amendment 376 #
Proposal for a regulation Article 10 a (new) Article 10a Information on chemicals in products and their alternatives 1. The ECHA shall establish and manage, as part of the common data platform, a new database containing information on chemicals in products and their alternatives generated or submitted as part of the implementation of Union chemicals legislation listed in Annex I. This database shall 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, the EEA, the EFSA, the 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. For each chemical in a product, where available, at least the following information shall be included: (a) chemical identity; (b) product uses identified; (c) uses for which available alternatives have been identified; (d) alternatives identified for each use; (e) available information on the suitability of alternatives; (f) available information on substitution plans and efforts for each use; 4. The ECHA shall encourage providers of alternatives referred to in paragraph 3 points (c) and (d) to identify themselves.
Amendment 377 #
Proposal for a regulation 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 378 #
Proposal for a regulation 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 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 380 #
Proposal for a regulation Article 12 – paragraph 2 2. Where standard data formats are established under the Union acts listed in Annex
Amendment 381 #
Proposal for a regulation Article 13 Amendment 382 #
Proposal for a regulation Article 13 – title Database on environmental sustainability and health related data
Amendment 383 #
Proposal for a regulation Article 13 – paragraph 1 1. At the latest within
Amendment 384 #
Proposal for a regulation Article 13 – paragraph 1 1. At the latest within t
Amendment 385 #
Proposal for a regulation Article 13 – paragraph 1 1.
Amendment 386 #
Proposal for a regulation 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 387 #
Proposal for a regulation Article 13 – paragraph 2 2. Where the Commission
Amendment 388 #
Proposal for a regulation Article 13 – paragraph 2 2. Where the
Amendment 389 #
Proposal for a regulation Article 13 – paragraph 3 3. Where researchers or research consortia, especially those funded by Union and national framework programmes make available to the ECHA, under Article 5(6), any environmental sustainability data on chemicals or materials they collect or generate, the ECHA shall integrate the relevant data in the database on environmental sustainability related data without undue delay.
Amendment 390 #
Proposal for a regulation 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 391 #
Proposal for a regulation 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
Amendment 392 #
Proposal for a regulation 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
Amendment 393 #
Proposal for a regulation Article 13 – paragraph 3 a (new) 3 a. The ECHA shall integrate the environmental sustainability or health related data on chemicals or materials, made available in accordance with Article 5(6a), in the database on environmental sustainability and health related data.
Amendment 394 #
Proposal for a regulation 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 395 #
Proposal for a regulation Article 13 – paragraph 4 4. By [OP please insert date: t
Amendment 396 #
Proposal for a regulation Article 13 – paragraph 4 4. By [OP please insert date:
Amendment 397 #
Proposal for a regulation Article 14 – paragraph 2 – point e a (new) (e a) increase transparency
Amendment 398 #
Proposal for a regulation Article 14 – paragraph 4 4. The
Amendment 399 #
Proposal for a regulation 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 400 #
Proposal for a regulation Article 14 – paragraph 5 – introductory part 5. The
Amendment 401 #
Proposal for a regulation Article 14 – paragraph 5 – point i a (new) (i a) (j) Regulation (EC) No 1107/2009 of the European Parliament and of the Council1a; _________________ 1a Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309 24.11.2009, p. 1).
Amendment 402 #
Proposal for a regulation Article 14 – paragraph 5 – point i a (new) (i a) Regulation (EC) No 1107/2009 of the European Parliament and of the Council1a. _________________ 1a Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
Amendment 403 #
Proposal for a regulation Article 14 – paragraph 5 – point i b (new) (i b) Regulation (EC) No 396/2005 of the European Parliament and of the Council1b; _________________ 1b Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC
Amendment 404 #
Proposal for a regulation Article 14 – paragraph 5 – point i b (new) (i b) Regulation (EC) No 396/2005 of the European Parliament and of the Council1a _________________ 1a Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70 16.3.2005, p. 1).
Amendment 405 #
Proposal for a regulation 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. When appropriate, they shall also consult stakeholders.
Amendment 406 #
Proposal for a regulation 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 407 #
Proposal for a regulation 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 408 #
Proposal for a regulation Article 14 – paragraph 6 6. The Commission and the Agencies shall cooperate when setting standard formats to ensure transparency and coherence with other formats and the interoperability of the standard formats with the common data platform and with existing data submission approaches.
Amendment 409 #
Proposal for a regulation Article 15 – paragraph 5 – point a (a) make them available free of charge through the common data platform
Amendment 410 #
Proposal for a regulation 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 411 #
Proposal for a regulation Article 15 – paragraph 6 6. The Commission and the Agencies shall cooperate with each other in setting the controlled vocabularies and shall consult stakeholders.
Amendment 412 #
Proposal for a regulation 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 413 #
Proposal for a regulation Article 15 a (new) Article 15a Uptake of research data 1. Researchers shall be able to submit publicly available research data on chemicals related to an entry in the common data platform. Research data shall be submitted in a format prescribed by the ECHA. 2. By [OP: insert 18 months after the entry into force of this Regulation], the ECHA shall establish and maintain an online platform for the submission process referred to in paragraph 1. 3. The ECHA shall assess the compliance of research data submitted through the portal referred to in paragraph 2 with the requirements set in the guidance referred to in paragraph 4. Where research data submitted are deemed to fulfil these requirements, the data shall be hosted on the common data platform together with the corresponding entry. 4. By [OP: insert 12 months after the entry into force of this Regulation], the Commission shall publish a guidance setting minimum quality and reporting requirements to improve the uptake of research data. 5. In order to ensure a uniform format of the research data submitted, the Commission shall, by means of implementing acts, adopt a standard format for the submission of research data. Those implementing acts shall be adopted by [OP: please insert the date = 12 months after the entry into force of this Regulation], in accordance with the examination procedure referred to in Article 24a(2).
Amendment 414 #
Proposal for a regulation Article 16 – paragraph -1 (new) -1. The public shall have access to all the chemicals data contained in the common data platform.
Amendment 415 #
Proposal for a regulation Article 16 – paragraph 1 1. The Authorities 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. Access to confidential data shall be limited to authorised entities performing regulatory tasks, with clear audit trails to monitor access and prevent misuse.
Amendment 416 #
Proposal for a regulation 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 417 #
Proposal for a regulation Article 16 – paragraph 2 2. The Authorities shall take the necessary measures to ensure that information contained in the common data platform marked as confidential in accordance with Article 5(2) is not made public. In the event of a conflict between confidentiality protections under this Regulation and sector-specific legislation, the latter shall prevail.
Amendment 418 #
Proposal for a regulation 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)
Amendment 419 #
Proposal for a regulation 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
Amendment 420 #
Proposal for a regulation 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)
Amendment 421 #
Proposal for a regulation 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 submitted. The designation of data as public shall respect existing confidentiality safeguards under Union acts, including protections for trade secrets as defined in Directive (EU) 2016/943.
Amendment 422 #
Proposal for a regulation Article 16 – paragraph 3 3. The
Amendment 423 #
Proposal for a regulation 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 424 #
Proposal for a regulation Article 16 – paragraph 3 3. The general public shall have access to all the chemicals data contained in the common data platform
Amendment 425 #
Proposal for a regulation 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
Amendment 426 #
Proposal for a regulation 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 427 #
Proposal for a regulation 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
Amendment 428 #
Proposal for a regulation 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
Amendment 429 #
Proposal for a regulation 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 430 #
Proposal for a regulation 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 431 #
Proposal for a regulation Article 17 – paragraph 3 3. When using chemicals data
Amendment 432 #
Proposal for a regulation 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 1. The EEA, in collaboration with the ECHA, the EFSA, the EMA, the EU- OSHA and the Commission, shall
Amendment 434 #
Proposal for a regulation 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,
Amendment 435 #
Proposal for a regulation 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
Amendment 436 #
Proposal for a regulation Article 18 – paragraph 1 1. The EEA, in collaboration with the ECHA, the EFSA, the EMA, the EU- OSHA and the Commission, shall
Amendment 437 #
Proposal for a regulation Article 18 – paragraph 1 a (new) 1 a. The EEA, on the basis of the framework of indicators referred to in paragraph 1, as well as data from the database on environmental sustainability and health related data referred to in Article 13, the Union early warning system for emerging chemical risks referred to in Article 19, and human biomonitoring data shall establish, operate, maintain, and update as appropriate an aggregated territory-based risk indicator at different administrative levels (Country, NUTS2 and NUTS3) based on the Nomenclature of territorial units for statistics (NUTS) as defined in Regulation (EC) No 1059/200, to monitor time and spatial trends in exposure of populations to individual and multiple chemicals and health risks associated to such exposure and co-exposure. Where possible, the EEA shall cross- reference the results of the aggregated risk indicator with other health and environment datasets, including epidemiological data, to identify potential emerging risks for the purpose of Article 19.
Amendment 438 #
Proposal for a regulation Article 18 – paragraph 2 2. The framework of indicators referred to in paragraph 1, and the aggregated indicator referred to in paragraph 1a, shall be accessible in the form of an indicator dashboard, which the EEA shall establish and which the ECHA shall make available through the common data platform.
Amendment 439 #
Proposal for a regulation Article 18 a (new) Article18a Substantiated concerns 1. Any natural or legal person, individually or in association, shall be entitled to submit to an Agency a substantiated concern regarding impacts of chemicals on humans and the environment, relating in particular to the properties, use, exposure, risk, occurrence and emissions of substances or groups of substances, and which is based on objective and verifiable information such as peer-reviewed studies, human biomonitoring data, or environmental monitoring data. 2. Where the concern does not correspond to the mandate of the Agency to which it is submitted, this Agency shall make it available to the authority or authorities with a corresponding mandate. 3. The authority or authorities with a mandate corresponding to the submitted concern shall diligently and impartially assess it and, where appropriate, take one or more of the following actions: (a) regulatory measures under Union legislation, including by imposing obligations on duty holders, such as to corroborate the evidence or mitigate any detrimental effects; (b) initiate or develop new policies addressing the concern submitted; (c) transfer the concern indicating a non- compliance to enforcement agencies. 4. The authority or authorities shall, within 6 months, inform the natural or legal persons referred to in paragraph 1 of any decision taken under paragraph 3, providing the reasons for such decision. 5. Any substantiated concern submitted under paragraph 1 and the information subject to paragraph 3 shall be made available to ECHA and compiled for publication in an annual report. The report shall be integrated in the common data platform without undue delay.
Amendment 440 #
Proposal for a regulation Article 18 a (new) Article 18a Substantiated concerns 1. Any natural or legal person, individually or in association, shall be entitled to submit to an Agency a substantiated concern regarding impacts of chemicals on humans and the environment, relating in particular to the properties, use, exposure, risk, occurrence and emissions of chemicals or groups of chemicals, and which is based on objective and verifiable information such as peer-reviewed studies, human biomonitoring data, or environmental monitoring data. 2. Where the concern does not correspond to the mandate of the Agency to which it is submitted, this Agency shall make it available to the authority or authorities with a corresponding mandate. 3. The authority or authorities with a mandate corresponding to the submitted concern shall diligently and impartially assess it and, where appropriate, take one or more of the following actions: (a) regulatory measures under Union legislation, including by imposing obligations on duty holders, such as to corroborate the evidence or mitigate any detrimental effects; (b) initiate or develop new policies addressing the concern submitted; (c) transfer the concern indicating a non- compliance to enforcement agencies. 4. The authority or authorities shall, within 6 months, inform the natural or legal persons referred to in paragraph 1 of any decision taken under paragraph 3, providing the reasons for such decision. 5. The ECHA shall publish an annual report compiling all substantiated concerns submitted under paragraph 1 and the information subject to paragraph 3. The report shall be integrated in the common data platform without undue delay.
Amendment 441 #
Proposal for a regulation Article 19 – paragraph 2 – subparagraph 1 – point b (b)
Amendment 442 #
Proposal for a regulation 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 443 #
Proposal for a regulation Article 19 – paragraph 2 – subparagraph 1 – point c (c) data that the EEA holds, including data from the framework of indicators, and the aggregated indicator as referred to in Article 18;
Amendment 444 #
Proposal for a regulation Article 19 – paragraph 2 – subparagraph 1 – point c (c) data that the EEA holds, including data from the framework of indicators as referred to in Article 18;
Amendment 445 #
Proposal for a regulation Article 19 – paragraph 2 – subparagraph 1 – point e a (new) (e a) substantiated concerns submitted in accordance with Article 18a and made available by an Agency.
Amendment 446 #
Proposal for a regulation Article 19 – paragraph 2 – subparagraph 1 – point e a (new) (e a) relevant information resulting from national enforcement programmes
Amendment 447 #
Proposal for a regulation Article 19 – paragraph 2 – subparagraph 1 – point e b (new) (e b) relevant data or information submitted by researchers.
Amendment 448 #
Proposal for a regulation 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 449 #
Proposal for a regulation 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 obtained in accordance with this Regulation or from the field falling within their mandate and provide this data to the EEA to host it.
Amendment 450 #
Proposal for a regulation 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 State competent authorities for consideration of the need for regulatory or policy action related to the early warning signals. Within six months of the presentation of the report, the Authorities shall consider undertaking regulatory, policy or enforcement actions accordingly or and justify if they decide not to proceed with any action related to any of the early warning signals identified by the report.
Amendment 451 #
Proposal for a regulation 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
Amendment 452 #
Proposal for a regulation Article 19 – paragraph 4 a (new) 4 a. Within two months after receipt of this report, the Commission, relevant Union agencies and Member State competent authorities shall publicly respond to the received early warning signals with the details and timeline of the undertaken or planned regulatory or policy action related to the early warning signals, or a justification of the lack of action.
Amendment 453 #
Proposal for a regulation Article 19 – paragraph 5 5. The EEA shall make all
Amendment 454 #
Proposal for a regulation Article 19 – paragraph 5 5. The EEA shall make all
Amendment 455 #
Proposal for a regulation Article 19 – paragraph 5 5. The EEA shall make all
Amendment 456 #
Proposal for a regulation 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 457 #
Proposal for a regulation Article 19 – paragraph 5 a (new) 5 a. Where the data analysis indicates there is a risk that warrants urgent action, the EEA shall inform the authorities without undue delay.
Amendment 458 #
Proposal for a regulation Article 19 – paragraph 5 b (new) 5 b. The Commission shall take into account the emerging chemicals risks identified in accordance with this Article in the strategic planning of R&I activities of Regulation (EU) 2021/6951a, where relevant. _________________ 1a Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013
Amendment 459 #
Proposal for a regulation Article 20 – paragraph 1 1. The ECHA shall establish, operate and maintain an observatory for specific chemicals or group of 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 460 #
Proposal for a regulation Article 20 – paragraph 1 1. The ECHA shall establish, operate and maintain an observatory for specific chemicals
Amendment 461 #
Proposal for a regulation Article 20 – paragraph 2 2. By [OP please insert date: 6 months after the date of entry into force of this Regulation] the Commission shall adopt and publish a list of the selected chemicals by means of
Amendment 462 #
Proposal for a regulation Article 20 – paragraph 2 2. By [OP please insert date: 6 months after the date of entry into force of this Regulation] the
Amendment 463 #
Proposal for a regulation Article 20 – paragraph 3 3. The
Amendment 464 #
Proposal for a regulation Article 20 – paragraph 4 – point c (c) make compiled data publicly available through the common data platform or other communication and outreach tools as appropriate, to facilitate the identification of potential further research needs or risk management measures, to facilitate informed societal discussion and increase public awareness on the properties, use and safety aspects of specific chemicals, and regularly update that information.
Amendment 465 #
Proposal for a regulation Article 20 – paragraph 4 – point c (c) make compiled data publicly available through the common data platform or other communication and outreach tools as appropriate, to facilitate the identification of potential further research needs or risk management measures, to facilitate informed societal discussion and increase public awareness on the properties, use and safety aspects of specific chemicals, and regularly update that information.
Amendment 466 #
Proposal for a regulation 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 467 #
Proposal for a regulation Article 21 – paragraph 1 1. Using the best independent resources available, the ECHA may commission scientific studies to
Amendment 468 #
Proposal for a regulation Article 21 – paragraph 1 – point a (new) (a) support the implementation of Union acts on chemicals listed in Annex I within its mandate and to contribute to the support, evaluation or development of a Union chemicals policy;
Amendment 469 #
Proposal for a regulation Article 21 – paragraph 1 – point b (new) (b) investigate further emerging chemical risks identified in the report referred to in Article 19(4) of this Regulation;
Amendment 470 #
Proposal for a regulation Article 21 – paragraph 1 – point c (new) (c) conduct Union-wide data sampling survey of human biomonitoring in collaboration with Member states.
Amendment 471 #
Proposal for a regulation 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 472 #
Proposal for a regulation Article 21 – paragraph 3 3. The ECHA shall only commission scientific studies when results cannot be obtained through existing legal provisions or processes under Union legislation listed in Annex I. It shall prioritise the use of non-animal methods, with animal tests only proposed as a last resort. Full justification for the need to perform any new test on animals shall be provided. It shall not commission studies with a predominant research objective.
Amendment 473 #
Proposal for a regulation 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 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 475 #
Proposal for a regulation 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.
Amendment 476 #
Proposal for a regulation 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 477 #
Proposal for a regulation 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 478 #
Proposal for a regulation Article 21 – paragraph 5 5. The ECHA shall commission these scientific studies in an open and transparent manner and shall open a public consultation to stakeholders affected by them.
Amendment 479 #
Proposal for a regulation 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 480 #
Proposal for a regulation 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 481 #
Proposal for a regulation Article 21 – paragraph 5 a (new) 5a. When a study is commissioned, the ECHA shall publish electronically the subject of the study, the reasons for it, details of the funding arrangements and the protocol to follow for its implementation.
Amendment 482 #
Proposal for a regulation Article 21 – paragraph 6 6. The ECHA, the EMA and the EFSA shall closely cooperate with each other on the planning and commissioning of scientific studies undertaken by the ECHA in accordance with paragraph 1 and of studies undertaken by the EFSA in accordance with Article 32 of Regulation (EC) No 178/2002 and studies undertaken by EMA. The agencies shall aim to avoid duplication and to ensure animal testing takes place only as a last resort and is fully justified.
Amendment 483 #
Proposal for a regulation 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 484 #
Proposal for a regulation 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 485 #
Proposal for a regulation Article 21 – paragraph 6 a (new) 6 a. Without prejudice to the obligation on applicants to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances of serious controversies or conflicting results, may request the ECHA to commission scientific studies with the objective of verifying evidence used in its hazard and risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification.
Amendment 486 #
Proposal for a regulation 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 487 #
Proposal for a regulation Article 21 – paragraph 6 a (new) 6 a. Interested stakeholders can appeal the decision to commission the study before the Board of Appeal.
Amendment 488 #
Proposal for a regulation Article 21 – paragraph 7 7. The ECHA shall make the results of the scientific studies performed under this Article available through the common data platform and shall, in advance, record the intention to perform new studies in accordance with Articles 9 and 10 of this Regulation.
Amendment 489 #
Proposal for a regulation 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 490 #
Proposal for a regulation Article 21 – paragraph 7 a (new) 7 a. In alignment with the REACH regulation and the CLP regulation, the obligations put forward in article 22 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 491 #
Proposal for a regulation Article 21 a (new) Article 21a Centralised data generation mechanism 1. The Commission, the Agencies, and Member states competent authorities may submit request for studies to the Commission in accordance with the governance scheme referred to in Article 21b(4). A request for studies shall include, at the minimum, the following: (a) a rational for the request, summarizing the current knowledge and latest relevant findings; (b) a proposal for testing, including technical feasibility, the involvement of national or EU reference laboratories where necessary, and possibilities for appropriate sample acquisition; (c) a preliminary cost estimate; (d) an estimated timeline. 2. Using the best independent resources available, the Commission may commission scientific studies on the basis of request submitted in accordance with paragraph 1 to: (a) support the implementation of Union acts on chemicals listed in Annex I within its mandate and to contribute to the support, evaluation or development of a Union chemicals policy; (b) investigate further emerging chemical risks identified in the report referred to in Article 19(4) of this Regulation; (c) conduct Union-wide data sampling survey of human biomonitoring in collaboration with Member states. 2. The Commission may mandate the Agencies to commission the scientific studies referred to in paragraph 1, in accordance with the governance scheme referred to in Article 21b(4). 3. The Commission shall only commission scientific studies when results cannot be obtained through existing legal provisions or processes under Union legislation listed in Annex I. 4. The Commission shall seek to avoid duplication with Member State or Union research or implementation programmes. 5. The Commission shall commission these scientific studies in an open and transparent manner. 6. The Agencies shall closely cooperate with each other on the submission of requests for and planning of scientific studies undertaken in accordance with paragraph 1. 7. Without prejudice to the obligation on applicants to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances of serious controversies or conflicting results, may request the Agencies to commission scientific studies with the objective of verifying evidence used in its hazard and risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification. 8. The Commission shall make the results of the scientific studies performed under this Article available through the common data platform.
Amendment 492 #
Proposal for a regulation Article 21 a (new) Article21a Consultation of stakeholders When carrying out activities under Articles 14, 15, 18 and 21, the Commission and the Agencies shall consult organisations representing, at Union level, economic operators who manufacture or otherwise handle the chemicals concerned in the course of their business.
Amendment 493 #
Proposal for a regulation Article 21 b (new) Article21b Governance of the centralised data generation mechanism 1. The Commission shall establish and manage a centralised data generation mechanism. 2. The Commission shall prepare and adopt a governance scheme for the data generation mechanism, in collaboration with the Agencies. 3. The Commission shall publish the governance scheme referred to in paragraph 2 and any revision thereof by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2). 4. That governance scheme shall describe: (a) the organisation of the main work structures supporting the development and implementation of the data generation mechanism; (b) the centralised system for the submission of testing proposals, the eligibility check, and the assessment and submissions; (c) the decision-making process for approval and prioritisation of the requests; (d) the procedural steps and assignment of responsibilities at the execution stage of data generation. 5. The Commission may establish an expert working group for the purpose of point (c) of paragraph 4. The expert working group shall be composed of representatives from the Commission, Union agencies, and Member States.
Amendment 494 #
Proposal for a regulation Article 22 Amendment 495 #
Proposal for a regulation Article 22 Amendment 496 #
Proposal for a regulation 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, 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. Studies conducted as part of Scientific Research and Development (SR&D) or Product and Process-Oriented Research and Development (PPORD), as defined under REACH (Article 9) and CLP, are exempt from this notification requirement unless explicitly mandated by the corresponding regulatory act. Notifications for SR&D and PPORD activities shall be limited to high-level summaries ensuring no disclosure of proprietary data, including detailed chemical identification or testing plans, which could compromise competitive interests or future intellectual property rights.
Amendment 497 #
Proposal for a regulation Article 22 – paragraph 1 1. Business operators shall notify to the Database of Study Notifications referred to in Article 9, with
Amendment 498 #
Proposal for a regulation Article 22 – paragraph 1 1. Business operators shall notify to the Database of Study Notifications referred to in Article 9, with
Amendment 499 #
Proposal for a regulation Article 22 – paragraph 1 1. Business operators shall notify to the Database of Study Notifications referred to in Article 9, with
Amendment 500 #
Proposal for a regulation Article 22 – paragraph 1 1. Business operators shall notify to the Database of Study Notifications referred to in Article 9, without undue delay,
Amendment 501 #
Proposal for a regulation Article 22 – paragraph 1 1. Business operators shall notify to the Database of Study Notifications referred to in Article 9, with
Amendment 502 #
Proposal for a regulation 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
Amendment 503 #
Proposal for a regulation 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
Amendment 504 #
Proposal for a regulation Article 22 – paragraph 1 – point a (new) (a) in case of studies that are to be notified under Article 32b of Regulation (EC) No 178/2002;
Amendment 505 #
Proposal for a regulation Article 22 – paragraph 1 – point b (new) (b) when a valid justification for late or non-notification is provided by business operators. The assessment of the validity of justifications for non- notifications shall be done by ECHA. [For research in and development of medicinal products,] studies conducted in the context of Scientific Research and Development (SR&D) or Product and Process Orientated Research and Development (PPORD), each as defined in Regulation (EC) No 1907/2006 (REACH), are sensitive data and commercially confidential by nature and shall be considered a valid justification for non-notification; or,
Amendment 506 #
Proposal for a regulation Article 22 – paragraph 1 – point c (new) (c) in case of studies under Articles 40, 41 and 46 of Regulation (EC) No 1907/2006 (REACH). They shall be excluded from the notification requirement, given that such studies are carried out in response to a request from the authority.
Amendment 507 #
Proposal for a regulation Article 22 – paragraph 1 a (new) 1 a. For the purpose of paragraphs 1 and 2, business operators, laboratories and testing facilities may claim all or part of the information in paragraph 2 is confidential in accordance with the provisions on confidentiality under the originating Union act.
Amendment 508 #
Proposal for a regulation Article 22 – paragraph 2 2. For the purposes of paragraph 1, information to be notified by business operators
Amendment 509 #
Proposal for a regulation Article 22 – paragraph 2 2. For the purposes of paragraph 1, business operators shall notify to the Database of Study Notifications referred to in Article 9 the identity of the chemical(s) concerned, title, scope, laboratory, or testing facility carrying out the study, the intended starting and planned completion dates, relevant GLP or equivalent compliance monitoring authority responsible for ensuring test facility compliance and, where relevant, whether the study is commissioned to comply with a decision of the ECHA pursuant to Articles 40, 41 or 46 of Regulation (EC) No 1907/2006.
Amendment 510 #
Proposal for a regulation 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 511 #
Proposal for a regulation Article 22 – paragraph 2 2. For the purposes of paragraph 1, business operators shall notify to the Database of Study Notifications referred to in Article 9 the identity of the chemical(s) concerned, title, scope, laboratory, or testing facility carrying out the study, the intended starting and planned completion dates and, where relevant, whether the study is commissioned to comply with a decision of the ECHA pursuant to Articles 40, 41 or 46 of Regulation (EC) No 1907/2006.
Amendment 512 #
Proposal for a regulation Article 22 – paragraph 2 a (new) 2 a. For the purpose of paragraphs 1 and 2, business operators may claim part of the information in paragraph 2 is confidential in accordance with the provisions on confidentiality under the originating Union act.
Amendment 513 #
Proposal for a regulation Article 22 – paragraph 3 3. Laboratories and testing facilities shall also, with
Amendment 514 #
Proposal for a regulation Article 22 – paragraph 3 3. Laboratories and testing facilities shall also, without undue delay, 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 shall be respected.
Amendment 515 #
Proposal for a regulation Article 22 – paragraph 3 3. Laboratories and testing facilities shall also, without undue delay, notify
Amendment 516 #
Proposal for a regulation Article 22 – paragraph 3 3. Laboratories and testing facilities shall also, without undue delay, notify any study commissioned by business operators to support an application, notification, or 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 517 #
Proposal for a regulation Article 22 – paragraph 4 4. For the purposes of paragraph 3, laboratories and testing facilities shall notify to the Database of Study Notifications referred to in Article 9 the identity of the chemical(s) concerned, title, scope, intended starting and planned completion dates of any test they carry out, as well as the name of the business operator who commissioned the test.
Amendment 518 #
Proposal for a regulation Article 22 – paragraph 5 a (new) 5 a. By ... [OP please insert date: 5 years after the date of entry into force of this Regulation], business operators shall notify to the Database of Study Notifications referred to in Article 9 any studies commissioned 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, for chemicals placed on the market before the entry into force of this Regulation, under the Union acts listed in Annex I. Subparagraph 1 shall only apply to chemicals placed on the market before the entry into force of this Regulation, under the Union acts listed in Annex I, and which are still authorised on the Union market by ... [OP please insert date: 5 years after the date of entry into force of this Regulation]. Studies notified in accordance with this paragraph shall only be included in the database for information and scientific purposes, and shall not, under any circumstances, have retroactive legal application.
Amendment 519 #
Proposal for a regulation Article 22 – paragraph 6 6. The obligations set under this article shall apply from [OP please insert date: 12
Amendment 520 #
Proposal for a regulation Article 22 – paragraph 6 6. The obligations set under this article shall apply from [OP please insert date: 12
Amendment 521 #
Proposal for a regulation 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 522 #
Proposal for a regulation 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 523 #
Proposal for a regulation Article 22 – paragraph 7 7. The ECHA shall, in consultation with EFSA, lay down the practical arrangements for implementing
Amendment 524 #
Proposal for a regulation Article 22 – paragraph 7 a (new) 7 a. The requirements outlined in this article do not apply to substances that are manufactured, imported, or used for Scientific Research and Development (SR&D) or Product and Process-Oriented Research and Development (PPORD), each as defined in Regulation (EC) No 1907/2006 (REACH), when used in, or for, research in, and development of, medicinal products.
Amendment 525 #
Proposal for a regulation Article 22 – paragraph 7 a (new) 7 a. 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), each as defined in Regulation (EC) No 1907/2006 (REACH), when used in or for research in and development of medicinal products.
Amendment 526 #
Proposal for a regulation 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 527 #
Proposal for a regulation 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 528 #
Proposal for a regulation Chapter VII a (new) VII a Chapter VIIa ACCESS TO JUSTICE Article 22a Access to Justice 1. Any natural or legal person which has submitted substantiated concerns in accordance with Article 18a shall have access to an administrative or judicial procedure to review the procedural and substantive legality of the decisions, acts or omissions of the relevant authority under paragraph 3 of Article 18a. 2. Member States shall ensure access to administrative or judicial procedures to review their decisions, acts and omissions, in accordance with national law or practice. Decisions and omissions by the Commission shall be subject to review in accordance with Regulation EU (No) 1367/2006. 3. The procedures referred to in paragraph 2 shall be fair, equitable, timely and not prohibitively expensive while providing adequate and effective remedies, including injunctive relief where necessary. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.
Amendment 529 #
Proposal for a regulation Chapter VIII – title VIII DELEGATED AND IMPLEMENTING POWERS
Amendment 530 #
Proposal for a regulation Article 23 – paragraph 2 2. The Commission is empowered to adopt delegated acts in accordance with Article 24 to amend Annex II by adding,
Amendment 531 #
Proposal for a regulation Article 24 a (new) Article24a Committee procedure 1. The Commission shall be assisted by the Committee established by Article 133 of Regulation (EC) No 1907/2006. That committee shall be a committee within the meaning of Regulation (EU) No 182/20111a. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. _________________ 1a Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 533 #
Proposal for a regulation Article 26 a (new) Article26a Reports 1. By [OP: please insert date: 2 years after the end of the first calendar year after entry into force of this Regulation], the Commission shall draw up a report, analysing the adequacy between the resources of the agencies and their current tasks, their new tasks under this Regulation, and a prospective view of the resources needed to address key areas of regulatory challenge. The Commission shall present this report to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions. 2. By [OP: please insert date: 2 years after the end of the first calendar year after entry into force of this Regulation], the Commission shall draw up a report, compiling and analysing data on the impacts of cumulative exposure to chemicals on health and the environment, and analysing the efficacy of the current risk assessment of chemicals to adequately address the combination effect of chemical mixtures to ensure a high level of protection of health and the environment. The Commission shall present this report to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions.
Amendment 534 #
Proposal for a regulation Article 26 a (new) Article26a Access to justice 1. Any natural or legal person which has submitted substantiated concerns in accordance with Article 18a shall have access to an administrative or judicial procedure to review the procedural and substantive legality of the decisions, acts or omissions of the relevant authority under paragraph 3 of Article 18a. 2. Member States shall ensure access to administrative or judicial procedures to review their decisions and omissions, in accordance with national law or practice. Decisions and omissions by the Commission shall be subject to review in accordance with Title IV of Regulation EU (No) 1367/2006. 3. The procedures referred to in paragraph 2 shall be fair, equitable, timely and not prohibitively expensive while providing adequate and effective remedies, including injunctive relief where necessary. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.
Amendment 535 #
Proposal for a regulation Article 26 b (new) Article 26b Review 1. No later than ... [OP: please insert the date = 5 years after the date of application of this Regulation], the Commission shall carry out a review of this Regulation. This review shall assess in particular (a) the efficacy of the early warning and action mechanism (b) whether it is appropriate to include additional data into the common data platform. 2. No later than ... [OP: please insert the date = 2 years after the date of application of this Regulation], the Commission shall assess the feasibility, in collaboration with scientific and academic publishers, of harmonised reporting and of enabling the integration of relevant contents from scientific journals and publications into the common data platform, in order to increase further the uptake of research data into the hazard and risk assessment of chemicals. 3. The Commission shall present a report on the main findings of the evaluation under paragraph 1, to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions. The report shall assess whether this Regulation has contributed sufficiently to achieve its objectives, in particular to allow a better reuse of data across the Union acts referred to in Annex I. 4. Based on the findings of the assessment referred to in paragraph 2 and the report referred to in paragraph 3, the Commission may, as appropriate, submit legislative proposals to the European Parliament and to the Council in this regard.
Amendment 536 #
Proposal for a regulation 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.
Amendment 537 #
Proposal for a regulation Annex I – point 9 Amendment 538 #
Proposal for a regulation Annex I – point 29 Amendment 539 #
Proposal for a regulation Annex I – point 65 Amendment 540 #
Proposal for a regulation 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 Amendment 542 #
Proposal for a regulation Annex II – Part 2 – paragraph 1 Amendment 543 #
Proposal for a regulation Annex III – point 21 Amendment 544 #
Proposal for a regulation Annex III – point 31 Amendment 545 #
Proposal for a regulation 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) 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 Specific data on
Amendment 91 #
Draft legislative resolution Paragraph 2 2. Calls on the Commission to refer the matter to Parliament again if it replaces,
Amendment 92 #
Proposal for a regulation Citation 1 Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114(1), 168 and 191 thereof.
Amendment 93 #
Proposal for a regulation Recital 1 (1) The European Green Deal1 sets a high ambition for enabling the transition towards a toxic-free environment and zero pollution. The Chemicals Strategy for Sustainability2 is a crucial delivery of this zero-pollution ambition and introduces the ‘one substance, one assessment’ approach, which aims to improve the efficiency, effectiveness, coherence, and transparency of safety assessments of chemicals across Union legislation. According to that Strategy, ‘safe and sustainable by design’ criteria should be developed to enable the production and use of chemicals that are safe and sustainable throughout their entire lifecycle. The Strategy also sets out that the interaction between scientific developments and policy-making should be strengthened by means of an early warning system for chemicals and groups of chemicals to ensure that Union policies address emerging chemical risks as soon as these are identified by monitoring and research, and that a framework of indicators should be developed to monitor the drivers and impacts of chemical pollution and to measure the effectiveness of chemicals legislation. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes3a establishes measures for the protection of animals used for scientific or educational purposes, making full replacement of animal testing its ultimate goal. According to the Strategy, safety testing and chemical risk assessment need to innovate in order to reduce dependency on animal testing but also to improve the quality, efficiency and speed of chemical hazard and risk assessments. This Regulation aims to implement these objectives.
Amendment 94 #
Proposal for a regulation Recital 1 (1) The European Green Deal1 sets a high ambition for enabling the transition towards a toxic-free environment and zero pollution. The Chemicals Strategy for Sustainability2 is a crucial delivery of this zero-pollution ambition and introduces the ‘one substance, one assessment’ approach, which aims to improve the efficiency, effectiveness, coherence, and transparency of safety assessments of chemicals across Union legislation. According to that Strategy, ‘safe and sustainable by design’ criteria should be developed to enable the production and use of chemicals that are safe and sustainable throughout their entire lifecycle. The Strategy also sets out that the interaction between scientific developments and policy-making should be strengthened by means of an early warning system for chemicals and groups of chemicals to ensure that Union policies address emerging chemical risks as soon as these are identified by monitoring and research, and that a framework of indicators should be developed to monitor the drivers and impacts of chemical pollution and to measure the effectiveness of chemicals legislation. This Regulation aims to implement these objectives.
Amendment 95 #
Proposal for a regulation 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.
Amendment 96 #
Proposal for a regulation 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
Amendment 97 #
Proposal for a regulation 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
Amendment 98 #
Proposal for a regulation 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
Amendment 99 #
Proposal for a regulation Recital 2 (2) The main objectives of this Regulation
source: 766.765
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