On the proposal for a regulation of the European Parliament and of the Council establishing 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

PR_COD_1amCom

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DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a regulation of the European Parliament and of the Council establishing 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

(COM(2023)0779 – C90449/2023 – 2023/0453(COD))

(Ordinary legislative procedure: first reading)

– having regard to the Commission proposal to Parliament and the Council (COM(2023)0779),

– having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90449/2023),

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– having regard to the opinion of the European Economic and Social Committee of 20 March 2024,

– having regard to Rule 60 of its Rules of Procedure,

– having regard to the report of the Committee on the Environment, Public Health and Food Safety (A100000/2024),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Amendment 1

Proposal for a regulation

Recital 6

Text proposed by the Commission

Amendment

(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.

(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.

Or. en

Justification

Whilst there is the inclusion of some provisions on the protection of confidential information, these provisions need to be strengthened to ensure that the protection of confidential information afforded under the applicable sector-specific legislation is not undermined by this proposal. Furthermore, in case of conflict between the provisions on confidentiality of this proposal and those laid in sector-specific legislation, the latter should prevail.

Amendment 2

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) The common data platform should contain chemicals-related data and information held by relevant Union agencies or the Commission generated or submitted as part of the implementation of Union chemicals legislation listed in Annex I. This includes, for instance, all regulatory dossiers or applications submitted to the relevant Union agencies, but also chemicals data on occurrence of chemicals submitted by Member States to Union agencies or the Commission in compliance with their reporting obligations. The common data platform should also include chemicals data and information generated as part of Union, national or international programmes or research activities related to chemicals, where this data and information is held by the Commission or one of the relevant agencies.

(7) The common data platform should contain chemicals-related data and information held by relevant Union agencies or the Commission generated and submitted to them as part of the implementation of Union chemicals legislation listed in Annex I. This includes, for instance, relevant dossiers 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.

Or. en

Justification

This amendment intends to clarify that only data and information that has to be submitted to Agencies or the Commission will be included in the Common Data Platform on Chemicals, in line with recital (31) which indicates that “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”. The scope of the Data Regulation is broad but still covering those submissions that are relevant for the CDP. The difference between 'regulatory dossiers' and 'applications' may also cause confusion.

Amendment 3

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(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. For medicinal active substances, only data on relevant substances should be included. These concern active substances covered by the medicines legislation and also used for other applications regulated by other Union legislation identified in this Regulation, as well as other active substances with particular persistent, bio-accumulative and toxic properties or with a known high level of residues in the environment.

(8) While some medicinal products are also chemicals and could fall under the objectives of this Regulation, the application and use of hazard and risk assessments performed on them under Union acts on medicinal products is different from the application and use of hazard and risk assessments performed under the main Union acts on chemicals. It is thus appropriate to adopt a stepwise approach and to include in the scope of this regulation at this stage, taking due account of the administrative burden for the European Medicines Agency (‘EMA’), only chemicals data with the highest added value. At this stage, data with the highest assessed added value are data on relevant active substances, which are considered to be active substances covered by Union legislation on medicinal products listed in Annex II, and also subject to regulatory procedures under other Union legislation listed in Annex I identified in this Regulation, as well as other active substances with particular persistent, bio-accumulative and toxic properties or with a known high level of residues in the environment. The specific chemicals data to be included for those relevant active substances should cover chemicals data related to environmental risk assessments carried out under Union legislation on medicinal products for human and veterinary use, non-clinical studies carried out under Union legislation on medicinal products for human use and maximum residue limit values and the chemicals data underlying their derivation that the EMA holds, as well as specific reference values.

Or. en

Justification

Pharmaceutical data is not restricted only to the data referred to in Annex II and falls within scope of legislations listed under Annex I. In addition, as this Regulation aims to bring together all data related to chemicals into a common data platform and the Annexes include pieces of legislation covering products which are not chemicals, these products should explicitly be excluded from the scope of this Regulation.

Amendment 4

Proposal for a regulation

Recital 8 a (new)

Text proposed by the Commission

Amendment

(8a) 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.

Or. en

Justification

The General Pharmaceutical Legislation rules governing general data protection provisions should take precedence over this legislation.

Amendment 5

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(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, 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.

(9) Considering the format of these data and the effort it would require to transform them into an appropriate format, for efficiency reasons, only data that are submitted to the EMA in the context of the relevant procedures that are finalised after the entry into force of this Regulation should be included in the common data platform.

Or. en

Justification

This recital takes into account how transforming the data would burden the EMA which is already under strained capacities. In addition, only data submitted after the entry into force of this Regulation should be added in the platform, as included former data retroactively would be too difficult and burdensome for the EMA.

Amendment 6

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(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.

(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 generated and submitted as part of the implementation of the Union chemicals legislation listed in Annex I and held by Union Agencies or the Commission should be included in the common data platform.

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6 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

6 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

7 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).

7 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).

Or. en

Justification

This amendment intends to clarify that only data and information that has to be submitted to Agencies or the Commission will be included in the Common Data Platform on Chemicals, in line with recital (31) which indicates that “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”.

Amendment 7

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(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.

(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, granting as a general principle, the widest possible access to chemicals data and, where appropriate, 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 those data are processed by the Authorities.

Or. en

Justification

The Regulation's objective is to enhance trust and clarify the rule and its exemptions. With regards to access to personal data, whilst there is the inclusion of some provisions on the protection of confidential information, these provisions need to be strengthened to ensure that the protection of confidential information afforded under the applicable sector-specific legislation is not undermined by this proposal.

Amendment 8

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(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.

(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 the general public, including business operators, should have restricted access to that data and information, which does not include access to confidential information.

Or. en

Justification

In the context of this proposal, the terms ‘general public’ refers to any users of the Common Data Platform on Chemicals, that is not an Authority, i.e., citizens, ‘business operators’, etc. In this respect and for the purpose of clarity, this amendment aims at replacing ‘business operators and the general public’ by ‘the general public, including business operators’.

Amendment 9

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(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.

(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. A clear mention should be made on the common data platform, which indicates to the general public that the data may be owned by third parties and that any use of the data without prior approval from the data owner might infringe its rights. The common data platform should also include terms and conditions, including regarding intellectual property rights and other rights.

Or. en

Justification

This suggested amendment intends to highlight the importance of the protection of intellectual property rights.

Amendment 10

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(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, as well as a dashboard of indicators on chemicals.

(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 alternatives, as well as a dashboard of indicators on chemicals.

Or. en

Justification

Data on substances in products (mixtures and articles in terms of REACH) are covered by the term “chemicals data” as proposed in Article 2(10), and so are data on alternatives to targeted substances. However, such data are scattered across different regulatory procedures, including from different legislations (e.g. RoHS, REACH). The proposal does not provide for the structured access to these important items, thereby not allowing targeted retrieval of relevant and actionable information, across legislations and procedures (e.g. all products linked with a specific substance, alternatives discussed in relation to a specific substance or use). Hence, to better contribute to the goals to achieve a high level of protection of human health and the environment, promote the circular economy, and to enable the development and use of sustainable chemicals, it is suggested that distinct services – within the meaning of Article 3(5) of the proposal – are established with all available data on substances in products and available data on alternatives. The additional costs linked with this service appear minimal.

Amendment 11

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

(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.

(23) To improve the uptake of academic data and to expand the knowledge base for chemicals safety assessments and environmental sustainability impacts of chemicals, researchers or research consortia funded by Union framework programmes should make available, in line with the ‘as open as possible, as closed as necessary’ principle, any human biomonitoring data they collect or generate resulting from research and development programmes to the EEA and any other chemicals, including environmental sustainability data on chemicals or materials they collect or generate to the ECHA. Member States should require researchers or research consortia funded by national framework programmes to make their data available to the EEA or to ECHA, as appropriate.

Or. en

Justification

Considering the regulation’s objectives, including enhancing trust and widening the scientific base of chemical policies, the proposal does not fully exploit available scientific resources, notably the valuable insights from independent research (e.g. peer-reviewed studies from academia, but is limited to Union research in certain areas (eg. sustainability). In line with the Chemicals Strategy for Sustainability commitment to “establish tools and practices to ensure that relevant academic data is easily and readily accessible for safety assessments and is suitable for regulatory purposes” (p.17), it is suggested to widen the scope of research uptake to all research generating chemicals data and originating from national funding.

Amendment 12

Proposal for a regulation

Recital 24 a (new)

Text proposed by the Commission

Amendment

(24a) 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 those 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.

Or. en

Justification

Other agencies, and most importantly the EMA, should be included in the processing of human biomonitoring data, and health data. The EMA would then be able to provide the necessary context around certain data, when relevant.

Amendment 13

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

(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.

(27) In order to increase transparency 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.

Or. en

Justification

The intention of this provision should be keeping sector-specific risk assessments (especially considering the animal testing ban in force for some sectors).

Amendment 14

Proposal for a regulation

Recital 28

Text proposed by the Commission

Amendment

(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.

(28) In order to increase transparency, as well as to enable Authorities to have complete prior knowledge of studies commissioned by business operators, irrespective of whether such studies are carried out by the business operator itself or are outsourced, business operators and laboratories should notify to a database of study notifications established and managed by the ECHA certain information related to the studies on chemicals they commission to support an application, notification or regulatory dossier intended to be notified or submitted to an authority for compliance with regulatory requirements under the Union acts listed in Annex I. For this purpose, the ECHA should establish and manage a database of study notifications, as a dedicated service of the common data platform, to store the information related to those studies. In order to allow business operators and laboratories sufficient time to prepare the notifications of studies, the obligation to notify studies should only start to apply two years after the date of entry into force of this Regulation.

Or. en

Justification

For the purpose of clarity, this provision intends to align this recital with Article 22.

Amendment 15

Proposal for a regulation

Recital 28 a (new)

Text proposed by the Commission

Amendment

(28a) 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.

Or. en

Justification

The proposed obligation for notification of studies will create a significant administrative burden. This burden on both the business operators and subsequently on the ECHA should not be underestimated, taking into account the large number and diversity of legislative acts included in Annex I, as well as the vast amount of studies, measurements and analyses performed on a daily basis. It must therefore be proportionately scoped and focused on studies with an added value to the risk or regulatory management of chemicals.

Amendment 16

Proposal for a regulation

Recital 31

Text proposed by the Commission

Amendment

(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 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.

(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 an application, notification or regulatory dossier intended to be notified or submitted to an Authority to ensure 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 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.

Or. en

Justification

This provision intends to align this recital with article 22 for the purpose of clarity.

Amendment 17

Proposal for a regulation

Recital 33

Text proposed by the Commission

Amendment

(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.

(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 to help them to verify compliance with the obligations laid out in Article 22.

Or. en

Justification

This provision is in light of ECHA's limited resources and the limited possibility to verify compliance with these obligations.

Amendment 18

Proposal for a regulation

Recital 42

Text proposed by the Commission

Amendment

(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 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.

(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 Union and national 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.

Or. en

Justification

Considering the regulation’s objectives, including enhancing trust and widening the scientific base of chemical policies, the proposal does not fully exploit available scientific resources, notably the valuable insights from independent research (e.g. peer-reviewed studies from academia, but is limited to Union research in certain areas (eg. sustainability). In line with the Chemicals Strategy for Sustainability commitment to “establish tools and practices to ensure that relevant academic data is easily and readily accessible for safety assessments and is suitable for regulatory purposes” (p.17), it is suggested to widen the scope of research uptake to all research generating chemicals data and originating from national funding.

Amendment 19

Proposal for a regulation

Recital 44

Text proposed by the Commission

Amendment

(44) 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. In its work, the EEA should include its own sources, targeted literature searches and make use of information from national early warning systems. It should also include relevant information made available by the related work of the ECHA, the EFSA, the EU-OSHA, the EMA and their networks, such as the EFSA’s task of identifying and collecting information on emerging risks under Regulation 178/2002. The EEA should make the summary report and the underlying data available through the common data platform, ensuring public access and its use for further action on existing and emerging risks. In order to allow the EEA sufficient time to organise the collection of early warning signals and to compile and analyse the initial information the EEA should only deliver the first report six months after the end of the first calendar year after entry into force of this Regulation. this Regulation sets a deadline for the first report and associated data.

(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 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. 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.

Or. en

Justification

The proposal does foresee the compilation and assessment of emerging risk signals, which are then presented to the Commission, Agencies and Member State Authorities in the form a report, for “consideration of the need for regulatory or policy action related to the early warning signals”. Enforcement activities should be expressly added to the scope, since signals may indicate non-compliance of industry with existing legal obligations. In addition, to instill trust in the system, presenting a report and leaving both the if and how of any follow-up activities to the full discretion of authorities is not sufficient. Instead, it is suggested that the named authorities should be obliged to react upon the report, explain which measures are planned and where reaction does not appear necessary, and justify any of the decisions to ensure minimum accountability of the regulatory bodies.

Amendment 20

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

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 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.

1. This Regulation aims to ensure the efficient delivery of coherent hazard and risk assessments of chemicals where those assessments are required to be submitted to Union Agencies or the Commission by Union legal acts listed in Annex I, 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.

Or. en

Justification

This provision intends to clarify that only data and information that has to be submitted to Union Agencies or the Commission will be included in the Common Data Platform on Chemicals, in line with recital (31) which indicates that “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”.

Amendment 21

Proposal for a regulation

Article 1 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) bring together data and information on chemicals and ensure that data and information are easily findable, accessible, interoperable and re-usable;

(a) bring together existing data and information on chemicals and ensure that data and information are easily findable, accessible, interoperable and re-usable;

Or. en

Justification

This provisions aims to clarify in the scope that this legislation applies to current and future data generated under the various chemical legislations in the EU, rather than introducing new data requirements, which is in the scope of the sector-specific legislation.

Amendment 22

Proposal for a regulation

Article 1 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) keep records of studies commissioned or carried out by business operators in the context of fulfilling their obligations set under Union chemicals legislation;

(b) keep records of studies commissioned or carried out by business operators in the context of fulfilling their obligations set under Union acts listed in Annex I, where those studies are commissioned to support an application, notification or regulatory dossier intended to be notified or submitted to an Authority to comply with regulatory requirements under the Union acts listed in Annex I;

Or. en

Justification

This provision intends to clarify that only data and information that has to be submitted to Union Agencies or the Commission will be included in the Common Data Platform on Chemicals, in line with recital (31) which indicates that “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”.

Amendment 23

Proposal for a regulation

Article 1 – paragraph 2 a new

Text proposed by the Commission

Amendment

2a. The scope of toxicological and ecotoxicological studies is limited to that performed in accordance with the Good Laboratory Practice Directive 2004/10/EC.

Or. en

Justification

The Notification of Studies (Article 22) will introduce a new obligation while the proposed obligation for notification of studies commissioned by the industry will create a significant administrative burden. This burden on both the business operators, labs and subsequently on the ECHA and enforcement authorities should not be underestimated, taking into account the large number and diversity of legislative acts included in Annex I (70 legislation), as well as the vast amount of studies, measurements and analyses performed on a daily basis. It must therefore be proportionately scoped and focused on studies with an added value to the risk or regulatory management of chemicals. The GLP Directive 2004/10/EC provides a good starting point of the suitable scoping.

Amendment 24

Proposal for a regulation

Article 2 – paragraph 1 – point 2

Text proposed by the Commission

Amendment

2. ‘Authorities’ means the European Commission, the competent authorities of the Member States as referred to in any of the Union acts listed in Annexes I and III, and the Agencies, excluding their management boards;

2. ‘Authorities’ means, when they are entrusted with regulatory tasks related to chemicals, the European Commission, the competent authorities of the Member States as referred to in any of the Union acts listed in Annexes I and III, and the Agencies, excluding their management boards;

Or. en

Justification

This provision is aligned with recital (12) and with article 17, paragraph 1.

Amendment 25

Proposal for a regulation

Article 2 – paragraph 1 – point 3

Text proposed by the Commission

Amendment

3. ‘duty holder’ means a natural or legal person responsible for meeting obligations under the Union acts listed in Annex I or II;

3. ‘duty holder’ means a natural or legal person other than the Authorities responsible for meeting obligations under the Union acts listed in Annex I or II;

Or. en

Justification

The proposed definition of ''duty holder'' by the European Commission seems to include ECHA and COM. Therefore, this amendment helps to clarify the reference in Article 17.2.

Amendment 26

Proposal for a regulation

Article 2 – paragraph 1 – point 4

Text proposed by the Commission

Amendment

4. ‘business operators’ means duty holders which are private or public undertakings;

4. ‘business operators’ means duty holders which are private or public undertakings excluding Member States and Agencies;

Or. en

Justification

This amendment to the legal act aims at clarifying the definition of ‘business operators’, while allowing a clear distinction between ‘business operators’ and ‘duty holder’.

Amendment 27

Proposal for a regulation

Article 2 – paragraph 1 – point 10

Text proposed by the Commission

Amendment

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, 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;

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, 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;

Or. en

Justification

This provision aims to clarify that data on alternatives fall into the scope of this Regulation. Besides, an important objective of the proposed regulation is to “improve the Union’s citizens’ trust in the scientific base for the decisions taken under Union legal acts on chemicals”. Lack of enforcement as regards eg. imported products is a concerning topic for the public. Hence, given the role of enforcement with a view to improving citizens’ trust, the common data platform should provide structured access to the enforcement activities at the European and national levels and their outcomes. In addition, greater visibility of enforcement activities would facilitate consistency in the enforcement approaches of Member States and promote a level playing field on the internal market. While the term “chemicals data” as proposed in Article 2(10) is rather inclusive, comprising both scientific facts and e.g. regulatory process-related information, it is not clear if this covers enforcement/compliance data. Therefore, it should be clarified that this type of information is included.

Amendment 28

Proposal for a regulation

Article 2 – paragraph 1 – point 11 – introductory part

Text proposed by the Commission

Amendment

11. ‘environmental sustainability related data’ means any data relevant for the environmental sustainability assessment of a chemical or material throughout its entire life cycle, including:

11. ‘environmental sustainability related data’ means any data relevant for the environmental sustainability assessment of a chemical throughout its entire life cycle, including:

Or. en

Justification

This provision aims at keeping the focus on chemicals since this is the object of the Common Data Platform on Chemicals.

Amendment 29

Proposal for a regulation

Article 2 – paragraph 1 – point 14 a (new)

Text proposed by the Commission

Amendment

14a. ‘data processor’ means processor as defined in Article 4, point (8), of Regulation (EU) 2016/679 of the European Parliament and of the Council;

Or. en

Justification

This provision amends the definition with the aim of taking into account the terms 'data processor'.

Amendment 30

Proposal for a regulation

Article 2 – paragraph 15 a (new)

Text proposed by the Commission

Amendment

15a. ‘study’ means research commissioned or carried out by business operators to support an application, notification or regulatory dossier intended to be notified or submitted to an Authority to comply with regulatory requirements under the Union acts listed in Annex I.

Or. en

Justification

This suggested amendment is proposed for clarity purposes. This amendment helps in clarifying what 'study' means.

Amendment 31

Proposal for a regulation

Article 2 – paragraph 15 b (new)

Text proposed by the Commission

Amendment

15b. ‘study summary’ means a summary as defined in Article 3(29) of the Regulation (EC) No 1907/2006 of the European Parliament and of the Council.

Or. en

Justification

Since not all sectorial legislations listed in Annex I have provisions on confidentiality or on the access of the public to studies, this suggested amendments aims at defining the terms ‘study summary’ to use this terminology in particular in article 9, paragraph 3.

Amendment 32

Proposal for a regulation

Article 3 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(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 or the Commission;

(a) generated and submitted as part of the implementation of the Union acts listed in Annex I to this Regulation and held by the Agencies or the Commission;

Or. en

Justification

This amendment intends to align article 3, paragraph 2, with recital (7).

Amendment 33

Proposal for a regulation

Article 3 – paragraph 2 - point c a (new)

Text proposed by the Commission

Amendment

ca. generated under Regulation (EU) 2024/1781 and accessible through the web portal under Article 14 of that regulation.

Or. en

Justification

There is an urgent need to improve data availability concerning substances in products and their alternatives (see the new proposed recital under Justification 2). When the Commission developed the OSOA package, they did not consider integrating information from the Digital Product Passport under the ESPR, as this information is stored decentrally and thus, technically, not held by an Agency or the Commission. Article 14 ESPR was not foreseen in the ESPR proposal but added later in the legislative procedure. The web portal creates an opportunity to fill a data gap under OSOA.

Amendment 34

Proposal for a regulation

Article 3 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

3. The following information shall not be included in the common data platform:

3. Notwithstanding Article 3, paragraph 2, the following information shall not be included in the common data platform:

Or. en

Justification

This amendment intends to clarify that only data and information that has to be submitted to Agencies or the Commission will be included in the Common Data Platform on Chemicals, in line with recital (31) which indicates that “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”.

Amendment 35

Proposal for a regulation

Article 3 – paragraph 5 – point d a (new)

Text proposed by the Commission

Amendment

(da) information on substances in products and their alternatives referred to in Article 10a;

Or. en

Justification

To be aligned with the recital 17.

Amendment 36

Proposal for a regulation

Article 3 – paragraph 9

Text proposed by the Commission

Amendment

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 and transmission of chemicals data to the common data platform. The ECHA shall design the common data platform in a way that guarantees that any access to confidential data is auditable.

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 the common data platform. The ECHA shall design the common data platform in a way that guarantees that any access to confidential data is auditable.

Or. en

Amendment 37

Proposal for a regulation

Article 3 – paragraph 10

Text proposed by the Commission

Amendment

10. The Commission or Agency under whose authority chemicals data is included in the common data platform on chemicals shall remain responsible for handling any requests for access to documents made under Regulation (EC) No 1049/200119 .

10. The Commission or Agency under whose authority chemicals data is included in the common data platform on chemicals shall remain the data controller with regard to the personal data it provided and shall also remain responsible for handling any requests for access to documents made under Regulation (EC) No 1049/200119.

__________________

__________________

19 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (. OJ L 145, 31.5.2001, p. 43).

19 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (. OJ L 145, 31.5.2001, p. 43).

Or. en

Justification

This provision aims to include specifications on 'data controllers' under the EU's Data Protection Regulation.

Amendment 38

Proposal for a regulation

Article 3 – paragraph 10 a (new)

Text proposed by the Commission

Amendment

10a. 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.

Or. en

Justification

This provision aims at clarifying ECHA's role and responsibilities of each participating authority for any personal data in the platform as recommended by the EDPS.

Amendment 39

Proposal for a regulation

Article 3 – paragraph 11

Text proposed by the Commission

Amendment

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. The relevant datasets shall be integrated progressively into the common data platform by [OP please insert date: ten years from the date of entry into force of this Regulation] according to the implementation plan referred to in Article 4 (1), first sentence. Upon integration of those datasets in the common data platform, when the ECHA receives chemicals data in accordance with Article 5, it shall make that data available through the common data platform without undue delay.

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. The relevant datasets, referred in the Union acts listed in Annexes I and II to this Regulation, shall be integrated progressively into the common data platform by [OP please insert date: ten years from the date of entry into force of this Regulation] according to the implementation plan referred to in Article 4 (1), first sentence. Upon integration of those datasets in the common data platform, when the ECHA receives chemicals data in accordance with Article 5, it shall make that data available through the common data platform without undue delay.

Or. en

Justification

This amendment provides more clarity on which chemicals data shall be included in the common data platform on chemicals and the reasons why they should be included. Only data currently made public under their corresponding EU act should also be made public on the common data platform on chemicals.

Amendment 40

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall, by means of an implementing decision, establish and manage a platform steering committee, which shall include one representative from the ECHA, one representative from the EEA, one representative from the EFSA, one representative from the EMA, one representative from the EU-OSHA and five representatives from the Commission.

2. The Commission shall, by means of an implementing decision, establish and manage a platform steering committee.

Or. en

Justification

For flexibility reasons, the composition can be dealt with an implementing decision.

Amendment 41

Proposal for a regulation

Article 4 – paragraph 5 – introductory part

Text proposed by the Commission

Amendment

5. That governance scheme shall describe:

5. That governance scheme shall take into account the extent of involvement of the different parties in the management and operation of the common data platform and shall describe:

Or. en

Justification

Any governance scheme should as far as possible strive to take into account the extent of involvement of the different parties in the management and operation of the common data platform.

Amendment 42

Proposal for a regulation

Article 5 – paragraph 2

Text proposed by the Commission

Amendment

2. Where the Commission or the Agencies hold data or information referred to in Article 3(2), they shall make that data available to the ECHA, in a standard format, where available, together with the relevant context data as referred to in Article 4(4), point (c). The Commission and the Agencies shall indicate whether that data or information is made available to the public under the originating Union act.

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(5), point (c).

Data from different existing platforms both at EU and Member States’ level shall be aligned with ECHA’s database, and where it concerns similar information or data, the existing platforms shall stipulate that the data available on those platforms become merged and harmonised with the data available on the ECHA database.

The Commission and the Agencies shall indicate whether that data or information can be made available to the public or they are deemed confidential in accordance with the provisions on confidentiality under the originating Union act.

Or. en

Justification

Whilst the proposal includes provisions protecting the confidentiality of some data shared, they need to be strengthened to ensure that the protection of confidential data granted under each corresponding EU act is not undermined by this proposal. Furthermore, in case of conflict between the provisions on confidentiality of this proposal and those laid in corresponding EU acts, the latter should prevail. In addition, the provision intends to correct the references to Articles 3 and 4.

Under OSOA, ECHA has the mandate to create a database covering all sectors of the chemical industry. At the same time, the EFSA and the Commission have a mandate to create a database on co-formulants in plant protection products as there is currently a lack of a single database for co-formulants. There should be clear communication between ECHA, EFSA and the Member States in order to align on the use of the ECHA database and avoid multiple and potentially diverging data being available on the different platforms existing both at the EU and MS level.

Amendment 43

Proposal for a regulation

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

3. The ECHA shall host and maintain occurrence data related to workplace monitoring.

3. The ECHA shall host and maintain occurrence data related to workplace monitoring.

Occurrence data related to workplace monitoring may include 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.

Or. en

Justification

Workplace monitoring data can include human biomonitoring data (HBMD) as well. To account for the need for a specific legal basis for processing such data, this provision mirrors the provision setting this out for EEA with regard to the HBMD they will hold.

Amendment 44

Proposal for a regulation

Article 5 – paragraph 5 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

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 + 6 months].

Or. en

Justification

Considering the regulation’s objectives, including enhancing trust and widening the scientific base of chemical policies, the proposal does not fully exploit available scientific resources, notably the valuable insights from independent research (e.g. peer-reviewed studies from academia, but is limited to Union research in certain areas (eg. sustainability). In line with the Chemicals Strategy for Sustainability commitment to “establish tools and practices to ensure that relevant academic data is easily and readily accessible for safety assessments and is suitable for regulatory purposes” (p.17), it is suggested to widen the scope of research uptake to all research generating chemicals data and originating from national funding.

Amendment 45

Proposal for a regulation

Article 5 – paragraph 6

Text proposed by the Commission

Amendment

6. Researchers or research consortia funded by 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].

6. Researchers or research consortia funded by Union framework programmes shall make available to the ECHA any chemical data other than biomonitoring data, including environmental sustainability data on chemicals or materials they collect or generate from [OP please insert: date of the entry into force of this Regulation].

Or. en

Justification

Alignment with the article 5.5 and its justification.

Amendment 46

Proposal for a regulation

Article 5 – paragraph 6 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

Member States shall require researchers or research consortia funded by national programmes, to make available to the ECHA any chemicals data other than biomonitoring data, including environmental sustainability data on chemicals or materials they collect or generate from [OP please insert: date of the entry into force of this Regulation + 6 months].

Or. en

Justification

Alignment with the article 5.5 and its justification.

Amendment 47

Proposal for a regulation

Article 5 – paragraph 8

Text proposed by the Commission

Amendment

8. For the purpose of paragraph 2, the Commission and the Agencies shall make chemicals data 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.

8. For the purpose of paragraph 2, the Commission and the Agencies shall make chemicals data available to the ECHA without undue delay after collection or receipt of the data submitted by duty holders in accordance with the implementation of Union acts listed in Annex I, 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.

Or. en

Justification

This provision aims at clarifying which data has to be made available to ECHA.

Amendment 48

Proposal for a regulation

Article 8 – paragraph 2

Text proposed by the Commission

Amendment

2. The ECHA shall include any reference value adopted under Union acts listed in Annex I or Annex II, Part 1, in the repository of reference values without undue delay.

2. Once notified by the Authority responsible, the ECHA shall include any reference value adopted under Union acts listed in Annex I or Annex II, Part 1, in the repository of reference values without undue delay.

Or. en

Justification

This provision intends to clarify the misconception that ECHA should have the responsibility to proactively seek any reference value that is published.

Amendment 49

Proposal for a regulation

Article 8 – paragraph 4 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

The ECHA shall include in the repository of reference values any reference value generated as part of Union, national or international programmes or research activities and made available to ECHA in the standard formats as referred to in Article 14.

Or. en

Justification

Considering the regulation’s objectives, including enhancing trust and widening the scientific base of chemical policies, the proposal does not fully exploit available scientific resources, notably the valuable insights from independent research (e.g. peer-reviewed studies from academia, but is limited to Union research in certain areas (eg. sustainability). In line with the Chemicals Strategy for Sustainability commitment to “establish tools and practices to ensure that relevant academic data is easily and readily accessible for safety assessments and is suitable for regulatory purposes” (p.17), it is suggested to widen the scope of research uptake to all research generating chemicals data and originating from national funding.

Amendment 50

Proposal for a regulation

Article 9 – paragraph 3

Text proposed by the Commission

Amendment

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 in accordance with the applicable rules on confidentiality.

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 summaries in accordance with the applicable rules on confidentiality.

Or. en

Justification

This provision aims at limiting the disclosing of studies to 'study summary’, with due respect to the protection of intellectual property rights of studies.

Amendment 51

Proposal for a regulation

Article 10 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

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. For each regulatory process or activity, at least the following information shall be included:

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.

Or. en

Justification

The data to be included will be determined by the format to be defined.

Amendment 52

Proposal for a regulation

Article 10 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) substance identity;

deleted

Or. en

Justification

The data to be included will be determined by the format to be defined.

Amendment 53

Proposal for a regulation

Article 10 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) the Union act and the regulatory process under which the activity takes place;

deleted

Or. en

Justification

The data to be included will be determined by the format to be defined.

Amendment 54

Proposal for a regulation

Article 10 – paragraph 3 – point c

Text proposed by the Commission

Amendment

(c) submitter or actor responsible for the regulatory process or activity;

deleted

Or. en

Justification

The data to be included will be determined by the format to be defined.

Amendment 55

Proposal for a regulation

Article 10 – paragraph 3 – point d

Text proposed by the Commission

Amendment

(d) status of the regulatory process or activity;

deleted

Or. en

Justification

The data to be included will be determined by the format to be defined.

Amendment 56

Proposal for a regulation

Article 10 – paragraph 3 – point e

Text proposed by the Commission

Amendment

(e) outcome of the regulatory process or activity, including, where applicable, reports or opinions adopted;

deleted

Or. en

Justification

The data to be included will be determined by the format to be defined.

Amendment 57

Proposal for a regulation

Article 10 – paragraph 3 – point f

Text proposed by the Commission

Amendment

(f) where applicable, date of intention to start the regulatory process or activity, completion and latest update.

deleted

Or. en

Justification

The data to be included will be determined by the format to be defined.

Amendment 58

Proposal for a regulation

Article 10 a (new)

Text proposed by the Commission

Amendment

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 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 to identify them.

Or. en

Justification

Data on substances in products (mixtures and articles in terms of REACH) are covered by the term “chemicals data” as proposed in Article 2(10), and so are data on alternatives to targeted substances. However, such data are scattered across different regulatory procedures, including from different legislations (e.g. RoHS, REACH). The proposal does not provide for the structured access to these important items, thereby not allowing targeted retrieval of relevant and actionable information, across legislations and procedures (e.g. all products linked with a specific substance, alternatives discussed in relation to a specific substance or use).

Amendment 59

Proposal for a regulation

Article 13 – paragraph 3

Text proposed by the Commission

Amendment

3. Where researchers or research consortia funded by Union framework programmes make available to the ECHA, under Article 5(6), any environmental sustainability data on chemicals or materials they collect or generate, the ECHA shall integrate the relevant data in the database on environmental sustainability related data.

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 they collect or generate, the ECHA shall integrate the relevant data in the database on environmental sustainability related data.

Or. en

Justification

This amendment to the legal act aims at keeping the focus on chemicals as per the Platform's objective.

Amendment 60

Proposal for a regulation

Article 14 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. This paragraph shall not apply to the Union acts listed in Annex II.

Or. en

Justification

According to the Staff Working Document accompanying the Proposal, this may gradually be imposed on applicants – increasing administrative burden. IUCLID isn’t suitable for human and animal medicines and therefore for the EMA. This requirement would therefore increase administrative burden on both industry and EMA. It should not apply to the Union acts listed in Annex II.

Amendment 61

Proposal for a regulation

Article 14 – paragraph 6

Text proposed by the Commission

Amendment

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.

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.

Or. en

Justification

Standard data formats and controlled vocabularies must be developed in consultation with stakeholders and especially the industry, as in the longer term, the formats and vocabularies set by the Agencies will also be used for the submission of data by the duty holders under the individual pieces of legislation.

Amendment 62

Proposal for a regulation

Article 14 – paragraph 7

Text proposed by the Commission

Amendment

7. The Commission and the Agencies shall take the necessary and appropriate measures to monitor and identify at an early stage any potential divergence between data formats that could cause interoperability problems. If a divergence is identified, the Agencies concerned shall cooperate to resolve it or, where the divergence is justified, explain the underlying reasons. Where the Agencies concerned are not able to resolve that divergence, they shall draw up a joint report and present it to the Commission. The report shall clearly outline the reasons for the divergence, clarify any underlying technical issue and make a proposal to remedy the divergence.

7. The Commission and the Agencies shall take the necessary and appropriate measures to monitor and identify at an early stage any potential divergence between data formats that could cause interoperability problems. Stakeholders shall be consulted to ensure duty holders contribute to ensure optimal operability. If a divergence is identified, the Agencies concerned shall cooperate to resolve it or, where the divergence is justified, explain the underlying reasons. Where the Agencies concerned are not able to resolve that divergence, they shall draw up a joint report and present it to the Commission. The report shall clearly outline the reasons for the divergence, clarify any underlying technical issue and make a proposal to remedy the divergence.

Or. en

Justification

Stakeholders should be consulted, because, in the longer term, the formats and vocabularies set by the Agencies will be used also for the submission of data by the duty holders under the individual pieces of legislation, therefore affecting different interested parties.

Amendment 63

Proposal for a regulation

Article 15 – paragraph 5 – point a

Text proposed by the Commission

Amendment

(a) make them available free of charge through the common data platform and as open datasets;

(a) make them available free of charge through the common data platform in a way that supports their re-use;

Or. en

Justification

The amendment aims at clarifying that these vocabularies should be freely available and open for re-use. Open data does not necessarily mean data free of IPR restrictions.

Amendment 64

Proposal for a regulation

Article 15 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission and the Agencies shall cooperate with each other in setting the controlled vocabularies.

6. The Commission and the Agencies shall cooperate with each other in setting the controlled vocabularies and shall consult stakeholders.

Or. en

Justification

Stakeholders should be consulted, because, in the longer term, the formats and vocabularies set by the Agencies will be used also for the submission of data by the duty holders under the individual pieces of legislation, therefore affecting different interested parties.

Amendment 65

Proposal for a regulation

Article 15 – paragraph 7

Text proposed by the Commission

Amendment

7. The Commission and the Agencies shall take the necessary and appropriate measures to monitor and identify at an early stage any potential divergence between controlled vocabularies. If a divergence is identified, the Agencies concerned shall cooperate to resolve it or, where the divergence is justified, explain the underlying reasons. Where the Agencies concerned are not able to resolve that divergence, they shall draw up a joint report and present it to the Commission. The report shall clearly outline the reasons for the divergence, clarify any underlying technical issue and make a proposal to remedy the divergence.

7. The Commission and the Agencies shall take the necessary and appropriate measures to monitor and identify at an early stage any potential divergence between controlled vocabularies. Stakeholders shall be consulted to ensure duty holders contribute to ensure optimal operability. If a divergence is identified, the Agencies concerned shall cooperate to resolve it or, where the divergence is justified, explain the underlying reasons. Where the Agencies concerned are not able to resolve that divergence, they shall draw up a joint report and present it to the Commission. The report shall clearly outline the reasons for the divergence, clarify any underlying technical issue and make a proposal to remedy the divergence.

Or. en

Justification

Stakeholders should be consulted, because, in the longer term, the formats and vocabularies set by the Agencies will be used also for the submission of data by the duty holders under the individual pieces of legislation, therefore affecting different interested parties.

Amendment 66

Proposal for a regulation

Article 15 – paragraph 8

Text proposed by the Commission

Amendment

8. The Commission shall adopt an implementing decision to remedy the divergence.

8. The Commission shall adopt an implementing decision to remedy the divergence in cases where it is not justified.

Or. en

Justification

There might be decisions where divergences will be justified.

Amendment 67

Proposal for a regulation

Article 16 – paragraph 1

Text proposed by the Commission

Amendment

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.

1. The Authorities shall have access to all the chemicals data contained in the common data platform, including data which is marked as confidential under Article 5(2), second sentence.

Or. en

Justification

This provision aims at providing further legal clarity and predictability.

Amendment 68

Proposal for a regulation

Article 16 – paragraph 2

Text proposed by the Commission

Amendment

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.

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 available to the public in accordance with the provisions on confidentiality under the originating Union act.

Or. en

Justification

Whilst the proposal includes provisions protecting the confidentiality of some data shared, they need to be strengthened to ensure that the protection of confidential data granted under each corresponding EU act is not undermined by this proposal. Furthermore, in case of conflict between the provisions on confidentiality of this proposal and those laid in corresponding EU acts, the latter should prevail.

Amendment 69

Proposal for a regulation

Article 16 – paragraph 3

Text proposed by the Commission

Amendment

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.

3. The general public shall only have access to the chemicals data contained in the common data platform considered as available to the public in accordance with the originating Union act.

Or. en

Justification

The use of the defined term 'originating Union act' aims to better clarify the relevant reference.

Amendment 70

Proposal for a regulation

Article 17 – paragraph 1

Text proposed by the Commission

Amendment

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 of chemicals legislation and policy.

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, implementation or enforcement of legislation and policy, in full transparency and in accordance with the consultation procedures stipulated in the relevant legislation.

Or. en

Justification

Lack of enforcement is a concerning topic for the public. Hence, given the role of enforcement with a view to improving citizens’ trust, the common data platform should provide structured access to the enforcement activities at the European and national levels and their outcomes. In addition, greater visibility of enforcement activities would facilitate consistency in the enforcement approaches of Member States and promote a level playing field on the internal market. While the term “chemicals data” as proposed in Article 2(10) is rather inclusive, comprising both scientific facts and e.g. regulatory process-related information, it is not clear if this covers enforcement/compliance data. Therefore, it should be clarified that this type of information is included. In addition, when the authorities intend to re-use the data for the secondary purposes (Article 17), it should be conducted in an open and transparent manner and in accordance with the consultation procedure stipulated in the relevant legislation. Each study is performed under the specific requirements and objectives of the concerned legislation. The validity and extent of the reuse of study outcomes for other purposes than the original objective needs to be carefully considered by taking the substance identity and limitation of applicability of each study into account.

Amendment 71

Proposal for a regulation

Article 17 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. Unless otherwise specified in the Union acts listed in Annex I, the data sharing and data protection rules in Article 25 of Regulation (EC) No 1907/2006 shall apply to any study summaries or robust summaries of studies made available through the common data platform.

Or. en

Justification

Data protection aspects are not explicitly included in the proposed Regulation but are vital to protect investments in new data by economic actors. The amendment seeks to align requirements in this Regulation with standard practices for data protection enshrined in the REACH Regulation.

Amendment 72

Proposal for a regulation

Article 17 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

3b. It shall be clearly mentioned on the common data platform, in particular for the attention of the general public, that the data may be owned by third parties and that any 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.

Or. en

Justification

This provision aims at ensuring that the general public understands that some data may be protected by intellectual property rights.

Amendment 73

Proposal for a regulation

Article 18 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. Stakeholders shall be consulted to help avoid unnecessary duplication of studies, within the EEA or beyond.

Or. en

Justification

The Framework of Indicators (Article 18) should involve the stakeholder consultation in the process. Before new scientific studies are undertaken, it is important that all relevant information is taken into consideration, including on the methodologies of the study and to avoid potential duplication of work.

Amendment 74

Proposal for a regulation

Article 19 – paragraph 3

Text proposed by the Commission

Amendment

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.

3. The ECHA, the EFSA, the EU-OSHA and the EMA shall identify and gather relevant available data obtained through the early warning signals system established by this Regulation or 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.

Or. en

Justification

The EEA should develop guidance for identification of emerging chemicals risks in cooperation with all relevant parties, based on current ECHA stakeholder practices. To ensure sufficient time for such a guidance document to be developed, there is a need to reconsider the timeline currently proposed in Article 19(4).

Amendment 75

Proposal for a regulation

Article 19 – paragraph 5

Text proposed by the Commission

Amendment

5. The EEA shall make all relevant data on early warning signals that it holds or hosts as well as the report referred to in paragraph 4 available to the ECHA for integration in the common data platform.

5. The EEA shall make data on early warning signals that it holds or hosts and that led to a positive identification of an emerging risk as well as the report referred to in paragraph 4 available to the ECHA for integration in the common data platform. Data that did not lead to a positive identification of an emerging risk as described in Article 19, paragraph 2, shall not be included in the common data platform.

Or. en

Justification

This provision aims at ensuring that data is assessed or complemented with scientific evidence before being listed publicly in the Common Data Platform on Chemicals as early warnings to avoid confusion among the users.

Amendment 76

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

1. Using the best independent resources available, the ECHA may commission scientific studies to 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.

1. Using the best resources available, the ECHA may commission scientific studies to 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.

Or. en

Amendment 77

Proposal for a regulation

Article 21 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission may request the ECHA to commission the scientific studies referred to in paragraph 1.

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.

Or. en

Justification

This amendment provides a better clarification.

Amendment 78

Proposal for a regulation

Article 21 – paragraph 3

Text proposed by the Commission

Amendment

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 not commission studies with a predominant research objective.

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 not commission studies with a predominant research objective. Stakeholders shall be consulted in order to avoid unnecessary duplication of studies.

Or. en

Justification

The Data Generation Mechanism (Article 21) should involve the stakeholder consultation in the process. Before new scientific studies are undertaken, it is important that all relevant information is taken into consideration, including on the methodologies of the study and to avoid potential duplication of work.

Amendment 79

Proposal for a regulation

Article 22 – paragraph 1

Text proposed by the Commission

Amendment

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.

1. Business operators shall notify to the Database of Study Notifications referred to in Article 9, within three months of the date of the commissioning, information referred to in paragraph 2 related to studies on chemicals they commission to support an application, notification or regulatory dossier notified or submitted to an Authority, under the Union acts listed in Annex I and where handling or holding of data is under the responsibility of EFSA and ECHA.

However, business operators shall not notify to the Database of Study Notifications referred to in Article 9

(a) in case of studies that are to be notified under Article 32b of Regulation (EC) No 178/2002;

(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

(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.

Or. en

Justification

The notification mechanism should be related to Annex I Union acts implemented only by EFSA and ECHA. Similarly to the EFSA Transparency Regulation (Article 32b), the possibility to submit late notifications or non-notification of studies must be included in Article 22 of the proposal, where valid justification is provided. The assessment of the validity of any justifications will be done by ECHA (as EFSA already does pursuant to Article 21 of the EFSA Practical Arrangements, taking into consideration all relevant factual elements as well as any additional elements of justification or clarification).

In addition, to ensure proportionality and feasibility of the proposed Regulation, this provision seeks to link notification requirements to studies commissioned solely in the context of specific EU regulations.

Prior to commissioning the studies, a testing proposal is submitted by the registrants to the authority, which already serves the objectives (see Recital 28) of the Article. Double notifications therefore need to be avoided to prevent increased administrative burdens. If necessary, the authorities who receive the relevant testing proposal should notify the studies to the database.

Amendment 80

Proposal for a regulation

Article 22 – paragraph 2

Text proposed by the Commission

Amendment

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.

2. For the purposes of paragraph 1, information to be notified by business operators to the Database of Study Notifications referred to in Article 9 shall be limited to 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.

Or. en

Justification

To ensure proportionality and feasibility of the proposed Regulation, this amendment seeks to define more clearly the boundaries of the information in scope of each notification. In addition, there is concern that the study notification obligation will result in the disclosure of business sensitive information and therefore, it is essential that confidentiality is protected for business operators and laboratories including information on laboratory or testing facility carrying out any studies, and the intended starting and completion dates.

Amendment 81

Proposal for a regulation

Article 22 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. 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.

Or. en

Justification

Sensitive data (e.g., for research and development, data sensitive under competition law, commercially valuable information) or confidential business information should be protected and excluded from the mandatory notification system. It is essential to maintain the protection of information as well as safeguard intellectual property rights. Data should be protected by the confidentiality as marked by the originator and not be disclosed to the public. No fee should be requested for the confidentiality claims, as fees were already paid by the business operator under the originating act, e.g. REACH.

Amendment 82

Proposal for a regulation

Article 22 – paragraph 3

Text proposed by the Commission

Amendment

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.

3. Laboratories and testing facilities shall also, within three months of the date of the commissioning, notify information referred to in paragraph 2 related to studies commissioned by business operators to support a regulatory dossier, under the Union acts listed in Annex I and where handling or holding of data is under the responsibility of EFSA and ECHA. 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.

Or. en

Justification

The reference to 'which an Agency is required to provide a scientific input' is unclear and may trigger confusion for duty holders. In addition, the other amendments to the legal act help clarifying that it will not be the studies as such to be notified, but well the information listed in article 22, paragraph 2, in line with the scope of the proposal. To achieve the objective of transparency pursued by the proposal, it would be important to keep a proportionate level of studies notification.

Amendment 83

Proposal for a regulation

Article 22 – paragraph 4

Text proposed by the Commission

Amendment

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 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.

4. For the purposes of paragraph 3, information to be notified by laboratories and testing facilities to the Database of Study Notifications referred to in Article 9 the 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.

Or. en

Justification

To ensure proportionality and feasibility of the proposed Regulation, this provision seeks to define more clearly the boundaries of the information in scope of each notification.

Amendment 84

Proposal for a regulation

Article 22 – paragraph 7

Text proposed by the Commission

Amendment

7. The ECHA shall lay down the practical arrangements for implementing the provisions of this Article.

7. The ECHA, in consultation with stakeholders, shall lay down the practical arrangements for implementing the provisions of this Article.

Or. en

Justification

Stakeholder engagement on the practical arrangements for implementing the provisions of this new obligation must be ensured, similarly to the interactions of EFSA with stakeholders during the implementation phase of the Transparency Regulation.

Amendment 85

Proposal for a regulation

Article 23 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission is empowered to adopt delegated acts in accordance with Article 24 to amend Annex II by adding, where relevant, new categories of data types.

2. The Commission is empowered to adopt delegated acts in accordance with Article 24 to amend Annex II by adding new categories of data types while respecting the confidentiality of certain data.

Or. en

Justification

Whilst there is the inclusion of some provisions on the protection of confidential information in the proposal, these provisions need to be strengthened to ensure that the protection of confidential information afforded under the applicable sector-specific legislation is not undermined.

Amendment 86

Proposal for a regulation

Annex I – point 9

Text proposed by the Commission

Amendment

9. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1)

deleted

Or. en

Justification

This regulation aims to bring together all data related to chemicals into on common data platform, therefore it is unclear why Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms is listed in Annex 1, as this legislation doesn’t cover chemicals but organisms.

Amendment 87

Proposal for a regulation

Annex I – point 65

Text proposed by the Commission

Amendment

65. Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1).

deleted

Or. en

Justification

Regulation 2019/4 concerns a specific route of administration for products authorised by the EMA under (EU) 2019/6. No data is generated under 2019/4. Therefore, this regulation should not be included in Annexes 1 and 3.

Amendment 88

Proposal for a regulation

Annex II – Part 1 – paragraph 2

Text proposed by the Commission

Amendment

These data shall be limited to data submitted to the EMA in the context of the relevant procedures that are concluded after the date of entry into force of this Regulation. Where relevant, the data held by the EMA resulting from procedures concluded before the entry into force of this Regulation may also be considered for inclusion into the common data platform.

These data shall be limited to data related to chemicals used in pharmaceuticals and submitted to the EMA in the context of the relevant procedures that are concluded after the date of entry into force of this Regulation. Where relevant, the data held by the EMA resulting from procedures concluded before the entry into force of this Regulation may also be considered for inclusion into the common data platform.

Or. en

Justification

In the context of medicinal products, it appears that all products covered by Regulation 2019/6 shall comply with this draft Regulation, however, some medicines such as immunologicals (e.g. vaccines) don’t use chemicals, but organisms. This is beyond the scope of the Common Data Platform and therefore represent disproportionate administrative burden for these products.

Amendment 89

Proposal for a regulation

Annex II – Part 2 – paragraph 2

Text proposed by the Commission

Amendment

These data shall be limited to data submitted to the EMA in the context of the relevant procedures that are concluded after the date of entry into force of this Regulation. Where relevant, data held by the EMA resulting from procedures concluded before the date of entry into force of this Regulation shall also be considered for inclusion into the common data platform.

These data shall be limited to data related to chemicals used in pharmaceuticals and submitted to the EMA in the context of the relevant procedures that are concluded after the date of entry into force of this Regulation. Where relevant, data held by the EMA resulting from procedures concluded before the date of entry into force of this Regulation shall also be considered for inclusion into the common data platform.

Or. en

Justification

To be in consistency with Annex II, Part 1, paragraph 1.

Amendment 90

Proposal for a regulation

Annex III – point 31

Text proposed by the Commission

Amendment

31. Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1).

deleted

Or. en

Justification

Regulation 2019/4 is a regulation about a specific route of administration for products authorised by the EMA under (EU) 2019/6. No data is generated under 2019/4. Therefore, this regulation should not be included in Annexes 1 and 3.

EXPLANATORY STATEMENT

The proposed regulation for a common data platform on chemicals presents an opportunity for harmonising data management and fostering transparency in the chemical industry. As part of its Chemicals Strategy for Sustainability (CSS), the use of One Substance – One Assessment approach (OSOA) will improve the efficiency, effectiveness, coherence and transparency of issuing safety assessments of chemicals across different pieces of EU legislation. The consolidation of all information and activities on a substance in one place, as proposed by the Regulation establishing a common data platform, is an essential step in the right direction. This would lead to important improvement of communication on planned and ongoing regulatory processes as well as the coordination of such activities and will allow better predictability for the industry.

The Rapporteur considers that the Commission’s proposal on the establishment of a common data platform on chemicals (CDPC) aims to fulfil the commitment defined in the CSS to start using the OSOA approach and to collate relevant information on the safety and sustainability of chemicals, and thus contributing to the protection of human health and the environment, and on early warning signals for chemicals risks.

This proposal builds a common data platform and drives a better chemical assessment coherence across pieces of EU legislation to allow timely identification of emerging chemical risks. In addition, the common data platform for chemicals is an important step towards administrative simplification, as it consolidates all information and activities in one place. This platform, as a part of the EU Chemicals Strategy for Sustainability, should be limited to chemicals.

The Rapporteur believes that centralizing all data for hazard assessment aims to increase efficiency and coherence, with a common starting point. In addition, collecting all available information in one place it makes safety assessments more robust and faster, and consequently reinforcing citizens’ trust in the chemical safety evaluation and in decision-making process for chemicals.

If the proposal is properly implemented, will boost innovation, support the circular economy and improve the consumer’s protection against hazardous chemicals.

However, the Rapporteur has identified certain issues and concerns in the OSOA package that may prevent it from achieving its full potential and to address these, he proposes relevant key improvements for the OSOA package.

The Rapporteur considers that chemicals data in the scope are only those that must be submitted to Union Agencies or the Commission, within the context of a safety assessment. In addition, it is of utmost importance to understand what type of data would be included in the scope, especially whether it would include data on all ingredients or only data on the regulated ingredients, in the case of cosmetic products.

Since the chemicals data and environmental sustainability related data definitions are very broad and for the data in scope of notification by business operators, the provision of a guidance document will be helpful.

With regards to the definitions, the difference between “duty holder” and “business operator” is not so clear and a clarification is needed.

The Rapporteur highlights that a common open data platform on chemicals and tools for accessing relevant academic data is a very good opportunity to streamline scientific work, centralise relevant hazard information and avoid duplication. It is essential to ensure sufficient uptake of independent research, including studies from academia, in regulatory decisions as promised in the CSS.

However, data inserted in such tools or platform must be robust and reliable. To achieve this, the mechanism that will check/validate the robustness of the data before adding them to the CDPC is important.

In particular, for medicinal active substances, only data on relevant substances needs to be included.

The proposal needs to clarify what type of studies should be notified. The Rapporteur considers that only final studies generated, as part of the regulatory obligation within a safety evaluation have to be notified. These studies should be limited to those relevant for hazards/risk identification, while clear acceptability standards and criteria for the studies should be also indicated.

The Rapporteur emphasises the importance of a high level of security of the confidential information contained in the platform, avoiding unnecessary burden on companies for the notification of commissioned studies and not to duplicate existing mechanisms or processes (such as substance evaluation under REACH). Safeguarding the confidentiality of industry’s sensitive or strategic information is crucial to preserve competition on the market and incentivize innovation. In this regard, the Rapporteur’s proposed measures for the protection of confidentiality and property of data generated by industry are robust enough.

It should be also clarified whether industry can define any data as confidential or whether there are specific criteria to meet. The Rapporteur considers that data standardization (format and vocabularies) should not create unnecessary burdens for industry and should be relevant to product specific needs.

The public will have access to chemicals data contained in the CDPC, when such information has been already disclosed in accordance with EU acts under which the data was submitted. However, when providing public access to information on the properties and effects of chemicals on human health and the environment, the Rapporteur has taken into account the legitimate rights of businesses to the protection of commercially valuable information and intellectual property rights.

Removing obstacles to the re-use of existing data, is important as it aims to reduce the need for generation of new data, saving cost and administrative burden for industry and/or authorities but also reducing animal testing. In this regards, any mechanism for sharing or re-use of data must respect data protection rules and prevent disclosure of confidential business information. The large number and diversity of legislative acts included in Annex I to the proposed Regulation, as well as the vast amount of studies, measurements and analyses performed on a daily basis by the industry should also be taken into account.

The Rapporteur aims to ensure proportionality and reduce administrative burden mostly for SMEs, by proposing to avoid any potential duplication of information across various platforms.

The Rapporteur agrees to keep data generation mechanism as agile as possible, but it should involve the stakeholder consultation in the process. The Data Generation mechanism should be used only when there is a clear and specific need for data that cannot be generated under existing processes.

In addition, standard data formats and controlled vocabularies must be developed in consultation with stakeholders and in particular with the industry. Adopting the principle of using the same data formats and tools across different pieces of legislation as much as possible, this should not increase the burden on industry or delay regulatory processes.

Regarding the notification, the Rapporteur supports that the scope should be limited to the notification of studies that are relevant for assessing the hazard and safety profiles of chemical substances, and it should be done only when the study is concluded. The proposed obligation for notification of studies commissioned by the industry must be proportionately scoped and focused on studies which would have an added value to the risk or regulatory management of chemicals. This is to avoid an unnecessary administrative burden for companies and subsequently the Agency.

ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he has received input from the following entities or persons in the preparation of the draft report:

Entity and/or person

CEFIC

COSMETICS EUROPE

EFPIA

SFEE (Hellenic Association of Pharmaceutical Companies)

BASF

EFEO

ECHA

L'Oréal group in Europe

AnimalhealthEurope

ClientEarth

European Environmental Bureau (EEB)

FuelsEurope

EFSA

EEA

EMA

Croplife Europe

DOW

AESPG

AISE

SMEunited

DUCC (Downstream Users of Chemicals Co-ordination group)

SEVAS (Association of the Greek Industry of Detergents and Soaps)

Eurometaux

Eurocolour

The list above is drawn up under the exclusive responsibility of the rapporteur.

Where natural persons are identified in the list by their name, by their function or by both, the rapporteur declares that he has submitted to the concerned natural persons the European Parliament's Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.