(1)

The European Green Deal (1) sets a high ambition for enabling the transition towards a toxic-free environment and zero pollution. The Chemicals Strategy for Sustainability (2) is a crucial delivery of this zero-pollution ambition and introduces the ‘one substance, one assessment’ approach, which aims to improve the efficiency, effectiveness, coherence, and transparency of safety assessments of chemicals across Union legislation. According to that Strategy, ‘safe and sustainable by design’ criteria should be developed to enable the production and use of chemicals that are safe and sustainable throughout their entire lifecycle. The Strategy also sets out that the interaction between scientific developments and policy-making should be strengthened by means of an early warning system for chemicals to ensure that Union policies address emerging chemical risks as soon as these are identified by monitoring and research, and that a framework of indicators should be developed to monitor the drivers and impacts of chemical pollution and to measure the effectiveness of chemicals legislation. This Regulation aims to implement these objectives.

(1)

The European Green Deal (1) sets a high ambition for enabling the transition towards a toxic-free environment and zero pollution. The Chemicals Strategy for Sustainability (2) is a crucial delivery of this zero-pollution ambition and introduces the ‘one substance, one assessment’ approach, which aims to improve the efficiency, effectiveness, coherence, and transparency of safety assessments of chemicals across Union legislation. According to that Strategy, ‘safe and sustainable by design’ criteria should be developed to enable the production and use of chemicals that are safe and sustainable throughout their entire lifecycle. The Strategy also sets out that the interaction between scientific developments and policy-making should be strengthened by means of an early warning system for chemicals and groups of chemicals to ensure that Union policies address emerging chemical risks as soon as these are identified by monitoring and research, and that a framework of indicators should be developed to monitor the drivers and impacts of chemical pollution and to measure the effectiveness of chemicals legislation. This Regulation aims to implement these objectives.

(2)

The main objective of this Regulation is to increase the level of protection of the environment and human health from the risks arising from hazardous chemicals, as well as to facilitate the functioning of the internal market for chemicals. For that purpose, this Regulation should establish a common data platform data on chemicals (‘the common data platform’), to be managed by the European Chemicals Agency (‘ECHA’). The common data platform is a digital infrastructure that brings together chemicals data and information generated under the Union chemicals acquis. This Regulation should also establish dedicated services within the common data platform and lay down rules on the accessibility and usability of the data contained in that platform. This Regulation aims to create a common knowledge base on chemicals available to authorities to enable better, complete, coherent and robust scientific assessments of chemicals and their impacts and to ensure the best use of existing information for the purpose of the implementation and the development of Union legislation on chemicals . Moreover, the Regulation aims to provide a one-stop-shop on chemicals data and information in the Union accessible to the general public and, thus, to increase the predictability and the transparency of regulatory processes on chemicals, as well as to strengthen public trust in the robustness of scientific decision-making.

(2)

The main objective of this Regulation is to increase the level of protection of the environment and human health from the risks arising from chemicals, as well as to facilitate the functioning of the internal market for chemicals . Improving the integration of information from different sources, and establishing a cost-effective digital infrastructure will improve the predictability and transparency of regulatory processes and result in a reduction of the administrative burden and overlaps . For that purpose, this Regulation should establish a common data platform data on chemicals (‘the common data platform’), to be managed by the European Chemicals Agency (‘ECHA’). The common data platform is a digital infrastructure that brings together chemicals data and information generated under the Union chemicals acquis. This Regulation should also establish dedicated services within the common data platform and lay down rules on the transparency, accessibility and usability of the data contained in that platform. This Regulation aims to create a common knowledge base on chemicals available to authorities to enable better, complete, coherent and robust scientific assessments of chemicals and their impacts and to ensure the best use of existing information for the purpose of the implementation and the development of Union legislation and thereby contribute to ensuring that testing on animals only takes place as a last resort . Moreover, the Regulation aims to provide a one-stop-shop on chemicals data and information in the Union accessible to the general public and, thus, to increase the predictability and the transparency of regulatory processes on chemicals, as well as to strengthen public trust in the robustness of scientific decision-making. By collecting and making available all data on chemicals that exist in the Union, the database will also foster innovation and support the development of advanced biologically-relevant tools, methods and models, and data analysis capacities.

(4)

In its communication of 19 February 2020 on a European strategy for data (4), the Commission described its vision of a common European data space and highlighted the need for the development of sectoral data spaces in strategic areas, since not all sectors of the economy and society are moving at the same speed. This Regulation aims therefore to build a data space for chemicals by establishing a common data platform on chemicals (‘common data platform’), which is also part of the Green Deal data space, as referred to in the European strategy for data. Furthermore, in that strategy, the Commission highlighted several issues concerning the availability of data for the public good, including data availability, data infrastructures and governance, interoperability, as well as the lack of adequate sharing of data between public authorities. This Regulation aims to increase data availability on chemicals by requiring the relevant Union agencies to make data available for integration in the common data platform on chemicals, to promote interoperability of that data by providing for the establishment of standard formats and controlled vocabularies, as well as to facilitate data exchange and use by public authorities to enable them to effectively carry out their regulatory and policy developing tasks.

(4)

In its communication of 19 February 2020 on a European strategy for data (4), the Commission described its vision of a common European data space and highlighted the need for the development of sectoral data spaces in strategic areas, since not all sectors of the economy and society are moving at the same speed. This Regulation aims therefore to build a data space for chemicals by establishing a common data platform on chemicals (‘common data platform’), which is also part of the Green Deal data space, as referred to in the European strategy for data. Furthermore, in that strategy, the Commission highlighted several issues concerning the availability of data for the public good, including data availability, data infrastructures and governance, interoperability, as well as the lack of adequate sharing of data between public authorities. This Regulation aims to increase data availability on chemicals by requiring the Commission and the relevant Union agencies to make data available for integration in the common data platform on chemicals, to promote interoperability of that data by providing for the establishment of standard formats and controlled vocabularies, as well as to facilitate data exchange and use by public authorities to enable them to effectively carry out their regulatory and policy developing tasks.

(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.

(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 , but not be limited to, all chemicals-related data and information held by relevant Union agencies or the Commission generated or submitted to them as part of the implementation of Union chemicals legislation listed in Annex I , unless this Regulation specifies otherwise . This includes, for instance, all regulatory dossiers or applications submitted to the relevant Union agencies, but also chemicals data on occurrence of chemicals submitted by Member States to Union agencies or the Commission in compliance with their reporting obligations and enforcement activities . 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.

(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)

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. The extension to further data categories or additional medicinal active substances should be assessed in the context of a review.

(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)

Taking due account of the administrative work for EMA coming from the adaptation of such data to an appropriate format for inclusion in the common data platform, it is appropriate to adopt a stepwise approach, and to include during the first stage only chemical data for active substances which are submitted to the EMA in the context of the relevant procedures that are finalised after the entry into force of this Regulation. No later than eight years after the entry into force of this regulation, EMA should also include the chemical data on active substances from procedures concluded before the entry into force of this Regulation.

(9a)

Active substances contained in medicinal products are covered by Annex II to this Regulation, but may also be regulated in legislation referred to in Annex I since active substances in medicinal products may also be used in applications that fall under Union legislation listed under Annex I. In order to protect the confidentiality of certain data, the provisions on confidentiality under the originating Union act apply.

(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.

(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. The common data platform should also include terms and conditions, particularly regarding the respect of intellectual property rights and other related rights.

(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 chemicals in articles, a database on safer alternatives to substances of concern, as well as a dashboard of indicators on chemicals.

(18)

The Commission should adopt an implementation plan identifying initial datasets to be made accessible via the platform and the timeline for their integration, informed by the preparatory work of the Commission and the Agencies (10). The Commission should set up a governance scheme to support and steer the common data platform’s operation and evolution covering the organisation of work structures and coordination between ECHA and data providers, required rules, formats and vocabularies for data integration, and maintain a rolling implementation plan to ensure the progress in identification and integration of new datasets and services for inclusion. The governance scheme should be adopted and updated as necessary by the Commission, after consultation with a newly established platform steering committee composed of representatives from Union agencies and the Commission. In order to ensure uniform conditions for the implementation of the obligations to establish an implementation plan and a governance scheme, implementing powers should be conferred on the Commission.

(18)

The Commission should adopt an implementation plan identifying datasets of chemicals data to be made accessible via the platform and the timeline for their integration, informed by the preparatory work of the Commission and the Agencies (10). The Commission should set up a governance scheme to support and steer the common data platform’s operation and evolution covering the organisation of work structures and coordination between ECHA and data providers, required rules, formats and vocabularies for data integration, and maintain a rolling implementation plan to ensure the progress in identification and integration of new datasets of chemicals data and services for inclusion. The governance scheme should be adopted and updated as necessary by the Commission, after consultation with a newly established platform steering committee composed of representatives from Union agencies and the Commission. In order to ensure uniform conditions for the implementation of the obligations to establish an implementation plan and a governance scheme, implementing powers should be conferred on the Commission.

(19)

The common data platform should serve the widest possible community, with the ability to address new use cases, incorporate new relevant datasets, develop new functionalities, and respond to developing tools and applications.

(19)

The common data platform should serve the widest possible community, with the ability to address new use cases, incorporate new relevant datasets of chemicals data , develop new functionalities, and respond to developing tools and applications.

(21)

To ensure that an adequate knowledge base on chemicals is available through the common data platform, the Commission should be able to request the Agencies to host, maintain and make available, via the common data platform, data generated as part of Union, national or international programmes or research activities beyond the data already flowing to the Agencies as part of the obligations under the Union acts listed in Annex I. The Commission should make such requests to the Agencies in accordance with their mandates and allocated tasks.

(21)

To ensure that an adequate knowledge base on chemicals is available through the common data platform, the Commission should be able to request the Agencies to host, maintain and make available, via the common data platform, chemicals data generated as part of Union, national or international programmes or research activities beyond the data already flowing to the Agencies as part of the obligations under the Union acts listed in Annex I or other obligations laid down in this Regulation . The Commission should make such requests to the Agencies in accordance with their mandates and allocated tasks. Other parties, such as Member States, national agencies, scientific bodies of Member States, national authorities or researchers or research consortia should be able to submit on a voluntary basis chemicals data to the Agencies or the Commission. Where such data are submitted, a standard format appropriate for the inclusion in the common data platform should be used, where available.

(22)

Some types of data are currently not within the mandate of any of the Agencies. In order to ensure clarity of responsibilities of the Agencies and efficient management of chemicals data, the Agencies should be required to host, maintain and provide specific data types to the common data platform. To this end, the ECHA should host and be a data provider to the common data platform for workplace monitoring data, and the EEA should host and be a data provider to the common data platform for data on indoor air quality and environment monitoring data, as well as data on concentrations of chemicals in human matrices such as blood or urine (‘human biomonitoring data’).

(22)

Some types of data are currently not within the mandate of any of the Agencies. In order to ensure clarity of responsibilities of the Agencies and efficient management of chemicals data, the Agencies should be required to host, maintain and provide specific data types to the common data platform. To this end, the ECHA should host and be a data provider to the common data platform for workplace monitoring data, including occupational human biomonitoring data, and the EEA should host and be a data provider to the common data platform for data on indoor air quality and environment monitoring data, as well as data on concentrations of chemicals in human matrices such as blood or urine (‘human biomonitoring data’).

(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 national or 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.

(24)

The EEA, as the agency responsible for monitoring data and information on chemicals in the environment, should also be responsible for collecting, hosting, and maintaining human biomonitoring data . To the extent that human biomonitoring data constitutes a special category of personal data, namely, health data, the EEA should process that data only where the processing is necessary for reasons of substantial public interest, as required by Article 10(2)(g) of the Regulation (EU) No 2018/1725 of the European Parliament and of the Council (11). This Regulation lays down the cases where there is such substantial public interest in processing human biomonitoring data: namely, where the EEA processes that data to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure, to develop health risk and impact indicators, to monitor the impact of regulatory intervention, and to support regulatory risk assessments .

(24)

The EEA, as the agency responsible for monitoring data and information on chemicals in the environment, should also be responsible for collecting, hosting, and maintaining human biomonitoring data , with the exception of occupational human biomonitoring data , which should be collected, hosted and maintained by the ECHA .

(24a)

The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission should be able to process human biomonitoring data constituting personal data. Since human biomonitoring personal data constitute a special category of personal data, namely, health data, the EEA, the Commission, the ECHA, the EFSA, the EU-OSHA and the EMA should process those data only where the processing is necessary for reasons of substantial public interest, as laid down in Article 10(2)(g) and for scientific research as laid down in Article 10(2)(j) of Regulation (EU) 2018/1725. The present Regulation lays down the cases where there is such substantial public interest in processing human biomonitoring data constituting personal data.

(24b)

The inclusion of human biomonitoring data collected prior to the entry into force of this Regulation in the common data platform is necessary to ensure the completeness and quality of the human biomonitoring datasets for the purposes of this Regulation.

(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 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. The ECHA should also include in the repository of reference values reference values that are generated through other programmes or research activities and that are made available to it.

(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 the studies on chemicals they commission for compliance with regulatory requirements under the Union acts listed in Annex I. Scientific studies that are conducted only for research purposes , that are not commissioned to support an application, notification or regulatory dossier notified or submitted to an Authority, or that are not part of a risk or safety assessment under Union acts listed in Annex I, do not need to be notified. The ECHA should establish and manage a database of study notifications to store the information related to those studies . That database should be a separate database in which notification information is kept confidential. The ECHA, in cooperation with the relevant Agencies, should take the necessary measures to protect the safe transmission of chemicals data . 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 18 months after the date of entry into force of this Regulation. The ECHA should also set up a mechanism to cooperate with authorities in third countries in order to exchange information about studies that are notified or submitted for regulatory purposes.

(30)

To ensure the coherence between those two study notification mechanisms, as well as to ensure certainty for business operators submitting notifications, the rules on the public dissemination of study notifications should, where relevant, correspond in that the notifications should only be made available through the common data platform once a corresponding registration, application, notification or other relevant regulatory dossier was submitted to the relevant Union or national institution and a decision on the confidentiality of the data contained in that regulatory dossier was taken by that Union or national institution . In addition, in order to facilitate compliance with the requirement to notify a study, the ECHA and the EFSA should cooperate to ensure a common approach for the identification of notified information in order to facilitate the traceability of studies notified to their respective databases.

(30)

To ensure the coherence between those two study notification mechanisms, as well as to ensure certainty for business operators submitting notifications, the rules on the public dissemination of study notifications should, where relevant, correspond in that the notifications should only be made available through the common data platform once a corresponding registration, application, notification or other relevant regulatory dossier was submitted to the relevant Union or national institution . In order to respect the confidentiality of relevant elements of study notifications when they are integrated in the common data platform, where the Commission or an Agency makes available to the ECHA the corresponding registration, application, notification or other relevant regulatory dossiers, it should also indicate which elements of the study notification are to be confidential when they will be included in the common data platform. Only those elements should be indicated as confidential where the same element is indicated as confidential in the corresponding application, notification or other relevant regulatory dossier in accordance with the provisions on confidentiality under the originating Union act . In order to facilitate compliance with the requirement to notify a study, the ECHA and the EFSA should cooperate to ensure a common approach for the identification of notified information in order to facilitate the traceability of studies notified to their respective databases. To avoid uncertainties for business operators resulting from the existence of two databases of study notifications, managed by ECHA and EFSA, respectively, the practical arrangements laid down by ECHA for implementing the provisions on notification of studies should as much as possible be aligned with the related practical arrangements of EFSA.

(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, as well as any studies on chemicals on their own or in products they commission as part of a risk or safety assessment, to ensure compliance under the Union acts listed in Annex I. On the basis of this objective and considering the fact that assessment procedures under Union acts on chemicals in Annex I may vary widely, it would be beyond the scope and aim of this Regulation to amend existing assessment processes set under those Union acts listed in Annex I by imposing additional conditions leading to potential market access consequences not foreseen in those Union acts. Consequently, it is not appropriate to introduce in this Regulation the consequences associated with non-compliance with the study notification obligation as laid out in Article 32b of Regulation (EC) No 178/2002 of the European Parliament and of the Council.

(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. Information on enforcement should be made public to enhance public trust in the effective implementation of Union law.

(36)

To strengthen the coordination and cooperation between the different bodies performing chemicals assessments in the Union, and to promote an increased transparency of chemicals assessments, the ECHA should establish and manage a database with information on regulatory processes or activities that are planned, ongoing or completed by Member States, the Commission and Agencies referred to in the Union acts listed in Annex III to this Regulation and integrate it into the common data platform for access by the authorities. The information on such regulatory processes or activities should include at least the substance identity and the identification, status and eventually the outcome of the regulatory process or activity. That information should also be made available without undue delay and kept updated through the assessment process. Once the process or activity has formally started, that information should be shared also publicly on the common data platform.

(36)

To strengthen the coordination and cooperation between the different bodies performing chemicals assessments in the Union, and to promote an increased transparency of chemicals assessments, the ECHA should establish and manage a database with information on regulatory processes or activities that are planned, ongoing or completed by Member States, the Commission and Agencies referred to in the Union acts listed in Annex III to this Regulation and integrate it into the common data platform for access by the authorities. The information on such regulatory processes or activities should include at least the substance identity and the identification, status and eventually the outcome of the regulatory process , or activity , including whether it involves animal testing . That information should also be made available without undue delay and kept updated through the assessment process. Once the process or activity has formally started, that information should be shared also publicly on the common data platform.

(36a)

There are data gaps on the occurrence of hazardous and other harmful chemicals in articles on the Union market. In order to enhance visibility on the availability of data, and to promote research and development activities as regards safer alternatives, as well as the uptake of such alternatives, ECHA should establish and manage a repository of information on chemicals in articles generated or submitted under Union acts listed in Annex I. This database should integrate the information required under Article 9(1)(i) of Directive 2008/98/EC and the web portal under Article 14 of Regulation (EU) 2024/1781. In addition, ECHA should also establish and manage a database collecting available information from Agencies, Member States and business operators on safer alternatives to substances of concern, as defined in Article 2(27) of Regulation (EU) 2024/1781 as well as substances that meet the criteria for classification in hazard classes referred to in Article 2(27)(b) of Regulation (EU) 2024/1781.

(38)

In order to ensure the interoperability and comparability of chemicals data and to facilitate their automatic and electronic exchange, the Agencies and the Commission should store chemicals data in adequate and mutually coherent and interoperable formats and use mutually coherent and interoperable controlled vocabularies. Some Union acts listed in Annex I or II set procedures to establish or make available data formats, in particular for the submission of chemicals data by business operators or Member States. Where such procedures do not exist in the Union acts listed in Annex I or II, the Agencies and the Commission should, where relevant, specify appropriate formats for chemicals data they receive and store, avoiding the use of proprietary standards while, as appropriate, using OECD or other internationally agreed formats, making use of existing formats and ensuring interoperability with existing data submission approaches.

(38)

In order to ensure chemicals data are easily findable within the database and to avoid duplicates, each chemical contained in the common data platform should be identified by a unique chemical identifier and a chemical notation specifying its molecular structure. In order to ensure the interoperability and comparability of chemicals data and to facilitate their automatic and electronic exchange, the Agencies and the Commission should store chemicals data in adequate and mutually coherent and interoperable formats and use mutually coherent and interoperable controlled vocabularies. Some Union acts listed in Annex I or II set procedures to establish or make available data formats, in particular for the submission of chemicals data by business operators or Member States. Where such procedures do not exist in the Union acts listed in Annex I or II, the Agencies and the Commission should, where relevant, specify appropriate formats for chemicals data they receive and store, avoiding the use of proprietary standards while, as appropriate, using OECD or other internationally agreed formats, making use of existing formats and ensuring interoperability with existing data submission approaches. When specifying such formats and controlled vocabularies, the Agencies and Commission should, where relevant, take into account input and contributions from Member States and stakeholders.

(41a)

Independent research studies are often given comparatively low weight as evidence in hazard and risk assessment of chemicals, thus creating a gap between independent research and chemicals regulation and policy. It is necessary to provide structure and transparency in the evaluation of research data in order to increase their use in regulatory assessment of chemicals. The Commission should publish guidance setting minimum quality and reporting requirements to improve the uptake of research data.

(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 of chemicals data 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 , national 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.

(43)

To monitor the impacts on humans and the environment, including the climate, of exposure to chemicals and to establish a knowledge base to measure the effectiveness of chemicals legislation in protecting human health and the environment, the EEA and the ECHA should jointly develop and regularly, at least every two years, update a set of indicators and present it in the form of a dashboard. The EFSA, the EMA, the EU-OSHA and the Commission shall regularly provide the EEA with any available data falling within their mandate and relevant for the establishment of the indicators. The EEA and the ECHA should integrate this dashboard of indicators into the common data platform.

(43)

To monitor the impacts on humans and the environment, including the climate, of exposure to chemicals and to establish a knowledge base to measure the effectiveness of chemicals legislation in protecting human health and the environment, the EEA , in collaboration with the Agencies, should jointly develop and regularly, at least every two years, update a set of indicators and present it in the form of a dashboard. In order to monitor the aggregated risk for territories associated with the impacts on humans and the environment, including on the climate, of exposure to chemicals and pollutants, the set of indicators should include an aggregated indicator for different territorial levels, developed in collaboration with the Joint Research Centre and drawing inspiration from its European wide vulnerability framework. The EEA should cross-reference the results of this indicator with other health and environment datasets, such as epidemiological data on occupational health, lifestyle factors, and socio-economic factors, in order to assess the impacts and risks of c cumulated risk factors on population at the territorial level. The Agencies and the Commission should regularly provide the EEA with any available data falling within their mandate and relevant for the establishment of the indicators. The EEA and the ECHA should integrate this dashboard of indicators into the common data platform.

(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 (EC) No 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 regulatory and policy 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 (EC) No 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 concerning chemicals, groups of chemicals, and cumulative exposure to chemicals . In order to allow the EEA sufficient time to organise the collection of early warning signals and to compile and analyse the initial information the EEA should only deliver the first report six months after the end of the first calendar year after entry into force of this Regulation. this Regulation sets a deadline for the first report and associated data. For any risk and warning signal identified by the report, the Authorities should consider undertaking regulatory, policy or enforcement actions and provide justification when they decide not to proceed with any action. Emerging chemical risks identified in the early warning and action system should also be taken into account when setting priorities for the strategic planning of Horizon Europe.

(46)

The ECHA should continue operating the EUON and transform it into an observatory for specific chemicals with potential contribution to emerging chemical risks (‘the observatory’), which should cover also other chemicals and innovative (rationally designed complex ‘advanced’) materials selected by the Commission, using, as appropriate, signals from the early warning and action system. One of the criteria for selecting chemicals for the observatory should be their novelty and disruptive potential that may contribute to an emerging chemical risk. Another criterion for that selection should be the higher degree of uncertainty surrounding them and, due to less regulatory experience regarding those chemicals, the resulting need for additional scrutiny and transparency. The observatory should facilitate regulatory implementation and responsible use of these chemicals by collecting, generating, and disseminating reliable information on selected chemicals’ properties, uses and market presence to the general public.

(46)

The ECHA should continue operating the EUON and transform it into an observatory for specific chemicals and groups of chemicals with potential contribution to emerging chemical risks (‘the observatory’), which should cover also other chemicals and innovative (rationally designed complex ‘advanced’) materials selected by the Commission, using, as appropriate, signals from the early warning and action system. One of the criteria for selecting chemicals for the observatory should be their novelty and disruptive potential that may contribute to an emerging chemical risk. Another criterion for that selection should be the higher degree of uncertainty surrounding them and, due to less regulatory experience regarding those chemicals, the resulting need for additional scrutiny and transparency. The observatory should facilitate regulatory implementation and responsible use of these chemicals by collecting, generating, and disseminating reliable information on selected chemicals’ properties, uses and market presence to the general public.

(48)

Under Regulation (EC) No 178/2002, the EFSA is able to commission, in an open and transparent manner, the scientific studies it needs to accomplish its mission, while seeking to avoid duplication with Member States or Union research programmes. The ECHA should also be able to commission studies to obtain adequate data and information on chemicals within its mission, while maintaining the principle that the burden to prove compliance with Union chemicals legislation remains on the duty holder. Furthermore, the ECHA should commission such studies out of its own initiative or at the request of the Commission, with the objective of supporting the effective and efficient implementation and evaluation of Union acts on chemicals within its mandate and contributing the development of a Union chemicals policy.

(48)

Under Regulation (EC) No 178/2002, the EFSA is able to commission, in an open and transparent manner, the scientific studies it needs to accomplish its mission, while seeking to avoid duplication with Member States or Union research programmes. The ECHA should also be able to commission studies to obtain adequate data and information on chemicals and groups of chemicals within its mission, while maintaining the principle that the burden to prove compliance with Union chemicals legislation remains on the duty holder. Furthermore, the ECHA should commission such studies out of its own initiative or at the request of the Commission, with the objective of supporting the effective and efficient implementation and evaluation of Union acts on chemicals within its mandate and contributing the development of a Union chemicals policy. When obtaining a sample of a substance is a precondition for conducting the scientific studies, ECHA should be given the necessary sample by the business operator, upon request, and provided that applicable confidentiality and data protection under Union law is ensured. Whenever possible, information generated through studies commissioned by the ECHA should be generated by means other than animal tests.

(48a)

To support the effective implementation and evaluation of Union acts on chemicals and to contribute to the development of a comprehensive Union chemicals policy, it is essential to conduct Union-wide human biomonitoring studies that provide high-quality and representative data at regular intervals. To support a resource-efficient approach, the ECHA and EFSA should cooperate closely in pooling resources and expertise for such studies. The Member States should cooperate with the Agencies to organise the human bio-monitoring in their respective territories, in terms of planning, coordination, collection and transmission of samples.

(48b)

In order to contribute to the overall objective of this Regulation to enable better, complete, coherent and robust scientific assessments of chemicals and their impacts, and to ensure the best use of existing information for the purpose of the implementation and the development of Union legislation on chemicals, this Regulation should require the Commission to draw up a report analysing how adequate the resources of the agencies are in relation to their current tasks and their new tasks under this Regulation, and a prospective view of the resources needed to address key areas of regulatory challenge in the future.

(48c)

As this Regulation expands the tasks and workload of the European Chemicals Agency, it should be provided with appropriate and stable resources, and stable governance of the scientific committees should be ensured. In this respect, it is appropriate that the Commission takes account of any developments and reflects the needs of the Agency to allow fulfilment of its tasks and potential.

(ba)

keep records of data on studies obtained from relevant third countries through the mechanism referred to in Article 9(1a);

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 , the European Commission, the competent authorities of the Member States as referred to in any of the Union acts listed in Annexes I , II and III, and the Agencies, excluding their management boards;

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 , fate and manufacturing process of the chemicals, as well as environmental sustainability related information, including climate change related information, on those chemicals, regulatory process-related information on chemicals, information on the availability and suitability of alternatives, standard formats, controlled vocabularies, or any information on applicable legal obligations related to chemicals and the enforcement thereof ;

11a.

'research data' means any hazard, occurrence, exposure and fate data derived from scientific studies published in peer-reviewed literature that are not carried out specifically to inform regulatory assessments;

14a.

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

(ba)

additional data provided on a voluntary basis by Member States, national agencies, research institutes or other parties;

(bb)

generated in the context of academic research activities in the sphere of chemicals not covered in point (b) and voluntarily submitted to ECHA by a third party;

4a.

Each chemical or material hosted on the common data platform shall be identified by a unique chemical identifier and a chemical notation specifying its molecular structure without prejudice to any confidentiality requirements in the original act or related legal obligations.

(da)

information on chemicals in articles as referred to in Article 10a;

(db)

information on safer alternatives to substances of concern as referred to in Article 10b;

(da)

the organisation and operation of the mechanisms for cooperation and information exchange with databases and similar platforms in third countries and internationally;

(f)

the operation of the steering committee itself.

(f)

the operation , reporting requirements and transparency obligations of the steering committee itself.

(e)

supporting regulatory risk assessments.

(e)

supporting regulatory risk assessments and management .

(ea)

supporting policy making and legislative processes at Union level;

(eb)

the creation of a 'chemicals exposure index' for each region in the Union, to provide an overview of the population's exposure to chemical substances and facilitate comparisons between different regions, geographical areas and Member States;

(ec)

facilitating the processing by the Commission, the ECHA, the EFSA, the EMA, and the EU-OSHA in accordance with paragraphs 4a, 4b, 4c, 4d and 4e of this Article.

(a)

scientific research aimed at policy making;

(b)

assessing the impact of chemicals on human health and the environment;

(c)

monitoring time and spatial trends in exposure;

(d)

developing health risk and impact indicators;

(e)

monitoring the impact of regulatory intervention;

(f)

assessing the need for further regulatory action and prioritising such action;

(g)

supporting regulatory risk assessment and risk management.

(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 assessment and management;

(f)

evaluating and prioritising required regulatory action;

(g)

performing assessments of chemicals;

(h)

as part of the commissioning of studies under the data generation mechanism referred to in Article 21.

(a)

evaluating and prioritising required regulatory action;

(b)

performing assessments of chemicals;

(c)

supporting regulatory risk management.

(a)

evaluating and prioritising required regulatory action;

(b)

performing assessments of chemicals;

(c)

supporting regulatory risk management.

(a)

scientific research aimed at policy making;

(b)

assessing the impact of chemicals on human health and the environment;

(c)

monitoring time and spatial trends in exposure;

(d)

monitoring the impact of regulatory intervention;

(e)

assessing the need for further regulatory action and prioritising such action;

(f)

supporting regulatory risk management.

4c.

(a)

chemical identity;

(b)

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

(c)

the submitter or actor responsible for the regulatory process or activity;

(d)

the status of the regulatory process or activity;

(e)

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

(f)

where applicable, the intended date for starting the regulatory process or activity, and the date of its completion and latest update;

(g)

where applicable, whether the process or activity includes the use of animals in testing and for which endpoints.

(a)

substance identity;

(a)

chemical identity;

(fa)

where applicable, whether the process or activity includes the use of animals in testing and for which endpoints.

(ia)

Regulation (EC) No 1107/2009 of the European Parliament and of the Council (1a).

(ib)

Regulation (EC) No 396/2005 of the European Parliament and of the Council (1b)

(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 as open datasets , supporting their re-use ;

(b)

existing national early warning systems;

(b)

national early warning systems;

(c)

data that the EEA holds;

(c)

data that the EEA holds , including data from human biomonitoring as referred to in Article 6, and data from the framework of indicators and the aggregated indicator as referred to in Article 18 ;

(ea)

relevant datasets from the EU Datasets Catalogue established by Article 57 of Regulation (EU) …/… of the European Parliament and of the Council on the European Health Data Space... [OP: please add number and publication reference];

(eb)

relevant information resulting from national enforcement programmes;

(ec)

relevant data or information submitted by researchers.

(c)

make compiled data publicly available through the common data platform or other communication and outreach tools as appropriate, to facilitate informed societal discussion and increase public awareness on the properties, use and safety aspects of specific chemicals, and regularly update that information.

(c)

make compiled data publicly available through the common data platform or other communication and outreach tools as appropriate , to facilitate the identification of potential further research needs or risk management measures , to facilitate informed societal discussion and increase public awareness on the properties, use and safety aspects of specific chemicals, and regularly update that information.

VIII

DELEGATED POWERS

VIII

DELEGATED POWERS AND COMMITTEE PROCEDURE

70a.

34a.