(1)

The communication of the Commission of 11 December 2019 on the European Green Deal sets high ambitions for enabling the transition towards a toxic-free environment and zero pollution. The strategy set out in the communication of the Commission of 14 October 2020 entitled ‘Chemicals Strategy for Sustainability Towards a Toxic-Free Environment’ (the ‘Strategy’) is a crucial step towards achieving zero-pollution 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 legal acts. According to the 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 states 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 they 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 Union law on chemicals. This Regulation aims to implement those 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 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 on chemicals (the ‘common data platform’), to be managed by the European Chemicals Agency (the ‘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 the platform. This Regulation aims to create a common knowledge base on chemicals, which would be available to risk assessors to enable better, complete, consistent and robust scientific assessments of chemicals and their impact and to ensure the best use of existing information for the purpose of the implementation and the development of Union legal acts and thereby contribute to the replacement and reduction of animal testing wherever possible. This Regulation aims to improve the integration of information from different sources and establish a cost-effective digital infrastructure, providing a one-stop-shop for chemicals data and information in the Union that is accessible to the public. This will increase the predictability and transparency of regulatory processes on chemicals and strengthen public trust in the robustness of scientific decision-making. By collecting and making available all data on chemicals in the Union, the data platform will also foster innovation and support the development of advanced tools, methods and models for chemicals assessments.

(3)

Under Decision (EU) 2022/591 of the European Parliament and of the Council (3), harnessing the potential of digital and data technologies to support environmental policy, including by delivering real-time data, where possible, and information on the state of ecosystems, while increasing efforts to minimise the environmental footprint of those technologies and ensuring that the data and information are transparent, authentic, interoperable and publicly accessible is a long-term priority objective. Data and information on chemicals are therefore essential for the proper development and implementation of the Union’s environmental policy and specifically of its chemicals policy.

(4)

In its communication of 19 February 2020 on a European strategy for data, 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 therefore aims to build a data space for chemicals by establishing the 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 accessibility, data infrastructures and governance, interoperability, as well as the lack of adequate sharing of data between public authorities. This Regulation therefore aims to increase the availability of data on chemicals by requiring the Commission and the relevant Union agencies, namely the European Agency for Safety and Health at Work (‘EU-OSHA’), the ECHA, the European Environment Agency (the ‘EEA’), the European Food Safety Authority (the ‘EFSA’), and the European Medicines Agency (the ‘EMA’) (together the ‘Agencies’), to make data available for incorporation in the common data platform, to promote interoperability of those data by providing for the establishment of standard formats and controlled vocabularies, as well as to facilitate data exchange and use by public authorities enabling them to effectively carry out their regulatory and policy development tasks.

(5)

This Regulation also aims to implement the principles laid out in the proposal for an Interoperable Europe Act in the chemicals sector by strengthening the cross-border interoperability of network and information systems used to provide or manage public services on chemicals in the Union. This Regulation will contribute to increasing cross-border data flows for truly European digital services and will broaden the access to publicly available chemicals data for utilisation in other sectors’ applications.

(6)

Business operators and competent authorities of the Member States are required by various Union legal 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 as well as in different formats. Such fragmentation prevents public authorities, as well as the 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 legal acts on chemicals, and of damaging the public’s trust in the scientific grounds for Union decisions on chemicals. In order to ensure that data on chemicals are easily findable, accessible, interoperable and reusable, the ECHA should establish the common data platform. The common data platform should serve as a single point of reference and as a broadened and shared evidence base to enable the efficient delivery of consistent hazard and risk assessments of chemicals across various Union legal 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)

Unless this Regulation specifies otherwise, the common data platform should contain, but not be limited to, all chemicals-related data and information held by the Agencies or the Commission and generated or submitted to them as part of the implementation of Union legal acts listed in Annex I. This includes, for instance, all regulatory dossiers or applications submitted to the Agencies, but also chemicals data on the occurrence of chemicals submitted by Member States to the Agencies or the Commission as well as chemicals data resulting from Member States’ implementation activities, 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 from research activities related to chemicals, where those data and that information are held by the Commission or one of the Agencies. In addition, the common data platform should allow for the incorporation of chemicals data provided on a voluntary basis by Member States and other parties, including national agencies and research institutes, as well as chemicals data resulting from international collaboration with third-country organisations and held by the Commission or one of the Agencies.

(8)

While some medicinal products are also chemicals and are relevant to the objectives of this Regulation, the application and use of hazard and risk assessments performed on chemicals under Union law on medicinal products is different from the application and use of hazard and risk assessments performed under the main Union legal acts on chemicals. It is thus appropriate to adopt a stepwise approach and to include, as a first step and taking due account of the administrative burden for the EMA, only the chemicals data which have the highest added value. Under that first step, the data with the highest assessed added value are data on relevant active substances, which are considered to be active substances covered by Union legal acts on medicinal products listed in Annex I, Part 2, and also subject to regulatory processes under other Union legal acts listed in Annex I, Part 1, 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 include chemicals data related to environmental risk assessments carried out under Union law on medicinal products for human and veterinary use, non-clinical studies carried out under Union law 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.

(9)

Taking due account of the administrative work for the EMA from the adaptation of such data to an appropriate format for incorporation in the common data platform, it is appropriate to adopt a stepwise approach and to include during the first stage only chemicals 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 six years after the entry into force of this Regulation, the EMA should also start incorporating chemicals data on active substances resulting from procedures concluded before the entry into force of this Regulation.

(10)

Other chemicals data submitted or generated under Union legal acts on medicinal products could also be of relevance to chemicals regulatory areas, such as data related to other active substances contained in medicinal products, clinical data and data related to other substances contained in medicinal products besides active substances. Moreover, a relevant part of the medicinal data is held by the competent authorities of the Member States. No later than 6 years after the entry into force of this Regulation, the Commission should therefore assess, in consultation with Member States and the Agencies, whether such additional data should be included in the common data platform. That assessment should also take into account the relevance, the anticipated added value and the cost-benefit balance of incorporating the additional data.

(11)

In order to add data to be made available by the EMA through the common data platform where relevant to support the achievement of the objectives of this Regulation, such as to ensure consistency and the efficient delivery of hazard and risk assessments of chemicals, or if, in view of scientific progress, there is new knowledge about the hazards or risks to the environment or human health, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of amending Article 3(3) of this Regulation.

(12)

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 Council (4), that information should not be included in the common data platform. Likewise, due to the commercial sensitivity 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 1223/2009 of the European Parliament and of the Council (5) 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.

(13)

To safeguard the ability of the European Commission, of the Agencies and of the competent authorities of the Member States to carry out their tasks, documents with chemicals data relating to their internal work or decision-making should, in principle, not be included in the common data platform.

(14)

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 access to the chemicals data contained in the common data platform. That framework should, as a general principle, grant the widest possible access to that chemicals data. It should also specify, where appropriate, who is entitled to access and use that chemicals data, under which conditions, on what basis, and for what purposes. The Authorities 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 fulfil their regulatory duties and tasks effectively, in order to improve the effectiveness, efficiency and consistency of chemicals-related assessments as well as the development of Union chemicals policies. Access to personal data should be limited to what is necessary for the purposes for which those data are processed by the Authorities.

(15)

Chemicals data and information generated as a result of obligations laid down by Union legal acts on chemicals could contain commercially sensitive information or be protected under those Union legal acts by confidentiality claims on confidential business information. The public dissemination of such data could affect the commercial interests of private parties. To ensure legal certainty and predictability for duty holders and to protect their legitimate expectations, as well as to ensure the 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 that end, the Authorities should have full access to all chemicals data and information contained in the common data platform, also in machine-readable formats, including access to all confidential information and information that is not made available to the public. In contrast, other parties should not have access via the common data platform to confidential data or to data that are not made available to the public under the originating Union act as they could contain commercially sensitive information and the confidentiality of those data has not been assessed. Nevertheless, all parties should maintain the right to request access to any data contained in the common data platform in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council (6).

(16)

When using data contained in the common data platform, the Authorities should respect the originator principle. Under that principle, the confidentiality marking of chemicals data as carried out by the originator and as correspondingly indicated by the relevant agency when it provides those data to the common data platform should be respected by the Authorities using those data to perform their regulatory functions or fulfil their tasks. The common data platform should also include terms and conditions of use of the data, including regarding intellectual property rights.

(17)

To ensure the protection of legitimate expectations of duty holders when generating or submitting data or information under the Union legal acts listed in Annex I, as well as to protect the confidentiality of that information when used by the Authorities, exceptional grounds for disclosing confidential information laid down in those Union legal acts should apply only to the disclosure of the data and information submitted or generated in compliance with those legal acts. For example, under Article 39(4) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (7), where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the EFSA can disclose information previously considered confidential under that Regulation and the EFSA is required to make public information which was previously considered confidential where that information forms part of the conclusions of scientific outputs of the EFSA which relate to foreseeable effects on human health, animal health or the environment. Likewise, Article 118 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (8) provides for the possibility for the ECHA to disclose confidential information submitted to it under that Regulation if urgent action is essential to protect human health, safety or the environment, such as in emergency situations.

(18)

When processing or disclosing personal data contained in the common data platform, the Agencies and the Commission should comply with Regulation (EU) 2018/1725 of the European Parliament and of the Council (9), and the competent authorities of the Member States should comply with Regulation (EU) 2016/679 of the European Parliament and of the Council (10).

(19)

Given that the Agencies would be required to store scientific data which includes confidential and personal data, it is necessary to ensure that such storage is carried out in accordance with a high level of information system security and that access to confidential data is auditable.

(20)

While the ECHA should identify and develop the technical functionalities of the common data platform in stages, certain dedicated services should be provided for 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. Those 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 of environmental sustainability-related data, a database on chemicals in articles or products, a database on alternatives to substances of concern and a dashboard of indicators on chemicals.

(21)

The Commission should adopt an implementation plan identifying datasets of chemicals data to be made accessible via the common data platform and the timeline for their incorporation, informed by the preparatory work of the Commission and the Agencies. The Commission should set up a governance scheme to support and steer the operation and evolution of the data platform, covering the organisation of work structures and coordination between the ECHA and data providers, required rules, formats and vocabularies for data incorporation, and, through an implementation plan, ensuring progress in identifying and incorporating new datasets of chemicals data and services for the common data platform. 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 the Agencies and the Commission. The Commission should ensure that all fields of work within the scope of this Regulation are considered by the steering committee. 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.

(22)

When exercising implementing powers, and in the cases in which Regulation (EU) No 182/2011 of the European Parliament and of the Council (11) does not apply, the Commission should, as part of its preparatory work, take into account the views of Member States.

(23)

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

(24)

In order to bring together all relevant chemicals data and information in the common data platform, the Commission and the Agencies should act as data providers and make available any such relevant data they have or hold to the ECHA for incorporation in the common data platform. The Agencies, including the ECHA itself when making its own data available, should provide the necessary standard metadata, contextual information and relevant mapping of the common data platform’s structure, and respect rules on standard formats and controlled vocabularies, where available. The quality control of data and completeness checks of data submissions should be carried out by the originator in accordance with the originating Union act under which the data was submitted or generated.

(25)

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 to the public, via the common data platform, chemicals data generated as part of Union, national or international programmes or from research activities other than the data already flowing to the Agencies pursuant to the obligations under the Union legal acts listed in Annex I or to other obligations laid down in this Regulation. The Commission should make such requests to the Agencies in accordance with their mandates and allocated tasks. Member States or other parties, including national agencies, research institutes and third country organisations should be able to offer chemicals data to the Agencies or the Commission using the appropriate standard format, where available. In such cases, it should be for the Agencies or the Commission, as appropriate, to decide whether to host and maintain the data.

(26)

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

(27)

To improve the uptake of academic data and to expand the knowledge base for safety assessments of chemicals and for environmental sustainability impacts of chemicals, researchers or research consortia funded by Union framework programmes or, as relevant, national programmes should, in line with the ‘as open as possible, as closed as necessary’ principle, make available any human biomonitoring data they collect or generate resulting from research and development programmes to the EEA and should make available any environmental sustainability-related data on chemicals or materials they collect or generate to the ECHA. For human biomonitoring data constituting personal data, the EEA should specify which type of data should be made available to it, that is to say whether they are anonymised, pseudonymised or identifiable data.

(28)

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

(29)

The Agencies and the Commission should be able to process human biomonitoring data constituting personal data. Since human biomonitoring data constituting personal data are a special category of personal data, namely, health data, the Agencies and the Commission should process such data only where the processing is necessary for reasons of substantial public interest, as laid down in Article 10(2)(g) of Regulation (EU) 2018/1725, or for scientific research as laid down in Article 10(2)(j) of that Regulation. This Regulation should lay down the cases in which there is such substantial public interest in processing human biomonitoring data constituting personal data.

(30)

Human biomonitoring data collected prior to the entry into force of this Regulation should be included in the common data platform to ensure the completeness and relevance of the human biomonitoring datasets for the purposes of this Regulation. Therefore, the Agencies and the Commission should be able to process any such data gathered prior to the entry into force of this Regulation.

(31)

The Agencies and the Commission should be able to process human biomonitoring data constituting personal data to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure, to assess the need for regulatory action and prioritise such action, to monitor the impact of regulatory action, and to support policy making and the development of legislation, including by carrying out scientific research for those purposes. In addition, taking into account their mission and activities, the EEA, the ECHA, the EFSA, EU-OSHA and the Commission should be able to process human biomonitoring data constituting personal data to develop health risk and impact indicators, the ECHA, the EFSA and the EMA should be able to process such data to perform regulatory risk assessments and support regulatory risk management, and the EEA, the ECHA, the EFSA and the Commission should be able to process such data in the context of studies under the data generation mechanism established through this Regulation. The EEA and EU-OSHA should also be able to process human biomonitoring data constituting personal data to support regulatory risk assessment and management and the Commission should be able to process such data to perform regulatory risk assessment and management. When processing human biomonitoring data constituting personal data, the Agencies and the Commission should pay particular attention to the need to comply with Article 13 of Regulation (EU) 2018/1725.

(32)

In order to ensure that appropriate safeguards are in place to secure the protection of human biomonitoring data constituting personal data, the EEA should only provide anonymised human biomonitoring data to the ECHA for incorporation in IPCHEM and the common data platform. IPCHEM, currently operated by the Commission, gathers occurrence data on chemicals in different media, including water, soil, indoor and outdoor air, biota, food and feed, humans and products. In order to take advantage of the incorporation of various information systems and to ensure that occurrence data on chemicals are made available for use together with the other chemicals data, the ECHA should take over the operation of IPCHEM from the Commission and incorporate IPCHEM in the common data platform as one of its main dedicated services.

(33)

In order to prevent any disruption to the current operation and functioning of IPCHEM, the ECHA should incorporate IPCHEM in the common data platform together with the data present in IPCHEM at the time of incorporation. At the same time, in order to enable optimal hosting and management of occurrence data on chemicals, the Commission should also transfer the data present in IPCHEM to the ECHA, the EEA or the EFSA for hosting and future updating in accordance with their respective mandates. In order to ensure that the ECHA takes over the operation of IPCHEM from the Commission and incorporates it into the common data platform, takes over the initial datasets and sets up adequate data flows, it is necessary to allow the ECHA sufficient time to carry out those actions, namely up to 3 years from the date of entry into force of this Regulation.

(34)

In order to promote the use and harmonisation of reference values among risk assessors and risk managers across different Union legal acts and to facilitate compliance with, and enforcement of, regulatory reference values, the ECHA should establish and maintain a repository of reference values that are established or adopted under the Union legal 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 legal acts for reference values adopted under them. To facilitate easy access of the public to up-to-date reference values, the ECHA should incorporate the repository of reference values in the common data platform as a dedicated service and include in that repository all reference values it has received or retrieved, together with the relevant context data. The ECHA should ensure that those values and those context data are machine readable. The ECHA should also include in the repository of reference values any other reference values it considers relevant and that are generated as part of Union, national or international programmes or from research activities and made available to the ECHA in a standard format where such format is available. For a reference value for the carcinogenic effect of a chemical for which no maximum exposure level can be specified below which no harmful effects on human health are to be expected, the statistical cancer risk associated with that reference value should also be specified, if known.

(35)

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 operators themselves 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 legal acts listed in Annex I, Part 1. The ECHA should establish and manage a database of study notifications, separate from the common data platform. That database should be used to store information related to those studies and that information should be kept confidential. Authorities and national enforcement authorities should have access to the database while ensuring safe transmission of data contained in it. In order to allow business operators and laboratories sufficient time to prepare study notifications, the obligation to notify studies should start to apply only 22 months after the date of entry into force of this Regulation.

(36)

Under Regulation (EC) No 178/2002, business operators and laboratories are obliged to notify to the database of study notifications established and managed by the EFSA the studies they commission to support an application or notification in relation to which Union law contains provisions for the EFSA to provide a scientific output. To avoid overburdening business operators and laboratories, they should therefore not be required to also notify those studies to the database of study notifications established and managed by the ECHA under this Regulation.

(37)

To ensure consistency between those two study notification mechanisms, as well as to ensure certainty for business operators that are required to notify studies, 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 incorporated in the common data platform, where the Commission or one of the Agencies makes the corresponding registration, application, notification or other relevant regulatory dossier available to the ECHA, it should also indicate which elements of the study notification are to be confidential when it is 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 uncertainty for business operators resulting from the existence of two databases of study notifications, one managed by the ECHA and one by the EFSA, the ECHA should lay down, in close cooperation with the EFSA and in consultation with stakeholders, practical arrangements to facilitate the implementation of the notification obligation, including details as regards the type of studies requiring notification.

(38)

While the obligation to notify studies under this Regulation should apply in the context of all the Union legal acts on chemicals listed in Annex I, Part 1, the various relevant data collection and safety assessment processes under those acts can 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, so as to make it possible to have 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, that business operators commission as part of a risk or safety assessment, to ensure compliance under the Union legal acts listed in Annex I. Given that objective and considering the fact that assessment processes under Union legal acts on chemicals listed in Annex I can vary widely, it would be beyond the scope and aims of this Regulation to amend those processes set out under the Union legal acts listed in Annex I by imposing additional conditions for those processes leading to potential consequences on market access not envisaged in those Union legal acts. Consequently, it is not appropriate, in this Regulation, to provide for consequences associated with non-compliance with the obligation to notify studies as those provided for in Article 32b of Regulation (EC) No 178/2002 for non-compliance with the obligation to notify studies under that Regulation.

(39)

Nevertheless, to ensure compliance with the obligation to notify studies under this Regulation, and to cater for the specificities of individual assessment processes, if any, Member States should lay down rules on penalties applicable to the infringement of that obligation and take all necessary measures to ensure that those rules are complied with. Those penalties should be effective, proportionate and dissuasive, since non-compliance with this Regulation could result in less robust risk assessments of chemicals, creating potential risks and consequently adverse effects on human health and the environment.

(40)

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 the ECHA should, where relevant, cooperate and exchange information with the Member State enforcement authorities to help them to check compliance with the obligations laid down in this Regulation.

(41)

While Regulation (EC) No 178/2002 also requires the consultation of stakeholders and the public following the notification to the EFSA of studies commissioned for the purposes of the renewal of an authorisation or approval, a similar requirement under this Regulation would impose a disproportionate administrative burden on the ECHA, given the wide scope of the studies that are to be notified under this Regulation.

(42)

Under the mechanism for study notifications established by Regulation (EC) No 1907/2006, where registrants are required to perform studies to generate data in accordance with requirements in Annexes IX and X to that Regulation, they are first to submit a testing proposal to the ECHA. The ECHA then issues a decision requiring them to perform a study. Such decisions can also be issued as an outcome of a compliance check or substance evaluation under that Regulation. In order to increase the transparency and traceability and to facilitate effective monitoring of studies commissioned or carried out pursuant to a decision of the ECHA in accordance with Articles 40, 41 or 46 of Regulation (EC) No 1907/2006, business operators should specify in their notifications of studies under this Regulation that those studies are being commissioned or carried out in compliance with those decisions.

(43)

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 national agencies, the Commission, the ECHA, the EEA, the EFSA and EU-OSHA and committees referred to in the Union legal acts listed in Annex III to this Regulation and incorporate that database into the common data platform for access by the Authorities. The information on such regulatory processes or activities should include at least the chemical identity and the identification, status and the outcome of the regulatory process or activity, if any. That information should also be made available without delay and kept updated through the assessment process. Once the process or activity has formally started, that information should also be shared publicly on the common data platform.

(44)

The use of articles or products containing chemicals could lead to exposure to those chemicals. Knowledge about the presence of chemicals in articles or products is therefore essential to understand the potential risk arising from the use of such articles or products, to steer innovation towards substitution in applications with the highest risk, as well as to provide information as to whether and how such articles and products can be recycled safely. Currently, there are data gaps on the occurrence of hazardous and other harmful chemicals in articles and products on the Union market. In order to enhance the visibility of the available data, the ECHA should establish and manage a database containing data on chemicals in articles or products that have been generated or submitted under Union legal acts listed in Annex V and incorporate it into the common data platform as a dedicated service.

(45)

In order to support and promote research and development as regards alternatives to substances of concern, and to promote the uptake of such alternatives, the ECHA should establish and manage a repository with data on alternatives to potential substances of concern, collect data that are made available by the Commission, Agencies and, as the case may be, competent authorities of the Member States, and incorporate that database into the common data platform as a dedicated service. The ECHA should also facilitate the voluntary submission by interested parties of information on alternatives to substances of concern, including information on alternative technologies or on materials not requiring such substances.

(46)

The existing project ‘The EU Chemicals Legislation Finder’, managed by the ECHA, makes it easier to find and identify legal obligations related to the use of a specific chemical. The project is especially helpful for small and medium sized enterprises in identifying their legal obligations. To reinforce the support function of the project for business operators, it should be established on a permanent basis and more Union legal acts should be included in its scope. For this purpose, the ECHA should collect information on the legal obligations deriving from the Union legal acts on chemicals listed in Annex I to this Regulation and incorporate that information into the common data platform as a dedicated service.

(47)

In order to ensure that chemicals data are easily findable in the common data platform and that all relevant data on a specific chemical or material are linked, each chemical or material should be identified by a unique technical identifier and, where possible and available, a chemical notation specifying the molecular structure, taking into account any applicable confidentiality requirements. In order to ensure that chemicals data are interoperable and comparable, and to facilitate their automatic and electronic exchange, the Agencies and the Commission should store chemicals data in appropriate, consistent and interoperable formats and use consistent and interoperable controlled vocabularies. Some Union legal acts listed in Annex I set procedures to establish or make data formats available to the public, in particular for the submission of chemicals data by business operators or Member States. Where such procedures do not exist in the Union legal acts listed in Annex I, 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 formats established by the Organisation for Economic Cooperation and Development (‘OECD’) or other internationally agreed formats, making use of existing formats and ensuring interoperability with existing data submission procedures. 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.

(48)

The Agencies and the Commission should specify appropriate controlled vocabularies for data they receive and store and, where relevant, incorporate them in submission software or formats. Moreover, in order to facilitate a smooth electronic exchange of data through the common data platform, the Agencies and the Commission should agree on the required formats and controlled vocabularies for providing data to the common data platform. Whenever the Agencies or the Commission establish formats or controlled vocabularies, they should cooperate with each other to ensure their consistency and interoperability. In order to ensure uniform conditions for resolving divergences in data formats and controlled vocabularies, implementing powers should be conferred on the Commission.

(49)

In order to promote the interoperability of database systems on chemicals beyond the common data platform, the ECHA should establish a repository of standard formats and controlled vocabularies as part of the common data platform. The Agencies and the Commission should make the formats and controlled vocabularies they set available to the repository, and the ECHA should make them available free of charge in electronic formats for use by developers of database systems and the public.

(50)

The International Uniform Chemical Information Database (‘IUCLID’) is a software application designed to record, store, maintain and exchange data on chemicals. The ECHA develops and maintains the IUCLID software and the underlying format in collaboration with the OECD. The IUCLID implements all OECD-harmonised templates, which are harmonised formats agreed at the OECD level to facilitate structured and consistent documentation of test outputs and similar chemicals data. Since chemicals data are being submitted to the ECHA in IUCLID under Union legal acts such as Regulation (EC) No 1907/2006, and Regulations (EC) No 1107/2009 (12) and (EU) No 528/2012 (13) of the European Parliament and of the Council, the ECHA is closely involved in the continued development of IUCLID and IUCLID implements the standard formats agreed at OECD level, it is appropriate and necessary to require the Commission and the Agencies to use IUCLID for the relevant parts of dossiers under specified Union legal acts listed in Annex I when they make the data contained in those dossiers available to the ECHA.

(51)

In order to support the uptake of peer-reviewed published research data in regulatory assessments of chemicals and the implementation of the obligation to consider all available data in such assessments, the Commission and the Agencies should promote the development and use of tools and practices facilitating such uptake, including the development and use of reporting standards for such data and tools to search, screen and extract relevant peer-reviewed published research data. Where the Commission or one of the Agencies engages in the development of such tools and practices they should closely cooperate and provide assistance as appropriate. In addition, the Commission should assess whether to collaborate with scientific and academic publishers and operators of databases containing contents of peer-reviewed journals on harmonised reporting and on the use of tools to search, screen and extract peer-reviewed published research data relevant for assessments of chemicals from databases containing contents of peer-reviewed journals. For the purposes of its assessment, the Commission should take into account the work done by the OECD on the generation, reporting and use of peer-reviewed published research data for regulatory assessments.

(52)

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 incorporation 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 of environmental sustainability-related data, collect any data made available by the Commission, the Agencies and, where relevant, by the researchers and research consortia funded by Union framework programmes, as well as by other parties, if any, and incorporate 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.

(53)

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, in collaboration with the EFSA, the EMA, EU-OSHA and the Commission, develop and regularly update, at least every two years, a framework of indicators and present it in the form of a dashboard. The framework of indicators should, where meaningful and to the extent possible, include an aggregated territory-based risk indicator at appropriate geographical levels to monitor time and spatial trends in the exposure of populations to chemicals, and health risks associated with such exposure. The EFSA, the EMA, EU-OSHA 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 incorporate the dashboard of indicators into the common data platform.

(54)

This Regulation should establish an early warning and action system to identify emerging chemical risks and enable early regulatory follow-up to such risks. To enable the identification and evaluation of emerging chemical risks, the EEA should develop and compile information on early warning signals, draw up an annual summary report and present it to the Authorities. In its work, the EEA should include its own sources and targeted literature searches, and should make use of information from national early warning systems as well as relevant datasets from the EU dataset catalogue established by Regulation (EU) 2025/327 of the European Parliament and of the Council (14). It should also include relevant information resulting from the related work of the ECHA, the EFSA, 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 to the data and the report, and the use thereof, 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 deliver the first report only six months after the end of the first calendar year after the entry into force of this Regulation. Based on the risks and warning signals identified in the report, the Authorities should consider taking regulatory, policy or enforcement action and should provide a justification if they decide not to act. Emerging chemical risks identified in the early warning and action system should also be considered a valuable source of information when setting priorities for the strategic planning of Horizon Europe – the Framework Programme for Research and Innovation established by Regulation (EU) 2021/695 of the European Parliament and of the Council (15).

(55)

In June 2017, at the Commission’ request, the ECHA set up the European Observatory for Nanomaterials (‘EUON’), which collects existing data and information from databases, registries and studies and generates new data through studies and surveys on nanomaterials on the Union market.

(56)

The ECHA should continue operating the EUON and transform it into an observatory for specific chemicals and groups of chemicals with the potential to contribute 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 could contribute to an emerging chemical risk. Another criterion for selection should be any higher degree of uncertainty surrounding the chemicals and, due to less regulatory experience regarding them, the resulting need for additional scrutiny and transparency. The observatory should facilitate regulatory implementation and responsible use of such chemicals by collecting, generating and disseminating reliable information on the properties, uses and market presence of selected chemicals to the public.

(57)

The observatory should not be regarded as a substitute for required risk management action on any chemical in cases where a hazard or risk has been identified. In order to provide for an efficient and consistent approach for the generation and dissemination of all such additional information, the ECHA should oversee the work of the observatory and make the regularly updated data and information it collects available through the common data platform or by means of other communication channels, as appropriate. In order to ensure uniform conditions for the implementation of the requirement to select chemicals to be included in the observatory, implementing powers should be conferred on the Commission.

(58)

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 State 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 mandate, while maintaining the principle that the burden of proof of compliance with Union chemicals legislation remains on the duty holder, and seeking to avoid duplication with Member State or Union research or implementation programmes. Furthermore, the ECHA should commission such studies on its own initiative or at the request of the Commission, with the objective of supporting the effective and efficient implementation and evaluation of Union legal acts on chemicals within its mandate and contributing to the development of a Union chemicals policy. Where obtaining a sample of a substance or mixture is a precondition for conducting the scientific studies, the ECHA should be given the necessary sample, including the substance or mixture characterisation where relevant, by the business operator free of charge and upon request. Where the business operator submits a justified confidentiality claim regarding the information it provides on the sample, the ECHA should respect that confidentiality. Where relevant and whenever possible, when commissioning a study, the ECHA should give priority to the use of validated non-animal test methods, using tests on vertebrate animals only as a last resort.

(59)

To gather information on the exposure of European citizens to chemicals, to support the effective implementation and evaluation of Union legal acts on chemicals and to contribute to the development of a comprehensive Union chemicals policy, the ECHA and the EFSA, in cooperation with the EEA, should commission a Union-wide human biomonitoring study. The Member States should cooperate with the ECHA, the EFSA and the EEA in the planning and organisation of that study, and should provide the necessary technical assistance and administrative support to the parties contracted by the ECHA or the EFSA to carry out the sampling in order to enable sampling in their territories and to ensure that the samples are sufficiently representative. The human biomonitoring study should adhere to ethical and confidentiality standards. Taking into account the experience gained through that human biomonitoring study, the Commission should assess the appropriateness of requiring regular human biomonitoring studies, as well as the resources necessary for such studies and modalities for involving Member States in such studies. Depending on the outcome of that assessment, the Commission should consider presenting a legislative proposal.

(60)

In order to ensure the optimal functioning of this Regulation and to stay abreast of technological and legislative developments, the Commission should carry out a general review of this Regulation and present a report to the European Parliament and the Council, accompanied, if appropriate, by a legislative proposal. The report should assess the progress made on the implementation and functioning of the common data platform, whether this Regulation has achieved its objectives, in particular to allow a better reuse of data across the Union legal acts listed in Annex I, and the appropriateness of resource allocation amongst the Agencies and the Commission.

(61)

In order to adjust the content of Annex I, which should list all Union legal acts pursuant to which chemicals data are generated or submitted to the Agencies or the Commission, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending Annex I by adding new Union legal acts pursuant to which relevant chemicals data and information are generated or submitted, as soon as such Union legal acts enter into force or are revised, unless otherwise provided.

(62)

In order to adjust the content of Annex II, which should list relevant reference values resulting from the implementation of Union legal acts listed in Annex I, Part 2, and held by the EMA, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending Annex II where, taking into account the digitalisation and interoperability of the reference values held by the EMA as well as the values’ usefulness for other policy areas and for the implementation of the Union acquis, there is a need to list additional reference values.

(63)

In order to adjust the content of Annex III, which should list all Union legal acts pursuant to which regulatory processes on chemicals or groups of chemicals are undertaken by competent authorities of the Member States, the Agencies or the Commission, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending Annex III by adding new Union legal acts pursuant to which relevant regulatory processes on chemicals or groups of chemicals are undertaken by competent authorities of the Member States, the Agencies or the Commission, as soon as such Union legal acts enter into force or are revised, unless otherwise provided.

(64)

In order to adjust the content of Annex V, which should list Union legal acts pursuant to which data on chemicals in articles or products are generated or submitted to the Agencies or the Commission, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending Annex V by adding any new Union legal act pursuant to which data on chemicals in articles or products are generated or submitted, as soon as it enters into force, unless such act contains a provision adding that act to Annex V, any existing Union legal act listed in Annex I which is amended in such a way that data on chemicals in articles or products are generated or submitted, as soon as the respective amending act enters into force, unless the amending act contains a provision adding that act to Annex V, or any existing Union legal act listed in Annex I for which it has become apparent from further verification that data on chemicals in articles or products are generated or submitted pursuant to it.

(65)

It is of particular importance that the Commission carry out appropriate consultations during its preparatory work in relation to the amendment of the Annexes by delegated act, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (16). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(66)

Since the objectives of this Regulation, namely to ensure the efficient delivery of consistent hazard and risk assessments of chemicals where those assessments are required by Union legal acts, in order to achieve a high level of protection of human health and the environment, enable the development and use of safe and sustainable chemicals, ensure the proper functioning of the single market for chemicals, improve the Union’s citizens’ knowledge about, and trust in, the scientific basis for decisions taken under Union legal acts on chemicals, and to contribute to the replacement and reduction of animal testing wherever possible, cannot be sufficiently achieved by the Member States as Member States do not hold the data within the scope of this Regulation and cannot establish a Union-wide common data platform, but can rather, by reason of chemicals data and information being held at Union level by the Agencies, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(67)

The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered an opinion on 29 January 2024,