Legal provisions of COM(2023)779 - Common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals - Main contents
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| dossier | COM(2023)779 - Common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, ... |
|---|---|
| document | COM(2023)779 |
| date | December 7, 2023 |
Chapter I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter and scope
1. This Regulation aims to ensure the efficient delivery of coherent hazard and risk assessments of chemicals where those assessments are required by Union legal acts, to achieve a high level of protection of human health and the environment, to enable the development and use of sustainable chemicals, to ensure the proper functioning of the single market for chemicals, and to improve the Union’s citizens’ trust in the scientific base for the decisions taken under Union legal acts on chemicals.
2. To achieve the objectives referred to in paragraph 1, this Regulation contains measures to:
(a) bring together data and information on chemicals and ensure that data and information are easily findable, accessible, interoperable and re-usable;
(b) keep records of studies commissioned or carried out by business operators in the context of fulfilling their obligations set under Union chemicals legislation;
(c) establish the widest possible scientific base for the implementation and development of Union legislation and policy on chemicals;
(d) establish an early warning and action system for emerging chemical risks.
3. The provisions laid down in this Regulation apply to chemicals data as laid out in Article 3(2).
Article 2
Definitions
For the purpose of this Regulation, the following definitions shall apply:
1. ‘Agencies’ means the European Chemicals Agency (‘ECHA’), the European Environment Agency (‘EEA’), the European Food Safety Authority (‘EFSA’) and the European Medicines Agency (‘EMA’) and the European Agency for Safety and Health at Work (‘EU-OSHA’);
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;
3. ‘duty holder’ means a natural or legal person responsible for meeting obligations under the Union acts listed in Annex I or II;
4. ‘business operators’ means duty holders which are private or public undertakings;
5. ‘human biomonitoring data’ means concentrations of chemicals measured in human matrices such as blood or urine;
6. ‘reference value’ means an estimate of a maximum exposure to or emission level of a chemical below which no or only acceptable adverse effects on human health or the environment are expected, or below which risks related to the adverse effects on human health or the environment are considered acceptable or tolerable;
7. ‘originator’ means the Commission, Agency, or Member State competent authority responsible for confidentiality assessments under any Union act listed in Annex I or Annex II;
8. ‘originating Union act’ means the Union act under which chemicals data and information were generated or submitted;
9. ‘controlled vocabularies’ means standardised and organised arrangements of words and phrases presented as lists of terms or as thesaurus and taxonomies with a hierarchical structure of broader and narrower terms;
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;
11. ‘environmental sustainability related data’ means any data relevant for the environmental sustainability assessment of a chemical or material throughout its entire life cycle, including:
(a) data on resources, including raw materials, water, energy, fossil fuels and land;
(b) data on emissions, including greenhouse gases, eutrophication-relevant substances, dust and all other polluting substances; and
(c) data on by-products originating during the chemical’s life cycle that can be used as resources for other production processes, including hydrogen and carbon monoxide.
12. ‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679 of the European Parliament and of the Council and as defined in Article 3, point (16), of Regulation (EU) 2018/175 of the European Parliament and of the Council;
13. ‘processing’ means processing as defined in Article 4, point (2), of Regulation (EU) 2016/679 of the European Parliament and of the Council and as defined in Article 3, point (3), of Regulation (EU) 2018/175 of the European Parliament and of the Council;
14. ‘data controller’ means controller as defined in Article 4, point (7), of Regulation (EU) 2016/679 and as defined in Article 3, point (8), of Regulation (EU) 2018/175 of the European Parliament and of the Council;
15. ‘interoperability’ means the ability of two or more data spaces or communication networks, systems, products, applications or components to exchange and use data in order to perform their functions.
Chapter II
INFORMATION SYSTEMS AND PLATFORMS
Article 3
Common Data Platform on Chemicals
1. The ECHA shall establish and manage a common data platform on chemicals (‘the common data platform’).
2. The common data platform shall provide access to all chemicals data:
(a) generated or submitted as part of the implementation of the Union acts listed in Annex I to this Regulation and held by the Agencies or the Commission;
(b) generated as part of Union, national or international programmes or research activities in the sphere of chemicals and held by the ECHA, the EEA, the EFSA, the EU-OSHA or the Commission;
(c) listed in Annex II and held by the EMA;
3. The following information shall not be included in the common data platform:
(a) the information referred to in Article 45 of Regulation (EC) No 1272/200850;
(b) the information related to cosmetic products and notified to the Cosmetic Product Notification Portal under Article 13 of Regulation (EC) No 1223/200951 of the European Parliament and of the Council.
4. Documents relating to Authorities’ internal work or decision-making processes need not be included in the common data platform, unless required under Article 10.
5. The common data platform shall provide the dedicated services identified in the governance scheme referred to in Article 4(3) including:
(a) the Information Platform for Chemical Monitoring (‘IPCHEM’) referred to in Article 7;
(b) the repository of reference values referred to in Article 8;
(c) the database of study notifications referred to in Article 9;
(d) information on regulatory processes referred to in Article 10;
(e) information on obligations under Union chemicals legislation referred to in Article 11;
(f) the repository of standard formats and controlled vocabularies referred to in Article 12;
(g) the database on environmental sustainability-related data referred to in Article 13.
6. The Authorities and the general public shall have access to the data contained in the common data platform in accordance with Article 16.
7. The data contained in the common data platform may be used in accordance with Article 17.
8. The data contained in the common data platform shall be made available in standard formats, where developed, and through controlled vocabularies where available.
9. The data contained in the common data platform shall be electronically accessible and searchable. The ECHA shall take measures to ensure a high standard of security appropriate to the security risks at stake for the storage of chemicals data in and transmission of chemicals data to the common data platform. The ECHA shall design the common data platform in a way that guarantees that any access to confidential data is auditable.
10. The Commission or Agency under whose authority chemicals data is included in the common data platform on chemicals shall remain responsible for handling any requests for access to documents made under Regulation (EC) No 1049/200152.
11. The common data platform and its dedicated services shall be established by [OP: please insert date: three years after the date of entry into force of this Regulation], unless specified otherwise. The relevant datasets shall be integrated progressively into the common data platform by [OP please insert date: ten years from the date of entry into force of this Regulation] according to the implementation plan referred to in Article 4 (1), first sentence. Upon integration of those datasets in the common data platform, when the ECHA receives chemicals data in accordance with Article 5, it shall make that data available through the common data platform without undue delay.
Article 4
Implementation plan and governance of the common data platform
1. By [OP please insert date: 6 months after the date of entry into force of this Regulation] the Commission shall adopt and publish an implementation plan identifying datasets for inclusion in the common data platform together with a timeline for their inclusion by means of an implementing decision. Subsequent rolling implementation plans shall be adopted in line with the governance scheme referred to in paragraph 3.
2. The Commission shall, by means of an implementing decision, establish and manage a platform steering committee, which shall include one representative from the ECHA, one representative from the EEA, one representative from the EFSA, one representative from the EMA, one representative from the EU-OSHA and five representatives from the Commission.
3. The platform steering committee shall advise the Commission in the preparation of the common data platform’s governance scheme.
4. The Commission shall adopt and publish the governance scheme referred to in paragraph 3 and any revision thereof by means of an implementing decision
5. That governance scheme shall describe:
(a) the organisation of the main work structures supporting the development and implementation of the common data platform;
(b) the preparation and adoption of rolling implementation plans for the common data platform;
(c) the principles on data governance and the required standard formats, controlled vocabularies and further conditions for the provision of information and context data to the common data platform;
(d) the decision-making procedures for the development of new dedicated services and the inclusion of new functionalities of the platform;
(e) any other rules or requirements necessary for the operation of the common data platform such as the data update, archiving and deletion policy;
(f) the operation of the steering committee itself.
Article 5
Data flows for the purpose of the common data platform
1. At the Commission’s request, the Agencies shall host and maintain chemicals data generated as part of Union, national or international legislation, programmes or research activities, corresponding to their mandate and the type of data they already hold.
2. Where the Commission or the Agencies hold data or information referred to in Article 3(2), they shall make that data available to the ECHA, in a standard format, where available, together with the relevant context data as referred to in Article 4(4), point (c). The Commission and the Agencies shall indicate whether that data or information is made available to the public under the originating Union act.
3. The ECHA shall host and maintain occurrence data related to workplace monitoring.
4. The EEA shall host and maintain human biomonitoring data, occurrence data for the environment and occurrence data related to indoor air quality.
5. Researchers or research consortia funded by Union framework programmes shall make available to the EEA any human biomonitoring data they collect or generate from [OP please insert: date of the entry into force of this Regulation].
6. Researchers or research consortia funded by Union framework programmes shall make available to the ECHA any environmental sustainability data on chemicals or materials they collect or generate from [OP please insert: date of the entry into force of this Regulation].
7. The Commission and the Agencies shall provide the necessary technical cooperation to the ECHA to enable the integration of the chemicals data provided in accordance with paragraph 2 in the common data platform as well as its publication through that platform.
8. For the purpose of paragraph 2, the Commission and the Agencies shall make chemicals data available to the ECHA without undue delay after collection or receipt of the data, after performance of validity and confidentiality assessments in accordance with applicable rules and once the corresponding dataset has been integrated in the common data platform.
9. The Commission and the Agencies shall ensure that data made available to the ECHA shall be downloadable, machine readable and interoperable. They shall appropriately curate and validate the data before providing them to the ECHA.
Article 6
Human biomonitoring data
1. The EEA shall collect, host, and maintain human biomonitoring data generated within the territory of the EEA’s member and cooperating countries.
2. At the latest by [OP please insert date: 3 years after entry into force of this Regulation] the Commission shall transfer any human biomonitoring data it holds to the EEA.
3. The EEA may process human biomonitoring data constituting personal data to support the Commission in its policy making or to support the Agencies in fulfilling their missions.
4. Human biomonitoring data constituting personal data may be processed by the EEA for the following purposes:
(a) assessing the impact of chemicals on human health and the environment;
(b) monitoring time and spatial trends in exposure;
(c) developing health risk and impact indicators;
(d) monitoring the impact of regulatory intervention;
(e) supporting regulatory risk assessments.
5. The EEA shall make human biomonitoring data they hold or host publicly available in anonymised form through the Information Platform for Chemical Monitoring.
6. The EEA shall act as data controller for the human biomonitoring personal data it holds or hosts and processes for the purposes referred to in paragraph 2.
Article 7
Information Platform for Chemical Monitoring
1. The ECHA shall operate and maintain the Information Platform for Chemical Monitoring containing occurrence data on chemicals across different media, including water, soil, indoor air, outdoor air, biota, food and feed, humans, and products as part of the common data platform.
2. At the latest by [OP please insert date: 3 years after the date of entry into force of this Regulation], the Commission shall transfer the chemicals data contained in the Information Platform for Chemical Monitoring at that moment to the ECHA for integration in the common data platform.
3. At the latest by [OP please insert date: 3 years after entry into force of this Regulation], the Commission shall transfer the chemicals data contained in the Information Platform for Chemical Monitoring to the ECHA, the EEA or the EFSA for hosting in accordance with the respective agencies’ mandate and in accordance with Article 5.
4. After the completion of the transfer referred to in paragraph 3, where the Commission or the Agencies host or hold occurrence data on chemicals and related chemicals data, they shall make that data available to the ECHA without undue delay for integration in the Information Platform for Chemical Monitoring.
5. The Commission and Agencies shall provide the necessary technical cooperation to the ECHA to enable the integration and publication of occurrence data and related chemicals data they host or hold through the common data platform.
6. The ECHA shall ensure that the data contained in the Information Platform for Chemical Monitoring is machine readable and downloadable.
Article 8
Repository of reference values
1. The ECHA shall establish and manage a repository of reference values as part of the common data platform.
2. The ECHA shall include any reference value adopted under Union acts listed in Annex I or Annex II, Part 1, in the repository of reference values without undue delay.
3. For reference values not falling under paragraph 2, the Agencies holding or establishing reference values as part of their activities under Union acts listed in Annex I, or the reference values referred to in Annex II, Part 2, shall make those reference values available to the ECHA, in the standard formats provided for in Article 14, where developed, and without undue delay, for integration in the repository of reference values.
4. For the purpose of paragraph 3, where reference values are included in a regulatory dossier submitted to the Agencies, the Agencies shall share those reference values in the standard formats with ECHA without undue delay and once relevant validity and confidentiality assessments have been completed by the originator in accordance with applicable rules.
5. The ECHA shall ensure that the data contained in the repository of reference values is machine readable.
Article 9
Database of Study Notifications
1. The ECHA shall establish and operate a Database of Study Notifications by [OP please insert date: two years after the date of entry into force of this Regulation].
2. The ECHA shall store in the Database of Study Notifications the data notified to it in accordance with Article 22.
3. The ECHA shall integrate the data contained in the Database of Study Notifications in the common data platform once a corresponding registration, application, notification or other relevant regulatory dossier was submitted to the relevant Union or national institution, agency, or body in accordance with corresponding Union law and after a decision was taken by that Union or national institution, agency, or body on the disclosure of the accompanying studies in accordance with the applicable rules on confidentiality.
4. The EFSA shall make the data contained in the database referred to in Article 32b of Regulation (EC) No 178/2002 available to the ECHA for integration in the common data platform once it has received a corresponding application and after it has decided on the disclosure of the accompanying studies in accordance with Articles 38 to 39e of Regulation (EC) No 178/2002.
5. The ECHA and the EFSA shall cooperate to ensure a common approach for the identification of information notified to them in accordance with Article 22 of this Regulation and Article 32b of Regulation (EC) No 178/2002, respectively and facilitate the traceability of the studies notified to their respective databases.
Article 10
Information on regulatory processes on chemicals
1. The ECHA shall establish and manage, as part of the common data platform, a new database containing information on regulatory processes on individual substances or groups of substances that are planned, ongoing or have been completed since the entry into force of this Regulation by the Member States or the Union institutions, agencies or committees referred to in the Union acts listed in Annex III.
2. Where Member State competent authorities as referred to in any of the Union acts listed in Annex III hold the information referred to in paragraph 1, they shall make that information available to the Union agency responsible under the respective Union act listed in Annex III without undue delay.
3. Where the ECHA, EEA, EFSA, EU-OSHA or the Commission hold the information referred to in paragraph 1, they shall make that information available to the ECHA for integration in the common data platform in the standard formats provided for in Article 14 without undue delay and, where relevant, once the responsible agency or the Commission has performed the validity assessment. For each regulatory process or activity, at least the following information shall be included:
(a) substance identity;
(b) the Union act and the regulatory process under which the activity takes place;
(c) submitter or actor responsible for the regulatory process or activity;
(d) status of the regulatory process or activity;
(e) outcome of the regulatory process or activity, including, where applicable, reports or opinions adopted;
(f) where applicable, date of intention to start the regulatory process or activity, completion and latest update.
4. The information referred to in paragraph 3, points (a) to (f), on a specific regulatory process or activity shall be made available to the public once that process or activity has formally started.
Article 11
Information on the obligations under Union acts on chemicals
1. The ECHA shall establish and manage, as part of the common data platform, a database with information on the provisions and legal obligations applicable to chemicals under the Union acts listed in Annex I.
2. The ECHA shall update the information in the database on a regular basis and in accordance with the governance scheme referred to in Article 4(3).
Article 12
Repository of standard formats and controlled vocabularies
1. The ECHA shall establish and manage as part of the common data platform a repository of standard formats and controlled vocabularies.
2. Where standard data formats are established under the Union acts listed in Annexes I and II, the ECHA shall include them in the common data platform.
3. Where the Commission or the Agencies specify a standard format or controlled vocabulary in accordance with Articles 14 or 15, the Commission or the Agency shall make it available to the ECHA without undue delay for integration in the common data platform.
Article 13
Database on environmental sustainability related data
1. At the latest within three years after the publication of the decision referred to in paragraph 4, the ECHA shall establish and manage, as part of the common data platform, a database containing environmental sustainability related data.
2. Where the Commission or the Agencies host or hold environmental sustainability related data in addition to the chemicals data already available in the common data platform, they shall make that data available to the ECHA without undue delay once the Commission or the Agency hosting or holding that data has completed, where relevant, validity and confidentiality assessments. The Commission and the Agencies shall provide the necessary technical cooperation to the ECHA to enable the integration of environmental sustainability related data in the database on environmental sustainability related data.
3. Where researchers or research consortia funded by Union framework programmes make available to the ECHA, under Article 5(6), any environmental sustainability data on chemicals or materials they collect or generate, the ECHA shall integrate the relevant data in the database on environmental sustainability related data.
4. By [OP please insert date: three years after the date of entry into force of this Regulation], the Commission shall adopt an implementing decision identifying existing datasets on environmental sustainability related data, other than those referred to in paragraph 2, for inclusion in the common data platform and shall design relevant related database functionalities.
Chapter III
DATA FORMATS AND CONTROLLED VOCABULARIES
Article 14
Standard formats
1. Without prejudice to Union provisions providing for the development or making available of data formats, the Commission and the Agencies shall specify, where relevant, for the data referred to in Article 3 (2) and falling within their mandate, standard formats and software packages and make them available free of charge through the common data platform.
2. The standard formats referred to in paragraph 1 shall, to the extent possible:
(a) avoid the use of proprietary standards;
(b) re-use existing data formats or parts of them;
(c) use OECD or other internationally agreed formats;
(d) be coherent with other existing data formats;
(e) ensure interoperability with existing data submission approaches.
3. Those standard formats shall be interoperable with the common data platform and be user-friendly.
4. The Commission and the Agencies shall exchange data contained in the common data platform in the relevant standard format.
5. The Commission and the Agencies shall use the International Uniform Chemical Information Database format (IUCLID) for making available to the ECHA for integration in the common data platform the relevant parts of dossiers under the following Union acts:
(a) Regulation (EC) No 1831/2003 of the European Parliament and of the Council53;
(b) Regulation (EC) No 1935/2004 of the European Parliament and of the Council54;
(c) Regulation (EC) No 1331/2008 of the European Parliament and of the Council55;
(d) Regulation (EC) No 1332/2008 of the European Parliament and of the Council56;
(e) Regulation (EC) No 1333/2008 of the European Parliament and of the Council57;
(f) Regulation (EC) No 1334/2008 of the European Parliament and of the Council58;
(g) Regulation (EC) No 1223/2009 of the European Parliament and of the Council 59;
(h) Commission Regulation (EU) No 234/201160;
(i) Directive 2009/48/EC of the European Parliament and of the Council.61
6. The Commission and the Agencies shall cooperate when setting standard formats to ensure coherence with other formats and the interoperability of the standard formats with the common data platform and with existing data submission approaches.
7. The Commission and the Agencies shall take the necessary and appropriate measures to monitor and identify at an early stage any potential divergence between data formats that could cause interoperability problems. If a divergence is identified, the Agencies concerned shall cooperate to resolve it or, where the divergence is justified, explain the underlying reasons. Where the Agencies concerned are not able to resolve that divergence, they shall draw up a joint report and present it to the Commission. The report shall clearly outline the reasons for the divergence, clarify any underlying technical issue and make a proposal to remedy the divergence.
8. The Commission shall adopt an implementing decision to remedy the divergence.
Article 15
Controlled vocabularies
1. The Commission and the Agencies shall specify and regularly update controlled vocabularies within their mandate for the data referred to in Article 3(2), where relevant.
2. The Commission and the Agencies shall prioritise specifying controlled vocabularies for the identification of chemicals and the characterisation of their forms.
3. Those controlled vocabularies shall:
(a) avoid the use of proprietary controlled vocabularies to the extent possible;
(b) re-use existing substance identifiers and controlled vocabularies or parts of them to the extent possible;
(c) use OECD or other internationally agreed controlled vocabularies to the extent possible;
(d) ensure coherence with other relevant controlled vocabularies including by preparing alignment tables.
4. Those controlled vocabularies shall be interoperable with the common data platform.
5. Where controlled vocabularies are specified, the Commission and the Agencies shall:
(a) make them available free of charge through the common data platform and as open datasets;
(b) integrate them in any submission software or template to be used by duty holders under the Union acts listed in Annex I and referred to in Article 3(2); and
(c) use them when exchanging data between them through the common data platform.
6. The Commission and the Agencies shall cooperate with each other in setting the controlled vocabularies.
7. The Commission and the Agencies shall take the necessary and appropriate measures to monitor and identify at an early stage any potential divergence between controlled vocabularies. If a divergence is identified, the Agencies concerned shall cooperate to resolve it or, where the divergence is justified, explain the underlying reasons. Where the Agencies concerned are not able to resolve that divergence, they shall draw up a joint report and present it to the Commission. The report shall clearly outline the reasons for the divergence, clarify any underlying technical issue and make a proposal to remedy the divergence.
8. The Commission shall adopt an implementing decision to remedy the divergence.
Chapter IV
CHEMICALS DATA CONFIDENTIALITY AND USE
Article 16
Access rights and transparency
1. The Authorities shall have access to all the chemicals data contained in the common data platform, including data which is deemed to be confidential under Article 5(2), second sentence.
2. The Authorities shall take the necessary measures to ensure that information contained in the common data platform marked as confidential in accordance with Article 5(2) is not made public.
3. The general public shall have access to all the chemicals data contained in the common data platform and considered as available to the public in accordance with the Union act under which the data was generated or submitted.
Article 17
Use of chemicals data contained in the common data platform
1. The Authorities may use the chemicals data contained in the common data platform in the performance of any of their activities, where those activities support the development or implementation of chemicals legislation and policy.
2. Without prejudice to existing provisions enabling the sharing and use of chemicals data under the Union acts listed in Annexes I and II, Authorities shall not use chemicals data contained in the common data platform to fulfil any legal obligations of duty holders.
3. When using chemicals data contained in the common data platform that is deemed confidential under Article 5(2), second sentence, the Authorities shall respect the confidentiality of information data as marked by the originator and shall not disclose that data to the public without the consent of the originator.
Chapter V
MONITORING AND OUTLOOK FRAMEWORK FOR CHEMICALS
Article 18
Framework of indicators
1. The EEA, in collaboration with the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission, shall establish, operate, and maintain a framework of indicators to monitor the drivers and impacts of exposure to chemicals, measure the effectiveness of chemicals legislation and measure the transition towards the production of safe and sustainable chemicals.
2. The framework of indicators referred to in paragraph 1 shall be accessible in the form of an indicator dashboard, which the EEA shall establish and which the ECHA shall make available through the common data platform.
Article 19
Early warning and action system for emerging chemical risks
1. The EEA shall establish, operate and maintain a Union early warning system for emerging chemical risks by [OP please insert date: one year after the date of entry into force of this Regulation].
2. For the purpose of paragraph 1, the EEA shall compile early warning signals, which shall include at least signals from:
(a) the EFSA’s emerging risks exchange network;
(b) existing national early warning systems;
(c) data that the EEA holds;
(d) targeted literature searches performed by the EEA;
(e) data made available by the ECHA, the EFSA, the EU-OSHA and the EMA in accordance with paragraph 3.
The early warning signals compiled by the EEA under the first subparagraph may be based on a positive identification of an emerging risk or on an uncertainty in the data leading to a potential positive identification of an emerging risk.
3. The ECHA, the EFSA, the EU-OSHA and the EMA shall identify and gather relevant available data on early warning signals from the field falling within their mandate and provide this data to the EEA.
4. The EEA shall draw up an annual report, compiling and analysing the data on early warning signals gathered in accordance with paragraphs 2 and 3. [The first report shall be prepared by [OP: please insert date: 6 months after the end of the first calendar year after entry into force of this Regulation]. The EEA shall present this report to the Commission, relevant Union agencies and Member State competent authorities for consideration of the need for regulatory or policy action related to the early warning signals.
5. The EEA shall make all relevant data on early warning signals that it holds or hosts as well as the report referred to in paragraph 4 available to the ECHA for integration in the common data platform.
Article 20
Observatory for specific chemicals with potential contribution to emerging chemical risks
1. The ECHA shall establish, operate and maintain an observatory for specific chemicals that the Commission considers as requiring additional scrutiny. The observatory shall include reliable information on the chemicals’ properties, safety aspects, uses and market presence.
2. By [OP please insert date: 6 months after the date of entry into force of this Regulation] the Commission shall adopt and publish a list of the selected chemicals by means of an implementing decision. The Commission shall review the list of selected chemicals regularly adopt any revision thereof by the same means.
3. The Commission shall select the chemicals referred to in paragraph 1 based on the scientific and technical progress and using the signals of the early warning system referred to in Article 19. The selection shall include potential contributors to new and emerging chemical risks among innovative rationally designed materials with new or enhanced properties or targeted or enhanced structural features at nanoscale.
4. For the purpose of operating the observatory referred to in paragraph 1, the ECHA shall:
(a) make use of relevant datasets integrated in the common data platform, and compile, analyse and curate further available data on selected chemicals or classes of chemicals;
(b) commission studies and, where relevant, use the data generation mechanism established under Article 21 to address knowledge gaps or significant uncertainties;
(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.
Chapter VI
DATA GENERATION MECHANISM
Article 21
Data generation mechanism
1. Using the best independent resources available, the ECHA may commission scientific studies to support the implementation of Union acts on chemicals listed in Annex I within its mandate and to contribute to the support, evaluation or development of a Union chemicals policy.
2. The Commission may request the ECHA to commission the scientific studies referred to in paragraph 1.
3. The ECHA shall only commission scientific studies when results cannot be obtained through existing legal provisions or processes under Union legislation listed in Annex I. It shall not commission studies with a predominant research objective.
4. The ECHA shall seek to avoid duplication with Member State or Union research or implementation programmes.
5. The ECHA shall commission these scientific studies in an open and transparent manner.
6. The ECHA and the EFSA shall closely cooperate with each other on the planning and commissioning of scientific studies undertaken by the ECHA in accordance with paragraph 1 and of studies undertaken by the EFSA in accordance with Article 32 of Regulation (EC) No 178/2002.
7. The ECHA shall make the results of the scientific studies performed under this Article available through the common data platform.
Chapter VII
NOTIFICATION OF STUDIES
Article 22
Notification of studies
1. Business operators shall notify to the Database of Study Notifications referred to in Article 9, without undue delay, any studies on chemicals they commission to support an application, notification or regulatory dossier notified or submitted to an Authority, as well as any studies on chemicals on their own or in products they commission as part of a risk or safety assessment , prior to placing on the market, under the Union acts listed in Annex I. However, business operators shall not notify to the Database of Study Notifications referred to in Article 9 studies that are to be notified under Article 32b of Regulation (EC) No 178/2002.
2. For the purposes of paragraph 1, business operators shall notify to the Database of Study Notifications referred to in Article 9 the title, scope, laboratory, or testing facility carrying out the study, the intended starting and planned completion dates and, where relevant, whether the study is commissioned to comply with a decision of the ECHA pursuant to Articles 40, 41 or 46 of Regulation (EC) No 1907/2006.
3. Laboratories and testing facilities shall also, without undue delay, notify any study commissioned by business operators to support a regulatory dossier on which an Agency is required to provide a scientific output, including a scientific opinion, under the Union acts listed in Annex I. However, laboratories and testing facilities shall not notify to the Database of Study Notifications referred to in Article 9 studies that are to be notified under Article 32b of Regulation (EC) No 178/2002.
4. For the purposes of paragraph 3, laboratories and testing facilities shall notify to the Database of Study Notifications referred to in Article 9 the title, scope, intended starting and planned completion dates of any test they carry out, as well as the name of the business operator who commissioned the test.
5. Paragraphs 3 and 4 shall apply, mutatis mutandis, to laboratories and testing facilities located in third countries insofar as set out in relevant agreements with those third countries.
6. The obligations set under this article shall apply from [OP please insert date: 24 months after the date of entry into force of this Regulation].
7. The ECHA shall lay down the practical arrangements for implementing the provisions of this Article.
Chapter VIII
DELEGATED POWERS
Article 23
Amendment of Annexes I, II and III
1. The Commission is empowered to adopt delegated acts in accordance with Article 24 to amend Annex I in order to adjust the content of that Annex to technical and scientific progress in the field of chemicals or, where the development of Union chemicals legislation so requires, to supplement that Annex by adding to it new Union acts under which relevant chemicals data is generated or submitted.
2. The Commission is empowered to adopt delegated acts in accordance with Article 24 to amend Annex II by adding, where relevant, new categories of data types.
3. The Commission is empowered to adopt delegated acts in accordance with Article 24 to amend Annex III in order to adjust the content of that Annex to technical and scientific and technical progress in the field of chemicals and, where the development of Union chemicals legislation so requires, to supplement that Annex by adding to it Union acts relevant for data on new regulatory processes on chemicals.
Article 24
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 23 shall be conferred on the Commission for a period of five years from [OP please insert: the date of the entry into force of this Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each five-year period.
3. The delegation of power referred to in Article 23 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 23 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.
Chapter IX
ENFORCEMENT AND PENALTIES
Article 25
Enforcement
The Agencies shall cooperate with Member States’ enforcement authorities and exchange information on the compliance, by business operators and laboratories, with the obligation to notify studies in accordance with Article 22.
Article 26
Penalties for non-compliance
1. Member States shall introduce penalties for non-compliance, by business operators and laboratories, with the obligations laid out in Article 22 and shall take all necessary measures to ensure that they are implemented. The penalties provided for shall be effective, proportionate, and dissuasive.
2. Member States shall notify the Commission of those rules and of those measures by 30 June 2025 and shall notify to the Commission without delay any subsequent amendment affecting them.
Article 27
Entry into force and application in time
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.