The Committee on the Environment, Climate and Food Safety adopted the report by Dimitris TSIODRAS (EPP, EL) on the proposal for a regulation of the European Parliament and of the Council establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals.
The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows:
Subject matter
The Regulation aims to:
- enable the development and use of safe and sustainable chemicals;
- improve the Union’s citizens’ knowledge of, and trust in, the scientific base for the decisions taken under Union legal acts on chemicals, and to contribute to the goal of phasing out animal testing wherever possible.
Common data platform on chemicals
Each chemical or material hosted on the common data platform should be identified by a unique chemical identifier and a chemical notation specifying its molecular structure without prejudice to any confidentiality requirements in the original act or related legal obligations.
The Authorities and the general public should have easy access, free of charge, to the data contained in the common data platform.
The common data platform should also include terms and conditions, particularly regarding the respect of intellectual property rights and other related rights.
Stepwise approach
Taking due account of the administrative work for EMA coming from the adaptation of such data to an appropriate format for inclusion in the common data platform, Members suggested adopting a stepwise approach, and including during the first stage only chemical data for active substances which are submitted to the EMA in the context of the relevant procedures that are finalised after the entry into force of this Regulation. No later than eight years after the entry into force of this regulation, EMA should also include the chemical data on active substances from procedures concluded before the entry into force of this Regulation.
Governance
The Commission should establish and manage, by means of an implementing act, a platform steering committee, comprising at least one representative from each Union agency required to submit chemicals-related data to the common data platform and as many representatives of the Commission as representatives of all Union agencies combined.
The governance scheme should describe: (i) the organisation and operation of cooperation and information exchange mechanisms with databases and similar platforms in third countries and at internationally; (ii) the operating, reporting requirements, and transparency obligations of the steering committee itself.
The Commission and the agencies should indicate whether the data or information included in the common data platform may be made publicly available or whether it is considered confidential. Members specify that ECHA should host and administer data on the presence of chemicals relevant for workplace monitoring, including human biomonitoring data in the workplace.
Human biomonitoring data
Human biomonitoring data that constitute personal should be processed by the EEA for the following purposes: providing support to policymaking and legislative processes at EU level; creating a ‘chemical exposure index’ for each EU region; and facilitating processing by the Commission, ECHA, EFSA, EMA, and EU-OSHA.
The Commission, ECHA, EFSA, EMA, and EU-OSHA should process human biomonitoring data that constitute personal data only for certain purposes (e.g., scientific research for policymaking; assessing the impact of chemicals on human health and the environment; conducting chemical assessments).
The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission should define the storage period, and carry out any review thereof, for the human biomonitoring data constituting personal data that they hold as well as the criteria used to define the storage period.
Information on chemicals
To enhance visibility on the availability of data, and to promote research and development activities as regards safer alternatives, ECHA should establish and manage a repository of information on chemicals in articles generated or submitted under Union acts listed in Annex I. In addition, ECHA should also establish and manage a database collecting available information from Agencies, Member States and business operators on safer alternatives to substances of concern.
Notification of studies relating to chemicals
Scientific studies that are conducted only for research purposes, that are not commissioned to support an application, notification or regulatory dossier notified or submitted to an Authority, or that are not part of a risk or safety assessment under Union acts listed in Annex I, do not need to be notified.
The obligation to notify studies should only start to apply 18 months after the date of entry into force of this Regulation.
Where the Commission or any of the Agencies makes available to the ECHA, a registration, application, notification, it should indicate which elements of the study notifications are confidential when included in the common data platform.