Common data platform on chemicals, establishing a monitoring and outlook framework for chemicals

The European Parliament adopted by 471 votes to 123, with 48 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals.

Parliament adopted its position at first reading by amending the proposal as follows:

Purpose and scope of application

This Regulation aims 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 the decisions taken under Union legal acts on chemicals,

- contribute to the replacement and reduction of animal testing wherever possible.

Common data platform on chemicals

The Regulation establishes a common data platform on chemicals managed by the European Chemicals Agency (ECHA), which will provide access to all data on chemicals, including data provided on a voluntary basis by Member States or other parties, including national agencies, research institutes and third-country organisations, and held or accepted by the ECHA, the EEA, the EFSA, EU-OSHA or the Commission.

Each chemical or material hosted on the common data platform must be identified by means of a unique chemical identifier and a chemical notation specifying, if possible, its molecular structure, without prejudice to the confidentiality requirements contained in the original act.

The common data platform will contain appropriate background and explanatory information in order to make it easier for the Authorities and the public to use those data in an informed manner. The Authorities and the public will have easy access, free of charge, to the data contained in the common data platform.

Stepwise approach

Taking due account of the administrative work for the European Medicines Agency (EMA) from the adaptation of such data to an appropriate format for incorporation in the common data platform, the amended text provides for 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 will also start incorporating chemicals data on active substances resulting from procedures concluded before the entry into force of this Regulation.

Governance

No later than six months from the date of entry into force of the Regulation, the Commission will adopt, by means of an implementing act, an implementation plan setting out the datasets on chemicals to be included in the common data platform and a timeline for their inclusion. The Commission will establish and manage, by means of an implementing act, a steering committee for the platform comprising at least one representative from each of the agencies and as many representatives of the Commission as representatives of all the agencies combined.

The ECHA will host and maintain occurrence data related to workplace monitoring, including occupational human biomonitoring data.

Human biomonitoring data

The Agencies and the Commission will 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.

Confidentiality of study notification elements

Where the Commission or one of the Agencies makes the corresponding registration, application, notification or other relevant regulatory dossier available to the ECHA, it will indicate which elements of the study notification are to be confidential when it is included in the common data platform.

To enhance the visibility of the available data, the ECHA will establish and manage a database containing data on chemicals in articles or products. It will also establish and manage a repository with data on alternatives to potential substances of concern.

Notification of studies

Business operators will notify to the database of study notifications, without delay, any studies that generate chemicals data and that 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 that business operators commission as part of a risk or safety assessment under the Union legal acts listed in Annex I, Part 1, to this Regulation.

The obligation to notify studies will not begin to apply until 22 months after the date of entry into force of the regulation.