EU: Public consultation on chemical safety – better access to chemicals data for safety assessments

 

The EU has published, for public consultation, a regulation 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 core aim of the Regulation is to increase the effectiveness, efficiency and coherence of chemicals assessments, thus contributing to the protection of human health and the environment. The Regulation targets key actors broadly referred to as authorities. These include the European Commission, the European Agency for Safety and Health at Work (‘EU-OSHA’), the European Chemicals Agency (‘ECHA’), the European Environment Agency (‘EEA’), the European Food Safety Authority (‘EFSA’), the European Medicines Agency (‘EMA’), and Member State authorities. Chapter II, Information System and Platforms, comprises 11 provisions that provide for the setup by the ECHA of a common data platform on chemicals providing access to chemicals related data. Such chemicals-related data comprises:

• physico-chemical, hazard, use, exposure safety, risk, occurrence, emissions and manufacturing process-related data and information on chemical substances, on their own, or in mixtures or articles, generated or submitted under EU chemicals legislation;
• Environmental sustainability related data and information, including climate change related information;
• information on legal obligations, academic studies and chemicals-related data not generated in an EU regulatory context but as part of EU, national or international programmes or research activities;
• data and information on reference values;
• data and information from study notifications;
• information related to regulatory processes under the Union acts listed in Annex III to this Regulation, as well as any data on applicable legal obligations under the EU legislation listed in Annex I; and
• data and information supporting the implementation of this Regulation such as standard formats and controlled vocabularies.

The proposal creates an obligation to ensure that chemicals-related data of the type explained above held by these agencies or the Commission is included in the common data platform. Documents relating to authorities’ internal work or decision-making processes need not be included in the common data platform, unless explicitly required so.

The full text of the draft regulation can be accessed HERE.

To find out more chemical compliance, and the EU chemical legislation please contact the Product Compliance Institute directly.