Internal Market, Industry, Entrepreneurship and SMEs

Commission proposes to improve the compliance of chemical registration dossiers with EU law

Commission proposes to improve the compliance of chemical registration dossiers with EU law
Published on: 20/09/2019
Yesterday the Member States in the REACH Committee agreed unanimously to a Commission proposal amending the compliance check target of registration dossiers in REACH from 5% to 20%. The Commission can proceed to adoption after a scrutiny period by the European Parliament and the Council of 3 months.

REACH is the most comprehensive chemical legislation in the world. Over the past 10 years, the EU has significantly reduced citizens’ exposure to harmful chemicals by requiring data from industry to demonstrate the safe use of chemicals in a registration dossier. Industry submitted more than 90,000 dossiers, however, in about 1/3 of the dossiers checked by the European Chemicals Agency (ECHA), the information did not meet the requirements specified in REACH. Therefore, the Commission and ECHA developed an Evaluation Action Plan, with the increase of dossiers checked for compliance as the first action.

ECHA may examine any registration dossier to verify if the information submitted by registrants is compliant with the legal requirements. Compliance checks evaluate the substance identity description, safety information related to human health and the environment. 

According to REACH, ECHA currently must check at least 5% of the registration dossiers of each tonnage band. To encourage dossier compliance, the Commission is proposing to raise the minimum target for compliance checks to 20%. Member States in the REACH Committee agreed to the proposal unanimously. After a scrutiny period of 3 months by the European Parliament and the Council, the Commission can adopt the proposal.

Compliance checks focus (not exclusively) on 8 key endpoints: genotoxicity, repeated-dose toxicity, pre-natal developmental toxicity, reproduction toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation. They are key endpoints for identifying substances of concern and concluding whether the criteria for substances of very high concern are likely to be fulfilled.

Under the new minimum target, ECHA aims to check 20% of dossiers for substances registered in very high volumes (over 100 tonnes per year) by 2023, and 20% of dossiers for substances registered in lower volumes (1-100 tonnes per year), covering approximately 30% of all registered substances by 2027.

The Evaluation Action Plan outlines the comprehensive strategy under which ECHA is screening all registration dossiers, proceeding directly with the development of further risk management measures where appropriate and launching compliance checks for those substances for which it considers that more information is needed.

Companies need to regularly review their registration dossiers and update them when necessary. The Commission is preparing an implementing regulation to further specify by which timelines the updates should be made. In addition, and based on ECHA’s experience, the Commission works on clarifying certain REACH information requirements to facilitate industry compliance and evaluation procedures, to be discussed at the REACH Committee before the end of this year.

Finally, enforcement is of course of utmost importance. This is the responsibility of Member States and is coordinated at EU level through the 'Forum for Enforcement'.