REACH Evaluation Report 2013: results and recommendations from dossier evaluation

ECHA/PR/14/04

ECHA's annual evaluation report 2013 gives recommendations to all registrants on how to improve the quality of their dossiers. As a consequence of ECHA's evaluation decisions, two thirds of evaluated registrations were brought into compliance following an update. In the course of 2013, the Agency forwarded 32 non-compliant cases to national enforcement authorities for their action.

Helsinki, 26 February 2014 - The annual evaluation report covers the Agency's evaluation activities and the corresponding output. In 2013, the focus of dossier evaluation activities was on compliance checks: 928 checks were concluded during the year. Altogether, ECHA has checked 1 130 dossiers, thereby exceeding the 5 % target of the total number of dossiers submitted for the 2010 registration deadline. In 61 % of the cases concluded in 2013, ECHA found that the dossiers did not comply with one or more REACH information requirements and sent draft decisions to the registrants. Due to the selection of dossiers with clear indications of potential non-compliance, this proportion is not a reliable indicator of data quality in all dossiers. Most of ECHA's information requests were related to substance identity, physicochemical properties, sub-chronic toxicity studies, pre-natal developmental toxicity studies and exposure assessment.

Regarding testing proposals, ECHA focused on decision-making for sets of dossiers relying on read-across and category approaches. The Agency concluded 157 examinations and took 111 decisions. In 71 cases, ECHA accepted the tests proposed by the registrants and in 37 cases, it modified at least one of the proposed tests. There were three decisions rejecting testing proposals.

ECHA conducted 222 follow-up evaluations in 2013, examining whether the registrants had provided the information requested in the ECHA decision by the set deadline. In 147 cases, the evaluation could be completed as the registrant had complied with the decision. In 43 cases, the requests in the decision have been complied with, but new requests for data are needed. For 22 compliance checks and 10 testing proposal decisions, ECHA concluded that they were not properly implemented; the Member States authorities were invited to start enforcing these evaluation decisions.

After the successful completion of the first substance evaluations initiated in 2012 by 17 Member States, ECHA adopted the first substance evaluation decisions with the agreement of the Member State Committee.

The report gives specific recommendations for both future registrants for the 2018 deadline and existing registrants who may need to update their dossiers. The recommendations cover these subjects:

• Improving the chemical safety report to reflect actual uses and risks.
• Knowing how to react to (draft) decisions.
• Keeping the dossier up-to-date.
• Substantiating the reasoning when adapting the standard testing regime.