Progress in evaluation in 2018

Under Article 54 of REACH, ECHA is reporting on the progress made in 2018 in dossier and substance evaluation. 

ECHA assessed 484 registrations either under compliance check (CCH) or under testing proposal examination (TPE), corresponding to 420 substances. ECHA issued 379 draft decisions: 211 on compliance check and 168 on testing proposal examination. The selection of registrations for compliance check was mainly based on a potential hazard- or exposure-based concern.

CCH draft decision issuedCCH concluded with no actionTPE draft decision issuedTerminated TPE Outcomes of compliance check and testing proposals examinations performed in 2018 211 75 168 30 substances addressed in evaluated dossiers Total: 484 registration dossiers 420

At the end of the year, there were still 45 dossiers undergoing compliance check and 65 dossiers undergoing testing proposal examination.

ECHA adopted 274 final decisions in which 888 information requests were made. Out of these 274 decisions, 144 were compliance check decisions and 130 originating from testing proposal examinations.

Final decisions sent to registrants in 2018 per dossier evaluation type Compliance checkTesting proposals examinations 130 144 information requests included in 274 final decisions 888

Out of the 274 final decisions, 216 were adopted without Member State Committee (MSC) involvement (no proposal for amendments received from Member States). 58 decisions were adopted with MSC involvement: 34 in written procedure and 24 in an MSC meeting.

At the end of 2018, there were another 174 compliance check and 109 testing proposal examination draft decisions from previous year in decision making. ECHA closed 52 compliance check cases and 44 testing proposal examination cases after a draft decision has been sent, as scientifically-relevant data or important administrative changes led to termination of the ongoing decision-making procedure.

Two draft decisions were referred to the Commission for decision making, both related to the design of the extended one-generation reproductive toxicity study design.

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