Progress in evaluation in 2018

Evaluation progress 2018

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

Dossier evaluation 2018

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.

Dossier evaluation 2018 -graph1

CCH draft decision issuedCCH concluded with no actionTPE draft decision issuedTerminated TPEOutcomes of compliance check and testing proposals examinations performed in 20182117516830substances addressedin evaluated dossiersTotal:484registration dossiers420

Dossier evaluation 2018 - second text

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 graphich

Final decisions sent to registrants in2018 per dossier evaluation typeCompliance checkTesting proposals examinations130144informationrequestsincluded in274finaldecisions888

Dossier evaluation 2018 - third text

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.