Progress in evaluation in 2020

ECHA reports on the progress made in 2020 in dossier and substance evaluation in line with Article 54 of REACH. 

Dossier evaluation 

In 2020, ECHA adopted 255 compliance check decisions addressing 1365 information requirements for which data gaps were identified. In addition, the Agency adopted 99 testing proposal decisions addressing 191 information requirements for which testing was originally proposed.

334 of the adopted decisions were adopted without the Member State Committee’s (MSC) involvement (i.e. the Member States did not send proposals for amendments). Twenty decisions were adopted with the MSC’s involvement: 12 in written procedure and 8 during the MSC meetings.

Information requests made in the adopted dossier evaluation decisions

Information requirements Number of requests in 255 compliance check decisions Number of requests in 99 testing proposal decisions Number of requests in all 354 decisions
Carcinogenicity 0 0 0
Mutagenicity/genotoxicity 275 11 286
Pre-natal developmental toxicity 160 60 220
Reproduction toxicity 107 24 131
Repeated-dose toxicity 108 35 143
Biodegradation 134 15 149
Bioaccumulation 22 2 24
Long-term aquatic toxicity 211 12 223
Physico-chemical properties 30 4 34
Other human health 64 0 64
Other environment 231 28 259
Annex I (incl. CSR, RSS, PBT) 3 N/A 3
Annex VI (incl. SID, C&L) 20 N/A 20
Total 1365 191 1556

CSR: chemical safety report; RSS: robust study summary; PBT: persistent, bioaccumulative and toxic; SID: substance identification; C&L: classification and labelling

Substance evaluation 

ECHA adopted 18 substance evaluation decisions, with 24 requests for further information to assess the safety of substances of potential concern.

8 of these decisions were adopted without the Member State Committee’s (MSC) involvement (i.e. the Member States did not submit proposals for amendments). The remaining 10 decisions were adopted with the MSC’s involvement: 7 in written procedure and 3 during the MSC meetings.

Information requests made in the adopted (i.e. final) substance evaluation decisions

Suspected concern Substance EC / list Number Information requested to clarify the concern Total requests*
Mutagenicity 215-175-0 Combined mammalian erythrocyte micronucleus test and mammalian alkaline comet assay 2
202-707-1
223-055-4 In vivo mammalian comet assay 1
202-707-1 In vitro mammalian cell micronucleus assay 1
Reproductive toxicity 201-159-0 Developmental neurotoxicity study 1
201-618-5 Sub-chronic 90-day toxicity study 1
Endocrine disruption 262-872-0 Amphibian metamorphosis assay 2
258-904-8
222-020-0 Fish sexual development test 1
206-354-4 Larval amphibian growth and development assay 1
215-925-7 In vitro alcohol dehydrogenase inhibition assay 1
PBT/vPvB** 435-790-1 Simulation biodegradation test 4
701-028-2
700-960-7
264-848-5 Ready biodegradation test 1
701-028-2 Physico-chemical test 1
700-960-7 Analytical information on composition 1
Other hazard-based concern 215-713-4 Sub-chronic 90-day toxicity study 3
231-146-5
249-820-2
931-745-8 Terrestrial toxicity test 2
931-745-8 Sediment-water toxicity test 1
Total 24

* A decision may contain more than one request.
** PBT: persistent, bioaccumulative and toxic; vPvB: very persistent and very bioaccumulative.