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- Progress in evaluation 2020
- Further information requests 2020
Progress in evaluation in 2020
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
- List of evaluated substances and issued requests in 2020 (compliance checks and testing proposals) [XLSX]
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.