- ECHA
- Legislation
- REACH
- Evaluation
- Progress in evaluation
- Progress in evaluation 2021
- Further information requests 2021
Progress in evaluation in 2021
Progress in evaluation in 2021
Dossier evaluation
In 2021, ECHA adopted 278 compliance check decisions addressing 1746 information requirements for which data gaps were identified. In addition, the Agency adopted 165 testing proposal decisions addressing 277 information requirements for which testing was originally proposed.
406 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). 37 decisions were adopted with the MSC’s involvement: 32 in written procedure and 5 during the MSC meetings
Information requests made in the adopted dossier evaluation decisions
Information requirements | Number of requests in 278 compliance check decisions |
Number of requests in 165 testing proposal decisions |
Number of requests in all 443 decisions |
---|---|---|---|
Carcinogenicity | 0 | 0 | 0 |
Mutagenicity/genotoxicity | 260 | 79 | 339 |
Pre-natal developmental toxicity | 134 | 51 | 185 |
Reproduction toxicity | 129 | 17 | 146 |
Repeated-dose toxicity | 79 | 37 | 116 |
Biodegradation | 187 | 18 | 205 |
Bioaccumulation | 53 | 1 | 54 |
Long-term aquatic toxicity | 344 | 41 | 385 |
Physico-chemical properties | 60 | 8 | 68 |
Other human health | 71 | 0 | 71 |
Other environment | 408 | 25 | 433 |
Annex I (incl. CSR, RSS, PBT) | 0 | N/A | 0 |
Annex VI (incl. SID, C&L) | 21 | N/A | 21 |
Total | 1746 | 277 | 2023 |
Substance evaluation
In 2021, ECHA adopted 10 substance evaluation decisions, with 14 requests for further information to assess the safety of substances of potential concern.
All 10 of these decisions were adopted with the MSC’s involvement: 9 in written procedure and 1 during the MSC meetings.
Suspected concern | Substance EC / List number |
Information requested to clarify the concern |
Total requests * |
---|---|---|---|
Endocrine disruption | 216-133-4 | Fish sexual development test | 1 |
203-585-2 | Larval amphibian growth and development assay |
1 | |
PBT/vPvB** | 267-636-0 267-636-0 429-320-2 229-782-3 458-680-3 700-992-1 |
Simulation biodegradation test | 7 |
203-372-4 | Ready biodegradation test | 1 | |
429-320-2 458-680-3 206-420-2 |
Bioaccumulation test in aquatic species | 3 | |
Other hazard-based concern |
236-675-5 | Intra-tracheal instillation study combined with comet assay |
1 |
Total | 14 |
* A decision may contain more than one request.
** PBT: persistent, bioaccumulative and toxic; vPvB: very persistent and very bioaccumulative.