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- Progress in evaluation 2023
- Further information requests 2023
Progress in evaluation in 2023
Progress in evaluation in 2023
Dossier evaluation
In 2023, ECHA adopted 251 compliance check decisions addressing 1290 information requirements for which data gaps were identified. In addition, the Agency adopted 116 testing proposal decisions addressing 275 information requirements for which testing was originally proposed.
334 decisions were adopted without the Member State Committee’s (MSC) involvement (i.e. the Member States did not send proposals for amendments). A further 33 decisions were adopted with the MSC’s involvement: 21 in written procedure and 12 during the MSC meetings.
Information requests made in the adopted dossier evaluation decisions
| Information requirements | Number of requests in
251 compliance check decisions |
Number of requests in 116 testing proposal decisions | Number of requests in all 367 dossier evaluation decisions |
|---|---|---|---|
| Carcinogenicity | 1 | 13 | 14 |
| Mutagenicity/genotoxicity | 228 | 71 | 299 |
| Pre-natal developmental toxicity | 77 | 49 | 126 |
| Reproduction toxicity* | 70 | 36 | 106 |
| Repeated-dose toxicity | 46 | 25 | 71 |
| Biodegradation | 181 | 9 | 190 |
| Bioaccumulation | 36 | 0 | 36 |
| Long-term aquatic toxicity | 254 | 51 | 305 |
| Physico-chemical properties | 15 | 4 | 19 |
| Other human health | 92 | 0 | 92 |
| Other environment | 252 | 17 | 269 |
| Annex I (incl. CSR, RSS, PBT) | 0 | N/A | 0 |
| Annex VI (incl. SID, C&L) | 38 | N/A | 38 |
| Total | 1 290 | 275 | 1 565 |
*CSR: chemical safety report; RSS: robust study summary; PBT: persistent, bioaccumulative and toxic; SID: substance identification; C&L: classification and labelling.
Substance evaluation
In 2023, ECHA adopted 6 substance evaluation decisions, with 10 requests for further information to assess the safety of substances of potential concern.
3 of the decisions were adopted without the Member State Committee’s (MSC) involvement (i.e. ECHA and the Member States did not submit proposals for amendments). 3 were adopted with the MSC’s involvement: 2 in written procedure and 1 during the MSC meetings.
Information requests made in the adopted substance evaluation decisions
| Suspected concern | Substance EC / List number |
Information requested to clarify the concern |
Total requests * |
|---|---|---|---|
| Endocrine disruption | 201-240-0 | Combination of fish short term reproduction assay and fish sexual development test | 1 |
| 274-581-6 | Amphibian metamorphosis assay | 1 | |
| PBT/vPvB** 2 | 701-385-4 | Daphnia magna reproduction test | 1 |
| 915-730-3 | Simulation biodegradation test | 1 | |
| 201-222-2 | Vapour pressure | 1 | |
| 201-222-2 | Determination of Henry's law constant | 1 | |
| 201-222-2 | Water solubility | 1 | |
| 201-222-2 | Partition Coefficient 1-Octanol/Water | 1 | |
| Mutagenicity | 201-240-0 | In vivo mammalian alkaline comet assay combined with in vivo mammalian erythrocyte micronucleus test | 1 |
| 274-581-6 | Transgenic rodent somatic and germ cell gene mutation assay | 1 | |
| Total | 10 | ||
* A decision may contain more than one request.
** PBT: persistent, bioaccumulative and toxic; vPvB: very persistent and very bioaccumulative.