- ECHA
- Zakonodaja
- REACH
- Evalvacija
- Napredek pri evalvaciji
- Progress in evaluation 2022
- Further information requests 2022
Progress in evaluation in 2022
Progress in evaluation in 2022
Evalvacija dokumentacije
V letu 2022 je agencija ECHA sprejela 252 sklepov o pregledih skladnosti, ki so se nanašali na 1 612 zahtev po informacijah v primerih, ko so bile ugotovljene vrzeli v podatkih. Poleg tega je izdala 169 sklepov o predlogih za testiranje, ki so obravnavali 347 zahtev po informacijah, pri katerih je bilo testiranje prvotno predlagano.
400 sklepov je bilo sprejetih brez sodelovanja Odbora držav članic (tj. države članice niso predložile predlogov za spremembo). Nadaljnjih 21 sklepov je bilo sprejetih s sodelovanjem Odbora držav članic, in sicer 18 po pisnem postopku, trije pa med sestanki Odbora držav članic.
Zahteve po informacijah v sprejetih sklepih o evalvaciji dokumentacije
Information requirements | Number of requests in 252 compliance check decisions |
Number of requests in 169 testing proposal decisions |
Number of requests in all 421 decisions |
---|---|---|---|
Carcinogenicity | 0 | 0 | 0 |
Mutagenicity/genotoxicity | 285 | 76 | 361 |
Pre-natal developmental toxicity | 128 | 66 | 194 |
Reproduction toxicity | 87 | 24 | 111 |
Repeated-dose toxicity | 71 | 35 | 106 |
Biodegradation | 243 | 22 | 265 |
Bioaccumulation | 28 | 2 | 30 |
Long-term aquatic toxicity | 341 | 63 | 404 |
Physico-chemical properties | 15 | 7 | 22 |
Other human health | 90 | 0 | 90 |
Other environment | 323 | 52 | 375 |
Annex I (incl. CSR, RSS, PBT)* | 0 | N/A | 0 |
Annex VI (incl. SID, C&L)* | 1 | N/A | 1 |
Total | 1 612 | 347 | 1 959 |
*CSR: chemical safety report; RSS: robust study summary; PBT: persistent, bioaccumulative and toxic; SID: substance identification; C&L: classification and labelling.
Evalvacija snovi
Leta 2021 je agencija ECHA izdala devet sklepov o evalvaciji snovi z 12 zahtevami po dodatnih informacijah za oceno varnosti snovi, ki bi utegnile vzbujati zaskrbljenost.
Štirje med njimi so bili izdani brez sodelovanja Odbora držav članic (tj. države članice niso predložile predlogov za spremembo). Pet sklepov je bilo sprejetih s sodelovanjem Odbora držav članic, in sicer štirje po pisnem postopku in eden med sestanki Odbora držav članic.
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 | 275-702-5 | Combination of fish short term reproduction assay and fish sexual development test | 1 |
228-250-8 | Larval amphibian growth and development assay | 1 | |
258-469-4 | Amphibian metamorphosis assay | 1 | |
Mutagenicity | 220-618-6 209-711-2 |
In vivo mammalian alkaline comet assay | 2 |
PBT/vPvB** 2 | 271-867-2 | Simulation biodegradation test | 1 |
400-370-7 | Partition Coefficient (1-Octanol/Water): Slow-Stirring Method or HPLC method | 1 | |
271-867-2 | Water solubility: column elution method | 1 | |
273-066-3 | Ready biodegradation test | 1 | |
201-236-9 | Bioaccumulation test in aquatic species | 1 | |
271-867-2 | Daphnia magna reproduction test | 1 | |
271-867-2 | Fish early-life stage toxicity test | 1 | |
Total | 12 |
* A decision may contain more than one request.
** PBT: persistent, bioaccumulative and toxic; vPvB: very persistent and very bioaccumulative.