- ECHA
- Zakonodaja
- REACH
- Evalvacija
- Napredek pri evalvaciji
- Progress in evaluation 2022
- Follow-up evaluation 2022
Progress in evaluation in 2022
Progress in evaluation in 2022
Nove informacije, prejete na podlagi sklepa agencije ECHA, se pregledajo, da se preveri, ali so zahteve izpolnjene in ali je nevarnost odpravljena oziroma pomislek pojasnjen, ter da se opredelijo primeri, v katerih so morda potrebni nadaljnji regulativni ukrepi.
Nadaljnji ukrepi po evalvaciji dokumentacije
Leta 2022 je bilo 438 snovi obravnavanih v fazi opredelitve nadaljnjih ukrepov po evalvaciji dokumentacije. Postopek je bil zaključen za 249 snovi.
Za 152 snovi so registracijski zavezanci predložili zahtevane informacije v danem roku. Za 37 snovi je bilo ugotovljeno, da potrebujejo usklajeno razvrstitev in označitev. Za eno snov je bila potrebna dodatna ocena v zvezi z njenimi lastnostmi obstojnosti, bioakumulativnosti in strupenosti. Štiri snovi so bile opredeljene kot kandidatke za evalvacijo snovi (SEv).
151 nadaljnjih ocen, ki so zajemale 146 snovi, je bilo napotenih na nacionalne izvršne organe, saj registracijski zavezanci niso pravočasno predložili zahtevanih informacij.
Po izreku izvršnih ukrepov so registracijski zavezanci predložili potrebne informacije v 82 primerih. Ocene, opravljene po napotitvi zadeve nacionalnim izvršnim organom, niso vključene v spodnjo preglednico kot ločena ocena, saj se štejejo za del prvotne evalvacije.
Number and outcome on substances subject to follow ups to dossier evaluation 2023
Decision type | Outcome | ||||
---|---|---|---|---|---|
Substances compliant with decision by the deadline | Substances compliant with decision after involving national enforcement authorities1 | Substances non-compliant with decision, assessments still open2 | Substances non-compliant with the decision, a new decision issued3 | Substances proposed as candidates for further regulatory process | |
Testing proposal decisions | 67 | 37 | 92 | 3 | 20 CLH, 1 SEv |
Compliance check decisions | 85 | 45 | 174 | 12 | 17 CLH, 3 SEv, 1 PBT |
Total | 152 | 82 | 266 | 15 | 37 CLH, 4 SEv, 1 PBT |
CLH: harmonised classification and labelling
1No or inadequate information was provided by the deadline. ECHA invited Member State competent authorities to consider enforcement actions against the registrant. This led to a dossier update with sufficient information.
2 No or inadequate information was provided by the deadline. ECHA invited Member State competent authorities to consider enforcement actions against the registrant. The requested information has not yet been provided.
3 Information has been provided, but the information requirement was not met.
Nadaljnji ukrepi po evalvaciji snovi
V letu 2022 je bilo evalviranih 23 snovi. V zvezi s štirimi snovmi je organ države članice, pristojen za evalvacijo, zahteval več informacij, saj predložene informacije niso razjasnile pomislekov oziroma so se zaradi njih pojavili dodatni pomisleki.
V zvezi s preostalimi 19 snovmi so pristojni organi menili, da razpoložljive informacije zadostujejo za razjasnitev zadevnih pomislekov in sprejetje odločitve, ali so potrebni nadaljnji regulativni ukrepi ali ne.
Sklepne ugotovitve
Organ države članice, pristojen za evalvacijo, lahko predlaga enega ali več regulativnih ukrepov za obravnavo pomislekov, na primer:
- usklajeno razvrstitev in označitev za snovi, ki so rakotvorne, mutagene ali strupene za razmnoževanje, povzročiteljice preobčutljivosti dihal ali ki vzbujajo druge pomisleke, npr. so nevarne za vodno okolje;
- opredelitev snovi kot snovi, ki vzbuja veliko zaskrbljenost (SVHC);
- omejitev snovi ali
- ukrepe, ki ne spadajo na področje uporabe uredbe REACH, kot so določitev mejne vrednosti izpostavljenosti na delovnem mestu v vsej EU, nacionalne ukrepi ali prostovoljne ukrepi v industriji.
Summary of concluded substance evaluations where further regulatory actions were proposed
Suspected concern | Concluded regulatory follow-up action at EU level | Concluded substances by EC/List number | Evaluating MSCA |
---|---|---|---|
Carcinogenicity | Harmonised classification and labelling | 204-077-3 | FR |
225-935-3 | DE | ||
Identification as an SVHC | 204-077-3 | FR | |
Mutagenicity | Harmonised classification and labelling | 218-645-3 | DK |
Reproductive toxicity | Harmonised classification and labelling | 229-962-1 | DE |
273-227-8 | DE | ||
To be confirmed* | 201-126-0 | FR | |
200-843-6 | FR | ||
PBT/vPvB** | Identification as an SVHC | 203-497-4 | NO |
205-491-7 | NO | ||
205-492-2 | NO | ||
473-390-7 | BE | ||
Restriction | 203-497-4 | NO | |
205-491-7 | NO | ||
205-492-2 | NO | ||
To be confirmed* | 203-497-4 | NO | |
205-491-7 | NO | ||
205-492-2 | NO | ||
473-390-7 | BE | ||
Endocrine disruption | To be confirmed* | 201-126-0 | FR |
Sensitisation (skin and/or respiratory) | Harmonised classification and labelling | 201-983-0 | DE |
204-077-3 | FR | ||
218-645-3 | DK | ||
273-227-8 | DE | ||
Identification as an SVHC | 204-077-3 | FR | |
Other concern | Harmonised classification and labelling | 201-052-9 | FR |
201-983-0 | DE | ||
204-077-3 | FR | ||
211-463-5 | DE | ||
215-160-9 | FR | ||
229-962-1 | DE | ||
246-677-8 | IT | ||
Restriction | 468-710-7 | DE | |
Other EU-wide regulatory risk management measures | 215-160-9 | FR | |
468-710-7 | DE | ||
To be confirmed* | 201-052-9 | FR | |
211-463-5 | DE | ||
215-160-9 | FR | ||
216-653-1 | FR |
* A need for further regulatory actions at EU level was identified but the risk management options analysis was not yet finalised. The evaluating MSCA will prepare a separate risk management option analysis to clarify the appropriate follow-up regulatory actions.
** PBT: persistent, bioaccumulative and toxic; vPvB: very persistent and very bioaccumulative.