Konzultációk az engedélyezési eljárás során
Konzultációk az engedélyezési eljárás során
The authorisation process aims to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where technically and economically feasible alternatives are available.
The authorisation process involves three steps: i) identification of SVHCs; ii) recommendation for inclusion in the Authorisation List; and iii) applications for authorisation. ECHA consults interested parties during all three steps and encourages all interested parties to get involved and give their views.
|Identification of SVHCs (more)||Recommendation for inclusion in the Authorisation List (more)||Applications for authorisation (more)|
|Purpose||To identify which substances will be included in the Candidate List||To define in which order substances from the Candidate List are included in the Authorisation List (Annex XIV)||Whether the use of the substance (as applied for by the applicant) can continue after the sunset date|
|What is prepared and by whom?||Annex XV report prepared by Member States or ECHA (on behalf of COM)||Draft recommendation prepared by ECHA||Relevant parts of the applications for authorisation prepared by industry|
|Factors considered during each step of the process||Intrinsic properties of the substance||All uses of the substance within the scope of the authorisation requirement||Use(s) applied for by an applicant:
|Type of information requested during the consultation||Identity of the substance and intrinsic properties relevant for the identification (unless identification is based on harmonised classification and labelling and cannot be challenged in this context). Additionally, information on uses, exposure potential and alternatives||Confirmation on uses and volumes used; Views on the transitional arrangements and possible exemptions.||Alternative substances or technologies to the use(s) applied for; risks, technical feasibility and costs of alternatives|
|When will it take place?||Twice a year (45 days in March-April and September-October)||Once every one to one and a half years (3 months at varying times of the year)||Quarterly (eight weeks starting mid-February, mid-May, mid-August and mid-November)|
During the consultation for the identification of an SVHC, ECHA particularly welcomes comments related to the substance identity (i.e. on the substance name/EC number/CAS number/molecular structure etc.) and/or intrinsic properties used to justify the identification. SVHC proposals based on harmonised classifications and labelling (CLH) included in the CLP Regulation cannot be challenged in the SVHC identification process. Therefore, comments questioning CLH will not be considered in this context.
Other types of comments, particularly those on uses, exposure potential and alternatives can be made and will be taken into account at the next stage in the process. This is because while they are not directly relevant for the identification of the SVHC, they are important for the prioritisation for inclusion in the Authorisation List step.
Main examples of information on uses relevant for ECHA's prioritisation task include:
- is the substance used on its own or in mixtures by professionals or consumers in the EU, and if yes in which applications, in which concentration (range) is the substance present in the mixture, what is the volume per use;
- is the substance present in articles, and if yes, which types of articles;
- information on other substance(s) on the Candidate List which could be used as an alternative to the proposed substance in its uses, or;
- other relevant information which illustrates the wide dispersiveness of the uses in the EU, e.g., significant monitoring/epidemiological data.
Nevertheless, please note that the REACH registrations are the main source of information for the recommendation of substances from the Candidate List to the Authorisation List (Annex XIV of REACH). Therefore registrants of the substances are encouraged to update their registration dossiers in case they have further or more precise information on uses, releases and exposures. Downstream users of the substance are encouraged to communicate relevant information on their uses and conditions of uses up the supply chain to ensure that registrants have sufficient information to update their registration dossiers, if necessary.
Any information on uses provided in the consultation should allow assessing its reliability and representativeness. Therefore, information should be accompanied by a description which clarifies the source of the information, the time period covered, the sector(s) / the share of the market / the number of users it represents and any other description which is relevant for the assessment of the reliability and representativeness of the information.
ECHA regularly assesses the substances from the Candidate List to determine which ones should be included in the Authorisation List as a priority. The prioritisation is mainly based on information in the registration dossiers on uses and volumes of the substances on the EU market that fall within the scope of the authorisation requirement. Any information submitted during the previous step (i.e. the identification of SVHCs) will also be taken into consideration.
The consultation on the draft recommendation for inclusion of substances in the Authorisation List mainly concerns the proposed Authorisation List entries for the prioritised substances, which include details on timelines and exemptions. In this context, information on the complexity of the supply chain is particularly welcome. ECHA also welcomes comments on the review periods, the transitional arrangements and on those uses which could possibly be exempted from the authorisation requirement. When proposing such exemptions, the conditions outlined in Article 58(2) of REACH should be taken into account, i.e. specific EU (not only national) legislation is in place that ensures the risk resulting from the specific use of the substance for human health or the environment is properly controlled and this legislation imposes minimum requirements relating to the protection of human health or the environment for the use of the substance.
ECHA takes the comments received into account when updating the draft recommendation. This updated draft recommendation will help the Member State Committee to draft its opinion. Taking the MSC opinion into account, ECHA will finalise its recommendation which is then submitted to the European Commission who makes the final decision on which substances to include in the Authorisation List and on the details for the respective entries.
For substances placed on the Authorisation List; manufacturers, importers and downstream users of the substance need to submit an application to ECHA if they wish to continue their use after the sunset date. The application for authorisation step includes an eight-week consultation on alternative substances or technologies for the uses of the substances subject to authorisation for which an authorisation application has been submitted.