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.