ECHA's restriction dossiers prepared according to Article 69(2)

After the sunset date has passed for a substance included on the Authorisation List (Annex XIV), Article 69(2) of REACH requires ECHA to consider if the use of the substance in articles is adequately controlled and, if it isn't, prepare a dossier which conforms to the requirements of an Annex XV dossier for restriction.

Following the latest application date for the substance specified on the Authorisation List, ECHA will gather information on all the uses of the substance in articles from various sources and then screen those uses for potential risks. If there is a potential for a risk from at least one of the uses, the preparation of an Annex XV restriction dossier will be initiated, at the latest, following the relevant sunset date.

 

Overview of Article 69(2) process

Overview of Article 69(2) process.

Where ECHA has determined that no restriction proposal should be prepared for a substance included in Annex XIV, a short justification will be given in the Annex XV format and put on ECHA's website.

 


Figure 1: Article 69(2) process.

The process for considering and developing a restriction is tiered, and is outlined in Figure 1 and in steps 1-5 below:

  1. For each SVHC included on the Authorisation List, ECHA will first assess whether or not the SVHC is present in articles. If the SVHC is not present or is not likely to be present in articles, then this would be documented and subjected to a specific call for evidence and the resulting report will be published on ECHA's website.
  2. For the SVHCs that pass through step 1, ECHA will identify an initial list of their uses from:
    1. the information on uses identified through registrations;
    2. SVHC in article notifications (REACH Article 7(2));
    3. RAPEX notifications;
    4. Member State enforcement information; and
    5. authorisation applications related to incorporating the SVHCs in articles.
  3. ECHA would then use a further call for evidence to identify any uses not already identified by the Agency. SVHCs that are confirmed as being present in articles would continue to the next step. SVHCs that are not present in articles will not be considered further. This will be documented in the Annex XV format.
  4. Based on the hazard information in the relevant SVHC documentation (for identification as an SVHC), any relevant opinion from ECHA's Committee for Risk Assessment (RAC) and the use information gathered, ECHA would carry out risk screening to determine if there is a risk from the use of the SVHC in the relevant article.
  5. Where there is a risk identified from a use in an article, ECHA would prepare an Annex XV restriction dossier for the substance, after the sunset date has passed. The dossier may include necessary derogations for uses where risks have been shown to be adequately controlled or where there is a socioeconomic justification.

The dossier would then be subject to the normal opinion-making procedure (Articles 69 to 73 procedure) in RAC and SEAC, and the final opinions transmitted to the Commission for decision making.

As mentioned above, ECHA's process to implement Article 69(2) of REACH would also depend on the progress of any relevant applications for authorisation for that substance. Any relevant decision related to whether or not an authorisation is granted for a use motivated by issues related to article service life will need to be taken into account.

When the sunset date for an SVHC included on the Authorisation List passes, there are a number of possibilities regarding granting or refusing authorisations for incorporation of a substance into an article. Either one or more of the authorisations may have been granted, with a relevant review date or one or more authorisations may have been refused, possibly due to considerations related to the use of the SVHC in an article during the article service life. In addition, there could have been no applications for authorisation of incorporation of substances into an article.

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