Now that the number of substances included on the European Union’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Candidate List is up to 47 and counting, it is important to pay closer attention to requirements pertaining to substances of very high concern (SVHC). Article 7 of REACH requires producers, importers, and suppliers of articles to notify the European Chemicals Agency (ECHA) of the presence in articles of SVHCs that have been on the Candidate List for at least six months. Notifications for substances listed before December 1, 2010, are due June 1, 2011. The current Candidate List is available online.
This memorandum briefly summarizes the requirements that must be met by the fast approaching June deadline.
Criteria for Notification
Under REACH, every producer or importer of an “article” (an object as defined in Article 3(3) of REACH) must notify ECHA of the presence of any SVHCs in an article if both of the following conditions are met:
- The SVHC is present in those articles at a volume of >1 metric ton per manufacturer/importer per year (please note this applies to the total sum of the SVHC in all articles and in the case of an importer includes supply of the substance from more than one supplier); and
- The SVHC is present in those articles above a concentration of 0.1% weight by weight (w/w).
Consistent with the European Commission’s view as well as ECHA’s Guidance on Substances in Articles, the threshold of 0.1% w/w applies to the article as a whole. Six member states and Norway, however, continue to advocate a dissenting minority view pertaining to the threshold of each component in an article. The debate continues, however, and the potential exists that this matter may ultimately be resolved by the European legal system.
Information to Be Submitted
The information to be submitted to ECHA includes:
- The identity/contact details of the producer or importer;
- The registration number(s), where these are available;
- The identity of the substance;
- The classification of the substance(s);
- A brief description of the use(s) of the substance(s) in the article and of the uses of the article(s); and
- The tonnage range of the substance(s) (for example 1 to 10 tons or 10 to 100 tons).
Exemptions
The notification requirements are not applicable when:
- The producer or importer can exclude exposure to humans or the environment under normal or reasonably foreseeable conditions of use, including disposal. In such cases, the producer or importer has to supply appropriate instructions to the recipient of the article; and
- The substance has already been registered for that use.
Useful Links
The Registry of Intentions is available online. Summary of Obligations for SVHCs is available online.