REACH regulations continue to pose questions. Here I look at substances of very high concern (SVHCs).
Notification of SVHC when present in articles:
Article 7 of REACH details the criteria under which an SVHC would need to be notified to the European Chemicals Agency (ECHA) if it is present in an article. Notification would be required if:
(a) The substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year, and;
(b) The substance is present in those articles above a concentration of 0.1 % weight by weight of the article (not homogeneous material as with RoHS).
Notification is not required, however, if the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal. (In such cases, the producer or importer shall supply appropriate instructions to the recipient of the article.) or, if the substance has already been registered for that use.
The SVHC's that may require notification will be named on the so called 'candidate list' - this doesn't exist yet, but should be published on the European Chemical Agency's (ECHA) website towards the end of this year or, more likely, early next year. Such notifications will not be required until June 2011 at the earliest.
Authorisation:
Substances that require authorisation will be published as Annex XIV of REACH. This will be developed from a list of proposed substances for authorisation which will be drawn from the "candidate list" mentioned above, but is likely to be much smaller. This proposed list will be published on the ECHA website by June 2009. If a substance eventually appears on Annex XIV it will require authorisation irrespective of the tonnages involved.
Any substance that falls into this category will require a safety data sheet to be provided to all the recipients of the substance or preparation containing the substance.
Directive Decoder