With the Authorisation process gaining momentum, many importers of articles and their non-EU suppliers have been asking REACHReady what it means for their business. Common themes have been emerging, so we have prepared this document to help clear up any confusion.
Truth: The Candidate List of Substances of Very High Concern for Authorisation, to give it its full title, is a list of substances that may be subject to strict controls in the EU/EEA. Such controls affect the EU/EEA use and supply of SVHCs that are listed in Annex XIV in their chemical form.
Candidate Listed substances that have not been added to Annex XIV are at an early stage of the regulatory process and are not yet subject to Authorisation. Inclusion on the Candidate List alone is not a ban on those substances, neither in articles nor as chemicals. Therefore, unless prohibited or regulated by other means, Candidate Listed substances may be present legally in articles supplied in the EU/EEA.
Some companies may choose to ban Candidate List substances through their contracts of supply; however, this is a business decision and not a requirement under REACH.
Truth: Under Art 33 of REACH, the obligation on EU/EEA suppliers of articles is to give recipients, as a minimum and to the best of their knowledge, the name of any substances on the Candidate List which are present above 0.1% w/w. This duty does not extend to substances of interest or concern on other lists, for example those on the SIN List or the Trade Union Priority List unless they are also Candidate Listed. However, suppliers may decide to make such voluntary disclosures.
Truth: The import of articles is not controlled by the Annex XIV to REACH. Articles containing Annex XIV substances may be imported into the EU/EEA legally, provided that doing so would not cause a breach of any other control measure in place (such as a restriction under Annex XVII to REACH). The importer may have to inform their customers (and, in some cases, ECHA) of the presence of the substance as it remains a Candidate Listed SVHC.
Truth: Authorisation does not regulate manufacturing, use or production processes outside the EU/EEA. It controls only those uses, and placing on the market for those uses, that take place within the jurisdiction of REACH, i.e. in the EU and EEA. The sunset dates in Annex XIV do not apply where the use of the substance is in the production of an article outside the EU/EEA; therefore, such goods may continue to be imported after the sunset date (provided that doing so would not breach any other regulatory controls). In contrast, a producer of articles in the EU/EEA cannot use an Annex XIV substance after the relevant sunset date without Authorisation granted by the European Commission, unless an exemption applies.
Note: Substances are added to Annex XIV because of severe risks to human health and/or the environment during their manufacture and/or use. The intrinsic properties of those substances do not change according to where they are used; therefore, non-EU/EEA users of these chemicals may substitute them for the purposes of their own human health and environmental protection – voluntarily, or in order to comply with their own domestic laws.
Since 1 June 2011 a new REACH obligation has applied affecting many suppliers of articles such as finished goods, spare parts and components. Importers and producers of articles containing Candidate List substances present above 0.1% by weight (w/w) may need to submit a notification dossier to the European Chemicals Agency, ECHA.
