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ECHA guidance on requirements for substances in articles had stated that the threshold should apply to complete product, but Austria, Belgium, Denmark, France Germany, Sweden and Norway disagreed with this position referring to the REACH Regulation which defined an article as “an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.” The Court agreed that there was no need to draw a distinction between the situation of articles incorporated as a component of a complex product and that of articles present in an isolated manner.
Following this ruling, producers and importers must notify ECHA if an SVHC is present in the articles they produce and/or import at a total of >1 tonne per producer/importer per year and the substance is present in those articles above a concentration of 0.1% (weight by weight). The duty to notify only applies to producers where that the producer itself has made or assembled the article. Thus, in a complex product, made of several articles, if the producer uses an article as an input made by a third party, the third party who produced that article would be subject to notify. The duty to notify does not apply if the substance has already been registered for that use or (which is challenging to prove), or humans and the environment would not be exposed to the substance during normal or reasonably foreseeable conditions of use.
The duty to communicate information on SVHCs similarly applies to constituent articles. Suppliers of products, any one of whose constituent articles contains an SVHC in a concentration above 0.1%, must provide the recipient with sufficient information to allow safe use of the item, to include, as a minimum, the name of that substance. The same information must also be provided within 45 days of receipt of the request.
The ruling gives clarity to companies importing into the European Economic Area, all of which must now apply the same definition of an article for the implementation of REACH. It also provides further justification for full material disclosure, which provides comprehensive substance tracking at all levels of product composition. With 163 Substances of Very High Concern on the Candidate List as of June 2015 and more likely to be added every six months, full material disclosure remains the most effective means of managing compliance information for REACH.