Under Europe’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, notifications are required for components of complex products that meet the 0.1% threshold concentration for certain chemicals, the European Court of Justice (ECJ) has ruled. The court’s decision, issued last week, overturns guidance issued in 2011 by the European Commission and European Chemicals Agency (ECHA). Interpreting Articles 7(2) and 33 of REACH, which require disclosures when an article contains more than 0.1% by weight of Substances of Very High Concern (SVHC), the ECJ found that “there is 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.” Thus, notification duties apply based on the concentration of SVHCs in component articles that make up a complex product, rather than the complex product’s total weight.
According to the court, a “complex product” is “made up of a number of manufactured objects meeting the criteria laid down in Article 3(3),” which defines 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.” Further,
It is therefore only if the production of an object using a combination of more than one article gives that object a special shape, surface or design which is more decisive for its function than its chemical composition that that object may be classified as an article. Accordingly, unlike a simple assembly process, that production process must alter the shape, surface or design of the articles used as components.
Article 7(2) requires producers and importers of articles to notify ECHA if an SVHC is present at a level greater than 0.1% and totals over one tonne per year. Under Article 33, suppliers must inform recipients of articles containing SVHCs at this level, and provide similar information in response to consumer inquiries within 45 days.
The court ruled that a “producer’s duty to notify covers only those articles which the producer itself has made or assembled,” while third-party assemblers must make notifications for complex products it assembles. Importers are subject to notification duties for articles that comprise components of complex products. Suppliers’ notification duties, which include providing the name of the SVHC, apply “to all operators along the supply chain.”
The ECJ’s decision affirms the position of France, Belgium, Denmark, Germany, Austria, Sweden, and Norway, and is in line with the opinion published in February by an ECJ Advocate General, a legal advisor to the court. According to Chemical Watch, ECHA said it will begin the process of revising its guidance in light of the ECJ’s ruling.