The European Court of Justice (ECJ) has ruled on “once an article, always an article” stating that each of the articles incorporated as a component of a complex product is covered by the relevant duties to notify and provide information when they contain a substance of very high concern (SVHC) in a concentration above 0.1% of their mass.
Producers, suppliers, importers and retailers must provide information in cases where their product contains an article that exceeds the 0.1 % SVHC threshold. Producers or importers need to notify the European Chemicals Agency (ECHA) if their article contains SVHC in quantities totaling over one ton per producer or importer per year, and if the substance is present in those articles above a concentration of 0.1% (w/w).
By its judgment, the Court recalls, firstly, that the regulation defines the concept of ‘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.’ However, it does not contain any provisions specifically governing the situation of a complex product containing several articles. Consequently, 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.
In those circumstances, the Court rules that each of the articles incorporated as a component of a complex product is covered by the relevant duties to notify and provide information when they contain a SVHC in a concentration above 0.1% of their mass. Therefore the definition of what is an article is decisive to calculate the 0.1 % threshold.
Why It Matters
The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation provides that, where a chemical substance ‘of very high concern’ for health or the environment because, in particular, of its carcinogenic, mutagenic or toxic properties is present in a concentration above 0.1% of the mass of an article, the producer, supplier, importer and retailer must provide the recipient of the article with sufficient information, to allow the safe use of the article.
Information must be provided to the recipient when they contain a SVHC in a concentration above 0.1%. Therefore the 0.1% threshold is no longer calculated on the basis of the whole article, which was the former ECHA interpretation, but of “each of the articles incorporated as a component of a complex product.”
This will affect the way samples are analyzed, the number of analysis to be conducted, and how they are reported at the component level.
How UL Can Help
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