With a long-awaited decision, the European Court of Justice (ECJ) causes headache and turbulences to manufacturers, importers and distributors of all kinds of products to be placed on the market in the European Union.
The ECJ has just significantly raised the bar on what you need to know about the chemical ingredients of your product. Only few observers expected the ECJ to adopt a far-reaching interpretation of certain information and notification requirements that manufacturers, importers and distributors must observe (file no. C-106/14).
While the EU Commission and most Member States argued that notification and information obligations regarding hazardous chemicals in products only apply to finished products, a group of six Member States, including Germany and France, argued that the need to know applies to each component, down to a screw.
This question is obviously of relevance, as the notification and information threshold of 0.1 % by weight may well be exceeded by smaller components of a product. So far this was considered not to trigger such obligations, as long as the amount of hazardous substance in the finished product itself stayed below the threshold.
The obligation concerns so-called “candidate substances” or “substances of very high concern” (“SVHC”) which are earmarked to be regulated under the EU chemicals scheme REACH. As of today, this list includes 162 substances. The ECJ decision concerned two provisions: Art. 7(2) obliges manufacturers and importers to notify the European Chemicals Agency (ECHA) if they make or import products containing SVHCs in amounts exceeding the weight by weight threshold and a total amount of 1 tonne per year. Art. 33 obliges any supplier of a product containing SVHCs above the 0.1 % threshold to inform his business customers about the presence of such SVHCs, irrespective of the total amount imported annually. In addition, consumers must be informed upon request within 45 business days.
So far, only few importers and distributors may have considered the question: “Do any of the parts which make up my product contain SVHCs in concentrations above 0.1 % by weight?” They will have to reconsider, to be compliant and to avoid claims by competitors, consumer organizations and NGOs, which are likely to test their products for SVHCs.
While EU-based manufacturers may rely on their suppliers who themselves must comply with the notification requirement for the components they produce, there is no third party upon which an importer or distributor of a product may rely regarding such components.
The ECJ decision fits into the general development under EU product regulation to expect, from manufacturers and importers, that they know the chemical composition of their products. Other pieces of regulation that point in the same direction are, to mention only two, RoHS and further provisions under REACH, most recently imposing mandatory thresholds for phthalates and PAH. The new decision further increases the pressure on companies to set up a comprehensive system to manage the substances which are present in their respective products.