A recent opinion from Advocate General Kokott of the Court of Justice of the European Union concludes that, for articles assembled from component articles, the notification and information obligations for Substances of Very High Concern (SVHCs) apply to each component article and not just the assembled article. This conclusion is contrary to current ECHA guidance and, if the Court adopts the Advocate General’s opinion, this may place additional administrative burdens on product manufacturers, importers and suppliers.
The question for the Court of Justice of the European Union
For an article that is composed of several elements, which amount to articles themselves, do the thresholds for the notification of SVHCs and the supply of information obligations (Articles 7(2) and 33 of REACH, see below) apply to the component articles or the assembled article?
The history: differing approaches by Member States
Under Article 7 of the REACH Regulation, producers and importers of articles must notify ECHA of SVHCs present in articles in quantities over 1 tonne per producer or importer per year, where the substance is present in the articles above a concentration of 0.1% weight by weight. Suppliers of articles with SVHCs at the same concentration have duties under Article 33 to provide information to recipients, and to consumers upon request.
Since the EU REACH Regulation came into force in 2007, there has been disagreement amongst the Member States on whether the 0.1% w/w threshold should apply to the constituent components of an assembled article or to the assembled article as a whole.
The European Commission’s view has been that the 0.1% w/w threshold applies to the assembled article. This view also has the support of the majority of the Member States (the majority view), and is reflected in current ECHA Guidance on Substances in Articles. The Guidance, however, expressly notes the dissenting views of Austria, Belgium, Denmark, German, Sweden and France.
Last year, two French trade federations challenged a 2011 French Ministerial Notice stating that the threshold applied to each component (the dissenting view). The French Council of State referred the case to the Court of Justice of the EU for a preliminary ruling.
Written observations were submitted by the six dissenting Member States and by Norway, Greece, Ireland and the Commission.
The REACH requirements
Article 7(2) – Any producer or importer of articles shall notify the European Chemicals Agency (ECHA) if an SVHC is present in those articles above a concentration of 0.1% weight by weight (w/w) and the substance is present in those articles in quantities totalling over one tonne per producer or importer per year.
Article 33 – Suppliers of articles containing an SVHC above a concentration of 0.1% w/w shall:
- provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article, including as a minimum the name of that substance
- provide that same information to a consumer, on request, free of charge, within 45 days
Article 3(3) 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.
It’s useful to think about it in terms of the examples given in AG Kokott’s opinion:
A bicycle’s handlebars
A bicycle might have plastic handlebars that contain plasticisers on the SVHC candidate list. The 0.1% w/w threshold might be reached for the handlebars, but may not be for the bicycle as a whole.
Seats within an aircraft
The seat covers might contain SVHCs. Does the 0.1% w/w threshold apply to the cover, the seat, or the aircraft as a whole?
AG Kokott concluded that the thresholds applied to the components of an assembled article (the dissenting view).
The Advocate General’s opinion is not binding; it merely provides an opinion for the Court to consider in due course. However, it is often the case that the Advocate General’s opinion is followed by the Court in its final ruling.
If the Court of Justice follows the opinion, then ECHA’s current guidance will require significant amendment and all importers, producers and suppliers of assembled articles will need to reconsider their current supply chain information. They will need to take steps to ensure that they comply with the notification and information obligations for components as well as assembled articles.
What action should you take now?
- Watch this space for the Court of Justice’s ruling
- Review your supply chain communications and information gathering procedures to establish whether you have the data you need at component level. Could you meet the requirements of the enhanced standards suggested in the Advocate General’s opinion?
AG Kokott’s conclusions:
- The producer of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own, but were made or assembled by other producers, is required to notify ECHA if a SVHC is present in the entire article above a concentration of 0.1% weight by weight (w/w).
- The importer of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own is required to notify ECHA if a SVHC is present in a component article above a concentration of 0.1% weight by weight (w/w).
- The supplier of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own is required to provide information to recipients and, on request, consumers under Article 33 of the REACH Regulation on a SVHC if it is present in a component article above a concentration of 0.1% weight by weight (w/w) and relevant information is available to the supplier.
A copy of the opinion can be found here.
What does this mean for business?
If the approach contained in the Advocate General’s Opinion is adopted by the Court, here are some of the potential implications.
Click here to view the table.