Chemicals Law Update - February 2015

REACH update: Advocate General’s opinion on the application of the 0.1% threshold for substances in articles

On 12 February, Advocate General Kokott of the EU’s Court of Justice issued an opinion on the interpretation of the 0.1% SVHC concentration threshold in articles under the REACH Regulation. Below, we set out the context and the key takeaways.

The ongoing debate between Member States as to the correct application of this threshold has been a cause of considerable uncertainty. This opinion, although providing further guidance, could result in an additional administrative burden for product manufacturers and importers.

Background

There has been a debate for many years as to whether the 0.1% Substance of Very High Concern (SVHC) notification and information communication obligations (in Article 7(2) and 33 of REACH respectively) apply to articles as a whole, or to ‘component’ parts. A classic example is a bicycle whose plastic handlebars contain plasticisers on the SVHC ‘candidate list’: the 0.1% (w/w) threshold may be met in respect of the handlebars, but would unlikely be met for the bicycle as a whole.

The case and the Advocate General's opinion

The case was brought by two French trade federations against a 2011 French Ministerial Notice stating that the 0.1% threshold was to apply to each component part (France being one of the ‘dissenting’ Member States).

The matter has now reached the EU Court of Justice where Advocate General Kokott has given her opinion. The opinion concludes as follows (assuming that the other conditions in Article 7(2) REACH are met):

‘Producers’ of entire articles (made up of component parts) should notify ECHA where a candidate list substance is present in the entire finished article above 0.1%;
‘Importers’ of entire articles (made up of component parts) should notify ECHA where a candidate list substance is present in the component part above 0.1%; and
‘Suppliers’ of entire articles (made up of component parts) should provide information to recipients, and, on request, to consumers under Article 33 of REACH where a candidate list substance is present in the component part above 0.1% and relevant information is available to the supplier.

A full copy of the opinion can be found here.

Divergent Member State approaches

Member States have, to date, taken divergent views on these provisions. The Commission and the majority of Member States have supported the application of the 0.1% threshold to the article as a whole. However, certain ‘dissenting’ Member States, including Belgium, Denmark, France, Germany, Norway and Sweden, have campaigned for this threshold to apply to component parts. Clearly, application of the 0.1% threshold to component parts will require more ECHA notifications, and a higher number of supply chain communications.

Next steps and take-away

The Advocate General’s opinion will now be considered by the Court before final judgment is given. More often than not, the Advocate General’s opinion is followed, although it would be speculation to comment what will happen in this case.

The take-away for companies impacted by REACH, particularly manufacturers and importers of articles, is that they should:

monitor the final judgement of the EU Court of Justice in this case;
review their current REACH notification and information communication processes to see whether they are in compliance with this enhanced standard; and
consider how, in practice, they will obtain the relevant information on candidate list substances from their suppliers.

A selection of our team's chemicals experience includes advising:

article manufacturers on REACH, including: registration of substances in articles, notification of SVHCs in articles, customer / consumer communications and supply chain risk management
a chemical manufacturer on an Ozone Depleting Substances, REACH and CLP warranty and indemnity claim
a clothing manufacturer on the new ‘treated article’ provisions of the Biocidal Products Regulation
chemicals manufacturers on the new phase-down requirements under the F-Gas Regulation and CLP Regulatory issues
U.S. importer on pan-European RoHS notifications
U.S. electronics manufacturer on an EU regulatory landscaping and compliance project

In addition, members of our team have previously advised on REACH consortium agreements, disputes over data usege and REACH matters in corporate transactions.