Calculating the 0.1% (w/w) threshold for complex articles under REACH

Spotlight
15 March 2015

In her opinion of 12 February 2015, Advocate General Kokott has advised the Court of Justice with regard to the calculation method for the 0.1% (w/w) threshold, above which producers, importers and suppliers of articles must fulfil certain obligations under REACH. Member States disagree concerning the calculation method. Advocate General Kokott mainly endorses the minority view, which Belgium supports along with some other Member States.

REACH obligations are for the most part linked to chemical substances on their own. Indeed, once a chemical substance has been integrated into a product, the greatest danger for the environment and human health seems to be out of the way.

Some substances that are known for their hazardous properties, however, are the subject of an obligation to provide information and a notification obligation, even after they have been integrated in a product.

However, those hazardous substances which are included on the candidate list for authorisation need to be present in the product in a sufficiently high concentration. Only if the substance occurs in a concentration of more than 0.1 per cent by weight (w/w), is the supplier of the product required (i) to provide information to its customers on the safe use of the product, including at least the name of the substance (Article 33 REACH), and (ii) to notify some limited information regarding the substance to the European Chemicals Agency (Article 7(2)–(4) REACH).

REACH does not refer to products, but articles. An article is 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 (Article 3(3) REACH). Taken together, a number of articles can constitute another article, which is then a complex article. For example, a car tyre is a component article which, together with other articles, forms a car, the complex article. The car tyre itself is also made up of component articles (rims, etc.).

One of the main points of discussion under REACH relates to the method of calculation of this threshold of 0.1%. The majority of Member States – supported by the European Commission – only take into account the entire, complex article and not all the parts thereof (the component articles) when calculating the threshold. A minority of Member States – Belgium, together with Austria, Denmark, France, Germany and Sweden – verify whether the threshold has been exceeded for each component article of the complex article.

The French Council of State ("Conseil d'État") submitted the dispute to the European Court of Justice with the following preliminary question: "Where an 'article' within the meaning of the REACH Regulation is composed of several elements which themselves meet the definition of 'article' in the regulation, are the obligations resulting from Article 7(2) and Article 33 of the regulation to apply only with regard to the assembled article or with regard to each of the elements which meet the definition of 'article'?".

In her opinion of 12 February 2015, Advocate General Kokott advised the Court of Justice, making a distinction between the obligation to notify under Article 7 of REACH and the obligation to provide information under Article 33 of REACH.

The notification obligation applies to both producers and importers of articles. A producer of an article manufactures or assembles an article within the European Economic Area (EEA), while an importer of an article imports an already finished article (which it can still use as a component for a complex article) from outside the EEA.

According to Advocate General Kokott, the producer of an article only needs to notify if a concentration of more than 0.1% is present in the entire, complex article. The importer of an article, by contrast, needs to notify each component article in which a concentration of more than 0.1% of the substance is present. The reason for this difference is the following: If a producer uses component articles as components for its article, those components will already have been notified earlier in the supply chain, by the producer or importer of the component article. This is not the case if an importer imports a complex article. Accordingly, the importer itself still needs to notify the component articles.

The information obligation rests on each supplier: not only on producers and importers of articles, but on all subsequent actors in the supply chain, such as distributors and retailers, as well. Each supplier of an article is at the same time the supplier of the component articles of which the article consists. As a consequence, a supplier must necessarily, at least according to Advocate General Kokott, provide customers with the required information for the component articles as well, provided that the threshold has been exceeded within that component article.

The principle of proportionality requires, however, that no unreasonable information obligations are imposed. The information obligation would thus be subject to that information being known to the supplier. This interpretation of Article 33 REACH was never before pointed out by Member States. Until now, it was always assumed that a supplier which does not receive sufficient information from its supplier must itself investigate the article in order to determine whether dangerous substances are present in a concentration that exceeds the threshold. This would thus no longer be necessary, although the supplier would then at least have to point out to its customers that it had not received any information concerning the presence of dangerous substances.

We will have to wait and see whether the Court accepts the viewpoint of Advocate General Kokott.