The new REACH chemical regulation puts obligations on the importer or manufacturer of an article in the EU depending on the concentration of substances in contains. Final draft guidance has just been published.

A Commission Working Group as part of REACH Implementation Project 3.8 (Requirements for articles) has been working on guidance for importers and manufacturers of articles. A final draft of this guidance was circulated to stakeholders in December.

Substances in articles - notification and provision of information. How to define the concentration limit
REACH requires notifying the authorities (Article 7(2)) or informing customers (Article 33) of the presence of a substance in an “article” (e.g. an electronic component, an assembly, or a finished product) under certain circumstances. In both cases, one of the criteria is if the concentration of the substance is greater than 0.1% by weight. As with the RoHS Directive there has been much debate concerning how this percentage is defined - by homogeneous material is one option as used by RoHS, another is as a proportion of the whole article.

With respect to the percentage definition, the guidance states the following:

“The substance concentration threshold of 0.1 % (w/w) applies to the article as produced or imported. It does not relate to the homogeneous materials or parts of an article, as it may in some other legislation, but relates to the article as such (i.e. as produced or imported).”

This clarifies that the percentage applies as a proportion of the article. Thus the obligations which arise in some cases will depend on at what stage of integration a product is imported into the EU. If the substance is imported as part of a small component it may be above the 0.1% limit but if imported as part of a larger finished product it may be well below the limit. The guidance gives an example to illustrate this point:

“If buttons for jackets are imported which contain such substance in concentrations of 0.5% (w/w), this needs to be communicated to the recipient. If these buttons are imported as part of jackets the concentration of the substance in relation to the imported article (the jacket) will probably be lower than 0.1% (w/w) and in that case no information would have to be communicated.”

Other issues covered by the guidance - packaging of articles, intentionally released substances, and more
The guidance also addresses issues such as whether articles and packaging are to be considered separately, registration of intentionally released substances and how to understand “intentional release”, and the interpretation of borderlines cases such as car batteries whose contents could be seen as a separate substance or part of the battery itself - an important issue in terms of defining the legal obligation that arise.

For more on understanding these issues read the full version of this article in Issue 38 of RE4view, ERA’s environmental newsletter providing up to date and expert analysis of all environmental regulations affecting the electrical product sector worldwide; RoHS, WEEE, REACH, EuP etc. To learn how to subscribe click here , phone +44 (0)1372 367444 or email.