REACH Update: EU Court of Justice Rules on SVCHs in Complex Articles

FANLING, China - Nov. 2, 2015 - PRLog -- The European REACH Regulation (Registration, Evaluation, Authorization and Restriction of Chemicals) [1] is a comprehensive piece of legislation for the management of substances to ensure a high level of protection of human health and the environment.

Under Article 3(3), an article is defined 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.

Under Article 7(2) ‘Notification of substances in articles’, a producer or importer of articles containing a substance of very high concern (SVHC) on the Candidate List is required to submit a notification to the European Chemicals Agency (ECHA) if the following conditions are met:

- The concentration of the SVHC is more than 0.1% in articles and
- The total quantity of the SVHC in articles is greater than 1 ton per producer or importer per year.

Under Article 33 ‘Duty to communicate information on substances in articles’, a supplier of an article containing an SVHC on the Candidate List in a concentration of more than 0.1% shall provide the recipient of the article with sufficient information, available to the supplier, to allow the safe use of the article, including, as a minimum, the name of the SVHC.

European Chemicals Agency Guideline on SVHC

In April 2011, the ECHA published a guideline for substances in articles to assist industry to comply, among others, with Article 7(2) and Article 33 of REACH.  This guidance document revealed that the threshold limit of 0.1% of an SVHC in an ‘article’ applies to the ‘entire article’ (complex article or whole product) at the EU level. The guideline also informed that 7 EU/EEA Member States (MS) (Austria, Belgium, Denmark, Germany, France, Norway and Sweden) have dissenting views on applying the threshold limit of 0.1% of an SVHC to an entire article. The concept by these 7 EU/EEA MS was, in simple terms, ‘once an article, always an article’. The ECHA and European Commission on one side and the MS with dissenting views on the other have not been able to find a consensus on the interpretation of an article regarding REACH duties to inform about SVHCs for operators in the supply chain.

Court of Justice of the European Union Recent Ruling on SVHC Notification

On 10 September 2015, a press release by the Court of Justice of the European Union (CJEU) announced that the ‘Notification’ of an SVHC in an article under the REACH Regulation applies to ‘each article in an entire article’ (each component in an entire article) rather than to the ‘entire article’ when the concentration of an SVHC is more than 0.1%.

The CJEU’s ruling was in line with the 7 EU/EEA MS and contradicted the views adopted by the European Commission and ECHA’s guidance for substances in articles. This ruling was not only restricted to manufacturers and importers in providing information to recipients and consumers of an article but to all economic operators along the supply chain when the economic operator supplies an article to a third party.

The new ruling did not indicate an effective date but can be considered as immediate. Highlights of the new ruling for Article 7(2) and Article 33 of REACH are summarized in Table 1 in the latest Safeguards bulletin while highlights of some illustrative examples on demonstrating how to apply the information duties with reference to the guideline ‘Guidance for Suppliers of Articles – The REACH Duties to inform about Candidate List Substances’ dated July 2013 are summarized in Table 2  in the latest Safeguards bulletin. These do not necessarily reflect the current understanding of the ECHA or European Commission.

Operators along the supply chain must now re-evaluate the risk of their products containing > 0.1% SVHC at the component article level and resulting duties to communicate information in the supply chain or provide a notification. Also, ECHA’s information on SVHCs in articles must be treated with care since the provided information from notifications is based on the interpretation of an article which was overruled.

Reference:

[1] The European REACH Regulation (Registration, Evaluation, Authorization and Restriction of Chemicals) (http://echa.europa.eu/web/guest/regulations/reach/legisla...)

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