ECHA to Update Hazardous Substance Threshold Guidance

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By Stephen Gardner

Sept. 11 — The European Chemicals Agency (ECHA) Sept. 11 confirmed that it will update guidance for companies that sell in, or import into, the European Union products that contain hazardous substances in the wake of an EU Court of Justice ruling on notification thresholds.

The ECJ ruled Sept. 10 that an obligation for companies to notify the agency if chemicals considered “substances of very high concern” (SVHCs) under the EU's REACH regulation appear in their products in volumes of more than 0.1 percent by weight, applies not only to complex products, such as automobiles, but also to their component parts.

The ruling, which overturns previous ECHA advice on the issue, will mean that potentially many more importers into the EU of products, or “articles” in REACH terminology, will be caught by the notification provision.

Under Article 7 of REACH (Regulation No. 1907/2006 on the registration, evaluation and authorization of chemicals), SVHC-in-article notifications to ECHA must include information on the substance identity and classification and a description of its use in the article.

ECHA issued guidance in April 2011 that said the notification obligation applied only to complex products and not to their component parts. The chemicals agency acknowledged, however, that some EU countries believed the obligation also should apply to component parts and that companies could voluntarily report uses of SVHCs in components.

France's Conseil d'Etat in March 2014 asked the ECJ to rule on the issue after two business federations challenged the French interpretation of the threshold, which was that it should apply at the component level.

‘Article’ Clarified

The ECJ ruling applies to the 163 substances that are currently on the ECHA SVHC list. Substances of very high concern are candidates for bans in the EU because of their hazardous properties.

ECHA told Bloomberg BNA in a statement that the court ruling meant that the 0.1 percent threshold applies to components of a complex article “as long as these [component] articles keep a special shape, surface or design, or as long as it does not become waste.”

The chemicals agency said it would revise REACH guidance and the parts of its website that provide information on the issue, but could not say when the revision would be completed.

Current guidance would not be withdrawn because it “includes also sections which provide advice on other issues which are not impacted by the 0.1 percent threshold,” ECHA said.

Notification Exemption 

Ruxandra Cana, a partner with attorneys Steptoe & Johnson LLP in Brussels, told Bloomberg BNA Sept. 11 that the ruling would affect companies importing or supplying articles in the European Union that incorporate SVHCs in ways that are not covered by the safe-use descriptions in the relevant REACH registration dossiers.

Under REACH, suppliers of substances subject to registration must include information in their registration dossiers setting out how substances can be used safely in different applications.

The chemicals agency confirmed that importers of articles “do not have to notify ECHA if the substance has already been REACH registered for the same use.”

It added, however, that “in practice, it appears to be difficult” for importers of articles into the EU to find out if their uses of an SVHC are covered by the registration dossier and therefore to “assess whether they can actually use this exemption provision.”

ECHA has received the relatively low number of 335 notifications of SVHCs in articles. Cana said the exemption for SVHC uses already covered in registration dossiers was the “most important factor in the low number of notifications.”

Case-by-Case Assessment

Cana said for uses of an SVHC to which the exemption does not apply “it remains a question of assessment on a case-by-case basis.”

Importers of articles into the EU would have to look at component parts to see if they meet the definition of an article, which is that it keeps “a special shape, surface or design” within a complex article, she said.

Lucas Bergkamp, a partner with Hunton & Williams LLP in Brussels, told Bloomberg BNA that the court ruling would “add to the compliance burden and make the analysis more granular and complicated” of whether or not notifications should be submitted.

The judgment was “not a pragmatic decision,” he said.

The European Commission, the EU's executive arm, said in a statement to Bloomberg BNA that it “acknowledges the ECJ ruling and will analyze it in detail, working with ECHA and member states to implement the judgment and consider the revision of guidance.”

To contact the reporter on this story: Stephen Gardner in Brussels at correspondents@bna.com

To contact the editor responsible for this story: Greg Henderson at ghenderson@bna.com

Information from the European Chemicals Agency on notification of SVHCs in articles is available at http://bit.ly/1ij6FTQ.