Regulatory Developments

ECHA Updates Guidance on Substances in Articles

April 5, 2011 PRINT

On April 1, 2011, the European Chemicals Agency (ECHA) announced the availability of an update to the Guidance on Requirements for Substances in Articles. The update replaces the previous Guidance. Beginning June 1, 2011, companies must notify to ECHA substances present in articles they produce or import that were included on the substances of very high concern (SVHC) Candidate List before December 1, 2010, if both of the following conditions are met:

  • The SVHC is present in those articles at a volume of >1 metric ton per manufacturer/importer per year; and
  • The SVHC is present in those articles above a concentration of 0.1 percent weight by weight (w/w).

The Guidance describes the registration, notification, and communication requirements related to substances in articles, and is intended to help producers, importers, and suppliers of articles to identify and fulfill their legal obligations. The Guidance explains how to check if a substance is already registered for a use and therefore whether a registration or notification is needed. Examples of borderline cases, such as blasting grits and wax crayons, are provided. The Guidance also explains how companies can predict the inclusion of substances in the Candidate List for authorization.

According to ECHA, the updated Guidance further clarifies the decision-making process as to whether an object is an article. The updated Guidance maintains the European Commission's view, as well as that stated in the previousGuidance, that the threshold of 0.1 percent w/w applies to the article as a whole. Six member states (Germany, France, Sweden, Austria, Belgium, and Denmark) and Norway advocated a dissenting minority view pertaining to the threshold of each component in an article. The updated Guidance includes a letter from ECHA Executive Director Geert Dancet noting that it "did not find full support by consulted national authorities of EU/EEA Member States in the stage of its final consultation," and, consequently, "companies may face diverging enforcement practices as to some of its aspects." More information is available online.


 
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