By Dr Paul Goodman, RINA Consulting, knowledge partner with Compliance & Risks

EU FlagbThe guidance on substances in articles is having to be amended because of the ruling of the European Court of Justice (ECJ) of September 2015, on the definition of articles when complying with Article 33 of the REACH Regulation. Article 33 requires suppliers to provide recipients of articles that contain a Substance of Very High Concern (SVHC) at >0.1% with safe use information.

The European Chemicals Agency (ECHA) produced “fast-track” guidance to change the original guidance in December 2015 to comply with the ECJ’s ruling and since then has published at least three new versions of guidance, the most recent in June 2017. There were significant changes between the first which was published in July 2016 and the version published in February 2017, but there far fewer changes between the February 2017 and June 2017 versions.

The main message of the guidance is still the same; suppliers must provide information on SVHCs at >0.1% in the simplest articles. For example, a through-hole capacitor may contain terminals, film and an enclosure, all of which are articles and SVHC information needs to be obtained for all of these simple articles. The guidance admits that compliance with article 33 for very complex articles is difficult and will be time consuming, but is still required.

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