On December 17, 2015, the European Chemicals Agency (ECHA) published updated guidance on requirements for substances in articles. The guidance is a “fast-track update” to make “quick” corrections to the guidance so that it conforms to the September 10, EU Court of Justice ruling on a the calculation of levels of substances of very high concern (SVHCs) in articles under the Registration, Evaluation and Authorization of Chemicals (REACH) regulation.
The Court of Justice ruling said that producers must calculate the levels of SVHCs in their products at the level of the “simple” article, rather than at the aggregate level of the “complex” article that was currently being used. The updated guidance confirms that “the substance concentration threshold of 0.1% (w/w) applies to every article supplied. This threshold applies to each article of an object made up of more than one article, which are joined or assembled together.”
The court ruling directly affects the disclosures required under REACH Article 33 requirement. This means that manufacturers must understand and report the presence of candidate list SVHCs (current count is 163) at a much lower level in their products. So rather than disclosing only if the level of an SVHC is above 0.1% by weight of your entire product, manufacturers must disclose its presence for each wire, cable, plastic casing, etc. that contains it above 0.1% by weight.
IPC will offer two workshops in February to help industry understand the changes and offer suggestions in updating regulatory compliance programs.