A complicated piece of legislation simplified to suit your needs
In 2007, the European Union adopted the Registration, Evaluation and Authorization of Chemicals (REACH) Regulation that regulates substances sold on the EU market. REACH is a very complex regulation that imposes obligations on all parts of the supply chain. According to the Directive, if a substance, preparation or article is not registered for a specific use that substance, preparation or article will not be allowed on the EU market.
REACH imposes additional requirements on manufacturers, importers and users of substances classified as substances of very high concern (SVHCs). These requirements include knowing whether a SVHC is present in your product above a certain threshold and if so notifying the European Chemicals Agency (ECHA). ECHA will update the SVHC list every six months. The current list includes one hundred sixty nine substances and can be found by visiting echa.europa.eu/chem_data/authorisation_process/candidate_list_en.asp. From the SVHC list ECHA will identify substances for authorization under Annex XIV of the REACH Regulation. Manufacturers, importers, and users of substances identified in Annex XIV must apply for authorization of that substance for a specific use in order to continue to place that substance on the market.
On September 10, the EU Court of Justice released a ruling on a case about the calculation of levels of substances of very high concern (SVHCs) in articles under the Registration, Evaluation and Authorization of Chemicals (REACH) regulation. The ruling says 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 is currently being used.
REACH defines an article 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.” In its original guidance on reporting SVHCs in articles, the European Commission suggested that the 0.1% threshold should be based on the weight of the entire article as imported or as provided to the customer. However, six countries (Austria, Belgium, Denmark, France, Germany and Sweden) disagreed with this guidance. The dissenting countries argued that an SVHC that is above the 0.1% level in any individual article (component) within a product may pose a health or environmental risk and should trigger the reporting and communication obligations for the SVHC. The ruling agrees with the dissenting countries’ opinion that the European Commission’s interpretation, as represented in ECHA’s 2011 Guidance, is wrong.
The court ruling directly affects the disclosures required under REACH Article 33 requirements:
Article 33 of Regulation No 1907/2006, as amended, must be interpreted as meaning that, for the purposes of application of that provision, it is for the supplier of a product one or more constituent articles of which contain(s) a substance of very high concern identified in accordance with Article 59(1) of that regulation in a concentration above 0.1% weight by weight of that article, to inform the recipient and, on request, the consumer, of the presence of that substance by providing them, as a minimum, with the name of the substance in question.
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 than they generally currently do, which means far more work and effort. So rather than disclosing only if the level of an SVHC is above 0.1% by weight of your entire product, you must disclose its presence for each wire, cable, plastic casing, etc. that contains it above 0.1% by weight.
On July 27, 2016 the European Chemicals Agency (ECHA) published draft guidance on the application of REACH (Registration, Evaluation and Authorization of Chemicals) to substances in Articles. The new guidance addresses the EU Court of Justice ruling on September 10, 2015 on the that levels of SVHCs must be calculate at the level of the “simple” article, not over the weight of the entire article as imported or as provided to the customer as stated in (ECHA’s 2011 guidance.
A final guide is expected by the end of 2016 or early 2017 and the EU member states are planning a six month enforcement pilot in early 2017.
ECHA draft Guidance on substances in Articles
IPC comments on ECHA guidance
EU court of Justice ruling
IPC REACH Guidebook
REACH: 10,000 Foot Summary
ECHA's REACH Website
Sweden to go Around REACH and Tax Main PCB Flame Retardant