17 Mar 2018
On September 10, 2015, the European Court of Justice (ECJ) released a ruling stating that the 0.1% threshold for notifying SVHCs in articles applies to “each of the articles incorporated as a component of a complex product” as a replacement for of the entire article as was the mandate earlier. This further implies that European Chemicals Agency( ECHA )will have to revisit the ‘article’ definition for REACH Regulations (1907/2006).
As part of the breakthrough change, the court mentioned that “the REACH Regulation’s definition of an “article”, taken together with the lack of any provisions specifically addressing the situation of a complex product containing several articles, means “there is no need to draw a distinction between the situation of articles incorporated as a component of a complex product and that of articles.”
The Advocate General, last year ( 18th February, 2015) had opined to ECJ that the 0.1% threshold should apply to each component separately and not to the whole article. Since the verdict has now been endorsed completely without any modifications by ECJ, REACH compliance will get stricter for companies selling products in the EU market. This would further result in increased compliance burden for manufacturers, importers and distributors differently, thereby ensuring that companies get their practices in line with the modified regulation.
ECJ’s decision comes in line with the views of the 5 EU member states and Norway (member of European Economic Area-EEA) but it contradicts the earlier view adopted by EC and ECHA.
As per REACH, when the article contains an SVHC in a concentration >0.1% then manufacturers should provide the information about the inclusion and safe use of the chemicals to the customers. Now after the ECJs ruling, the 0.1% threshold is no longer calculated on the basis of the whole article (former ECHA interpretation) but of “each of the articles incorporated as a component of a complex product.”
This ruling will have a huge impact in the manufacturing industry as it increases the burden of REACH compliance in companies at a deeper and complex level. It will affect the way samples are analyzed (at the component level), the number of analysis to be conducted, and how they are reported under REACH to become compliant.
There will also be a substantial impact on REACH documentation, since manufacturers of finished electronic products will need to have a REACH declaration for each individual component before the complete product could be declared. Some manufacturers may need hundreds of declarations from their suppliers so as to confirm their products as ‘not containing SVHC’.
With respect to SVHC notification, EU producers and importers would have to notify listed SVHC’s above the threshold in each component (possibly including sub-assemblies) they produce/import and in the article as a whole. Suppliers or downstream users have to collect declarations from the producers for the products they supply (and each component the product contains, if required) and pass it to the customers.
A person supplying a product with one or more constituent articles containing an SVHC above the threshold will have to make sure that he receives all the required declarations for the article as a whole and for each component inside the article from the manufacturer. So in fact the enquiries to manufacturing companies will increase in huge number as a result of this ruling of ECJ and the compliance burden would thereby drastically increase in the testing as well as documentation side for the manufacturers of finished electronic products.
For the future, lots of clarifications and guidance required from ECHA for manufacturers on how to handle the new changes in REACH and the guidelines needs to be modified by ECHA.