REACH for Article Manufacturers
Note: ECHA has finalized version 4 of the guidance on Requirements for Substances in Articles under REACH. You can download it here. This version incorporates their interpretation of the EU Court of Justice's clarification/correction of the meaning of the term "article". This has an impact on nearly every manufacturer of articles that sells articles (or complex articles or complex objects) in the EU.
REACH is a European Union regulation that effectively hands the chemical industry and their customers' supply chains responsibility for proving that otherwise grandfathered substances are safe and can be handled and managed safely throughout their entire lifecycle. Previously, since the US first developed the chemicals policy defined by the Toxic Substance Control Act (TSCA) in 1976, governments have had the responsibility to prove that grandfathered chemicals in commerce were unsafe. For example, only five substances have been successfully banned under TSCA (and one, the asbestos ban, was overturned). The EU has determined that this form of chemical policy is failing to protect users, consumers, and the general public and, thus, developed and implemented REACH. Other countries like China and South Korea are adopting REACH-like requirements, and recently the Lautenberg Safe Chemicals Act nudged TSCA in this direction.
Articles, and complex objects comprised of articles such as electronics, furniture, toys, and apparel are generally excluded from many aspects of REACH, except for specific obligations, which include:
Substances that are intentionally released from articles and are present, in aggregate, in an amount greater than one metric ton per year must be registered.
Producers selling articles that contain substances listed on the Candidate List of Substances of Very High Concern (SVHCs) over 0.1% weight-by-weight of an article in your product and are present in aggregate quantities greater than one metric ton per year may, under certain rather rare circumstances, have to notify the European Chemicals Agency. There are subtle but important differences between how EU-based and non-EU-based manufacturers and importers are treated for this requirement.
c. Customer Disclosure
Manufacturers, and their downstream sellers like distributors, must disclose any SVHCs that are in your product above 0.1% weight-by-weight to professional and business customers, and provide adequate safe use information to them as necessary. Based on the 10 September 2015 ruling by the EU Court of Justice, manufacturers of complex object that are comprised of articles must disclose based on the presence of the SVHC above 0.1% weight-by-weight of those articles. Note that many component and part types (such as integrated circuits, diodes, electrolytic capacitors, and so on) consist of more than one article. So the calculation may not be as straightforward as the percent weight of the SVHC against the weight of the component/part that contains it. See the DCA article on this topic at TTI's MarketEYE site.
Note that assessing what is and is not an "article" can be complex; DCA provides detailed and customized training on this (and all other aspects of REACH for article manufacturers).
If any consumer asks, manufacturers, or their downstream sellers, will need to similarly disclose the presence of any SVHCs in a product above 0.1% weight-by-weight in any article contained in the product, and provide adequate safe use information to them. "Consumer" is not defined by the regulation, but essentially means anybody besides a professional and business customer.
e. ECHA Disclosure
Article 10 of Directive (EU) 2018/851 amends Article 9, paragraph (1)(i) of the Waste Directive, 2008/98/EC to say that suppliers of articles must (also) provide SVHC information per Art. 33(1) of REACH to ECHA as of January 5, 2021 by loading it into the Substances of Concern In articles, as such or in complex objects (Products), or SCIP, database.
Annex XVII of REACH holds most (but not all) of the more general substance restrictions that are active in the EU. The scope varies with each entry in the annex. Knowledge of this annex by any manufacturer of any substance, mixture, article, component or finished good is critical to ensuring compliance with REACH. How familiar are you with this ever-growing listing? Do you know how it's managed and maintained? Are you aware of how substances are added?
What can DCA Do for You?
DCA can help you learn about and manage the impact of REACH and other EU, national and international regulatory and market requirements, and plan your compliance approach, as well as how you will manage and maintain compliance. From assessing your suppliers' compliance capabilities, to updating key design and procurement supplier and component-related business processes, to identifying and working with you to select and configure a systems solution that tracks material composition, to identifying and resolving potential and actual technical and management risks, we can do it all. Please contact us for more information.