Principal Consultant Adam Wheeler discusses ECHA’s revised ‘Guidance on requirements for substances in articles’ and the next steps for article manufacturers and their suppliers.
The European Chemicals Agency, commonly known as ECHA, has (finally!) published their revised Guidance on substances in articles for REACH (June 2017, Version 4.0). The main driver for this update was the 2015 European Court of Justice (ECJ) ruling that “each of the articles incorporated as a component of a complex product is covered by the relevant duties to notify and provide information when they contain substances of very high concern (SVHC) in a concentration above 0.1% of their mass”[1]. This is also commonly referred to as “once an article, always an article”.
The revised guidance provides more clarity and illustrative examples to determine applicability of registration, communication and notification obligations of substances in articles, as well as complex objects and very complex objects. The two primary provisions that apply to manufactured products that are articles under REACH are:
These obligations start by determining what an article is and, subsequently, whether there are any SVHC within the article exceeding the 0.1% threshold. Per the REACH Regulation, “article means 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”[2].
The 2015 ECJ court ruling and updated guidance also introduced two new terms:
Two examples from ECHA of how articles can be incorporated into complex objects and very complex objects include:
Further information on these terms can be found in section 2.4 of ECHA’s guidance. In some cases, a combination of articles may form new articles if they meet the definition from the REACH Regulation (referred to previously). Specific examples are available in Appendix 5 of the guidance, and demonstrate how a very complex object may be broken down to the article level. These examples highlight the increased granularity that is required under the new article definition interpretation.
ECHA has also established a working group to develop a pilot project on substances in articles, with a target to implement this in Quarter three of 2017[3]. With the final chemical substance registration deadline nearing for phase-in substances, our speculation is that ECHA will have more bandwidth to focus on these article requirements. Moreover, ECHA also expressed a desire to grow the SVHC list even quicker than before, while maintaining the bi-annual updates, which would put all the more burden on manufacturers.
As the guidance pushes for manufacturers to identify SVHC at a component part level, so does the demand to execute more thorough risk assessments and to collect detailed SVHC concentration information from the supply chain. Anthesis can help manufacturers establish a REACH compliance system through a combination of the following approaches:
Anthesis has the expertise, experience, and resources to implement a systematic approach for engaging and training suppliers on completing material declarations, collecting and evaluating declaration for completeness and accuracy, and executing risk assessment for materials lacking supplier input. If you’d like to know more get in touch with Adam, or alternatively, use our fill out form below.