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”. This is also commonly referred to as “once an article, always an article”.
Applicable REACH Articles
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:
- Article 7(2) (“Notification”) states that article producers and importers must notify ECHA if:
- A SVHC is present in articles over one tonne per producer or importer annually, and
- A concentration higher than 0.1% by weight.
- Article 33 (“Communication”) requires companies to communicate information on Candidate List substances above 0.1% concentration within articles to any article recipients (such as industrial or professional users and distributors). It also requires a reply within 45 days if asked by consumers about the presence – above 0.1% concentration – of SVHC in their products.
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”.
Complex Objects and Very Complex Objects
The 2015 ECJ court ruling and updated guidance also introduced two new terms:
- Complex objects, which refers to any object made up of more than one article.
- Very complex objects, which refers to a further combination of simpler complex objects.
Two examples from ECHA of how articles can be incorporated into complex objects and very complex objects include:
- Articles mechanically assembled, such as a pair of metallic scissors or foldback clips
- Joining together two or more articles using substance(s)/mixture(s), such as a block of sticky notes, glued chip in a bank card, or an unpainted bicycle frame formed by welding together multiple steel tubes.
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. 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.
How can Anthesis help?
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:
- Collecting full material disclosure from suppliers – this has emerged as a best practice for leading manufacturers and OEMS. It eliminates the need to regularly query the supply chain every time the REACH SVHC list is updated.
- Collect supplier declaration – this is an easier requirement for most suppliers, but requires regular maintenance and continuous interaction every time the SHVC list is updated.
- Execute risk assessment of the articles containing one or more of the current SVHC – this is the most laborious solution since it requires knowledge of the materials in all of the articles of a complex object, as well as information about which materials one would expect to find usage of SVHC. Often, without confirmation from the supplier, many materials can pose some risk of containing one or more SVHC. In addition to these issues, just like collecting supplier declarations, this exercise must be repeated regularly to account for newly added SVHC.
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.