While the European Union’s REACH regulation (formally, Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals) has been in force for nearly two years, it is rolling out in a slow and determined fashion. In October 2008 the European Chemicals Agency (ECHA) produced the first candidate list of 15 substances of very high concern (SVHCs). Last spring, in early June, seven of those substances were prioritized to be the first to go through the authorization process. This is the next step towards possible future restrictions for these substances. Then, in early September the second list of 15 proposed candidate SVHCs was issued and 14 of these substances were then added to the candidate list of SVHCs in mid-January this year. What is next and what does all this mean to manufacturers of electronic components and products?
The key concerns for non-EU-based manufacturers of components and discrete products – termed “article manufacturers” in REACH – are twofold:
- Understanding which substances must be disclosed to customers downstream in the supply chain if they are present in the product you are selling in amounts greater than 0.1% by weight (of the entire article), and
- Knowing when restrictions come in to play
EU-based manufacturers must also be concerned with substances that are going through the authorization process and whether their supply chains must replace these substances or should apply for an authorization to allow continued use.
All substances on the candidate list that meet the concentration requirement described above must be disclosed directly to your immediate customer in the EU, unless that customer is an end-user/consumer. Today there are 29 substances (some have more than one CAS number; for instance, hexabromocyclododecane has several “diastereoisomers” – certain atoms, in this case bromine, can have different sets of locations on the molecule, resulting in different configurations  and therefore different CAS numbers) you will have to disclose the presence of those substances in your products per article 33(1) of the REACH regulation.
ECHA has said it intends to produce new candidate lists of SVHCs twice a year from now on, with the next proposal coming out in the February/March timeframe – it may in fact be published by the time you read this. It will then go through a 45-day stakeholder consultation process where you can provide technical – not editorial –comments on why substances should or should not be considered for the actual list. Some time after that, some or all of the proposed substances will again be added to the candidate list of SVHCs.
The candidate list of SVHCs identifies candidates for the Authorization process. The authorization process defines a timeline for prioritized SVHCs to be “sunsetted”, or restricted. If a (EU-based) manufacturer wants to continue to use a prioritized SVHC beyond the sunset date, they must identify the source of the substance that (pre)registered it in their supply chain, and have them apply for an authorization for your (and all their other customers’) specific use. The authorization process will not be easy; it will require a fee to be paid, and justifications based either on socio-economic impact (e.g. replacement substance is too expensive or unavailable) or adequate control of exposure during the substance’s lifetime, including and after disposal. Suppliers may decide not to apply in which case the manufacturer may have to find another source or reformulate the product, or move production outside of the EU (though, as pointed out above, that might only delay the inevitable). As I write this in late January we are awaiting both guidance documents for industry on the authorization process, and the Commission’s documentation officially modifying REACH Annex XIV to officially include some or all seven SVHC substances as proposed by ECHA.
Note that importers of articles (functional components, electronics, wires, cables, connectors, etc…nearly everything in the electronics world except individual chemical substances like pure solvents, or formulations such as adhesives, solder, or bar stock) are effectively exempt from the authorization process, so they can still export product to their EU markets that contain sunsetted substances after the sunset date. However, don’t expect this “loophole” to provide indefinite freedom to continue shipping. Article 69 of REACH allows ECHA and the EU Member States to directly apply restrictions to imported articles, so expect that process to be started soon after the sunset dates start occurring.
While this new, and very different, chemical policy might seem to be slow in rolling out, do not expect it to stay that way. These are new processes that the ECHA and the EU Member State chemical and enforcement agencies are essentially running through their paces. Once they better understand the resource requirements and work out any kinks in the processes of candidate list definition, substance authorization and restriction, and enforcement, expect the lists of candidate SVHCs and prioritized SVHCs to rapidly become more voluminous. This does today, and will tomorrow. require a deeper understanding by manufacturers of what substances are in your products, in what quantities, and what their toxicity profiles are. If they meet the definition of SVHCs (see article 57 in REACH) and are generally used in high volume (since it’s likely these will get ECHA’s attention more quickly than low volume SVHCs), you may consider getting ahead of the process by prioritizing these substances (based, for instance, on relative toxicity), and reformulating products or designing out offending components as soon as is practical. In addition to reducing business and fiduciary risk, you may also gain a marketing advantage by doing so.
DCA produced an in-depth, 2 ½ hour webinar on REACH for article manufacturers on December 16, 2009. You can gain a deeper understanding by viewing this webinar and downloading the associated slide set. Please visit the DCA website for more information.
- See, for example, Heeb, et al., Structure elucidation of hexabromocyclododecanes — a class of compounds with a complex stereochemistry, Chemosphere 61 (2005) 65–73, at http://www.empa.ch/plugin/template/empa/*/54786/—/l=2
Michael Kirschner is president of Design Chain Associates, LLC, a consultancy that provides services that help Electronics OEMs and other product manufacturers increase engineering, procurement, and production efficiency, product and operational environmental performance, and corporate profitability by ensuring that the right decisions about supply base and the environment are made during the earliest stages of the product lifecycle, and are built-in to corporate strategies and tactics. Contact Mike at (415) 904-8330 or mike @designchainassociates.com.