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Dr Reach - Claiming due diligence for substances in articles

At times, there appears to be no end to REACH. On the one hand, it is important to avoid reading too much into the legal text. On the other hand, clarifications resulting from detailed analyses are critical to interpretation and implementation.

Perhaps this dichotomy is best illustrated by the requirements relating to Candidate List substances of very high concern (SVHCs) in articles. To date, the corresponding guidance on articles is the only RIP-derived document that has had objections from certain Member States formally referenced and published as "dissenting views".

Article 33 of REACH appears to have catalysed a necessary clarification: how to determine the 0.1% w/w of a Candidate List substance in an article. Article 33 was an amendment put forward in at least four different possible variations by the European Parliament. It appeared to have disappeared, until the last minute when it was re-introduced and incorporated in the legal text.

SVHC obligations

With direct and immediate effect, Article 33 impacts global supply chains. As soon as a substance is added to the Candidate List, its presence if above 0.1% w/w must be communicated under REACH.

The only other clause in the Regulation that specifically relates to SVHCs in articles above 0.1% w/w is Article 7. By contrast to the immediate obligations triggered by Article 33, the notification requirement in Article 7 only starts from 1 June 2011. In addition, there are various limitations to the scope of Article 7, such as tonnage, exemptions to Title II (eg medical devices, food packaging), and exclusions if a substance is already registered for a given use.

ECHA has launched a project to review the current REACH guidance on articles and to propose methods for compliance (CW 12 March 2009). It remains to be seen to what extent this is successful in resolving the dispute over whether the determination of the percent weight/weight fraction of a substance in an article applies based on the total weight of an article or at a component or material level.

Variations in references to articles exist through the legislation. Under Article 33, the requirement refers to 'article' rather than 'articles' as in Article 7. Restrictions in Annex XVII refer to 'articles and components of such articles', 'articles or the components of the articles', 'finished articles or components of articles'. There are also certain provisions relating to parts or materials of an article that may be treated with a substance, such as a dye, plasticiser or flame-retardant.

Fundamentally, the objective of Article 33 concerns the communication of information to allow safe use of an article. Based on this premise alone, it could be deduced that the mass fraction relates to the exposure potential of a substance in an article.

Therefore, the mass fraction may apply to that part of a material that comes in direct contact with a consumer, for instance, or that is subject to particular conditions that may result in the release of the SVHC. This follows the premise established in legal recitals that information collection should extend as far as 'reasonably necessary' and that this is part of a wider 'responsibility'. This would also appear in line with the rationale behind many of the initial Article 33 proposals.

However, only one of the four amendments specifically stated that the 0.1% threshold applies to a homogeneous part of the article. But this was not the version that was ultimately adopted. Consequently, the lack of reference to specific parts or components compared to the original proposals and other parts of the regulation give weight to the potential application at a total article level. In any case, the European Commission's legal services have stated that the requirement applies to the whole article.

For compliance testing, the ability to sample and test the % w/w yields further conclusions. Test methods may refer to components or may only be relevant to certain material systems. Obtaining a representative cross-section of material can also limit options.

Practical considerations

Ultimately, practical considerations could determine how the Article 33 requirement is implemented. Firstly, a SVHC often may not be present in a material at all, simply because it is not chemically compatible or necessary. Secondly, where it is in a material, the presence will typically be far below or far above the 0.1% w/w threshold at that material level. Thirdly, responding to questionnaires and issuing declarations requires co-ordination of interpretation through the supply chain. And of course, the obligations pivot around 'available information' - at least for Article 33 (but not Article 7).

What emerges is a need for a 'due diligence' approach to managing SVHCs in articles. Regulators may rightly point out that there is no such clause in REACH, unlike in the EU Directive on the restriction of hazardous substances in electrical and electronic equipment. Nevertheless it is a powerful principle that provides a practical tool.

Under due diligence, a company sets out its assessment and management systems. When reasonable steps and precautions are taken, this offers security and defence. Often this forms an important component of insurance and protection against potential litigation based on claims of negligence. Specific actions under the approach may therefore differ between companies, products and supply chains, yet still achieve an equivalent level of safety and be regarded as compliant.

Debate this issue with Dr Reach:

Dr Steffen Erler invites Chemical Watch readers to send comments to: steffen@chemicalwatch.com. A selection will be posted at Dr Reach for all our readers to view. Your comments can be posted anonymously upon request.

Legal Disclaimer The information contained in this communication follows a technical interpretation of REACH to serve as a thought-starter for discussions; it does not constitute legal or any other form of advice. Note that technical aspects are subject to review and references should be checked for updates. The legal text of the REACH Regulation must serve as the basis for REACH compliance and it may be advisable to seek legal and/or other expert advice on any given issue. The author and Chemical Watch accept no liability whatsoever with regard to the use of information contained in this communication.