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Are you fulfilling your ‘substances of very high concern’ obligations?

Does your business supply furniture, clothes, jewelry, newspapers, plastic packaging, tools or other ‘articles’ in the EU? If so, are you aware that you might have obligations under the European REACH legislation?

Many companies affected don’t realize these obligations apply to them, so our Senior Regulatory Consultant Pearl Nemeth explains not only your legal obligations so that you can ensure your reputation isn’t put at risk through non-compliance, but also why it can be an opportunity to review your products to have earlier insight to potential challenges.

In early March, the European Chemicals Agency (ECHA) released a 3-month public consultation on its draft 8th recommendation for the inclusion of a further 7 substances in the Authorization List (Annex XIV) of REACH. Inclusion of a substance in Annex XIV is the end of a long and onerous regulatory process, firstly identifying and then prioritizing substances of very high concern (SVHC) to require Authorization for use after a so-called sunset date. Application for Authorization itself is a complex and expensive exercise, meaning it’s easy for affected companies to focus only on this final step. However, by doing so, companies are sometimes missing other legal obligations which are prompted earlier than this stage. In this blog, I’m focusing on stage 2 of the diagram below: the required legal obligations from the moment a substance appears on the candidate list.

journey to authorization

Click image to enlarge – The journey to the Authorization List. Modified from ECHA source

Currently, there are 173 substances on the candidate list, but the SVHC Roadmap[1] gives an EU-wide commitment for having all relevant currently known substances of very high concern (SVHCs) included in the Candidate List by 2020[2]. The candidate list, and therefore the number of the substances which trigger the following obligations, is expected to grow significantly.

What are these obligations?

  • Suppliers of substances on the candidate list must provide a Safety Data Sheet (SDS).
  • Suppliers of mixtures not classified as hazardous themselves, but containing at least one substance on the candidate list (above 0.1%), must also provide an SDS upon request.
  • Suppliers of articles containing over 0.1% of a candidate list substance should provide sufficient information to allow safe use. This means, as a minimum, upon a customer’s request, the name of the substance the article contains is to be disclosed within 45 days. Companies have been caught out for not meeting this obligation in the past, and failing to comply is a reputational risk.
  • Producers and importers of articles must notify ECHA if their article contains over 0.1% of an SVHC, and if the total quantity per producer/importer is greater than 1 tonne. They must provide this notification no later than 6 months after inclusion on the candidate list. They are exempted however, if exposure to humans and environment during use and disposal can be excluded or the substance has been registered for that use.

The first two obligations concern companies trading in the chemicals sector, meaning these companies are most likely to already be aware of their obligations to REACH legislation.

The second two, however, relate to articles such as clothing, flooring, furniture, jewelry, newspapers, tools and plastic packaging. Companies dealing with such items are usually further down the supply chain from those that consider themselves to be the ‘chemical industry’ and so might not be aware of these obligations, or know exactly what substances are present in their products, and in what concentration exactly.

The above obstacles may be part of the reason why (according to ECHA’s Report on the Operation of REACH and CLP 2016) this information providing obligations of the article producers and importers do not work very well in practice:

‘There are clear indications that the information on substances is not adequately communicated in the article supply chains. In this context, it is important to note that in 2015 ‘chemical risk’ was the most reported safety concern under the EU’s rapid alert system, accounting for a quarter of notifications, with 62% of all flagged products originating from China’[3]

So, how can you make sure you’re following the rules?

To comply with your obligations for chemicals on the candidate list, you could potentially need to provide information to ECHA on their identification, composition, and classification, as well as the volume, production sites, identified use, and form in the supply chain (including a description of the article, its concentration, which part of the article has the substance, and how the article is foreseen to be used).

The first step in achieving the above is understanding what substances might be included in your , a step which involves detailed mapping of your supply chain. The second step is to look at the candidate list to identify any SVHCs that may be present in your product line. If you identify any, you should then check the substance registration to see if your use is already covered; if not, ECHA. Information on substance can be searched here, and a step-by-step guide on how to submit the notification is available in the related ECHA Manual or, if you prefer, a webinar ‘providing legal background and practical information on how to prepare and submit a notification of a SVHC in articles using IUCLID and REACH IT.’

After complying with the obligations triggered by the listing on the candidate list, companies are advised to keep an eye on the substance’s further journey to the Authorization List. Remember, if you are using one of the substances in the draft 8th recommendation you can submit comments until 2nd June 2017.

So, while complying with the above process might cause a headache for those companies affected, it’s important to keep in mind the reasons you’re obliged to notify ECHA and inform customers in case your article contains SVHCs. Doing so is key to ensuring the safe use of chemicals; to finding substitutions for substances which should no longer be used; to helping realize the concept of the ‘circular economy’; and to avoiding risk to your reputation.

Anthesis has vast experience in supply chain mapping and monitoring, and development of comprehensive chemical strategy – reach about our recent work with major US retailer Target here. Please get in touch with Pearl Nemeth or Helen Kean if you’d like to discuss how we can help your organization, or alternatively, use our fill out form below.

See more content related to sustainable chemistry.

 

 

[1] Roadmap for SVHC identification and implementation of REACH Risk Management measures from now to 2020

[2] https://echa.europa.eu/candidate-list-table 

[3] https://echa.europa.eu/documents/10162/13634/operation_reach_clp_2016_en.pdf p120


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A couple of definitions:

An article covers a very broad range of materials, and is defined by REACH as an object which, during production, is given a special shape, surface or design that determines its function to a greater degree than its chemical composition. For example, clothing, packaging, etc.

A candidate list is a list of chemical substances which are considered to be substances of very high concern (e.g. harmful to human health or the environment), and hence identified as needing to be further regulated through the Authorization part of REACH.

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