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REACH Authorisation
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Identification of Substances of Very High Concern

A Roadmap for Industry

► Addressing the immediate impact of an SVHC identification

As soon as the substance appears in the Candidate List or Authorisation List (Annex XIV), there are administrative obligations that immediately apply to EU and EAA suppliers of substances or mixtures.

Substances alone
The rule is that suppliers of substances on the Candidate List have to provide their customers with a safety data sheet from the date of inclusion on the list, if the substance didn’t already have a safety data sheet.

Substances in Mixtures/Preparations
EU and EEA suppliers of mixtures not classified as dangerous according to the Dangerous Preparations Directive (1999/45/EC) must provide the recipients, at their request, with a safety data sheet. This applies if the mixture contains at least one substance on the Candidate List with a concentration in the mixture equal or above 0.1% (w/w) for non-gaseous mixtures if the substance is a PBT or a vPvB.

Substances in Articles
From the date of inclusion, suppliers of articles that contain substances on the Candidate List in a concentration above 0.1% (w/w) have to provide sufficient information to allow safe use of the article to their customers or upon request, to a consumer within 45 days of the receipt of the request. This information must contain as a minimum the name of the substance.

EU and EEA producers or importers of articles have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present in those articles in quantities totaling over one ton per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).

The ECHA Guidance on substances in articles states that in multicomponent articles such as a vehicle the 0,1% W/W limit applies to the average concentration of the entire article and not the individual component. Denmark, Belgium, France, Germany, Norway and Sweden disagree with this view. They estimate that the rule should be “once an article, always an article” and that the concentration limit applies to the component in which the substance is present.

For substances included in the Candidate List, the notifications have to be submitted no later than 6 months after the inclusion.

    A notification is not required when:
  • the producer or importer of an article can exclude exposure of humans and the environment during the use and disposal of the article. He must however supply appropriate instructions to the recipient of the article.
  • The substance has already been registered for that use, further up the supply chain.

Please note that article suppliers not only need to comply with the requirements of SVHC, they also need to comply with the requirements of REACH Restriction. Indeed there may be substances on the SVHC list (for example, anthracene, cadmium) that are also on Annex XVII, the list of substances subjected to Restriction. Involved parties must screen the REACH Restriction list for the Restriction most relevant to the products and ensure that the presence of restricted substances in products does not exceed threshold limits set by REACH.

In many instances, this may not suffice. The selection as an SVHC sends out to the world the message that the substance has been considered as relevant to be put on the waiting list for Authorisation. It’s then only a matter of time before its uses may become problematic. NGOs will make sure that no substance on the Candidate List gets off the hook lightly and thus suppliers or customers in Europe or abroad may become alarmed and will consider their options.

Being able to communicate a thoroughly developed game plan may then prove to be invaluable in preventing market disruptions and helping focus energies toward an acceptable outcome of the steps that will follow.

Do prepare a communication strategy for the eventuality of an inclusion on the Candidate List.
Do be careful with the interpretation of the concentration of an SVHC in an article, as there are opposing views in the EU.

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