SVHC and Authorisation

SVHC and Authorisation

REACH SVHC are Substances of Very High Concern, that feature on the REACH Candidate List.   Some substances are also subject to REACH Authorisation. For using these, a permit is necessary.   Both the REACH Candidate Lists and Annex XIV with Authorised substances are ever growing.

REACH Authorisation

The REACH Authorisation addresses Substances of Very High Concern.   The substances subject to Authorisation are listed in REACH Annex XIV. This annex is regularly expanded.   The manufacturer or importer of a substance subject to REACH authorisation must obtain a permit for every different use for that substance.
Permits will only be issued if there are no alternatives, if the socio-economic advantages outweigh the risk and if the risk is adequately controlled.   Requests are complicated and NGO’s will have their say.   In practice, this means that many uses of these substances will be prohibited or restricted.

REACH Candidate List & Priority List

Before a substance is taken up into Annex XIV and becomes subject to authorisation, it will first appear on the ‘REACH Candidate List’.   Within the REACH Candidate List some substances will ‘Prioritised’ and later these may appear in Annex XIV.   Inclusion of a substance in the REACH Candidate List already leads to obligations.   When mixtures contain candidate list substances, this must be mentioned in the Safety Data Sheet.
When articles contain Candidate List substances, the industrial user and ultimately the consumer must be informed.   Where articles contain Candidate List substances, REACH Notification to ECHA is often required.   The REACH Candidate List is regularly expanded. It is expected to list some 150 substances by the end of 2012.   The latest Candidate List can be found on the ECHA web site. A link is provided under ‘REACH Lists’.

REACH Candidate List Obligations

When a substance features on the REACH Candidate List, this leads to obligations:   SVHC Information to be provided   When a Candidate List substance is used in a mixture (> 0,1%) this must be indicated on the Safety Data Sheet.   When a Candidate List substance is used in an article (> 0,1%), professional and industrial users must be informed.   In both cases Consumers must be informed within 45 days after at their request.   NGO’s provide standard letters with such SVHC information requests.   SVHC Notification to ECHA   When a Candidate List substance is used in an article (> 0,1% and > 1 tonne per year), a Notification to ECHA must be submitted.   This applies also to imported articles.
SVHC Notification to ECHA can only be avoided if:   • Exposure to humans and the environment can be fully excluded (also in the waste stage!), or   • Someone has registered the substance in question for the particular use. (Registration not necessarily by the manufacturer of the substance)   If ECHA notification is avoided, the decision must be documented appropriately.   Please note: When a substances becomes subject to REACH Authorisation, it is not deleted from the REACH Candidate List! The obligations mentioned above stay in place.

REACH SVHC: Concentrations, Cut-off-points and Thresholds

REACH obligations for Candidate List substances kick in at certain concentrations.   For both mixtures and articles the cut-off points are:   • >0,1% ww for PBT, vPvB, Carcinogens and Mutagens cat 1&2   • >0,5% ww for reprotoxic cat 1&2.   For mixtures, the % is simply calculated over the total weight of the formulation.   For articles the situation is more complex. There is disagreement about what in this case is an article: the whole Korean car or every single nut or bolt?
According to the European Commission, the total article weight should be taken into account: i.e. the whole weight of the imported car and not just the weight of a tyre or another component.   Several EU Member States however do not agree and regard each component as a separate article.   The threshold for REACH Notification to ECHA is 1 tonne per year, per importer or producer and per ‘article type’.   Please note: When a substances becomes subject to REACH Authorisation, it is not deleted from the REACH Candidate List! The obligations mentioned above stay in place.

Imported articles and Authorised substances

REACH does officially not restrict the import of articles containing substances subject to authorisation.   The Authorisation part of the REACH regulation only addresses placing on the market of substances.   For this reason Annex XVII (Restrictions to Marketing and Use) may be expanded to cover also imported articles containing Authorised substances. This will make import of articles containing these substances illegal.
Also, substances subject to REACH Authorisation stay on the Candidate List. Therefore the requirements to provide information to customers still apply.   This information requirement will often make it commercially unattractive to import articles containing substances subject to authorisation into the EU.   Sitmae has developed a compliance method for REACH and articles. See our webpage REACH Compliance.

Which substances are eligible for Authorisation?

The following categories of substances may be subject to authorisation:   • CMR cat 1 & 2 (Substances that have been proven to cause cancer, genetic mutations or reproduction problems).   • PBT (Persistent, Bioaccumulative and Toxic).   • vPvB (very Persistent and very Bioaccumulative).   • Substances of ‘Similar Concern’.
Please note:   • Under GHS, CMR cat 1 & 2 are called cat 1 & 2A.   • The PBT and vPvB categories are separately defined in REACH annex XIII.   • The undefined ‘Similar Concern’ category is aimed mainly at endocrine disruptors.

Exemptions to REACH Authorisation

Food contact materials and cosmetics   Some CMR’s are permitted for EU use in food contact materials and cosmetics. They are of course subject to very strict limits.   Where this is the case, these CMR’s will not need authorisation for these particular uses.
Additional Exemptions   When a substance is made subject to REACH Authorisation, Annex XIV may list additional exemptions.   The use in medical devices is for example exempted for several substances.   Please note: Substances subject to REACH Authorisation stay on the Candidate List. Therefore the requirements to provide information to customers still apply.

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