SVHC List

Identifying an SVHC is the first step in the Authorisation process.  The point of the Authorisation process is to remove substances from the EU supply chain entirely, unlike restriction, where the point is usually to allow substances to be used under conditions which will reduce the risk to humans and/or the environment across the EU.

A substance which is a potential SVHC must have one or more of these properties:

• Classified in CLP as a Category 1A or Category 1B Carcinogen (H350)
• Classified in CLP as a Category 1A or Category 1B Mutagen (H340)
• Classified in CLP as a Category 1A or Category 1B Reproductive Toxin (H360)
• Identified as being PBT, Persistent, Bio-accumulative and Toxic
• Identified as being vPvB, very Persistent, very Bio-accumulative
• Identified as having an “equivalent level of concern”, which ECHA defines as chemicals which are endocrine disruptors, or respiratory sensitisers (H334) etc.

The idea is that all chemicals with these properties are to be reviewed by 2020, and the ones which are of most concern, either because of the severity of their hazards, or the potential for widespread exposure to vulnerable populations, are placed on the SVHC Candidate List, which is a formal process for gathering all available information on the impact of that substance.

The SVHC designation does NOT apply to onsite isolated intermediates, or transported isolated intermediates, so if you can demonstrate that the SVHC is completely used up in your process (eg via reaction), and none the SVHC could affect the general public or environment, you may not require an authorisation.  If you are in this situation, we advise you to seek help from the HSE helpdesk, and one or more experts in this area.

A full list of exemptions from SVHC is given on the ECHA website at https://echa.europa.eu/documents/10162/13640/generic_exemptions_authorisation_en.pdf/9291ab2a-fe2f-418d-9ce7-4c5abaaa04fc .

In effect, the SVHC process is one of screening and evaluation, although the public consultation steps for some chemicals have been quite political at times, with a lot of input from NGOs, some of whom appear to be very “anti-chemical”.

The SVHC process (click on image to enlarge it).

As soon as a substance has been placed on the SVHC Candidate List, it must have a Safety Data Sheet (SDS), even where it is not classified as hazardous under CLP.  The safety data sheet for an SVHC substance must be provided on or before the time of first supply.  Mixtures containing SVHC candidate list substances (down to 0.1% w/w) should have an SDS available on request.  There may be further obligations if you produce articles containing the substance.

Once a substance is on the Candidate List, ECHA recommend that you consider substituting it, in case it goes forward for authorisation.  However, this may not be necessary in all cases, as some SVHC substances have not been taken forward to authorisation, and are unlikely to be authorised.  (Unfortunately, there does not seem to be a mechanism to have them removed from the SVHC Candidate List!).

The SVHC Candidate List (Substances of Very High Concern) includes possible SVHCs and also SVHCs which have been authorised.  It is understood that the Authorised substances are kept on the SVHC Candidate List because it is referred to in CLP and REACH.

Current SVHC Candidate List (with date last downloaded from ECHA website): SVHC-candidate-list-export-22-01-2018.  This can also be downloaded direct from the ECHA website at https://echa.europa.eu/candidate-list-table .

This list is published by ECHA, who also publish a list of Authorised Substances, that is “definite” SVHCs.  For the current Authorisation List, see https://ttenvironmenta.wpengine.com/clp-knowledgebase/authorisation-list/ .  This can also be downloaded direct from the ECHA website at https://echa.europa.eu/authorisation-list .

However, ECHA do not publish a list of SVHC Candidates only. The reason why ECHA do not publish the list of SVHCs minus the list of Authorised Substances appears to be because the REACH and CLP Regulations refer to the SVHC Candidate List alone, rather than referring to it and also the list of Authorised Substances.  We have generated this list by removing the authorised substances from the Candidate List, for reference.

Current SVHC Candidates only List (with date last updated): SVHC-candidate-only-list-21-01-2018 .

There are even moves to amend the EU Waste Framework Directive, to encourage “progressive substitution” of SVHCs, see https://chemicalwatch.com/54675/meps-back-svhc-substitution-measures-in-waste-directive , although what MEPs think should happen, and what actually is written into EU law by the European Commission can be quite different.