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REACH Authorisation
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Identification of Substances of Very High Concern

The Process

Preparing the Annex XV Report: Identifying Relevant SVHCs

► What is an SVHC according to REACH?

Quite a significant number of substances may at some stage be selected as an SVHC if the criteria set in Article 57 of REACH is considered. The criteria for substances that may be selected as SVHCs are as follows:

  • Carcinogenic, Mutagenic or toxic for Reproduction (CMR) cat 1A or 1B in accordance with the CLP
  • Persistent, Bioaccumulative and Toxic (PBT) in accordance with the criteria set out in Annex XIII of the REACH Regulation
  • Very Persistent and very Bioaccumulative (vPvB)
  • Giving rise to an equivalent level of concern to substances indicated above. They may have endocrine disrupting properties or there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in the points above. Such substances will be identified on a case-by-case basis in accordance with the procedure set out in Article 59.

However, a substance will not be selected just because it displays these properties. The SVHC list is deliberately called the “Candidate List” as it is seen as a ‘waiting list’ for later prioritisation and being put on the Authorisation list, i.e. Annex XIV. That is the reason why those proposing the identification of an SVHC already have from the onset, the next step, i.e. Authorisation, in mind, and therefore consider the relevance of this identification as SVHC. Substances mostly used as intermediates will not be considered initially, and the authorities will focus on those substances that have a perceived health policy relevance. Some countries, for example, are mainly concerned about endocrine disruptors.

CMRs: registration dossiers will be screened on a regular basis.

Sensitizers: focus will be placed first on respiratory sensitizers. The next step will be the skin sensitizers but only those fulfilling the “equivalent concern criterion” which is under discussion.

PBTs-vPvBs: first focus on Evaluation and only after an RMO analysis could be conducted gradually.

Endocrine disruptors: first screening expected in 2014 and 2015 for assessment of the fulfilment criteria. RMO would only be conducted after 2015

STOT RE: on 4 March 2013, ECHA launched a public consultation where, for the first time it was proposed to identify SVHCs based on their specific target organ toxicity after repeated exposure. (Cadmium, cadmium oxide, UV-320 and UV-328). This selection criterion is still under development.

Comment on the usage of the Equivalent Concern notion:

On 20 June 2013, ECHA published an updated Candidate List, which then contained 144 entries. Cadmium was one of the new entries. It was considered that cadmium meets the criteria as SVHC according to article 57a (CMR) and 57f (Equivalent Concern). The substance has a harmonised classification as Carc 1B which could not be contested. Sweden, as the dossier submitter, proposed to also consider an Equivalent Concern as cadmium is classified as STOT RE 1 based on effects on kidneys, bones and probably also lungs. Identification of a substance as SVHC on the basis of an Equivalent Concern is to be done on a case-by-case basis where severity and irreversibility of possible health effects, and uncertainties on derivation of a ‘safe concentration’, create a concern equivalent as CMRs.

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