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Update of the guidance about the preparation of dossiers for Annex XV of REACH


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SVHC substances: what is the guidance update?

ECHA published on the website an update of the guidance after a consultation process and taking into account both the modifications to the Annex XIII of REACH (according to Regulation N. 253/2011) and the experience of the competent authorities of Member States and of ECHA. The first version of the guidance dated back to 2007. 
The update involved a complete revision of the text and it contains specific instructions about how to prepare a dossier for the Annex XV on SVHC substances.

What are SVHC substances?

The Substances of Very High Concern (SVHC) are identified as substances of great concern for health and for the environment because they have one or more of the following characteristics:

  • they are CMR substances (carcinogenic, mutagenic, toxic for reproduction);
  • they are vPvB substances (very persistent and very bioaccumulative);
  • they are PBT substances (persistent, bioaccumulative and toxic);
  • they are substances of concern because they produce serious irreversible effects on health and on the environment, for example the Endocrine disruptors

The identification of a substance as SVHC and its inclusion in the Candidate list are the first steps towards the authorisation procedure. The inclusion of a substance in the candidate list implies also some obligations of information about the presence of this substance in preparations. 

If a substance is included in Annex XIV of REACH regulation, an application for authorisation must be submitted to the Agency in order to use and commercialize this substance. The authorisation will be given if the risks related to its use may be adequately managed.

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