Substance of very high concern

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A very high concern ( SVHC from English Substance of Very High Concern ) is a chemical substance (element, compound, or a group of chemical compounds), which according to the REACH Regulation has been identified as an especially hazardous properties and serious impact on human health or the environment.

The identification of a substance as SVHC by the European Chemicals Agency (ECHA) is the first step for inclusion in the list of substances subject to authorization according to Annex XIV of the REACH Regulation # Annex XIV of the REACH Regulation and thus subjecting it to an authorization requirement. Alternatively, SVHC can also be included in Annex XVII of the REACH Regulation and thus subject to restrictions.

The first SVHC list was published on October 28, 2008 and has since been supplemented every six months in late June and late December. For identified SVHC, special information requirements apply within the supply chain.

Criteria and admission procedure

The way to include a substance in the candidate list is described in Article 59 of the REACH regulation. According to this, the substance must at least meet the criteria of Article 57 of the REACH regulation. A substance can therefore be proposed if it meets one or more of the following criteria:

  • carcinogenic according to Article 57a (classification in the hazard class carcinogenicity of category 1A or 1B according to CLP );
  • mutagenic according to Article 57b (classification in the hazard class germ cell mutagenicity of category 1A or 1B according to CLP);
  • toxic to reproduction according to Article 57c (classification in the reproductive toxicity hazard class of category 1A or 1B according to CLP);
  • persistent , bioaccumulative and toxic according to the criteria in Annex XIII of the REACH regulation ( PBT substances ) according to Article 57d;
  • very persistent and very bioaccumulative according to the criteria in Annex XIII of the REACH regulation ( vPvB substances ) according to Article 57e;
  • there is scientific evidence of likely serious effects on human health or the environment, for example neurotoxic agents and endocrine disruptors ; such substances are assessed on a case-by-case basis in accordance with Article 57f.

There are three priority groups under Article 58:

The fact that a substance meets one or more criteria does not mean that it is proposed as an SVHC. A number of such substances are already subject to restrictions, such as those listed in Annex XVII of the REACH regulation.

The first step in including a substance in the SVHC list (candidate list) is the creation of a dossier in accordance with Annex XV of the REACH regulation, which can either be prepared by ECHA or a member state. This will be published by ECHA and all interested parties will be asked to submit comments within 45 days. The other Member States or the Agency can also submit comments within 60 days. The further course then depends on the comments received:

  • if no comments are received, the substance will be included in the candidate list and the agency can recommend inclusion in Annex XIV.
  • if comments are received, ECHA will refer the dossier to the Member State Committee within 15 days of the 60-day deadline. If the committee reaches a unanimous agreement within a further 30 days, the substance will be added to the candidate list and the agency can recommend inclusion in Annex XIV.
  • If comments are received and the Member State Committee does not reach a unanimous agreement, the Commission shall prepare a draft proposal for the identification of the substance within three months of the Member State Committee's opinion. A final decision on the identification of the substance will be made in accordance with the procedure referred to in Article 133 (3).

The Agency publishes and updates the SVHC list on its website immediately after a decision on the inclusion of a substance has been taken.

Candidate List / SVHC List

Actually, "List of qualifying for a registration in question SVHCs" or "candidate list of SVHCs," but also referred to as "candidate list" or "SVHC list" because of the English name Candidate List of Substances of Very High Concern for Authorization called . As of June 25, 2020, 209 substances / groups of substances are included in the candidate list.

The substances in the candidate list are ranked according to their priority. This ranking is used to further check whether a substance is included in Annex XIV of the REACH regulation for authorization.

Annex XIV of the REACH regulation - List of substances subject to authorization

As of February 27, 2020, 54 substances or groups of substances from the candidate list were included in Annex XIV of the REACH regulation (list of substances subject to authorization) and are therefore substances subject to authorization. A further 48 substances are currently recommended for inclusion in Annex XIV.

Switzerland

In Switzerland, the SVHC substances are included in Appendix 3 of the Chemicals Ordinance (ChemV). The entries from the EU register of substances subject to authorization are included in Annex 1.17 of the Ordinance on Chemical Risk Reduction (ORRChem) after additional clarifications by authorities and industry .

Web links

Individual evidence

  1. ↑ a b c d Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of December 18, 2006 on the registration, evaluation, authorization and restriction of chemical substances (REACH) . In: Official Journal of the European Communities . L396 of December 30, 2006, pp. 1-849.
  2. ↑ a b REACH regulation, Annex XIII, pp. 383–385.
  3. ^ ECHA - Candidate List of Substances of Very High Concern for Authorization. In: echa.europa.eu. Retrieved June 26, 2020 .
  4. ↑ Results of the prioritization of the SVHCs on the Candidate List , June 15, 2011.
  5. ↑ ECHA: Annex XIV of the REACH regulation - List of substances subject to authorization , accessed on February 12, 2020.
  6. ↑ REACH-CLP-Biocide Helpdesk: Annex XIV of the REACH regulation , accessed on January 7, 2019.
  7. ↑ Previous recommendations - ECHA. In: echa.europa.eu. July 10, 2019, accessed March 7, 2020 .
  8. ↑ Registration office for chemicals: List of substances of very high concern (SVHC). Retrieved April 3, 2020 .