The Candidate List of Substances of Very High Concern

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What are SVHCs?

The REACH Regulation [1] aims to ensure a high level of protection of human health and the environment from hazardous chemical products. One way that REACH achieves this is to identify and restrict the use of substances of very high concern (SVHCs), which are defined in Article 57 of REACH, and includes:

  • Substances meeting the criteria for classification in the following hazard classes: Carc 1A or 1B, Muta 1A or 1B, Repr 1A or 1B. These substances are expected to cause cancer, transmissible genetic defects, or reproductive or developmental effects in humans, and are collectively known as CMRs.
  • Substances meeting the criteria for classification as PBT or vPvB substances. These are long-lasting chemicals that accumulate in animal tissues.
  • Other substances of equivalent level of concern to the above, with endocrine disruptors being specifically mentioned.

SVHCs are subject to the Authorisation process. Substance on the Authorisation list (REACH Annex XIV) can only be used if the European Chemicals Agency (ECHA) gives dispensation to use it for specific purposes under controlled conditions, with the aim of encouraging substitution of SVHCs with safer alternatives.

The process for an SVHC to be listed in Annex XIV is complicated and lengthy. The first stage is that suspected SVHCs are assessed by Member State authorities in a Community Rolling Action Plan (CoRAP).

If the assessment supports further regulatory action, the substance is placed on the Candidate List.

Following consultation with industry and review, ECHA may place the substance may on REACH Annex XIV (List of Substances Subject to Authorisation). To use a substance on Annex XIV, an applicant must demonstrate, using a socio-economic analysis, that continuing to use the substance is better than using alternatives.

Obligations for substances on the Candidate List

The official Candidate List is only published online at the ECHA website, and not in the Official Journal of the European Union, which is the definitive version of legal texts such as REACH.

Once the substance is included on the Candidate List, suppliers have certain obligations.

  • Suppliers of a listed substance must provide a safety data sheet even if the substance does not meet the criteria for classification.
  • Suppliers of a mixture containing a listed substance at > 0.1wt% must provide a safety data sheet on request, even if the mixture does not meet the criteria for classification.
  • Suppliers of an article containing a listed substance at > 0.1 wt% must provide the downstream user of the article with sufficient information to allow safe use of the article including, as a minimum, the name of the listed substance.
  • In addition, the supplier of such articles must provide consumers with sufficient information to allow safe use of the article including, as a minimum, the name of the listed substance, if they request it.
  • A producer or importer of articles containing a listed substance at > 0.1wt% must make a Notification to ECHA, if the total amount of listed substance in the articles is > 1 tonne/year, and exemptions do not apply (eg lack of human and environmental exposure).

Notification of Articles Containing Candidate List Substances

REACH regulates chemical products as substances, mixtures (of substances), or substances in articles.  

The REACH Regulation defines an article as ‘an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition’.

The definition is generally common sense, so a metal spoon is an object, but an ingot of the same metal is a substance, but there has been a great deal of discussion on exactly where the boundaries lie between substance, mixture, and article.

Notification is required if the Candidate List substance is present in the article at > 0.1 wt%, and the total amount of substance is > 1 tonne/year, unless any of the derogations apply:

  • Human and environmental exposure can be ruled out for the lifecycle of the article.
  • The substance has a REACH Registration in place covering the particular use in the article.
  • The articles were only produced or imported before the substance was included in the Candidate List.
  • For a substance that is intentionally released from the article (eg as a fragrance), then REACH Registration of the substance may be required, rather than notification.

If the Notification is required, then it should be made within 6 months of the substance being included in the Candidate List [2].

The notification is made through REACH IT with basic information [3] (REACH Article 7.4.):

  • the identity and contact details of the producer or importer of the article.
  • the name and identity of the Candidate List substance.
  • the hazard classification of the substance
  • a description of the uses of the substance in the article, and the article itself
  • the tonnage range of the substance, eg 1 to 10 tonnes.

Information Requests from Consumers on Candidate List Substances in Articles

Suppliers of an article containing a Candidate List substance at > 0.1 wt% must provide consumers (ie the public) with sufficient information to allow safe use of the article including, as a minimum, the name of the listed substance (REACH Article 33).

The information must be provided free of charge and within 45 days of the request. There is no tonnage trigger for these obligations.

This provision allows consumers to make informed choices on the articles, but is also useful to NGOs wishing to investigate the use of Candidate List substances, as no purchase is necessary to make the request for information.

Friends of the Earth (Germany) launched its ToxFox app in 2016 to help consumers file ‘Article 33’ information requests with article suppliers. The app has been downloaded over a million times, and can be used to scan barcodes to provide information on Candidate List substances in such diverse products as toys, textiles, furniture, and electronics.

The Check Chemistry app, developed by the German Environment Agency, also uses barcode scanning to deliver SVHC information to consumers. If the item has not yet been notified, the app will contact the supplier with an information request.

The supplier is not obliged to provide information if their article does not contain Candidate List substances.

These apps and the increasing awareness of consumers about SVHCs, particularly some flame-retardants and water-repellents, in everyday products provide a strong incentive for transparency from suppliers, and substitution of harmful substances.


References

[1] Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH); as amended. [back]

[2] Guidance on requirements for substances in articles; Version 4.0; June 2017; ECHA. [back]

[3] How to prepare a substance in articles notification; Version 4.0; October 2019; ECHA. [back]

Alchemy Compliance has 22 years of regulatory experience with industrial chemicals, in EU REACH Registration, safety data sheet compilation (EU, US, and beyond), and chemical hazard assessment. Contact us for more information.