• 10 New SVHCs

10 New SVHCs Added to EU REACH Candidate List – Compliance Digest

July 5, 2018 By
In this edition of the Compliance Digest, we cover the addition of ten new substances of very high concern (SVHCs) to the EU REACH Candidate List.

What is it?

On June 27, 2018, the European Chemicals Agency (ECHA) announced the addition of ten new substances to the Candidate List of substances of very high concern (SVHCs).

The Candidate List of SVHCs now includes 191 substances. Under the EU’s REACH regulation, SVHCs are assessed to determine whether they should be included on the Authorisation List (Annex XIV of REACH).

Substances on the Authorisation List can only be placed on the EU market or used after a given date if an authorisation is granted for a specific use, or the use is exempted from authorisation. Manufacturers, importers or downstream users can apply for authorisations, which are granted if applicants can demonstrate that risks from the uses of the substances are adequately controlled.

What are the ten new SVHCs?

Here are the ten SVHCs. Click on the substance names to get to the corresponding webpage on ECHA’s website:

Octamethylcyclotetrasiloxane (D4)

CAS number: 556-67-2
Examples of uses: Used in washing and cleaning products, polishes and waxes, and cosmetics and personal care products.

Decamethylcyclopentasiloxane (D5)

CAS number: 541-02-6
Examples of uses: Used in washing and cleaning products, polishes and waxes, cosmetics and personal care products, textile treatment products, and dyes.

Dodecamethylcyclohexasiloxane (D6)

CAS number: 540-97-6
Examples of uses: Used in washing and cleaning products, polishes and waxes, and cosmetics and personal care products.

Lead

CAS number: 7439-92-1
Examples of uses: Used in metals, welding and soldering products, metal surface treatment products, and polymers.

Disodium octaborate

CAS number: 12008-41-2
Examples of uses: Used in anti-freeze products, heat transfer fluids, lubricants and greases, and washing and cleaning products.

Benzo[ghi]perylene

CAS number: 191-24-2
Examples of use: Normally not produced intentionally but rather occurs as a constituent or impurity in other substances.

Terphenyl hydrogenated

CAS number: 61788-32-7
Examples of uses: Used as a plastic additive, solvent, in coatings/inks, in adhesives and sealants, and heat transfer fluids.

Ethylenediamine (EDA)

CAS number: 107-15-3
Examples of uses: Used in adhesives and sealants, coating products, fillers, putties, plasters, modelling clay, pH regulators, and water treatment products.

Benzene-1,2,4-tricarboxylic acid 1,2 anhydride (trimellitic anhydride) (TMA)

CAS number: 552-30-7
Examples of uses: Used in the manufacture of esters and polymers.

Dicyclohexyl phthalate (DCHP)

CAS number: 84-61-7
Examples of uses: Used in plastisol, PVC, rubber and plastic articles. Also used as a phlegmatiser and dispersing agent for formulations of organic peroxides.

What are the obligations?

Legal obligations associated with SVHCs apply to companies from both EU and non-EU countries that manufacture products in the EU or EEA, or place products on the EU or EEA market, and they vary based on the type of product:

  • Substances on their own:
    • Provide customers with a safety data sheet (SDS).
  • Substances in Mixtures:
    • For mixtures not classified as dangerous according to Directive 1999/45/EC:
      • Provide recipients, at their request, with an SDS if the mixture contains at least one substance on the Candidate List and the individual concentration of the substance in the mixture is ≥ 0.1% (w/w) for non-gaseous mixtures if the substance is a PBT or vPvB.
  • Substances in Articles:
    • For articles that contain substances on the Candidate List in a concentration above 0.1% (w/w):
      • Provide sufficient information to allow safe use of the article to customers or, upon request, to a consumer within 45 days of the receipt of the request.
      • Notify ECHA if the substance is present in quantities totaling over one ton per producer or importer per year. A notification is not required if:
        • Humans and the environment are not exposed to the substance during the use and disposal of the article.
        • The substance has already been registered for that use.

What is next?

Companies located in the EU or EEA, as well as companies located in non-EU countries that market into the EU/EEA should analyze their product portfolio and determine whether any of the following conditions apply regarding any of the ten new SVHCs:

  • Is the substance placed on the EU/EEA market on its own?
  • Is the substance placed on the EU/EEA market as part of a mixture or article and is the substance present at a concentration above 0.1% (w/w) in the mixture or article?

If any condition applies, companies may need to fulfill the legal obligations outlined in the previous section.

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Categories: EHS

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