Summary of obligations resulting from inclusion of SVHCS in the Candidate List

Companies may have legal obligations resulting from the inclusion of substances in the Candidate List. These obligations, which are effective from the date of inclusion, refer not only to the listed substances on their own or in mixtures but also to their presence in articles.

Substances in Articles

EU or EEA suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% w/w have to provide sufficient information to allow safe use of the article to their customers.

Upon request by a consumer, EU or EEA suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% w/w have to provide sufficient information to allow safe use of the article. This information must be provided within 45 days of the receipt of the request.

EU and EEA producers or importers of articles have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present in those articles in quantities totalling over one tonne per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% w/w.

The notifications have to be submitted no later than 6 months after the inclusion in the Candidate List. A notification is not required when:

  • the producer or importer of an article can exclude exposure of humans and the environment during the use and disposal of the article. In such cases, the producer or importer must however supply appropriate instructions to the recipient of the article.
  • The substance has already been registered for that use.

Safety Data Sheets for substances on their own and substances in mixtures

EU and EEA suppliers of substances on the Candidate List (supplied either on their own or in mixtures) have to provide their customers with a safety data sheet.

Section 15 of pre-existing safety data sheets should be updated to reflect the identification of the substance as an SVHC (Article 31(9)(a)).

EU and EEA suppliers of mixtures not classified as hazardous according to the Regulation on classification, labelling and packaging of substances and mixtures (EC) No 1272/2008 have to provide the recipients, at their request, with a safety data sheet if:

  • the mixture contains at least one substance with an individual concentration in the mixture ≥ 0.1% w/w for non-gaseous mixtures; and
  • that substance is on the Candidate List under either Articles 57(d) (persistent, bioaccumulative and toxic (PBT)), (e) (very persistent and very bioaccumulative (vPvB)) or (f) (substance raising an equivalent level of concern).

This is without prejudice to the general obligation for all EU and EEA suppliers of mixtures not classified as hazardous under Regulation (EC) No 1272/2008 to provide the recipients, at their request, with a safety data sheet if the mixture contains a substance with an individual concentration ≥ 1% w/w for non-gaseous mixtures and ≥ 0.2% by volume for gaseous mixtures where that substance poses human health or environmental hazards.

Minimisation of releases

For substances satisfying the PBT and vPvB criteria, and at the latest when they are included as such in the Candidate List, manufacturers and importers shall use the information in their CSR when implementing on their sites, and recommending for downstream users, risk management measures which minimise exposures and emissions to humans and the environment. On the basis of that recommendation, downstream users must identify and apply appropriate measures to adequately control the related risks.

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