Authorization

The authorisation procedure aims to ensure that substances of very high concern (SVHC) are replaced progressively by less dangerous substances or technologies, where they are available alternatives from the point of view of technical and economic.
The process of authorization begins when a member State or ECHA at the request of the Commission, proposes a substance to be identified as SVHC.
The substances with hazardous properties can be identified as SVHC:

  • substances that meet the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B according to CLP regulation;
  • substances that are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) in accordance with REACH annex XIII);
  • the substances identified for each case, that are of an equivalent level of concern to substances with CMR or PBT/vPvB substances.

The process of identification of a substance as SVHC includes a public consultation of 45 days. When it was identified as an SVHC, a substance is included in the candidate list. Inclusion in the candidate list includes obligations immediate for its suppliers, such as, for example:

  • provide a safety data sheet (SDS);
  • communicate the safety instructions of use;
  • respond to requests from consumers within 45 days;
  • notify ECHA if the item that produce contains a SVHC in quantities above one tonne per producer/importer per year and if the substance is present in those articles above a concentration of 0.1 % (weight/weight).

The obligations resulting from the inclusion of the SVHC in the candidate list

Companies may be subject to the legal obligations arising from the inclusion of substances in the candidate list. These obligations, which shall enter into force from the date of inclusion, concerning not only the substances included in the list, alone or in mixtures, but also those present in the articles.
Suppliers of articles operating in the EU and in the EEA are required to make available to customers information reasonably sufficient to permit the safe use of such articles, if these contain substances included in the candidate list in concentration above 0,1 % weight by weight.
At the request of a customer, the suppliers of the items active in the EU and in the EEA are required to disclose sufficient information to allow the safe use of such articles, if these contain substances included in the candidate list in concentration above 0,1 % weight by weight. Such information should be made available within 45 days from the receipt of the request.
Manufacturers, or importers operating in the EU and in the EEA must notify to ECHA if their articles contain substances included in the candidate list. This obligation applies if a substance is present in those articles in quantities totaling over one tonne per producer or importer per year and if the substance is present in those articles to the higher concentration values of 0.1% weight/weight.

The notifications must be submitted within 6 months from the date of inclusion in the candidate list. It is not necessary to transmit a notification if:

  • the manufacturer or importer of a particular article can exclude exposure to humans and the environment during the use and disposal of the article. In such cases, the manufacturer or importer must, however, provide appropriate instructions to the recipient of the article;
  • the substance is already registered for the specific use.

Safety data sheets for substances from the sun and substances, mixtures

In the EU and in the EEA suppliers of substances included on the candidate list (alone or in mixtures) are required to make available to customers with a safety data sheet.
Section 15 of the safety data sheets of the pre-existing needs to be updated to take account of the identification of a substance as SVHC (article 31, paragraph 9 (a)].
In the EU and in the EEA suppliers of mixtures not classified as hazardous according to regulation (EC) no. 1272/2008 on classification, labelling and packaging of substances and mixtures, are required to provide to the recipients, at their request, a safety data sheet if:

  • the mixture contains at least one substance of which the individual concentration in the mixture is ≥ 0,1 % weight by weight in the case of non-gaseous mixtures;
  • this substance is included on the candidate list according to article 57 (d) (persistent, bioaccumulative and toxic (PBT)), (e) (very persistent and very bioaccumulative (vPvB)) or (f) (substance that gives rise to an equivalent level of concern)

This is without prejudice to the general obligation for all providers in the EU and in the EEA of the mixtures are not classified as hazardous according to regulation (EC) no. 1272/2008 provide to the recipients, at their request, a safety data sheet if the mixture contains a substance with an individual concentration of ≥ 1 % weight by weight for non-gaseous mixtures and ≥ 0,2 % by volume for gaseous mixtures where the substance presents a risk to human health or the environment.

Reduction to the minimum of the release

In the case of substances that fulfil the PBT and vPvB criteria, and no later than at the time of their inclusion, as such, the candidate list of substances, manufacturers and importers are required to use the information present in their chemical safety reports (CSR), when they are implementing at their sites, the risk management measures aimed at reducing to a minimum the exposure of humans and the releases to the environment, as well as when it is advisable to adopt such measures to the downstream users. Taking into account these indications, the downstream user must identify and apply appropriate measures for the adequate control of risks.