The Candidate List
The first step in the authorisation process is to identify those substances that may have serious effects on human health or the environment and, therefore, the risks resulting from their use must be properly controlled and the substances progressively replaced when possible.
A Member State or ECHA at the request of the European Commission, can propose a substance to be identified as a Substance of Very High Concern (SVHC). If identified, the substance is added to the Candidate List, which includes candidate substances for possible inclusion in the Authorisation List (Annex XIV).
The inclusion of a substance in the Candidate List creates legal obligations to companies manufacturing, importing or using such substances, whether on their own, in preparations or in articles.
The intention to propose a substance to be identified as an SVHC is made public in the registry of intentions before the proposal is submitted so as to give advanced information to industry and other stakeholders.
The proposal is prepared according to Annex XV of REACH and includes two main parts. The first one provides the data and justification for identifying the substance as an SVHC. The second part, examined during the follow-up steps in the identification, includes information on volumes on the EU market and the uses of the substance, the resulting release and exposure, and possible alternatives to the substance.
After publication of the proposal anyone can comment on it or add further information, for example, related to the properties, uses and risks of the proposed substance or its alternatives. If no comments are received, the substance is included in the Candidate List. The proposals and the comments will be forwarded to the Member State Committee (MSC) to agree on the identification as an SVHC. If the committee does not reach a unanimous agreement, the matter will be referred to the European Commission.