Authorisation
For substances of very high concern (SVHC), an authorisation is required for their use and their placing on the market. The substances required to be authorized are substances that:
- are carcinogenic, mutagenic or toxic for reproduction (CMRs) category 1 and 2
- are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative (PBTs/vPvBs) according to given criteria, and/or
- give rise to an ‘equivalent level of concern’ to those mentioned above where there is scientific evidence of probable serious effects to humans or the environment (e.g. endocrine disruptors) which will be identified on a case-by-case basis.
These substances are considered to have hazardous properties of such high concern that it is necessary to regulate them centrally through a mechanism that ensures that the risks related to their actual uses are assessed, considered and then decided upon on an EU-wide basis. The justification is that the effects on humans and the environment of these substances are very serious and normally irreversible. Substances that fall into these categories will be fed into the authorisation system as resources allow. Their uses will not be banned by default.
An authorisation can be based solely on ‘adequate control’ (demonstrated in the CSR) of the substance for the use in question. However, ‘adequate control’ cannot apply to PBTs, vPvBs and non threshold CMRs as it is not possible to determine a ‘safe’ exposure. All applications for an authorisation must be accompanied by an analysis of possible alternatives considering their risks and the technical and economic feasibility of substitution. All authorizations will be subject to a time-limited review. This would enable further consideration of the availability of alternatives at some point in the future.
In 2008 ECHA published a list of 15 substances as candidates for listing as Substances of Very High Concern for authorization. This listing obligates that companies using these 15 substances to provide hazard and use data to customers and interested consumers to ensure that the substances, or the articles in which they are contained, can be used safely. Further, 7 of these 15 substances have been recommended for strict control whereby ECHA suggests that their use be restricted unless specifically authorized because they are CMRs, PBTs, vPvB, and/or used in products which expose consumers and workers.
Note that one non-governmental organization, the International Chemicals Secretariat, created its own authorization list, the Substitute In Now (SIN) List, to identify candidates for authorization and to provide market signals to chemical manufacturers and users of chemicals to avoid.
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