The European Commission has requested ECHA to prepare dossiers for 37 substances on their behalf. Austria, Germany, the Netherlands, Poland, Slovakia, Sweden and the United Kingdom have also put forward proposals for the identification of 17 substances.<br/><br/>
Amongst the substances, 44 are proposed to be identified as SVHCs on the basis of their classifications as carcinogenic, mutagenic and/or toxic for reproduction (REACH Article 57(a–c)). One of these substances is also suggested as being of equivalent concern in accordance with Article 57(f) based on its endocrine disrupting properties.
Five further substances are proposed to be of equivalent concern. In particular, three of those are respiratory sensitisers and proposed to be of equivalent level of concern for human health. Two further proposals comprise substances proposed to be of equivalent concern for the environment due to endocrine disrupting properties or because they are degrading to the already identified endocrine disruptor (1,1,3,3-tetramethylbutyl)phenol.
The public consultation will be open for 45 days and will end on 18 October 2012. Interested parties can post their comments on the ECHA website.
The authorisation procedure aims to assure that the risks from Substances of Very High Concern are properly controlled and that these substances are progressively replaced by suitable alternatives while ensuring the good functioning of the EU internal market.
Substances with the following hazard properties may be identified as Substances of Very High Concern (SVHCs):
- Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction category 1A or 1B in accordance with Commission Regulation (EC) No 1272/2008 (CMR substances)
- Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to REACH (Annex XIII)
- Substances identified on a case-by-case basis, for which there is scientific evidence of probable serious effects that cause an equivalent level of concern as with CMR or PBT/vPvB substances
After a two-step regulatory process, SVHCs may be included in the Authorisation List and become subject to authorisation. These substances cannot be placed on the market or used after a given date, unless an authorisation is granted for their specific use, or the use is exempted from authorisation.
Manufacturers, importers or downstream users of a substance on the Authorisation List can apply for authorisation.