Authorisation was the most debated part of the REACH Regulation during the second reading in the European Parliament in 2006. Several years later, it is becoming clear what an extensive process this really is.
The first step in the authorisation procedure is the identification of a substance as a “Substance of Very High Concern (SVHC).” Once identified as such, the substance is included in the “Candidate List” of SVHCs.
The process of bringing substances onto the Candidate List, however, remains insufficiently understood by many companies. This is why Cefic organises training sessions to explain the different steps in the processes and at what stages and how industry can contribute to the discussion and decision-making.
The Candidate List is likely to be a long list of substances, and not all of these will end up in the authorisation process. Cefic will inform those companies which have the listed substances in their product portfolio, and tell them how they can contribute in the best way.
Cefic will make sure that the rules are carefully respected and that substances coming onto the Candidate List do fulfil the criteria.
Under the REACH Regulation, SVHCs include substances which are:
- Carcinogenic, Mutagenic or toxic to Reproduction (CMR),
- Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB)
- Substances of equivalent concern
The possibility must remain of obtaining an authorisation for substances where adequate control can be ensured. Cefic will monitor developments closely to ensure that the possibilities offered by the legal text are respected.
The only way to obtain an authorisation if no concentration without a concern can be defined is to demonstrate that there are more benefits to society than disadvantages to human health or environment on the basis of socio-economic factors. If this is not handled correctly, industry may find itself in a situation where hardly any authorisations will be granted.
Once substances are on the Candidate List, the granting of the authorisation will be the problem. The process is entirely new for industry and for regulators, and difficulties in the analysis of alternatives and substitution plans are to be expected for the first substances that will go through the process.