 AUTHORISATION |
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The REACH proposal sets up a system under which the use of substances with properties of very high concern and their placing on the market can be made subject to an authorisation requirement.
This authorisation requirement ensures that risks from the use of such substances are either adequately controlled or justified by socio-economic grounds, having taken into account the available information on alternative substances or processes.
The substances selected for the authorisation system have hazardous properties of such very high concern that the Community needs to decide about the adequacy of the control of risks arising from their uses or about the socio-economic benefits of the uses of such substances that justify risks arising from their use:
Category 1 and 2 CMR substances have effects on humans which are generally so serious and cannot normally be reversed, and PBT and vPvB substances accumulate in living organisms, which cannot normally be reversed, either. To provide a security net, other substances with serious and irreversible effects of an equivalent level of concern as the CMR, PBT and vPvB substances, can be identified on a case-by-case basis. This could for example be endocrine disrupters which are not already covered by the CMR criteria.
The authorisation provisions require those using or making available substances with properties of very high concern which are included into the system to apply for an authorisation for each use, regardless of the quantity of the substance used, within deadlines set by the Commission.
The burden of proof is placed on the applicant to demonstrate that the risk from the use is adequately controlled or that the socio-economic benefits outweigh the risks. In the latter case, applicants need to submit a substitution plan along with a socio-economic analysis.
The Agency, via its Committees for Risk Assessment and Socio-economic Analysis provides opinions on the applications, which the Commission will use for its decisions on applications.
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In particular the Authorisation process ensures that:
. the burden of proof to demonstrate that the risk from the use is adequately controlled or that the socio-economic benefits outweigh the risks are placed on the applicants for authorisation.
. the Commission and the MS authorities can monitor the progress;
. the Commission, the MS authorities and industry can focus their resources by starting with those substances that are considered to pose the greatest current risk and to deliver the 'Highest Expected Regulatory Outcome' (Hero). |
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