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Evaluation Process

The evaluation process has three purposes:

  • The first purpose is for authorities to evaluate the testing proposals made by industry to ensure the safety of their products and thereby ensuring that animal testing is kept to a minimum.
  • The second purpose is to check compliance with the requirements of the regulation.
  • The third purpose is to examine any suspicion of risks to human health and the environment arising from substances.
  • Evaluation provides a means for the authorities to require registrants, and in very limited cases downstream users, to provide further information.
  • There are two types of evaluation: dossier evaluation and substance evaluation:

    Dossier evaluation is conducted by authorities to examine proposals for testing to ensure that unnecessary animal tests and costs are avoided, and to check the compliance of registration dossier with the registration requirements.
    Substance evaluation is performed by authorities when there is a reason to suspect that a substance presents a risk to human health or the environment (e.g. because of its structural similarity to another substance). Therefore, all registration dossiers submitted for a substance are examined together and any other available information is taken into account.

    AUTHORISATION

    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.


    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).

      RESTRICTIONS

      The restrictions procedure is a safety net for substances posing an unacceptable risk to human health or the environment arising from its manufacture, use or placing on the market, which need to be addressed on a Community wide basis.

      The basis of the demonstration of the unacceptable risk to human health or the environment on a Community wide basis, will be a risk assessment. This will be different from the CSR of the individual dossiers as they usually won’t deal with regional ‘exposure’, aggregate volumes, and multiple exposures.

      A restriction of a substance is any condition for, or prohibition of, its manufacture, use or placing on the market. Restrictions enable risk management measures beyond those already implemented by manufacturers, importers and downstream users, to be introduced across the Community where they are shown to be necessary. Restrictions can also impose a harmonised level of risk management measures. Restrictions apply to all manufacturers, importers, downstream users and distributors of a substance if the manufacture, use or placing on the market (activity) of this substance is included in Annex XVII.

      Annex XVII contains restrictions on the manufacture, placing on the market and use of certains dangerous substances, preparations and articles; a consolidation of the restrictions contained in Directive 76/769/EC.

      Activities with the substances not included in Annex XVII are allowed, provided there is no restriction in other, sector specific Community legislation, and the substance is not subject to authorisation (Annex XIV).


      All substances on their own, in preparations or in articles may be subject to restrictions, regardless of any duty to register the substance. Restrictions apply to activities regardless of the quantity, unless the annex specifies thresholds. However, use of a restricted substance in scientific research and development, as well as product and process oriented research and development activities in quantities below 1 tonne per year, is exempted.

      The restrictions also do not apply to substances that are waste being treated in a waste treatment installation within the conditions of a permit.

   
 
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