Other Reach Processes
Dossiers submitted in support of registration will be subject to evaluation under REACH as follows:
• Compliance checking: This is a check of the quality of the information submitted by industry. It will be undertaken by the European Chemicals Agency (ECHA) in Helsinki and will be on a sample (at least 5%) of dossiers submitted at each tonnage level.
• Dossier Evaluation: For substances registered at the highest tonnage levels (≥100 tonnes/annum) a proposal is made by the registrant detailing those animal tests they consider are required from the list of standard tests in Annexes IX and X of REACH. The ECHA will evaluate these testing proposals to prevent unnecessary animal testing.
• Substance evaluation: This is undertaken by national Competent Authorities on substances that have been prioritised for potential regulatory action because of concerns about their hazardous properties. A key regulatory outcome of evaluation could be the imposition of restrictions on the manufacture, supply or use of a substance. Substance evaluation may also lead to a substance being added to the priority list for authorisation or a proposal to change the classification and labelling.
All dossiers will undergo an automated completeness check to ensure that all the relevant pieces of information are present. This completeness check will not assess the quality or suitability of the information.
Substances of Very High Concern
Some substances have hazards that have serious consequences, e.g. they cause cancer (carcinogenic), or they have other harmful properties and remain in the environment for a long time (persistent) and gradually build up in animals (bioaccumulative). These are substances of very high concern . This category also includes substances demonstrated to be of equivalent concern, such as “endocrine disruptors”. One of the aims of REACH is to control the use of such substances via authorisation and encourage industry to substitute these substances for safer ones.
Some of the substances with properties that are deemed to be of “very high concern” are added to Annex XIV of REACH. For these, in order to place the substances on the market for a use or for their own use industry must apply for an authorisation. The European Chemicals Agency (ECHA) in Helsinki will publish an initial list containing substances to be considered for the authorisation process by 1 June 2009. A company wishing to market or use such a substance must submit an application to the ECHA for an authorisation. Decisions on authorisation are made by the European Commission, taking advice from the ECHA and member states. Applicants will have to demonstrate that risks associated with uses of these substances are adequately controlled or that the socio-economic benefits of their use outweigh the risks. Applicants must also analyse whether there are safer suitable alternatives or technologies. If there arealternatives available, but it would take time to implement these alternatives, then they must prepare substitution plans; if not then they should provide information on research and development activities (if appropriate).
Any substance that poses a particular threat that is deemed to require Community-wide action can be restricted. Restrictions take many forms, for example, from a total ban to not being allowed to supply it to the general public. Restrictions can be applied to any substance, including those that do not require registration. This part of REACH takes over the provisions of the Marketing & Use Directive.
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