B7.2.6 REACH continued…
Evaluation
All information (dossiers) submitted under REACH is evaluated.
- 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 the REACH Regulations. 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.
Authorisation
An Authorisation must be applied for if you wish to place substance on the market, or use substances, that have properties deemed to be of “very high concern”.
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 are, then they must prepare substitution plans and if not, then they should provide information on research and development activities if appropriate.
Very High Concern
These are substances that have hazards with serious consequences, e.g. they include substances that are:
- Carcinogenic (cause cancer).
- Persistent (have other harmful properties and remain in the environment for a long time).
- Bioaccumulative (gradually build up in animals).
Restrictions
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.
Classification and labelling
The classification and labelling requirements in REACH reflect the existing systems.
Information in the Supply Chain
REACH provides a framework in which information can be passed both up and down supply chains. A Safety Data Sheet should accompany materials down through the supply chain, providing the information users need to ensure chemicals are safely managed.