REACH Testing Proposals Development

The information requirements for the registration are specified in Annexes VI to XI of the REACH Regulation, according to the tonnage bands.

Having gathered and reviewed the available data and identified gaps, for each missing information requirement, it has to be decided how to generate the necessary information most efficiently. The 'intelligent testing strategy' approach adopted by REACH encourages a scientific approach to testing with sufficient justification to meet the objectives of each Annex. If testing is needed, a first option is to consider if an in vitro (i.e. non-animal) test is adequate, as the aim is only to conduct new in vivo testing using experimental animals as a last resort. Any ‘core’ registration data missing from Annex VII and VIII needs to be generated for the registration. For the ‘higher-tier’ tests from Annex IX and X a testing proposal should be submitted.

Proposals for additional testing to fill data gaps have to be submitted to the European Chemicals Agency (ECHA) for approval. When putting together testing proposals, you need to comply with REACH requirements on the use of animal tests. REACH is clear that animal tests must only be used as a last resort, when no suitable non-animal alternative tests are available. Where animal tests are necessary, once done they may not be repeated. The preferred means of obtaining information on the properties of a substance must always be by use of non-animal test methods wherever possible.

We can:

• advise on the necessary and appropriate testing with regards to higher-tier tests that are generally required for substances above 100 tonnes;
• provide you with information on third parties with capabilities to implement your testing proposal, once accepted.