注册后的程序.pdf

Post registration REACH Capacity Building Workshop Erik van de Plassche European Commission, DG JRC Institute for Health and Consumer Protection (IHCP) European Chemicals Bureau (ECB) Post registration What happens after registration with a positive completeness check? • Evaluation: – Dossier evaluation: • Evaluation of testing proposals • Compliance check of registration dossiers – Substance evaluation • Authorisation • Restrictions REACH Capacity Building Workshops China and ASEAN Evaluation Provide confidence that industry is meeting obligations Prevent unnecessary testing Dossier evaluation Substance evaluation Examine any information on Test proposals Compliance a substance Result: • Request for further information • Information to other parts of REACH or other legislation REACH Capacity Building Workshops China and ASEAN EVALUATION OF TESTING PROPOSALS REACH Capacity Building Workshops China and ASEAN Testing proposals When Annexes IX or XI apply a testing proposal has to be submitted in the registration dossier providing justification: • The test is necessary • The testing proposal is adequate • The Agency will evaluate all testing proposals • Priority is given to: CMR, PBT, classified as dangerous above 100 tonnes/year and widespread use → Guidance under development REACH Capacity Building Workshops China and ASEAN Evaluation testing proposals In the evaluation of testing proposals the Agency would use and document considerations like: – Is t