The various roles in the registration process
Case A-008-2012 concerned the substance identity requirements for a registered substance following a compliance check.
The Board of Appeal decision clarifies the interpretation of ‘substance’ and ‘mixture’ with regard to the registration requirements under the REACH Regulation in the context of this particular case.
The Board of Appeal decision emphasises the important role ECHA plays in providing advice to registrants on their registration strategy and the information required to make a compliant registration.
In the ECHA decision challenged in the appeal, the Agency had found that the Appellant’s registration dossier contained information on more than one substance. The Board of Appeal’s decision confirmed that registration dossiers should contain information on only one substance. However, the appeal was upheld as the Board of Appeal considered that the ECHA decision appeared to direct the registrant as to the substance that should be included in the registration dossier when this decision is the sole responsibility of the registrant.
The risks of ECHA directing a registrant in this way was clearly illustrated in this case as information made available during the appeal proceedings showed that ECHA’s assumptions on the substance that the registrant needed to register may have been based on a false premise.
In its decision, the Board of Appeal also encourages the Appellant to re-examine its registration strategy to ensure compliance with the registration requirements under the REACH Regulation.
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