The various roles in the registration process

Case A-008-2012 concerned the substance identity requirements for a registered substance following a compliance check.

07-Apr-2014 - Finland

The Board of Appeal decision highlights that it is the responsibility of the registrant to decide which substance(s) it is required to register (its registration strategy) and to act accordingly (e.g. by submitting compliant registrations). The Agency is responsible under the compliance check procedure for verifying whether the information provided by the registrant meets the requirements of the REACH Regulation. The Member State enforcement authorities are responsible for taking action if they consider that a manufacturer or importer has failed to register a substance in accordance with the REACH Regulation.

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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