Board of Appeal decision on ‘one substance, one registration’

In Case A-022-2013, the Appellant, the lead registrant for the joint submission for charcoal, contested an Agency decision granting a registration number to a company which made its registration outside the joint submission and which was also, according to the Appellant, incomplete. The decision examines the rules in REACH regarding whether all registrations of the same substance need to be part of the same joint submission or whether individual registrations, when there is an existing joint submission, are allowed. The decision also examines the implications of individual and joint submissions with regard to the requirements in REACH for cost and data sharing. The decision finds that REACH requires all registrants of the same substance to be part of the same joint submission (‘one substance, one registration’). This helps ensure that the requirements put in place in REACH to minimise testing on vertebrate animals and to share the costs of data and the preparation of registrations can be fully and effectively applied by all registrants. In one of its most important decisions to date, the Board of Appeal annulled the contested decision on the grounds that the Agency had considered a registration to be complete when it was, on the admission of the Agency, not complete and also because the Agency had granted a registration number for a registration that was made outside an existing joint submission thereby breaching the requirement for ‘one substance, one registration’. Further details on the decision is available at: Board of Appeal decisions

ECHA Weekly, 16 March 2016 ; ;