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12.—(1) A user must not undertake a contained use involving larger GMOs unless the provisions of this regulation have been complied with.
(2) A person responsible for the contained use must submit a notification to the competent authority containing the information specified in Schedule 6.
(3) The Executive must send an acknowledgement of receipt to the notifier within 10 working days of the competent authority receiving the notification.
(4) A user may undertake the contained use if—
(a)45 days have elapsed since the acknowledgement of receipt was received, provided that the competent authority has not informed the notifier that the contained use may not be undertaken; or
(b)the competent authority has agreed in writing that the contained use may commence sooner.
(5) This regulation does not apply to a contained use which results in a larger GMO that poses no greater risk to humans than its unmodified parental organism.
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