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12.—(1) Where the Department reasonably considers that a product which it has approved, or is required to approve, under regulation 11 constitutes a risk to human or animal health or the environment, it may provisionally restrict or prohibit its sale or use in Northern Ireland and shall immediately notify the holder of the approval or the applicant (as the case may be), the relevant competent authorities and the Commission of such action, giving reasons for the decision.
(2) A provisional restriction or prohibition under paragraph (1) shall survive so long as its survival is consistent with Article 11(2).
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