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4.—(1) Any person who applies for the inclusion of a new active substance in Annex I shall submit to the Department, the relevant competent authorities and the Commission a dossier which satisfies the requirements of Annex II, a declaration that the active substances is intended for use in a plant protection product, and a dossier complying with Annex III on at least one preparation containing that active substance.
(2) Where any active substance has been included in Annex I, any person may make an application for variation of the conditions subject to which the active substance was included.
(3) Any person who applies under paragraph (2) shall submit the application to the Department, the relevant competent authorities and the Commission.
(4) This regulation applies to any person whose principal place of business in the United Kingdom is situated in Northern Ireland.
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