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PART IVDUTIES AFTER THE MAKING OF APPLICATIONS

Decisions by the Department on applications for consents to market genetically modified organisms

24.—(1) The Department may grant an application for consent to market genetically modified organisms only where it has prepared an assessment report which indicates that the genetically modified organisms should be marketed and –

(a)no objection has been raised by a Member State or by the Commission during a 60 day period beginning on the day the Commission circulated the assessment report, or

(b)an objection or objections have been raised by either a Member State or by the Commission but outstanding issues have been resolved in accordance with Article 15(l) of the Deliberate Release Directive within a 105 day period beginning on the day the Commission circulated the assessment report; or

(c)an objection has been raised by a Member State or the Commission and the Commission has adopted a decision in accordance with Article 18(l) of the Deliberate Release Directive in favour of granting consent.

(2) The Department shall inform the competent authority or authorities of each Member State and the Commission of its decision to grant consent to market genetically modified organisms within thirty days of its grant.

(3) For the purpose of calculating the final 45 day period of 105 days in paragraph (1)(b) no period during which further information is awaited from the applicant shall be taken into account.

(4) Subject to paragraphs (5) and (6), a consent to market genetically modified organisms shall be given for a maximum period of ten years beginning with the day on which the consent is issued.

(5) For the purpose of granting consent to market a genetically modified organism or any progeny of that genetically modified organism contained in a plant variety where that plant variety is intended only for the marketing of its seeds under the relevant Community provisions the period of the first consent shall end at the latest ten years after the date of the first inclusion of the first plant variety containing the genetically modified organism on an official national catalogue of plant varieties in accordance with Directives 2002/53/EC(1) and 2002/55/EC(2).

(6) For the purpose of granting consent to market a genetically modified organism contained in forest reproductive material, the period of any first consent shall end at the latest ten years after the date of the first inclusion of basic material containing the genetically modified organism on an official national register of basic material in accordance with Council Directive 1999/105/EC(3).

(1)

O.J. No. L193, 20.7.2002, p. 1

(2)

O.J. No. 193, 20.7.2002, p. 33

(3)

Council Directive 1999/105/EC on the marketing of forest reproductive material (O.J. No. L11 15.1.2000, p. 17)