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The Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003

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New information on risks of damage from marketing genetically modified organisms

31.—(1) The Department shall immediately forward to the Commission and the competent authority or authorities of each Member State any new information which becomes available to it which it considers could affect the assessment of the risk of the damage being caused to the environment by releasing or placing on the market genetically modified organisms.

(2) Where an application for consent or for renewal of consent to place on the market genetically modified organisms has been made and the information referred to in paragraph (1) becomes available to the Department before the consent has been granted or renewed, the Department may seek to reach agreement with the Commission and other Member States pursuant to Articles 15(1) or 17(7) of the Deliberate Release Directive as applicable.

(3) Where an application for consent or for renewal of consent to place on the market genetically modified organisms has been made and the information referred to in paragraph (1) becomes available to the Department after the consent has been granted or renewed, it shall within 60 days after receipt of the new information, forward to the Commission an assessment report indicating whether the conditions of the consent should be varied, and, if so, how, or whether the consent should be revoked.

(4) The Department shall not forward an assessment report indicating that the consent to place on the market genetically modified organisms as it relates to the protection of human health should be varied without the agreement of the Executive.

(5) Where the Department has indicated that the consent should be varied and either –

(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 a Member State or by the Commission but outstanding issues have been resolved in accordance with Article 20(3) of the Deliberate Release Directive;

it shall vary the consent as proposed and inform the applicant, the competent authority or authorities of each Member State and the Commission that it has done so within 30 days thereof.

(6) The Department shall only vary or revoke a consent to market genetically modified organisms under Article 8(10) of the Order –

(a)where the information referred to in paragraph (1) has become available to it, and the procedure referred to in paragraphs (3) and (5) has been complied with, or

(b)in accordance with a decision by the Commission under Article 18(1) or Article 23(2) of the Deliberate Release Directive.

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