PART IV DUTIES AFTER THE MAKING OF APPLICATIONS

Decisions by the Secretary of State on applications for consent to market24

F41

The Secretary of State must not grant an application for consent to market genetically modified organisms under section 111(1) of the Act as it relates to the protection of human health without the agreement of the Health and Safety Executive.

2

Where the Secretary of State invites representations on an assessment report relating to an application for consent to market genetically modified organisms—

a

the Secretary of State must not determine whether to grant or refuse the application before the period for making representations under regulation 23(4) has ended and the Secretary of State has considered any representations made in accordance with that regulation;

b

the Secretary of State must, within 105 days after the end of the period for making representations under regulation 23(4)—

i

determine the application, and

ii

notify the applicant in writing of the decision to grant or refuse the application, and the reasons for the decision.

3

The period referred to in paragraph (2)(b) does not include any period beginning with the day on which the Secretary of State gives notice in writing under section 111(6) of the Act that further information in respect of the application is required and ending on the day on which that information is received by the Secretary of State.

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 F1... 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 F2a National List in accordance with regulation 3 of the Seeds (National Lists of Varieties) Regulations 2001 .

6

For the purpose of granting consent to market a genetically modified organism contained in forest reproductive material, the period of the 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 F3the National Register in accordance with regulations 6 and 7 of the Forest Reproductive Material (Great Britain) Regulations 2002 .