Genetically Modified Organisms (Deliberate Release) Regulations 2002

Applications for consent to market

16.—(1) An application for consent to market genetically modified organisms under section 111(1) of the Act must be made in writing to the Secretary of State.

(2) An application for a consent to market genetically modified organisms which is not an application for renewal of a consent must contain the following information—

(a) [F1 subject to paragraph (2A)] the information prescribed in—

(i) [F2 Schedule 1A] where the application is for consent to market any genetically modified higher plant, or

(ii) Schedule 2 in any other case,

F3 ...

(b) information on data or results from any previous release of the organisms, or of the same combination of organisms, which has been carried out by the applicant either inside or outside the [F4 United Kingdom], and information from any previous application for consent to release the organisms, or the same combination of organisms, which the applicant has made to the Secretary of State in accordance with the Act and these Regulations, F5 ...

(c) an environmental risk assessment prepared in accordance with regulation 6,

(d) the information prescribed in Schedule 3,

(e) the proposed conditions for the marketing of the product, including specific conditions of use and handling,

(f) a proposed period for the consent which shall not exceed ten years,

(g) a monitoring plan prepared in accordance with Annex VII of the Deliberate Release Directive [F6 , as read with the guidance notes set out in Commission Decision 2002/811/EC,] which shall include a proposal for the time period of the plan which may differ from the proposed period for the consent,

(h) a proposal for labelling which shall comply with the requirements laid down in Schedule 3,

(i) a proposal for packaging,

(j) a summary of the application in the format [F7 set out in the Annex to Commission Decision 2002/812/EC].

[F8 (k) in respect of each subset of information required in this paragraph—

(i) summaries and results of studies referred to in the application, including an explanation of their relevance to the environmental risk assessment, as appropriate,

(ii) details of studies referred to in the application, including materials and methods used or reference to standardised or internationally recognised methods and the name of the body or bodies responsible for carrying out those studies.]

[F9 (2A) The information specified in paragraph (2)(a) is only required to be provided if it is necessary for the completion of an environmental risk assessment in the context of a specific application, and the level of detail to be provided may vary according to the nature and the scale of the proposed release resulting from the marketing of a genetically modified higher plant.]

(3) The application may in addition contain—

(a) data or results from an application for consent to release genetically modified organisms previously made by some other person, provided that a copy of that person’s agreement in writing is contained in the application, and

(b) any other information which the applicant considers relevant.

(4) The information provided in accordance with sub paragraphs (2)(a) and (d) shall take into account the diversity of sites of use of the genetically modified organisms and shall include information on any results obtained from research and developmental releases concerning the impact of the release on human health and the environment.

(5) Where the applicant can demonstrate in his application to the satisfaction of the Secretary of State, that, on the basis of the results of any release in pursuance of and in accordance with a consent under section 111(1) of the Act or under Part B of either the Deliberate Release Directive or the 1990 Directive, or on other substantive, reasoned scientific grounds, the marketing and use of the product do not pose a risk of damage to the environment, he may omit from the application part or all of the information prescribed in Part II of Schedule 3.

Textual Amendments

F1 Words in reg. 16(2)(a) inserted (29.9.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2019 (S.I. 2019/1252), regs. 1(1), 5(a)(i)

F2 Words in reg. 16(2)(a)(i) substituted (29.9.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2019 (S.I. 2019/1252), regs. 1(1), 5(a)(ii)

F3 Words in reg. 16(2)(a) omitted (29.9.2019) by virtue of The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2019 (S.I. 2019/1252), regs. 1(1), 5(a)(iii)

F4 Words in reg. 16(2)(b) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(6)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in reg. 16(2)(b) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(6)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in reg. 16(2)(g) inserted (31.12.2020) by The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(6)(b); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in reg. 16(2)(j) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(6)(c); 2020 c. 1, Sch. 5 para. 1(1)

F8 Reg. 16(2)(k) inserted (29.9.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2019 (S.I. 2019/1252), regs. 1(1), 5(b)

F9 Reg. 16(2A) inserted (29.9.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2019 (S.I. 2019/1252), regs. 1(1), 5(c)