9.—(1) The Genetically Modified Organisms (Deliberate Release) Regulations 2002 M1 are amended as follows.
(2) In regulation 23—
(a)in paragraph (1)—
(i)omit sub-paragraphs (b) and (e);
(ii)in sub-paragraph (d)(ii), at the end, for “, and” substitute “ . ”;
(b)in paragraph (3), for “periods” substitute “ period ”;
(c)for paragraph (4) substitute—
“(4) Where the assessment report referred to in paragraph (1)(d) indicates that the genetically modified organisms to which an application relates should be permitted to be marketed, the Secretary of State must invite any person, by means of a request placed on the register, to make representations on the assessment report, which must be received by the Secretary of State within a period of 30 days beginning with the day on which the request is placed on the register (which must not be earlier than the day on which the assessment report is placed on the register under regulation 35(7A)).”.
(3) In regulation 24, for paragraphs (1) to (3) substitute—
“24.—(1) 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) In regulation 34, after paragraph (7) insert—
“(7A) A copy of any assessment report produced in accordance with regulation 23(1)(d) or regulation 25(1)(c).”.
(5) In regulation 35—
(a)in paragraph (2), after “(a) to (g)” insert “ and (i) ”;
(b)after paragraph (3) insert—
“(3A) The information prescribed in regulation 34(3A) shall be placed on the register within twelve days of receipt by the Secretary of State of the application for consent to market.”;
(c)after paragraph (7) insert—
“(7A) The information prescribed in regulation 34(7A) shall be placed on the register within twelve days of its production.”.
Commencement Information
I1Reg. 9 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(b)
Marginal Citations
M1S.I. 2002/2443, amended by S.I. 2004/2411, 2005/2759, 2009/1892, 2011/1043, 2018/575 and 2019/88.
10.—(1) The Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003 M2 are amended as follows.
(2) In regulation 23—
(a)in paragraph (1)—
(i)omit sub-paragraphs (b) and (e);
(ii)in sub-paragraph (d)(ii), at the end, for “and” substitute “ . ”;
(b)in paragraph (3), for “periods” substitute “ period ”;
(c)for paragraph (4) substitute—
“(4) Where the assessment report referred to in paragraph (1)(d) indicates that the genetically modified organisms to which an application relates should be permitted to be marketed, the Department must invite any person, by means of a request placed on the register, to make representations on the assessment report, which must be received by the Department within a period of 30 days beginning with the day on which the request is placed on the register (which must not be earlier than the day on which the assessment report is placed on the register under regulation 35(7A)).”.
(3) In regulation 24, for paragraphs (1) to (3) substitute—
“24.—(1) The Department must not grant an application for consent to market genetically modified organisms under Article 8(1) of the Order as it relates to the protection of human health without the agreement of the Health and Safety Executive Northern Ireland.
(2) Where the Department invites representations on the assessment report relating to an application for consent to market genetically modified organisms—
(a)the Department must not determine whether to grant or refuse the application before the period for making representations under regulation 23(4) has ended and the Department has considered any representations made in accordance with that regulation;
(b)the Department 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 that decision.
(3) The period referred to in paragraph (2)(b) does not include any period beginning with the day on which the Department gives notice in writing under Article 8(6) of the Order that further information in respect of the application is required and ending on the day on which that information is received by the Department.”.
(4) In regulation 34, after paragraph (7) insert—
“(7A) A copy of any assessment report produced in accordance with regulation 23(1)(d) or regulation 25(1)(c).”.
(5) In regulation 35—
(a)in paragraph (2), after “(a) to (g)” insert “ and (i) ”;
(b)after paragraph (3) insert—
“(3A) The information prescribed in regulation 34(3A) shall be placed on the register within twelve days of its receipt by the Department of the application for consent to market.”;
(c)after paragraph (7) insert—
“(7A) The information prescribed in regulation 34(7A) shall be placed on the register within twelve days of its production.”.
Commencement Information
I2Reg. 10 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(b)
Marginal Citations
M2S.R. 2003 No.167, amended by S.R. 2005 No. 272 and S.I. 2019/190.
11. In the Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 M3, in regulation 3, omit paragraphs (9)(a) and (d) and (10)(a).
Commencement Information
I3Reg. 11 in force at 31.12.2020 immediately before IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(a)
Marginal Citations
12.—(1) The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 M4 are amended as follows.
(2) For regulation 5(3)(a) substitute—
“(a)for paragraph 10(a) substitute—
“(a)the permanent or temporary leaving of the United Kingdom of GMOs which originated—
(i)in the United Kingdom, or
(ii)in a third country but have entered, and are in free circulation in, the United Kingdom;”;”.
(3) In regulation 6(2), in paragraph 1 of substituted Article 1, in the words before point (a), for “ and ” in the second place it occurs substitute “ or ”.
Commencement Information
I4Reg. 12 in force at 31.12.2020 immediately before IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(a)
Marginal Citations
13. In the Genetically Modified Organisms (Amendment) (Northern Ireland) (EU Exit) Regulations 2019 M5, in regulation 3, omit paragraphs (9)(a) and (d) and (10)(a).
Commencement Information
I5Reg. 13 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(b)
Marginal Citations