The Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002

PART V S GENERAL PROVISION FOR CONSENTS

General provisions of consents to market S

28.  A consent to market genetically modified organisms granted by the Scottish Ministers under section 111(1) of the Act shall specify–

(a) the scope of the consent, including the identity of the genetically modified organisms to be marketed, and their unique identifier;

(b) the period of validity of the consent;

(c) the conditions for marketing the product, including any specific conditions of use, handling and packaging of the genetically modified organisms, and conditions for the protection of particular ecosystems or environments or geographical areas as applicable;

(d) that the applicant shall make control samples available to the Scottish Ministers on request;

(e) the labelling requirements, in accordance with paragraph 8 of Schedule 4, which shall include a requirement to notify the Scottish Ministers of any new commercial name of the product after consent has been given; and

(f) monitoring requirements which shall be in accordance with the monitoring plan, and shall include the time period of the monitoring plan, an obligation that the applicant shall submit [F1 monitoring reports to the Scottish Ministers in the relevant format set out in the Annexes to Decision 2009/770/EC] and, where appropriate, any obligations on any person selling the product or any user of it, which may include an obligation to provide information at an appropriate level on the location of the genetically modified organisms that are grown.

Textual Amendments

F1 Words in reg. 28(f) substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(16); 2020 c. 1, Sch. 5 para. 1(1)

General conditions on consents to release or market genetically modified organisms S

29.—(1) Section 112 of the Act (consents: limitations and conditions) is amended as follows.

(2) In subsection (1) (power of Scottish Ministers to impose limitations and conditions) at the end insert “ for the purpose of ensuring that all appropriate measures are taken to avoid damage to the environment which may arise from the activity permitted by the consent ”.

(3) In subsection (5) (implied condition when releasing or marketing)–

(a) in paragraph (b) (obligation to notify Scottish Ministers of new information etc.)–

(i) before the word “of” where it appears for the second time insert “ forthwith ”;

(ii) omit subparagraph (ii); and

(iii) after that subparagraph insert–

“(iii) any unforeseen event, occurring in connection with a release by him, which might affect the risks there are of damage to the environment being caused as a result of their being released;”;

(b) for paragraph (c) (duty as regards preventing damage to environment) substitute–

“(c) take such measures as are necessary to prevent damage to the environment being caused as a result of the release, or, as the case may be, the marketing of the organisms;”;

and

(c) after that paragraph insert–

“(d) notify the Scottish Ministers forthwith of the measures (if any) taken as a result of new information becoming available or an unforeseen event occurring as described in paragraph (b)(iii); and

(e) in a case where new information becomes available or an unforeseen event so occurs, revise the information contained in his application for a consent accordingly and supply the revised information to the Scottish Ministers in such form and manner as they may specify.”.

[F2 Restrictions on cultivation S

29A.— (1) This regulation applies to—

(a) a consent [F3 granted] by the Scottish Ministers under section 111(1) of the Act (including a renewed consent [F4 granted under that section in accordance with] regulation 26),

(b) [F5 a pre-exit] approved product, or

(c) an authorisation under the Food and Feed Regulation [F6 .]

F7 ...

F8 (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) The Scottish Ministers may, in the circumstances prescribed in paragraph (7), do any of the following—

(a) include [F9 such limitations and conditions in the consent or renewed consent as they consider appropriate to restrict or prohibit the cultivation of genetically modified organisms in all or any part of Scotland],

(b) issue a suspension notice in respect of [F10 the] consent or renewed consent,

(c) issue a suspension notice in respect of the [F11 pre-exit] approved product, or

(d) issue a suspension notice in respect of the authorisation under the Food and Feed Regulation.

(4) The effect of a suspension notice issued under paragraph (3)(b) is to suspend the operation of the consent in respect of the cultivation of a genetically modified organism for all or a specified geographical area of Scotland.

(5) The effect of a suspension notice issued under paragraph (3)(c) is to suspend, so far as it applies to the requirement in section 111(1)(a) of the Act for all or a specified geographical area of Scotland, the operation of the exemption in regulation [F12 15(aa)] (exempt activities), in respect of the cultivation of a specified [F13 pre-exit] approved product.

(6) The effect of a suspension notice issued under paragraph (3)(d) is to suspend, so far as it applies to the requirement in section 111(1)(a) of the Act for all or a specified geographical area of Scotland, the operation of the exemption in regulation [F14 15(a)], in respect of the cultivation of genetically modified food or [F15 genetically modified] feed authorised under the Food and Feed Regulation.

(7) The prescribed circumstances are that the Scottish Ministers are of the view that it is necessary to restrict [F16 or, as the case may be, prohibit] the cultivation of a genetically modified organism, or a group of genetically modified organisms, on the basis of compelling grounds that—

(a) may include one or more of the following—

(i) environmental policy objectives,

(ii) town and country planning,

(iii) land use,

(iv) socio-economic impacts,

(v) the avoidance of the presence of genetically modified organisms in other products F17 ...,

(vi) agricultural policy objectives,

(vii) subject to paragraph (8), public policy,

(b) are in conformity with [F18 assimilated] law,

(c) are proportional,

(d) are non-discriminatory, and

(e) do not conflict with the environmental risk assessment carried out pursuant to [F19 [F20 assimilated] law on the deliberate release into the environment of genetically modified organisms (including the Food and Feed Regulation)].

(8) Public policy can only be relied upon in combination with at least one other ground included in sub-paragraph (a)(i) to (vi) of paragraph (7).

(9) Before taking any of the actions in paragraph (3), the Scottish Ministers must—

F21 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) where they consider appropriate, in the case of a notice served under regulation 29A(3)(d), notify Food Standards Scotland, and

(c) make the reasons for the decision to take those actions available to the public.

(10) A condition or suspension notice under paragraph (3) must not take effect until the expiry of the period of 75 days starting on the date of the notification under paragraph (9).

(11) The Scottish Ministers may amend a [F22 limitation or condition referred to in paragraph (3)(a), or a suspension notice issued under paragraph (3)(b), (c) or (d),] to take account of [F23 any comments they receive] prior to its coming into force.

(12) The Scottish Ministers must—

(a) communicate the [F24 limitation,] condition or suspension notice [F25 , as the case may be,] to F26 ... the consent or authorisation holder without delay, and

(b) make details of the condition or suspension notice available to the public.]

Textual Amendments

F2 Regs. 29A, 29B inserted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 13

F3 Word in reg. 29A(1)(a) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(11)(a)(i)

F4 Words in reg. 29A(1)(a) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(11)(a)(ii)

F5 Words in reg. 29A(1)(b) substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(17)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F6 Reg. 29A(1)(c): full stop substituted for comma (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(17)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in reg. 29A(1) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(17)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F8 Reg. 29A(2) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(17)(b); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in reg. 29A(3)(a) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(11)(b)(i)

F10 Word in reg. 29A(3)(b) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(11)(b)(ii)

F11 Word in reg. 29A(3)(c) inserted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(17)(c); 2020 c. 1, Sch. 5 para. 1(1)

F12 Word in reg. 29A(5) substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(17)(d)(i); 2020 c. 1, Sch. 5 para. 1(1)

F13 Word in reg. 29A(5) inserted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(17)(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F14 Word in reg. 29A(6) substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(17)(e); 2020 c. 1, Sch. 5 para. 1(1)

F15 Words in reg. 29A(6) inserted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(11)(c)

F16 Words in reg. 29A(7) inserted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(11)(d)

F17 Words in reg. 29A(7)(a)(v) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(17)(f)(i); 2020 c. 1, Sch. 5 para. 1(1)

F18 Word in reg. 29A(7)(b) substituted (1.1.2024) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) (Scotland) Regulations 2023 (S.S.I. 2023/374), reg. 1(1), sch. 2 para. 2(2)

F19 Words in reg. 29A(7)(e) substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(17)(f)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F20 Word in reg. 29A(7)(e) substituted (1.1.2024) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) (Scotland) Regulations 2023 (S.S.I. 2023/374), reg. 1(1), sch. 2 para. 2(3)

F21 Reg. 29A(9)(a) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(17)(g); 2020 c. 1, Sch. 5 para. 1(1)

F22 Words in reg. 29A(11) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(11)(e)

F23 Words in reg. 29A(11) substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(17)(h); 2020 c. 1, Sch. 5 para. 1(1)

F24 Word in reg. 29A(12)(a) inserted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(11)(f)(i)

F25 Words in reg. 29A(12)(a) inserted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(11)(f)(ii)

F26 Words in reg. 29A(12)(a) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(17)(i); 2020 c. 1, Sch. 5 para. 1(1)

[F2 Removal of restrictions under regulation 29A S

29B.— (1) The Scottish Ministers may, at any time, do any of the following in respect of measures adopted under regulation 29A—

(a) vary a [F27 limitation or] condition in a consent [F28 or renewed consent] to remove [F29 or modify a restriction or prohibition on the cultivation of genetically modified organisms in all or any part of Scotland],

(b) withdraw a suspension notice in respect of a consent [F30 or renewed consent],

(c) withdraw a suspension notice in respect of [F31 a pre-exit] approved product,

(d) withdraw a suspension notice in respect of an authorisation under the Food and Feed Regulation.

(2) The Scottish Ministers must notify the [F32 consent or authorisation holder] of any action taken under paragraph (1) without delay.]

Textual Amendments

F2 Regs. 29A, 29B inserted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 13

F27 Words in reg. 29B(1)(a) inserted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(12)(a)(i)

F28 Words in reg. 29B(1)(a) inserted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(12)(a)(ii)

F29 Words in reg. 29B(1)(a) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(12)(a)(iii)

F30 Words in reg. 29B(1)(b) inserted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(12)(b)

F31 Words in reg. 29B(1)(c) substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(18)(a); 2020 c. 1, Sch. 5 para. 1(1)

F32 Words in reg. 29B(2) substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(18)(b); 2020 c. 1, Sch. 5 para. 1(1)

Proof of compliance with consent conditions S

30.  In section 119 of the Act (onus of proof as regards techniques and evidence) in subsection (1) (accused to prove use of best available techniques) after “the accused to prove” insert

“the matters described in subsection (1A) below.

(1A) The matters referred to in subsection (1) above are–

(a) in the case of an offence under section 118(1)(c) above consisting in a failure to comply with the general condition implied by section 112(5)(c) above–

(i) that no measures, other than the measures taken by him, were necessary to prevent damage being caused to the environment from the release or, as the case may be, marketing of the organisms, or

(ii) in a case where he took no measures, that no measures were necessary; and

(b) in any other case,”.

[F33 Stop notices S

30A.— (1) The Scottish Ministers may serve a notice under this regulation (a “stop notice”) on any person they have reason to believe—

(a) is releasing or marketing a genetically modified organism, or has released or marketed a genetically modified organism, and the release or marketing of that organism is not—

(i) pursuant to a consent [F34 required] under section 111(1) of the Act F35 ..., F36 ...

(ii) under and in accordance with any limitation or condition to which such a consent is subject, [F37 or]

[F38 (iii) exempt from any such requirement for consent, including by virtue of not being in accordance with any limitation or condition to which the exemption is subject,]

(b) is cultivating or has cultivated a genetically modified organism in contravention of a [F39 limitation or condition included in] a consent to market [F40 pursuant to] regulation 24(7) or a renewed consent to market [F40 pursuant to] regulation 26(5),

(c) is cultivating or has cultivated a genetically modified organism in contravention of a [F41 limitation or condition included in a consent or a renewed consent pursuant to] regulation 29A(3)(a), or

(d) is cultivating or has cultivated a genetically modified organism or approved product in contravention of a suspension notice issued under regulation 29A(3)(b) [F42 , (c) or (d)].

(2) A stop notice served on a person may—

(a) prohibit a person from carrying out any act,

(b) require a person to cease carrying out any act,

(c) require a person to carry out any act,

for the purposes of ensuring, in so far as is possible, that the release, cultivation, placing on the market or marketing of the genetically modified organism is terminated.

(3) The stop notice must—

(a) state that the Scottish Ministers are, in relation to the person on whom it is served, of the belief mentioned in paragraph (1),

(b) specify, for the purposes of paragraph (2), what act is to be prohibited, required or ceased and any applicable timescale, and

(c) specify the date on which the stop notice takes effect (which may be the date of service).

(4) The Scottish Ministers must, where they consider appropriate, notify Food Standards Scotland before serving a stop notice.

(5) The Scottish Ministers may at any time vary or withdraw a stop notice served on any person by giving reasonable notice.]

Textual Amendments

F33 Reg. 30A inserted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 14

F34 Word in reg. 30A(1)(a)(i) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(13)(a)(i)(aa)

F35 Words in reg. 30A(1)(a)(i) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(19); 2020 c. 1, Sch. 5 para. 1(1)

F36 Word in reg. 30A(1)(a)(i) omitted (28.3.2019) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(13)(a)(i)(bb)

F37 Word in reg. 30A(1)(a)(ii) inserted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(13)(a)(ii)

F38 Reg. 30A(1)(a)(iii) inserted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(13)(a)(iii)

F39 Words in reg. 30A(1)(b) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(13)(b)(i)

F40 Words in reg. 30A(1)(b) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(13)(b)(ii)

F41 Words in reg. 30A(1)(c) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(13)(c)

F42 Words in reg. 30A(1)(d) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(13)(d)

[F43 Variation or revocation of consents to market S

31.— (1) The Scottish Ministers may only vary or revoke a consent to market genetically modified organisms under section 111(10) of the Act without the agreement of the holder of the consent where new information has become available which the Scottish Ministers consider would affect the assessment of the risk of damage being caused to the environment by the release.

(2) The Scottish Ministers must not revoke or vary a consent to market genetically modified organisms under section 111(10) of the Act as it relates to the protection of human health without the agreement of the Health and Safety Executive.]

Textual Amendments

F43 Reg. 31 substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(20); 2020 c. 1, Sch. 5 para. 1(1)