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

Scottish Statutory Instruments

2002 No. 541

ENVIRONMENTAL PROTECTION

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

Made

4th December 2002

Coming into force in accordance with regulation 1(1)

The Scottish Ministers, in exercise of the powers conferred by section 2(2) of the European Communities Act 1972M1 and of all other powers enabling them in that behalf hereby make the following Regulations, a draft of which has, in accordance with paragraph 2(2) of Schedule 2 to that Act been laid before, and approved by resolution of, the Scottish Parliament:

Marginal Citations

M1 1972 c.68; section 2(2) was amended by the Scotland Act 1998 (c.46), Schedule 8, paragraph 15(3). The function conferred upon the Minister of the Crown under section 2(2) of the European Communities Act 1972, insofar as within devolved competence, was transferred to the Scottish Ministers by virtue of section 53 of the Scotland Act 1998.

PART I S GENERAL

Citation, commencement and extent S

1.—(1) These Regulations may be cited as the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 and shall come into force on the day after the day on which they are made.

(2) These Regulations extend to Scotland only.

Interpretation S

2.—(1) In these Regulations, unless the context otherwise requires–

• “the Act” means the Environmental Protection Act 1990 M2 ;

• “the Advisory Committee on Releases to the Environment” means the committee appointed for the purposes of, and in accordance with, section 124 of the Act;

• “antibiotic resistance markers” means genes employed in the modification of an organism to make that organism express resistance to a particular antibiotic or antibiotics;

• “application for consent to release” shall include any notification made under the First Simplified Procedure (crop plants) Decision;

• [F1 “approved product” means a product consisting of or including genetically modified organisms which—

  (a)

  is permitted to be marketed in Scotland in pursuance of—

  (i)

  a consent granted by the Scottish Ministers under section 111(1) of the Act, or

  (ii)

  an authorisation under the Food and Feed Regulation, or

  (b)

  is a pre-exit approved product,]

• F2 ...

• “community council” means a community council constituted under section 51 of the Local Government (Scotland) Act 1973 M3 ;

• F3 ...

• [F4 “the Deliberate Release Directive” means Directive 2001/18/EC of the European Parliament and the Council on the deliberate release into the environment of genetically modified organisms [F5 , as last amended by Commission Directive (EU) 2018/350];]

• [F6 “1990 Directive” means Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, as it had effect before it was repealed by Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC,]

• “electronic communication” has the same meaning as in the Electronic Communications Act 2000 M4 ;

• “environmental risk assessment” means the environmental risk assessment required to be contained in an application for consent to release or market genetically modified organisms by virtue of regulation 11(1)(c) and regulation 16(2)(c) respectively;

• [F7 “the First Simplified Procedure (crop plants) Decision” means Commission Decision 94/730/EC establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants pursuant to Article 6(5) of Council Directive 90/220/EEC,]

• [F8 “the Food and Feed Regulation” means Council Regulation (EC) No 1829/2003 on genetically modified food and feed,]

• [F9 “genetically modified feed” means–

  (a)

  feed containing or consisting of genetically modified organisms;

  (b)

  feed derived in whole or in part from, but not containing or consisting of genetically modified organisms; or

  (c)

  genetically modified organisms that may be used as feed or as a source material for the production of feed;]

• [F9 “genetically modified food” means–

  (a)

  food containing or consisting of genetically modified organisms;

  (b)

  food, or food containing ingredients, derived in whole or in part from genetically modified organisms, but not containing or consisting of genetically modified organisms; or

  (c)

  genetically modified organisms that may be used as food or as a source material for the production of food;]

• “[F10 Food Standards Scotland]” means [F10 Food Standards Scotland] established under section 1 of the [F11 Food (Scotland) Act 2015];

• “genetically modified organisms” means a genetically modified organism or a combination of genetically modified organisms;

• “the Health and Safety Executive” means the Health and Safety Executive established under section 10 of the Health and Safety at Work etc. Act 1974 M5 ;

• “higher plant” means a plant belonging to the taxonomic group Spermatophyta (Gymnospermae or Angiospermae);

• “local authority” means a council constituted under section 2 of the Local Government etc. (Scotland) Act 1994 M6 ;

• “monitoring plan” means the plan required by regulation 16(2)(g);

• [F12 “pre-exit approved product” means a product consisting of or including genetically modified organisms which, immediately before exit day, was permitted to be marketed in Scotland in pursuance of a consent granted (other than by the Scottish Ministers under section 111(1) of the Act) in accordance with—

  (a)

  Article 15(3), 17(6) or 18(2) of the Deliberate Release Directive, or

  (b)

  Article 13(2) or (4) of the 1990 Directive,]

• “the register” means the public register kept by the Scottish Ministers under section 122 of the Act;

• F13 ...

• “the 1992 Regulations” means the Genetically Modified Organisms (Deliberate Release) Regulations 1992 M7 .

(2) Expressions used in these Regulations have, unless the contrary intention appears, the meaning which they bear in Part VI of the Act and in regulations 8, 9, 14, 15, 33 and 34 the prescribing of cases, circumstances, descriptions and matters shall be treated as being cases, circumstances, descriptions and matters prescribed in accordance with and under the Act.

(3) In these Regulations, unless the context otherwise requires–

(a) any reference to a numbered regulation or to a numbered Schedule or to a numbered Part is a reference to the regulation or Schedule or Part in these Regulations so numbered; and

(b) a reference to a numbered paragraph is a reference to the paragraph so numbered in the regulation or Schedule to which that reference occurs.

Textual Amendments

F1 Words in reg. 2(1) 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(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 2(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(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in reg. 2(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(2)(c); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in reg. 2 substituted (15.11.2004) by The Genetically Modified Organisms (Deliberate Release) (Scotland) Amendment Regulations 2004 (S.S.I. 2004/439), regs. 1, 3(a)

F5 Words in reg. 2(1) substituted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 3(c)

F6 Words in reg. 2(1) substituted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 3(d)

F7 Words in reg. 2(1) substituted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 3(e)

F8 Words in reg. 2(1) substituted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 3(f)

F9 Words in reg. 2 inserted (15.11.2004) by The Genetically Modified Organisms (Deliberate Release) (Scotland) Amendment Regulations 2004 (S.S.I. 2004/439), regs. 1, 3(b)

F10 Words in reg. 2(1) substituted (1.4.2015) by The Food (Scotland) Act 2015 (Consequential and Transitional Provisions) Order 2015 (S.S.I. 2015/100), arts. 1(2), 2, sch. para. 8

F11 Words in reg. 2(1) 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(2)

F12 Words in reg. 2(1) 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(2)(d); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in reg. 2(1) omitted (15.3.2019) by virtue of The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 3(g)

Marginal Citations

M2 1990 c.43.

M3 1973 c.65.

M4 2000 c.7.

M5 1974 c.37.

M6 1994 c.39.

M7 S.I. 1992/3280, as amended by S.I. 1993/152, 1995/304, 1997/1900 and 2000/2831.

Purpose of Part VI of the Act and meaning of “genetically modified organisms” etc. S

3.—(1) Section 106 of the Act (purpose of Part VI and meaning of “genetically modified organisms” etc.) is amended as follows.

(2) For subsection (1) (purpose of Part VI) substitute–

“(1) This Part has effect for the purpose of ensuring that all appropriate measures are taken to avoid damage to the environment which may arise from the escape or release from human control of genetically modified organisms.”.

(3) In subsection (4) (definition of organism which is genetically modified)–

(a) insert after “this Part”–

“, subject to subsection (4C) below,”;

and

(b) for paragraph (a) (modification of prescribed artificial technique) substitute–

“(a) have been artificially modified, or”.

(4) After subsection (4) insert–

“(4A) subject to subsections (4B) and (4C) below, genes or other genetic material in an organism are “artificially modified” for the purposes of subsection (4) above if they are altered otherwise than by a process which occurs naturally in mating or natural recombination.

(4B) For the purposes of subsection (4) above–

(a) genes or other genetic material shall be taken to be artificially modified if they are altered using such techniques as may be prescribed for the purposes of this paragraph;

(b) genes or other genetic material shall not be regarded as artificially modified by reason only of being altered by the use of such techniques as may be prescribed for the purposes of this paragraph.

(4C) An organism shall be taken not to be a genetically modified organism for the purposes of this Part if it is an organism of a prescribed description.

(4D) In subsections (4B) and (4C) above, “prescribed” means prescribed by regulations made by the Scottish Ministers.”.

(5) Subsections (5) (techniques which may be prescribed as genetic modification) and (6)(direct or indirect means of modification immaterial) are omitted.

Meaning of “damage to the environment” etc. S

4.—(1) Section 107 of the Act (meaning of “damage to the environment” etc.) is amended as follows.

(2) For subsection (2) (meaning of “environment”) substitute–

“(2) The “environment” includes land, air and water and the living organisms supported by any of those media.”.

(3) In subsection (3)(meaning of “damage to the environment”) the words “to the living organisms supported by the environment” are omitted.

(4) For subsection (6) (meaning of “harm”) substitute–

“(6) “Harm” means adverse effects as regards the health of humans or the environment.”.

(5) For subsection (9) (meaning of organism being under a person’s “control”) substitute–

“(9) Organisms of any description are under the “control” of a person where that person keeps them contained by specific measure designed to limit their contact with humans and the environment and to prevent or minimise the risk of harm.”.

(6) For subsection (11) (meaning of “marketed”) substitute–

“(11) Genetically modified organisms of any description are “marketed” when products consisting of or including such organisms are placed on the market by being made available to other persons, whether or not for consideration.”.

Techniques of genetic modification S

5.—(1) Until the coming into force of the first regulations made by the Scottish Ministers under section 106(4B)(a) (power to prescribe techniques, alteration by which shall be taken to be artificial modification) M8 of the Act, genes or other genetic material shall be taken, for the purposes of subsection (4) of that section, to be artificially modified if they are altered using any of the following techniques:–

(a) recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation;

(b) techniques involving the direct introduction into an organism of heritable material prepared outside the organism including micro-injection, macro-injection and micro-encapsulation;

(c) cell fusion (including protoplast fusion) or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.

(2) Until the coming into force of the first regulations made by the Scottish Ministers under section 106(4B)(b) (power to prescribe techniques, alteration by which shall not be taken to be artificial modification) of the Act, genes or other genetic material shall not be taken, for the purposes of subsection (4) of that section, to be artificially modified by reason only of being altered by the use of any of the following techniques:–

(a) in vitro fertilisation;

(b) natural processes including conjugation, transduction or transformation;

(c) polyploidy induction:

Provided that such techniques do not involve the use of recombinant nucleic acid molecules or genetically modified organisms made by techniques or methods other than–

(i)

mutagenesis; or

(ii)

cell fusion (including protoplast fusion) of plant cells of organisms which can exchange genetic material through traditional breeding methods.

(3) Until the coming into force of the first regulations made by the Scottish Ministers under section 106(4C) (power to prescribe organisms which shall be taken not to be genetically modified) of the Act, an organism shall be taken, for the purposes of Part VI of the Act, not to be a genetically modified organism if it is yielded from the techniques or methods listed in paragraph (2)(i) or (ii):

Provided that those techniques or methods did not involve the use of recombinant nucleic acid molecules or genetically modified organisms (other than those made by techniques or methods listed in that paragraph).

Marginal Citations

M8 Section 106(4) is amended by regulation 3(3) and section 106(4A) to (4D) is inserted by regulation 3(4).

Environmental risk assessment S

6.—(1) An environmental risk assessment contained in an application for consent to release or market genetically modified organisms or for renewal of consent to market genetically modified organisms shall–

(a) identify and evaluate the potential damage to the environment, whether direct or indirect, immediate or delayed, which may arise from the release or marketing of the genetically modified organisms;

(b) be carried out in accordance with [F14 schedule 1] and contain the conclusions required in [F15 Part D of that schedule]; and

(c) include any bibliographic references and indications of the methods used, where applicable.

(2) Where the genetically modified organisms contain antibiotic resistance markers, the environmental risk assessment shall include an examination of the particular risks of damage to the environment which may be posed by the deliberate release or marketing of those genetically modified organisms.

Textual Amendments

F14 Words in reg. 6(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(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F15 Words in reg. 6(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(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

Communication with an applicant for consent S

7.—(1) Notwithstanding paragraph (2), wherever an applicant for a consent or renewal of a consent to which these Regulations apply or a holder of such consent is required under these Regulations to submit any document in writing or in written form, whether before or after consent is granted, the applicant shall submit that document both in writing and in an electronic form acceptable to the Scottish Ministers.

(2) A reference in these Regulations to anything done in writing or produced in written form which does not fall within the provisions of paragraph (1) includes a reference to an electronic communication which has been recorded and is consequently capable of being reproduced.

PART II S RELEASING ORGANISMS FOR ANY OTHER PURPOSE THAN MARKETING

Requirement for consent to release S

8.  The cases and circumstances prescribed for the purposes of section 111(1)(a) of the Act in relation to the release of any genetically modified organisms are all cases and circumstances in which genetically modified organisms are intended to be released.

Exempt activities S

9.  The cases and circumstances prescribed for the purposes of section 111(7) of the Act in which persons are exempt from the requirements of section 111(1)(a) of the Act, insofar as those requirements apply to the release of genetically modified organisms, are all cases and circumstances in which an approved product [F16 , which is permitted to be marketed for a use in pursuance of its consent [F17 or authorisation],] is released in accordance with the [F18 limitations, conditions and restrictions] to which [F19 that use] of the product is subject.

Textual Amendments

F16 Words in reg. 9 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(3)(a)

F17 Words in reg. 9 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(4); 2020 c. 1, Sch. 5 para. 1(1)

F18 Words in reg. 9 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(3)(b)

F19 Words in reg. 9 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(3)(c)

Applications for consent to release – general provisions S

10.—(1) An application for a consent to release genetically modified organisms must be submitted in writing to the Scottish Ministers.

(2) The Scottish Ministers may accept that proposed releases of the same genetically modified organism or of a combination of genetically modified organisms on the same site or on different sites for the same purpose and within a defined period may be notified in a single application.

(3) Where an application for a consent to release genetically modified organisms is expressed to rely on the First Simplified Procedure (crop plants) Decision, in the event of any inconsistency in the requirements as to information to be provided under that Decision and the requirements as to information to be provided under these Regulations, the provisions of that Decision shall prevail.

Information to be contained in application for consent to release S

11.—(1) An application for a consent to release genetically modified organisms must contain–

[F20 (a) the information prescribed in Part 1 of schedule 2, where the application is for consent to release any genetically modified higher plant, or schedule 3 in any other case, to the extent that such information is—

(i) appropriate to the nature and scale of the release or application, and

(ii) in the case of schedule 2, relevant and necessary for the purposes of the environmental risk assessment referred to in sub-paragraph (c), in view particularly of the characteristics of the genetically modified organism and of the scale and conditions of the release or of its intended conditions of use;

(aa) where the application is for consent to release a genetically modified higher plant, summaries and results of studies referred to in the application for consent to release, including an explanation of their relevance to the environmental risk assessment under sub-paragraph (c), where applicable,]

(b) information on data or results from any previous release of the organisms, or the same combination of organisms, which has been carried out by the applicant, and information from any previous application for the release of the organisms, or of the same combination of organisms, which the applicant has made [F21 under section 111(1) of the Act (in relation to any part of the United Kingdom) or] to any competent authority of [F22 a member] State F23 ... in accordance with Article 6 of the Deliberate Release Directive or Article 5 of the 1990 Directive;

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

(d) a summary F24 ... of the information contained in the application [F25 , in the relevant format set out in the Annex to Decision 2002/813/EC].

(2) The application may contain–

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

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

Textual Amendments

F20 Reg. 11(1)(a)(aa) substituted for reg. 11(1)(a) (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 4

F21 Words in reg. 11(1)(b) 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(5)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F22 Words in reg. 11(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(4)

F23 Words in reg. 11(1)(b) 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(5)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F24 Words in reg. 11(1)(d) 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(5)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F25 Words in reg. 11(1)(d) 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(5)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

Advertisement of applications for consent to release S

12.—(1) Subject to paragraphs (2) and (3), a person who makes an application for a consent to release genetically modified organisms shall, not more than ten days after the applicant sends that application to the Scottish Ministers, cause to be published in any newspaper to be specified by the Scottish Ministers a notice approved by the Scottish Ministers containing the following information:–

(a) the name and address of the applicant;

(b) the general description of the organisms to be released;

(c) the location and purpose of the release;

(d) the intended date of the release;

(e) a statement that information about the application will be placed on the register by the Scottish Ministers within 12 days of their receipt of the application;

(f) the means by which the register can be inspected; and

(g) a statement that the Scottish Ministers shall, within a period which they shall specify in accordance with these Regulations, have regard to any representations made to them in writing relating to risks of damage to the environment M9 posed by the release of the genetically modified organisms,

and that person shall–

(i) immediately send to the Scottish Ministers confirmation that such information was placed in such newspaper and the date on which the information was published in the newspaper; and

(ii) if requested to do so by the Scottish Ministers, send a copy of such newspaper containing the advertisement to them.

(2) A notice published under paragraph (1) need not contain the information referred to in subparagraphs (c) and (d) of that paragraph insofar as the First Simplified Procedure (crop plants) Decision does not require that information to be submitted with the application and that information is not submitted with the application.

(3) An applicant for consent shall ascertain from the Scottish Ministers the level of detail on the location of the release which will be placed on the register and shall include the same level of detail in the notice to be published under paragraph (1).

(4) A person who makes an application for a consent to release genetically modified organisms shall, subject to paragraph (5), not more than ten days after that person sends that application to the Scottish Ministers, give to the following persons notice in writing that the application has been made and the information prescribed in paragraph (1)(a) to (g) (save insofar as paragraph (2) permits such information to be excluded from the notice referred to in paragraph (1)):–

(a) the local authority and community council for the area of each proposed release;

(b) the owner of the site of each proposed release, if such person is not the applicant;

[F26 (c) any person, or a genetic modification safety committee, from whom advice must be obtained under regulation 8 of the Genetically Modified Organisms (Contained Use) Regulations 2014,]

(d) any National Park Authority designated under section 6 of the National Parks (Scotland) Act 2000 M10 for the area of each proposed release;

(e) Scottish Natural Heritage established under section 1 of the Natural Heritage (Scotland) Act 1991 M11 ; and

(f) such other body as the Scottish Ministers may notify the applicant that they consider appropriate,

and shall immediately send to the Scottish Ministers copies of the notices given under this paragraph.

(5) Notwithstanding paragraph (4), the applicant shall give any body which the Scottish Ministers consider appropriate, for the purposes of paragraph (4)(f), the notice referred to in paragraph (4) within ten days of receipt by the applicant of the notification of such body as the Scottish Ministers consider appropriate.

Textual Amendments

F26 Reg. 12(4)(c) substituted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 5

Marginal Citations

M9 As defined in section 107(2), (3) and (6) of the Act as amended by regulation 4(2) to (4).

M10 2000 asp 10.

M11 1991 c.28.

Transitional provisions in respect of applications to release S

F27 13.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F27 Reg. 13 omitted (15.3.2019) by virtue of The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 6

PART III S MARKETING ORGANISMS

Requirement for consent to market S

14.  The cases and circumstances prescribed for the purposes of section 111(1)(a) of the Act in relation to marketing genetically modified organisms are all cases and circumstances in relation to the marketing of genetically modified organisms.

Exempt activities S

15.— [F28 (1)] The cases and circumstances prescribed for the purposes of [F29 section] 111(7) of the Act in which persons are exempt from the requirements of F30 ... section 111(1)(a) of the Act (to obtain consent) F31 ... insofar as [F32 it relates] to marketing genetically modified organisms, are all cases and circumstances in which–

(a) an approved product [F33 , which is permitted to be marketed in Scotland in pursuance of an authorisation under the Food and Feed Regulation,] is marketed for a use for which it has approval [F34 and in accordance with the limitations [F35 , conditions and restrictions] to which [F36 that use of the] product is subject];

[F37 (aa) a pre-exit approved product is marketed during the relevant period—

(i) for a use (other than cultivation in Scotland) for which it had marketing consent in accordance with the Deliberate Release Directive or the 1990 Directive immediately before exit day and for which it continues to have consent for that use in Scotland, and

(ii) in accordance with the limitations and conditions to which that use of the product was subject immediately before exit day, as may be modified by virtue of these Regulations or the Act,]

(b) genetically modified micro-organisms are made available for activities regulated under [F38 the Genetically Modified Organisms (Contained Use) Regulations 2014] (including culture collections);

F39 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d) genetically modified organisms are made available to be used exclusively for deliberate releases complying with the requirements laid down in Part II; [F40 and]

[F41 (e) a genetically modified organism is marketed which is, or is contained in, a medicinal product authorised under—

(i) the Human Medicines Regulations 2012, or

(ii) the Veterinary Medicines Regulations 2013.]

F42 (f) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F43 (g) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F44 (2) For the purposes of paragraph (1), “the relevant period”, in relation to a pre-exit approved product, means the period beginning with exit day and ending with the day which immediately precedes the day on which the consent concerned ceases to be valid.]

Textual Amendments

F28 Reg. 15 renumbered as reg. 15(1) (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 7(a)

F29 Word in reg. 15(1) 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(5)(a)

F30 Words in reg. 15(1) 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(5)(b)(i)

F31 Word in reg. 15(1) 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(5)(b)(ii)

F32 Words in reg. 15(1) 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(5)(c)

F33 Words in reg. 15(1)(a) 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(6)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F34 Words in reg. 15(a) added (15.11.2004) by The Genetically Modified Organisms (Deliberate Release) (Scotland) Amendment Regulations 2004 (S.S.I. 2004/439), regs. 1, 4(a)

F35 Words in reg. 15(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(5)(d)(i)

F36 Words in reg. 15(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(5)(d)(ii)

F37 Reg. 15(1)(aa) 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(6)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F38 Words in reg. 15(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(6)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F39 Reg. 15(1)(c) 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(6)(a)(iv); 2020 c. 1, Sch. 5 para. 1(1)

F40 Word in reg. 15(1)(d) 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(6)(a)(v); 2020 c. 1, Sch. 5 para. 1(1)

F41 Reg. 15(1)(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(6)(a)(vi); 2020 c. 1, Sch. 5 para. 1(1)

F42 Reg. 15(1)(f) and word omitted (15.3.2019) by virtue of The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 7(d)

F43 Reg. 15(1)(g) 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(6)(a)(vii); 2020 c. 1, Sch. 5 para. 1(1)

F44 Reg. 15(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(6)(b); 2020 c. 1, Sch. 5 para. 1(1)

Applications for consent to market S

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

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

[F45 (a) the information prescribed in Part 2 of schedule 2, where the application is for consent to market any genetically modified higher plant, or schedule 3 in any other case, to the extent that such information is—

(i) appropriate to the nature and scale of the release or application, and

(ii) in the case of schedule 2, relevant and necessary for the purposes of the environmental risk assessment referred to in sub-paragraph (c), in view especially of the characteristics of the genetically modified organism and of the scale and conditions of the release or of its intended conditions of use,

(aa) where the application is for consent to market a genetically modified higher plant, summaries and results of studies referred to in the application for consent to market, including an explanation of their relevance to the environmental risk assessment referred to in sub-paragraph (c), where applicable,

(ab) where the application is for consent to market a genetically modified higher plant, detailed information on the studies referred to in the application for consent to market, including—

(i) a description of the methods and materials used or the reference to standardised or internationally recognised methods, and

(ii) the name of the body or bodies responsible for carrying out the studies,]

(b) information on data or results from any previous release of the same genetically modified organisms, or of the same combination of genetically modified organisms, which has been carried out by the applicant anywhere, and information from any previous application for consent to release the same genetically modified organisms, or the same combination of genetically modified organisms, which the applicant has made [F46 under section 111(1) of the Act (in relation to any part of the United Kingdom)];

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

(d) subject to paragraph (4), the information prescribed in Schedule 4;

(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 [F47 schedule 5A] 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 4;

(i) a proposal for packaging; and

(j) a summary of the application in the format [F48 set out in the Annex to Commission Decision 2002/812/EC].

(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 if the data or results are confidential 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 paragraph (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 data or 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 the application by that person to the satisfaction of the Scottish Ministers that, on the basis of the results of any release in pursuance of and in accordance with a consent for a deliberate release granted [F49 under section 111(1) of the Act or a consent under Part B of either] the Deliberate Release Directive or F50 ... the 1990 Directive, or on other substantive, reasoned scientific grounds, that the marketing and use of the product consisting of or including the genetically modified organisms do not pose a risk of damage to the environment, the applicant may omit from the application part or all of the information prescribed in Part II of Schedule 4.

Textual Amendments

F45 Reg. 16(2)(a)-(ab) substituted for reg. 16(2)(a) (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 8

F46 Words in reg. 16(2)(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(7)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F47 Words in reg. 16(2)(g) 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(7)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F48 Words in reg. 16(2)(j) 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(7)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F49 Words in reg. 16(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(7)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F50 Words in reg. 16(5) 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(7)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

Transitional provision in respect of applications to market S

F51 17.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F51 Reg. 17 omitted (15.3.2019) by virtue of The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 9(a)

Transitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation. S

F52 17A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F52 Reg. 17A omitted (15.3.2019) by virtue of The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 9(b)

Applications for renewal of consent to market S

18.—(1) Where a consent has been granted under section 111(1) of the Act to market genetically modified organisms which were first marketed in Scotland, any application to renew that consent shall be made in writing to the Scottish Ministers–

(a) before 17th October 2006 where the consent was granted before the coming into force date of these Regulations; or

(b) no later than nine months before the expiry of the consent in all other cases.

(2) The application shall contain–

(a) a copy of the consent to market the genetically modified organisms;

(b) where the consent to market was granted–

(i) after the coming into force date of these Regulations, a report on the results of the monitoring carried out in accordance with the requirements of regulation 28(f); or

(ii) before that date, a report on the results of any monitoring carried out on the relevant product;

(c) any other new information which has become available with regard to the risks of the product causing damage to the environment; and

(d) as appropriate, a proposal for amending, complementing or adding to the conditions of the existing consent, including the conditions concerning future monitoring, and a proposal for the time limitation of the new consent.

(3) Any consent to market genetically modified organisms first marketed in Scotland which was granted under section 111(1) of the Act before the coming into force date of these Regulations and for which no application for renewal under paragraph (1) has been received by the Scottish Ministers before 17th October 2006 shall be treated as having expired on that date.

(4) Any consent to market genetically modified organisms marketed in Scotland which was granted under section 111(1) of the Act before the coming into force date of these Regulations and for which an application for renewal under paragraph (1) is refused shall be treated as having expired on 17th October 2006 or the date of refusal of the application, whichever is the later.

PART IV S DUTIES AFTER THE MAKING OF APPLICATIONS

Duty of the applicant after applying for consent to release or to market S

19.—(1) Section 111 of the Act (consents required by certain persons) is amended as follows:–

(a) in subsection (6)–

(i) after the word “period” where it appears for the first time insert “ and in such form and manner ”; and

(ii) after the word “period” where it appears for the second time insert “ and in the specified form and manner ”; and

(b) after subsection (6) (power of Scottish Ministers to require further information) insert–

“(6ZA) A notice under subsection (6) must state the reasons for requiring the further information specified in the notice.”.

(2) An applicant for a consent to release or to market genetically modified organisms who notifies the Scottish Ministers of any information in accordance with section 111(6A) of the Act (requirement for applicant to notify new information regarding risks of damage to the environment) M12 shall submit in writing to the Scottish Ministers a revised version of the original application for consent amended to take account of the new information.

Marginal Citations

M12 Section 111(6A) was added by S.I. 1992/3280.

Duties of the Scottish Ministers in relation to applications for consent to release S

20.  Following receipt of an application for consent to release genetically modified organisms the Scottish Ministers shall–

(a) inform the applicant in writing of the date of receipt of the application;

(b) invite any person by means of a request placed on the register, to make representations in writing to the Scottish Ministers relating to any risks of damage being caused to the environment M13 by the release before the end of a period to be specified which shall not be less than sixty days from the date the application was received by the Scottish Ministers;

F53 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d) examine the application for its conformity with the requirements of the Act and of these Regulations;

(e) evaluate the risks of damage being caused to the environment by the proposed release having regard to the environmental risk assessment prepared in accordance with regulation 6; and

[F54 (f) take into account and give due weight to any representations made to them before the end of the period specified pursuant to paragraph (b) relating to risks of damage being caused to the environment by the release.]

Textual Amendments

F53 Reg. 20(c) 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(8)(a); 2020 c. 1, Sch. 5 para. 1(1)

F54 Reg. 20(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(8)(b); 2020 c. 1, Sch. 5 para. 1(1)

Marginal Citations

M13 As defined in section 107(2), (3) and (6) of the Act as amended by regulation 4(2) to (4).

Decisions by the Scottish Ministers on applications for consent to release S

21.—(1) The Scottish Ministers shall not grant consent to release 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.

[F55 (2) The Scottish Ministers shall not grant or refuse consent to release genetically modified organisms before the end of the period specified for representations F56 ... in accordance with regulation 20(b) F57 ....]

[F58 (3) The Scottish Ministers must communicate in writing their decision on an application for a consent to release genetically modified organisms to the applicant before the end of a period of 90 days beginning with the day on which the application was received, and must include in any refusal of consent the reason for the decision.]

(4) The period prescribed in paragraph (3) shall not include–

(a) any period beginning with the day on which the Scottish Ministers give 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 Scottish Ministers; or

(b) any period of time during which the Scottish Ministers are considering representations submitted by any persons in accordance with regulation 20(b), provided that this consideration shall not prolong the ninety day period referred to in paragraph (3) by more than thirty days.

(5) A consent to release genetically modified organisms shall require the applicant to send any information which might be relevant to assessing the risk of damage being caused to the environment, with, where appropriate, particular reference to any product which it is intended to market in the future, to the Scottish Ministers as soon as reasonably practicable after completion of the release and thereafter, at such intervals as the Scottish Ministers shall consider appropriate on the basis of the results of the environmental risk assessment.

[F59 (6) Information submitted in accordance with paragraph (5) must be provided in the format set out in the Annex to Decision 2003/701/EC.]

Textual Amendments

F55 Reg. 21(2) substituted (15.11.2004) by The Genetically Modified Organisms (Deliberate Release) (Scotland) Amendment Regulations 2004 (S.S.I. 2004/439), regs. 1, 6

F56 Words in reg. 21(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(9)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F57 Words in reg. 21(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(9)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F58 Reg. 21(3) 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(9)(b); 2020 c. 1, Sch. 5 para. 1(1)

F59 Reg. 21(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(9)(c); 2020 c. 1, Sch. 5 para. 1(1)

Variation or revocation of consents to release S

22.—(1) The Scottish Ministers shall only vary or revoke a consent to release 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 to them which they consider would affect the assessment of the risk of damage being caused to the environment by the release.

(2) The Scottish Ministers shall not revoke or vary a consent to release 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.

[F60 Duties of the Scottish Ministers in relation to applications for consent to market S

23.— (1) On receipt of an application for consent to market genetically modified organisms, the Scottish Ministers must—

(a) inform the applicant in writing of the date of receipt of the application,

(b) without delay examine the application for its conformity with the requirements of the Act and of these Regulations and, if necessary, request the applicant to supply additional information, and

(c) before the end of a period of 90 days beginning with the day on which they received the application, either—

(i) send to the applicant an assessment report prepared in accordance with schedule 5 which indicates that the genetically modified organisms should be permitted to be marketed and under which conditions, or

(ii) refuse the application, stating reasons for their decision, supported by an assessment report prepared in accordance with schedule 5 which indicates that the genetically modified organisms should not be marketed.

(2) The period of 90 days referred to in paragraph (1)(c) must not include any period beginning with the day on which the Scottish Ministers give 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 Scottish Ministers.

(3) Where the assessment report referred to in paragraph (1)(c) indicates that the genetically modified organisms to which an application relates should be permitted to be marketed, the Scottish Ministers 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 Scottish Ministers 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 in accordance with regulation 35(7A)).]

Textual Amendments

F60 Reg. 23 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(10); 2020 c. 1, Sch. 5 para. 1(1)

[F61 Decisions by the Scottish Ministers on applications for consent to market S

24.— (1) The Scottish Ministers must not grant 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 Scottish Ministers invite representations under regulation 23(3) in relation to an application for consent to market genetically modified organisms, the Scottish Ministers—

(a) must not determine whether to grant or refuse consent to market the genetically modified organisms until after the period for making representations under regulation 23(3) has ended and they have considered any representations made in accordance with that regulation, and

(b) must, within a period of 105 days beginning with the day after the end of the period for making representations under regulation 23(3)—

(i) determine the application, and

(ii) notify the applicant in writing of the decision to grant or refuse consent to market the genetically modified organisms, and the reasons for the decision.

(3) The period of 105 days referred to in paragraph (2)(b) does not include any period beginning with the day on which the Scottish Ministers give 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 Scottish Ministers.

(4) Subject to paragraphs (5) and (6) and regulation 26, a consent to market genetically modified organisms may be granted by the Scottish Ministers under section 111(1) of the Act for a maximum period of up to 10 years beginning with the day on which the consent is granted.

(5) In the case of a 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, the period of the first consent must end at the latest 10 years after the date of the first inclusion of the first plant variety containing the genetically modified organism on a National List in accordance with regulation 3 of the Seeds (National Lists of Varieties) Regulations 2001.

(6) In the case of a consent to market a genetically modified organism contained in forest reproductive material, the period of the first consent must end at the latest 10 years after the date of the first inclusion of basic material containing the genetically modified organism on the National Register in accordance with regulations 6 and 7 of the Forest Reproductive Material (Great Britain) Regulations 2002.

(7) A consent to market genetically modified organisms granted by the Scottish Ministers under section 111(1) of the Act may include such limitations or conditions as they consider appropriate to restrict or prohibit the cultivation of the genetically modified organisms in all or any part of Scotland.

(8) The Scottish Ministers may, where any such consent includes a limitation or condition referred to in paragraph (7), vary the consent to remove or modify the limitation or condition.

(9) The Scottish Ministers must inform the holder of the consent of any variation under paragraph (8).]

Textual Amendments

F61 Reg. 24 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(11); 2020 c. 1, Sch. 5 para. 1(1)

Duties on the Scottish Ministers on receiving applications for renewal of consent to market S

25.—(1) On receipt of an application for renewal of consent to market genetically modified organisms the Scottish Ministers shall–

(a) inform the applicant in writing of the date of receipt of the application;

(b) examine the application for its conformity with the requirements of the Act and of these Regulations and, if necessary, request the applicant to supply additional information; [F62 and]

(c) either–

(i) send to the applicant an assessment report prepared in accordance with Schedule 5 which indicates that the genetically modified organisms should continue to be permitted to be marketed and under which conditions; or

(ii) refuse the application, stating reasons for their decision, supported by an assessment report [F63 prepared in accordance with schedule 5] which indicates that the genetically modified organisms should not continue to be marketed [F64 .]

F65 (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F66 (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F62 Word in reg. 25(1)(b) 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(12)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F63 Words in reg. 25(1)(c)(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(7)(a)(ii)

F64 Reg. 25(1)(c): full stop substituted for word (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(12)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F65 Reg. 25(1)(d) 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(12)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F66 Reg. 25(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(12)(b); 2020 c. 1, Sch. 5 para. 1(1)

Decisions by the Scottish Ministers on applications for renewals of consents to market S

26.— [F67 (1) The Scottish Ministers must not grant a renewal of consent under section 111(1) of the Act to market genetically modified organisms as it relates to the protection of human health without the agreement of the Health and Safety Executive.]

[F68 (2) The Scottish Ministers must communicate a decision on an application to renew a consent to market genetically modified organisms to the applicant as soon as possible and must include in any refusal of consent the reasons for the decision.]

(3) The renewed consent to market genetically modified organisms shall be given for ten years unless the Scottish Ministers consider that a shorter or longer period is justified, in which case they shall give their reasons therefor in writing.

(4) The applicant may continue to market the genetically modified organisms [F69 in accordance with the limitations and conditions included the existing marketing consent] until a final decision has been taken on the application.

[F70 [F71 (5) A renewed consent to market genetically modified organisms granted by the Scottish Ministers under section 111(1) of the Act may include such limitations or conditions as they consider appropriate to restrict or prohibit the cultivation of the genetically modified organisms in all or any part of Scotland.]

(6) The Scottish Ministers may, [F72 where any such consent includes a limitation or condition referred to in paragraph (5), vary the consent to remove or modify the limitation or condition].

[F73 (7) The Scottish Ministers must inform the holder of the renewed consent of any variation under paragraph (6).]]

Textual Amendments

F67 Reg. 26(1) 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(13)(a); 2020 c. 1, Sch. 5 para. 1(1)

F68 Reg. 26(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(13)(a); 2020 c. 1, Sch. 5 para. 1(1)

F69 Words in reg. 26(4) 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(8)(a)

F70 Reg. 26(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(13)(b); 2020 c. 1, Sch. 5 para. 1(1)

F71 Reg. 26(5)-(8) 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), 11

F72 Words in reg. 26(6) 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(8)(c)

F73 Reg. 26(7) substituted for reg. 26(7)(8) (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(13)(c); 2020 c. 1, Sch. 5 para. 1(1)

[F74 Demand to adjust a food or feed authorisation to prohibit the cultivation of genetically modified organisms in all or part of Scotland S

26A.— (1) On receipt of a relevant application Food Standards Scotland must forward a copy of the application to the Scottish Ministers.

(2) The Scottish Ministers may, in respect of a relevant application, demand that any resulting authorisation is adjusted to ensure that genetically modified organisms are prohibited from cultivation in all or such part of Scotland as is specified in the demand.

(3) A demand under paragraph (2) must be communicated by the Scottish Ministers to the Food Standards Scotland before it determines the application.

(4) In this regulation, “relevant application” means an application for—

(a) an authorisation to place on the market genetically modified organisms under Article 5 or 17 of the Food and Feed Regulation, or

(b) renewal of an authorisation to place on the market genetically modified organisms under Article 11 or 23 of the Food and Feed Regulation.]

Textual Amendments

F74 Reg. 26A 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(14); 2020 c. 1, Sch. 5 para. 1(1)

[F75 Request to adjust a food or feed authorisation to remove or modify a restriction or prohibition on the cultivation of genetically modified organisms in all or part of Scotland S

26B.— (1) Where an authorisation referred to in sub-paragraph (a) or (b) of regulation 26A(4) restricts or prohibits the cultivation of genetically modified organisms in all or any part of Scotland, the Scottish Ministers may request that the authorisation is adjusted to remove or modify, insofar as they consider appropriate, any such restriction or prohibition.

(2) A request under paragraph (1) is to be made by notifying Food Standards Scotland.]

Textual Amendments

F75 Reg. 26B 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(15); 2020 c. 1, Sch. 5 para. 1(1)

Genetically modified organisms containing antibiotic resistance markers S

27.—(1) The Scottish Ministers shall not grant a consent to an application for the release or marketing of genetically modified organisms containing antibiotic resistance markers which may have adverse effects on human health and the environment after–

(i) 31st December 2004 in the case of marketing; and

(ii) 31st December 2008 in the case of release.

(2) Where prior to 31st December 2004 in the case of marketing and 31st December 2008 in the case of release, an application is made for consent to release or market genetically modified organisms containing antibiotic resistance markers, the Scottish Ministers shall evaluate the information in the environmental risk assessment accompanying the application, taking into particular consideration those antibiotic resistance markers in use for medical or veterinary treatment, with a view to identifying and phasing out the release or marketing of the genetically modified organisms referred to in paragraph (1) within the time limits specified in that paragraph.

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 [F76 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

F76 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.”.

[F77 Restrictions on cultivation S

29A.— (1) This regulation applies to—

(a) a consent [F78 granted] by the Scottish Ministers under section 111(1) of the Act (including a renewed consent [F79 granted under that section in accordance with] regulation 26),

(b) [F80 a pre-exit] approved product, or

(c) an authorisation under the Food and Feed Regulation [F81 .]

F82 ...

F83 (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

(a) include [F84 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 [F85 the] consent or renewed consent,

(c) issue a suspension notice in respect of the [F86 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 [F87 15(aa)] (exempt activities), in respect of the cultivation of a specified [F88 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 [F89 15(a)], in respect of the cultivation of genetically modified food or [F90 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 [F91 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 F92 ...,

(vi) agricultural policy objectives,

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

(b) are in conformity with [F93 retained] EU law,

(c) are proportional,

(d) are non-discriminatory, and

(e) do not conflict with the environmental risk assessment carried out pursuant to [F94 retained EU 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—

F95 (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 [F96 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 [F97 any comments they receive] prior to its coming into force.

(12) The Scottish Ministers must—

(a) communicate the [F98 limitation,] condition or suspension notice [F99 , as the case may be,] to F100 ... the consent or authorisation holder without delay, and

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

Textual Amendments

F77 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

F78 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)

F79 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)

F80 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)

F81 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)

F82 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)

F83 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)

F84 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)

F85 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)

F86 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)

F87 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)

F88 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)

F89 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)

F90 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)

F91 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)

F92 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)

F93 Word in reg. 29A(7)(b) 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)(f)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F94 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)

F95 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)

F96 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)

F97 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)

F98 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)

F99 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)

F100 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)

[F77 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 [F101 limitation or] condition in a consent [F102 or renewed consent] to remove [F103 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 [F104 or renewed consent],

(c) withdraw a suspension notice in respect of [F105 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 [F106 consent or authorisation holder] of any action taken under paragraph (1) without delay.]

Textual Amendments

F77 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

F101 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)

F102 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)

F103 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)

F104 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)

F105 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)

F106 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,”.

[F107 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 [F108 required] under section 111(1) of the Act F109 ..., F110 ...

(ii) under and in accordance with any limitation or condition to which such a consent is subject, [F111 or]

[F112 (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 [F113 limitation or condition included in] a consent to market [F114 pursuant to] regulation 24(7) or a renewed consent to market [F114 pursuant to] regulation 26(5),

(c) is cultivating or has cultivated a genetically modified organism in contravention of a [F115 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) [F116 , (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

F107 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

F108 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)

F109 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)

F110 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)

F111 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)

F112 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)

F113 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)

F114 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)

F115 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)

F116 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)

[F117 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

F117 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)

PART VI S SAFEGUARD

Safeguard S

32.—(1) The Scottish Ministers may serve a prohibition notice under section 110 of the Act to prohibit an act which is authorised by a consent granted [F118 by them under section 111(1) of the Act] [F119 , by an authorisation under the Food and Feed Regulation, or by a consent granted in respect of a pre-exit approved product,] only if their opinion that doing such an act would involve a risk of causing damage to the environment is based on detailed grounds as the result of either–

(a) new or additional information made available since the date of the consent which affects the environmental risk assessment in respect of that product; or

(b) a reassessment of existing information in respect of that product on the basis of new or additional scientific information.

(2) Where, in the circumstances described in paragraph (1), the Scottish Ministers consider that the risk of damage being caused to the environment is severe they shall serve a prohibition notice requiring such measures to be taken as they may consider appropriate and once any work required by the notice has been carried out they shall enter details of that work on the register.

F120 (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F120 (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F120 (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) References in this regulation to the Scottish Ministers exercising a function under section 110 of the Act shall, in any case to which section 126(3) (requirement to act jointly with [F121 Food Standards Scotland]) of the Act applies, be treated as references to the Scottish Ministers and [F121 Food Standards Scotland] acting jointly.

Textual Amendments

F118 Words in reg. 32(1) 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), 15

F119 Words in reg. 32(1) 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(21)(a); 2020 c. 1, Sch. 5 para. 1(1)

F120 Reg. 32(3)-(5) 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(21)(b); 2020 c. 1, Sch. 5 para. 1(1)

F121 Words in reg. 32(6) substituted (1.4.2015) by The Food (Scotland) Act 2015 (Consequential and Transitional Provisions) Order 2015 (S.S.I. 2015/100), arts. 1(2), 2, sch. para. 8

[F122 PART VIA S Inspection powers, offences and service of notices

Textual Amendments

F122 Pt. 6A 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), 16

Powers of inspectors S

32A.— (1) For the purpose of enforcing these Regulations, an inspector may exercise any of the powers specified in this regulation.

(2) An inspector may, on producing if so required a duly authenticated document showing their authority, at all reasonable hours enter any land (excluding any premises used wholly or mainly as a private dwelling).

(3) If a sheriff, on sworn information in writing, is satisfied that there are reasonable grounds for entry into any premises by an inspector under this regulation and either that—

(a) entry has been refused or a refusal is reasonably expected, and that person has given notice to the occupier of their intention to apply for an entry warrant, or

(b) a request for entry, or the giving of such a notice, would frustrate the object of entry, or entry is urgently required, or the premises are unoccupied, or the occupier is temporarily absent and it would frustrate the object of entry to await the occupier’s return,

the sheriff, may, by signed warrant, valid for a period of no more than one month, authorise that person, together with any person who may accompany an inspector by virtue of paragraph (4)(a), to enter the premises, if need be by reasonable force.

(4) An inspector may—

(a) take onto the land such other persons and such materials and equipment (including vehicles) as may be reasonably required for the purpose of assisting the inspector to exercise the power,

(b) do anything else which is reasonably required for that purpose,

(c) take samples of things on the land,

(d) mark anything on the land for identification purposes,

(e) in the case of anything on the land which appears to contain or have contained a genetically modified organism-

(i) cause it to be dismantled or subjected to any process or test, or

(ii) examine it,

(f) take a photograph or any other digital record of anything on the land,

(g) require access to, inspect and take copies of, or extracts from, any information on the land,

(h) take away any information to enable it to be copied or kept as evidence,

(i) require access to, inspect and check the operation of any computer and any associated apparatus or material and, for this purpose, require any person having charge of, or otherwise concerned with the operation of, any computer, apparatus or material to give the inspector such assistance as the inspector may reasonably require,

(j) where information is kept by means of a computer, require it to be produced in a form in which it can be taken away.

(5) If an inspector causes damage in exercising the power, they must take reasonable steps to remedy the damage.

(6) If an inspector enters unoccupied land in exercising the power, the inspector must leave the land as effectively secured against unauthorised entry as the inspector found it.

(7) In this regulation, “inspector” means a person appointed by the Scottish Ministers.

(8) In this regulation, “sheriff” includes a summary sheriff.

Offences and penalties S

32B.— (1) A person commits an offence if that person—

(a) contravenes anything required of that person in a stop notice,

(b) obstructs an inspector (or a person accompanying an inspector and acting under the inspector’s instructions) in exercise of the power conferred by regulation 32A,

(c) supplies to an inspector (or a person accompanying an inspector and acting under the inspector’s instructions) any information knowing it to be false or misleading,

(d) cultivates a genetically modified organism in contravention of a [F123 limitation or condition included in] a consent to market [F124 pursuant to] regulation 24(7) or a renewed consent to market [F124 pursuant to] regulation 26(5),

(e) cultivates a genetically modified organism in contravention of a [F125 limitation or condition included in a consent or a renewed consent pursuant to] regulation 29A(3)(a), or

(f) cultivates a genetically modified organism or approved product in contravention of a suspension notice issued under regulation 29A(3)(b),(c) or (d).

(2) It is a defence for a person charged with an offence under paragraph (1) to show that they took all reasonable precautions and exercised all due diligence to avoid committing that offence.

(3) A person who commits an offence under paragraph (1) is liable—

(a) on summary conviction, to a fine not exceeding level 5 on the standard scale or to imprisonment for a term not exceeding three months, or to both, or

(b) on conviction on indictment, to a fine or to imprisonment for a terms not exceeding 2 years or both.

Textual Amendments

F123 Words in reg. 32B(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(14)(a)(i)

F124 Words in reg. 32B(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(14)(a)(ii)

F125 Words in reg. 32B(1)(e) 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(14)(b)

Individual culpability for offending by an organisation S

32C.— (1) Paragraph (2) applies where—

(a) an offence under these regulations is committed by a relevant organisation, and

(b) the commission of the offence involves the consent or connivance of, or is attributable to the neglect of—

(i) a responsible official of the organisation, or

(ii) an individual purporting to act in the capacity of a responsible official.

(2) The responsible official (or, as the case may be, the individual purporting to act in that capacity) as well as the organisation, commits the offence.

(3) “Relevant organisation” means—

(a) a company,

(b) a partnership (including a limited liability partnership),

(c) another body or association.

(4) “Responsible official” means—

(a) in the case of a company—

(i) a director, secretary, manager or similar officer, or

(i) where the affairs of the company are managed by its members, a member,

(b) in the case of a limited liability partnership, a member,

(c) in the case of a partnership other than a limited liability partnership, a partner,

(d) in the case of another body or association, a person who is concerned in the management or control of its affairs.

Service of notices S

32D.— (1) Any notice required to be given to any person by the Scottish Ministers by virtue of these Regulations may be given by—

(a) delivering it to that person,

(b) leaving it at that person’s proper address,

(c) sending it by post or fax to that person’s proper address, or

(d) sending it by email to that person’s last known email address.

(2) For the purposes of paragraph (1)(a), a notice is delivered to—

(a) a body corporate where it is given to a relevant individual within that body,

(b) a partnership where it is given to a partner or a person having control or management of the partnership, and

(c) an unincorporated association where it is given to an officer or a member of the governing body of the association or any other person having management responsibilities in respect of the association.

(3) For the purposes of paragraph (1)(b) and (c) and section 7 of the Interpretation Act 1978 (service of documents by post) in its application to this regulation, “proper address” means—

(a) in the case of a body corporate, the registered office (if it is in the United Kingdom) or the principal office of the body in the United Kingdom,

(b) in the case of a partnership, the principal office of the partnership,

(c) in the case of an unincorporated association, the principal office of the association,

(d) in any other case, a person’s last known address.

(4) For the purposes of paragraph (1)(d), a notice is sent to an email address of—

(a) a body corporate, where it is sent to an email address of—

(i) the body corporate, or

(ii) a relevant individual within that body,

where that address is supplied by that body for the conduct of the affairs of that body,

(b) a partnership, where it is sent to an email address of—

(i) the partnership, or

(ii) a partner or person having control or management of that partnership,

where that address is supplied by that partnership for the conduct of the affairs of the partnership,

(c) an unincorporated association, where it is sent to an email address of—

(i) an officer or member of the governing body of the association, or

(ii) any other person having management responsibilities in respect of the association,

where that address is supplied by that association for the conduct of the affairs of that association, and

(d) a person other than a person mentioned in sub-paragraph (a), (b) or (c), where it is sent to an email address supplied by that person for the conduct of the affairs of that person.

(5) In this regulation—

(a) “partnership” includes a Scottish partnership, and

(b) “relevant individual” means—

(i) a director, manager, secretary or other similar officer of the body corporate, or

(ii) where the affairs of the body corporate are managed by its members, a member.]

PART VII S CONFIDENTIALITY

Confidentiality S

33.—(1) For the purposes of section 123(7) of the Act (exclusion from the register of certain information) the following descriptions of information are also information which the public interest requires to be included in the register notwithstanding that it may be commercially confidential:–

(a) the location of the release of the genetically modified organism to which the information relates;

(b) the intended use of the genetically modified organism to which the information relates;

(c) the environmental risk assessment;

(d) the methods and plans for monitoring and for responding to an emergency in relation to the genetically modified organisms to which the information relates; and

(e) the name and address of the holder of a consent to which a prohibition notice or other information relates.

(2) In section 123 of the Act (exclusion from register of certain information) in subsection (7) (particulars included even if commercially confidential)–

(a) after “section 122(1)(a),” insert “ (c), ”;

(b) in paragraph (b), after the word “the” where it appears for the first time insert “ general ”; and

(c) paragraphs (c) and (e) are omitted.

PART VIII S REGISTER OF INFORMATION

Information to be included in the register S

34.—(1) The register shall contain the particulars set out in paragraphs (2) to (10).

(2) In relation to a prohibition notice served by the Scottish Ministers under section 110 of the Act–

(a) the name and address of the person on whom the notice is served;

(b) the description of the genetically modified organisms in relation to which the notice is served;

(c) the location at which the genetically modified organisms are proposed to be released;

(d) the purpose for which the genetically modified organisms are proposed to be released or marketed;

(e) the reason for the service of the notice; and

(f) any date specified in the notice as the date on which the prohibition is to take effect.

(3) Subject to paragraph (4), in relation to an application for a consent under section 111(1) of the Act–

(a) the name and address of the applicant;

(b) a general description of the genetically modified organisms in relation to which the application is being made;

(c) the location at which the genetically modified organisms are proposed to be released, to the extent that this information is notified to the Scottish Ministers;

(d) the purpose for which the genetically modified organisms are proposed to be released (including any future use to which they are intended to be put) or, in relation to a consent to market, the purpose for which they will be marketed;

(e) the intended dates of the release;

(f) the environmental risk assessment;

(g) the methods and plans for monitoring the genetically modified organisms and for responding to an emergency; F126 ...

(h) a summary of any advice the Scottish Ministers have received from the Advisory Committee on Releases to the Environment as to whether [F127 the applied for consent to release or, as the case may be, market] genetically modified organisms should be granted or [F128 refused], and either–

(i) the conditions or limitations in accordance with which that Committee has advised that the consent should be granted; or

(ii) a summary of the reasons why that Committee has advised that the consent should not be granted [F129 , and]

[F130 (i) the summary of the application required by regulation 11(1)(d) or regulation 16(2)(j), as the case may be.]

[F131 (3A) Subject to paragraph (4) and to the information not being confidential, in relation to an application for a consent under section 111(1) of the Act to market genetically modified organisms—

(a) the name and address of the person who is responsible for the marketing, whether manufacturer, importer or distributor,

(b) the proposed commercial name of the product,

(c) the names of the genetically modified organisms in the product, including the scientific and common names of, where appropriate, the parental, recipient and donor organisms,

(d) the unique identifiers for the genetically modified organisms in the product,

(e) an application reference code assigned by the Scottish Ministers,

(f) the information included in the application as specified at paragraphs 3 and 7 of schedule 4, and

(g) information on stored samples of the genetically modified organisms, including the type of material, its genetic characterisation and stability, the amount of repository material, and the conditions of appropriate storage and shelf-life.]

(4) Where the Scottish Ministers are or become aware that information regarding the genetically modified organisms or the purpose for which they will be released or marketed has been published which is more detailed than that which would satisfy the requirements of paragraph (3), they shall enter so much of that more detailed information on the register as they consider appropriate.

(5) In relation to consents granted under section 111(1) of the Act–

(a) a copy of the consent, and a reference to the application in respect of which it was granted;

(b) any information supplied to the Scottish Ministers in accordance with conditions imposed on the consent;

(c) the fact that the consent has been varied or revoked, the contents of the notice by which the consent was varied or revoked and, where applicable, a copy of the varied consent; and

(d) a summary of any advice the Scottish Ministers have received from the Advisory Committee on Releases to the Environment as to whether a consent to release genetically modified organisms should be varied or revoked.

(6) The following information concerning genetically modified organisms released or grown pursuant to a consent, or proposed to be released or grown pursuant to a consent, as the case may be:–

(a) any information provided to the Scottish Ministers in accordance with section 111(6A) or 112(5)(b)(i) of the Act;

(b) any information relating to an unforeseen event occurring in connection with a release of a genetically modified organism which might affect the risks there are of damage being caused to the environment notified to the Scottish Ministers in accordance with section 112(5)(b)(iii) M14 of the Act.

(7) A copy of any consent to market genetically modified organisms granted [F132 before exit day] by a competent authority of [F133 a] [F134 member] State [F135 or, at the time it was granted, the United Kingdom].

[F136 (7A) A copy of any assessment report referred to in regulation 23(1)(c) or regulation 25(1)(c).]

(8) The location of any genetically modified organisms grown in Scotland pursuant to a consent to market insofar as that information is supplied to the Scottish Ministers in accordance with the monitoring requirements imposed in the consent.

(9) Any decision adopted [F137 before exit day by the European] Commission in accordance with Article 18 of the Deliberate Release Directive and such decisions are prescribed as matters relating to Part VI of the Act for the purposes of section 122(1)(h) of the Act.

(10) In relation to convictions for any offence under section 118 of the Act–

(a) the name and address of the person convicted;

(b) the description of any genetically modified organisms in relation to which the conviction was obtained;

(c) the offence which was committed;

(d) the date on which the offence was committed;

(e) the date on which the person was convicted; and

(f) the penalty imposed and any order made by the court under section 120 of the Act (power of the court to order cause of offence to be remedied).

Textual Amendments

F126 Word in reg. 34(3)(g) 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(22)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F127 Words in reg. 34(3)(h) 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(15)(a)(i)

F128 Word in reg. 34(3)(h) 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(15)(a)(ii)

F129 Word in reg. 34(3)(h) 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(22)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F130 Reg. 34(3)(i) 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(22)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F131 Reg. 34(3A) 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(22)(b); 2020 c. 1, Sch. 5 para. 1(1)

F132 Words in reg. 34(7) 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(22)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F133 Word in reg. 34(7) 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(22)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F134 Word in reg. 34(7) 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(15)(b)

F135 Words in reg. 34(7) 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(22)(c)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F136 Reg. 34(7A) 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(22)(d); 2020 c. 1, Sch. 5 para. 1(1)

F137 Words in reg. 34(9) 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(22)(e); 2020 c. 1, Sch. 5 para. 1(1)

Marginal Citations

M14 Section 112(5)(b)(iii) has been inserted by regulation 29(3)(iii).

Keeping the register S

35.—(1) The information on the register shall be made available to the public by such means as the Scottish Ministers shall consider appropriate.

(2) The information prescribed in regulation 34(2) shall be placed on the register within twelve days of the prohibition notice being served.

(3) The information prescribed in regulation 34(3) (a) to (g) [F138 and (i)] shall be placed on the register within twelve days of receipt by the Scottish Ministers of the application for consent to release or market.

[F139 (3A) The information prescribed in regulation 34(3A) must be placed on the register within 12 days of receipt by the Scottish Ministers of the application for consent to market.]

(4) The information prescribed in regulation 34(3)(h) shall be placed on the register within twelve days of the consent being granted or refused.

(5) The information prescribed in regulation 34(5)(a) shall be placed on the register within twelve days of the consent being granted.

(6) The information prescribed in regulation 34(5)(b) and (d) shall be placed on the register within twelve days of its receipt by the Scottish Ministers.

(7) The information prescribed in regulation 34(5)(c) shall be placed on the register within fourteen days of the consent being revoked or varied.

[F140 (7A) The information prescribed in regulation 34(7A) must be placed on the register within 12 days of its production.]

(8) The information prescribed in regulations 34(6) and 34(10) shall be placed on the register within fourteen days of its receipt by the Scottish Ministers.

F141 (9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(10) The information prescribed in regulation 34(8) shall be placed on the register within fourteen days of its receipt by the Scottish Ministers.

F142 (11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(12) The information prescribed in regulation 34(10) in relation to any particular conviction shall be removed from the register when that conviction is spent within the meaning of the Rehabilitation of Offenders Act 1974 M15 .

Textual Amendments

F138 Words in reg. 35(3) 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(23)(a); 2020 c. 1, Sch. 5 para. 1(1)

F139 Reg. 35(3A) 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(23)(b); 2020 c. 1, Sch. 5 para. 1(1)

F140 Reg. 35(7A) 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(23)(c); 2020 c. 1, Sch. 5 para. 1(1)

F141 Reg. 35(9) 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(23)(d); 2020 c. 1, Sch. 5 para. 1(1)

F142 Reg. 35(11) 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(23)(d); 2020 c. 1, Sch. 5 para. 1(1)

Marginal Citations

M15 1974 c.53.

Publication of representations S

36.—(1) Subject to paragraph (2), the Scottish Ministers shall, within a period of twenty eight days after granting consent to or rejecting an application for the release of genetically modified organisms, make available to the public by whatever means they shall consider appropriate details of where, when and how copies of representations received may be inspected.

(2) Paragraph (1) shall not require copies of representations to be made publicly available where they contain confidential information and the person making the representation has asked the Scottish Ministers to treat that information as confidential.

PART IX S CONSEQUENTIAL AND OTHER AMENDMENTS AND REVOCATIONS

Consequential and other amendments – agency arrangements S

37.  The Scotland Act 1998 (Agency Arrangements) (Specification) (No. 2) Order 2002 M16 shall be amended in accordance with Schedule 6.

Marginal Citations

M16 S.I. 2002/800.

Revocations S

38.  The Regulations set out in column 1 of Schedule 7 are revoked to the extent specified in the corresponding entry in relation to those Regulations in column 3 of that Schedule.

ROSS FINNIE

A member of the Scottish Executive

St Andrew’s House, Edinburgh

Regulation 6(1) and schedule 2

[F143 SCHEDULE 1 S PRINCIPLES FOR ENVIRONMENTAL RISK ASSESSMENT

Introduction S

1.— (1) This schedule describes in general terms the objective to be achieved, the elements to be considered and the general principles and methodology to be followed to perform the environmental risk assessment.

(2) In this schedule—

“cumulative long-term effects” means the accumulated effects of consents on human health and the environment, including among other things flora and fauna, soil fertility, soil degradation of organic material, the feed/food chain, biological diversity, animal health and resistance problems in relation to antibiotics,

“delayed effects” means the effects on human health or the environment which may not be observed during the period of the release of the genetically modified organism, but become apparent as a direct or indirect effect either at a later stage or after termination of the release,

“direct effects” means the primary effects on human health or the environment which are a result of the genetically modified organism itself and which do not occur through a causal chain of events,

“immediate effects” means the effects on human health or the environment which are observed during the period of the release of the genetically modified organism. Immediate effects may be direct or indirect, and

“indirect effects” means the effects on human health or the environment occurring through a causal chain of events, through mechanisms such as interactions with other organisms, transfer of genetic material, or changes in use or management (observations of indirect effects are likely to be delayed).

(3) A general principle for environmental risk assessment is that an analysis of the cumulative long-term effects relevant to the release and the placing on the market of genetically modified organisms is to be carried out.

PART A S OBJECTIVE

2.   The objective of an environmental risk assessment is, on a case by case basis, to identify and evaluate potential adverse effects of the genetically modified organism, either direct and indirect, immediate or delayed, on human health and the environment which the deliberate release or the placing on the market of genetically modified organisms may have. The environmental risk assessment should be conducted with a view to identifying if there is a need for risk management and if so, the most appropriate methods to be used. S

PART B S GENERAL PRINCIPLES

3.   In accordance with the precautionary principle, the following general principles should be followed when performing the environmental risk assessment— S

(a) identified characteristics of the genetically modified organism and its use which have the potential to cause adverse effects should be compared to those presented by the non-modified organism from which it is derived and its use under corresponding situations,

(b) the environmental risk assessment should be carried out in a scientifically sound and transparent manner based on available scientific and technical data,

(c) the environmental risk assessment should be carried out on a case by case basis, meaning that the required information may vary depending on the type of the genetically modified organisms concerned, their intended use and the potential receiving environment, taking into account, among other things, genetically modified organisms already in the environment, and

(d) if new information on the genetically modified organism and its effects on human health or the environment becomes available, the environmental risk assessment may need to be readdressed in order to—

(i) determine whether the risk has changed, and

(ii) determine whether there is a need for amending the risk management accordingly.

PART C S METHODOLOGY

CHAPTER C.1 S GENERAL AND SPECIFIC CONSIDERATION FOR THE ENVIRONMENTAL RISK ASSESSMENT

Step 1: Intended and unintended changes S

4.— (1) As part of the identification and evaluation of the potential adverse effects referred to in Part A of this schedule, the environmental risk assessment must identify the intended and unintended changes resulting from the genetic modification and must evaluate their potential to cause adverse effects on human health and on the environment.

(2) Intended changes resulting from the genetic modification are changes that are designed to occur and which fulfil the original objectives of the genetic modification.

(3) Unintended changes resulting from the genetic modification are consistent changes which go beyond the intended change(s) resulting from the genetic modification.

(4) Intended and unintended changes can have either direct or indirect, and either immediate or delayed effects on human health and on the environment.

Step 2: Long-term adverse effects and cumulative long-term adverse effects in the environmental risk assessment of applications to which Part 3 of these Regulations applies S

5.— (1) Long-term effects of a genetically modified organism are effects resulting either from a delayed response by organisms or their progeny to long-term or chronic exposure to a genetically modified organism or from an extensive use of a genetically modified organism in time and space.

(2) The identification and evaluation of the potential long-term adverse effects of a genetically modified organism on human health and on the environment must take into account the following—

(a) the long-term interactions of the genetically modified organism and the receiving environment,

(b) the characteristics of the genetically modified organism which become important on a long- term basis, and

(c) data obtained from repeated deliberate releases or placings on the market of the genetically modified organism over a long period.

(3) The identification and evaluation of the potential cumulative long-term adverse effects referred to in the introduction of this schedule must also take into account the genetically modified organisms deliberately released or placed on the market in the past.

Step 3: Quality of the data S

6.— (1) In order to carry out an environmental risk assessment for an application to which Part 3 of these Regulations applies, the applicant must collate already available data from scientific literature or from other sources, including monitoring reports, and must generate the necessary data by performing, where possible, appropriate studies. Where applicable, the applicant must justify in the environmental risk assessment why generating data by studies is not possible.

(2) The environmental risk assessment for applications to which Part 2 of these Regulations applies must be based at least on already available data from scientific literature or from other sources and may be supplemented by additional data generated by the applicant.

(3) Where data generated outside the United Kingdom is provided in the environmental risk assessment, its relevance to receiving environment(s) in the United Kingdom must be justified.

(4) Data provided in the environmental risk assessment for applications to which Part 3 of these Regulations applies, must comply with the following requirements—

(a) where toxicological studies carried out to assess risk to human or animal health are provided in the environmental risk assessment, the applicant must provide evidence to demonstrate that they were conducted in facilities which comply with—

(i) if carried out in [F144 Great Britain], retained EU law relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances,

(ii) if carried out in a member State of the EU [F145 or in Northern Ireland], EU law relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances, or

(iii) if carried out elsewhere, the ‘OECD Principles on Good Laboratory Practice’,

(b) where studies other than toxicological studies are provided in the environmental risk assessment, they must—

(i) comply with the principles of Good Laboratory Practice laid down in retained EU law, where relevant, or

(ii) be conducted by organisations accredited under the relevant ISO standard, or

(iii) in the absence of a relevant ISO standard, be conducted in accordance with internationally recognised standards,

(c) information on the results obtained from the studies referred to in sub-paragraphs (a) and (b) and on the study protocols used must be reliable and comprehensive and must include the raw data in an electronic format suitable for carrying out statistical or other analysis,

(d) the applicant must specify, where possible, the size of effect that each study performed intends to detect and justify it,

(e) the selection of sites for field studies must be based on relevant receiving environments in view of the potential exposure and impact that would be observed where the genetically modified organism may be released. The selection must be justified in the environmental risk assessment, and

(f) the non-genetically modified comparator must be appropriate for the relevant receiving environment(s) and must have a genetic background comparable to the genetically modified organism. The choice of the comparator must be justified in the environmental risk assessment.

Textual Amendments

F144 Words in sch. 1 para. 6(4)(a)(i) substituted (2.2.2023) by The Agriculture (Retained EU Law and Data) (Scotland) Act 2020 (Consequential Modifications) and Agricultural Products, Aquatic Animal Health and Genetically Modified Organisms (EU Exit) (Amendment) Regulations 2022 (S.S.I. 2022/361), regs. 1, 14(2)(i)

F145 Words in sch. 1 para. 6(4)(a)(ii) inserted (2.2.2023) by The Agriculture (Retained EU Law and Data) (Scotland) Act 2020 (Consequential Modifications) and Agricultural Products, Aquatic Animal Health and Genetically Modified Organisms (EU Exit) (Amendment) Regulations 2022 (S.S.I. 2022/361), regs. 1, 14(2)(ii)

Step 4: Stacked transformation events in applications to which Part 3 of these Regulations applies S

7.   The following must apply to the environmental risk assessment of a genetically modified organism containing stacked transformation events in applications to which Part 3 of these Regulations applies—

(a) the applicant must provide an environmental risk assessment for each single transformation event in the genetically modified organism or refer to already submitted applications (or equivalent notifications) for those single transformation events,

(b) the applicant must provide an assessment of the following aspects—

(i) the stability of the transformation events,

(ii) the expression of the transformation events, and

(iii) the potential additive, synergistic or antagonistic effects resulting from the combination of the transformation events, and

(c) where the progeny of the genetically modified organism can contain various sub-combinations of the stacked transformation events, the applicant must provide a scientific rationale justifying that there is no need to provide experimental data for the concerned sub-combinations, independently of their origin, or, in the absence of such scientific rationale, must provide the relevant experimental data.

CHAPTER C.2 S CHARACTERISTICS OF THE GENETICALLY MODIFIED ORGANISM AND OF THE RELEASES

8.— (1) The environmental risk assessment must take into account the relevant technical and scientific details regarding characteristics of— S

(a) the recipient or parental organism(s),

(b) the genetic modification(s), be it insertion or deletion of genetic material, and relevant information on the vector and the donor,

(c) the genetically modified organism,

(d) the intended release or use including its scale,

(e) the potential receiving environment(s) into which the genetically modified organism will be released and into which the transgene may spread, and

(f) the interaction(s) between these characteristics.

(2) Relevant information from previous releases of the same or similar genetically modified organisms and organisms with similar traits and their biotic and abiotic interaction with similar receiving environments, including information resulting from the monitoring of such organisms, must be considered in the environmental risk assessment, subject to regulations 11(2) and 16(3).

CHAPTER C.3 S STEPS IN THE ENVIRONMENTAL RISK ASSESSMENT

9.   The environmental risk assessment must be conducted for each relevant area of risk referred to in Chapters D.1 and D.2 of Part D of this schedule in accordance with the following six steps. S

Step 1: Problem formulation including hazard identification S

10.— (1) The problem formulation must—

(a) identify any changes in the characteristics of the organism, linked to the genetic modification, by comparing the characteristics of the genetically modified organism with those of the chosen non-genetically modified comparator under corresponding conditions of release or use,

(b) identify potential adverse effects on human health or the environment which are linked to the changes that have been identified under sub-paragraph (1)(a),

(c) identify relevant assessment end-points,

(d) identify and describe the exposure pathways or other mechanisms through which adverse effects may occur,

(e) formulate testable hypotheses, and define relevant measurement end-points, to allow, where possible, a quantitative evaluation of the potential adverse effect(s), and

(f) consider possible uncertainties, including knowledge gaps and methodological limitations.

(2) For the purposes of sub-paragraph (1)(b)—

(a) potential adverse effects must not be discounted on the basis that they are unlikely to occur,

(b) potential adverse effects will vary from case to case, and may include—

(i) effects on the dynamics of populations of species in the receiving environment and the genetic diversity of each of these populations leading to a potential decline in biodiversity,

(ii) altered susceptibility to pathogens facilitating the dissemination of infectious diseases or creating new reservoirs or vectors,

(iii) compromising prophylactic or therapeutic medical, veterinary, or plant protection treatments, for example by transfer of genes conferring resistance to antibiotics used in human or veterinary medicine,

(iv) effects on biogeochemistry (biogeochemical cycles), including carbon and nitrogen recycling through changes in soil decomposition of organic material,

(v) disease affecting humans, including allergenic or toxic reactions, and

(vi) disease affecting animals and plants, including toxic, and, in the case of animals, allergenic reactions, where appropriate, and

(c) where potential long-term adverse effects of a genetically modified organism are identified, they must be assessed in the form of desk based studies using, where possible, one or more of the following—

(i) evidence from previous experiences,

(ii) available data sets or literature, or

(iii) mathematical modelling.

(3) For the purposes of sub-paragraph (1)(c), the potential adverse effects that could impact the identified assessment end-points must be considered in the next steps of the risk assessment.

(4) For the purposes of sub-paragraph (1)(d), adverse effects may occur directly or indirectly through exposure pathways or other mechanisms which may include—

(a) the spread of the genetically modified organism(s) in the environment,

(b) the transfer of the inserted genetic material to the same organism or other organisms, whether genetically modified or not,

(c) phenotypic and genetic instability,

(d) interactions with other organisms, and

(e) changes in management, including, where applicable, in agricultural practices.

Step 2: Hazard characterisation S

11.— (1) The magnitude of each potential adverse effect must be evaluated. This evaluation must assume that such an adverse effect will occur. The environmental risk assessment must consider that the magnitude is likely to be influenced by the receiving environment(s) into which the genetically modified organism is intended to be released and by the scale and conditions of the release.

(2) Where possible, the evaluation must be expressed in quantitative terms.

(3) Where the evaluation is expressed in qualitative terms, a categorical description (‘high’, ‘moderate’, ‘low’ or ‘negligible’) must be used and an explanation of the scale of effect represented by each category must be provided.

Step 3: Exposure characterisation S

12.— (1) The likelihood or probability of each identified potential adverse effect occurring must be evaluated to provide, where possible, a quantitative assessment of the exposure as a relative measure of probability, or otherwise a qualitative assessment of the exposure. The characteristics of the receiving environment(s) and the scope of the application must be taken into consideration.

(2) Where the evaluation is expressed in qualitative terms, a categorical description (‘high’, ‘moderate’, ‘low’ or ‘negligible’) of the exposure must be used and an explanation of the scale of effect represented by each category must be provided.

Step 4: Risk characterisation S

13.— (1) The risk must be characterised by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk.

(2) Where a quantitative or semi quantitative estimation is not possible, a qualitative estimation of the risk must be provided. In that case, a categorical description (‘high’, ‘moderate’, ‘low’ or ‘negligible’) of the risk must be used and an explanation of the scale of effect represented by each category must be provided.

(3) Where relevant, the uncertainty for each identified risk must be described and, where possible, expressed in quantitative terms.

Step 5: Risk management strategies S

14.— (1) Where risks are identified that require, on the basis of their characterisation, measures to manage them, a risk management strategy must be proposed for each risk.

(2) The risk management strategies must be described in terms of reducing the hazard or the exposure, or both, and must be proportionate to the intended reduction of the risk, the scale and conditions of the release and the levels of uncertainty identified in the environmental risk assessment

(3) The consequent reduction in overall risk must be quantified where possible.

Step 6: Overall risk evaluation and conclusions S

15.— (1) A qualitative and, where possible, quantitative evaluation of the overall risk of the genetically modified organism must be made taking into account the results of the risk characterisation, the proposed risk management strategies and the associated levels of uncertainty.

(2) The overall risk evaluation must include, where applicable, the risk management strategies proposed for each identified risk.

(3) The overall risk evaluation and conclusions must also propose specific requirements for the monitoring plan of the genetically modified organism and, where appropriate, the monitoring of the efficacy of the proposed risk management measures.

(4) For applications to which Part 3 of these Regulations applies, the overall risk evaluation must also include an explanation of the assumptions made during the environmental risk assessment and of the nature and magnitude of uncertainties associated with the risks, and a justification of the risk management measures proposed.

PART D S CONCLUSIONS ON THE SPECIFIC AREAS OF RISK OF THE ENVIRONMENTAL RISK ASSESSMENT

16.   Conclusions on the potential environmental impact in relevant receiving environments from the release or the placing on the market of genetically modified organisms must be drawn for each relevant area of risk listed in Chapter D.1 for genetically modified organisms other than higher plants or, as the case may be, Chapter D.2 for genetically modified higher plants, on the basis of an environmental risk assessment carried out in accordance with the principles outlined in Part B of this schedule and following the methodology described in Part C of this schedule, and on the basis of the information required pursuant to schedules 2 and 3. S

CHAPTER D.1 S GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER PLANTS

Areas of risk S

17.— (1) Likelihood of the genetically modified organism becoming persistent and invasive in natural habitats under the conditions of the proposed release(s).

(2) Any selective advantage or disadvantage conferred to the genetically modified organism and the likelihood of this becoming realised under the conditions of the proposed release(s).

(3) Potential for gene transfer to other species under conditions of the proposed release of the genetically modified organism and any selective advantage or disadvantage conferred to those species.

(4) Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the genetically modified organism and target organisms (if applicable).

(5) Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the genetically modified organism with non-target organisms, including impact on population levels of competitors, prey, hosts, symbionts, predators, parasites and pathogens.

(6) Possible immediate and/or delayed effects on human health resulting from potential direct and indirect interactions of the genetically modified organism and persons working with, coming into contact with or in the vicinity of the genetically modified organism release(s).

(7) Possible immediate and/or delayed effects on animal health and consequences for the feed/food chain resulting from consumption of the genetically modified organism and any product derived from it, if it is intended to be used as animal feed.

(8) Possible immediate and/or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions of the genetically modified organism and target and non-target organisms in the vicinity of the genetically modified organism release(s).

(9) Possible immediate and/or delayed, direct and indirect environmental impacts of the specific techniques used for the management of the genetically modified organism where these are different from those used for non-genetically modified organisms.

CHAPTER D.2 S GENETICALLY MODIFIED HIGHER PLANTS

Areas of risk S

18.— (1) Persistence and invasiveness of the genetically modified higher plants, including plant to plant gene transfer.

(2) Plant to micro-organisms gene transfer.

(3) Interactions of the genetically modified higher plants with target organisms.

(4) Interactions of the genetically modified higher plants with non-target organisms.

(5) Impacts of the specific cultivation, management and harvesting techniques.

(6) Effects on biogeochemical processes.

(7) Effects on human and animal health.]

Regulations 11(1) and 16(2)

[F146 SCHEDULE 2 S INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE OR MARKET GENETICALLY MODIFIED HIGHER PLANTS

Textual Amendments

F146 Sch. 2 substituted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 18

PART 1 S INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE FOR ANY OTHER PURPOSE THAN FOR PLACING ON THE MARKET

A. General information S

1.   The name and address of the applicant, and the name, qualifications and experience of the scientist and of every other person who will be responsible for planning and carrying out the release of the organisms, and for the supervision, monitoring and safety of the release.

2.   The title of the project.

B. Information relating to the release S

3.   The purpose of the release.

4.   The foreseen date or dates and duration of the release.

5.   The method by which the genetically modified plants will be released.

6.   The method for preparing and managing the release site, prior to, during and after the release, including cultivation practices and harvesting methods.

7.   The approximate number of genetically modified plants (or plants per square metre) to be released.

C. Information relating to the site of release S

8.   The location and size of the release site or sites.

9.   A description of the release site ecosystem, including climate, flora and fauna.

10.   The details of any sexually compatible wild relatives or cultivated plant species site or sites.

11.   The proximity of the release site or sites to officially recognised biotopes or protected areas which may be affected.

D. Information relating to the recipient plant or, where appropriate, to the parental plants S

12.   The full name of the plant, that is—

(a) family name,

(b) genus,

(c) species,

(d) subspecies,

(e) cultivar or breeding line, and

(f) common name.

13.   The geographical distribution and cultivation of the plant within the [F147 United Kingdom].

Textual Amendments

F147 Words in sch. 2 para. 13 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(25)(a); 2020 c. 1, Sch. 5 para. 1(1)

14.   Information concerning—

(a) the reproduction of the plant, that is—

(i) the mode or modes of reproduction,

(ii) any specific factors affecting reproduction,

(iii) the generation time, and

(b) the sexual compatibility of the plant with other cultivated or wild plant species including the distribution in [F148 the United Kingdom] of the compatible species.

Textual Amendments

F148 Words in sch. 2 para. 14(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(25)(b); 2020 c. 1, Sch. 5 para. 1(1)

15.   Information concerning the survivability of the plant, that is—

(a) its ability to form structures for survival or dormancy, and

(b) any specific factors affecting survivability.

16.   Information concerning the dissemination of the plant, that is—

(a) the ways and extent of dissemination, and

(b) any specific factors affecting dissemination.

17.   Where the application relates to a plant species which is not normally grown in the UK a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.

18.   Information concerning any other potential interactions, relevant to the genetically modified organism, of the plant with organisms in the ecosystem where it is usually grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.

E. Molecular characterisation S

19.   Information relating to the genetic modification, that is—

(a) a description of the methods used for the genetic modification,

(b) the nature and source of the vector used, and

(c) the source of the nucleic acid or acids used for transformation, size, and intended function of each constituent fragment of the region intended for insertion.

20.   Information relating to the genetically modified higher plant, that is—

(a) a general description of the trait or traits and characteristics which have been introduced or modified,

(b) information on the sequences actually inserted or deleted, namely—

(i) the size and copy number of all insert or inserts and methods used for its or their characterisation,

(ii) in case of deletion, size and function of the deleted region or regions,

(iii) the subcellular location or locations of the insert or inserts in the plant cells (integrated in the nucleus, chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its/their determination,

(c) parts of the plant where the insert is expressed, and

(d) the genetic stability of the insert and phenotypic stability of the genetically modified higher plant.

21.   Conclusions of the molecular characterisation

F. Information on specific areas of risk S

22.   Any change to the persistence or invasiveness of the genetically modified higher plant, and its ability to transfer genetic material to sexually compatible relatives and the adverse environmental effects thereof.

23.   Any change to the ability of the genetically modified higher plant to transfer genetic material to microorganisms and the adverse environmental effects thereof.

24.   Information on the mechanism of interaction between the genetically modified higher plant and target organisms (if applicable) and the adverse environmental effects thereof.

25.   Information on the potential changes in the interactions of the genetically modified higher plant with non-target organisms resulting from the genetic modification and the adverse environmental effects thereof.

26.   Information on the potential changes in agricultural practices and management of the genetically modified higher plant resulting from the genetic modification and the adverse environmental effects thereof.

27.   Information on the potential interactions with the abiotic environment and the adverse environmental effects thereof.

28.   Information on any toxic, allergenic or other harmful effects on human and animal health arising from the genetic modification.

29.   Conclusions on the specific areas of risk.

G. Information on control, monitoring, post-release and waste treatment plans S

30.   Any measures taken, including—

(a) spatial and temporal isolation from sexually compatible plant species, both wild and weedy relatives and crops, and

(b) any measures to minimise or prevent the dispersal of any reproductive part of the genetically modified higher plant.

31.   A description of methods for post-release treatment of the site.

32.   A description of post-release treatment methods for the genetically modified plant material including wastes.

33.   A description of monitoring plans and techniques.

34.   A description of any emergency plans.

35.   A description of the methods and procedures to,—

(a) avoid or minimise the spread of the genetically modified higher plants beyond the site of release,

(b) protect the site from intrusion by unauthorised individuals, and

(c) prevent other organisms from entering the site or minimise such entries.

H. Other S

36.   A description of detection and identification techniques for the genetically modified higher plant.

37.   Information about previous releases of the genetically modified higher plant, if applicable.

PART 2 S INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO PLACE ON MARKET

A. General information S

38.   The name and address of the applicant, and the name, qualifications and experience of the scientist and of every other person who will be responsible for planning and carrying out the release of the organisms, and for the supervision, monitoring and safety of the release.

39.   The designation and specification of the genetically modified higher plant.

40.   The scope of the notification including—

(a) cultivation

(b) any other use.

B. Information relating to the recipient plant or, where appropriate, to the parental plants S

41.   The complete name of the plant, that is—

(a) family name,

(b) genus,

(c) species,

(d) subspecies,

(e) cultivar/breeding line, and

(f) common name.

42.   The geographical distribution and cultivation of the plant within the [F149 United Kingdom].

Textual Amendments

F149 Words in sch. 2 para. 42 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(25)(c); 2020 c. 1, Sch. 5 para. 1(1)

43.   The reproduction of the plant, that is—

(a) the mode or modes of reproduction,

(b) any specific factors affecting reproduction,

(c) generation time, and

(d) the sexual compatibility of the plant with other cultivated or wild plant species including the distribution in the [F150 United Kingdom] of the compatible species.

Textual Amendments

F150 Words in sch. 2 para. 43 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(25)(c); 2020 c. 1, Sch. 5 para. 1(1)

44.   Information concerning the survivability of the plant, that is—

(a) its ability to form structures for survival or dormancy, and

(b) any specific factors affecting survivability.

45.   Information concerning the dissemination: of the plant, that is—

(a) the ways and extent of dissemination, and

(b) any specific factors affecting dissemination.

46.   Where a plant species is not normally grown in the [F151 United Kingdom], a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.

Textual Amendments

F151 Words in sch. 2 para. 46 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(25)(c); 2020 c. 1, Sch. 5 para. 1(1)

47.   Information concerning any other potential interactions, relevant to the genetically modified higher plant with organisms in the ecosystem where it is usually grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.

C. Molecular Characterisation S

48.   Information relating to the genetic modification including—

(a) a description of the methods used for the genetic modification,

(b) the nature and source of the vector used, and

(c) the source of the nucleic acid or acids used for transformation, size, and intended function of each constituent fragment of the region intended for insertion.

49.— (1) Information relating to the genetically modified plant, that is—

(a) a description of the trait or traits and characteristics which have been introduced or modified,

(b) information on the sequences actually inserted or deleted namely—

(i) the size and copy number of all detectable inserts, both partial and complete, and methods used for its characterisation,

(ii) the organisation and sequence of the inserted genetic material at each insertion site in a standardised electronic format,

(iii) in case of deletion, the size and function of the deleted region or regions,

(iv) the subcellular location or locations of the insert or inserts (integrated in the nucleus, chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its or their determination,

(v) in the case of modifications other than insertion or deletion, the function of the modified genetic material before and after the modification, as well as direct changes in expression of genes as a result of the modification,

(vi) the sequence information in a standardised electronic format for both 5′ and 3′ flanking regions at each insertion site,

(vii) the bioinformatic analysis using up-to-date databases, to investigate possible interruptions of known genes,

(viii) all Open Reading Frames, (‘ORFs’) within the insert (either due to rearrangement or not) and those created as a result of the genetic modification at the junction sites with genomic DNA,

(ix) the bioinformatic analysis using up-to-date databases, to investigate possible similarities between the ORFs and known genes which may have adverse effects,

(x) the primary structure (amino acid sequence) and, if necessary, other structures, of the newly expressed protein, and

(xi) the bioinformatic analysis using up-to-date databases, to investigate possible sequence homologies and, if necessary, structural similarities between the newly expressed protein and known proteins or peptides which may have adverse effects.

(2) An ‘ORF’ is defined as a nucleotide sequence that contains a string of codons that is uninterrupted by the presence of a stop codon in the same reading frame.

50.   Information on the expression of the insert that is—

(a) the method or methods used for expression analysis together with their performance characteristics,

(b) any information on the developmental expression of the insert during the life cycle of the plant,

(c) the parts of the plant where the insert or modified sequence is expressed,

(d) the potential unintended expression of new ORFs identified under paragraph 49(b)(vii), which raise a safety concern,

(e) the protein expression data, including the raw data, obtained from field studies and related to the conditions in which the crop is grown and,

(f) the genetic stability of the insert and phenotypic stability of the genetically modified higher plant.

51.   The conclusions of molecular characterisation.

D. Comparative analysis of agronomic and phenotypic characteristics and of composition of the genetically modified higher plant. S

52.   The comparative analysis of agronomic and phenotypic characteristics and of composition that is—

(a) the choice of conventional counterpart and additional comparators,

(b) the choice of sites for field studies,

(c) the experimental design and statistical analysis of data from field trials for comparative analysis namely—

(i) a description of field studies design

(ii) a description of the relevant aspect of the receiving environments,

(iii) the statistical analysis,

(d) the selection of plant material for analysis, if relevant,

(e) the comparative analysis of agronomic and phenotypic characteristics,

(f) the comparative analysis of composition, if relevant, and

(g) the conclusions of the comparative analysis.

53.   For each of the seven areas of risk referred to in [F152 in Chapter D.2 of Part D of schedule 1], a description of the pathway to harm explaining in a chain of cause and effect how the release of the genetically modified higher plant could lead to harm, taking into account both hazard and exposure.

Textual Amendments

F152 Words in sch. 2 para. 53 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(25)(d); 2020 c. 1, Sch. 5 para. 1(1)

54.   The following information is required, except where it is not relevant in view of the intended uses of the genetically modified organism—

(a) in respect of persistence and invasiveness including plant to plant gene transfer—

(i) an assessment of the potential for the genetically modified higher plant to become more persistent or invasive and the adverse environmental effects thereof,

(ii) an assessment of the potential for the genetically modified higher plant to transmit transgene or transgenes to sexually compatible relatives and the adverse environmental effects thereof, and

(iii) conclusions on the adverse environmental effect of persistence and invasiveness of the genetically modified higher plant including the adverse environmental effect of plant-to-plant gene transfer,

(b) in respect of plant to micro-organism gene transfer—

(i) an assessment of the potential for transfer of newly inserted DNA from the genetically modified higher plant to microorganisms and the adverse effect or effects thereof, and

(ii) the conclusions on the adverse effect or effects of the transfer of newly inserted DNA from the genetically modified higher plant to microorganisms for human and animal health and the environment,

(c) in respect of interactions of the genetically modified higher plant with target organisms, if relevant—

(i) an assessment of the potential for changes in the direct and indirect interactions between the genetically modified higher plant and target organisms and the adverse environmental effect or effects,

(ii) an assessment of the potential for evolution of resistance of the target organism to the expressed protein (based on the history of evolution of resistance to conventional pesticides or transgenic plants expressing similar traits) and any adverse environmental effect or effects thereof, and

(iii) the conclusions on adverse environmental effect or effects of interactions of the genetically modified higher plant with target organisms,

(d) the interactions of the genetically modified higher plant with non-target organisms namely—

(i) an assessment of the potential for direct and indirect interactions of the genetically modified higher plant with non-target organisms, including protected species, and the adverse effect or effects thereof,

(ii) an assessment of the potential adverse effect or effects on relevant ecosystem services and on the species providing those services,

(iii) the conclusions on adverse environmental effect or effects of the interactions of the genetically modified higher plant with non-target organisms,

(e) the impacts of the specific cultivation, management and harvesting techniques, namely—

(i) for genetically modified higher plants for cultivation, an assessment of the changes in the specific cultivation, management and harvesting techniques used for the genetically modified higher plant and the adverse environmental effect or effects thereof, and

(ii) the conclusions on the adverse environmental effect or effects of the specific cultivation, management and harvesting techniques,

(f) the effects on biogeochemical processes, namely—

(i) an assessment of the changes in the biogeochemical processes within the area in which the genetically modified higher plant is to be grown and in the wider environment, and the adverse effects thereof, and

(ii) the conclusions on adverse effects on biogeochemical processes,

(g) the effects on human and animal health, namely—

(i) an assessment of the potential direct and indirect interactions between the genetically modified higher plant and persons working with or coming into contact with the genetically modified higher plants, including through pollen or dust from a processed genetically modified higher plant, and an assessment of the adverse effects of those interactions on human health,

(ii) for genetically modified higher plants not destined for human consumption, but where the recipient or parental organism or organisms may be considered for human consumption, an assessment of the likelihood of and possible adverse effects on human health due to accidental intake,

(iii) an assessment of the potential adverse effects on animal health due to accidental consumption of the genetically modified higher plant or of material from that plant by animals,

(iv) the conclusions on the effects on human and animal health, and

(h) an overall risk evaluation and conclusions, namely a summary of all the conclusions under each area of risk taking into account—

(i) the risk characterisation in accordance with steps 1 to 4 of the methodology described in [F153 Chapter C.3 of Part C of schedule 1], and

(ii) the risk management strategies proposed in accordance with [F154 step 5 of the methodology described in that Chapter].

Textual Amendments

F153 Words in sch. 2 para. 54(h)(i) 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(25)(e)(i); 2020 c. 1, Sch. 5 para. 1(1)

F154 Words in sch. 2 para. 54(h)(ii) 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(25)(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)

55.   A description of detection and identification techniques for the genetically modified higher plant.

56.   Information about previous releases of the genetically modified higher plant, if applicable.]

Regulations 11(1) and 16(2)

SCHEDULE 3 S INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE OR MARKET ORGANISMS OTHER THAN GENETICALLY MODIFIED HIGHER PLANTS

PART I S GENERAL INFORMATION

1.  The name and address of the applicant, and the name, qualifications and experience of the scientist and of every other person who will be responsible for planning and carrying out the release of the organisms, and for the supervision, monitoring and safety of the release. S

2.  The title of the project. S

PART II S INFORMATION RELATING TO THE ORGANISMS

Characteristics of donor, parental and recipient organisms S

1.   

3.  Scientific name and taxonomy. S

4.  Usual strain, cultivar or other name. S

5.  Phenotypic and genetic markers. S

6.  The degree of relatedness between donor and recipient or between parental organisms. S

7.  The description of identification and detection techniques. S

8.  The sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques. S

9.  The description of the geographic distribution and of the natural habitat of the organisms including information on natural predators, prey, parasites and competitors, symbionts and hosts. S

10.  The organisms with which transfer of genetic material is known to occur under natural conditions. S

11.  Verification of the genetic stability of the organisms and factors affecting that stability. S

12.  The following pathological, ecological and physiological traits:– S

(a) the classification of hazard according to [F155 retained EU law] concerning the protection of human health and the environment;

(b) the generation time in natural ecosystems, sexual and asexual reproductive cycle;

(c) information on survivability, including seasonability and the ability to form survival structures, including seeds, spores and sclerotia;

(d) pathogencity, including infectivity, toxigenicity, virulence, allergenicity, carrier (vector) of pathogen, possible vectors, host range including non-target organisms and possible activation of latent viruses (proviruses) and ability to colonise other organisms;

(e) antibiotic resistance, and potential use of these antibiotics in humans and domestic organisms for prophylaxis and therapy; and

(f) involvement in environmental processes, including primary production, nutrient turnover, decomposition of organic matter and respiration.

Textual Amendments

F155 Words in sch. 3 para. 12(a) 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(26); 2020 c. 1, Sch. 5 para. 1(1)

13.  The sequence, frequency of mobilisation and specificity of indigenous vectors, and the presence in those vectors of genes which confer resistance to environmental stresses. S

14.  The history of genetic modifications. S

Characteristics of the vector S

2.   

15.  The nature and source of the vector. S

16.  The sequence of transposons, vectors and other non-coding genetic segments used to construct the genetically modified organisms and to make the introduced vector and insert function in those organisms. S

17.  The frequency of mobilisation, genetic transfer capabilities and/or methods of determination of the inserted vector. S

18.  Information on the degree to which the vector is limited to the DNA required to perform the intended function. S

Characteristics of the modified organisms S

3.   

19.  The methods used for the modification. S

20.  The methods used– S

(a) to construct inserts and to introduce them into the recipient organism; and

(b) to delete a sequence.

21.  The description of any insert and/or vector construction. S

22.  The purity of the insert from any unknown sequence and information on the degree to which the inserted sequence is limited to the DNA required to perform the intended function. S

23.  The methods and criteria used for selection. S

24.  The sequence, functional identity and location of the altered, inserted or deleted nucleic acid segment or segments in question, and in particular any known harmful sequence. S

Characteristics of the genetically modified organisms in their final form S

4.   

25.  The description of genetic traits or phenotypic characteristics and in particular any new traits and characteristics which may be expressed or no longer expressed. S

26.  The structure and amount of any vector or donor nucleic acid remaining in the final construction of the modified organism. S

27.  The stability of the organism in terms of genetic traits. S

28.  The rate and level of expression of the new genetic material in the organism, and the method and sensitivity of measurement of that rate and level. S

29.  The activity of the expressed protein. S

30.  The description of identification and detection techniques, including techniques for the identification and detection of the inserted sequence and vector. S

31.  The sensitivity, reliability (in quantitative terms), and specificity of detection and identification techniques. S

32.  The history of previous releases or uses of the genetically modified organisms. S

33.  In relation to human health, animal health and plant health– S

(a) the toxic or allergenic effects of the organisms and/or their metabolic products;

(b) the comparison of the modified organism to the donor, recipient or (where appropriate) parental organism regarding pathogenicity;

(c) the capacity of the organisms for colonisation;

(d) if the organism is pathogenic to humans who are immunocompetent–

(i) diseases caused and mechanism of pathogenicity including invasiveness and virulence;

(ii) communicability;

(iii) infective dose;

(iv) host range and possibility of alteration;

(v) possibility of survival outside of human host;

(vi) presence of vectors or means of dissemination;

(vii) biological stability;

(viii) antibiotic resistance patterns;

(ix) allergenicity; and

(x) availability of appropriate therapies; and

(e) the other product hazards.

PART III S INFORMATION RELATING TO THE CONDITIONS OF RELEASE AND THE RECEIVING ENVIRONMENT

The release S

5.   

34.  The description of the proposed deliberate release, including the purpose of the release and the foreseen products of the release. S

35.  The foreseen dates of the release and time planning of the experiment including frequency and duration of releases. S

36.  The preparation of the site before the release. S

37.  The size of the site. S

38.  The methods to be used for the release. S

39.  The quantity of organisms to be released. S

40.  The disturbance of the site, including the type and method of cultivation, mining, irrigation or other activities. S

41.  The worker protection measures taken during the release. S

42.  The post-release treatment of the site. S

43.  The techniques foreseen for elimination or inactivation of the genetically modified organisms at the end of the experiment or other purpose of the release. S

44.  Information on, and the results of, previous releases of the organisms, and in particular, releases on a different scale or into different ecosystems. S

The environment (both on the site and in the wider environment) S

6.   

45.  The geographical location and national grid reference of the site onto which the release will be made, or in the case of applications for consent to market or renewed consent to market the foreseen areas of use of the product. S

46.  The physical or biological proximity of the site of the organisms to humans and other significant biota. S

47.  The proximity to significant biotopes, protected areas or drinking water supplies. S

48.  The climatic characteristics of the region or regions likely to be affected. S

49.  The geographical, geological and pedological characteristics. S

50.  The flora and fauna, including crops, livestock and migratory species. S

51.  The description of the target and non-target ecosystems likely to be affected. S

52.  A comparison of the natural habitat of the recipient organism with the proposed site or sites of release. S

53.  Any known planned developments or changes in land use in the region which could influence the environmental impact of the release. S

PART IV S INFORMATION RELATING TO THE INTERACTIONS BETWEEN THE GENETICALLY MODIFIED ORGANISMS AND THE ENVIRONMENT

Characteristics affecting survival, multiplication and dissemination S

7.   

54.  The biological features which affect survival, multiplication and dispersal. S

55.  The known or predicted environmental conditions which may affect survival, multiplication and dissemination, including wind, water, soil, temperature and pH. S

56.  The sensitivity to specific agents. S

Interactions with the environment S

8.   

57.  The predicted habitat of the genetically modified organisms. S

58.  The studies on the behaviour and characteristics of the genetically modified organisms and their ecological impact carried out in simulated natural environments, such as microcosms, growth rooms and greenhouses. S

59.  The capability of post-release transfer of genetic material– S

(a) from the genetically modified organisms into organisms in affected ecosystems;

(b) from indigenous organisms to the genetically modified organisms.

60.  The likelihood of post-release selection leading to the expression of unexpected and/or undesirable traits in the genetically modified organism. S

61.  The measures employed to ensure and to verify genetic stability, the description of genetic traits which may prevent or minimise dispersal of genetic material, and methods to verify genetic stability. S

62.  The routes of biological dispersal, known or potential modes of interaction with the disseminating agent, including inhalation, ingestion, surface contact and burrowing. S

63.  The description of ecosystems to which the genetically modified organisms could be disseminated. S

64.  The potential for excessive population increase of the genetically modified organisms in the environment. S

65.  The competitive advantage of the genetically modified organisms in relation to the unmodified recipient or parental organisms. S

66.  The identification and description of the target organisms if applicable. S

67.  The anticipated mechanism and result of interaction between the released genetically modified organisms and the target organisms, if applicable. S

68.  The identification and description of non-target organisms which may be adversely affected by the release of the genetically modified organism, and the anticipated mechanisms of any identified adverse interaction. S

69.  The likelihood of post release shifts in biological interactions or in the host range. S

70.  The known or predicted interactions with non-target organisms in the environment, including competitors, preys, hosts, symbionts, predators, parasites and pathogens. S

71.  The known or predicted involvement of the genetically modified organisms in biogeochemical processes. S

72.  Any other potential interactions of the organisms with the environment. S

PART V S INFORMATION ON MONITORING, CONTROL, WASTE TREATMENT AND EMERGENCY RESPONSE PLANS

Monitoring techniques S

9.   

73.  Methods for tracing the genetically modified organisms and for monitoring their effects. S

74.  Specificity (to identify the genetically modified organisms, and to distinguish them from the donor, recipient or, where appropriate, the parental organisms), sensitivity and reliability of the monitoring techniques. S

75.  Techniques for detecting transfer of the donated genetic material to other organisms. S

76.  Duration and frequency of the monitoring. S

Control of the release S

10.   

77.  Methods and procedures to avoid and/or minimise the spread of the genetically modified organisms beyond the site of release or the designated area for use. S

78.  Methods and procedures to protect the site from intrusion by unauthorised individuals. S

79.  Methods and procedures to prevent other organisms from entering the site. S

Waste treatment S

11.   

80.  Type of waste generated. S

81.  Expected amount of waste. S

82.  Description of treatment envisaged. S

Emergency response plans S

12.   

83.  Methods and procedures for controlling the genetically modified organisms in case of unexpected spread. S

84.  Methods, such as eradication of the genetically modified organisms, for decontamination of the areas affected. S

85.  Methods for disposal or sanitation of plants, animals, soils, and any other thing exposed during or after the spread. S

86.  Methods for the isolation of the area affected by the spread. S

87.  Plans for protecting human health and the environment in case of the occurrence of an undesirable effect. S

PART VI S INFORMATION ON METHODOLOGY

88.  A description of the methods used or a reference to standardised or internationally recognised methods used to compile the information required by this Schedule, and the name of the body or bodies responsible for carrying out the studies. S

Regulations 16(2), 16(5) and 28

SCHEDULE 4 S INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO MARKET GENETICALLY MODIFIED ORGANISMS

PART I S GENERAL INFORMATION

[F156 1.   The proposed commercial name of the product or products (which must be provided to the [F157 Scottish Ministers] after consent has been granted) and name or names of the genetically modified organism or organisms in the product or products, and a proposal for a unique identifier of the genetically modified organism developed in accordance with Commission Regulation (EC) No 65/2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms.] S

Textual Amendments

F156 Sch. 4 para. 1 substituted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 19(a)

F157 Words in sch. 4 para. 1 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(27)(a); 2020 c. 1, Sch. 5 para. 1(1)

2.  The name and address F158 ... of the person who is responsible for the placing on the market, whether it be the manufacturer, importer or distributor. S

Textual Amendments

F158 Words in sch. 4 para. 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(27)(b); 2020 c. 1, Sch. 5 para. 1(1)

3.  The name and address of the supplier of control samples. S

4.  A description of how the product and the genetically modified organism as or in the product are intended to be used, highlighting any differences in use or management of the genetically modified organism compared to similar non-genetically modified products. S

5.  A description of the geographical area and types of environment where the product is intended to be used F159 ..., including, where possible, an estimate of the scale of use in each area. S

Textual Amendments

F159 Words in sch. 4 para. 5 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(27)(c); 2020 c. 1, Sch. 5 para. 1(1)

6.  A description of the intended categories of users of the product, such as industry, agriculture, skilled trades or consumer use by the public at large. S

[F160 7.   Methods for the detection, identification and, where appropriate, quantification of the transformation event, samples of the genetically modified organism or organisms and their control samples, and information as to the place where the reference material can be accessed (identifying any such information that cannot be placed, for confidentiality reasons, in the [F161 register]).] S

Textual Amendments

F160 Sch. 4 para. 7 substituted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 19(b)

F161 Word in sch. 4 para. 7 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(27)(d); 2020 c. 1, Sch. 5 para. 1(1)

8.  Information regarding proposed labelling, which must include, in a label or an accompanying document, at least in summarised form, a commercial name of the product, a statement that “This product contains genetically modified organisms”, the name of the genetically modified organism and the name and address of the person F162 ... who is responsible for the placing on the market, and how to access the information in the publicly accessible part of the register. S

Textual Amendments

F162 Words in sch. 4 para. 8 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(27)(e); 2020 c. 1, Sch. 5 para. 1(1)

PART II S ADDITIONAL RELEVANT INFORMATION

9.  The measures to be taken in the event of the escape of the organisms in the product or misuse of the product. S

10.  Specific instructions or recommendations for storage and handling of the product. S

11.  Specific instructions for carrying out monitoring and reporting to the applicant and, if required, the Scottish Ministers, which are consistent with [F163 Part C of schedule 5A], so that the Scottish Ministers can be effectively informed of any adverse effect. S

Textual Amendments

F163 Words in sch. 4 para. 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(27)(f); 2020 c. 1, Sch. 5 para. 1(1)

12.  The proposed restrictions in the approved use of the genetically modified organism, such as where the product may be used and for what purposes. S

13.  The proposed packaging. S

14.  The estimated production in and/or imports to [F164 Scotland and other parts of the United Kingdom]. S

Textual Amendments

F164 Words in sch. 4 para. 14 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(27)(g); 2020 c. 1, Sch. 5 para. 1(1)

15.  Any proposed additional labelling, which may include, at least in summarised form, the information referred to in paragraphs 4 and 5 of Part I of this Schedule, or paragraphs 9 to 12 of this Part. S

Regulations 23(1), 25(1) and 31(3)

SCHEDULE 5 S INFORMATION TO BE INCLUDED IN AN ASSESSMENT REPORT

1.  An identification of the characteristics of the recipient organism which are relevant to the assessment of the relevant genetically modified organisms. S

2.  An identification of any known risks to human health and the environment resulting from the release into the environment of the recipient non-modified organism. S

3.  A description of the result of the genetic modification in the modified organism. S

4.  An assessment of whether the genetic modification has been characterised sufficiently for the purpose of evaluating any risks to human health and the environment. S

5.  An identification of any new risks to human health and the environment that may arise from the release of the relevant genetically modified organisms as compared to the release of the corresponding non-modified organism, based on the environmental risk assessment carried out in accordance with regulation 6. S

6.  A conclusion which addresses the proposed use of the product, risk management and the proposed monitoring plan, and states whether the relevant genetically modified organisms should be placed on the market on its own or in a product and under which conditions, or not placed on the market for reasons which are specified F165 .... Where it is concluded that the genetically modified organisms should not be placed on the market the Scottish Ministers shall give reasons for their conclusion. S

Textual Amendments

F165 Words in sch. 5 para. 6 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(28); 2020 c. 1, Sch. 5 para. 1(1)

Regulation 16(2)(g) and schedule 4

[F166 SCHEDULE 5A S MONITORING PLAN

Textual Amendments

F166 Sch. 5A inserted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), reg. 1(2)(b), sch. 2; 2020 c. 1, Sch. 5 para. 1(1)

Introduction S

1.   This schedule describes in general terms the objective to be achieved and the general principles to be followed in the design of the monitoring plan referred to in regulations 16(2)(g) and 28(f).

PART A S OBJECTIVE

2.   The objective of a monitoring plan is to— S

(a) confirm that any assumption regarding the occurrence and impact of potential adverse effects of the genetically modified organism or its use in the environmental risk assessment are correct, and

(b) identify the occurrence of adverse effects of the genetically modified organism or its use on human health or the environment which were not anticipated in the environmental risk assessment.

PART B S GENERAL PRINCIPLES

3.— (1) Monitoring takes place after the consent to the placing of a genetically modified organism on the market. S

(2) The interpretation of the data collected by monitoring should be considered in the light of other existing environmental conditions and activities. Where changes in the environment are observed, further assessment should be considered to establish whether they are a consequence of the genetically modified organism or its use, as such changes may be the result of environmental factors other than the placing of the genetically modified organism on the market.

(3) Experience and data gained through the monitoring of experimental releases of genetically modified organisms may assist in designing the post marketing monitoring regime required for the placing on the market of genetically modified organisms as or in products.

PART C S DESIGN OF THE MONITORING PLAN

4.   The design of the monitoring plan should— S

(a) be detailed on a case by case basis taking into account the environmental risk assessment,

(b) take into account the characteristics of the genetically modified organism, the characteristics and scale of its intended use and the range of relevant environmental conditions where the genetically modified organism is expected to be released,

(c) incorporate general surveillance for unanticipated adverse effects and, if necessary, (case-)specific monitoring focusing on adverse effects identified in the environmental risk assessment—

(i) whereas case-specific monitoring should be carried out for a sufficient time period to detect immediate and direct as well as, where appropriate, delayed or indirect effects which have been identified in the environmental risk assessment, and

(ii) whereas surveillance could, if appropriate, make use of already established routine surveillance practices such as the monitoring of agricultural cultivars, plant protection, or veterinary and medical products. An explanation as to how relevant information collected through established routine surveillance practices will be made available to the consent-holder should be provided,

(d) facilitate the observation, in a systematic manner, of the release of a genetically modified organism in the receiving environment and the interpretation of these observations with respect to safety to human health or the environment,

(e) identify who (applicant, users) will carry out the various tasks the monitoring plan requires and who is responsible for ensuring that the monitoring plan is set into place and carried out appropriately, and ensure that there is a route by which the consent holder and the Scottish Ministers will be informed on any observed adverse effects on human health and the environment (time points and intervals for reports on the results of the monitoring must be indicated), and

(f) give consideration to the mechanisms for identifying and confirming any observed adverse effects on human health and environment and enable the consent holder or the Scottish Ministers, where appropriate, to take the measures necessary to protect human health and the environment.]

Regulation 37

SCHEDULE 6 S AMENDMENT TO THE SCOTLAND ACT 1998 (AGENCY ARRANGEMENTS) (SPECIFICATION) (NO. 2) ORDER 2002

For paragraphs (d) and (e) of the Schedule to the Scotland Act 1998 (Agency Arrangements) (Specification) (No. 2) Order 2002 M17 substitute–

“(ca) Section 126(5)(b) of the Environmental Protection Act 1990 (function of consulting the Food Standards Agency).

(cb) Regulation 16(5) of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (function of consideration whether applicant may omit certain information from an application for consent to market genetically modified organisms).

(cc) Regulation 20 of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (functions on receiving applications for consent to release genetically modified organisms).

(cd) Regulation 23(1) of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (functions on receipt of applications for consent to market genetically modified organisms).

(ce) Regulations 23(4) and 31(4) of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (function of consulting the Health and Safety Executive).

(cf) Regulation 27(2) of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (function of evaluating information in environmental risk assessments).

(cg) Regulation 35 of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (function of maintaining the register).”.

Marginal Citations

M17 S.I. 2002/800.

Regulation 38

SCHEDULE 7 S REVOCATIONS

Regulations revoked	References	Extent
The Genetically Modified Organisms (Deliberate Release) Regulations 1992	S.I. 1992/3280 as amended by the Genetically Modified Organisms (Deliberate Release) Regulations 1993 (S.I. 1993/152), the Genetically Modified Organisms (Deliberate Release) Regulations 1995 (S.I. 1995/304), the Genetically Modified Organisms (Deliberate Release) and Risk Assessment–Amendment) Regulations 1997 (S.I. 1997/1900) and the Genetically Modified Organisms (Contained Use) Regulations 2000 (S.I. 2000/2831)	The whole Regulations other than for the purposes of regulations 9 and 13 of those Regulations
The Genetically Modified Organisms (Deliberate Release) Regulations 1993	S.I. 1993/152	The whole Regulations
The Genetically Modified Organisms (Deliberate Release) Regulations 1995	S.I. 1995/304	The whole Regulations
The Genetically Modified Organisms (Deliberate Release and Risk Assessment-Amendment) Regulations 1997	S.I. 1997/1900	Regulation 2
The Genetically Modified Organisms (Contained Use) Regulations 2000	S.I. 2000/2831	Regulation 31(2)

Explanatory Note

(This note is not part of the Regulations)

These Regulations implement, in respect of Scotland, Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms (“the Directive”) which replaced Council Directive 1990/220/EEC (as amended) of the same title.

The subject matter of the Directive and its predecessor is the control of the deliberate release into the environment and the marketing of genetically modified organisms by means of the imposition of a requirement to obtain consent for those activities and to comply with the conditions imposed on the consent. The changes introduced by the Directive strengthen the existing control regime, particularly in respect of post marketing monitoring.

Directive 1990/220/EEC was implemented partly by the (pre-existing) provisions of Part VI of the Environmental Protection Act 1990 (“the Act”) and partly by the Genetically Modified Organisms (Deliberate Release) Regulations 1992 (as subsequently amended).

These Regulations include amendments to the Act, applicable only to Scotland, required to implement the Directive and revoke, subject to exceptions, the 1992 Regulations.

The statutory basis for the requirement to obtain consent for the release or marketing of genetically modified organisms is section 111(1) of the Act. The cases and circumstances in which consent is required are prescribed in these Regulations. A general requirement to obtain consent for the release or marketing of genetically modified organisms is imposed by regulation 8 (for release) and regulation 14 (for marketing). This general requirement is subject to the exemptions provided for in regulations 9 (for release) and 15 (for marketing).

The definitions used in the provisions relating to the control regime are contained in sections 106, 107 and 127(1) of the Act. Regulations 3 and 4 amend a number of these definitions to reflect provisions of the Directive. Regulation 3 also amends the power in section 106 for the Scottish Ministers to prescribe techniques which result in organisms becoming “genetically modified”. However under regulation 5, until the coming into force of the first regulations made by the Scottish Ministers prescribing such techniques, references in the Act to “genetically modified organisms” will be interpreted by reference to the modification techniques described in that regulation.

Parts II and III of the Regulations impose requirements for applications for consent to release and market, respectively, genetically modified organisms (including transitional provisions).

Part IV lays down the procedure for dealing with applications from their receipt to their determination (and, in the case of consents to release, their subsequent variation or revocation). For release consents this includes provisions for public consultation and for marketing consents (and renewals of such consents) their agreement at European Community level.

Part V includes general requirements for marketing consents and amends section 112 of the Act (which imposes conditions on consents). It also provides for what should happen when new information becomes available which affects the risk assessment for the marketing of a genetically modified organism.

Part VI supplements section 110 of the Act insofar as it allows action to be taken to prohibit the marketing of a genetically modified organism which has consent so as to bring it into line with the taking of “safeguard action” under the Directive.

Part VII prescribes additional categories of information to be made public, notwithstanding that they may be commercially confidential, for the purposes of section 123(7) of the Act.

Part VIII includes the requirement for different categories of information to be included in the public register to be kept by the Scottish Ministers under section 122 of the Act.

Part IX and Schedule 6 principally update the Scotland Act 1998 (Agency Arrangements) (Specification) (No. 2) Order 2002 in consequence of the implementation of the Directive, which permits the Scottish Ministers to enter into agency arrangements with the Secretary of State to allow her to carry out specified functions on behalf of the Scottish Ministers. It also corrects an omission from that Order. Such agency arrangements will not affect the Scottish Ministers’ powers or responsibilities in relation to these functions.

Schedule 7 provides for certain revocations of the Genetically Modified Organisms (Deliberate Release) Regulations 1992 and amending instruments.