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PART IVS DUTIES AFTER THE MAKING OF APPLICATIONS

Duty of the applicant after applying for consent to release or to marketS

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) M1 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

Duties of the Scottish Ministers in relation to applications for consent to releaseS

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 M2 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;

F1(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

[F2(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

Marginal Citations

M2As 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 releaseS

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.

[F3(2) The Scottish Ministers shall not grant or refuse consent to release genetically modified organisms before the end of the period specified for representations F4... in accordance with regulation 20(b) F5....]

[F6(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.

[F7(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

Variation or revocation of consents to releaseS

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.

[F8Duties of the Scottish Ministers in relation to applications for consent to marketS

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

[F9Decisions by the Scottish Ministers on applications for consent to marketS

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

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

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; [F10and]

(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 [F11prepared in accordance with schedule 5] which indicates that the genetically modified organisms should not continue to be marketed [F12.]

F13(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F14(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

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

26.—[F15(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.]

[F16(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 [F17in accordance with the limitations and conditions included the existing marketing consent] until a final decision has been taken on the application.

[F18[F19(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, [F20where any such consent includes a limitation or condition referred to in paragraph (5), vary the consent to remove or modify the limitation or condition].

[F21(7) The Scottish Ministers must inform the holder of the renewed consent of any variation under paragraph (6).]]

Textual Amendments

[F22Demand to adjust a food or feed authorisation to prohibit the cultivation of genetically modified organisms in all or part of ScotlandS

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

[F23Request 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 ScotlandS

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

Genetically modified organisms containing antibiotic resistance markersS

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.