20.—(1) The amendment of section 111 of the Act (consents required by certain persons) made by regulation 19(1) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002, which inserts as a second sentence in subsection (6) the following—
“A notice under this subsection must state the reasons for requiring the further information specified in the notice.”,
also has effect in relation to Wales.
(2) An applicant for a consent to release or to market genetically modified organisms who notifies the National Assembly for Wales 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) shall submit in writing to the National Assembly for Wales a revised version of the original application for consent amended to take account of the new information.
21. Following receipt of an application for consent to release genetically modified organisms the National Assembly for Wales 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 to it relating to 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 it;
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; and
(f)take into account any representations relating to risks of damage being caused to the environment by the release made to it before the end of the period specified in accordance with paragraph (b) F2...
Textual Amendments
22.—(1) The National Assembly for Wales shall not grant a 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 M1.
[F3(2) the National Assembly for Wales shall not grant or refuse consent to release genetically modified organisms before the end of the period specified for representations in accordance with regulations 21(b) and (f) above and, if any comments referred to in regulation 21(f) are received within that period, before it has considered those comments.]
(3) The National Assembly for Wales shall communicate its decision on an application for a consent to release genetically modified organisms to the applicant F4... before the end of a period of 90 days beginning with the day on which the application was received and shall include in any refusal of consent the reasons for the decision.
(4) The period prescribed in paragraph (3) shall not include—
(a)any period beginning with the day on which the National Assembly for Wales gives notice in writing under section 111(6) of the Act that further information in respect of the application is required and ending on the day on which that information is received by the National Assembly for Wales, or
(b)a period of time during which the National Assembly for Wales is considering representations submitted by any persons in accordance with regulation 21(b), provided that this consideration shall not prolong the 90 day period referred to in paragraph (3) by more than 30 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 National Assembly for Wales after completion of the release and thereafter, at such intervals as the National Assembly for Wales shall consider appropriate on the basis of the results of the environmental risk assessment.
[F5(6) Information submitted in accordance with paragraph (5) must be provided in the format set out in the Annex to Commission Decision 2003/701/EC.]
Textual Amendments
F3Reg. 22(2) substituted (15.7.2005) by The Genetically Modified Organisms (Deliberate Release) (Wales) (Amendment) Regulations 2005 (S.I. 2005/1913), regs. 1, 2(5)
F4Words in reg. 22(3) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(8)(a); 2020 c. 1, Sch. 5 para. 1(1)
F5Reg. 22(6) substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(8)(b); 2020 c. 1, Sch. 5 para. 1(1)
Marginal Citations
M1 See section 10 of the Health and Safety at Work etc. Act 1974 (c.37).
23. The National Assembly for Wales 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 it which it considers would affect the assessment of the risk of damage being caused to the environment by the release.
24.—(1) Following the receipt of an application for consent to market genetically modified organisms under section 111(1) of the Act the Welsh Ministers must—
(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 pursuant to section 111(6) of the Act;
(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 4 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 4 which indicates that the genetically modified organisms should not be marketed.
(2) The 90 day period prescribed in paragraph (1)(c) does not include any period beginning with the day on which the Welsh 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 Welsh 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 Welsh 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 Welsh 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 registers under regulation 35(7A).]
Textual Amendments
25.—(1) The Welsh Ministers must not grant an application for consent to market genetically modified organisms under section 111(1) of the Act as it relates to the protection of human health without the agreement of the Health and Safety Executive.
(2) Where the Welsh Ministers invite representations on an assessment report relating to an application for consent to market genetically modified organisms—
(a)the Welsh Ministers must not determine whether to grant or refuse the application before the period for making representations under regulation 24(3) has ended and the Welsh Ministers have considered any representations made in accordance with that regulation;
(b)the Welsh Ministers must, within 105 days after the end of the period for making representations under regulation 24(3)—
(i)determine the application, and
(ii)notify the applicant in writing of the decision to grant or refuse the application, and the reasons for the decision.
(3) the period referred to in paragraph (2)(b) does not include any period beginning with the day on which the Welsh 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 Welsh Ministers.
(4) Subject to paragraphs (5) and (6), a consent to market genetically modified organisms may be given for a maximum period of ten years beginning with the day on which the Welsh Ministers grant a consent under section 111 of the Act.
(5) The period of the first consent to market—
(a)a genetically modified organism, or
(b)a progeny of that genetically modified organism contained in a plant variety where the plant variety is intended only for the marketing of its seeds,
must end at the latest ten 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) For the purpose of granting consent to market a genetically modified organism contained in forest reproductive material, the period of the first consent shall end at the latest ten years after the specified date.
(7) In paragraph (6), “the specified date” means 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.]
Textual Amendments
26.—(1) Following receipt of an application for renewal of consent to market genetically modified organisms the National Assembly for Wales 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;
(c)either—
(i)send to the applicant an assessment report prepared in accordance with Schedule 4 which indicates that the genetically modified organisms should continue to be marketed and under which conditions, or
(ii)refuse the application, stating reasons for its decision, supported by an assessment report which indicates that the genetically modified organisms should not continue to be marketed;
F8(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F9(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
27.—[F10(1) The Welsh Ministers must not grant, under section 111(1), of the Act an application for the renewal of a consent to market genetically modified organisms as it relates to the protection of human health without the agreement of the Health and Safety Executive.]
[F11(2) The Welsh 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 to renew a consent the reasons for that decision.]
(3) The renewed consent to market genetically modified organisms may be given for a maximum of 10 years unless the National Assembly for Wales considers that a shorter or longer period is justified, in which case it shall give its reasons in writing.
(4) The applicant may continue to market the genetically modified organisms under the conditions specified in the original consent until a final decision has been taken on the application.
Textual Amendments
28.—(1) The National Assembly for Wales 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 National Assembly for Wales shall evaluate the information in the environmental 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.