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

Duties of the National Assembly for Wales in relation to applications for consent to market genetically modified organisms

24.—(1) Following receipt of an application for 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) ensure that a summary of that application in the format established by the Commission under Article 13(2)(h) of the Deliberate Release Directive is forwarded immediately to the Commission and to the competent authorities of the Member States;

(c) 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;

(d) before the end of a period of 90 days beginning with the day on which it 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 its decision, supported by an assessment report prepared in accordance with Schedule 4 which indicates that the genetically modified organisms should not be marketed;

(e) ensure that a copy of the application is forwarded to the Commission when satisfied it conforms to the requirements prescribed in regulation 15 and no later than when it sends its assessment report in accordance with paragraph (d).

(2) The National Assembly for Wales shall ensure that—

(i) its assessment report,

(ii) any further information it has received from the applicant pursuant to the service of a notice under section 111(6) of the Act,

(iii) any additional information on which it has based its assessment report,

are forwarded to the Commission in the circumstances described in regulation 24(1)(d)(i), before the end of a period of ninety days beginning with the day on which it received the application and, in the circumstances described in regulation 24(1)(d)(ii), no sooner than fifteen days from the date it sent the assessment report to the applicant and no later than one hundred and five days from the date it received the application.

(3) The ninety day periods prescribed in paragraphs (1) and (2) shall not include 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.

(4) Where the National Assembly for Wales intends to submit to the Commission an assessment report which indicates that the genetically modified organisms to which an application relates should be permitted to be marketed, the National Assembly for Wales shall first consult the Health and Safety Executive and shall not forward a favourable opinion on the application as it relates to the protection of human health where the Health and Safety Executive has informed the National Assembly for Wales that it does not fulfil the requirements of the Act and of these Regulations.