Directive 2001/18/EC of the European Parliament and of the CouncilShow full title

Article 6 U.K. Standard authorisation procedure

1. Without prejudice to Article 5, any person must, before undertaking a deliberate release of a GMO or of a combination of GMOs, submit a notification to the competent authority of the Member State within whose territory the release is to take place.

2. The notification referred to in paragraph 1 shall include:

(a) a technical dossier supplying the information specified in Annex III necessary for carrying out the environmental risk assessment of the deliberate release of a GMO or combination of GMOs, in particular:

(i)

general information including information on personnel and training,

(ii)

information relating to the GMO(s),

(iii)

information relating to the conditions of release and the potential receiving environment,

(iv)

information on the interactions between the GMO(s) and the environment,

(v)

a plan for monitoring in accordance with the relevant parts of Annex III in order to identify effects of the GMO(s) on human health or the environment,

(vi)

information on control, remediation methods, waste treatment and emergency response plans,

(vii)

a summary of the dossier;

(b) the environmental risk assessment and the conclusions required in Annex II, section D, together with any bibliographic reference and indications of the methods used.

3. The notifier may refer to data or results from notifications previously submitted by other notifiers, provided that the information, data and results are non confidential or these notifiers have given their agreement in writing, or may submit additional information he considers relevant.

4. The competent authority may accept that releases of the same GMO or of a combination of GMOs on the same site or on different sites for the same purpose and within a defined period may be notified in a single notification.

5. The competent authority shall acknowledge the date of receipt of the notification and, having considered, where appropriate, any observations by other Member States made in accordance with Article 11, shall respond in writing to the notifier within 90 days of receipt of the notification by either:

(a) indicating that it is satisfied that the notification is in compliance with this Directive and that the release may proceed; or

(b) indicating that the release does not fulfil the conditions of this Directive and that notification is therefore rejected.

6. For the purpose of calculating the 90 day period referred to in paragraph 5, no account shall be taken of any periods of time during which the competent authority:

(a) is awaiting further information which it may have requested from the notifier, or

(b) is carrying out a public inquiry or consultation in accordance with Article 9; this public inquiry or consultation shall not prolong the 90 day period referred to in paragraph 5 by more than 30 days.

7. If the competent authority requests new information it must simultaneously give its reasons for so doing.

8. The notifier may proceed with the release only when he has received the written consent of the competent authority, and in conformity with any conditions required in this consent.

9. Member States shall ensure that no material derived from GMOs which are deliberately released in accordance with part B is placed on the market, unless in accordance with part C.