S.L. 549.60 Art. 6Standard authorisation procedure.

(1) Without prejudice to regulation 5, any person shall, before undertaking a deliberate release of a GMO or of a combination of GMOs, submit a notification to the competent authority.

(2) The notification referred to in sub-regulation (1) shall include:

(a) a technical dossier supplying the information specified in Schedule III necessary for carrying out the environment 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 any GMO,

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

(iv) information on the interactions between any GMO and the environment,

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

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

(vii) a summary of the dossier in the format established in accordance with the procedure laid down in Article 30(2) of the Directive;

(b) the environment risk assessment and the conclusions required in Schedule II, section D, together with any bibliographic reference and indications of the methods used;

(c) the notification shall be accompanied by the relevant documents and any other requisite information as specified and required by the competent authority. The notifier shall clearly indicate whether the notification would prejudice any enforcement case, court case or other causes currently sub-judice.

(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) On receipt of the notification under sub-regulation (1) the competent authority shall:

(a) acknowledge to the notifier the date of such receipt in writing;

(b) forward to the Commission, within 30 days of receipt of the notification, a copy of the summary of the notification received in accordance with sub-regulation (2)(a)(vii);

(c) examine it for compliance with these regulations;

(d) consider any observations received from a competent authority of another Member State in accordance with Article 11(2) of the Directive;

(e) if requested by a competent authority of another Member State for the purposes of the Directive, forward a copy of the full notification to the said authority;

(f) evaluate the risks posed by the proposed deliberate release for human health and the environment; and

(g) record its conclusions in writing.

(6) The competent authority shall respond in writing to the notifier within ninety days of receipt of the notification by indicating that consent to the deliberate release is either -

(a) granted, with or without, conditions, or

(b) refused and the reasons for the refusal.

(7) For the purpose of calculating the ninety day period referred to in sub-regulation (6), 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 regulation 9; this public inquiry or consultation shall not prolong the ninety day period referred to in sub-regulation (6) by more than thirty days.

(8) If the competent authority requests new information it shall simultaneously give its reasons for so doing.

(9) 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.

(10) No material derived from GMOs which are deliberately released in accordance with Part B shall be placed on the market, unless in accordance with Part C.