S.L. 549.60 Art. 12Notification procedure.

(1)(a) Before a GMO or a combination of GMOs as or in products is placed on the market for the first time, a notification shall be submitted to the competent authority.

(b) The competent authority shall acknowledge the date of receipt of the notification.

(c) The competent authority shall without delay examine whether the notification is in accordance with sub-regulation (2) and shall, if necessary, ask the notifier for additional information.

(2) The notification shall contain:

(a) the information required in Schedules III and IV. This information shall take into account the diversity of sites of use of the GMO as or in a product and shall include information on data and results obtained from research and developmental conclusions concerning the impact of the release on human health and the environment;

(b) the environment risk assessment and the conclusions required in Schedule II;

(c) the conclusions arrived at by the notifier in accordance with Schedule II, together with any bibliographic references and details of the methods used;

(d) the conditions for the placing on the market of the product, including specific conditions of use and handling;

(e) with reference to regulation 14(5), a proposed period for the consent which should not exceed ten years;

(f) a plan for monitoring in accordance with Schedule VII, including a proposal for the time-period of the monitoring plan; this time period may be different from the proposed period for the consent;

(g) a proposal for labelling which shall comply with the requirements laid down in Schedule IV and, the labelling shall clearly state that a GMO is present and, the words "this product contains genetically modified organisms" shall appear either on a label or in an accompanying document;

(h) a proposal for packaging which shall comprise the requirements laid down in Schedule IV;

(i) a summary of the notification as may be established by the competent authority from time to time in the format established in accordance with the procedure laid down in Article 30(2) of the Directive; this shall also apply in a case to which Article 16 of the Directive applies;

(j) the notifier shall clearly indicate whether the notification would prejudice any enforcement case, court case or other causes currently sub-judice: Provided that if on the basis of the results of any release notified under Part B, or on other substantive, reasoned scientific grounds, a notifier considers that the placing on the market and use of a GMO as or in a product do not pose a risk to human health and the environment, he may propose to the competent authority not to provide part or all of the information required in Schedule IV, section B.

(3) The notifier shall include in this notification information on data or results from releases of the same GMOs or the same combination of GMOs previously or currently notified or carried out by the notifier either in Malta or abroad.

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

(5) The notifier proposing to place a product containing or consisting of a genetically modified organism on the market for the first time shall publish a notice according to regulation 9 with the wording "PROPOSED PLACING ON THE MARKET OF A PRODUCT CONTAINING/CONSISTING OF A GENETICALLY MODIFIED ORGANISM". In addition to the relevant requirements laid down in regulation 9(2) the notice shall also include -

(a) the full postal address of the Commission,

(b) with respect to a notification submitted in accordance with sub-regulation (1), regulation 9(2)(g) shall not apply and shall be replaced by paragraph (c),

(c) the fact that any person or body may make representations in writing to the said Commission regarding the notification within the period of thirty days beginning on the day that the Commission makes the summary of the notification received by it in accordance with regulation 13(1)(b) available to the public.

(6) In order for a GMO or combination of GMOs to be used for a purpose different from that already specified in a notification, a separate notification shall be submitted.

(7) If new information has become available with regard to the risks of the GMO to human health or the environment, before the written consent is granted, the notifier shall immediately take the measures necessary to protect human health and the environment, and inform the competent authority thereof. In addition, the notifier shall revise the information and conditions specified in the notification and submit an amended notification to the competent authority, and the first notification under sub-regulation (1) shall not be further considered by the competent authority.