S.L. 549.60 Art. 16Consent.

(1) Only if a written consent has been given for the placing on the market of a GMO as or in a product by a competent authority of a Member State may that product be used without further notification to the competent authority in so far as the specific conditions of use and the environment or geographical areas stipulated in these conditions are strictly adhered to.

(2) (a) The notifier may proceed with the placing on the market only when he has received the written consent of the competent authority in accordance with regulations 14 and 15 and in conformity with any conditions required in that consent.

(b) The competent authority shall take all necessary measures to ensure that any written consent is made accessible to the public and that conditions specified in the written consent are complied with.

(3) The written consent referred to in regulations 14 and 15 shall, in all cases, explicitly specify:

(a) the scope of the consent, including the identity of any GMO to be placed on the market as or in products, and their unique identifier;

(b) the period of validity of the consent;

(c) the conditions for the placing on the market of the product, including any specific condition of use, handling and packaging of any GMO as or in products, and conditions for the protection of particular ecosystems, environments or geographical areas;

(d) that, without prejudice to regulation 20, the notifier shall make control samples available to the competent authority on request;

(e) the labelling requirements, in compliance with the requirements laid down in Schedule IV. The labelling shall clearly state that a GMO is present. The words "This product contains genetically modified organisms" shall appear either on a label or in a document accompanying the product or other products containing any GMO;

(f) monitoring requirements in accordance with Schedule VII, including obligations to report to the Commission, the time period of the monitoring plan and, where appropriate, any obligations on any person selling the product or any user of it, in the inter alia, case of any GMO grown, concerning a level of information deemed appropriate on their location.

(4) (a) Another Member State may request the competent authority to reintegrate all or part of its territory into the geographical scope of a consent from which it was excluded pursuant to sub-regulations 13(5) and 15(5). The competent authority shall then amend the geographical scope of the consent accordingly.

(b) The competent authority may, if necessary, reintegrate all or part of the Maltese Islands into the geographical scope of the consent from which it had been excluded pursuant to sub-regulations 13(5) and 15(5).

(c) Once the adjustment pursuant to paragraph (a) or (b) is completed the competent authority shall duly inform the Commission, the Member States and the consent holder.