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

Article 17 U.K. Renewal of consent

1. By way of derogation from Articles 13, 14 and 15, the procedure set out in paragraphs 2 to 9 shall be applied to the renewal of:

(a) consents granted under part C; and

(b) before 17 October 2006 of consents granted under Directive 90/220/EEC for placing on the market of GMOs as or in products before 17 October 2002,

2. At the latest nine months before the expiry of the consent, for the consents referred to in paragraph 1(a), and before 17 October 2006, for the consents referred to in paragraph 1(b), the notifier under this Article shall submit a notification to the competent authority which received the original notification, which shall contain:

(a) a copy of the consent to the placing on the market of the GMOs;

(b) a report on the results of the monitoring which was carried out according to Article 20. In the case of consents referred to in paragraph 1(b), this report shall be submitted when the monitoring was carried out;

(c) any other new information which has become available with regard to the risks of the product to human health and/or the environment; and

(d) as appropriate, a proposal for amending or complementing the conditions of the original consent, inter alia the conditions concerning future monitoring and the time limitation of the consent.

The competent authority shall acknowledge the date of receipt of the notification and when the notification is in accordance with this paragraph it shall without delay forward a copy of the notification and its assessment report to the Commission, which shall, within 30 days of their receipt, forward them to the competent authorities of the other Member States. It shall also send its assessment report to the notifier.

3. The assessment report shall indicate whether:

(a) the GMO(s) should remain on the market and under which conditions; or

(b) the GMO(s) should not remain on the market.

4. The other competent authorities or the Commission may ask for further information, make comments, or present reasoned objections within a period of 60 days from the date of circulation of the assessment report.

5. All comments, reasoned objections and replies shall be forwarded to the Commission which shall immediately circulate them to all competent authorities.

6. In the case of paragraph 3(a) and in the absence of any reasoned objection from a Member State or the Commission within 60 days from the date of circulation of the assessment report, the competent authority which prepared the report shall transmit to the notifier the final decision in writing and shall inform the other Member States and the Commission thereof within 30 days. The validity of the consent should not, as a general rule, exceed ten years and may be limited or extended as appropriate for specific reasons.

7. The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 75 days from the date of circulation of the assessment report.

8. If outstanding issues are resolved within the 75 day period referred to in paragraph 7, the competent authority which prepared the report shall transmit to the notifier its final decision in writing and shall inform the other Member States and the Commission thereof within 30 days. The validity of the consent may be limited as appropriate.

9. Following a notification for the renewal of a consent in accordance with paragraph 2, the notifier may continue to place the GMOs on the market under the conditions specified in that consent until a final decision has been taken on the notification.