S.L. 549.60 Art. 13Assessment report.

(1) On receipt of a notification under regulation 12(2) the competent authority shall:

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

(b) immediately forward a copy of the summary notification received in accordance with regulation 12(2)(i) to the competent authorities of the other Member States for the purposes of the Directive and to the Commission,

(c) examine it for compliance with these regulations and in particular regulation 12,

(d) ask the notifier in writing for any further information which the competent authority considers necessary, stating its reasons for so doing. Any periods of time during which the competent authority is awaiting further information shall not be taken into account when calculating the ninety-day period referred to in sub-regulation (2),

(e) send a copy of the notification to the Commission once it is satisfied that the requirements of regulation 12 have been complied with, and no later than the time at which it sends to the Commission a copy of the assessment report mentioned in accordance with sub-regulation (3) or (4).

(2) Within ninety days of the receipt of a notification under regulation 12, the competent authority shall:

(a) prepare, in accordance with Schedule VI, an assessment report which shall also indicate whether:

(i) the genetically modified organism concerned should be placed on the market and under which conditions (referred to as a "favourable assessment"); or

(ii) the genetically modified organism concerned should not be placed on the market (referred to as an "unfavourable assessment"), and

(b) send a copy of the assessment report to the notifier.

(3) In the case of a favourable assessment, the competent authority shall send a copy of the assessment report to the notifier and to the Commission, any further information obtained from the notifier in accordance with sub-regulation (l)(d), and any other information on which the competent authority has based its report.

(4) In the case of an unfavourable assessment, the competent authority shall, no sooner than fifteen days after it sends a copy of the assessment report to the notifier and no later than one hundred and five days after it received the notification, send to the Commission a copy of the said report, any further information obtained from the notifier in accordance with sub-regulation (l)(d), and any other information on which the competent authority has based its report.

(5) Without prejudice to Regulation (EC) No 1829/2003 on genetically modified food and feed:

(a) during the authorisation procedure the competent authority or other Member States may demand that the geographical scope of the written consent be adjusted to the effect that all or part of the territory of Malta or the concerned Member State, as the case may be, is to be excluded from cultivation. Such a demand shall be made in accordance with Article 26b (1) of the Directive;

(b) within thirty (30) days from the presentation of the demand to the notifier by the Commission, the notifier may adjust or confirm the geographical scope of the initial notification;

(c) in the absence of the confirmation of the initial geographical scope by the notifier, the adjustment of the geographical scope shall be implemented in the written consent issued under these regulations;

(d) where applicable, the written consent issued under these regulations by the competent authority shall then be issued on the basis of the adjusted geographical scope of the notification.