S.L. 549.60 Art. 17Monitoring and handling of new information.

(1) Following the placing on the market of a GMO as or in a product, the notifier shall ensure that monitoring and reporting on it are carried out according to the conditions specified in the consent. On the basis of these reports, in accordance with the consent and within the framework for the monitoring plan specified in the consent, the competent authority may adapt the monitoring plan after the first or subsequent monitoring period.

(2) If new information has become available, from the users or other sources, with regard to the risks of any GMO to human health or the environment after the written consent has been given, the notifier shall:

(a) revise the notification, as required; and

(b) immediately take the measures necessary to protect human health and the environment, and inform the competent authority thereof.

(3) If information becomes available to the competent authority which could have consequences for the risks of any GMO to human health or the environment, or under the circumstances described in sub-regulation (2), it may avail itself of the provisions in regulation 14 and 15where appropriate, when the information has become available before the written consent.

(4) If, after granting consent under regulation 14 or renewing a consent under regulation 15, the competent authority is informed or becomes aware, of information which could have consequences for the risks of any GMO to human health or the environment, or under the circumstances described in sub-regulation (2), it shall:

(a) immediately forward the information to the Commission and to the competent authorities of the Member States for the purposes of the Directive,

(b) prepare an assessment report in accordance with Schedule VI which shall indicate:

(i) whether the genetically modified organism concerned should remain on the market and under which conditions (referred to as "favourable assessment");

(ii) or the genetically modified organism concerned should not remain on the market (referred to as "unfavourable assessment"),

(c) within sixty days of the receipt of the information, forward a copy of the assessment report to the Commission, and

(d) send a copy of the assessment report to the notifier. If the competent authority deems through the assessment report, that the new information provides considerable changes to the notification, the competent authority may ask the notifier to cease marketing under this regulation and submit an amended notification:

Provided that in case of impacts to human health and the environment, the notifier may be asked to defray or contribute towards any or all of the costs incurred by it in order to protect human health and the environment.

(5) In the case of a favourable assessment, the competent authority shall:

(a) provide any further information to the Commission where such information is requested by the said Commission or by a competent authority of a Member State for the purposes of the Directive;

(b) consider any comments, concerns or reasoned objections to the assessment report referred to in sub-regulation (4)(b) made by the Commission or by a competent authority of another Member State for the purposes of the Directive where such comments or objections are made within a period of sixty days beginning on the day on which a copy of the said assessment report was forwarded to each such competent authority by the Commission, and

(c) participate in any discussions in relation to the assessment report initiated by the Commission on the grounds of reasoned objections made in accordance with paragraph (b) with a view to reaching an agreement within a period of seventy-five days, beginning on the day on which the documents referred to in sub-regulation (4)(b) were forwarded to each such competent authority by the Commission.

(6) The competent authority shall consent to the continued marketing of a product where it has concluded a favourable assessment of the information, and -

(a) no reasoned objection to the favourable assessment has been made by the Commission or by a competent authority of a Member State in accordance with sub-regulation (5)(b), or

(b) a reasoned objection to the favourable assessment has been made by the Commission or by a competent authority of a Member State in accordance with sub-regulation (5)(b) but the matters concerned have been resolved in accordance with the provisions of Article 20(3) of the Directive, or

(c) a reasoned objection to the favourable assessment has been made by the Commission or by a competent authority of a Member State in accordance with sub-regulation (5)(b) and the said Commission has adopted a favourable decision in accordance with the provisions of Article 18(1) of the Directive.

(7) The competent authority shall, within a period of thirty days beginning on the day that consent to the continued marketing is granted, inform the competent authority of each Member State and the Commission that it has done so.

(8) The competent authority shall, where it has concluded an unfavourable assessment, or where the Commission has adopted an unfavourable decision in accordance with the provisions of Article 18(1) of the Directive, direct the notifier to cease marketing the product and stating the reasons for the direction.

(9) The notifier shall comply with any direction given by the competent authority under sub-regulation (8).

(10) A consent to continue, or a direction to cease, marketing under this regulation shall be conveyed by the competent authority to the notifier in writing.

(11) The competent authority shall make the results of the monitoring carried out under Part C publicly available.