S.L. 549.60 · Deliberate Release Into The (S.L. 549.60)
S.L. 549.60 Art. 14Standard procedure.
PART C:
(1) 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, or reasoned objections concerning the placing of the product on the market 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 (60) days beginning on the day on which the documents referred to in regulation 13(3) were 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 grounds of reasoned objections made in accordance with paragraph (b) with a view to reaching an agreement within a period of one hundred and five days, beginning on the day on which the documents referred to in regulation 13(3) were forwarded to each such competent authority by the Commission:
Provided that any periods of time during which further information from the notifier is awaited shall not be taken into account for the purpose of calculating the final forty-five day period for arriving at an agreement.
(2) The competent authority shall grant consent to the notifier, in writing, to place the product on the market where it has concluded a favourable assessment of the proposal, 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 (1)(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 (1)(b) but the matters concerned have been resolved in accordance with the provisions of Article 15(1) 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 (1)(b) and the said Commission has adopted a favourable decision in accordance with the provisions of Article 18(1) of the Directive.
(3) If the competent authority decides that the product may be placed on the market, it shall give consent in writing, transmit it to the notifier and inform other Member States and the Commission thereof within a period of thirty (30) days:
Provided that where a demand, or demands, in accordance with regulation 13(5) are communicated to the Commission after the date of the circulation of the assessment report required under regulation 13(2) the timelines to issue the written consent shall be extended by a single period of fifteen (15) days, regardless of the number of the demands presented. Such further provision shall be without prejudice to Regulation (EC) No 1829/2003 on genetically modified food and feed.
(4) 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, inform the notifier in writing, that consent is refused and stating the reasons for the refusal.
(5) Subject to the provisions of sub-regulation (6), the competent authority shall not grant a consent under Part C for a period which exceeds 10 years beginning on the date on which the consent is issued.
(6) In cases relating to a genetically modified organism or a progeny of that organism intended only for the marketing of its seeds under legislation of the European Union for the time being in force, or to genetically modified forest reproductive material, the period of first consent shall be limited in accordance with the provisions of Article 15(4) of the Directive.
Änderungsgeschichte
- Amended by L.N. 182 of 2019