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1. In the case of a genetically modified variety within the meaning of points 1 and 2 of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (1) , the variety shall be accepted only if all appropriate measures have been taken to avoid adverse effects on human health and the environment.
2. With regard to genetically modified varieties within the meaning of paragraph 1:
(a) a specific environmental risk assessment equivalent to the assessment provided for in Directive 2001/18/EC and in accordance with the principles set out in Annex II and on the basis of the information specified in Annex III of that Directive shall be carried out;
(b) the procedures intended to ensure the equivalence of the specific risk assessment and other relevant requirements, in particular those regarding risk management, labelling, and any monitoring required, public information and a safeguard clause with those established by Directive 2001/18/EC shall be introduced, on a proposal from the Commission, by a Regulation of the European Parliament and of the Council. Pending the entry into force of that Regulation, genetically modified varieties shall be accepted for inclusion in a national catalogue only when they have been accepted for marketing in accordance with Directive 2001/18/EC;
(c) Articles 13 to 24 of Directive 2001/18/EC shall no longer apply to genetically modified varieties of vine authorised in conformity with the Regulation referred to in point (b).
[F33. (a) Where products derived from vine-propagating material are intended to be used as or in food falling within the scope of Article 3 or as or in a feed falling within the scope of Article 15 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (2) , the vine variety concerned shall be accepted only if it has been authorised pursuant to the said Regulation.
(b) Member States shall ensure that a vine variety, from the propagating material of which products were derived intended for use in food and feed pursuant to Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety (3) shall be accepted only if it has been authorised pursuant to the relevant legislation.] ] ]
Textual Amendments
F1 Inserted by Council Directive of 22 March 1971 amending the Directive of 9 April 1968 on the marketing of material for the vegetative propagation of the vine (71/140/EEC).
[F1 [F2 OJ L 106, 17.4.2001, p. 1 .] ]
[F1 [F2 [F3 OJ L 268, 18.10.2003, p. 1 .] ] ]
[F1 [F2 [F3 OJ L 31, 1.2.2002, p. 1 .] ] ]
Textual Amendments
F1 Inserted by Council Directive of 22 March 1971 amending the Directive of 9 April 1968 on the marketing of material for the vegetative propagation of the vine (71/140/EEC).
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