Article 6
Directive 70/457/EEC is hereby amended as follows: 1. the following paragraphs shall be added after Article 4(3): '4. In the case of a genetically modified variety within the meaning of Article 2(1) and (2) of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (*), the variety shall be accepted only if all appropriate measures have been taken to avoid adverse effects on human health and the environment. 5. However, where material derived from a plant variety is intended to be used as a food or food ingredient falling within the scope of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (**), these foods or food ingredients must not: - present a danger for the consumer, - mislead the consumer, - differ from foods or food ingredients which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer. 095.1 6. In the interest of conserving plant genetic resources as specified in Article 20(a)(3)(a) and (3)(b), the Member States may depart from the acceptance criteria set out in the first sentence of paragraph 1 in so far as specific conditions are established in accordance with the procedure laid down in Article 23 considering the requirements of Article 20(a)(4)(i), (4)(ii) and (4)(iii). (*) OJ L 117, 8.5.1990, p. 15. Directive as last amended by Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72). (**) OJ L 43, 14.2.1997, p. 1.`; 2. the following subparagraph shall be added to Article 7(2): '(c) the necessary arrangements for the growing trials to be carried out with a view to assessing the value for cultivation or use; these arrangements may determine: - the procedures and conditions under which all or several Member States may agree to include in the growing trials, by way of administrative assistance, varieties for which a request for acceptance has been introduced in another Member State; - the terms of cooperation between the authorities of the participating Member States; - the impact of the results of the growing trials; - the standards relating to information on growing trials for assessment of the value for cultivation or use.`; 3. the following paragraph shall be added after Article 7(3): '4. (a) In the case of a genetically modified variety referred to in Article 4(4), an environmental risk assessment equivalent to that laid down in Directive 90/220/EEC shall be carried out. (b) The procedures ensuring that the environmental risk assessment and other relevant elements shall be equivalent to those laid down in Directive 90/220/EEC shall be introduced on a proposal from the Commission, in a Council Regulation based on the appropriate legal basis in the Treaty. Until this Regulation enters into force genetically modified varieties shall only be accepted for inclusion in a national catalogue after having been accepted for marketing in accordance with Directive 90/220/EEC. (c) Articles 11 to 18 of Directive 90/220/EEC shall no longer apply to genetically modified varieties once the Regulation referred to in subparagraph (b) above has entered into force. (d) The technical and scientific details of the implementation of the environmental risk assessment shall be adopted in accordance with the procedure laid down in Article 23.`; 4. the following paragraph shall be added after Article 7(4): '5. (a) The Member States shall ensure that a variety intended to be used for the purpose laid down in this paragraph is accepted only if: - the food or the food ingredient has already been authorised pursuant to Regulation (EC) No 258/97, or - the authorisation decisions referred to in Regulation (EC) No 258/97 are taken in accordance with the procedure provided for in Article 23 of this Directive. (b) In the case laid down in the second indent of paragraph (a), the criteria set out in Article 4(5) and the assessment principles laid down in Regulation (EC) No 258/97 shall be taken into account. (c) The technical and scientific details of the implementation of the measures laid down in paragraph (b) shall be adopted in accordance with the procedure laid down in Article 23 of this Directive.`; 5. the following paragraph shall be added after Article 9(4): '5. Member States shall ensure that genetically modified varieties which have been accepted are clearly indicated as such in the catalogue of varieties. They shall further ensure that any person marketing such a variety clearly indicates in his sales catalogue that the variety is genetically modified.`; 6. the following paragraph shall be added after Article 12(a)(3): '4. In accordance with the procedure laid down in Article 23 rules may be established for the application of paragraphs 1 and 2.`; 7. Article 12(2) shall be replaced by the following: '2. Acceptance of a variety may be renewed at given intervals if it is still cultivated on such a scale as to justify this, or should be retained in the interest of conserving plant genetic resources, and providing that the requirements as to distinctness, uniformity and stability, or the criteria determined under Article 20(a)3 and 4, are still satisfied. Except in the case of plant genetic resources within the meaning of Article 20(a) applications for renewal shall be submitted not later than two years before expiry of acceptance.`; 8. Article 15(1) shall be replaced by the following: '1. Member States shall ensure that, with effect from the publication referred to in Article 18, seed of varieties accepted in accordance with this Directive or in accordance with principles corresponding to those of this Directive is not subject to any marketing restrictions relating to variety.`; 9. Article 15(2) shall be replaced by the following: '2. A Member State may, upon application which shall be dealt with as provided for in Article 23 or in Article 23a in the case of genetically modified varieties, be authorised to prohibit the use of the variety in all or in part of its territory or to lay down appropriate conditions for cultivating the variety in accordance, in cases provided for in subparagraph (c), with the conditions for using the products resulting from such cultivation: (a) where it is established that the cultivation of the variety could be harmful from the point of view of plant health to the cultivation of other varieties or species, or (b) where official growing trials carried out in the applicant Member States, Article 5(4) being applied correspondingly, show that the variety does not, in any part of its territory, produce results corresponding to those obtained from a comparable variety accepted in the territory of that Member State or, where it is well known that the variety is not suitable for cultivation in any part of its territory because of its type or maturity class. The application shall be lodged before the end of the third calendar year following that of acceptance; (c) where it has valid reasons other than those already mentioned or which may have been mentioned during the procedure referred to in Article 10(2) for considering that the variety presents a risk for human health or the environment.`; 10. Article 15(3) shall be repealed; 11. Article 15(4) shall be repealed; 12. Article 15(5) shall be repealed; 13. Article 15(6) shall be repealed; 14. Article 15(7) shall be repealed; 15. the following subparagraph shall be added after the second subparagraph of Article 18: 'The published notice shall clearly indicate those varieties which have been genetically modified.`; 16. Article 19 shall be replaced by the following: 'Article 19 If it is established that the cultivation of a variety included in the common catalogue of varieties could in any Member State be harmful from the point of view of plant health to the cultivation of other varieties or species, or present a risk for the environment or for human health, that Member State may upon application, be authorised in accordance with the procedure laid down in Article 23 or in Article 23a in the case of a genetically modified variety to prohibit the marketing of the seed or propagating material of that variety in all or part of its territory. Where there is imminent danger of the spread of harmful organisms or imminent danger for human health or for the environment, that prohibition may be imposed by the Member State concerned as soon as its application has been lodged until such time as a final decision has been taken. That decision shall be taken within a period of three months in accordance with the procedure laid down in Article 23 or in Article 23a in the case of a genetically modified variety.`; 17. the following Article shall be added after Article 20: 'Article 20a 1. Specific conditions may be established in accordance with the procedure laid down in Article 23 to take account of developments in relation to the conditions under which chemically treated seed may be marketed. 2. Without prejudice to Council Regulation (EC) No 1467/94 of 20 June 1994 on the conservation, characterisation, collection and utilisation of genetic resources in agriculture (*), specific conditions shall be established in accordance with the procedure laid down in Article 23 to take account of developments in relation to the conservation in situ and the sustainable use of plant genetic resources through growing and marketing of seed of landraces and varieties which are naturally adapted to the local and regional conditions and threatened by genetic erosion. 3. The specific conditions referred to in paragraph 2 above shall include in particular the following points: (i) landraces and varieties shall be accepted in accordance with the provisions of this Directive. The procedure for official acceptance shall take into account specific quality characteristics and requirements. In particular the results of unofficial tests and knowledge gained from practical experience during cultivation, reproduction and use and the detailed descriptions of the varieties and their relevant denominations, as notified to the Member State concerned, shall be taken into account and, if sufficient, shall result in exemption from the requirement of official examination. Upon acceptance of such a landrace or variety, it shall be indicated as a 'conservation variety` in the common catalogue; (ii) appropriate quantitative restrictions. (*) OJ L 159, 28.6.1994, p. 1.`; 18. the following Article shall be added after Article 23: 'Article 23a 1. Where the procedure laid down in this Article is to be followed, matters shall be referred by the Chairman, either on his own initiative or at the request of the representative of a Member State, to the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry (hereinafter called the "Committee"). 2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. If the measures envisaged are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If on the expiry of a period of three months from referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.`; 19. the following Article shall be added after Article 24: 'Article 24a Specific conditions may be established in accordance with the procedure laid down in Article 23 to take account of developments in the area of the conservation of genetic resources.`