Directive 70/458/EEC is hereby amended as follows:
1. Article 1 shall be replaced by the following:
'Article 1
This Directive shall apply to the production with a view to marketing, and to the marketing, of vegetable seed within the Community.`;
2. the following Article shall be added after Article 1:
'Article 1a
For the purposes of this Directive, "marketing" shall mean the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer aimed at commercial exploitation of seed to third parties, whether or not for consideration.
Trade in seed not aimed at commercial exploitation of the variety, such as the following operations, shall not be regarded as marketing:
- the supply of seed to official testing and inspection bodies,
- the supply of seed to providers of services for processing or packaging, provided the provider of services does not acquire title to seed thus supplied.
The supply of seed under certain conditions to providers of services for the production of certain agricultural raw materials, intended for industrial purposes, or seed propagation for that purpose, shall not be regarded as marketing, provided the provider of services does not acquire title to either the seed thus supplied or the product of the harvest. The supplier of seed shall provide the Certification Authority with a copy of the relevant parts of the contract made with the provider of services and this shall include the standards and conditions currently met by the seed provided.
The conditions for the application of this provision shall be determined in accordance with the procedure laid down in Article 40.`;
3. Article 2(1b) shall be repealed;
4. Article 4 shall be replaced by the following:
'Article 4
1. The Member States shall ensure that a variety is accepted only if it is distinct, stable and sufficiently uniform.
In the case of industrial chicory, the variety must be of satisfactory value for cultivation and use.
2. 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.
3. 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.
4. In the interest of conserving plant genetic resources as specified in Article 39(a)(2)(a) and (2)(b), the Member States may depart from the acceptance criteria set out in paragraph 1 in so far as specific conditions are established in accordance with the procedure laid down in Article 40 considering the requirements of Article 39(a)(3)(i) and 3(ii).
(*) 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.`;
5. in Article 7(1), first subparagraph, the following shall be added to the last sentence: 'in relation to the results of an official examination.`;
6. the following paragraph shall be added after Article 7(3):
'4. (a) In the case of a genetically modified variety as 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 an 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 being 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 40.`;
7. the following paragraphs 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 this paragraph is accepted only if:
- the food or the food ingredient have 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 40 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 40 of this Directive.`;
8. the following paragraph shall be added after Article 10(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.`;
9. Article 13(2) shall be replaced by the following:
'2. Acceptance of a variety may be renewed a 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 39(a)(3) and (4), are still satisfied. Except in the case of plant genetic resources within the meaning of Article 39(a), applications for renewal shall be submitted not later than two years before expiry of acceptance.`;
10. the following paragraph shall be added after Article 15(2):
'3. In the case of varieties the acceptance of which has been renewed pursuant to Article 13(3), Member States may allow the names used before such renewal to be used until 30 June 1994.`;
11. the following paragraph shall be added after Article 13(a)(3):
'4. In accordance with the procedure laid down in Article 40 rules may be established for the application of paragraphs 1, 2 and 3.`;
12. in the second and third subparagraphs of Article 16(1), the words 'after expiry of a period of two months following` shall be replaced by the words 'with effect from`;
13. in Article 17, the words 'after expiry of a period of two months` shall be deleted;
14. Article 16(2) shall be replaced by the following:
'2. A Member State may, upon application which shall be dealt with as provided for in Article 40 or in Article 40(a) 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 paragraph (b), 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 it has valid reasons other than those already mentioned or which may have been mentioned during the procedure referred to in Article 11(2) for considering that the variety presents a risk for human health or the environment.`;
15. Article 16(3) shall be repealed;
16. Article 16(4) shall be repealed;
17. the following paragraph shall be added after the second paragraph of Article 17:
'The published notice shall clearly indicate those varieties which have been genetically modified.`;
18. Article 18 shall be replaced by the following:
'Article 18
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 40 or in Article 40(a) 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 40 or in Article 40(a) in the case of genetically modified variety.`;
19. in Article 20(1), the words 'and unless it satisfies the conditions laid down in Annex II` shall be deleted;
20. in Article 20(1)(a), the words 'and unless it satisfies the conditions laid down in Annex II` shall be deleted;
21. Article 20(4) shall be repealed;
22. the following Article shall be inserted after Article 20:
'Article 20a
Notwithstanding Article 20(1) and (1a), Member States shall provide that:
- bred seed of generations prior to basic seed, and
- seed as grown, marketed for processing, provided that the identity of the seed is ensured,
may be placed on the market.`;
23. the following subparagraph shall be added at the end of Article 21:
'Member States making use of the derogation provided for in either subparagraph (a) or (b) shall assist each other administratively as regards inspection.`;
24. the following Article shall be inserted after Article 21:
'Article 21a
1. Notwithstanding Article 20(1) and (1a), Member States may:
(a) authorise producers on their own territory to place on the market small quantities of seed for scientific or selection purposes;
(b) authorise breeders and their representatives established in their territory to market, for a limited period, seed belonging to a variety for which an application for inclusion in a national catalogue has been submitted in at least one Member State and for which specific technical information has been submitted.
2. The conditions under which Member States may grant the authorisations referred to in paragraph (b) above shall be determined in accordance with the procedure laid down in Article 40, particularly as regards the acquisition of data, the type of data, the storage and name of the variety and the labelling of packages.
3. Authorisations granted before the date of adoption of the present directive by Member States to producers in their own territory for the purposes set out in paragraph 1 shall remain in force pending determination of the provisions referred to in paragraph 2. Thereafter, all such authorisations shall respect the provisions established in accordance with paragraph 2.`;
25. Article 24(3) shall be replaced by the following:
'3. Notwithstanding paragraph 1, Member States may authorise their own producers to place on the market small packages of mixtures of standard seed of different varieties of the same species. The species, where this provision applies, the rules for the maximum size of the small packages and the requirements for labelling shall be established in accordance with the procedure laid down in Article 40.`;
26. the following words shall be added at the end of Article 25(4):
'. . . closed on their own territory. Conditions relating to these exceptions may be determined in accordance with the procedure laid down in Article 40.`;
27. Article 26(1a) shall be replaced by the following:
'1a. Member States may provide for exceptions to paragraph 1 in the case of small packages sealed in their own territory. Conditions relating to these exceptions may be determined in accordance with the procedure laid down in Article 40.`;
28. Article 28(1) shall be replaced by the following:
'1. In accordance with the procedure laid down in Article 40, it may be provided that in cases other than those already provided for in this Directive, packages of basic seed, certified seed of any kind or standard seed shall bear a supplier's label (which may either be a label separate from the official label or take the form of supplier's information printed on the package itself).
The particulars to be provided on any such label shall also be established in accordance with the procedure laid down in Article 40.`;
29. the following Article shall be inserted after Article 28:
'Article 28a
In the case of seed of a variety which has been genetically modified, any label or document, official or otherwise, which is affixed to or accompanies the seed lot, under the provisions of this Directive, shall clearly indicate that the variety has been genetically modified.`;
30. Article 30(1) shall be replaced by the following:
'1. Member States shall ensure that seed which is placed on the market under the provisions of this Directive, whether mandatory or discretionary, is not subject to any marketing restrictions as regards its characteristics, examination requirements, marking and sealing other than those laid down in this or any other Community Directive.`;
31. Article 30(3) shall be repealed;
32. the following Article shall be inserted after Article 30:
'Article 30a
The conditions under which bred seed of generations prior to basic seed may be placed on the market under the first indent of Article 20a, shall be as follows:
(a) it must have been officially inspected by the competent certification authority in accordance with the provisions applicable to the certification of basic seed;
(b) it must be packed in accordance with this Directive; and
(c) the packages must bear an official label giving at least the following particulars:
- certification authority and Member State or their distinguishing abbreviation,
- lot reference number,
- month and year of sealing, or
- month and year of the last official sampling for the purposes of certification,
- species, indicated at least under its botanical name, which may be given in abridged form and without the authors' names, in Roman characters,
- variety, indicated at least in Roman characters,
- the description 'pre-basic seed`,
- number of generations preceding seed of the category 'certified seed`.
The label shall be white with a diagonal violet line.`;
33. Article 31(2) shall be replaced by the following:
'2. Vegetable seed which has been harvested in the Community and which is intended for certification in accordance with paragraph 1 shall:
- be packed and labelled with an official label satisfying the conditions laid down in Annex V(A) and (B), in accordance with Article 25(1), and
- be accompanied by an official document satisfying the conditions laid down in Annex V(C).
The provisions in the first indent on packaging and labelling may be waived if the authorities responsible for field inspections, those drawing up the documents for the certification of seeds which have not been definitively certified and those responsible for certification are the same, or if they agree on exemption.`;
34. Article 33 shall be replaced by the following:
'Article 33
1. In order to remove any temporary difficulties in the general supply of basic certified or standard seed that occur in the Community and cannot be otherwise overcome, it may be decided in accordance with the procedure laid down in Article 40 that Member States shall permit, for a specified period, the marketing throughout the Community in quantities necessary to resolve the supply difficulties of seed of a category subject to less stringent requirements, or of seed of a variety not included in the Common Catalogue of Varieties of Vegetable Species or in the national catalogues of varieties of the Member States.
2. For a category of seed of any given variety, the official label or suppliers' label shall be that provided for the corresponding category; for seed of varieties not included in the abovementioned catalogues the colour of the label shall be brown. The label shall always state that the seed in question is of a category satisfying less stringent requirements.
3. Rules for the application of paragraph 1 may be adopted in accordance with the procedure laid down in Article 40.`;
35. Article 35(1) shall be replaced by the following:
'1. Member States shall ensure that official inspections are carried out in relation to the marketing of vegetable seed, at least by random checks, to verify compliance with the requirements and conditions of this Directive.`;
36. Article 35(2) shall be replaced by the following:
'2. Without prejudice to the free movement of seed within the Community, Member States shall take all necessary measures to ensure that they are supplied with the following particulars during the marketing of quantities exceeding two kilograms of seed imported from third countries:
(a) species;
(b) variety;
(c) category;
(d) country of production and official inspection authority;
(e) country of dispatch;
(f) importer;
(g) quantity of seed.
The manner in which these particulars are to be presented may be determined in accordance with the procedure laid down in Article 40.`;
37. the following Article shall be added after Article 39:
'Article 39a
1. Specific conditions may be established in accordance with the procedure laid down in Article 40 to take account of developments in relation to the conditions under which chemically treated seed may be marketed.
2. Specific conditions shall be established in accordance with the procedure laid down in Article 40 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:
(a) landraces and varieties which have been traditionally grown in particular localities and regions and threatened by genetic erosion without prejudice to the provisions of Regulation (EC) No 1467/94;
(b) varieties with no intrinsic value for commercial crop production but developed for growing under particular conditions.
3. The specific conditions referred to in paragraph 2 shall include in particular the following points:
(i) in the case of (a), the landraces and varieties shall be accepted in accordance with the provisions of this Directive. 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) in the case of (a) and (b) appropriate quantitative restrictions.`;
38. the following Article shall be added after Article 40:
'Article 40a
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.`;
39. the following Article shall be inserted after Article 41:
'Article 41a
1. Specific conditions may be established in accordance with the procedure laid down in Article 40 to take account of developments in the areas of:
(a) conditions under which chemically treated seed may be marketed;
(b) conditions under which seed may be marketed in relation to the conservation in situ and the sustainable use of plant genetic resources, including seed mixtures of species which also include species listed in Article 1 of Council Directive 70/457/EEC, and are associated with specific natural and semi-natural habitats and are threatened by genetic erosion;
(c) conditions under which seed suitable for organic production may be marketed.
2. The specific conditions referred to in paragraph 1 shall include in particular the following points:
(i) in the case of (b), the seed of these species shall be of a known provenance approved by the appropriate Authority in each Member State for marketing the seed in defined areas;
(ii) in the case of (b), appropriate quantitative restrictions.`;
40. Article 42 shall be replaced by the following:
'Article 42
Upon application by a Member State, which will be dealt with as provided for in Article 40, that State may be wholly or partially released from the obligation to apply this Directive, to certain species which are not normally reproduced or marketed in its territory, save where this would run counter to Articles 16(1) and 30(1).`