Amended proposal for a Council Directive amending Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 69/208/EEC, 70/457/EEC and 70/458/EEC on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, seed of oil and fibre plants and vegetable seed and on the common catalogue of varieties of agricultural plants
•;*!•,I tjf^àijtigi COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 19. 12. 1997 COM(97) 690 final - CNS 808 Amended proposal for a COUNCIL DIRECTIVE amending Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 69/208/EEC, 70/457/EEC and 70/458/EEC on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, seed of oil and fibre plants and vegetable seed and on the common catalogue of varieties of agricultural plants (presented by the Commission pursuant to Article 189 a (2) of the EC Treaty) EXPLANATORY MEMORANDUM At its session of 15 July 1997, the European Parliament delivered its opinion on the Commission proposal contained in Document COM(93)598 final, concerning a proposal for a Council Directive amending Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 69/208/EEC, 70/457/EEC and 70/458/EEC on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, seed of oil and fibre plants and vegetable seed and on the common catalogue of varieties of agricultural plants. The present amended proposal takes into account the amendments suggested by the European Parliament on which the Commission has taken a favourable position, namely amendments 1, 2, 20, 21, 5, 6, 7, 9, 10, 11, 22, 23, 24, 25, 16 and 25. Amendment 8 was withdrawn in discussions before the session on 15 July 1997. Amended proposal for a Council Directive amending Directives 66/400/EEC, 66/401/EEC,' 66/402/EEC, 66/403/EEC, 69/208/EEC, 70/457/EEC and 70/458/EEC on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, seed of oil and fibre plants and vegetable seed and on the common catalogue of varieties of agricultural plants In response to the opinion delivered by the European Parliament at its plenary session of 14 to 18 July 1997 on the proposal for a Council Directive presented en 26 November 1993 amending Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 69/208/EEC, 70/457/EEC and 7C/458/EEC on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, seed of oil and fibre plants and vegetable seed and en the common catalogue of varieties of agricultural plants, and in accordance with Article 189(2) (a) of the EC Treaty the Commission has decided to amend the aforementioned proposal as follows: 1. The third recital is replaced by the following: "Whereas for the same reasons, the scope of the said Directives should be enlarged to cover the production and marketing of seed;". 2. The eighteenth recital is replaced by the ' following : "Whereas it is essential to ensure that genetic resources are conserved; whereas a legal basis to that end should be introduced to permit -within the framework of legislation on the seed trade, the conservation, by use in situ,-of varieties threatened with genetic erosion;". 3. The following recital is added after the last recital: "Whereas a legal basis to establish conditions under which seed suitable for organic growing may be marketed should be introduced;". 4. Article 1(1} is replaced by the following: "1. Article 1 is replaced by the following: "This Directive shall apply to the production with a view to marketing and the marketing of beet seed within the Community. "" 5. The following paragraph is added after Article 1(1): "1(a) The following Article is added after Article 1: "Article la For the purposes of this Directive "marketing* means the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer of seed to third parties, whether or not for consideration, aimed at commercial exploitation. 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 seed propagation or production of an agricultural raw material 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 conditions for the application of this provision shall be determined in accordance with the procedure laid down in Article 21. "" 6. Article 1(6) is replaced by the following: "6. The following article is inserted after Article 4: "Article 4a 1. Notwithstanding the provisions of Article 3(1) Member States may authorise producers on their own territory to place on the market appropriate quantities of seed for testes, scientific purposes or selection work. 2. The conditions under which Member States may grant such authorizations may be determined in accordance with the procedure laid down in Article 21. "" 7. The following paragraph is added after Article 1(12): "12a The following article is added after Article 12: "Article 12a 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. "" 8. Article 1(20) is replaced by the following: "20. Article 17 is replaced by the following: 1. In order to remove any temporary difficulties in the general supply of basic or certified seed that occur in the Community and cannot be otherwise overcome, it may be decided in accordance with the procedure laid down in Article 21 that Member States shall permit, for a specified period, the marketing throughout the Community, of seed of a category subject to less stringent requirements, or of seed of varieties not included in the "Common Catalogue of Varieties of Agricultural Plant Species" or in the national catalogues of varieties of the Member States; the marketing shall be confined to purposes of use of the seed by growers of beet who are affected by those difficulties in all or part of the Community. 2. For a category of seed of any given variety, the official label shall be that provided for the corresponding category; in all other cases it shall be that provided for commercial seed. The label shall always state that the seed in question is of a category satisfying less stringent requirements. The Member States shall ensure that official labels are issued only for the amount of seed permitted for marketing pursuant to paragraph 1. 3. Rules for the application of paragraph 1 may be adopted in accordance with the procedure laid down in Article 21. "" 9. Article 1(21) ia replaced by the following: "21. Article 19(1) is replaced by the following: "1. Member States shall ensure that official inspections are carried out in relation to the marketing of beet seed, at least by random checks, to verify compliance with the requirements of this Directive. "" 10. Article 2(1) is replaced by the following: "1. Article 1 is replaced by the following: "This Directive shall apply to the production with a view to marketing and the marketing of fodder plant seed within the Community. "" 11. The following paragraph is added after Article 2(1): "1(a) The following article is added after Article 1: "Article la For the purposes of this Directive "marketing' means the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer of seed to third parties, whether or not for consideration, aimed at commercial exploitation. 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 seed propagation or production of an agricultural raw material 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 conditions for the application of this provision shall be determined in accordance with the procedure laid down in Article 21. "" 12. Article 2(15) is replaced by the following: "15. The following article is inserted after Article 4: "Article 4a 1. Notwithstanding the provisions of Article 3(1) Member States may authorise producers on their own territory to place on the market appropriate quantities of seed for tests, scientific purposes or selection work. 2. The conditions under which Member States may grant such authorizations may be determined in accordance with the procedure laid down in Article 21. "" 13. The following paragraph is inserted after Article 2(15): "15a. The following article is inserted after Article 5: "Article 5a Member States may restrict the certification of seed of Lupinus spp. , Pisum sativum and Vicia spp. to that of the first generation. "" 14. The following paragraph is inserted after Article 2(19): "19a. The following article is added after Article 11: "Article 11a 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. "" 15. Article 2(20) is replaced by the following: "20. Article 13. (2) is replaced by the following: "Notwithstanding paragraph 1 Member States may authorize their own producers to place on the market fodder plant seed in the form of mixtures intended for the production of fodder plants provided that such mixtures contain seed of plant species listed in Council Directives 66/401/EEC, 66/402/EEC or 69/208/EEC, but excluding those varieties referred to in Article 4(2)(a) of Directive 70/457/EEC and the various components of the mixture complied, before mixing, with the. marketing regulations applicable to them. "" 16. Article 2(27) is replaced by the following: "27. Article 17 is replaced by the following: "1. In order to remove any temporary difficulties in the general supply of basic, certified or commercial seed that occur in the Community and cannot be otherwise overcome, it may be decided in accordance with the procedure laid down in Article 21 that Member States shall permit, for a specified period, the marketing throughout the Community, of seed of a category subject to less stringent requirements, or of seed of varieties not included in the "Common Catalogue of Varieties of Agricultural Plant Species" or in the national catalogues of varieties of the Member States; thé marketing shall be confined to purposes of use of the seed by growers of fodder plants who are affected by those difficulties in all or part of the Community. 2. For a category of seed of any given variety, the official label shall be that provided for the corresponding category; in all other cases it shall be that provided for commercial seed. The label shall always state that the seed in question is of a category satisfying less stringent requirements. The Member States shall ensure that official labels are issued only for the amount of seed permitted for marketing pursuant to paragraph 1. 3. Rules for the application of paragraph 1 may be adopted in accordance with the procedure laid down in Article 21. "" 17. Article 2(28) is replaced by the following: "28. Article 19(1) is replaced by the following: "1. Member States shall ensure that official inspections are carried out in relation to the marketing of fodder plant seed, at least by random checks, to verity compliance with the requirements of this Directive. "" 18. Article 3(1) is replaced by the following: "1. Article 1 is replaced by the following. "This Directive shall apply to the production with a view to marketing and the marketing of cereal seed within the Community. "" 19. The following paragraph is added after Article 3(1): "1(a) The following article is added after Article 1: "Article la For the purposes of this Directive "marketing' means the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer of seed to third parties, whether or not for consideration, aimed at commercial exploitation. 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 seed propagation or production of an agricultural raw material 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 conditions for the application of this provision shall be determined in accordance with the procedure laid down in Article 21. "" 20. Article 3(7) is replaced by the following: "7. The following article is inserted after Article 4: - "Article 4a 1. Notwithstanding the provisions of Article 3(1) Member States may authorize producers on their own territory to place on the market appropriate quantities of seed for tests, scientific purposes or selection work. 2. The conditions under which Member States may grant such authorizations may be determined in accordance with the procedure laid down in Article 21. "" 21. The following paragraph is inserted after Article 3(12): "12a The following article is added after Article 11: "Article 11a 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. "" 10 22. Article 3(21) is replaced by the following: "21. Article 17 is replaced by the following: "1. In order to remove any temporary difficulties in the general supply of basic or certified seed that occur in the Community and cannot be otherwise overcome, it may be decided in accordance with the procedure laid down in Article 21 that Member States shall permit, for a specified period, the marketing throughout the Community, of seed of a category subject to less stringent requirements, or of seed of varieties not included in the "Common Catalogue of Varieties of Agricultural Plant Species" or in the national catalogues of varieties of the Member States; the marketing shall be confined to purposes of use of the seed by growers of cereals who are affected by those difficulties in all or part of the Community. 2. For a category of seed of any given variety, the official label shall be that provided for the corresponding category; in all other cases it shall be that provided for commercial seed. The label shall always state that the seed in question is of a category satisfying less stringent requirements. The Member States shall ensure that official -labels are issued only for the amount of seed permitted for marketing pursuant to paragraph 1. 3. Rules for the application of paragraph 1 may be adopted in accordance with the procedure laid down in Article 21. "" 23. Article 3(22) is replaced by the following: "22. Article 19(1) is replaced by the following: "1. Member States shall ensure that official inspections are carried out in relation to the marketing of cereal seed, at least by random checks, to verify compliance with the requirements of this Directive. "" 11 24. Article 4(1) is replaced by the following: "1. Article 1 is replaced by the following: This Directive shall apply to the production with a view to marketing and the marketing of seed potatoes within the Community. "" 25. The following paragraph is added after Article 4(1): "1(a) The following article is added after Article 1: "Article la For the purposes of this Directive "marketing1 means the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer of seed potatoes to third parties, whether or not for consideration, aimed at commercial exploitation. Trade in seed potatoes not aimed at commercial exploitation of the variety, such as the following operations, shall not be regarded as marketing: the supply of seed potatoes to official testing and inspection bodies; the supply of seed potatoes to providers of services for processing or packaging, provided the provider of services does not acquire title to seed potatoes thus supplied. The supply of seed potatoes under certain conditions to providers of services for seed potato propagation or production of an agricultural raw material shall not be regarded as marketing, provided the provider of services does not acquire title to either the seed potatoes thus supplied or the product of the harvest. The conditions for the application of this provision shall be determined in accordance with the procedure laid down in Article 19. " 12 26. Article 4(4) is replaced by the following: "4. The following article is inserted after Article 4: "Article 4a 1. Notwithstanding the provisions of Article 3(1) Member States may authorise producers on their own territory to place on the market appropriate quantities of seed potatoes for tests, scientific purposes or selection work. 2. The conditions under which Member States may grant such authorizations may be determined in accordance with the procedure laid down in Article 21. "" 27. The following paragraph is inserted after Article 4(9): "9a. The following article is added after Article 11: "Article 11a. In the case of seed potatoes 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. "" 28. Article 4(17) is replaced by the following: "17. Article 16 is replaced by the following: "1. In order to remove any temporary difficulties in the general supply of basic or certified seed potatoes that occur in the Community and cannot be otherwise overcome, it may be decided in accordance with the procedure laid down in Article 19 that Member States shall permit, for a specified period, the marketing throughout the Community, of seed potatoes of a category subject to less stringent requirements, or of seed potatoes of varieties not included in the "Common Catalogue of Varieties of Agricultural Plant Species" or in the national catalogues of varieties of the Member States; the marketing shall be confined to purposes of use of the seed potatoes by growers of potatoes who are affected by those difficulties in all or part of the Community. 13 2. For a category of seed potatoes of any given variety, the official label shall be that provided for the corresponding category; in all other cases it shall be that provided for commercial seed potatoes. The label shall always state that the seed potatoes in question are of a category satisfying less stringent requirements. The Member States shall ensure that official labels are issued only for the amount of seed potatoes permitted for marketing pursuant to paragraph 1. 3. Rules for the application of paragraph 1 may be adopted in accordance with the procedure laid down in Article 19. "" 29. Article 4(18) is replaced by the following: "18. Article 18(1) is replaced by the following: "1. Member States shall ensure that official inspections are carried out in relation to the marketing, of seed potatoes, at least by random checks, to verify compliance with the requirements of this Directive. "" 30. Article 5(1) is replaced by the following: "1. Article 1 is replaced by the following: "This Directive shall apply to the production with a view to marketing and the marketing of seed of oil and fibre plants within the Community and intended for agricultural production but excluding use for ornamental purposes. "" 31. The following paragraph is added after Article 5(1): "1(a) The following article is added after Article 1: "Article la For the purposes of this Directive "marketing' means the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer of seed to third parties, whether or not for consideration, aimed at commercial exploitation. 14 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 seed propagation or production of an agricultural raw material 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 conditions for the application of this provision shall be determined in accordance with the procedure laid down in Article 20. "" 32. Article 5(7) is replaced by the following: "7. The following article is inserted after Article 4: "Article 4a 1. Notwithstanding the provisions of Article 3(1) and (2) Member States may authorise producers on their own territory to place on the market appropriate quantities of seed for tests, scientific purposes or selection work. 2. The conditions under which Member States may grant such authorizations may be determined in accordance with the procedure laid down in Article 20. "" 15 33. The following paragraph is inserted after Article 5(10): "10a The following article is added after Article 11: "Article 11a 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. "" 34. Article 5(16) is replaced by the following: "16. Article 16 is replaced by the following: "1. In order to remove any temporary difficulties in the general supply of basic or certified seed that occur in the Community and cannot be otherwise overcome, it may be decided in accordance with the procedure laid down in Article 20 that Member States shall permit, for a specified period, the marketing throughout the Community, of seed of a category subject to less stringent requirements, or of seed of varieties not included in the "Common Catalogue of Varieties of Agricultural Plant Species" or in the national catalogues of varieties of the Member States; the marketing shall be confined to purposes of use of the seed by growers of oil and fibre plants who are affected by those difficulties in all or part of the Community. 2. For a category of seed of any given variety, the official label shall be that provided for the corresponding category; in all other cases it shall be that provided for commercial seed. The label shall always state that the seed in question is of a category satisfying less stringent requirements. The Member States shall ensure that official labels are issued only for the amount of seed permitted for marketing pursuant to paragraph 1. 16 3. Rules for the application of paragraph 1 may be adopted in accordance with the procedure laid down in Article 20. "" 35. Article 5(17) is replaced by the following: "17. Article 18(1) is replaced by the following: "1. Member States shall ensure that official inspections are carried out in relation to the marketing of seed of oil and fibre plants, at least by random checks, ,to verify compliance with the requirements of this Directive. "" 36. Article 6(1) is replaced by the following: "1. The following paragraphs are added after Article 4(3): "4. In the case of a genetically modified variety within the meaning of Article 2(1) and (2) of Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, the variety shall only be accepted if it is safe for human health and the environment. 5. Furthermore, where material of a variety referred to in paragraph (4) is intended to be used as a food or food ingredient falling within the scope of Council Regulation (EC) No 258/97 concerning novel foods or food ingredients, the Member States shall ensure, before accepting the variety, that the food or food ingredient has been authorized in accordance with Regulation (EC) No 258/97, or that the food or food ingredient complies with the general criteria mentioned in Annex II to Regulation (EC) No 258/97. 6. In the interest of conserving the genetic diversity of traditional rural varieties, the Member States may depart from the acceptance criteria set out in the first sentence of paragraph 1. " 17 37. Article 6(3) is replaced by the following: "3. The following paragraph is 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 similar to that laid down in Directive 90/220/EEC shall be carried out. "(b) The procedures ensuring that the environmental risk assessment is similar to that 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. (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. *" 38. The following paragraph is added after Article 6(4): "4a The following paragraph is 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. " 39. The following paragraph is added after Article 6(12): "12a The following paragraph is added after the second paragraph of Article 18: "The published notice shall clearly indicate those varieties which have been genetically modified. "" 18 40. The following paragraph is added after Article 6(12a): "12b The following article is added after Article 20: "Article 20a 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 seed suitable for organic growing may be marketed. Specific conditions shall be established in accordance with the procedure laid down in Article 23 to take account of developments in relation to: a) the conditions under which chemically treated seed may be marketed; b) the conservation in situ and the sustainable use of plant genetic resources through growing and marketing of landraces and varieties which are naturally adapted to the local and regional conditions and threatened by genetic erosion without prejudice to the provisions of Regulation (EC) No 1467/94. The specific conditions referred to in subparagraph (b) above shall include in particular the following points: a) The 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 conclusive, 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; b) a definition of the areas of maintenance of the landrace or variety and the definition of the areas of marketing of seed; 19 c) the maximum quantity of seed of such varieties which may be marketed in given periods. 41. Article 6(13) is replaced by the following: "13 The following article is added after Article 24: "Article 24a Specific conditions shall be established according to the procedure laid down in Article 23 to take account of developments in the areas of the conservation, by use in situ, of genetic resources. "" 42. Article 7(1) is replaced by the following: "1. Article 1 is replaced by the following: "This Directive shall apply to the production with a view to marketing and the marketing of vegetable seed within the Community. "" 43. The following paragraph is added after Article 7(1): "1(a) The following article is added after Article 1: "Article la For the purposes of this Directive "marketing' means the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer of seed to third parties, whether or not for consideration, aimed at commercial exploitation. 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. 20 The supply of seed under certain conditions to providers of services for seed propagation or production of an agricultural raw material 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 conditions for the application of this provision shall be determined in accordance with the procedure laid down in Article 41. " 44. Article 7(3) is replaced by the following: "3. The following paragraphs are added after Article 4(1): "2. In the case of a genetically modified variety within the meaning of Article 2(1) and (2) of Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, the variety shall only be accepted if it is safe for human health and the environment. 3. Furthermore, where material of a variety referred to in paragraph (2) is intended to be used as a food or food ingredient falling within the scope of Council Regulation (EC) No 258/97 concerning novel foods or food ingredients the Member States shall ensure, before accepting the variety, that the food or food ingredient has been authorized in accordance with Regulation (EC) No 258/97 or that the food or food ingredient complies with the general criteria mentioned in Annex II to Regulation (EC) No 258/97. 4. In the interest of conserving the genetic diversity of traditional rural varieties, Member States may depart from the acceptance criteria set out in paragraph 1. "" 21 45. Article 7(4) is replaced by the following: "4. The following paragraph is 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 similar to that laid down in Directive 90/220/EEC shall be carried out. "(b) The procedures ensuring that the environmental risk assessment is similar to that 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. (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. '" 46. The following paragraph is added after Article 7(5): "5a The following paragraph is 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. "" 47. The following paragraph is added after Article 7(11): "11a The following paragraph is added after the second paragraph of Article 17: "The published notice shall clearly indicate those varieties which have been genetically modified. "" 22 48. Article 7(17) is replaced by the following: "17 The following article is inserted after Article 21: "Article 21a 1. Notwithstanding Article 20(1) and (la), the Member States may a) authorize producers on their own territory to place on the market small quantities of seed for scientific purposes or selection work; b) authorize producers and their representatives established in their territory to market, for a limited period, seeds belonging to a variety for which an application for admission to a national catalogue has been submitted in at least one Member State and for which specific technical information has been supplied. 2. The conditions under which Member States may grant the authorizations referred to in subparagraph 1(b) above shall be determined in accordance with the procedure laid down in Article 40, particularly in relation to the acquisition of data, the type of such data, the maintenance and denomination of the variety and the labelling of packages. "" 49. The following paragraph is inserted after Article 7(20): "20a The following article is 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. "" 23 50. Article 7(25) is replaced by the following: "25. Article 33 is replaced by the following: "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, of seed of a category subject to less stringent requirements, or of seed of varieties not included in the "Common Catalogue of Varieties of Vegetable Species" or in the national catalogues of varieties of the Member States; the marketing shall be confined to purposes of use of the seed by growers of vegetables who are affected by those difficulties in all or part of the Community. 2. For a category of seed of any given variety, the official label shall be that provided for the corresponding category; in all other cases it shall be that provided for commercial seed. The label shall always state that the seed in question is of a category satisfying less stringent requirements. The Member States shall ensure that official labels are issued only for the amount of seed permitted for marketing pursuant to paragraph 1. 3. Rules for the application of paragraph 1 may be adopted in accordance with the procedure laid down in Article 40. "" 51. Article 7(26) is replaced by the following: "26. Article 35(1) is 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 of this Directive. 24 52. The following paragraph is added after-Article 7(27): "27a The following article is added after Article 39: "Article 39a 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 seed suitable for organic growing may be marketed. Specific conditions shall be established in accordance with the procedure laid down in Article 40 to take account of developments in relation to: a) the conditions under which chemically treated seed may be marketed; b) the conservation in situ and the sustainable use of plant genetic resources through growing and marketing of landraces and varieties which are naturally adapted to the local and regional conditions and threatened by genetic erosion without prejudice to the provisions of Regulation (EC) No 1467/94. The specific conditions referred to in subparagraph (b) above shall include in particular the following points: a) The 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 conclusive, 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; 25 b) a definition of the areas of maintenance of the landrace or variety and the definition of the areas of marketing of seed; c) the maximum quantity of seed of such varieties which may be marketed in given periods. "" Done at Brussels, For the Council 26 ISSN 0254-1475 COM(97) 690 final DOCUMENTS EN 02 03 Catalogue number : CB-CO-97-707-EN-C ISBN 92-78-29061-0 Office for Official Publications of the European Communities L-2985 Luxembourg 2-f