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31978L0692

Council Directive 78/692/EEC of 25 July 1978 amending Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 68/193/EEC, 69/208/EEC and 70/458/EEC on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, material for the vegetative propagation of the vine, seed of oil and fibre plants and vegetable seed

Official Journal L 236 , 26/08/1978 P. 0013 - 0018 Greek special edition: Chapter 03 Volume 22 P. 0166  Spanish special edition: Chapter 03 Volume 14 P. 0267  Portuguese special edition Chapter 03 Volume 14 P. 0267  Finnish special edition: Chapter 3 Volume 10 P. 0105  Swedish special edition: Chapter 3 Volume 10 P. 0105

COUNCIL DIRECTIVE  of 25 July 1978  amending Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 68/193/EEC, 69/208/EEC and 70/458/EEC on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, material for the vegetative propagation of the vine, seed of oil and fibre plants and vegetable seed  (78/692/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas, for the reasons given below, certain Directives on the marketing of seeds and propagating material should be amended;  Whereas the present provisions of the Directives relating to the sealing and marking of seeds and propagating material do not take into account technical progress in the sphere of packaging materials, sealing systems and labelling methods ; whereas they should therefore be brought up to date;  Whereas, in the case of seed potatoes also, samples for the examination of the tubers for certification should be taken officially in accordance with appropriate methods,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Council Directive 66/400/EEC of 14 June 1966 on the marketing of beet seed (3), as last amended by Directive 78/55/EEC (4), shall be amended as follows:    1. Article 10 (1) shall be replaced by the following:  "1. The Member States shall require that packages of basic seed and certified seed, except where seed of the latter category takes the form of small EEC packages, be sealed officially or under official supervision in such a manner that they cannot be opened without damaging the sealing system or leaving evidence of tampering on either the official label provided for in Article 11 (1) or the package.  In order to ensure sealing, the sealing system shall comprise at least either the abovementioned label or the affixing of an official seal.  The measures provided for in the second subparagraph shall not be necessary where a non-reusable sealing system is used.  In accordance with the procedure laid down in Article 21, it may be established whether a particular sealing system fulfils the provisions of this paragraph."       2. In the first sentence of Article 10 (2), the words "or under official supervision" shall be inserted after "officially".       3. Article 10 (3) shall be replaced by the following:  "3. The Member States shall require that small EEC packages be sealed in such a manner that they cannot be opened without damaging the sealing system or leaving evidence of tampering on the label or package. In accordance with the procedure laid down in Article 21, it may be established whether a particular sealing system complies with the provisions of this paragraph. Packages shall not be resealed on one or more occasions except under official supervision."  (1)OJ No C 183, 1.8.1977, p. 64. (2)OJ No C 180, 28.7.1977, p. 29. (3)OJ No 125, 11.7.1966, p. 2290/66. (4)OJ No L 16, 20.1.1978, p. 23.        4. In Article 14 (3) (c), the following particulars shall be added after the indent "lot reference number":  " - month and year of sealing,  or  - month and year of the last official sampling for the purposes of certification."       5. In Annex III (A) (I), the following shall be added:  "3. (a) month and year of sealing expressed thus : "sealed ..." (month and year),  or  month and year of the last official sampling for the purposes of certification expressed thus : "sampled ..." (month and year)."          Article 2 Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (1), as last amended by Directive 78/386/EEC (2), shall be amended as follows:    1. Article 9 (1) shall be replaced by the following:  "1. Member States shall require that packages of basic seed, certified seed and commercial seed, except where seed of the two latter categories takes the form of small EEC B packages, be sealed officially or under official supervision in such a manner that they cannot be opened without damaging the sealing system or leaving evidence of tampering on either the official label provided for in Article 10 (1) or the package.  In order to ensure sealing, the sealing system shall comprise at least either the abovementioned label or the affixing of an official seal.  The measures provided for in the second subparagraph shall not be necessary where a non-reusable sealing system is used.  In accordance with the procedure laid down in Article 21, it may be established whether a particular sealing system complies with the provisions of this paragraph."       2. In the first sentence of Article 9 (2), the words "or under official supervision" shall be inserted after "officially".       3. Article 9 (3) shall be replaced by the following:  "3. The Member States shall require that small EEC B packages be sealed in such a manner that they cannot be opened without damaging the sealing system or leaving evidence of tampering on the label or package. In accordance with the procedure laid down in Article 21, it may be established whether a particular sealing system complies with the provisions of this paragraph. Packages shall not be resealed on one or more occasions except under official supervision."       4. In Article 14 (3) (c), the following particulars shall be added after the indent "lot reference number":  " - month and year of sealing,  or  - month and year of the last official sampling for the purposes of certification."       5. In Annex IV (A) (I), the following shall be added under (a):  "3. (a) month and year of sealing expressed thus : "sealed ..." (month and year),  or  month and year of the last official sampling for the purposes of certification expressed thus : "sampled ..." (month and year)."       6. In Annex IV (A) (I), the following shall be added under (b):  "4a. month and year of sealing expressed thus : "sealed ..." (month and year),  or  month and year of the last official sampling for the purposes of certification expressed thus : "sampled ..." (month and year)."       7. In Annex IV (A) (I), the following shall be added under (c):  "3. (a) month and year of sealing expressed thus : "sealed ..." (month and year),  (1)OJ No 125, 11.7.1966, p. 2298/66. (2)OJ No L 113, 25.5.1978, p. 1.           Article 3 Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (1), as last amended by Directive 78/387/EEC (2), shall be amended as follows:    1. Article 9 (1) shall be replaced by the following:  "1. The Member States shall require that packages of basic seed and certified seed of all categories be sealed officially or under official supervision in such a manner that they cannot be opened without damaging the sealing system or without leaving evidence of tampering on either the official label provided for in Article 10 (1) or the package.  In order to ensure sealing, the sealing system shall comprise at least either the abovementioned label or the affixing of an official seal.  The measures provided for in the second subparagraph above shall not be necessary where a non-reusable sealing system is used.  In accordance with the procedure laid down in Article 21, it may be established whether a particular sealing system complies with the provisions of this paragraph."       2. In the first sentence of Article 9 (2), the words "or under official supervision" shall be inserted after "officially".       3. In Article 14 (3) (c), the following shall be added after the indent "lot reference number":  " - month and year of sealing,  or  - month and year of the last official sampling for the purposes of certification."       4. In Annex IV (A), the following shall be added under (a):  "3a. month and year of sealing expressed thus : "sealed ..." (month and year),  or  month and year of the last official sampling for the purposes of certification expressed thus : "sampled ..." (month and year)."       5. In Annex IV (A), the following is added under (b):  "3a. month and year of sealing expressed thus : "sealed ..." (year and month)."          Article 4 Council Directive 66/403/EEC of 14 June 1966 on the marketing of seed potatoes (3), as last amended by Directive 77/648/EEC (4), shall be amended as follows:    1. The following Article shall be added:  "Article 5  The Member States shall require that, for the examination of seed potato tubers for certification, samples are taken officially in accordance with appropriate methods."       2. Article 9 (1) shall be replaced by the following:  "1. Member States shall require that packages and containers of basic seed potatoes and certified potatoes be sealed officially or under official supervision in such a manner that they cannot be opened without damaging the system of closing or leaving evidence of tampering on either the official label provided for in Article 10 (1) or the package.  In order to ensure closure, the sealing system shall comprise at least either the abovementioned label or the affixing of an official seal.  The measures provided for in the second subparagraph above shall not be necessary where a non-reusable sealing system is used.  In accordance with the procedure laid down in Article 19 it may be established whether a particular sealing system complies with the provisions of this paragraph."       3. In the first sentence of Article 9 (2), the words "or under official supervision" shall be inserted after "officially".       4. Article 10 shall be replaced by the following:  "Article 10  1. Member States shall require that packages and containers of basic seed potatoes and certified seed potatoes:  (1)OJ No 125, 11.7.1966, p. 2309/66. (2)OJ No L 113, 25.4.1978, p. 13. (3)OJ No 125, 11.7.1966, p. 2320/66. (4)OJ No L 261, 14.10.1977, p. 21.         (a) be labelled on the outside with an official label which has not previously been used, which fulfils the conditions laid down in Annex III and the particulars of which are provided in one of the official languages of the Community. The colour of the label shall be white for basic seed potatoes and blue for certified seed potatoes. When a label with a string-hole is used, its attachment shall be ensured in all cases with an official seal. The use of official adhesive labels shall be authorized. In accordance with the procedure laid down in Article 19, the indelible printing of the prescribed particulars on the package in accordance with the label model may be authorized under official supervision;               (b) contain an official document, in the same colour as the label, providing at least the label particulars required under Annex III (A) (3), (4) and (6). This document shall be drawn up in such a manner that it cannot be confused with the official label referred to under (a).  This document shall not be necessary if the particulars are printed indelibly on the, package or if, in accordance with the provisions under (a), an adhesive label or a label of tear resistant material is used.                 2. The Member States may provide for derogations from paragraph 1 in the case of small packages where they are marked : "Passed for marketing in ..." (Member State concerned) only."  5. In Article 13 (1), the words "marked and sealed officially or under official supervision" shall replace "officially marked and sealed".  6. In Article 13 (4) (c), the following shall be added after the indent "lot reference number":  "- month and year of sealing."  7. In Annex III (A), the following shall be added:  "3a. month and year of sealing."  8. In Annex III (A), point 9 shall be deleted.              Article 5 Article 9 of Council Directive 68/193/EEC of 9 April 1968 on the marketing of material for the vegetative propagation of the vine (1), as last amended by Directive 78/55/EEC shall be replaced by the following:  "Article 9  The Member States shall require that packages and bundles of propagation material be sealed in such a manner that they cannot be opened without damaging the sealing system or leaving evidence of tampering on either the label provided for in Article 10 (1) or - in the case of packages - on the package. They shall also bear a lead or equivalent sealing device attached by the person responsible for attaching the labels. In accordance with the procedure laid down in Article 17 it may be established whether a particular sealing system complies with the provisions of this Article. Packages shall not be resealed on one or more occasions except under official supervision."   Article 6 Council Directive 69/208/EEC of 30 June 1969 on the marketing of seed of oil and fibre plants (2), as last amended by Directive 78/388/EEC (3), shall be amended as follows:    1. Article 9 (1) shall be replaced by:  "1. The Member States shall require that packages of basic seed, certified seed of all categories and commercial seed, be sealed officially or under official supervision in such a manner that they cannot be opened without damaging the sealing system or leaving evidence of tampering on either the official label provided for in Article 10 (1) or the package.  In order to ensure sealing, the sealing system shall comprise at least either the abovementioned label or the affixing of an official seal.  The measures provided for in the second subparagraph above shall not be necessary where a non-reusable sealing system is used.  In accordance with the procedure laid down in Article 20, it may be established whether a particular sealing system complies with the provisions of this paragraph."       2. In the first sentence of Article 9 (2), the words "or under official supervision" shall be inserted after "officially".       3. In Article 13 (3) (c), the following shall be added after the indent "lot reference number":  (1)OJ No L 93, 17.4.1968, p. 15. (2)OJ No L 169, 10.7.1969, p. 3. (3)OJ No L 113, 25.4.1978, p. 20.   " - month and year of sampling,  or  - month and year of the last official sampling for the purposes of certification."       4. In Annex IV (A) under (a), the text of item 3 shall be replaced by the following:  " - month and year of sealing expressed thus : "sealed ..." (month and year),  or  - month and year of the last official sampling for the purposes of certification expressed thus : "sampled ..." (month and year)."       5. In Annex IV (A) under (b), the text of item 4 shall be replaced by the following:  "- month and year of sealing expressed thus : "sealed ..." (month and year)."          Article 7 Council Directive 70/458/EEC of 29 September 1970 on the marketing of vegetable seed (1), as last amended by Directive 78/55/EEC, shall be amended as follows:    1. The following shall be substituted for Article 25 (1):  "1. The Member States shall require that packages of basic and certified seed, not made up in the form of EEC small packages, be sealed officially or under official supervision in such a manner that they cannot be opened without damaging the sealing system or leaving evidence of tampering on either the official label provided for in Article 26 (1) or the package.  In order to ensure sealing, the sealing system shall comprise at least either the abovementioned label or the affixing of an official seal.  The measures provided for in the second subparagraph shall not be necessary where a non-reusable sealing system is used.  In accordance with the procedure laid down in Article 40 it may be established whether a particular sealing system complies with the provisions of this paragraph."       2. In the first sentence of Article 25 (2), the words "or under official supervision" shall be inserted after "officially".       3. Article 25 (3) shall be replaced by the following:  "3. The Member States shall require that packages of standard seed and small packages of seeds of the category certified seed be closed in such a manner that they cannot be opened without damaging the system of closing or without leaving evidence of tampering on the label provided for in Article 26 (3) or the package. Except in the case of small packages, they shall also bear a lead or an equivalent sealing device attached by the person responsible for attaching labels. In accordance with the procedure laid down in Article 40, it may be established whether a particular system of closing complies with the provisions of this paragraph. In the case of small packages of the category certified seed, packages shall not be sealed on one or more occasions except under official supervision."       4. The following paragraph shall be added to Article 25:  "4. The Member States may provide for derogations from paragraphs 1 and 2 in the case of small packages of basic seed."       5. In Article 30 (3) (c), the following particulars shall be added after the indent "lot reference number":  " - month and year of sealing,  or  - month and year of the last official sampling for the purposes of certification."       6. Annex IV (A) (a) shall be replaced by the following:  " 1. EEC rules and standards.  2. Certification authority and Member State or their initials.   3. Month and year of sealing expressed thus : "sealed ..." (month and year),  or  month and year of the last official sampling for the purposes of certification expressed thus : "sampled ..." (month and year).  (1)OJ No L 225, 12.10.1970, p. 7.    4. Reference number of lot.   5. Species.   6. Variety.   7. Category.   8. Country of production.   9. Declared net or gross weight or declared number of seeds.   10. Where weight is indicated and granulated pesticides, pelleting substances or other solid additives are used, the nature of the additive and also the approximate ratio between the weight of clusters or pure seeds and total weight.   11. Where at least germination has been retested, the words "retested ..." (month and year) may be indicated."   7. Annex IV (B) (a) shall be replaced by the following:  " 1. EEC rules and standards.  2. Name and address of the person responsible for affixing the labels or his identification mark.   3. Marketing year of the sealing or of the last examination of germination. The end of the marketing year may be indicated.   4. Species.   5. Variety.   6. Category : in the case of small packages, certified seed may be marked with the letter "C" or "Z" and standard seed with the letters "ST".   7. Reference number given by the person responsible for affixing the labels - in the case of standard seed.   8. Reference number enabling the certified lot to be indentified - in the case certified seed.   9. Declared net or gross weight or declared number of seeds, except for small packages of up to 500 grams.   10. Where weight is indicated and granulated pesticides, pelleting substances or other solid additives are used, the nature of the additive and also the approximate ratio between the weight of clusters or pure seeds and the total weight."          Article 8 The Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with:    - Articles 1 to 4, 6 and 7 on or before 1 July 1977,  and       - all the other provisions of this Directive on or before 1 July 1979.          Article 9 This Directive is addressed to the Member States.     Done at Brussels, 25 July 1978.  For the Council  The President  H.J. ROHR


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31985L0328

Council Directive 85/328/EEC of 20 June 1985 amending Directive 77/99/EEC on health problems affecting intra- Community trade in meat products

Official Journal L 168 , 28/06/1985 P. 0050 - 0050 Spanish special edition: Chapter 03 Volume 35 P. 0183  Portuguese special edition Chapter 03 Volume 35 P. 0183

*****COUNCIL  DIRECTIVE  of 20 June 1985  amending Directive 77/99/EEC on health problems affecting intra-Community trade in meat products  (85/328/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas by Directive 77/99/EEC (4), as last amended by Directive 85/327/EEC (5), the Community made arrangements for intra-Community trade in meat products as regards health requirements;  Whereas, pending the introduction of Community arrangements on the import of meat products from third countries, Community preference should be respected;  Whereas adequate Community inspection should be introduced; whereas the Community should bear the expenditure incurred by such inspection; whereas, to this end, Article 17 of Directive 77/99/EEC should be amended,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Article 17 of Directive 77/99/EEC is hereby replaced by the following:  'Article 17  1. Pending the implementation of Community provisions concerning imports of meat products from third countries, Member States shall apply to such imports provisions which shall not be more favourable than those governing intra-Community trade.  To ensure uniform respect of these provisions, inspections shall be carried out on the spot by veterinary experts of the Member States and the Commission.  Member States' experts undertaking these inspections shall be designated by the Commission on a proposal from the Member States.  The inspections shall be carried out on behalf of the Community, which shall bear the expenditure incurred.  However, Member States shall be entitled to continue to make inspections under national arrangements of any third country meat products plants which have not been inspected under the Community procedure.  A list of establishments meeting the conditions referred to in the Annex shall be drawn up under the Article 18 procedure.  2. The health certificate which accompanies the meat product on import, and the form and nature of the health mark which this product shall bear, shall correspond to a model to be determined in accordance with the Article 18 procedure.'  Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1986.  They shall forthwith inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Luxembourg, 20 June 1985.  For the Council  The President  R. ALTISSIMO  (1) OJ No C 179, 7. 7. 1984, p. 6.  (2) Opinion delivered on 14 June 1985 (not yet published in the Official Journal).  (3) OJ No C 87, 9. 4. 1985, p. 6.  (4) OJ No L 26, 31. 1. 1977, p. 55.  (5) See page 49 of this Official Journal.


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31983L0116

Commission Directive 83/116/EEC of 8 March 1983 amending Directive 82/287/EEC amending the Annexes to Council Directives 66/401/EEC and 69/208/EEC on the marketing of fodder plant seed and seed of oil and fibre plants respectively, and Directives 78/386/EEC and 78/388/EEC

Official Journal L 076 , 22/03/1983 P. 0021 - 0021 Finnish special edition: Chapter 3 Volume 16 P. 0054  Spanish special edition: Chapter 03 Volume 27 P. 0101  Swedish special edition: Chapter 3 Volume 16 P. 0054  Portuguese special edition Chapter 03 Volume 27 P. 0101

*****COMMISSION  DIRECTIVE  of 8 March 1983  amending Directive 82/287/EEC amending the Annexes to Council Directives 66/401/EEC and 69/208/EEC on the marketing of fodder plant seed and seed of oil and fibre plants respectively, and Directives 78/386/EEC and 78/388/EEC  (83/116/EEC)  THE COMMISSION OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (1), as last amended by Directive 82/287/EEC (2), and in particular Article 21a thereof,  Whereas, in the light of the development of scientific and technical knowledge, amendments were made to Annexes I and II to Directives 66/401/EEC and 69/208/EEC by Directive 82/287/EEC, including amendments relating to the varietal purity of seeds of Poa spp;  Whereas 1 January 1983 was fixed as the date for implementing the provisions necessary to comply with those amendments;  Whereas the rules adopted to that end in the schemes for the varietal certification of seed intended for international trade laid down by the Organization for Economic Cooperation and Development (OECD) are at present undergoing thorough scrutiny by that organization;  Whereas the outcome of that scrutiny should be awaited;  Whereas a more suitable date should therefore be fixed for implementing the provisions in question, in order to avoid untimely measures;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,  HAS ADOPTED THIS DIRECTIVE;  Article 1  1. In the second indent of Article 7 (1) of Directive 82/287/EEC the words '1 January 1983' are replaced by '1 January 1984 at the latest'.  2. In Article 7 (2) of Directive 82/287/EEC, the words 'the third indent' are replaced by 'the second and third indents'.  Article 2  This Directive is addressed to the Member States.  Done at Brussels, 8 March 1983.  For the Commission  Poul DALSAGER  Member of the Commission  (1) OJ No 125, 11. 7. 1966, p. 2298/66.  (2) OJ No L 131, 13. 5. 1982, p. 24.


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31990L0118

Council Directive 90/118/EEC of 5 March 1990 on the acceptance of pure-bred breeding pigs for breeding

Official Journal L 071 , 17/03/1990 P. 0034 - 0035 Finnish special edition: Chapter 3 Volume 32 P. 0082  Swedish special edition: Chapter 3 Volume 32 P. 0082

*****COUNCIL  DIRECTIVE  of 5 March 1990  on the acceptance of pure-bred breeding pigs for breeding  (90/118/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 88/661/EEC of 19 December 1988 on the zootechnical standards applicable to breeding animals of the porcine species (1) and in particular Article 3 thereof,  Having regard to the proposal from the Commission,  Whereas Directive 88/661/EEC was particularly intended gradually to liberalize intra-Community trade in pure-bred breeding pigs; whereas, for this purpose, additional harmonization with regard to the acceptance of such animals for breeding purposes is necessary;  Whereas the provisions concerning acceptance for breeding relate both to animals as well as their semen, ova and embryos;  Whereas, in this respect, it is necessary to prevent national provisions relating to the acceptance for breeding purposes of pure-bred breeding pigs and their semen, ova and embryos from constituting a prohibition or restriction of intra-Community trade or an obstacle thereto whether in the case of natural service, artifical insemination or the taking of ova or embryos;  Whereas pure-bred female pigs, their ova and embryos should be subject to no prohibition, restriction or obstacle in connection with breeding;  Whereas artificial insemination constitutes an important technique for increasing the use of the best breeders and, hence, for improving the procine species; whereas in so doing, however, any impairment of the pedigree must be avoided, particularly with regard to male breeders, which must possess all guarantees of their genetic value and of their freedom from hereditary defects;  Whereas it is necessary to make a distinction between the acceptance for artificial insemination of pure-bred breeding pigs and their semen which have undergone all the official tests laid down for their breed in a Member State and the acceptance of them solely for the purposes of official testing;  Whereas it is useful to establish a procedure for solving, in particular, disputes that may arise in the assessment of the result of tests;  Whereas the provision that semen, ova and embryos must be manipulated by officially approved staff is capable of providing the guarantees necessary for attaining the desired end;  Whereas in the light of particular conditions currently existing in Spain and Portugal it is necessary to provide for a longer period for the implementation of this Directive in those Member States,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Member States shall ensure that, without prejudice to animal health rules, there is no prohibition or restriction of or obstacle to:  - the acceptance of pure-bred breeding female pigs for breeding,  - the acceptance of pure-bred breeding male pigs for natural service,  - the use of ova and embryos from pure-bred breeding female pigs.  Article 2  1. A Member State may not prohibit, restrict or impede:  - the acceptance for artificial insemination within its territory of pure-bred breeding male pigs or the use of their semen when those animals have been accepted for artificial insemination in a Member State on the basis of tests for monitoring their performance and assessing their genetic value to be carried out in accordance with Commission Decision 89/507/EEC (1),  - the acceptance for official testing of pure-bred breeding male pigs or the use of their semen within the quantitative limits necessary for the tests for monitoring their performance and assessing their genetic value to be carried out in accordance with Decision 89/507/EEC by officially approved associations or organizations.  2. Where implementation of the provisions of paragraph 1 would give rise to disputes, particularly with regard to interpretation of the tests, operators shall have the right to seek the opinion of an expert.  In the light of the expert's opinion, measures may be adopted at the request of a Member State in accordance with the procedure laid down in Article 4.  3. The general rules for implementing paragraph 2 shall, where necessary, be adopted in accordance with the procedure set out in Article 4.  Article 3  Member States shall ensure that, without prejudice to animal health rules, for marketing, the semen, ova and embryos are collected, treated and stored by an officially approved centre or officially approved staff.  Article 4  Where the procedure laid down in this Article is to be followed, the Standing Committee on Zootechnics, set up by Decision 77/505/EEC (2) shall act in accordance with the rules set out in Article 11 of Directive 88/661/EEC (3).  Article 5  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by not later than 1 January 1991. They shall forthwith inform the Commission thereof.  However, the Kingdom of Spain and the Portuguese Republic shall have an additional period of time of two years within which to comply with this Directive.  Article 6  This Directive is addressed to the Member States.  Done at Brussels, 5 March 1990.  For the Council  The President  J. WALSH  (1) OJ No L 382, 31. 12. 1988, p. 36.  (1) OJ No L 247, 23. 8. 1989, p. 43.  (2) OJ No L 206, 12. 8. 1977, p. 11.  (3) OJ No L 382, 31. 12. 1988, p. 36.


title: Commission Directive 2010/17/EU of 9 March 2010 amending Council Directive 91/414/EEC to include malathion as active substance (Text with EEA relevance)

text:
               10.3.2010

               EN

               Official Journal of the European Union

               L 60/17

         COMMISSION DIRECTIVE 2010/17/EU
   of 9 March 2010
   amending Council Directive 91/414/EEC to include malathion as active substance
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 451/2000 (2) and (EC) No 703/2001 (3) lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included malathion. By Commission Decision 2007/389/EC (4) it was decided not to include malathion in Annex I to Directive 91/414/EEC.

               (2)

               Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier submitted a new application requesting the application of the accelerated procedure provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

               (3)

               The application was submitted to the United Kingdom, replacing Finland which had originally been designated rapporteur Member State by Regulation (EC) No 451/2000. The time period for the accelerated procedure was respected. The specification of the active substance is the same as was the subject of Decision 2007/389/EC while the initially supported use on apples has been replaced by strawberry and the application rate has been lowered. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (4)

               The United Kingdom evaluated the new information and data submitted by the notifier and prepared an additional report in February 2009.

               (5)

               The additional report was peer reviewed by the Member States and the EFSA and presented to the Commission on 17 July 2009 in the format of the EFSA Scientific Report for malathion (6). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 22 January 2010 in the format of the Commission review report for malathion.

               (6)

               The new assessment by the rapporteur Member State and the new conclusion by the EFSA concentrated on the concerns that lead to the non-inclusion. Those concerns were in particular the presence in the technical material of varying levels of isomalathion, an impurity that contributes significantly to the toxicity profile of malathion and the genotoxicity of which cannot be excluded. Because of this fact it was impossible to assess the risk to operators, workers and bystanders. Moreover, information on the effects of certain toxicologically relevant metabolites was insufficient, and it had, hence, not been demonstrated that the estimated exposure of consumers resulting from the acute and chronic intake of edible crops is acceptable.

               (7)

               New data and information were submitted by the notifier in the new dossier and a new assessment was performed, as included in the additional report and in the EFSA conclusions. Those new data show that the genotoxicity of malathion containing not more than 2 g/kg isomalathion can be ruled out. It has therefore been possible to determine acceptable levels of exposure of operators, workers and bystanders. Use by non-professionals could, however, raise concerns, as it cannot be assumed that these have recourse to the adequate personal protective equipment. As a consequence, such use should not be authorised.

               (8)

               Without prejudice to those conclusions, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EC provides that the inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that the notifier submit further information as regards consumer intakes, the acute and long-term risk assessment for insectivorous birds, and on the quantification of the different potency of malaoxon and malathion, before authorisations are granted. As regards the consumer exposure, the information currently available allows nonetheless to conclude that the risk is acceptable, given the large margin of safety that exists.

               (9)

               Consequently, the additional data and information provided by the notifier permit to eliminate the specific concerns that led to the non-inclusion. No other open scientific questions have arisen.

               (10)

               It has appeared from the various examinations made that plant protection products containing malathion may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include malathion in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.

               (11)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (12)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 2010 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   This Directive shall enter into force on 1 May 2010.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 9 March 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

      (3)  OJ L 98, 7.4.2001, p. 6.

      (4)  OJ L 146, 8.6.2007, p. 19.

      (5)  OJ L 15, 18.1.2008, p. 5.

      (6)  EFSA Scientific Report (2009) 333 — Conclusion on pesticide peer review — peer review of the pesticide risk assessment of the active substance malathion (re-issued on 17 July 2009).

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

                     No

                     Common Name,
                     Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘Malathion
                     CAS No: 121-75-5
                     CIPAC No: 12

                        diethyl (dimethoxyphosphinothioylthio)succinate

                        or

                        S-1,2-bis(ethoxycarbonyl)ethyl O,O-dimethyl phosphorodithioate

                     racemate

                     ≥ 950 g/kg
                     Impurities:
                     Isomalathion: not more than 2 g/kg

                     1 May 2010

                     PART A
                     Only uses as insecticide may be authorised. Authorisations shall be limited to professional users.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on malathion, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 the operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment;

                                 —

                                 the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones;

                                 —

                                 the protection of insectivorous birds and honey bees: conditions of authorisation shall include risk mitigation measures, where appropriate. As regards bees, the necessary indications shall be provided on the labelling and the accompanying instructions as to avoid exposure.

                           Member States shall ensure that malathion-based formulations are accompanied by the necessary instructions to avoid any risk of formation of isomalathion in excess of the permitted maximum quantities during storage and transport.
                     Where appropriate, conditions of authorisation shall include further risk mitigation measures.
                     The Member States concerned shall ensure that the notifier presents to the Commission:

                                 —

                                 information confirming the consumer risk assessment and the acute and long-term risk assessment for insectivorous birds;

                                 —

                                 information on the quantification of the different potency of malaoxon and malathion.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


Avis juridique important

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31993L0113

Council Directive 93/113/EC of 14 December 1993 concerning the use and marketing of enzymes, micro- organisms and their preparations in animal nutrition

Official Journal L 334 , 31/12/1993 P. 0017 - 0023 Finnish special edition: Chapter 3 Volume 54 P. 0195  Swedish special edition: Chapter 3 Volume 54 P. 0195

COUNCIL DIRECTIVE 93/113/EC of 14 December 1993 concerning the use and marketing of enzymes, micro-organisms and their preparations in animal nutritionTHE COUNCIL OF THE EUROPEAN UNION,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,  Having regard to the proposal from the Commission(1) ,  Having regard to the opinion of the European Parliament(2) ,  Having regard of the opinion of the Economic and Social Committee(3) ,  Whereas Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(4) , lays down the principles relating to the admission and the use of additives;  Whereas Council Directive 87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in feedingstuffs(5)  constitutes a guide for defining the scientific information necessary to identify and characterize these products as well as  the studies necessary to evaluate, in particular, their efficacy and innocuousness for humans, animals and the environment;  Whereas advances in scientific and technological knowledge permit the use of certain enzymes, micro-organisms and their preparations in animal nutrition in order in particular to improve the digestibility of such nutrients, or to stabilize the flora of  the digestive system of animals and to reduce the ejection of certain undesirable substances into the environment; whereas at the moment no criteria exist for the examination of requests for authorization for use as additives of this new generation of  products;  Whereas it is essential, pending amendment of the guidelines and in order to allow the preparation of dossiers for these products, to allow provisionally the use and marketing of enzymes, micro-organisms and their preparations at national level,  provided they do not present any danger to human or animal health;  Whereas allowing these products necessitates an inventory of them in each Member State, and the transmission to the Commission of certain information justifying their inclusion in national lists;  Whereas Member States may not restrict the marketing of livestock products obtained from feeds containing enzymes, micro-organisms or their preparations when these are included on a national list established according to this Decision;  Whereas this Directive does not apply to enzymes, micro-organisms, or to their preparations when used as silage agents;  Whereas this Directive applies without prejudice to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(6) ;  Whereas this Directive is to apply without prejudice to Directive 70/524/EEC;  Whereas Directive 87/153/EEC should quickly be amended accordingly, with a view to making available the necessary rules for the specific examination of additives belonging to the new group of enzymes and micro-organisms; whereas, in the meantime, the  dossiers to be submitted with a view to assessing products included in the national lists must be prepared according to the guidelines established for additives in general;  Whereas it is advisable that industry be given sufficient time to apply the new labelling provisions laid down for enzymes, micro-organisms and their preparations as well as premixtures and feedingstuffs containing them,  HAS ADOPTED THIS DIRECTIVE:   Article 1  1.  This Directive shall apply to the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition.  2.  This Directive shall apply without prejudice to Directive 70/524/EEC and particularly to the provisions concerning the authorization of enzymes, micro-organisms and their preparations for use as additives.   Article 2  1.  By way of derogation from Article 3 of Directive 70/524/EEC, Member States shall temporarily allow the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition within their territory, provided that, on the  basis of the information available, the products do not present a danger to human or animal health, and that they are included in the list established by virtue of Article 3.  2.  All forms of use for animal nutrition other than the incorporation of such products into feedingstuffs shall be prohibited.   Article 3  On the basis of the information provided by the persons responsible for putting the products into circulation Member States shall forward:  (a) to the Commission before 1 November 1994:  - a list of enzymes and micro-organisms and their preparations according to the model given in Annex I,  - an identification note drawn up for each product according the the model given in Annex II by the person responsible for putting the product into circulation;  (b) to the Commission and to the other Member States before 1 January 1996, the dossiers to justify these authorizations by the person(s) responsible requesting the inclusion of their product(s) in the list referred to in the first indent of point (a).    Article 4  1.  As and when the requested information reaches it, the Commission shall communicate to Member States the lists of enzymes, micro-organisms or their preparations sent to it in accordance with Article 3.  2.  Where enzymes, micro-organisms or preparations manufactured from them are included in several national lists, it may be agreed between the Member States concerned that a single dossier should be submitted by one of them. In this case the Member  State appointed to submit the dossier shall inform the Commission accordingly.  3.  Before 31 March 1996 and on the basis of the dossiers which have been forwarded to it in accordance with Article 3, the Commission shall publish in the 'C' series of the Official Journal of the European Communities a list of enzymes, micro-organisms  and their preparations permitted in the various Member States.   Article 5  Before 1 January 1997, a ruling will be given in accordance with the procedure laid down in Article 24 of Directive 70/524/EEC on the dossiers referred to in Article 3 (b) concerning the authorization of additives in animal nutrition.   Article 6  Where Member States find it impossible to satisfy one of the conditions referred to in Article 3, for an enzyme, micro-organisms or preparation used in their territory, they shall take all the necessary measures to ensure that the enzyme,  micro-organism or preparation obtained from them is no longer used or marketed in their territories.   Article 7  1.  Enzymes, micro-organisms and their preparations, as well as premixtures and compound feedingstuffs in which they have been incorporated, may be marketed only if the particulars listed below, which must be clearly visible, legible and  indelible and for which the producer, packer, importer, vendor or distributor established within the Community shall be held responsible, are shown on the packaging, the container or on a label attached thereto:  A. for enzymes and their preparations:  (a) the specific name of the active constituent(s) according to their enzymatic activity(ies) and the identification number(s) according to the International Union of Biochemistry;  (b) the activity units (activity units(7)  per g or activity units per ml);  (c) the name or business name and the address or registered place of business of the person responsible for the particulars in this paragraph;  (d) the name or business name and address or registered place of business of the manufacturer if he is not responsible for the particulars on the label;  (e) the expiry date of the guarantee or the storage life from the date of manufacture;  (f) the batch reference number and the date of manufacture;  (g) directions for use and where appropriate, a safety recommendation;  (h) the net weight and for liquid additives either the net volume or the net weight;  (i) the indication 'to be used exclusively for the manufacture of feedingstuffs';  mB. for micro-organisms and their preparations:  (a) the identifications of the strain(s) according to a recognized international code of nomenclature and the deposit number of the strain(s);  (b) the number of colony-forming units (CFU/g);  (c) the name or business name and address or registered place of business of the person responsible for the particulars referred to in this paragraph;  (d) the name or business name and address or registered place of busniess of the manufacturer if he is not responsible for the particulars on the label;  (e) the expiry date of the guarantee or the storage life from the date of manufacture;  (f) the batch reference number and the date of manufacture;  (g) the directions for use and, where appropriate, a safety recommendation;  (h) the net weight and for liquid additives either the net volume or the net weight;  (i) the indication 'to be used exclusively in the manufacture of feedingstuffs';  (j) where appropriate, indication of any particular significant characteristics due to the manufacturing process;  C. for premixtures containing enzymes:  (a) the description 'premixture';  (b) the indication 'to be used exclusively in the manufacture of feedingstuffs';  (c) the directions for use and any safety recommendations regarding the use of premixtures;  (d) the animal species or category of animals for which the premixture is intended;  (e) the name or business name and the address or registered place of business of the person responsible for the particulars referred to in this paragraph;  (f) the net weight and for liquids either the net volume or the net weight;  (g) the specific name of the active constituent(s) according to their enzymatic activity(ies) and the identification number(s) according to the International Union of Biochemistry;  (h) the activity units (activity units per g or activity units per ml);  (i) the expiry date of the guarantee or the storage life from the date of manufacture;  (j) the name or business name and address or registered place of business of the manufacturer if he is not responsible for the particulars on the label;  D. for premixtures containing micro-organisms:  (a) the description 'premixture';  (b) the indication 'to be used exclusively in the manufacture of feedingstuffs';  (c) the directions for use and any safety recommendations regarding the use of premixtures;  (d) the animal species or category of animals for which the premixture is intended;  (e) the name or business name and the address or registered place of business of the person responsible for the particulars referred to in this paragraph;  (f) the net weight and for liquids either the volume or net weight;  (g) the identification of the strain(s) according to a recognized international code of nomenclature and the deposit number(s) of the strain(s);  (h) the number of colony-forming units (CFU/g);  (i) the expiry date of the guarantee or the storage life from the date of manufacture;  (j) the name or business name and address or registered place of business of the manufacturer if he is not responsible for the particulars on the label;  (k) where appropriate, indication of any particular significant characteristics due to the manufacturing process;  E. for compound feeds into which enzymes have been incorporated:  (a) the specific name of the active constituent(s) according to their enzymatic activity(ies) and the identification number according to the International Union of Biochemistry;  (b) the activity units (activity units per kg or activity units per l) provided that such units are measurable by an official or scientifically valid method);  (c) the expiry date of the guarantee or the storage life from the date of manufacture.  F. For compound feeds into which micro-organisms have been incorporated:  (a) the identification of the strain(s) according to a recognized international code of nomenclature and the deposit number(s) of the strain(s);  (b) the number of colony-forming units (CFU/kg) provided that the number is measurable by an official or scientifically valid method;  (c) the expiry date of the guarantee or the storage life from the date of manufacture;  (d) where appropriate, indication of any particular significant characteristics due to the manufacturing process.  2.  Particulars other than those prescribed in paragraph 1, under A, B, C and D such as the trade name, may be included on the packaging, containers or on a label attached thereto, provided that they are clearly separated from the said particulars.   Article 8  1.  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than:  - 1 January 1995 as regards Article 7, and - 1 October 1994 as regards the other provisions.  They shall forthwith inform the Commission thereof.  When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such reference shall be laid down by Member States.  2.  Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof.   Article 9  This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.   Article 10  This Directive is addressed to the Member States.  Done at Brussels, 14 December 1993.  For the Council The President A. BOURGEOIS  (1) OJ No C 116, 27. 4. 1993, p. 6.  (2) OJ No C 329, 6. 12. 1993.  (3) OJ No C 201, 26. 7. 1993, p. 34.  (4) OJ No L 270, 14. 12. 1970, p. 1. Directive as last amended by Directive 93/114/EC (see page 24 of this Official Journal).  (5) OJ No L 64, 7. 3. 1987, p. 19.  (6) OJ No L 117, 8. 5. 1990, p. 15.  (7) Units of activity expressed as mole of product released per minute per gram of enzymatic preparation.     ANNEX I   Model layout for the list mentioned in Article 3 (a) first indent  >(1) "> ID="1"" ID="2"" ID="3"" ID="4"""" (1) For micro-organisms: the identification of the strain according to a recognized international code of nomenclature and the deposit number of the strain.  For enzymes: the specific name according to their enzymatic activity, the identification number according to the International Union of Biochemistry and, where they are of microbial origin, the identification of the strain according to a recognized  international code of nomenclature and the deposit number of the strain.     ANNEX II  MODEL OF IDENTIFICATION NOTE REFERRED TO ARTICLE 3 (a) SECOND INDENT  (to be filled in by the person responsible for putting the product into circulation) 1. Identity of the product Trade name.  Qualitative and quantitative composition:  - active substance(1) ,  - other components,  - impurities,  - undesirable substances.  Name or business name and address or registered place of business of the manufacturer.  Place of manufacture Name or business name and address or registered place of business of the person responsible for placing the product on the market, if he is not the manufacturer.  2. Specifications concerning the active substance 2.1. For micro-organisms:  - name and taxonomic description according to an international code of nomenclature(2) ,  - name and place of culture collection where the strain is registered and deposited and the number of registration and deposit,  - state whether genetic manipulation has taken place,  - the number of colony-forming units (CFU/g).  2.2. For enzymes:  - name according to main enzymatic activities and Community number(3) ,  - state the biological origin. In the case of microbial origin, the information required in the first two indents of point 2.1, must be given,  - state whether the organism of origin has been genetically manipulated,  - relevant activities with regard to appropriate types of chemically pure substrates (expressed in activity units(4)  per g).  NB: If the active substance is a mixture of active components, all the components must be described separately with an indication of their proportion in the mixture.  3. Properties of the product Main effect:  - information concerning effectiveness,  - justification for the presence of each component if the substance is a mixture of active components.  Other effects.  m4. Product safety Available information on safety.  5. Conditions for the use of product Uses provided for in animal nutrition (species or categories of animal, type of feedingstuffs, period of use, etc).  Proposed dosage in premixes and feedingstuffs (appropriate units of biological activity such as CFU per gram of product for micro-organisms or activity units per gram for enzyme preparations).  Other known uses of the active substance or the preparation (in foodstuffs, human or veterinary medicine, industry etc).  Recommendations concerning product safety in relation to targeted species, the consumer and the environment.  If necessary, measures for the prevention of risks and means of protection during manufacture and use.  6. Technological information Stability of the product:  - with regard to atmospheric agents,  - during the preparation of premixes and feedingstuffs,  - during the storage of premixes and feedingstuffs,  - description of the process of manufacture and methods used concerning the control of the quality of the product during its manufacture.  7. Control Method(s) of analysis for determining the active component(s) in:  - the product itself,  - premixes,  - feedingstuffs.  8. Attestation of the person responsible certifying the accuracy of the information given.   (1) If the active substance is a mixture of clearly definable active components, indicate the main components.  (2) Such as 'Bergey's Manual of Systematic Bacteriology', 'The Yeasts, a taxonomic study' by Lodder and Kreger van Rij, 'Ainsworth and Bisby's Dictionary of the Fungi' by Hawksworth, Sutton and Ainsworth or 'The Genus Asperigillus' by Raper and Fennel.   (3) Enzyme Nomenclature Recommendations (1984) of the Nomenclature Committee of the International Union of Biochemistry, Academic Press 1984.  (4) Activity units expressed as mole of product released per minute per gram of enzymatic preparation.