Avis juridique important

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31996L0022

Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC

Official Journal L 125 , 23/05/1996 P. 0003 - 0009

COUNCIL DIRECTIVE 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EECTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European 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 to the opinion of the Economic and Social Committee (3),(1) Whereas Directive 81/602/EEC (4) prohibits certain substances having a hormonal action and any substances having a thyrostatic action and whereas Directive 88/146/EEC (5) prohibits the use in stockfarming of certain substances having a hormonal action, whilst conceding derogations;(2) Whereas Council Directive 88/299/EEC (6) lays down the conditions for applying the derogations provided for in Article 7 of Directive 88/146/EEC from the prohibition on trade in certain categories of animals and their meat;(3) Whereas, on account of the residues they leave in meat and other foodstuffs of animal origin, certain substances having a thyrostatic, oestrogenic, androgenic or gestagenic action may be dangerous for consumers and may also affect the quality of foodstuffs of animal origin;(4) Whereas new substances having an anabolizing action such as beta-agonists are used illegally in livestock-rearing with a view to stimulating the growth and yield of animals;(5) Whereas the results of an enquiry conducted by the Commission in the Member States from 1990 to 1992 show that beta-agonists are widely available in the livestock-rearing sector, leading to their illegal use;(6) Whereas the improper use of beta-agonists can be a serious risk to human health; whereas, in the interests of the consumer, the holding, administering to animals of any species and the placing on the market for that purpose of beta-agonists should be prohibited; whereas, moreover, the holding, administering to animals of any species and the placing on the market of stilbenes and thyrostatic substances should be prohibited and the use of other substances regulated;(7) Whereas, however, the administering of medicinal products based on beta-agonists may be authorized for well-defined therapeutic purposes, in the case of certain categories of bovine animals, equidae and pets;(8) Whereas, moreover, it is necessary to ensure that all consumers are able to acquire meat and foodstuffs derived therefrom under the same conditions of supply and that those products correspond as closely as possible to their concerns and expectations; whereas, given consumer sensitivity, this can only bring about an increase in the consumption of the products in question;(9) Whereas the prohibition on the use of hormonal substances for fattening purposes should continue to apply; whereas the use of certain substances for therapeutic or zootechnical purposes may be authorized but must be strictly controlled in order to prevent any misuse;(10) Whereas withdrawal periods are not harmonized at Community level and there are considerable differences between Member States, particularly as regards authorized veterinary medicinal products containing hormonal substances or beta-agonists; whereas, in the interests of harmonization, maximum withdrawal periods should therefore be set for such medicinal products;(11) Whereas, furthermore, live animals so treated for therapeutic or zootechnical purposes and the meat from such animals should not as a general rule be traded, since this could impair the effectiveness of the control arrangements of the scheme as a whole; whereas, however, derogations from the prohibition may, subject to certain conditions, be provided for in respect of intra-Community trade and imports from third countries of animals intended for breeding and breeding animals at the end of their reproductive life;(12) Whereas such derogations may be authorized where adequate guarantees are provided so as to prevent distortion of trade; whereas such guarantees must cover the products which may be used, the conditions governing their use and the checks to ensure that the conditions are complied with, particularly with regard to the necessary withdrawal period;(13) Whereas provision should be made for the effective verification of application of the provisions deriving from this Directive;(14) Whereas Directives 81/602/EEC, 88/146/EEC and 88/299/EEC should be repealed;(15) Whereas, if the illegal use of growth and productivity promoters in stockfarming is to be combated effectively in all Member States, action will have to be organized at Community level;(16) Whereas, on 18 January 1996, the European Parliament asked the Commission and the Council to continue opposing the importation into the Community of meat treated with hormones, requested the maintenance of the total ban on the use of growth promoters in stockfarming and, to that end, asked the Council to adopt without delay the Commission proposal on which the European Parliament had delivered its opinion on 19 April 1994,HAS ADOPTED THIS DIRECTIVE:Article 11. For the purposes of this Directive, the definitions of meat and meat products given in Directives 64/433/EEC (7), 71/118/EEC (8), 77/99/EEC (9), and 91/495/EEC (10), the definitions of aquaculture products given in Directive 91/493/EEC (11) and the definitions of veterinary medicinal products given in Directives 81/851/EEC (12) and 81/852/EEC (13) shall apply.2. In addition, the following definitions shall apply:(a) 'farm animals` shall mean domestic animals of the bovine, porcine, ovine and caprine species, domestic solipeds, poultry and rabbits, as well as wild animals of those species and wild ruminants which have been raised on a holding;(b) 'therapeutic treatment` shall mean the administering - under Article 4 of this Directive - to an individual farm animal of an authorized substance to treat, after examination by a veterinarian, a fertility problem - including the termination of unwanted gestation - and, in the case of beta-agonists, to induce tocolysis in cows when calving and to treat respiratory problems and to induce tocolysis in equidae raised for purposes other than meat production;(c) 'zootechnical treatment` shall mean the administering:(i) to an individual farm animal of any substance authorized under Article 5 of this Directive for synchronizing oestrus and preparing donors and recipients for the implantation of embryos, after examination of the animal by a veterinarian or, in accordance with the second paragraph of Article 5, under his responsibility;(ii) in the case of aquaculture animals, to a group of breeding animals for sex inversion, on a veterinarian's prescription and under his responsibility;(d) 'illegal treatment` shall mean the use of unauthorized substances or products or the use of substances or products authorized under Community legislation for purposes or under conditions other than those laid down in Community legislation.Article 2Member States shall prohibit:(a) the placing on the market of stilbenes, stilbene derivatives, their salts and esters and thyrostatic substances for administering to animals of all species;(b) the placing on the market of beta-agonists for administering to animals the flesh and products of which are intended for human consumption for purposes other than those provided for in point 2 of Article 4.Article 3Member States shall prohibit:(a) the administering to a farm or aquaculture animal, by any means whatsoever, of substances having a thyrostatic, oestrogenic, androgenic or gestagenic action and of beta-agonists;(b) the holding, except under official control, of animals referred to in (a) on a farm, the placing on the market or slaughter for human consumption of farm animals or of aquaculture animals which contain the substances referred to in (a) or in which the presence of such substances has been established, unless proof can be given that the animals in question have been treated in accordance with Articles 4 or 5;(c) the placing on the market for human consumption of aquaculture animals to which substances referred to in (a) have been administered and of processed products derived from such animals;(d) the placing on the market of meat of the animals referred to in (b);(e) the processing of the meat referred to in (d).Article 4Notwithstanding Articles 2 and 3, Member States may authorize:1. the administering to farm animals, for therapeutic purposes, of oestradiol 17 â, testosterone and progesterone and derivatives which readily yield the parent compound on hydrolysis after absorption at the site of application. Veterinary medicinal products used for therapeutic treatment must comply with the requirements for placing on the market laid down in Directive 81/851/EEC and be administered only by a veterinarian, by injection or for the treatment of ovarian dysfunction in the form of vaginal spirals, but not by implant, to farm animals which have been clearly identified. Treatment of identified animals must be registered by the veterinarian responsible. The latter must record at least the following details in a register, which may be the one provided for in Directive 81/851/EEC:- type of treatment,- the type of products authorized,- the date of treatment,- the identity of the animals treated.The register must be made available to the competent authority at its request;2. the administering for therapeutic purposes of authorized veterinary medicinal products containing:(i) allyl trenbolone, administered orally, or beta-agonists to equidae and pets, provided they are used in accordance with the manufacturer's instructions;(ii) beta-agonists, in the form of an injection to induce tocolysis in cows when calving.Such substances must be administered by a veterinarian or, in the case of the veterinary medicinal products referred to in (i), under his direct responsibility; treatment must be registered by the veterinarian responsible, who shall record at least the details referred to in point 1.Farmers shall be prohibited from holding veterinary medicinal products containing beta-agonists which may be used for induction purposes in the treatment of tocolysis.However, without prejudice to the first subparagraph of point 2 (ii), therapeutic treatment of production animals, including breeding animals at the end of their reproductive life, shall be prohibited.Article 5Notwithstanding Article 3 (a) and without prejudice to Article 2, Member States may authorize the administering to farm animals, for the purpose of zootechnical treatment, of veterinary medicinal products having an oestrogenic, androgenic or gestagenic action which are authorized in accordance with Directives 81/851/EEC and 81/852/EEC. Such veterinary medicinal products must be administered by a veterinarian to clearly identified animals; the treatment must be recorded by the veterinarian responsible in accordance with point 1 of Article 4.However, Member States may allow the synchronization of oestrus and the preparation of donors and recipients for the implantation of embryos to be effected not by the veterinarian direct, but under his responsibility.With regard to aquaculture animals young fish may be treated for the first three months for the purpose of sex inversion with veterinary medicinal products that have an androgenous action and are authorized in accordance with Directives 81/851/EEC and 81/852/EEC.In the cases provided for in this Article, the veterinarian shall make out a non-renewable prescription, specifying the treatment in question and the quantity of the product required and shall record the products prescribed.However, zootechnical treatment of production animals, including during the fattening period for breeding animals at the end of their reproductive life, shall be prohibited.Article 61. Hormonal products and beta-agonists the administration of which to farm animals is authorized in accordance with Articles 4 and 5 must meet the requirements of Directives 81/851/EEC and 81/852/EEC.2. The following may not, however, be authorized in accordance with paragraph 1:(a) the following hormonal products:(i) products acting as a deposit;(ii) products with a withdrawal period of more than 15 days after the end of treatment;(iii) products:- which were authorized under rules that preceded the amendment made by Regulation (EEC) No 2309/93 (14),- whose conditions of use are not known,- for which no reagents or equipment exist for use in the analytical techniques for detecting the presence of residues in excess of the permitted limits,(b) veterinary medicinal products containing beta-agonists which have a withdrawal period of more than 28 days after the end of treatment.Article 71. For the purpose of trade, Member States may authorize the placing on the market of animals for breeding and breeding animals at the end of their reproductive life which, during the latter period, have undergone a treatment referred to in Articles 4 and 5 and may authorize the affixing of the Community stamp to meat from such animals where the conditions laid down in Articles 4 and 5 and the minimum withdrawal periods laid down in Article 6 (2), under (a) (ii) or (b) respectively or the withdrawal periods provided for in the authorization to place on the market are complied with.However, trade in high-value horses, and in particular racehorses, competition horses, circus horses or horses intended for stud purposes or for exhibitions, including registered equidae to which veterinary medicinal products containing allyl trenbolone or beta-agonists have been administered for the purposes referred to in Article 4, may take place before the end of the withdrawal period, provided that the conditions governing administration are fulfilled and that the type and date of treatment are entered on the certificate or passport accompanying these animals.2. Meat or products from animals to which substances having an oestrogenic, androgenic or gestagenic action or beta-agonists have been administered in accordance with the dispensatory provisions of this Directive may not be placed on the market for human consumption unless the animals in question have been treated with veterinary medicinal products complying with the requirements of Article 6 and in so far as the withdrawal period laid down was observed before the animals were slaughtered.Article 8Member States shall ensure that:1. at the time of the import, manufacture, storage, distribution, sale and use of the substances referred to in Articles 2 and 3 (a), their possession is restricted to the persons authorized by national legislation in accordance with Article 1 of Directive 90/676EEC (15);2. in addition to the checks provided for in the Directives governing the placing on the market of the various products in question, the official checks provided for in Article 11 of Directive 96/23/EC (16) are carried out by the competent national authorities without prior notice, with a view to ascertaining:(a) the possession or presence of substances or products prohibited under Article 2, intended to be administered to animals for the purpose of fattening;(b) the illegal treatment of animals;(c) failure to observe the withdrawal periods provided for in Article 6;(d) failure to observe the restrictions on the use of certain substances or products laid down in Articles 4 and 5;3. the tests for the presence of:(a) the substances referred to in point 1 in animals, in the drinking water of animals and in all places where animals are bred or kept;(b) residues of the aforementioned substances in live animals, their excrement and body fluids and in animal tissues and productsare carried out in accordance with Annexes III and IV to Directive 96/23/EC;4. where the checks provided for in points 2 and 3 reveal:(a) the presence of substances or products the use or possession of which is prohibited, or the presence of residues of substances the administering of which comes under the heading of illegal treatment, such substances or products are confiscated, while any animals treated or the meat therefrom is placed under official supervision until the requisite penalties have been applied;(b) failure to comply with the requirements of points 2 (b) and (c), the competent authority takes appropriate measures consistent with the gravity of the infringement.Article 9Without prejudice to Directive 81/851/EEC, undertakings buying or producing substances having a thyrostatic, oestrogenic, androgenic or gestagenic action and beta-agonists, undertakings authorized in any capacity to market such substances and undertakings buying or producing pharmaceutical and veterinary medicinal products from such substances shall be required to keep registers detailing, in chronological order, quantities produced or acquired and those sold or used for the production of pharmaceutical and veterinary medicinal products and the names of the persons to whom such quantities were sold or from whom they were purchased.The above information must be made available to the competent authority at its request and, in the case of computerized records, in the form of a printout.Article 10Where the results of checks carried out in a Member State show failure to comply with the requirements of this Directive in the country of origin of the animals or products, the competent authority of that Member State shall have recourse to Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters (17).Article 111. Third countries whose legislation authorizes the placing on the market and administration of stilbenes, stilbene derivatives, their salts and esters, or of thyrostatic substances for administering to animals of all species may not appear on any of the lists of countries provided for under Community legislation from which Member States are authorized to import farm or aquaculture animals or meat or products obtained from such animals.2. Member States shall also prohibit the importation from third countries on any of the lists referred to in paragraph 1 of:(a) farm or aquaculture animals(i) to which products or substances referred to in point (a) of Article 2 have been administered by any means whatsoever;(ii) to which substances or products referred to in point (a) of Article 3 have been administered, unless those substances or products were administered in compliance with the provisions and requirements laid down in Articles 4, 5 and 7 and the withdrawal periods allowed in international recommendations have been observed;(b) meat or products obtained from animals the importation of which is prohibited under point (a).3. However, animals intended for breeding, breeding animals at the end of their reproductive life, or meat therefrom, from third countries may be imported subject to their affording guarantees at least equivalent to those laid down in this Directive, which have been established in accordance with the procedure laid down in Article 33 of Directive 96/23/EC for the purpose of giving effect to Chapter V of that Directive.4. Checks on imports from third countries shall be carried out in accordance with Article 4 (2) (c) of Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries (18) and Article 8 (2) of Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (19).Article 12The Council, acting by a qualified majority on a proposal from the Commission, may adopt transitional measures necessary for the introduction of the arrangements provided for in this Directive.Article 131. Directives 81/602/EEC, 88/146/EEC and 88/299EEC are hereby repealed as from 1 July 1997.2. References made to the repealed Directives shall be construed as being made to this Directive and should be read in accordance with the correlation table in the Annex.Article 141. Member States shall bring into force the laws, regulations and administrative provisions, including any penalties, necessary to comply with this Directive on 1 July 1997, and, for beta-agonists, by 1 July 1997 at the latest. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion 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 text of the main provisions of national law which they adopt in the field governed by this Directive.3. Pending application of the provisions of this Directive as regards beta-agonists, the relevant national rules shall continue to apply in compliance with the general provisions of the Treaty.Article 15This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 16This Directive is addressed to the Member States.Done at Luxembourg, 29 April 1996.For the CouncilThe PresidentW. LUCHETTI(1) OJ No C 302, 9. 11. 1993, p. 8 and OJ No C 222, 10. 8. 1994, p. 16.(2) OJ No C 128, 9. 5. 1994, p. 107.(3) OJ No C 52, 19. 2. 1994, p. 30.(4) OJ No L 222, 7. 8. 1981, p. 32. Directive as amended by Directive 85/358/EEC (OJ No L 191, 23. 7. 1985, p. 46).(5) OJ No L 70, 16. 3. 1988, p. 16. Directive as amended by the 1994 Act of Accession.(6) OJ No L 128, 21. 5. 1988, p. 36.(7) OJ No 121, 29. 7. 1964, p. 2012/64. Directive as last amended by Directive 95/23/EC (OJ No L 243, 11. 10. 1995, p. 7).(8) OJ No L 55, 8. 3. 1971, p. 23. Directive as last amended by the 1994 Act of Accession.(9) OJ No L 26, 31. 1. 1977, p. 85. Directive as last amended by Directive 85/68/EC (OJ No L 332, 30. 12. 1995, p. 10).(10) OJ No L 268, 24. 9. 1991, p. 41. Directive as last amended by the 1994 Act of Accession.(11) OJ No L 268, 24. 9. 1991, p. 15. Directive as last amended by Directive 95/71/EC (OJ No L 332, 30. 12. 1995, p. 40).(12) OJ No L 317, 6. 11. 1981, p. 1. Directive as last amended by Directive 93/40/EEC (OJ No L 214, 24. 8. 1993, p. 31).(13) OJ No L 317, 6. 11. 1981, p. 16. Directive as last amended by Directive 93/40/EEC (OJ No L 214, 24. 8. 1993, p. 31).(14) OJ No L 214, 24. 8. 1993, p. 1.(15) OJ No L 373, 31. 12. 1990, p. 15.(16) See p. 10 of this Official Journal.(17) OJ No L 351, 2. 12. 1989, p. 34.(18) OJ No L 268, 24. 9. 1991, p. 56. Directive as last amended by Commission Decision 95/157/EC (OJ No L 103, 6. 5. 1995, p. 40).(19) OJ No L 373, 31. 12. 1990, p. 1. Directive as last amended by Directive 95/52/EC (OJ No L 265, 8. 11. 1995, p. 16).ANNEX >TABLE>


Avis juridique important

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31978L0609

Council Directive 78/609/EEC of 29 June 1978 amending for the fifth time Directive 73/241/EEC on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption

Official Journal L 197 , 22/07/1978 P. 0010 - 0011 Finnish special edition: Chapter 13 Volume 8 P. 0151  Greek special edition: Chapter 03 Volume 22 P. 0032  Swedish special edition: Chapter 13 Volume 8 P. 0151  Spanish special edition: Chapter 13 Volume 8 P. 0201  Portuguese special edition Chapter 13 Volume 8 P. 0201

COUNCIL DIRECTIVE  of 29 June 1978  amending for the fifth time Directive 73/241/EEC on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption  (78/609/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal fom 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 item 1.19 of Annex I to Council Directive 73/241/EEC of 24 July 1973 on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption (3), as last amended by Directive 76/628/EEC (4), defines gianduja nut chocolate;  Whereas the definition of this type of chocolate given in Annex I does not provide for the use of milk in various forms ; whereas this could eventually prevent further manufacture of this type of chocolate, which is, moreover, a quality product;  Whereas the product may traditionally contain a certain quantity of milk ; whereas therefore a better definition should be laid down and the addition of small quantities of milk in various forms authorized,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Item 1.19 of Annex I to Directive 73/241/EEC shall be replaced by the following:  "1.19 Gianduja (or one of the derivatives of the word "gianduja") nut chocolate  the product obtained firstly from chocolate having a minimum total dry cocoa solids content of 32 % including a minimum dry non-fat cocoa solids content of 8 %, and secondly from finely ground hazelnuts in such quantities that 100 g of the product contain not less than 20 g and not more than 40 g of nuts.  The following may also be added:  - milk or dry matter produced by the partial or complete dehydration of whole milk or partially or fully skimmed milk in a proportion such that the finished  (1)OJ No C 108, 8.5.1978, p. 16. (2)OJ No C 84, 8.4.1978, p. 7. (3)OJ No L 228, 16.8.1973, p. 23. (4)OJ No L 223, 16.8.1976, p. 1.   product contains no more than a total of 5 % by weight of dry milk solids including not more than 1 725 % of butterfat,   - almonds, hazelnuts and other nut varieties, either whole or broken, in such quantities that, together with the ground hazelnuts, they do not exceed 60 % of the total weight of the product;".     Article 2 Within one year of the date of notification of this Directive, Member States shall amend their laws where necessary in order to comply with the provisions of this Directive and shall forthwith inform the Commission thereof.  The laws thus amended shall be applied so as to:    - permit the marketing of products conforming to this Directive within two years of the date of notification;       - ban the marketing of products not conforming with this Directive within three years of the date of notification.          Article 3 This Directive is addressed to the Member States.     Done at Luxembourg, 29 June 1978.  For the Council  The President  S. AUKEN


Avis juridique important

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31989L0556

Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species

Official Journal L 302 , 19/10/1989 P. 0001 - 0011 Finnish special edition: Chapter 3 Volume 30 P. 0166  Swedish special edition: Chapter 3 Volume 30 P. 0166

COUNCIL DIRECTIVE of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species (89/556/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  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 to the opinion of the Economic and Social Committee (3),  Whereas the use of embryos of domestic animals of the bovine species is part of an efficient breeding policy which leads to better productivity and increased margins in this sector; whereas, in addition, the free movement of such embryos should  encourage a rational development by taking into account the use of optimum production factors;  Whereas the provisions relating to animal health problems in intra-Community trade in bovine animals and swine appear in Directive 64/432/EEC (4), as last amended by Directive 89/360/EEC (5); whereas in addition, Directive 72/462/ EEC (6), as last amended by Directive 89/227/EEC (7) contains provisions relating to veterinary inspection problems upon importation of bovine animals and swine from third countries;   Whereas the abovementioned provisions have ensured, with regard to intra-Community trade and imports into the Community of bovine animals and swine from third countries, that the country of provenance guarantees that animal health criteria have been  fulfilled, so that the risk of animal disease spreading has been virtually eliminated; whereas there is nevertheless a certain risk of the spread of such disease in the case of trade in embryos;  Whereas in the context of the Community policy of harmonizing national animal health provisions governing intra-Community trade in animals and animal products, it is now necessary to create a harmonized system for intra-Community trade and imports into  the Community of embryos of bovine animals;  Whereas in the context of intra-Community trade in embryos, the Member State where the embryos are collected should be under an obligation to ensure that such embryos have been collected and processed by approved and supervised embryo collection teams,  that they have been obtained from animals whose health status is such as to ensure that the risk of spread of animal disease is eliminated, that they have been collected, processed, stored and transported in accordance with the rules which preserve  their health status and are accompanied during transport to the country of destination by an animal health certificate in order to ensure that this obligation has been fulfilled;  Whereas the difference in the policies pursued within the Community with regard to vaccination against foot-and-mouth disease justifies the maintenance, for fresh embryos, of derogations, limited in time, authorizing the requirement by the Member States  of additional protection against that disease;  Whereas a list of third countries should be drawn up, taking into account animal health criteria, from which embryos may be imported into the Community; whereas without prejudice to such a list the Member States must not authorize importation unless the  embryos have been collected, processed and stored by embryo collection teams which reach certain standards and which are officially supervised; whereas, in addition, in respect of countries on that list, specific animal health conditions should be laid  down according to circumstances; whereas on-the-spot checks may be carried out in order to verify compliance with those standards;  Whereas in order to prevent the transmission of certain contagious diseases, import controls should be carried out when a consignment of embryos arrives on the territory of the Community, except in the case of external transit;  Whereas, in the case of internal transit, the measures to be taken by Member States after such controls must be defined;  Whereas the Commission should be entrusted with taking certain measures for implementing this Directive; whereas to that end procedures should be established for cooperation between the Commission and the Member States;  Whereas this Directive does not affect trade in embryos obtained, treated or stored before the date on which the Member States must comply with it,   HAS ADOPTED THIS DIRECTIVE:  CHAPTER I General provisions Article 1 1.  This Directive defines the animal health conditions governing intra-Community trade in and importation from third countries of fresh and frozen embryos of domestic animals of the bovine species.  2.  This Directive shall not apply to embryos resulting from in vitro fertilization nor to embryos subjected to sexing, splitting (twinning), cloning or any manipulation which interferes with the integrity of the 'zona pellucida'.  The Commission shall submit to the Council, before 1 January 1992, a report, together with any proposals, on the conditions for bringing such embryos within the scope of this Directive.  The Council shall act on these proposals by a qualified majority.  Article 2 For the purposes of this Directive, the definitions contained in Article 2 of Directive 64/432/EEC and Article 2 of Directive 72/462/EEC shall apply as necessary.  Moreover:  (a)  'embryo' means the initial stage of development of a domestic animal of the bovine species while it is capable of being transferred to a recipient dam;  (b) 'embryo collection team' means an officially approved group of technicians or structure supervised by a team veterinarian competent to perform the collection, processing and storage of embryos according to the conditions set out in Annex A;  (c) 'team veterinarian' means the veterinarian responsible for the supervision of an embryo collection team in accordance with the conditions laid down in Annex A;  (d) 'consignment of embryos' means a quantity of embryos removed in one operation from a single donor and covered by a single certificate;  (e) 'country of collection' means the Member State or third country in which embryos are produced, collected, processed and, where necessary, stored, and from which they are sent to a Member State;  (f) 'approved diagnostic laboratory' means a laboratory situated in the territory of a Member State or third country approved by the competent veterinary authority to carry out the diagnostic tests laid down in this Directive.   CHAPTER II Rules for intra-Community trade Article 3 Each Member State shall ensure that embryos shall not be sent from its territory to that of another Member State unless they meet the following conditions:  (a)  they must have been conceived as a result of artificial insemination with semen from a donor sire standing at a semen collection centre as defined in Article 2 (b) of Directive 88/407/EEC (8).  In accordance with the procedure laid down in Article 18, the Commission may authorize trade in embryos of certain specific species conceived as a result of natural service by bulls whose health status complies with Annex B to that Directive;   (b) they must have been collected from domestic animals of the bovine species whose health status complies with Annex B of this Directive;  (c) they must have been collected, processed and stored by an embryo collection team approved in accordance with Article 5 (1);  (d) they must have been collected, processed and stored by the embryo collection team in accordance with Annex A of this Directive;  (e) they must be accompanied, during transport to the Member State of destination, by an animal health certificate complying with Article 6 (1).  Article 4 1.  Member States which do not practise vaccination against foot-and-mouth disease may, until 31 December 1992:  - prohibit the introduction into their territory of fresh embryos from Member States where vaccination is practised, and - require, in the case of importation of frozen embryos from Member States where vaccination is practised, in addition that:  i(i)  the donor animals come from a holding:  -  in which no animal has been vaccinated against foot-and-mouth disease during the 30 days prior to collection,  -  which is not subject to prohibition or quarantine measures pursuant to Directive 64/432/EEC.  (ii)  the embryos must have been stored under approved conditions during a minimum period of 30 days before consignment.  2.  Before 1 January 1992 the Council shall review this Article on the basis of a Commission report accompanied by any proposals.  Article 5 1.  Approval of an embryo collection team as provided for in Article 3 (c) shall be granted only where the provisions of Annex A, Chapter I are observed and where the embryo collection team is able to satisfy the other provisions of this  Directive.  Any major change in the organization of the team is to be notified to the competent authority.  The approval of the team shall be renewed whenever the team veterinarian is replaced or whenever any major changes are made in its organization or the laboratories or equipment at its disposal.  The official veterinarian shall supervise observance of the provisions outlined above. Approval shall be withdrawn where one or more of the provisions is no longer observed.  2.  All approved embryo collection teams shall be registered by the competent authority of the Member State concerned, each team being given a veterinary registration number. A list of embryo collection teams and their veterinary registration numbers  shall be sent by each Member State to the other Member States and to the Commission, which shall also be notified of any amendment made to that list.  Where a Member State considers that the provisions governing approval are not, or are no longer, observed by an embryo collection team in another Member State, it shall inform the competent authority of that State. The latter shall then take all  necessary measures and notify the competent authority of the other Member State of the decisions taken and the reasons for them.  If that other Member State fears that the necessary measures have not been taken or are inadequate, it shall so inform the Commission, which will seek the opinion of one or more veterinary experts. In the light of that opinion, Member States may be  authorized, in accordance with the procedure laid down in Article 17, to prohibit temporarily the admission into their territory of embryos collected by the team in question.  Such authorization may be withdrawn in accordance with the procedure laid down in Article 17 in the light of a fresh opinion delivered by one or more veterinary experts.  The veterinary experts must be nationals of a Member State other than those involved in the dispute.  3.  The detailed rules for applying this Article shall be adopted in accordance with the procedure laid down in Article 18.  Article 6 1.  An animal health certificate drawn up by an official veterinarian of the Member State of collection on a form conforming to the specimen in Annex C shall accompany each consignment of embryos. A separate certificate shall be issued for  each consignment.  2.  The animal health certificate must:  (a)  consist of a single form and be drawn up in at least the official language(s) of the Member State of destination;  (b)  be made out to a single consignee;  (c)  accompany the consignment of embryos to its destination in its original form.  CHAPTER III Rules for importation from third countries Article 7 1.  Embryos shall be imported only from those third countries or parts thereof which appear on a list drawn up in accordance with the procedure laid down in Article 18. That list may be supplemented or amended in accordance with the same  procedure.  2.  In deciding whether a third country or parts thereof may appear on the list referred to in paragraph 1, particular account shall be taken of:  (a)  the state of health of the livestock, other domestic animals and wildlife in the third country, with particular reference to exotic animal diseases, and of the environmental health situation in that country, which might endanger animal health in  the Member States;  (b) the regularity and rapidity of the information supplied by the third country concerning the existence of contagious animal diseases in its territory, in particular those diseases mentioned in lists A and B of the International Office of Epizootic  Diseases;  (c) the rules of the third country on animal disease prevention and control;  (d) the structure of the veterinary services in the third country and their powers;  (e) the organization and implementation of measures to prevent and control contagious animal diseases; and (f) the guarantees which the third country can give with regard to compliance with the rules set out in this Directive.  3.  The list referred to in paragraph 1 and all amendments thereto shall be published in the Official Journal of the European Communities.  Article 8 1.  In accordance with the procedure laid down in Article 18, a list shall be drawn up of embryo collection teams which are authorized to collect, process or store in third countries embryos which are destined for the Member States. The list  may be amended or supplemented in accordance with the same procedure.  2.  In deciding whether an embryo collection team in a third country may appear on the list referred to in paragraph 1, particular account shall be taken of the veterinary supervision of embryo collection systems in that country, the powers of the  veterinary services and the supervision to which embryo collection teams are subject.  3.  An embryo collection team may appear on the list provided for in paragraph 1 only if:  (a)  it carries out its activities in one of the countries or parts thereof on the list referred to in Article 7 (1);  (b)  it fulfils the requirements of Annex A;  (c)  it has been officially approved for exports to the Community by the veterinary services of the third country concerned; and (d) it is subject to inspections at least twice a year by an official veterinarian of the third country concerned.  Article 9 1.  Importation of embryos from the territory of a third country or part thereof on the list drawn up in accordance with Article 7 (1) shall take place only if the embryos:  (a)  come from donor animals which, immediately prior to the collection of their embryos, have remained for at least six months in the territory of the third country concerned, and in a maximum of two herds complying with at least the requirements set  out in paragraph 2;  (b) comply with the animal health requirements adopted in accordance with the procedure laid down in Article 18 for imports of embryos from that country.  In adopting the requirements referred to in the first subparagraph, consideration shall be given to:  (a)  the health situation in the area surrounding the place of embryo collection, with particular reference to the diseases appearing on list A of the International Office of Epizootic Diseases;  (b) the state of health of the herd concerned in the embryo collection, including testing requirements;  (c) the state of health of the donor animal and testing requirements;  (d) collecting, processing and storing requirements in relation to embryos.  2.  The reference basis for fixing animal health conditions in accordance with paragraph 1 for tuberculosis, bovine brucellosis and enzootic bovine leucosis shall be the standards laid down in Annexes A and G to Directive 64/432/EEC. Under the procedure  laid down in Article 18 and on a case-by-case basis, derogations from those provisions may be decided upon where an interested third country provides similar and at least equivalent guarantees with reference to animal health.  3.  Article 4 shall apply mutatis mutandis.  Article 10 1.  Importation of embryos shall be authorized only on submission of an animal health certificate drawn up and signed by an official veterinarian of the third country of collection.  The certificate must:  (a)  be drawn up in at least the official language or languages of the Member State of destination and the official language or languages of the Member State where the import control provided for in Article 11 is carried out;  (b) be made out to a single consignee;  (c) accompany the embryos in the original.  2.  The animal health certificate must be on a form conforming to a specimen drawn up in accordance with the procedure laid down in Article 18.  Article 11 1.  Each consignment of embryos entering the territory of the Community shall be subjected to control before being put into free circulation or placed under a customs procedure.  The admission of such embryos into the Community shall be prohibited if the import control made on arrival reveals that:  - the embryos do not come from the territory of a third country or parts thereof on the list drawn up in accordance with Article 7 (1),  - the embryos were not collected, processed and stored by an embryo collection team on the list provided for in Article 8 (1),  - the embryos come from the territory of a third country or parts thereof from which imports are prohibited in accordance with Article 14 (2),  - the animal health certificate which accompanies the embryos is not in conformity with the conditions laid down in Article 10 and fixed pursuant thereto.  This paragraph shall not apply to consignments of embryos which arrive in the customs territory of the Community and are placed under a customs transit procedure for consignment to a destination situated outside the said territory.  However, it shall be applicable where customs transit is waived during transport through the territory of the Community.  2.  Necessary measures may be taken by a Member State of destination, including storage in quarantine, in order to obtain definite proof in cases where embryos are suspected of being contaminated by pathogenic organisms.  3.  If the importation of embryos has been prohibited on any of the grounds set out in paragraphs 1 and 2 and the exporting third country does not within 30 days authorize the return of the embryos, the competent veterinary authority of the Member State  of destination may order them to be destroyed.  Article 12 Each consignment of embryos authorized for importation into the Community by a Member State on the basis of the control referred to in Article 11 (1) must, when sent to the territory of another Member State, be accompanied by the original  animal health certificate or an authenticated copy thereof, suitably endorsed, in either case, by the competent authority which was responsible for the control carried out in accordance with Article 11.  Article 13 Any costs arising from implementation of measures pursuant to Article 11 (2) and (3) shall be chargeable to the consignor, the consignee or their agent, without compensation by the Member States.   CHAPTER IV Rules on safeguard and control measures Article 14 1.  If a contagious animal disease which can be carried by embryos breaks out or spreads or if any other reason connected with animal health which might endanger the health of the livestock in a Member State so justify and where:  - the territory of a Member State is concerned, the safeguard measures laid down in Article 9 of Directive 64/432/EEC may be applied,  - all or part of the territory of a third country is concerned, the Member State of destination shall prohibit the importation of those embryos whether imported directly or indirectly through another Member State, either from the whole of the third  country or from part only of its territory.  2.  Measures taken by Member States pursuant to paragraph 1 and the repeal of such measures must be communicated immediately to the other Member States and the Commission together with the reasons for such measures.  In accordance with the procedure laid down in Article 17 it may be decided that those measures must be amended, in particular in order to coordinate them with measures adopted by other Member States, or that they must be repealed.  3.  If the situation envisaged in paragraph 1 arises and if it is necessary that other Member States also apply the measures taken under that paragraph, amended where necessary in accordance with paragraph 2, appropriate steps shall be taken in  accordance with the procedure laid down in Article 17. Resumption of importation from the third country concerned shall be authorized in accordance with the same procedure.  Article 15 1.  Veterinary experts from the Commission may, in cooperation with the competent authorities of the Member States or third countries, make on-the-spot checks in so far as that is indispensable for ensuring uniform application of this  Directive.  The country of collection within whose territory a check is being carried out shall give all necessary assistance to the experts in carrying out their duties. The Commission shall inform the country of collection concerned of the results of the  investigation.  The country of collection concerned shall take any measures which may prove necessary to take account of the results of the investigation. If the country of collection does not take those measures, the Commission may, after the situation has been  examined by the Standing Veterinary Committee, authorize Member States to refuse entry into their territory for embryos obtained, processed or stored by the collection team in question or withdraw approval in the case of third countries.  2.  The general provisions for implenting this Article, especially as regards the frequency and method of carrying out the checks referred to in the first subparagraph of paragraph 1, shall be laid down in accordance with the procedure set out in  Article 18.   CHAPTER V Final provisions Article 16 Amendments to the Annexes, in particular to adapt them to advances in technology, shall be decided in accordance with the procedure set out in Article 18.  Article 17 1.  Where the procedure laid down in this Article is to be followed, the chairman shall refer the matter forthwith to the committee either on his initiative or at the request of the representative of a Member State.  2.  The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the  Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.  3.  The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.  4.  If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a  qualified majority.  If, within 15 days of the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.  Article 18 1.  Where the procedure laid down in this Article is to be followed, the chairman shall refer the matter without delay to the committee either on his own initiative or at the request of the representative of a Member State.  2.  The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter.  The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the  committee shall be weighted in the manner set out in that Article. The chairman shall not vote.  3.  The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.  4.  If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a  qualified majority.  If, within three months of the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.  Article 19 1.  This Directive shall not apply to embryos collected, processed and stored in a Member State before 1 January 1991.  2.  Until the date of entry into force of the decisions adopted pursuant to Articles 7, 8 and 9, the Member States shall not apply to imports of embryos from third countries more favourable conditions than those resulting from the application of Chapter  II.  Article 20 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 January 1991. They shall forthwith inform the Commission thereof.  Article 21 This Directive is addressed to the Member States.   Done at Brussels, 25 September 1989.  For the Council The President H. NALLET  (1) OJ No C 76, 28. 3. 1989, p. 1. (2) OJ No C 120, 16. 5. 1989, p. 313. (3) OJ No C 139, 5. 6. 1989, p. 56. (4) OJ No 121, 29. 7. 1964, p. 1977/64. (5) OJ No L 153, 6. 6. 1989, p. 29. (6) OJ No L 302, 31. 12. 1972, p. 28. (7) OJ No L 93, 6. 4. 1989, p. 25.(8) OJ No L 194, 22. 7. 1988, p. 10.   ANNEX A   CHAPTER I  Conditions for the approval of an embryo collection team In order to be given approval each embryo collection team must fulfil the following requirements:  (a)  the collection, processing and storage of embryos must be carried out either by a team veterinarian or under his responsibility by one or more technicians who are competent and trained by the team veterinarian in methods and techniques of hygiene;   (b) it must be placed under the general supervision and authority of the official veterinarian;  (c) it must have at its disposal permanent or mobile laboratory facilities where embryos can be examined, processed and packed, consisting of at least a work surface, a microscope and cryogenic equipment;  (d) in the case of a permanently sited laboratory, it must have at its disposal:  - a room where embryos can be manipulated which is adjacent to but physically separate from the area used to handle the donor animals during collection,  - a room or area equipped for cleansing and sterilizing instruments and equipment used in embryo collection and manipulation;  (e) it must have at its disposal in the case of a mobile laboratory a specially equipped part of the vehicle consisting of two separate sections,  - one for the examination and manipulation of embryos which shall be a clean section, and - the other for accommodating equipment and materials used in contact with the donor animals.  A mobile laboratory shall always have contact with a permanently sited laboratory to ensure the sterilization of its equipment and the provision of fluids and other products necessary for the collection and manipulation of embryos.   CHAPTER II  Conditions relating to the collection, processing, storage and transport of embryos by the approved embryo collection team 1.  Collection and processing (a)  Embryos shall be collected and processed by an approved collection team, without coming into contact with any other consignment of embryos not meeting the requirements of this Directive.  (b) Embryos shall be collected in a place which is isolated from other parts of the premises or holding and which must be in good repair and easy to cleanse and disinfect.  (c) Embryos shall be processed (examined, washed, treated and placed in identified and sterile containers) in either a permanent laboratory facility or a mobile laboratory facility, which is not situated in a zone subject to prohibition or quarantine  measures.  (d) All implements which come into contact with the embryos or the donor animal during collection and processing shall be disposable or shall be properly disinfected or sterilized prior to use.  (e) Products of animal origin used during collection of the embryos and in the transport medium shall be obtained from sources which present no animal health risk or are to be so treated prior to use so that such risk is prevented.  (f) Storage flasks and transport flasks shall be properly disinfected or sterilized before the commencement of each filling operation.  (g) The cryogenic agent used shall not have been previously used for other products of animal origin.  (h) Each embryo container and the containers in which they are stored and transported shall be clearly code-marked in such a way that the date of collection of the embryos and the breed and identification of the donor sire and donor dam, as well as the  registration number of the team can be readily established. The characteristics and form of this code-marking shall be established in accordance with the procedure laid down in Article 18.  (i) Each embryo shall be washed at least 10 times in a special fluid for embryos which shall be changed each time and which, unless decided otherwise under point (m), shall contain trypsin, in accordance with internationally recognized procedures. Each wash  shall be a 100-fold dilution of the previous wash and a sterile micropipette shall be used to transfer the embryo on each occasion.  (j) After the last wash each embryo shall be subjected to microscopic examination over its entire surface to determine that the 'zona pellucida' is intact and is free from any adherent material.  (k) Each consignment of embryos that has successfully undergone the examination provided for in (j) shall be placed in a sterile container marked in accordance with (h) and which shall be sealed immediately.  (l) Each embryo shall, where appropriate, be frozen as soon as possible and stored in a place which is under the control of the team veterinarian and which is subject to regular inspection by an official veterinarian.  (m) In accordance with the procedure laid down in Article 18 a protocol shall be drawn up before the date provided for in Article 20 concerning authorized flushing and washing fluids, washing techniques and, where necessary, enzymatic treatments together  with authorized transportation media.  Pending the adoption of a protocol on enzymatic treatments, the national rules on the use of trypsin shall continue to apply, in compliance with the general provisions of the Treaty.  (n) Each collection team must submit routine samples of flushing fluids, washing fluids, disintegrated embryos, non-fertilized ova etc., resulting from its activities for official examination for bacterial and viral contamination. The procedure for  collecting of samples, conducting such examinations, together with the standards to be achieved shall be decided in accordance with the procedure laid down in Article 18. If the standards laid down are not achieved the competent authority which granted  the official approval to the team shall withdraw that approval.  (o) Each collection team must keep a record of its activities in respect of embryo collection during the 12 months before and 12 months after storage including: - the breed, age and identification of the donor animals concerned,  - the place of collection, processing and storage of embryos collected by the team,  - the identification of the embryos together with details of their destination if known.  2.  Storage Each embryo collection team shall ensure that the embryos are stored at suitable temperatures in premises approved for the purpose by the competent authority.  In order to be approved these premises must:  ii(i)  comprise at least one lockable room intended exclusively for embryo storage;  i(ii)  be easy to cleanse and disinfect;  (iii)  have permanent records of all incoming and outgoing movements of embryos. The final destination of the embryos in particular shall be specified in such records;  (iv)  be subject to inspection by the official veterinarian.  The competent authority may authorize the storage of semen that fulfils the requirements of Directive 88/407/EEC in the approved storage premises.  3.  Transport Embryos for trade must be transported in satisfactory hygienic conditions in sealed containers from the approved storage premises until their arrival at their destination.  The containers must be marked in such a way that the number coincides with the number on the animal health certificate.    ANNEX B   Conditions applying to donor animals  1.  For the purposes of embryo collection donor animals must meet the following requirements:  (a)  they must have spent the previous six months within Community territory or in the third country of collection in at least one herd:  - which is officially tuberculosis free, and - which is officially brucellosis free or brucellosis free,  - which is enzootic bovine leucosis free or which, during the three previous years, has shown no clinical signs of enzootic bovine leucosis;  - which, during the previous year, has shown no clinical signs of infectious bovine rhinotracheitis/ infectious pustular vulvo-vaginitis;  (b)  during the six months preceding embryo collection, donor cows may have spent successive periods in a maximum of two different herds meeting the requirements set out above.  2.  On the day of embryo collection the donor cow:  (a)  shall be resident in a holding which is not subject to veterinary prohibition or quarantine measures;  (b)  shall show no clinical signs of disease.    ANNEX C    1. Consignor (name and full address) ANIMAL HEALTH CERTIFICATE  NoORIGINAL  2. Member State of collection  3. Consignee (name and full address) NOTES (a) A separate certificate must be issued for each consignment of embryos (b) The original of this certificate must accompany the consignment to the place of destination  6. Place of loading  8. Means of transport  9. Place and Member State of destination 11. Number and code-mark of embryo containers  4. COMPETENT AUTHORITY  5. COMPETENT LOCAL AUTHORITY  7. Name and address of embryo collection team 10. Registration number of embryo collection team 12. Identification of consignment (a) Number of embryos (b)  Date(s) of collection (c)  Breed 13. I, the undersigned official veterinarian, certify that:  (a) the embryos described above were collected, processed and stored under conditions which comply with the standards laid down in Directive No 89/556/EEC and, where consigned to a Member State which does not vaccinate against foot-and-mouth disease,  with the requirements set out in the second indent of Article 4 (1) of that Directive;  (b) the embryos described above were sent to the place of loading in sealed containers under conditions which comply with the provisions of Directive No 89/556/EEC.  Done at .,  .  Signature: .  Name and qualification (in block letters):  .  .  Stamp


Avis juridique important

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32004L0004

Commission Directive 2004/4/EC of 15 January 2004 amending Directive 96/3/EC granting a derogation from certain provisions of Council Directive 93/43/EEC on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea (Text with EEA relevance)

Official Journal L 015 , 22/01/2004 P. 0025 - 0030

Commission Directive 2004/4/ECof 15 January 2004amending Directive 96/3/EC granting a derogation from certain provisions of Council Directive 93/43/EEC on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs(1), and in particular Article 3(3) thereof,Whereas:(1) It is necessary to amend Commission Directive 96/3/EC of 26 January 1996 granting a derogation from certain provisions of Council Directive 93/43/EEC on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea(2), in order to take account of scientific developments.(2) On the basis of evaluations carried out by the Scientific Committee on Food and, in particular, of its opinion of 20 September 1996, as amended on 12 June 1997 (107th plenary meeting), and the updated opinion of 4 April 2003 on the potential risk to human health arising from the transport in ships' tanks of oils and fats from substances proposed as acceptable previous cargoes, it is necessary to amend the list of acceptable previous cargoes set out in the Annex to Directive 96/3/EC.(3) In the case of cyclohexanol, 2,3-butanediol, iso-butanol and nonane, the information available was inadequate or needed additional clarification to allow a sound scientific assessment of the toxicological properties and the Scientific Committee on Food was unable to carry out the requested evaluations. These substances were considered by the Scientific Committee on Food not acceptable as previous cargoes and therefore should be removed from the list of acceptable previous cargoes.(4) In the case of methyl esters of fatty acids (laurate, palmitate, stearate, oleate), acetic anhydride, ammonium polyphosphate, propylene tetramer, propyl alcohol, sodium silicate, in view of data available, the assessment of the Scientific Committee on Food has resulted in the acceptance of these substances as previous cargoes. These substances should be therefore added to the list of acceptable previous cargoes.(5) In the case of iso-decanol, iso-nonanol, iso-octanol, montan wax, paraffin wax and white mineral oils the information available was inadequate to carry out a complete evaluation. However, according to the opinion of the Scientific Committee on Food, these substances may be considered as provisionally acceptable as previous cargoes considering their unlikely genotoxic potential, their easy removal by tank cleaning procedures and the very low residues expected as a result of these factors and their likely dilution.(6) These provisionally acceptable substances should be reassessed on the basis of new scientific data and the Annex reviewed as appropriate within an adequate period of time. The data needed for the above evaluation should be provided, in particular, by relevant food business operators.(7) 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 1The Annex to Directive 96/3/EC is replaced by the Annex hereto.Article 2The substances iso-decanol, iso-nonanol, iso-octanol, montan wax, paraffin wax and white mineral oils, shall be reassessed on the basis of new scientific data and the Annex reviewed as appropriate by 31 December 2006.Article 3Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 June 2004 at the latest. They shall forthwith inform the Commission thereof.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 4This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.Article 5This Directive is addressed to the Member States.Done at Brussels, 15 January 2004.For the CommissionDavid ByrneMember of the Commission(1) OJ L 175, 19.7.1993, p. 1.(2) OJ L 21, 27.1.1996, p. 42.ANNEX"ANNEXLIST OF ACCEPTABLE PREVIOUS CARGOES>TABLE>"