Avis juridique important

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31991L0495

Council Directive 91/495/EEC of 27 November 1990 concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat

Official Journal L 268 , 24/09/1991 P. 0041 - 0055 Finnish special edition: Chapter 3 Volume 39 P. 0030  Swedish special edition: Chapter 3 Volume 39 P. 0030

COUNCIL DIRECTIVE of 27 November 1990 concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat (91/495/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 rabbit meat and farmed game meat are included in the list of products in Annex II to the Treaty; whereas rabbit and game farming are generally included in the farming sector; whereas this farming constitutes a source of income for part of the  farming population;  Whereas, in order to ensure the rational development of this sector and to improve productivity, rules concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat must be  laid down at Community level;  Whereas disparities as regards animal health and public health conditions in the Member States should be eliminated in order to encourage intra-Community trade in rabbit meat and farmed game meat, with a view to the completion of the internal market;  Whereas diseases transmissible to domestic animals and humans may be spread by rabbit meat and farmed game meat; whereas it is necessary to lay down rules enabling these risks to be controlled;  Whereas the meat in question must be treated in good hygienic conditions in order to avoid food-borne infections and intoxications;  Whereas Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community (4), as last amended by Directive 89/162/EEC (5), lays down the conditions for notification of animal diseases in the Community; whereas  it is opportune to have, for certain contagious diseases affecting farmed game, the same information as for other domestic animals;  Whereas Council Directive 64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat (6), as last amended by Directive 89/662/EEC (7) and Council Directive 71/118/EEC of 15 February 1971 on health problems affecting  trade in fresh poultrymeat (8), as last amended by Directive 90/539/EEC (9), lay down the health requirements for, respectively, fresh meat and fresh poultrymeat; whereas farmed wildlife used for game production is similar to farmed mammals and farmed  birds; whereas it is therefore opportune to extend to farmed game meat, while taking into account certain specific aspects, the health rules already applied for trade in fresh meat and poultrymeat;  Whereas it is appropriate to lay down exceptions for small quantitites of rabbit meat and farmed game meat used for local trade;  Whereas, in respect of the organization of, and the follow-up to, the checks to be carried out by the Member State of destination and the safeguard measures to be implemented, reference should be made to the general rules laid down in Council Directive  90/425/EEC of 26 June 1990 concerning veterinary and zoo-technical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (10);  Whereas the Commission should be entrusted with the task of adopting measures for applying this Directive; whereas, to that end, provision should be made for procedures establishing close and effective cooperation between the Commission and the Member  States within the Standing Veterinary Committee,  HAS ADOPTED THIS DIRECTIVE:  CHAPTER I General rules   Article 1  This Directive lays down requirements concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat.  Article 2  For the purposes of this Directive, the definitions given in Article 2 of Directive 64/433/EEC and in Article 2 of Directive 71/118/EEC shall apply.  The following definitions shall also apply:  1.  'rabbit meat': all parts of domestic rabbit which are fit for human consumption;  2.  'farmed game meat': all parts of wild land mammals and wild birds - including the species referred to in Article 2 (1) of Directive 90/539/EEC - bred, reared and slaughtered in captivity which are fit for human consumption;  3.  'farmed game': land mammals, or birds, which are not considered as domestic and not referred to in Article 1 (1) of Directive 64/433/EEC or in Article 1 of Council Directive 71/118/EEC, but which are farmed as domestic animals. However, wild mammals  living within an enclosed territory under conditions of freedom similar to those enjoyed by wild game shall not be deemed farmed game;  4.  'country of production': the Member State in the territory of which the farm of production is situated.   CHAPTER II Rules applicable to the production and placing on the market of rabbit meat   Article 3  1.  Member States shall see to it that rabbit meat:  (a)  is obtained in an establishment fulfilling the general conditions of Directive 71/118/EEC and approved for the purposes of this chapter in accordance with Article 14;  (b) comes from animals from farms or areas in which bans have not been imposed for veterinary inspection reasons;  (c) comes from animals which have undergone ante-mortem inspection by an official veterinarian or by assistants, in accordance with Article 4 of Directive 71/118/EEC, such inspection being in accordance with Chapter I of Annex I to this Directive and which  have been deemed suitable for slaughter following such inspection;  (d) has been treated under satisfactory hygiene conditions similar to those provided for in Chapter V of Annex I to Directive 71/118/EEC, except for those in points 28a and 28b;  (e) has undergone, in accordance with Chapter II of Annex I to this Directive, post-mortem inspection by an official veterinarian or, pursuant to Article 4 of Directive 71/118/EEC, by assistants, and has not shown any change except for traumatic lesions  which occurred shortly before slaughter or localized malformations or changes, provided that it is established, if necessary by appropriate laboratory tests, that these do not render the carcase or offal unfit for human consumption or dangerous to human  health;  (f) bears a health mark in accordance with Chapter III of Annex I to this Directive.  A decision may be taken, where appropriate, to amend or supplement the provisions of the aforementioned Chapter in accordance with the procedure provided for in Article 20, in order to take into account notably the different forms of presentation,  providing they conform to the rules covering hygiene; in particular, and by way of derogation from the said Chapter, the said procedure shall determine - before 1 January 1992 for the first time - the conditions under which the marketing, in large  packages, which have not been marked in accordance with section 11.3 (a) of the said Chapter, of carcases, parts of carcases or of offal may be authorized;  (g) is stored in accordance with Chapter IV of Annex I to this Directive after post-mortem inspection under satisfactory hygiene conditions in establishments approved in accordance with Article 14 or in stores approved in accordance with Community rules;  (h) has been transported under satisfactory hygiene conditions in accordance with Chapter V of Annex I to this Directive;  (i) in the case of parts of carcases or boned meat, has also been obtained in conditions similar to those provided for in Article 3 of Directive 71/118/EEC, in establishments specially approved for this purpose in accordance with Article 14 of this Directive.  2.  Each Member State shall also see to it that fresh rabbit meat sent to the territory of another Member State is accompanied by a health certificate during its transport to the country of destination.  The original of the health certificate, which must accompany the fresh rabbit meat during its transport to the consignee,  must be issued by an official veterinarian at the moment of loading. The health certificate must correspond, in presentation and context, to the model in Annex II; it must be drawn up at least in the language or languages of the country of destination  and must contain the information provided for in the model in the said Annex.   Article 4  1.  By way of derogation from Article 3, Member States may authorize:  (a)  the direct supply of rabbit meat by a small producer to a private individual for his own consumption;  (b) the supply of fresh rabbit meat in small quantities, by farmers who produce rabbits on a small scale:  - either directly to the final consumer at those local markets which are closest to their farms,  - or to a retailer with a view to direct sale to the final consumer, provided that such retailer conducts his business in the same locality as that of the producer or in a neighbouring locality.  The said possible derogation shall not include itinerant sales, mail order sales and, as far as the retailer is concerned, sales on a market.  2.  Member States shall take the measures necessary to ensure the health control of these operations provided for in paragraph 1 and to adopt rules enabling the original holding of such meat to be traced.  3.  Under the procedure laid down in Article 20, the Commission may adopt the detailed rules for applying this Article and in particular, at the request of Member State, fix the maximum limits of quantities which may be supplied pursuant to paragraph 1.    CHAPTER III Rules applicable to the production and marketing of farmed game meat   Article 5  Member States shall ensure that intra-Community trade in farmed game meat is subject:  (a)  where farmed game birds are concerned, to the requirements of Council Directive 91/494/EEC of 26 June 1990 on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultrymeat (;);  (b) where other species of farmed game are concerned, to the requirements of Council Directive 72/461/EEC of 12 December 1972 on health problems affecting intra-Community trade in fresh meat ($), as last amended by Directive 89/662/EEC.  Article 6  1.  Farmed game meat obtained from cloven-hoofed wild land mammals shall fulfil the relevant conditions referred to in Article 3 and Article 5 (b) to (k) of Directive 64/433/EEC, provided that the original herd undergoes regular veterinary inspection  and is not under any restrictions following the survey performed according to Article 11 or as a result of veterinary inspection. The detailed rules for this inspection shall be laid down in accordance with the procedure set out in Article 20.  The animals in question shall be treated at different times from bovine animals, swine, sheep and goats.  The health certificate which must accompany such meat shall correspond to the model in Annex IV to this Directive.  Meat from farmed wild pigs or other species sensitive to Trichina infestation shall be subjected to examination by digestion in accordance with Council Directive 77/96/EEC of 21 December 1976 on examination for Trichinae (trichinella spiralis) upon  importation from third countries of fresh meat derived from domestic swine (11) as last amended by Directive 89/321/EEC (12).  2.  Notwithstanding paragraph 1, the official service may authorize the slaughter of farmed game in the place of origin, where it cannot be transported, in order to avoid any risk for the handler or to protect the welfare of the animals. This  authorization may be granted provided that:  - the herd undergoes regular veterinary inspection and is not under any restrictions following the survey performed according to Article 12 or as a result of veterinary inspection,  - a request is submitted by the owner of the animals,  - the official service is informed in advance of the date of slaughtering of the animals,  - the holding has a centre for mustering wild animals where an ante-mortem inspection of the group for slaughter can be carried out,  - the holding has premises suitable for the slaughter, sticking and bleeding of the animals,  - slaughter by means of sticking and bleeding is preceded by stunning, which must be carried out in the conditions laid down in Directive 74/577/EEC (13); the veterinary service may authorize shooting only in special cases,  - the slaughtered and bled animals are hung as quickly as possible after slaughter and are transported under satisfactory hygiene conditions to a slaughterhouse approved in accordance with Directive 66/433/EEC. Where game slaughtered at the place of  rearing cannot be brought within the hour to a slaughterhouse approved in accordance with Article 8 of Directive 64/433/EEC, it must be transported in a container or means of transport in which the ambient temperature is maintained at between 0 oC and 4  oC. Evisceration must be carried out no later than three hours after stunning,  - during transportation to the slaughterhouse the slaughtered animals are accompanied by a certificate issued by the veterinary service attesting to the favourable outcome of the ante-mortem inspection, the correct conduct of bleeding and the time of  slaughter; this certificate must correspond to the model in Annex III.  3.  Pending the adoption of health rules applicable to meat reserved for the domestic market, the slaughtering of farmed big game and the cutting and storage of the meat referred to in paragraph 1 may, by way of derogation from paragraph 1, be performed in establishments approved by the national authorities for the domestic market, provided that such meat does not enter intra-Community trade.  Article 7  1.  Countries of destination may, with due regard for the general provisions of the Treaty, grant one or more countries of consignment general authorizations or authorizations restricted to specific cases, whereby the fresh meat referred to in Article 5  (b) and (i) to (k) of Directive 64/433/EEC may be admitted to their territory.  Such fresh meat may be sent solely in accordance with Article 3 (1) and (3) of Directive 64/433/EEC.  2.  If a country of destination grants a general authorization in accordance with paragraph 1, it shall immediately inform the other Member States and the Commission thereof.  3.  The countries of consignment shall make all necessary arrangements to ensure that health certificates, a specimen of which is provided in Annex IV, mention that one of the options provided for in paragraph 1 has been taken up.  Article 8  Meat of farmed game birds shall fulfil the conditions referred to in Article 3 of Directive 71/118/EEC.  Meat of farmed game birds intended for intra-Community trade shall be accompanied by the health certificate provided for in Article 8 of Directive 71/118/EEC, which shall correspond to the model in Annex IV to this Directive.  However, notwithstanding Chapter V (23) of Annex I to Directive 71/118/EEC, where, in the case of quail and pigeon, the evisceration technique used does not permit complete health inspection of the viscera of each bird, that inspection may be carried  out on a sample of at least 5 % of each batch of 500 birds, and in corresponding proportion beyond 500 birds, provided that the batches are homogeneous in terms of their nature, weight and origin.  Where the results are not clearly satisfactory, the opinion expressed on the basis of such sample inspection of the viscera as to whether the slaughtered birds are fit for consumption shall apply to the entire batch.  Article 9  Notwithstanding Article 8, first subparagraph, in the case of meat from farmed game birds obtained and put on the market in their territory, Member States may, with due regard for the general provisions of the Treaty, grant those slaughterhouses or  cutting premises situated in their territory which were engaged in that activity prior to the date of notification of this Directive and which expressly so request, a derogation from the slaughter and evisceration provisions laid down in Chapter V of  Annex I to Directive 71/118/EEC in the case of the production of partially eviscerated or non-eviscerated farmed game birds.  The use of the health mark provided for in Chapter X of Annex I to Directive 71/118/EEC shall be prohibited in the event that this derogation is exercised.  Article 10  Article 8 shall not apply to meat of farmed game birds which, in isolated cases, is supplied by the producer thereof direct to the final consumer for his own consumption otherwise than by itinerant sale, sale by mail order or sale on a market.  Under the procedure laid down in Article 20, the Commission may adopt the detailed rules for applying this Article and in particular, at the request of Member State, fix the maximum limits of quantities which may be supplied pursuant to the first  paragraph.  CHAPTER IV Common provisions   Article 11  1.  Member States shall ensure that a survey of the health of rabbit and farmed game is performed on holdings on their territories at regular intervals.  2.  To this end a central service or body shall be entrusted with the task of collecting and using the results of the health inspections carried out in accordance with this Directive, where diseases transmissible to humans or animals or the presence of  residues in excess of permitted levels are diagnosed.  3.  Where a disease or condition referred to in paragraph 2 is diagnosed, the survey results relating to the specific case shall be communicated as soon as possible to the official service responsible for supervision of the stock from which the animals  originate.  4.  Depending on the epizootic situation, the official service shall carry out specific tests on farmed game in order to detect the presence of the diseases referred to in Annex I to Directive 82/894/EEC.  The presence of these diseases shall be communicated to the Commission and to the other Member States in accordance with the said Directive.  Article 12  1.  Member States shall supplement their plans for measures on residues referred to in Article 4 of Council Directive 86/469/EEC of 16 September 1986 concerning the examination of animals and fresh meat for the presence of residues (14) in order to  subject rabbits and farmed game to the inspections provided for in that Directive and also to monitor wild game for contaminants present in the environment.  2.  Taking into account the results of the monitoring referred to Article 11 (4), Member States shall impose limitations on the use of game meat from holdings or territories implicated by the monitoring.  3.  The Commission shall adopt the detailed rules for application of this Article in accordance with the procedure laid down in Article 20.  Article 13  Rabbit meat or meat of farmed game birds shall not be used for human consumption if:  (a)  found to have one of the faults listed in point 9 (a) of Annex I;  (b) originating from animals to which substances likely to make the meat dangerous or harmful to human health have been administered and on which a decision has been taken, in accordance with the procedure provided for in Article 20, following the opinion  of the Scientific Veterinary Committee. Pending that decision, national rules on authorized substances shall remain in force in accordance with the general provisions of the Treaty;  (c) without prejudice to possible Community regulations applicable in the field of ionization, treated with ionizing or ultraviolet radiaton or treated with tenderizers or other substances which could affect the organoleptic properties of the meat or  colorants other than those used for health marking.  Article 14  1.  Each Member State shall draw up a list of the establishments approved by it, each establishment having a veterinary approval number. Member States may approve for slaughtering and cutting of rabbit and farmed game establishments approved according  to Directive 71/118/EEC or Directive 64/433/EEC, provided that those establishments are equipped for the processing of rabbit meat and/or farmed game meat and that those operations are performed in such a way as to comply with hygiene rules. Member  States shall send this list to the other Member States and to the Commission.  2.  No Member State shall approve an establishment unless compliance with this Directive is assured. Member States shall withdraw approval if the conditions for granting it cease to be fulfilled.  3.  If a check has been made in accordance with Article 16, the Member State concerned shall take account of the conclusions resulting therefrom. The other Member States and the Commission shall be informed of the withdrawal of approval.  4.  Inspection and supervision of approved establishments shall be carried out under the responsibility of the official veterinarian who, without prejudice to the tasks devolved to assistants under Directive 71/118/EEC, may be assisted in purely  material tasks by staff specially trained for the purpose. The official veterinarian must at all times have free access to all parts of establishments in order to ensure that this Directive is being complied with.  The detailed rules governing this assistance shall be determined in accordance with the procedure laid down in Article 20.  Article 15  Veterinary experts from the Commission may, insofar as it is necessary to ensure uniform application of this Directive,  make on-the-spot checks in co-operation with the competent authorities of the Member States; they may verify whether approved establishments are actually complying with this Directive. The Commission shall inform the Member States of the results of the  checks.  A Member State in whose territory a check is being carried out shall give all the necessary assistance to the experts carrying out their duties.  The general provisions for implementing this Article shall be determined in accordance with the procedure laid down in Article 20.  Article 16  1.  The rules laid down in Council Directive 89/662/EEC concerning veterinary checks to be carried out in intra-Community trade with a view to the completion of the internal market shall apply in particular to the organization of, and the action to be  taken following the checks carried out by the country of destination and to the safeguard measures to be applied in relation to health problems affecting the production and distribution of rabbit and game meat in the territory of the Community.  2.  Directive 89/662/EEC shall be amended as follows:  (a)  in Annex A, the following should be added in fine:  '- Council Directive 91/495/EEC of 27 November 1990 on public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat. (OJ No L 268, 24. 9. 1991, p. 41) (Excluding rabbit meat and farmed  game meat imported from third countries)';  (b) in Annex B, the indent 'rabbit and game meat' shall be replaced by 'wild game meat'.  Article 17  Pending the implementation of Community provisions concerning imports of rabbit and game meat from third countries, Member States shall apply to such imports provisions which are at least equivalent to those of this Directive.  However, pending the implementation of these provisions, Member States shall ensure that imports from third countries remain subject to the rules laid down in the third subparagraph of Article 6 (1) (b) of Directive 89/662/EEC and also that:  i(i)  fresh rabbit meat and fresh farmed game meat may not, under any circumstances, bear the public health marking referred to in Chapter X of Annex I to Directive 71/118/EEC and, if cut and boned, must be treated in accordance with Article 3 (1) (B)  of that Directive;  (ii) meat from species susceptible to trichinosis shall be subjected to examination by digestion in accordance with Directive 77/96/EEC.   CHAPTER V Final provisions   Article 18  This Directive shall not affect Community rules adopted in order to protect wildlife.  Article 19  The Annexes to this Directive shall be amended by the Council acting by a qualified majority on a proposal from the Commission in order in particular to bring it into line with technological progress.  Article 20  1.  Where the procedure laid down in this Article is to be used, matters shall without delay be referred by the Chairman, either on his own initiative or at the request of a Member State, to the Standing Veterinary Committee (hereinafter called 'the  Committee') set up by Decision 68/361/EEC (15).  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, upon expiry of a period of three months from the date of referral to the Council, the Council has not acted, the Commission shall adopt the proposed measures and implement them immediately, save where the Council has decided against the said measures by a simple majority.  Article 21  Pending implementation of Community health and veterinary inspection rules on the production and marketing of meat of wild game to be adopted not later than 31 March 1991, wild game meat fit for consumption shall be subject to the rules of Article 3  (3), the second indent of the second subparagraph of Article 4 (1) and to Article 5 (2) of Directive 89/662/EEC.  Article 22  1.  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1993. They shall forthwith inform the Commission thereof.  2.  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 a reference shall be laid down by the  Member States.  Article 23  This Directive is addressed to the Member States.  Done at Brussels, 27 November 1990.  For the Council The President V. SACCOMANDI (1) OJ No C 327, 30. 12. 1989, p. 40.(2) OJ No C 260, 15. 10. 1990, p. 154.(3) OJ No C 124, 21. 5. 1990, p. 7.(4) OJ No L 378, 31. 12. 1982, p. 58.(5) OJ No L 61, 4. 3. 1989, p. 48.(6) OJ No 121, 29. 7. 1964, p. 2012/64.(7) OJ No L 395, 30.  12. 1989, p. 13.(8) OJ No L 55, 8. 3. 1971, p. 23.(9) OJ No L 303, 31. 10. 1990, p. 6.(10) OJ No L 224, 18. 9. 1990, p. 29.(11) See page 35 of this Official Journal.(12) OJ No L 302, 31. 12. 1972, p. 24.(13) OJ No L 26, 31. 1. 1977, p. 67.(14) OJ No L  133, 17. 5. 1989, p. 33.(15) OJ No L 316, 26. 11. 1974, p. 10.(16) OJ No L 275, 26. 9. 1986, p. 36.(17) OJ No L 255, 18. 10. 1968, p. 23.   ANNEX I  CHAPTER I Ante-mortem health inspection of rabbits   1.  Animals must undergo ante-mortem inspection before they are slaughtered. As a general rule, such ante-mortem inspection must be carried out at the holding before loading.  (a)  If the ante-mortem inspection has been carried out at the holding of origin, ante-mortem inspection at the slaughterhouse may be restricted to detecting injuries received in transport if the rabbits have been inspected at the holding of origin  within the previous 24 hours and found to be healthy. In addition, the identity of the rabbits must be proved on arrival at the slaughterhouse.  If the ante-mortem inspection at the holding of origin and at the slaughterhouse is not carried out by the same official veterinarian, a health certificate stating the particulars required under Annex III must accompany the animals.  (b) If the ante-mortem inspection is not carried out at the holding of origin, rabbits for slaughter must undergo ante-mortem inspection within 24 hours of arrival at the slaughterhouse. The inspection must be repeated immediately before slaughter if more  than 24 hours have elapsed since ante-mortem inspection.  The operator of the slaughterhouse or his agent must facilitate operations for performing ante-mortem health inspections and in particular any handling which is considered necessary.  Each animal or batch of animals sent for slaughter must be identified in order to allow the competent authority to determine its origin.   2.  The ante-mortem inspection must be carried out by the official veterinarian in accordance with professional rules under suitable lighting.   3.  The inspection must determine:  (a)  whether the animals are suffering from a disease which can be transmitted to humans or animals, whether they show symptoms or whether their general condition is such as to indicate that the disease may occur;  (b)  whether they show symptoms of a disease or of a disorder affecting their general condition which may make the meat unfit for human consumption.   4.  Animals may not be slaughtered for human consumption where it is established that they suffer from the conditions referred to at point 3.   5.  The animals referred to at point 4 must be killed separately or after slaughter of all other rabbits and their meat hygienically disposed of.   CHAPTER II Post-mortem health inspection of rabbits   6.  Slaughtered rabbits must be inspected immediately after slaughter.   7.  The post-mortem inspection must be carried out under suitable lighting.   8.  The post-mortem health inspection must include:  (a)  visual inspection of the slaughtered animal;  (b) palpation and, where necessary, incision of the lungs, liver, spleen, kidneys and parts of the carcase which have undergone any change;  (c) investigations of anomalies of consistency, colour, smell and, where appropriate, taste;  (d) where necessary, laboratory tests.   9.  (a)  Rabbits shall be declared totally unfit for human consumption where the post-mortem inspection reveals the following:  - diseases transmissible to man or animals;  - malignant or multiple tumours; multiple abscesses;  - extensive parasitic infestation in the subcutaneous or muscle tissues;  - presence of residues of forbidden substances or residues in excess of permitted Community levels, including substances with a pharmacological effect;  - poisoning;  - extensive injuries or extensive blood or serum imbibition;  - anomalies as regards colour, smell or taste;  - anomalies as regards consistency, particularly oedema or severe emaciation.  (b) Parts of slaughtered animals which show localized lesions or contaminations not affecting the health of the rest of the meat shall be declared unfit for human consumption.  (c) The results of the ante-mortem and post-mortem health inspections shall be recorded by the official veterinarian and, if the presence of the diseases referred to in point 3 or the presence of residues are found, these shall be communicated to the  authorities of the official service responsible for supervision of the stock from which the animals originated, as well as to the person responsible for the stock in question.   CHAPTER III Public health marking  10.  The public health marking must be made under the responsibility of the official veterinarian, who shall keep and maintain for that purpose:  (a)  instruments for making the public health marking on meat, to be handed over to the assistant staff only at the actual time of marking and for the length of time necessary for this purpose;  (b)  labels and wrappers where these already bear one of the marks or of the seals referred to in point 11. These labels, wrappers and seals shall be handed over in the required number to the assistant staff at the time when they must be used.  11.1.  The public health marking shall consist of the following:  (a)  - on the upper part, the initial letter or letters in capitals of the name of the country of dispatch:  B, D, DK, EL, ESP, F, IRL, I, L, NL, P, UK,  - in the centre, the veterinary approval number of the slaughterhouse or, where appropriate, the cutting premises,  - on the lower part, one of the following sets of initials:  CEE, EEG, EWG, EOEF, EEC or EOK,  the letters and figures must be 0,2 cm high or (b)  an oval containing the information listed in (a); the letters must be 0,8 cm high and the figures 1,1 cm high.  2.  The material used for marking must meet all hygiene requirements and the information referred to in point 1 shall appear on it in perfectly legible form.  3.  (a)  The public health marking referred to in point 1 (a) must be made: - on unwrapped carcases by means of a seal containing the information listed in point 1 (a),  - on or visibly beneath wrappers or other packaging of packed carcases,  - on or visibly beneath wrappers or other packaging of parts of carcases or offal packed in small quantities;  (b)  The public health marking referred to in point 1 (b) must be made on large packaging.  4.  Where a public health marking appears on the wrapper or packaging in accordance with point 3:  - it must be applied in such a way that it is destroyed when the wrapper or packaging is opened, or - the wrapper or packaging must be sealed in such a way that it cannot be re-used after opening.   CHAPTER IV Storage  12.  After post-mortem inspection, rabbit meat must be chilled or frozen and kept at a temperature which must not at any time exceed -4 oC if chilled or -12 oC if frozen.   CHAPTER V Transport  13.  The rabbit meat must be dispatched in such a way that during transport it is protected from anything liable to contaminate it or to affect it unfavourably, having regard to the duration and conditions of transport and to the  means of transport employed. In particular, vehicles used for this transport must be equipped in such a way as to ensure that the temperatures laid down at point 12 are not exceeded.   ANNEX II  MODEL PUBLIC HEALTH CERTIFICATE for fresh rabbit meat (¹) intended for consignment to a Member State of the EEC  Exporting country: .  No (²): .  Ministry: .  Competent service: .  Ref. (²): .  I.  Identification of meat Meat of: .  (animal species)  Nature of cuts: .  Nature of packaging: .  Number of packages: .  Net weight: .  III.  Origin of meat Address(es) and veterinary approval number(s) of the slaughterhouse(s) (%): .  .  Address(es) and veterinary approval number(s) of the approved cutting premises (%): .  .  III.  Destination of meat The meat will be sent from .  (place of loading)  to .  (country and place of destination)  by the following means of transport (³): .  Name and address of consignor: .  .  Name and address of consignee: .  .  (¹) Fresh rabbit meat which has not been treated to ensure its preservation; however, rabbit meat which has been chilled or frozen shall be considered to be fresh.  (²) Optional.  (³) For railway wagons and lorries the registration number, for aircraft the flight number and for ships the name should be given.  (%) Delete as appropriate.  IV.  Public health attestation I, the undersigned, official veterinarian, certify that:  (a)  - the rabbit meat described (%),  - the packaging of the meat described above (%) bears a mark proving that:  - the meat comes from animals slaughtered in approved slaughterhouses (%),  - the meat was cut in approved cutting premises (%);  (b) this meat has been passed as fit for human consumption following a veterinary inspection carried out in accordance with Council Directive 90/495/EEC of 27 November 1990 concerning public health and animal health problems affecting the production and  placing on the market of rabbit meat and farmed game meat;  (c) the transport vehicles or containers and the loading conditions of this consignment meet the hygiene requirements laid down in that Directive.  Done at .  on .  .  (signature of official veterinarian) (%) Delete as appropriate.   ANNEX III  MODEL HEALTH CERTIFICATE for farmed rabbits or game (¹) transported from the farm to the slaughterhouse  Competent service: .  No (²): .  I.  Identification of animals Animal species: .  Number of animals: .  Identification marking: .  III.  Origin of animals Address of holding of origin: .  .  III.  Destination of animals The animals will be sent to the following slaughterhouse: .  .  by the following means of transport: .  IV.  Attestation I, the undersigned, official veterinarian, hereby certify that the animals described above underwent an ante-mortem inspection at the above holding at .  . . . . . . . . . . . . . on . . . . . . . . . . . and were found to be healthy.  Done at .  on .  .  (signature of official veterinarian) (¹) Under the conditions provided for in Article 6 (3) of Directive 90/495/EEC.  (²) Optional.   ANNEX IV  MODEL HEALTH CERTIFICATE for fresh farmed game meat (¹) intended for consignment to a Member State of the EEC  Exporting country: .  No (²): .  Ministry: .  Competent service: .  Ref. (²): .  I.  Identification of meat Meat of: .  (animals species)  Nature of cuts: .  Nature of packaging: .  Number of packages: .  Net weight: .  III.  Origin of meat Address(es) and veterinary approval number(s) of the slaughterhouse(s) (%): .  .  Address(es) and veterinary approval number(s) of the approved cutting premises (%): .  .  III.  Destination of meat The meat will be sent from .  (place of loading)  to .  (country and place of destination)  by the following means of transport (³): .  Name and address of consignor: .  .  Name and address of consignee: .  .  (¹) Fresh meat of farmed game birds and of farmed wild mammals which has not been treated to ensure its preservation; however, meat which has been chilled or frozen shall be considered to be fresh.  (²) Optional.  (³) For railway wagons and lorries the registration number, for aircraft the flight number and for ships the name should be given.  (%) Delete as appropriate.  IV.  Health attestation I, the undersigned, official veterinarian, certify that:  (a)  - the meat of the species described above (%),  - the packaging of the meat described above (%),  bears a mark proving that:  - the meat comes from animals slaughtered in approved slaughterhouses (%),  - the meat was cut in approved cutting premises (%);  (b) this meat has been passed as fit for human consumption following a veterinary inspection carried out in accordance with:  - the Council Directive 77/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat (%),  - Council Directive 64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat (%);  (c) the transport vehicles or containers and the loading conditions of this consignment meet the hygiene requirements laid down in that Directive.  Done at . ,  on .  .  (Signature of official veterinarian) (%) Delete as appropriate.


title: Council Directive 2009/82/EC of 13 July 2009 amending Directive 91/414/EEC to include tetraconazole as an active substance (Text with EEA relevance )

text:
               28.7.2009

               EN

               Official Journal of the European Union

               L 196/10

      COUNCIL DIRECTIVE 2009/82/EC
   of 13 July 2009
   amending Directive 91/414/EEC to include tetraconazole as an active substance
   (Text with EEA relevance)
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community,
   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 1490/2002 (3) lay down the detailed rules for the implementation of the third 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 includes tetraconazole.

               (2)

               For tetraconazole the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 1490/2002 for a range of uses proposed by the notifier. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 10(1) of Regulation (EC) No 1490/2002. For tetraconazole the rapporteur Member State was Italy and all relevant information was submitted on 15 July 2005.

               (3)

               The assessment report has been peer reviewed by the Member States and the EFSA, and presented to the Commission on 31 July 2008 in the format of the EFSA Scientific Report for tetraconazole. This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 26 February 2009 in the format of the Commission review report for tetraconazole.

               (4)

               It has appeared from the various examinations made that plant protection products containing tetraconazole 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 have been examined and detailed in the Commission review report. It is therefore appropriate to include tetraconazole in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

               (5)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate as regards tetraconazole, to require that the notifier submits further information on a refined consumer risk assessment, on the specification regarding ecotoxicology, on the fate and behaviour of potential metabolites in all relevant compartments, on the refined risk assessment of such metabolites to birds, mammals aquatic organisms and non-target arthropods and on the potential for endocrine disrupting effects to birds, mammals and fish.

               (6)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

               (7)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection containing tetraconazole to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (8)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (4) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties, it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

               (9)

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

               (10)

               The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time-limit laid down by its Chairman.

               (11)

               In accordance with point 34 of the Interinstitutional agreement on better law-making (5), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables, which will, as far as possible, illustrate the correlation between this Directive and the transposition measures, and to make them public,

         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 adopt and publish by 30 June 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
   They shall apply these provisions from 1 July 2010.
   When they are adopted by Member States, these measures 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.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing tetraconazole as an active substance by 30 June 2010.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to tetraconazole are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing tetraconazole as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 December 2009 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning tetraconazole. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in points (b), (c), (d) and (e) of Article 4(1) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing tetraconazole as the only active substance, where necessary, amend or withdraw the authorisation by 30 June 2014; or

               (b)

               in the case of a product containing tetraconazole as one of several active substances, where necessary, amend or withdraw the authorisation by 30 June 2014 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 January 2010.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 13 July 2009.

            For the Council

            The President

         E. ERLANDSSON

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

      (3)  OJ L 224, 21.8.2002, p. 23.

      (4)  OJ L 366, 15.12.1992, p. 10.

      (5)  OJ C 321, 31.12.2003, p. 1.

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

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘Tetraconazole
                     CAS No 112281-77-3
                     CIPAC No 726

                        (RS)-2-(2,4-dichlorophenyl)-3-(1H-1.2,4-triazol-1-yl)-propyl-1.1,2,2-tetrafluoroethyl ether

                     ≥ 950 g/kg (racemic mixture)
                     Impurity toluene: not more than 13 g/kg

                     1 January 2010

                     31 December 2019

                     PART A
                     Only uses as fungicide in field crops with an application of max. 0,100 kg/ha every third year on the same field may be authorised. Uses in apples and grapes must not be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on tetraconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,

                                 —

                                 the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

                           The Member States concerned shall request:

                                 —

                                 the submission of further information on a refined consumer risk assessment,

                                 —

                                 further information on the specification regarding ecotoxicology,

                                 —

                                 further information on the fate and behaviour of potential metabolites in all relevant compartments,

                                 —

                                 the refined risk assessment of such metabolites to birds, mammals aquatic organisms and non-target arthropods,

                                 —

                                 further information on the potential for endocrine disrupting effects to birds, mammals and fish,

                           They shall ensure that the notifier provides such information to the Commission by 31 December 2011.’

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