Important legal notice

Council Directive 77/96/EEC of 21 December 1976 on the examination for trichinae (trichinella spiralis) upon importation from third countries of fresh meat derived from domestic swine Official Journal L 026 , 31/01/1977 P. 0067 - 0077 Finnish special edition: Chapter 3 Volume 8 P. 0041 Greek special edition: Chapter 03 Volume 17 P. 0042 Swedish special edition: Chapter 3 Volume 8 P. 0041 Spanish special edition: Chapter 03 Volume 11 P. 0156 Portuguese special edition Chapter 03 Volume 11 P. 0156 Special edition in Czech Chapter 3 Volume 03 P. 67 - 77 Special edition in Estonian Chapter 3 Volume 03 P. 67 - 77 Special edition in Hungarian Chapter 3 Volume 03 P. 67 - 77 Special edition in Lithuanian Chapter 3 Volume 03 P. 67 - 77 Special edition in Latvian Chapter 3 Volume 03 P. 67 - 77 Special edition in Maltese Chapter 3 Volume 03 P. 67 - 77 Special edition in Polish Chapter 3 Volume 03 P. 67 - 77 Special edition in Slovakian Chapter 3 Volume 03 P. 67 - 77 Special edition in Slovenian Chapter 3 Volume 03 P. 67 - 77

Council Directive of 21 December 1976 on the examination for trichinae (trichinella spiralis) upon importation from third countries of fresh meat derived from domestic swine (77/96/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries [1], as last amended by Directive 75/379/EEC [2], and in particular Article 21 thereof, Having regard to the proposal from the Commission, Whereas in Directive 72/462/EEC the Council provided in Article 21 for the laying down of the method and procedures required for detecting the presence of trichinae in fresh pigmeat; Whereas the application of Directive 72/462/EEC will not have the desired effects as long as disparities exist between the Member States as to the guarantees required in respect of the detection of trichinae upon importation of fresh meat from third countries; whereas it is therefore necessary to lay down Community arrangements in this field; Whereas, in order to protect consumer health, it is necessary that fresh pigmeat be systematically subjected to an examination using methods recognized as effective, in order to eliminate meat containing trichinae; Whereas when the examination is carried out in the exporting third country, it must be carried out in slaughterhouses which comply with certain conditions and which contain, in particular, a screening laboratory provided with suitable equipment; Whereas in order to be able to distinguish the meat samples examined from those not examined it is necessary to provide for the affixing of a special mark to meat which has been examined with a negative result; Whereas there should be a procedure establishing close and effective cooperation between the Commission and the Member States for assessing the advisability of permitting establishments in the third countries to carry out this examination or to work on the meat examined; whereas there should also be a procedure for bringing the technical provisions relating in particular to the examination methods, the requirements concerning the screening laboratories and the procedure for marking examined meat into line with technical progress and with experience acquired; Whereas the Member States should be allowed to admit fresh meat which has not been screened for trichinae in the exporting third country, provided that this meat, undergoes treatment by freezing; which ensures that any trichinae which may be present are rendered harmless, either in the exporting third country, or in the Member State for which the meat is intended; whereas this treatment must nevertheless be carried out according to certain well defined procedures and establishments fulfilling certain conditions, HAS ADOPTED THIS DIRECTIVE: Article 1 The definitions used in this Directive are those contained in Directive 72/462/EEC. Moreover: (a) "fresh meat" means fresh meat of domestic swine; (b) "examination" refers to the examination to detect the presence of trichinae in fresh meat. Article 2 1. In order to be admitted to intra-Community trade, fresh meat originating in third countries which contains skeletal muscles (striated muscles) shall be examined under the supervision and responsibility of an official veterinarian. 2. The examination shall be carried out in accordance with one of the methods provided for in Annex I, on the whole carcase or, failing this, on each half carcase, quarter carcase or piece to be imported into the Community. 3. The examination shall take place in a slaughterhouse approved in the exporting country in accordance with Article 4 of Directive 72/462/EEC and authorized to carry out this examination in accordance with Article 4 of this Directive. 4. The examination shall take place before the health marking provided for in Chapter X of Annex B to Directive 72/462/EEC. 5. If it is not possible to carry out the examination in the exporting country, the Member State for which the fresh meat is intended may authorize its importation provided that the examination is carried out within its territory at the time of the public health inspection provided for in Article 24 (2) of Directive 72/462/EEC, at an inspection post within the meaning of Article 27 (1) (b) of that Directive. 6. (a) If the outcome of the examination is negative, the fresh meat shall be marked immediately after the examination, in accordance with Annex III. (b) In the case of ink stamping, use shall be made of a colorant within the meaning of Article 17 (3) of Directive 72/462/EEC. Article 3 1. By way of derogation from Article 2, the Member State for which it is intended may authorize the exemption from examination of fresh meat from certain third countries or parts of such countries, provided it is frozen in accordance with the provisions of Annex IV. 2. This treatment shall be carried out in an establishment situated in the exporting third country, and described in Article 4 (1). Freezing in the exporting third country must be the subject of certification by the official veterinarian on the health certificate accompanying the meat, as referred to in Article 22 (3) of Directive 72/462/EEC. 3. If the treatment has not been carried out in the exporting third country, it must be carried out at an inspection post as described in Article 2 (5). Freezing in a Member State must be the subject of certification by the official veterinarian on the certificates accompanying the meat, as referred to in Article 25 of Directive 72/462/EEC. Article 4 1. The authorization for a slaughterhouse to carry out the examination and of a cutting plant to cut up or bone meat which has undergone such examination, or the authorization for an establishment to carry out the freezing treatment referred to in Article 3, shall be decided on in accordance with the procedure laid down in Article 9. In addition to the requirements of Article 4 of Directive 72/462/EEC, account shall be taken of the guarantees given in respect of compliance with this Directive and, in the case of slaughterhouses, of: (a) the presence of the rooms and apparatus necessary for carrying out the examination; (b) the qualifications of the personnel responsible for carrying out the examination. Authorization shall be granted to a slaughterhouse and cutting plant only where the competent authorities of the third country concerned have officially recognized that the slaughterhouse and cutting plant are in a position to satisfy the conditions laid down in Article 5 and in Annex III; also, in the case of a slaughterhouse, that it has a laboratory which complies with the conditions laid down in Annex II, Chapter I, and which is in a position to satisfy the requirements of the other chapters of Annex II and those of Annex I. Authorization shall be granted to an establishment to carry out the freezing treatment only if the competent authorities of the third country concerned have officially recognized that the establishment is in a position to satisfy the conditions laid down in Annex IV. 2. On the list(s) referred to in Article 4 (4) of Directive 72/462/EEC, a special indication shall be inserted against the names of the establishments which have been granted an authorization within the meaning of paragraph 1. Article 5 1. In slaughterhouses which have been granted an authorization in accordance with Article 4, swine the meat of which is intended for the Community must be slaughtered in different rooms or in the absence thereof at different times from swine the meat of which is not intended for the Community, unless the meat of such swine is examined in accordance with the same procedure. 2. The cutting and boning of meat which has undergone an examination with negative results and is intended for the Community must be carried out in cutting plants, in accordance with Article 4. In these cutting plants, the cutting and boning of such meat must be carried out in different rooms or in the absence thereof, at different times from meat which is not intended for the Community, unless the meat is examined in accordance with the same procedure. Article 6 The inspections in third countries provided for in Article 5 of Directive 72/462/EEC must also verify whether the present Directive is being applied. Article 7 The Member States shall draw up and communicate to the Commission the list of the inspection posts referred to in Article 2 (5) at which: - the examination, - the freezing referred to in Article 3, may be carried out. They shall ensure that these posts have the equipment necessary for carrying out the operations in question. Article 8 Acting on a proposal from the Commission, the Council shall decide before 1 January 1979 on any additions to be made to the methods laid down in Annex I. Article 9 1. Where the procedure laid down in this Article is followed, the matter 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 referred to as "the Committee") set up by the Council Decision of 15 October 1968. 2. Within the Committee the votes of the Member States shall be weighted as laid down in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The representative of the Commission shall submit a draft of the measure to be adopted. The Committee shall deliver its opinion on these measures within a time limit set by the chairman having regard to the urgency of the questions under examination. Opinions shall be delivered by a majority of 41 votes. 4. The Commission shall adopt the measures and shall implement them immediately, where they are in accordance with the opinion of the Committee. Where 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 on the measures to be taken. The Council shall adopt the measures by a qualified majority. If the Council has not adopted any measures within three months of the date on which the matter is referred to it, the Commission shall adopt the proposed measures and shall implement them immediately save where the Council has decided against such measures by a simple majority. Article 10 Article 9 shall apply until 21 June 1981. Article 11 The Member States shall bring into force on 1 January 1979 at the latest the laws, regulations and administrative provisions needed for compliance with this Directive. They shall forthwith inform the Commission thereof. Article 12 This Directive is addressed to the Member States. Done at Brussels, 21 December 1976. For the Council The President A. P. L. M. M. van der Stee [1] OJ No L 302, 31. 12. 1972, p. 28. [2] OJ No L 172, 3. 7. 1975, p. 17. -------------------------------------------------- ANNEX I METHODS OF EXAMINATION FOR TRICHINAE I. TRICHINOSCOPIC EXAMINATION (a) Apparatus An incandescent lamp trichinoscope with 50 × and 80 to 100 × magnification. A pressure glass consisting of two glass plates — one of which is divided into equal fields — small curved scissors, small forceps, a knife for cutting specimens, small numbered containers for storing the specimens separately, a dropping pipette, a glass of acetic acid and a glass of potassium hydroxide solution for brightening any calcifications or softening dried meat. (b) Taking of specimens In the case of whole carcases, at least one specimen of the size of a hazelnut is to be taken from both diaphragm pillars at the transition of the sinewy part. If there is only one diaphragm pillar, one specimen the size of two hazelnuts is to be taken. In the absence of both diaphragm pillars, two specimens approximately the size of a hazelnut are to be taken from the rib part or the breastbone part of the diaphragm or, as the case may be, from the lingual muscle or the jaw muscle or from the abdominal muscles. For pieces of meat, from each piece take three samples of skeletal muscle, containing little fat, if possible the size of a hazelnut, and taken from different points, where possible near to bones or tendons. (c) Method If both diaphragm pillars are present the trichinae inspector must cut, from each of the above specimens taken from a whole carcase, seven pieces the size of an oat-kernel making 14 in all; if only one diaphragm pillar is present, 14 pieces, from different places and if possible from the transition to the sinewy part; he must then compress them between the glass plates in such a way that normal print can be clearly read through the slide preparation. If the flesh of the specimens to be examined is dry and old, the preparations must be softened in a mixture of one part potassium hydroxide solution to about two parts water for 10 to 20 minutes before pressing. If, in the case of whole carcases, specimens have to be taken from the rib part or the breastbone part of the diaphragm, the lingual muscle or jaw muscle or the abdominal muscles, then 14 pieces the size of an oat-kernal are to be cut from each specimen, i.e. a total of 28. From each of the samples taken from pieces of meat, the trichinae inspector must cut four pieces the size of an oat-kernal, making 12 pieces in all. The trichinoscopic examination must be carried out in such a manner that each preparation is scanned slowly and carefully. If the trichinoscopic examination reveals suspect areas, the nature of which cannot be definitely ascertained even with the most powerful magnification of the trichinoscope, these must be checked by microscope. The microscopic examination should be carried out in such a manner that each preparation is scanned slowly and carefully at a magnification of 30 to 40 ×. In the case of an uncertain result, the examination must be continued on a further number of specimens and slide preparations, if necessary with the aid of higher magnifications, until the information required is obtained. The trichinoscopic examination must be carried out for at least three minutes. The trichinoscopic examination must be carried out for at least six minutes in the case of substitute specimens taken from the rib part or breastbone part of the diaphragm pillars, the lingual muscle or the jaw muscle or the abdominal muscles. The minimum time fixed for the examination does not include the time necessary for sample-taking and for making the preparations. As a general rule, the trichinoscopic examiner should not inspect more than 840 pieces a day, though by way of exception he may inspect up to 1050. II. THE ARTIFICIAL DIGESTION METHOD (a) Apparatus and material - knife for taking samples, - small numbered containers, with closures, for storing samples, if necessary until repetition of the examinations, - incubator, - 2 to 3 litre glass funnel with stand, a connecting hose in rubber, clamps for fastening the connecting hose, - a plastic sieve (approximately 18 cm in diameter, and approximately 1 mm mesh), - gauze, - a small tapering tube with a sealed end, - a glass block dish, - a meat mincer, - a stereo-microscope, - digestive liquid made up as follows: 10 g of pepsin (1200 u/g), 5 ml HCl (at least 37 %) made up to a litre with tap water. (b) Taking of specimens 1. In the case of whole carcases a sample of at least 20 g to be taken from a diaphragm pillar at the transition to the sinewy part. In the absence of diaphragm pillars a specimen of at least 20 g to be taken from the rib part or the breastbone part of the diaphragm or from the lingual muscle or the jaw muscle or the abdominal muscles. 2. For pieces of meat, a sample of at least 20 g of skeletal muscle to be taken, containing little fat and where possible near to bones or tendons. (c) Method For the examination of a collective specimen from 10 pigs, a 10 g specimen shall be prepared from each individual 20 g sample. The remaining 10 g shall be kept for additional single-specimen examination should this be necessary. 10 specimens, each weighing 10 g, shall be combined into a collective specimen; it shall be minced in a meat mincer (with 2 mm perforations) and placed loosely in a sieve lined with a layer of gauze. The sieve shall then be placed in a funnel connected by a length of rubber hose to a small tapered tube with a sealed end; the funnel shall be filled from the edge with digestive liquid until the matter for analysis is completely covered. The proportion of matter for analysis to digestive liquid must be approximately 1:20 to 1:30. After 18 to 20 hours of incubation at 37 to 39 °C, the small tapered tube shall be disconnected and removed. After carefully drawing off the supernatant liquid, the sediment present in the tip of the tube is to be carefully rinsed in a dish. Then to be examined for the presence of trichinae with a stereo-microscope at 20 to 40 × magnification. In the case of a positive or doubtful result from the examination of a collective specimen, the remaining single specimens to be examined individually after addition of a further 20 g from each pig, or in the case of pieces of meat, the addition of 20 g taken from each piece, according to (b) above. III. METHOD USING THE ARTIFICIAL DIGESTION OF COLLECTIVE SAMPLES (a) Apparatus and reagents - knife and tweezers for collecting specimens, - meat mincer with 2 to 3 mm diameter perforations, - a 3 ml Erlenmeyer flask with a rubber or cotton-wool plug, - a conical separation funnel of 2000 ml capacity, - an ordinary A-base stand of approximately 28 cm length with an 80 cm stem, - a ring, diameter approximately 10 to 11 cm which can be fixed to the stand, - a clamp with a flat vice (23 × 40 mm) which can be attached to the stand by means of a double coupling, - an Endecott sieve number 80 (mesh fineness 177) with an external diameter of 11 cm fitted with brass or stainless steel mesh, - a plastic funnel with an internal diameter of not less than 12 cm, - an ordinary dissection microscope (magnification 40 ×) fitted with its ordinary lamp, or a standard binocular microscope (magnification 40 ×), - a trichinoscope with horizontal table for the compressor, - when using the trichinoscope: a larvae counting basin of the same outer shape as the compressor with a volume of approximately 60 to 65 cc. The larvae counting basin may be described as follows: The shape of the basin consists of a 23 cm long glass plate being of the same thickness as that of a single plate in a common compressor. The width, however, is slightly less, e.g. 4·5 cm in order to provide for the fixation of a glass plate, 2 mm thick, 1·8 cm high, and 17·5 cm long, on both of the long sides of the bottom plate. The basin is closed at the ends by two glass plates fixed directly onto the bottom plate, and which are 5 cm long, 1 cm high, and 2 mm thick. The height of the basin, measured from inside, will thus be about 1 cm. The plates are glued together with ordinary glass adhesive. Approximately 2·8 cm of the bottom plate is left free at both ends for protection purposes, and for easy handling of the filled basin. The volume of the basin is approximately 60 to 65 cc in total, - when using the microscope a number of 9 cm diameter Petri dishes are needed, - a speedmarker for marking out in the bottom of the Petri dish the 1 cm square examination areas, - a number of 10 litre bins to be used when applying formol treatment to the apparatus, and for the remaining digestive juice in the case of positive results, - concentrated (37 %) hydrochloric acid, - 30000 units per gram of "Merck" powdered pepsin, or pepsin with known strength from another firm, - one or two trays which can hold 100 samples or approximately 2 g of meat. (b) Collection of specimens 1. In the case of whole carcases a specimen to be taken of approximately 2 g from a pillar of the diaphragm at the transition to the sinewy part. In the absence of diaphragm pillars a specimen of the same size to be taken from the rib part or the breastbone part of the diaphragm, from the lingual muscle or the jaw muscle or the abdominal muscles. 2. For cuts of meat, a sample of approximately 2 g of skeletal muscle to be taken, containing little fat and where possible near to bones or tendons. (c) Method Approximately 1 g of sample shall be taken from each of the 100 individual samples from the pigs. The pooled sample is put once through the mincer. The minced meat shall be placed in the 3 litre Erlenmeyer flask together with 7 g of pepsin, approximately 2 litres of tap water heated to about 37 to 40 °C, and 25 ml of concentrated hydrochloric acid. The mixture shall be shaken to dissolve the pepsin. The pH of the solution will be about 1·5 to 2. - For digestion the Erlenmeyer flask shall be incubated at 37 °C for approximately four hours. The flask shall be regularly shaken during the time of incubation, e.g. once or twice every hour. - The digested solution shall be filtered through the sieve into the conical 2 litre separation funnel and left undisturbed on the stand for at least one hour. - A total volume of approximately 45 cc shall be run out of the funnel and divided between three Petri dishes, the bottoms of which shall be marked out in 1 cm squares, with 15 ml in each dish. - Each Petri dish shall be minutely examined for larval trichinae under the microscope (around 40 × magnification). - Where larvae counting basins are employed, the 45 cc shall, be distributed between two larvae counting basins and examined under the trichinoscope. The larvae appear as identifable organisms in the deposit, and often, when the water is lukewarm, rolling and unrolling movements of the "spiral" may be observed. If an insufficiently transparent sediment forms, it shall be clarified by rinsing. The final sample of 45 ml is poured into a test tube and allowed to settle for 15 minutes. The supernatant liquid shall then be carefully removed by suction and the sediment placed into suspension in about 45 ml of tap water. After a further settling period of 15 minutes, the supernatant liquid shall again be carefully removed by suction and the sediment carefully rinsed in about 20 ml of tap water in a Petri dish, and examined. In the case of a positive or doubtful result from analysis of a collective specimen, the remaining single specimens to be analyzed individually after addition of a further 20 g from each pig, or, in the case of pieces of meat, the addition of 20 g taken from each piece, in accordance with (b) above. -------------------------------------------------- ANNEX II CHAPTER I CONDITIONS FOR THE AUTHORIZATION OF TRICHINAE (TRICHINELLA SPIRALIS) LABORATORIES 1. Trichinae laboratories must be situated next to the swine slaughterhouses and, if the establishment does not already possess such facilities to fulfil the other requirements of the Directive on third countries, have at least the following facilities available: (a) a lockable room adequately equipped for the preparation of specimens; its walls must be smooth and must be lined with a washable light-coloured covering or paint up to a height of 2 m. A preparation room must be provided for each method of examination used; (b) an adequately equipped lockable examination room for trichinoscopy and microscopy; (c) equipment providing adequate ventilation and, if necessary, air conditioning equipment which ensures that the room temperature does not exceed + 25 °C; (d) adequate natural or artificial lighting which does not alter colours; direct sunlight must be avoided; (e) in the preparation room, adequate equipment for cleaning and disinfecting hands; (f) equipment for darkening the examination room; (g) possibly, refrigerators in which to store meat samples; (h) a washroom for cleansing and disinfecting examination equipment (e.g. containers for samples, compressors, knives and scissors), with: - a waterproof floor-covering which is rot-proof and easy to clean and disinfect, - smooth walls which, up to a height of at least 2 m, are lined by a washable, and light-coloured covering or paint; (i) changing rooms, wash basins and rest rooms and flush lavatories; (j) wash basins with hot and cold running water, provided with cleansing and disinfecting materials and disposable towels; (k) watertight corrosion-resistant containers, with hermetically sealed lids, for collecting the samples after examination, and so designed as to prevent unauthorized removal of the contents; (l) adequate supplies of hot and cold drinking water; (m) equipment for removing waste water which fulfils the conditions for the authorization of slaughterhouses; (n) proper equipment for protection against pests (insects, rodents, etc.). CHAPTER II REQUIREMENTS APPLICABLE TO STAFF, PREMISES, EQUIPMENT AND INSTRUMENTS IN TRICHINAE LABORATORIES 2. Absolute cleanliness is required at all times of laboratory staff, premises, equipment and instruments: (a) staff must wear clean working clothes and wash their hands several times during working hours and after each break; (b) no animal may enter trichinae laboratories; (c) equipment and instruments used must be kept clean and in good repair. They must be carefully cleansed and disinfected several times during and at the end of the day's work. 3. Drinking water must be used for all purposes. 4. As regards health, staff taking meat samples for examination must comply with the rules in Annex B, Chapter IV (11) and (12) of Directive 72/462/EEC. 5. The meat samples required for examination must be taken immediately after slaughter and examined without delay in the trichinae laboratory of the slaughterhouse. These examinations are forbidden away from the slaughterhouse in which the animals were slaughtered. 6. To avoid fatigue and its consequences, inspection staff should be given short breaks during the working day. CHAPTER III REQUIREMENTS IN RESPECT OF TRICHINOSCOPES The construction and design of trichinoscopes must meet the following minimum criteria: 1. Simple operation. 2. High light intensity: - accurate results must be obtainable even in a room which is not completely dark, - a projector bulb of 100 W (12 V) must be used as the light source. 3. Adequate magnification: - normal working magnification: 50 x, - 80 to 100 x magnification for more precise assessment of objects not clearly identifiable under normal working magnification. 4. Resolving power: - a clear sharp picture of well-defined colour must be obtainable at each magnification. 5. Switch mechanism: - each change of magnification must be accompanied by automatic adjustment of the brightness of the image. 6. Increase of contrast: - the condensor must be provided with an iris diaphragm enabling the contrast to be increased for the closer inspection of difficult cases, - the iris diaphragm must be easy to operate (e.g. control lever on the platform of the trichinoscope). 7. Easy focusing: - rapid focusing by means of an adjusting ring, - precise focusing by means of a control lever. 8. Voltage regulation: - so that brightness may be adjusted as required. 9. One-way movement of the compressor: - an automatic blocking mechanism must ensure that the compressor moves in only one direction, to prevent unintentional displacement. 10. Free view of the projector screen. 11. Projector screen: - at least 54 cm in diameter, - high reflecting capability, - durable, - can be dismantled, - easy to clean. -------------------------------------------------- ANNEX III MARKING OF MEAT WHICH HAS BEEN EXAMINED FOR TRICHINAE 1. Marking of the meat must be carried out under the responsibility of the official veterinarian. For this purpose, he shall keep and maintain: - the instruments intended for marking which he may hand over to the assistant staff only at the time of marking and for the length of time required for this purpose, - the tags mentioned in paragraph 5. These tags shall be given to the assistant staff at the time when they must be used and in the required number. 2. The mark must be round with a diameter of 2·5 cm. The following information must appear on the mark in perfectly legible characters: - towards the centre the capital letter "T" with arms 1 cm long and 0·2 cm wide, - under the letter "T" one of the following sets of initials: CEE, EEG, EWG, EØF or EEC. The letters must be 0·4 cm high. 3. Carcases must be marked in ink or hot-branded on the inside of the thighs, in accordance with paragraph 2. 4. Heads must be marked in ink or hot-branded, with a mark meeting the requirements of paragraph 2. With the exception of cuts exempt from health marking by virtue of Annex B, Chapter X (43) of Council Directive 72/462/EEC, those taken in cutting plants from carcases marked in accordance with the rules must, where they bear no stamp, be marked in accordance with paragraph 2 before the health mark is affixed. The label provided for in the second subparagraph of the abovementioned paragraph 43 must comply with the conditions of paragraph 6 below. 5. Marking may also be effected by means of a round tag. This tag, to be affixed to each piece or to each carcase must not be reusable, must be made of strong materials and must meet all hygiene requirements. The following information must appear on the stamp seals in perfectly legible characters: - towards the centre the capital letter "T", - under the letter "T" one of the following sets of initials: CEE, EEG, EWG, EØF or EEC. The letters must be 0·2 cm high. 6. The label provided for in Annex B, Chapter X (44) of the Directive mentioned in paragraph 4 above must, in addition to the health mark, bear a clearly legible mark identical to that provided for in paragraph 2. -------------------------------------------------- ANNEX IV THE FREEZING OF MEAT 1. Meat brought in already frozen must be kept in this condition. 2. The technical equipment and energy supply of the refrigerating room, must be such as to ensure that the temperature referred to under paragraph 6 is reached very rapidly and maintained in all parts of the room and of the meat. 3. Insulated packaging should be removed before freezing, except for meat which has already reached throughout the temperature referred to under paragraph 6 when it is brought into the refrigeration room. 4. Consignments in the refrigeration room must be kept separately and under lock. 5. The date and time when each consignment is brought into the refrigeration room must be recorded. 6. The temperature in the refrigeration room must be at least − 25 °C. It should be measured with calibrated thermo-electric instruments and continuously recorded. It may not be measured directly in the cold air flow. The instruments must be kept under lock. The charts must include the relevant numbers from the meat inspection register on importation and the date and time of the commencement and completion of freezing, and must be retained for one year after compilation. 7. Meat with a diameter or thickness of up to 25 cm must be frozen for at least 240 consecutive hours, and meat with a diameter or thickness of between 25 and 50 cm must be frozen for at least 480 consecutive hours. This freezing process may not be applied to meat which has a larger diameter or is thicker. The freezing time shall be calculated from the point when the temperature referred to in paragraph 6 is reached in the freezing room. --------------------------------------------------

Council Directive

of 21 December 1976

on the examination for trichinae (trichinella spiralis) upon importation from third countries of fresh meat derived from domestic swine

(77/96/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries [1], as last amended by Directive 75/379/EEC [2], and in particular Article 21 thereof,

Having regard to the proposal from the Commission,

Whereas in Directive 72/462/EEC the Council provided in Article 21 for the laying down of the method and procedures required for detecting the presence of trichinae in fresh pigmeat;

Whereas the application of Directive 72/462/EEC will not have the desired effects as long as disparities exist between the Member States as to the guarantees required in respect of the detection of trichinae upon importation of fresh meat from third countries; whereas it is therefore necessary to lay down Community arrangements in this field;

Whereas, in order to protect consumer health, it is necessary that fresh pigmeat be systematically subjected to an examination using methods recognized as effective, in order to eliminate meat containing trichinae;

Whereas when the examination is carried out in the exporting third country, it must be carried out in slaughterhouses which comply with certain conditions and which contain, in particular, a screening laboratory provided with suitable equipment;

Whereas in order to be able to distinguish the meat samples examined from those not examined it is necessary to provide for the affixing of a special mark to meat which has been examined with a negative result;

Whereas there should be a procedure establishing close and effective cooperation between the Commission and the Member States for assessing the advisability of permitting establishments in the third countries to carry out this examination or to work on the meat examined; whereas there should also be a procedure for bringing the technical provisions relating in particular to the examination methods, the requirements concerning the screening laboratories and the procedure for marking examined meat into line with technical progress and with experience acquired;

Whereas the Member States should be allowed to admit fresh meat which has not been screened for trichinae in the exporting third country, provided that this meat, undergoes treatment by freezing; which ensures that any trichinae which may be present are rendered harmless, either in the exporting third country, or in the Member State for which the meat is intended; whereas this treatment must nevertheless be carried out according to certain well defined procedures and establishments fulfilling certain conditions,

HAS ADOPTED THIS DIRECTIVE:

The definitions used in this Directive are those contained in Directive 72/462/EEC.

Moreover:

(a) "fresh meat" means fresh meat of domestic swine;

(b) "examination" refers to the examination to detect the presence of trichinae in fresh meat.

1. In order to be admitted to intra-Community trade, fresh meat originating in third countries which contains skeletal muscles (striated muscles) shall be examined under the supervision and responsibility of an official veterinarian.

2. The examination shall be carried out in accordance with one of the methods provided for in Annex I, on the whole carcase or, failing this, on each half carcase, quarter carcase or piece to be imported into the Community.

3. The examination shall take place in a slaughterhouse approved in the exporting country in accordance with Article 4 of Directive 72/462/EEC and authorized to carry out this examination in accordance with Article 4 of this Directive.

4. The examination shall take place before the health marking provided for in Chapter X of Annex B to Directive 72/462/EEC.

5. If it is not possible to carry out the examination in the exporting country, the Member State for which the fresh meat is intended may authorize its importation provided that the examination is carried out within its territory at the time of the public health inspection provided for in Article 24 (2) of Directive 72/462/EEC, at an inspection post within the meaning of Article 27 (1) (b) of that Directive.

6. (a) If the outcome of the examination is negative, the fresh meat shall be marked immediately after the examination, in accordance with Annex III.

(b) In the case of ink stamping, use shall be made of a colorant within the meaning of Article 17 (3) of Directive 72/462/EEC.

1. By way of derogation from Article 2, the Member State for which it is intended may authorize the exemption from examination of fresh meat from certain third countries or parts of such countries, provided it is frozen in accordance with the provisions of Annex IV.

2. This treatment shall be carried out in an establishment situated in the exporting third country, and described in Article 4 (1).

Freezing in the exporting third country must be the subject of certification by the official veterinarian on the health certificate accompanying the meat, as referred to in Article 22 (3) of Directive 72/462/EEC.

3. If the treatment has not been carried out in the exporting third country, it must be carried out at an inspection post as described in Article 2 (5).

Freezing in a Member State must be the subject of certification by the official veterinarian on the certificates accompanying the meat, as referred to in Article 25 of Directive 72/462/EEC.

1. The authorization for a slaughterhouse to carry out the examination and of a cutting plant to cut up or bone meat which has undergone such examination, or the authorization for an establishment to carry out the freezing treatment referred to in Article 3, shall be decided on in accordance with the procedure laid down in Article 9. In addition to the requirements of Article 4 of Directive 72/462/EEC, account shall be taken of the guarantees given in respect of compliance with this Directive and, in the case of slaughterhouses, of:

(a) the presence of the rooms and apparatus necessary for carrying out the examination;

(b) the qualifications of the personnel responsible for carrying out the examination.

Authorization shall be granted to a slaughterhouse and cutting plant only where the competent authorities of the third country concerned have officially recognized that the slaughterhouse and cutting plant are in a position to satisfy the conditions laid down in Article 5 and in Annex III; also, in the case of a slaughterhouse, that it has a laboratory which complies with the conditions laid down in Annex II, Chapter I, and which is in a position to satisfy the requirements of the other chapters of Annex II and those of Annex I.

Authorization shall be granted to an establishment to carry out the freezing treatment only if the competent authorities of the third country concerned have officially recognized that the establishment is in a position to satisfy the conditions laid down in Annex IV.

2. On the list(s) referred to in Article 4 (4) of Directive 72/462/EEC, a special indication shall be inserted against the names of the establishments which have been granted an authorization within the meaning of paragraph 1.

1. In slaughterhouses which have been granted an authorization in accordance with Article 4, swine the meat of which is intended for the Community must be slaughtered in different rooms or in the absence thereof at different times from swine the meat of which is not intended for the Community, unless the meat of such swine is examined in accordance with the same procedure.

2. The cutting and boning of meat which has undergone an examination with negative results and is intended for the Community must be carried out in cutting plants, in accordance with Article 4.

In these cutting plants, the cutting and boning of such meat must be carried out in different rooms or in the absence thereof, at different times from meat which is not intended for the Community, unless the meat is examined in accordance with the same procedure.

The inspections in third countries provided for in Article 5 of Directive 72/462/EEC must also verify whether the present Directive is being applied.

Article 7

The Member States shall draw up and communicate to the Commission the list of the inspection posts referred to in Article 2 (5) at which:

- the examination,

- the freezing referred to in Article 3,

may be carried out.

They shall ensure that these posts have the equipment necessary for carrying out the operations in question.

Acting on a proposal from the Commission, the Council shall decide before 1 January 1979 on any additions to be made to the methods laid down in Annex I.

1. Where the procedure laid down in this Article is followed, the matter 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 referred to as "the Committee") set up by the Council Decision of 15 October 1968.

2. Within the Committee the votes of the Member States shall be weighted as laid down in Article 148 (2) of the Treaty. The chairman shall not vote.

3. The representative of the Commission shall submit a draft of the measure to be adopted. The Committee shall deliver its opinion on these measures within a time limit set by the chairman having regard to the urgency of the questions under examination. Opinions shall be delivered by a majority of 41 votes.

4. The Commission shall adopt the measures and shall implement them immediately, where they are in accordance with the opinion of the Committee. Where 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 on the measures to be taken.

The Council shall adopt the measures by a qualified majority.

If the Council has not adopted any measures within three months of the date on which the matter is referred to it, the Commission shall adopt the proposed measures and shall implement them immediately save where the Council has decided against such measures by a simple majority.

Article 10

Article 9 shall apply until 21 June 1981.

The Member States shall bring into force on 1 January 1979 at the latest the laws, regulations and administrative provisions needed for compliance with this Directive. They shall forthwith inform the Commission thereof.

This Directive is addressed to the Member States.

Done at Brussels, 21 December 1976.

For the Council

The President

A. P. L. M. M. van der Stee

[1] OJ No L 302, 31. 12. 1972, p. 28.

[2] OJ No L 172, 3. 7. 1975, p. 17.

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ANNEX I

METHODS OF EXAMINATION FOR TRICHINAE

I. TRICHINOSCOPIC EXAMINATION

(a) Apparatus

An incandescent lamp trichinoscope with 50 × and 80 to 100 × magnification.

A pressure glass consisting of two glass plates — one of which is divided into equal fields — small curved scissors, small forceps, a knife for cutting specimens, small numbered containers for storing the specimens separately, a dropping pipette, a glass of acetic acid and a glass of potassium hydroxide solution for brightening any calcifications or softening dried meat.

(b) Taking of specimens

In the case of whole carcases, at least one specimen of the size of a hazelnut is to be taken from both diaphragm pillars at the transition of the sinewy part.

If there is only one diaphragm pillar, one specimen the size of two hazelnuts is to be taken. In the absence of both diaphragm pillars, two specimens approximately the size of a hazelnut are to be taken from the rib part or the breastbone part of the diaphragm or, as the case may be, from the lingual muscle or the jaw muscle or from the abdominal muscles.

For pieces of meat, from each piece take three samples of skeletal muscle, containing little fat, if possible the size of a hazelnut, and taken from different points, where possible near to bones or tendons.

(c) Method

If both diaphragm pillars are present the trichinae inspector must cut, from each of the above specimens taken from a whole carcase, seven pieces the size of an oat-kernel making 14 in all; if only one diaphragm pillar is present, 14 pieces, from different places and if possible from the transition to the sinewy part; he must then compress them between the glass plates in such a way that normal print can be clearly read through the slide preparation. If the flesh of the specimens to be examined is dry and old, the preparations must be softened in a mixture of one part potassium hydroxide solution to about two parts water for 10 to 20 minutes before pressing.

If, in the case of whole carcases, specimens have to be taken from the rib part or the breastbone part of the diaphragm, the lingual muscle or jaw muscle or the abdominal muscles, then 14 pieces the size of an oat-kernal are to be cut from each specimen, i.e. a total of 28.

From each of the samples taken from pieces of meat, the trichinae inspector must cut four pieces the size of an oat-kernal, making 12 pieces in all.

The trichinoscopic examination must be carried out in such a manner that each preparation is scanned slowly and carefully. If the trichinoscopic examination reveals suspect areas, the nature of which cannot be definitely ascertained even with the most powerful magnification of the trichinoscope, these must be checked by microscope.

The microscopic examination should be carried out in such a manner that each preparation is scanned slowly and carefully at a magnification of 30 to 40 ×.

In the case of an uncertain result, the examination must be continued on a further number of specimens and slide preparations, if necessary with the aid of higher magnifications, until the information required is obtained. The trichinoscopic examination must be carried out for at least three minutes.

The trichinoscopic examination must be carried out for at least six minutes in the case of substitute specimens taken from the rib part or breastbone part of the diaphragm pillars, the lingual muscle or the jaw muscle or the abdominal muscles.

The minimum time fixed for the examination does not include the time necessary for sample-taking and for making the preparations.

As a general rule, the trichinoscopic examiner should not inspect more than 840 pieces a day, though by way of exception he may inspect up to 1050.

II. THE ARTIFICIAL DIGESTION METHOD

(a) Apparatus and material

- knife for taking samples,

- small numbered containers, with closures, for storing samples, if necessary until repetition of the examinations,

- incubator,

- 2 to 3 litre glass funnel with stand, a connecting hose in rubber, clamps for fastening the connecting hose,

- a plastic sieve (approximately 18 cm in diameter, and approximately 1 mm mesh),

- gauze,

- a small tapering tube with a sealed end,

- a glass block dish,

- a meat mincer,

- a stereo-microscope,

- digestive liquid made up as follows:

10 g of pepsin (1200 u/g), 5 ml HCl (at least 37 %) made up to a litre with tap water.

(b) Taking of specimens

1. In the case of whole carcases a sample of at least 20 g to be taken from a diaphragm pillar at the transition to the sinewy part. In the absence of diaphragm pillars a specimen of at least 20 g to be taken from the rib part or the breastbone part of the diaphragm or from the lingual muscle or the jaw muscle or the abdominal muscles.

2. For pieces of meat, a sample of at least 20 g of skeletal muscle to be taken, containing little fat and where possible near to bones or tendons.

(c) Method

For the examination of a collective specimen from 10 pigs, a 10 g specimen shall be prepared from each individual 20 g sample. The remaining 10 g shall be kept for additional single-specimen examination should this be necessary.

10 specimens, each weighing 10 g, shall be combined into a collective specimen; it shall be minced in a meat mincer (with 2 mm perforations) and placed loosely in a sieve lined with a layer of gauze. The sieve shall then be placed in a funnel connected by a length of rubber hose to a small tapered tube with a sealed end; the funnel shall be filled from the edge with digestive liquid until the matter for analysis is completely covered. The proportion of matter for analysis to digestive liquid must be approximately 1:20 to 1:30.

After 18 to 20 hours of incubation at 37 to 39 °C, the small tapered tube shall be disconnected and removed. After carefully drawing off the supernatant liquid, the sediment present in the tip of the tube is to be carefully rinsed in a dish. Then to be examined for the presence of trichinae with a stereo-microscope at 20 to 40 × magnification.

In the case of a positive or doubtful result from the examination of a collective specimen, the remaining single specimens to be examined individually after addition of a further 20 g from each pig, or in the case of pieces of meat, the addition of 20 g taken from each piece, according to (b) above.

III. METHOD USING THE ARTIFICIAL DIGESTION OF COLLECTIVE SAMPLES

(a) Apparatus and reagents

- knife and tweezers for collecting specimens,

- meat mincer with 2 to 3 mm diameter perforations,

- a 3 ml Erlenmeyer flask with a rubber or cotton-wool plug,

- a conical separation funnel of 2000 ml capacity,

- an ordinary A-base stand of approximately 28 cm length with an 80 cm stem,

- a ring, diameter approximately 10 to 11 cm which can be fixed to the stand,

- a clamp with a flat vice (23 × 40 mm) which can be attached to the stand by means of a double coupling,

- an Endecott sieve number 80 (mesh fineness 177) with an external diameter of 11 cm fitted with brass or stainless steel mesh,

- a plastic funnel with an internal diameter of not less than 12 cm,

- an ordinary dissection microscope (magnification 40 ×) fitted with its ordinary lamp, or a standard binocular microscope (magnification 40 ×),

- a trichinoscope with horizontal table for the compressor,

- when using the trichinoscope: a larvae counting basin of the same outer shape as the compressor with a volume of approximately 60 to 65 cc. The larvae counting basin may be described as follows:

The shape of the basin consists of a 23 cm long glass plate being of the same thickness as that of a single plate in a common compressor. The width, however, is slightly less, e.g. 4·5 cm in order to provide for the fixation of a glass plate, 2 mm thick, 1·8 cm high, and 17·5 cm long, on both of the long sides of the bottom plate.

The basin is closed at the ends by two glass plates fixed directly onto the bottom plate, and which are 5 cm long, 1 cm high, and 2 mm thick. The height of the basin, measured from inside, will thus be about 1 cm.

The plates are glued together with ordinary glass adhesive. Approximately 2·8 cm of the bottom plate is left free at both ends for protection purposes, and for easy handling of the filled basin.

The volume of the basin is approximately 60 to 65 cc in total,

- when using the microscope a number of 9 cm diameter Petri dishes are needed,

- a speedmarker for marking out in the bottom of the Petri dish the 1 cm square examination areas,

- a number of 10 litre bins to be used when applying formol treatment to the apparatus, and for the remaining digestive juice in the case of positive results,

- concentrated (37 %) hydrochloric acid,

- 30000 units per gram of "Merck" powdered pepsin, or pepsin with known strength from another firm,

- one or two trays which can hold 100 samples or approximately 2 g of meat.

(b) Collection of specimens

1. In the case of whole carcases a specimen to be taken of approximately 2 g from a pillar of the diaphragm at the transition to the sinewy part. In the absence of diaphragm pillars a specimen of the same size to be taken from the rib part or the breastbone part of the diaphragm, from the lingual muscle or the jaw muscle or the abdominal muscles.

2. For cuts of meat, a sample of approximately 2 g of skeletal muscle to be taken, containing little fat and where possible near to bones or tendons.

(c) Method

Approximately 1 g of sample shall be taken from each of the 100 individual samples from the pigs. The pooled sample is put once through the mincer.

The minced meat shall be placed in the 3 litre Erlenmeyer flask together with 7 g of pepsin, approximately 2 litres of tap water heated to about 37 to 40 °C, and 25 ml of concentrated hydrochloric acid. The mixture shall be shaken to dissolve the pepsin.

The pH of the solution will be about 1·5 to 2.

- For digestion the Erlenmeyer flask shall be incubated at 37 °C for approximately four hours. The flask shall be regularly shaken during the time of incubation, e.g. once or twice every hour.

- The digested solution shall be filtered through the sieve into the conical 2 litre separation funnel and left undisturbed on the stand for at least one hour.

- A total volume of approximately 45 cc shall be run out of the funnel and divided between three Petri dishes, the bottoms of which shall be marked out in 1 cm squares, with 15 ml in each dish.

- Each Petri dish shall be minutely examined for larval trichinae under the microscope (around 40 × magnification).

- Where larvae counting basins are employed, the 45 cc shall, be distributed between two larvae counting basins and examined under the trichinoscope.

The larvae appear as identifable organisms in the deposit, and often, when the water is lukewarm, rolling and unrolling movements of the "spiral" may be observed.

If an insufficiently transparent sediment forms, it shall be clarified by rinsing. The final sample of 45 ml is poured into a test tube and allowed to settle for 15 minutes. The supernatant liquid shall then be carefully removed by suction and the sediment placed into suspension in about 45 ml of tap water.

After a further settling period of 15 minutes, the supernatant liquid shall again be carefully removed by suction and the sediment carefully rinsed in about 20 ml of tap water in a Petri dish, and examined.

In the case of a positive or doubtful result from analysis of a collective specimen, the remaining single specimens to be analyzed individually after addition of a further 20 g from each pig, or, in the case of pieces of meat, the addition of 20 g taken from each piece, in accordance with (b) above.

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ANNEX II

CHAPTER I

CONDITIONS FOR THE AUTHORIZATION OF TRICHINAE (TRICHINELLA SPIRALIS) LABORATORIES

1. Trichinae laboratories must be situated next to the swine slaughterhouses and, if the establishment does not already possess such facilities to fulfil the other requirements of the Directive on third countries, have at least the following facilities available:

(a) a lockable room adequately equipped for the preparation of specimens; its walls must be smooth and must be lined with a washable light-coloured covering or paint up to a height of 2 m. A preparation room must be provided for each method of examination used;

(b) an adequately equipped lockable examination room for trichinoscopy and microscopy;

(c) equipment providing adequate ventilation and, if necessary, air conditioning equipment which ensures that the room temperature does not exceed + 25 °C;

(d) adequate natural or artificial lighting which does not alter colours; direct sunlight must be avoided;

(e) in the preparation room, adequate equipment for cleaning and disinfecting hands;

(f) equipment for darkening the examination room;

(g) possibly, refrigerators in which to store meat samples;

(h) a washroom for cleansing and disinfecting examination equipment (e.g. containers for samples, compressors, knives and scissors), with:

- a waterproof floor-covering which is rot-proof and easy to clean and disinfect,

- smooth walls which, up to a height of at least 2 m, are lined by a washable, and light-coloured covering or paint;

(i) changing rooms, wash basins and rest rooms and flush lavatories;

(j) wash basins with hot and cold running water, provided with cleansing and disinfecting materials and disposable towels;

(k) watertight corrosion-resistant containers, with hermetically sealed lids, for collecting the samples after examination, and so designed as to prevent unauthorized removal of the contents;

(l) adequate supplies of hot and cold drinking water;

(m) equipment for removing waste water which fulfils the conditions for the authorization of slaughterhouses;

(n) proper equipment for protection against pests (insects, rodents, etc.).

CHAPTER II

REQUIREMENTS APPLICABLE TO STAFF, PREMISES, EQUIPMENT AND INSTRUMENTS IN TRICHINAE LABORATORIES

2. Absolute cleanliness is required at all times of laboratory staff, premises, equipment and instruments:

(a) staff must wear clean working clothes and wash their hands several times during working hours and after each break;

(b) no animal may enter trichinae laboratories;

(c) equipment and instruments used must be kept clean and in good repair. They must be carefully cleansed and disinfected several times during and at the end of the day's work.

3. Drinking water must be used for all purposes.

4. As regards health, staff taking meat samples for examination must comply with the rules in Annex B, Chapter IV (11) and (12) of Directive 72/462/EEC.

5. The meat samples required for examination must be taken immediately after slaughter and examined without delay in the trichinae laboratory of the slaughterhouse.

These examinations are forbidden away from the slaughterhouse in which the animals were slaughtered.

6. To avoid fatigue and its consequences, inspection staff should be given short breaks during the working day.

CHAPTER III

REQUIREMENTS IN RESPECT OF TRICHINOSCOPES

The construction and design of trichinoscopes must meet the following minimum criteria:

1. Simple operation.

2. High light intensity:

- accurate results must be obtainable even in a room which is not completely dark,

- a projector bulb of 100 W (12 V) must be used as the light source.

3. Adequate magnification:

- normal working magnification: 50 x,

- 80 to 100 x magnification for more precise assessment of objects not clearly identifiable under normal working magnification.

4. Resolving power:

- a clear sharp picture of well-defined colour must be obtainable at each magnification.

5. Switch mechanism:

- each change of magnification must be accompanied by automatic adjustment of the brightness of the image.

6. Increase of contrast:

- the condensor must be provided with an iris diaphragm enabling the contrast to be increased for the closer inspection of difficult cases,

- the iris diaphragm must be easy to operate (e.g. control lever on the platform of the trichinoscope).

7. Easy focusing:

- rapid focusing by means of an adjusting ring,

- precise focusing by means of a control lever.

8. Voltage regulation:

- so that brightness may be adjusted as required.

9. One-way movement of the compressor:

- an automatic blocking mechanism must ensure that the compressor moves in only one direction, to prevent unintentional displacement.

10. Free view of the projector screen.

11. Projector screen:

- at least 54 cm in diameter,

- high reflecting capability,

- durable,

- can be dismantled,

- easy to clean.

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ANNEX III

MARKING OF MEAT WHICH HAS BEEN EXAMINED FOR TRICHINAE

1. Marking of the meat must be carried out under the responsibility of the official veterinarian. For this purpose, he shall keep and maintain:

- the instruments intended for marking which he may hand over to the assistant staff only at the time of marking and for the length of time required for this purpose,

- the tags mentioned in paragraph 5. These tags shall be given to the assistant staff at the time when they must be used and in the required number.

2. The mark must be round with a diameter of 2·5 cm. The following information must appear on the mark in perfectly legible characters:

- towards the centre the capital letter "T" with arms 1 cm long and 0·2 cm wide,

- under the letter "T" one of the following sets of initials: CEE, EEG, EWG, EØF or EEC. The letters must be 0·4 cm high.

3. Carcases must be marked in ink or hot-branded on the inside of the thighs, in accordance with paragraph 2.

4. Heads must be marked in ink or hot-branded, with a mark meeting the requirements of paragraph 2.

With the exception of cuts exempt from health marking by virtue of Annex B, Chapter X (43) of Council Directive 72/462/EEC, those taken in cutting plants from carcases marked in accordance with the rules must, where they bear no stamp, be marked in accordance with paragraph 2 before the health mark is affixed.

The label provided for in the second subparagraph of the abovementioned paragraph 43 must comply with the conditions of paragraph 6 below.

5. Marking may also be effected by means of a round tag. This tag, to be affixed to each piece or to each carcase must not be reusable, must be made of strong materials and must meet all hygiene requirements. The following information must appear on the stamp seals in perfectly legible characters:

- towards the centre the capital letter "T",

- under the letter "T" one of the following sets of initials: CEE, EEG, EWG, EØF or EEC. The letters must be 0·2 cm high.

6. The label provided for in Annex B, Chapter X (44) of the Directive mentioned in paragraph 4 above must, in addition to the health mark, bear a clearly legible mark identical to that provided for in paragraph 2.

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ANNEX IV

THE FREEZING OF MEAT

1. Meat brought in already frozen must be kept in this condition.

2. The technical equipment and energy supply of the refrigerating room, must be such as to ensure that the temperature referred to under paragraph 6 is reached very rapidly and maintained in all parts of the room and of the meat.

3. Insulated packaging should be removed before freezing, except for meat which has already reached throughout the temperature referred to under paragraph 6 when it is brought into the refrigeration room.

4. Consignments in the refrigeration room must be kept separately and under lock.

5. The date and time when each consignment is brought into the refrigeration room must be recorded.

6. The temperature in the refrigeration room must be at least − 25 °C. It should be measured with calibrated thermo-electric instruments and continuously recorded. It may not be measured directly in the cold air flow. The instruments must be kept under lock. The charts must include the relevant numbers from the meat inspection register on importation and the date and time of the commencement and completion of freezing, and must be retained for one year after compilation.

7. Meat with a diameter or thickness of up to 25 cm must be frozen for at least 240 consecutive hours, and meat with a diameter or thickness of between 25 and 50 cm must be frozen for at least 480 consecutive hours. This freezing process may not be applied to meat which has a larger diameter or is thicker. The freezing time shall be calculated from the point when the temperature referred to in paragraph 6 is reached in the freezing room.

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