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Council Directive 88/657/EEC of 14 December 1988 laying down the requirements for the production of, and trade in, minced meat, meat in pieces of less than 100 grams and meat preparations and amending Directives 64/433/EEC, 71/118/EEC and 72/462/EEC Official Journal L 382 , 31/12/1988 P. 0003 - 0014 Finnish special edition: Chapter 3 Volume 28 P. 0064 Swedish special edition: Chapter 3 Volume 28 P. 0064

COUNCIL DIRECTIVE of 14 December 1988 laying down the requirements for the production of, and trade in, minced meat, meat in pieces of less than 100 grams and meat preparations and amending Directives 64/433/EEC, 71/118/EEC and 72/462/EEC (88/657/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 provisions relating to the preparation, packaging, storage and transport of minced meat, meat in pieces of less than 100 grams and meat preparations should be laid down; whereas the health requirement which such meat must fulfil should also be laid down; Whereas Directive 64/433/EEC (4), as last amended by Directive 88/288/EEC (5), and Directive 71/118/EEC (6), as last amended by Regulation (EEC) No 3805/87 (7), harmonized the health rules relating to intra-Community trade in fresh meat and trade in fresh poultrymeat; Whereas Directive 77/99/EEC (8), as last amended by Regulation (EEC) No 3805/87, harmonized the health rules relating to intra-Community trade in meat products; Whereas the directives in force must be taken as a basis for laying down the rules relating to meat intended for use as a raw material and to the approval of establishments; whereas, moreover, certain provisions of Directive 64/433/EEC on intra-Community trade may be applied to trade in minced meat, meat in pieces of less than 100 grams and meat preparations; Whereas, so long as intra-Community trade is hindered by differences between the health requirements of Member States concerning minced meat, meat in pieces of less than 100 grams and meat preparations, the harmonious functioning of the common market and in particular of the relevant common organization of markets will not have the desired effect; Whereas the particularly sensitive nature of these products has led to the adoption by Member States of national rules governing the composition thereof and of production standards for them; whereas the existence of these divergent national rules applicable to production as a whole would lead to border controls being maintained; Whereas it is therefore necessary, in order to eliminate these disparities, to approximate the provisions of Member States governing production of these products; Whereas, in the context of the aims of bringing about an internal market, provision should be made forthwith for the principle of extending the harmonized rules to Community production as a whole; whereas such extension must, however, be dependent upon the rules to be laid down for meat by virtue of Article 5 of Council Directive 88/409/EEC of 15 June 1988 laying down the health rules applying to meat intended for the domestic market and the levels of the fees to be charged, pursuant to Directive 85/73/EEC, in respect of the inspection of such meat (9); Whereas, in order to harmonize the rules applicable to the import of meat in pieces of less than 100 grams, it is necessary to amend Directive 72/462/EEC (10), as last amended by Directive 88/289/EEC (11), which governs the import of fresh meat, in order to make certain special requirements apply to them; Whereas, in order to guarantee that consumers are well informed, it is necessary to derogate from the rules laid down by Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (12), as last amended by Directive 86/197/EEC (13) : Whereas it has established that all Member States have national rules governing the composition of the products covered by this Directive and limiting the additives which may be used for the manufacture of these products; whereas the existence of different standards in this context may run counter to the requirements of the internal market; whereas it is therefore advisable to lay down maximum limits for these standards; whereas it is appropriate to postpone, until a decision is taken within a Community framework, the laying down of common rules governing the additives which may be used for the products in question; Whereasthe Commission should be entrusted with the task of adopting certain measures for implementing this Directive; whereas, to that end, procedures should be laid down introducing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee, HAS ADOPTED THIS DIRECTIVE: Article 1 This Directive lays down the requirements to be complied with for the production of, and intra-Community trade in, minced meat, meat in pieces of less than 100 grams and meat preparations intended for direct human consumption or for industry. Article 2 For the purposes of this Directive: 1. the definitions contained in Article 2 of Directive 64/433/EEC, Article 2 of Directive 72/462/EEC and Articles 1 and 2 of Directive 71/118/EEC shall apply where necessary; 2. the following definitions shall apply: (a) minced meat: preparations obtained by mincing into fragments fresh meat as defined in Directivé 64/433/EEC: ´minced meat' shall also be taken to include meat which has passed through a spiral-screw mincer; (b) meat in pieces of less than 100 grams: fresh meat as defined in Directive 64/433/EEC divided into pieces of less than 100 grams; (c) meat preparations: preparations made wholly or partly from fresh meat, minced meat or meat pieces of less than 100 grams which have - either undergone treatment other than that defined in Article 2 (a) and (d) of Directive 77/99/EEC, - or been prepared by addition of foodstuffs, seasonings or additives, - or undergone a combination of the above. The preparations must be such that the cellular structure of the meat is unaffected and the finished product contains no fragments of bone. However, minced meat or meat in pieces of less than 100 grams which have undergone only cold treatment shall not be regarded as meat preparations; (d) seasonings: salt intended for human consumption, mustard, spices and spice extracts, aromatic herbs and extracts thereof: (e) foodstuff: any product of animal or vegetable origin considered fit for human consumption; (f) production plant: any cutting plant or establishment producing minced meat and meat in pieces of less than 100 grams fulfilling the requirements of Chapter I of Annex I to this Directive and any plant producing meat preparations fulfilling the requirements of Chapter I of Annex A to Directive 77/99/EEC: (g) independent production unit: a production plant not located on the premises or in an annex to an establishment approved in accordance with Directives 64/433/EEC or 77/99/EEC which fulfils the requirements of Chapter I of Annex I to this Directive; 3. the following shall not be considered as minced meat, meat in pieces of less than 100 grams or meat preparations within the meaning of this Directive but as meat products: products which have undergone one of the treatments specified in Article 2 (d) of Directive 77/99/EEC and which no longer display the characteristics of fresh meat. Article 3 1. Each Member State shall ensure that meat and meat preparations as defined in Article 2 (2) are dispatched from its territory to the territory of another Member State only if they meet the following conditions: (a) they must have been prepared from fresh meat: (i) either in compliance with Directive 64/433/EEC or with Directive 71/118/EEC: (ii) or in compliance with Directive 72/462/EEC and coming from a third country either directly or via another Member State. In the case of fresh pigmeat, it must have been examined for trichinae in accordance with Article 2 of Directive 77/96EEC (14); (b) they must have been prepared in a preparation plant which: ii) meets the requirements of Chapter I of Annex I to this Directive whether it is an independent production unit or a plant located in, or in an annex to, an establishment already approved in accordance with Directives 64/433/EEC or 77/99/EEC; (ii) has been approved and is included on the list(s) drawn up in accordance with Article 7 (1); (c) they must have been prepared, packaged and stored in accordance with Chapters II, III and IV of Annex I; (d) they must have been inspected in accordance with Chapters V and VI of Annex I; (e) they must be marked in accordance with Chapter VII of Annex I; (f) they must be transported in accordance with Chapter VIII of Annex I; (g) during transport to the country of destination they must be accompanied by a health certificate that satisfies the requirements in Chapter XII of Annex I to Directive 64/433/EEC and is marked as follows: ´The undersigned, official veterinarian, hereby certifies that the minced meat, meat in pieces of less than 100 grams, meat preparations (a) described above was/were obtained under the conditions of production and inspection laid down in Directive 88/657/EEC laying down the requirements for the production of, and trade in, minced meat, meat in pieces of less than 100 grams and meat preparations and amending Directives 64/433/EEC, 71/118/EEC and 72/462/EEC. (aj Delete where inapplicable'; (h) the designations ´lean minced meat' and ´minced meat', possibly combined with the names of the species of the animals from which the meat is obtained, must be restricted to products for the final consumer which, in addition to the general conditions imposed in Chapter III of Annex I, meet the requirements set out in Section I of Annex II. 2. Member States shall ensure that - in addition to the general conditions laid down in I - minced meat, meat in pieces of less than 100 grams and, in so far as they contain such meat, meat preparations intended for intra-Community trade comply with the following requirements: (a) they must be obtained, without prejudice to Article 4, from fresh meat from slaughter animals: (i) in the case of meat that has been frozen or deep-frozen without bones, within a maximum of 18 months for beef and veal, 12 months for sheepmeat and 6 months for pigmeat of freezing or deep-freezing in a warehouse approved in accordance with Article 9 of Directive 64/33/EEC; (ii) in the case of other fresh meat, within a maximum of six days after the slaughter of the animal of origin, compliance with this requirement being guaranteed by a method of identification to be specified by the competent authority; (b) they must have undergone cold treatment within a maximum of one hour after cutting into portions and wrapping except where processes requiring the lowering of the internal temperature of the meat during preparation are used; (c) if they are to be placed on the market: - chilled and wrapped for the final consumer, they must be obtained exclusively from meat as referred to in (a) (ii) and cooled to an internal temperature below + 2oC in a period of not more than one hour; - deep-frozen and wrapped for the final consumer, they must be obtained from meat as referred to in paragraph (a) (ii) or, without prejudice to the prohibition laid down in the first subparagraph of Article 6 (1), from meat as referred to in (a) (i) and cooled to an internal temperature below - 18 oC in a period of not more than four hours; - frozen, they may be obtained from meat as referred to in (a) (i) or (ii) and cooled to an internal temperature below - 12 oC in a period of not more than 12 hours. Such meat may not be wrapped for the final consumer; (d) they must not have been subjected to ionizing radiation or ultra-violet treatment; (e) as regards meat preparations, seasonings may not exceed 3 % of the finished product if added dry or 10 % if added in any other state. Article 4 Member States shall ensure - without prejudice to Article 6 - that the following meat is not dispatched from their territory to the territory of another Member State: (a) minced soliped meat or soliped meat weighing less than 100 grams; (b) minced meat containing offal; (c) minced meat, meat in pieces of less than 100 grams and meat preparations obtained from or using mechanically separated meat; (d) minced poultrymeat. Article 5 1. Countries of destination may, subject to compliance with the general provisions of the Treaty, grant to one or more exporting countries general authorizations or authorizations restricted to specific cases for the importation into their territory of: (i) meat or preparations referred to in Article 2 (2) which fail(s) to meet the standards laid down in Article 3 () (h) and 3 (2) (a) (i) and (c) or the standards laid down in Chapter VI of Annex I; (ii) meat or preparations referred to in Article 4. Such products may not be dispatched unless this is done in accordance with Article 3. 2. When a country of destination grants an authorization under paragraph 1, it shall inform the Commission and the other Member States within the Standing Veterinary Committee thereof. 3. The exporting countries shall take all measures necessary to ensure thatthe health certificate referred to in Article 3 (1) (g) mentions that use has been made of the possibilities provided for in paragraph 1 of this Article. Article 6 1. Member States which prohibit the use of meat as referred to in Article 3 (2) (a) (i) for the manufacture of deep-frozen meat preparations wrapped for the final consumer or the transport within their territory of minced meat, meat in pieces of less than 100 grams or meat preparations that have not been frozen or deep-frozen may prohibit or limit the introduction into their territory of such meat or preparations from other Member States. Member States wishing to invoke this option shall first inform the Commission and the other Member States within the Standing Veterinary Committee. 2. Member States which authorize the production or marketing within their territory of: - minced meat with seasonings or meat preparations both obtained from offal, - minced meat obtained from or using fresh meat from domestic solipeds or obtained from or using fresh poultry meat intended for the processing industry, may not prohibit or restrict the introduction into their territory of minced meat or meat preparations obtained in similar conditions in another Member State. In trade in the minced meat and the meat preparations referred to in the first subparagraph, the conditions imposed in this Directive must be complied with. Such minced meat and meat preparations may be dispatched only in accordance with Article 3 (2) and, in the case of meat including fresh poultrymeat, the latter must meet the requirements of Directive 71/118/EEC. For the purposes of this Article, Article 6 (2) and (3) of Directive 64/433/EEC shall apply mutatis mutandis. 3. Acting on a proposal from the Commission, the Council shall decide by 31 December 1991 on the conditions for extending the requirements of this Directive to the products referred to in the preceding paragraphs, in particular in the light of the decisions to be taken pursuant to Article 13 (2). Article 7 1. Each Member State shall draw up a list of the establishments manufacturing products referred to in Article 2 (15) (a), (b) and (c). This list shall be forwarded to the other Member States and the Commission, stating whether these establishments are production plants or independent production units. Each plant shall receive an approval number, which in the first case shall be that of the establishment that has been approved, with the indication that it has been approved for the production of the meat and preparations defined in Article 2. Plants thus approved shall be entered in a separate column on the list of establishments referred to in Article 8 of Directive 64/433/EEC or that referred to in Article 6 of Directive 77/99/EEC or, in the case of an independent production unit, on a separate list drawn up according to the same criteria. 2. A Member State shall not include a production plant or an independent production unit on the list referred to in paragraph 1 unless it is sure that the establishment satisfies the conditions laid down in this Directive. The Member States shall withdraw the specific indication if the conditions cease to be fulfilled. 3. The Member States shall take account of the results of any checks performed in accordance with Article 9 of Directive 64/433/EEC. The other Member States and the Commission shall be informed of the withdrawal of the specific indication provided for in paragraph 1. Article 8 1. Member States shall ensure that production plants and independent production units undergo official inspection in order to ensure that production hygiene requirements are fulfilled. If the inspection or inspections referred to in the first subparagraph and in paragraph 2 show that not all hygiene requirements are being fulfilled, the official veterinarian shall take appropriate steps. 2. Member States shall ensure that meat in pieces of less than 100 grams, minced meat and meat preparations undergo microbiological checks carried out by the establishments, under the supervision, control and responsibility of the official veterinarian, in order to ensure that such meat complies with the requirements of this Directive. 3. Member States shall ensure that regular microbiological checks are effected to examine for aerobic mesophile bacteria, salmonella, staphylococci, Escherichia coli and sulphite-reducing anaerobes in accordance with the conditions laid down in Chapter VI of Annex I. 4. Member States shall ensure that the standards and methods of interpretation set out in section II of Annex II to this Directive are applied to all their production of meat and preparations defined in Article 2 (2), except for those prepared on the spot at the request of the purchaser and such meat obtained in establishments selling directly to the consumer where transport and packaging are not involved. Member States shall, however, be authorized to postpone application pending implementation of the decisions provided for in Article 1 3. They shall inform the Commission and the other Member States therof within the Standing Veterinary Committee. Member States which do not avail themselves of the possibility offered in the second subparagraph may make imports into their territory of meat and meat preparations defined in Article 2 (2) subject to the requirement that they mut come from establishments conforming with the standards laid down in Annex II. 5. The microbiological checks must be carried out in accordance with proven methods which are scientifically recognized, in particular those laid down in Community Directives or other international standards. The results of the microbiological checks must be assessed using the standards for interpretation laid down in Annex II. In the event of disputes arising in trade, Member States shall recognize the ISO methods as reference methods. 6. For the purpose of inspecting production holdings, the Commission - after consultation of the Standing Veterinary Committee - shall draw up a general code of hygiene which shall specify the general conditions of hygiene to be complied with in production plants and independent production units, in particular the conditions for the upkeep of premises. The Commission will publish that code. 7. Where there is good reason to suspect that the requirements of this Directive are not being satisfied, the official veterinarian shall carry out the necessary checks and, if that suspicion is confirmed, take appropriate measures, and in particular suggest to the competent authority that approval be suspended. Article 9 For the purposes of this Directive, the inspection and supervision of the establishments referred to in Article 7 shall be performed in accordance with Article 8 (2) of Directive 64/433/EEC, Article 6 (2) of Directive 77/99/EEC and Article 2 of Directive 88/409/EEC. Article 10 1. Article 8 (3) of Directive 64/433/EEC shall apply mutatis mutandis in the event of disputes concerning compliance in an approved establishment with the conditions laid down in this Directive. 2. Article 9 of Directive 64/433/EEC shall apply to mutatis mutandis to the on-the-spot inspection necessary for the uniform application of this Directive in the establishments referred to in Article 7. 3. Articles 10 and 11 of Directive 64/433/EEC shall apply mutatis mutandis to trade in the meat defined in Article 2 (2) of this Directive. Article 11 1. Directive 64/433/EEC is hereby amended as follows: (a) in Article 5, point (b) is replaced by: ´(b) mechanically separated meat'; (b) in Article 5, point 1 is deleted; (c) in Article 6 (1), point (iii) is replaced by: ´(iii) fresh meat referred to in Article 5 (b) and (i) to (k)'. 2. Directive 71/118/EEC is hereby amended as follows: (a) the following subparagraph is added to Article 3 (3): ´Intra-Community trade in fresh poultrymeat ground or similarly comminuted shall be excluded.' (b) Article 15 a is repealed. 3. Article 18 (2) of Directive 72/462/EEC is replaced by the following: ´2. Article 20 (j) and (k) notwithstanding, Member States may authorize importation into their territories of meat in pieces of less than 100 grams within the meaning of Article 2 (2) (b) of Directive 88/657/EEC (16) from masseter muscles and brains provided that rhey comply with the requirements of Article 17 (2) and with paragraph 1 (b) (iii), (iv) and (v) of this Article and, as regards meat in pieces of less than 100 grams, with the conditions laid down in Directive 88/657/EEC. Article 12 Trade in meat and meat preparations defined in Article 2 (2) shall be subject to the animal health rules governing trade in fresh meat laid down in Directive 72/461/EEC. Article 13 1. Member States shall ensure that, by no later than the date to be fixed for the implementation of the decisions provided for in Article 5 (1) of Directive 88/409/EEC, all meat and meat preparations referred to in Article 2 (2) and produced in their territory for marketing there, subject to the second subparagraph of this paragraph, satisfy the requirements of this Directive, save in the case of derogations (in particular from the provisions of Article 3 (2) (c)) to be decided by the Council, before 1 January 1992, in connection with the decision referred to in paragraph 2. The preceding subparagraph shall not apply to meat and meat preparations mentioned in Article 4, meat prepared on the spot at the request of the purchaser and such meat obtained in establishments selling directly to the consumer where transport and packaging are not involved. 2. The Council, acting by a qualified majority on a proposal from the Commission shall adopt before 1 January 1992 the minimum rules which must be complied with by an establishment intending to restrict its production to the local market and shall at the same time re-examine Article 6. Article 14 The Annexes to this Directive may be amended by the Council, acting by a qualified majority on a proposal from the Commission, in particular in order to adapt them to technological progress. Before 1 January 1991, the Council shall re-examine the data concerning the microbiological standards of Section II of Annex II in the light of a Commission report based upon scientific conclusions together with possible proposals on which it will take a decision in accordance with the procedure provided for in the first subparagraph. Article 15 Pending compilation, in the context of Community legislation on additives, of the list of foodstuffs to which the additives authorized for use may be added and establishment of the conditions under which they may be added and, where appropriate, a limit on the technological purpose of their use, the national rules and the bilateral arrangements existing on the date on which this Directive is brought into application restricting the use of additives in the products covered by this Directive shall remain applicable, with due regard for the general provisions of the Treaty, provided that they apply without distinction to domestic production and to trade. Article 16 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1992. They shall forthwith inform the Commission thereof. Article 17 This Directive is addressed to the Member States. Done at Brussels, 14 December 1988. For the Council The President Y. POTTAKIS (1) OJ No C 18, 23. 1. 1988, p. 8. (2) OJ No C 290, 14. 11. 1988, p. 49. (3) OJ No C 134, 24. 5. 1988, p. 8. (4) OJ No 121, 29. 7. 1964, p. 2012/64. (5) OJ No L 124, 18. 5. 1988, p. 28. (6) OJ No L 55, 8. 3. 1971, p. 23. (7) OJ No L 357, 19. 12. 1987, p. 1.(8) OJ No L 26, 31. 1. 1977, p. 85.(9) OJ No L 194, 22. 7. 1988, p. 28. (10) OJ No L 302, 31. 12. 1972, p. 28. (11) OJ No L 124, 18. 5. 1988, p. 31. (12) OJ No L 33, 8. 2. 1979, p. 1. (13) OJ No L 144, 29. 5. 1986, p. 38.(14) OJ No L 26, 31. 1. 1977, p. 67.(15) OJ NO L 382, 31. 12. 1988, p. 3.' ANNEX I CHAPTER I SPECIAL CONDITIONS FOR THE APPROVAL OF ESTABLISHMENTS PRODUCING THE MEAT DEFINED IN ARTICLE 2 (2) 1. Over and above the general conditions laid down in, respectively Annex I points 1 to 12 and points 14, 15 and 16 of Directive 64/433/EEC and Chapter I of Annex A to Directive 77/99/EEC, production plants or independent production units as defined in Article 2 (2) of this Directive must have at least: (a) a room separate from the cutting room for mincing, wrapping and for the addition of other foodstuffs, equipped with a recording thermometer or recording telethermometer. However, the competent authority may authorize the mincing of meat in the cutting room provided that the mincing is carried out in a separate area and does not involve the addition of seasonings and other foodstuffs; (b) a room for packaging, unless the conditions laid down in point 62 of Chapter XI of Annex I to Directive 64/433/EEC are fulfilled; (c) a room for storing seasonings and other cleaned foodstuffs ready for use; (d) refrigeration equipment enabiing the temperatures laid down in this Directive to be adhered to. Establishments producing meat preparations must also comply with the relevant requirements of Chapter I of Annex B to Directive 77/99/EEC. 2. The rules laid down in Chapter IV of Annex I to Directive 64/433/EEC shall apply as regards the hygiene of the staff, premises and equipment in the establishments. Staff engaged in the manual preparation of minced meat must also wear masks covering their noses and mouths and surgical-type gloves. CHAPTER II CONDITIONS FOR THE PRODUCTION OF MEAT IN PIEGES OF LESS THAN 100 GRAMS 3. Meat is examined before cutting. All soiled or suspect parts are removed and condemned before the meat is cut up. 4. Meat in pieces of less than 100 grams may not be obtained from scrap cuttings or scrap trimmings or from offal. For the purposes of this Directive, however, offal in slices obtained under hygienically satisfactory conditions is to be regarded as meatin pieces of less than 100 grams. 5. Where the operations carried out from the time when the meat enters the room referred to in Chapter I, point 1 (a) to the time when the finished product undergoes the chilling or freezing process are performed within a maximum period of one hour, the internal temperature of the meat must be no higher than + 7 oC and the temperature of the production premises must be no higher than + 12 oC. the competent authority may authorize a longer time limit in individuai cases where the addition of seasonings or foodstuffs justifies this on technical grounds, provided hygiene rules are not affected by that derogation. Where the duration of these operations is over one hour or over the period authorized by the competent authority in accordance with the preceding subparagraph, the fresh meat may not be used until the internal temperature of the meat has been reduced to a maximum of + 4 oC. 6. Immediately after production, meat in pieces of less than 100 grams must be hygienically wrapped and packaged and stored at a temperature of not more than + 2 oC in the case of chilled meat and not more than - 18 oC in the case of deep frozen meat or not more than - 12 oC in the case of frozen meat. CHAPTER III CONDITIONS FOR THE PRODUCTION OF MINCED MEAT 7. Meat is examined before mincing. All soiled and suspect parts are removed and condemned before the meat is minced. 8. Minced meat may not be obtained from scrap cuttings or scrap trimmings. In particular, it may not be prepared from meat from the following parts of bovine animals, pigs, sheep or goats: fragments of muscles from the head, boned shin meat, the point at which the sticking of the animal took place, injection areas, diaphragm and the central part of the belly muscles and bone scrapings. It must not contain any bone fragments. The rules laid down in point 5 for meat in pieces of less than 100 grams apply mutatis mutandis to the production of minced meat. 9. Immediately after production the minced meat must be hygienically wrapped and packaged and stored at the temperatures prescribed in Article 3 (2) (c). CHAPTER IV SPECIAL REQUIREMENTS FOR THE PRODUCTION OF MEAT PREPARATIONS 10. Over and above the general requirements of Chapter I, and depending on the type of production concerned: (a) the production of meat preparations must take place under conditions of temperature control. Immediately after production, meat preparations must be forthwith cooled to the temperatures provided for in Article 3 (2) (c); (b) meat preparations made from meat which has been minced as provided for in Article 2 (2) (c) may be dispatched only on condition that: - they are frozen at a freezing speed of one cm/hour, - they are wrapped in consignments. Such preparations must be marketed within a period not exceeding six months; (c) meat preparations other than those referred to in point (b) and intended for direct sale to the final consumer must be wrapped in indivisible commercial portions; (d) refreezing of meat preparations is prohibited. CHAPTER V INSPECTION 11. Establishments which produce the meat or meat preparations defined in Article 2 (2) are subject to inspection by the official service. The official veterinarian must be present when work is undertaken on meat or preparations defined in Article 2. The official veterinarian may, when carrying out the inspection, be helped by assistants placed under his authority and responsibility. Detailed rules governing this assistance shall, in so far as necessary, be determined in accordance with the procedure laid down in Article 19 of Directive 77/99/EEC. The details of the professional qualifications of the assistants referred to in this paragraph and of the duties they are to perform shall be determined by the Council acting on a proposal from the Commission. 12. Inspection by the official veterinarian shall include the following tasks: - inspecting the entries of fresh meat, - inspecting the outgoing meat defined in Article 2 (2), - hygiene inspection of the premises, facilities and instruments, - taking of any necessary samples and in particular those required for the microbiological tests referred to in Chapter VI. CHAPTER VI MICROBIOLOGICAL TESTS 13. The production of minced meat, meat in pieces of less than 100 grams and meat preparations must be monitored by means of daily microbiological tests in the production establishment or in an approved laboratory. To that end the operator or proprietor of the establishment or his representative must conduct a regular check on the general hygiene of conditions of production in his establishment, in particular by microbiological controls. These controls shall cover utensils, fittings and machinery at all stages of production and, according to the type of production concerned, products. He must be in a position, upon request from the official service, to inform the competent authority or the Commission's veterinary experts of the nature,frequency and results of the controls conducted to this end, together with the name of the investigating laboratory if need be. The competent authority shall regularly analyse the results of the monitoring provided for in the first subparagraph. It may, on the basis of this analysis, conduct further microbiological examinations at all stages of production or on the products. The results of these analyses shall be written up in a report, the conclusions and recommendations of which shall be notified to the operator, who shall see to the rectification of shortcomings noted with a view to improving hygiene. 14. The sample taken for analysis must comprise five units weighing 100 grams each. Where minced meat is being produced in portions intended for the final consumer, the sample must be taken from wrapped products. The samples must be representative of daily production. 15. According to the type of production concerned, samples must be examined every day for aerobic mesophile bacteria and salmonella and every week for staphylococci, Eschericha coli and sulphite-reducing anaerobes. However, - where the standards for salmonella have been adhered to over a three-month period, the competent authority may authorize weekly examinations. - in the case of products to be placed on the market frozen or deep-frozen, the competent authority may waive the test for staphylococci. 16. In spot checks carried out by production plants or independent production units, production of the meat and meat preparations referred to in Article 2 (2) must, depending on the type of meat used, comply with the standards laid down in section II of Annex II. I7. The results of the microbiological tests must be at the official veterinarian's disposal. The establishment shall inform the official veterinarian when the standards laid down in section II of Annex II are reached. The official veterinarian shall take the appropriate measures. If, after the expiry of 15 days starting from the time of sampling, the output from production plants or independent production units still does not meet the standards prescribed, products from such establishments must be excluded from intra-Community trade and, once the standards are applied as laid down in the first subparagraph of Article 8 (4), from domestic trade. CHAPTER VII MARKING AND LABELLING 18. Meat and meat preparations must be marked on the packaging with the health mark of the establishment as defined respectively in Chapter X of Annex I to Directive 64/433/EEC and in Chapter VIII of Annex A to Directive 77/99/EEC. Meat and meat preparations, as defined in Article 2 (2) of this Directive and produced in the establishments referred to in Article 3 (1) (b) of the said Directive, must be marked on the packaging with the health mark of the establishment as defined in Chapter VIII of Annex A to Directive 77/99/EEC. 19. The producer must ensure for inspection purposes that the following information is visibly and legibly displayed on the wrapping of minced meat and meat in pieces of less than 100 grams and on meat preparations in so far as it is not required by Directive 79/112/EEC: - where it is not clear from the sales description, the species from which the meat was obtained, and, in the case of a mixture, the percentage of each species, - the date of preparation. - the list of seasonings and of any other foodstuffs, - the word: ´percentage of fat under...' - the words: ´Collagen: meat protein ratio under...'. 20. Without prejudice to paragraphs 18 and 19, where the meat defined in Article 2 (2) of this Directive is wrapped in commercial portions intended for direct sale to the consumer, a printed reproduction of the mark provided for in paragraph 18 must appear on the wrapping or on a label applied to the wrapping. The mark must include the establishment's approval number. The dimensions laid down in Directives 64/433/EEC and 77/99/EEC do not apply to the marking referred to in this paragraph, provided that the required information is legible. CHAPTER VIII TRANSPORT 21. The meat defined in Article 2 (2) 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 to transport the meat defined in Article 2 (2) must be equipped in such a way as to ensure that the temperatures laid down in this Directive are not exceeded and for long-distance intra-Community trade they must be equipped with a recording thermometer to ensure that the latter requirement is fulfilled. ANNEX II COMPOSITON STANDARDS AND MICROBIOLOGICAL STANDARDS I. COMPOSITION SIANDARDS Fast content Collagen meat protein ratio - lean minced meat 7 % 12 % - minced pure beef 20 % 15 % - minced meat containing pigmeat 30 % 18 % - minced meat of other species 25 % 15 % II. MICROBIOLOGICAL STANDARDS Production plants and independent production units must ensure that, in accordance with Chapter VI of Annex I and with the methods of interpretation set out below, minced meat and meat in pieces of less than 100 grams intended to be marketed without further processing or as an ingredient in meat preparations, comply with the following standards: M (;) m($) Aerobic mesophile bacteria 5 x 10(/g 5 x 10& /g n (=) = 5 c (%) = 2 Escherchia coli 5 x 10($)/g 50/g n = 5 c = 2 Sulphite-reducing anaerobes 10($)/g 10/g n = 5 c = 1 Staphylococci 5 x 10($)/g 50/g n = 5 c = 1 Salmonella absence in 25 g n = 5 c = 0 (;) M = acceptability threshold, above whith results are no longer considered satisfactory where M equals 10 m where the count is made in a solid medium and M equals 30 m where the count is made in a liquid medium. ($) m = threshold below which all results are considered satisfactory. (=) Number of units making up the sample. (%) Number of units in the sample giving valus between m and M. The resuits of the microbiological analyses must be interpreted according to: A. Three categories of contamination for aerobic mesophile bacteria, Escherichia coli, sulphite-reducing anaerobes and staphylococci, viz.: - up to and including the criterion m, - between the criterion m and the threshold M, - above the threshold M. 1. The quality of the consignment shall be considered: (a) satisfactory, where all the values observed are equal to or less than 3 m where a solid medium has been used or 10 m where a liquid medium has been used: (b) acceptable where all the values observed are between: (i) 3 m and 10 m (= M) in a solid medium; (ii) 10 m and 30 M (= M) in a liquid medium and where c/n is equal to or less than 2/5 where n = 5 und c = 2 or any other figures of equivalent or greater reliability to be recognized by the Council, acting by a qualified majority on a proposal from the Commission. 2. The quality of the consignment shall be considered unsatisfactory: - in all cases where values in excess of M are observed, - when c/n is 2/5. However, where this latter threshold has been exceeded for aerobic micro-organisms at + 30 oC while all the other criteria have been fulfilled, this exceeding of the threshold must be the subject of a further interpretation,in particular in the case of raw products. In any event, the product must be considered toxic or tainted when contamination reaches the microbic limit value S, which for general purposes is set at 10= m. In the case of Staphylococcus aureus, the value of 5 must never be allowed to exceed 5 x 10%. Tolerances related to analytical techniques shall not apply to the values M and S. B. Two categories for salmonella, with no category tolerance permitted: - ´Absence in': the result is considered satisfactory, - ´Presence in': the result is considered unsatisfactory.

COUNCIL DIRECTIVE of 14 December 1988 laying down the requirements for the production of, and trade in, minced meat, meat in pieces of less than 100 grams and meat preparations and amending Directives 64/433/EEC, 71/118/EEC and 72/462/EEC (88/657/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 provisions relating to the preparation, packaging, storage and transport of minced meat, meat in pieces of less than 100 grams and meat preparations should be laid down; whereas the health requirement which such meat must fulfil should also be laid down;

Whereas Directive 64/433/EEC (4), as last amended by Directive 88/288/EEC (5), and Directive 71/118/EEC (6), as last amended by Regulation (EEC) No 3805/87 (7), harmonized the health rules relating to intra-Community trade in fresh meat and trade in fresh poultrymeat;

Whereas Directive 77/99/EEC (8), as last amended by Regulation (EEC) No 3805/87, harmonized the health rules relating to intra-Community trade in meat products;

Whereas the directives in force must be taken as a basis for laying down the rules relating to meat intended for use as a raw material and to the approval of establishments; whereas, moreover, certain provisions of Directive 64/433/EEC on intra-Community trade may be applied to trade in minced meat, meat in pieces of less than 100 grams and meat preparations;

Whereas, so long as intra-Community trade is hindered by differences between the health requirements of Member States concerning minced meat, meat in pieces of less than 100 grams and meat preparations, the harmonious functioning of the common market and in particular of the relevant common organization of markets will not have the desired effect;

Whereas the particularly sensitive nature of these products has led to the adoption by Member States of national rules governing the composition thereof and of production standards for them; whereas the existence of these divergent national rules applicable to production as a whole would lead to border controls being maintained;

Whereas it is therefore necessary, in order to eliminate these disparities, to approximate the provisions of Member States governing production of these products;

Whereas, in the context of the aims of bringing about an internal market, provision should be made forthwith for the principle of extending the harmonized rules to Community production as a whole; whereas such extension must, however, be dependent upon the rules to be laid down for meat by virtue of Article 5 of Council Directive 88/409/EEC

of 15 June 1988 laying down the health rules applying to meat intended for the domestic market and the levels of the fees to be charged, pursuant to Directive 85/73/EEC, in respect of the inspection of such meat (9);

Whereas, in order to harmonize the rules applicable to the import of meat in pieces of less than 100 grams, it is necessary to amend Directive 72/462/EEC (10), as last amended by Directive 88/289/EEC (11), which governs the import of fresh meat, in order to make certain special requirements apply to them;

Whereas, in order to guarantee that consumers are well informed, it is necessary to derogate from the rules laid down by Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (12), as last amended by Directive 86/197/EEC (13) :

Whereas it has established that all Member States have national rules governing the composition of the products covered by this Directive and limiting the additives which may be used for the manufacture of these products; whereas the existence of different standards in this context may run counter to the requirements of the internal market; whereas it is therefore advisable to lay down maximum limits for these standards; whereas it is appropriate to postpone, until a decision is taken within a Community framework, the laying down of common rules governing the additives which may be used for the products in question;

Whereasthe Commission should be entrusted with the task of adopting certain measures for implementing this Directive; whereas, to that end, procedures should be laid down introducing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee,

HAS ADOPTED THIS DIRECTIVE:

1. the definitions contained in Article 2 of Directive 64/433/EEC, Article 2 of Directive 72/462/EEC and Articles 1 and 2 of Directive 71/118/EEC shall apply where necessary;

2. the following definitions shall apply:

(a) minced meat: preparations obtained by mincing into fragments fresh meat as defined in Directivé 64/433/EEC:

´minced meat' shall also be taken to include meat which has passed through a spiral-screw mincer;

(b) meat in pieces of less than 100 grams: fresh meat as defined in Directive 64/433/EEC divided into pieces of less than 100 grams;

(c) meat preparations: preparations made wholly or partly from fresh meat, minced meat or meat pieces of less than 100 grams which have

- either undergone treatment other than that defined in Article 2 (a) and (d) of Directive 77/99/EEC,

- or been prepared by addition of foodstuffs, seasonings or additives,

- or undergone a combination of the above. The preparations must be such that the cellular structure of the meat is unaffected and the finished product contains no fragments of bone.

However, minced meat or meat in pieces of less than 100 grams which have undergone only cold treatment shall not be regarded as meat preparations;

(d) seasonings: salt intended for human consumption, mustard, spices and spice extracts, aromatic herbs and extracts thereof:

(e) foodstuff: any product of animal or vegetable origin considered fit for human consumption;

(f) production plant: any cutting plant or establishment producing minced meat and meat in pieces of less than 100 grams fulfilling the requirements of Chapter I of Annex I to this Directive and any plant producing meat preparations fulfilling the requirements of Chapter I of Annex A to Directive 77/99/EEC:

(g) independent production unit: a production plant not located on the premises or in an annex to an establishment approved in accordance with Directives 64/433/EEC or 77/99/EEC which fulfils the requirements of Chapter I of Annex I to this Directive;

3. the following shall not be considered as minced meat, meat in pieces of less than 100 grams or meat preparations within the meaning of this Directive but as meat products: products which have undergone one of the treatments specified in Article 2 (d) of Directive 77/99/EEC and which no longer display the characteristics of fresh meat.

its territory to the territory of another Member State only if they meet the following conditions:

(a) they must have been prepared from fresh meat: (i) either in compliance with Directive 64/433/EEC or with Directive 71/118/EEC:

(ii) or in compliance with Directive 72/462/EEC and coming from a third country either directly or via another Member State. In the case of fresh pigmeat, it must have been examined for trichinae in accordance with Article 2 of Directive 77/96EEC (14);

(b) they must have been prepared in a preparation plant which:

ii) meets the requirements of Chapter I of Annex I to this Directive whether it is an independent production unit or a plant located in, or in an annex to, an establishment already approved in accordance with Directives 64/433/EEC or 77/99/EEC;

(ii) has been approved and is included on the list(s) drawn up in accordance with Article 7 (1);

(c) they must have been prepared, packaged and stored in accordance with Chapters II, III and IV of Annex I;

(d) they must have been inspected in accordance with Chapters V and VI of Annex I;

(e) they must be marked in accordance with Chapter VII of Annex I;

(f) they must be transported in accordance with Chapter VIII of Annex I;

(g) during transport to the country of destination they must be accompanied by a health certificate that satisfies the requirements in Chapter XII of Annex I to Directive 64/433/EEC and is marked as follows:

´The undersigned, official veterinarian, hereby certifies that the minced meat, meat in pieces of less than 100 grams, meat preparations (a) described above was/were obtained under the conditions of production and inspection laid down in Directive 88/657/EEC laying down the requirements for the production of, and trade in, minced meat, meat in pieces of less than 100 grams and meat preparations and amending Directives 64/433/EEC, 71/118/EEC and 72/462/EEC.

(aj Delete where inapplicable';

(h) the designations ´lean minced meat' and ´minced meat', possibly combined with the names of the species of the animals from which the meat is obtained, must be restricted to products for the final consumer which, in

addition to the general conditions imposed in Chapter III of Annex I, meet the requirements set out in Section I of Annex II.

2. Member States shall ensure that - in addition to the general conditions laid down in I - minced meat, meat in pieces of less than 100 grams and, in so far as they contain such meat, meat preparations intended for intra-Community trade comply with the following requirements:

(a) they must be obtained, without prejudice to Article 4, from fresh meat from slaughter animals:

(i) in the case of meat that has been frozen or deep-frozen without bones, within a maximum of 18 months for beef and veal, 12 months for sheepmeat and 6 months for pigmeat of freezing or deep-freezing in a warehouse approved in accordance with Article 9 of Directive 64/33/EEC;

(ii) in the case of other fresh meat, within a maximum of six days after the slaughter of the animal of origin, compliance with this requirement being guaranteed by a method of identification to be specified by the competent authority;

(b) they must have undergone cold treatment within a maximum of one hour after cutting into portions and wrapping except where processes requiring the lowering of the internal temperature of the meat during preparation are used;

(c) if they are to be placed on the market:

- chilled and wrapped for the final consumer, they must be obtained exclusively from meat as referred to in (a) (ii) and cooled to an internal temperature below + 2oC in a period of not more than one hour;

- deep-frozen and wrapped for the final consumer, they must be obtained from meat as referred to in paragraph (a) (ii) or, without prejudice to the prohibition laid down in the first subparagraph of Article 6 (1), from meat as referred to in (a) (i) and cooled to an internal temperature below - 18 oC in a period of not more than four hours;

- frozen, they may be obtained from meat as referred to in (a) (i) or (ii) and cooled to an internal temperature below - 12 oC in a period of not more than 12 hours. Such meat may not be wrapped for the final consumer;

(d) they must not have been subjected to ionizing radiation or ultra-violet treatment;

(e) as regards meat preparations, seasonings may not exceed 3 % of the finished product if added dry or 10 % if added in any other state.

(a) minced soliped meat or soliped meat weighing less than 100 grams;

(b) minced meat containing offal;

(c) minced meat, meat in pieces of less than 100 grams and meat preparations obtained from or using mechanically separated meat;

(d) minced poultrymeat.

(i) meat or preparations referred to in Article 2 (2) which fail(s) to meet the standards laid down in Article 3 () (h) and 3 (2) (a) (i) and (c) or the standards laid down in Chapter VI of Annex I;

(ii) meat or preparations referred to in Article 4.

Such products may not be dispatched unless this is done in accordance with Article 3.

2. When a country of destination grants an authorization under paragraph 1, it shall inform the Commission and the other Member States within the Standing Veterinary Committee thereof.

3. The exporting countries shall take all measures necessary to ensure thatthe health certificate referred to in Article 3 (1) (g) mentions that use has been made of the possibilities provided for in paragraph 1 of this Article.

Member States wishing to invoke this option shall first inform the Commission and the other Member States within the Standing Veterinary Committee.

2. Member States which authorize the production or marketing within their territory of:

- minced meat with seasonings or meat preparations both obtained from offal,

- minced meat obtained from or using fresh meat from domestic solipeds or obtained from or using fresh poultry meat intended for the processing industry,

may not prohibit or restrict the introduction into their territory of minced meat or meat preparations obtained in similar conditions in another Member State.

In trade in the minced meat and the meat preparations referred to in the first subparagraph, the conditions imposed in this Directive must be complied with.

Such minced meat and meat preparations may be dispatched only in accordance with Article 3 (2) and, in the case of meat including fresh poultrymeat, the latter must meet the requirements of Directive 71/118/EEC.

For the purposes of this Article, Article 6 (2) and (3) of Directive 64/433/EEC shall apply mutatis mutandis.

3. Acting on a proposal from the Commission, the Council shall decide by 31 December 1991 on the conditions for extending the requirements of this Directive to the products referred to in the preceding paragraphs, in particular in the light of the decisions to be taken pursuant to Article 13 (2).

Each plant shall receive an approval number, which in the first case shall be that of the establishment that has been approved, with the indication that it has been approved for the production of the meat and preparations defined in Article 2.

Plants thus approved shall be entered in a separate column on the list of establishments referred to in Article 8 of Directive 64/433/EEC or that referred to in Article 6 of Directive 77/99/EEC or, in the case of an independent production unit, on a separate list drawn up according to the same criteria.

2. A Member State shall not include a production plant or an independent production unit on the list referred to in

paragraph 1 unless it is sure that the establishment satisfies the conditions laid down in this Directive. The Member States shall withdraw the specific indication if the conditions cease to be fulfilled.

3. The Member States shall take account of the results of any checks performed in accordance with Article 9 of Directive 64/433/EEC. The other Member States and the Commission shall be informed of the withdrawal of the specific indication provided for in paragraph 1.

If the inspection or inspections referred to in the first subparagraph and in paragraph 2 show that not all hygiene requirements are being fulfilled, the official veterinarian shall take appropriate steps.

2. Member States shall ensure that meat in pieces of less than 100 grams, minced meat and meat preparations undergo microbiological checks carried out by the establishments, under the supervision, control and responsibility of the official veterinarian, in order to ensure that such meat complies with the requirements of this Directive.

3. Member States shall ensure that regular microbiological checks are effected to examine for aerobic mesophile bacteria, salmonella, staphylococci, Escherichia coli and sulphite-reducing anaerobes in accordance with the conditions laid down in Chapter VI of Annex I.

4. Member States shall ensure that the standards and methods of interpretation set out in section II of Annex II to this Directive are applied to all their production of meat and preparations defined in Article 2 (2), except for those prepared on the spot at the request of the purchaser and such meat obtained in establishments selling directly to the consumer where transport and packaging are not involved.

Member States shall, however, be authorized to postpone application pending implementation of the decisions provided for in Article 1 3. They shall inform the Commission and the other Member States therof within the Standing Veterinary Committee.

Member States which do not avail themselves of the possibility offered in the second subparagraph may make imports into their territory of meat and meat preparations defined in Article 2 (2) subject to the requirement that they mut come from establishments conforming with the standards laid down in Annex II.

5. The microbiological checks must be carried out in accordance with proven methods which are scientifically recognized, in particular those laid down in Community Directives or other international standards.

The results of the microbiological checks must be assessed using the standards for interpretation laid down in Annex II.

In the event of disputes arising in trade, Member States shall recognize the ISO methods as reference methods.

6. For the purpose of inspecting production holdings, the Commission - after consultation of the Standing Veterinary Committee - shall draw up a general code of hygiene which shall specify the general conditions of hygiene to be complied with in production plants and independent production units, in particular the conditions for the upkeep of premises. The Commission will publish that code.

7. Where there is good reason to suspect that the requirements of this Directive are not being satisfied, the official veterinarian shall carry out the necessary checks and, if that suspicion is confirmed, take appropriate measures, and in particular suggest to the competent authority that approval be suspended.

2. Article 9 of Directive 64/433/EEC shall apply to mutatis mutandis to the on-the-spot inspection necessary for the uniform application of this Directive in the establishments referred to in Article 7.

3. Articles 10 and 11 of Directive 64/433/EEC shall apply mutatis mutandis to trade in the meat defined in Article 2 (2) of this Directive.

(a) in Article 5, point (b) is replaced by:

´(b) mechanically separated meat';

(b) in Article 5, point 1 is deleted;

(c) in Article 6 (1), point (iii) is replaced by:

´(iii) fresh meat referred to in Article 5 (b) and (i) to (k)'.

2. Directive 71/118/EEC is hereby amended as follows:

(a) the following subparagraph is added to Article 3 (3):

´Intra-Community trade in fresh poultrymeat ground or similarly comminuted shall be excluded.'

(b) Article 15 a is repealed.

3. Article 18 (2) of Directive 72/462/EEC is replaced by the following:

´2. Article 20 (j) and (k) notwithstanding, Member States may authorize importation into their territories of meat in pieces of less than 100 grams within the meaning of Article 2 (2) (b) of Directive 88/657/EEC (16) from masseter muscles and brains provided that rhey comply with the requirements of Article 17 (2) and with paragraph 1 (b) (iii), (iv) and (v) of this Article and, as regards meat in pieces of less than 100 grams, with the conditions laid down in Directive 88/657/EEC.

Article 12

Trade in meat and meat preparations defined in Article 2 (2) shall be subject to the animal health rules governing trade in fresh meat laid down in Directive 72/461/EEC.

The preceding subparagraph shall not apply to meat and meat preparations mentioned in Article 4, meat prepared on the spot at the request of the purchaser and such meat obtained in establishments selling directly to the consumer where transport and packaging are not involved.

2. The Council, acting by a qualified majority on a proposal from the Commission shall adopt before 1 January 1992 the minimum rules which must be complied with by an establishment intending to restrict its production to the local market and shall at the same time re-examine Article 6.

Before 1 January 1991, the Council shall re-examine the data concerning the microbiological standards of Section II of Annex II in the light of a Commission report based upon scientific conclusions together with possible proposals on which it will take a decision in accordance with the procedure provided for in the first subparagraph.

Article 16 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1992. They shall forthwith inform the Commission thereof.

Article 17 This Directive is addressed to the Member States.

Done at Brussels, 14 December 1988.

For the Council

The President

Y. POTTAKIS

(1) OJ No C 18, 23. 1. 1988, p. 8.

(2) OJ No C 290, 14. 11. 1988, p. 49.

(3) OJ No C 134, 24. 5. 1988, p. 8.

(4) OJ No 121, 29. 7. 1964, p. 2012/64.

(5) OJ No L 124, 18. 5. 1988, p. 28.

(6) OJ No L 55, 8. 3. 1971, p. 23.

(7) OJ No L 357, 19. 12. 1987, p. 1.(8) OJ No L 26, 31. 1. 1977, p. 85.(9) OJ No L 194, 22. 7. 1988, p. 28.

(10) OJ No L 302, 31. 12. 1972, p. 28.

(11) OJ No L 124, 18. 5. 1988, p. 31.

(12) OJ No L 33, 8. 2. 1979, p. 1.

(13) OJ No L 144, 29. 5. 1986, p. 38.(14) OJ No L 26, 31. 1. 1977, p. 67.(15) OJ NO L 382, 31. 12. 1988, p. 3.' ANNEX I CHAPTER I SPECIAL CONDITIONS FOR THE APPROVAL OF ESTABLISHMENTS PRODUCING THE MEAT DEFINED IN ARTICLE 2 (2)

1. Over and above the general conditions laid down in, respectively Annex I points 1 to 12 and points 14, 15 and 16 of Directive 64/433/EEC and Chapter I of Annex A to Directive 77/99/EEC, production plants or independent production units as defined in Article 2 (2) of this Directive must have at least:

(a) a room separate from the cutting room for mincing, wrapping and for the addition of other foodstuffs, equipped with a recording thermometer or recording telethermometer.

However, the competent authority may authorize the mincing of meat in the cutting room provided that the mincing is carried out in a separate area and does not involve the addition of seasonings and other foodstuffs;

(b) a room for packaging, unless the conditions laid down in point 62 of Chapter XI of Annex I to Directive 64/433/EEC are fulfilled;

(c) a room for storing seasonings and other cleaned foodstuffs ready for use;

(d) refrigeration equipment enabiing the temperatures laid down in this Directive to be adhered to.

Establishments producing meat preparations must also comply with the relevant requirements of Chapter I of Annex B to Directive 77/99/EEC.

2. The rules laid down in Chapter IV of Annex I to Directive 64/433/EEC shall apply as regards the hygiene of the staff, premises and equipment in the establishments.

Staff engaged in the manual preparation of minced meat must also wear masks covering their noses and mouths and surgical-type gloves. CHAPTER II CONDITIONS FOR THE PRODUCTION OF MEAT IN PIEGES OF LESS THAN 100 GRAMS

3. Meat is examined before cutting. All soiled or suspect parts are removed and condemned before the meat is cut up.

4. Meat in pieces of less than 100 grams may not be obtained from scrap cuttings or scrap trimmings or from offal.

For the purposes of this Directive, however, offal in slices obtained under hygienically satisfactory conditions is to be regarded as meatin pieces of less than 100 grams.

5. Where the operations carried out from the time when the meat enters the room referred to in Chapter I, point 1 (a) to the time when the finished product undergoes the chilling or freezing process are performed within a maximum period of one hour, the internal temperature of the meat must be no higher than + 7 oC and the temperature of the production premises must be no higher than + 12 oC. the competent authority may authorize a longer time limit in individuai cases where the addition of seasonings or foodstuffs justifies this on technical grounds, provided hygiene rules are not affected by that derogation.

Where the duration of these operations is over one hour or over the period authorized by the competent authority in accordance with the preceding subparagraph, the fresh meat may not be used until the internal temperature of the meat has been reduced to a maximum of + 4 oC.

6. Immediately after production, meat in pieces of less than 100 grams must be hygienically wrapped and packaged and stored at a temperature of not more than + 2 oC in the case of chilled meat and not more than

- 18 oC in the case of deep frozen meat or not more than - 12 oC in the case of frozen meat.

CHAPTER III CONDITIONS FOR THE PRODUCTION OF MINCED MEAT

7. Meat is examined before mincing. All soiled and suspect parts are removed and condemned before the meat is minced.

8. Minced meat may not be obtained from scrap cuttings or scrap trimmings.

In particular, it may not be prepared from meat from the following parts of bovine animals, pigs, sheep or goats: fragments of muscles from the head, boned shin meat, the point at which the sticking of the animal took place, injection areas, diaphragm and the central part of the belly muscles and bone scrapings. It must not contain any bone fragments.

The rules laid down in point 5 for meat in pieces of less than 100 grams apply mutatis mutandis to the production of minced meat.

9. Immediately after production the minced meat must be hygienically wrapped and packaged and stored at the temperatures prescribed in Article 3 (2) (c).

CHAPTER IV SPECIAL REQUIREMENTS FOR THE PRODUCTION OF MEAT PREPARATIONS

10. Over and above the general requirements of Chapter I, and depending on the type of production concerned:

(a) the production of meat preparations must take place under conditions of temperature control. Immediately after production, meat preparations must be forthwith cooled to the temperatures provided for in Article 3 (2) (c);

(b) meat preparations made from meat which has been minced as provided for in Article 2 (2) (c) may be dispatched only on condition that:

- they are frozen at a freezing speed of one cm/hour,

- they are wrapped in consignments.

Such preparations must be marketed within a period not exceeding six months;

(c) meat preparations other than those referred to in point (b) and intended for direct sale to the final consumer must be wrapped in indivisible commercial portions;

(d) refreezing of meat preparations is prohibited.

CHAPTER V INSPECTION

11. Establishments which produce the meat or meat preparations defined in Article 2 (2) are subject to inspection by the official service. The official veterinarian must be present when work is undertaken on meat or preparations defined in Article 2.

The official veterinarian may, when carrying out the inspection, be helped by assistants placed under his authority and responsibility.

Detailed rules governing this assistance shall, in so far as necessary, be determined in accordance with the procedure laid down in Article 19 of Directive 77/99/EEC.

The details of the professional qualifications of the assistants referred to in this paragraph and of the duties they are to perform shall be determined by the Council acting on a proposal from the Commission.

12. Inspection by the official veterinarian shall include the following tasks:

- inspecting the entries of fresh meat,

- inspecting the outgoing meat defined in Article 2 (2),

- hygiene inspection of the premises, facilities and instruments,

- taking of any necessary samples and in particular those required for the microbiological tests referred to in Chapter VI.

CHAPTER VI MICROBIOLOGICAL TESTS

13. The production of minced meat, meat in pieces of less than 100 grams and meat preparations must be monitored by means of daily microbiological tests in the production establishment or in an approved laboratory.

To that end the operator or proprietor of the establishment or his representative must conduct a regular check on the general hygiene of conditions of production in his establishment, in particular by microbiological controls.

These controls shall cover utensils, fittings and machinery at all stages of production and, according to the type of production concerned, products.

He must be in a position, upon request from the official service, to inform the competent authority or the Commission's veterinary experts of the nature,frequency and results of the controls conducted to this end, together with the name of the investigating laboratory if need be.

The competent authority shall regularly analyse the results of the monitoring provided for in the first subparagraph. It may, on the basis of this analysis, conduct further microbiological examinations at all stages of production or on the products.

The results of these analyses shall be written up in a report, the conclusions and recommendations of which shall be notified to the operator, who shall see to the rectification of shortcomings noted with a view to improving hygiene.

14. The sample taken for analysis must comprise five units weighing 100 grams each. Where minced meat is being produced in portions intended for the final consumer, the sample must be taken from wrapped products. The samples must be representative of daily production.

15. According to the type of production concerned, samples must be examined every day for aerobic mesophile bacteria and salmonella and every week for staphylococci, Eschericha coli and sulphite-reducing anaerobes.

However,

- where the standards for salmonella have been adhered to over a three-month period, the competent authority may authorize weekly examinations.

- in the case of products to be placed on the market frozen or deep-frozen, the competent authority may waive the test for staphylococci.

16. In spot checks carried out by production plants or independent production units, production of the meat and meat preparations referred to in Article 2 (2) must, depending on the type of meat used, comply with the standards laid down in section II of Annex II.

I7. The results of the microbiological tests must be at the official veterinarian's disposal.

The establishment shall inform the official veterinarian when the standards laid down in section II of Annex II are reached. The official veterinarian shall take the appropriate measures.

If, after the expiry of 15 days starting from the time of sampling, the output from production plants or independent production units still does not meet the standards prescribed, products from such establishments must be excluded from intra-Community trade and, once the standards are applied as laid down in the first subparagraph of Article 8 (4), from domestic trade.

CHAPTER VII MARKING AND LABELLING

18. Meat and meat preparations must be marked on the packaging with the health mark of the establishment as defined respectively in Chapter X of Annex I to Directive 64/433/EEC and in Chapter VIII of Annex A to Directive 77/99/EEC.

Meat and meat preparations, as defined in Article 2 (2) of this Directive and produced in the establishments referred to in Article 3 (1) (b) of the said Directive, must be marked on the packaging with the health mark of the establishment as defined in Chapter VIII of Annex A to Directive 77/99/EEC.

19. The producer must ensure for inspection purposes that the following information is visibly and legibly displayed on the wrapping of minced meat and meat in pieces of less than 100 grams and on meat preparations in so far as it is not required by Directive 79/112/EEC:

- where it is not clear from the sales description, the species from which the meat was obtained, and, in the case of a mixture, the percentage of each species,

- the date of preparation.

- the list of seasonings and of any other foodstuffs,

- the word: ´percentage of fat under...'

- the words: ´Collagen: meat protein ratio under...'.

20. Without prejudice to paragraphs 18 and 19, where the meat defined in Article 2 (2) of this Directive is wrapped in commercial portions intended for direct sale to the consumer, a printed reproduction of the mark provided for in paragraph 18 must appear on the wrapping or on a label applied to the wrapping. The mark must include the establishment's approval number. The dimensions laid down in Directives 64/433/EEC and 77/99/EEC do not apply to the marking referred to in this paragraph, provided that the required information is legible.

CHAPTER VIII TRANSPORT

21. The meat defined in Article 2 (2) 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 to transport the meat defined in Article 2 (2) must be equipped in such a way as to ensure that the temperatures laid down in this Directive are not exceeded and for long-distance intra-Community trade they must be equipped with a recording thermometer to ensure that the latter requirement is fulfilled.

ANNEX II COMPOSITON STANDARDS AND MICROBIOLOGICAL STANDARDS

I. COMPOSITION SIANDARDS

Fast content Collagen meat protein ratio

- lean minced meat 7 % 12 %

- minced pure beef 20 % 15 %

- minced meat containing pigmeat 30 % 18 %

- minced meat of other species 25 % 15 %

II. MICROBIOLOGICAL STANDARDS

Production plants and independent production units must ensure that, in accordance with Chapter VI of Annex I and with the methods of interpretation set out below, minced meat and meat in pieces of less than 100 grams intended to be marketed without further processing or as an ingredient in meat preparations, comply with the following standards:

M (;) m($)

Aerobic mesophile bacteria 5 x 10(/g 5 x 10& /g

n (=) = 5 c (%) = 2

Escherchia coli 5 x 10($)/g 50/g

n = 5 c = 2

Sulphite-reducing anaerobes 10($)/g 10/g

n = 5 c = 1

Staphylococci 5 x 10($)/g 50/g

n = 5 c = 1

Salmonella absence in 25 g

n = 5 c = 0

(;) M = acceptability threshold, above whith results are no longer considered satisfactory where M equals 10 m where the count is made in a solid medium and M equals 30 m where the count is made in a liquid medium.

($) m = threshold below which all results are considered satisfactory.

(=) Number of units making up the sample.

(%) Number of units in the sample giving valus between m and M.

The resuits of the microbiological analyses must be interpreted according to:

A. Three categories of contamination for aerobic mesophile bacteria, Escherichia coli, sulphite-reducing anaerobes and staphylococci, viz.:

- up to and including the criterion m,

- between the criterion m and the threshold M,

- above the threshold M.

1. The quality of the consignment shall be considered:

(a) satisfactory, where all the values observed are equal to or less than 3 m where a solid medium has been used or 10 m where a liquid medium has been used:

(b) acceptable where all the values observed are between:

(i) 3 m and 10 m (= M) in a solid medium;

(ii) 10 m and 30 M (= M) in a liquid medium

and where c/n is equal to or less than 2/5 where n = 5 und c = 2 or any other figures of equivalent or greater reliability to be recognized by the Council, acting by a qualified majority on a proposal from the Commission.

2. The quality of the consignment shall be considered unsatisfactory:

- in all cases where values in excess of M are observed,

- when c/n is 2/5.

However, where this latter threshold has been exceeded for aerobic micro-organisms at + 30 oC while all the other criteria have been fulfilled, this exceeding of the threshold must be the subject of a further interpretation,in particular in the case of raw products.

In any event, the product must be considered toxic or tainted when contamination reaches the microbic limit value S, which for general purposes is set at 10= m.

In the case of Staphylococcus aureus, the value of 5 must never be allowed to exceed 5 x 10%.

Tolerances related to analytical techniques shall not apply to the values M and S.

B. Two categories for salmonella, with no category tolerance permitted:

- ´Absence in': the result is considered satisfactory,

- ´Presence in': the result is considered unsatisfactory.