EN Official Journal of the European Union L 226/22

Corrigendum to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin

( Official Journal of the European Union L 139 of 30 April 2004 )

Regulation (EC) No 853/2004 should read as follows:

REGULATION (EC) No 853/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 laying down specific hygiene rules for food of animal origin THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Economic and Social Committee (2), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) Pursuant to Regulation (EC) No 852/2004 (4), the European Parliament and the Council laid down general rules for food business operators on the hygiene of foodstuffs. (2) Certain foodstuffs may present specific hazards to human health, requiring the setting of specific hygiene rules. This is particularly the case for food of animal origin, in which microbiological and chemical hazards have frequently been reported. (3) In the context of the common agricultural policy, many Directives have been adopted to establish specific health rules for the production and placing on the market of the products listed in Annex I to the Treaty. These health rules have reduced trade barriers for the products concerned, contributing to the creation of the internal market while ensuring a high level of protection of public health. (4) With regard to public health, these rules contain common principles, in particular in relation to the manufacturers ‘and competent authorities’ responsibilities, structural, operational and hygiene requirements for establishments, procedures for the approval of establishments, requirements for storage and transport and health marks. (5) These principles constitute a common basis for the hygienic production of food of animal origin, permitting the simplification of the existing directives. (6) It is desirable to achieve further simplification by applying the same rules wherever appropriate to all products of animal origin. (7) The requirement in Regulation (EC) No 852/2004 whereby food business operators carrying out any stage of production, processing and distribution of food after primary production and associated operations must put in place, implement and maintain procedures based on hazard analysis and critical control point (HACCP) principles also permits simplification. (8) Taken together, these elements justify a recasting of the specific hygiene rules contained in existing directives. (9) The principal objectives of the recasting are to secure a high level of consumer protection with regard to food safety, in particular by making food business operators throughout the Community subject to the same rules, and to ensure the proper functioning of the internal market in products of animal origin, thus contributing to the achievement of the objectives of the common agricultural policy. (10) It is necessary to maintain and, where required to ensure consumer protection, to tighten detailed hygiene rules for products of animal origin. (11) Community rules should not apply either to primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption. Moreover, where small quantities of primary products or of certain types of meat are supplied directly by the food business operator producing them to the final consumer or to a local retail establishment, it is appropriate to protect public health through national law, in particular because of the close relationship between the producer and the consumer. (12) The requirements of Regulation (EC) No 852/2004 are generally sufficient to ensure food safety in establishments carrying out retail activities involving the direct sale or supply of food of animal origin to the final consumer. This Regulation should generally apply to wholesale activities (that is, when a retail establishment carries out operations with a view to supplying food of animal origin to another establishment). Nevertheless, with the exception of the specific temperature requirements laid down in this Regulation, the requirements of Regulation (EC) No 852/2004 should suffice for wholesale activities consisting only of storage or transport. (13) Member States should have some discretion to extend or to limit the application of the requirements of this Regulation to retail under national law. However, they may limit their application only if they consider that the requirements of Regulation (EC) No 852/2004 are sufficient to achieve food hygiene objectives and when the supply of food of animal origin from a retail establishment to another establishment is a marginal, localised and restricted activity. Such supply should therefore be only a small part of the establishment's business; the establishments supplied should be situated in its immediate vicinity; and the supply should concern only certain types of products or establishments. (14) In accordance with Article 10 of the Treaty, Member States are to take all appropriate measures to ensure that food business operators comply with the obligations laid down in this Regulation. (15) The traceability of food is an essential element in ensuring food safety. In addition to complying with the general rules of Regulation (EC) No 178/2002 (5), food business operators responsible for establishments that are subject to approval in accordance with this Regulation should ensure that all products of animal origin that they place on the market bear either a health mark or an identification mark. (16) Food imported into the Community is to comply with the general requirements laid down in Regulation (EC) No 178/2002 or to satisfy rules that are equivalent to Community rules. This Regulation defines specific hygiene requirements for food of animal origin imported into the Community. (17) The adoption of this Regulation should not reduce the level of protection provided by the additional guarantees agreed for Finland and Sweden on their accession to the Community and confirmed by Commission Decisions 94/968/EC (6), 95/50/EC (7), 95/160/EC (8), 95/161/E (9) and 95/168/EC (10), and Council Decisions 95/409/EC (11), 95/410/EC (12) and 95/411/EC (13). It should establish a procedure for the granting, for a transitional period, of guarantees to any Member State that has an approved national control programme which, for the food of animal origin concerned, is equivalent to those approved for Finland and Sweden. Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (14) provides for a similar procedure in respect of live animals and hatching eggs. (18) It is appropriate for the structural and hygiene requirements laid down in this Regulation to apply to all types of establishments, including small businesses and mobile slaughterhouses. (19) Flexibility is appropriate to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food and in relation to structural requirements for establishments. Flexibility is particularly important for regions that are subject to special geographical constraints, including the outermost regions referred to in Article 299(2) of the Treaty. However, flexibility should not compromise food hygiene objectives. Moreover, since all food produced in accordance with the hygiene rules will normally be in free circulation throughout the Community, the procedure allowing Member States to exercise flexibility should be fully transparent. It should provide, where necessary to resolve disagreements, for discussion within the Standing Committee on the Food Chain and Animal Health established by Regulation (EC) No 178/2002 and for the Commission to coordinate the process and take appropriate measures. (20) The definition of mechanically separated meat (MSM) should be a generic one covering all methods of mechanical separation. Rapid technological developments in this area mean that a flexible definition is appropriate. The technical requirements for MSM should differ, however, depending on a risk assessment of the product resulting from different methods. (21) There are interactions between food business operators, including the animal feed sector, and connections between animal health, animal welfare and public health considerations at all stages of production, processing and distribution. This requires adequate communication between the different stakeholders along the food chain from primary production to retail. (22) In order to ensure proper inspection of hunted wild game placed on the Community market, bodies of hunted animals and their viscera should be presented for official post-mortem inspection at a game-handling establishment. However, to preserve certain hunting traditions without prejudicing food safety, it is appropriate to provide for training for hunters who place wild game on the market for human consumption. This should enable hunters to undertake an initial examination of wild game on the spot. In these circumstances, it is not necessary to require trained hunters to deliver all viscera to the game-handling establishment for post-mortem examination, if they carry out this initial examination and identify no anomalies or hazards. However, Member States should be allowed to establish stricter rules within their territories to take account of specific risks. (23) This Regulation should establish criteria for raw milk pending the adoption of new requirements for its placing on the market. These criteria should be trigger values, implying that, in the event of any overshooting, food business operators are to take corrective action and to notify the competent authority. The criteria should not be maximum figures beyond which raw milk cannot be placed on the market. This implies that, in certain circumstances, raw milk not fully meeting the criteria can safely be used for human consumption, if appropriate measures are taken. As regards raw milk and raw cream intended for direct human consumption, it is appropriate to enable each Member State to maintain or establish appropriate health measures to ensure the achievement of the objectives of this Regulation on its territory. (24) It is appropriate for the criterion for raw milk used to manufacture dairy products to be three times as high as the criterion for raw milk collected from the farm. The criterion for milk used to manufacture processed dairy products is an absolute value, whereas for raw milk collected from the farm it is an average. Compliance with the temperature requirements laid down in this Regulation will not halt all bacterial growth during transport and storage. (25) The present recasting means that the existing hygiene rules can be repealed. Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain directives on food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption (15) achieves this. (26) In addition, the rules of this Regulation on eggs replace those of Council Decision 94/371/EC of 20 June 1994 laying down specific public health conditions for the putting on the market of certain types of eggs (16), which the repeal of Annex II to Council Directive 92/118/EEC (17) renders void. (27) Scientific advice should underpin Community legislation on food hygiene. To this end, the European Food Safety Authority should be consulted whenever necessary. (28) To take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Committee on the Food Chain and Animal Health. (29) The requirements of this Regulation should not apply until all parts of the new legislation on food hygiene have entered into force. It is also appropriate to provide for at least 18 months to elapse between entry into force and the application of the new rules, to allow the industries affected time to adapt. (30) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (18), HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Scope 1. This Regulation lays down specific rules on the hygiene of food of animal origin for food business operators. These rules supplement those laid down by Regulation (EC) No 852/2004. They shall apply to unprocessed and processed products of animal origin. 2. Unless expressly indicated to the contrary, this Regulation shall not apply to food containing both products of plant origin and processed products of animal origin. However, processed products of animal origin used to prepare such food shall be obtained and handled in accordance with the requirements of this Regulation. 3. This Regulation shall not apply in relation to: (a) primary production for private domestic use; (b) the domestic preparation, handling or storage of food for private domestic consumption; (c) the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer; (d) the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer as fresh meat; (e) hunters who supply small quantities of wild game or wild game meat directly to the final consumer or to local retail establishments directly supplying the final consumer. 4. Member States shall establish, according to national law, rules governing the activities and persons referred to in paragraph 3(c), (d) and (e). Such national rules shall ensure the achievement of the objectives of this Regulation. 5. (a) Unless expressly indicated to the contrary, this Regulation shall not apply to retail. (b) However, this Regulation shall apply to retail when operations are carried out with a view to the supply of food of animal origin to another establishment, unless: (i) the operations consist only of storage or transport, in which case the specific temperature requirements laid down in Annex III shall nevertheless apply; or (ii) the supply of food of animal origin from the retail establishment is to other retail establishments only and, in accordance with national law, is a marginal, localised and restricted activity. (c) Member States may adopt national measures to apply the requirements of this Regulation to retail establishments situated on their territory to which it would not apply pursuant to subparagraphs (a) or (b). 6. This Regulation shall apply without prejudice to: (a) relevant animal and public health rules, including more stringent rules laid down for the prevention, control and eradication of certain transmissible spongiform encephalopathies; (b) animal welfare requirements; and (c) requirements concerning the identification of animals and the traceability of products of animal origin. Article 2 Definitions The following definitions shall apply for the purposes of this Regulation: 1. the definitions laid down in Regulation (EC) No 178/2002; 2. the definitions laid down in Regulation (EC) No 852/2004; 3. the definitions laid down in Annex I; and 4. any technical definitions contained in Annexes II and III. CHAPTER II FOOD BUSINESS OPERATORS' OBLIGATIONS Article 3 General obligations 1. Food business operators shall comply with the relevant provisions of Annexes II and III. 2. Food business operators shall not use any substance other than potable water — or, when Regulation (EC) No 852/2004 or this Regulation permits its use, clean water — to remove surface contamination from products of animal origin, unless use of the substance has been approved in accordance with the procedure referred to in Article 12(2). Food business operators shall also comply with any conditions for use that may be adopted under the same procedure. The use of an approved substance shall not affect the food business operator's duty to comply with the requirements of this Regulation. Article 4 Registration and approval of establishments 1. Food business operators shall place products of animal origin manufactured in the Community on the market only if they have been prepared and handled exclusively in establishments: (a) that meet the relevant requirements of Regulation (EC) No 852/2004, those of Annexes II and III of this Regulation and other relevant requirements of food law; and (b) that the competent authority has registered or, where required in accordance with paragraph 2, approved. 2. Without prejudice to Article 6(3) of Regulation (EC) No 852/2004, establishments handling those products of animal origin for which Annex III to this Regulation lays down requirements shall not operate unless the competent authority has approved them in accordance with paragraph 3 of this Article, with the exception of establishments carrying out only: (a) primary production; (b) transport operations; (c) the storage of products not requiring temperature-controlled storage conditions; or (d) retail operations other than those to which this Regulation applies pursuant to Article 1(5)(b). 3. An establishment subject to approval in accordance with paragraph 2 shall not operate unless the competent authority has, in accordance with Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (19): (a) granted the establishment approval to operate following an on-site visit; or (b) provided the establishment with conditional approval. 4. Food business operators shall cooperate with the competent authorities in accordance with Regulation (EC) No 854/2004. In particular, food business operators shall ensure that an establishment ceases to operate if the competent authority withdraws its approval or, in the case of conditional approval, fails to prolong it or to grant full approval. 5. This Article shall not prevent an establishment from placing food on the market between the date of application of this Regulation and the first subsequent inspection by the competent authority, if the establishment: (a) is subject to approval in accordance with paragraph 2 and placed products of animal origin on the market in accordance with Community legislation immediately prior to the application of this Regulation; or (b) is of a type in respect of which there was no requirement for approval before the application of this Regulation. Article 5 Health and identification marking 1. Food business operators shall not place on the market a product of animal origin handled in an establishment subject to approval in accordance with Article 4(2) unless it has either: (a) a health mark applied in accordance with Regulation (EC) No 854/2004; or (b) when that Regulation does not provide for the application of a health mark, an identification mark applied in accordance with Annex II, Section I, of this Regulation. 2. Food business operators may apply an identification mark to a product of animal origin only if the product has been manufactured in accordance with this Regulation in establishments meeting the requirements of Article 4. 3. Food business operators may not remove a health mark applied in accordance with Regulation (EC) No 854/2004 from meat unless they cut or process it or work upon it in another manner. Article 6 Products of animal origin from outside the Community 1. Food business operators importing products of animal origin from third countries shall ensure that importation takes place only if: (a) the third country of dispatch appears on a list, drawn up in accordance with Article 11 of Regulation (EC) No 854/2004, of third countries from which imports of that product are permitted; (b) (i) the establishment from which that product was dispatched, and in which it was obtained or prepared, appears on a list, drawn up in accordance with Article 12 of Regulation (EC) No 854/2004, of establishments from which imports of that product are permitted, when applicable, (ii) in the case of fresh meat, minced meat, meat preparations, meat products and MSM, the product was manufactured from meat obtained in slaughterhouses and cutting plants appearing on lists drawn up and updated in accordance with Article 12 of Regulation (EC) No 854/2004 or in approved Community establishments, and (iii) in the case of live bivalve molluscs, echinoderms, tunicates and marine gastropods, the production area appears on a list drawn up in accordance with Article 13 of that Regulation, when applicable; (c) the product satisfies: (i) the requirements of this Regulation, including the requirements of Article 5 on health and identification marking; (ii) the requirements of Regulation (EC) No 852/2004; and (iii) any import conditions laid down in accordance with Community legislation governing import controls for products of animal origin, and (d) the requirements of Article 14 of Regulation (EC) No 854/2004 concerning certificates and documents are satisfied, when applicable. 2. By way of derogation from paragraph 1, the importation of fishery products may also take place in accordance with the special provisions laid down in Article 15 of Regulation (EC) No 854/2004. 3. Food business operators importing products of animal origin shall ensure that: (a) products are made available for control upon importation in accordance with Directive 97/78/EC (20); (b) importation complies with the requirements of Directive 2002/99/EC (21); and (c) operations under their control that take place after importation are carried out in accordance with the requirements of Annex III. 4. Food business operators importing food containing both products of plant origin and processed products of animal origin shall ensure that the processed products of animal origin contained in such food satisfy the requirements of paragraphs 1 to 3. They must be able to demonstrate that they have done so (for example, through appropriate documentation or certification, which need not be in the format specified in paragraph 1(d)). CHAPTER III TRADE Article 7 Documents 1. When required in accordance with Annex II or III, food business operators shall ensure that certificates or other documents accompany consignments of products of animal origin. 2. In accordance with the procedure referred to in Article 12(2): (a) model documents may be established; and (b) provision may be made for the use of electronic documents. Article 8 Special guarantees 1. Food business operators intending to place the following food of animal origin on the market in Sweden or Finland shall comply with the rules set out in paragraph 2 in respect of salmonella: (a) meat from bovine and porcine animals, including minced meat but excluding meat preparations and MSM; (b) meat from poultry of the following species: domestic fowl, turkeys, guinea-fowl, ducks and geese, including minced meat but excluding meat preparations and MSM; and (c) eggs. 2. (a) In the case of meat from bovine and porcine animals and meat from poultry, samples of consignments shall have been taken in the dispatching establishment and been subjected to a microbiological test with negative results in accordance with Community legislation. (b) In the case of eggs, packing centres shall provide a guarantee that consignments originate from flocks that have been subjected to a microbiological test with negative results in accordance with Community legislation. (c) In the case of meat from bovine and porcine animals, the test provided for in subparagraph (a) need not be carried out for consignments intended for an establishment for the purposes of pasteurisation, sterilisation or treatment having a similar effect. In the case of eggs, the test provided for in subparagraph (b) need not be carried out for consignments intended for the manufacture of processed products by a process that guarantees the elimination of salmonella. (d) The tests provided for in subparagraphs (a) and (b) need not be carried out for foodstuffs originating in an establishment that is subject to a control programme recognised, in respect of the food of animal origin concerned and in accordance with the procedure referred to in Article 12(2), as equivalent to that approved for Sweden and Finland. (e) In the case of meat from bovine and porcine animals and meat from poultry, a trade document or certificate conforming to a model laid down by Community legislation shall accompany the food and state that: (i) the checks referred to in subparagraph (a) have been carried out with negative results; or (ii) the meat is intended for one of the purposes referred to in subparagraph (c); or (iii) the meat comes from an establishment covered by subparagraph (d). (f) In the case of eggs, a certificate stating that the tests referred to in subparagraph (b) have been carried out with negative results, or that the eggs are destined to be used in the manner referred to in subparagraph (c), must accompany consignments. 3. In accordance with the procedure referred to in Article 12(2): (a) the requirements of paragraphs 1 and 2 may be updated to take account in particular of changes to Member States' control programmes or the adoption of microbiological criteria in accordance with Regulation (EC) No 852/2004; and (b) the rules laid down in paragraph 2 in respect of any of the foodstuffs referred to in paragraph 1 may be extended, in whole or in part, to any Member State, or any region of a Member State, that has a control programme recognised as equivalent to that approved for Sweden and Finland in respect of the food of animal origin concerned. 4. For the purposes of this Article, ‘control programme’ means a control programme approved in accordance with Regulation (EC) No 2160/2003. CHAPTER IV FINAL PROVISIONS Article 9 Implementing measures and transitional measures Implementing measures and transitional arrangements may be laid down in accordance with the procedure referred to in Article 12(2). Article 10 Amendment and adaptation of Annexes II and III 1. Annexes II and III may be adapted or updated in accordance with the procedure referred to in Article 12(2), taking into account: (a) the development of guides to good practice; (b) the experience gained from the implementation of HACCP-based systems pursuant to Article 5 of Regulation (EC) No 852/2004; (c) the technological developments and their practical consequences and consumer expectations with regard to food composition; (d) scientific advice, particularly new risk assessments; (e) microbiological and temperature criteria for foodstuffs; (f) changes in patterns of consumption. 2. Exemptions from Annex II and III may be granted in accordance with the procedure referred to in Article 12(2), provided that they do not affect the achievement of the objectives of this Regulation. 3. Member States may, without compromising achievement of the objectives of this Regulation, adopt, in accordance with paragraphs 4 to 8, national measures adapting the requirements laid down in Annex III. 4. (a) The national measures referred to in paragraph 3 shall have the aim of: (i) enabling the continued use of traditional methods at any of the stages of production, processing or distribution of food; or (ii) accommodating the needs of food businesses situated in regions that are subject to special geographic constraints. (b) In other cases, they shall apply only to the construction, layout and equipment of establishments. 5. Any Member State wishing to adopt national measures as referred to in paragraph 3 shall notify the Commission and other Member States. Each notification shall: (a) provide a detailed description of the requirements that that Member State considers need to be adapted and the nature of the adaptation sought; (b) describe the foodstuffs and establishments concerned; (c) explain the reasons for the adaptation, including, where relevant, by providing a summary of the hazard analysis carried out and any measures to be taken to ensure that the adaptation will not compromise the objectives of this Regulation; and (d) give any other relevant information. 6. The other Member States shall have three months from the receipt of a notification referred to in paragraph 5 to send written comments to the Commission. In the case of adaptations arising from paragraph 4(b), this period shall, at the request of any Member State, be extended to four months. The Commission may, and when it receives written comments from one or more Member States shall, consult Member States within the committee referred to in Article 12(1). The Commission may decide, in accordance with the procedure referred to in Article 12(2), whether the envisaged measures may be implemented, subject, if necessary, to appropriate amendments. Where appropriate, the Commission may propose general measures in accordance with paragraph 1 or 2 of this Article. 7. A Member State may adopt national measures adapting the requirements of Annex III only: (a) in compliance with a decision adopted in accordance with paragraph 6; (b) if, one month after the expiry of the period referred to in paragraph 6, the Commission has not informed Member States that it has received written comments or that it intends to propose the adoption of a decision in accordance with paragraph 6; or (c) in accordance with paragraph 8. 8. A Member State may, of its own initiative and subject to the general provisions of the Treaty, maintain or establish national rules: (a) prohibiting or restricting the placing on the market within its territory of raw milk or raw cream intended for direct human consumption; or (b) permitting the use, with the authorisation of the competent authority, of raw milk not meeting the criteria laid down in Annex III, Section IX, as regards plate count and somatic cell count of the manufacture of cheeses with an ageing or ripening period of at least 60 days, and dairy products obtained in connection with the manufacture of such cheeses, provided that this does not prejudice the achievement of the objectives of this Regulation. Article 11 Specific decisions Without prejudice to the generality of Article 9 and Article 10(1), implementing measures may be laid down, or amendments to Annex II or III adopted, in accordance with the procedure referred to in Article 12(2): 1. to lay down rules for the transport of meat while it is warm; 2. to specify, in respect of MSM, which calcium content is not significantly higher than that of minced meat; 3. to lay down other treatments that may be applied in a processing establishment to live bivalve molluscs from class B or C production areas that have not been submitted to purification or relaying; 4. to specify recognised testing methods for marine biotoxins; 5. to lay down additional health standards for live bivalve molluscs in cooperation with the relevant Community Reference Laboratory, including: (a) limit values and analysis methods for other marine biotoxins; (b) virus testing procedures and virological standards; and (c) sampling plans and the methods and analytical tolerances to be applied to check compliance with the health standards; 6. to lay down health standards or checks, where there is scientific evidence indicating that they are necessary to protect public health; 7. to extend Annex III, Section VII, Chapter IX, to live bivalve molluscs other than pectinidae; 8. to specify criteria for determining when epidemiological data indicate that a fishing ground does not present a health hazard with regard to the presence of parasites and, consequently, for determining when the competent authority may authorise food business operators not to freeze fishery products in accordance with Annex III, Section VIII, Chapter III, Part D; 9. to lay down freshness criteria and limits with regard to histamine and total volatile nitrogen for fisheries products; 10. to permit the use for the manufacture of certain dairy products of raw milk not meeting the criteria laid down in Annex III, Section IX, as regards its plate count and somatic cell count; 11. without prejudice to Directive 96/23/EC (22), to fix a maximum permitted value for the combined total of residues of antibiotic substances in raw milk; and 12. to approve equivalent processes for the production of gelatine or collagen. Article 12 Committee procedure 1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. Article 13 Consultation of the European Food Safety Authority The Commission shall consult the European Food Safety Authority on any matter falling within the scope of this Regulation that could have a significant impact on public health and, in particular, before proposing to extend Annex III, Section III, to other animal species. Article 14 Report to the European Parliament and to the Council 1. The Commission shall, not later than 20 May 2009, submit a report to the European Parliament and the Council reviewing the experience gained from the implementation of this Regulation. 2. The Commission shall, if appropriate, accompany the report with relevant proposals. Article 15 This Regulation shall enter into force on the 20th day after that of its publication in the Official Journal of the European Union. It shall apply 18 months after the date on which all of the following acts have entered into force: (a) Regulation (EC) No 852/2004; (b) Regulation (EC) No 854/2004; and (c) Directive 2004/41/EC. However, it shall apply no earlier than 1 January 2006. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 29 April 2004. For the European Parliament The President P. COX For the Council The President M. McDOWELL

ANNEX I DEFINITIONS For the purpose of this Regulation: 1. MEAT 1.1. ‘Meat’ means edible parts of the animals referred to in points 1.2 to 1.8, including blood. 1.2. ‘Domestic ungulates’ means domestic bovine (including Bubalus and Bison species), porcine, ovine and caprine animals, and domestic solipeds. 1.3. ‘Poultry’ means farmed birds, including birds that are not considered as domestic but which are farmed as domestic animals, with the exception of ratites. 1.4. ‘Lagomorphs’ means rabbits, hares and rodents. 1.5. ‘Wild game’ means: — wild ungulates and lagomorphs, as well as other land mammals that are hunted for human consumption and are considered to be wild game under the applicable law in the Member State concerned, including mammals living in enclosed territory under conditions of freedom similar to those of wild game; and — wild birds that are hunted for human consumption. 1.6. ‘Farmed game’ means farmed ratites and farmed land mammals other than those referred to in point 1.2. 1.7. ‘Small wild game’ means wild game birds and lagomorphs living freely in the wild. 1.8. ‘Large wild game’ means wild land mammals living freely in the wild that do not fall within the definition of small wild game. 1.9. ‘Carcase’ means the body of an animal after slaughter and dressing. 1.10. ‘Fresh meat’ means meat that has not undergone any preserving process other than chilling, freezing or quick-freezing, including meat that is vacuum-wrapped or wrapped in a controlled atmosphere. 1.11. ‘Offal’ means fresh meat other than that of the carcase, including viscera and blood. 1.12. ‘Viscera’ means the organs of the thoracic, abdominal and pelvic cavities, as well as the trachea and oesophagus and, in birds, the crop. 1.13. ‘Minced meat’ means boned meat that has been minced into fragments and contains less than 1 % salt. 1.14. ‘Mechanically separated meat’ or ‘MSM’ means the product obtained by removing meat from flesh-bearing bones after boning or from poultry carcases, using mechanical means resulting in the loss or modification of the muscle fibre structure. 1.15. ‘Meat preparations’ means fresh meat, including meat that has been reduced to fragments, which has had foodstuffs, seasonings or additives added to it or which has undergone processes insufficient to modify the internal muscle fibre structure of the meat and thus to eliminate the characteristics of fresh meat. 1.16. ‘Slaughterhouse’ means an establishment used for slaughtering and dressing animals, the meat of which is intended for human consumption. 1.17. ‘Cutting plant’ means an establishment used for boning and/or cutting up meat. 1.18. ‘Game-handling establishment’ means any establishment in which game and game meat obtained after hunting are prepared for placing on the market. 2. LIVE BIVALVE MOLLUSCS 2.1. ‘Bivalve molluscs’ means filter-feeding lamellibranch molluscs. 2.2. ‘Marine biotoxins’ means poisonous substances accumulated by bivalve molluscs, in particular as a result of feeding on plankton containing toxins. 2.3. ‘Conditioning’ means the storage of live bivalve molluscs coming from class A production areas, purification centres or dispatch centres in tanks or any other installation containing clean seawater, or in natural sites, to remove sand, mud or slime, to preserve or to improve organoleptic qualities and to ensure that they are in a good state of vitality before wrapping or packaging. 2.4. ‘Gatherer’ means any natural or legal person who collects live bivalve molluscs by any means from a harvesting area for the purpose of handling and placing on the market. 2.5. ‘Production area’ means any sea, estuarine or lagoon area, containing either natural beds of bivalve molluscs or sites used for the cultivation of bivalve molluscs, and from which live bivalve molluscs are taken. 2.6. ‘Relaying area’ means any sea, estuarine or lagoon area with boundaries clearly marked and indicated by buoys, posts or any other fixed means, and used exclusively for the natural purification of live bivalve molluscs. 2.7. ‘Dispatch centre’ means any on-shore or off-shore establishment for the reception, conditioning, washing, cleaning, grading, wrapping and packaging of live bivalve molluscs fit for human consumption. 2.8. ‘Purification centre’ means an establishment with tanks fed by clean seawater in which live bivalve molluscs are placed for the time necessary to reduce contamination to make them fit for human consumption. 2.9. ‘Relaying’ means the transfer of live bivalve molluscs to sea, lagoon or estuarine areas for the time necessary to reduce contamination to make them fit for human consumption. This does not include the specific operation of transferring bivalve molluscs to areas more suitable for further growth or fattening. 3. FISHERY PRODUCTS 3.1. ‘Fishery products’ means all seawater or freshwater animals (except for live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods, and all mammals, reptiles and frogs) whether wild or farmed and including all edible forms, parts and products of such animals. 3.2. ‘Factory vessel’ means any vessel on board which fishery products undergo one or more of the following operations followed by wrapping or packaging and, if necessary, chilling or freezing: filleting, slicing, skinning, shelling, shucking, mincing or processing. 3.3. ‘Freezer vessel’ means any vessel on board which freezing of fishery products is carried out, where appropriate after preparatory work such as bleeding, heading, gutting and removal of fins and, where necessary, followed by wrapping or packaging. 3.4. ‘Mechanically separated fishery product’ means any product obtained by removing flesh from fishery products using mechanical means resulting in the loss or modification of the flesh structure. 3.5. ‘Fresh fishery products’ means unprocessed fishery products, whether whole or prepared, including products packaged under vacuum or in a modified atmosphere, that have not undergone any treatment to ensure preservation other than chilling. 3.6. ‘Prepared fishery products’ means unprocessed fishery products that have undergone an operation affecting their anatomical wholeness, such as gutting, heading, slicing, filleting, and chopping. 4. MILK 4.1. ‘Raw milk’ means milk produced by the secretion of the mammary gland of farmed animals that has not been heated to more than 40 °C or undergone any treatment that has an equivalent effect. 4.2. ‘Milk production holding’ means an establishment where one or more farmed animals are kept to produce milk with a view to placing it on the market as food. 5. EGGS 5.1. ‘Eggs’ means eggs in shell — other than broken, incubated or cooked eggs — that are produced by farmed birds and are fit for direct human consumption or for the preparation of egg products. 5.2. ‘Liquid egg’ means unprocessed egg contents after removal of the shell. 5.3. ‘Cracked eggs’ means eggs with damaged shell and intact membranes. 5.4. ‘Packing centre’ means an establishment where eggs are graded by quality and weight. 6. FROGS' LEGS AND SNAILS 6.1. ‘Frogs' legs’ means the posterior part of the body divided by a transverse cut behind the front limbs, eviscerated and skinned, of the species RNA (family Ranidae). 6.2. ‘Snails’ means terrestrial gastropods of the species Helix pomatiaLinné, Helix aspersaMuller, Helix lucorum and species of the family Achatinidae. 7. PROCESSED PRODUCTS 7.1. ‘Meat products’ means processed products resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat. 7.2. ‘Dairy products’ means processed products resulting from the processing of raw milk or from the further processing of such processed products. 7.3. ‘Egg products’ means processed products resulting from the processing of eggs, or of various components or mixtures of eggs, or from the further processing of such processed products. 7.4. ‘Processed fishery products’ means processed products resulting from the processing of fishery products or from the further processing of such processed products. 7.5. ‘Rendered animal fat’ means fat derived from rendering meat, including bones, and intended for human consumption. 7.6. ‘Greaves’ means the protein-containing residue of rendering, after partial separation of fat and water. 7.7. ‘Gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals. 7.8. ‘Collagen’ means the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of this Regulation. 7.9. ‘Treated stomachs, bladders and intestines’ means stomachs, bladders and intestines that have been submitted to a treatment such as salting, heating or drying after they have been obtained and after cleaning. 8. OTHER DEFINITIONS 8.1. ‘Products of animal origin’ means: — food of animal origin, including honey and blood; — live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption; and — other animals destined to be prepared with a view to being supplied live to the final consumer. 8.2. ‘Wholesale market’ means a food business that includes several separate units which share common installations and sections where foodstuffs are sold to food business operators.

ANNEX II REQUIREMENTS CONCERNING SEVERAL PRODUCTS OF ANIMAL ORIGIN SECTION I: IDENTIFICATION MARKING When required in accordance with Article 5 or 6, and subject to the provisions of Annex III, food business operators must ensure that products of animal origin have an identification mark applied in compliance with the following provisions. A. APPLICATION OF THE IDENTIFICATION MARK 1. The identification mark must be applied before the product leaves the establishment. 2. However, a new mark need not be applied to a product unless its packaging and/or wrapping is removed or it is further processed in another establishment, in which case the new mark must indicate the approval number of the establishment where these operations take place. 3. An identification mark is not necessary for eggs in respect of which Regulation (EC) No 1907/90 (23) lays down requirements concerning labelling or marking. 4. Food business operators must, in accordance with Article 18 of Regulation (EC) No 178/2002, have in place systems and procedures to identify food business operators from whom they have received and to whom they have delivered products of animal origin. B. FORM OF THE IDENTIFICATION MARK 5. The mark must be legible and indelible, and the characters easily decipherable. It must be clearly displayed for the competent authorities. 6. The mark must indicate the name of the country in which the establishment is located, which may be written out in full or shown as a two-letter code in accordance with the relevant ISO standard. In the case of Member States, however, these codes are AT, BE, DE, DK, ES, FI, FR, GR, IE, IT, LU, NL, PT, SE and UK. Food business operators may continue to use stocks and equipment that they ordered before the entry into force of this Regulation until they are exhausted or require replacement. 7. The mark must indicate the approval number of the establishment. If an establishment manufactures both food to which this Regulation applies and food to which it does not, the food business operator may apply the same identification mark to both types of food. 8. When applied in an establishment located within the Community, the mark must be oval in shape and include the abbreviation CE, EC, EF, EG, EK or EY. C. METHOD OF MARKING 9. The mark may, depending on the presentation of different products of animal origin, be applied directly to the product, the wrapping or the packaging, or be printed on a label affixed to the product, the wrapping or the packaging. The mark may also be an irremovable tag made of a resistant material. 10. In the case of packaging containing cut meat or offal, the mark must be applied to a label fixed to the packaging, or printed on the packaging, in such a way that it is destroyed when the packaging is opened. This is not necessary, however, if the process of opening destroys the packaging. When wrapping provides the same protection as packaging, the label may be affixed to the wrapping. 11. For products of animal origin that are placed in transport containers or large packages and are intended for further handling, processing, wrapping or packaging in another establishment, the mark may be applied to the external surface of the container or packaging. 12. In the case of liquid, granulate and powdered products of animal origin carried in bulk, and fishery products carried in bulk, an identification mark is not necessary if accompanying documentation contains the information specified in points 6, 7 and, where appropriate, 8. 13. When products of animal origin are placed in a package destined for direct supply to the final consumer, it is sufficient to apply the mark to the exterior of that package only. 14. When the mark is applied directly to products of animal origin, the colours used must be authorised in accordance with Community rules on the use of colouring substances in foodstuffs. SECTION II: OBJECTIVES OF HACCP-BASED PROCEDURES 1. Food business operators operating slaughterhouses must ensure that the procedures that they have put in place in accordance with the general requirements of Article 5 of Regulation (EC) No 852/2004 meet the requirements that the hazard analysis shows to be necessary and the specific requirements listed in point 2. 2. The procedures must guarantee that each animal or, where appropriate, each lot of animals accepted onto the slaughterhouse premises: (a) is properly identified; (b) is accompanied by the relevant information from the holding of provenance referred to in Section III; (c) does not come from a holding or an area subject to a movement prohibition or other restriction for reasons of animal or public health, except when the competent authority so permits; (d) is clean; (e) is healthy, as far as the food business operator can judge; and (f) is in a satisfactory state as regards welfare on arrival at the slaughterhouse. 3. In the event of failure to comply with any of the requirements listed under point 2, the food business operator must notify the official veterinarian and take appropriate measures. SECTION III: FOOD CHAIN INFORMATION Food business operators operating slaughterhouses must, as appropriate, request, receive, check and act upon food chain information as set out in this Section in respect of all animals, other than wild game, sent or intended to be sent to the slaughterhouse. 1. Slaughterhouse operators must not accept animals onto the slaughterhouse premises unless they have requested and been provided with relevant food safety information contained in the records kept at the holding of provenance in accordance with Regulation (EC) No 852/2004. 2. Slaughterhouse operators must be provided with the information no less than 24 hours before the arrival of animals at the slaughterhouse, except in the circumstances mentioned in point 7. 3. The relevant food safety information referred to in point 1 is to cover, in particular: (a) the status of the holding of provenance or the regional animal health status; (b) the animals' health status; (c) veterinary medicinal products or other treatments administered to the animals within a relevant period and with a withdrawal period greater than zero, together with their dates of administration and withdrawal periods; (d) the occurrence of diseases that may affect the safety of meat; (e) the results, if they are relevant to the protection of public health, of any analysis carried out on samples taken from the animals or other samples taken to diagnose diseases that may affect the safety of meat, including samples taken in the framework of the monitoring and control of zoonoses and residues; (f) relevant reports about previous ante- and post-mortem inspections of animals from the same holding of provenance including, in particular, reports from the official veterinarian; (g) production data, when this might indicate the presence of disease; and (h) the name and address of the private veterinarian normally attending the holding of provenance. 4. (a) However, it is not necessary for the slaughterhouse operator to be provided with: (i) the information referred to in point 3(a), (b), (f) and (h), if the operator is already aware of this information (for example, through a standing arrangement or a quality assurance scheme); or (ii) the information referred to in point 3(a), (b), (f) and (g), if the producer declares that there is no relevant information to report. (b) The information need not be provided as a verbatim extract from the records of the holding of provenance. It may be provided through electronic data exchange or in the form of a standardised declaration signed by the producer. 5. Food business operators deciding to accept animals onto the slaughterhouse premises after evaluating the relevant food chain information must make it available to the official veterinarian without delay and, except in the circumstances mentioned in point 7, no less than 24 hours before the arrival of the animal or lot. The food business operator must notify the official veterinarian of any information that gives rise to health concerns before ante-mortem inspection of the animal concerned. 6. If any animal arrives at the slaughterhouse without food chain information, the operator must immediately notify the official veterinarian. Slaughter of the animal may not take place until the official veterinarian so permits. 7. If the competent authority so permits, food chain information may accompany the animals to which it relates to the slaughterhouse, rather than arriving at least 24 hours in advance, in the case of: (a) porcine animals, poultry or farmed game that have undergone ante-mortem inspection at the holding of provenance, if a certificate that the veterinarian has signed stating that he or she examined the animals at the holding and found them to be healthy accompanies them; (b) domestic solipeds; (c) animals that have undergone emergency slaughter, if a declaration, that the veterinarian has signed recording the favourable outcome of the ante-mortem inspection accompanies them; and (d) animals that are not delivered directly from the holding of provenance to the slaughterhouse. Slaughterhouse operators must evaluate the relevant information. If they accept the animals for slaughter, they must give the documents mentioned in subparagraphs (a) and (c) to the official veterinarian. Slaughter or dressing of the animals may not take place until the official veterinarian so permits. 8. Food business operators must check passports accompanying domestic solipeds to ensure that the animal is intended for slaughter for human consumption. If they accept the animal for slaughter, they must give the passport to the official veterinarian.

ANNEX III SPECIFIC REQUIREMENTS SECTION I: MEAT OF DOMESTIC UNGULATES CHAPTER I: TRANSPORT OF LIVE ANIMALS TO THE SLAUGHTERHOUSE Food business operators transporting live animals to slaughterhouses must ensure compliance with the following requirements. 1. During collection and transport, animals must be handled carefully without causing unnecessary distress. 2. Animals showing symptoms of disease or originating in herds known to be contaminated with agents of public health importance may only be transported to the slaughterhouse when the competent authority so permits. CHAPTER II: REQUIREMENTS FOR SLAUGHTERHOUSES Food business operators must ensure that the construction, layout and equipment of slaughterhouses in which domestic ungulates are slaughtered meet the following requirements. 1. (a) Slaughterhouses must have adequate and hygienic lairage facilities or, climate permitting, waiting pens that are easy to clean and disinfect. These facilities must be equipped for watering the animals and, if necessary, feeding them. The drainage of the wastewater must not compromise food safety. (b) They must also have separate lockable facilities or, climate permitting, pens for sick or suspect animals with separate draining and sited in such a way as to avoid contamination of other animals, unless the competent authority considers that such facilities are unnecessary. (c) The size of the lairage facilities must ensure that the welfare of the animals is respected. Their layout must facilitate ante-mortem inspections, including the identification of the animals or groups of animals. 2. To avoid contaminating meat, they must: (a) have a sufficient number of rooms, appropriate to the operations being carried out; (b) have a separate room for the emptying and cleaning of stomachs and intestines, unless the competent authority authorises the separation in time of these operations within a specific slaughterhouse on a case-by-case basis; (c) ensure separation in space or time of the following operations: (i) stunning and bleeding; (ii) in the case of porcine animals, scalding, depilation, scraping and singeing; (iii) evisceration and further dressing; (iv) handling clean guts and tripe; (v) preparation and cleaning of other offal, particularly the handling of skinned heads if it does not take place at the slaughter line; (vi) packaging offal; and (vii) dispatching meat; (d) have installations that prevent contact between the meat and the floors, walls and fixtures; and (e) have slaughter lines (where operated) that are designed to allow constant progress of the slaughter process and to avoid cross-contamination between the different parts of the slaughter line. Where more than one slaughter line is operated in the same premises, there must be adequate separation of the lines to prevent cross-contamination. 3. They must have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect. 4. The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to prevent the spread of contamination. 5. There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption. 6. There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of means of transport for livestock. However, slaughterhouses need not have these places and facilities if the competent authority so permits and official authorised places and facilities exist nearby. 7. They must have lockable facilities reserved for the slaughter of sick and suspect animals. This is not essential if this slaughter takes place in other establishments authorised by the competent authority for this purpose, or at the end of the normal slaughter period. 8. If manure or digestive tract content is stored in the slaughterhouse, there must be a special area or place for that purpose. 9. They must have an adequately equipped lockable facility or, where needed, room for the exclusive use of the veterinary service. CHAPTER III: REQUIREMENTS FOR CUTTING PLANTS Food business operators must ensure that cutting plants handling meat of domestic ungulates: 1. are constructed so as to avoid contamination of meat, in particular by: (a) allowing constant progress of the operations; or (b) ensuring separation between the different production batches; 2. have rooms for the separate storage of packaged and exposed meat, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat; 3. have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V; 4. have equipment for washing hands with taps designed to prevent the spread of contamination, for use by staff engaged in handling exposed meat; and 5. have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect. CHAPTER IV: SLAUGHTER HYGIENE Food business operators operating slaughterhouses in which domestic ungulates are slaughtered must ensure compliance with the following requirements. 1. After arrival in the slaughterhouse, the slaughter of the animals must not be unduly delayed. However, where required for welfare reasons, animals must be given a resting period before slaughter. 2. (a) Meat from animals other than those referred to in subparagraphs (b) and (c) must not be used for human consumption if they die otherwise than by being slaughtered in the slaughterhouse. (b) Only live animals intended for slaughter may be brought into the slaughter premises, with the exception of: (i) animals that have undergone emergency slaughter outside the slaughterhouse in accordance with Chapter VI; (ii) animals slaughtered at the place of production in accordance with Section III; and (iii) wild game, in compliance with Section IV, Chapter II. (c) Meat from animals that undergo slaughter following an accident in a slaughterhouse may be used for human consumption if, on inspection, no serious lesions other than those due to the accident are found. 3. The animals or, where appropriate, each batch of animals sent for slaughter must be identified so that their origin can be traced. 4. Animals must be clean. 5. Slaughterhouse operators must follow the instructions of the veterinarian appointed by the competent authority in accordance with Regulation (EC) No 854/2004 to ensure that ante-mortem inspection of every animal to be slaughtered is carried out under suitable conditions. 6. Animals brought into the slaughter hall must be slaughtered without undue delay. 7. Stunning, bleeding, skinning, evisceration and other dressing must be carried out without undue delay and in a manner that avoids contaminating the meat. In particular: (a) the trachea and oesophagus must remain intact during bleeding, except in the case of slaughter according to a religious custom; (b) during the removal of hides and fleece: (i) contact between the outside of the skin and the carcase must be prevented; and (ii) operators and equipment coming into contact with the outer surface of hides and fleece must not touch the meat; (c) measures must be taken to prevent the spillage of digestive tract content during and after evisceration and to ensure that evisceration is completed as soon as possible after stunning; and (d) removal of the udder must not result in contamination of the carcase with milk or colostrum. 8. Complete skinning of the carcase and other parts of the body intended for human consumption must be carried out, except for porcine animals and the heads and feet of ovine and caprine animals and calves. Heads and feet must be handled so as to avoid contamination of other meat. 9. When not skinned, porcine animals must have their bristles removed immediately. The risk of contamination of the meat with scalding water must be minimised. Only approved additives may be used for this operation. Porcine animals must be thoroughly rinsed afterwards with potable water. 10. The carcases must not contain visible faecal contamination. Any visible contamination must be removed without delay by trimming or alternative means having an equivalent effect. 11. Carcases and offal must not come into contact with floors, walls or work stands. 12. Slaughterhouse operators must follow the instructions of the competent authority to ensure that post-mortem inspection of all slaughtered animals is carried out under suitable conditions in accordance with Regulation (EC) No 854/2004. 13. Until post-mortem inspection is completed, parts of a slaughtered animal subject to such inspection must: (a) remain identifiable as belonging to a given carcase; and (b) come into contact with no other carcase, offal or viscera, including those that have already undergone post-mortem inspection. However, provided that it shows no pathological lesion, the penis may be discarded immediately. 14. Both kidneys must be removed from their fatty covering. In the case of bovine and porcine animals, and solipeds, the peri-renal capsule must also be removed. 15. If the blood or other offal of several animals is collected in the same container before completion of post-mortem inspection, the entire contents must be declared unfit for human consumption if the carcase of one or more of the animals concerned has been declared unfit for human consumption. 16. After post-mortem inspection: (a) the tonsils of bovine animals and solipeds must be removed hygienically; (b) parts unfit for human consumption must be removed as soon as possible from the clean sector of the establishment; (c) meat detained or declared unfit for human consumption and inedible by-products must not come into contact with meat declared fit for human consumption; and (d) viscera or parts of viscera remaining in the carcase, except for the kidneys, must be removed entirely and as soon as possible, unless the competent authority authorises otherwise. 17. After completion of slaughter and post-mortem inspection, the meat must be stored in accordance with the requirements laid down in Chapter VII. 18. When destined for further handling: (a) stomachs must be scalded or cleaned; (b) intestines must be emptied and cleaned; and (c) heads and feet must be skinned or scalded and depilated. 19. Where establishments are approved for the slaughter of different animal species or for the handling of carcases of farmed game and wild game, precautions must be taken to prevent cross-contamination by separation either in time or in space of operations carried out on the different species. Separate facilities for the reception and storage of unskinned carcases of farmed game slaughtered at the farm and for wild game must be available. 20. If the slaughterhouse does not have lockable facilities reserved for the slaughter of sick or suspect animals, the facilities used to slaughter such animals must be cleaned, washed and disinfected under official supervision before the slaughter of other animals is resumed. CHAPTER V: HYGIENE DURING CUTTING AND BONING Food business operators must ensure that cutting and boning of meat of domestic ungulates takes place in accordance with the following requirements. 1. Carcases of domestic ungulates may be cut into half-carcases or quarters, and half carcases into no more than three wholesale cuts, in slaughterhouses. Further cutting and boning must be carried out in a cutting plant. 2. The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that: (a) meat intended for cutting is brought into the workrooms progressively as needed; (b) during cutting, boning, trimming, slicing, dicing, wrapping and packaging, the meat is maintained at not more than 3 °C for offal and 7 °C for other meat, by means of an ambient temperature of not more than 12 °C or an alternative system having an equivalent effect; and (c) where the premises are approved for the cutting of meat of different animal species, precautions are taken to avoid cross-contamination, where necessary by separation of the operations on the different species in either space or time. 3. However, meat may be boned and cut before it reaches the temperature referred to in point 2(b) in accordance with Chapter VII, point 3. 4. Meat may also be boned and cut prior to reaching the temperature referred to in point 2(b) when the cutting room is on the same site as the slaughter premises. In this case, the meat must be transferred to the cutting room either directly from the slaughter premises or after a waiting period in a chilling or refrigerating room. As soon as it is cut and, where appropriate, packaged, the meat must be chilled to the temperature referred to in point 2(b). CHAPTER VI: EMERGENCY SLAUGHTER OUTSIDE THE SLAUGHTERHOUSE Food business operators must ensure that meat from domestic ungulates that have undergone emergency slaughter outside the slaughterhouse may be used for human consumption only if it complies with all the following requirements. 1. An otherwise healthy animal must have suffered an accident that prevented its transport to the slaughterhouse for welfare reasons. 2. A veterinarian must carry out an ante-mortem inspection of the animal. 3. The slaughtered and bled animal must be transported to the slaughterhouse hygienically and without undue delay. Removal of the stomach and intestines, but no other dressing, may take place on the spot, under the supervision of the veterinarian. Any viscera removed must accompany the slaughtered animal to the slaughterhouse and be identified as belonging to that animal. 4. If more than two hours elapse between slaughter and arrival at the slaughterhouse, the animal must be refrigerated. Where climatic conditions so permit, active chilling is not necessary. 5. A declaration by the food business operator who reared the animal, stating the identity of the animal and indicating any veterinary products or other treatments administered to the animal, dates of administration and withdrawal periods, must accompany the slaughtered animal to the slaughterhouse. 6. A declaration issued by the veterinarian recording the favourable outcome of the ante-mortem inspection, the date and time of, and reason for, emergency slaughter, and the nature of any treatment administered by the veterinarian to the animal, must accompany the slaughtered animal to the slaughterhouse. 7. The slaughtered animal must be fit for human consumption following post-mortem inspection carried out in the slaughterhouse in accordance with Regulation (EC) No 854/2004, including any additional tests required in the case of emergency slaughter. 8. Food business operators must follow any instructions that the official veterinarian may give after post-mortem inspection concerning the use of the meat. 9. Food business operators may not place meat from animals having undergone emergency slaughter on the market unless it bears a special health mark which cannot be confused either with the health mark provided for in Regulation (EC) No 854/2004 or with the identification mark provided for in Annex II, Section I to this Regulation. Such meat may be placed on the market only in the Member State where slaughter takes place and in accordance with national law. CHAPTER VII: STORAGE AND TRANSPORT Food business operators must ensure that the storage and transport of meat of domestic ungulates takes place in accordance with the following requirements. 1. (a) Unless other specific provisions provide otherwise, post-mortem inspection must be followed immediately by chilling in the slaughterhouse to ensure a temperature throughout the meat of not more than 3 °C for offal and 7 °C for other meat along a chilling curve that ensures a continuous decrease of the temperature. However, meat may be cut and boned during chilling in accordance with Chapter V, point 4. (b) During the chilling operations, there must be adequate ventilation to prevent condensation on the surface of the meat. 2. Meat must attain the temperature specified in point 1 and remain at that temperature during storage. 3. Meat must attain the temperature specified in point 1 before transport, and remain at that temperature during transport. However, transport may also take place if the competent authority so authorises to enable the production of specific products, provided that: (a) such transport takes place in accordance with the requirements that the competent authority specifies in respect of transport from one given establishment to another; and (b) the meat leaves the slaughterhouse, or a cutting room on the same site as the slaughter premises, immediately and transport takes no more than two hours. 4. Meat intended for freezing must be frozen without undue delay, taking into account where necessary a stabilisation period before freezing. 5. Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at different times or in such a way that the packaging material and the manner of storage or transport cannot be a source of contamination for the meat. SECTION II: MEAT FROM POULTRY AND LAGOMORPHS CHAPTER I: TRANSPORT OF LIVE ANIMALS TO THE SLAUGHTERHOUSE Food business operators transporting live animals to slaughterhouses must ensure compliance with the following requirements. 1. During collection and transport, animals must be handled carefully without causing unnecessary distress. 2. Animals showing symptoms of disease or originating in flocks known to be contaminated with agents of public-health importance may only be transported to the slaughterhouse when permitted by the competent authority. 3. Crates for delivering animals to the slaughterhouse and modules, where used, must be made of non-corrodible material and be easy to clean and disinfect. Immediately after emptying and, if necessary, before re-use, all equipment used for collecting and delivering live animals must be cleaned, washed and disinfected. CHAPTER II: REQUIREMENTS FOR SLAUGHTERHOUSES Food business operators must ensure that the construction, layout and equipment of slaughterhouses in which poultry or lagomorphs are slaughtered meet the following requirements. 1. They must have a room or covered space for the reception of the animals and for their inspection before slaughter. 2. To avoid contaminating meat, they must: (a) have a sufficient number of rooms, appropriate to the operations being carried out; (b) have a separate room for evisceration and further dressing, including the addition of seasonings to whole poultry carcases, unless the competent authority authorises separation in time of these operations within a specific slaughterhouse on a case-by-case basis; (c) ensure separation in space or time of the following operations: (i) stunning and bleeding; (ii) plucking or skinning, and any scalding; and (iii) dispatching meat; (d) have installations that prevent contact between the meat and the floors, walls and fixtures; and (e) have slaughter lines (where operated) that are designed to allow a constant progress of the slaughter process and to avoid cross-contamination between the different parts of the slaughter line. Where more than one slaughter line is operated in the same premises, there must be adequate separation of the lines to prevent cross-contamination. 3. They must have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect. 4. The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to prevent the spread of contamination. 5. There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption. 6. There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of: (a) transport equipment such as crates; and (b) means of transport. These places and facilities are not compulsory for (b) if officially authorised places and facilities exist nearby. 7. They must have an adequately equipped lockable facility or, where needed, room for the exclusive use of the veterinary service. CHAPTER III: REQUIREMENTS FOR CUTTING PLANTS 1. Food business operators must ensure that cutting plants handling meat from poultry or lagomorphs: (a) are constructed so as to avoid contamination of meat, in particular by: (i) allowing constant progress of the operations; or (ii) ensuring separation between the different production batches; (b) have rooms for the separate storage of packaged and exposed meat, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat; (c) have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V; (d) have equipment for washing hands used by staff handling exposed meat with taps designed to prevent the spread of contamination; and (e) have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect. 2. If the following operations are undertaken in a cutting plant: (a) the evisceration of geese and ducks reared for the production of ‘foie gras’, which have been stunned, bled and plucked on the fattening farm; or (b) the evisceration of delayed eviscerated poultry, food business operators must ensure that separate rooms are available for that purpose. CHAPTER IV: SLAUGHTER HYGIENE Food business operators operating slaughterhouses in which poultry or lagomorphs are slaughtered must ensure compliance with the following requirements. 1. (a) Meat from animals other than those referred to in (b) must not be used for human consumption if they die otherwise than by being slaughtered in the slaughterhouse. (b) Only live animals intended for slaughter may be brought into the slaughter premises, with the exception of: (i) delayed eviscerated poultry, geese and ducks reared for the production of ‘foie gras’ and birds that are not considered as domestic but which are farmed as domestic animals, if slaughtered at the farm in accordance with Chapter VI; (ii) farmed game slaughtered at the place of production in accordance with Section III; and (iii) small wild game in accordance with Section IV, Chapter III. 2. Slaughterhouse operators must follow the instructions of the competent authority to ensure that ante-mortem inspection is carried out under suitable conditions. 3. Where establishments are approved for the slaughter of different animal species or for the handling of farmed ratites and small wild game, precautions must be taken to prevent cross contamination by separation either in time or in space of the operations carried out on the different species. Separate facilities for the reception and storage of carcases of farmed ratites slaughtered at the farm and for small wild game must be available. 4. Animals brought into the slaughter room must be slaughtered without undue delay. 5. Stunning, bleeding, skinning or plucking, evisceration and other dressing must be carried out without undue delay in such a way that contamination of the meat is avoided. In particular, measures must be taken to prevent the spillage of digestive tract contents during evisceration. 6. Slaughterhouse operators must follow the instructions of the competent authority to ensure that the post-mortem inspection is carried out under suitable conditions, and in particular that slaughtered animals can be inspected properly. 7. After post-mortem inspection: (a) parts unfit for human consumption must be removed as soon as possible from the clean sector of the establishment; (b) meat detained or declared unfit for human consumption and inedible by-products must not come into contact with meat declared fit for human consumption; and (c) viscera or parts of viscera remaining in the carcase, except for the kidneys, must be removed entirely, if possible, and as soon as possible, unless otherwise authorised by the competent authority. 8. After inspection and evisceration, slaughtered animals must be cleaned and chilled to not more than 4 °C as soon as possible, unless the meat is cut while warm. 9. When carcases are subjected to an immersion chilling process, account must be taken of the following. (a) Every precaution must be taken to avoid contamination of carcases, taking into account parameters such as carcase weight, water temperature, volume and direction of water flow and chilling time. (b) Equipment must be entirely emptied, cleaned and disinfected whenever this is necessary and at least once a day. 10. Sick or suspect animals, and animals slaughtered in application of disease eradication or control programmes, must not be slaughtered in the establishment except when permitted by the competent authority. In that event, slaughter must be performed under official supervision and steps taken to prevent contamination; the premises must be cleaned and disinfected before being used again. CHAPTER V: HYGIENE DURING AND AFTER CUTTING AND BONING Food business operators must ensure that cutting and boning of meat of poultry and lagomorphs takes place in accordance with the following requirements. 1. The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that: (a) meat intended for cutting is brought into the workrooms progressively as needed; (b) during cutting, boning, trimming, slicing, dicing, wrapping and packaging, the temperature of the meat is maintained at not more than 4 °C by means of an ambient temperature of 12 °C or an alternative system having an equivalent effect; and (c) where the premises are approved for the cutting of meat of different animal species, precautions are taken to avoid cross-contamination, where necessary by separation of the operations on the different species in either space or time. 2. However, meat may be boned and cut prior to reaching the temperature referred to in point 1(b) when the cutting room is on the same site as the slaughter premises, provided that it is transferred to the cutting room either: (a) directly from the slaughter premises; or (b) after a waiting period in a chilling or refrigerating room. 3. As soon as it is cut and, where appropriate, packaged, the meat must be chilled to the temperature referred to in point 1(b). 4. Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at different times or in such a way that the packaging material and the manner of storage or transport cannot be a source of contamination for the meat. CHAPTER VI: SLAUGHTER ON THE FARM Food business operators may slaughter poultry referred to in Chapter IV, point 1(b)(i), on the farm only with the authorisation of the competent authority and in compliance with the following requirements. 1. The farm must undergo regular veterinary inspection. 2. The food business operator must inform the competent authority in advance of the date and time of slaughter. 3. The holding must have facilities for concentrating the birds to allow an ante-mortem inspection of the group to be made. 4. The holding must have premises suitable for the hygienic slaughter and further handling of the birds. 5. Animal welfare requirements must be complied with. 6. The slaughtered birds must be accompanied to the slaughterhouse by a declaration by the food business operator who reared the animal indicating any veterinary products or other treatments administered to the animal, dates of administration and withdrawal periods, and the date and time of slaughter. 7. The slaughtered animal must be accompanied to the slaughterhouse by a certificate issued by the official veterinarian or approved veterinarian in accordance with Regulation (EC) No 854/2004. 8. In the case of poultry reared for the production of ‘foie gras’, the uneviscerated birds must be transported immediately and, if necessary, refrigerated to a slaughterhouse or cutting plant. They must be eviscerated within 24 hours of slaughter under the supervision of the competent authority. 9. Delayed eviscerated poultry obtained at the farm of production may be kept for up to 15 days at a temperature of not more than 4 °C. It must then be eviscerated in a slaughterhouse or in a cutting plant located in the same Member State as the farm of production. SECTION III: MEAT OF FARMED GAME 1. The provisions of Section I apply to the production and placing on the market of meat from even-toed farmed game mammals (Cervidae and Suidae), unless the competent authority considers them inappropriate. 2. The provisions of Section II apply to the production and placing on the market of meat from ratites. However, those of Section I apply where the competent authority considers them appropriate. Appropriate facilities must be provided, adapted to the size of the animals. 3. Notwithstanding points 1 and 2, food business operators may slaughter farmed ratites and farmed ungulates referred to in point 1 at the place of origin with the authorisation of the competent authority if: (a) the animals cannot be transported, to avoid any risk for the handler or to protect the welfare of the animals; (b) the herd undergoes regular veterinary inspection; (c) the owner of the animals submits a request; (d) the competent authority is informed in advance of the date and time of slaughter of the animals; (e) the holding has procedures for concentrating the animals to allow an ante-mortem inspection of the group to be made; (f) the holding has facilities suitable for the slaughter, bleeding and, where ratites are to be plucked, plucking of the animals; (g) animal welfare requirements are complied with; (h) slaughtered and bled animals are transported to the slaughterhouse hygienically and without undue delay. If transport takes more than two hours, the animals are, if necessary, refrigerated. Evisceration may take place on the spot, under the supervision of the veterinarian; (i) a declaration by the food business operator who reared the animals, stating their identity and indicating any veterinary products or other treatments administered, dates of administration and withdrawal periods, accompanies the slaughtered animals to the slaughterhouse; and (j) during transport to the approved establishment, a certificate issued and signed by the official veterinarian or approved veterinarian, attesting to a favourable result of the ante-mortem inspection, correct slaughter and bleeding and the date and time of slaughter, accompanies the slaughtered animals. 4. Food business operators may also slaughter bison on the farm in accordance with point 3 in exceptional circumstances. SECTION IV: WILD GAME MEAT CHAPTER I: TRAINING OF HUNTERS IN HEALTH AND HYGIENE 1. Persons who hunt wild game with a view to placing it on the market for human consumption must have sufficient knowledge of the pathology of wild game, and of the production and handling of wild game and wild game meat after hunting, to undertake an initial examination of wild game on the spot. 2. It is however enough if at least one person of a hunting team has the knowledge referred to in point 1. References in this Section to a ‘trained person’ are references to that person. 3. The trained person could also be the gamekeeper or the game manager if he or she is part of the hunting team or located in the immediate vicinity of where hunting is taking place. In the latter case, the hunter must present the wild game to the gamekeeper or game manager and inform them of any abnormal behaviour observed before killing. 4. Training must be provided to the satisfaction of the competent authority to enable hunters to become trained persons. It should cover at least the following subjects: (a) the normal anatomy, physiology and behaviour of wild game; (b) abnormal behaviour and pathological changes in wild game due to diseases, environmental contamination or other factors which may affect human health after consumption; (c) the hygiene rules and proper techniques for the handling, transportation, evisceration, etc. of wild game animals after killing; and (d) legislation and administrative provisions on the animal and public health and hygiene conditions governing the placing on the market of wild game. 5. The competent authority should encourage hunters' organisations to provide such training. CHAPTER II: HANDLING OF LARGE WILD GAME 1. After killing, large wild game must have their stomachs and intestines removed as soon as possible and, if necessary, be bled. 2. The trained person must carry out an examination of the body, and of any viscera removed, to identify any characteristics that may indicate that the meat presents a health risk. The examination must take place as soon as possible after killing. 3. Meat of large wild game may be placed on the market only if the body is transported to a game-handling establishment as soon as possible after the examination referred to in point 2. The viscera must accompany the body as specified in point 4. The viscera must be identifiable as belonging to a given animal. 4. (a) If no abnormal characteristics are found during the examination referred to in point 2, no abnormal behaviour was observed before killing, and there is no suspicion of environmental contamination, the trained person must attach to the animal body a numbered declaration stating this. This declaration must also indicate the date, time and place of killing. In this case, the head and the viscera need not accompany the body, except in the case of species susceptible to Trichinosis (porcine animals, solipeds and others), whose head (except for tusks) and diaphragm must accompany the body. However, hunters must comply with any additional requirements imposed in the Member State where hunting takes place, in particular to permit the monitoring of certain residues and substances in accordance with Directive 96/23/EC; (b) In other circumstances, the head (except for tusks, antlers and horns) and all the viscera except for the stomach and intestines must accompany the body. The trained person who carried out the examination must inform the competent authority of the abnormal characteristics, abnormal behaviour or suspicion of environmental contamination that prevented him or her from making a declaration in accordance with (a); (c) If no trained person is available to carry out the examination referred to in point 2 in a particular case, the head (except for tusks, antlers and horns) and all the viscera except for the stomach and the intestines must accompany the body. 5. Chilling must begin within a reasonable period of time after killing and achieve a temperature throughout the meat of not more than 7 °C. Where climatic conditions so permit, active chilling is not necessary. 6. During transport to the game-handling establishment, heaping must be avoided. 7. Large wild game delivered to a game-handling establishment must be presented to the competent authority for inspection. 8. In addition, unskinned large wild game may be skinned and placed on the market only if: (a) before skinning, it is stored and handled separately from other food and not frozen; and (b) after skinning, it undergoes a final inspection in accordance with Regulation (EC) No 854/2004. 9. The rules laid down in Section I, Chapter V, apply to the cutting and boning of large wild game. CHAPTER III: HANDLING OF SMALL WILD GAME 1. The trained person must carry out an examination to identify any characteristics that may indicate that the meat presents a health risk. The examination must take place as soon as possible after killing. 2. If abnormal characteristics are found during the examination, abnormal behaviour was observed before killing, or environmental contamination is suspected, the trained person must inform the competent authority. 3. Meat of small wild game may be placed on the market only if the body is transported to a game-handling establishment as soon as possible after the examination referred to in point 1. 4. Chilling must begin within a reasonable period of time of killing and achieve a temperature throughout the meat of not more than 4 °C. Where climatic conditions so permit, active chilling is not necessary. 5. Evisceration must be carried out, or completed, without undue delay upon arrival at the game -handling establishment, unless the competent authority permits otherwise. 6. Small wild game delivered to a game-handling establishment must be presented to the competent authority for inspection. 7. The rules laid down in Section II, Chapter V, apply to the cutting and boning of small wild game. SECTION V: MINCED MEAT, MEAT PREPARATIONS AND MECHANICALLY SEPARATED MEAT (MSM) CHAPTER I: REQUIREMENTS FOR PRODUCTION ESTABLISHMENTS Food business operators operating establishments producing minced meat, meat preparations or MSM must ensure that they: 1. are constructed so as to avoid contamination of meat and products, in particular by: (a) allowing constant progress of the operations; or (b) ensuring separation between the different production batches; 2. have rooms for the separate storage of packaged and exposed meat and products, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat or products; 3. have rooms equipped to ensure compliance with the temperature requirements laid down in Chapter III; 4. have equipment for washing hands used by staff handling exposed meat and products with taps designed to prevent the spread of contamination; and 5. have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect. CHAPTER II: REQUIREMENTS FOR RAW MATERIAL Food business operators producing minced meat, meat preparations or MSM must ensure that the raw materials used satisfy the following requirements. 1. The raw material used to prepare minced meat must meet the following requirements. (a) It must comply with the requirements for fresh meat; (b) It must derive from skeletal muscle, including adherent fatty tissues; (c) It must not derive from: (i) scrap cuttings and scrap trimmings (other than whole muscle cuttings); (ii) MSM; (iii) meat containing bone fragments or skin; or (iv) meat of the head with the exception of the masseters, the non-muscular part of the linea alba, the region of the carpus and the tarsus, bone scrapings and the muscles of the diaphragm (unless the serosa has been removed). 2. The following raw material may be used to prepare meat preparations: (a) fresh meat; (b) meat meeting the requirements of point 1; and (c) if the meat preparation is clearly not intended to be consumed without first undergoing heat treatment: (i) meat derived from the mincing or fragmentation of meat meeting the requirements of point 1 other than point 1(c)(i); and (ii) MSM meeting the requirements of Chapter III, point 3(d). 3. The raw material used to produce MSM must meet the following requirements. (a) It must comply with the requirements for fresh meat; (b) The following material must not be used to produce MSM: (i) for poultry, the feet, neckskin and head; and (ii) for other animals, the bones of the head, feet, tails, femur, tibia, fibula, humerus, radius and ulna. CHAPTER III: HYGIENE DURING AND AFTER PRODUCTION Food business operators producing minced meat, meat preparations or MSM must ensure compliance with the following requirements. 1. The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that the meat used is: (a) at a temperature of not more than 4 °C for poultry, 3 °C for offal and 7 °C for other meat; and (b) brought into the preparation room progressively as needed. 2. The following requirements apply to the production of minced meat and meat preparations. (a) Unless the competent authority authorises boning immediately before mincing, frozen or deep-frozen meat used for the preparation of minced meat or meat preparations must be boned before freezing. It may be stored only for a limited period. (b) When prepared from chilled meat, minced meat must be prepared: (i) in the case of poultry, within no more than three days of their slaughter; (ii) in the case of animal other than poultry, within no more than six days of their slaughter; or (iii) within no more than 15 days from the slaughter of the animals in the case of boned, vacuum-packed beef and veal. (c) Immediately after production, minced meat and meat preparations must be wrapped or packaged and be: (i) chilled to an internal temperature of not more than 2 °C for minced meat and 4 °C for meat preparations; or (ii) frozen to an internal temperature of not more than -18 °C. These temperature conditions must be maintained during storage and transport. 3. The following requirements apply to the production and use of MSM produced using techniques that do not alter the structure of the bones used in the production of MSM and the calcium content of which is not significantly higher than that of minced meat. (a) Raw material for deboning from an on-site slaughterhouse must be no more than seven days old; otherwise, raw material for deboning must be no more than five days old. However, poultry carcases must be no more than three days old. (b) Mechanical separation must take place immediately after deboning. (c) If not used immediately after being obtained, MSM must be wrapped or packaged and then chilled to a temperature of not more than 2 °C or frozen to an internal temperature of not more than –18 °C. These temperature requirements must be maintained during storage and transport. (d) If the food business operator has carried out analyses demonstrating that MSM complies with the microbiological criteria for minced meat adopted in accordance with Regulation (EC) No 852/2004 it may be used in meat preparations that are clearly not intended to be consumed without first undergoing heat treatment and in meat products. (e) MSM not shown to comply with the criteria referred to in (d) may be used only to manufacture heat-treated meat products in establishments approved in accordance with this Regulation. 4. The following requirements apply to the production and use of MSM produced using techniques other than those mentioned in point 3. (a) Raw material for deboning from an on-site slaughterhouse must be no more than seven days old; otherwise, raw material for deboning must be no more than five days old. However, poultry carcases must be no more than three days old. (b) If mechanical separation does not take place immediately after deboning the flesh-bearing bones must be stored and transported at a temperature of not more than 2 °C or, if frozen, at a temperature of not more than -18 °C. (c) Flesh-bearing bones obtained from frozen carcases must not be refrozen. (d) If not used within one hour of being obtained, MSM must be chilled immediately to a temperature of not more than 2 °C. (e) If, after chilling, MSM is not processed within 24 hours, it must be frozen within 12 hours of production and reach an internal temperature of not more than –18 °C within six hours. (f) Frozen MSM must be wrapped or packaged before storage or transport, must not be stored for more than three months and must be maintained at a temperature of not more than –18 °C during storage and transport. (g) MSM may be used only to manufacture heat-treated meat products in establishments approved in accordance with this Regulation. 5. Minced meat, meat preparations and MSM must not be re-frozen after thawing. CHAPTER IV: LABELLING 1. In addition to the requirements of Directive 2000/13/EC (24), food business operators must ensure compliance with the requirement of point 2 if, and to the extent that, national rules in the Member State in the territory of which the product is placed on the market so require. 2. Packages intended for supply to the final consumer containing minced meat from poultry or solipeds or meat preparations containing MSM must bear a notice indicating that such products should be cooked before consumption. SECTION VI: MEAT PRODUCTS 1. Food business operators must ensure that the following items are not used in the preparation of meat products: (a) genital organs of either female or male animals, except testicles; (b) urinary organs, except the kidneys and the bladder; (c) the cartilage of the larynx, the trachea and the extra-lobular bronchi; (d) eyes and eyelids; (e) the external auditory meatus; (f) horn tissue; and (g) in poultry, the head — except the comb and the ears, the wattles and caruncles — the oesophagus, the crop, the intestines and the genital organs. 2. All meat, including minced meat and meat preparations, used to produce meat product must meet the requirements for fresh meat. However, minced meat and meat preparations used to produce meat products need not satisfy other specific requirements of Section V. SECTION VII: LIVE BIVALVE MOLLUSCS 1. This Section applies to live bivalve molluscs. With the exception of the provisions on purification, it also applies to live echinoderms, tunicates and marine gastropods. 2. Chapters I to VIII apply to animals harvested from production areas that the competent authority has classified in accordance with Regulation (EC) No 854/2004. Chapter IX applies to pectinidae harvested outside those areas. 3. Chapters V, VI, VIII and IX, and po