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

CHAPTER I GENERAL PROVISIONS

Article 1

Scope

• (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;

• (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.

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).

• (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;

• 1. the definitions laid down in Regulation (EC) No 852/2004;

• 1. the definitions laid down in Annex I; and

• 1. any technical definitions contained in Annexes II and III.

CHAPTER II FOOD BUSINESS OPERATORS' OBLIGATIONS

Article 3

General obligations

Article 4

Registration and approval of 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.

• (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).

• (a) granted the establishment approval to operate following an on-site visit; or

• (b) provided the establishment with conditional approval.

• (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

• (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.

Article 6

Products of animal origin from outside the Community

• (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.

• (a) products are made available for control upon importation in accordance with Directive 97/78/EC ([^E0002]);

• (b) importation complies with the requirements of Directive 2002/99/EC ([^E0003]); and

• (c) operations under their control that take place after importation are carried out in accordance with the requirements of Annex III.

CHAPTER III TRADE

Article 7

Documents

• (a) model documents may be established; and

• (b) provision may be made for the use of electronic documents.

Article 8

Special guarantees

• (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.

• (a) The Commission is empowered to adopt delegated acts in accordance with Article 11a amending paragraphs 1 and 2 of this Article in order to update the requirements set out in those paragraphs, taking into account changes in Member States’ control programmes or the adoption of microbiological criteria in accordance with Regulation (EC) No 852/2004.

• (b) In accordance with the regulatory procedure referred to in Article 12(2), the rules laid down in paragraph 2 of this Article in respect of any of the foodstuffs referred to in paragraph 1 of this Article 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.

CHAPTER IV FINAL PROVISIONS

Article 10

Amendment and adaptation of Annexes II and III

• (a) the experience gained by food business operators and/or competent authorities, in particular on the implementation of HACCP-based systems pursuant to Article 5;

• (b) the experience gained by the Commission, in particular on the outcome of its audits;

• (c) 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.

The amendments referred to in the first subparagraph shall concern:

• (a) the requirements on the identification marking of products of animal origin;

• (b) the objectives of HACCP-based procedures;

• (c) the requirements on the food chain information;

• (d) the specific hygiene requirements for the premises, including means of transport, where products of animal origin are produced, handled, processed, stored or distributed;

• (e) the specific hygiene requirements for the operations involving the production, handling, processing, storage, transport or distribution of products of animal origin;

• (f) the rules for the transport of meat while it is warm;

• (g) the health standards or checks, where there is scientific evidence indicating that they are necessary to protect public health;

• (h) the extension of Annex III, Section VII, Chapter IX, to live bivalve molluscs other than pectinidae;

• (i) the 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;

• (j) the additional health standards for live bivalve molluscs in cooperation with the relevant Union Reference Laboratory, including:
• (i) limit values and analysis methods for other marine biotoxins;
• (ii) virus testing procedures and virological standards; and
• (iii) sampling plans and the methods and analytical tolerances to be applied to check compliance with the health standards.

• (a) to facilitate the fulfilment, by small businesses, of the requirements laid down in the Annexes;

• (b) to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food;

• (c) to accommodate the needs of food businesses situated in regions that are subject to special geographic constraints;

• (d) to facilitate the work of establishments producing raw material which is intended for the production of highly refined food products and which has undergone a treatment ensuring its safety.

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.

• (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.

• (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.

• (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 general application of Article 9 and Article 10(1), the Commission may lay down the following measures by means of implementing act. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 12(2):

• 1. to specify, in respect of MSM, which calcium content is not significantly higher than that of minced meat;

• 1. 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;

• 1. to specify recognised testing methods for marine biotoxins;

• 1. to lay down freshness criteria and limits with regard to histamine and total volatile nitrogen for fisheries products;

• 1. 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;

• 1. without prejudice to Directive 96/23/EC ([^E0004]), to fix a maximum permitted value for the combined total of residues of antibiotic substances in raw milk; and

• 1. to approve equivalent processes for the production of gelatine or collagen.

Article 11a

Exercise of the delegation

Article 12

Committee procedure

The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

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.

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 of production.

• 2.However, when a product's packaging and/or wrapping is removed or it is further processed in another establishment, a new mark must be applied to the product. In such cases, the new mark must indicate the approval number of the establishment where these operations take place.

• 3.An identification mark is not necessary on packs of eggs when a packing centre code is applied in accordance with Part A of Annex XIV to Council Regulation (EC) No 1234/2007 ([^E0006]).

• 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 ([^E0007]), however, these codes are BE, BG, CZ, DK, DE, EE, GR, ES, FR, HR, IE, IT, CY, LV, LT, LU, HU, MT, NL, AT, PL, PT, SI, SK, FI, RO, SE and UK(NI)

• 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 Union, the mark must be oval in shape and include the abbreviation of European Union (‘EU’) in one of the official languages of the Union as follows: EC, EU, EL, UE, EE, AE, ES, EÚ.;

• Those abbreviations must not be included in marks applied by establishments located outside the Union on products imported into the Union.

• 8a.The requirements on the form of the identification mark in this Part B may be replaced by the requirements for a special identification mark in accordance with Article 65(1), point (h), of Regulation (EU) 2016/429 of the European Parliament and of the Council ([^E0008]), and the rules adopted in accordance with Article 67, point (a), Article 71(3) or (4), or Article 259(1) or (2) of that Regulation.

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 or game-handling establishments 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 or game-handling establishment.

• 1. Slaughterhouse or game-handling establishment operators must not accept animals onto the  slaughterhouse or game-handling establishment premises unless they have requested, and been provided with, relevant food chain information contained in the records kept at the holding of provenance in accordance with Regulation (EC) No 852/2004.

• 1. Slaughterhouse or game-handling establishment 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 chain 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, and whether the holding is officially recognised to apply controlled housing conditions in relation to Trichinella in accordance with Point A of Chapter I of Annex IV to Commission Regulation (EC) No 2075/2005 ([^E0009]);

• (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.

• 1. (a) However, it is not necessary for the  slaughterhouse or game-handling establishment 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 or game-handling establishment 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 or game-handling establishment 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 and provided it does not jeopardise the objectives of this Regulation, food chain information may arrive less than 24 hours before the arrival of the animals of all species to which it relates at the  slaughterhouse or game-handling establishment or accompany these animals to the  slaughterhouse or game-handling establishment.

• However, any item of food chain information, knowledge of which may result in serious disruption of the  slaughterhouse or game-handling establishment activity, is to be made available to the food business operator operating the  slaughterhouse or game-handling establishment in sufficient time before the animals arrive at the  slaughterhouse or game-handling establishment, in order for that food business operator to plan the  slaughterhouse or game-handling establishment activity accordingly.

• The food business operator operating the  slaughterhouse or game-handling establishment must evaluate the relevant information and must submit the food chain information received to the official veterinarian. The 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.

SECTION IV:   REQUIREMENTS APPLICABLE TO FROZEN FOOD OF ANIMAL ORIGIN

• 1.For the purposes of this Section, ‘date of production’ means:

• (a) the date of slaughter in the case of carcasses, half carcasses or quarter carcases;

• (b) the date of killing in the case of bodies of wild game;

• (c) the date of harvesting or catching, in the case of fishery products;

• (d) the date of processing, cutting, mincing or preparation, as appropriate, for any other food of animal origin.

• 2.Until the stage at which a food is labelled in accordance with Directive 2000/13/EC or used for further processing, food business operators must ensure that in the case of frozen food of animal origin intended for human consumption, the following information is made available to the food business operator to whom the food is supplied and, upon request, to the competent authority:

• (a) the date of production; and

• (b) the date of freezing, if different from the date of production.

• Where a food is made from a batch of raw materials with different dates of production and of freezing, the oldest dates of production and/or of freezing, as appropriate, must be made available.

• 3.The appropriate form in which the information must be made available is up to the choice of the supplier of the frozen food, as long as the information requested in paragraph 2 will be clearly and unequivocally available to and retrievable by the business operator to whom the food is supplied.

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.

• 1. 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 requirements laid down in the following points 1 to 9. Mobile partial slaughterhouses must operate in cooperation with complementary permanent slaughtering facilities in order to constitute a complete slaughterhouse complying with the requirements laid down in the following points 1 to 9. Mobile partial slaughterhouses may operate with several complementary slaughtering facilities, thus constituting several slaughterhouses.

• 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.

• 1. 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.

• 1. 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.

• 1. The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to prevent the spread of contamination.

• 1. 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.

• 1. 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.

• 1. 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.

• 1. If manure or digestive tract content is stored in the slaughterhouse, there must be a special area or place for that purpose.

• 1. 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;

• 1. 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;

• 1. have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V;

• 1. have equipment for washing hands with taps designed to prevent the spread of contamination, for use by staff engaged in handling exposed meat; and

• 1. 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 at 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. Animals that are presented at a slaughterhouse for slaughter shall be slaughtered there and direct movements to another slaughterhouse may be allowed only in exceptional cases in accordance with Article 43(6), second subparagraph of Implementing Regulation (EU) 2019/627.

• 1. • (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 holding of provenance in accordance with Chapter VIa of this Section or in accordance with point 3 of Section III;
• (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.

• 1. The animals or, where appropriate, each batch of animals sent for slaughter must be identified so that their origin can be traced.

• 1. Animals must be clean.

• 1. 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.

• 1. Animals brought into the slaughter hall must be slaughtered without undue delay.

• 1. 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.

• 1. Carcases and other parts of the body intended for human consumption must be completely skinned, except in the case of porcine animals, the heads of ovine and caprine animals and calves, the muzzle and lips of bovine animals and the feet of bovine, ovine and caprine animals. Heads, including muzzle and lips, and feet must be handled in such a way as to avoid contamination.

• 1. 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.

• 1. 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.

• 1. Carcases and offal must not come into contact with floors, walls or work stands.

• 1. 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.

• 1. 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.

• 1. 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.

• 1. 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.

• 1. After post-mortem inspection:
• (a) the tonsils of bovine animals, porcine 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.

• 1. After completion of slaughter and post-mortem inspection, the meat must be stored in accordance with the requirements laid down in Chapter VII.

• 1. Unless intended for use as animal by-product in accordance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council ([^E0010]):
• (a) stomachs must be scalded or cleaned; however, when intended for rennet production, the stomachs:
• (i) are only required to be emptied in the case of young bovine animals
• (ii) are not required to be emptied, scalded or cleaned in the case of young ovine and caprine animals;
• (b) intestines must be emptied and cleaned;
• (c) heads and feet must be skinned or scalded and depilated; however, when authorised by the competent authority, visibly clean heads, not containing specified risk materials in accordance with Article 8 of Regulation (EC) No 999/2001 of the European Parliament and of the Council ([^E0011]), and visibly clean feet, intended for processing into food, may be transported to and skinned or scalded and depilated in an approved establishment.

• 1. 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.

• 1. 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.

• 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 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.

• 1. 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.

• 1. 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).

• 1. Carcases, half carcases, quarters, or half carcases cut into no more than three wholesale cuts may be boned and cut prior to reaching the temperature referred to in point 2(b) when they have been transported under the derogation set out in point 3(b) of Chapter VII of Section I. In this case, throughout cutting or boning, the meat must be subjected to air temperatures that ensure a continuous decrease of the temperature of the meat. As soon as it is cut and, where appropriate, packaged, the meat must be chilled to the temperature referred to in point 2(b) if it is not already below this temperature.

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 animal must be unfit for transport to a slaughterhouse in accordance with the technical rules on fitness for transport laid down in point 2 of Chapter I of Annex I to Council Regulation (EC) No 1/2005 ([^E0012]).

• 1. The official veterinarian must carry out an ante-mortem inspection of the animal, verifying in particular compliance with the requirements for:
• (a) live animals to be accepted for slaughter for human consumption in accordance with Article 43 of Implementing Regulation (EU) 2019/627;
• (b) fresh meat to be fit for human consumption in accordance with Article 45 of Implementing Regulation (EU) 2019/627 when possible to verify by ante-mortem inspection.

• 1. 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 official veterinarian. Any viscera removed must accompany the slaughtered animal to the slaughterhouse and be identified as belonging to that animal.

• 1. 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.

• 1. The food chain information required in accordance with Section III of Annex II must accompany the slaughtered animal to the slaughterhouse.

• 1. The official certificate set out in Chapter 5 of Annex IV to Commission Implementing Regulation (EU) 2020/2235 ([^E0013]) shall accompany the slaughtered animal to the slaughterhouse or be sent in advance in any format.

• 1. 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.

• 1. Food business operators must follow any instructions that the official veterinarian may give after post-mortem inspection concerning the use of the meat.

CHAPTER VIa:   SLAUGHTER AT THE HOLDING OF PROVENANCE OF DOMESTIC BOVINE ANIMALS, OTHERS THAN BISONS, AND OVINE, CAPRINE AND PORCINE ANIMALS AND DOMESTIC SOLIPEDS OTHER THAN EMERGENCY SLAUGHTER

Up to three domestic bovine animals, other than bisons, up to three domestic solipeds, up to six domestic porcine animals or up to nine ovine or caprine animals may be slaughtered at the same occasion at the holding of provenance, when authorised by the competent authority in accordance with the following requirements:

• (b) there is an agreement between the slaughterhouse and the owner of the animal intended for slaughter; the owner must inform the competent authority in writing of such an agreement;

• (c) the slaughterhouse or the owner of the animals intended for slaughter must inform the official veterinarian at least three days in advance of the date and time of intended slaughter of the animals;

• (d) the official veterinarian who carries out the ante-mortem inspection of the animal intended for slaughter must be present at the time of slaughter;

• (e) the mobile unit to be used for the bleeding and transport of the slaughtered animals to the slaughterhouse must allow their hygienic handling and bleeding, and the proper disposal of their blood and must be part of a slaughterhouse approved by the competent authority in accordance with Article 4(2); however the competent authority may allow bleeding outside the mobile unit if the blood is not intended for human consumption and the slaughter does not take place in restricted zones as defined in Article 4(41) of Regulation (EU) 2016/429 of the European Parliament and of the Council ([^E0014]) or establishments in which animal health restrictions are applied in accordance with Regulation (EU) 2016/429 and any acts adopted on its basis;

• (f) the slaughtered and bled animals must be transported directly 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 official veterinarian; any viscera removed must accompany the slaughtered animal to the slaughterhouse and be identified as belonging to each individual animal;

• (g) if more than two hours elapse between the time of slaughter of the first animal and the time of arrival at the slaughterhouse of the slaughtered animals, the slaughtered animals must be refrigerated; where climatic conditions so permit, active chilling is not necessary;

• (h) the owner of the animal must inform the slaughterhouse in advance of the intended time of arrival of the slaughtered animals, which must be handled without undue delay after arrival at the slaughterhouse;

• (i) in addition to the food chain information to be submitted in accordance with Section III of Annex II to this Regulation, the official certificate set out in Chapter 3 of Annex IV to Implementing Regulation (EU) 2020/2235 must accompany the slaughtered animals to the slaughterhouse or be sent in advance in any format.

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.

• 1. Meat must attain the temperature specified in point 1 and remain at that temperature during storage.