Annexes to COM(2000)574 - Health rules concerning animal by-products not intended for human consumption - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2000)574 - Health rules concerning animal by-products not intended for human consumption. |
|---|---|
| document | COM(2000)574  |
| date | October 3, 2002 |
SPECIFIC DEFINITIONS
For the purpose of this Regulation:
1. "apiculture products" means honey, beeswax, royal jelly, propolis or pollen used in bee-keeping;
2. "batch" means a unit of production produced in a single plant using uniform production parameters - or a number of such units, when stored together - and that can be identified for the purposes of recall and re-treatment or disposal should tests show that to be necessary;
3. "biogas plant" means a plant in which biological degradation of products of animal origin is undertaken under anaerobic conditions for the production and collection of biogas;
4. "blood products" means products derived from blood or fractions of blood, excluding blood meal; they include dried/frozen/liquid plasma, dried whole blood, dried/frozen/liquid red cells or fractions thereof and mixtures;
5. "blood" means fresh whole blood;
6. "bloodmeal" means products derived from the heat-treatment of blood in accordance with Annex VII, Chapter II, and intended for animal consumption or organic fertilizers;
7. "canned petfood" means heat-processed petfood contained within a hermetically sealed container;
8. "Category 1 or Category 2 intermediate plant" means a plant in which unprocessed Category 1 or Category 2 material is handled and/or temporarily stored for the purpose of further transportation to its final destination and where certain preliminary activities, such as removal of hides and skins and performing post-mortem examinations, may take place;
9. "Category 1 processing plant" means a plant in which Category 1 material is processed before its final disposal;
10. "Category 2 oleochemical plant" means a plant processing rendered fats derived from Category 2 material under conditions set out in Annex VI, Chapter III;
11. "Category 2 processing plant" means a plant in which Category 2 material is processed before its final disposal, further transformation or use;
12. "Category 3 intermediate plant" means a plant in which unprocessed Category 3 material is sorted and/or cut and/or chilled or deep-frozen into blocks and/or temporarily stored for the purpose of further transporting to its final destination;
13. "Category 3 oleochemical plant" means a plant processing rendered fats derived from Category 3 material;
14. "Category 3 processing plant" means a plant in which Category 3 material is processed into processed animal protein and other processed products that could be used as feed material;
15. "catering waste" means all waste food originating in restaurants, catering facilities and kitchens, including central kitchens and household kitchens;
16. "co-incineration plant" means a disposal site as defined in Article 3(5) of Directive 2000/76/EC;
17. "co-incineration" means the disposal of animal by-products or products derived therefrom in a co-incineration plant;
18. "collection centres" means premises collecting and treating certain animal by-products intended to be used for the feeding of the animals specified in Article 23(2)(c);
19. "composting plant" means a plant in which biological degradation of products of animal origin is undertaken under aerobic conditions;
20. "digestion residues" means residues resulting from the transformation of animal by-products in a biogas plant;
21. "digestive tract content" means the content of the digestive tract of mammals and ratites, whether or not separated from the digestive tract;
22. "dogchews" means untanned products for pet animals to chew, produced from hides and skins of ungulates or other animal material;
23. "feed material" means those feed materials, as defined in Directive 96/25/EC(1), that are of animal origin including processed animal proteins, blood products, rendered fats, fish oil, fat derivatives, gelatin and hydrolysed proteins, dicalcium phosphate, milk, milk-based products and colostrum;
24. "fishmeal" means processed animal protein derived from sea animals, except sea mammals;
25. "fur animals" means animals kept or reared for the production of fur and not used for human consumption;
26. "gelatin" 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 (including fish and poultry);
27. "greaves" means the protein-containing residue of rendering, after partial separation of fat and water;
28. "hermetically sealed container" means a container that is designed and intended to be secure against the entry of micro-organisms;
29. "hides and skins" means all cutaneous and subcutaneous tissues;
30. "high-capacity incineration plant" means an incineration plant other than a low-capacity incineration plant;
31. "hydrolysed proteins" means polypeptides, peptides and aminoacids, and mixtures thereof, obtained by the hydrolysis of animal by-products;
32. "incineration plant" means a disposal site as defined in Article 3(4) of Directive 2000/76/EC;
33. "incineration" means the disposal of animal by-products or products derived therefrom in an incineration plant;
34. "laboratory reagent" means a packaged product, ready for use by the end user, containing a blood product, and intended for laboratory use as reagent or reagent product, whether used alone or in combination;
35. "landfill" means a disposal site as defined by Directive 1999/31/EC;
36. "low-capacity incineration plant" means an incineration plant with a throughput of less than 50 kg of animal by-products per hour;
37. "manure" means any excrement and/or urine of farmed animals, with or without litter, and guano;
38. "organic fertilizers" and "soil improvers" mean materials of animal origin used to maintain or improve plant nutrition and the physical and chemical properties and biological activity of soils, either separately or together; they may include manure, digestive tract content, compost and digestion residues;
39. "pasture land" means land covered with grass or other herbage and grazed by farmed animals;
40. "petfood plant" means a plant producing petfood or dogchews and in which certain animal by-products are used in the preparation of such petfood or dogchews;
41. "petfood" means food for pet animals containing Category 3 material;
42. "processed animal protein" means animal proteins derived entirely from Category 3 material, which have been treated in accordance with this Regulation so as to render them suitable for direct use as feed material or other use in feedingstuffs, including petfood, or use in organic fertilizers or soil improvers; it does not include blood products, milk, milk-based products, colostrum, gelatin, hydrolysed proteins and dicalcium phosphate;
43. "processed petfood" means petfood, other than raw petfood, that has undergone treatment in accordance with the requirements of Annex VIII;
44. "processed products" means animal by-products that have undergone one of the processing methods or another treatment required by Annex VII or VIII;
45. "processing methods" means the methods listed in Annex V, Chapter III;
46. "processing plant" means an animal by-products processing plant;
47. "product used for in vitro diagnosis" means a packaged product, ready for use by the end user, containing a blood product, and used as a reagent, reagent product, calibrator, kit or any other system, whether used alone or in combination, intended to be used in vitro for the examination of samples of human or animal origin, with the exception of donated organs or blood, solely or principally with a view to the diagnosis of a physiological state, state of health, disease or genetic abnormality or to determine safety and compatibility with reagents;
48. "raw petfood" means petfood which has not undergone any preserving process other than chilling, freezing or quick freezing to ensure preservation;
49. "remote areas" means areas where the animal population is so small, and where facilities are so far away, that the arrangements necessary for collection and transport would be unacceptably onerous compared to local disposal;
50. "rendered fats" means fats derived from processing of Category 2 material or Category 3 material;
51. "storage plant" means a plant, other than establishments and intermediaries covered by Directive 95/69/EC(2), in which processed products are temporarily stored before their final use or disposal;
52. "tanning" means the hardening of hides, using vegetable tanning agents, chromium salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents;
53. "technical plant" means a plant in which animal by-products are used to produce technical products;
54. "technical products" means products directly derived from certain animal by-products, intended for purposes other than human or animal consumption, including tanned and treated hides and skins, game trophies, processed wool, hair, bristles, feathers and parts of feathers, serum of equidae, blood products, pharmaceuticals, medical devices, cosmetics, bone products for china, gelatin and glue, organic fertilizers, soil improvers, rendered fats, fat derivatives, processed manure and milk and milk-based products;
55. "unprocessed feathers and parts of feathers" means feathers and parts of feathers that have not been treated with a steam current or by some other method ensuring that no pathogens are transmitted;
56. "unprocessed wool" means sheep's wool that has neither undergone factory washing nor been obtained from tanning;
57. "unprocessed hair" means ruminant hair that has neither undergone factory washing nor been obtained from tanning;
58. "unprocessed pig bristles" means pig bristles that have neither undergone factory washing nor been obtained from tanning.
(1) Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC (OJ L 125, 23.5.1996, p. 35). Directive as last amended by Directive 2001/46/EC (OJ L 234, 1.9.2001, p. 55).
(2) Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector and amending Directives 70/524/EEC, 74/63/EEC, 79/373/EEC and 82/471/EEC (OJ L 332, 30.12.1995, p. 15). Directive as last amended by Directive 1999/29/EC (OJ L 115, 4.5.1999, p. 32).
ANNEX II
HYGIENE REQUIREMENTS FOR THE COLLECTION AND TRANSPORT OF ANIMAL BY-PRODUCTS AND PROCESSED PRODUCTS
CHAPTER I
Identification
1. All necessary measures must be taken to ensure that:
(a) Category 1, Category 2 and Category 3 materials are identifiable and kept separate and identifiable during collection and transportation; and
(b) processed products are identifiable and kept separate and identifiable during transportation.
2. During transport, a label attached to the vehicle, container, carton or other packaging material must clearly indicate:
(a) the category of the animal by-products or, in the case of processed products, the category of animal by-products from which the processed products were derived; and
(b) (i) in the case of Category 3 material, the words "not for human consumption",
(ii) in the case of Category 2 material, other than manure and digestive tract content, and processed products derived therefrom, the words "not for animal consumption", or
(iii) in the case of Category 1 material and processed products derived therefrom, the words "for disposal only".
CHAPTER II
Vehicles and containers
1. Animal by-products and processed products must be collected and transported in sealed new packaging or covered leak-proof containers or vehicles.
2. Vehicles and reusable containers, and all reusable items of equipment or appliances that come into contact with animal by-products or processed products, must be:
(a) cleaned, washed and disinfected after each use;
(b) maintained in a clean condition; and
(c) clean and dry before use.
3. Reusable containers must be dedicated to the carriage of a particular product to the extent necessary to avoid cross-contamination.
CHAPTER III
Commercial documents and health certificates
1. During transportation, a commercial document or, when required by this Regulation, a health certificate must accompany animal by-products and processed products.
2. Commercial documents must specify:
(a) the date on which the material was taken from the premises;
(b) the description of the material, including the information referred to in Chapter I, the animal species for Category 3 material and processed products derived therefrom destined for use as feed material and, if applicable, the ear-tag number;
(c) the quantity of the material;
(d) the place of origin of the material;
(e) the name and the address of the carrier;
(f) the name and the address of the receiver and, if applicable, its approval number; and
(g) if appropriate:
(i) the approval number of the plant of origin, and
(ii) the nature and the methods of the treatment.
3. The commercial document must be produced at least in triplicate (one original and two copies). The original must accompany the consignment to its final destination. The receiver must retain it. The producer must retain one of the copies and the carrier the other.
4. A model for the commercial document may be laid down under the procedure referred to in Article 33(2).
5. Health certificates must be issued and signed by the competent authority.
CHAPTER IV
Records
The records referred to in Article 9 must contain the information referred to in Chapter III, paragraph 2, as follows. They must contain:
(a) the information referred to in subparagraphs (b) and (c); and
(b) in the case of records kept by any person consigning animal by-products, the information referred to in subparagraphs (a), (e) and, if known, (f); or
(c) in the case of records kept by any person transporting animal by-products, the information referred to in subparagraphs (a), (d) and (f); or
(d) in the case of records kept by any person receiving animal by-products, the date of reception and the information referred to in subparagraphs (d) and (e).
CHAPTER V
Retention of documents
The commercial document and the health certificate referred to in Chapter III, and the records referred to in Chapter IV, must be kept for a period of at least two years for presentation to the competent authority.
CHAPTER VI
Temperature conditions
1. The transport of animal by-products must take place at an appropriate temperature, to avoid any risk to animal or public health.
2. Unprocessed Category 3 material destined for the production of feed material or pet food must be transported chilled or frozen, unless processed within 24 hours of departure.
3. The design of vehicles used for refrigerated transport must ensure the maintenance of an appropriate temperature throughout transport.
CHAPTER VII
Specific rules for transit
The carriage of animal by-products and processed products in transit must meet the requirements of Chapters I, II, III and VI.
CHAPTER VIII
Control measures
The competent authority must take the necessary measures to control the collection, transport, use and disposal of animal by-products and processed products, including by checking the keeping of required records and documents and, when this Regulation requires it or the competent authority considers it necessary, by sealing.
When the competent authority applies a seal to a consignment of animal by-products or processed products, it must inform the competent authority of the place of destination.
ANNEX III
HYGIENE REQUIREMENTS FOR INTERMEDIATE AND STORAGE PLANTS
CHAPTER I
Requirements for the approval of intermediate plants
1. Premises and facilities must meet at least the following requirements.
(a) The premises must be adequately separated from the public highway and other premises such as slaughterhouses. The layout of plants must ensure the total separation of Category 1 and Category 2 material from Category 3 material from reception until dispatch.
(b) The plant must have a covered space to receive animal by-products.
(c) The plant must be constructed in such a way that it is easy to clean and disinfect. Floors must be laid down in such a way as to facilitate the draining of liquids.
(d) The plant must have adequate lavatories, changing rooms and washbasins for staff.
(e) The plant must have appropriate arrangements for protection against pests, such as insects, rodents and birds.
(f) The plant must have a waste-water disposal system which meets hygiene requirements.
(g) Where it is necessary for the purpose of achieving the objectives of this Regulation, plants must have suitable temperature-controlled storage facilities of sufficient capacity for maintaining animal by-products at appropriate temperatures and designed to allow the monitoring and recording of those temperatures.
2. The plant must have adequate facilities for cleaning and disinfecting the containers or receptacles in which animal by-products are received and the vehicles, other than ships, in which they are transported. Adequate facilities must be provided for the disinfecting of vehicle wheels.
CHAPTER II
General hygiene requirements
A. Category 3 intermediate plants
1. The plant must not engage in activities other than the importation, collection, sorting, cutting, chilling, freezing into blocks, temporary storage and dispatching of Category 3 material.
2. The sorting of Category 3 material must be carried out in such a way as to avoid any risk of the propagation of animal diseases.
3. All the time during sorting or storage, Category 3 material must be handled and stored separately from goods other than other Category 3 material and in such a way as to prevent any propagation of pathogens and to ensure compliance with Article 22.
4. Category 3 material must be stored properly, and, where appropriate, chilled or frozen, until re-dispatched.
5. Packaging material must be incinerated or disposed of by some other means in accordance with instructions from the competent authority.
B. Category 1 or Category 2 intermediate plants
6. The plant must not engage in activities other than the collection, handling, temporary storage and dispatching of Category 1 or Category 2 material.
7. The sorting of the Category 1 or Category 2 material must be carried out in such a way as to avoid any risk of the propagation of animal diseases.
8. All the time during storage, the Category 1 or Category 2 material must be handled and stored separately from other goods and in such a way as to prevent any propagation of pathogens.
9. Category 1 or Category 2 material must be stored properly, including under appropriate temperature conditions, until re-dispatched.
10. Packaging material must be incinerated or disposed of by some other means in accordance with instructions from the competent authority.
11. Waste water must be treated to ensure, as far as is reasonably practicable, that no pathogens remain. Specific requirements for the treatment of waste water from Category 1 and Category 2 intermediate plants may be laid down in accordance with the procedure referred to in Article 33(2).
CHAPTER III
Requirements for the approval of storage plants
Premises and facilities must meet at least the following requirements.
1. Premises storing processed products derived from Category 3 material must not be at the same site as premises storing processed products derived from Category 1 or Category 2 material, unless in a completely separate building.
2. The plant must:
(a) have a covered space to receive the products;
(b) be constructed in such a way that it is easy to clean and disinfect. Floors must be laid down in such a way as to facilitate the draining of liquids;
(c) have adequate lavatories, changing rooms and washbasins for staff; and
(d) have appropriate arrangements for protection against pests, such as insects, rodents and birds.
3. The plant must have adequate facilities for cleaning and disinfecting the containers or receptacles in which the products are received and the vehicles, other than ships, in which they are transported. Adequate facilities must be provided for the disinfecting of vehicle wheels.
4. Products must be stored properly until re-dispatched.
ANNEX IV
REQUIREMENTS FOR INCINERATION AND CO-INCINERATION PLANTS TO WHICH DIRECTIVE 2000/76/EC DOES NOT APPLY
CHAPTER I
General conditions
1. Incineration or co-incineration plants must be designed, equipped and operated in such a manner as to fulfil the requirements of this Regulation.
2. The operator of an incineration or co-incineration plant must take all necessary precautions concerning the reception of animal by-products to prevent, or limit as far as practicable, direct risks to human or animal health.
CHAPTER II
Operating conditions
3. Incineration or co-incineration plants must be designed, equipped, built and operated in such a way that the gas resulting from the process is raised in a controlled and homogeneous fashion, even under the most unfavourable conditions, to a temperature of 850 °C, as measured near the inner wall or at another representative point of the combustion chamber as authorised by the competent authority, for two seconds.
4. Each line of high-capacity incineration plants must be equipped with at least one auxiliary burner. This burner must be switched on automatically when the temperature of the combustion gases after the last injection of combustion air falls below 850 °C. It must also be used during plant start-up and shut-down operations to ensure that the temperature of 850 °C is maintained at all times during these operations and as long as unburned material is in the combustion chamber.
5. High-capacity incineration or co-incineration plants must have and operate an automatic system to prevent feed with animal by-products:
(a) at start-up, until the temperature of 850 °C has been reached; and
(b) whenever the temperature of 850 °C is not maintained.
6. Animal by-products should, where practicable, be placed straight in the furnace without direct handling.
CHAPTER III
Water discharges
7. Incineration or co-incineration plant sites, including associated storage areas for animal by-products, must be designed in such a way as to prevent unauthorised and accidental release of any polluting substances into soil, surface water and groundwater in accordance with the provisions provided for in relevant Community legislation. Moreover, storage capacity must be provided for contaminated rainwater run-off from the incineration plant site or for contaminated water arising from spillage or fire-fighting operations.
8. The storage capacity must be adequate to ensure that such waters can be tested and treated before discharge where necessary.
CHAPTER IV
Residues
9. For the purposes of this Chapter, "residues" means any liquid or solid material generated by the incineration or co-incineration process, the waste-water treatment or other processes within the incineration or co-incineration plant. They include bottom ash and slag, fly ash and boiler dust.
10. Residues resulting from the operation of the incineration or co-incineration plant must be minimised in their amount and harmfulness. Residues must be recycled, where appropriate, directly in the plant or outside in accordance with relevant Community legislation.
11. Transport and intermediate storage of dry residues in the form of dust must take place in such a way as to prevent dispersal in the environment (e.g., in closed containers).
CHAPTER V
Temperature measurement
12. Techniques must be used to monitor the parameters and conditions relevant to the incineration or co-incineration process. High-capacity incineration and co-incineration plants must have and use temperature measurement equipment.
13. The approval issued by the competent authority, or conditions attached to it, must lay down temperature measurement requirements.
14. The appropriate installation and the functioning of any automated monitoring equipment must be subject to control and to an annual surveillance test. Calibration must be carried out by means of parallel measurements with the reference methods at least every three years.
15. Temperature measurement results must be recorded and presented in an appropriate fashion to enable the competent authority to verify compliance with the permitted operating conditions laid down in this Regulation in accordance with procedures to be decided upon by that authority.
CHAPTER VI
Abnormal operating
16. In the case of a breakdown, or abnormal operating conditions, the operator must reduce or close down operations as soon as practicable until normal operations can be resumed.
ANNEX V
GENERAL HYGIENE REQUIREMENTS FOR THE PROCESSING OF CATEGORY 1, 2 AND 3 MATERIAL
CHAPTER I
General requirements for the approval of Category 1, 2 and 3 processing plants
1. Premises and facilities must meet at least the following requirements:
(a) premises for the processing of animal by-products must not be at the same site as slaughterhouses, unless in a completely separate building. Unauthorised persons and animals must not have access to the plant;
(b) the processing plant must have a clean and unclean sector, adequately separated. The unclean sector must have a covered place to receive animal by-products and must be constructed in such a way that it is easy to clean and disinfect. Floors must be laid in such a way as to facilitate the draining of liquids. The processing plant must have adequate lavatories, changing rooms and washbasins for staff;
(c) the processing plant must have sufficient production capacity for hot water and steam for the processing of animal by-products;
(d) the unclean sector must, if appropriate, contain equipment to reduce the size of animal by-products and equipment for loading the crushed animal by-products into the processing unit;
(e) all installations in which animal by-products are processed must operate in accordance with the requirements of Chapter II. Where heat treatment is required, all installations must be equipped with:
(i) measuring equipment to monitor temperature against time and, if necessary, pressure at critical points;
(ii) recording devices to record continuously the results of these measurements; and
(iii) an adequate safety system to prevent insufficient heating;
(f) to prevent recontamination of the finished product by incoming animal by-products, there must be a clear separation between the area of the plant where incoming material for processing is unloaded and the areas set aside for the processing of that product and the storage of the processed product.
2. The processing plant must have adequate facilities for cleaning and disinfecting the containers or receptacles in which animal by-products are received and the vehicles, other than ships, in which they are transported.
3. Adequate facilities must be provided for the disinfecting of vehicle wheels, on leaving the unclean sector of the processing plant.
4. All processing plants must have a waste-water disposal system meeting the competent authority's requirements.
5. The processing plant must have its own laboratory or make use of the services of an external laboratory. The laboratory must be equipped to carry out necessary analyses and be approved by the competent authority.
CHAPTER II
General hygiene requirements
1. Animal by-products must be processed as soon as possible after arrival. They must be stored properly until processed.
2. Containers, receptacles and vehicles used for transporting unprocessed material must be cleaned in a designated area. That area must be situated or designed to prevent the risk of contamination of processed products.
3. Persons working in the unclean sector must not enter the clean sector without changing their working clothes and footwear or without disinfecting the latter. Equipment and utensils must not be taken from the unclean sector into the clean sector, unless first cleaned and disinfected. Personnel movement procedures must be established to control the movement of personnel between areas and to prescribe the proper use of foot baths and wheel baths.
4. Waste water originating in the unclean sector must be treated to ensure, as far as is reasonably practicable, that no pathogens remain. Specific requirements for the treatment of waste water from processing plants may be laid down under the procedure referred to in Article 33(2).
5. Preventive measures against birds, rodents, insects or other vermin must be taken systematically. A documented pest control programme must be used for that purpose.
6. Cleaning procedures must be established and documented for all parts of the premises. Suitable equipment and cleaning agents must be provided for cleaning.
7. Hygiene control must include regular inspections of the environment and equipment. Inspection schedules and results must be documented and maintained for at least two years.
8. Installations and equipment must be kept in a good state of repair and measuring equipment must be calibrated at regular intervals.
9. Processed products must be handled and stored at the processing plant in such a way as to preclude recontamination.
CHAPTER III
Processing methods
Method 1
Reduction
1. If the particle size of the animal by-products to be processed is more than 50 millimetres, the animal by-products must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 50 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks disclose the existence of particles larger than 50 millimetres, the process must be stopped and repairs made before the process is resumed.
Time, temperature and pressure
2. After reduction the animal by-products must be heated to a core temperature of more than 133 °C for at least 20 minutes without interruption at a pressure (absolute) of at least 3 bars produced by saturated steam(1); the heat treatment may be applied as the sole process or as a pre- or post-process sterilisation phase.
3. The processing may be carried out in batch or continuous systems.
Method 2
Reduction
1. If the particle size of the animal by-products to be processed is more than 150 millimetres, the animal by-products must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 150 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks disclose the existence of particles larger than 150 millimetres, the process must be stopped and repairs made before the process is resumed.
Time, temperature and pressure
2. After reduction the animal by-products must be heated to a core temperature greater than 100 °C for at least 125 minutes, a core temperature greater than 110 °C for at least 120 minutes and a core temperature greater that 120 °C for at least 50 minutes.
3. The processing must be carried out in a batch system.
4. The animal by-products must be cooked in such a manner that the time-temperature requirements are achieved at the same time.
Method 3
Reduction
1. If the particle size of the animal by-products to be processed is more than 30 millimetres, the animal by-products must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 30 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks disclose the existence of particles larger than 30 millimetres, the process must be stopped and repairs made before the process is resumed.
Time, temperature and pressure
2. After reduction the animal by-products must be heated to a core temperature greater than 100 °C for at least 95 minutes, a core temperature greater than 110 °C for at least 55 minutes and a core temperature greater that 120 °C for at least 13 minutes.
3. The processing may be carried out in batch or continuous systems.
4. The animal by-products may be cooked in such a manner that the time-temperature requirements are achieved at the same time.
Method 4
Reduction
1. If the particle size of the animal by-products to be processed is more than 30 millimetres, the animal by-products must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 30 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks disclose the existence of particles larger than 30 millimetres, the process must be stopped and repairs made before the process is resumed.
Time, temperature and pressure
2. After reduction the animal by-products must be placed in a vessel with added fat and heated to a core temperature greater than 100 °C for at least 16 minutes, a core temperature greater than 110 °C for at least 13 minutes, a core temperature greater that 120 °C for at least eight minutes and a core temperature greater that 130 °C for at least three minutes.
3. The processing may be carried out in batch or continuous systems.
4. The animal by-products may be cooked in such a manner that the time-temperature requirements are achieved at the same time.
Method 5
Reduction
1. If the particle size of the animal by-products to be processed is more than 20 millimetres, the animal by-products must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 20 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks disclose the existence of particles larger than 20 millimetres, the process must be stopped and repairs made before the process is resumed.
Time, temperature and pressure
2. After reduction the animal by-products must be heated until they coagulate and then pressed so that fat and water are removed from the proteinaceous material. The proteinaceous material must then be heated to a core temperature greater than 80 °C for at least 120 minutes and a core temperature greater than 100 °C for at least 60 minutes.
3. The processing may be carried out in batch or continuous systems.
4. The animal by-products may be cooked in such a manner that the time-temperature requirements are achieved at the same time.
Method 6
(for animal by-products of fish origin only)
Reduction
1. The animal by-products must be reduced to ... millimetres. They must then be mixed with formic acid to reduce the pH to .... The mixture must be stored for ... hours pending further treatment.
2. The mixture must then be introduced into a heat converter and be heated to a core temperature of ... °C for at least ... minutes. The progression of the product through the heat converter must be controlled by means of mechanical commands limiting its displacement in such a way that at the end of the heat treatment operation the product has undergone a cycle which is sufficient in both time and temperature.
3. After heat treatment, the product must be separated into liquid, fat and greaves by mechanical means. To obtain processed animal protein concentrate, the liquid phase must be pumped into two heat exchangers which are steam-heated and equipped with vacuum chambers in order for its humidity to be removed therein in the form of water vapour. The greaves must be reincorporated into the protein concentrate before storage.
Method 7
1. Any processing method approved by the competent authority where it has been demonstrated to that authority that the final product has been sampled on a daily basis over a period of one month in compliance with the following microbiological standards:
(a) Samples of material taken directly after heat treatment:
Clostridium perfringens absent in 1 g of the products
(b) Samples of material taken during or upon withdrawal from storage at the processing plant:
Salmonella: absence in 25 g: n = 5, c = 0, m = 0, M = 0
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 g
where:
n= number of samples to be tested;
m= threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m;
M= maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more; and
c= number of samples the bacterial count of which may be between m and M, the sample still being considered acceptable if the bacterial count of the other samples is m or less.
2. Details of the critical control points under which each processing plant satisfactorily complies with the microbiological standards must be recorded and maintained so that the owner, operator or their representative and the competent authority can monitor the operation of the processing plant. The information to be recorded and monitored must include the particle size, critical temperature and, as appropriate, the absolute time, pressure profile, raw material feed-rate and fat recycling rate.
3. This information must be made available to the Commission on request.
CHAPTER IV
Supervision of production
1. The competent authority must supervise processing plants to ensure compliance with the requirements of this Regulation. It must in particular:
(a) check:
(i) the general conditions of hygiene of the premises, equipment and staff;
(ii) the efficacy of the own checks carried out by the plant, in accordance with Article 25, particularly by examining the results and taking samples;
(iii) the standards of the products after processing. The analyses and tests must be carried out in accordance with scientifically-recognised methods (in particular, those laid down in Community legislation or, where none exist, recognised international standards or, in their absence, national standards); and
(iv) the storage conditions;
(b) take any samples required for laboratory tests; and
(c) make any other checks it considers necessary to ensure compliance with this Regulation.
2. To allow it to carry out its responsibilities under paragraph 1, the competent authority must have free access at all times to all parts of the processing plant and to records, commercial documents and health certificates.
CHAPTER V
Validation procedures
1. The competent authority must validate the processing plant in accordance with the following procedures and indicators:
(a) description of the process (by a process flow diagram);
(b) identification of critical control points (CCPs) including the material process rate for continuous systems;
(c) compliance with the specific process requirements laid down by this Regulation; and
(d) achievement of the following requirements:
(i) particle size for batch-pressure and continuous processes - defined by the mincer hole or the anvil gap size, and
(ii) temperature, pressure, processing time and material processing rate (for continuous system only) as specified in paragraphs 2 and 3.
2. In the case of a batch pressure system:
(a) the temperature must be monitored with a permanent thermocouple and it must be plotted against real time;
(b) the pressure stage must be monitored with a permanent pressure gauge. Pressure must be plotted against real time;
(c) the processing time must be shown by time/temperature and time/pressure diagrams.
At least once a year the thermocouple and the pressure gauge must be calibrated.
3. In the case of a continuous pressure system:
(a) the temperature and the pressure must be monitored with thermocouples, or an infrared temperature gun, and pressure gauges used at defined positions throughout the process system in such a way that temperature and pressure comply with the required conditions inside the whole continuous system or in a section of it. The temperature and pressure must be plotted against real time;
(b) measurement of the minimum transit time inside the whole relevant part of the continuous system where the temperature and pressure comply with the required conditions, must be provided to the competent authorities, using insoluble markers (for example, manganese dioxide) or a method which offers equivalent guarantees. Accurate measurement and control of the material process rate is essential and must be measured during the validation test in relation to a CCP that can be continuously monitored such as:
(i) feed screw revolutions per minute (rev./min.),
(ii) electric power (amps at given voltage),
(iii) evaporation/condensation rate, or
(iv) number of pump strokes per unit time.
All measuring and monitoring equipment must be calibrated at least once a year.
4. The competent authority must repeat the validation procedures periodically, when it considers it necessary, and in any case each time any significant alterations are made to the process (for example, modification of the machinery or a change of raw materials).
5. Validation procedures based on testing methods may be laid down under the procedure referred to in Article 33(2).
(1) "Saturated steam" means that all air is evacuated and replaced by steam in the whole sterilisation chamber.
ANNEX VI
SPECIFIC REQUIREMENTS FOR THE PROCESSING OF CATEGORY 1 AND 2 MATERIAL AND FOR BIOGAS AND COMPOSTING PLANTS
CHAPTER I
Specific requirements for the processing of Category 1 and Category 2 material
The following requirements apply in addition to the general requirements laid down in Annex V.
A. Premises
1. The layout of Category 1 and Category 2 processing plants must ensure the total separation of Category 1 material from Category 2 material from reception of the raw material until dispatch of the resulting processed product.
2. However, the competent authority may authorise the temporary use of a Category 2 processing plant for the processing of Category 1 material when a widespread outbreak of an epizootic disease or other extraordinary and unforeseeable circumstances leads to a lack of capacity at a Category 1 processing plant.
The competent authority must re-approve the Category 2 processing plant in accordance with Article 13 before it processes Category 2 material again.
B. Processing standards
3. The critical control points that determine the extent of the heat treatments applied in processing must be identified for each processing method as specified in Annex V, Chapter III. The critical control points may include:
(a) raw material particle size;
(b) temperature achieved in the heat treatment process;
(c) pressure applied to the raw material; and
(d) duration of the heat treatment process or feed rate to a continuous system.
Minimum process standards must be specified for each applicable critical control point.
4. Records must be maintained for at least two years to show that the minimum process values for each critical control point are applied.
5. Accurately calibrated gauges/recorders must be used to monitor continuously the processing conditions. Records must be kept to show the date of calibration of gauges/recorders.
6. Material that may not have received the specified heat treatment (e.g. material discharged at start up, or leakage from cookers) must be recirculated through the heat treatment or collected and reprocessed.
7. Animal by-products must be processed in accordance with the following processing standards.
(a) Processing method 1 must be applied to:
(i) Category 2 material, other than manure and digestive tract content, destined for biogas or composting plants or intended to be used as organic fertilizers or soil improvers, and
(ii) Category 1 and Category 2 material destined for landfill.
(b) Any of processing methods 1 to 5 must be applied to:
(i) Category 2 material from which the resulting protein is destined for incineration or co-incineration,
(ii) Category 2 material from which the rendered fat is destined for a Category 2 oleochemical plant, and
(iii) Category 1 or Category 2 material destined for incineration or co-incineration.
However, the competent authority may require processing method 1 to be applied to Category 1 material destined for incineration or co-incineration.
C. Processed products
8. Processed products derived from Category 1 or 2 materials, with the exception of liquid products destined for biogas or composting plants, must be permanently marked, where technically possible with smell, using a system approved by the competent authority. Detailed rules for such marking may be laid down under the procedure referred to in Article 33(2).
9. Samples of processed products destined for biogas or composting plants or landfill, taken directly after heat treatment, must be free from heat-resistant pathogenic bacteria spores (Clostridium perfringens absent in 1 g of the products).
CHAPTER II
Specific requirements for the approval of biogas and composting plants
A. Premises
1. Biogas plants must be equipped with:
(a) a pasteurisation/hygienisation unit, which cannot be bypassed, with:
(i) installations for monitoring temperature against time;
(ii) recording devices to record the results of these measurements continuously; and
(iii) an adequate safety system to prevent insufficient heating; and
(b) adequate facilities for cleaning and disinfecting vehicles and containers on leaving the biogas plant.
However, a pasteurisation/hygienisation unit is not mandatory for biogas plants that transform only animal by-products that have undergone processing method 1.
2. Composting plants must be equipped with:
(a) a closed composting reactor, which cannot be bypassed, with:
(i) installations for monitoring temperature against time;
(ii) recording devices to record the results of these measurements continuously; and
(iii) an adequate safety system to prevent insufficient heating; and
(b) adequate facilities for cleaning and disinfecting vehicles and containers transporting untreated animal by-products.
3. Each biogas plant and composting plant must have its own laboratory or make use of an external laboratory. The laboratory must be equipped to carry out the necessary analyses and approved by the competent authority.
B. Hygiene requirements
4. Only the following animal by-products may be transformed in a biogas or composting plant:
(a) Category 2 material, when using processing method 1 in a Category 2 processing plant;
(b) manure and digestive tract content; and
(c) Category 3 material.
5. Animal by-products referred to in paragraph 4 must be transformed as soon as possible after arrival. They must be stored properly until treated.
6. Containers, receptacles and vehicles used for transporting untreated material must be cleaned in a designated area. This area must be situated or designed to prevent risk of contamination of treated products.
7. Preventive measures against birds, rodents, insects or other vermin must be taken systematically. A documented pest-control programme must be used for that purpose.
8. Cleaning procedures must be documented and established for all parts of the premises. Suitable equipment and cleaning agents must be provided for cleaning.
9. Hygiene control must include regular inspections of the environment and equipment. Inspection schedules and results must be documented.
10. Installations and equipment must be kept in a good state of repair and measuring equipment must be calibrated at regular intervals.
11. Digestion residues must be handled and stored at the plant in such a way as to preclude recontamination.
C. Processing standards
12. Category 3 material used as raw material in a biogas plant equipped with a pasteurisation/hygienisation unit must be submitted to the following minimum requirements:
(a) maximum particle size before entering the unit: 12 mm;
(b) minimum temperature in all material in the unit: 70 °C; and
(c) minimum time in the unit without interruption: 60 minutes.
13. Category 3 material used as raw material in a composting plant must be submitted to the following minimum requirements:
(a) maximum particle size before entering the composting reactor: 12 mm,
(b) minimum temperature in all material in the reactor: 70 °C; and
(c) minimum time in the reactor at 70 °C (all material): 60 minutes.
14. However, pending the adoption of rules in accordance with Article 6(2)(g), the competent authority may, when catering waste is the only animal by-product used as raw material in a biogas or composting plant, authorise the use of processing standards other than those laid down in paragraphs 12 and 13 provided that they guarantee an equivalent effect regarding the reduction of pathogens.
D. Digestion residues and compost
15. Samples of the digestion residues or compost taken during or on withdrawal from storage at the biogas or composting plant must comply with the following standards:
Salmonella: absence in 25 g: n = 5, c = 0, m = 0, M = 0
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 g
where:
n= number of samples to be tested;
m= threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m;
M= maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more; and
c= number of samples the bacterial count of which may be between m and M, the sample still being considered acceptable if the bacterial count of the other samples is m or less.
CHAPTER III
Treatment standards for the further processing of rendered fats
The following processes may be used to produce fat derivatives from rendered fats derived from Category 2 material:
1. transesterification or hydrolysis at least 200 °C, under corresponding appropriate pressure, for 20 minutes (glycerol, fatty acids and esters); or
2. saponification with NaOH 12M (glycerol and soap):
(a) in a batch process at 95 °C for three hours; or
(b) in a continuous process at 140 °C 2 bars (2000 hPa) for eight minutes, or under equivalent conditions laid down in accordance with the procedure referred to in Article 33(2).
ANNEX VII
SPECIFIC HYGIENE REQUIREMENTS FOR THE PROCESSING AND PLACING ON THE MARKET OF PROCESSED ANIMAL PROTEIN AND OTHER PROCESSED PRODUCTS THAT COULD BE USED AS FEED MATERIAL
CHAPTER I
Specific requirements for the approval of Category 3 processing plants
The following requirements apply in addition to the general requirements laid down in Annex V.
A. Premises
1. Premises for the processing of Category 3 material must not be at the same site as premises processing Category 1 or Category 2 material, unless in a completely separate building.
2. However, the competent authority may authorise the temporary use of a Category 3 processing plant for the processing of Category 1 or Category 2 material when a widespread outbreak of an epizootic disease or other extraordinary and unforeseeable circumstances lead to a lack of capacity at a Category 1 or Category 2 processing plant.
The competent authority must re-approve the Category 3 processing plant in accordance with Article 17 before it processes Category 3 material again.
3. Category 3 processing plants must have:
(a) an installation to check the presence of extraneous matter, such as packaging material, metallic pieces, etc. in the animal by-products; and
(b) if the volume of products treated requires regular or permanent presence of the competent authority, an adequately equipped lockable room for the exclusive use of the inspection service.
B. Raw material
4. Only Category 3 material listed in paragraph 1(a) to (j) of Article 6 that has been handled, stored and transported in accordance with Article 22 may be used for the production of processed animal proteins and other feed material.
5. Before processing, animal by-products must be checked for the presence of extraneous matter. When present, it must be removed immediately.
C. Processing standards
6. The critical control points that determine the extent of the heat treatments applied in processing must be identified for each processing method as specified in Annex V, Chapter III. The critical control points must at least include:
- raw material particle size,
- temperature achieved in the heat treatment process,
- pressure applied to the raw material, if applicable, and
- duration of the heat treatment process or feed rate to a continuous system.
Minimum process standards must be specified for each applicable critical control point.
7. Records must be maintained for at least two years to show that the minimum process values for each critical control point are applied.
8. Accurately calibrated gauges/recorders must be used to monitor continuously the processing conditions. Records must be kept for at least two years to show the date of calibration of gauges/recorders.
9. Material that may not have received the specified heat treatment (for example, material discharged at start up, or leakage from cookers) must be recirculated through the heat treatment or collected and reprocessed.
D. Processed products
10. Samples of the final products taken during or on withdrawal from storage at the processing plant must comply with the following standards:
Salmonella: absence in 25 g: n = 5, c = 0, m = 0, M = 0
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 g
where:
n= number of samples to be tested;
m= threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m;
M= maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more; and
c= number of samples the bacterial count of which may be between m and M, the sample still being considered acceptable if the bacterial count of the other samples is m or less.
CHAPTER II
Specific requirements for processed animal protein
The following conditions apply in addition to the general conditions laid down in Chapter I.
A. Processing standards
1. Mammalian processed animal protein must have been submitted to processing method 1.
2. Non-mammalian processed animal protein, with the exclusion of fishmeal, must have been submitted to any of processing methods 1 to 5 or 7.
3. Fishmeal must have been submitted:
(a) to any of the processing methods; or
(b) to a method and parameters which ensure that the product complies with the microbiological standards set in Chapter I, paragraph 10.
B. Storage
4. Processed animal protein must be packed and stored in new or sterilised bags or stored in properly constructed bulk bins.
5. Sufficient measures must be taken to minimise condensation inside bins, conveyors or elevators.
6. Products in conveyors, elevators and bins must be protected from casual contamination.
7. Processed animal protein handling equipment must be maintained in a clean and dry condition and should have adequate inspection points so that equipment can be examined for cleanliness. All storage facilities must be emptied and cleaned regularly, as production requirements require.
8. Processed animal protein must be kept dry. Leakages and condensation in the storage area must be prevented.
C. Importation
9. Member States must authorise the importation of processed animal protein:
(a) if it comes from third countries that appear on the list in Part II of Annex XI or, in the case of fishmeal, that appear on the list in Part III of Annex XI;
(b) if it comes from a processing plant that appears on the list referred to in Article 29(4);
(c) if it has been produced in accordance with this Regulation; and
(d) if it is accompanied by a health certificate as provided for in Article 29(6).
10. Before consignments are released for free circulation within the Community, the competent authority must sample imports of processed animal protein at the border inspection post to ensure compliance with the requirements of Chapter I, paragraph 10. The competent authority must:
(a) sample each consignment of products carried in bulk; and
(b) carry out random sampling of consignments of products packaged in the manufacturing plant of origin.
11. However, when six consecutive tests on bulk consignments originating in a given third country prove negative, the competent authority may carry out random sampling of subsequent bulk consignments from that third country. If one of these random samples proves positive, the competent authority carrying out the sampling must inform the competent authority of the country of origin so that it can take appropriate measures to remedy the situation. The competent authority of the country of origin must bring these measures to the attention of the competent authority carrying out the sampling. In the event of a further positive result from the same source, the competent authority must sample each consignment from the same source until six consecutive tests again prove negative.
12. Competent authorities must keep a record for at least two years of the results of sampling carried out on all consignments that have undergone sampling.
13. Where a consignment proves to be positive for salmonella, it must either:
(a) be dealt with in accordance with the procedure laid down by Article 17(2)(a) of Directive 97/78/EC(1); or
(b) reprocessed in a processing plant approved pursuant to this Regulation or decontaminated by a treatment authorised by the competent authority. A list of permitted treatments may be established in accordance with the procedure referred to in Article 33(2). The consignment must not be released until it has been treated, tested for salmonella by the competent authority in accordance with Chapter I, paragraph 10, and a negative result obtained.
CHAPTER III
Specific requirements for blood products
The following conditions apply in addition to the general conditions laid down in Chapter I.
A. Raw material
1. Only blood coming under paragraph 1(a) and (b) of Article 6 may be used for the production of blood products.
B. Processing standards
2. Blood products must have been submitted:
(a) to any of processing methods 1 to 5 or 7; or
(b) to a method and parameters which ensure that the product complies with the microbiological standards set in Chapter I, paragraph 10.
C. Importation
3. Member States must authorise the importation of blood products if they:
(a) come from third countries that appear on the list in Part V of Annex XI;
(b) come from a processing plant that appears on the list referred to in Article 29(4);
(c) have been produced in accordance with this Regulation; and
(d) are accompanied by a health certificate as provided for in Article 29(6).
CHAPTER IV
Specific requirements for rendered fats and fish oil
The following conditions apply in addition to the general conditions laid down in Chapter I.
A. Processing standards
1. Rendered fats derived from ruminant animals must be purified in such a way that the maximum levels of remaining total insoluble impurities does not exceed 0,15 % in weight.
B. Importation of rendered fats
2. Member States must authorise the importation of rendered fats if they:
(a) come from third countries appearing on the list in Part IV of Annex XI;
(b) come from a processing plant that appears on the list referred to in Article 29(4);
(c) have been produced in accordance with this Regulation;
(d) either:
(i) are entirely or partly derived from swine raw material and come from a country or a part of the territory of a country free from foot-and-mouth disease for the previous 24 months and free from classical swine fever and African swine fever for the previous 12 months,
(ii) are entirely or partly derived from poultry raw material and come from a country or a part of the territory of a country free from Newcastle disease and avian influenza for the previous six months,
(iii) are entirely or partly derived from ruminant raw material and come from a country or a part of the territory of a country free from foot-and-mouth disease for the previous 24 months and free from Rinderpest for the previous 12 months, or
(iv) where there has been an outbreak of one of the abovementioned diseases during the relevant period mentioned above, have been subjected to one of the following heat treatment processes:
- at least 70 °C for at least 30 minutes, or
- at least 90 °C for at least 15 minutes,
and details of the critical control points are recorded and maintained so that the owner, operator or their representative and, as necessary, the competent authority can monitor the operation of the plant. The information must include the particle size, critical temperature and, as appropriate, the absolute time, pressure profile, raw material feed-rate and fat recycling rate; and
(e) are accompanied by a health certificate as provided for in Article 29(6).
C. Importation of fish oil
3. Member States must authorise the importation of fish oil if it:
(a) comes from third countries appearing on the list in Part III of Annex XI;
(b) comes from a processing plant that appears on the list referred to in Article 29(4);
(c) has been produced in accordance with this Regulation; and
(d) is accompanied by a health certificate as provided for in Article 29(6).
D. Hygiene requirements
4. Where rendered fat or fish oil is packaged, it must be packaged in new containers or in containers that have been cleaned, and all precautions must be taken to prevent its recontamination. Where bulk transport of the products is intended, the pipe, pumps and bulk tanks and any other bulk container or bulk road tanker used in the transportation of the products from the manufacturing plant either directly on to the ship or into shore tanks or direct to plants must have been inspected and found to be clean before use.
CHAPTER V
Specific requirements for milk, milk-based products and colostrum
The following conditions apply in addition to the general conditions laid down in Chapter I.
A. Processing standards
1. Raw milk and colostrum must be produced under conditions offering adequate guarantees as regards animal health. Such conditions may be established in accordance with the procedure referred to in Article 33(2).
2. Milk or treated or processed milk products must be subjected to a heat treatment of at least 2 °C for at least 15 seconds or any combination of temperature and time having at least an equivalent heat effect and producing a negative reaction to the phosphatase test, followed by:
(a) in the case of dried milk or dried milk products, a drying process; or
(b) in the case of an acidified milk product, a process by which the pH is reduced and kept for at least one hour at a level below 6.
3. In addition to the requirements laid down in paragraph 2, dried milk or dried-milk products must meet the following requirements:
(a) after completion of the drying process, every precaution must be taken to prevent contamination of the products; and
(b) the final product must be:
(i) packed in new containers, or
(ii) in the case of bulk transport, transported in vehicles or containers that have been disinfected using a product approved by the competent authority before loading with the milk, milk-based product or colostrum.
B. Importation
4. Member States must authorise imports of milk and milk-based products if:
(a) they come from third countries appearing on the list in Part I of Annex XI;
(b) in the case of milk and milk-based products from third countries or parts of third countries listed in column B of the Annex to Decision 95/340/EC(2), they have undergone a pasteurisation treatment sufficient to produce a negative phosphatase test and a health certificate conforming to the model laid down in Chapter 2(A) of Annex X accompanies them;
(c) in the case of milk-based products with a pH reduced to less than 6 from third countries or parts of third countries listed in column C of the Annex to Decision 95/340/EC, they have first undergone a pasteurisation treatment sufficient to produce a negative phosphatase test and a health certificate conforming to the model laid down in Chapter 2(B) of Annex X accompanies them;
(d) in the case of milk and milk-based products from third countries or parts of third countries listed in column C of the Annex to Decision 95/340/EC, they have first undergone a sterilisation process or a double heat treatment where each treatment was sufficient to produce a negative phosphatase test on its own and a health certificate conforming to the model laid down in Chapter 2(C) of Annex X accompanies them; and
(e) they come from a processing plant which appears on the list referred to in Article 29(4).
5. Milk and milk-based products from third countries or parts of third countries listed in column C of the Annex to Decision 95/340/EC where there has been an outbreak of foot-and-mouth disease in the last 12 months or where vaccination against foot-and-mouth disease has been carried out in the last 12 months must, before introduction on to Community territory, have undergone either:
(a) a sterilisation process whereby an Fc value equal to or greater than 3 is achieved; or
(b) an initial heat treatment with a heating effect at least equal to that achieved by a pasteurisation process of at least 72 °C for at least 15 seconds and sufficient to produce a negative reaction to a phosphatase test, followed by:
(i) a second heat treatment with a heating effect at least equal to that achieved by the initial heat treatment, and which would be sufficient to produce a negative reaction to a phosphatase test, followed, in the case of dried milk, or dried milk-based products, by a drying process, or
(ii) an acidification process such that the pH has been maintained at less than 6 for at least one hour.
6. Where a risk of introduction of an exotic disease or any other risk to animal health is identified, additional conditions for the protection of animal health may be established in accordance with the procedure referred to in Article 33(2).
CHAPTER VI
Specific requirements for gelatin and hydrolysed protein
The following conditions apply in addition to the general conditions laid down in Chapter I.
A. Processing standards for gelatin
1. (a) Gelatin must be produced by a process that ensures that unprocessed Category 3 material is subjected to a treatment with acid or alkali, followed by one or more rinses. The pH must be adjusted subsequently. Gelatin must be extracted by heating one or several times in succession, followed by purification by means of filtration and sterilisation.
(b) After having been subjected to the processes referred to in subparagraph (a), gelatin may undergo a drying process and, where appropriate, a process of pulverisation or lamination.
(c) The use of preservatives, other than sulphur dioxide and hydrogen peroxide, is prohibited.
2. Gelatin must be wrapped, packaged, stored and transported under satisfactory hygiene conditions. In particular:
(a) a room must be provided for storing materials for wrapping and packaging;
(b) wrapping and packaging must take place in a room or in a place intended for that purpose;
and
(c) wrappings and packages containing gelatin must carry the words "gelatin suitable for animal consumption".
B. Processing standards for hydrolysed protein
3. Hydrolysed protein must be produced by a production process which involves appropriate measures to minimise contamination of raw Category 3 material. Preparation of the raw Category 3 material by brining, liming and intensive washing must be followed by:
(a) exposure of the material to a pH of more than 11 for more than three hours at a temperature of more than 80 °C and subsequently by heat treatment at more than 140 °C for 30 minutes at more than 3,6 bar;
(b) exposure of the material to a pH of 1 to 2, followed by a pH of more than 11, followed by heat treatment at 140 °C for 30 minutes at 3 bar; or
(c) an equivalent production process approved in accordance with the procedure referred to in Article 33(2).
C. Importation
4. Member States must authorise the importation of gelatin and hydrolysed proteins if they:
(a) come from third countries that appear on the list in Part XI of Annex X;
(b) come from a processing plant that appears on the list referred to in Article 29(4);
(c) have been produced in accordance with this Regulation; and
(d) are accompanied by a health certificate as provided for in Article 29(6).
CHAPTER VII
Specific requirements for dicalcium phosphate
The following conditions apply in addition to the general conditions laid down in Chapter I.
A. Processing standards
1. Dicalcium phosphate must be produced by a process that:
(a) ensures that all Category 3 bone-material is finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at a minimum concentration of 4 % and a pH of less than 1,5) over a period of at least two days;
(b) follows this with treatment of the obtained phosphoric liquor with lime, resulting in a precipitate of dicalcium phosphate at pH 4 to 7; and
(c) finally air dries this precipitate for 15 minutes, with inlet temperature of 270 to 325 °C and end temperature between 60 and 65 °C,
or by an equivalent process approved in accordance with the procedure referred to in Article 33(2).
B. Importation
2. Member States must authorise the importation of dicalcium phosphate if it:
(a) comes from third countries that appear on the list in Part XI of Annex X;
(b) comes from a processing plant that appears on the list referred to in Article 29(4);
(c) has been produced in accordance with this Regulation; and
(d) is accompanied by a health certificate as provided for in Article 29(6).
(1) Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (OJ L 24, 30.1.1998, p. 9).
(2) Commission Decision 95/340/EC of 27 July 1995 drawing up a provisional list of third countries from which Member States authorise imports of milk and milk-based products and revoking Decision 94/70/EC (OJ L 200, 24.8.1995, p. 38). Decision as last amended by Decision 96/584/EC (OJ L 255, 9.10.1996, p. 20).
ANNEX VIII
REQUIREMENTS FOR THE PLACING ON THE MARKET OF PETFOOD, DOGCHEWS AND TECHNICAL PRODUCTS
CHAPTER I
Requirements for the approval of petfood and technical plants
Plants producing petfood, dogchews and technical products, other than organic fertilizers, soil improvers and fat derivatives derived from Category 2 material, must fulfil the following requirements:
1. they must have adequate facilities for storing and treating incoming material in complete safety; and
2. they must have adequate facilities for disposing of unused animal by-products remaining after the production of the products in accordance with this Regulation, or this material must be sent to a processing plant or to an incineration or co-incineration plant in accordance with this Regulation.
CHAPTER II
Requirements for petfood and dogchews
A. Raw material
1. The only animal by-products that may be used to produce petfood and dogchews are those referred to in Article 6(1)(a) to (j). However, raw petfood may be manufactured only from animal by-products referred to in Article 6(1)(a).
B. Processing standards
2. Canned petfood must be subjected to heat treatment to a minimum Fc value of 3.
3. Processed petfood other than canned petfood must be subjected to a heat treatment of at least 90 °C throughout its substance. After treatment, every precaution must be taken to ensure that the product is not exposed to contamination. The product must be packed in new packaging.
4. Dogchews must be subjected to a heat treatment during processing sufficient to destroy pathogenic organisms (including salmonella). After treatment, every precaution must be taken to ensure that the product is not exposed to contamination. The product must be packed in new packaging.
5. Raw petfood must be packed in new packaging preventing any leakage. Effective steps must be taken to ensure that the product is not exposed to contamination throughout the production chain and up to the point of sale. The wording "petfood only" must be visibly and legibly displayed on the packaging.
6. Random samples must be taken during production and/or during storage (before dispatching) to verify compliance with the following standards:
Salmonella: absence in 25 g: n = 5, c = 0, m = 0, M = 0
where:
n= number of samples to be tested;
m= threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m;
M= maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more; and
c= number of samples the bacterial count of which may be between m and M, the sample still being considered acceptable if the bacterial count of the other samples is m or less.
C. Importation
7. Member States must authorise importation of petfood and dogchews if they:
(a) come from third countries that appear on the list in Part X of Annex XI;
(b) come from petfood plants approved by the competent authority of the third country meeting the specific conditions laid down in this Regulation;
(c) have been produced in accordance with this Regulation;
(d) are accompanied:
(i) in the case of canned petfood, by a certificate that conforms to the model laid down in Chapter 3(A) of Annex X,
(ii) in the case of processed petfood other than canned petfood, by a certificate that conforms to the model laid down in Chapter 3(B) of Annex X,
(iii) in the case of dogchews, by a certificate that conforms to the model laid down in Chapter 3(C) of Annex X, or
(iv) in the case of raw petfood, by a certificate that conforms to the model laid down in Chapter 3(D) of Annex X.
CHAPTER III
Requirements for manure, processed manure and processed manure products
I. Unprocessed manure
A. Trade
1. (a) Trade in unprocessed manure of species other than poultry or equidae is prohibited, except for manure:
(i) from an area which is not subject to restrictions by virtue of a serious transmissible disease, and
(ii) intended for application, under the supervision of the competent authorities, to land forming part of a single holding located on both sides of the border of two Member States.
(b) However, the competent authority may grant specific approval for the introduction on to its territory of:
(i) manure intended for processing in a technical plant or a biogas plant or in a composting plant approved by the competent authority in accordance with this Regulation with a view to the manufacture of the products referred to under Section II below. The competent authority must take account of the origin of the manure when approving such plants; or
(ii) manure intended for applying to land on a holding. Such trade can only occur with the consent of the competent authorities of both the Member States of origin and destination. When considering giving consent, the competent authorities must have particular regard to the origin of the manure, its destination and animal health and safety considerations.
A health certificate conforming to a model laid down under the procedure referred to in Article 33(2) must accompany the manure in such cases.
2. Trade in unprocessed poultry manure is subject to the following conditions:
(a) the manure must originate in an area which is not subject to restrictions by virtue of Newcastle disease or avian influenza;
(b) in addition, unprocessed manure from poultry flocks vaccinated against Newcastle disease must not be dispatched to a region which has obtained Newcastle disease non-vaccinating status pursuant to Article 15(2) of Directive 90/539/EEC(1); and
(c) a health certificate conforming to a model laid down under the procedure referred to in Article 33(2) must accompany the manure.
3. Trade in unprocessed manure of equidae is not subject to any animal health conditions.
B. Importation
4. Member States must authorise the importation of unprocessed manure if it:
(a) comes from third countries that appear on the list in Part IX of Annex XI;
(b) satisfies, according to the species concerned, the requirements of paragraph 1(a);
(c) is accompanied by a health certificate as provided for in Article 29(6).
II. Processed manure and processed manure products
A. Placing on the market
5. The placing on the market of processed manure and processed manure products is subject to the following conditions:
(a) they must come from a technical plant, a biogas plant or a composting plant approved by the competent authority in accordance with this Regulation;
(b) they must have been subjected to a heat treatment process of at least 70 °C for at least 60 minutes or to an equivalent treatment in accordance with rules laid down under the procedure referred to in Article 33(2);
(c) they must:
(i) be free from salmonella (no salmonella in 25 g treated product),
(ii) be free from enterobacteriaceae (based on the aerobic bacteria count: < 1000 cfu per gram of treated products), and
(iii) have been subjected to reduction in spore-forming bacteria and toxic formation; and
(d) they must be stored in such a way that, once processed, contamination or secondary infection and dampness is impossible. They must therefore be stored in:
(i) well-sealed and insulated silos, or
(ii) properly sealed packs (plastic bags or "big bags").
B. Importation
6. Member States must authorise importation of processed manure and processed manure products if they:
(a) come from third countries that appear on the list in Part IX of Annex XI;
(b) come from a plant approved by the competent authority of the third country meeting the specific conditions laid down in this Regulation;
(c) satisfy the requirements of paragraph 5 above; and
(d) are accompanied by a health certificate as provided for in Article 29(6).
III. Guano
7. The placing on the market of "guano" is not subject to any animal health conditions.
CHAPTER IV
Requirements for blood and blood products used for technical purposes, including pharmaceuticals, in vitro diagnosis and laboratory agents, but excluding serum of equidae
A. Placing on the market
1. The placing on the market of blood products covered by this Chapter is subject to the requirements laid down in Article 20.
B. Importation
2. Imports of blood are subject to the requirements laid down in Chapter XI.
3. Member States must authorise importation of blood products if they:
(a) come from third countries that appear on the list in Part VI of Annex XI;
(b) come from a plant approved by the competent authority of the third country meeting the specific conditions laid down in this Regulation; and
(c) are accompanied by a health certificate as provided for in Article 29(6); and either
(d) originate in a third country in which no case of foot-and-mouth disease has been recorded within at least 24 months and no case of vesicular stomatitis, swine vesicular disease, rinderpest, peste des petits ruminants, Rift Valley Fever, blue tongue, African horse sickness, classical swine fever, African swine fever, Newcastle disease or avian influenza has been recorded for 12 months in the susceptible species and in which vaccination has not been carried out against those diseases for at least 12 months. The health certificate may be made out according to the species of animal from which the blood products are derived; or
(e) in the case of blood products derived from bovine animals:
(i) originate in an area of a third country fulfilling the requirements of subparagraph (d) from which imports of bovine animals, their fresh meat or their sperm are authorised pursuant to Community legislation. The blood from which such products are manufactured must be from bovine animals from that area of the third country and must have been collected:
- in slaughterhouses approved in accordance with Community legislation,
or
- in slaughterhouses approved and supervised by the competent authority of the third country. The Commission and Member States must be notified of the address and approval number of such slaughterhouse or the certificate must indicate them;
(ii) have undergone one of the following treatments guaranteeing the absence of pathogens of the bovine diseases referred to in subparagraph (d):
- heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check,
- irradiation at 2,5 megarads or by gamma rays, followed by an effectiveness check,
- change in pH to pH 5 for two hours, followed by an effectiveness check,
- heat treatment of at least 90 °C throughout their substance, followed by an effectiveness check, or
- any other treatment provided for in accordance with the procedure referred to in Article 33(2); or
(iii) fulfil the requirements laid down in Chapter X. In this case, the packaging may not be opened during storage and the technical plant must carry out one of the treatments listed in point (ii).
4. The specific conditions relating to imports of products for use in in vitro diagnosis and laboratory reagents may be laid down, where necessary, under the procedure referred to in Article 33(2).
CHAPTER V
Requirements for serum of equidae
A. Raw material
1. Serum must:
(a) come from equidae which show no signs of the serious transmissible diseases referred to in Directive 90/426/EEC(2) or of any other serious transmissible disease to which equidae are susceptible; and
(b) have been obtained in bodies or centres not subject to health restrictions pursuant to that Directive.
B. Importation
2. Member States must authorise the import of serum of equidae if:
(a) it comes from equidae born and raised in a third country from which the importation of horses for slaughter is authorised;
(b) it was obtained, processed and dispatched in conformity with the following conditions:
(i) it comes from a country where the following diseases are compulsorily notifiable: African horse sickness, dourine, glanders, equine encephalomyelitis (all types including VEE), equine infectious anaemia, vesicular stomatitis, rabies, anthrax;
(ii) it was obtained, under the supervision of a veterinarian, from equidae which, at the time of collection, were free from clinical signs of infectious disease;
(iii) it was obtained from equidae that have remained since birth in the territory or, in case of official regionalisation according to Community legislation, in parts of the territory of a third country in which:
- Venezuelan equine encephalomyelitis had not occurred during the last two years,
- dourine had not occurred during the last six months, and
- glanders had not occurred during the last six months;
(iv) it was obtained from equidae that had never been present on a holding that had been subject to prohibition for animal health reasons or where:
- in the case of equine encephalomyelitis, the date on which all the equidae suffering from the disease were slaughtered was at least six months before the date of collection,
- in the case of infectious anaemia, all the infected animals had been slaughtered and the remaining animals showed a negative reaction to two Coggins tests carried out three months apart,
- in the case of vesicular stomatitis, the prohibition was lifted at least six months before the date of collection,
- in the case of rabies, the last recorded case was at least a month before the date of collection,
- in the case of anthrax, the last recorded case was at least 15 days before the date of collection, or
- all the animals of species susceptible to the disease located on the holding were slaughtered and the premises disinfected, at least 30 days before the date of collection (or, in the case of anthrax, at least 15 days before);
(v) it has undergone all precautions to avoid contamination with pathogenic agents during production, handling and packaging;
(vi) it was packed in sealed impermeable containers clearly labelled "serum from equidae" and bearing the registration number of the establishment of collection;
(c) it comes from a plant approved by the competent authority of the third country meeting the specific conditions laid down in this Regulation; and
(d) a certificate conforming to the model laid down in Chapter 4 of Annex X accompanies it.
CHAPTER VI
Requirements for hides and skins of ungulates
A. Scope
1. The provisions of this Chapter do not apply:
(a) to hides and skins of ungulates fulfilling the requirements of Council Directive 64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat(3);
(b) to hides and skins of ungulates having undergone the complete process of tanning;
(c) to "wet blue";
(d) to "pickled pelts"; and
(e) to limed hides (treated with lime and in brine at a pH of 12 to 13 for at least eight hours).
2. Within the scope defined in paragraph 1, the provisions of this Chapter apply to fresh, chilled and treated hides and skins. For the purpose of this Chapter, "treated hides and skins" means hides and skins that have been:
(a) dried;
(b) dry-salted or wet-salted for at least 14 days prior to dispatch;
(c) salted for seven days in sea salt with the addition of 2 % of sodium carbonate;
(d) dried for 42 days at a temperature of at least 20 °C; or
(e) preserved by a process other than tanning specified in accordance with the procedure referred to in Article 33(2).
B. Trade
3. Trade in fresh or chilled hides and skins is subject to the same health conditions as those applicable to fresh meat pursuant to Council Directive 72/461/EEC of 12 December 1972 on health problems affecting intra-Community trade in fresh meat(4).
4. Trade in treated hides and skins is authorised on condition that the commercial document provided for in Annex II accompanies each consignment and attests that:
(a) the hides and skins have been treated in accordance with paragraph 2; and
(b) the consignment has not been in contact with other animal products or live animals presenting a risk of spreading a serious transmissible disease.
C. Importation
5. Member States must authorise the import of fresh or chilled hides and skins if:
(a) they have been obtained from animals referred to in Article 6(1)(b) or (c);
(b) they originate from a third country or, in the case of regionalisation in accordance with Community legislation, from a part of a third country from which imports of all categories of fresh meat of the corresponding species are authorised and which:
(i) for at least 12 months before dispatch, has been free from the following diseases:
- classical swine fever,
- African swine fever, and
- rinderpest, and
(ii) has been free for at least 24 months before dispatch from foot-and-mouth disease and where, for 12 months before dispatch, no vaccination has been carried out against foot-and-mouth disease;
(c) they have been obtained from:
(i) animals that have remained in the territory of the country of origin for at least three months before being slaughtered or since birth in the case of animals less that three months old,
(ii) in the case of hides and skins from bi-ungulates, animals that come from holdings in which there has been no outbreak of foot-and-mouth disease in the previous 30 days, and around which within a radius of 10 km there has been no case of foot-and-mouth disease for 30 days,
(iii) in the case of hides and skins from swine, animals that come from holdings in which there has been no outbreak of swine vesicular disease in the previous 30 days, or of classical or African swine fever in the previous 40 days, and around which within a radius of 10 km there has been no case of these diseases for 30 days, or
(iv) animals that have passed the ante-mortem health inspection at the slaughterhouse during the 24 hours before slaughter and have shown no evidence of foot-and-mouth disease, rinderpest, classical swine fever, African swine fever or swine vesicular disease;
(d) they have undergone all precautions to avoid recontamination with pathogenic agents; and
(e) a certificate conforming to the model laid down in Chapter 5(A) of Annex X accompanies them.
6. Member States must authorise the import of treated hides and skins if:
(a) they have been obtained from animals referred to in Article 6(1)(b), (c) or (k);
(b) a certificate conforming to the model laid down in Chapter 5(B) of Annex X accompanies them;
(c) they come either:
(i) from animals originating in a region of a third country or in a third country not subject, pursuant to Community legislation, to restrictions as a result of an outbreak of a serious transmissible disease to which the animals of the species concerned are susceptible and they have been treated in accordance with paragraph 2, or
(ii) from animals originating from other regions of a third country or other third countries and they have been treated in accordance with paragraph 2(c) or (d), or
(iii) from ruminant animals and have been treated in accordance with paragraph 2 and have been kept separate for 21 days or have undergone transport for 21 uninterrupted days. In this case, the certificate referred to in subparagraph (b) is replaced by a declaration conforming to the model laid down in Chapter 5(C) of Annex X, to the effect that or proving that those requirements have been met;
(d) in the case of salted hides and skins transported by ship, the hides have been salted before importation for the duration stated in the certificate accompanying the consignment; and
(e) the consignment has not been in contact with other animal products or with live animals presenting a risk of spreading a serious transmissible disease.
7. Fresh, chilled or treated hides and skins of ungulates must be imported in containers, road vehicles, railway wagons or bales sealed by the competent authority of the third country of dispatch.
CHAPTER VII
Requirements for game trophies
A. Raw material
1. Without prejudice to the measures adopted pursuant to Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein(5), game trophies:
(a) of ungulates and birds having undergone a complete taxidermy treatment ensuring their preservation at ambient temperatures; and
(b) of species other than ungulates and birds,
are not subject to any ban or restriction for reasons of animal health.
2. Without prejudice to the measures adopted pursuant to Regulation (EC) No 338/97, game trophies of ungulates and birds not having undergone the treatment mentioned in paragraph 1(a) are subject to the following conditions. They must:
(a) come from animals originating in an area not subject to restrictions as a result of the presence of serious transmissible diseases to which animals of the species concerned are susceptible; or
(b) comply with the conditions laid down in paragraphs 3 or 4 if they come from animals originating in an area subject to restrictions as a result of the presence of serious transmissible diseases to which animals of the species concerned are susceptible.
3. In respect of game trophies consisting solely of bone, horns, hooves, claws, antlers or teeth, the trophies must:
(a) have been immersed in boiling water for an appropriate time so as to ensure that any matter other than bone, horns, hooves, claws, antlers or teeth is removed;
(b) have been disinfected with a product authorised by the competent authority, in particular with hydrogen peroxide where parts consisting of bone are concerned;
(c) be packaged, immediately after treatment, without being in contact with other products of animal origin likely to contaminate them, in individual, transparent and closed packages so as to avoid any subsequent contamination; and
(d) be accompanied by a document or certificate certifying that the above conditions have been met.
4. In respect of game trophies consisting solely of hides or skin, the trophies must:
(a) have been either:
(i) dried, or
(ii) dry- or wet-salted for a minimum of 14 days before dispatch, or
(iii) preserved by a treatment other that tanning approved in accordance with the procedure referred to in Article 33(2);
(b) be packaged, immediately after treatment, without being in contact with other products of animal origin likely to contaminate them, in individual, transparent and closed packages so as to avoid any subsequent contamination; and
(c) be accompanied by a document or certificate certifying that the above conditions have been met.
B. Importation
5. Member States must authorise the importation of treated game trophies from birds and ungulates, being solely bones, horns, hooves, claws, antlers, teeth, hides or skins, from third countries if:
(a) a certificate that conforms to the model laid down in Chapter 6(A) of Annex X accompanies them; and
(b) they comply with the requirements of paragraphs 3 and 4. However, in the case of dry-salted or wet-salted skins transported by ship, the skins need not be salted 14 days before dispatch, provided that they are salted for 14 days before importation.
6. Member States must, in accordance with the requirements of paragraph 7, authorise the importation of game trophies from birds and ungulates consisting of entire anatomical parts, not having been treated in any way, from third countries:
(a) that appear in one of the lists in the Annex to Commission Decision 94/86/EC of 16 February 1994 drawing up a provisional list of third countries from which Member States authorise imports of wild game meat(6); and
(b) from which the importation of all categories of fresh meat of the corresponding species is authorised.
7. Member States must authorise importation of the game trophies referred to in paragraph 6 if:
(a) they come from animals originating in an area not subject to restrictions as a result of the presence of serious transmissible diseases to which animals of the species concerned are susceptible;
(b) they were packaged, immediately after treatment, without being in contact with other products of animal origin likely to contaminate them, in individual, transparent and closed packages so as to avoid any subsequent contamination; and
(c) a certificate conforming to the model laid down in Chapter 6(B) of Annex X accompanies them.
CHAPTER VIII
Requirements for wool, hair, pig bristles, feathers and parts of feathers
A. Raw material
1. Unprocessed wool, unprocessed hair, unprocessed pig bristles and unprocessed feathers and parts of feathers must have been obtained from animals referred to in Article 6(1)(c) or (k). They must be securely enclosed in packaging and dry. However, movements of pig bristles from regions in which African swine fever is endemic are prohibited except for pig bristles that have:
(a) been boiled, dyed or bleached; or
(b) undergone some other form of treatment which is certain to kill pathogenic agents, provided that evidence to this effect is submitted in the form of a certificate from the veterinarian responsible for the place of origin. Factory washing may not be regarded as a form of treatment for the purposes of this provision.
2. The provisions of paragraph 1 do not apply to decorative feathers or feathers:
(a) carried by travellers for their private use; or
(b) in the form of consignments sent to private individuals for non-industrial purposes.
B. Importation
3. Member States must authorise the importation of pig bristles from third countries or, in case of regionalisation according to Community legislation, regions thereof, if:
(a) the pig bristles were obtained from animals originating, and slaughtered in a slaughterhouse, in the country of origin; and
(b) either:
(i) where no case of African swine fever has occurred during the previous 12 months, a certificate conforming to the model laid down in Chapter 7(A) of Annex X accompanies the consignment; or
(ii) where one or more cases of African swine fever have occurred during the previous 12 months, a certificate conforming to the model laid down in Chapter 7(B) of Annex X accompanies the consignment.
4. Member States must authorise the importation of unprocessed wool, hair, feathers and parts of feathers if they are:
(a) securely enclosed in packaging and dry; and
(b) sent directly to the technical plant or to an intermediate plant in conditions such that any spread of pathogenic agents is avoided.
CHAPTER IX
Requirements for apiculture products
A. Raw material
1. Apiculture products intended exclusively for use in apiculture must:
(a) not come from an area which is the subject of a prohibition order associated with an occurrence of American foulbrood or acariosis if, in the case of acariosis, the area of destination has obtained additional guarantees in accordance with Article 14(2) of Directive 92/65/EEC(7); and
(b) meet the requirements imposed by Article 8(a) of Directive 92/65/EEC.
Any derogation must be established, as necessary, in accordance with the procedure referred to in Article 33(2).
B. Importation
2. Member States must authorise the importation of apiculture products intended for use in apiculture if:
(a) the commercial document accompanying the consignment includes the following information:
(i) the country of origin,
(ii) the name of the establishment of production,
(iii) the registration number of the establishment of production,
(iv) the nature of the products, and
(v) the indication: "Apiculture products intended exclusively for use in apiculture originating from a holding not subject to restrictions because of occurrence of bee diseases and collected in the centre of a region with a radius of 3 kilometres which is not subjected to restrictions because of American foulbrood, which is a notifiable disease, for at least 30 days."; and
(b) the competent authority supervising the registered establishment of production has stamped the commercial document.
CHAPTER X
Requirements for bones and bone products (excluding bone meal), horns and horn products (excluding horn meal) and hooves and hoof products (excluding hoof meal) intended for use other than as feed material, organic fertilizers or soil improvers
1. Member States must authorise the importation of bones and bone products (excluding bone meal), horns and horn products (excluding horn meal) and hooves and hoof products (excluding hoof meal) to produce technical products if:
(a) the products are dried before export and not chilled or frozen;
(b) the products are conveyed only by land and sea from their country of origin direct to a border inspection post in the Community and are not transhipped at any port or place outside the Community;
(c) following the document checks provided for in Directive 97/78/EC, the products are conveyed directly to the technical plant.
2. Each consignment must be accompanied by:
(a) a commercial document stamped by the competent authority supervising the establishment of origin, including the following information:
(i) the country of origin,
(ii) the name of the establishment of production,
(iii) the nature of the product (dried bone/dried bone product/dried horns/dried horn products/dried hooves/dried hoof products), and
(iv) the fact that the product was:
- derived from healthy animals slaughtered in a slaughterhouse, or
- dried for 42 days at an average temperature of at least 20 °C, or
- heated for one hour to at least 80 °C to the core before drying, or
- ashed for one hour to at least 80 °C to the core before drying, or
- underwent an acidification process such that the pH was maintained at less than 6 to the core for at least one hour before drying, and
is not intended at any stage to be diverted for any use in food, feed material, organic fertilizers or soil improvers; and
(b) the following declaration of the importer which must be in at least one official language of the Member State through which the consignment first enters the Community and in at least one official language of the Member State of destination:
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3. On dispatch to the Community territory, the material must be enclosed in sealed containers or vehicles or carried in bulk in a ship. If transported in containers, the containers, and in all cases all the accompanying documents, must bear the name and the address of the technical plant.
4. Following the border check provided for in Directive 97/78/EC, and in accordance with the rules laid down in Article 9(4) of that Directive, the material must be transported direct to the technical plant.
5. Records must be kept of the quantity and nature of the material, during manufacture, in such a way as to ensure that the material has actually been used for the intended purposes.
CHAPTER XI
Animal by-products for the manufacture of petfood and pharmaceutical and other technical products
Member States must authorise the importation of animal by-products intended for the manufacture of petfood, pharmaceutical products and other technical products if:
1. they come from third countries which appear on the list in Part VII of Annex XI;
2. they consist only of animal by-products referred to in Article 6(1)(a);
3. they have been deep frozen at the plant of origin;
4. they have undergone all precautions to avoid recontamination with pathogenic agents;
5. they were packed in new packaging preventing any leakage;
6. a certificate conforming to the model laid down in Chapter 8 of Annex X accompanies them; and
7. following the border check provided for in Directive 97/78/EC, and in accordance with the rules laid down in Article 9(4) of that Directive, they are transported either:
(a) directly to a petfood or technical plant, which has given the guarantee that the animal by-products will be used only for the permitted purpose and will not leave the plant untreated; or
(b) to an intermediate plant.
CHAPTER XII
Rendered fats for oleochemical purposes
Member States must authorise the importation of rendered fat intended to be processed by a method that at least meets the standards of one of the processes described in Annex VI, Chapter III, if:
1. the product is conveyed only by land and sea from the country of origin direct to a border inspection post in the Community;
2. following the document checks provided for in Directive 97/78/EC, and in accordance with the rules laid down in Article 9(4) of that Directive, the products are conveyed to the oleochemical plant where they will be processed;
3. a declaration made by the importer accompanies each consignment. This declaration must state that products imported in accordance with this Chapter will not be diverted for any use other than further processing by a method which at least meets the standards of one of the processes described in Annex VI, Chapter III. This declaration must be presented to, and annotated by, the competent authority at the border inspection post at the first point of entry of the goods into the Community, and thereafter accompany the consignment up to the oleochemical plant.
(1) Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of poultry and hatching eggs (OJ L 303, 31.10.1990, p. 6). Directive as last amended by Commission Decision 2000/505/EC (OJ L 201, 9.8.2000, p. 8).
(2) Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of equidae (OJ L 224, 18.8.1990, p. 42). Directive as last amended by Commission Decision 2001/298/EC (OJ L 102, 12.4.2001, p. 63).
(3) OJ 121, 29.7.1964, p. 2012. Directive as last amended by Directive 95/23/EC (OJ L 243, 11.10.1995, p. 7).
(4) OJ L 302, 31.12.1972, p. 24. Directive last amended by the 1994 Act of Accession.
(5) OJ L 61, 3.3.1997, p. 1. Regulation as last amended by Commission Regulation No 1579/2001 (OJ L 209, 2.8.2001, p. 14).
(6) OJ L 44, 17.2.1994, p. 33.
(7) Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54). Directive as last amended by Commission Decision 2001/298/EC (OJ L 102, 12.4.2001, p. 63).
ANNEX IX
RULES APPLICABLE TO THE USE OF CERTAIN CATEGORY 2 AND CATEGORY 3 MATERIAL FOR THE FEEDING OF CERTAIN ANIMALS IN ACCORDANCE WITH ARTICLE 23(2)
1. This Annex applies only to users and collection centres authorised and registered pursuant to Article 23(2)(c)(iv), (vi) and (vii). For the purposes of this Annex, "relevant material" means the animal by-products specified in Article 23(2)(b) and products derived therefrom.
2. Relevant material must be transported to the users or to collection centres in accordance with Annex II.
3. Collection centres must:
(a) comply at least with the following requirements of Annex V:
(i) Chapter I, paragraphs 1(a), (b), (c), (d) and (f), 2, 3 and 4, and
(ii) Chapter II, paragraphs 1, 2, 4, 5 and 9; and
(b) have adequate facilities for destroying unused unprocessed relevant material, or send it to a processing plant or to an incineration or co-incineration plant in accordance with this Regulation.
Member States may authorise the use of a Category 2 processing plant as a collection centre.
4. In addition to the records required in accordance with Annex II, the following records must be kept in relation to relevant material:
(a) in the case of final users, the quantity used and the date of use; and
(b) in the case of collection centres:
(i) the quantity treated in accordance with paragraph 5;
(ii) the name and address of each final user buying the material;
(iii) the premises to which the material is taken for use;
(iv) the quantity dispatched; and
(v) the date on which the material was dispatched.
5. Operators of collection centres supplying relevant material other than fish offal to final users, must ensure that:
(a) it undergoes one of the following treatments (either in the collection centre or in a slaughterhouse approved by the competent authority in accordance with Community legislation):
(i) denaturing with a solution of a colouring agent approved by the competent authority. The solution must be of such a strength that the colouring on the stained material is clearly visible, and the whole surface of all pieces of material have been covered with a solution as aforesaid either by immersing the material in, or spraying or otherwise applying the solution;
(ii) sterilisation, that is to say boiling or steaming under pressure until every piece of material is cooked throughout; or
(iii) any other treatment approved by the competent authority; and
(b) it is packaged after treatment and before distribution in packaging that is clearly and legibly marked with the name and the address of the collection centre and the indication "not for human consumption".
ANNEX X
MODEL HEALTH CERTIFICATES FOR THE IMPORTATION FROM THIRD COUNTRIES OF CERTAIN ANIMAL BY-PRODUCTS AND PRODUCTS DERIVED THEREFROM
CHAPTER 1
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CHAPTER 2(A)
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CHAPTER 2(B)
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CHAPTER 2(C)
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CHAPTER 3(A)
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CHAPTER 3(B)
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CHAPTER 3(C)
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CHAPTER 3(D)
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CHAPTER 4
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CHAPTER 5(A)
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CHAPTER 5(B)
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CHAPTER 5(C)
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CHAPTER 6(A)
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CHAPTER 6(B)
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CHAPTER 7(A)
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CHAPTER 7(B)
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CHAPTER 8
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ANNEX XI
LISTS OF THIRD COUNTRIES FROM WHICH MEMBER STATES MAY AUTHORISE IMPORTS OF ANIMAL BY-PRODUCTS NOT INTENDED FOR HUMAN CONSUMPTION
The inclusion of a country on one of the following lists is a necessary, but not sufficient, condition for the importation of relevant products from that country. Imports must also fulfil the relevant animal health and public health requirements.
PART I
List of third countries from which Member States may authorise imports of milk and milk-based products
Third countries listed in column B or column C of the Annex to Decision 95/340/EC.
PART II
List of third countries from which Member States may authorise imports of processed animal proteins (excluding fishmeal)
Third countries listed in Part I of the Annex to Decision 79/542/EEC.
PART III
List of third countries from which Member States may authorise imports of fishmeal and fishoil
Third countries listed in the Annex to Decision 97/296/EC.
PART IV
List of third countries from which Member States may authorise imports of rendered fats (excluding fishoil)
Third countries listed in Part I of the Annex to Decision 79/542/EEC.
PART V
List of third countries from which Member States may authorise imports of blood products for feed material
A. Blood products from ungulates
Third countries or parts of countries listed in Part I of the Annex to Decision 79/542/EEC from which imports of all categories of fresh meat of the respective species are authorised.
B. Blood products from other species
Third countries listed in Part I of the Annex to Decision 79/542/EEC.
PART VI
List of third countries from which Member States may authorise imports of blood products (with the exception of equidae) intended for technical and pharmaceutical uses
A. Blood products from ungulates
Third countries or parts of countries listed in Part I of the Annex to Decision 79/542/EEC from which imports of all categories of fresh meat of the respective species are authorised.
B. Blood products from other species
Third countries listed in Part I of the Annex to Decision 79/542/EEC.
PART VII
List of third countries from which Member States may authorise imports of unprocessed material for the manufacture of petfood and technical products
A. Unprocessed material from bovine, ovine, caprine, porcine and equine animals
Third countries or parts of countries listed in Part I of the Annex to Decision 79/542/EEC from which imports of all categories of fresh meat of the respective species are authorised.
B. Unprocessed material from poultry
Third countries from which Member States authorise imports of fresh poultrymeat.
C. Unprocessed material from other species
Third countries listed in Part I of the Annex to Decision 79/542/EEC.
PART VIII
List of third countries from which Member States may authorise imports of untreated pig bristles
Third countries listed in Part I of the Annex to Decision 79/542/EEC.
PART IX
List of third countries from which Member States may authorise imports of manure for treatment of the soil
A. Processed manure products
Third countries listed in Part I of the Annex to Decision 79/542/EEC.
B. Processed manure from equidae
Third countries listed in Part I of the Annex to Decision 79/542/EEC for live equidae.
C. Unprocessed manure from poultry
Third countries from which Member States authorise imports of fresh poultrymeat.
PART X
List of third countries from which Member States may authorise imports of petfood and dogchews
Third countries listed in Part I of the Annex to Decision 79/542/EEC, and the following countries:
(LK) Sri Lanka(1)
(JP) Japan(2)
(TW) Taiwan(3).
PART XI
List of third countries from which Member States may authorise imports of gelatin, hydrolysed protein and dicalcium phosphate
Third countries listed in Part I of the Annex to Decision 79/542/EEC, and the following countries:
(KR) The Republic of Korea(4)
(MY) Malaysia(5)
(PK) Pakistan(6)
(TW) Taiwan(7).
(1) Dogchews made from hides and skins of ungulates only.
(2) Processed petfood for ornamental fish only.
(3) Processed petfood for ornamental fish only.
(4) Gelatin only.
(5) Gelatin only.
(6) Gelatin only.
(7) Gelatin only.