Regulation (EC) No 1774/2002 of the European Parliament and of the Council (repealed)Show full title

ANNEX V U.K. GENERAL HYGIENE REQUIREMENTS FOR THE PROCESSING OF CATEGORY 1, 2 AND 3 MATERIAL

CHAPTER I U.K. General requirements for the approval of Category 1, 2 and 3 processing plants

1. Premises and facilities must meet at least the following requirements: U.K.

(a)

[F1 Processing plants shall not be situated on the same site as slaughterhouses, unless the risks to public and animal health, resulting from the processing of animal by-products which originate from such slaughterhouses, are mitigated by compliance with at least the following conditions:

(i)

the processing plant must be physically separated from the slaughterhouse; where appropriate by locating the processing plant in a building that is completely separated from the slaughterhouse;

(ii)

the following must be installed and operated:

• a conveyer system which links the processing plant to the slaughterhouse,

• separate entrances, reception bays, equipment and exits for the processing plant and the slaughterhouse;

(iii)

measures must be taken to prevent the spreading of risks through the operation of personnel which is employed in the processing plant and in the slaughterhouse;

(iv)

unauthorised persons and animals must not have access to the processing plant.

By way of derogation from points (i) to (iv), in the case of Category 3 processing plants, the competent authority may authorise other conditions instead of those set out in those points, aimed at mitigating the risks to public and animal health, including the risks arising from the processing of Category 3 material, which originates from off-site establishments approved under Regulation (EC) No 853/2004. Member States shall inform the Commission and the other Member States in the framework of the Committee referred to in Article 33(1) of the use made of this derogation by their competent authorities;]

(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.

Textual Amendments

F1 Substituted by Commission Regulation (EC) No 777/2008 of 4 August 2008 amending Annexes I, V and VII to Regulation (EC) No 1774/2002 of the European Parliament and of the Council laying down health rules concerning animal by-products not intended for human consumption (Text with EEA relevance).

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. U.K.

3. Adequate facilities must be provided for the disinfecting of vehicle wheels, on leaving the unclean sector of the processing plant. U.K.

4. All processing plants must have a waste-water disposal system meeting the competent authority's requirements. U.K.

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. U.K.

CHAPTER II U.K. General hygiene requirements

1. Animal by-products must be processed as soon as possible after arrival. They must be stored properly until processed. U.K.

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. U.K.

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. U.K.

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). U.K.

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. U.K.

6. Cleaning procedures must be established and documented for all parts of the premises. Suitable equipment and cleaning agents must be provided for cleaning. U.K.

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. U.K.

8. Installations and equipment must be kept in a good state of repair and measuring equipment must be calibrated at regular intervals. U.K.

9. Processed products must be handled and stored at the processing plant in such a way as to preclude recontamination. U.K.

CHAPTER III U.K. Processing methods

Method 1 U.K.

Reduction U.K.

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. U.K.

Time, temperature and pressure U.K.

2. After reduction the animal by-products must be heated to a core temperature of more than 133 ^oC 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. U.K.

3. The processing may be carried out in batch or continuous systems. U.K.

Method 2 U.K.

Reduction U.K.

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. U.K.

Time, temperature and pressure U.K.

2. After reduction the animal by-products must be heated to a core temperature greater than 100 ^oC for at least 125 minutes, a core temperature greater than 110 ^oC for at least 120 minutes and a core temperature greater that 120 ^oC for at least 50 minutes. U.K.

3. The processing must be carried out in a batch system. U.K.

[F2 4. The animal by-products may be cooked in such a manner that the time-temperature requirements are achieved at the same time.] U.K.

Textual Amendments

F2 Substituted by Commission Regulation (EC) No 808/2003 of 12 May 2003 amending Regulation (EC) No 1774/2002 of the European Parliament and of the Council laying down health rules concerning animal by-products not intended for human consumption (Text with EEA relevance).

Method 3 U.K.

Reduction U.K.

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. U.K.

Time, temperature and pressure U.K.

2. After reduction the animal by-products must be heated to a core temperature greater than 100 ^oC for at least 95 minutes, a core temperature greater than 110 ^oC for at least 55 minutes and a core temperature greater that 120 ^oC for at least 13 minutes. U.K.

3. The processing may be carried out in batch or continuous systems. U.K.

4. The animal by-products may be cooked in such a manner that the time-temperature requirements are achieved at the same time. U.K.

Method 4 U.K.

Reduction U.K.

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. U.K.

Time, temperature and pressure U.K.

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 ^oC for at least 16 minutes, a core temperature greater than 110 ^oC for at least 13 minutes, a core temperature greater that 120 ^oC for at least eight minutes and a core temperature greater that 130 ^oC for at least three minutes. U.K.

3. The processing may be carried out in batch or continuous systems. U.K.

4. The animal by-products may be cooked in such a manner that the time-temperature requirements are achieved at the same time. U.K.

Method 5 U.K.

Reduction U.K.

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. U.K.

Time, temperature and pressure U.K.

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 ^oC for at least 120 minutes and a core temperature greater than 100 ^oC for at least 60 minutes. U.K.

3. The processing may be carried out in batch or continuous systems. U.K.

4. The animal by-products may be cooked in such a manner that the time-temperature requirements are achieved at the same time. U.K.

[F3 Method 6 (For Category 3 animal by-products of fish origin only) U.K.

Reduction U.K.

1. The animal by-products must be reduced to at least: U.K.

(a)

50 mm in case of heat treatment in accordance with paragraph 2(a); or

(b)

30 mm in case of heat treatment in accordance with paragraph 2(b).

They must then be mixed with formic acid to reduce and maintain the pH to 4,0 or lower. The mixture must be stored for at least 24 hours pending further treatment.

Time and temperature U.K.

2. Following reduction, the mixture must be heated to: U.K.

(a)

a core temperature of at least 90 °C for at least 60 minutes; or

(b)

a core temperature of at least 70 °C for at least 60 minutes.

When using a continuous flow system, 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.]

Textual Amendments

F3 Substituted by Commission Regulation (EC) No 93/2005 of 19 January 2005 amending Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards processing of animal by-products of fish origin and commercial documents for the transportation of animal by-products (Text with EEA relevance).

Method 7 U.K.

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: U.K.

(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. U.K.

3. This information must be made available to the Commission on request. U.K.

CHAPTER IV U.K. Supervision of production

1. The competent authority must supervise processing plants to ensure compliance with the requirements of this Regulation. It must in particular: U.K.

(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. U.K.

CHAPTER V U.K. Validation procedures

1. The competent authority must validate the processing plant in accordance with the following procedures and indicators: U.K.

(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: U.K.

(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: U.K.

(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). U.K.

5. Validation procedures based on testing methods may be laid down under the procedure referred to in Article 33(2). U.K.

(1)

‘Saturated steam’ means that all air is evacuated and replaced by steam in the whole sterilisation chamber.