Processing plants must not be situated on the same site as slaughterhouses or other establishments which have been approved or registered in accordance with Regulation (EC) No 852/2004 or Regulation (EC) No 853/2004, unless the risks to public and animal health resulting from the processing of animal by-products, which originate from such slaughterhouses or other establishments, are mitigated by compliance with at least the following conditions:
the processing plant must be physically separated from the slaughterhouse or other establishment, where appropriate by locating the processing plant in a building that is completely separated from the slaughterhouse or other establishment;
the following must be installed and operated in the processing plant:
a conveyer system which links the processing plant to the slaughterhouse or other establishment and which may not be by-passed,
separate entrances, reception bays, equipment and exits for both the processing plant and the slaughterhouse or establishment;
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 or other establishment;
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 processing plants processing Category 3 material, 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 or registered in accordance with Regulation (EC) No 852/2004 or Regulation (EC) No 853/2004.
Member States shall inform the Commission and the other Member States in the framework of the Standing Committee on the Food Chain and Animal Health referred to in Article 52(1) of Regulation (EC) No 1069/2009 of the use made of this derogation by their competent authorities;
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 facilities including lavatories, changing rooms and washbasins for staff;
The processing plant must have sufficient production capacity for hot water and steam for the processing of animal by-products;
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;
Where heat treatment is required, all installations must be equipped with:
measuring equipment to monitor temperature against time and, if applicable for the processing method used, pressure at critical points;
recording devices to record continuously the results of these measurements in a way so that they remain accessible for the purpose of checks and official controls;
an adequate safety system to prevent insufficient heating;
To prevent recontamination of the derived product by the introduction of 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 derived product.
The equipment used in the pre-treatment process shall consist of drain traps or screens with apertures with a filter pore or a mesh size of no more than 6 mm in the downstream end of the process or equivalent systems that ensure that the solid particles in the wastewater passing through them are no more than 6 mm.
However, Category 3 material comprising of centrifuge or separator sludge may be disposed of through the wastewater stream, provided that it has been subject to one of the treatments for centrifuge or separator sludge set out in Part III of Section 4 of Chapter II of Annex X hereto.
The layout of processing plants processing Category 1 and Category 2 materials must ensure the total separation of Category 1 material from Category 2 material from reception of the raw material until dispatch of the resulting derived product, unless a mixture of Category 1 material and Category 2 material is processed as Category 1 material.
The following requirements shall apply in addition to the general conditions set out in Section 1:
Processing plants processing Category 3 materials shall not be located at the same site as processing plants processing Category 1 or Category 2 materials, unless located in a completely separate building.
However, the competent authority may authorise the processing of Category 3 material on a site where handling or processing of Category 1 or Category 2 material takes place, if cross-contamination is prevented due to:
the layout of the premises, in particular the arrangements for the reception, and by way of the further handling of raw materials;
the layout and the management of the equipment used for processing, including the layout and the management of separate processing lines or of cleaning procedures which are excluding the propagation of any possible risks to public and animal health; and
the layout and the management of the areas for the temporary storage of the end products.
Processing plants processing Category 3 material shall have in place an installation to check the presence of foreign bodies, such as packaging material or metallic pieces, in the animal by-products or derived products, if they are processing materials which are destined for feeding. Such foreign bodies shall be removed before or during processing.
In addition to the general hygiene requirements provided for in Article 25 of Regulation (EC) No 1069/2009, processing plants shall have a documented pest control programme in place for the implementation of the arrangements for protection against pests, such as insects, rodents and birds, referred to in Article 25(1)(c) of that Regulation.
Unless the competent authority requires the application of pressure sterilisation (method 1), Category 1 and Category 2 material shall be processed in accordance with processing methods 2, 3, 4 or 5 as referred to in Chapter III.
raw material particle size;
temperature achieved in the heat treatment process;
pressure, if applied to the raw material;
duration of the heat treatment process or feed rate to a continuous system. Minimum processing standards must be specified for each applicable critical control point.
The core temperatures may be achieved consecutively or through a coincidental combination of the time periods indicated.
The core temperatures may be achieved consecutively or through a coincidental combination of the time periods indicated.
The core temperatures may be achieved consecutively or through a coincidental combination of the time periods indicated.
The core temperatures may be achieved consecutively or through a coincidental combination of the time periods indicated.
50 mm, in case of heat treatment in accordance with point 2(a); or
30 mm, in case of heat treatment in accordance with point 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.
a core temperature of at least 90 °C for at least 60 minutes; or
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 way that at the end of the heat treatment operation the product has undergone a cycle which is sufficient in both time and temperature.
the identification of relevant hazards in the starting material, in view of the origin of the material, and of the potential risks in view of the animal health status of the Member State or the area or zone where the method is to be used;
the capacity of the processing method to reduce those hazards to a level which does not pose any significant risks to public and animal health;
the sampling of the final product on a daily basis over a period of 30 production days in compliance with the following microbiological standards:
Samples of material taken directly after the treatment:
Clostridium perfringens absent in 1 g of the products
Samples of material taken during or upon withdrawal from storage:
Salmonella: absence in 25g: n=5, c=0, m=0, M=0
Enterobacteriaceae: n=5, c=2; m=10; M=300 in 1 g
where:
=
number of samples to be tested;
=
threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed 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
=
number of samples the bacterial count of which may be between m and M, the samples still being considered acceptable if the bacterial count of the other samples is m or less.
For this process, animal by-products of all categories may be used.
Alkaline hydrolysis shall be carried out according to the following processing standards:
Either a sodium hydroxide (NaOH) or potassium hydroxide (KOH) solution (or a combination thereof) must be used in an amount that assures approximate molar equivalency to the weight, type and composition of the animal by-products to be digested.
In the case of high fat in the animal by-products that neutralises the base, the added base must be adjusted so that the molar equivalency referred to is achieved.
Animal by-products must be placed in a steel alloy container. The measured amount of alkali must be added either in solid form or as a solution as referred to in point (a).
The container must be closed and the animal by-products and alkali mixture must be heated to a core temperature of at least 150 °C and at a pressure (absolute) of at least 4 bars for at least:
three hours without interruption;
six hours without interruption in case of treatment of animal by-products referred to in Article 8(a)(i) and (ii) of Regulation (EC) No 1069/2009.
However, materials derived from Category 1 materials comprising of animals killed in the context of TSE eradication measures which are either ruminants not requiring TSE testing or ruminants which have been tested with a negative result in accordance with Article 6(1) of Regulation (EC) No 999/2001 may be processed in accordance with point 2(c)(i) of this Section; or
one hour without interruption in the case of animal by-products consisting of fish or of poultry materials.
The process must be carried out in a batch system and the material in the vessel must be constantly mixed in order to facilitate the digestion process until the tissues are dissolved and bones and teeth are softened; and
The animal by-products must be treated in such way that the requirements regarding time, temperature and pressure are achieved at the same time.
For this process, Category 2 and Category 3 materials may be used.
High pressure high temperature hydrolysis shall be carried out according to the following processing standards:
The animal by-products must be heated to a core temperature of at least 180 °C for at least 40 minutes without interruption at a pressure (absolute) of at least 12 bar, heated by indirect steam application to the biolytic reactor;
The process must be carried out in a batch and the material in the vessel must be constantly mixed; and
The animal by-products must be treated in such a manner that the requirements regarding time, temperature and pressure are achieved at the same time.
For this process, animal by-products of all categories may be used.
The high pressure hydrolysis biogas process shall be carried out according to the following processing standards:
The animal by-products must be first processed using processing method 1 (pressure sterilisation) as set out in Chapter III in an approved processing plant;
Following the process referred to in point (a), the defatted materials must be treated at a temperature of at least 220 °C for at least 20 minutes at a pressure (absolute) of at least 25 bar, heated in a two-step procedure, first by direct steam injection, secondly indirect in a coaxial heat exchanger;
The process must be carried out in a batch or continuous system and the material is constantly mixed;
The animal by-products must be treated in such a manner that the requirements regarding time, temperature and pressure are achieved at the same time;
The resulting material must then be mixed with water and anaerobically fermented (biogas transformation) in a biogas reactor;
In the case of starting material of Category 1, the entire process must take place on the same site and in a closed system and the biogas produced during the process must be combusted rapidly in the same plant at a minimum of 900 °C followed by rapid chilling (‘quenching’).
For this process, a fat fraction derived from animal by-products of all categories may be used.
Biodiesel production shall be carried out according to the following processing standards:
Unless fish oil or rendered fat are used which have been produced in accordance with Sections VIII or XII of Annex III to Regulation (EC) No 853/2004, respectively, the fat fraction derived from animal by-products must be first processed using:
in the case of Category 1 or 2 materials, processing method 1 (pressure sterilisation) as set out in Chapter III; and
in the case of Category 3 materials, any of the processing methods 1 to 5 or processing method 7 or, in the case of material derived from fish, processing methods 1 to 7 as set out in Chapter III;
The processed fat must then be processed further using one of the following methods:
a process whereby the processed fat must be separated from the protein and in the case of fat from ruminant origin, insoluble impurities in excess of 0,15 % by weight must be removed, and the processed fat must be subsequently submitted to esterfication and transesterfication.
However, esterfication is not required for processed fat derived from Category 3 material. For esterfication the pH must be reduced to less than 1 by adding sulphuric acid (H2SO4) or an equivalent acid and the mixture must be heated to 72 °C for at least two hours during which it must be intensely mixed.
Transesterfication must be carried out by increasing the pH to about 14 with potassium hydroxide or with an equivalent base at 35 °C to 50 °C for at least 15 minutes. Transesterfication shall be carried out twice under the conditions described in this point using a new base solution. This process must be followed by refinement of the products including vacuum distillation at 150 °C, leading to biodiesel;
a process using equivalent process parameters authorised by the competent authority.
For this process, Category 2 and Category 3 material may be used.
Brookes’ gasification shall be carried out according to the following processing standards:
The afterburner chamber must be warmed up using natural gas;
The animal by-products must be loaded into the primary chamber of the gasificator and the door must be closed. The primary chamber must have no burners and must be heated instead by the transfer of heat by conduction from the afterburner, which must be underneath the primary chamber. The only air admitted to the primary chamber must be via three inlet valves mounted on the main door to enhance the efficiency of the process;
The animal by-products must be volatilised into complex hydrocarbons and the resultant gases must pass from the primary chamber via a narrow opening at the top of the back wall to the mixing and cracking zones, where they must be broken down into their constituent elements. Finally the gases must pass into the afterburner chamber where they must be burned in the flame of a natural gas fired burner in the presence of excess air;
Each process unit must have two burners and two secondary air fans for back-up in case of burner or fan failure. The secondary chamber must be designed to give a minimum residence time of two seconds at a temperature of at least 950 °C under all conditions of combustion;
On leaving the secondary chamber the exhaust gases must pass through a barometric damper at the base of the stack, which cools and dilutes them with ambient air, maintaining a constant pressure in the primary and secondary chambers;
The process must be carried out over a 24-hour cycle, which includes loading, processing, cool down and ash removal. At the end of the cycle the residual ash must be removed from the primary chamber by a vacuum extraction system into enclosed bags and sealed before transporting;
The gasification of material other than animal by-products must not be permitted.
For this process, a fat fraction derived from animal by-products of all categories may be used.
Combustion of animal fat in a thermal boiler shall be carried out according to the following processing standards:
Unless fish oil or rendered fat are used which has been produced in accordance with Sections VIII or XII of Annex III to Regulation (EC) No 853/2004, respectively, the fat fraction derived from animal by-products must first be processed using:
in the case of fat fraction of Category 1 and 2 materials which is intended to be combusted in another plant,
for the fat fraction from the processing of ruminants which have been tested with a negative result in accordance with Article 6(1) of Regulation (EC) No 999/2001 and from the processing of animals, other than ruminants which require TSE testing, any of the processing methods 1 to 5 as set out in Chapter III of this Annex.
for the fat fraction from the processing of other ruminants, processing method 1 as referred in Chapter III; and
in the case of Category 1 and 2 materials intended for combustion within the same plant and in the case of Category 3 material, any of the processing methods 1 to 5 or processing method 7; in the case the materials are derived from fish, processing methods 1 to 7 as set out in Chapter III;
The fat fraction must be separated from the protein and in the case of fat from ruminant origin which is intended to be combusted in another plant, insoluble impurities in excess of 0,15 % by weight must be removed;
Following the process referred to in points (a) and (b), the fat must be:
vaporised in a steam-raising boiler and combusted at a temperature of at least 1 100 °C for at least 0,2 seconds; or
processed using equivalent process parameters authorised by the competent authority;
The combustion of material of animal origin other than animal fat must not be permitted;
The combustion of the fat derived from Category 1 and Category 2 materials shall take place in the same plant where the fat is rendered with the aim of utilising the energy generated for the rendering processes. However, the competent authority may authorise the movement of that fat to other plants for combustion provided that:
the plant of destination is authorised for the combustion;
the processing of food or feed in an approved plant on the same premises takes place under strict conditions of separation;
The combustion must be carried out in accordance with Union legislation for the protection of the environment, in particular, with reference to the standards of that legislation regarding best available techniques for the control and monitoring of emissions.
For this process, manure and digestive tract content and Category 3 material may be used.
Thermomechanical biofuel production shall be carried out according to the following processing standards:
The animal by-products must be loaded into a converter and subsequently treated at a temperature of 80 °C for a period of eight hours. During this period, the material must be constantly reduced in size using appropriate mechanical abrasion equipment.
The material must be subsequently treated at a temperature of 100 °C for at least two hours.
The particle size of the resulting material must not be larger than 20 millimetres;
The animal by-products must be treated in such a manner that the requirements regarding time, temperature and pressure set out in points (a) and (b) are achieved at the same time;
During the heat treatment of the material, evaporated water must be continually extracted from the air-space above the biofuel and must be passed through a stainless steel condenser. The condensate must be kept at a temperature of at least 70 °C for at least one hour before being discharged as wastewater;
After the heat treatment of the material, the resulting biofuel from the converter must then be discharged and automatically conveyed by a fully covered and interlocked conveyor to incineration or co-incineration on the same site;
The process must be carried out in a batch mode.
Category 1 material shall be:
disposed of in accordance with Article 12(a) or (b) of Regulation (EC) No 1069/2009;
disposed of by burial in an authorised landfill;
transformed into biogas, provided the digestion residues are disposed of in accordance with points (i) or (ii); or
further processed into fat derivatives for uses other than feeding.
Category 2 or Category 3 material shall be:
disposed of as provided for in point 1(a)(i) or (ii), with or without prior processing as provided for in Article 12(a) and (b) of Regulation (EC) No 1069/2009;
further processed into fat derivatives for uses other than feeding;
used as an organic fertiliser or soil improver; or
composted or transformed into biogas.
the alkaline hydrolysis process defined in point A of Section 2 may be transformed in a biogas plant and subsequently combusted rapidly at a minimum of 900°C, followed by rapid chilling (‘quenching’); where material referred to in Article 8(a) and (b) of Regulation (EC) No 1069/2009 has been used as starting material, the transformation into biogas shall take place on the same site as the processing and in a closed system;
the biodiesel production process may be:
in the case of biodiesel and of residues from the distillation of biodiesel, used as a fuel without restrictions under this Regulation (end point);
in the case of potassium sulphate, used for the production of derived products for application to land;
in the case of glycerine:
derived from Category 1 or Category 2 material which has been processed in accordance with processing method 1 as set out in Chapter III, transformed into biogas.
derived from Category 3 material, used for feeding.