for the public and animal health rules for animal by-products and derived products laid down in Regulation (EC) No 1069/2009;

concerning certain samples and items exempt from veterinary checks at border inspection posts as provided for in Article 16(1)(e) and (f) of Directive 97/78/EC.

biodiesel which fulfils the requirements for the disposal and use of derived products set out in point 2(b) of Section 3 of Chapter IV of Annex IV;

processed petfood which fulfil the specific requirements for processed petfood set out in point 7(a) of Chapter II of Annex XIII;

dogchews which fulfil the specific requirements for dogchews set out in point 7(b) of Chapter II of Annex XIII;

hides and skins of ungulates which fulfil the specific requirements for the end point for those products set out in point C of Chapter V of Annex XIII;

wool and hair, which fulfil the specific requirements for the end point for those products set out in point B of Chapter VII of Annex XIII;

feathers and down, which fulfil the specific requirements for the end point for those products set out in point C of Chapter VII of Annex XIII;

fur which fulfils the special requirements for the end point for that product set out in Chapter VIII of Annex XIII;

fish oil for the production of medicinal products which fulfils the special requirements for the end point for that product set out in Chapter XIII of Annex XIII;

gasoline and fuels which fulfil the specific requirements for products from the multi-step catalytic process for the production of renewable fuels set out in point 2(c) of Section 3 of Chapter IV of Annex IV;

oleochemical products derived from rendered fats and which fulfil the requirements set out in Chapter XI of Annex XIII;

renewable diesel, renewable jet fuel, renewable propane and renewable gasoline which fulfil the specific requirements for products from the multi-step catalytic hydro-treatment for the production of renewable fuels set out in point 2(f) of Section 3 of Chapter IV of Annex IV.

imported petfood or petfood produced from imported materials, from Category 1 material referred to in Article 8(c) of Regulation (EC) No 1069/2009;

Category 3 material referred to in Article 10(f) and (g) of Regulation (EC) No 1069/2009, provided that:

the hygiene and processing requirements set out in Chapter II;

the standard processing methods set out in Chapter III, provided such methods are used in the establishment or plant;

the alternative processing methods set out in Chapter IV, provided such methods are used in the establishment or plant.

the special disposal rules for animal by-products set out in Section 1;

the rules for the burning and burial of animal by-products in remote areas set out in Section 2;

the rules for the burning and burial of bees and apiculture by-products set out in Section 3.

Chapter I, where they manufacture petfood as referred to in Article 24(1)(e) of that Regulation;

Chapter II, where they store animal by-products as referred to in Article 24(1)(i) of that Regulation and where they handle animal by-products after their collection, by way of the following operations referred to in Article 24(1)(h) of that Regulation:

Chapter III, where they store derived products for certain intended purposes as referred to in Article 24(1)(j) of that Regulation;

Chapter V, where they store on the farm animal by-products intended for subsequent disposal as referred to in Article 4 of that Regulation.

drawn up in accordance with the technical specifications published on the Commission website ( 1 );

either entered in TRACES or accessible by means of TRACES as of 31 October 2021 at the latest.

those materials must not be Category 1 materials derived from any of the following animals:

those materials must not be intended for any of the following uses:

the materials must be imported with a label and must comply with the specific requirements for certain movements of animal by-products set out in Section 1 of Chapter IV of Annex XIV hereto;

the materials must be imported in accordance with sanitary certification requirements laid down in national legislation.

the introduction of the consignment must have been authorised in advance by the competent authority of the Member State of destination; and

the consignment must be sent directly from the point of entry into the Union to the authorised user.

processed animal protein and other derived products referred to in Chapter II of Annex X hereto;

petfood and certain other derived products referred to in Annex XIII hereto;

animal by-products and the derived products imported into or in transit through the Union as referred to in Annex XIV hereto.

‘fur animals’ means animals kept or reared for the production of fur and not used for human consumption;

‘blood’ means fresh whole blood;

‘feed material’ means those feed materials, as defined in Article 3(2)(g) of Regulation (EC) No 767/2009, that are of animal origin, including processed animal proteins, blood products, rendered fats, egg products, fish oil, fat derivatives, collagen, gelatine and hydrolysed proteins, dicalcium phosphate, tricalcium phosphate, milk, milk-based products, milk-derived products, colostrum, colostrum products and centrifuge or separator sludge;

‘blood products’ means derived products 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;

‘processed animal protein’ means animal protein derived entirely from Category 3 material, which have been treated in accordance with Section 1 of Chapter II of Annex X (including blood meal and fishmeal) so as to render them suitable for direct use as feed material or for any other use in feedingstuffs, including petfood, or for use in organic fertilisers or soil improvers; however, it does not include blood products, milk, milk-based products, milk-derived products, colostrum, colostrum products, centrifuge or separator sludge, gelatine, hydrolysed proteins and dicalcium phosphate, eggs and egg-products, including eggshells, tricalcium phosphate and collagen;

‘blood meal’ means processed animal protein derived from the heat treatment of blood or fractions of blood in accordance with Section 1 of Chapter II of Annex X;

‘fishmeal’ means processed animal protein derived from aquatic animals except sea mammals, including farmed aquatic invertebrates, including those covered by Article 3(1)(e) of Council Directive 2006/88/EC ( 2 ), and starfish of the species Asterias rubens which are harvested in a mollusc production area;

‘rendered fats’ means either fats derived from the processing of:

‘fish oil’ means oil derived from the processing of aquatic animals except sea mammals, including farmed aquatic invertebrates, including those covered by Article 3(1)(e) of Directive 2006/88/EC, and starfish of the species Asterias rubens which are harvested in a mollusc production area, or oil from the processing of fish for human consumption, which an operator has destined for purposes other than human consumption;

‘apiculture by-products’ means honey, beeswax, royal jelly, propolis or pollen not intended for human consumption;

‘collagen’ means protein-based products derived from hides, skins, bones and tendons of animals;

‘gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals;

‘greaves’ means the protein-containing residue of rendering, after partial separation of fat and water;

‘hydrolysed proteins’ means polypeptides, peptides and aminoacids, and mixtures thereof, obtained by the hydrolysis of animal by-products;

‘white water’ means a mixture of milk, milk-based products or products derived thereof with water which is collected during the rinsing of dairy equipment including containers used for dairy products, prior to their cleaning and disinfection;

‘canned petfood’ means heat-processed petfood contained within a hermetically sealed container;

‘dogchews’ means products for pet animals to chew, produced from untanned hides and skins of ungulates or from other material of animal origin;

‘flavouring innards’ means a liquid or dehydrated derived product of animal origin used to enhance the palatability values of petfood;

‘petfood’ means feed, other than material referred to in Article 24(2), for use as feed for pet animals, and dogchews consisting of animal by-products or derived products which:

‘processed petfood’ means petfood, other than raw petfood, which has been processed in accordance with point 3 of Chapter II of Annex XIII;

‘raw petfood’ means petfood containing certain Category 3 material which has not undergone any preserving process other than chilling or freezing;

‘catering waste’ means all waste food, including used cooking oil originating in restaurants, catering facilities and kitchens, including central kitchens and household kitchens;

‘digestion residues’ means residues, including the liquid fraction, resulting from the transformation of animal by-products in a biogas plant;

‘digestive tract content’ means the content of the digestive tract of mammals and ratites;

‘fat derivatives’ means derived products from rendered fats, which, as regards rendered fats of Category 1 or Category 2 material, have been processed in accordance with Chapter XI of Annex XIII;

‘guano’ means a natural product which has been collected from the excrements of bats or wild sea birds and which is not mineralised;

‘meat-and-bone meal’ means animal protein derived from the processing of Category 1 or Category 2 materials in accordance with one of the processing methods set out in Chapter III of Annex IV;

‘treated hides and skins’ means derived products from untreated hides and skins, other than dogchews, that have been:

‘untreated hides and skins’ means all cutaneous and subcutaneous tissues that have not undergone any treatment, other than cutting, chilling or freezing;

‘untreated feathers and parts of feathers’ means feathers and parts of feathers, other than feathers or parts of feathers, which have been treated:

‘untreated wool’ means wool, other than wool which has:

‘untreated hair’ means hair, other than hair which has:

‘untreated pig bristles’ means pig bristles, other than pig bristles which have:

‘display item’ means animal by-products or derived products intended for exhibitions or artistic activities;

‘intermediate product’ means a derived product:

‘laboratory reagent’ means a packaged product, ready for use, containing animal by-products or derived products and intended as such or in combination with substances of non-animal origin for specific laboratory use as a reagent or reagent product, calibrator or control material to detect, measure, examine or produce other substances;

‘product used for in vitro diagnosis’ means a packaged product, ready for use, containing a blood product or another animal by-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, 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; it does not include donated organs or blood;

‘research and diagnostic samples’ means animal by-products and derived products intended for the following purposes: examination in the context of diagnostic activities or analysis for the promotion of progress in science and technology, in the context of educational or research activities;

‘trade samples’ means animal by-products or derived products intended for particular studies or analyses authorised by the competent authority in accordance with Article 17(1) of Regulation (EC) No 1069/2009 with a view to carrying out a production process, including the processing of animal by-products or derived products, the development of feedingstuff, pet food or derived products, or the testing of machinery or equipment;

‘co-incineration’ means the recovery or disposal of animal by-products or derived products, if they are waste, in a co-incineration plant;

‘combustion’ means a process involving the oxidisation of fuel in order to use the energy value of the animal by-products or derived products, if they are not waste;

‘incineration’ means the disposal of animal by-products or derived products as waste, in an incineration plant, as defined in point 4 of Article 3 of Directive 2000/76/EC;

‘incineration and co-incineration residues’ means any residues as defined in point 13 of Article 3 of Directive 2000/76/EC, which are generated by incineration or co-incineration plants treating animal by-products or derived products;

‘colour-coding’ means the systematic use of colours as set out in point 1(c) of Chapter II of Annex VIII for displaying information as provided for in this Regulation on the surface or on part of the surface of a packaging, container or vehicle, or on a label or symbol applied to them;

‘intermediate operations’ means the operations, other than storage, referred to in Article 19(b);

‘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;

‘taxidermy’ means the art of preparing, stuffing and mounting the skins of animals with lifelike effect, so that no unacceptable risks to public and animal health may be transmitted through the mounted skin;

‘trade’ means trade in goods between Member States as referred to in Article 28 of the Treaty on the Functioning of the European Union;

‘processing methods’ means the methods listed in Chapters III and IV of Annex IV;

‘batch’ means a unit of production produced in a single plant using uniform production parameters, such as the origin of the materials, or a number of such units, when produced in continuous order in a single plant and stored together as a shipping unit;

‘hermetically sealed container’ means a container that is designed and intended to be secure against the entry of micro-organisms;

‘biogas plant’ means a plant in which animal by-products or derived products are at least part of the material which is submitted to biological degradation under anaerobic conditions;

‘collection centres’ means premises other than processing plants in which the animal by-products referred to in Article 18(1) of Regulation (EC) No 1069/2009 are collected with the intention to be used for feeding to the animals referred to in the same Article;

‘composting plant’ means a plant in which animal by-products or derived products are at least part of the material which is submitted to biological degradation under aerobic conditions;

‘co-incineration plant’ means any stationary or mobile plant whose main purpose is the generation of energy or the production of material products as defined in point 5 of Article 3 of Directive 2000/76/EC;

‘incineration plant’ means any stationary or mobile technical unit and equipment dedicated to the thermal treatment of waste as defined in point 4 of Article 3 of Directive 2000/76/EC;

‘petfood plant’ means premises or facilities for the production of petfood or flavouring innards, as referred to in Article 24(1)(e) of Regulation (EC) No 1069/2009;

‘processing plant’ means premises or facilities for the processing of animal by-products as referred to in Article 24(1)(a) of Regulation (EC) No 1069/2009, in which animal by-products are processed in accordance with Annex IV and/or Annex X;

‘growing media’ means materials, including potting soil, other than soil in situ, in which plants are grown and which is used independently from soil in situ.

foxes (Vulpes vulpes and Alopex lagopus);

raccoon dogs (Nyctereutes procyonides).

Feeding shall only take place in farms:

The operator of the farm shall ensure that meat-and-bone meal or other products derived from one species and intended for the feeding of the same species must:

In the event of any known or suspected contact with any farm with a suspected or confirmed outbreak of TSE, the operator of the farm must immediately:

The waiting period of at least 21 days referred to in Article 11(1)(c) of Regulation (EC) No 1069/2009 must have been observed,

Only organic fertilisers and soil improvers have been used which comply with Article 32(1) and (2) of Regulation (EC) No 1069/2009 and with Chapter II of Annex XI hereto.

manure and guano;

digestive tract content, milk, milk-based products, milk-derived products, colostrum and colostrum products, which the competent authority does not consider to present a risk for the spread of any serious animal disease.

Animal by-products and derived products must be disposed of as soon as possible after arrival, in accordance with conditions laid down by the competent authority. They shall be stored properly until disposal, in accordance with conditions laid down by the competent authority.

Plants must have appropriate arrangements for the cleaning and disinfection of containers and vehicles in place, in particular in a designated area from which wastewater is disposed of in accordance with Union legislation, to avoid risks of contamination.

Plants must be located on a well-drained hardstanding.

Plants must have appropriate arrangements for protection against pests, such as insects, rodents and birds. A documented pest control programme must be used for that purpose.

Staff must have access to adequate facilities for personal hygiene such as lavatories, changing rooms and washbasins, if necessary to prevent risks of contamination.

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

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.

there must be total physical separation between the incineration or co-incineration equipment and the livestock and their feed and bedding, with fencing where necessary;

equipment must be dedicated entirely to the operation of the incinerator and not used elsewhere on the holding or, alternatively, cleaned and disinfected before such use;

personnel working in the plant must change their outer clothing and footwear before handling livestock or livestock feed.

The plants must be equipped for each line with at least one auxiliary burner. This burner shall be switched on automatically when the temperature of the combustion gases after the last injection of combustion air falls below 850 °C or 1 100 °C, as applicable. It must also be used during plant start-up and shut-down operations to ensure that the temperature of 850 °C or of 1 100 °C, as applicable, is maintained at all times during these operations and as long as unburned material is in the chamber where the incineration or co-incineration is carried out.

When animal by-products or derived products are introduced into the chamber where the incineration or co-incineration is carried out by a continuous process, the plant must operate an automatic system to prevent the introduction of animal by-products or derived products at start-up, until the temperature of 850 °C or of 1 100 °C, as applicable, has been reached, and whenever the temperature is not maintained.

The operator must operate the incineration plant in such manner that a level of incineration is achieved such that the slag and bottom ashes total organic carbon content is less than 3 % or their loss on ignition is less than 5 % of the dry weight of the material. If necessary, appropriate techniques of pre-treatment shall be used.

only be used for the disposal of:

when Category 1 materials referred to in Article 8(b) of Regulation (EC) No 1069/2009 are introduced into the low-capacity plant, be equipped with an auxiliary burner;

operate in such way that the animal by-products are completely reduced to ash.

Animal by-products and derived products intended to be used as a fuel must be utilised for that purpose as soon as possible or safely stored until used.

The combustion plants must have in place appropriate measures to ensure that cleaning and disinfection of containers and vehicles are carried out in a designated area of their premises from which the wastewater can be collected and disposed of in accordance with Union legislation, to avoid risks of contamination of the environment.

By way of derogation from the requirements set out in the first subparagraph, containers and vehicles used for the transport of rendered fats may be cleaned and disinfected at the plant of loading or at any other plant approved or registered under Regulation (EC) No 1069/2009.

The combustion plants must be located on a well-drained hard standing.

The combustion plants must have appropriate measures in place for the protection against pests. A documented pest control programme must be used for that purpose.

Staff must have access to adequate facilities for personal hygiene such as lavatories, changing rooms and washbasins, if necessary, to prevent risks of contamination of equipment for handling of farmed animals or their feedstuffs.

Cleaning and disinfection procedures, must be established and documented for all parts of the combustion plant. Suitable equipment and cleaning agents must be provided for cleaning.

Hygiene control must include regular inspections of the environment and equipment. Inspection schedules and results must be documented and retained for a period of at least two years.

Where rendered fats are used as a fuel for combustion in stationary internal combustion engines located within approved or registered food or feed processing plants, the processing of food or feed on the same site must take place under strict conditions of separation.

there must be total physical separation between the combustion equipment and the animals including their feed and bedding;

equipment must be dedicated entirely to the operation of the combustion plant and not used elsewhere on the holding unless it had been effectively cleaned and disinfected before such use;

personnel working in the combustion plant must change their outer clothing and footwear and take personal hygiene measures before handling animals on this or any other holding or their feed or bedding material.

unless fish oil or rendered fat is used which has been produced in accordance with Section 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:

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.

the fat fractions referred to in points 1(a) and (b) must be combusted:

the combustion of material of animal origin other than animal fat must not be permitted;

the animal fat derived from Category 1 or Category 2 combusted in premises approved or registered in accordance with Regulations (EC) No 852/2004, (EC) No 853/2004, 183/2005, or in public places must have been processed with processing method 1 as set out in Chapter III of Annex IV;

the combustion of animal fat must be carried out in accordance with Union legislation for the protection of the environment, in particular, with reference to the standards and requirements of that legislation and the requirements regarding best available techniques for the control and monitoring of emissions.

The manure shall be stored securely in a closed storage area to minimise the need for further handling and to prevent cross contamination with other areas on a holding keeping animals of food producing species.

The on-farm combustion plant must be equipped with:

The emissions of sulphur dioxide, nitrogen oxides (namely the sum of nitrogen monoxide and nitrogen dioxide, expressed as nitrogen dioxide) and particulate matter shall not exceed the following emission limit values, expressed in mg/Nm3 at a temperature of 273,15 K, a pressure of 101,3 kPa and an oxygen content of 11 per cent, after correction for the water vapour content of the waste gases:

The operator of the on-farm combustion plant shall carry out at least annual measurements of sulphur dioxide, nitrogen oxides and particulate matter.

As an alternative to the measurements referred to in the first subparagraph, other procedures, verified and approved by the competent authority, may be used to determine the emissions of sulphur dioxide.

Monitoring shall be carried out by or on behalf of the operator in accordance with CEN standards. Where CEN standards are not available, ISO, national or other international standards which ensure the provision of data of an equivalent scientific quality shall apply.

All results shall be recorded, processed and presented in such a way as to enable the competent authority to verify compliance with the emission limit values.

For on-farm combustion plants applying secondary abatement equipment in order to meet the emission limit values, the effective operation of that equipment shall be monitored continuously and the results thereof recorded.

In the event of non-compliance with the emission limit values referred to in point (a) or where an on-farm combustion plant does not meet the requirements of point 1 of Section 2 of Chapter IV, operators shall immediately inform the competent authority and take the measures necessary to ensure that compliance is restored within the shortest possible time. Where compliance cannot be restored, the competent authority shall suspend the operation of the plant and withdraw its approval.

The operator shall notify the competent authority of any planned change of the on-farm combustion plant which would affect its emissions at least one month before the date on which the change takes place.

The operator shall take the necessary measures to ensure that the periods of start-up and shut-down of the on-farm combustion plant and of any malfunctions are kept as short as possible. In the case of a malfunction or a breakdown of secondary abatement equipment, the operator shall immediately inform the competent authority.

by way of derogation from point B(3)(b)(ii), grant combustion plants operating on 2 August 2017 an additional time period of maximum 6 years to comply with the first paragraph of point 2 of Section 2 of Chapter IV of Annex III to this Regulation;

by way of derogation from point B(4), authorise emissions of particulate matter not exceeding 50 mg/m3, provided the total rated thermal input of the combustion plants does not exceed 5 MW;

by way of derogation from point B(3)(b)(i), authorise manual placement of horse manure as fuel in the combustion chamber when a total rated thermal input not exceeding 0,5 MW.

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:

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:

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.

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:

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.

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.

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).

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.

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:

biodiesel produced in accordance with point D;

hydrolysed materials referred to in point H;

mixtures of pig and poultry manure with quick lime produced in accordance with point I;

renewable fuels produced from rendered fats, which are derived from Category 1 and Category 2 materials, in accordance with point J and L.

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:

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.

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.

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’).

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:

The processed fat must then be processed further using one of the following methods:

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.

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:

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:

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 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.

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.

have a screw diameter of 0,55 m and a screw length of 3,5 m;

operate with a power of 30 kW and a rotation speed of the screw of 156 rpm;

have a treatment capacity of 10 tonnes per hour.

60 °C for 60 minutes; or

70 °C for 30 minutes.

rendered fats derived from Category 2 material, which have been processed using processing method 1 (pressure sterilisation);

fish oil or rendered fats derived from Category 3 material, which have been processed using:

fish oil or rendered fat which have been produced in accordance with Sections VIII or XII of Annex III to Regulation (EC) No 853/2004, respectively.

the bleaching of the centrifuged materials by passing them through a clay filter;

the removal of remaining insoluble impurities by filtration.

Category 2 materials referred to in Article 9(f)(i) and (iii) of Regulation (EC) No 1069/2009;

Category 3 materials.

rendered fats derived from Category 1 material, which have been processed using processing method 1 (pressure sterilisation);

rendered fats and fish oil complying with point J(1)(a) of this Section.

The rendered fat must be submitted to a pre-treatment which consists at least of bleaching of the starting material, including rendered fats, with acid in the presence of bleaching clay and subsequent removal of the used bleaching clay and insoluble impurities by filtration.

Prior to this treatment rendered fat may be degummed with acid and/or caustic solution in order to remove impurities from the rendered fat by forming gums and subsequently separating those gums by centrifugation.

The pre-treated materials must be submitted to a hydro-treatment process which consists of a catalytic hydro-treatment step, a stripping step followed by an isomerisation step.

The materials must be submitted to a pressure of at least 30 bars at a temperature of at least 265 °C for at least 20 minutes.

Category 1 material shall be:

▼M4

▼B

Category 2 or Category 3 material shall be:

▼M4

▼B

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:

▼M4

the multi-step catalytic process for the production of renewable fuels may be:

the lime-treated mixture of pig and poultry manure may be applied to land as processed manure;

The final product derived from the ensilaging of fish material may:

the multiple-step catalytic hydro-treatment for the production of renewable fuels may be:

installations for monitoring that the temperature of 70 °C is reached during the time of one hour;

recording devices to record continuously the results of the monitoring measurements referred to in point (a); and

an adequate system to prevent insufficient heating.

Category 2 material that has been processed in accordance with processing method 1 as set out in Chapter III of Annex IV;

Category 3 material that has been processed in accordance with any of the processing methods 1 to 5 or processing method 7, or in the case of material originating from aquatic animals, any of the processing methods 1 to 7, as set out in Chapter III of Annex IV;

Category 3 material that has undergone pasteurisation/hygienisation in another approved plant;

animal by-products which may be applied to land without processing in accordance with Article 13(f) of Regulation (EC) No 1069/2009 and with this Regulation, if the competent authority does not consider them to present a risk of spreading any serious transmissible disease to humans or animals;

animal by-products which have been subject to the alkaline hydrolysis process set out in point A of Section 2 of Chapter IV of Annex IV;

the following animal by-products, if authorised by the competent authority:

installations for monitoring temperature against time;

recording devices to record, where appropriate continuously, the results of the monitoring measurements referred to in point (a);

an adequate safety system to prevent insufficient heating.

are managed in such a way that all the material in the system achieves the required time and temperature parameters, including, where appropriate, continuous monitoring of the parameters; or

transform only materials referred to in point 2 of Section 1; and

comply with all other relevant requirements of this Regulation.

maximum particle size before entering the unit: 12 mm;

minimum temperature in all material in the unit: 70 °C; and

minimum time in the unit without interruption: 60 minutes.

maximum particle size before entering the composting reactor: 12 mm;

minimum temperature in all material in the reactor: 70 °C; and

minimum time without interruption: 60 minutes.

Identification and analysis of possible hazards, including the impact of input material, based on a full description of the transformation conditions and parameters;

A risk assessment, which evaluates how the specific transformation conditions referred to in point (a) are achieved in practice under normal and atypical situations;

Validation of the intended process by measuring the reduction of viability/infectivity of:

The validation of the intended process referred to in point (c) must demonstrate that the process achieves the following overall risk reduction:

Designing a complete control programme including procedures for monitoring the functioning of the process referred to in point (c);

Measures ensuring continuous monitoring and supervision of the relevant process parameters fixed in the control programme when operating the plant.

Details on the relevant process parameters used in a biogas or composting plant as well as other critical control points must be recorded and maintained so that the owner, operator or their representative and the competent authority can monitor the operation of the plant.

Records must be made available by the operator to the competent authority on request. Information relating to a process authorised under this point must be made available to the Commission on request.

catering waste used as the only animal by-product in a biogas or composting plant; and

mixtures of catering waste with the following materials:

▼M9

▼M9

▼B

does not consider that those materials present a risk of spreading any serious transmissible disease to humans or animals;

considers that the digestion residues or compost are unprocessed material and obliges operators to handle them in accordance with Regulation (EC) No 1069/2009, with this Regulation or, in the case of compost or digestion residues derived from catering waste, to recover or dispose of in accordance with the environmental legislation.

in accordance with point 1;

in accordance with points 2 and 3, only within the Member State where those parameters have been authorised.

the description of the material and the animal species of origin;

the category of the material;

the quantity of the material;

the place of origin and the place of dispatch of the material;

the name and the address of the consignor;

the name and the address of the consignee and/or user.

as waste by incineration or co-incineration;

in case of the animal by-products or derived products referred to in Article 8 (a)(iv), Article 8(c) and (d) and Article 9 and Article 10 of Regulation (EC) No 1069/2009 which are part of cell cultures, laboratory kits or laboratory samples, by a treatment under conditions which are at least equivalent to the validated method for steam autoclaves ( 6 ) and subsequent disposal as waste or wastewater in accordance with relevant Union legislation;

by pressure sterilisation and subsequent disposal or use in accordance with Articles 12, 13 and 14 of Regulation (EC) No 1069/2009.

redispatched to the Member State of origin;

dispatched to another Member State or third country, if such dispatch has been authorised by the competent authority of the Member State or third country of destination in advance; or

disposed of or used in accordance with Articles 12, 13 and 14 of Regulation (EC) No 1069/2009.

The animal by-products shall be transported to the users or to collection centres in accordance with Sections 1 and 3 of Chapter I of Annex VIII.

Collection centres shall be registered by the competent authority, provided that:

Member States may authorise the use of a processing plant for Category 2 material as a collection centre.

Operators of collection centres supplying material, other than animal by-products originating from aquatic animals and from aquatic invertebrates, to final users must ensure that it undergoes one of the following treatments:

The material must be fed to:

▼M9

▼B

The competent authority has granted an authorisation to the operator responsible for the feeding station.

The competent authority shall grant such authorisations provided that:

The competent authority must ensure coordination with any other competent authorities responsible for the supervision of the requirements laid down in the authorisation;

The competent authority must be satisfied, on the basis of an assessment of the specific situation of the species concerned and their habitat, that the conservation status of the species will be improved;

The authorisation granted by the competent authority must:

The operator responsible for the feeding shall:

a detailed justification for the extension of the list to include certain species of necrophagous birds in that Member State, including an explanation of the reasons why it is necessary to feed such birds with Category 1 material instead of with Category 2 or Category 3 material;

an explanation of the measures which will be taken in order to ensure compliance with point 1.

The competent authority must be satisfied, on the basis of an assessment of the specific situation of the species concerned and their habitat, that the conservation status of the species will be improved;

The competent authority must identify in the authorisation, holdings or herds within a geographically defined feeding zone under the following conditions:

The competent authority must have granted an authorisation to the operator responsible for the feeding. The competent authority shall grant such authorisations provided that:

The authorisation granted by the competent authority must be immediately suspended in the case of:

The operator responsible for the feeding shall:

by burning or burial on the premises on which the animal by-products originate;

in an authorised landfill; or

by burning or burial at a site which minimises the risk to animal and public health and the environment, provided that the site is located within a range of distance sufficient to enable the competent authority to manage the prevention of the risk to animal and public health and the environment.

on a properly constructed pyre and the animal by-products reduced to ash;

without endangering human health;

without using processes or methods which could harm the environment, in particular when they could result in risks to water, air, soil and plants and animals or through noise or odours;

under conditions which ensure that any resulting ash is disposed of by burial in an authorised landfill.

in such a way that carnivorous or omnivorous animals cannot gain access to them;

in an authorised landfill or in another site without endangering human health and using processes or methods which do not harm the environment, in particular when they could result in risks to water, air, soil and plants and animals, or through noise or odours.

the animal by-products are transported in secure, leak-proof containers or vehicles;

the loading and unloading of the animal by-products is supervised by the competent authority, if appropriate;

the vehicle wheels are disinfected upon leaving the site of origin;

containers and vehicles used for transporting animal by-products are thoroughly cleansed and disinfected after unloading of the animal by-products; and

adequate escorts for the vehicles, leak testing and double covering are provided, if appropriate.

10 % of the bovine population of the Member State concerned;

25 % of the ovine and caprine population of the Member State concerned;

10 % of the porcine population of the Member State concerned; and

a percentage of the population of other species which is determined by the competent authority, on the basis of an assessment of the possible risks for public and animal health which arise from the disposal of animals of those species by burning or burial on site.

the materials do not exceed a volume of 20 kg per week from the establishment or plant where the materials are collected, regardless of the species of origin of the materials;

the materials are collected, transported and disposed of by means which prevent the transmission of unacceptable risks to public and animal health;

the competent authority carries out regular checks, including checks on the records kept by operators, in the establishments or plants where the materials are collected, to ensure compliance with the provisions of this Section.

indicate the applicable points in Articles 8, 9 and 10 of Regulation (EC) No 1069/2009 including the physical status of those materials and, if applicable, any pre-treatment to which those materials have been submitted and indicating any materials other than animal by-products which are to be used in the process.

include a HACCP protocol and a flow diagram which clearly indicates the individual steps of the process, identifies the parameters critical for the inactivation of relevant pathogens such as temperature, pressure, exposure time, adjustment of the pH value and particle size and is complemented by technical data sheets of the equipment used during the process;

identify and characterize biological hazards for human and animal health represented by the categories of animal by-products intended to be submitted to the method;

show that the most resistant biological hazards associated with the category of materials to be processed are reduced in any products generated during the process, including the waste water, at least to the degree achieved by the processing standards laid down in this Regulation for the same category of animal by-products. The degree of risk reduction must be determined with validated direct measurements, unless modelling or comparisons with other processes are acceptable.

measuring the reduction of viability/infectivity of: endogenous indicator organisms during the process, where the indicator is:

using a well-characterised test organism or virus introduced in a suitable test body into the starting material.

If several treatment steps are involved, an assessment must be performed on the degree to which individual titre reduction steps are additive, or whether early steps in the process may compromise the efficacy of subsequent steps;

reporting complete results by

the risks associated with interdependent processes, and in particular on the outcome of an evaluation of possible indirect impacts, which may:

the risks associated with the intended end use of the products, in particular:

a flow diagram showing the functioning of the process;

the evidence referred to in point 2(d), as well as other evidence aiming to substantiate the information provided in the framework of the application as set out in point 2.

clean and dry before use; and

cleaned, washed and/or disinfected after each use to the extent necessary to avoid cross-contamination.

for the carriage of different animal by-products or derived products provided that they are cleaned and disinfected between the different uses in a manner which prevents cross-contamination;

for the carriage of animal by-products or derived products referred to in Article 10(f) of Regulation (EC) No 1069/2009, following their use for the carriage of products intended for human consumption, under conditions which prevent cross-contamination.

it is processed within 24 hours after collection or after the end of storage in chilled or frozen form, if the subsequent transport takes place in means of transport in which the storage temperature is maintained;

in the case of milk, milk-based products or milk-derived products which have not been subject to any of the treatments referred to in Part I of Section 4 of Chapter II of Annex X, it is transported chilled and in insulated containers, unless risks can be mitigated by other measures, due to the characteristics of the material.

consignments of animal by-products and derived products are identifiable and kept separate and identifiable during collection where the animal by-products originate and during transportation;

a marking substance for the identification of animal by-products or derived products of a specific category is only used for the category for which its use is required under this Regulation, or is established or laid down pursuant to point 4;

consignments of animal by-products and derived products are dispatched from one Member State to another Member State in packaging, containers or vehicles which are prominently and, at least for the period of transport, indelibly colour-coded for displaying information as provided for in this Regulation on the surface or part of the surface of a packaging, container or vehicle, or on a label or symbol applied to them as follows:

clearly indicate the category of the animal by-products or of the derived products; and

bear the following words visibly and legibly displayed on the packaging, a container or vehicle, as applicable:

▼M1

▼M4

▼B

However, the label referred to in point (b)(xi) shall not be required for the following organic fertilisers and soil improvers:

points 1 and 2 of this Chapter shall not apply to the identification of Category 3 material comprising of milk, milk-based products and milk-derived products, by operators of milk-processing establishments which have been approved in accordance with Article 4 of Regulation (EC) No 853/2004, where they are receiving products which they have previously delivered and which are returned to them, in particular from their customers;

the competent authority may accept the identification of manure which is transported between two points located on the same farm or between farms and users located in the same Member State by other means, by way of derogation from points 1 and 2;

compound feeds as defined in Article 3(2)(h) of Regulation (EC) No 767/2009 which have been manufactured from animal by-products or from derived products and which are packaged and placed on the market as feed in accordance with Article 4 of Regulation (EC) No 767/2009 do not have to be identified in accordance with point 1 and they do not have to be labelled in accordance with point 2.

derived products from Category 3 material and organic fertilisers and soil improvers are supplied within the same Member State by retailers to final users other than business operators;

milk, milk-based products and milk-derived products which are Category 3 materials are collected and returned to operators of milk-processing establishments, which have been approved in accordance with Article 4 of Regulation (EC) No 853/2004, if those operators are receiving products, in particular from their customers, which they have previously delivered;

compound feeds as defined in Article 3(2)(h) of Regulation (EC) No 767/2009 which have been manufactured from animal by-products or from derived products, are placed on the market packaged and labelled in accordance with Article 4 of Regulation (EC) No 767/2009.

a different commercial document, in paper or in electronic form, provided that such commercial document contains the information referred to in point (f) of the Notes under point 6 of this Chapter;

a commercial document in which the quantity of the material is expressed in weight or volume of the material or in the number of packages.

the date on which the material was taken from the premises;

the description of the material, including

the quantity of the material, in volume, weight or number of packages;

the name and address of the establishment or plant of origin of the material and its approval or registration number assigned in accordance with Regulation (EC) No 1069/2009 or, where applicable, in accordance with Regulations (EC) No 852/2004 ( 7 ), (EC) No 853/2004 ( 8 ) or (EC) No 183/2005 of the European Parliament and of the Council ( 9 ), and the nature and the method of the treatment, as applicable;

the name, the address and the registration number of the transporter of the material;

the name and address of the establishment or plant of destination and the registration or approval number assigned in accordance with Regulation (EC) No 1069/2009 or, where applicable, in accordance with Regulations (EC) No 852/2004 or (EC) No 183/2005;

in case of transport in containers, the complete container identification number (‘BIC code’) issued in accordance with the requirements of the Bureau International des Containers et du Transport Intermodal ( 10 );

in case of export of processed animal protein and products containing processed animal proteins as referred to in Annex IV to Regulation (EC) No 999/2001, the Member State of exit and border inspection post referred to in Commission Decision 2009/821/EC ( 11 ) of exit.