The following requirements apply in addition to the general requirements laid down in Annex V.
Premises
Premises for the processing of Category 3 material must not be at the same site as premises processing Category 1 or Category 2 material, unless in a completely separate building.
However, the competent authority may authorise the temporary use of a Category 3 processing plant for the processing of Category 1 or Category 2 material when a widespread outbreak of an epizootic disease or other extraordinary and unforeseeable circumstances lead to a lack of capacity at a Category 1 or Category 2 processing plant.
The competent authority must re-approve the Category 3 processing plant in accordance with Article 17 before it processes Category 3 material again.
Category 3 processing plants must have:
an installation to check the presence of extraneous matter, such as packaging material, metallic pieces, etc. in the animal by-products; and
if the volume of products treated requires regular or permanent presence of the competent authority, an adequately equipped lockable room for the exclusive use of the inspection service.
Raw material
[F1Only Category 3 material listed in points (a) to (j) of Article 6(1) that has been handled, stored and transported in accordance with Articles 7, 8 and 9 may be used for the production of processed animal proteins and other feed material.]
Before processing, animal by-products must be checked for the presence of extraneous matter. When present, it must be removed immediately.
Processing standards
The critical control points that determine the extent of the heat treatments applied in processing must be identified for each processing method as specified in Annex V, Chapter III. The critical control points must at least include:
raw material particle size,
temperature achieved in the heat treatment process,
pressure applied to the raw material, if applicable, and
duration of the heat treatment process or feed rate to a continuous system.
Minimum process standards must be specified for each applicable critical control point.
Records must be maintained for at least two years to show that the minimum process values for each critical control point are applied.
Accurately calibrated gauges/recorders must be used to monitor continuously the processing conditions. Records must be kept for at least two years to show the date of calibration of gauges/recorders.
Material that may not have received the specified heat treatment (for example, material discharged at start up, or leakage from cookers) must be recirculated through the heat treatment or collected and reprocessed.
Processed products
Samples of the final products taken during or on withdrawal from storage at the processing plant must comply with the following standards:
Salmonella: absence in 25 g: n = 5, c = 0, m = 0, M = 0
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 g
where:
=
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 sample still being considered acceptable if the bacterial count of the other samples is m or less.
[F2Unused or surplus processed products may after they have been permanently marked:
be disposed of as waste by incineration or co-incineration in an incineration or co-incineration plant approved in accordance with Article 12;
be disposed of in a landfill approved under Directive 1999/31/EC; or
be transformed in a biogas plant or in a composting plant approved in accordance with Article 15.]
Textual Amendments
The following conditions apply in addition to the general conditions laid down in Chapter I.
Processing standards
[F1Mammalian processed animal protein must have been submitted to processing Method 1.
However, while the feed ban provided for in Council Decision 2000/766/EC remains in force, mammalian processed animal protein may have been submitted to any of the processing Methods 1 to 5 or Method 7, and shall be permanently marked with a stain or otherwise immediately after that processing, before its disposal as waste in accordance with applicable Community legislation.
In addition, while the feed ban provided for in Council Decision 2000/766/EC remains in force, processed animal protein of mammalian origin exclusively destined for use in petfood, which is transported in dedicated containers that are not used for the transport of animal by-products or feedingstuffs for farmed animals, and which is consigned directly from Category 3 processing plant to the petfood plants, may have been submitted to any of the processing Methods 1 to 5 or 7.]
Non-mammalian processed animal protein, with the exclusion of fishmeal, must have been submitted to any of processing methods 1 to 5 or 7.
Fishmeal must have been submitted:
to any of the processing methods; or
to a method and parameters which ensure that the product complies with the microbiological standards set in Chapter I, paragraph 10.
Storage
Processed animal protein must be packed and stored in new or sterilised bags or stored in properly constructed bulk bins.
Sufficient measures must be taken to minimise condensation inside bins, conveyors or elevators.
Products in conveyors, elevators and bins must be protected from casual contamination.
Processed animal protein handling equipment must be maintained in a clean and dry condition and should have adequate inspection points so that equipment can be examined for cleanliness. All storage facilities must be emptied and cleaned regularly, as production requirements require.
Processed animal protein must be kept dry. Leakages and condensation in the storage area must be prevented.
Importation
Member States must authorise the importation of processed animal protein:
if it comes from third countries that appear on the list in Part II of Annex XI or, in the case of fishmeal, that appear on the list in Part III of Annex XI;
if it comes from a processing plant that appears on the list referred to in Article 29(4);
if it has been produced in accordance with this Regulation; and
[F3if it is accompanied by a health certificate that conforms to the model set out in Chapter 1 of Annex X.]
Before consignments are released for free circulation within the Community, the competent authority must sample imports of processed animal protein at the border inspection post to ensure compliance with the requirements of Chapter I, paragraph 10. The competent authority must:
sample each consignment of products carried in bulk; and
carry out random sampling of consignments of products packaged in the manufacturing plant of origin.
However, when six consecutive tests on bulk consignments originating in a given third country prove negative, the competent authority may carry out random sampling of subsequent bulk consignments from that third country. If one of these random samples proves positive, the competent authority carrying out the sampling must inform the competent authority of the country of origin so that it can take appropriate measures to remedy the situation. The competent authority of the country of origin must bring these measures to the attention of the competent authority carrying out the sampling. In the event of a further positive result from the same source, the competent authority must sample each consignment from the same source until six consecutive tests again prove negative.
Competent authorities must keep a record for at least two years of the results of sampling carried out on all consignments that have undergone sampling.
Where a consignment proves to be positive for salmonella, it must either:
be dealt with in accordance with the procedure laid down by Article 17(2)(a) of Directive 97/78/EC(1); or
reprocessed in a processing plant approved pursuant to this Regulation or decontaminated by a treatment authorised by the competent authority. A list of permitted treatments may be established in accordance with the procedure referred to in Article 33(2). The consignment must not be released until it has been treated, tested for salmonella by the competent authority in accordance with Chapter I, paragraph 10, and a negative result obtained.
Textual Amendments
The following conditions apply in addition to the general conditions laid down in Chapter I.
Raw material
Only blood coming under paragraph 1(a) and (b) of Article 6 may be used for the production of blood products.
Processing standards
Blood products must have been submitted:
to any of processing methods 1 to 5 or 7; or
to a method and parameters which ensure that the product complies with the microbiological standards set in Chapter I, paragraph 10.
Importation
Member States must authorise the importation of blood products if they:
[F3come from third countries that appear on the list of part V and part VI of Annex XI as appropriate;]
come from a processing plant that appears on the list referred to in Article 29(4);
have been produced in accordance with this Regulation; and
[F3if it is accompanied by a health certificate that conforms to the model set out in Chapter 4(B) of Annex X.]
The following conditions apply in addition to the general conditions laid down in Chapter I.
Processing standards
[F1Unless the rendered fats have been produced in accordance with Chapter II of Annex C to Council Directive 77/99/EEC (2) , or Chapter 9 of Annex I to Council Directive 92/118/EEC (3) , rendered fats must be produced using Methods 1 to 5 or Method 7, and fish oils may be produced using Method 6, as referred to in Annex V, Chapter III.
Rendered fats derived from ruminant animals must be purified in such a way that the maximum levels of remaining total insoluble impurities does not exceed 0,15 % in weight.]
Importation of rendered fats
Member States must authorise the importation of rendered fats if they:
come from third countries appearing on the list in Part IV of Annex XI;
come from a processing plant that appears on the list referred to in Article 29(4);
have been produced in accordance with this Regulation;
either:
are entirely or partly derived from swine raw material and come from a country or a part of the territory of a country free from foot-and-mouth disease for the previous 24 months and free from classical swine fever and African swine fever for the previous 12 months,
are entirely or partly derived from poultry raw material and come from a country or a part of the territory of a country free from Newcastle disease and avian influenza for the previous six months,
are entirely or partly derived from ruminant raw material and come from a country or a part of the territory of a country free from foot-and-mouth disease for the previous 24 months and free from Rinderpest for the previous 12 months, or
where there has been an outbreak of one of the abovementioned diseases during the relevant period mentioned above, have been subjected to one of the following heat treatment processes:
at least 70 oC for at least 30 minutes, or
at least 90 oC for at least 15 minutes,
and details of the critical control points are recorded and maintained so that the owner, operator or their representative and, as necessary, the competent authority can monitor the operation of the plant. The information must include the particle size, critical temperature and, as appropriate, the absolute time, pressure profile, raw material feed-rate and fat recycling rate; and
[F3are accompanied by a health certificate that conforms to the model set out in Chapter 10(A) of Annex X.]
Importation of fish oil
Member States must authorise the importation of fish oil if it:
comes from third countries appearing on the list in Part III of Annex XI;
comes from a processing plant that appears on the list referred to in Article 29(4);
has been produced in accordance with this Regulation; and
[F3is accompanied by a health certificate that conforms to the model set out in Chapter 9 of Annex X.]
Hygiene requirements
Where rendered fat or fish oil is packaged, it must be packaged in new containers or in containers that have been cleaned, and all precautions must be taken to prevent its recontamination. Where bulk transport of the products is intended, the pipe, pumps and bulk tanks and any other bulk container or bulk road tanker used in the transportation of the products from the manufacturing plant either directly on to the ship or into shore tanks or direct to plants must have been inspected and found to be clean before use.
The following conditions apply in addition to the general conditions laid down in Chapter I.
Processing standards
Raw milk and colostrum must be produced under conditions offering adequate guarantees as regards animal health. Such conditions may be established in accordance with the procedure referred to in Article 33(2).
Milk or treated or processed milk products must be subjected to a heat treatment of at least 2 oC for at least 15 seconds or any combination of temperature and time having at least an equivalent heat effect and producing a negative reaction to the phosphatase test, followed by:
in the case of dried milk or dried milk products, a drying process; or
in the case of an acidified milk product, a process by which the pH is reduced and kept for at least one hour at a level below 6.
In addition to the requirements laid down in paragraph 2, dried milk or dried-milk products must meet the following requirements:
after completion of the drying process, every precaution must be taken to prevent contamination of the products; and
the final product must be:
packed in new containers, or
in the case of bulk transport, transported in vehicles or containers that have been disinfected using a product approved by the competent authority before loading with the milk, milk-based product or colostrum.
Importation
Member States must authorise imports of milk and milk-based products if:
they come from third countries appearing on the list in Part I of Annex XI;
in the case of milk and milk-based products from third countries or parts of third countries listed in column B of the Annex to Decision 95/340/EC(4), they have undergone a pasteurisation treatment sufficient to produce a negative phosphatase test and a health certificate conforming to the model laid down in Chapter 2(A) of Annex X accompanies them;
in the case of milk-based products with a pH reduced to less than 6 from third countries or parts of third countries listed in column C of the Annex to Decision 95/340/EC, they have first undergone a pasteurisation treatment sufficient to produce a negative phosphatase test and a health certificate conforming to the model laid down in Chapter 2(B) of Annex X accompanies them;
in the case of milk and milk-based products from third countries or parts of third countries listed in column C of the Annex to Decision 95/340/EC, they have first undergone a sterilisation process or a double heat treatment where each treatment was sufficient to produce a negative phosphatase test on its own and a health certificate conforming to the model laid down in Chapter 2(C) of Annex X accompanies them; and
they come from a processing plant which appears on the list referred to in Article 29(4).
Milk and milk-based products from third countries or parts of third countries listed in column C of the Annex to Decision 95/340/EC where there has been an outbreak of foot-and-mouth disease in the last 12 months or where vaccination against foot-and-mouth disease has been carried out in the last 12 months must, before introduction on to Community territory, have undergone either:
a sterilisation process whereby an Fc value equal to or greater than 3 is achieved; or
an initial heat treatment with a heating effect at least equal to that achieved by a pasteurisation process of at least 72 oC for at least 15 seconds and sufficient to produce a negative reaction to a phosphatase test, followed by:
a second heat treatment with a heating effect at least equal to that achieved by the initial heat treatment, and which would be sufficient to produce a negative reaction to a phosphatase test, followed, in the case of dried milk, or dried milk-based products, by a drying process, or
an acidification process such that the pH has been maintained at less than 6 for at least one hour.
Where a risk of introduction of an exotic disease or any other risk to animal health is identified, additional conditions for the protection of animal health may be established in accordance with the procedure referred to in Article 33(2).
The following conditions apply in addition to the general conditions laid down in Chapter I.
Processing standards for gelatin
Gelatin must be produced by a process that ensures that unprocessed Category 3 material is subjected to a treatment with acid or alkali, followed by one or more rinses. The pH must be adjusted subsequently. Gelatin must be extracted by heating one or several times in succession, followed by purification by means of filtration and sterilisation.
After having been subjected to the processes referred to in subparagraph (a), gelatin may undergo a drying process and, where appropriate, a process of pulverisation or lamination.
The use of preservatives, other than sulphur dioxide and hydrogen peroxide, is prohibited.
Gelatin must be wrapped, packaged, stored and transported under satisfactory hygiene conditions. In particular:
a room must be provided for storing materials for wrapping and packaging;
wrapping and packaging must take place in a room or in a place intended for that purpose;
and
wrappings and packages containing gelatin must carry the words ‘gelatin suitable for animal consumption’.
Processing standards for hydrolysed protein
[F1Hydrolysed protein must be produced using a production process involving appropriate measures to minimise contamination of raw Category 3 material. Hydrolysed protein shall have a molecular weight below 10 000 Dalton.
In addition, hydrolysed proteins entirely or partly derived from ruminants hides and skins shall be produced in a processing plant dedicated only to hydrolysed protein production, using a process involving the preparation of raw Category 3 material by brining, liming and intensive washing followed by:
exposure of the material to a pH of more than 11 for more than three hours at a temperature of more than 80 o C and subsequently by heat treatment at more than 140 o C for 30 minutes at more than 3,6 bar;
exposure of the material to a pH of 1 to 2, followed by a pH of more than 11, followed by heat treatment at 140 o C for 30 minutes at 3 bar; or
an equivalent production process approved in accordance with the procedure referred to in Article 33(2).]
Importation
[F1Member States must authorise the importation of gelatine and hydrolysed proteins if they:
come from third countries that appear on the list in Part XI of Annex XI;
come from a processing plant that appears on the list referred to in Article 29(4);
have been produced in accordance with this Regulation; and
[F3are accompanied by a health certificate that conforms to the models set out in Chapter 11 and Chapter 12 of Annex X as appropriate.] ]
The following conditions apply in addition to the general conditions laid down in Chapter I.
ensures that all Category 3 bone-material is finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at a minimum concentration of 4 % and a pH of less than 1,5) over a period of at least two days;
following the procedure at (a), applies a treatment of the obtained phosphoric liquor with lime, resulting in a precipitate of dicalcium phosphate at pH 4 to 7; and
finally, air dries the precipitate of dicalcium phosphate with inlet temperature of 65 o C to 325 o C and end temperature between 30 o C and 65 o C, or
by an equivalent process approved in accordance with the procedure referred to in Article 33(2).
comes from third countries that appear on the list in Part XI of Annex XI;
comes from a processing plant that appears on the list referred to in Article 29(4);
has been produced in accordance with this Regulation; and
[F3is accompanied by a health certificate that conforms to the model set out in Chapter 12 of Annex X.] ]
The following conditions apply in addition to the general conditions laid down in Chapter I.
that all Category 3 bone-material is finely crushed and degreased in counter-flow with hot water (bone chips less than 14 mm);
[F3continuous cooking with steam at 145 o C during 30 minutes at 4 bars;]
separation of the protein broth from the hydroxyapatite (tricalcium phosphate) by centrifugation; and
granulation of the tricalcium phosphate after drying in a fluid bed with air at 200 o C; or
by an equivalent production process approved in accordance with the procedure referred to in Article 33(2).
comes from third countries that appear on the list in Part XI of Annex XI;
comes from a processing plant that appears on the list referred to in Article 29(4);
has been produced in accordance with this Regulation; and
[F3is accompanied by a health certificate that conforms to the model set out in Chapter 12 of Annex X.] ]
The following conditions apply in addition to the general conditions laid down in Chapter I.
a room must be provided for storing materials for wrapping and packaging;
wrapping and packaging must take place in a room or in a place intended for that purpose; and
wrapping and packages containing collagen must be labelled with the words ‘ collagen suitable for animal consumption ’ .
comes from a third country that appears on a Community list set out in Part XI of Annex XI;
comes from a plant that appears on the list referred to in Article 29(4);
has been produced in accordance with this Regulation; and
is accompanied by a health certificate that conforms to the model set out in Chapter 11 of Annex X.
Textual Amendments
The following conditions apply in addition to the general conditions laid down in Chapter I.
submitted to any of processing Methods 1 to 5 or 7; or
submitted to a method and parameters which ensure that the products comply with the microbiological standards set in Chapter I, paragraph 10; or
treated in accordance with Chapter V of the Annex to Council Directive 89/437/EC (5) laying down hygiene and health problems affecting the production and the placing on the market of egg products.
come from a third country that appears on a Community list set out in Part XVI of Annex XI;
come from a plant that appears on the list referred to in Article 29(4);
have been produced in accordance with this Regulation; and
are accompanied by a health certificate that conforms to the model set out in Chapter 15 of Annex X.]
Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (OJ L 24, 30.1.1998, p. 9).
Commission Decision 95/340/EC of 27 July 1995 drawing up a provisional list of third countries from which Member States authorise imports of milk and milk-based products and revoking Decision 94/70/EC (OJ L 200, 24.8.1995, p. 38). Decision as last amended by Decision 96/584/EC (OJ L 255, 9.10.1996, p. 20).