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Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (Text with EEA relevance)
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Microbiological standards for derived products
The following microbiological standards shall apply to derived 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.
However, the microbiological standards set out in this Chapter shall not apply to rendered fats and fish oil from the processing of animal by-products, when the processed animal protein, which is obtained during the same processing, is subject to sampling to ensure compliance with those standards.
Black Soldier Fly ( Hermetia illucens ) and Common Housefly ( Musca domestica );
Yellow Mealworm ( Tenebrio molitor ) and Lesser Mealworm ( Alphitobius diaperinus );
House cricket ( Acheta domesticus ), Banded cricket ( Gryllodes sigillatus ) and Field Cricket ( Gryllus assimilis ).]
Textual Amendments
F1Substituted by Commission Regulation (EU) 2017/893 of 24 May 2017 amending Annexes I and IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council and Annexes X, XIV and XV to Commission Regulation (EU) No 142/2011 as regards the provisions on processed animal protein (Text with EEA relevance).
However,
porcine blood or fractions of porcine blood for the production of bloodmeal may have been submitted instead to any of the processing methods 1 to 5 or processing method 7 as set out in Chapter III of Annex IV, provided that in the case of processing method 7, a heat treatment throughout its substance at a temperature of 80 °C has been applied;
processed animal protein of mammalian origin
may have been submitted to any of the processing methods 1 to 5 or processing method 7, as set out in Chapter III of Annex IV, provided that it is subsequently disposed of or used as a fuel for combustion;
where it is exclusively destined for use in petfood, it may have been submitted to any of the processing methods 1 to 5 or processing method 7, as set out in Chapter III of Annex IV, provided that it is:
transported in dedicated containers that are not used for the transport of animal by-products or feedingstuffs for farmed animals, and
consigned directly from a processing plant for Category 3 material to the petfood plant or to an approved storage plant, from where it is directly consigned to a petfood plant.
any of the processing methods set out in Chapter III of Annex IV; or
another method which ensures that the product complies with the microbiological standards for derived products set in Chapter I of this Annex.
Sufficient measures must be taken to minimise condensation inside bins, conveyors or elevators.
All storage facilities must be emptied and cleaned regularly, to the extent necessary to prevent contamination.
Leakages and condensation in the storage area must be prevented.
Only blood referred to in Article 10(a) and Article 10(b)(i) of Regulation (EC) No 1069/2009 may be used for the production of blood products.
Blood products must have been submitted to:
any of the processing methods 1 to 5 or processing method 7, as set out in Chapter III of Annex IV; or
another method which ensures that the blood product complies with the microbiological standards for derived products set out in Chapter I of this Annex.
Only Category 3 material, other than Category 3 materials referred to in Article 10(n), (o) and (p) of Regulation (EC) No 1069/2009, may be used for the production of rendered fat.]
Textual Amendments
F2Substituted by Commission Regulation (EU) 2015/9 of 6 January 2015 amending Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (Text with EEA relevance).
Only Category 3 material referred to in Article 10(i), (j) and (l) of Regulation (EC) No 1069/2009 and Category 3 material of aquatic animal origin referred to in Article 10(e) and (f) of that Regulation may be used for the production of fish oil.]
Textual Amendments
Unless the fish oil or rendered fats have been produced in accordance with Sections VIII or XII of Annex III to Regulation (EC) No 853/2004, respectively, rendered fats must be produced using any of the processing methods 1 to 5 or processing method 7, and fish oils may be produced:
using processing methods 1 to 7, as set out in Chapter III of Annex IV; or
in accordance with another method which ensures that the product complies with the microbiological standards for derived products set out in Chapter I of this Annex.
Rendered fats derived from ruminant animals must be purified in such a way that the maximum level of remaining total insoluble impurities does not exceed 0,15 % in weight.
Fat derivatives from Category 3 rendered fats or fish oil shall be produced in accordance with one of the processing methods referred to in Chapter III of Annex IV.
Where rendered fat or fish oil is packaged, it must be packaged in new containers or in containers that have been cleaned and disinfected if necessary for the prevention of contamination and all precautions must be taken to prevent its recontamination.
Where bulk transport of those 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 directly to plants must be clean before use.
Only milk referred to in Article 10(e) of Regulation (EC) No 1069/2009, other than centrifuge or separator sludge, and milk referred to in Article 10(f) and (h) of Regulation (EC) No 1069/2009 may be used for the production of milk, milk-based products and milk-derived products.
Colostrum may only be used provided that it originates from live animals that did not show any signs of disease communicable through the colostrum to humans or animals.
sterilisation at an F0 (1) value of three or more;
UHT(2) combined with one of the following:
a subsequent physical treatment, by:
a drying process, combined in the case of milk intended for feeding with additional heating to 72 °C or more; or
lowering the pH below 6 for at least 1 hour;
the condition that the milk, milk-based product or milk-derived product has been produced at least 21 days before shipping and that during that period no case of foot-and-mouth disease has been detected in the [F4country] of origin;
HTST(3) applied twice;
HTST in combination with one of the following:
a subsequent physical treatment, by:
a drying process, combined in the case of milk intended for feeding with additional heating to 72 °C or more; or
lowering the pH below 6,0 for at least 1 hour;
the condition that the milk, milk-based product or milk-derived product has been produced at least 21 days before shipping and that during that period no case of foot-and-mouth disease has been detected in the [F5country] of origin.
Textual Amendments
F4Word in Annex 10 Ch. 2 Section 4 Pt. 1 point B(1.2)(b) substituted (E.W.S) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(57)(a)(i)
F5Word in Annex 10 Ch. 2 Section 4 Pt. 1 point B(1.4)(b) substituted (E.W.S) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(57)(a)(i)
either be collected at least 16 hours following milk clotting and its pH must be recorded as below 6,0 before transport to animal holdings; or
have been produced at least 21 days before shipping and during that period no case of foot-and-mouth disease has been detected in the [F6country] of origin.
Textual Amendments
F6Word in Annex 10 Ch. 2 Section 4 Pt. 1 point B(3)(b) substituted (E.W.S) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(57)(a)(i)
after completion of the processing, every precaution must be taken to prevent contamination of the products;
the final product must be labelled so as to indicate that it contains Category 3 material and is not intended for human consumption, and it must be:
packed in new containers; or
transported in bulk in containers or other means of transport that before use were thoroughly cleansed and disinfected.
be obtained from bovine animals kept on a holding on which all bovine herds are recognised as officially tuberculosis-free, officially brucellosis-free and officially enzootic-bovine-leukosis-free as defined in Article 2(2)(d), (f) and (j) of Directive 64/432/EEC [F7taken with the Annexes to which they refer, reading the relevant provisions as if:
in Annexes A.1 and A.2, for references to “a Member State” or “Member States” there were substituted references to “a constituent nation” or “constituent nations”; and
in Annex D, in Chapter 1—
in the title, for the reference to “, Member States” there were substituted a reference to “countries”;
in Section A(iii), for the reference to “Member State” there were substituted a reference to “country”;
in Section B(iv), for the reference to “Directive 72/462/EEC” there were substituted a reference to “Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products and the Trade in Animals and Related Products Regulations 2011, the Trade in Animals and Related Products (Wales) Regulations 2011 or the Trade in Animals and Related Products (Scotland) Regulations 2012”;]
have been produced at least 21 days before shipping and during that period no case of foot-and-mouth disease has been detected in the [F8country] of origin;
have undergone a single HTST treatment(3);
comply with the requirements set out in point 4 of this Part.
Textual Amendments
F7Words in Annex 10 Ch. 2 Section 4 Pt. 1 point B(6.1) inserted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(57)(a)(ii)
F8Word in Annex 10 Ch. 2 Section 4 Pt. 1 point B(6.2) substituted (E.W.S) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(57)(a)(i)
Textual Amendments
F9Substituted by Commission Regulation (EU) No 294/2013 of 14 March 2013 amending and correcting Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (Text with EEA relevance).
in [F10Great Britain], in the case of derived products, including white water, which have been in contact with raw milk and/or milk pasteurised in accordance with the requirements for heat treatment set out in point II.1(a) or (b) of Chapter II of Section IX of Annex III to Regulation (EC) No 853/2004, if those derived products have been subject to one of the following treatments:
UHT;
sterilisation whereby either an Fc value equal or greater than 3 is achieved, or which was carried out at a temperature of at least 115 °C for 15 minutes or an equivalent combination of temperature and time;
pasteurisation or sterilisation, other than that referred to in point (ii), followed by:
in the case of dried milk or dried milk-based products or milk-derived products, a drying process;
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 [F11Great Britain],
in the case of derived products, including white water, which have been in contact with milk that has only been pasteurised in accordance with the requirements for heat treatment set out in point II.1 (a) of Chapter II of Section IX of Annex III to Regulation (EC) No 853/2004, and whey produced from non heat-treated milk-based products, which has been collected at least 16 hours after milk clotting and where the pH must be recorded as < 6,0 before supplying the whey for feeding, provided that they are sent to a limited number of authorised animal holdings, fixed on the basis of the risk assessment for the best and worst case scenarios carried out by the [F12appropriate authority] in preparation of the contingency plans for epizootic diseases, in particular foot-and-mouth disease;
in the case of raw products, including white water that has been in contact with raw milk and other products for which the treatments referred to in point (a) and point (b)(i) cannot be ensured, provided that they are sent to a limited number of authorised animal holdings, fixed on the basis of a risk assessment for the best and worst case scenarios carried out by the [F13appropriate authority] in preparation of the contingency plans for epizootic diseases, in particular foot-and-mouth disease, and provided that the animals present in the authorised animal holdings can only be moved
either directly to a slaughterhouse located in the [F14United Kingdom], or
to another holding in the [F14United Kingdom], for which the competent authority guarantees that animals susceptible to foot-and-mouth disease may leave the holding only either directly to a slaughterhouse located in the [F14United Kingdom], or if the animals have been dispatched to a holding not feeding the products referred to in this point (ii), after a 21-day standstill period has elapsed from the introduction of the animals.
Textual Amendments
F10Words in Annex 10 Ch. 2 Section 4 Pt. 2 point 3(a) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(57)(b)(i)
F11Words in Annex 10 Ch. 2 Section 4 Pt. 2 point 3(b) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(57)(b)(ii)(aa)
F12Words in Annex 10 Ch. 2 Section 4 Pt. 2 point 3(b)(i) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(57)(b)(ii)(bb)
F13Words in Annex 10 Ch. 2 Section 4 Pt. 2 point 3(b)(ii) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(57)(b)(ii)(bb)
F14Words in Annex 10 Ch. 2 Section 4 Pt. 2 point 3(b)(ii) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(57)(b)(ii)(cc)
Textual Amendments
F15Words in Annex 10 Ch. 2 Section 4 Pt. 2 point 4 inserted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(57)(b)(iii)(aa)
F16Words in Annex 10 Ch. 2 Section 4 Pt. 2 point 4 substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(57)(b)(iii)(bb)
Category 3 material comprising of centrifuge or separator sludge must have been subjected to a heat treatment of at least 70 °C for 60 minutes or of at least 80 °C for 30 minutes, before it may be placed on the market for feeding to farmed animals.
[F17By way of derogation from the first paragraph, the competent authority may authorise alternative parameters for the heat treatment of centrifuge or separator sludge destined for uses within [F18constituent nations whose appropriate authorities] have authorised those alternative parameters, provided operators can demonstrate that the heat treatment according to the alternative parameters guarantees at least the same risk reduction as the treatment carried out according to the parameters set out in the first paragraph.]
Textual Amendments
F17Inserted by Commission Regulation (EU) 2015/9 of 6 January 2015 amending Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (Text with EEA relevance).
F18Words in Annex 10 Ch. 2 Section 4 Pt. 3 substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(57)(c)
Only animal by-products which are Category 3 material or products which are derived from such animal by-products, other than materials referred to in Article 10(m), (n), (o) and (p) of Regulation (EC) No 1069/2009 may be used for the production of gelatine and hydrolysed protein.
The pH must be adjusted subsequently. Gelatine must be extracted by heating one or several times in succession, followed by purification by means of filtration and sterilisation.
Gelatine must be wrapped, packaged, stored and transported under satisfactory hygiene conditions.
In particular:
a room or a dedicated place 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.
Hydrolysed protein must be produced using a production process involving appropriate measures to minimise contamination. Hydrolysed protein derived from ruminants shall have a molecular weight below 10 000 Dalton.
In addition to the requirements of the first paragraph, 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 °C and subsequently by heat treatment at more than 140 °C for 30 minutes at more than 3,6 bar; or
a pH of 1 to 2, followed by a pH of more than 11, followed by heat treatment at 140 °C for 30 minutes at 3 bar.
Only animal by-products which are Category 3 material or products which are derived from such animal by-products, other than materials referred to in Article 10(m), (n), (o) and (p) of Regulation (EC) No 1069/2009 may be used for the production of dicalcium phosphate.
firstly, ensures that all bone that is Category 3 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;
secondly, following the part of the process referred to in point (a), applies a treatment of the obtained phosphoric liquor with lime, resulting in a precipitate of dicalcium phosphate at pH 4 to 7;
finally, air-dries the precipitate of dicalcium phosphate with inlet temperature of 65 °C to 325 °C and end temperature between 30 °C and 65 °C.
Only animal by-products which are Category 3 material or products which are derived from such animal by-products, other than materials referred to in Article 10(m), (n), (o) and (p) of Regulation (EC) No 1069/2009 may be used for the production of tricalcium phosphate.
Tricalcium phosphate must be produced by a process that ensures:
that all bone that is Category 3 material is finely crushed and degreased in counterflow with hot water (bone chips must be less than 14 mm);
continuous cooking with steam at 145 °C during 30 minutes at 4 bars;
separation of the protein broth from the hydroxyapatite (tricalcium phosphate) by centrifugation;
granulation of the tricalcium phosphate after drying in a fluidised bed with air at 200 °C.
Only animal by-products which are Category 3 material or products which are derived from such animal by-products, other than materials referred to in Article 10(m), (n), (o) and (p) of Regulation (EC) No 1069/2009 may be used for the production of collagen.
After that treatment collagen may undergo a drying process.
Textual Amendments
F19Words in Regulation substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(2)(a)
Collagen must be wrapped, packaged, stored and transported under satisfactory hygiene conditions. In particular:
a room or a dedicated place 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.
Only animal by-products referred to in Article 10(e) and (f) and Article 10(k)(ii) of Regulation (EC) No 1069/2009 may be used for the production of egg products.
Egg products must have been:
submitted to any of the processing methods 1 to 5 or processing method 7 set out in Chapter III of Annex IV;
submitted to another method and parameters which ensure that the products comply with the microbiological standards for derived products set out in Chapter I; or
treated in accordance with the requirements for eggs and egg products set out in Chapters I, II and III of Section X of Annex III to Regulation (EC) No 853/2004.
Category 3 material comprising of foodstuffs containing products of animal origin originating from [F20the British Islands] which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise, referred to in Article 10(f) of Regulation (EC) No 1069/2009, may be placed on the market for feeding to farmed animals, other than fur animals, without further treatment, provided that the material:
Textual Amendments
F20Words in Annex 10 Ch. 2 Section 10 substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(58)
has undergone processing as defined in Article 2(1)(m) of Regulation (EC) No 852/2004 or in accordance with this Regulation;
is composed of or contain one or more of the following Category 3 materials referred to in Article 10(f) of Regulation (EC) No 1069/2009:
milk,
milk-based products,
milk-derived products,
eggs,
egg products,
honey,
rendered fats,
collagen,
gelatine;
has not been in contact with any other Category 3 materials; and
all necessary precautions have been taken to prevent the contamination of the material.]
be handled and processed separately from material not authorised for that purpose;
originate
from wild fish or other aquatic animals, except sea mammals, landed for commercial purposes, or from animal by-products from wild fish originating in plants manufacturing fish products for human consumption; or
from farmed fish, provided it is fed to farmed fish of another species;
be processed in a processing plant in accordance with a method which ensures a microbiologically safe product, including with regard to fish pathogens.
as feed for farmed fish or for aquatic invertebrates, when the animal by-products have not been processed in accordance with point 1(c);
as fishing bait, including bait for aquatic invertebrates.
F0 is the calculated killing effect on bacterial spores. An F0 value of 3, 00 means that the coldest point in the product has been heated sufficiently to achieve the same killing effect as 121 °C (250 °F) in three minutes with instantaneous heating and chilling.
UHT = Ultra High Temperature treatment at 132 °C for at least one second.
HTST = High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or equivalent pasteurisation effect achieving a negative reaction to a phosphatase test.
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