Commission Regulation (EU) No 142/2011Show full title

Section 4 U.K. Specific requirements for milk, colostrum and certain other products derived from milk or colostrum

Part I U.K. General requirements

A. Raw material U.K.

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.

B. Processing standards U.K.

1. Milk must be subjected to one of the following treatments: U.K.

1.1.

sterilisation at an F₀ (1) value of three or more;

1.2.

UHT(2) combined with one of the following:

(a)

a subsequent physical treatment, by:

(i)

a drying process, combined in the case of milk intended for feeding with additional heating to 72 °C or more; or

(ii)

lowering the pH below 6 for at least 1 hour;

(b)

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 [F1 country] of origin;

1.3.

HTST(3) applied twice;

1.4.

HTST in combination with one of the following:

(a)

a subsequent physical treatment, by:

(i)

a drying process, combined in the case of milk intended for feeding with additional heating to 72 °C or more; or

(ii)

lowering the pH below 6,0 for at least 1 hour;

(b)

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 [F2 country] of origin.

Textual Amendments

F1 Word 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)

F2 Word 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)

2. Milk-based products and milk-derived products must either be subjected to at least one of the treatments provided for in point 1 or be produced from milk treated in accordance with point 1. U.K.

3. Whey to be fed to animals of species susceptible to foot-and-mouth disease and produced from milk treated in accordance with point 1 must: U.K.

(a)

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

(b)

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 [F3 country] of origin.

Textual Amendments

F3 Word 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)

4. In addition to the requirements set out in points 1, 2 and 3, milk, milk-based products and milk-derived products must meet the following requirements: U.K.

4.1.

after completion of the processing, every precaution must be taken to prevent contamination of the products;

4.2.

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:

(a)

packed in new containers; or

(b)

transported in bulk in containers or other means of transport that before use were thoroughly cleansed and disinfected.

5. Raw milk must be produced under conditions offering adequate guarantees as regards animal health. U.K.

6. Colostrum and colostrum products must: U.K.

6.1.

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 [F4 taken with the Annexes to which they refer, reading the relevant provisions as if:

(a)

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

(b)

in Annex D, in Chapter 1—

(i)

in the title, for the reference to “, Member States” there were substituted a reference to “countries”;

(ii)

in Section A(iii), for the reference to “Member State” there were substituted a reference to “country”;

(iii)

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”;]

6.2.

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 [F5 country] of origin;

6.3.

have undergone a single HTST treatment(3);

6.4.

comply with the requirements set out in point 4 of this Part.

Textual Amendments

F4 Words 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)

F5 Word 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)

Part II U.K. Derogation for the placing on the market of milk processed in accordance with national standards

[F6 1. The requirements laid down in points 2 and 3 of this Part shall apply to the processing, use and storage of milk, milk-based products and milk-derived products which are Category 3 material, as referred to in Article 10(e) of Regulation (EC) No 1069/2009, other than centrifuge or separator sludge, and milk, milk-based products and milk-derived products referred to in Article 10(f) and (h) of that Regulation, that have not been processed in accordance with Part I of this Section.] U.K.

Textual Amendments

F6 Substituted 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).

2. The competent authority shall authorise milk processing establishments approved or registered in accordance with Article 4 of Regulation (EC) No 853/2004 to supply milk, milk-based products and milk-derived products for the purposes referred to in point 3 of this Part provided the establishment concerned ensures the traceability of the products. U.K.

3. Milk, milk-based products and milk-derived products may be supplied and used as feed material: U.K.

(a)

in [F7 Great 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:

(i)

UHT;

(ii)

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;

(iii)

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;

(b)

in [F8 Great Britain],

(i)

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 [F9 appropriate authority] in preparation of the contingency plans for epizootic diseases, in particular foot-and-mouth disease;

(ii)

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 [F10 appropriate 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 [F11 United Kingdom], or

• to another holding in the [F11 United 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 [F11 United 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

F7 Words 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)

F8 Words 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)

F9 Words 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)

F10 Words 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)

F11 Words 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)

4. The competent authority may authorise the supply of colostrum which does not comply with the conditions set out in point B.6 of Part I from one farmer [F12 in Great Britain] to another farmer within the [F13 United Kingdom] for feeding purposes, under conditions which prevent the transmission of health risks. U.K.

Textual Amendments

F12 Words 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)

F13 Words 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)

Part III U.K. Special requirements for centrifuge or separator sludge

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.

[F14 By 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 [F15 constituent 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

F14 Inserted 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).

F15 Words 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)

(1)

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.

(2)

UHT = Ultra High Temperature treatment at 132 °C for at least one second.

(3)

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.