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[F1Commission Regulation (EU) No 605/2010

of 2 July 2010

laying down animal and public health and veterinary certification conditions for the introduction into the European Union of raw milk, dairy products, colostrum and colostrum-based products intended for human consumption]

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption(1), and in particular the introductory phrase of Article 8, the first subparagraph of point (1) and point (4) of Article 8 and Article 9(4) thereof,

Having regard to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs(2), and in particular Article 12 thereof,

Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin(3), and in particular Article 9 thereof,

Having regard to Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption(4), and in particular Articles 11(1) and 14 (4) and Article 16 thereof,

Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules(5), and in particular Article 48 (1) thereof,

Whereas:

(1) Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products(6) provided for a list to be drawn up of third countries or parts thereof from which Member States were to authorise the introduction of milk or milk-based products and for such commodities to be accompanied by a health certificate and comply with certain requirements, including heat treatment requirements, and guarantees.

(2) Accordingly, Commission Decision 2004/438/EC of 29 April 2004 laying down animal and public health and veterinary certifications conditions for introduction in the Community of heat-treated milk, milk-based products and raw milk intended for human consumption(7) was adopted.

(3) Since the date of adoption of that Decision, a number of new animal health and public health requirements have been laid down, constituting a new regulatory framework in this area, which should be taken into account in this Regulation. In addition, Directive 92/46/EEC was repealed by Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain Directive concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption(8).

(4) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(9) lays down the general principles governing food and feed in general, and food and feed safety in particular, at European Union and national level.

(5) Directive 2002/99/EC lays down rules governing the introduction from third countries of products of animal origin intended for human consumption. It provides that such products are only to be introduced into the European Union if they comply with the requirements applicable to all stages of the production, processing and distribution of those products in the European Union or if they offer equivalent animal health guarantees.

(6) Regulation (EC) No 852/2004 lays down the general rules for food business operators on the hygiene of foodstuffs at all stages of the food chain, including at primary production level.

(7) Regulation (EC) No 853/2004 lays down specific rules for food business operators on the hygiene of food of animal origin. That Regulation provides that food business operators producing raw milk and dairy products intended for human consumption are to comply with the relevant provisions of Annex III thereto.

(8) Regulation (EC) No 854/2004 lays down specific rules for the organisation of official controls on products of animal origin.

(9) Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs(10) lays down the microbiological criteria for certain micro-organisms and the implementing rules to be complied with by food business operators when implementing the general and specific hygiene measures referred to in Article 4 of Regulation (EC) No 852/2004. Regulation (EC) No 2073/2005 provides that food business operators are to ensure that foodstuffs comply with the relevant microbiological criteria set out in that Regulation.

(10) Under the scope of Council Directive 92/46/EEC, raw milk and products thereof could only be obtained from cows, ewes, goats or buffaloes. However, the definitions of raw milk and dairy products set out in Annex I to Regulation (EC) No 853/2004 broadens the scope of milk hygiene rules to all mammalian species and defines raw milk as milk produced by the secretion of the mammary gland of farmed animals that has not been heated to more than 40 °C or undergone any treatment that has an equivalent effect. In addition, it defines dairy products as processed products resulting from the processing of raw milk or from further processing of such processed products.

(11) In view of the entry into application of Regulations (EC) Nos 852/2004, 853/2004 and 854/2004 and the acts implementing those Regulations, it is necessary to amend and update European Union public and animal health conditions and certification requirements for the introduction into the European Union of raw milk and dairy products intended for human consumption.

(12) In the interests of consistency of Union law, this Regulation should also take into account the rules laid down in Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council(11) and its implementing rules laid down in Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin(12) and Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC(13).

(13) Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products(14) lays down the rules to be observed in issuing certificates required by veterinary legislation to prevent misleading or fraudulent certification. It is appropriate to ensure that certification requirements at least equivalent to those laid down in that Directive are applied by the competent authorities of exporting third countries.

(14) In addition, Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the intenal market(15), provides for a computerized system linking veterinary authorities which has been developed in the Europena Union. The format of all model health certificates need to be amended to take into account their compatibility with possible electronic certification under the Trade Control and Expert System (TRACES) provided for in Directive 90/425/EEC. According, the rules laid down in this Regulation should take account of TRACES.

(15) 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(16) lays down rules concerning veterinary checks on products of animal origin introduced into the European Union from third countries for their importation or transit, including certain certification requirements. Those rules are applicable to the commodities covered by this Regulation.

(16) Specific conditions for transit via the European Union of consignments to and from Russia should be provided for, owing to the geographical situation of Kaliningrad, which only concerns Latvia, Lithuania and Poland.

(17) In the interests of clarity of European law, Commission Decision 2004/438/EC should be repealed and replaced by this Regulation.

(18) To avoid any disruption in trade, the use of health certificates issued in accordance with Decision 2004/438/EC should be authorised during a transitional period.

(19) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Textual Amendments

Article 1U.K.Subject matter and scope

[F21.]This Regulation lays down:

(a)

[F1the public and animal health conditions and certification requirements for the introduction into [F3Great Britain] of consignments of raw milk, dairy products, colostrum and colostrum-based products;]

(b)

the list of third countries from which the introduction into [F4Great Britain] of such consignments is authorised.

[F5This Regulation shall apply without prejudice to any specific certification requirements laid down in other [F6United Kingdom agreements] with third countries.]

[F72.In this Regulation:

Textual Amendments

[F1 Article 2 U.K. Importation of raw milk, dairy products, colostrum and colostrum-based products from third countries or parts thereof F8...

[F9The appropriate authority] shall authorise the importation of consignments of raw milk, dairy products, colostrum and colostrum-based products from [F10such of the third countries listed in Annex 1, or parts thereof, as the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this Article].]

Textual Amendments

Article 3U.K.Imports of certain dairy products from third countries or parts thereof [F11not at risk of foot-and-mouth disease]

[F12The appropriate authority shall authorise the importation of consignments of dairy products derived from raw milk of cows, ewes, goats or buffaloes from such of the third countries listed in Annex 1, or parts thereof, not at risk from foot-and-mouth disease as the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this Article, provided that such dairy products have undergone, or been produced from raw milk which has undergone, a pasteurisation treatment involving a single heat treatment—]

(a)

with a heating effect at least equivalent to that achieved by a pasteurisation process of at least 72 °C for 15 seconds;

(b)

where applicable, sufficient to ensure a negative reaction to an alkaline phosphatase test applied immediately after the heat treatment.

Textual Amendments

Article 4U.K.Imports of certain dairy products from third countries or parts thereof [F13at risk of foot-and-mouth disease]

1.[F14The appropriate authority shall authorise the importation of consignments of the dairy products listed in paragraph 1A, provided that the dairy products have undergone, or been produced from raw milk which has undergone, a heat treatment involving—]

(a)a sterilisation process, to achieve an F0 value equal to or greater than three;

(b)an ultra high temperature (UHT) treatment at not less than 135 °C in combination with a suitable holding time;

(i)

a high temperature short time pasteurisation treatment (HTST) at 72 °C for 15 seconds applied twice to milk with a pH equal to or greater than 7.0 achieving, where applicable, a negative reaction to a alkaline phosphatase test, applied immediately after the heat treatment; or

(ii)

a treatment with an equivalent pasteurisation effect to point (i) achieving, where applicable, a negative reaction to an alkaline phosphatase test, applied immediately after the heat treatment;

(d)a HTST treatment of milk with a pH below 7.0; or

(e)a HTST treatment combined with another physical treatment by either:

(i)

lowering the pH below 6 for one hour, or

(ii)

additional heating equal to or greater than 72 °C, combined with desiccation.

[F151A.The dairy products referred to in paragraph 1 are—

(a)dairy products derived from raw milk of cows, ewes, goats or buffaloes from such of the third countries or territories listed in Annex 1 (excluding the Emirates of Abu Dhabi and Dubai of the United Arab Emirates), or parts thereof, at risk of foot-and-mouth disease as the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this paragraph;

(b)dairy products derived from raw milk from camels of the species Camelus dromedarius from the Emirates of Abu Dhabi and Dubai of the United Arab Emirates, or parts thereof, where such products are specified by the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), in a document published for the purposes of this paragraph.]

2.[F16The appropriate authority] shall authorise the importation of consignments of dairy products derived from raw milk of animals other than those referred to in paragraph 1, from [F17such of the third countries listed in Annex 1 or parts thereof, at risk of foot-and-mouth disease as the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this paragraph], provided that such dairy products have undergone, or been produced from raw milk which has undergone a treatment involving:

(a)a sterilisation process, to achieve an F0 value equal to or greater than three; or

(b)an ultra high temperature (UHT) treatment at not less than 135 °C in combination with a suitable holding time.

Textual Amendments

Article 5U.K.Certificates

[F18Consignments authorised for importation in accordance with Articles 2, 3 and 4 must be accompanied by a health certificate, in the form published by the appropriate authority from time to time, for the commodity concerned and completed in accordance with any accompanying explanatory notes.]

However, the requirements laid down in this Article shall not preclude the use of electronic certification F19....

Textual Amendments

[F1 Article 6 U.K. Transit and storage conditions

The introduction into [F20Great Britain] of consignments of raw milk, dairy products, colostrum and colostrum-based products not intended for importation into [F20Great Britain] but destined for a third country either by immediate transit or after storage in [F21Great Britain], in accordance with [F22Commission Delegated Regulation (EU) 2019/2124], shall only be authorised if the consignments comply with the following conditions:

(a)

they come from a third country or part thereof listed in Annex I for the introduction into [F23Great Britain] of consignments of raw milk, dairy products, colostrum or colostrum-based products and comply with the appropriate treatment conditions for such consignments, as provided for in Articles 2, 3 and 4;

(b)

they comply with the specific animal health conditions for importation into [F24Great Britain] of the raw milk, dairy products, colostrum or colostrum-based products concerned, as laid down in the animal health attestation in [F25the health certificate, in the form published by the appropriate authority from time to time];

(c)

they are accompanied by a health certificate [F26, in the form published by the appropriate authority from time to time and completed in accordance with any accompanying explanatory notes];

(d)

[F27they are certified as acceptable for transit, including for storage as appropriate, on the Common Health Entry Document referred to in Article 2(3) of Commission Implementing Regulation (EU) 2019/2130, signed by the official veterinarian of the border control post of introduction into Great Britain.]]

Textual Amendments

F28Article 7U.K.Derogation concerning transit and storage conditions

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Textual Amendments

F29 Article 7a U.K. Derogation for transit through Croatia of consignments coming from Bosnia and Herzegovina and destined to third countries

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Textual Amendments

[F1 Article 8 U.K. Specific treatment

Consignments of dairy products and colostrum-based products authorised for introduction into [F30Great Britain] in accordance with [F31Articles 2, 3, 4 and 6] from third countries or parts thereof where an outbreak of foot-and-mouth disease has occurred within the period of 12 months preceding the date of signature of the health certificate, or which have carried out vaccination against that disease during that period, shall only be authorised for introduction into [F30Great Britain] if such products have undergone one of the treatments listed in Article 4.]

Textual Amendments

[F32Article 8aU.K.Matters relating to the exercise of powers under this Regulation

1.The powers exercisable by the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), under the provisions listed in paragraph 2 may be exercised only where it is necessary or appropriate to do so in the light of an assessment of the risk to animal or public health in the United Kingdom, taking into account the animal health criteria and the public health criteria.

2.The provisions are—

(a)Article 2 (importation of raw milk, dairy products, colostrum and colostrum-based products from third countries or parts thereof);

(b)Article 3 (importation of dairy products from third countries or parts thereof not at risk of foot-and-mouth disease);

(c)in Article 4 (importation of dairy products from third countries or parts thereof at risk of foot-and-mouth disease), paragraphs 1A(a) and (b) and 2.

3.Any assessment which is relied upon for the purposes of paragraph 1 must have been approved by the Secretary of State, the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales).

4.Where the Scottish Ministers or the Welsh Ministers request that the Secretary of State exercise a power under a provision listed in paragraph 2 the Secretary of State must have regard to that request.

5.In this Article—

Textual Amendments

Article 9U.K.Repeal

Decision 2004/438/EC is repealed.

References to Decision 2004/438/EC shall be construed as references to this Regulation.

F33Article 10U.K.Transitional provisions

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Textual Amendments

Article 11U.K.Entry into force and applicability

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

F34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

This Regulation shall be binding in its entirety and directly applicable in all Member States.

[F1ANNEX I U.K.

Modifications etc. (not altering text)

List of third countries F35... authorised for the introduction into [F36Great Britain] of consignments of raw milk, dairy products, colostrum a and colostrum-based products a and indicating the type of heat treatment required for such commodities

‘+’

:

third country is authorised

‘0’

:

third country is not authorised

a

The colostrum and colostrum-based products can only be introduced into [F37Great Britain] from countries authorised [F38by the Secretary of State with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales)].

F39. . .
F40. . .
b

The former Yugoslav Republic of Macedonia; the definitive nomenclature for this country will be agreed following the conclusion of the negotiations currently taking place on this subject at UN level.

c

Not including Kosovo which is at present under international administration pursuant to United Nations Security Council Resolution 1244 of 10 June 1999 .

d

Only dairy products from camels of the species Camelus dromedarius.

e

Dairy products from camels of the species Camelus dromedarius are authorised. ]

ISO code of third country Third country F41... F42... F43... F44...
[F45AE The Emirates of Abu Dhabi and Dubai of the United Arab Emirates d F42... F43... F44...] e
AD Andorra F42... F43... F44...
AL Albania F42... F43... F44...
AR Argentina F42... F43... F44...
AU Australia F42... F43... F44...
BR Brazil F42... F43... F44...
BW Botswana F42... F43... F44...
BY Belarus F42... F43... F44...
BZ Belize F42... F43... F44...
[F46BA Bosnia and Herzegovina F42... F43... F44...]
CA Canada F42... F43... F44...
CH Switzerland F39. . . F42... F43... F44...
CL Chile F42... F43... F44...
CN China F42... F43... F44...
CO Colombia F42... F43... F44...
CR Costa Rica F42... F43... F44...
CU Cuba F42... F43... F44...
DZ Algeria F42... F43... F44...
ET Ethiopia F42... F43... F44...
[F47EU member States, Liechtenstein and Norway]
GL Greenland F42... F43... F44...
GT Guatemala F42... F43... F44...
HK Hong Kong F42... F43... F44...
HN Honduras F42... F43... F44...
IL Israel F42... F43... F44...
IN India F42... F43... F44...
IS Iceland F40. . . F42... F43... F44...
[F48JP Japan F42... F43... F44...]
KE Kenya F42... F43... F44...
MA Morocco F42... F43... F44...
[F49ME Montenegro F42... F43... F44...]
MG Madagascar F42... F43... F44...
MK b former Yugoslav Republic of Macedonia F42... F43... F44...
MR Mauritania F42... F43... F44...
MU Mauritius F42... F43... F44...
MX Mexico F42... F43... F44...
NA Namibia F42... F43... F44...
NI Nicaragua F42... F43... F44...
NZ New Zealand F42... F43... F44...
PA Panama F42... F43... F44...
PY Paraguay F42... F43... F44...
RS c Serbia F42... F43... F44...
RU Russia F42... F43... F44...
SG Singapore F42... F43... F44...
SV El Salvador F42... F43... F44...
SZ Swaziland F42... F43... F44...
TH Thailand F42... F43... F44...
TN Tunisia F42... F43... F44...
TR Turkey F42... F43... F44...
UA Ukraine F42... F43... F44...
US United States F42... F43... F44...
UY Uruguay F42... F43... F44...
ZA South Africa F42... F43... F44...
ZW Zimbabwe F42... F43... F44...

Textual Amendments

F50ANNEX IIU.K.

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Textual Amendments