Commission Regulation (EC) No 437/2008 of 21 May 2008 amending Annexes VII, X and XI to Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the requirements for the processing of milk and milk products defined as Category 3 material (Text with EEA relevance)
Date: 2008-05-21
Institutions: European Commission
Subjects: food processing, health certificate, health control, import, milk

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COMMISSION REGULATION (EC) No 437/2008

of 21 May 2008

amending Annexes VII, X and XI to Regulation (EC) No 1774/2002 of the European Parliament and
of the Council as regards the requirements for the processing of milk and milk products defined as
Category 3 material

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 1774/2002 of
the
European Parliament and of the Council of 3 October 2002
laying down health rules concerning animal by-products not
intended for human consumption (1),
and in particular
Article 32(1) thereof,

Whereas:

(1)

(2)

(3)

Regulation (EC) No 1774/2002 lays down health rules
concerning animal by-products not intended for human
consumption. It provides that animal by-products that
may be used as feed material have to be processed in
accordance with the requirements laid down in that
Regulation.

Annex VII to Regulation (EC) No 1774/2002 sets out
specific hygiene requirements for the processing and
placing on the market of processed animal protein and
other processed products that could be used as feed
material.
that Annex
provides for specific requirements for the processing of
milk, milk products and colostrum.

In particular, Chapter V of

In accordance with the first paragraph of Article 28 of
Regulation (EC) No 1774/2002 the provisions applicable
to the importation of products referred to in Annexes VII
and VIII to that Regulation from non-member countries
are not to be more favourable or less favourable than
those applicable to the production and marketing of
those products in the Community. Chapter V of Annex

to introduce certain technical amendments,

VII to that Regulation should therefore be amended, in
order
to
harmonise the processing standards for milk and milk
products
requirements
applicable to them.

and to clarify

import

the

the European Food Safety
Following the opinion of
Authority, adopted on 29 March 2006, related to the
animal health risks of feeding animals with ready-to-use
dairy products without further treatment (2), it is appro-
priate to amend the specific hygiene requirements for
milk, milk-based products and colostrums. Account
should also be taken of the methods for the inactivation
in milk
of possible
described
Scientific
Committee on Animal Health and Animal Welfare on
a Strategy for Emergency Vaccination against Foot-and-
Mouth Disease (3)
the
Terrestrial Animal Health Code (4), 2005 edition, of the
World Organisation for Animal Health (OIE).

foot-and-mouth disease
in the 1999 Report of

and of Appendix 3.6.2 of

virus
the

it

the

account of

amended specific hygiene
Taking
requirements in Chapter V of Annex VII to Regulation
(EC) No 1774/2002,
is appropriate to replace the
model health certificates in Chapters 2(A), 2(B) and
2(C) of Annex X to that Regulation by a single model
certificate for the importation from third countries of
milk and milk products not
intended for human
consumption.

It is necessary to update the reference to the specific
health certificate in Part I of Annex XI to Regulation
(EC) No 1774/2002 setting out lists of third countries
from which Member States may authorise imports of
animal
human
consumption.

by-products

intended

not

for

(4)

(5)

(6)

(7)

Annexes VII, X and XI to Regulation (EC) No 1774/2002
should therefore be amended accordingly.

(1) OJ L 273, 10.10.2002, p. 1. Regulation as last amended by
Commission Regulation (EC) No 399/2008 (OJ L 118, 6.5.2008,
p. 12).

(2) http://www.efsa.europa.eu/en/science/ahaw/ahaw_opinions/

1447.html

(3) http://ec.europa.eu/food/fs/sc/scah/out22_en.html
(4) http://www.oie.int/eng/normes/mcode/en_chapitre_3.6.2.htm

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(8)

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

opinion

the

the

of

This Regulation shall be applicable from 1 May 2008.

Article 2

HAS ADOPTED THIS REGULATION:

Article 1

Annexes VII, X and XI to Regulation (EC) No 1774/2002 are
amended in accordance with the Annex to this Regulation.

Consignments
for which veterinary certificates were issued
before 1 November 2008 in accordance with the models estab-
lished by Regulation (EC) No 1774/2002 before its amendment
by the present Regulation, shall be accepted for import into the
Community until 1 February 2009.

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

Done at Brussels, 21 May 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

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ANNEX

Regulation (EC) No 1774/2002 is amended as follows:

(1) In Annex VII, Chapter V is replaced by the following:

Specific requirements for milk, milk products and colostrum

The following conditions apply in addition to the general conditions laid down in Chapter I.

‘CHAPTER V

A. Processing standards

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

1.1. sterilisation at an F0 (*) value of three or more;

1.2. UHT (**) 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 or milk 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 Member State of origin;

1.3. HTST (***) 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 for at least 1 hour;

(b) the condition that the milk or milk 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 Member State of origin.

2. Milk products must either be subjected to at least one of the treatments provided for in paragraph 1 or be

produced from milk treated in accordance with paragraph 1.

3. Whey to be fed to animals of species susceptible to foot-and-mouth disease and produced from milk treated
in accordance with paragraph 1 must be collected at least 16 hours after milk clotting and its pH must be
recorded as below 6,0 before transport to animal holdings.

4.

In addition to the requirements laid down in paragraphs 1, 2 and 3, milk and milk products must meet the
following requirements:

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

(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 using a disinfectant approved for the purpose by the competent authority.

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5. 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).

B.

Importation

1. Member States shall authorise imports of milk and milk products subject to compliance with the following

conditions:

1.1. they come from third countries appearing on the list in Part I of Annex XI;

1.2. they come from a processing plant which appears on the list referred to in Article 29(4);

1.3. they are accompanied by a health certificate conforming to the model laid down in Chapter 2 of Annex X;

1.4. they have undergone at least one of the treatments provided for in paragraphs 1.1, 1.2, 1.3 and point (a) of

paragraph 1.4 of Part A;

1.5. they comply with paragraphs 2 and 4, and, in the case of whey, paragraph 3 of Part A.

2.

By way of derogation from paragraph 1.4, Member States shall authorise imports of milk and milk products
from third countries so authorised in Column “A” of Annex I to Commission Decision 2004/438/EC (****)
provided that the milk or milk products have undergone a single HTST treatment and have been produced:

(i) either at least 21 days before shipping and that during this period no case of foot-and-mouth disease has

been detected in the exporting country; or

(ii) have been presented at an EU border inspection post at least 21 days after production and that during this

period no case of foot-and-mouth disease has been detected in the exporting country.

3. 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).

___________

(*) 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

(****) OJ L 154, 30.4.2004, p. 72, as corrected by OJ L 189, 27.5.2004, p. 57.’

effect achieving a negative reaction to a phosphatase test.

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(2) In Annex X, Chapters 2(A), 2(B) and 2(C) are replaced by the following:

‘CHAPTER 2

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(3) In Annex XI, Part I is replaced by the following:

‘PART I

List of third countries from which Member States may authorise imports of milk and milk products (health
certificate Chapter 2)

Authorised third countries listed in Annex I to Decision 2004/438/EC.’