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 establishing the European
Community,
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) Regulation (EC) No 1774/2002 lays down health rules
concerning animal by-products not intended for humanconsumption. It provides that animal by-products thatmay be used as feed material have to be processed inaccordance with the requirements laid down in thatRegulation.
(2) Annex VII to Regulation (EC) No 1774/2002 sets outspecific hygiene requirements for the processing andplacing on the market of processed animal protein andother processed products that could be used as feedmaterial. In particular, Chapter V of that Annexprovides for specific requirements for the processing ofmilk, milk products and colostrum.
(3) In accordance with the first paragraph of Article 28 ofRegulation (EC) No 1774/2002 the provisions applicableto the importation of products referred to in Annexes VIIand VIII to that Regulation from non-member countriesare not to be more favourable or less favourable thanthose applicable to the production and marketing ofthose products in the Community. Chapter V of AnnexVII to that Regulation should therefore be amended, in
order to introduce certain technical amendments, to
harmonise the processing standards for milk and milk
products and to clarify the import requirementsapplicable to them.
(4) Following the opinion of the European Food SafetyAuthority, adopted on 29 March 2006, related to theanimal health risks of feeding animals with ready-to-usedairy products without further treatment (
2), it is appro-
priate to amend the specific hygiene requirements formilk, milk-based products and colostrums. Accountshould also be taken of the methods for the inactivationof possible foot-and-mouth disease virus in milkdescribed in the 1999 Report of the ScientificCommittee on Animal Health and Animal Welfare ona Strategy for Emergency Vaccination against Foot-and-Mouth Disease (
3) and of Appendix 3.6.2 of the
Terrestrial Animal Health Code (4), 2005 edition, of the
World Organisation for Animal Health (OIE).
(5) Taking account of the amended specific hygienerequirements in Chapter V of Annex VII to Regulation(EC) No 1774/2002, it is appropriate to replace themodel health certificates in Chapters 2(A), 2(B) and2(C) of Annex X to that Regulation by a single modelcertificate for the importation from third countries ofmilk and milk products not intended for human
consumption.
(6) 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 ofanimal by-products not intended for humanconsumption.
(7) Annexes VII, X and XI to Regulation (EC) No 1774/2002should therefore be amended accordingly.EN 22.5.2008 Official Journal of the European Union L 132/7
(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(8) The measures provided for in this Regulation are in
accordance with the opinion of the StandingCommittee on the Food Chain and Animal Health,
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.Article 2
This Regulation shall be applicable from 1 May 2008.
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 amendmentby 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 CommissionEN L 132/8 Official Journal of the European Union 22.5.2008ANNEX
Regulation (EC) No 1774/2002 is amended as follows:
(1) In Annex VII, Chapter V is replaced by the following:
‘CHAPTER V
Specific requirements for milk, milk products and colostrum
The following conditions apply in addition to the general conditions laid down in Chapter I.
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.EN 22.5.2008 Official Journal of the European Union L 132/95. 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).
___________
(*) F0is the calculated killing effect on bacterial spores. An F0value 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 withinstantaneous 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.
(****) OJ L 154, 30.4.2004, p. 72, as corrected by OJ L 189, 27.5.2004, p. 57. ’EN L 132/10 Official Journal of the European Union 22.5.2008(2) In Annex X, Chapters 2(A), 2(B) and 2(C) are replaced by the following:
‘CHAPTER 2
EN 22.5.2008 Official Journal of the European Union L 132/11EN L 132/12 Official Journal of the European Union 22.5.2008(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. ’EN 22.5.2008 Official Journal of the European Union L 132/13