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)
Commission Regulation (EC) No 437/2008of 21 May 2008amending 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 consumptionOJ 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)., 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 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.(2)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. In particular, Chapter V of that Annex provides for specific requirements for the processing of milk, milk products and colostrum.(3)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 VII 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 requirements applicable to them.(4)Following the opinion of the European Food Safety Authority, adopted on 29 March 2006, related to the animal health risks of feeding animals with ready-to-use dairy products without further treatmenthttp://www.efsa.europa.eu/en/science/ahaw/ahaw_opinions/1447.html, it is appropriate to amend the specific hygiene requirements for milk, milk-based products and colostrums. Account should also be taken of the methods for the inactivation of possible foot-and-mouth disease virus in milk described in the 1999 Report of the Scientific Committee on Animal Health and Animal Welfare on a Strategy for Emergency Vaccination against Foot-and-Mouth Diseasehttp://ec.europa.eu/food/fs/sc/scah/out22_en.html and of Appendix 3.6.2 of the Terrestrial Animal Health Codehttp://www.oie.int/eng/normes/mcode/en_chapitre_3.6.2.htm, 2005 edition, of the World Organisation for Animal Health (OIE).(5)Taking account of the amended specific hygiene requirements in Chapter V of Annex VII to Regulation (EC) No 1774/2002, it 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.(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 of animal by-products not intended for human consumption.(7)Annexes VII, X and XI to Regulation (EC) No 1774/2002 should therefore be amended accordingly.(8)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:
Article 1Annexes VII, X and XI to Regulation (EC) No 1774/2002 are amended in accordance with the Annex to this Regulation.
Article 2This Regulation shall be applicable from 1 May 2008.Consignments for which veterinary certificates were issued before 1 November 2008 in accordance with the models established 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 CommissionAndroulla VassiliouMember of the CommissionANNEXRegulation (EC) No 1774/2002 is amended as follows:(1)In Annex VII, Chapter V is replaced by the following:"CHAPTER VSpecific requirements for milk, milk products and colostrumThe following conditions apply in addition to the general conditions laid down in Chapter I.A.Processing standards1.Milk must be subjected to one of the following treatments:1.1.sterilisation at an F0F0 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. value of three or more;1.2.UHTUHTUltra High Temperature treatment at 132 °C for at least one second. 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.HTSTHTSTHigh Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or equivalent pasteurisation effect achieving a negative reaction to a phosphatase test. applied twice;1.4.HTSTHTSTHigh Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or equivalent pasteurisation effect achieving a negative reaction to a phosphatase test. 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.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.Importation1.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/ECOJ L 154, 30.4.2004, p. 72, as corrected by OJ L 189, 27.5.2004, p. 57." 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.UHTUltra High Temperature treatment at 132 °C for at least one second.HTSTHigh Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or equivalent pasteurisation effect achieving a negative reaction to a phosphatase test.HTSTHigh 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."(2)In Annex X, Chapters 2(A), 2(B) and 2(C) are replaced by the following:"CHAPTER 232008R0437_en_img_132008R0437_en_img_232008R0437_en_img_3(3)In Annex XI, Part I is replaced by the following:"PART IList 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."