Article 1Regulation (EC) No 853/2004 is amended as follows:1.Annex II is amended in accordance with Annex I to this Regulation.2.Annex III is amended in accordance with Annex II to this Regulation.

Article 2This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 6 November 2006.For the CommissionMarkos KyprianouMember of the CommissionANNEX ISection I, Part A, point (2) of Annex II to Regulation (EC) No 853/2004 is replaced by the following:"2.However, when a product's packaging and/or wrapping is removed or it is further processed in another establishment, a new mark must be applied to the product. In such cases, the new mark must indicate the approval number of the establishment where these operations take place."ANNEX IIAnnex III to Regulation (EC) No 853/2004 is amended as follows:1.In Section I, Chapter IV is amended as follows:(a)Point 8 is replaced by the following:"8.Carcases and other parts of the body intended for human consumption must be completely skinned, except in the case of porcine animals, the heads of ovine and caprine animals and calves, the muzzle and lips of bovine animals and the feet of bovine, ovine and caprine animals. Heads, including muzzle and lips, and feet must be handled in such a way as to avoid contamination."(b)Point 16(a) is replaced by the following:"(a)the tonsils of bovine animals, porcine animals and solipeds must be removed hygienically;".2.In Section VIII, Chapter III, Part E is added as follows:"E.REQUIREMENTS FOR FISH OIL FOR HUMAN CONSUMPTIONFood business operators must ensure that raw materials used in the preparation of fish oil for human consumption comply with the following requirements:1.they must derive from fishery products which have been found fit for human consumption;2.they must come from establishments, including vessels, approved in accordance with this Regulation;3.they must be transported and stored until processing in hygienic conditions."3.Section IX is replaced by the following:"SECTION IX: RAW MILK, COLOSTRUM, DAIRY PRODUCTS AND COLOSTRUM-BASED PRODUCTSFor the purpose of this Section,1."Colostrum" means the fluid secreted by the mammary glands of milk-producing animals up to three to five days post parturition that is rich in antibodies and minerals, and precedes the production of raw milk.2."Colostrum-based products" means processed products resulting from the processing of colostrum or from the further processing of such processed products.CHAPTER I: RAW MILK AND COLOSTRUM — PRIMARY PRODUCTIONFood business operators producing or, as appropriate, collecting raw milk and colostrum must ensure compliance with the requirements laid down in this Chapter.I.HEALTH REQUIREMENTS FOR RAW MILK AND COLOSTRUM PRODUCTION1.Raw milk and colostrum must come from animals:(a)that do not show any symptoms of infectious diseases communicable to humans through milk and colostrum;(b)that are in a good general state of health, present no sign of disease that might result in the contamination of milk and colostrum and, in particular, are not suffering from any infection of the genital tract with discharge, enteritis with diarrhoea and fever, or a recognisable inflammation of the udder;(c)that do not have any udder wound likely to affect the milk and colostrum;(d)to which no unauthorised substances or products have been administered and that have not undergone illegal treatment within the meaning of Directive 96/23/EC;(e)in respect of which, where authorised products or substances have been administered, the withdrawal periods prescribed for these products or substances have been observed.2.(a)In particular, as regards brucellosis, raw milk and colostrum must come from:(i)cows or buffaloes belonging to a herd which, within the meaning of Directive 64/432/EECCouncil Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ 121, 29.7.1964, p. 1977/64). Directive as last amended by Regulation (EC) No 21/2004 (OJ L 5, 9.1.2004, p. 8)., is free or officially free of brucellosis;(ii)sheep or goats belonging to a holding officially free or free of brucellosis within the meaning of Directive 91/68/EECCouncil Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (OJ L 46, 19.2.1991, p. 19). Directive as last amended by Commission Decision 2005/932/EC.; or(iii)females of other species belonging, for species susceptible to brucellosis, to herds regularly checked for that disease under a control plan that the competent authority has approved.(b)As regards tuberculosis, raw milk and colostrum must come from:(i)cows or buffaloes belonging to a herd which, within the meaning of Directive 64/432/EEC, is officially free of tuberculosis; or(ii)females of other species belonging, for species susceptible to tuberculosis, to herds regularly checked for this disease under a control plan that the competent authority has approved.(c)If goats are kept together with cows, such goats must be inspected and tested for tuberculosis.3.However, raw milk from animals that does not meet the requirements of point 2 may be used with the authorisation of the competent authority:(a)in the case of cows or buffaloes that do not show a positive reaction to tests for tuberculosis or brucellosis, nor any symptoms of these diseases, after having undergone a heat treatment such as to show a negative reaction to the alkaline phosphatase test;(b)in the case of sheep or goats that do not show a positive reaction to tests for brucellosis, or which have been vaccinated against brucellosis as part of an approved eradication programme, and which do not show any symptom of that disease, either:(i)for the manufacture of cheese with a maturation period of at least two months; or(ii)after having undergone heat treatment such as to show a negative reaction to the alkaline phosphatase test; and(c)in the case of females of other species that do not show a positive reaction to tests for tuberculosis or brucellosis, nor any symptoms of these diseases, but belong to a herd where brucellosis or tuberculosis has been detected after the checks referred to in point 2(a)(iii) or 2(b)(ii), if treated to ensure its safety.4.Raw milk and colostrum from any animal not complying with the appropriate requirements of points 1 to 3, and in particular, any animal showing individually a positive reaction to the prophylactic tests vis-à-vis tuberculosis or brucellosis as laid down in Directive 64/432/EEC and Directive 91/68/EEC, must not be used for human consumption.5.The isolation of animals that are infected, or suspected of being infected, with any of the diseases referred to in point 1 or 2 must be effective to avoid any adverse effect on other animals' milk and colostrum.II.HYGIENE ON MILK AND COLOSTRUM PRODUCTION HOLDINGSA.Requirements for premises and equipment1.Milking equipment and premises where milk and colostrum are stored, handled or cooled must be located and constructed so as to limit the risk of contamination of milk and colostrum.2.Premises for the storage of milk and colostrum must be protected against vermin, have adequate separation from premises where animals are housed and, where necessary to meet the requirements laid down in Part B, have suitable refrigeration equipment.3.Surfaces of equipment that are intended to come into contact with milk and colostrum (utensils, containers, tanks, etc. intended for milking, collection or transport) must be easy to clean and, where necessary, disinfect and must be maintained in a sound condition. This requires the use of smooth, washable and non-toxic materials.4.After use, such surfaces must be cleaned and, where necessary, disinfected. After each journey, or after each series of journeys when the period of time between unloading and the following loading is very short, but in all cases at least once a day, containers and tanks used for the transport of milk and colostrum must be cleaned and disinfected in an appropriate manner before re-use.B.Hygiene during milking, collection and transport1.Milking must be carried out hygienically, ensuring in particular:(a)that, before milking starts, the teats, udder and adjacent parts are clean;(b)that milk and colostrum from each animal is checked for organoleptic or physico-chemical abnormalities by the milker or a method achieving similar results and that milk and colostrum presenting such abnormalities is not used for human consumption;(c)that milk and colostrum from animals showing clinical signs of udder disease are not used for human consumption otherwise than in accordance with the instructions of a veterinarian;(d)the identification of animals undergoing medical treatment likely to transfer residues to the milk and colostrum, and that milk and colostrum obtained from such animals before the end of the prescribed withdrawal period are not used for human consumption; and(e)that teat dips or sprays are used only after authorisation or registration in accordance with the procedures laid down in Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the marketOJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission Directive 2006/50/EC (OJ L 142, 30.5.2006, p. 6).:(f)that colostrum is milked separately and not mixed together with raw milk.2.Immediately after milking, milk and colostrum must be held in a clean place designed and equipped to avoid contamination.(a)Milk must be cooled immediately to not more than 8 oC in the case of daily collection, or not more than 6 oC if collection is not daily;(b)Colostrum must be stored separately and immediately cooled to not more than 8 oC in the case of daily collection, or not more than 6 oC if collection is not daily, or frozen.3.During transport the cold chain must be maintained and, on arrival at the establishment of destination, the temperature of the milk and the colostrum must not be more than 10 oC.4.Food business operators need not comply with the temperature requirements laid down in points 2 and 3 if the milk meets the criteria provided for in Part III and either:(a)the milk is processed within two hours of milking; or(b)a higher temperature is necessary for technological reasons related to the manufacture of certain dairy products and the competent authority so authorises.C.Staff hygiene1.Persons performing milking and/or handling raw milk and colostrum must wear suitable clean clothes.2.Persons performing milking must maintain a high degree of personal cleanliness. Suitable facilities must be available near the place of milking to enable persons performing milking and handling raw milk and colostrum to wash their hands and arms.III.CRITERIA FOR RAW MILK AND COLOSTRUM1.(a)The following criteria for raw milk apply pending the establishment of standards in the context of more specific legislation on the quality of milk and dairy products.(b)National criteria for colostrum, as regards plate count, somatic cell count or antibiotic residues, apply pending the establishment of specific Community legislation.2.A representative number of samples of raw milk and colostrum collected from milk production holdings taken by random sampling must be checked for compliance with points 3 and 4 in case of raw milk and with the existing national criteria referred to in point 1(b) in case of colostrum. The checks may be carried out by, or on behalf of:(a)the food business operator producing the milk;(b)the food business operator collecting or processing the milk;(c)a group of food business operators; or(d)in the context of a national or regional control scheme.3.(a)Food business operators must initiate procedures to ensure that raw milk meets the following criteria:(i)for raw cows' milk:

Rolling geometric average over a two-month period, with at least two samples per month.Rolling geometric average over a three-month period, with at least one sample per month, unless the competent authority specifies another methodology to take account of seasonal variations in production levels.

Plate count at 30 oC (per ml)	≤ 100000
Somatic cell count (per ml)	≤ 400000

(ii)for raw milk from other species:

Rolling geometric average over a two-month period, with at least two samples per month.

Plate count at 30 oC (per ml)

≤ 1500000

(b)However, if raw milk from species other than cows is intended for the manufacture of products made with raw milk by a process that does not involve any heat treatment, food business operators must take steps to ensure that the raw milk used meets the following criterion:

Rolling geometric average over a two-month period, with at least two samples per month.

Plate count at 30 oC (per ml)

≤ 500000

4.Without prejudice to Directive 96/23/EC, food business operators must initiate procedures to ensure that raw milk is not placed on the market if either:(a)it contains antibiotic residues in a quantity that, in respect of any one of the substances referred to in Annexes I and III to Regulation (EEC) No 2377/90Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ L 224, 18.8.1990, p. 1). Regulation as last amended by Commission Regulation (EC) No 1231/2006 (OJ L 225, 17.8.2006, p. 3).", exceeds the levels authorised under that Regulation; or(b)the combined total of residues of antibiotic substances exceeds any maximum permitted value.5.When raw milk fails to comply with point 3 or 4, the food business operator must inform the competent authority and take measures to correct the situation.CHAPTER II: REQUIREMENTS CONCERNING DAIRY AND COLOSTRUM-BASED PRODUCTSI.TEMPERATURE REQUIREMENTS1.Food business operators must ensure that, upon acceptance at a processing establishment,(a)milk is quickly cooled to not more than 6 oC;(b)colostrum is quickly cooled to not more than 6 oC or maintained frozen,and kept at that temperature until processed.2.However, food business operators may keep milk and colostrum at a higher temperature if:(a)processing begins immediately after milking, or within four hours of acceptance at the processing establishment; or(b)the competent authority authorises a higher temperature for technological reasons concerning the manufacture of certain dairy or colostrum-based products.II.REQUIREMENTS FOR HEAT TREATMENT1.When raw milk, colostrum, dairy or colostrum-based products undergo heat treatment, food business operators must ensure that this satisfies the requirements laid down in Chapter XI of Annex II to Regulation (EC) No 852/2004. In particular, they shall ensure, when using the following processes, that they comply with the specifications mentioned:(a)Pasteurisation is achieved by a treatment involving:(i)a high temperature for a short time (at least 72 oC for 15 seconds);(ii)a low temperature for a long time (at least 63 oC for 30 minutes); or(iii)any other combination of time-temperature conditions to obtain an equivalent effect,such that the products show, where applicable, a negative reaction to an alkaline phosphatase test immediately after such treatment.(b)Ultra high temperature (UHT) treatment is achieved by a treatment:(i)involving a continuous flow of heat at a high temperature for a short time (not less than 135 oC in combination with a suitable holding time) such that there are no viable microorganisms or spores capable of growing in the treated product when kept in an aseptic closed container at ambient temperature, and(ii)sufficient to ensure that the products remain microbiologically stable after incubating for 15 days at 30 oC in closed containers or for seven days at 55 oC in closed containers or after any other method demonstrating that the appropriate heat treatment has been applied.2.When considering whether to subject raw milk and colostrum to heat treatment, food business operators must:(a)have regard to the procedures developed in accordance with the HACCP principles pursuant to Regulation (EC) No 852/2004; and(b)comply with any requirements that the competent authority may impose in this regard when approving establishments or carrying out checks in accordance with Regulation (EC) No 854/2004.III.CRITERIA FOR RAW COWS' MILK1.Food business operators manufacturing dairy products must initiate procedures to ensure that, immediately before processing:(a)raw cows' milk used to prepare dairy products has a plate count at 30 oC of less than 300000 per ml; and(b)processed cows' milk used to prepare dairy products has a plate count at 30 oC of less than 100000 per ml.2.When milk fails to meet the criteria laid down in paragraph 1, the food business operator must inform the competent authority and take measures to correct the situation.CHAPTER III: WRAPPING AND PACKAGINGSealing of consumer packages must be carried out immediately after filling in the establishment where the last heat treatment of liquid dairy products and colostrum-based products, takes place by means of sealing devices that prevent contamination. The sealing system must be designed in such a way that, after opening, the evidence of its opening remains clear and easy to check.CHAPTER IV: LABELLING1.In addition to the requirements of Directive 2000/13/EC, except in the cases envisaged in Article 13(4) and (5) of that Directive, labelling must clearly show:(a)in the case of raw milk intended for direct human consumption, the words "raw milk";(b)in the case of products made with raw milk, the manufacturing process for which does not include any heat treatment or any physical or chemical treatment, the words "made with raw milk";(c)in case of colostrum, the word "colostrum";(d)in case of products made with colostrum, the words "made with colostrum".2.The requirements of paragraph 1 apply to products destined for retail trade. The term "labelling" includes any packaging, document, notice, label, ring or collar accompanying or referring to such products.CHAPTER V: IDENTIFICATION MARKINGBy way of derogation from the requirements of Annex II, Section I:1.rather than indicating the approval number of the establishment, the identification mark may include a reference to where on the wrapping or packaging the approval number of the establishment is indicated;2.in the case of the reusable bottles, the identification mark may indicate only the initials of the consigning country and the approval number of the establishment.

----------------------

Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ 121, 29.7.1964, p. 1977/64). Directive as last amended by Regulation (EC) No 21/2004 (OJ L 5, 9.1.2004, p. 8).Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (OJ L 46, 19.2.1991, p. 19). Directive as last amended by Commission Decision 2005/932/EC.OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission Directive 2006/50/EC (OJ L 142, 30.5.2006, p. 6).Rolling geometric average over a two-month period, with at least two samples per month.Rolling geometric average over a three-month period, with at least one sample per month, unless the competent authority specifies another methodology to take account of seasonal variations in production levels.Rolling geometric average over a two-month period, with at least two samples per month.Rolling geometric average over a two-month period, with at least two samples per month.Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ L 224, 18.8.1990, p. 1). Regulation as last amended by Commission Regulation (EC) No 1231/2006 (OJ L 225, 17.8.2006, p. 3)."4.In Section XV, Chapter III, point 1 is replaced by the following:"1.Collagen must be produced by a process that ensures that the raw material is subjected to a treatment involving washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion or by an approved equivalent process. The extrusion step may be not carried out when manufacturing low molecular collagen from raw materials of non-ruminant origin."

Commission Regulation (EC) No 1662/2006 of 6 November 2006 amending Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin (Text with EEA relevance)