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I Milk

Physicochemical Properties of Milk:

At first , milk might seem to be a simple white liquid. But in fact, it is a complexmixture of a wide range of compounds imprortant to the neonate. The gross propertiesof milk include:

Milk is an emulsion of fat globules, and a suspension of casein micelles (casein, calcium, phosphorous), all of which are suspended in an aqueous phase,

that contains solublized lactose, whey proteins, and some minerals.

Leukocytes in milk are part of the suspended phase.

In the diagram below, milk is viewed at two magnifications; the left view is whatwould be seen at about 500X magnification, and the right view at about 50,000X. This

illustrates that milk is an emulsion of milk fat globules (left view) in a partially stableemulsion of the plasma phase of milk (the skim milk). In the right view, the casein

micelles are in a colloidal suspension in the serum phase of milk (the whey). Milk fatglobules in cow milk range in size from 0.1 to 15 micrometers. Milk fat has a density ofabout 0.92 g/ml. Calculations of the total surface area of fat globules in a liter of milkis about 80 square meters. Casein micelles range in size from about 10 to 300nanometers and have a density of 1.11 g/ml. The number of casein molecules in amicelle ranges from 20,000 to 150,000. The calcium content in micelles is about 8 g/100 g casein.

Some other physicochemical characteristics of cow milk:

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Acidity pH of normal milk is about 6.6- 6.9 (milk of carnivores is about 6.2;human milk is about 7.0; cow colostrum as low as 6.0; milk from cows withmastitis as high as 7.5)

Acidity titration SH 6.2-7.8

Freezing point -0.540 C -0.520C The density of milk (g.cm-3) at 20C 1,028

Acidity active pH

-- titration SH

The titration total acidity or the amount of alkali 0,25 mol. NaOH (ml) required to

neutralize the acidic in 100 ml of milk with fenolftalein to pinkish colour. and compliance

with standards.

pHFresh milk is slightly acid (pH of drinking water is 7.0-8.5). Generally the pH is lower (pH

6.5) in colostrum and higher (up to 7.5) during mastitis than in normal milk of mid-lactation.

More properties of milk :

Freezing point of milk: -0.520 C Freezing point of a solution depends on the numberof particles in the solvent (water phase of milk), rather than the kind of particles.

Why would someone want to measure milk freezing point? Producers have beenknown to add water to their bulk tank to increase the volume of milk that theyship. They are paid in part on the total mass of milk that they ship to the processingplant. Obviously, those paying for the milk do not want to pay for added water and thefreezing point of milk has ben used as a means of detecting these types of infractions.

However, freezing point of milk as a regulatory standard is really only valid for milkpooled form many cows (bulk tank milk). Many factors may affect freezing point of milk

from individual cows. High producing cows might be expected to have higher freezingpoints than lower producing cows. Diet, and how and when the diet is fed relative to

collecting the milk sample, also may affect freezing point from individual cows. Littlework has been done in recent years to define freezing point on milk from modern high

producing dairy cattle. [see Sherbon JW, Physical Properties of Milk, Chapter 8 in Wonget al, 1988]

Chemical composition of milk

Composition of cows milk

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Main constituentRange

(%)Mean(%)

Water 85.5 89.5 87.0

Total solids 10.5 14.5 13.0

Fat 2.5 6.0 4.0

Proteins 2.9 5.0 3.4

Lactose 3.6 5.5 4.8

Minerals 0.6 0.9 0.8

PRINT THIS PAGE Milk Compostion - Species Table Diversity

SPECIES

FA

T

%

PROTEI

N

%

LACTOS

E

%

AS

H

%

TOTAL

SOLIDS

%

Antelope 1.3 6.9 4 1.3 25.2

Ass (donkey) 1.2 1.7 6.90.4

510.2

Bear, polar 31 10.2 0.5 1.2 42.9

Bison 1.7 4.8 5.70.9

613.2

Buffalo, Philippine 10.4

5.9 4.3 0.8 21.5

Camel 4.9 3.7 5.1 0.7 14.4

Cat10.

911.1 3.4 --- 25.4

Cow:

Ayrshire

Brown Swiss

Guernsey

Holstein

JerseyZebu

4.1

4.0

5.0

3.5

5.54.9

3.6

3.6

3.8

3.1

3.93.9

4.7

5.0

4.9

4.9

4.95.1

0.7

0.7

0.7

0.7

0.70.8

13.1

13.3

14.4

12.2

15.014.7

Deer19.

710.4 2.6 1.4 34.1

Dog 8.3 9.5 3.7 1.2 20.7

Dolphin14.

110.4 5.9 --- 30.4

Elephant15.

14.9 3.4

0.7

626.9

Goat 3.5 3.1 4.6 0.79

12

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Guinea Pig 3.9 8.1 30.8

215.8

Horse 1.6 2.7 6.10.5

111

Human 4.5 1.1 6.8 0.2 12.6

Kangaroo 2.1 6.2 Trace 1.2 9.5

Mink 8 7 6.9 0.7 22.6

Monkey 3.9 2.1 5.9 2.6 14.5

Opossum 6.1 9.2 3.2 1.6 24.5

Pig 8.2 5.8 4.80.6

319.9

Rabbit12.

210.4 1.8 2 26.4

Rat14.

811.3 2.9 1.5 31.7

Reindeer22.

510.3 2.5 1.4 36.7

Seal, gray53.

211.2 2.6 0.7 67.7

Sheep 5.3 5.5 4.6 0.9 16.3

Whale34.

813.6 1.8 1.6 51.2

Table is adapted from course notes by Robert D. Bremel, University of Wisconsin and from

Handbook of Milk Composition, by R. G. Jensen, Academic Press, 1995

Differences in milk composition also

occur among strains or breeds of othermammals. As an example, milkcomposition of a typical Americanbreed of pig (Yorkshire) and theChinese Meishan breed of pigs is givenbelow. These animals were fed the

same feed and raised under the sameenvironment.

Study Question: What differences inmilk composition do you find among

these two swine breeds?

Day of Lactation

0 1 7 21

Lactose (mg/ml)

Meishan 19.9 31.7 43.5 51.4

Yorkshire 30.4 38.1 47.1 49.6

Fat (%)

Meishan 7.4 10.9 10.0 7.78Yorkshire 5.5 7.8 7.8 6.58

Protein (mg/ml)

Meishan 154.4 28.4 28.4 28.9

Yorkshire 139.7 58.8 35.7 36.5

[Data from Zou et al. 1992 ]

Water is the main constituent of milk and much milk processing is designed to remove waterfrom milk or reduce the moisture content of the product.

Milk fat

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If milk is left to stand, a layer of cream forms on the surface. The cream differs considerablyin appearance from the lower layer of skim milk.

Under the microscope cream can be seen to consist of a large number of spheres of varyingsizes floating in the milk. Each sphere is surrounded by a thin skinthe fat globulemembranewhich acts as the emulsifying agent for the fat suspended in milk (Figure 3).Themembrane protects the fat from enzymes and prevents the globules coalescing into buttergrains. The fat is present as an oil-in-water emulsion: this emulsion can be broken bymechanical action such as shaking.

Figure 3. Fat globules in milk.

Fats are partly solid at room temperature. The term oil is reserved for fats that are completelyliquid at room temperature. Fats and oils are soluble in non-polar solvents, e.g. ether.

About 98% of milk fat is a mixture of triacyl glycerides. There are also neutral lipids, fat-soluble vitamins and pigments (e.g. carotene, which gives butter its yellow colour), sterolsand waxes. Fats supply the body with a concentrated source of energy: oxidation of fat in thebody yields 9 calories/g. Milk fat acts as a solvent for the fat-soluble vitamins A, D, E and Kand also supplies essential fatty acids (linoleic, linolenic and arachidonic).

A fatty-acid molecule comprises a hydrocarbon chain and a carboxyl group (-COOH). Insaturated fatty acids the carbon atoms are linked in a chain by single bonds. In unsaturatedfatty acids there is one double bond and in poly-unsaturated fatty acids there is more than

one double bond. Examples of each type of fatty acid are shown in Figure 4.

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Figure 4.Structural formulae of four 18-carbon fatty acids varying in degree of saturation.

Fatty acids vary in chain length from 4 carbon atoms, as in butyric acid (found only inbutterfat), to 20 carbon atoms, as in arachidonic acid. Nearly all the fatty acids in milk containan even number of carbon atoms.

Fatty acids can also vary in degree of unsaturation, e.g. C18:0 stearic (saturated), C18:1oleic (one double bond), C18:2 linoleic (two double bonds), C18:3 linolenic (three doublebonds).

The most important fatty acids found in milk triglycerides are shown in Table 2. Fatty acidsare esterified with glycerol as follows:

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Glycerol + fatty acids triglyceride (fat) + water

Table 2. Principal fatty acids found in milk triglycerides.

Molecular formula Chainlength

Melting point

Butyric CH3(CH2)2COOH C4 8C

Caproic CH3(CH2)4COOH C6 2C

Caprylic CH2(CH2)6COOH C8 16C

Capric CH3(CH2)8COOH C10 31.5C

Lauric CH3(CH2)10COOH C12 44C

Myristic CH3(CH2)12COOH C14 58C

Palmitic CH3(CH2)14COOH C16 64C

Stearic CH3(CH2)16COOH C18 70C

Arichidonic CH3(CH2)18COOH C20

Oleic CH3(CH2)7CH=CH(CH2)7COOH C18: 1 13C

Linoleic CH3(CH2)4(CH=CH.CH2)2(CH2)6COOH C18: 2 5C

Linolenic CH3.CH2(CH=CH.CH2)3(CH2)6COOH C18: 3

The melting point and hardness of the fatty acid is affected by:

the length of the carbon chain, and the degree of unsaturation.

As chain length increases, melting point increases. As the degree of unsaturation increases,the melting point decreases.

Fats composed of short-chain, unsaturated fatty acids have low melting points and are liquidat room temperature, i.e. oils. Fats high in long-chain saturated fatty acids have high meltingpoints and are solid at room temperature. Butterfat is a mixture of fatty acids with differentmelting points, and therefore does not have a distinct melting point. Since butterfat meltsgradually over the temperature range of 040C, some of the fat is liquid and some solid attemperatures between 16 and 25C. The ratio of solid to liquid fat at the time of churninginfluences the rate of churning and the yield and quality of butter.

Fats readily absorb flavours. For example, butter made in a smoked gourd has a smokeyflavour.

Fats in foods are subject to two types of deterioration that affect the flavour of food products.

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1. Hydrolytic rancidity: In hydrolytic rancidity, fatty acids are broken off from the glycerolmolecule by lipase enzymes produced by milk bacteria. The resulting free fatty acidsare volatile and contribute significantly to the flavour of the product.

2. Oxidative rancidity: Oxidative rancidity occurs when fatty acids are oxidised. In milkproducts it causes tallowy flavours. Oxidative rancidity of dry butterfat causes off-

flavours in recombined milk.

Milk proteins

Proteins are an extremely important class of naturally occurring compounds that areessential to all life processes. They perform a variety of functions in living organisms rangingfrom providing structure to reproduction. Milk proteins represent one of the greatestcontributions of milk to human nutrition. Proteins are polymers of amino acids. Only 20different amino acids occur, regularly in proteins. They have the general structure:

R represents the organic radical. Each amino acid has a different radical and this affects theproperties of the acid. The content and sequence of amino acids in a protein therefore affectits properties. Some proteins contain substances other than amino acids, e.g. lipoproteinscontain fat and protein. Such proteins are called conjugated proteins:

Phosphoproteins:Phosphate is linked chemically to these proteinsexamples includecasein in milk and phosphoproteins in egg yolk.

Lipoproteins: These combinations of lipid and protein are excellent emulsifying agents.Lipoproteins are found in milk and egg yolk.

Chromoproteins:These are proteins with a coloured prosthetic group and includehaemoglobin and myoglobin.

Casein

Casein was first separated from milk in 1830, by adding acid to milk, thus establishing itsexistence as a distinct protein. In 1895 the whey proteins were separated into globulin andalbumin fractions.

It was subsequently shown that casein is made up of a number of fractions and is thereforeheterogeneous. The whey proteins are also made up of a number of distinct proteins asshown in the scheme in Figure 5.

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Figure 5. Milk protein fractions.

Casein is easily separated from milk, either by acid precipitation or by adding rennin. Incheese-making most of the casein is recovered with the milk fat. Casein can also berecovered from skim milk as a separate product.

Casein is dispersed in milk in the form of micelles. The micelles are stabilised by the -

casein. Caseins are hydrophobic but -casein contains a hydrophilic portion known as the

glycomacropeptide and it is this that stabilises the micelles. The structure of the micelles isnot fully understood.

When the pH of milk is changed, the acidic or basic groups of the proteins will be neutralised.At the pH at which the positive charge on a protein equals exactly the negative charge, thenet total charge of the protein is zero. This pH is called the isoelectric point of the protein (pH4.6 for casein). If an acid is added to milk, or if acid-producing bacteria are allowed to grow inmilk, the pH falls. As the pH falls the charge on casein falls and it precipitates. Hence milkcurdles as it sours, or the casein precipitates more completely at low pH.

Casein Micelle Structure

The first representation of casein micelle structure shown here is that of the "casein sub-

micelle" model. It has evolved from several earlier models. It is very difficult to imagine

exactly what the micelle looks like. However, scientists do know a great deal about the micelle

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from its behaviour, and any model needs to account for all of the known facts. This model,

which nows dates to about 20 years old, is based on the inclusion of many known facts about

casein micelle behaviour. See Walstra and Jenness for discussion of this model.

There is not universal acceptance of the above model among dairy scientists, in fact there is

mounting evidence that well-defined casein submicelles do not exist, rather the structure is

more open and fluid, perhaps a "bowl-of-spaghetti" type of model. The big problem with the

earlier model was the distribution of calcium phosphate, and it is certainly apparent now thatcalcium phosphate exists more evenly distributed throughout the micelle, so based on the above

model, both within and outside the submicelles.

The next model shown here has evolved recently, from work especially by Carl Holt and co-

workers at Hannah Research Institute, Scotland. It shows a more or less spherical, highly

hydrated, and fairly open particle. Polypeptide chains in the core are partly cross-linked by

nanometer sized clusters of Ca phosphate; the internal structure gives rise to an external region

of lower segment density known as the hairy layer, which confers steric and/or charge stability

to native casein particles. This figure also shows equilibria between the micelle and the milk

serum with acidification and with heating. (Thanks to Dr. Carole Tranchant, Ph.D. Disertation,

Univ. of Guelph, 1999, for use of this figure). It may be many years yet before out visualization

techniques (e.g., electron microscopy) allow us to know the true structure of the casein micelle.

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Selected References

Holt, C. & D. S. Horne. 1996. The hairy casein micelle: evolution of the concept and its

implication for dairy technology. Neth. Milk Dairy J. 50: 85-111.

Horne, D. S. 1998. Casein interactions: casting light on the black boxes, the structure in dairy

products. Internat. Dairy J. 8: 171-177.

Walstra, P. 1999. Casein sub-micelles: do they exist? Internat. Dairy J. 9: 189-192.

Horne, D. S. 2002. Casein structure, self-assembly and gelation. Current Opinion in Colloid and

Interface Sci. 7: 456-461.

Back to the Home Page of

Whey proteins

After the fat and casein have been removed from milk, one is left with whey, whichcontains the soluble milk salts, milk sugar and the remainder of the milk proteins. Like theproteins in eggs, whey proteins can be coagulated by heat. When coagulated, they can be

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recovered with caseins in the manufacture of acid-type cheeses. The whey proteins are

made up of a number of distinct proteins, the most important of which are-lactoglobulinand lactoglobulin.-lactoglobulin accounts for about 50% of the whey proteins, andhas a high content of essential amino acids. It forms a complex with -casein when milk is

heated to more than 75C, and this complex affects the functional properties of milk.

Denaturation of-lactoglobulin causes the cooked flavour of heated milk.

Other milk proteins

In addition to the major protein fractions outlined, milk contains a number ofenzymes. Themain enzymes present are lipases, which cause rancidity, particularly in homogenised milk,and phosphatase enzymes, which catalyse the hydrolysis of organic phosphates. Measuringthe inactivation of alkaline phosphatase is a method of testing the effectiveness ofpasteurisation of milk.

Peroxidase enzymes, which catalyse the breakdown of hydrogen peroxide to water and

oxygen, are also present. Lactoperoxidase can be activated and use is made of this for milkpreservation.

Milk also contains protease enzymes, which catalyse the hydrolysis of proteins, andlactalbumin, bovine serum albumin, the immune globulins and lactoferrin, which protect theyoung calf against infection.

Milk carbohydrates

Lactose is the major carbohydrate fraction in milk. It is made up of two sugars,glucose and galactose (Figure 6). The average lactose content of milk varies between 4.7

and 4.9%, though milk from individual cows may vary more. Mastitis reduces lactosesecretion.

Figure 6. Structure of a lactose molecule.

Lactose is a source of energy for the young calf, and provides 4 calories/g of lactosemetabolised. It is less soluble in water than sucrose and is also less sweet. It can be broken

down to glucose and galactose by bacteria that have the enzyme -galactosidase. Theglucose and galactose can then be fermented to lactic acid. This occurs when milk goessour. Under controlled conditions they can also be fermented to other acids to give a desired

flavour, such as propionic acid fermentation in Swiss-cheese manufacture.

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Lactose is present in milk in molecular solution. In cheese-making lactose remains in the whey fraction. It has been recovered fromwhey for use in the pharmaceutical industry, where its low solubility in water makes it suitable for coating tablets. It is used to fortifybaby-food formula. Lactose can be sprayed on silage to increase the rate of acid development in silage fermentation. It can beconverted into ethanol using certain strains of yeast, and the yeast biomass recovered and used as animal feed. However, theseprocesses are expensive and a large throughput is necessary for them to be profitable. For smallholders, whey is best used as afood without any further processing.

Heating milk to above 100

o

C causes lactose to combine irreversibly with the milk proteins. This reduces the nutritional value of themilk and also turns it brown.

Because lactose is not as soluble in water as sucrose, adding sucrose to milk forces lactose out of solution and it crystallises. Thiscauses sandiness in such products as ice cream. Special processing is required to crystallise lactose when manufacturingproducts such as instant skim milk powders.

Some people are unable to metabolise lactose and suffer from an allergy as a result. Pre-treatment of milk with lactase enzymebreaks down the lactose and helps overcome this difficulty.

In addition to lactose, milk contains traces of glucose and galactose. Carbohydrates are also present in association with protein. -

casein, which stabilises the casein system, is a carbohydrate-containing protein.

Minor milk constituents

In addition to the major constituents discussed above, milk also contains a number of organicand inorganic compounds in small or trace amounts, some of which affect both theprocessing and nutritional properties of milk.

Milk salts

Milk salts are mainly chlorides, phosphates and citrates of sodium, calcium and magnesium.Although salts comprise less than 1 % of the milk they influence its rate of coagulation andother functional properties. Some salts are present in true solution. The physical state ofother salts is not fully understood. Calcium, magnesium, phosphorous andcitrate are

distributed between the soluble and colloidal phases (Table 3). Their equilibria are altered byheating, cooling and by a change in pH.

Table 3. Distribution of milk salts between the soluble and colloidal phases.

Total Dissolved Colloidal

(mg/100 ml of milk)

Calcium 1320.1 51.8 80.3

Magnesium 10.8 7.9 2.9

Total phosphorus 95.8 36.3 59.6

Citrate 156.6 141.6 15.0

In addition to the major salts, milk also contains trace elements. Some elements come to themilk from feeds, but milking utensils and equipment are important sources of such elementsas copper, iron, nickel and zinc.

Milk vitamins

Milk contains the fat-soluble vitamins A, D, E and K in association with the fat fraction andwater-soluble vitamins B complex and C in association with the water phase. Vitamins areunstable and processing can therefore reduce the effective vitamin content of milk.

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(Acts whose publication is obligatory)COMMISSION REGULATION (EC) No 1662/2006of 6 November 2006amending Regulation (EC) No 853/2004 of the European Parliament and of the Councillaying downspecific hygiene rules for food of animal origin(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 853/2004 of the European

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Parliament and of the Council of 29 April 2004 laying downspecific hygiene rules for food of animal origin (1), and inparticular Article 10(1) thereof,Whereas:(1) When subject to the provisions of Annex III to Regulation (EC) No 853/2004, food businessoperators should ensure that each product of animal origin has an identification mark applied incompliance with the provisions laid down in Section I of Annex II to that Regulation. Unlessexpressly indicated and for control reasons, products of animal origin should not bear more thanone identification mark.(2) Section I of Annex III to Regulation (EC) No 853/2004 lays down rules on the production andplacing on the market of meat from domestic ungulates. Exceptions to the complete skinning ofthe carcase and other parts of the body intended for human consumption are set out in point 8of Chapter IV of that Section. Provision should be made to extend these exceptions to themuzzle and lips from bovine animals, provided they comply with the same conditions as thoseapplying to heads of ovine and caprine animals.(3)The tonsils serve as a filter of all noxious agents entering the oral cavity of animals andshould be removed for hygienic and safety reasons during the process of slaughtering domesticungulates. Since the removal was inadvertently omitted as mandatory for domestic swine, therequirement for removal of porcine tonsils should be re-inserted.(4) Section VIII of Annex III to Regulation (EC) No 853/2004 sets out the requirements governing

the production and placing on the market of fishery products intended for human consumption.Fish oil is included in the definition of fishery products. Specific requirements for production andplacing on the market of fish oil for human consumption should, therefore, be laid down.

Transitional arrangements should also be foreseen to give the possibility to establishments inthird countries to adapt to the new situation.(5) Colostrum is considered as a product of animal origin but is not covered by the definition ofraw milk as referred to in Annex I to Regulation (EC) No 853/2004. Colostrum is produced in asimilar way and can be considered as presenting a similar risk to human health as raw milk. It istherefore necessary to introduce specific hygiene rules for colostrum production.(6) Section XV of Annex III to Regulation (EC) No 853/2004 sets out the requirements for theproduction of collagen. It specifies that collagen must be produced using a process that ensuresthat the raw material is subjected to a treatment involving washing, pH adjustment using acid oralkali followed by one or more rinses, filtration and extrusion or by an approved equivalent

process. A different process resulting in a hydrolysed collagen that cannot be extruded wassubmitted for assessment to EFSA. EFSA adopted on 26 January 2005 an opinion on safety ofcollagen and a processing method for the production of collagen. It concluded that theproduction process proposed above ensures equivalent or higher health safety for collagenintended for human consumption compared to the safety achieved by applying the standards ofSection XV. The conditions for the production of collagen should therefore be modified.(7) Regulation (EC) No 853/2004 should be amended accordingly.(8)The measures provided for in this Regulation are in accordance with the opinion of theStanding Committee on the Food Chain and Animal Health, 18.11.2006 EN Official Journal of theEuropean Union L 320/1(1) OJ L 139, 30.4.2004, p. 55, as corrected by OJ L 226, 25.6.2004, p. 22. Regulation as last amended byCommission Regulation (EC) No 2076/2005 (OJ L 338, 22.12.2005, p. 83). HAS ADOPTED THIS REGULATION:

Article 1

Regulation (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 thisRegulation.

Article 2This Regulation shall enter into force on the seventh day following its publication in the OfficialJournal 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 Commission L 320/2 EN Official Journal of the European Union 18.11.2006

ANNEX 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 anotherestablishment,

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a new mark must be applied to the product. In such cases, the new mark must indicate the approvalnumber of theestablishment where these operations take place.

18.11.2006 EN Official Journal of the European Union L 320/3

ANNEX II

Annex 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 consumptionmust be completely skinned, except in the case of porcine animals, theheads of ovine and caprine animals and calves, the muzzle and lips ofbovine 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 toavoid 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 thepreparation of fish oil for human consumption comply with the followingrequirements:1. they must derive from fishery products which have been found fit forhuman consumption;2. they must come from establishments, including vessels, approved inaccordance 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 PRODUCTS For the purpose of this Section,1. Colostrum means the fluid secreted by the mammary glands ofmilk-producing animals up to three to five days post parturitionthat is rich in antibodies and minerals, and precedes the productionof raw milk.2. Colostrum-based products means processed products resulting fromthe processing of colostrum or from the further processing of suchprocessed products.CHAPTER I: RAW MILK AND COLOSTRUM PRIMARY PRODUCTIONFood business operators producing or, as appropriate, collecting raw milkand colostrum must ensure compliance with the requirements laid down inthis 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 diseasescommunicable to humans through milk and colostrum;(b) that are in a good general state of health, present no sign ofdisease that might result in the contamination of milk and

colostrum and, in particular, are not suffering from any infection of

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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 andcolostrum;(d) to which no unauthorised substances or products have been

administered and that have not undergone illegal treatment withinthe meaning of Directive 96/23/EC;L 320/4 EN Official Journal of the European Union 18.11.2006(e) in respect of which, where authorised products or substanceshave been administered, the withdrawal periods prescribed forthese products or substances have been observed.2. (a) In particular, as regards brucellosis, raw milk and colostrummust come from:(i) cows or buffaloes belonging to a herd which, within the meaningof Directive 64/432/EEC (1), is free or officially free of brucellosis;(ii) sheep or goats belonging to a holding officially free or free ofbrucellosis within the meaning of Directive 91/68/EEC (2); or(iii) females of other species belonging, for species susceptible tobrucellosis, to herds regularly checked for that disease under acontrol plan that the competent authority has approved.(b) As regards tuberculosis, raw milk and colostrum must comefrom:(i) cows or buffaloes belonging to a herd which, within the meaningof Directive 64/432/EEC, is officially free of tuberculosis; or(ii) females of other species belonging, for species susceptible totuberculosis, 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 beinspected and tested for tuberculosis.3. However, raw milk from animals that does not meet therequirements of point 2 may be used with the authorisation of thecompetent authority:(a) in the case of cows or buffaloes that do not show a positivereaction to tests for tuberculosis or brucellosis, nor any symptomsof these diseases, after having undergone a heat treatment such asto 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 vaccinatedagainst 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 atleast two months; or(ii) after having undergone heat treatment such as to show anegative reaction to the alkaline phosphatase test; and(c) in the case of females of other species that do not show apositive reaction to tests for tuberculosis or brucellosis, nor anysymptoms of these diseases, but belong to a herd wherebrucellosis or tuberculosis has been detected after the checksreferred to in point 2(a)(iii) or 2(b)(ii), if treated to ensure itssafety.

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4. Raw milk and colostrum from any animal not complying with theappropriate requirements of points 1 to 3, and in particular, anyanimal showing individually a positive reaction to the prophylactictests vis -vis tuberculosis or brucellosis as laid down in Directive 64/432/EEC and Directive 91/68/EEC, must not be used for human

consumption.

18.11.2006 EN Official Journal of the European Union L 320/5(1) Council Directive 64/432/EEC of 26 June 1964 on animal health problems affectingintra-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).(2) Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governingintra-Community trade in ovine and caprine animals (OJ L 46, 19.2.1991, p. 19). Directiveas last amended by Commission Decision 2005/932/EC.

5. The isolation of animals that are infected, or suspected of beinginfected, with any of the diseases referred to in point 1 or 2 mustbe 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 ofcontamination of milk and colostrum.2. Premises for the storage of milk and colostrum must be protected againstvermin, have adequate separation from premises where animals are housedand, 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 milkand 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 useof 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 theperiod 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 thetransport 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 orphysico-chemical abnormalities by the milker or a method achieving similarresults and that milk and colostrum presenting such abnormalities is notused for human consumption;(c) that milk and colostrum from animals showing clinical signs of udderdisease are not used for human consumption otherwise than in accordancewith the instructions of a veterinarian;(d) the identification of animals undergoing medical treatment likely totransfer residues to the milk and colostrum, and that milk and colostrum

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obtained from such animals before the end of the prescribed withdrawalperiod are not used for human consumption; and(e) that teat dips or sprays are used only after authorisation or registrationin accordance with the procedures laid down in Directive 98/8/EC of theEuropean Parliament and of the Council of 16 February 1998 concerning the

placing of biocidal products on the market (1):(f) that colostrum is milked separately and not mixed together with rawmilk.2. Immediately after milking, milk and colostrum must be held in a cleanplace designed and equipped to avoid contamination.(a) Milk must be cooled immediately to not more than 8 oC in the case ofdaily collection, or not more than 6 oC if collection is not daily;(b) Colostrum must be stored separately and immediately cooled to notmore than 8 oC in the case of daily collection, or not more than 6 oC ifcollection is not daily, or frozen.L 320/6 EN Official Journal of the European Union 18.11.2006

(1) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission Directive2006/50/EC (OJ L 142, 30.5.2006, p. 6).

3. During transport the cold chain must be maintained and, on arrival at theestablishment of destination, the temperature of the milk and the colostrummust not be more than 10 oC.4. Food business operators need not comply with the temperaturerequirements laid down in points 2 and 3 if the milk meets the criteriaprovided 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 tothe manufacture of certain dairy products and the competent authority so

authorises.C. Staff hygiene1. Persons performing milking and/or handling raw milk and colostrum mustwear suitable clean clothes.2. Persons performing milking must maintain a high degree of personalcleanliness. Suitable facilities must be available near the place of milking toenable persons performing milking and handling raw milk and colostrum towash their hands and arms.III. CRITERIA FOR RAW MILK AND COLOSTRUM1. (a) The following criteria for raw milk apply pending the establishment of standards inthe 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 antibioticresidues, apply pending the establishment of specific Community legislation.2. A representative number of samples of raw milk and colostrum collected from milkproduction holdings taken by random sampling must be checked for compliance with points3 and 4 in case of raw milk and with the existing national criteria referred to in point 1(b) incase 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 ensurethat raw milk meets the following criteria:

(i) for raw cows' milk:Plate count at 30 oC (per ml) 100 000 (*)

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Somatic cell count (per ml) 400 000 (**)(*) Rolling geometric average over a two-month period, with atleast two samples per month.(**) Rolling geometric average over a three-month period, with atleast one sample per month, unless the competent authority

specifies another methodology to take account of seasonalvariations in production levels.(ii) for raw milk from other species:Plate count at 30 oC (per ml) 1 500 000 (*)(*) Rolling geometric average over a two-month period, with atleast two samples per month.18.11.2006 EN Official Journal of the European Union L 320/7(b) However, if raw milk from species other than cows is intendedfor the manufacture of products made with raw milk by a processthat does not involve any heat treatment, food business operatorsmust take steps to ensure that the raw milk used meets thefollowing criterion:Plate count at 30 oC (per ml) 500 000 (*)(*) Rolling geometric average over a two-month period, with at least twosamples per month.4. Without prejudice to Directive 96/23/EC, food business operators mustinitiate procedures to ensure that raw milk is not placed on the market ifeither:(a) it contains antibiotic residues in a quantity that, in respect of any one ofthe substances referred to in Annexes I and III to Regulation (EEC) No2377/90 (1), exceeds the levels authorised under that Regulation; or

(b) the combined total of residues of antibiotic substances exceeds anymaximum permitted value.5. When raw milk fails to comply with point 3 or 4, the food businessoperator must inform the competent authority and take measures to correctthe situation.CHAPTER II: REQUIREMENTS CONCERNING DAIRY AND COLOSTRUM-BASEDPRODUCTSI. TEMPERATURE REQUIREMENTS1. Food business operators must ensure that, upon acceptance at aprocessing 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 ahigher temperature if:(a) processing begins immediately after milking, or within four hours ofacceptance at the processing establishment; or(b) the competent authority authorises a higher temperature fortechnological reasonsconcerning the manufacture of certain dairy or colostrum-based products.II. REQUIREMENTS FOR HEAT TREATMENT1. When raw milk, colostrum, dairy or colostrum-based products undergoheat treatment, food business operators must ensure that this satisfies therequirements laid down in Chapter XI of Annex II to Regulation (EC) No

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852/2004. In particular, they shall ensure, when using the followingprocesses, 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

L 320/8 EN Official Journal of the European Union 18.11.2006(1) Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down aCommunity procedure for the establishment of maximum residue limits ofveterinary 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).(iii) any other combination of time-temperature conditions to obtain anequivalent effect, such that the products show, where applicable, a negativereaction 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 ashort time (not less than 135 oC in combination with a suitable holdingtime) such that there are no viablemicroorganisms or spores capable of growing in the treated product whenkept in anaseptic closed container at ambient temperature, and(ii) sufficient to ensure that the products remain microbiologicallystable after incubating for 15 days at 30 oC in closed containers orfor seven days at 55 oC in closed containers or after any othermethod demonstrating that the appropriate heat treatment hasbeen applied.

2. When considering whether to subject raw milk and colostrum to heattreatment, food business operators must:(a) have regard to the procedures developed in accordance with the HACCPprinciples pursuant to Regulation (EC) No 852/2004; and(b) comply with any requirements that the competent authority may imposein this regard when approving establishments or carrying out checks inaccordance with Regulation (EC) No 854/ 2004.III. CRITERIA FOR RAW COWS' MILK1. Food business operators manufacturing dairy products must initiateprocedures 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 300 000 per ml; and(b) processed cows' milk used to prepare dairy products has a plate count at30 oC of less than 100 000 per ml.2. When milk fails to meet the criteria laid down in paragraph 1, the foodbusiness operator must inform the competent authority and take measuresto correct the situation.CHAPTER III: WRAPPING AND PACKAGINGSealing of consumer packages must be carried out immediately after fillingin the establishment where the last heat treatment of liquid dairy productsand colostrum-based products, takes place by means of sealing devices thatprevent contamination. The sealing system must be designed in such a waythat, after opening, the evidence of its opening remains clear and easy tocheck.

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CHAPTER IV: LABELLING1. In addition to the requirements of Directive 2000/13/EC, except in thecases 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 processfor which does not include any heat treatment or any physical or chemicaltreatment, 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 withcolostrum.18.11.2006 EN Official Journal of the European Union L 320/92. The requirements of paragraph 1 apply to products destined for retailtrade. 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, theidentification mark may include a reference to where on the wrapping orpackaging the approval number of the establishment is indicated;2. in the case of the reusable bottles, the identification mark may indicateonly the initials of the consigning country and the approval number of theestablishment.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 usingacid or alkali followed by one or more rinses, filtration and extrusion or byanapproved equivalent process. The extrusion step may be not carried outwhen manufacturing low molecular collagen from raw materials of non-ruminant origin.L 320/10 EN Official Journal of the European Union 18.11.2006

COMMISSION REGULATION (EC) No 1663/2006 of 6 November 2006amending Regulation (EC) No 854/2004 of the European Parliamentand of the Council laying down specific rules for the organisation ofofficial controls on products of animal origin intended for humanconsumption (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community, Havingregard to Regulation (EC) No 854/2004 of the European Parliament and ofthe Council of 29 April 2004 laying down specific rules for the organisationof official controls on products of animal origin intended for humanconsumption (1), and in particular Article 17(1) thereof,Whereas:

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(1) According to Regulation (EC) No 853/2004 of the European Parliamentand of the Council of 29 April 2004 laying down specific hygiene rules forfood of animalorigin (2), it is for the food business operator to remove tonsils after postmortem inspection.

(2) Regulation (EC) No 853/2004 lays down requirements for the productionof colostrum. It should therefore be subject to official controls.(3) Annex VI to Regulation (EC) No 854/2004 establishes general principlesto be followed for certificates accompanying imports of products of animalorigin from thirdcountries. In particular, it requires certificates to be drawn up at least in theofficial language of the third country of dispatch and the Member State ofentry. Due to manypractical and operational problems already raised by this doublerequirement, it is more appropriate to limit these requirements to the basicprinciple of an obligation to draw up certificates at least in the officiallanguage or languages of the Member State of entry. However, due to itsinterest in certain situations, provision allowing the third country of dispatchto use its official language should be maintained as one possibility insupplement to the above principle.Annex VI should be amended accordingly.(4) Regulation (EC) No 854/2004 should be amended accordingly.(5) The measures provided for in this Regulation are in accordance with theopinion of the Standing Committee on the Food Chain and Animal Health,HAS ADOPTED THIS REGULATION:Article 1

Annexes I, IV and VI to Regulation (EC) No 854/2004 are amended in accordance with theAnnex to this RegulationArticle 2This Regulation shall enter into force on the seventh day following its publication in theOfficial 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 Commission18.11.2006 EN Official Journal of the European Union L 320/11(1) OJ L 139, 30.4.2004, p. 206. Corrected by OJ L 226, 25.6.2004,p. 83. Regulation as last amended by Regulation (EC) No 2076/2005

(OJ L 338, 22.12.2005, p. 83).(2) OJ L 139, 30.4.2004, p. 55. Corrected by OJ L 226, 25.6.2004,p. 22. Regulation as last amended by Regulation (EC) No 2076/2005ANNEX1. Annex I to Regulation (EC) No 854/2004 is amended as follows:(a) in Section IV, Chapter I:(i) Part A, Point 1, the words removal of the tonsils are deleted;(ii) Part B, Point 1, the sentence The tonsils must be removed is deleted;(b) in Section IV, Chapter III, Point 1, the sentence The tonsils must be removed is deleted.2. Annex IV to Regulation (EC) No 854/2004 is replaced by the following:

ANNEX IVRAW MILK, COLOSTRUM, DAIRY PRODUCTS AND COLOSTRUM BASED

PRODUCTSCHAPTER I: CONTROL OF MILK AND COLOSTRUM PRODUCTION HOLDINGS

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1. Animals on milk and colostrum production holdings must be subject toofficial controls to verify that the health requirements for raw milk andcolostrum production, and in particular the health status of the animals andthe use of veterinary medicinal products, are being complied with. Thesecontrols may take place at the occasion of veterinary checks carried out

pursuant to Community provisions on animal or public health or animalwelfare and may be carried out by an approved veterinarian.2. If there are grounds for suspecting that the animal health requirementsare not being complied with, the general health status of the animals is tobe checked.3. Milk and colostrum production holdings are to undergo official controls toverify that hygiene requirements are being complied with. These officialcontrols may involve inspections and/or the monitoring of controls thatprofessional organisations carry out. If it is shown that the hygiene isinadequate, the competent authority is to verify that appropriate steps aretaken to correct the situation.CHAPTER II: CONTROL OF RAW MILK AND COLOSTRUM UPON COLLECTION1. In the case of raw milk and colostrum, the competent authority is tomonitor the checks carried out in accordance with Annex III, Section IX,Chapter I, Part III to Regulation (EC) No 853/2004:2. If the food business operator has not corrected the situation within threemonths of first notifying the competent authority of non-compliance withthe criteria with regard to plate count and/or somatic cell count, delivery ofraw milk and colostrum from the production holding is to be suspended or in accordance with a specific authorisation of, or general instructionsfrom, the competent authority subjected to requirements concerning its

treatment and use necessary to protect public health. This suspension orthese requirements are to remain in place until the food business operatorhas proved that the raw milk and colostrum again complies with thecriteria.;3. in Annex VI to Regulation (EC) No 854/2004 point 2 is replaced by thefollowing:2. Certificates must be drawn up at least in the official language orlanguages of the Member State of destination and those of the MemberState in which the border inspection takes place, or be accompanied by acertified translation into that language or languages. However, a MemberState may consent to the use of an official Community language other than

its own.L 320/12 EN Official Journal of the European Union 18.11.2006

Sensual requirements for caws milk

Colour: white with yellow toneConsistence: homogenous liquid without impurities and sediment (pus)Taste and odour: typical for milk without unknown taste and odour

Physical-chemical requirements:

- fat min. 3,3g.100g-1,

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- protein min. 2,8 g.100g-1,

- temperature of milk frost -0,520 C,

- titration acidity 6,2 to 7,8 SH,

dry mater without fat 8,50 g.100g-1,

density 1.028 g.cm-3

Additional parameters quality

microbiological:

- count of coliform bacteria max. 1 000 v 1 ml,

- anaerobe sporulating bacteria in 0,1 ml test negativ,

- psychrotrophe bacteria max. 50 000 v 1 ml

- thermoresistant bacteria max. 2 000 v 1 ml.

content of free fatty acids :

- max. 13,0 mmol.kg-1 churn out method,

- max. 32,0 mmol.kg-1 extraction method .

Ability of fermentation by yogurt bacteria min. 25SH.

Sensual requirements for sheep milk

Colour: white with yellow toneConsistence: homogenous liquid without impurities and sediment (pus)Taste and odour: typical for sheep milk without unknown taste and odour

Physical-chemical requirements:

- fat min. 5.5g.100g-1,

- protein min. 4.8 g.100g-1,

- titration acidity 12 SH,

dry mater without fat 9,50 g.100g-1,

density 1.033 g.cm-3

Sensual requirements for goat milk

Colour: whiteConsistence: homogenous liquid without impurities and sediment (pus)Taste and odour: typical for goat milk without unknown taste and odour

Physical-chemical requirements:

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- fat min. 3,0g.100g-1,

- protein min. 3,0 g.100g-1,

- titration acidity 5-8 SH,

dry mater without fat 8,30 g.100g-1,

density 1.028 g.cm-3