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)
Date: 2006-11-06
Institutions: European Commission
Subjects: animal product, food inspection, foodstuff, health control, marketing standard

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I

(Acts whose publication is obligatory)

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)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Commu-
nity,

Having regard to Regulation (EC) No 853/2004 of the European
Parliament and of the Council of 29 April 2004 laying down
specific hygiene rules for food of animal origin (1), and in
particular Article 10(1) thereof,

Whereas:

(1) When subject to the provisions of Annex III to Regulation
(EC) No 853/2004, food business operators should ensure
that each product of animal origin has an identification
mark applied in compliance with the provisions laid down
in Section I of Annex II to that Regulation. Unless expressly
indicated and for control reasons, products of animal origin
should not bear more than one identification mark.

(2)

(3)

(4)

Section I of Annex III to Regulation (EC) No 853/2004 lays
down rules on the production and placing on the market of
meat from domestic ungulates. Exceptions to the complete
skinning of
the body
the carcase and other parts of
intended for human consumption are set out in point 8 of
Chapter IV of that Section. Provision should be made to
extend these exceptions to the muzzle and lips from bovine
animals, provided they comply with the same conditions as
those applying to heads of ovine and caprine animals.

The tonsils serve as a filter of all noxious agents entering the
oral cavity of animals and should be removed for hygienic
and safety reasons during the process of slaughtering
domestic ungulates. Since the removal was inadvertently
omitted as mandatory for domestic swine, the requirement
for removal of porcine tonsils should be re-inserted.

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
and placing on the market of
for human
consumption should, therefore, be laid down. Transitional
arrangements should also be foreseen to give the possibility
to establishments in third countries to adapt to the new
situation.

fish oil

(5) Colostrum is considered as a product of animal origin but is
not covered by the definition of raw milk as referred to in
Annex I to Regulation (EC) No 853/2004. Colostrum is
produced in a similar way and can be considered as
presenting a similar risk to human health as raw milk. It is
therefore necessary to introduce specific hygiene rules for
colostrum production.

(6)

followed by one or more rinses,

Section XV of Annex III to Regulation (EC) No 853/2004
sets out the requirements for the production of collagen. It
specifies that collagen must be produced using a process
is subjected to a
the raw material
that ensures that
treatment involving washing, pH adjustment using acid or
alkali
filtration and
extrusion or by an approved equivalent process. A different
process resulting in a hydrolysed collagen that cannot be
extruded was submitted for assessment to EFSA. EFSA
adopted on 26 January 2005 an opinion on safety of
collagen and a processing method for the production of
collagen.
the production process
proposed above ensures equivalent or higher health safety
for collagen intended for human consumption compared to
the safety achieved by applying the standards of Section XV.
The conditions for the production of collagen should
therefore be modified.

concluded that

It

(7) Regulation (EC) No 853/2004 should be

amended

accordingly.

(1) OJ L 139, 30.4.2004, p. 55, as corrected by OJ L 226, 25.6.2004,
p. 22. Regulation as last amended by Commission Regulation (EC)
No 2076/2005 (OJ L 338, 22.12.2005, p. 83).

(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,

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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 this
Regulation.

Article 2

This 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 Commission

Markos KYPRIANOU

Member of the Commission

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ANNEX I

Section 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.’

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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 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 CONSUMPTION

Food business operators must ensure that raw materials used in the preparation of fish oil for human
consumption comply with the following requirements:

1.

2.

3.

they must derive from fishery products which have been found fit for human consumption;

they must come from establishments, including vessels, approved in accordance with this Regulation;

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.

2.

“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.

“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 PRODUCTION

Food 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 PRODUCTION

1.

Raw milk and colostrum must come from animals:

(a)

(b)

that do not show any symptoms of infectious diseases communicable to humans through milk and
colostrum;

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;

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(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/EEC (1),
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/EEC (2); 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)

(b)

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;

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.

(1) 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).

(2) 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.

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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 HOLDINGS

A.

Requirements for premises and equipment

1.

2.

3.

4.

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.

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.

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.

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 transport

1.

Milking must be carried out hygienically, ensuring in particular:

(a)

that, before milking starts, the teats, udder and adjacent parts are clean;

(b)

(c)

(d)

(e)

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;

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;

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

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 market (1):

(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.

(1) 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).

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3.

4.

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.

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 hygiene

1.

2.

Persons performing milking and/or handling raw milk and colostrum must wear suitable clean
clothes.

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 COLOSTRUM

1.

(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:

Plate count at 30 oC (per ml)
Somatic cell count (per ml)

≤ 100 000 (*)
≤ 400 000 (**)

(*) 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.

(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 at least two samples per month.

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(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:

Plate count at 30 oC (per ml)

≤ 500 000 (*)

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

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 2377/90 (1), 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 PRODUCTS

I.

TEMPERATURE REQUIREMENTS

1.

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)

(b)

processing begins immediately after milking, or within four hours of acceptance at the
processing establishment; or

the competent authority authorises a higher
concerning the manufacture of certain dairy or colostrum-based products.

temperature for

technological

reasons

II.

REQUIREMENTS FOR HEAT TREATMENT

1. 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

(1) 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).’

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(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)

(ii)

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

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)

(b)

have regard to the procedures developed in accordance with the HACCP principles pursuant
to Regulation (EC) No 852/2004; and

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' MILK

1.

Food business operators manufacturing dairy products must initiate procedures to ensure that,
immediately before processing:

(a)

(b)

raw cows' milk used to prepare dairy products has a plate count at 30 oC of less than 300 000
per ml; and

processed cows' milk used to prepare dairy products has a plate count at 30 oC of less than
100 000 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 PACKAGING

Sealing 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: LABELLING

1.

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”.

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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 MARKING

By way of derogation from the requirements of Annex II, Section I:

1.

2.

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;

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.

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.’