NoC 84/130 Official Journal of the European Communities 2. 4. 90 
In any event, the product must be considered toxic or tainted when contamination reaches the microbic 
limit value S, which for general purposes is set at 103 m. 
In the case of Staphylococcus aureus, the value of S must be allowed to exceed 5 x 104. 
Tolerances related to analytical techniques shall not apply to the values M and S. 
B. Two categories for salmonella, with no category tolerance permitted: 
— 'Absence in': the result is considered satisfactory, 
— 'Presence in': the result is considered unsatifactory. 
2. The microbiological methods for examination will be established according to the procedure referred to in 
Article 9. 
Proposal for a Council Regulation (EEC) adopting health rules for the production and placing on the 
market of heat-treated drinking milk 
COM(89) 672 final 
(Submitted by the Commission on 23 March 1990) 
(90/C 84/12) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 43 
thereof, 
Having regard to the proposal of the Commission, 
Having regard to the opinion of the European Parliament, 
Having regard to the opinion of the Economic and Social 
Committee, 
Whereas heat-treated drinking milk is included in the list of 
products in Annex II to the Treaty; whereas the production 
of and trade in raw milk used for the preparation of 
heat-treated drinking milk constitute an important source of 
income for the farming population; 
Whereas in order to ensure rational development of this 
sector and to increase productivity, public health rules 
governing the production and placing on the market of this 
product should be adopted at Community level; 
Whereas the Community must adopt the measures intended 
to progressively establish the internal market over a period 
expiring on 31 December 1992; 
Whereas the laying down of health rules promotes the 
protection of public health and completion of the internal 
market; 
Whereas it is necessary to extend the principles laid down in 
Council Directive 85/397/EEC of 5 August 1985 on health and animal health problems affecting intra-Community 
trade in heat-treated milk (l), as last amended by Directive 
89/165/EEC (2); whereas this extension requires certain 
technical amendments to the said Directive; 
Whereas it is possible that, due to certain circumstances, 
some establishments operating prior to 1 January 1992 will 
not be able to comply with all the rules laid down in 
this Regulation; whereas the question of whether limited 
or temporary derogations may be granted to such 
establishments within the general framework laid down in 
Council Decision .../.. ./EEC of ... on the conditions 
for granting temporary and limited derogations from specific 
Community health rules for certain products of animal 
origin (3) should be resolved; 
Whereas it should be stressed that the granting of derogations 
from the health rules laid down in this Regulation is without 
prejudice to the submission of all operations of production 
and placing on the market of heat-treated milk to the general 
health rules laid down in Council Regulation (EEC) No . . . 
of . . . laying down general health rules for the production 
and placing on the market of products of animal origin and 
specific health rules for certain products of animal 
origin (4); 
Whereas Council Directive 79/112/EEC of 18 December 
1978 on the approximation of the laws of the Member States 
H OJ No L 226, 24. 8. 1985, p. 13. 
(2) OJ NoL 61, 4. 3. 1989, p. 57. 
(3) OJ No L . . . 
(«) OJ No L . . . 
2. 4. 90 Official Journal of the European Communities No C 84/131 
relating to the labelling, presentation and advertising of 
foodstuffs (1), as last amended by Council Directive 
89/395/EEC(2), and Council Directive 89/396/EEC of 
14 June 1989 on indications or markings identifying the lot 
to which a foodstuff belongs (3) are applicable; 
Whereas the Commission should be entrusted with the task 
of adopting measures for implementing this Regulation; 
whereas, to that end, procedures should be laid down 
establishing close and effective cooperation between the 
Commission and the Member States within the Standing 
Veterinary Committee, 
HAS ADOPTED THIS REGULATION: 
Article 1 
This Regulation lays down health rules for the production 
and placing on the market of heat-treated drinking milk. 
Article 2 
For the purposes of this Regulation: 
1. 'raw milk' means milk as produced by secretion from the 
mammary glands of one or more dairy cows which has 
not been heated beyond 40 °C or subjected to similar 
treatment; 
2. 'production holding' means an establishment at which 
one or more milk-producing cows are kept; 
3. 'beat-treated drinking milk' means prepacked drinking 
milk intended for sale to the final consumer and to 
institutions, obtained by heat treatment and presented in 
the form of pasteurized, UHT or sterilized milk ad 
defined in Annex B, Chapter VI (4), (6) and (7); 
4. 'competent authority' means the health authority 
designated by the Member State concerned; 
5. 'milk treatment establishment' means an establishment at 
which milk is heat-treated; 
6. the definitions in Article 2 of Council Directive 
64/432/EEC of 26 June 1964 on animal health 
problems affecting intra-Community trade in bovine 
animals and swine (4) and Article 3 of Regulation (EEC) 
No 1411/71 of 29 June 1971 laying down additional 
rules on the common organization of the market in milk 
and milk products falling within tariff heading 04-01 (5) 
shall apply as necessary. 
i1) OJNoL 33, 8. 2. 1979, p. 1. 
;2) OJ No L 186, 30. 6. 1989, p. 17. 
[3) OJ No L 186, 30. 6. 1989, p. 21. 
;4) OJ No 121, 29. 7. 1964, p. 1977/64. 
s) OJNoL 148, 3.7. 1971, p. 4. Article 3 
Heat-treated milk must meet the following conditions: 
1. It must have been obtained from raw milk: 
(a) from which nothing has been removed and to which 
nothing has been added, except as an inherent 
consequence of standardization and purification 
operations; 
(b) which meets the conditions laid down in Annex A, 
Chapter I; 
(c) which comes from production holdings which meet 
the general hygiene conditions laid down in Annex 
A, Chapter II; 
(d) in respect of which the standards of hygiene 
observed during milking, collection, handling and 
transport, and those of the staff carrying out those 
operations, satisfy the requirements of Annex A, 
Chapter III; 
(e) which comes from cows and production holdings 
which are checked at regular intervals by the 
competent authorities, in particular pursuant to 
Article 5 (1); 
(f) which has been checked in accordance with Article 7 
(1) and which meets the standards set out in Annex 
A, Chapter IV; 
(g) which, if appropriate, has been channelled through 
a milk-collection centre fulfilling the conditions laid 
down in Annex B, Chapters I, III and V; 
(h) which, if appropriate, has been channelled through 
a milk-standardization centre fulfilling the 
conditions laid down in Annex B, Chapters I, IV and 
V; 
(i) which, if appropriate, has undergone an initial heat 
treatment in another establishment which fulfils the 
conditions laid down in paragraph 2. 
2. It must come from a milk-treatment establishment which 
meets the conditions laid down in Annex B, Chapters I, II 
and V. 
3. It must have been treated there in accordance with the 
requirements laid down in Annex B, Chapter VI; 
4. It must have been packaged in accordance with Annex B, 
Chapter VII, at a milk-treatment establishment where 
the milk has been subjected to final treatment. 
5. It must have been stored in accordance with Annex B, 
Chapter VIII. 
6. It must be transported under satisfactory conditions of 
hygiene in accordance with Annex B, Chapter IX. 
7. It must have a weight of not less than 1 030 grams per 
litre, as recorded in whole milk at 20 °C, or the 
equivalent as recorded in totally fat-free milk at 20 °C, 
and contain a minimum of 28 grams of protein (total 
nitrogen minus non-protein nitrogen) per litre and a 
fat-free dry matter content of not less than 8,5%. 
No C 84/132 Official Journal of the European Communities 2. 4. 90 
Article 4 
1. The reference methods and, where necessary, routine 
methods of analysis and testing to be used to monitor 
compliance with the conditions laid down in Article 3 (1) (f), 
and (3), shall be adopted in accordance with the procedure 
laid down in Article 16. If necessary, the sampling methods 
shall be defined in accordance with the same procedure. 
2. The reference methods and, where necessary routine 
methods to be used to monitor compliance with the 
conditions laid down in Article 3 (7) shall be adopted in 
accordance with the procedure laid down in Article 16. 
In accordance with the same procedure, limits and methods 
shall be established to enable a distinction to be made 
between different types of heat-treated milk as defined in 
Annex B, Chapter VI. 
3. However, pending the decisions referred to in 
paragraphs 1 and 2, any internationally accepted analysis 
and test methods shall be recognized as reference 
methods. 
Article 5 
1. Production holdings shall undergo periodic inspection 
by the competent authority in order to ensure that hygiene 
requirements are fulfilled. 
In addition, if there are reasonable grounds for suspecting 
that the animal health requirements laid down in Annex A 
are not being fulfilled, the official veterinarian shall check the 
general state of health of the dairy animals and, should it 
prove necessary, shall have a clinical examination of the 
udders of those animals carried out. 
If the inspection or inspections referred to in the first and 
second subparagraphs show that not all hygiene 
requirements are being fulfilled, the competent authority 
shall take appropriate steps. 
2. The detailed arrangements for the inspection referred 
to in paragraph 1 and the general hygiene conditions to be 
complied with by milk production holdings, in particular the 
conditions for the upkeep of premises and those relating to 
milking, shall be adopted in accordance with the procedure 
laid down in Article 16. 
Article 6 
1. Each Member State shall draw up a list of 
milk-treatment establishments approved by it and a list of 
approved collecition centres and standardization centres. 
Each such establishment or centre shall have an approval 
number. 
A Member State shall not approve an establishment or centre 
unless compliance with this Regulation is assured. A Member 
State shall withdraw approval if the conditions for approval 
cease to be met. 
2. Regular inspection of approved establishments and 
centres shell be carried out by the competent authority. The 
inspection and supervision of establishments and of collection and standardization centres shall be carried out 
under the responsibility of the competent authority. 
The competent authority must at all times have free access to 
all parts of establishments or centres involved in the 
production of heat-treated drinking milk in order to ensure 
that this Regulation is being complied with. 
3. The detailed rules for the application of this Article shall 
be determined in accordance with the procedure laid down in 
Article 17. 
Article 7 
1. Raw milk and heat-treated drinking milk shall undergo 
checks carried out by milk-treatment establishments, under 
the supervision and responsibility of the competent 
authority, with periodic inspection by the latter, in order to 
ensure that the milk complies with the requirements of this 
Regulation. 
2. Where there are reasonable grounds for suspecting that 
the requirements of this Regulation are not being satisfied, 
the competent authority shall carry out the necessary checks 
and, if that suspicion is confirmed, take appropriate 
measures, in particular the suspension of approval. 
3. The detailed rules for the application of this Article 
shall, if necessary, be determined in accordance with the 
procedure laid down in Article 17. 
Article 8 
1. The competent authority shall carry out checks to 
detect any residues of substances having a pharmacological 
or hormonal action, and of antibiotics, pesticides, detergents 
and other substances which are harmful or which might alter 
the organoleptic characteristics of milk or make its 
consumption dangerous or harmful to human health, in so 
far as those residues exceed the permitted tolerance limits. 
2. If the milk examined shows traces of residues which 
exceed the permitted tolerances, the heat-treated milk must 
be excluded from human consumption. 
3. Examinations for residues must be carried out in 
accordance with proven methods which are scientifically 
recognized, in particular those laid down in Community 
provisions or other international standards. 
4. In accordance with the procedure laid down in Article 
16, the Commission shall adopt the detailed arrangements 
for and the frequency of the checks, and, if necessary, the 
tolerances provided for in paragraph 1 and the reference 
methods provided for in paragraph 3. 
In accordance with the same procedure, a decision may be 
taken to extend the examinations to substances oth«r than 
those referred to in paragraph 1. 
2,^0 Official journal of the European Communities ^oC^gP33 
^. Ontiltheentrymtoforceoftheimplementmgmeasures 
forthisAi^ticle^ national rules shall remain applicable suh^ect 
to compliance with the general provisions of theLreaty. 
P ^iilk tankers^ premises^ installations and working 
equipmentmay he usedforotherfoodstuffs provided that all 
appropriate measures are taken to present contamination or 
deterioration of heattreated drinking milk, 
2. ^dilktankersmusthearacleanndicationthattheymay 
he used only for the transport of foodstuffs. 
3. ^here an estahhshment makes products ohtamed in 
part from milk and milk productsm^ Products used in the 
manufacture of these foodstuffs must^ if they ha^e not 
previously undergone heat treatment or another kind of 
treatment which does not adversely affect milk or milk 
products^ he stored and treated in premises specially 
provided for this purpose. 
^ In accordance with the procedure laid down in Article 
l^the Commission shall adopt the detailed rules for the 
application of this Articled and in particular the conditions 
relating to washings cleaning and disinfecting hefore reused 
and the conditions of transport. 
^uch rules may include an exclusion of certain types of 
foodstuffs^ if the conditions are not adequate for these 
products. 
Ar^^ 
1. Vetermarye^pertsfromthe Commission may make 
onthe^spot checks insofar as it is necessary for ensuring 
uniform application of this regulations they may^ in 
particulars verify whether estahhshments are actually 
complying with this regulation, rhe Commission shall 
inform the ^iemher states of the results of the 
inspections. 
A^viemher^tate in whose terntoryan inspection isheing 
carried out shall gi^e all the necessary assistance to the 
experts carrying out their dutis. 
2. If necessary m^^tieral provisions in paragraphlof 
this Article shall he determined in accordance with the 
procedure laid down in Article PB. 
In accordance withthe same procedure^acode containing 
the rules to he followed forthe purpose ofthe checks referred 
toinparagraphlmayheestahhshed. 
t. In accordance with the procedure laid down in Article 
^derogations from the piDo^isions of Anne^l^ Chapters!^ 
tptU and IV may he granted for estahhshments with limited 
production. 2. In examining the derogations referred to in paragraph 
P the Commission shall take into consideration the 
information and criteria laiddown in Articles2and3of 
Uecison ...B.g^^C of ... ^on the conditions for 
granting temporary andhmitedderogationsfrom specific 
health rules for the production and placing on the market of 
certain products of animal origins 
3. ^hen granting the derogations referred to in 
paragraph P the Commission shall set the general and 
particular terms apphcahle to the implementationofeach 
derogation in accordance with the procedure laid down in 
Article ID. 
Ar^^^2 
Lhe rules laid down in Council regulation ^EEC^o...of 
...concerning ^etermarychecks in mtra^Commumtytrade 
witha^iewto the completion ofthe internal marketP^shall 
applymn particular with respect to the organisation and the 
action to he taken following the checks carried out hy the 
^iemher^tate of destination and the safeguard measures to 
he applied. 
Ar^^^ 
d^he Commission may^in accordance with the procedure laid 
down in Articlel^ draw up recommendations containing 
guidelines on good manufacturmgp^actices apphcahle at the 
different stages of production and placing on the market. 
I^he Annexes shall he amended^mp^rticularwitha^iew to 
adaptmgthem to take account of scientific and technological 
progress^ hy the Commission in accordance with the 
procedure laid down in Articled. 
Ar^^^ 
dihe Commission shall he assisted hythe^tandingVetennary 
Committeesetup hy Council tOecision ^^^3^1BP^C0^ 
hereinafter referred to as ^the Committee. 
Ar^^^ 
^here the procedure laid down in this Article is to he 
followed^ the following provisions shall apppA 
d^he representative of the Commissions after consulting the 
management Committee for ^iilk and ^lilk products set up 
hy Council regulation ^C^o^O^B^^^m cases where 
aspects ofchemist^y or technology are m^ol^ed^ shall suhmit 
to the Committeeadraft of the measures to he adopted.d^he 
Committee shall deliver its opinion on thedraftwithmatime 
limit whichthe chairman maylaydown according tothe 
urgency of the matter, rhe opinion shall he delivered hy the 
majority laid downmArticlet^^ofthe^Preaty in thecase 
e^o^^Lt^^^ r^^,D t^ 
No C 84/134 Official Journal of the European Communities 2. 4. 90 
of decisions which the Council is required to adopt on 
a proposal from the Commission. The votes of the 
representatives of the Member States within the Committee 
shall be weighted in the manner set out in that Article. The 
Chairman shall not vote. The Commission shall take the utmost account of the 
opinion delivered by the Committee. It shall inform the 
Committee of the manner in which its opinion has been taken 
into account. 
The Commission shall adopt the proposed measures if they 
are in accordance with the opinion of the Committee. 
If the proposed measures are not in accordance with the 
opinion of the Committee, or if no opinion is delivered, the 
Commission shall, without delay, submit to the Council a 
proposal relating to the measures to be taken. The Council 
shall act by a qualified majority. 
If, on the expiry of a period of three months from the date of 
referral to the Council, the Council has not acted, the 
proposed measures shall be adopted by the Commission. 
Article 17 
Where the procedure laid down in the Article is to be 
followed, the following provisions shall apply: Article 18 
Until Community rules concerning the importation of 
heat-treated drinking milk from third countries are 
implemented, Member States shall apply to such imports 
conditions at least equivalent to those laid down in this 
Regulation. 
Article 19 
1. Directive 85/397/EEC is hereby repealed with effect 
from 1 January 1993. 
2. However, the implementing provisions adopted under 
Directive 85/397/EEC shall remain valid for the purposes of 
this Regulation. 
Article 20 
The representative of the Commission shall submit to the 
Committee a draft of the measures to be taken. The 
Committee shall deliver its opinion on the draft within a time 
limit which the Chairman may lay down according to the 
urgency of the matter, if necessary, by taking a vote. This Regulation shall enter into force on the 30th day 
following its publication in the Official Journal of the 
European Communities. 
It shall apply from 1 January 1993. 
The opinion shall be recorded in the minutes; in addition, 
each Member State shall have the right to have its position 
recorded in the minutes. This Regulation shall be binding in its entirety and directly 
applicable in all Member States. 
ANNEX A 
REQUIREMENTS RELATING TO THE ADMISSION OF RAW MILK TO TREATMENT 
ESTABLISHMENTS 
CHAPTER I 
Conditions for raw milk 
1. The raw milk must come from cows: 
(a) belonging to a bovine herd which is officially tuberculosis-free and free or officially free from 
brucellosis; 
(b) not showing any symptoms of infectious diseases communicable to human beings through milk or likely to 
give the milk abnormal organoleptic characteristics; 
(c) whose general state of health is not impaired by any visible disorder and which must not be suffering from 
any infection of the genital tract with discharge, enteritis with diarrhoea and fever, or a recognizable 
inflammation affecting the udder or the skin of the udder; 
(d) not showing any udder wound likely to affect the milk; 
(e) yielding at least two litres of milk a day; 
2. 4. 90 Official Journal of the European Communities No C 84/135 
(f) which have not been treated with substances that are transmissible to milk and that are dangerous or likely 
to be dangerous to human health, unless the milk has complied with an official waiting period laid down in 
Community provisions or, if absent, in national provisions. 
2. Raw milk must be excluded from treatment if it: 
(a) comes from animals which are treated with unauthorized substances referred to in Directives 
81/602/EEC (») and 88/146/EEC (2); 
(b) contains residues of the substances referred to in Article 8 (1), in so far as those residues exceed the 
permitted tolerance levels 
CHAPTER II 
Hygiene of the holding 
1. Raw milk must come from production holdings which are registered and checked in accordance with 
Article 5. The premises so used must be designed, constructed, maintained and managed in such a way as to 
ensure: 
(i) good conditions of housing, hygiene, cleanliness and health of the cows; and 
(ii) good hygienic conditions for milking, the handling and the storage of milk. 
2. Premises where cows are milked or milk is stored, handled and cooled must be so sited and constructed as to 
avoid risk of contamination of the milk. They must be easy to wash and disinfect and have at least: 
(a) walls and flooring capable of being readily cleansed in those areas liable to soiling or infection; 
(b) flooring laid in such a way as to facilitate the draining of liquids and satisfactory means of disposing of 
waste; 
(c) adequate ventilation and lighting; 
(d) an adequate and sufficient supply of potable water within the meaning of Directive 80/778/EEC (3) for 
use in milking, cleansing and cooling operations; 
(e) adequate separation from all sources of contamination such as lavatories and dung heaps; 
(f) fittings and equipment which are capable of being readily and properly washed, cleansed and 
disinfected. 
In addition, premises for the storage of milk must have suitable milk refrigeration equipment, must be suitably 
protected against vermin and must have adequate separation from any premises where animals are 
housed. 
3. If a movable milking bail is used, the requirements in point 2 (d) and (f) must be satisfied and in addition the bail 
must: 
(a) be sited on fresh ground which is free from any accumulation of excreta or other waste matter; 
(b) provide protection for the milk during the whole period in which it is in use; 
(c) be so constructed and finished as to permit the interior surfaces to be kept clean. 
4. A milking parlour or milking area, adequately separated from the housing area, is obligatory when the cows 
are loose housed. 
5. The isolation of animals which are infected, or suspected of being infected, with any of the diseases referred to 
in Chapter I (1) (b) or the separation of the animals referred to in Chapter I (1) (c) from the rest of the herd must 
be possible and effective. 
6. Animals of all species must be kept from premises and sites where milk is stored, handled or cooled. 
(') OJ No L 222, 1. 8. 1981, p. 32. 
(2) OJ No L 70, 16. 3. 1988, p. 16. 
(3) OJ No L 229, 30. 8. 1980, p. 11. 
No C 84/136 Official Journal of the European Communities 2. 4. 90 
CHAPTER III 
Hygiene in milking, in collecting raw milk and in its transport from the production holding to the collection or 
standardization centre or to the milk-treatment establishment - hygiene of staff 
1. Milking must be carried out hygienically and under the general conditions of hygiene referred to in Article 5(2) 
of this Regulation. 
2. Immediately after milking, the milk must be placed in a clean place which is so equipped as to avoid adverse 
effects on the milk. If it is not collected within two hours of milking, the milk must be cooled to a temperature of 
8 °C at least in the case of daily collection or 6 °C if collection is not daily; while the refrigerated milk is being 
transported to the treatment establishments its temperature must not exceed 10 °C. 
3. Equipment and instruments or their surfaces which are intended to come into contact with milk (utensils 
containers, tanks, etc., intended for milking, the collection or the transport of milk) must be made of smooth 
material which is easy to wash, clean and disinfect, resists corrosion and does not transfer substances to the 
milk in such quantities as to endanger human health, cause deterioration in the composition of the milk or 
adversely affect its organoleptic characteristics. 
4. After use, the utensils used in milking, the mechanical milking equipment and the containers which come into 
contact with the milk in any way must be washed, cleaned and disinfected. After each journey, or after each 
series of journeys where there is only a very short space of time between unloading and the following loading, 
but in any event at least once a day, containers and tanks used for transporting raw milk to the milk collection 
or standardization centre or to the milk treatment establishment must be washed, cleaned and disinfected 
before re-use. 
5. Where chemicals are used for the disinfection operations laid down in point 4, such chemicals must have been 
approved for that purpose by the competent authority. 
6. The tanks used in the collection of milk must be used in accordance with Article 9 and Annex B, 
Chapter IX. 
7. Persons who might transmit infectious diseases or any other kind of disease through the milk shall be 
prohibited from milking and from handling and collecting milk. 
CHAPTER IV 
Standards to be met on admission 
1. In order to be able to receive heat treatment and to meet the requirements of this Regulation, raw milk from 
each holding must satisfy the following minimum standards. 
Compliance with the standards must be checked either by means of random samples taken during collection at 
the farm, or when the raw milk is admitted to the treatment establishment, or at the milk collection or 
standardization centre. 
Plate count 30 °C (per ml) 
Somatic cell count (per ml) 
Antibiotics (per ml) 
— penicillin 
— other < 100 000 0) 
< 400 000 (2) 
< 0,004 ng 
undetectable 
(1) Geometric average recorded over a period of two months, with at least two samples a 
month. 
(2) Geometric average recorded over a period of three months, with at least one sample a 
month. 
When the maximum standards are exceeded the competent authority shall take appropriate measures. 
2. 4. 90 Official Journal of the European Communities No C 84/137 
2. A control system shall be established under the supervision of the competent authority to prevent the presence 
of extraneous water in milk. This system shall in particular include regular checks on the freezing point of milk 
from each production holding. When extraneous water is detected the competent authority shall take 
appropriate measures. 
3. The treatment establishment shall inform the official veterinarian as soon as the maximum standards fixed for 
the cell count have been exceeded. The official veterinarian shall take the appropriate measures. 
4. If, within three months after notification of the measures referred to in points 1,2 and 3, milk from the holding 
in question does not meet the standards laid down, the holding must temporarily be excluded from supplying 
raw milk for the production of heat-treated drinking milk, until such time as it meets the standards 
again. 
However, milk containing residues of antibiotics which exceed the permitted levels must be excluded from 
human consumption. 
ANNEXB 
CHAPTER I 
General approval requirements 
The general requirements for establishments and cold stores laid down in Chapter I of the Annex to Council 
Regulation (EEC) No . . . (general hygiene rules) shall apply to collection centres, standardization centres and 
treatment establishments. 
CHAPTER II 
Special requirements for the approval of treatment establishments 
In addition to the general requirements laid down in Chapter I, treatment establishments must have at least: 
(a) equipment for the mechanical filling and proper automatic sealing of containers which are to be used for 
packaging heat-treated drinking milk, after filling, excluding churns and tanks in so far as such an operation is 
carried out there; 
(b) equipment for the cooling and cold storage of heat-treated milk and, in the cases provided for in Chapters III, 
IV and VII (1), raw milk. Cold stores must be equipped with temperature-measuring apparatus; 
(c) — in the case of packaging in disposable containers, an area for the storage of such containers and for storage 
of the raw materials intended for their manufacture, 
— in the case of packaging in re-usable containers, a special area for their storage and equipment designed to 
clean and disinfect them mechanically; 
(d) containers for storing raw milk, standardization equipment and containers for storing standardized milk; 
(e) centrifuges or any other suitable means for purifying milk; 
(f) heat-treatment equipment approved or authorized by the competent authority, fitted with: 
— an automatic temperature control, 
— a recording thermometer, 
— an automatic safety device preventing insufficient heating, 
— an adequate safety system preventing the mixture of pasteurized or sterilized milk with incompletely 
heated milk, 
— an automatic safety recording device preventing the aforementioned mixture. 
NoC 84/138 Official Journal of the European Communities 2. 4. 90 
CHAPTER HI 
Special requirements for registration of collection centres 
In addition to the general requirements laid down in Chapter I, milk collection centres must have at least: 
(a) cooling equipment or appropriate means for cooling and milk and, if milk is stored at the collection centre, an 
installation for cold-storing milk; 
(b) if milk is purified at the milk collection centre, purification must be carried out by means of centrifuges or by 
any other suitable mechanical means. 
CHAPTER IV 
Special requirements for registration of standardization centres 
In addition to the general requirements laid down in Chapter I, milk standardization centres must have at 
least: 
(a) containers for the cold storage of raw milk, standardization equipment and containers for the storage of 
standardized milk; 
(b) centrifuges or any other suitable mechanical means for purifying milk. 
CHAPTER V 
Hygiene requirements relating to the premises, equipment and staff of establishments 
The general requirements laid down in Chapter II of the Annex to Council Regulation (EEC) No . . . (general 
hygiene rules) shall apply. In addition: 
1. the treatment premises must be cleaned at least once each working day; 
2. equipment, containers and installations which come into contact with milk, milk products or other foodstuffs 
must be washed, cleaned and disinfected at the end of each work phase and at least once each working 
day; 
3. as soon as possible after each journey, or after each series of journeys where there is only a very short space of 
time between unloading and the following loading, but in any event at least once a day, containers and tanks 
used for transporting raw milk to the milk collection or standardization centre or to the milk treatment 
establishment must be washed, cleaned and disinfected before re-use. 
CHAPTER VI 
Requirements relating to heat treatment 
1. Upon admission to a treatment establishment, milk must, unless treated within four hours of its arrival, be 
cooled to a temperature not exceeding + 6 °C and maintained at that temperature until heat-treated. 
2. The manufacture of heat-treated milk shall include all necessary measures, in particular by means of random 
sampling checks, to ensure that: 
(a) raw milk, if it is not treated within 36 hours of its arrival, has, immediately before heat-treatment, a plate 
count of 30 °C not exceeding 200 000 per ml; 
(b) milk which has been subjected to a previous pasteurization has, immediately before the second heat 
treatment, a plate count at 30 °C not exceeding 100 000 per ml. 
2. 4. 90 Official Journal of the European Communities No C 84/139 
3. Pasteurized milk which has been subjected to high-temperature pasteurization, UHT milk and sterilized milk 
may be produced from milk which has undergone, in another establishment, an initial heat treatment. In this 
case the 'time-temperature' set must be lower than or equivalent to pasteurization and the milk must show a 
positive reaction to the peroxidase test. 
4. Pasteurized milk must have been obtained by means of a treatment involving a high temperature for a short 
time (at least 71,7 °C for 15 seconds or any equivalent combination). 
5. In the random sampling checks carried out in a treatment establishment, pasteurized milk must also satisfy 
the following standards: 
A. Microbiological standards 
Pathogens: absent in 25 grams: n = 5,c = 0, m = 0, M = 0 
Coliform (per ml): n = 5, c = 1, m = 0, m = 5 
After incubation at 6 °C in five days: 
Plate count 21 °C (per ml): n = 5, c=l,m = 5x 104, M = 105 
where: 
n = number of sample units comprising the sample; 
m = threshold value for the number of bacteria; the result is considered satisfactory if the number of 
bacteria in all sample units does not exceed m; 
M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of 
bacteria in one or more sample units is M or more; 
c = number of sample units the bacterial count of which may be between m and M, the sample still 
being considered acceptable if the bacterial count of the other sample units is m or less. 
In accordance with the procedure laid down in Article 16 the Commission may establish microbiological 
standards applicable to the labelled 'use by' date and the necessary implementing measures. 
B. Other standards 
(a) Pasteurized milk must show a negative reaction to the phosphatase test and a positive reaction to 
the peroxidase test, however, the production of pasteurized milk which shows a negative reaction 
to the peroxidase test is authorized, provided that the milk is labelled as 'high-temperature 
pasteurized'. 
(b) Antibiotics (per ml): may not exceed permitted levels. 
6. UHT milk must satisfy the following conditions: 
— it must have been obtained by applying a continuous flow of heat entailing the application of a high 
temperature for a short time (not less than 135 °C for not less than a second) with the aim of destroying all 
residual spoilage microorganisms and their spores, and the use of aseptic opaque containers for 
packaging, but so that the chemical, physical and organoleptic changes are minimal, 
— its preservability must be such that no deterioration can be observed by means of random sampling checks 
after it has spent 15 days in a closed container at a temperature of + 30 °C; where necessary, provision 
can also be made for a period of seven days in a closed container at a temperature of + 55 °C; 
Where the 'ultra-high temperature' milk treatment process is employed by direct contact of milk and steam, 
the steam must be obtained from potable water and must not leave deposits of foreign matter in the milk or 
affect it adversely. Moreover, the use of this process must not cause any change in the water content of the 
treated milk. 
7. Sterilized milk must: 
— have been heated and sterilized in hermetically sealed packagings or containers, the seal of which must 
remain intact, 
— in the event of random sampling, have a preservability such that no deterioration can be observed after it 
has spent 15 days in a closed container at a temperature of + 30 °C; where necessary, provision can also 
be made for a period of seven days in a closed container at a temperature of + 55 °C; 
8. In the random sampling checks carried out in the treatment establishment, sterilized milk and UHT milk must 
meet the following standards after incubation at 30 °C for 15 days: 
— plate count (30 °C): < 10 (per 0,1 ml), 
— organoleptic check: normal, 
— antibiotics: not exceeding permitted levels. 
No C 84/140 Official Journal of the European Communities 2. 4. 90 
9. For checks on the presence of extraneous water in milk the following provisions apply: 
(a) heat-treated drinking milk shall be subjected to regular checks on the presence of extraneous water, in 
particular by verification of the freezing point. For this purpose a control system shall be established 
under the supervision of the competent authority. When extraneous water is detected the competent 
authority shall take adequate measures; 
(b) in establishing a control system the competent authority shall take account of: 
— the results of the checks on raw milk referred to in Annex A, Chapter IV (2), and in particular their 
variation and average; 
— the effect of storage and processing of milk under Good Manufacturing Practices (GMP) conditions 
on the freezing point. 
(c) the Member States shall communicate to the Commission all details of the control system which they 
apply and its justification before 1 June 1993. 
10. Heat-treated drinking milk may be subjected to any test which gives an indication of the microbiological 
condition of the milk before heat-treatment. The rules for the application of such tests and the criteria to be 
respected shall be established in accordance with the procedure laid down in Article 16. 
11. Heating processes, the temperatures and duration of heating in respect of pasteurized, sterilized and UHT 
milk, the types of heating equipment, the flow-diversion valve and the types of temperature controlling and 
recording devices shall be approved or authorized by the competent central authorities of the Member 
States. 
12. After pasteurization, milk must be cooled immediately, in order to comply with the temperatures laid down in 
Chapters VIII and IX as soon as possible. 
13. The graphs produced by recording thermometers must be dated and kept for two years so that they 
can be shown upon request to the officials appointed by the competent authorities to inspect the 
establishment. 
CHAPTER VII 
Packaging at the treatment establishment of heat-treated drinking milk in containers intended for sale to the final 
consumer 
1. Without prejudice to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws 
of the Member States relating to materials and articles intended to come into contact with foodstuffs (*), 
wrapping and packaging shall comply with all the rules of hygiene and be strong enough to protect the 
heat-treated milk effectively. 
2. Bottling, filling, sealing of containers and packaging must be carried out automatically. 
3. Sealing must be carried out in the treatment establishment in which the heat treatment has been carried out 
immediately after filling, by means of a sealing device which ensures that the milk is protected from any adverse 
effects of external origin on its characteristics and that the seal cannot be re-used after opening. 
4. The producer must ensure for control purposes that in addition to the information required by Directive 
79/112/EEC (2) the following information is visibly and legibly displayed on the packaging of the 
product: 
(a) the nature of the heat treatment which the milk has undergone; 
(b) a batch identification and, in the case of pasteurized milk, the temperature at which the product must be 
stored; 
(c) the initials (in latin script) of the country of production, i.e. B, DK, D, EL, ESP, F, IRL, I, L, NL, P or UK, 
followed by the approval number of the treatment establishment and one of the following sets of initials: 
CEE — EEG — EWG — E0F — EEC — EOK. 
(') OJ No L 40, 11. 2. 1989, p. 38. 
(2) OJNoL 33, 8.2. 1979, p. 1. 
2. 4. 90 Official Journal of the European Communities NoC 84/141 
CHAPTER VIII 
The storage of pasteurized milk in the treatment establishment 
After cooling, the maximum temperature of pasteurized milk must be + 6 °C until it leaves the treatment 
establishment. 
The storage temperature of the storage rooms must be recorded. 
CHAPTER IX 
Transport of heat-treated milk 
1. Tanks, churns and other containers which are used for the transport of pasteurized milk must comply with all 
the rules of hygiene and in particular the following: 
— their inside surfaces and any other part which may come into contact with the milk must be made of smooth 
material which is easy to wash, clean and disinfect, resists corrosion and does not transfer substances to the 
milk in such quantities as to endanger human health, cause deterioration in the composition of the milk or 
adversely affect its organoleptic characteristics, 
— they must be designed so that the milk can drain away completely; if they are fitted with taps, these must be 
easy to remove, dismantle, wash, clean and disinfect, 
— they must be washed, cleaned and disinfected immediately after each use and as necessary before further 
use; cleaning and disinfection must be carried out in accordance with Chapter V (2) and (3), 
— they must be hermetically sealed shut before and during transportation by means of a watertight 
closure. 
2. Vehicles and containers used for transporting pasteurized milk must be designed and equipped in such a way 
that the temperatures laid down in paragraph 5 can be maintained throughout the period of transport. 
3. Vehicles used for transporting heat-treated drinking milk and milk in small containers or in churns must be in 
good condition. They may not be used to transport any other product or object likely to cause the milk to 
deteriorate. Their internal surfaces must be smooth and easy to wash, clean and disinfect. The interiors of 
vehicles intended for transporting milk must comply with all the rules of hygiene. Vehicles intended for the 
transport of heat-treated milk in small containers or churns must be so designed as to give the containers or 
churns adequate protection against all contamination and atmospheric indluences and may not be used to 
transport animals. 
4. To that end, the competent authority must regularly check that the means of transport and loading conditions 
meet the hygiene requirements of this Chapter. 
5. During transport, the temperature of pasteurized milk transported in tanks or packed in small containers and 
in churns must not exceed 6 °C. However, the competent authorities may grant a derogation from this 
requirement for door-step deliveries. 
6. When heat-treated drinking milk is transported in tanks the information referred to in point 4 (a), (b) and (c) of 
Chapter VII shall be given in accompanying documents.