COMMISSION OF THE EUROPEAN COMMUNITIES 
C0MC89) 672 final 
Brussels, 16 March 1990 
Proposal for a 
COUNCIL REGULATION (EEC) 
adopting health rules for the production and placing on the market 
of heat-treated drinking milk 
(presented by the Commission) 

- 2 - C0M(89)672final-EN 
EXPLANATORY MEMQjRANEOM 
The Community must adopt measures aimed at establishing the internal market 
before 31 December 1992. The need for free movement of products of animal 
origin must be reconciled with the need to protect public health. 
The objective of the present proposal is the harmonization of health rules 
applicable to heat-treated drinking milk for sale to the final consumer and 
to institutions. 
On 5 August 1985 the Council adopted a Directive on health and animal 
health problems affecting intra-Community trade in heat-treated milk. The 
present proposal is intended to extend the principles laid down in the said 
Directive to all Community production. 
However, it is necessary to amend certain technical rules, in particular 
those concerning the transport and the checks on raw milk and heat-treated 
drinking milk. Provision should be made for establishments which will not 
be in a position to comply with all the rules laid down at 1 January 1993. 
The proposal also provides for derogations to be granted to establishments 
with a limited production capacity. 
The general hygiene rules laid down in Council Regulation (EEC) No / 
of 1989 on general health rules for the production and placing 
on the market in the Community of products of animal origin and specific 
health rules for certain products of animal origin will apply in all cases. 
For the purpose of some of the implementing decisions, the Commission has 
opted for the Regulatory Committee procedure. In addition, where aspects 
of chemistry or technology are involved, provision is made for the 
Management Committee for Milk and Milk Products to be consulted. In the 
case at hand this choice is justified in that the Commission does not wish 
to upset the management inachinery which is in use in the veterinary field. 
Such a choice is without prejudice to the Commission's preference for the 
Advisory Committee procedure. 
This proposal appears in the timetable in the Annex to the White Paper on 
completing the internal market. 
- 3 
Proposal 
for a Council Regulation (EEC) 
adopting health rules for the production and 
placing on the market of heat-treated milk 
THE COUNCIL OF THE EUROPEAN OCMMUNITIES, 
Having regard to the Treaty establishing the European Economic Community, and in 
particular Article 43 thereof, 
Having regard to the proposal of the Commission^1), 
Having regard to the opinion of the European Pari lament(2), 
Having regard to the opinion of the Economic and Social Committee^3), 
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^4), as last amended by Directive 
89/165/EEC^5); whereas this extension requires certain technical amendments to 
the said Directive; 
(1) OJ No C p. .. 
(2) OJ No C p. 
(3) OJ No C , p. .. 
(4) ŒT No L 226, 24.08.1985, p. 13 
(5) OJ No L 61, 04.03.1989, p. 57 
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Whereas it is possible that, due to certain particular 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 
establ 1 shments 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 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 (2) 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; 
Whereas Ctouncil Directive 79/112/EEC of 18 December 1978 on the 
approximation of the laws of the Member States relating to the labelling, 
presentation and advertising of f oodstuf fs^3), as last amended by Council 
Directive 89/395/EEcC4), and ODuncil Directive 89/396/EEC of 14 June 1989 
on indications or markings identifying the lot to which a foodstuff 
belongs^5) are applicable; 
Whereas the Commission should be made 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 RBGULATICN : 
(1) OJNoL 
(2) OJ No L 
(3) OJ No L 33, 08.02.1979, p. 1 
(4) OJ No L 186, 30.06.1989, p. 17 
(5) OJ No L 186, 30.06.1989, p. 21 
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This Regulation lays down health rules for the production and placing on 
the market of heat-treated drinking milk. 
Article 3 
For the purposes of this Regulation 
1. "W7 P11*" 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 Tyfl fling" means an establishment at which one or more milk-
producing cows are kept; 
3. "heat-treatfyl 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 as 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 trmtment flfrh^jjfljhmmt'' 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 intraHDommunity trade in 
bovine animals and swine1 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^ shall apply as necessary. 
1 OJ No 121, 29.7.1964, p. 1977/64. 
2 OJ No L 148, 3.7.1971, p. 4. 
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Article 5 
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; 
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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 DC. 
7. It must have a weight of not less than 1 030 grammes 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 grammes of 
protein (total nitrogen minus non protein nitrogen) per litre and a 
fat-free dry matter content of not less than 8.50%. 
Article 4 
1. The reference methods and, where necessary, routine methods of 
analysis and testing to be used to monitor coimpliance with the 
conditions laid down in Article 3 (1) (f), and (3J 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, lijnits and methods sha.11 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. 
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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 collection 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 shall 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. 
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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 other than those referred to in paragraph 1. 
5. Until the entry into force of the implementing measures for this Article, 
national rules shall remain applicable subject to compliance with the general 
provisions of the Treaty. 
10 -
Article 9 
1. Milk tankers, premises, installations and working equipment may be used 
for other foodstuffs provided that all appropriate measures are taken to 
prevent contamination or deterioration of heat-treated drinking milk. 
2. Milk tankers must bear a clear Indication that they may be used only for 
the transport of foodstuffs. 
3. Where an establishment makes products obtained in part from milk and 
milk products, the products used in the manufacture of these foodstuffs 
must, if they have not previously undergone heat treatment or another 
kind of treatment which does not adversely affect milk or milk products, 
be stored and treated in premises specially provided for this purpose. 
4. In accordance with the procedure laid down in Article 16, the Commission 
shall adopt the detailed rules for the application of this Article, and 
in particular the conditions relating to washing, cleaning and 
disinfecting before re-use, and the conditions of transport. 
Such rules may Include an exclusion of certain types of foodstuffs, if 
the conditions are not adequate for these products. 
Article 10 
1. Veterinary experts from the Commission may make on-the-spot checks in so 
far as it is necessary for ensuring uniform application of this 
Regulation; they may, in particular, verify whether establishments are 
actually cxamplying with this Regulation. The Commission shall inform 
the Member States of the results of the inspections. 
A Member State in whose territory an inspection is being carried out 
shall give all the necessary assistance to the experts carrying out 
their duties. 
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2. If necessary, the general provisions in paragraph 1 of this Article shall be 
determined in accordance with the procedure laid down in Article 17. 
In accordance with the same procedure, a code containing the rules to be 
followed for the purpose of the checks referred to in paragraph 1 may be 
established. 
Article 11 
1. In accordance with the procedure laid down in Article 16, derogations from 
the provisions of Annex B, Chapters I, II, III and IV may be granted for 
establishments with limited production. 
2. In examining the derogations referred to in paragraph 1, the Commission shall 
take into consideration the information and criteria laid down in Articles 2 
and 3 of Decision .. / /EEC of [on the conditions for granting 
temporary and limited derogations from specific health rules for the 
production and placing on the market of certain products of animal origin]. 
3. When granting the derogations referred to in paragraph 1, the Commission 
shall, set the general and particular terms applicable to the implementation 
of each derogation in accordance with the procedure laid down in Article 16. 
Article 12 
The rules laid down in Council Regulation (EEC) No concerning 
veterinary checks in intra-Ctammunity trade with a view to the completion of the 
internal market CD shall apply, in particular with respect to the organization 
and the action to be taken following the checks carried out by the Member State 
of destination and the safeguard measures to be applied. 
Article 13 
The Commission may, in accordance with the procedure laid down in Article 17, 
draw up recommendations containing guidelines on good manufacturing practices 
applicable at the different stages of production and placing on the market. 
Article 14 
The Annexes shall be amended, in particular with a view to adapting them to take 
account of scientific and technological progress, by the Commission in 
accordance with the procedure laid down in Article 16. 
(1) ŒT No L 
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The Commission shall be assisted by the Standing Veterinary Committee set up by 
Council Decision 68/361/EEcC1), hereinafter referred to as "the Committee". 
Article 16 
Where the procedure laid down in this Article is to be followed, the following 
provisions shall apply. 
The representative of the Commission, after consulting the Management Committee 
for Milk and Milk Products set up by Council Regulation (EEC) No 804/68(2) in 
cases where aspects of chemistry or technology are involved, shall submit to the 
Committee a draft of the measures to be adopted. 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. The opinion shall be delivered by the 
majority laid down in Article 148(2) of the Treaty in the case 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 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 this Article is to be followed, the following 
provisions shall apply : 
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. 
(1) CJNoL 255, 18.10.1968, p. 23 
(2) OJNoL 148, 28.09.1968, p. 13 
13 -
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. 
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. 
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. 
EMUOIHaiuL.JBUL 
This Regulation shall enter into force on the thirtieth day following its 
publication in the Official Journal of the European Communities. 
It shall apply with effect from 1 January 1993. 
This Regulation shall be binding in its entirety and directly applicable in 
all Member States. 
Done at Brussels, For the Council, 
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ANNELA 
REQUIREMENTS RELATING TO THE ATMTfiRICW OF RAW MUX 
CHAPTER I 
rnwr>TTTn^.q van PAW MTTK 
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; 
(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(1) 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. 
(1) OJ No L 222, 01.08.1981, p. 32 
(2) OJ No L 70, 16.03.1988, p. 16 
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HYGIENE OF THE HOJTJDING 
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/EEC1 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 andumals are 
housed. 
1 OJ NO L 229, 30.8.1980, p. 11. 
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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. 
ÇSÊS3SSLHL 
HÏGIENE IN MILKING, IN COLLECTING RAW MELK AND IN ITS TRANSPORT 
FROM THE PRODUCTION HOLDING TO THE OOLLEGnON OR STANDARDIZATION CENTRE 
OR TO THE MILK TREATMENT ESTABLISHMENT - HYGIENE OF STAFF 
Milking must be carried out hygienically and under the general 
conditions of hygiene referred to in Article 5 (2) of this Regulation. 
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 dally 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. 
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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. 
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. 
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. 
The tanks used in the collection of milk must be used in accordance 
with Article 9 and Annex B, Chapter IX. 
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 QN AEMISSIQN 
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. 
- 18 
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 (1) 
< 400 000 (2) 
< 0.004 ug 
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. A control system shall be established under the supervision of the 
competent authority to prevent the presence of extraneous water in 
milk. This system sha.11 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. 
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AMBLE 
GENERAL APPROVAL RBOTBEKENTS 
The general requirements for establ i shments 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 
fiPETCCAL FWTTRMFNTO KB TM A^P^AL OF TREATMENT EflTAfiI,ISHMENTS 
In addition to the general requirements laid down in Chapter I, treatment 
establ 1 shments 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; 
- 20 
(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. 
SPECIAL RETIREMENTS KfR REGISTRATION OF OÏÏ.T.rmTm 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. 
SPECIAL REQUIREMENTS FOR REGISTRATTON 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. 
21 
CHAPTER V 
HYGIENE RETIREMENTS RELATING TO THE PREMISES. 
EWIFMENT AND STAFF OF ESTArTOfiHMrWS 
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. 
RETIREMENTS RELATIFS 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 at 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. 
?.? 
3. Pasteurized milk which is has been subjected to high-temperature 
pasteurization, UHT milk and sterilized milk lay be produced from milk 
which has undergone, in another establishment, an initial heat 
treatment. In this case the "t^me-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. MICTQBIQKGICAL STANDARDS 
Pathogens : absent in 25g : n=5, c=0, m=0, M=0 
Coliform (per ml) : n=5, c=l, m=0, M=5 
After incubation at 6°C 
in five days: 
Plate count 21°C 
(per ml) :n=5, c=l, m=5xl04, M^O5 
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. 
- 23 -
B. OIBER 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 "Mgh-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; 
- 24 - . 
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) 
organoleptic check 
antibiotics <10 (per 0.1 ml) 
normal 
not exceeding permitted levels. 
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. 
25 -
13. The graphs produced by recording tiiermoraeters 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 
PACKAGD*; AT THE TREATMENT ESTATÏÏ.T.SHMENT OF HEAT-TREATED 
PRTTCTTT MTTK TN OfflTAINERS JffllEHDED FOR SALE TO THE FINAL QQNSTOSER 
1. Without prejudice to Council Directive 89/109/EEC of 21.12.1988 on the 
approximation of the laws of the Member States relating to materials and 
articles intended to come into contact with foodstuffs^1), 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 - EOF - EEC - BCK. 
(1) OJ No L 40, 11.02.1989, p. 38 
(2) OJ No L 33, 08.02.1979, p. 1 
- 26 -
CHAPTER VIII 
THE. STORAGE QF PASTEPRIZED MTTK TN THE TREATMENT TCTAr¥iTSnMENT 
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 QF HEAT-TREATED MH£ 
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. 
- 27 
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 influences 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. 
- 28 -
FINANCIAL STATEMENT 
Concerning: Draft proposal for a Council Regulation laying down 
health rules for the production and placing on the market of heat-
treated drinking milk and repealing Directive 85/397/EEC) 
1. Budget, heading item. Title 
III b 382 Inspection in agriculture 
2. Legal basis 
Article 43 of the Treaty 
3. Classification : Non-compulsory expenditure 
Verification of the application of the Regulation (Article 10) 
5.1. Form of expenditure: Mission expenses 
5.2. Community contribution: 100% 
5.3. najoniation 
200 mission days per year at ECU 170 per day (current cost 
of inspections) - ECU 34 000 per year. 
6. Financial implication as regards operating appropriations 
6.1. Schedule of commitment appropriations and payment appropriations 
(ECU million) 
Year C.A. /P.A. 
1991 
1992 
1993 0,034 
1994 0,034 
1995 0,034 
following years 
Total 0,102 
6.2. Financing during current year : NIL 
7. Observations: 
This proposal also calls for two additional A7/6 posts. 
The Budget Committee wil decide under which item this expenditure will 
be charged when the 1990 draft budget is drawn up. 
- 29 -
STATEMENT OF IMPACT ON BUSINESS 
Name of proposa Draft proposal for a Council Regulation laying 
down the health rules for the production and 
placing on the market of heat-treated drinking 
milk and repealing Directive 85/397/EEC. 
Object Ives The proposal Intends to complete the harmonization 
of health rules for the production and placing on 
the market of heat-treated drinking milk by 
extending the principles of Directive 85/397/EEC 
to natlonal markets. 
Impact on Business-. At this moment certain health rules exist at 
Community level for Intra-Communlty trade of heat-
treated milk. in order to avoid competitive 
distortions in a single market It is necessary to 
complete the harmonization In this field. 
To avoid certain problems, which in particular at 
farm level might occur if all rules of 
Directive85/397/EEC would be extended to the 
national markets, a number of modifications are 
proposed. 
Drinking milk is at present almost exclusively 
produced at Industrial level due to the necessary 
Investments In storage, heat-treatment and 
packaging equipment. Most manufacturers will at 
present to a high degree comply with the proposed 
health requirements. 
Therefore, In genera 
expected to be small. the Impact on business is 

- 30 -
ISSN 0254-1475 
COM(89) 672 final 
DOCUMENTS 
EN 03 
Catalogue number : CB-CO-90-007-EN-C 
ISBN 92-77-56533-0 
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