No C 332/102 Official Journal of the European Communities 31. 12. 90 
Opinion on the proposal for a Council Regulation adopting health rules for the production 
and placing on the market of heat-treated drinking milk (*) 
(90/C 332/29) 
On 2 April 1990 the Council decided to consult the Economic and Social Committee, under 
Article 198 of the Treaty establishing the European Community, on the abovementioned 
proposal. 
The Section for Agriculture and Fisheries, which was responsible for preparing the Com­
mittee's work on the subject, adopted its Opinion on 12 July 1990. The Rapporteur was 
Mr Gardner. 
At its 279th plenary session (meeting of 19 September 1990), the Economic and Social 
Committee adopted the following Opinion by 72 votes to 0, with two abstentions. 
1. Introduction 
1.1, This proposal updates Directive 85/397/EEC of 
5 Augustus 1985, which deals with trade between Mem­
ber States and adapts it to the 1993 market without 
frontiers. The Committee approves, subject to the fol­
lowing remarks and changes. 
2. General comments 
2.1. The Committee sees three overall problems with 
this proposal: 
2.1.1. This is another proposal which does not 
include in the 'whereas' or in the text, appropriate 
reference to the general hygiene Directive being worked 
out by another part of the Commission, through 
Article 1.2 of COM(89) 492 final (proposal for general 
health rules for certain products of animal origin), 
clearly states that 'the present regulations shall apply 
without prejudice to future horizontal hygiene legis­
lation on foodstuffs'. 
2.1.2. It is essential that this proposal should provide 
for compliance with that directive where necessary. 
This is particularly important for the establishments 
which may be exempted from these rules. While exemp­
tion from some of the detailed rules is reasonable, this 
would leave the establishments concerned without any 
alternative Community rules and could thus present a 
danger to the public. 
2.1.3. Public health is not divisable and smaller 
establishments merely endanger fewer people. All estab­
lishments must therefore be covered by proper health 
rules, the details of which should be adapted to the 
type and size of the establishment. 2.1.4. Milk health rules are divided into two separate 
proposals, this one and that on milk-based products. 
There are numerous cross reference between the two 
and their interplay is extremely confusing. The Com­
mission would be better advised to re-write them as 
one document after having taken the Committee's com­
ments into account. 
2.1.5. On several occasions the proposal drifts into 
quality rules. These should be dealt with by appropriate 
quality directives and not be allowed to dilute the 
impact of health rules. 
3. Detailed comments 
3.1. Preamble 
3.1.1. Given our general comments, there should be 
a further 'whereas': 
'Whereas the granting of the derogations from spec­
ific Community health rules to certain establish­
ments does not affect compliance with the require­
ments of Directive No ... of ... on the protection of 
human health by monitoring the wholesomeness of 
food and observing basic principles of hygiene dur­
ing the production, handling and sale.' 
3.2. Article 2.1 
Heat-treated milk from goats, buffaloes, sheep, etc. is 
not covered by this proposal but is apparently con­
sidered a milk-based product and thus comes under 
COM(89) 667 final. This seems illogical and should be 
included in this proposal if the two proposals are kept 
separate. 
3.3. Article 2.3 
3.3.1. Delete: the word 'prepacked' from the defi­
nition. 
(*) OJ No C 84, 2. 4. 1990, p. 130. 3.3.2. In spite of the hazards of selling loose milk 
31.12. 90 Official Journal of the European Communities No C 332/103 
this is returning in some countries under the impulses 
of 'green' policies. 
3.4. Article 3.4 
The last sentence should be changed to: 
'... subject to final heat treatment.' 
3.5. Article 3.7 
3.5.1. This paragraph should be deleted. 
3.5.2. These are purely quality standards, not health 
ones and, moreover, they are in part incorrect. Thus a 
density of 1,030 g/1 is too high and so is the fat-free dry 
matter content of 8,5 %. These figures vary with breed, 
individual cow and time of year. Corrected figures 
should be put into a quality directive and there should 
be provision for referring back to the actual cow (called 
apeal to cow in Irish and UK law). 
3.6. Article 7.1 
The competent authorities do not exert full-time con­
trol, but need to ensure that proper testing is carried 
out by the establishment. The text should therefore be 
changed to: 
'Raw milk and heat-treated drinking milk shall 
undergo checks carried out by milk-treatment estab­
lishments under the overall supervision and 
responsibility of the competent authority and using 
methods approved by the latter in order ...' 
3.7. Article 9.3 
The last line to be changed to: 
'...be stored and treated in such a way as to prevent 
cross-contamination given the nature of the 
product.' 
3.8. Article 11 
3.8.1. For the reasons given in the general comments, 
we would want this Article to be deleted. 
3.8.2. If it is maintained, it is essential: 
a) That 'limited production' is defined so as to ensure 
as far as possible that such a product is only used 
within a Member State. b) That a further point 4 is added: 
'4. The establishments with derogations under 1 
shall comply with the requirements of Directive 
No ... of... on the protection of human health by 
monitoring the wholesomeness of food and observ­
ing basic principles of hygiene during the pro­
duction, handling and sale.' 
c) That a list of these establishments is published in 
the Official Journal or some other place where the 
public has access to it. 
3.9. Annex A 
3.9.1. Chapter III.2 
To ensure that the hygienic quality of milk is 
maintained, the requirements should be for 6°C 
throughout, unless the milk is collected within two 
hours of milking. This is also in line with Annex B, 
chapter VI. 1. 
3.9.2. Chapter III.7 
As the Committee has noted previously, it is essential 
that national insurance schemes facilitate employees in 
staying away from work if necessary and not penalize 
them. 
3.9.3. Chapter IV.1 
3.9.3.1. In the table, change last point to: 
'Antibiotics (per ml) not detectable by recognised 
biological methods.' 
3.9.3.2. The present 'undetectable' is meaningless. 
3.9.3.3. Also the Commission should agree standards 
for aflatoxin Ml and then include these. 
3.9.3.4. Plate counts and somatic cell counts at the 
levels given in the proposal are quality and animal 
husbandry criteria which have little relevance to public 
health. They should be in separate proposals dealing 
with these subjects. 
3.9.3.5. If they are retained in this proposal, it must 
be made clear, that they are indicative standards only 
and not rejection ones. 
3.9.4. Chapter IV.4 
3.9.4.1. Change first sentence to: 
'If the holding does not meet the standards within 
the following time limits: 
Plate count - two weeks 
No C 332/104 Official Journal of the European Communities 31. 12. 90 
Somatic cell count - three months 
Added water - immediately but only if second check 
confirms the result 
Aflatoxin and antibiotics - immediately but only if 
result is confirmed by a further check 
Then the holding must temporarily...' 
3.10. Annex B 
3.10.1. Chapter VI.2a 
This should be deleted, being a quality, not a health 
requirement. If it is retained, the level could well be 
raised to: 
'not exceeding 500 000 per ml.' 
3.10.2. Chapter VI.3 
Improve clarity by changing to: 
'in this case the time temperature of the initial heat 
treatment...' 
3.10.3. Chapter VI.5 
One of the best ways of protecting the consumer is to 
apply GMP (Good Manufacturing Practice) principles 
and manufacture based on HACCP (Hazard Analysis 
of Critical Control Points). With such an approach it 
is necessary to have microbiological criteria to verify 
that GMP has been applied. The proposal needs to 
emphasize this and the fact that these standards are 
intended for such verification. 
Done at Brussels, 19 September 1990. 3.10.4. Chapter VI, 5A 
The test after incubation at 6°C has been taken over 
from the present Directive. This test has proved to be 
poorly reproductible and difficult to apply. It needs 
replacing by a better method. 
3.10.5. Chapter VII. 1 
The Committee approves the requirement to comply 
with the Council Directive 89/109/EEC and would 
emphasise that hygiene must remain of paramount 
importance in packaging for milk. 
3.10.6. Chapter VII.4 
The initials 'EEC are redundant and could well be 
omitted. 
3.10.7. Chapter VIII 
For milk in glass bottles, best hygiene requires them to 
be filled immediately after cleaning while the are still 
warm. The following therefore should be added: 
'For milk sold in glass bottles, the temperature may 
rise to 10 °C during the filling operation, but must 
be brought to 6°C and held there until the milk 
leaves the establishment.' 
3.10.8. Chapter IX.5 
Change at the end to: 
'... vehicles involved in doorstep deliveries.' 
The Chairman 
of the Economic and Social Committee 
Alberto MASPRONE