COMMISSION OF THE EUROPEAN COMMUNITIES 
C0M(93) 715 final 
Brussels, 10 January 1994 
Proposal for a 
COUNCIL PI RECTI YE 
amending Directive 92/46/EEC laying down the health rules 
for the production and placing on the market of raw milk, 
heat-treated milk and milk-based products 
(presented by the Commission) 
I 
EXPLANATORY MEMORANDUM 
In June 1992 the Community adopted measures on the production and placing of the 
market of raw milk, heat-treated drinking milk, milk for the manufacture of 
milk-based products and milk-based products. 
In the light of the experience gained, it has been found necessary to make 
certain technical adjustments and additional specifications in the annexes to 
Directive 92/46/EEC. 
The amendments, which are presented in the form of a proposal for a Directive, do 
not concern the body of the Directive but only its annexes. 
They concern, in particular: 
- the temperatures for collection and transport of raw milk from the production 
holding to the treatment or processing establishment. 
These amendments must take account of the fact that several species of 
milk-producing animals are covered by the Directive and uniform treatment would 
compromise certain traditional industrial practices; 
- the rules concerning equipment in treatment or processing establishments. 
Amendments are needed because of the very wide diversity in the size of 
industrial establishments. The need to adapt the rules to take account of this 
. diversity has lead to greater flexibility for small establishments, without 
Jeopardizing the hygiene of products or compromising consumer protection; 
3 
- lastly, hygiene and standardization requirements for the production of 
heat-treated drinking milk and milk-based products in order to improve checks 
by the competent authorities and to facilitate greater harmonization of the 
rules when these are transposed into national law. 
These amendments are simply technical adjustments to the annexes with a view to 
improving the application of Community legislation, particularly the measures 
establishing the single market and free movement of foodstuffs of animal origin; 
the amendments in no way call into question the high level of public health 
protection; they adjust the requirements so as to take better account of the 
different species of animal concerned and the differences in the initial 
situations in the Member States. It, too is in the form of a Directive, which 
Member States are required to implement under Commission supervision. 
The proposal has no implications for the Community budget. 
Proposal for a 
COUNCIL DIRECTIVE 
amending Directive 92/46/EEC laying down the health rules 
for the production and placing on the market of raw milk, 
heat-treated milk and milk-based products 
THE COUNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty establishing the European Community, 
Having regard to Council Directive 92/46/EEC laying down the health rules for the 
production and placing on the market of raw milk, heat-treated milk and 
milk-based products*1*, and in particular Article 21 thereof, 
Having regard to the proposal from the Commission^2), 
Whereas, following a detailed study of certain provisions In the Annexes to 
Directive 92/46/EEC, it has been found necessary to make certain technical 
adjustments in order to ensure better application; whereas such amendments 
concern, in particular, the collection temperatures for raw milk, the rules on 
equipment in treatment or processing establishments and the manufacture of 
heat-treated milk and milk-based products, 
(1) OJ No L 268, 14.09.1992, p. 1 
(2) OJ No L 
J" 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Directive 92/46/EEC is hereby amended as follows: 
1. In Annex A, the second subparagraph of Chapter II1(A)(2) is replaced by the 
fo11owIng: 
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 the milk is not 
collected within two hours of milking, it must be cooled to a temperature 
of 8"C or lower in the case of daily collection or 6"C if collection is 
not daily. While the milk is being transported to the treatment and/or 
processing establishment its temperature must not exceed 10'C unless the 
milk has been collected within two hours of milking." 
For technological reasons concerning the manufacture of certain products 
based on goat's or ewe's milk, the competent authorities may authorize 
derogations to the temperatures laid down in the preceding subparagraph 
provided the end product meets the standards set out in Chapter II of 
Annex C." 
2. In Annex B, Chapter I, the first sentence of (3) is replaced by the following: 
"in rooms where the raw materials and the products covered by this Directive 
are stored, the same conditions as those at 2(a) to (f), except:" 
G 
3. in Annex B, Chapter 11(A)(3) is replaced by the following: 
"3. Working areas, instruments and working equipment must be used only for 
work on products for which approval has been granted. 
However, following authorization by the competent authority, they may be 
used at the same time or other times for work on other foodstuffs fit for 
human consumption or other milk-based products intended for use other than 
human consumption, provided they do not create contamination of the 
products for which agreement has been given." 
4. In Annex B, the title of Chapter III is replaced by: 
"Special requirements for approval of collection centres". 
5. In Annex B, the title of Chapter IV is replaced by: 
"Special requirements for approval of standardization centres". 
6. In Annex B, Chapter V(a) is replaced by the following: 
"(a) equipment for the mechanical filling and proper automatic sealing of 
containers which are to be used for packaging heat-treated drinking milk 
and milk-based products in liquid form, after filling, excluding churns, 
tanks and bulk packaging of more than 5 litres, insofar as such 
operations are carried out there; 
However, in the case of limited production, the competent authorities 
may authorize alternative non-automatic sealing methods provided that 
such methods carry equal assurances with regard to hygiene". 
7. In Annex B, Chapter V(f) is replaced by the following: 
"(f) In the case of treatment establishments, 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, 
9 
- an adequate safety system preventing the mixture of heat-treated milk 
with incompletely heated milk; 
- an automatic recording device for the safety system referred to in the 
preceding indent. 
However, the competent authorities may authorize different equipment 
with equivalent performance guarantees and equal assurances with 
regard to hygiene. 
In the case of processing establishments, insofar as such operations are 
carried out there, equipment and methods for heating, thermization or 
heat-treatment, meeting the hygiene requirements". 
8. In Annex B, Chapter VI(3) is replaced by the following: 
"3. Equipment, containers and installations which come into contact with milk 
or milk-based products or other perishable raw materials during 
production must be cleaned and if necessary disinfected according to a 
frequency and procedures consistent with the principles referred to in 
Article 14(1)". 
9. In Annex V, Chapter VI(4) is replaced by the following: 
"4. The treatment premises must in principle be cleaned according to a 
frequency and procedures consistent in accordance with the principles 
referred to in Article 14(1)." 
10. In Annex C, in the first sentence of the second subparagraph of 
Chapter 1(A)(2), the word "cow's" is inserted between "raw" and "milk". 
11. In Annex C, the first indent of Chapter 1(A)(3)(a) is replaced by the 
fol Iow i ng: 
"- raw milk, if it is not treated within 36 hours of acceptance, does not 
exceed immediately before heat treatment a plate count at 30*C of 300 000 
per ml in the case of cow's milk or 1 000 000 per ml in the case of 
sheep's, ewe's or buffalo's milk". 
? 
12. In Annex C, the following is added to Chapter 1(A)(4)(d): 
"Pasteurized milk may be produced in the same conditions from raw milk which 
has undergone only initial thermization". 
13. In Annex C, Chapter 1(B)(1) is replaced by the following: 
"1. The operator or manager of the processing establishment must take all 
necessary steps to ensure that the raw milk is heat-treated, or used, in 
the case of products "made with raw milk", 
- as soon as possible after acceptance if the milk has not been 
refrigerated, 
- within 36 hours of acceptance if the milk is kept at a temperature not 
exceeding 6*C, 
- within 48 hours of acceptance if the miik is kept at a temperature not 
exceeding 4'C. 
However, for technological reasons concerning the manufacture of certain 
milk-based products, the competent authorities may authorize the times 
and temperatures referred to in the above three indents to be exceeded. 
They shall inform the Commission of such derogations, and their technical 
Just ification. 
14. In Annex C, Chapter I(B)(3)(a)(i) is replaced by the following: 
"(i) have been obtained from raw milk which, if it is not treated within 
36 hours of acceptance by the establishment, has a plate count at 30'C 
which does not exceed 300 000 per ml in the case of cow's milk and 
1 000 000 per ml in the case of buffalo's, goat's or ewe's milk". 
15. In Annex C, Chapter I (B)(3)(a)(iii) is replaced by the following: 
"If it is used for the production of pasteurized, UHT or sterilized milk 
intended for the manufacture of milk-based products, meet the following 
standards before treatment: plate count at 30'C equal to or less than 
100 000 per ml". 
3 
16. In Annex C, the last two subparagraphs of Chapter 11(A)(2) are replaced by 
the fol lowing: 
"In addition, whenever the standard M is exceeded in the case of cheese made 
from raw milk and from thermized milk and soft cheese, either testing must be 
carried out for the possible presence of toxins in such products, or strains 
of enterotoxinogenic Staphylococcus aureus or strains of Escherichia coli 
that are presumed to be pathogenic must be identified by means of methods to 
be determined in accordance with the procedure laid down in Article 31 of 
this Directive. If toxins are found or the above-mentioned strains are 
identified, all the batches involved shall be withdrawn from the market. In 
this case the competent authority shall be informed of the findings, pursuant 
to the fifth indent of Article 14(1) of this Directive, and of the action 
taken to withdraw the suspect batches and the corrective procedures 
introduced into the production monitoring system." 
17. "In Annex C, the first sentence of Chapter 11(A)(4) is replaced by the 
fol lowing: 
"In addition, milk-based products which have undergone UHT treatment or 
sterilization which are intended for conservation at room temperature must 
meet the following standards after incubation for 15 days at 30'C:" 
18. In Annex C, the following is added to Chapter lll(3): 
"However, in the case of limited production, the competent authorities may 
authorize non-automatic sealing methods provided that these provide equal 
assurances with regard to hygiene". 
19. In Annex C, the second subparagraph of Chapter lll(4) is replaced by the 
foI Iow i ng: 
"Sealing must be carried out in the establishment in which the last heat 
treatment of drinking milk and/or milk-based products in liquid form has been 
carried out, immediately after filling, by means of sealing devices which 
ensure that the milk is protected from any adverse effects of external origin 
on its characteristics. The sealing system must be so designed that once the 
container has been opened, the evidence that it has been opened remains clear 
and easy to check." 
1o 
20. In Annex C, Chapter lll(5) is replaced by the following: 
"5. The operator or manager of the establishment must ensure for control 
purposes that in addition to the information required by Chapter IV the 
following information is visibly and legibly displayed on the packaging 
of the heat-treated milk and milk-based products in liquid form: 
- the nature*of the heat treatment which the milk has undergone, 
- an indication, in code or not, whereby the date of the last heat 
treatment may be established and, in the case of pasteurized milk, the 
temperature at which the product must be stored". 
21. In Annex C, the last sentence of Chapter IV(A)(1) is replaced by the 
following: 
"However, where a product is individually wrapped and packaged or split into 
small packaged units to be supplied to the final consumer by an institution, 
it will suffice for the health mark to be applied to the packaging." 
22. In Annex C, the following is added to Chapter IV(A)(3)(a): 
"In the case of the bottles, packaging and recipients referred to in 
Article 11(4) and (6) of Directive 79/112/EEC, the health mark may indicate 
only the initials of the consigning country and the approval number of the 
establishment". 
23. In Annex C, the last sentence of Chapter IV(A)(3)(b) is deleted. 
24. In Annex C, the following is added to Chapter IV(A): 
"4. To take account of the disposal of existing packaging, application of the 
health mark on packaging shall be compulsory only from 1 January 1995. 
However, the health mark must be shown on the accompanying commercial 
document provided for in Article 5(8) and the last subparagraph of 
Article 7(A)(9) of this Directive". 
41 
25. In Annex C, the following is added to Chapter V(7): 
"and authorize a tolerance of +2'C during deliveries to retail 
establishments". 
Article Z 
Member States shall bring into force the laws, regulations and administrative 
provisions necessary to comply with this Directive before 1 July 1994. They shall 
forthwith inform the Commission thereof. 
When these measures are adopted by the Member States, they shall contain a 
reference to this Directive or shall be accompanied by such reference on the 
occasion of their official publication. The methods of making such a reference 
shall be laid down by the Member States. 
Article 3 
This Directive is addressed to the Member States. 
ISsK 0254-1475 
COM(93) 715 final 
DOCUMENTS 
EN 03 
Catalogue number : CB-CO-93-766-EN-C 
ISBN 92-77-63789-7 
Office for Official Publications of the European Communities 
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