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COMMISSION OF THE EUROPEAN COMMUNITIES 
COM(ai) 425 final 
Brussels, 11 November 1991 
Amendment to the 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 pursuant to Article 149(3) 
of the EEC-Treaty) 
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EXPLANATORY MEMORANDUM 
On 22 March 1990 the Commission submitted to the Council a proposal for a 
Regulation (EEC) adopting health rules for the production and placing on the 
market of heat-treated drinking milk.1 
As a result of the opinion delivered by the European Parliament at its 
part-session of 11 June 1991,2 the Commission has decided, in compliance with 
Article 149(3) of the Treaty, to amend its original proposal. 
1 0J No C 84, 2.4.1990, p. 130. 
2 0J No C 
-Ab+o -
amendment of a 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 pursuant to Article 149(3) 
of the EEC-Treaty) 
On 22 March 1990 the Commission submitted the aforementioned proposal to the 
Council. As a result of the opinion of the European Parliament delivered at its 
part-session of 11 June 1991, the initial proposal is hereby amended as follows: 5 
1. The following recital is added: 
"whereas the Commission has decided to submit to the Council, as soon as 
possible and preferably before the end of 1991, a framework directive of 
general application on food hygiene and safety;" 
2. The following paragraph is added to Article 1: 
"drinking milk for sale in the Community must comply with the requirements 
of this Regulation, and horizontal legislation on products of animal 
origin and food labelling. These rules are without prejudice to future 
horizontal legislation with regard to food hygiene which may define and 
supplement them." 
2 -
3. Article 2(3) is replaced by the following: 
"3. "heat-treated drinking milk" means 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) and milk treated by the 
process of pasteurization for bulk supply;" 
- Article 2(4) is replaced by the following: 
"4. "competent authority" means the authority or body designated by the 
Member State concerned;" 
4. Article 3(1)(a) is replaced by the following: 
"(a) which complies with Regulation (EEC) No.1411/71;" 
Article 3(1)(g) is replaced by the following: 
"(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, or transferred between tankers under conditions which meet 
good hygiene and distribution practice;" 
5. Article 9(2) is replaced by the following: 
"2. Tankers used for milk must bear a clear indication that they may be 
used only for the transport of foodstuffs." 
- 3 -
Article 9(3) is replaced by the following: 
"3. Where establishments produce foodstuffs containing milk or milk 
products together with other ingredients which have not undergone heat 
treatment or another means of preservation, the milk and ingredients 
should be stored separately to prevent cross-contamination, and 
treated or processed in premises suitable for the purpose." 
6. The first subparagraph of Article 10(1) Is replaced by the following: 
"1. Veterinary and other competent 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, verifiy 
whether establishments are actually complying with this Regulation. 
The Commission shall inform the Member States of the results of the 
inspect ions." 
7. Point 2 of Annex A, Chapter III is replaced by the following: 
"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. Milk 
must be chilled to a temperature of not more than 6"C within four 
hours of milking, and should not exceed this temperature during 
transportât ion." 
Point 5 of Annex A, Chapter III is replaced by the following: 
"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 and must be washed off." 
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8. The second and third sub-paragraphs of Annex A, Chapter IV, point 1, are 
replaced by the following: 
"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) 100 000(1) 
Somatic cell count (per ml) 500 000(2) 
Antibiotics (per ml) 
- peniciI I In < 0.004 ug 
- other 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 six months, with at least 
one sample a month. 
When the maximum standards are exceeded and when subsequent investigation 
indicates a potential danger to health, the competent authorities shall take 
appropriate measures." 
9. Point b in Annex B, Chapter II, is replaced by the following: 
"(b) equipment for the cooling and cold storage of heat-treated milk and, 
in the cases provided for in Chapters III, IV and VI (1), raw milk. 
Cold stores must be equipped with correctly calibrated 
temperature-measur i ng apparatus." 
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10. Point 4 of Annex B, Chapter VI is replaced by the following: 
"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) or a pasteurization process 
using different time and temperature combinations to achieve an 
equivalent effect." 
Point 5B(b) of Annex B, Chapter VI is replaced by the following: 
"(b) Absence of antibiotic residues detectable by official methods." 
Point 11 of Annex B, Chapter VI is replaced by the following: 
"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 according to 
Community or international standards." 

ISSN 0254-1475 
COM(91) 425 final 
DOCUMENTS 
EN 03 
Catalogue number : CB-ÇO-91-484-EN-C 
ISBN 92-77-77040-6 
Office for Official Publications of the European Communities 
L-2985 Luxembourg