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i*#= COMMISSION OF THE EUROPEAN COMMUNITIES 
C0M(91) 420 final 
Brussels, 29 October 1991 
Amendment to the proposal for a 
COUNCIL REGULATION (EEC) 
laying down the health rules for the production and 
placing on the market of raw milk, of milk for the manufacture 
of milk-based products and of milk-based products 
(presented by the Commission pursuant to Article 149(3) 
of the EEC Treaty) 
S5piS^ic^£ 
EXPLANATORY MEMORANDUM 
On 13 February 1990, the Commission submitted to the Council a proposal for a 
Regulation (EEC) laying down the health rules for the production and placing on 
the market of raw milk, of milk for the manufacture of milk-based products and 
of milk-based products.1 
In the wake of the opinion delivered by Parliament at its sitting of 
11 June 1991,2 the Commission decided to amend its original proposal in , 
accordance with Article 149(3) of the Treaty. 
1 OJ C 84, 2.4.1990, p. 112 
2 OJ C ... 
AMENDMENTS TO THE PROPOSAL FOR A 
COUNCIL REGULATION (EEC) No 
laying down the health rules for the production and 
placing on the market of raw milk, of milk for the manufacture 
of milk-based products and of milk-based products 
(Submitted by the Commission pursuant to 
Article 149(3) of the EEC Treaty) 
On 13 February 1990, the Commission submitted the abovementloned proposal to the 
Council. Following the opinion of the European Par I iament .de I ivered at its 
sitting of 11 June 1991, the original proposal is hereby amended as foi lows: 
1. The second recital is replaced by the following: 
"Whereas, in order to ensure the rational development of this sector and to 
increase productivity and competitiveness, health rules governing the 
production and placing on the market of raw milk, of milk for the manufacture 
of milk-based products and of milk-based products should be laid down at 
Communi ty level ; " ; 
2. The fourth recital is replaced by the following: 
"Whereas the introduction of such rules will help to ensure a high levé! of 
protection for the public health of citizens;"; 
3. The sixth recital is replaced by the following: 
"Whereas it seems necessary to exclude from the scope of this Regulation 
certain products sold directly by the producer to the consumer, on condition 
that a minimum number of essential conditions of hygiene are guaranteed;"; 
2 -
4. The following recitals are inserted after the sixth recital: 
"Whereas it is vital for Community rules to be clear and comprehensible to 
the people concerned; 
Whereas the starting points in terms of the health conditions of livestock 
and production and processing structures differ from one Member State to 
another ; 
Whereas the Commission must be provided with sufficient organizational, 
staffing and financial means fully to carry out its monitoring tasks;"; 
5. The following recital is added: 
"Whereas the Commission has agreed to submit to the Council a proposal for a 
Directive laying down a general framework for standards of health and safety 
for foodstuffs as soon as possible and preferably before the end of 1991;"; 
6. The first indent of Article 1(2) is replaced by the following: 
by the producer, of raw milk produced on his farm, from a herd which is 
free of brucellosis and tuberculosis provided that the hygiene 
conditions of the holding comply with the minimum health guarantees laid 
down by the competent authority;"; 
-' 3 -
7. In Artide 2: 
- point 2 is replaced by the following: 
" 2) 'milk for the manufacture of milk-based products' means either raw 
milk for processing or liquid or frozen milk obtained from raw 
milk, whether or not it has undergone an authorized physical 
treatment, such as heat treatment or thermization, or modified in 
its composition, provided that these modifications are restricted 
to an addition and/or withdrawal of any of the natural milk 
constituents in accordance with Regulation (EEC) No 1411/71 of 
29 June 1971 (D." 
- point 9 is replaced by the following: 
"9) 'competent authority' means the competent authority or the body 
designated by the Member State." 
- point 10 is replaced by the following: 
"10) the definitions set out 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 and of 
Council Regulation (EEC) No 91/68/EEC of 28 January 1991 on animal 
health conditions governing intra-Community trade in ovine and 
caprine animals^2), whiich define operating conditions, animals 
for slaughter, production and reproduction, as well as animals, 
holdings or zones free of tuberculosis, brucellosis and epizootic 
diseases, notifiable diseases, exporting country and country of 
destination, shall apply where necessary. 
8. In Ar tide 3: 
- point 1 is replaced by the following: 
"1) be checked in accordance Article 9(1), which refers to the need to 
introduce periodic checks in order to ensure that hygiene 
requirements are met;" 
(1) OJ No. L 148 of 03.07.1971, p.4. 
(2) OJ No. L 46 of 19.02.1991, p.19 
- 4 -
- point 2 is replaced by the following: 
"2) meet the standards laid down in Chapter II of the Annex hereto, 
which lays down standards for raw milk;" 
- point 3 is replaced by the following: 
"3) where appropriate, satisfy the requirements laid down in 
Article 3(1)(g) of Regulation (EEC) No ... (heat-treated drinking 
milk) relating to the general conditions governing approval, 
registration and hygiene in respect of the premises, equipment and 
staff of collection centres;" 
- point 4 is replaced by the following: 
"4) in the case of cow's milk, satisfy the requirements laid down in 
Article 3(1)(b), (c) and (d) of Regulation (EEC) No ... 
(heat-treated drinking milk), which stipulate the conditions for 
the admission of raw milk to treatment establishments, the hygiene 
of holdings and the milking, collection and transport of raw milk;" 
In Art icle 4: 
- point 2 is replaced by the following: 
"2) where it is not sold to the consumer within two hours after the end 
of milking, be cooled in accordance with Chapter I M of Annex A to 
Regulation (EEC) No ...(heat-treated drinking milk), which ensures 
hygiene in milking, in collecting raw milk and in its transport, 
and the hygiene of staff involved in handling and collecting milk;" 
- point 3 is replaced by the following: 
"3) satisfy the requirements set out in point 1 of Chapter V of the 
Annex hereto-," 
- point 4 is replaced by the following: 
"4) satisfy the additional requirements set out in accordance with the 
procedure laid down in Article 15 of this Regulation." 
- 5 -
10. In Article 5: 
- point 3 is replaced by the following: 
"3) where appropriate, be obtained in a processing establishment that 
meets the requirements set out in Article 3(2) of Regulation (EEC) 
No ... (heat-treated drinking milk), which lays down the general 
and special conditions for the approval of treatment establishments 
and the hygiene requirements relating to premises, equipment and 
staff;" 
- point 4 is replaced by the following: 
"4) where appropriate, be stored, irrespective of the treatment it 
undergoes, in accordance with Article 3(5) of Regulation (EEC) 
No ... (heat-treated drinking milk), which stipulates the way in 
which pasteurized milk must be stored in the treatment 
establishment;" 
- point 5 is replaced by the following: 
"5) be transported in accordance with Article 3(6) of Regulation (EEC) 
No (heat-treated drinking milk), which lays down the 
satisfactory conditions of hygiene relating to such transport." 
11. In Article 6: 
- point 2 is replaced by the following: 
"2) be prepared in a processing establishment that meets the 
requirements of Article 3(2) of Regulation (EEC) No . . . 
(heat-treated drinking milk), which lays down the features and 
equipment necessary to ensure the best possible conditions relating 
to the treatment of milk and the hygiene of the premises, equipment 
and staff of such processing establishments;" 
- 6 -
- point 4 is replaced by the following: 
"4) be packaged and wrapped in accordance with Chapter IV of the Annex 
to Regulation (EEC) No (general health rules) and, if they are 
in liquid form and intended for sale to the end user, with 
points 1, 2 and 3 of Chapter VII of Annex B to Regulation (EEC) 
No . . . (heat-treated drinking milk), which lay down rules relating 
to packaging in containers intended for sale to the final 
consumer ;" 
- point 5 is replaced by the following: 
"5) be labelled in accordance with Chapter V of the Annex to Regulation 
(EEC) No ... (general health rules), as regards the labelling of 
products of animal origin, and with Chapter V of the Annex hereto;" 
- point 7 is replaced by the following: 
"7) be checked in accordance with Article 9(4) of and Chapter I I I of 
the Annex to Regulation (EEC) No (general health rules), which 
establish systems of health checks and inspection and the 
supervision of production;" 
- point 9 is replaced by the following: 
"9) involve heat treatment during the manufacturing process or be made 
from products that have undergone a heat treatment, or be subject 
to sufficient hygiene provisions to meet the hygiene criteria laid 
down for finished products." 
- 7 -
12. In Article 7: 
- paragraph 2 is replaced by the following: 
"2) Milk from animals that are not infected or suspected of being 
infected with tuberculosis or brucellosis and do not comply with 
the provisions of point 1(a) of Chapter I of Annex A to Regulation 
(EEC) No ... (heat-treated drinking milk), which lays down the 
conditions under which a herd is officially considered safe, or 
with points A(1) and (2) of Chapter l(A) of the Annex hereto may, 
by way of derogation from Article 3(4) and (5), be used under the 
supervision of the competent authority to manufacture milk-based 
products during the period in which the holding is disinfected. 
In this event, heat treatment of the milk shall be compulsory." 
- paragraph 3 is replaced by the following: 
"3) The manufacture of milk-based products with traditional 
characteristics may be exempted from Article 6(1) to (4), subject 
to the provisions of Chapter II of the Annex, in accordance with 
the procedure laid down in Article 15. In this event, the general 
and particular conditions applicable to the manufacture of each 
specific product shall be determined in accordance with the same 
procedure." 
- paragraph 4 is replaced by the following: 
"4. Manufacture of cheese with a long period of ageing or ripening 
shall not be subject to the provisions of Articie 6(1), (2) and 
(4). The procedure laid down in Article 15 shall be used to fix 
general and special requirements applicable to the manufacture of 
individual products, and if necessary standards for this type of 
product." 
8 -
13. In Ar tide 8: 
- paragraph 1 is replaced by the following: 
"1. Derogations from Article 6(2) and Chapter II of the Annex may be 
granted in accordance with the procedure laid down in Article 15 
for establishments with limited production." 
- the following paragraph 1a is inserted: 
"1a. 'Limited production' means a quantity of litres per day fixed by 
the Committee in accordance with Article 15." 
- paragraph 2 is replaced by the following: 
"2) When examining the derogations referred to in paragraph 1, the 
Commission shall take account of the information and criteria set 
out in Articles 2 and 3 of Decision .../.../EEC of ... on the 
conditions for granting temporary and limited derogations from 
specific Community health rules on the production and marketing of 
products of animal origin, which lay down the procedure for 
requesting, considering and granting such derogations." 
14. In Article 9: 
- paragraph 1 is replaced by the following: 
"1) Article 5 of Regulation (EEC) No ... (heat-treated drinking milk), 
which lays down the periodic checks on production holdings to be 
carried out by the competent authority in order to ensure adequate 
conditions of hygiene, shall apply." 
- paragraph 2 is replaced by the following: 
"2. Article 6 of Regulation (EEC) No ... (heat-treated drinking milk), 
which requires each Member State to draw up a list of 
milk-treatment establishments approved by it, shall apply 
mutatis mutandis in respect of collection centres and processing 
estabI ishments." 
- 9 -
- paragraph 3 is replaced by the following: 
"3) Article 7 of Regulation (EEC) No ... (heat-treated drinking milk) 
relating to checks carried out in treatment establishments shall 
apply mutatis mutandis in respect of raw milk, of milk for the 
manufacture of milk-based products and of milk-based products, and 
in respect of processing establishments." 
- paragraph 4 is replaced by the following: 
"4) Articles 8, 9 and 10 of Regulation (EEC) No ... (heat-treated 
drinking milk), which lay down the checks to be carried out on 
residues of substances, the conditions governing combined use of 
equipment for the transport of other foodstuffs and the checks 
which may be carried out by veterinary experts from the Commission, 
shall apply mutatis mutandis in respect of raw milk, of milk for 
the manufacture of milk-based products and of milk-based products." 
15. The following paragraph is added to Article 10: 
"All Community checks shall be carried out in close cooperation with the 
competent authority of each Member State." 
16. The title of Chapter I of the Annex is replaced by the following: 
"ANIMAL HEALTH REQUIREMENTS FOR RAW MILK" 
17. Point A of Chapter I of the Annex is replaced by the following: 
"A. CONDITIONS GOVERNING RAW MILK 
1. Raw milk must originate as follows: 
a) from cows: 
i) belonging to a herd which is officially free of 
tuberculosis and brucellosis and which does not show any 
symptoms of infectious diseases communicable to human 
beings through milk or likely to give the milk abnormal 
organoleptic characteristics; 
- 10 -
ii) 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 skin of 
the udder ; 
iii) which do not show any udder wound likely to affect the milk, 
and which yield at least two litres of milk a day; 
iv) which have not been treated with substances that are 
transmissible to milk or 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; 
b) from buffaloes: 
i) belonging to a herd officially free of tuberculosis and 
officially free or free of brucellosis, as defined in 
Chapters I and II of Annex A to Directive 64/432/EEC; 
ii) satisfying the requirements laid down in point (a); 
c) sheep and goats: 
i) belonging to a herd officially free or free of brucellosis 
(Brucella melitensis), 
ii) satisfying the requirements laid down in point (a). 
2. When the different animal species are kept together on the holding, each 
species must satisfy the health conditions which would be required if it 
were alone. 
In addition, if goats are kept together with cows, they must undergo a 
tuberculosis check. 
3. Raw milk must be excluded from treatment, processing, sale and consumption 
if it: 
a) is obtained from animals to which substances within the meaning of 
Directives 81/602/EEC and 88/146/EEC have been administered illegally; 
11 -
b) contains residues of substances within the meaning of Article 9(4) which 
exceed the permitted level." 
18. Point B of Chapter I of the Annex is replaced by the following: 
"B. HYGIENE OF THE HOLDING 
1. The raw milk must come from production holdings which are 
registered and checked in accordance with Article 9(1). The 
premises so used must be designed, constructed, maintained and 
managed in such a way as to ensure: 
a) good conditions of housing, hygiene, cleanliness and health of 
the animals, and 
b) satisfactory hygienic conditions for milking, handling and 
stor ing milk. 
Premises used for specific purposes must comply with the 
conditions described below. 
2. Premises where cows are milked or milk is stored, handled or cooled 
must be so sitd and constructed as to avoid all 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 drinking water in 
accordance with Directive 80/778/EEC for use in milking, 
cleansing and cooling operations; 
e) adequate separation from all sources of contamination such as 
lavoratories and dung heaps; 
- 12 -
f) fittings and equipment which are easy to wash, cleanse and 
dis infect. 
In addition, premises for the storage of milk must have suitable 
milk refrigeration equipment, must be 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 
housiing 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 Section A(l)(b) 
or the separation of the animals referred to in Section A(1)(c) 
from the rest of the herd must be possible and effective. 
6. Animals of all species must be kept away from premises and sites 
where milk is stored, handled or cooled." 
19. Point C of Chapter I of the Annex is replaced by the following: 
"C. HYGIENE IN MILKING, THE COLLECTION OF TAW MILK AND ITS TRANSPORT FROM 
THE PRODUCTION HOLDING TO THE COLLECTION OR STANDARDIZATION CENTRE OR 
TO THE MILK TREATMENT ESTABLISHMENT - HYGIENE OF STAFF 
13 
1. Milking must be carried out hygienically and under the general 
conditions of hygiene referred to in Article 5(2) of Regulation (EEC) 
No .../... (general health rules). 
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 for 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. A control system shall be established under the supervision of the 
competent authority to prevent the presence of extraneous water in milk. 
This sytem 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. 
- 14 
6. The treatment establishment shall inform the official veterinarian as 
soon as the maximum standards fixed for the cell count have been 
reached. The official veterinarian shall take the appropriate measures 
7. 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 such standards again. However, milk 
containing residues of antibiotics which exceed the permitted levels 
must be excluded from human consumption." 
20 In Chapter II of the Annex: 
paragraph 1 is replaced by the following: 
"1. Raw cow's milk for the manufacture of fermented, renneted, gelified 
or flavoured milk, milk desserts, creams, uncured or unripened 
cheeses and other milk-based products must satisfy the following 
standards: 
Place count 30'C 
(per ml) 
Somat ic ce I I count 
(per ml) 
Ant ibiot ics (per ml) 
- pen ic i I I in 
- other from 
1.1. 1993 
< 400.000(1) 
< 600.000(2) 
< 0,004 )ug 
non 
detectable from 
1 .1 .1995 
< 300.000(1) 
< 500.000(2) 
< 0,004 /zg 
non 
detectable from 
1.1.1997 
< 100.000(1) 
< 400.000(2) 
< 0,004 fig 
non 
detectable 
(1) Geometric average over a period of two months, with at least two 
samples a month. 
(2) Geometric average over a period of three months, with at least one 
sample a month. 
- 15 -
Compliance with the standards must be checked by random sampling, 
either on collection at the production holding or on acceptance of 
the raw milk at the processing establishment or collection centre; 
With regard to the minimum permitted values for antibiotics other 
than penicillin, the Veterinary Committee shall lay down the 
detectable limits to be required using recognized biological 
methods." 
- Paragraph 3 is deleted. 
- Paragraph 4 is replaced by the following: 
"3. Raw milk other than cow's milk must, on accpetance, satisfy 
standards to be laid down under the Article 15 procedure." 
21. Point 1 of Chapter I I I of the Annex is replaced by the following: 
"1. The person in charge of the processing establishment must take all 
necessary steps to ensure that, in the case of products 'made with 
raw milk', the milk is treated or processed within 36 hours of 
acceptance, if the milk is kept at a temperature above 4"C, or 
within 48 hours of acceptance if the milk is kept at a temperature 
of or lower than 4'C." 
22. The third indent of point 1(A) of Chapter IV of the Annex is replaced by 
the foI lowing: 
"- Staphylococcus aureus - cheese made from raw milk 
m=l03, M=104, n=5, c=2 
- soft cheese 
m = 102, M = 103, n = 5, c - 2 
- 16 -
- fresh cheese 
m - 10, M - 102, n - 5, c = 2 
- frozen mi Ik products 
m«0, M=10,n=5, c=2." 
23. Point 1(B) of Chapter IV of the Annex is replaced by the following: 
"B . Index organ i sms 
- Conforms (44"C) - soft cheese m = 102, M = 103, n = 5, c - 2 
- cheese made from raw milk 
m=104,M=105, n - 5. c = 2." 
ISSN 0254-1475 
COM(91) 420 final 
DOCUMENTS 
EN 03 
Catalogue number : CB-CO-91-477-EN-C 
ISBN 92-77-76878-9 
Of&ce for Official Pablications of the European Communities 
1^2985 Luxembourg