No C 84/112 Official Journal of the European Communities 2. 4. 90 
ANNEX G 
Semen, ova and embryos 
Semen, ova and embryos of equidae, sheep and goats, ova and embryos of swine and bovine ova must: 
(a) have been removed, treated, stored and transported subject to conditions adopted in accordance with the 
procedure laid down for in Article 10; 
(b) come from animals which satisfy the health requirements adopted in accordance with the procedure laid down 
in Article 10. 
ANNEXH 
Apiculture products 
Apiculture products must not have originated in an area which is the subject of a prohibition order associated with 
an occurrence of American foulbrood or acariosis disease. The period of prohibition after the last recorded case 
must be at least 30 days, within a radius of 5 kilometres. Any derogations from these requirements must be 
determined in accordance with the procedure laid down in Article 10. 
ANNEX I 
Milk and milk-based products 
Milk and milk-based products must not have originated in a surveillance area as provided for in Directive 
85/511/EEC. However, they may be placed on the market if the milk has been pasteurized (72 °C, 15 seconds) 
under the supervision of the competent authority. 
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 
COM(89) 667 final 
(Submitted by the Commission on 13 February 1990) 
(90/C 84/10) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 43 
thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European Parliament, Having regard to the opinion of the Economic and Social 
Committee, 
Whereas raw milk, milk for the manufacture of milk-based 
products and milk-based products are included in the list of 
products in Annex II to the Treaty; whereas the production 
of and trade in raw milk, milk for the manufacture of 
milk-based products and milk-based products constitute a 
2. 4. 90 Official Journal of the European Communities NoC 84/113 
source of income for a large part of the agricultural 
population; 
Whereas, in order to ensure the rational development of this 
sector and to increase productivity, health rules govering 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 Community 
level; 
Whereas the Community must adopt measures to bring 
about the progressive establishment of the internal market in 
the period ending on 31 December 1992; 
Whereas the introduction of such rules will help to protect 
public health and to complete the internal market; 
Whereas for certain requirements reference should be made 
to Council Regulation (EEC) No . . . of . . . laying down 
health rules for the production and placing on the market of 
heat-treated drinking milk (J); 
Whereas it seems necessary to exclude from the scope of this 
Regulation certain products sold directly by the producer to 
the consumer; 
Whereas it is possible that, owing to certain special 
circumstances, certain establishments that were in operation 
before 1 January 1992 will be unable to comply with all the 
rules laid down by this Regulation; whereas the question of 
whether limited and temporary derogations may be granted 
to such establishments within the general framework of 
Council Decision . . ./EEC of ... on the conditions for 
granting limited and temporary derogations from specific 
Community health rules on the production and marketing of 
products of animal origin should be resolved (2); 
Whereas it should be stressed that the exclusion of certain 
operations from the scope of application of this Regulation 
and the granting of any possible derogations from the health 
rules laid down by this Regulation are without prejudice to 
the bringing of all operations relating to the production and 
placing on the market of raw milk, of milk for the 
manufacture of milk-based products and of milk-based 
products under the general health rules laid down by Council 
Regulation (EEC) No . . . of. . . laying down general health 
rules for the production and placing on the market of 
products of animal origins and specific health rules for 
certain products of animal origin (3); 
Whereas Council 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 
foodstuffs for sale to the ultimate consumer (4) as last 
amended by Directive 89/395/EEC (5) and Council 
Directive 89/396/EEC of 14 June 1989 on indications or 
marks identifying the lot to which a foodstuff belongs (6) are 
applicable; 
(») OJ No L . . . 
(2) OJ No L . . . 
(3) OJ No L . . . 
(4) OJ NoL33, 8. 2. 1979, p. 1. 
(s) OJ No L 186, 30. 6. 1989, p. 17. 
(6) OJ No L 186, 30. 6. 1989, p. 21. Whereas health rules should be laid down for the placing on 
the market of raw milk, of milk for the manufacture of 
milk-based products and of milk-based products; whereas 
these rules should cover, in particular, production, storage, 
packaging and transport; 
Whereas certain milk-based products may be manufactured 
from raw milk; whereas given the nature of these products, it 
may be necessary to draw up a list of such products as might 
be marketed; 
Whereas account should be taken of certain special 
cheesemaking techniques; 
Whereas the Commission should be entrusted with the 
adoption of measures for implementing this Regulation; 
whereas, for this purpose, a procedure should be provided 
for establishing close and efficient cooperation between the 
Commission and the Member States within the Standing 
Veterinary Committee, 
HAS ADOPTED THIS REGULATION: 
Article 1 
1. This Regulation lays down health rules for the 
production and placing on the market of the following 
products intended for human consumption: raw milk, milk 
for the manufacture of milk-based products, and milk-based 
products. 
2. This Regulation shall not apply to the direct sale to the 
consumer: 
— by the producer, of raw milk produced on his farm, 
— by the producer, of milk-based products-processed on the 
producer's farm from milk produced on his farm, 
— by the manufacturer, of milk-based products at his 
processing plant, provided his entire production is sold 
directly to the consumer on the spot. 
3. The Commission shall, where necessary, adopt 
suitable rules for the uniform application of paragraph 2 in 
accordance with the procedure laid down in Article 15. 
4. This Regulation shall apply without prejudice to: 
— Council Directive 76 /118 / EEC of 18 December 1975 on 
the approximation of the laws of the Member States 
relating to certain partly or wholly dehydrated preserved 
milk for human consumption (7), 
— Council Directive 83/417/EEC of 25 July 1983 on the 
approximation of the laws of the Member States relating 
to certain lactoproteins (caseins and caseinates) intended 
for human consumption (8), 
— Council Regulation (EEC) No . . . of . . . (heat-treated 
milk). 
(7) OJ No L 24, 30. 1. 1976, p. 49. 
(8) OJ No L 237, 26. 8. 1983, p. 25. 
NoC 84/114 Official Journal of the European Communities 2. 4. 90 
Article 2 
For the purposes of this Regulation: 
1. raw milk means milk as produced by secretion of the 
mammary glands of one or more cows, ewes, goats or 
buffaloes, which has not been heated beyond 40° C or 
undergone a treatment that has an equivalent effect; 
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 natural 
milk constituents; 
3. milk-based products means milk products, namely 
products exclusively derived from milk, it being 
accepted that substances necessary for their 
manufacture may be added, provided that these 
substances are not used to replace in part or in whole 
any milk constituent, and composite milk products, 
namely products of which no part takes or is intended to 
take the place of any milk constituent and of which milk 
or a milk product is an essential part either by quantity 
or for characterization; 
4. heat treatment means any treatment involving heating 
that causes, immediately after it has been applied, a 
negative reaction to the phosphatase test; 
5. thermization means the heating of milk under such 
combined conditions of time and temperature that the 
reaction to the phosphatase test remains positive; 
6. production holding means an establishment at which 
one or more milk-producing cows, ewes, goats or 
buffaloes are kept; 
7. collection centre means an establishment where raw 
milk may be collected and possibly cooled and 
filtered; 
8. processing establishment means an establishment 
where milk for the manufacture of milk-based products 
-and milk-based products are treated, processed and 
packaged. 
9. competent authority means the competent public health 
authority designated by the Member State; 
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 (x) and of Council Regulation (EEC) 
No ... of ... on animal health conditions governing 
intra-Community trade on ovine and caprine 
animals (2) shall apply where necessary. 
Article 3 
Raw milk for the manufacture of milk-based products 
must: 
1. be checked in accordance with Article 9 (1); 
(') OJ No 121, 29. 7. 1964, p. 1977/64. 
(2) OJ No 1 2. meet the standards laid down in Chapter II of the Annex 
hereto; 
3. where appropriate, satisfy the requirements laid down in 
Article 3 (l)(g) of Regulation (EEC) No... 
(heat-treated drinking milk); 
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); 
5. in the case of milk of other animals, satisfy the 
requirements set out in Chapter I of the Annex hereto. 
Article 4 
Raw milk intended for direct human consumption must: 
1. satisfy the requirements laid down in Article 3 and in 
point 2 of Chapter II of the Annex hereto; 
2. where it is not sold to the consumer within 2 hours after 
the end of milking, be cooled in accordance with 
Chapter III of Annex A to Regulation (EEC) No . . . 
(heat-treated drinking milk); 
3. where appropriate, satisfy the requirements set out in 
point 1 of Chapter V of the Annex hereto; 
4. where appropriate, satisfy the additional requirements 
set out in accordance with the procedure laid down in 
Article 15 of this Regulation. 
Article 5 
Milk for the manufacture of milk-based products must: 
1. be obtained from raw milk that meets the requirements 
set out in Article 3; 
2. meet the standards and specifications laid down in 
Chapter III of the Annex hereto; 
3. where appropriate, be obtained in a processing 
establishment that meets the requirements set out in 
Article 3 (2) of Regulation (EEC) No . . . (heat-created 
drinking milk); 
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); 
5. where appropriate, be transported in accordance with 
Article 3 (6) of Regulation (EEC) No . . . (heat-treated 
drinking milk). 
Article 6 
Milk-based products must: 
1. be obtained from milk that meets the requirements of 
Articles 3 or 5 or from milk-based products that satisfy 
the requirements of this Article or of Article 7; 
2. be prepared in a processing establishment that meets the 
requirements of Article 3 (2) of Regulation (EEC) 
No . . . (heat-treated drinking milk); 
2. 4. 90 Official Journal of the European Communities No C 84/115 
3. meet the standards laid down in Chapter IV of the Annex 
hereto; 
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 VIII of Annex B to Regulation (EEC) No . . . 
(heat-treated drinking milk); 
5. be labelled in accordance with Chapter V of the Annex to 
Regulation (EEC) No . . . (general health rules) and with 
Chapter V of the Annex hereto; 
6. be stored and transported in accordance with Chapter VI 
of the Annex to Regulation (EEC) No . . . (general 
health rules) and with Article 9 of and Chapter IX of the 
Annex to Regulation (EEC) No . . . (heat-treated 
drinking milk); 
7. be checked in accordance with Article 9 (4) of and 
Chapter III of the Annex to Regulation (EEC) No . . . 
(general health rules); 
8. where appropriate, contain only substances, other than 
milk, that are fit for human consumption; 
9. involve heat treatment during the manufacturing process 
or be made from products that have undergone a heat 
treatment. 
Article 7 
1. Article 6 (9) shall not apply to products 'made with 
raw milk'. Where appropriate, a list of products 'made with 
raw milk' that may be placed on the market shall be drawn up 
in accordance with the procedure laid down in Article 15. 
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 the 
Annex to Regulation (EEC) No . . . (heat-treated drinking 
milk) or with points A (1) and (2) of Chapter I (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. 
3. The manufacture of milk-based products with 
traditional characteristics may be exempted from 
Article 6(1) to (4) 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. 
4. Manufacture of cheese with a long period of ageing or 
ripening shall not be subject to the provisions of Article 6(1) 
to (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. 
5. The Commission shall, where necessary, adopt 
suitable rules for the uniform application of paragraphs 1 to 
4 in accordance with the procedure laid down in 
Article 15. Article 8 
1. Derogations from Article 6 (2) may be granted in 
accordance with the procedure laid down in Article 15 for 
establishments with limited production. 
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. 
3. When granting derogations within the meaning of 
paragraph 1, the Commission shall determine in accordance 
with the procedure laid down in Article 15 the general and 
particular conditions applicable to the implementation of 
each derogation. 
Article 9 
1. Article 5 of Regulation (EEC) No . . . (heat-treated 
drinking milk) shall apply. 
2. Article 6 of Regulation (EEC) No . . . (heat-treated 
drinking milk) shall apply mutatis mutandis in respect of 
collection centres and processing establishments. 
3. Article 7 of Regulation (EEC) No . . . (heat-treated 
drinking milk) 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. 
4. Articles 8, 9 and 10 of Regulation (EEC) No . . . 
(heat-treated drinking milk) shall apply mutatis mutandis in 
respect of raw milk, of milk for the manufacture of 
milk-based products and of milk-based products. 
Article 10 
Council Regulation (EEC) No . . . concerning veterinary 
checks in intra-Community trade with a view to the 
completion of the internal market (l) shall apply, in 
particular in respect oi the organization and monitoring of 
checks carried out by the Member State of destination and 
the protective measures to be applied. 
Article 11 
The Commission in accordance with the procedure laid 
down in Article 16 may draw up recommendations 
accompanied by guidelines on good manufacturing practices 
to be applied at the various stages of production and placing 
on the market. 
Article 12 
The Annex to this Regulation shall be amended, in particular 
so as to adapt it to technological and scientific developments, 
in accordance with the procedure laid down in Article 15. 
NoC 84/116 Official Journal of the European Communities 2. 4. 90 
Article 13 
The reference methods and, where appropriate, the analysis 
and test methods to be used to check that the standards laid 
down in Articles 3 (2), 5 (2) and 6 (3) are being complied 
with shall be adopted in accordance with the procedure laid 
down in Article 15. Where necessary, rules for the taking of 
samples shall be laid down in accordance with the same 
procedure. 
However, pending these decisions, the internationally 
accepted analysis and test methods shall be recognized as 
reference methods. 
Article 14 
Until Community arrangements on imports of raw milk, of 
milk for the manufacture of milk-based products and of 
milk-based products from third countries have been adopted, 
Member States shall apply rules in respect of such imports 
that must be at least equivalent to those laid down by this 
Regulation. 
Article 15 
1. The Commission shall be assisted by the Standing 
Veterinary Committee set up by Council Decision 
68/361/EEC (*), hereinafter referred to as 'the 
Committee'. 
2. Where the procedure laid down in this Article is to be 
followed, the provisions set out below shall apply. 
The representative of the Commission, after consulting the 
Management Committee for Milk and Milk Products 
established by Council Regulation (EEC) No 804/68 (2) 
where matters of chemistry or technology are involved, 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. 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 measures envisaged if they 
are in accordance with the opinion of the Committee. 
Where the measures envisaged 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 16 
Where the procedure laid down in this Article is to be 
followed, the following rules 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. 
The opinion shall be recorded in the minutes; in addition, 
each Member State shall have the right to ask 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 17 
This Regulation shall enter into force on the thirtieth day 
following that of its publication in the Official Journal of the 
European Communities. 
It shall apply from 1 January 1993. 
This Regulation shall be binding in its entirety and directly 
applicable in all Member States. 
(!) OJ No L 244, 19. 10. 1968, p. 23. 
(2) OJ No L 148, 28. 9. 1968, p. 13. 
2. 4. 90 Official Journal of the European Communities No C 84/117 
ANNEX 
CHAPTER 
ANIMAL HEALTH REQUIREMENTS FOR THE PRODUCTION OF RAW MILK OTHER THAN 
COW'S MILK 
A. Conditions governing raw milk 
1. Raw milk must come from: 
(a) sheep and goats 
(i) belonging to a herd officially free or free of brucellosis (Brucella melitensis); 
(ii) satisfying the requirements laid down in points 1 (b), (c), (d) and (f) of Chapter I of Annex A to 
Council Regulation (EEC) No .../... (heat-treated drinking milk); 
(b) 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 (a) (ii). 
2. Where 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 and processing if it: 
(a) is obtained from animals to which substances within the meaning of Directives 81/602/EEC (2) and 
88/146/EEC (3) have been administered illegally; 
(b) contains residues of substances within the meaning of Article 9 (4) which exceed the permitted 
level. 
B. Hygiene of the holding 
The raw milk must come from production holdings which are registered and checked in accordance with 
Article 9(1). 
The animals must be kept in good conditions of housing, hygiene, cleanliness and health. 
There must be good hygienic conditions for milking, handling and storage of milk. 
C. Hygiene in milking, the collection of raw milk and its treatment from the production holding to the collection 
centre or to the processing establishment — staff hygiene 
The provisions of Chapter III of Annex A to Regulation (EEC) No .../... (heat-treated drinking milk) shall 
apply. 
(') OJ No 121, 29. 7. 1964, p. 1977/64. 
(2) OJ No L 222, 1. 8. 1981, p. 32. 
(3) OJ No L 70, 16. 3. 1988, p. 16. 
NoC 84/118 Official Journal of the European Communities 2. 4. 90 
CHAPTER II 
STANDARDS FOR RAW MILK 
1. Raw cow's milk for the manufacture of fermented, renneted, gelified or flavoured milk, milk desserts, creams 
and uncured or unripened cheeses must: 
(a) satisfy the following standards: 
Plate count 30° (per ml) 
Somatic cell count (per ml) 
Antibiotics (per ml) 
— penicillin 
— other ^ 100 000 (') 
< 400 000 (2) 
< 0,004 ug 
undetectable 
(M 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. 
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; 
(b) unless it is treated within four hours of its arrival at the processing establishment, be cooled to a 
temperature of not more than 6 °C and kept at that temperature until used. 
2. Raw cow's milk intended for direct human consumption and raw cow's milk for the manufacture of products 
'made with raw milk' whose manufacturing process does not involve any heat treatment must: 
(a) satisfy the requirements of paragraph 1; 
(b) in addition satisfy the following standard: 
Staphylococcus aureus: 
n = 5, m = 100, M = 300, c = 2 
where: 
n — is the number of samples collected 
m — is the microorganism threshold value; the result being considered satisfactory if all the samples have 
a level of microorganisms less than or equal to "m"; 
M — is the maximum permitted microorganism level; the result being considered unsatisfactory if one or 
more samples have a level of microorganisms greater than or equal to "M"; 
c — is the number of samples where the microorganism level may be between "m" and "M", the result 
still being considered acceptable if the other samples have a microorganism level less than or equal 
to "m". 
3. Raw cow's milk for the manufacture of milk-based products other than those referred to in points 1 
and 2: 
Plate count 30 °C (per ml) 
Somatic cell count (per ml) 
Antibiotics (per ml) 
— penicillin 
— others From 1 January 1993 
< 300 000 0) 
< 500 000 (2) 
< 0,004 ug 
undetectable From 1 January 1995 
< lOOOOO(') 
< 400 000 (2) 
< 0,004 ug 
undetectable 
(') 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. 
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. 
4. Non-bovine raw milk must, on acceptance, satisfy standards to be laid down under the Article 15 
procedure. 
2. 4. 90 Official Journal of the European Communities No C 84/119 
CHAPTER HI 
STANDARDS FOR MILK FOR THE MANUFACTURE OF MILK-BASED PRODUCTS 
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. 
2. Where necessary, standards may be set in respect of milk for the manufacture of milk-based products in 
accordance with the procedure laid down in Article 15. 
CHAPTER IV 
STANDARDS FOR MILK-BASED PRODUCTS 
1. Microbiological standards for certain milk-based products on removal from the processing establishment 
Type of microorganism 
A. 
B. 
C. 
D Pathogenic 
microorganisms 
— Listeria monocyto­
genes 
— Salmonella 
— Staphylococcus 
aureus 
— Other pathogens 
Index organisms 
— Coliforms (44 °C) 
Indicator organisms 
— Coliforms (30 °C) 
Other organisms 
— Total plate count Products 
— all 
— all 
— soft cheese 
— fresh cheese 
— frozen milk prod 
— all 
— soft cheese 
— liquid milk and 
products 
— butter 
— soft cheese 
— fresh cheese JCtS 
liquid 
— powdered milk products 
— frozen milk prod 
— heat treated 
liquid milk 
products (') ucts milk 
unfermented 
and milk 
— frozen milk products (2) Standard (ml, g) 
ab,< 
abs 
m 
m 
m ent in 25 (mi, g) n = 5, c = 0 
>ent in 25 (ml, g) n = 5, c = 0 
= 102, M = 10-\ n = 5, c = 2 
= 10, M = 102, n = 5, c = 2 
= 0, M = 10, n = 5, c = 2 
absent in 25 (ml, g) n = 5, c = 0 
m 
m 
m 
m 
m 
m 
m 
m 
m = 102, M = 10J, n = 5, c = 2 
= 0, M = 5, n = 5, c = 2 
= 0, M = 10, n = 5, c = 2 
= 104, M = 105, n = 5, c = 2 
= 102, M = 103, n = 5, c = 2 
= 0, M = 10, n = 5, c = 2 
= 0, M = 5, n = 5, c = 2 
= 5 x 104, M = 103,n = 5,c = 1 
= 105, M = 3 x 105, n = 5, c = 2 
(') After incubation at 6 °C for five days (plate count at 21 °C). 
(2) Plate count at 30 °C. 
where: 
n — is the number of samples collected; 
m — is the microorganism threshold value; the result being considered satisfactory if all the samples have a level of 
microorganisms less than or equal to 'm'; 
M — is the maximum permitted microorganism level; the result being considered unsatisfactory if one or more samples have a 
level of microorganisms greater than or equal to 'M'; 
c — is the number of samples where the microorganism level may be between 'm' and 'M', the result still being considered 
acceptable if the other samples have a microorganism level less than or equal to 'm'. 
2. Standards for sterilized or UHT-treated milk-based products 
Sterilized or UHT-treated milk-based products that have been heat-treated in accordance with the 
requirements laid down in points 6 and 7 of Chapter VI of Annex B to Regulation (EEC) No .../... 
(heat-treated drinking milk) must satisfy the following standards after incubation for 15 days at 30 °C. 
(a) plate count at 30 °C (per 0,1 ml): < 10, 
(b) organoleptic test: normal. 
No C 84/120 Official Journal of the European Communities 2. 4. 90 
3. Where necessary, standards other than those set out in points 1 and 2 may be set in respect of milk-based 
products in accordance with the procedure laid down in Article 15. 
Microbiological standards applicable, under conditions managed and controlled by the manufacturer, to the 
use-by date and, where appropriate, detailed rules of application may be laid down in accordnce with the same 
procedure. 
CHAPTER V 
CONDITIONS GOVERNING LABELLING 
1. For inspection purposes, the words 'raw milk' must appear clearly in the labelling of raw milk intended for 
direct human consumption. 
2. For inspection purposes, the words 'made with raw milk' must appear clearly in the labelling of milk-based 
products manufactured from raw milk whose manufacturing process does not include heat treatment. 
3. For inspection purposes, the labelling of milk-based products must, where appropriate, specify the type of heat 
treatment applied at the end of the manufacturing process. 
The type of heat treatment concerned may be pasteurization, UHT treatment or sterilization within the 
meaning of Regulation (EEC) No .../... (heat-treated drinking milk). 
Proposal for a Council Regulation (EEC) laying down the health rules for the production and placing 
on the market of minced meat, meat preparations and comminuted meat for industrial use 
COM(89) 671 final 
(Submitted by the Commission on 16 February 1990) 
(90/C 84/11) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 43 
thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European Parliament, 
Having regard to the opinion of the Economic and Social 
Committee, 
Whereas minced meat, meat preparations and cominuted 
meat for industrial use are included in the list of products in 
Annex II to the Treaty; whereas the production of and trade 
in minced meat, meat preparations and comminuted meat for 
industrial use constitute an important source of income for 
part of the farming population; 
Whereas in order to ensure the rational development of the 
industry producing such meat and to increase productivity, 
public health rules for the production and placing an the 
market of such meat must be laid down 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 such rules improves the 
protection of public health and consequently facilitates the 
completion of the internal market; 
Whereas, to achieve this purpose, it is necessary to extend the 
principal health rules laid down in Council Directive 
88/657/EEC of 16 December 1988 laying down the 
requirements for the production of, and trade in, minced 
meat, meat in pieces of less than 100 grams and meat 
preparations and amending Directives 64/433/EEC, 
71/118/EEC and 72/462/EEC (») to all production and 
placing on the market of minced meat and meat preparations 
in the Community; 
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 
(') OJNoL382, 31. 12. 1988, p. 3.