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. 
2. 4. 90 Official Journal of the European Communities No C 84/121 
limited and temporary derogations may be granted to such 
establishments within the general framework laid down in 
Council Decision .../.. ./EEC on the granting of 
temporary and limited derogations from specific Community 
health rules on the production and marketing of products of 
animal origin (*) should be resolved; 
Whereas it should be stressed that the granting of derogations 
from the health rules laid down in this Regulation is without 
prejudice to the submission of all operations of production 
and placing on the market of minced meat, meat 
preparations and comminuted meat for industrial use to the 
general health rules laid down by Council Regulation (EEC) 
No . . . laying down general health rules applicable to the 
production and placing on the market of products of animal 
origin and specific health rules applicable to certain products 
of animal origin (2); 
Whereas Council Directive 79/112/EEC of 18 December 
1978 on the approximation of the laws of the Member States 
relating to the labelling, preservation and advertising of 
foodstuffs (3) as last amended by Council Directive 
89/395/EEC (4), and Council Directive 89/396/EEC of 14 
June 1989 on indications or marks identifying the lot to 
which a foodstuff belongs (5) are applicable; 
Whereas the Commission should be entrusted with the task 
of adopting certain measures for implementing this 
Regulation; whereas, to that end, procedures should be laid 
down establishing close and effective 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 in the Community of 
minced meat, meat preparations and comminuted meat for 
industrial use. 
2. This Regulation shall not apply to minced meat and 
meat preparations obtained in retail shops or in premises 
adjacent to sale points, prepared on the spot at the request of 
the purchaser or to such meat obtained in establishments 
selling directly to the consumer where transport and 
packaging are not involved. 
3. This Regulation shall not apply to comminuted meat 
for industrial use produced in establishments approved 
according to Regulation (EEC) No .../... (6) (on health 
conditions for the production and placing on the market of 
I1) OJNoL. . . 
;2) OJ No L . . . 
[3) OJ No L 33, 8. 2. 1979, p. 1. 
4) OJ No L 186, 30. 6. 1989, p. 17. 
5) OJ No L 186, 30. 6. 1989, p. 21. 
'«) OJ No L . . . meat products) where the transformation into meat products 
is performed in the establishment of production. 
4. If necessary, the Commission shall adopt appropriate 
rules for a uniform application of paragraphs 2 and 3, in 
accordance with the procedure referred to in Article 9. 
Article 2 
For the purpose of this Regulation: 
1. minced meat means preparations obtained by mincing 
into fragments or passing through a spiral-screw mincer 
fresh meat as defined in Regulation (EEC) 
No .../... (7) laying down the health rules for 
production and placing on the market of fresh meat. 
2. meat preparations means preparations made wholly or 
partly from fresh meat as defined in 
(a) Regulation (EEC) No . ../... (laying down the 
health rules for production and placing on the 
market of fresh meat) 
(b) Regulation (EEC) No .../... (8) (laying down the 
health rules for production and placing on the 
market of fresh poultrymeat) 
or from minced meat. 
Meat preparations are preparations which have 
undergone 
— either a treatment other than those referred to in 
Regulation (EEC) No .../... (laying down health 
rules for the production and placing on the market of 
meat products); 
— or been prepared by addition of foodstuffs, seasoning 
or additives; 
— or undergone a combination of the above. 
The preparation must be such that the cellular structure 
of the meat is unaffected and the finished product 
contains no fragments of bone. 
Minced meat and fresh meat which have undergone only 
cold treatment shall not be regarded as meat 
preparations. 
3. Seasoning means salt intended for human consumption, 
mustard, spices and spice extracts, aromatic herbs and 
extracts thereof. 
4. Foodstuffs means any product of animal or vegetable 
origin considered fit for human consumption. 
5. Products for direct consumption means minced meat or 
meat preparations intended to be consumed directly 
without undergoing any further treatment. 
(7) OJ No L . . . 
(8) OJ No L . . . 
NoC 84/122 Official Journal of the European Communities 2. 4. 90 
6. comminuted meat for industrial use means minced meat 
or mechanically recovered meat intended to undergo one 
of the treatments referred to in Regulation (EEC) 
No .../... (laying down the health rules for 
production and placing on the market of meat 
products). 
7. Establishment means a processing plant for production 
of minced meat and/or meat preparations and/or 
comminuted meat for industrial use. 
The definitions given in Articles 2 of 
— Regulation (EEC) No .../... (laying down the 
health rules for production and placing on the market 
of fresh meat) 
— Regulation (EEC) No .../... (laying down the 
health rules for production and placing on the market 
of fresh poultrymeat) 
— Regulation (EEC) No .../... (laying down the 
health rules for production and placing on the market 
of meat products) 
shall apply where necessary. 
Article 3 
Minced meat, meat preparations and comminuted meat for 
industrial use must meet the following conditions: 
A. Minced meat must 
(a) have been prepared from fresh meat 
(i) either in compliance with Regulation (EEC) 
No .../... (laying down the health rules for 
production and placing on the market of fresh 
meat) 
(ii) or in compliance with Directive 
72/462/EEC (J) and coming from a third 
country either directly or via another Member 
State. In the case of fresh pigmeat it must have 
been examined for trichinae in accordance with 
Article 2 of Directive 77/96/EEC (2). 
(b) have been prepared in 
(i) either a cutting plant approved according to 
Regulation (EEC) No .../... (laying down 
the health rules for production and placing on 
the market of fresh meat) 
(ii) or an establishment approved according to 
Article 5 for this purpose; 
(c) have been prepared, packaged and stored in 
accordance with Chapter HI of Annex I; 
(') OJ No L 302, 31. 12. 1972, p. 28. 
(2) OJ No L 26, 31. 1. 1977, p. 67. (d) have been inspected in accordance with Chapters V 
and VI of Annex I; 
(e) have been marked in accordance with Chapter VII 
of Annex I; 
(f) have been transported in accordance with 
Chapter VIII of Annex I; 
(g) comply with the microbiological standards referred 
to in Annex II, in case of products for direct 
consumption or as ingredient for meat 
preparations. 
B. Meat preparations must 
(a) have been prepared from fresh meat 
(i) either in compliance with point A; 
(ii) or in compliance with Regulation (EEC) 
No .../... (laying down the health rules for 
production and placing on the market of fresh 
meat); 
(iii) or in compliance with Directive 72/462/EEC 
and coming from a third country either directly 
or via another Member State. In the case of 
fresh pigmeat it must have been examined for 
trichinae in accordance with Article 2 of 
Directive 77/96/EEC; 
(iv) or in compliance with Regulation (EEC) 
No .../... (laying down the health rules of 
production and placing on the market of fresh 
poultrymeat). In this case the mincing of 
poultrymeat shall be performed in the 
establishment of production of meat 
preparations. 
(b) have been prepared in an establishment approved 
according to Article 5 for this purpose; 
(c) have been prepared, packaged and stored in 
accordance with Chapter II of Annex I; 
(d) have been inspected in accordance with Chapters V 
and VI of Annex I; 
(e) have been marked in accordance with Chapter VII 
of Annex I; 
(f) have been transported in accordance with 
Chapter VIII of Annex I; 
(g) comply with the microbiological standards referred 
to in Annex II in case of products for direct 
consumption. However, derogations can be 
established according to the procedure referred to in 
Article 9 for some products not obtained from 
minced meat or for some products obtained from 
poultrymeat. 
C. Comminuted meat for industrial use must 
(a) have come from fresh meat: 
(i) either in compliance with Regulation (EEC) 
No .../... (laying down the health rules for 
production and placing on the market of fresh 
meat); 
2. 4. 90 Official Journal of the European Communities No C 84/123 
(ii) or in compliance with Directive 72/462/EEC 
and coming from a third country either directly 
or via another Member State; 
(iii) or in compliance with Regulation (EEC) 
No .../... (laying down the health rules for 
production and placing on the market of fresh 
poultrymeat); 
(b) have been prepared, as appropriate, in, 
(i) either a cutting plant approved according to 
Regulation (EEC) No .../... (laying down 
the health rules for production and placing on 
the market of fresh meat); 
(ii) or a cutting plant approved according to 
Regulation (EEC) No .../... (laying down 
the health rules for production and placing on 
the market of fresh poultrymeat); 
(iii) or an establishment approved according to 
Regulation (EEC) No .../... (laying down 
the health rules for production and placing on 
the market of meat products); 
(iv) or an establishment approved according to 
Article 5 for this purpose; 
(c) have been prepared, packaged and stored in 
accordance with Chapter IV of Annex I; 
(d) have been inspected in accordance with Chapters V 
and VI of Annex I; 
(e) have been marked in accordance with Chapter VII 
of Annex J; 
(f) have been transported in accordance with 
Chapter VIII of Annex I; In this case they must be obtained from the meat 
referred to in subparagraph (a) (i), 
(ii) or quick frozen and wrapped for the final consumer, 
in this case they must conform with the Council 
Directive 89/108/EEC ('); 
2. The additives used must be in conformity with 
Community rules. 
Article 5 
1. Each Member State shall draw up a list of the 
establishments manufacturing 
— minced meat, 
— meat preparations, 
— comminuted meat for industrial use approved by it. 
This list shall be forwarded to the other Member States and 
the Commission, stating whether these establishments are 
connected to establishments approved according to the 
Regulations referred to in (a), (b) or (c) or are independent 
establishments. 
Each establishment shall receive an approval number, which 
in the first case shall be that of the establishment that has been 
approved, indicating that it has been approved for the 
production of minced meat, meat preparations and 
comminuted meat for industrial use. 
Establishments thus approved shall be entered in a separate 
column either on the list of establishments referred to in 
Article 4 
1. In addition to the general conditions laid down in 
Article 3, minced meat and, insofar as they contain such 
meat, meat preparations must 
(a) (i) either be obtained from chilled fresh meat, within a 
maximum of six days after the slaughter of the 
animal of origin, compliance with this requirement 
being guaranteed by a method of identification to be 
specified by the competent authority; 
(ii) or be obtained from frozen or quick frozen boneless 
meat. 
(b) undergo cold treatment referred in subparagraph (c) 
within a maximum of one hour after cutting into 
portions and wrapping except where processes 
requiring the lowering of internal temperature of the 
meat during preparation are used; 
(c) be placed on the market, 
(i) either chilled and wrapped for the final consumer 
and cooled at an internal temperature below + 2° C 
in a period of not more than one hour. (a) Regulation (EEC) No .../... (laying down the health 
rules for production and placing on the market of fresh 
meat) or 
(b) Regulation (EEC) No .../... (laying down the health 
rules for production and placing on the market of fresh 
poultrymeat) or 
(c) Regulation (EEC) No .../... (laying down the health 
rules for production and placing on the market of meat 
products) 
(d) or, in case of independent establishments, on a separate 
list drawn up according to the same criteria. 
2. A Member State shall not include an establishment on 
the list referred to in paragraph 1 unless it is sure that the 
establishment satisfies the conditions laid down in this 
Regulation. 
Member States shall withdraw the approval if the conditions 
cease to be met. 
(M OJ No L 40, 11. 2. 1989, p. 43. 
NoC 84/124 Official Journal of the European Communities 2. 4. 90 
If a check has been made in accordance with Article 6, the 
Member State concerned shall take account of the 
conclusions thereof. The other Member States and the 
Commission shall be informed in the event of approval being 
withdrawn. 
3. The inspection and supervision of establishments shall 
be carried out under the responsibility of the competent 
authority which may be assisted in purely practical tasks by 
staff specially trained for the purpose. The competent 
authority must at all times have free access to all parts of the 
establishments in order to ensure that this Regulation is being 
complied with. 
The detailed rules governing this assistance shall be 
determined in accordance with the procedure laid down in 
Article 10. 
4. The production of the health mark and sealing material 
referred to in Chapter VII of Annex I must be authorized by 
the authorities of the Member State which supervise their 
use. 
Article 6 
1. Veterinary experts from the Commission may, in so far 
as is necessary to ensure uniform application of this 
Regulation, make on-the-spot checks; they may verify 
whether establishments are actually complying with this 
Regulation. The Commission shall inform the Member 
States of the results of the investigation. 
A Member State in whose territory a check is being carried 
out shall give all the necessary assistance to the experts in 
carrying out their duties. 
2. If necessary, the general provisions for implementing 
this Article shall be determined in accordance with the 
procedure laid down in Article 20. In accordance with the 
same procedure, a code containing the rules to be followed 
for the purpose of the checks provided for in paragraph 1 
may be established. 
Article 7 
The rules laid down in Council Regulation (EEC) No . . . (*) 
(concerning veterinary checks on intra-Community trade in 
view of completing the internal market), shall apply in 
particular with respect to the organization of and the action 
to be taken following the checks carried out by the country of 
destination and the safeguard measures to be applied in 
relation to health problems affecting production and 
distribution of fresh meat in the territory of the 
Community. 
Article 8 
The Annexes in particular, to adapt them to advances in 
science and technology, shall be amended by the Commission 
in accordance with the procedure referred to in Article 9. Article 9 
1. The Commission shall be assisted by the Standing 
Veterinary Committee, set up by the Council Decision 
68/361/EEC (2), hereinafter referred to as 'the 
Committee'. 
2. Where the procedure laid down in this Article is to be 
followed, the following provisions 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. 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. 
If 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 10 
Where the procedure laid down in this Article is to be 
followed, the following provisions 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 11 
1. In accordance with the procedure referred to in 
Article 9, derogations from the rules referred to in the 
Annexes may be granted in favour of establishments which 
have small production. 
(>) OJNoL... (2) OJ No L 255, 18. 10. 1968, p. 23. 
2. 4. 90 Official Journal of the European Communities No C 84/125 
2. When examining the derogations referred to in 
paragraph 1, the Commission shall take into account the 
information and the criteria referred to in Articles 2 and 3 of 
Council Decision .../.. ./EEC (on the granting of 
temporary and limited derogations from specific Community 
health rules on the production and marketing of products of 
animal origin). 
3. When granting the derogations referred to in 
paragraph 1, the Commission shall establish in accordance 
with the procedure referred to in Article 9, the general and 
particular conditions applicable to the enforcement of each 
derogation. 
Article 12 
The Commission may, in accordance with the procedure 
referred to in Article 10, draw up recommendations 
containing guidelines concerning good manufacturing 
practices applicable to different stages of production and 
placing on the market. Article 13 
1. Directive 88/657/EEC is hereby repealed with effect 
from 1 January 1993. 
2. However, the implementing provisions adopted under 
Directive 88/ 657/ EEC shall remain valid for the purposes of 
this Regulation. 
Article 14 
This Regulation shall enter into force on the thirtieth day 
following its publication in the Official Journal of the 
European Communities. 
It shall apply with effect from 1 January 1993. 
This Regulation shall be binding in its entirety and directly 
applicable in all Member States. 
ANNEX I 
CHAPTER I 
SPECIAL CONDITIONS FOR THE APPROVAL OF ESTABLISHMENTS PRODUCING MINCED MEAT, 
MEAT PREPARATIONS, COMMINUTED MEAT FOR INDUSTRIAL USE 
Over and above the general conditions laid down in, respectively Annex I, points 1 to 12 and points 14,15 
and 16 of Regulation (EEC) No .../... (laying down the health rules for production and placing on the 
market of fresh meat and repealing Directive 64/433/EEC) and Chapter I of Annex A to Regulation (EEC) 
No .../.. . [laying down the health rules for the production and placing on the market of meat products and 
repealing Directive 77/99/EEC] and points 1 to 12 and points 14, 15 and 16 of Regulation (EEC) 
No .../... [laying down the health rules for production and placing on the market of fresh poultrymeat and 
repealing Directive 71/118/EEC], production plants or independent production units shall have at 
least: 
(a) a room separate from the cutting room for mincing, wrapping and for the addition of other foodstuffs, 
equipped with a recording thermometer or recording telethermometer. 
However, the competent authority may authorize the mincing of meat in the cutting room provided that 
the mincing is carried out in a separate area and does not involve the addition of seasonings and other 
foodstuffs; 
(b) a room for packaging, unless the conditions laid down in point 62 of Chapter XI of Annex I to 
Regulation (EEC) No .../... [laying down the health rules for production and placing on the market 
of fresh meat and repealing Directive 64/433/EEC] are fulfilled; 
(c) a room for storing seasonings and other cleaned foodstuffs ready for use; 
(d) refrigeration equipment enabling the temperatures laid down in this Regulation to be adhered to. 
Establishments producing meat preparations shall also comply with the relevant requirements of Chapter I of 
Annex B to Regulation (EEC) No .../... [laying down the health rules for the production and placing on 
the market of meat products and repealing Directive 77/99/EEC]. 
The rules laid down in Chapter IV of Annex I to Regulation (EEC) No .../.. . [laying down the health rules 
for production and placing on the market of fresh meat and repealing Directive 64/433/EEC] shall apply as 
regards the hygiene of the staff, premises and equipment in the establishments. 
Staff engaged in the manual preparation of minced meat shall also wear masks covering their noses and 
mouths and surgical-type gloves. 
^oC^Bt^ COt^c^i^onrn^otr^cLuro^^nCornrnnnin^ ^^ ^0 
^ Meat shall be examined before cutting All soiled orsuspect parts shall be removed and condemned before the 
meat is cut up 
^ Comminuted meat for industrial use shall not be obtained from contaminated meat tn particular, 
mechanically recovered meat shall be obtained from flesh bearing bones apart from the bones of the head, 
extremities of the limbs below the carpal and tarsal joints and, in case of swme, the coccydeal 
vertebrae 
^ ^here the operations carried out fromthe time when the meat enters the room referred tomChaptert, 
pomttmMo^he time when the finished product undergoes the chilling or fieeBmg process,the internal 
temperature of the meat shall be no higher than^^^Cfor fresh meat and^^Cfor fresh poultrymeat and 
the temperature of the production premises shall be no higher than ^t^C 
^ Immediately after production,comminuted meat shall be hygiemcally wrapped andpickaged and stored ata 
temperature of not more than ^^^Cm the case of chilled meat and not more than f^^Cmthecaseof 
frozen meat 
cnAtnm^na 
co^ntTto^^o^^onucrto^o^Mt^c^nM^AT 
7 Meat shall be examined before mincing All soiled and suspect parts shall be removed and condemned before 
the meat is minced 
^ Minced meat shall not be obtained from scrap cuttings or scrap trimmings, 
tn particular, it shall not be prepared from meat from the following parts of bovine animals, pigs, sheep or 
goats fragments of muscles from the head, boned shin meat, the point at which the stacking of the animal 
took place, m^ect^on areas, diaphragm and the central part of the belly muscles and bone scrapings ttshalt 
not contain any bone fragments 
^ ^here the operations carried out from the time when the meat enters the room referred to in Chapter t, 
pomtt mm^^he time when the finished product undergoes the chilling or freeing process are performed 
withmamaximum period of one hour,the internal temperatuieof the meat shatl be no higher than ^B^^C 
and the temperature of the production premises shall be no higher than ^f^e. The competent authority 
mayauthon^ealonger time limit in individual cases where the addition of seasonings or foodstuffs justifies 
this on technical grounds, provided hygiene rules are not affected by that derogation 
^here the duration of these operations is over one hour or over the period authorised by the competent 
authority in accordance with the preceding subparagraph, the fresh meat may not be used until the internal 
temperature of the meat has been reduced toamaximum of ^^^C 
Immediately after production the minced meat shall be hygiemcally wrapped and packaged and stored at the 
temperatures prescribed in Article ^mn^ 
cnA^r^^tv 
^^CtAL^^Ut^^M^^T^^O^Tn^^OOUCnO^O^M^AT^^ 
fO Over and above the general requirements of Chapter t, and depending on the type of production 
concerned 
^ the production of meat preparations shall take place under conditions of temperature control 
tmmediately after production,meat preparations must be forthwith cooled toatemperature below 
^^C,if they contain minced meat,they shall be cooled to the temperatures provided for in Articled 
^ meat preparations intended for direct sale to the final consumer shall be wrapped in indivisible 
commercial portions, 
^ refree^mg of meat preparations shall be prohibited 
2. 4. 90 Official Journal of the European Communities No C 84/127 
CHAPTER V 
INSPECTION 
11. Establishments which produce the minced meat or meat preparations or comminuted meat for industrial use 
shall be subject to inspection by the official service. The official service shall be present when work is 
undertaken. . 
12. Inspection by the official service shall include the following tasks: 
— inspecting the entries of fresh meat, 
— inspecting the outgoing products, 
— hygiene inspection of the premises, facilities and instruments, 
— taking of any necessary samples and in particular those required for the microbiological tests referred to in 
Chapter VI. 
CHAPTER VI 
MICROBIOLOGICAL TESTS 
13. The production of minced meat, comminuted meat for industrial use and meat perparations shall be 
monitored by means of daily microbiological tests in the production establishment or in an approved 
laboratory. 
To that end, the operator or proprietor of the establishment or his representative shall conduct a regular 
check on the general hygiene of conditions of production in his establishment, in particular by 
microbiological controls. 
These controls shall cover utensils, fittings and machinery at all stages of production and, according to the 
type of production concerned, products. 
He shall be in a position, upon request from the official service, to inform the competent authority or the 
Commission's veterinary experts of the nature, frequency and results of the controls conducted to this end, 
together with the name of the investigating laboratory if need be. 
The competent authority shall regularly analyze the results of the monitoring provided for in the first 
subparagraph. It may, on the basis of this analysis, conduct further microbiological examinations at all stages 
of production or on the products. 
The results of these analyses shall be written up in a report, the conclusions and recommendations of which 
shall be notified to the operator, who shall see to the rectification of shortcomings noted with a view to 
improving hygiene. 
14. The sample taken for analysis shall comprise five units weighing 100 grams each. Where minced meat is being 
produced in portions intended for the final consumer, the sample shall be taken from wrapped products. The 
samples shall be representative of daily production. 
15. According to the type of production concerned, samples shall be examined every day for aerobic mesophile 
bacteria and salmonella and every week for staphylococci, Escherichia coli and sulphite-reducing 
anaerobes. 
However, 
— for comminuted meat for industrial use, the competent authority, taking into account the intended 
utilization of the product, may require only the examination for aerobic mesophile bacteria, 
— where the standards for salmonella have been adhered to over a three-month period, the competent 
authority may authorize weekly examinations, 
— in the case of products to be placed on the market frozen or deep-frozen, the competent authority may 
waive the test for staphylococci. 
16. In spot checks carried out by production plants or independent production units, production of the minced 
meat and meat preparations shall, depending on the type of meat used, comply with the standards laid down 
in Annex II. 
NoC 84/128 Official Journal of the European Communities 2. 4. 90 
17. The results of the microbiological tests shall be at the official veterinarian's disposal. 
The establishment shall inform the official veterinarian when the standards laid down in Annex II are 
reached. The official veterinarian shall take the appropriate measures. 
If, after the expiry of 15 days starting from the time of sampling, the output from production plants or 
independent production units does not meet the standards prescribed, products from such establishments 
shall be excluded from human consumption. 
CHAPTER VII 
MARKING AND LABELLING 
18. — Minced meat shall be marked on the packaging with the health mark of the establishment as defined in 
Chapter X of Annex I to Regulation (EEC) No .../.. . (laying down the health rules for production and 
placing on the market of fresh meat and repealing Directive 64/433/EEC). 
— Meat preparations shall be marked on the packaging with the health mark of the establishment as defined 
in Chapter V of Annex A to Regulation (EEC) No .../... (laying down the health rules for the 
production and placing on the market of meat products and repealing Directive 77/99/EEC). 
— Comminuted meat for industrial use shall be marked on the packaging with the health mark of the 
establishment oi production. 
19. Without prejudice to Directive 79/112/EEC, for inspection purposes that the following information is 
visibly and legibly displayed on the packaging of minced meat, meat preparations and comminuted meat for 
industrial preparation, 
— where it is not clear from the sales description or from the list of ingredients in accordance with Directive 
79/112/EEC, the species from which the meat was obtained, and, in the case of a mixture, the percentage 
of each species, 
— for packaging not intended for the final consumer, the date of preparation. 
20. Without prejudice to points 18 and 19, for minced meat or meat preparations wrapped in commercial 
portions intended for direct sale to the consumer, a printed reproduction of the information referred to in 
point 19 and of the mark provided for in paragraph 18 shall appear on the wrapping or on a label applied to 
the wrapping. The mark shall include the establishment's approval number. The dimensions laid down in 
Regulation (EEC) No .../... (laying down the health rules for production and placing on the market of 
fresh meat and repealing Directive 64/433/EEC) and Regulation (EEC) No .../... (laying down the 
health rules for production and placing on the market of fresh poultrymeat and repealing Directive 
71/118/EEC) and Regulation (EEC) No .../... (laying down the health rules for the production and 
placing on the market of meat products and repealing Directive 77/99/EEC), shall not apply to the marking 
referred to in this paragraph, provided that the required information is legible. 
CHAPTER VIII 
TRANSPORT 
21. The minced meat, meat preparations and comminuted meat for industrial use must be dispatched in such a 
way that during tansport it is protected from anything liable to contaminate it or to affect it unfavourably, 
having regard to the duration and conditions of transport and to the means of transport employed. In 
particular, vehicles used to transport minced meat, meat preparations and comminuted meat for industrial 
use, shall be equipped in such a way as to ensure that the temperatures laid down in this Regulation ar not 
exceeded and for long-distance trade they must be equipped with a recording thermometer to ensure that the 
latter requirement is fulfilled. 
2. 4. 90 Official Journal of the European Communities No C 84/129 
ANNEX II 
MICROBIOLOGICAL STANDARDS 
1. Microbiological standards 
Establishments must ensure that, in accordance with Chapter VI of Annex I and with the methods of 
interpretation set out below, minced meat intended to be marketed without further processing or as an 
ingredient in meat preparations, comply with the following standards: 
Aerobic mesophile bacteria 
n(3) = 5 cH = 2 
Escherichia coli 
n = 5 c = 2 
Sulphite-reducing anaerobes 
n = 5 c = 1 
Staphylococci 
n = 5 c = 1 
Salmonella 
n = 5 c = 0 M(>) 
5 x 106/g 
5 x 102/g 
102/g 
5 x 102/g m(2) 
5 x 105/g 
50/g 
10/g 
50/g 
absence in 25 g 
(') M = acceptability threshold, above which results are no longer considered satisfactory where M equals 10m where the 
count is made in a solid medium and M equals 30 m where the count is made in a liquid medium. 
(2) m = threshold below which all results are considered satisfactory. 
(3) Number of units making up the sample. 
(4) Number of units in the sample giving values between m and M. 
A. Three categories of contamination for aerobic mesophile bacteria, Escherichia coli, sulphite-reducing 
anaerobes and staphylococci, viz.: 
— up to and including the criterion m, 
— between the criterion m and the threshold M, 
— above the threshold M. 
1. The quality of the consignment shall be considered: 
(a) satisfactory, where all the values observed are equal to or less than 3 m where a solid medium has 
been used or 10 m where a liquid medium has been used; 
(b) acceptable, where all the values observed are between: 
(i) 3 m and 10 m ( = M) in a solid medium; 
(ii) 10 m and 30 M ( = M) in a liquid medium 
and where c/n is equal to or less than 2/5 where n = 5andc = 2 or any other figures of equivalent 
or greater reliability to be recognized according to the procedure referred to in Article 9. 
2. The quality of the consignment shall be considered unsatisfactory: 
— in all cases where values in excess of M are observed, 
— when c/n is > 2/5. 
However, where this latter threshold has been exceeded for aerobic micro-organisms at + 30 °C while 
all the other criteria have been fulfilled, this exceeding of the threshold must be the subject of a further 
interpretation, in particular in the case of raw products. 
NoC 84/130 Official Journal of the European Communities 2. 4. 90 
In any event, the product must be considered toxic or tainted when contamination reaches the microbic 
limit value S, which for general purposes is set at 103 m. 
In the case of Staphylococcus aureus, the value of S must be allowed to exceed 5 x 104. 
Tolerances related to analytical techniques shall not apply to the values M and S. 
B. Two categories for salmonella, with no category tolerance permitted: 
— 'Absence in': the result is considered satisfactory, 
— 'Presence in': the result is considered unsatifactory. 
2. The microbiological methods for examination will be established according to the procedure referred to in 
Article 9. 
Proposal for a Council Regulation (EEC) adopting health rules for the production and placing on the 
market of heat-treated drinking milk 
COM(89) 672 final 
(Submitted by the Commission on 23 March 1990) 
(90/C 84/12) 
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 of the Commission, 
Having regard to the opinion of the European Parliament, 
Having regard to the opinion of the Economic and Social 
Committee, 
Whereas heat-treated drinking milk is included in the list of 
products in Annex II to the Treaty; whereas the production 
of and trade in raw milk used for the preparation of 
heat-treated drinking milk constitute an important source of 
income for the farming population; 
Whereas in order to ensure rational development of this 
sector and to increase productivity, public health rules 
governing the production and placing on the market of this 
product should be adopted 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 health rules promotes the 
protection of public health and completion of the internal 
market; 
Whereas it is necessary to extend the principles laid down in 
Council Directive 85/397/EEC of 5 August 1985 on health and animal health problems affecting intra-Community 
trade in heat-treated milk (l), as last amended by Directive 
89/165/EEC (2); whereas this extension requires certain 
technical amendments to the said Directive; 
Whereas it is possible that, due to certain 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 limited 
or temporary derogations may be granted to such 
establishments within the general framework laid down in 
Council Decision .../.. ./EEC of ... on the conditions 
for granting temporary and limited derogations from specific 
Community health rules for certain products of animal 
origin (3) should be resolved; 
Whereas it should be stressed that the granting of derogations 
from the health rules laid down in this Regulation is without 
prejudice to the submission of all operations of production 
and placing on the market of heat-treated milk to the general 
health rules laid down in Council Regulation (EEC) No . . . 
of . . . laying down general health rules for the production 
and placing on the market of products of animal origin and 
specific health rules for certain products of animal 
origin (4); 
Whereas Council Directive 79/112/EEC of 18 December 
1978 on the approximation of the laws of the Member States 
H OJ No L 226, 24. 8. 1985, p. 13. 
(2) OJ NoL 61, 4. 3. 1989, p. 57. 
(3) OJ No L . . . 
(«) OJ No L . . .