No C 332/94 Official Journal of the European Communities 31. 12. 90 
3.16.2. The Committee would emphasize that pro­
tection of the consumer is best served by having GMP 
(Good Manufacturing Practice) principles and manu­
facture based on HACCP (Hazard Analysis of Critical 
Control Points). With such an approach it is necessary 
to have microbiological criteria for the manufacturer 
to verify that GMP has been applied. 
3.16.3. Only the figures for pathogens and for faecal 
(44 °C) coliforms are actual health standards which 
must be strictly observed. The proposal must make 
the distinction clearer and say that the table must be 
interpreted in this light. 
3.16.4. Aside from this the table needs changes as 
follows: 
Done at Brussels, 19 September 1990. 
1. Introduction 
1.1. This proposal deals with health rules governing 
meat which has undergone some treatment and includes 
such products as ham, salami and other sausages, salted 
beef, etc. 
C1) OJ No C 84, 2. 4. 1990, p. 89. — Not all pathogens are relevant to all products. 
Listeria for instance is not relevant to powdered 
milk. 
— The term 'Other pathogens' is too vague and needs 
differentiating by product and type of pathogen. 
For instance yersinia enterocolitica is relevant to 
pasteurised milk but not to UHT. 
3.17. Chapter IV.l.b 
3.17.1. Organoleptic tests are quality, not health 
standards. 
3.18. Chapter V 
3.18.1. In the English version, change 'inspection' to 
'control' throughout to conform with the original 
French text. 
The Chairman 
of the Economic and Social Committee 
Alberto MASPRONE 
1.2. The Committee welcomes the proposal in prin­
ciple, but wants a number of changes as shown below. 
2. General remarks 
2.1. This is another proposal which does not include 
in the 'whereas' or in the text, appropriate reference to Opinion on the proposal for a Council Regulation laying down the health rules for the 
production and placing on the market of meat products (1) 
(90/C 332/28) 
On 21 February 1990 the Council decided to consult the Economic and Social Committee, 
under Article 198 of the Treaty establishing the European Community, on the abovemen-
tioned proposal. 
The Section for Agriculture and Fisheries, which was responsible for preparing the Com­
mittee's work on the subject, adopted its Opinion on 12 July 1990. The Rapporteur was 
Mr Gardner. 
At its 279th plenary session (meeting of 19 September 1990) the Economic and Social 
Committee adopted the following Opinion by 68 votes to 0, with 2 abstentions. 
31. 12. 90 Official Journal of the European Communities No C 332/95 
the general hygiene Directive being worked out by 
another part of the Commission, though Article 1.2 of 
COM (89) 492 final (proposal for general health rules 
for certain products of animal origin), clearly states that 
'the present regulations shall apply without prejudice to 
future horizontal hygiene legislation on foodstuffs'. 
2.2. It is essential that this proposal should provide 
for compliance with that Directive where necessary. 
This particularly important for the establishments 
which may be exempted from these rules. While exemp­
tion from some of the detailed rules is reasonable, this 
would leave the establishments concerned without any 
alternative Community rules and could thus present a 
danger to the public. 
2.3. Public health is not divisible and smaller estab­
lishment merely endanger fewer people. All establish­
ments must therefore be covered by proper health rules, 
the details of which should be adapted to the type and 
size of the establishment. 
3. Detailed comments 
3.1. Preamble 
3.1.1. Given our general comments, there should be 
a further 'whereas': 
'Whereas the granting of the derogations from spec­
ific Community health rules to certain establish­
ments does not affect the requirement to comply 
with Directive No .../... of ... on the protection of 
human health by monitoring the wholesomeness of 
food and observing basic principles of hygiene dur­
ing the production, handling and sale.' 
3.2. Article 1.1 
3.2.1. The scope of the proposal must be defined as 
it is under Article 43 of the Treaty. The following 
therefore should be added: 
'... of meat products within the scope of Annex II 
of the Treaty and their placing...' 
33. Article 1.2 
3.3.1. To protect the consumer, there must be posi­
tive cover for these exempt shops or premises, either 
by the general hygiene Directive or by a separate instru­
ment. There should therefore be a further sentence: 
'the provisions of the present regulation including 
its exemptions shall apply only so far as they are compatible with the Directive No .../... on the pro­
tection of human health by monitoring the whole­
someness of food and observing basic principles of 
hygiene during their production, handling and sale.' 
3.4. Article 2.14 
3.4.1. Add a fourth indent: 
'— Directive No .../... of ... (on the protection of 
human health by monitoring the wholesomeness of 
food and observing basic principles of hygiene dur­
ing their production, handling and sale)'. 
3.5. Article 4.2 
3.5.1. Transport and storage requirements are not 
necessarily the same. The wording therefore should be 
changed: 
'... the temperature at which the products must be 
stored and that at which they must be 
transported ...' 
3.5.2. Also to conform with the French text change 
'inspection' to 'control' here and throughout this text. 
3.6. Article 5.1 
3.6.1. The list of establishments that are approved 
should be published in the Official Journal or an other 
communication accessible throughout the Community. 
Such publication should also note any derogations 
applied under article 7. 
3.7. Article 5.2. Second paragraph 
3.7.1. Change to: 
'the competent authority must at all times have free 
access to all areas concerned with production ...' 
3.7.2. Health rules in offices, laboratories, pilot 
plants etc. are not part of this proposal. 
3.7.3. End of last sentence change to: 
'... take the necessary steps to ensure that the pro­
ducer rectifies the situation. These measures include 
prohibition on the use of unacceptable equipment.' 
No C 332/96 Official Journal of the European Communities 31. 12. 90 
3.8. Article 6.1 
3.8.1. Add: 
'... and shall inform the producers of the results and 
any corrective measures required.' 
3.9. Article 7 
3.9.1. This appears to cover permanent derogations. 
This Article is only acceptable if there are alternative 
health rules for these establishments. If the proposed 
general hygiene Directive is adequate for this, then there 
should be a cross-reference at this point. If not there 
must be a separate published instrument. Rules under 
a Committee procedure are not adequate. We propose 
a new point: 
3.10. Article 7.4 (new) 
These derogations apply only in so far as they are 
compatible with the Directive No .../... of ... on the 
protection of human health by monitoring the whole-
someness of food and observing basic principles of 
hygiene during their production, handling and sale.' 
3.11. Article 11 
3.11.1. The Committee does not agree with leaving 
significant derogations affecting public health to a com­
mittee procedure without any involvement by the pub­
lic. A possible way of overcoming this problem would 
be to inform the ESC immediately of any proposals for 
significant derogations so that the Committee can give 
an Opinion on these if necessary. 
3.12. Article 14 
3.12.1. Given the normal delays in finalizing Com­
munity instruments, the timing seems problematical. 
However the Commission informs us that preparations 
for the application of this proposal may start on the 
thirteenth day following its publication. 
3.13. ANNEX A 
3.13.1. Chapter I — General conditions for approval 
of establishments 
3.13.1.1. la line 4 add: 
'... Such drains, gratings and traps and any associ­
ated pipe work which have direct contact with production areas should be cleanable and hygieni-
cally designed to minimize the chances of product 
contamination.' 
Reason 
This is to avoid the drainage system becoming a source 
of contamination in processing areas. It has been found 
that drains frequently harbour listeria, therefore this 
provision is especially important in areas handling 
ready-to-eat foods. 
3.13.1.2. lb add: 
'Corners and joints with floors and ceilings should 
be rounded to prevent the accumulation of dirt.' 
3.13.1.3. le: 
'Adequate ventilation and if necessary goods extrac­
tion of steam and water vapour to minimize conden­
sation.' 
Reason 
It is well known that permanently damp factories sup­
port the growth of bacteria—such as listeria. 
3.13.1.4. lg 
Replace by: 
'— clean and easily cleaned overhead structures 
including ceilings, fixtures and equipment and a 
roof covering with an interior surface which fulfils 
these requirements;' 
Reason 
It is often the ceiling mounted equipment which pro­
vides a source of contamination, rather than the ceiling 
itself. 
3.13.1.5. la 
Change at end: 
'A sufficient number of facilities for cleaning and 
disinfecting hands and sufficient separate facilities 
for cleaning tools with hot water. For washing 
hands these facilities must have hot and cold run­
ning water or water premixed to a suitable tempera­
ture, hand cleaning and disinfecting products which 
will not cause a deterioration in hand condition 
with repeated use, and hand towels which can be 
used once only or hot air hand driers.' 
31. 12. 90 Official Journal of the European Communities No C 332/97 
Reason 
Separation of hand and tool washing is essential to 
ensure that the facilities are available when needed. 
Because operators repeatedly wash their hands, suitable 
products ensuring reliable hand-care with repeated 
usage are essential. The use of hot air driers provides 
an effective way of hand drying and enables the general 
standard of hygiene in washing areas to be maintained. 
3.13.1.6. 2b line 3 
Change to: 
'Facilities for disinfecting tools, where water is used 
as the disinfecting agent it should be supplied at 
not less than 82°C. Such facilities for cleaning and 
disinfecting tools are not required when all such 
cleaning is effected by a machine situated in a separ­
ate room or area;' 
3.13.1.7. 4d 
Replace: 'lids' by 'covers'. 
3.13.1.8. 5, Paragraph 2 
Change to: 
'Parts of the refrigeration plant coming directly or 
indirectly in contact with products should be easily 
cleanable and kept clean and shall include a hygienic 
system for draining off condensed water without 
any possibility of contamination of the surrounding 
area or the meat, minced meat, meat products or 
meat preparations.' 
3.13.2. Chapter II—Hygiene of staff etc. 
3.13.2.1. la 
Change as follows: 
'Staff shall in particular wear working clothes and 
headgear and, where necessary, a neck shield. 
Working practices and the changing of clothing 
shall be designed to minimize cross-contamination 
between raw and processed meat products. Staff 
engaged in working on or handling meat, minced 
meat, meat products or meat preparations or their 
wrapping shall always wash and disinfect their 
hands after visiting the toilet and several times 
during the working day and each time work is 
resumed. 
Persons who have been in contact with infected 
meat shall immediately wash their hands and arms 
carefully with hot water and then disinfect them. 
Smoking is forbidden in production and storage 
areas or rooms.' Reason 
Good discipline of hand and clothing hygiene is essen­
tial to prevent the transmission of food borne pathogens 
from raw meat to finished product. 
3.13.2.2. lc 
Change to: 
'Equipment and implements used for working on 
meat, minced meat, meat products and meat prep­
arations shall be hygienically designed and kept 
clean and in a good state of repair. 
They shall be thoroughly cleaned and disinfected as 
required during the working period to ensure that 
they do not contaminate the product. At least they 
should be cleaned at the end of the work period 
and before being re-used once they become soiled 
and left for extended periods without further use.' 
3.13.2.3. Last paragraph 
Change to: 
'Where machines operate continuously, or where a 
continuous process operates as a linked series of 
unit operations, cleaning shall be done when there 
is a danger of the machines, or in-process material 
accumulating in the machines, contaminating the 
product. Such machines will be cleaned when work 
is finished or in the event of a prolonged break­
down.' 
3.13.2.4. 3) 
Last sentence change to: 
'Care shall be taken to ensure that there is no 
contact between raw materials and finished prod­
ucts and that personnel do not constitute a route 
for cross-contamination between raw and cooked 
products.' 
3.13.2.5. 6) 
Change to: 
'Detergents, disinfectants and similar substances 
shall be used in such a way that equipment and 
working instruments are kept clean and neither 
equipment nor meat, minced meat, meat products 
and meat preparations are adversely affected. Their 
use shall be followed by thorough rinsing of such 
equipment and working instruments with potable 
water, unless the disinfectants used are suitable for 
food contact use. Products for maintenance and 
cleaning shall be kept in a separate locked place to 
ensure that the possibility of food contamination is 
minimized.' 
No C 332/98 Official Journal of the European Communities 31. 12. 90 
Reason 
Some disinfectants, such as alcohol, are designed for 
the dry disinfection of equipment—to prevent microbial 
growth—rinsing after such treatment destroys the disin­
fectant effect. 
3.13.2.6. 8) 
Add to last sentence: 
'..., unless some other staff medical check-up or 
screening procedure offering equivalent guarantees, 
is recognized in accordance with the procedure laid 
down in Article 11.' 
3.13.2.7. 10) 
Change end of first paragraph: 
'... conditioning to control the temperature and 
minimize condensation. Except in exceptional cir­
cumstances in production areas, the flow of air 
should be opposite to the flow of product, to avoid 
transmitting contamination.' 
Reason 
Cooling of production areas will cause condensation 
during production and cleaning periods, such damp, 
cool conditions encourage the growth of food borne 
pathogens. 
3.13.3. Chapter III—Supervision of production 
3.13.3.1. 3) 
Change to: 
'The results of the various checks to be carried out 
by the producer must be kept for a period exceeding 
the maximum period of storage and use of the 
product for sale, so that they can be shown on 
receipt of any request from the competent autho­
rity.' 
Reason 
For products with a shelf-life of a few days, it may not 
be necessary to store QA records for two years, whereas 
for canned or frozen goods it is essential. Availability 
of records should exceed the product shelf-life. 
3.13.4. Chapter IV—Wrapping and packaging of meat 
products 
3.13.4.1. 1) 
Change to: 
'Wrapping and packaging shall take place under 
satisfactory hygiene in rooms or specified, separate 
areas provided for that purpose;' Reason 
It often allows better management of hygiene when 
production areas are open, allowing a logical flow of 
product. 
3.13.4.2. 4(a) 
Change to: 
'the room shall be sufficiently large with its layout 
designed to prevent cross-contamination and assure 
the hygiene of personnel and the operations carried 
out in it;' 
3.13.4.3. 4(e) 
Add words in bold: 
'Packaging shall be brought to the room under 
hygienic conditions and used without delay. It may 
not be handled by staff handling unwrapped meat, 
minced meat, meat preparations or meat products 
unless their intervening hygiene procedures avoid 
the chances of cross-contamination.' 
Reason 
Where there are limited numbers of staff available it is 
impractical to confine them to particular duties. The 
important matter is that they do not transmit food 
borne pathogens onto the packaging material. 
3.13.4.4. New 4(f) 
'Operational and hygiene procedures should be 
designed to minimize the chances of transmitting 
food borne pathogens from one product or product 
type to another, where products which have 
received different previous processing are handled 
in the same packaging area.' 
Reason 
Hams and other meat processed products will be free 
of food borne pathogens when they go for slicing; 
salamis and other raw products may not be. Therefore, 
it is essential that operation procedures do not allow 
cross contamination during slicing and wrapping, for 
example. 
3.13.4.5. Existing 4f becomes 4g. 
3.13.5. Chapter VI—Storage and transport 
3.13.5.1. 1) paragraph 2, change to: 
'However, meat products which can be kept at 
ambient temperature may be stored in stores ap-
31. 12. 90 Official Journal of the European Communities No C 332/99 
proved by the competent authority; theses stores 
must be easy to clean and disinfect, pest-proof and 
of suitable design and construction to prevent dam­
age to and deterioration of the packaging of the 
products.' 
Reason 
Such stores should keep the packaging in good con­
dition and able to exclude bacteria as it is the most 
important contributor to product safety. 
3.14. ANNEX B 
3.14.1. Chapter I—Special conditions for approval of 
establishments etc. 
3.14.1.1. Change as follows: 
1(b): 
'One or more suitable rooms or areas sufficiently 
large for manufacture and wrapping.' 
1(c): 
'a separate room for the storage of certain ingredi­
ents such as additives.' 
Kd): 
'A room or area for packaging, unless the conditions 
laid down for packaging in Annex A, chapter IV(4) 
are fulfilled and a room for dispatch.' — for retorting (the retorts shall be fitted with a 
recording thermometer), a direct reading refer­
ence thermometer retorts shall also be equipped 
with a manometer and an accurate timing 
device.' 
2(p): add 
'Where plastic containers are used a means of ensur­
ing they are clean and free from damage before 
filling must be used;' 
2(q): 
'A room, area or suitable equipment for cooling 
heat-treated containers under hygienic conditions.' 
2(r): 
'suitable procedures and facilities, including com­
petent staff, for detecting contaminated or under-
processed products, for example by incubation of 
samples or inspection of process records' 
Add new 2(t): 
'Adequate control and monitoring equipment and 
procedures to ensure that the producer can demon­
strate that every batch of product has received the 
intended heating process.' 
Add new 2(u): 
'n — o do not apply to plastic pouches, bowls or 
cans.' 
Reason 
Reason 
The dispatch room will have direct contact to the 
outside and be maintained at a lower temperature than 
the packaging area. 
Kf): 
'A room or area with good ventilation for cleaning 
moveable equipment and a lockable room or cup­
board for the storage of cleaning and maintenance 
products and equipement.' 
2(d): 
'A room or if there is no danger contaminating heat-
processed product, an area for filling containers 
prior to heat treatment. 
2(e) 
'A room or area containing the equipment: 
— for cooking (equipment for heat treatment shall 
be fitted with a recording thermometer or tele-
thermometer), It is vital that the producers knows that all heat-process­
ing he has done has been safe—reliance on sampling/ 
incubation does not give good enough security. 
Page 29, bottom paragraph 
'The operations carried out in the rooms referred 
to in (c), (d), (e), (g) and (m) may be carried out in 
the room referred to in point l.b) provided that the 
installations constitute a single cycle of a continuous 
production line or a linked series of unit operations 
without intermediate storage off the line and 
guarantee that the other requirements of this regu­
lation are complied with and that there is not risk 
of contamination of the meat, minced meat, meat 
preparations or meat products by material at an 
earlier stage of processing.' 
Reason 
Clarification of this is important because of the increas­
ing use of automated lines which run as single pieces 
of equipment and therefore cannot be put in separate 
rooms. 
No C 332/100 Official Journal of the European Communities 31. 12. 90 
3.14.2. Chapter II—Specific requirements concerning 
hermetically sealed containers 
3.14.2.1. 1(a) 
Change last sentence to: 
'the operator or proprietor of the establishment or 
his representative must ensure by sampling or by 
the provision of adequate process records that:' 
Reason 
Provision of adequate records gives a much better idea 
of product safety than a low level of sampling. 
3.14.2.2. 1(a) 
Sixth indent change to: 
'the necessary checks are carried out to ensure that 
the cooling water contains a residual level of free 
chlorine after use and has had an adequate contact 
time with chlorine to allow disinfection before use;' 
3.14.2.3. Add seventh indent: 
'the producer must maintain adequate records to 
demonstrate that every batch of product has 
received an adequate heat process.' 
3.14.2.4. 1(b) 
Add: 
'Chill-stable products in hermetically sealed con­
tainers should be cooled quickly either in the heating 
apparatus or in a specified area. The pack surfaces 
should be dried hygienically and the packs not tou­
ched by hand until dry. 
All post-heat process handling of ambient and chill-
stable products should be done under hygienic con­
ditions and procedures should minimize the chances 
of contaminating the containers with unprocessed 
product.' 
Reason 
Increasing numbers of chill-stable products are made 
in hermetically sealed containers—it is important that 
these are covered by the Regulation! 
3.14.2.5. 1(c) 
Add: 
'Batches containing cans which appear in any way 
abnormal should undergo further examination, 
including inspection of processing records, prior to 
release for sale'. 3.14.2.6. 1(d) 
Replace: 
'Thermometers, manometers and timing devices 
used for control purposes must be regularly and 
frequently checked against calibrated, reference 
instruments'. 
3.14.2.7. 2 
Containers shall be: 
First indent change to: 
'— rejected if there are doubts about their ability 
to exclude bacteria, their specification, or if they 
are damaged.' 
Second indent: 
'— Cleanliness of packaging materials or containers 
prior to filling must be ensured, if it cannot then the 
containers must be thoroughy cleaned immediately 
before filling, by means of cleaning facilities or 
equipment. The use of static water is not author­
ized.' 
Fifth indent: 
'— Cooled, after heating in air or in water meeting 
the requirements in the sixth indent 1(a) or by other 
means.' 
3.14.2.8. 4 
Change to: 
'Member States may allow the use of recirculated 
water for cooling heat-processed containers. Such 
water must be filtered to remove suspended solids 
and have been effectively disinfected with chlorine 
or undergone some other treatment to ensure its 
microbiological safety and approved in accordance 
with the procedure laid down in Article 11.' 
Paragraph 2: 
'The recirculated water shall circulate in a close 
circuit, with no direct access to the potable water 
supply, so that it cannot be used for other purposes. 
There must be adequate hygiene measures to ensure 
closed circuit itself does not provide a source of 
contamination.' 
3.14.3. Chapter III—Special requirements for the pro­
duction of prepared meals 
3.14.3.1. 1(a) 
The reference to chapter l(l)(c) appears to be in error. 
Replace this by all below: 
'If the production of prepared meals cannot take 
place in suitable rooms or areas suggested within 
the scheme indicated in Annex B, chapter 1, the 
establishment shall designate a separate manufac­
turing area for the production of prepared meals. 
31.12. 90 Official Journal of the European Communities No C 332/101 
This area should be designed to minimize the chanc­
es of the manufacturing process contaminating the 
finished product'. 
3.14.3.2. 
Change to: 
'2. (a) The operator or proprietor of the establisment 
or his representative shall identify and control the 
critical control points in his manufacturing oper­
ation. He will conduct sufficiently frequent moni­
toring to ensure that adequate control exists. Special 
attention will be paid to the general hygiene of 
conditions of production in the establishment, in 
particular by microbiological, visual and process 
record inspections. 
The controls shall cover utensils, fittings, equip­
ment, personnel, raw materials and products con­
centrating on the stages of production critical to 
microbiological, safety'. 
3.14.3.3. 3. 
Change to: 
'In addition, prepared meals containing only 
fully cooked ingredients (cooked sufficient-
Done at Brussels, 19 September 1990. ly to free the ingredients from infectious patho­
gens): 
— be either wrapped before cooking or made from 
cooked ingredients which have been cooled, 
assembled, packed and wrapped under con­
ditions preventing re-contamination by food-
borne pathogens, 
— be cooled sufficiently rapidly to stop the growth 
of any organisms surviving the heating process 
or any contaminants introduced after heating; 
the internal temperature of the meal should 
not exceed 10 °C more than 4 hours after the 
completion of cooking and the time spent 
between 15 ° and 55 ° should be kept to a 
minimum, 
— where appropriate, be frozen or quick frozen as 
soon as possible after cooling, 
— the packaging used should prevent microbiologi­
cal contamination of the product, 
— where these products rely on a chill storage for 
microbiological safety, the operator or pro­
prietor should ensure that storage, handling and 
distribution are done at temperatures ensuring 
the microbiological safety of the product.' 
The Chairman 
of the Economic and Social Committee 
Alberto MASPRONE