codex alimentarius commission

FOOD AND AGRICULTURE WORLD HEALTH

ORGANIZATION ORGANIZATION
OF THE UNITED NATIONS

JOINT OFFICE: Via delle Terme di Caracalla 00100 ROME: Tel. 57971 Telex: 610181 FAO I. Cables Foodagri

ALINORM 85/13
CODEX ALIMENTARIUS COMMISSION
Sixteenth Session 1985

REPORT OF THE NINETEENTH SESSION OF THE

CODEX COMMITTEE ON FOOD HYGIENE
Washington, D.C., 26-30 September 1983

INTRODUCTION

The Nineteenth Session of the Codex Committee on Food Hygiene was held in the
Main Conference Room, Department of State, Washington, D.C., from 26 to 30 September 1983
by courtesy of the Government of the United States of America. The Session was attended
by representatives and observers from 26 countries and two international organizations
(see Appendix I for list of participants). The Chairman of the Session was
Dr. R.B. Read, Director, Division of MiCrobiology, FDA.

The Session was opened by Dr. Sanford Miller, Director, Bureau of Foods, Food and
Drug Administration who welcomed the participants on behalf of the Government of the USA.
He underlined the importance of the aims of the Codex Alimentarius Commission one of
which was to protect the consumer by assuring that foods moving in international trade
were safe for human consumption. He referred to the recent meeting in Geneva of a Joint
FAO/WHO Expert Consultation on Food Safety which had emphasized that food-borne diseases
were still the largest source of illness in the world and that to alleviate the problem,
international organizations must devote more resources to the special needs of developing
countries when establishing food control systems.

Referring to items which the Committee would consider at its present Session,
Dr. Miller underlined the prime importance of developing procedures for maintaining the
integrity of containers for processed foods and of providing guidance for the preparation
and cooking of foods consumed outside the home.

INFORMATION ON ACTIVITIES WITHIN WHO OF INTEREST TO THE COMMITTEE

The representative of WHO reviewed the activities of his organization relating

to the work of the Committee.

He informed the Committee of the different programmes of WHO (Veterinary Public

Health, Food Safety Programme, Diarrhoeal Diseases Programme, Nutrition International
Programme on Chemical Safety) which were involved in food hygiene activities and of the
report on these activities related to the work of the Codex which had been presented in
detail at the latest meeting of the Codex Alimentarius Commission in July 1983 (see
document ALINORM 83/6). He also drew attention to further WHO activities not mentioned
in the above document.

The Veterinary Public Health Unit was the coordinator of four guidelines on Food
Virology, Prevention and Control of Salmonellosis, Organization and Management of
Surveillance of Food-borne Diseases,and Paralytic Shellfish Poisoning. These guidelines
had already been prepared and would be issued in the near future.

w/M 6995
 -2-

In preparing comprehensive guidelines on salmonellosis which were intended for

different professions involved in the prevention and control of this widespread zoonosis,
several Codex documents were used. In particular, the Recommended International Codes of
Hygienic Practice for Fresh Meat (CAC/RCP 11-1976), for Ante-mortem and Post-mortem
Inspection of Slaughter Animals (CAC/RCP 12-1976) for Processed Meat Products
(CAC/RCP 13-1976), for Poultry Processing (CAC/RCP 14-1976), as well as General Principles
of Food Hygiene (CAC/RCP 1-1969, Rev. 1), served as background documents for elaboration
of the main principles on prevention and control of salmonellosis during slaughtering and
processing meat and poultry.

The report of the WHO Expert Consultation on Intersectorial Coordination of Food

Hygiene Programmes (VPH/83.45) was now available from WHO. This document which gave the
conclusions and recommendations of the majority of developing countries of the
Mediterranean region underlined once again that "national and intercountry food hygiene
programmes require the close collaboration of experts from a number of different
disciplines."

The four reports of the FAO/WHO Expert Consulations and Working Groups on
microbiological criteria for foods had been summarized by Dr. Christian (ICMSF) and were
reviewed with him during his short visit to Geneva. The purpose of this work was to
select for the reader the most important information with regard to microbiological
criteria, including general principles for their establishment and application, as well
as concrete recommendations on microbiological limits. After some editorial work the
document would be issued by WHO.

Together with the International Union of Microbiological Societies' Committee on

Food Microbiology and Hygiene, WHO convened a consultation on the present international
problems in food hygiene (Budapest, 18-19 July 1983). Among the items proposed for
future international activity on elaboration of microbiological criteria, the
consultation suggested the following: dessicated coconuts, spices, smoked fish, fresh
cheeses, pre-cooked chilled meals and chocolate.
The WHO European Surveillance Programme for the Control of Food-borne Infections
and Intoxications in Europe was carried out by the FAO/WHO Collaborating Centre in Berlin
(West). A second comprehensive report on the present situation with regard to food-borne
diseases in Europe was under preparation and should soon be finalized.

WHO was continuing its training activities in the field of food hygiene. This
year the Organization conducted an expert consultation on undergraduate and post-graduate
teaching in veterinary public health (Brno, Czechoslovakia, 20-24 June 1983).

This consultation elaborated syllabi for different veterinary subjects, including

food hygiene and technology, and surveillance, prevention and control of zoonoses and
food-borne diseases and guiding principles for teaching these disciplines.

The Committee expressed the opinion that the scope of the WHO European Surveillance
Programme for the Control of Food-bore Infections and Intoxications (see para. 9) was
of great importance andshould be extended world-wide.

ACTIVITIES OF ISO

Madame Gantois, as Representative of the ISO Secretariat, informed the Committee

of the work of ISO in the field - of microbiology.

Two sub-committees of ISO were specifically concerned with microbiology.

Sub-committee 9 of Techriical Committee 34 "Agricultural Food Products" was responsible
for developing general guidance standards for food products and Sub-committee 4 of
Technical Committee 147 "Water Quality" specialized in water microbiology. The work of
these two Sub-committees concerned mostly the standardization of analytical methods.

ISO/TC 34/SC9: Food Microbiology

The last meeting of Sub-committee 9 was held, at the invitation of Hungary, in

September 1983 at Balatonfured, under the chairmanship of Mr. Auclair (France) 15 countries
 3

and five international organizations were represented, among them Thailand and Tanzania
for the first time.

16. The following topics were discussed:

Enumeration of Enterobacteriaceae

Both a MPN Method and a Colony Count Method were used. The prescribed incubation
temperature was 37 0C. In the case of the MPN technique (medium: E E broth),it was agreed
to prescribe a double concentration medium in order to lower the detection limit from 10
to 1 bacteria per gram. The Colony Count Method was performed using Violet Red Bile
Agar (VRBA Medium).
4-4

Enumeration of Clostridium Perfringens

A Colony Count Method was used. The prescribed medium was Sulfite Cycloserine
(SC Medium) and "Motility-nitrate and Gelatin-lactose Media were used for the confirmation
tests. The incubation temperature was again discussed, but it was finally agreed to
maintain a temperature of 37 0 C. Some countries had expressed the need for a method
allowing enumeration of Clostridium perfringens in small numbers. A survey had been
organized in response and the recently recorded results seemed to justify such a request.

General Guidelines for Microbiological Examination

An Ad hoc Working Group has been set up to accelerate the completion of this
document. This Group met twice in Brussels and was soon expected to distribute a draft
international standard (DIS). (See Appendix II).

Enumeration of Yeasts and Moulds

Agreement was reached on the main parameters.

The Yeast-mould Group should be considered as a whole, and when counting no

distinction was made between these two types of micro-organisms.

The prescribed medium was a yeast extract-dextrose-chloramphenicol medium. This

was a medium already recommended for milk products by the International Dairy
Federation (IDF).

Enumeration of Bacillus cereus (Colony Count Method)

Incubation temperature was at 25°C for a period of five days. The prescribed
medium was the Mossel Medium, and the confirmation tests were:

- glucose fermentation
4
production of acetylmethylcarbinol

- nitrate reduction

The Need for Resuscitation in Microbiological Examaninations

The studies had not yet been completed and it seemed very difficult to present any
in
proposal for general guidelines. It was difficult to find a solution to this problem
view of the diversity of products to be examined. It had nevertheless been considered
useful to include a resuscitation step in the Enterobacteriaceae count.

Microbiological Analysis of Canned Products

A better definition had been achieved. The aims for the standardization of future
available
documents had been better defined. It had been thought worthwhile to have
methods for evaluating the uniformity of a batch or assessing microbiological
examinations. This programme of work should be pursued in close relationship with the
Codex activities, so as to avoid duplication.
 -4

The next meeting of SC 9 had been scheduled for April 1984; in a country yet to
be decided. There were some other microbiological studies in progress in other
sub-committees of TC 34 concerning specific products.

SC 4 Cereals and Cereal Products

SC 5 Milk and Milk Products
SC 6 Meat and Meat Products

A summary of the State of Work of these Subcommittees is given in Appendix II.

17. ISO/TC 147/SC 4: Water Microbiology

The last meetings of ISO/TC 147/SC 4 and its working groups were held in Stockholm
in June 1982. The status of the work was the following:

- General Guidance for Microbiological Analysis (Sc 4/WC 1). A proposed DP (DP p199)
had been circulated to the working group. The results of the survey would be studied at
the Working. Group's next meeting (October 1984).

Conforms (SC 4 WG 2)

The proposals for enumeration of coliforms and thermotolerant coliforms (also

called presumptive faecal califorms) by enrichment in liquid medium and by membrane
filtration had been completed for the detection of presumptive E. coli and the
identification of E. coli. These projects will be reviewed at the next meeting of the
working group (October 1984) before being registered as ISO draft proposals.

Pseudomona aeruginosa (Sc 4/CT 3)

Two proposals for the enumeration of Pseudomonas aeruginoga (DP 8360/1 )

enrichment in liquid-medium and DP 8360/2 membrane filtration) were now being submitted
for approval to the member committees.

Faecal Streptococci (Sc 4/WC 4)

A draft proposal had been submitted to the ISO Central Secretariat for registration
as a Draft International Standard (DIS 7899 Isolation and enumeration of presumptive Group
D Streptococci - Part 1: enrichment in liquid medium; Part 2: membrane filtration.
Voting on this draft project was now taking place.

Spores of Sulphite-reducing Anaerobes (Sc 4/WC 5)

At the last meeting of the working group (June 1982), it had been agreed to present
a new version of DP 6461: Isolation and enumeration of the spores of sulphite reducing
anaerobes -(Part 1: enrichment in liquid medium; Part 2: membrane filtration).

Salmonella (SC 4/WC 7) e

,A revised proposal based on a method similar to ISO Method 6579 "Microbiology -

General Guidance for Detection of Salmonellae" (TC 34/SC 9) had just been distributed.

Quality of the Membrane Filters used in Water Microbiology (Sc 4/WC 9)

A proposed draft project had been submitted to the ISO Central Secretariat for
registration as a draft international standard (DIS 7704 Water Quality - Evaluation of
the membrane filters used for microbiological analysis). Voting on this draft project
was now taking place.

All these working groups would meet in the Hague from October 17 to 21, 1984.
 -5 -

REVIEW OF MATTERS RELEVANT TO THE COMMITTEE AS DISCUSSED BY THE CODEX

• ALIMENTARIUS COMMISSION AND VARIOUS CODEX COMMITTEES

A. CODEX ALIMENTARIUS COMMISSION FIFTEENTH SESSION (4-15 July 1983)

18. The following Codes of Hygienic Practice were advanced to Step 8:

Dried Milk - and Annex I "Microbiological Criteria for Dried Milk Products"
Processing of Froglegs.

The Commission had noted that two provisions in the Code of Hygienic Practice for
Dried Milk required further examination - the definition for "pasteurization" (2.9) whith
would be considered by the International Dairy Federation and the definition for "lot"
(7.5.5) which would be considered by this Committee at its present Session.

The Commission had also advanced the proposed Draft Code of Hygienic Practice for
the Collecting, Processing and Marketing of Natural Mineral Waters to Step 6.

The Committee noted that two Codes of Hygienic Practice "General Principles of
Food Hygiene" (first revision 1979) and "Low-acid and Acidified Low-acid Canned Food"
which had been adopted by the Commission would be published soon respectively in
Volumes A and G of the Codex Alimentarius.
B. OTHER BUSINESS
21. Codex Committee on Food Additives (CCFA)

Codex General Standard for Irradiated Foods (Step 8)

The CCFA re-examined Section 3 - Wholesomeness of Irradiated Foods and amended it

to include an appropriate reference to the FAO/WHO/IAEA publication on wholesomeness of
Irradiated Food. The CCFA also agreed to use the word "shall" rather than "should" in
referring to the recommendations on food hygiene in Sub-section 3.1 (see ALINORM 83/12A,
para 159). At its Fifteenth Session the Commission had noted that the use of "shall"
would make it mandatory for all those member governments accepting the standard to apply
the Codex General Principles of Food Hygiene and Codes of Hygienic Practice to foods that
were irradiated. Since Codex Code's of Practice were advisory texts the Commission agreed
to maintain the use of "should", bearing in mind that irradiation should not be used as
a substitute for Good Manufacturing Practice.

The Committee endorsed the following text:

2.2 Absorbed Dose

The overall average dose absorbed by a food subject to radiation processing should
not exceed 10 kGy (*). (**)

2.3 Facilities and Control of the Process

2.3.1 Radiation treatment of foods shall be carried out in facilities licensed and
registered for this purpose by the competent national authority.

2.3.2 The facilities shall be designed to meet the requirements of safety, efficacy and
good hygienic practices of food processing.

(*) For measurement and calculation of overall average dose absorbed see Annex A of
the Recommended International Code of Practice for the Operation of Radiation
Facilities used for Treatment of Foods.
(**) The wholesomeness of foods, irradiated so as to have absorbed an overall average
dose of up to 10 kGy, is not impaired. In this context the term "wholesomeness"
refers to safety for consumption of irradiated foods from the toxicological point
of view. The irradiation of foods up to an overall average dose of 10 kGy introduces
no special nutritional or microbiological problems (Wholesomeness of Irradiated
Foods,Report of a Joint FAO/WHO/IAEA Expert Committee, Technical Report Series
659, WHO, Geneva, 1981).
 -6

3. HYGIENE OF IRRADIATED FOODS

3.1 The food should comply with the provisions of the Recommended International Code
of Hygienic Practice of the Codex Alimentarius relative to a particular food.

3.2 Any relevant national public health requirement affecting microbiological safety
and nutritional adequacy applicable in the country in which the food is sold should
be observed.

B. CODEX STANDARD FOR FOOD GRADE SALT (STEP 8)

The Committee endorsed the following provisions:

6. HYGIENE

In order to ensure that proper standards of food hygiene are maintained until the
product reaches the consumer, the method of production, packaging, storage and
transportation of food grade salt should be such as to avoid any risk of contamination.

22. Codex Committee on Cocoa Products and Chocolate (CCCPC)

Codex Standard for Cocoa (Cacao) Nib, Cocoa (Cacao) Mass, Cocoa Press Cake and
Cocoa Dust (Cocoa Fines) for use in the Manufacture of Cocoa Products and
Chocolate

Codex Standard for Composite and Filled Chocolate

Codex Standard for White Chocolate/Cocoa Butter Confectionary

The following hygiene provisions were endorsed for the above standards:

"6. HYGIENE

6.1 It is recommended that the products covered by the provisons of this Standard be
prepared in accordance with the appropriate sections of the Recommended
International Code of Practice - General Principles of Food Hygiene
(Ref. No. CAC/RCP 1-1969).

6.2 To the extent possible in good manufacturing practice, the products shall be free
from objectionable matter.

6.3 When tested by appropriate methods of sampling and examination, the products:

shall be free from micro-organisms capable of development under normal

conditions of storage; and

shall not contain any substances originating from micro-organisms in amounts

which may represent a hazard to health.

23. Codex Committee on Fats and Oils

The following provisions were endorsed:

Draft Standard for Venaspati/Vegetable Fat Mixture

"6. HYGIENE

It is recommended that the product covered b ly the provisions of this Standard be

prepared in accordance with the appropriate sections of the General Principles of Food
Hygiene recommended by the Codex Alimentarius Commission (Ref. No. CAC/RCP 1-1969, Rev.1).
 - 7 -

Draft Standard for Vanaapati/SubstitUte . Ghee

"6. HYGIENE

It is recommended that the product covered by the provisions of this Standard be

prepared in accordance with the appropriate sections of the General Principles of Food
Hygiene recommended by the Codex Alimentarius Commission (Ref. No. CAC/RCP 1-1969, Rev.1)
and the Recommended International Code of Hygienic Practice for Processed Meat Products
(CAC/RCP 13-1976).

Codex Committee on Fish and Fishery Products (CCFFP)

Draft Standard for Quick Frozen Blocks of Fish Fillets, Minced Fish Flesh and
Mixtures of Fillets and Minced Fish Flesh

Hygiene and Handling

The CCFFP had considered the written comments of France which proposed an
additional point 5.2(d) requiring that the products "must not contain biotoxins". At
the session the Delegation of France had also questioned the provisions of 5.2(b) which
required that the product "shall be free from parasites which may represent a hazard
to health", since the presence of all parasites was undesirable.

The CCFFP had noted that the presence of parasites carried major penalties in the
defects table (Annex D. 6). It recognized that the two types of parasite defects were
difficult to distinguish but decided to leave both Sub-section 5.2(h) and Annex D
unchanged since the former allowed for control of harmful parasites when suitable methods
of testing were available and the latter for the control of all visible parasites.

With regard to biotoxins the CCFFP decided that their presence was controlled in
part by the necessity for adherence to good manufacturing practice expressed in the
Hygiene and Handling Provisions and in part by Section 3, "Essential Composition and
Quality Factors" which required that the raw material should consist of "sound fish which
are of a quality fit to be sold fresh for human consumption".

The Committee agreed with the CCFFP that the present provisions adequately covered
the nature and quality of the fish required and endorsed the following provisions:

5. HYGIENE AND HANDLING

5.1 When tested by appropriate methods of sampling and examination, the product:

shall be free from micro-organisms in amounts which may represent a hazard

to health;

shall be free from parasites which may represent a hazard to health; and

(e) shall not contain any substances originating from micro-organisms in amounts
which may represent a hazard to health.

5.2 To the extent possible in good manufacturing practice, the product shall be free
from objectionable matter.

5.3 It is recommended that the product covered by the provisions of this Standard be
prepared and handled in accordance with the following codes:

the appropriate sections of the Recommended International Code of Practice -

General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 1);
the Recottended International Code of Practice for . FrO2ét Fish (CAC/RCP
(CAC/RCP 1-1969, Rev. 1);

the Draft Code of Practice for Minced Fish (ALINOMR 81/18, Appendix VIII).
 -8

28. Code of Practice for Food Grade Fish Concentrate

The Committee noted that the CCFFP had deferred further consideration on the
elaboration of the above Code until more comprehensive data on production, trade and
consumption of the product were available.

29. Coordinating Committee for Europe

Draft Regional Standard for Vinegar

The Committee endorsed the following provisions:

6. HYGIENE

6.1 It is recommended that the products covered by the provisions of this Standard be
prepared in accordance with the Recommended International Code of Practice -
General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 1).

6.2 When tested by appropriate methods of sampling and examination the product:

shall be free from micro-organisms capable of development under normal

conditions of storage in amounts which represent a hazard to health;

shall not contain vinegar eels or substantial quantities of other suspended

matters and sediments; and shall be free from turbidity caused by micro-
organisms (mother of vinegar); and

(e) shall not contain any substances originating from micro-organisms in amounts
which may represent a hazard to health.

30. Codex Committee on Processed Meat and Poultry Products (CCPMPP)

Recommended International Code of Hygienic Practice for Processed Meat and Poultry
Products

The Committee noted that the above Code had undergone a major revision both with
regard to technical content and layout and that the hazard analysis critical control
point (RACCP) system had been used when amending this text.

The Committee noted that the HACCP system was an attempt to exercise greater
control over microbiological hazards in foods by pinpointing the steps in the processing,
and, if necessary,in the distribution, wholesale and retail storage and ultimate use of
foods where such hazards were most likely to occur.

This approach was originally developed for use in food processing establishments
in the USA and had the full support of WHO. A meeting of members of the International 0-

Commission on Microbiological Specifications for Foods (ICMSF) had been convened by WHO
in Geneva 9-11 June 1980 to discuss the further development of the HACCP system, which
included: assessment of the health and spoilage risks associated with processing and
marketing a given food product; determination of Critical Control Points in the
manufacturing process, and the establishment of programmes for monitoring Critical Points.

The Committee noted that the Code of Hygienic Practice for Low-acid and Acidified
Low-acid Canned Foods had been elaborated along HACCP lines and agreed that in the
elaboration of future Codes such as the proposed Draft Code for Pre-cooked Meals and for
Caterin, and in the revision of existing Codes, the HACCP approach should be borne in
mind.

Evaluation of Alternative Treatment of Spices to be used in Meat Products

The Committee noted that the CCPMPP had considered a document CX/PMPP 82/11 which
contained information received from Governments on (i) Methods presently used for
sterilizing spices; (ii) Methods permitted for sterilizing spices and changes to be
foreseen in present legislation if any; and (iii) Methods of sterilizing spices which
were considered to be preferable for future legislation, supplemented by similar
information from current literature.
 -9-

The CCPMPP noted that sterilization of spices was also of concern to other Codex
Commodity Committees and agreed to recommend that methods for sterilizing spices be
harmonized internationally. It was also agreed to ask the Commission to consider the
elaboration of a code of practice for production, handling and treatment of spices, a
task which could be entrusted to the Codex Committee on Food Hygiene.

At its Fifteenth Session the Commission had noted the concern of the CCPMPP
regarding the sterilization of spices for use in processed meat and poultry products.
The common method of treatment by ethylene oxide was under heavy criticism for
toxicological reasons and was expected to be prohibited at least in some countries in
the near future.

As there was a real need for spices of good bacteriological quality for use in
processed meat and poultry products moving in international trade and also for products
other than meat products, the CCPMPP agreed to seek the advice of the Commission regarding
the desirability of elaborating a Code of Hygienic Practice for Production, Handling and
Treatment of Spices, with a view to international harmonization. The Commission had
recognized the need for such a Code and requested the Codex Committee on Food Hygiene to
consider undertaking such a task at its next session.

In discussing the request of the Commission, the Committee noted that an alternative
method, irradiation of spices at an average radiation dose of up to 10 kGy had received
unconditional acceptance by the FAO/WHO IAEA Joint Expert Committee on Food Irradiation in
1981 and could be an efficient method for reducing the microbial load and the number of
pathogenic micro-organisms in spices. Norway had already permitted irradiation of spices
for food manufacturing purposes and provisional acceptance had also been given by certain
countries.

At the present session, the Delegation of Norway was of the opinion that the
preparation of spices which were free from microbiological hazard was not only a question
of sterilizing treatment but also one of food harvesting and storage practices and
suggested that the proposed Code should also take this into account.

Other delegations pointed out that several spices had been reported as the source
of microbiological contamination and that the problem was not confined to the use of
spices in processed meat and poultry products.

After further discussion in which the possibility of developing two separate

Codes, one for the production, harvesting and handling of spices and another for
subsequent treatment was considered, the Committee agreed that a background document
should be prepared for consideration at its next session on the manufacturure and
treatment of spices following which the Committee would decide how best to proceed with
the elaboration of a Code or Codes of Practice to ensure good manufacturing practices and
adequate treatment of spices. The Delegation of the Netherlands agreed to prepare such
a document in cooperation with Canada, Denmark, France, UK and USA.

Codex Committee on Cereals, Pulses and Legumes (CCCPL)

Draft Standard for Maize (Corn)

Draft Standard for Wheat Flour

The CCCPL had, in line with the comments made by this Committee at its last
session (see ALINORM 83/13, paras 44-48), amended the hygiene provision and for the
above standard and now submitted them for endorsement. The texts read as follows:

For Maize

5.1 Unchanged
5.2 When tested by appropriate methods of sampling and examination the product:
5.2.1 shall, to the extent possible in Good Manufacturing Practice, be free from
objectionable matter, having regard to the tolerance indicated in
Sub-section 3.4 where applicable.
 5.2.2 shall be free from micro-organisms, substances originating from micro-
organisms, or other poisonous or deleterious substances in amounts which
may resonably represent a hazard to health.

For Wheat Flour

6.1 Unchanged

6.2 When tested by appropriate methods of sampling and examination the flour
shall be:

6.2.1 to the extent possible in Good Manufacturing Practice, free from

objectionable matter.

6.2.2 free from micro-organisms, substances originating from micro-organisms

or other poisonous deleterious substances in amounts which may reasonably
represent a hazard to health.

Before endorsement the Committee considered whether specific references to

freedom from mycotoxins should be made.

The Committee recognized that limits for mycotoxins varied considerably in

national legislation and that it was not possible to provide a complete listing of all
mycotoxins nor to give guideline figures for some of the more recently discovered
mycotoxins. It was agreed for these reasons to maintain the present provision unchanged.

Amendments to the Codex Procedures for the Elaboration of World-wide and Regional
Standards

A proposed revised procedure for the elaboration of Codex Standards had been
discussed both by the Executive Committee and by the Codex Committee on General
Principles. The Commission adopted the new procedure (ALINORM 81/13, paras 157-165)
which was now published in the Fifth Edition of the Procedural Manual.

The revised procedure was aimed at shortening the time needed to develop standards
while safeguarding the opportunity for member governments and the Commission to examine
and approve standards and codes. In essence there were now 8 rather than 11 steps.

The new procedure allowed the adoption of a draft standard as a Codex Standard
at Step 8 and this would be the procedure to be followed by Committees in elaborating
their future standards.

Publication of Codex Standards

The Committee noted that several volumes of the Codex Standards had now been
published in loose-leaf form and that work was also in progress on the preparation of
Codex Codes of Practice and Codes of Hygiene Practice in similar form. It was hoped
that this would facilitate the insertion of amendments to Standards and Codes in the
future.

PROVISIONS FOR THE TEARDOWN EXAMINATION OF CANNED SEAMS

The Committee had available a document containing the report of a Working Group
(see Appendix III) which had met in Ottawa from 11 to 14 November 1982 to provide further
clarification and detail for certain provisions of the Codes of Hygienic Practice for
Low-acid and Acidified Low-acid Canned Foods, and for the Salvaging of Damaged Canned
Foods. The report dealt with classification of visual defects and a sampling plan
including limits for acceptance. Some countries expressed doubts as to the statistical
validity and possible misuse of the sampling plan. It was agreed that an appropriate
explanatory preface should - be drafted before the plan was inserted into a Codex document.

Before convening an ad hoc Working Group to discuss the report at the Session the
Chairman of the Working Group, Mr. I.E. Erdman (Canada) informed the Committee informed
the Committee that defects classification and lot evaluation provisions had been prepared
to be used in conjunction with the Draft Codes but that proposals for microbiological
examination and methods had not been included in the Report.
 He sought guidance from the Committee on whether the defects classification and
the microbiological examination methods, when prepared, should be annexes to the two
Codes or whether they should be separate documents.

Before the Committee considered the matter Mr. Erdman showed slides illustrating
the types of visual defects encountered in the production processing and distribution of
canned goods as classified by the Working Group.

After some further discussion the Committee decided that the tests for examination
of visual defects and for microbiological examination should be prepared as separate
documents and should not be attached to the Codes.

The Committee also noted that a document compiled in France by CNRS and AFNOR
dealing with defects and contamination not only in cans, but glass and metallo-plastic
containers, should be taken into account when preparing the final text,

At a later stage there was further discussion on the contents of the two proposed
documents.

(a) Visual Inspection and Teardown

It was pointed out that visual inspection and teardown examination were two
separate steps, one to be carried out by an operative who might require a manual of
visual defects and the other in the laboratory where a manual of instructions for
teardown would be required.

The Committee recognized that adequate instruction manuals for teardown

inspection already existed and decided the Working Group should prepare guidelines in
colour, classifying visual defects only.

The Chairman of the Working Group agreed to prepare such guidelines and to send
them to the Codex Secretariat which would look into the possibility of printing the
guidelines in colour and distributing them for comments at Step 3 of the procedure.

It was pointed out that Government consultation on the guidelines was essential,
because the defects classification itself required further work on, for instance, defect
descriptions. The special problems of goods damaged in transport rather than in
processing were also noted.

(h) Microbiological Examination and Methods

The Committee noted that microbiological examination of defects formed an essential

link between the Guidelines on visual defects and the "Salvaging Code". The Group was of
the opinion that the preparation of such criteria was of sufficiently high priority to
warrant consideration by a Joint FAO/WHO Working Group or Consultation. It made a strong
recommendation to the Joint FAO/WHO Food Standards Programme to find resources to
organize such a body.

Updating of the Code of Hygienic Practice for Low-acid and Acidified Low-Acid
Canned Foods

The Committee noted that proposals made in the report of the Working Group would
require revision of the above Code, in particular with regard to can integrity and post-
thermal process hygiene. It was agreed that the Working Group would prepare spcific
amendments to the Code for consideration at the next session of the Committee.

AD HOC WORKING GROUP ON CANNED FOODS

60 This Working Group met under the chairmanship of I.E. Erdman, (Canada), to
consider: (a) Sampling and Inspection Procedures for Microbiological Examination of
Meat Products in Hermetically Sealed Containers (ALINORM 83/16, Appendix III); and
(h) Code of Hygienic Practice forSalvaging of Damaged Canned Foods (ALINORM 83/13,
•
 - 12 -

Appendix VII, CX/FH 83/4). Mr.B.E. Brown (Canada) was rapporteur. The Working Group
noted that the above Code (b),which is presently at Step 4, was out for government
comments and should remain at this step until sufficient time had elapsed to permit
receipt of any comments. Thus these should be available for study at the next meeting
of the Committee.

Comments on Document (a)

1. Preface

61. Opinion was expressed that the use of a preface as such in Codex Codes was unique.
The material contained in the preface was important and 'should be re-located in
appropriate places in the body of the document. For example,paras 1 and 5 should be used
better define the Scope in Section I.

2. Scope

62. In addition to the inclusion of the pertinent parts of paras 1 and 5 from the
preface, the scope should stress that the investigational guidelines and/or procedures
were concerned only with microbiological analysis. The comments in paras 1 and 5
certainly detailed some of the important reasons why end-product analysis was futile in
control of microbiological problems in such products. The scope should therefore be
more specific as to when and how the procedures outlined should be used.

3. Definitions

63. (0 Lot While the definition given might be appropriate for the class of foods
covered by this document, the Working Group advised that consideration
be given to the results of the discussions on a definition which would
be reviewed by the Committee at this meeting. (see paras 148-152).

64. (ii) Reject: This term was considered to the too harsh. The term "detain" was
suggested as a replacement and would be in more keeping with the
definition given in the footnote.

4. Procedure

PART A - HEAT-TREATED SHELF-STABLE PRODUCTS

65. Para 2 of the preface should, with some editorial amendments, be used as the lead
paragraph. As a guide to sampling for investigation of microbiological problems, the
Working Group felt that this section was adequate. It could be strengthened by a
reference to the large number of sample units which would have to be analyzed to detect
low incidences of defectives. Perhaps this could be done by an example, for instance,
for an incidence of 1/10,000 (0.0001) there was only a probability of 0.39 (39%) of
detecting one or more defectives in 5,000 sample units.

PART B - NON SHELF-STABLE PRODUCTS

The Working Group had considerable difficulty with this procedure. After much
discussion it was assumed that this procedure was intended to be used in cases where
there had been temperature abuse and warm zones within the lot could be determined. For
such conditions, the sample of 5 cans represented a "worst possible situation", and
therefore was a biased sample. The analysis of such samples should be as complete a
microbiological profile, including pathogens, as was possible. Since the sample was
biased, a three-class acceptance plan of the type given should not be used.
Interpretation of the results was largely dependent upon other relevant information,
e.g., microbiological flora of the product, etc.

For general investigation of microbiological problems in lots of such products

the instructions and guidance given in PART A were pertinent.

Since these products were primarily dependent upon refrigeration for their
preservation, the control and recording of temperatures during storage and transportation
was most important. This fact should be dealt with in the body of the Code.
 - 13 -

The Committee agreed with the recommendation of the Working Group to relocate
sections of the preface in the body of the document.

With regard to the Working Group's suggestion to replace the word "reject" by
"retain" it was noted that "reject" was used in Section 2 and in the footnote which was
taken from the General Principles for the Establishment of Microbiological Criteria for
Foods. In the opinion of the Working Group, however, the use of "detain" was more
acceptable to many agencies and more in line with the intent of the footnote.

The Delegation of Denmark pointed out that in its opinion the observation of the
Working Group regarding temperature controls and recording during storage and
transportation was covered under provision 6.6.2.5 of the main code. The Committee
agreed that the point should be brought to the particular attention of the Codex
CoMmittee on Processed Meat and Poultry Products for examination.

The Delegation of the Republic of Argentina, in line with the statement Made at
the last session of the Codex Committee on Processed Meat and Poultry Products agreed
with the sampling procedures proposed for the microbiological examination of hermetically
sealed containers since the Draft Code of Hygienic Practice for Processed Meat and
Poultry Products (ALINORM 83/16, Appendix IV) has taken into account almost all the
observations made by the Republic of Argentina on the subject.

Argentina considered that the Code should reflect a firm guarantee that bacterial
proliferation does not result in the production of thermostable, toxins which could
persist during the treatment of products undergoing re-processing.

In addition, the microbiological limits of micro-organisms which present a health

hazard to the consumer should be quantified and indicated in the Code.

The Committee expressed its appreciation to the Working Group for its excellent
work.

CONSIDERATION OF AMENDMENT TO CODEX EUROPEAN REGIONAL STANDARD FOR NATURAL MINERAL WATERS -
SUB-SECTION 5.1 (MICROBIOLOGfCAt SPECIFICATIONS)

The Committee had decided to establish an Ad hoc Working Group under the
chairmanship of the Delegation of Switzerland to examine the proposed amendment as
contained in para 34 of ALINORM 83/19. It had been agreed that the Working Group should
make a recommendation to the Committee as regards endorsment of the amendment and
inclusion of an identical provision into the section on end-product specifications of
the Draft Code of Hygienic Practice for the Collecting, Processing and Marketing of
Natural Mineral Waters (Section VIII).

The Delegation of Switzerland pointed out that while much work had been carried
out on the 42 0 C method proposed at the previous session of this Committee, the results
had not yet been published. Futhermore, certain aspects of the methods had to undergo
more testing. The Delegation of Switzerland offered to prepare, in collaboration with
the EEC, a working paper on the matter and expressed the view that governments would be
in a position to comment on the revised proposal since the results of testing the method
developed by Dr. Schmidt-Lorenz would also be available at that time.

The Committee decided that the Swiss paper should be first submitted to the next
session of the Coordinating Committee for Europe (June 1984) and that this Committee
would examine it in the light of comments from governments and the Coordinating
Committee at its next session. It was noted that if necessary a proposal for new
specifications to replace those in para 34 of ALINORM 83/19 would be included in the
working paper.
 - 14 -

CONSIDERATION OF DRAFT CODE OF HYGIENIC PRACTICE FOR THE COLLECTING, PROCESSING AND
MARKETING OF NATURAL MINERAL WATERS AT STEP 6

The Committee had before it the above Code as contained in Appendix V to

ALINORM 83/13. The Committee was informed that the Fifteenth Session of the Commission
had advanced the Code to Step 6 of the Procedure. Due to the timing of sessions a
Circular Letter requesting comments at Step 6 had been issued only recently and
governments had, therefore, not had an opportunity to send in written documents.

The Committee decided to discuss briefly the Code and agreed that any pertinent
comments be communicated to governments for information.

The Committee agreed that an editorial amendment should be made, replacing "food"
by "natural mineral water" wherever it appeared in the Code and several typing errors be
corrected.

On the proposal of the Delegation of the Netherlands, the Committee agreed to

include in Sub-section 4.3.1 (Type of Construction) cross reference to the requirements
laid down in Sub-section 3.7 (Protection of the Extraction Areas).

The Delegation of Denmark suggested to qualify the term "screens" in

Sub-section 4.3.7 (windows) by adding "insects" to assure that those screens were suitable
for their purpose. It was noted that the provision presently contained in the Code had
been taken over from the General Principles of Food Hygiene and that the Codex Committee
on Processed Meat and Poultry Products had amended the provision to include reference to
"insect" screens.

In Sub-section 4.4.1.1 (Water gupply) it was questioned whether the Code should
allow for potable water in a factory for bottling natural mineral water. The Committee
agreed that the provision for potable water should be retained.

One delegation expressed the view that Sub-section 5.5 (Exclusion of Animals)
should be amended to prohibit the presence of all animals whether controlled or
uncontrolled to avoid contamination of the soil. The Committee recalled that this
provision had been established to permit e.g., guard dogs on the premises. The Committee
agreed that comments were needed on this matter.

The Committee noted the view of the Delegation of the United Kingdom that
Sub-section 7.3.4 (Treatment) should be deleted since natural mineral waters were not
permitted to be preserved.

Concerning Sub-section 7.8 (Processing and Production Records) the Committee

noted that many mineral waters had a shelf-life of more than two years. The Committee
decided, therefore, that no time limit should be included in this provision and deleted
the following "but unless a specific need exists they need not be kept for more than
two years".

Status of the Code

87 , The Committee decided to retain the Code as contained in Appendix IV to this

Report at Step 6.

CONSIDERATION OF PROPOSED DRAFT CODE OF HYGIENIC PRACTICE FOR (PRE-) COOKED MEALS IN
MASS CATERING AT STEP 2

88. The Committee had before it working paper CX/FH 83/5 containing the above Draft
Code and some explanatory notes thereto. As agreed to earlier in the session an Ad hoc
Working Group had examined the need for such a Code as well as the Draft itself section
by section.

Members of the Delegations of Australia, Brazil, Canada, Denmark, France, Finland,

Greece, Federal Republic of Germany, Netherlands, New Zealand, Norway, Sweden,
Switzerland, United Kingdom and United States participated at the meeting of the Working
Group which had been chaired by Mr. Van Havere of Belgium.
 - 15 -

The Chairman of the Working Group presented the following report to the
Committee:
89.

"(1) The question was raised whether such a code was justified in the light of
lack of international trade in catering. The Working Group believed that
it is one of the responsibilities of Codex to assist countries in their
domestic food hygiene, an introductory note added to the Draft Code
could clarify the reasons why such a code was justified.

Before discussing the scope of this code, the Working Group felt the need
to describe in a firm definition what it meant by "mass-catering":
"Mass-catering is the bulk preparation, portioning, storage, handling
transportation, serving etc., of prepared meals for a group of persons":

On the other hand, preparation did not only mean "cooking" in the sense of
heat treatment but also preparing salads, filet americain, etc.

After preparation the food might be handled in several different ways.

Therefore, the Working Group agreed not to list the categories in the scope.
However, it was clear that in the definitions the categories could be
retained. As consequence of a wider scope due to the new mass-catering
definition, the code was applicable to many aspects of airline catering
(international or domestic) and to many fast foods and snack bars.

Pre-packed quick frozen meals intended for retail sale were excluded
(see Committee on Quick Frozen Products).

Beside a mass-catering definition, the term "catering establishment" would

be defined as a restaurant, canteen or other establishement where food is
prepared and served for delivery to the ultimate consumer". Thus "serving
rooms" were also included in the code.

Some delegations mentioned cases where food was prepared and served in the
same room. Others stipulatcd that serving room could even include a hospital
room or the open air (barbecues, wedding parties...).

The term "cooked ready-to-eat" should be replaced by "cooked for immediate

consumption". The temperature of 75°C was considered as too high. A
temperature of 600 -65 °C was sufficient.

Referring to the other sections (Section III up to VII) the General

Principles of Hygiene (G.P.) were mostly applicable. The side-lined
sentences were changes or additions to the G.P. Although members of the
Working Group did not agree with all the draft proposals, it was recognized
that certain activities in catering had to be considered as critical points.
Therefore, the procedure of control of critical points should be applied
(HACCP note by Dr. Bryan).

Some of these possible critical points were:

4.4 Water supply: the Danish Delegation referred to the re-draft text of the
Code of Hygienic Practice for Processed Meat Products.

4.4.3 Refrigeration: Especially the problem of "undercapacity of equipment' could

lead to critical situations. Chilling and freezing will be split into two
separate items.
on
5.2 Cleaniils and disinfection (see also the extensive re-drafted GP text
cleaning and disinfection).

7.1.5 Separate storage of raw and cooked materials (question of off-flavour and
Cross contamination).

7.4.1 Keeping the food at temperature of 60°C. Th P main point was that 'heated food
should never be stored between 7 0C and 60°C. End-product Specification could
 - 16-

- 7.4.1 (cont.)
be justified by a HACCP - note. As a matter of information, France had
obligatory microbiological specifications for prepared meals. U.K. had
some guidelines. They would be sent to the Committee for information.

(9) Finally, the Group agreed to re-draft the text before sending for government
comments at Step 3."

The Committee congratulated Dr. Van Havere on the excellent paper and expressed
its appreciation to the Working Group for having thoroughly examined the Draft Code. The
Committee agreed with the conclusions arrived at by the Working Group.

Several delegations wished to be informed whether a code which dealt with

products moving largely domestically only was within the remit of this Committee. The
Committee noted that this Committee should, according to its terms of reference, deal
with all matters related to hygiene and that one of the major aims of the Codex
Alimentarius Commission was to protect the health of the consumer. The Committee agreed
that it was well justified to continue with the work on the code and an introductory note
was needed.

The Committee was informed that the European Regional Office of WHO had published
a book on Mass-Catering (Author Dr. R.H.G. Charles) as a WHO Regional Publication,
European Series No. 15, which might be of interest to delegates dealing with that matter,
as it described areas where mass-catering could involve problems.

The Delegation of the Netherlands, inquired whether airline meals were also
excluded from the Code. The question was also raised whether the Code was relevant to
railroad meals. The Committee decided that airline as well as railroad meals were
covered by the Code. The Committee noted the WHO publication on Aviation Catering.

The Committee agreed with the Delegation of New Zealnd that the definition of
catering establishment in para 6 of the Working Group Report should be amended as follows:
It
is prepared and/or served...". It was also agreed to substitute "area" for "room"
in the same paragraph.

To clarify further the scope of the Code, the Committee discussed whether
pre-cooked, frozen or chilled meals as such should be included. (See also para 89(5)).
Attention was drawn to the large retail trade in such meals. It was noted that this type
of meal was prepared in factories whereas food for mass-catering was More often prepared
in large individual kitchens. Pre-cooked meals for retail sale required also different
forms of packaging, labelling and storage instructions. The Committee agreed that they
fell under the terms of reference of the Codex Alimentarius/UNECE Group of Experts on
Quick Frozen Foods and were covered by the Code on Handling of Quick Frozen Foods.

The Committee also agreed that the period of time between preparation and
consumption of meals for mass-catering was usually brief but this did not require the
introduction of a time limit into the Code.

The Committee accepted the kind offer of the delegation of Belgium to re-draft
the Code, having regard to the conclusions'. of the Working Group and the additional
comments in paras 91-96 above.

Status of the Code

The Committee advanced the Code to Step 3 of the Procedure and noted that the
revised text of the Code would be sent out for comments at Step 3.
 - 17 -

REVISION OF THE AMENDED INTERNATIONAL CODE OF HYGIENIC PRACTICE FOR EGG PRODUCTS TO
INCLUDE MELANGE

The Committee had before it the above Code (Ref. No. CAC/RCP 15-1976) and the
proposed amendments in working paper CX/FH 83/6.

The paper was introduced by Dr. K. Buchli of the Netherlands who pointed out that
this revision had been initiated in order to accommodate the requirements of the Expert
Group on Egg Products of UN/ECE. Since the term "melange" for egg products was not
much used in international trade and even by the ECE Group, the author proposed that the
above Code be amended to include a definition and provisions for egg products. These
proposed amendments dealt also with (a) handling of cracked eggs on the farm as well as
at the packing station; and (b) the centrifuging of egg products.

Definition of Egg Products (Section 2)

101 The Committee agreed with the definition of "egg products" as contained in
CX/FH 83/6.

Handling Cracked Eggs on the Farm (Section 3)

The Delegation of the United Kingdom proposed to clarify the meaning of the
heading by including the term "in shell". This was agreed.

Sub-section 3.2.9

There was an extensive discussion on the type of containers to be used for the
collection of the egg product. (Stainless steel, maximum 15 litres volume). The
Delegation of Denmark indicated, that in their country, plastic bags in outer cartons
were used as single-use containers. Other delegations stated that suitable plastic
containers were used and it was not feasible to stipulate requirements for volume of
those containers. The volume of containers would vary according to farm size. The
Committee agreed to delete the following part of the sentence "of stainless steel with
a volume of not more than ( ) litres". The Committee further agreed to prescribe that
the containers be fitted with suitable closures.

The Delegation of Switzerland questioned the need for disinfection since the use
of chemical disinfectants might lead to neglecting the cleaning operations. Furthermore,
the product would be subject to microbiological contamination during the egg breaking and
consequently Sub-section 4.4.4.5.1 required these products to be pasteurized. The
Committee recalled that it was one of the principles of food hygiene to keep the
microbial load as low as possible at all times. The Committee also noted that
disinfection included chemical as well as physical methods. The Committee decided to
retain the requirement for disinfection, if necessary. The Committee also agreed that
the room for breaking eggs on the farm should be subject to the same requirements as at
an egg processing plant and decided to add an appropriate reference to Sub-section 4.1.1.
,Several delegations indicated that in their countries no egg breaking operation was
permitted to be carried out at farm level.

Sub-section 3.2.10

The Committee agreed that Sub-section 3.2.10 should preceed Sub-section 3.2.9.

Sub-section 3.2.12

The Delegation of France expressed concern that the provision as written could be
interpreted in such a way that egg ptoducts had to be transported in frozen form, which
was not acceptable. The Committee noted that egg products were not in a frozen state
at a temperature of 00C but agreed to clarify the provision by introducing a temperature
of 0-7°C.
 - 18 -

Section 4 Plant, Facilities and Operation Requirements

Sub-section 4.4.4.1

The Committee noted that an additional provision had been proposed for inclusion
in this Sub-section to deal with centrifuging after breaking to remove the last part of
the egg albumen from the egg shells. It was noted that this process should be permitted
only for eggs washed before breaking, i.e., not for cracked egg which could not be
washed. The Committee agreed that the text as contained in CX/FH 83/6 was suitable.

Sub-section 4.4.4.5.1

The Committee noted this provision required pasteurization in the plant of egg
products received from farms or packing stations and agreed that such a provision would
safeguard the hygienic quality of egg products which had not been prepared at the plant
and should therefore be included in the revised code. The Delegation of. the Federal
Republic of Germany suggested to allow also for other methods to prevent multiplication
of microbes in egg products such as fermentation or addition of salt or sugar.

The Committee agreed that the Secretariat be asked to review the numbering of the
proposed additional sections. The Committee also decided that government comments should
be requested only on the additional sections (amendments) to the Code of Hygienic
Practice for Egg Products (CAC/RCP 15-1976) as contained in Appendix V to this Report.

Status of the Amendments

The Committee decided to advance the above amendments to Step 3 of the Procedure.

CONSIDERATION OF PROPOSALS FOR AMENDMENT OF SECTION V - END-PRODUCT SPECIFICATIONS OF

THE RECOMMENDED INTERNATIONAL CODE OF HYGIENIC PRACTICE FOR DESICCATED COCONUT
(CAC/RCP . 4-1969)

The WHO Representative introduced for consideration by the Committee the

government comments on microbiological specifications for desiccated coconut
(document CX/FH 83/7). He recalled that this product was reported as a source of food-
borne diseases, particularly Salmonellosis and that elaboration of microbiological
specifications for desiccated coconut could be of interest for many developing countries
as well as for other countries which imported this product.

Written comments on the subject had been received from the USA, Thailand, Sweden,
Poland, Netherlands and Uruguay. All of them except the Netherlands, included a test for
Salmonellae. However, some countries also performed tests for coliforms (Poland, Uruguay),
moulds and mesophilic aerobic bacteria (Hungary).

The Delegations from Netherlands, Canada, Belgium, FRG and UK expressed concern
with regard to the problem of aflatoxin in desiccated coconuts. The Committee agreed to
include a general statement on public health hazard of mycotoxins in desiccated coconut.
No concrete limits were proposed to be included into the end-product specifications.

The Committee considered the recommendations of the ICMSF on microbiological

specifications for tree and ground nuts and found them useful to some extent for
desiccated coconut. In this connection, the Representative of the ICMSF madb a proposal
to include in the microbiological end-product specification for desiccated coconuts as
such, only salmonellae which should not be isolated from 10 samples of the product (the
size of the sample is 25 grams). This proposal was adopted by the Committee (n = 10,
c = 0).

The Committee decided that the above Code should be amended as follows:

"SECTION V - END-PRODUCT SPECIFICATIONS

Substitute the following text for Section B:

(a) Salmonellae: Salmonellae organisms should not be recovered from any of the
25 grams samples examined when the test is carried out according to the method
described (n = 10, c = 0, m = 0). Appropriate method: ISO 3565 - 1975.
 - 19 -

(h) The product should not contain any substances originating from micro-organisms,
particularly mycotoxins, in amounts which exceed the tolerances or criteria
established by the official agency having jurisdiction."

Status of the Amendment

115. The Committee advanced the above amendment to Step 3 of the Procedure subject to
approval by the Executive Committee acting on behalf of the Commission.

MICROBIOLOGICAL CRITERIA FOR PRE-COOKED FROZEN SHRIMPS AND PRAWNS

The Representative of WHO informed the Committee of the results of the Working
Group on Microbiological Criteria for Pre-cooked Frozen Shrimps and Prawns (see documents
CX/FH 83/8 and CX/FH 83/2) which had met during the Fifteenth Session of the Codex
Committee on Fish and Fishery Products. In particular, he drew attention to the
discussion on whether the microbiological criteria elaborated by the above Working Group
were microbiological guidelines or end-product specifications.

The Delegation of the Netherlands stressed in this context that the majority of
the Working Group had proposed the microbiological criteria as guidelines and not
end-product specifications. After a three-year period of testing there would be
sufficient information available to decide whether to introduce end-product
specifications.

The Representative of MHO reminded the Committee that the question of the
establishment of microbiological guidelines for the purposes of the FAO/WHO Food
Standards Programme was thoroughly considered at the Eighteenth Session of the Codex
Committee on Food Hygiene (ALINORM 83/13, para 114) which recommended that "the
manufacturer should define his own sampling plan for microbiological purposes and
establish limits that will ensure that limits in microbiological end-product
specifications will be as a minimum adhered to and preferably bettered". In his opinion,
it would therfore be a logical sequence to elaborate, first of all, end-product
specifications which would help the manufacturer define his own sampling plan, thus
producing the food in accordance with existing codes of hygienic practice.

The Delegations of the UK, USA, France, Canada and Australia expressed a preference
for the proposed microbiological criteria as end-product specifications to be attached to
the appropriate Code of Hygienic Practice. The Committee agreed with this point of view.

The attention of the Committee was drawn to the fact that the Delegation of
Thailand which participated in the above Working Group noted that if the microbiological
criteria were considered by the Food Hygiene Committee as an end-product specification the
figure for Staphylococcus aureus would be 2 instead of 1. The Committee accepted this
proposal. The Delegation of Denmark proposed to include enterococci for control of
production hygiene.

The Delegation of France informed the Committee that existing provisions in

national regulations distinguished between whole pre-cooked frozen shrimps and peeled
pre-cooked frozen shrimps. Tests for the determination of Staphylococcus were only made
on peeled shrimps because the extra handling increased the risk of contamination. The
Delegation of France would also prefer to include a criterion for E. coli as a good
indicator of faecal contamination rather than make reference to Enterococci.

The Secretariat referred to the discussion on this subject by the Working Group
as well as to the recommendations of the Second Joint FAO/WHO Expert Committee which
had concluded that "the inclusion of a microbiological criterion for E. cou i offered no
added benefit in deciding compliance with the Code of Practice". The Committee decided
to not include E. coli or enterococci in the proposed end-product specifications and
recommended the following microbial limits:
Mesophilic aerobic bacteria
n = 5, c = 2, m = 10 5 , M = 10 6

* Method to be added later.

 - 20-

Staphylococcus aureus
n = 5, c = 2, m = 500, M = 5000
*
Salmonella
n = 5, c = 9, m = O.

The Committee agreed that these criteria should be circulated to governments at

Step 3 of the Procedure with a view to their incorporation as end-product specification
into the Code of Hygienic Practice for Shrimps and Prawns.

Microbiological Safety of Irradiated Foods

The Committee had before it a report of the Board of the International Committee
on Food Microbiology and Hygiene (ICFMH) of the International Union of Microbiological
Societies (IUMS). (see Appendix VI).

The Board had met in Copenhagen in 1982 at the request of FAO and WHO to consider
the above subject. These organizations hoped that irradiation of food, by reducing
contamination with pathogenic micro-organisms and food loss from spoilage, would
contribute to achieving health for all by the year 2000 by improving both food safety
and nutrition, but wished to be assured that irradiation of food did not create a health
hazard.

The Committee recalled that the Codex Committee on Food Additives had, in
co-operation with the Federal Research Centre for Nutrition in Karlsruhe and the Joint
FAO/WHO/IAEA Expert Committee on the Wholesomeness of Irradiated Food (JECFI)
elaborated a Codex Standard for Irradiated Foods. This Standard had come before this
Committee at its 16th Session, at which time some concerns were expressed on the possible
effects of sub-lethal doses of irradiation on the microbial flora of treated foods and
on food-borne pathogens and the possible consequences to public health.

The Board had considered these views of the Committee and had concluded that:

"after analyzing the scientific knowledge to date, it was satisfied that there was
no cause for concern. Irradiation induced genetic mutation of pathogens in food
did not create an increased hazard to health and in the Board's opinion there
would be no qualitative difference between the kind of mutation indiced by
ionizing irradiation and that induced by any other pasteurization/partial
preservation methods such as heat treatment or vacuum drying.

Modern food handling technology was adequate to control problems created by

suppression of spoilage micro-organisms. Food irradiation was an important
addition to the methods of control of food-borne pathogens and did not present
any additional hazards to health provided it is not used as a substitute for food
manufacturing practice in Codes of Practice".

The Committee expressed its satisfaction with the above conclusions and its
appreciation to those who had participated in the Meeting of the Board and the
preparation of its report.

The Delegation of Norway referred to the Committee's earlier endorsement of the

hygiene provision of the revised Codex General Standard for Irradiated Foods (see
para 21) and in the light of the Board's conclusions questioned whether Sub-section 3.2
which read:

"Any relevant national public health requirement affecting microbiological

safety and nutritional adequacy applicable in the country in which the food is
sold should be observed".

should be retained.

* Method to be added later.

 - 21 -

The Delegation pointed out that this provision did not appear in any other Codex
Standard and could be interpreted as applying specifically to irradiated foods.

The Committee did not think that the provision implied that there was any
specific hazard associated with irradiation and made no change to the text.

CONSIDERATION OF PRIORITY FOODS FOR FUTURE WORK ON MICROBIOLOGICAL CRITERIA

The Representative of WHO presented the Committee with some proposals for work on
microbiological criteria listed by the Second FAO/WHO Expert Consultation on
microbiological specifications for foods (working document CX/FH 83/10) as well as by
the International Union of Microbiological Societies/Committee on Food Microbiology and
Hygiene. Among food items mentioned were: spices, smoked fish, fresh cheese, pre-cooked
chilled meat, chocolate and canned foods.

The Delegation of Australia stressed that further microbiological criteria should

be elaborated for those foods, the production of which had been already covered by Codes
of Hygienic Practice. Moreover, some work could be done on the revision of existing
microbiological criteria which had been already incorporated in the Codes. The Committee
referred to the earlier discussion on the necessity of microbiological criteria for
canned food, and decided that this should be given priority. (see para 58).

The Delegation of the USA made a suggestion for elaboration of microbiological

criteria for waters other than mineral waters, dried fishery and meat products, and soy
products and agreed to prepare a background paper on these subjects for consideration by
the Committee at its next session.

HISTAMINE (SCOMBRIDAE) POISONING

The WHO Representative informed the Committee that he had made a request for
information on histamine poisoning at the Fifteenth Session of the Codex Committee on
Fish and Fishery Products (CCFFP). (ALINORM 83/18, paras 284-286). Many countries
replied to the Circular Letter issued by the Secretariat and supplied data on the
incidence of histamine poisoning, on control measures, and on existing regulatory limits
for histamine in foods. These data were collated in the comprehensive document
"Monograph on histamine poisoning" (CX/FH 83/11) prepared by Dr. S.L. Taylor.

Dr. Taylor presented this document to the Committee which noted that the monograph
contained valuable information on the epidemiology of histamine poisoning in foods
identified, as sources of food-borne disease, on methodology for detection of histamine,
regulatory limits for histamine in foods, as well as a comprehensive list of references.
Delegations from Canada, Denmark, Netherlands, USA, UK, FRG, Norway, New Zealand and
Japan commented on the document. In particular it was recognized that it was difficult
to assess the full extent of histamine poisoning in the world since good statistics on
its incidence did not exist. For a variety of reasons, incidents of histamine poisoning
often go unreported.

Knowledge with regard to the formation of histamine in such foods as cheese and
wine which had been reported as causing histamine poisoning was very limited. There
were also difficulties because methodology for the detection of histamine varied greatly
in different countries and required standardization.

Most countries did not have firm regulatory limits on the permissible levels of
histamine in foods, which reflected an understandable degree of uncertainty with regard
to the threshold toxic dose for histamine.

The Committee noted that in the .fishing industry, bacteria). histamine produption.
could often be effectively controlled in some cases 'and for sortespecies by the use of
low storage temperature; the Delegation of Japan informed the Committee that the
introduction of a temperature of 5 0C in its fishing industry had significantly decreased
the cases of histamine poisoning. However, in Norway it had been found that the use .
of low storage temperatures did not always seem to effectively prevent the accumulation
of.histamine in fish products especially fermented fish products. When good manufacturing
practices were followed, histamine could still sometimes develop in fermented herring
 - 22-

products of good quality, even at temperatures as low as 10°C. The use of lower
temperatures might prevent the development of the desired flavour characteristics. It
was pointed out that such fermented products, judged to be of high organoleptic quality
have been a long-standing traditional food without apparently causing histamine poisonIng,
even though present knowledge suggested that they might have contained histamine.

The Delegation of the USA pointed out that for many species, particularly in the
tropical and sub-tropical regions the conditions required for bacterial histamine
formation was not known. Thus advice, such as the routine application of the Codes of
Practice for temperature control of fish and fishery products as a preventive measure
might be incorrect and possibly misleading.

Taking into account the increasing incidence of histamine poisoning and the lack
of knowledge in this field in many countries the Committee requested WHO to issue the
monograph on histamine poisoning as a FAO/WHO document for world-wide distribution.

The Committee recognized that at the present time it would be too premature to
elaborate any internationally acceptable regulatory limits within the framework of the
FAO/WHO Food Standards Programme on histamine in foods as well as to make recommendations
on how to prevent and control such intoxications.

Additional research in this field with regard to the mechanism of histamine

formation in different foods as well as further work on epidemiology of this disease,
development of safe and accurate methodology for detection of histamine on foods,
elaboration of preventive and control measures and regulatory limits for histamine in
foods were needed.

The Committee agreed that before the monograph was published Dr. Taylor should
incorporate further information supplied by countries and suggest research lines for
future action.

The Committee was of the opinion that fish technologists should have an
opportunity to discuss the incidence of histamine in fish and fishery products and
agreed to bring this discussion and Dr. Taylor's background paper to the attention of
the Codex Committee on Fish and Fishery Products.

DEFINITION OF LOT" IN CODEX TEXTS

The Committee has before it a working document entitled "Consideration of the

Definitions of the term "lot" used in Codex Standards and Codes of Practice" (CX/FH 83/12)
and the Report of an Ad hoc Working Group that had been established to examine the above
document where appropriate.

The Chairman of the Working Group, Dr. W.A. Royal of New Zealand recalled that
the Fifteenth Session of the Commission had adopted a Code of Hygienic Practice for Dried
Milk and Annex I thereto concerning microbiological criteria for dried milk products.
Both documents contained definitions of "lot" which, however, were not identical. It
had recommended to determine whether one definition only of lot could be elaborated for
use in Codex documents where appropriate.

The Chairman of the Working Group pointed out that the working paper mentioned
above contained an outline of Codex provisions for lot and lot identification as well
as several proposed definitions and recommendations concerning action by this and
other Codex Committees.
 - 23-

147. The Chairman of the Working Group presented the following report by the Working
Group which had consisted of Delegates from Norway (Rapporteur), Australia, Canada,
Netherlands, Switzerland, UK and USA:

"The approach adopted by the Working Group was to review and comment on the
summary of recommendations contained in the working document CX/FH 83/12, page 6,
para 38".

148. Taking each recommendation in turn, the conclusions of the Working Group were
as follows:

Paragraph 14: "Consideration be given to the inclusion of a statement in the Code

of General Principles of Food Hygiene to the effect that the Code is the primary
point of reference for definitions and general principles, and that all special
codes contain elaboration on the general principles". This principle was
accepted by the Working Group.

Paragraph 18: "A standard text for "lot identification" is required". The
recommendation was accepted and the text inthe revised draft of the general
labelling standard was adopted for recommendation to the Committee. This text
reads: "Each container shall be embossed or otherwise permanently marked in
code or in clear to identify the producing factory and the lot".

Paragraph 21: "A common definition for "lot" is appropriate to the Code of
General Principles of Food Hygiene and the General Standard for Food Labelling".

The Working Group agreed: that a common definition was possible and proposed the
following text: "A lot means a definite quantity of a commodity produced under
essentially the same conditions". The Working Group recognized that this broad
definition may need to be expanded and clarified in relation to particular
products.

Paragraph 26: "Consideration be given to establishing a uniform style and

approach to citation of sampling plans and lot acceptance provisions". This
principle was endorsed and it was recommended that the proposal be taken MD by
Codex Committee on Methods of Analysis and Sampling and the Codex Commodity
Committees.

Paragraph 36: "Amplification of general definitions to cover the requirements of

individual commodities or interest groups should be accomodated in the "lot
inspection" and "lot acceptance" criteria where they are specially needed". In
the light of the recognition by the Working Group that the definition of lot may
need to be expanded for particular products (Ref. (c) above), it was also
recognized that such specification/clarification may have to be included as part
of the lot inspection and lot acceptance criteria in the specific standards".

149. The Committee joined the Working Group in expressing its thanks for the excellent
paper and congratulated the Working Group on its work.

The Committee agreed with the conclusions and recommendations of the Working Group
as set forth in para 148 (a) to (e) above.

150. The Committee agreed that the definitions for lot in the Code of Hygienic
Practice for Dried Milk and Annex I thereto needed to be re-examined in the light of the
decisions made by the Committee under para 148 (c) and (g) above. It was agreed that
expertise for such a task was available in the Joint FAO/WHO Committee of Government
Experts on the Code of Principle concerning Milk and Milk Products which would meet once
more. The Committee decided to refer the matter to the "Milk Committee".
 - 24-

The Committee agreed that the Secretariat should be required to initiate the
amendment of the General Principles of Food Hygiene in order to (i) include into the
Code the statement required under para 148 (a); and (ii) to amend the definition of
lot under para 148 (c), and the provision for lot identification. Sub-section 7.5.4).

The Committee further agreed that the definition of lot and the provision for
lot identification should also be amended in other Codes as appropriate and that the
Secretariat should take the necessary action.

OTHER BUSINESS

Sub-section 3.4.9 of Revision of the Recommended International Code of Hygienic Practice

for Processed Meat and Poultry Products (para 115 of ALINORM 83/16)

The Delegation of Denmark drew attention to a discussion on the requirements for

walls and floors (Sub-section 3.4.9) of the above Code at the 12th Session of the
Committee on Processed Meat and Poultry Products (para 115 of ALINORM 83/16). The
requirement that walls and floors should be of non-toxic material was questioned, since
they did not usually come into contact with the food. If there was a danger of
contamination the same requirements should also apply to the other parts of the building
such as ceiling and windows. The Committee had made no change since the text had been
taken from the General Principles of Food Hygiene, but requested advice from this
Committee.

The Committee agreed that indeed there could be undesirable contamina:tion from
toxic vapours given off by certain construction materials. The Committee also agreed
that the matter of avoiding toxic materials was not limited to walls and floors and
decided, therefore, to propose amending sub-section 4.3.1 of the General Principles of
Food Hygiene, adding the following sentence: "All construction materials should be such,
that when construction is completed, they do not emit toxic vapours". The Secretariat
was requested to take appropriate action.

The Committee expressed its appreciation to the Codex Committee on Processed

Meat and Poultry Products for having brought up the matter and recommended also that
the Committee adopt the text outlined in para 154 above.

Hygienic Requirements for Water in Airplanes

The Delegation of the Netherlands informed the Committee of problems which arose
in connection with obtaining and maintaining potable water of good quality in airplanes.
Complaints had been noted that in some airports the available potable water supply for
planes was not in conformity with microbiological specifications for potable water.
Difficulties had been experienced in cleaning up the pipe-system in airplanes after such
unsuitable water had been used.

The Delegation of the Netherlands also stated that substances might have to be
added to drinking water for airplanes which were normally not allowed in drinking
water. The Delegation therefore sought the views of the Committee on whether it should
deal with this matter.

The Committee noted that WHO had developed guidelines for Drinking Water'
(previously International Standards for Drinking Water) and had also published a Guide
to Hygiene in Aviation. The Committee concluded that it would therefore be appropriate
for WHO to provide guidance on this particular problem.

Statement by the Delegation of Argentina

The Delegation of Argentina stated that due to the late arrival of several
documents it had not been able to obtain advice from the authorities concerned on a
number of agenda items and had, therefore, not been in a position to participate in the
discussion of those items. The Delegation of Argentina wished to record its reservation.
 - 25-

Several other delegations stated that they had not been able to obtain the
necessary comments within their countries since some of the documents had not been
available in time.

The Committee noted that every effort was made to distribute the documents in
good time before the meeting. To achieve this purpose governments were invited to
submit their comments within the deadline indicated in the Circular Letters.

Date and Place of Next Session

The Committee noted that its 20th Session would take place in October 1984. The
Droposed date was October 1-5, 1984 fixed by agreement between the Codex Secretariat and
the United States Government.
•
The Delegation of New Zealand noted with regret that the next sessions of the
Codex Committees on Food Hygiene and Food Labelling were not to be held in consecutive
weeks as in previous years. This separation of meetings caused difficulties for those
countries having to travel long distances to attend separated meetings with separate
delegates.
 - 26-

ALINORM 85/13
APPENDIX I
LIST OF PARTICIPANTS
LISTE DES PARTICIPANTS
LISTA DE PARTICIPANTES

Chairman

R.B. Read, Jr.

Director
Division of Microbiology
Bureau of Foods
Food and Administration
Department of Health, Education and Welfare.
200 C Street, S.W.
Washington, D.C., 20204, U.S.A.

MEMBER COUNTRIES

AFGHANISTAN (DEMOCRATIC REPUBLIC OF) AUSTRALIA (CONT.)

AFGANISTAN (REPUBLICA DEMOCRÁTICA DEL) AUSTRALIE (CONT.)

Delegate Dr. Edward J. Humphries

Veterinary Attaché
Mr. Mohammad Haider Refq Embassy of Australia
Second Secretary 1601 Massachusetts Ave., N.W.
Embassy of thé Democratic Republic Washington, D.C., 20036
of Afghanistan U.S.A.
2341 Wyoming Ave., N.W.
Washington, D.C., 20008 BELGIUM
U.S.A. BELGIQUE
BELGICA
ARGENTINA
ARGENTINE Delegate

Head of Delegation Mr. R. Van Havere

Food Inspector
Mr. Robert Jorge Frasisti Ministry of Public Health
Embassy of the Republic of Argentina Brussels
Minister Counselor for Economic and
Commercial Affairs BRAZIL
1600 N.H. Ave., N.W. BRESIL
Washington, D.C., 20009 BRASIL
U.S.A.
Delegates
Delegate
Dr. Adalberto Bezerra de Alcantara
Mrs. Liliana Arauz de Alfaro Deputy Secretary
Commercial Secretary Animal Products Inspection Service
Embassy of the Republic of Argentina National Livestock Protection
1600 N.H. Ave., N.W. Department - SNAD
Washington, D.C., 20009 Ministry of Agriculture
U.S.A. Rio de Janeiro

AUSTRALIA Ms Leonilda Alves Correa

AUSTRALIE Secretary
Head of the Commercial Section
Delegates Brazilian Embassy
3006 Massachusetts Ave., N.W.
Mr. John H.B. Christian Washington, D.C., 20008
Chief U.S.A.
CS IRO
Division of Food Research
P.O. Box 52
N.S.W. 2113
Australia
 - 27-
ALINORM 85/13
APPENDIX I

BRAZIL (CONT.) CANADA (CONT.). _

BRESIL
BRASIL Mr. Adrian Gervais
Chief
Mx. Alberto Vierira Technical Services Division
Technical Assistant Inspection and Technology Branch
Commercial Section Fisheries and Oceans
Brazilian Embassy Ottawa, Ontario K1A 0E6
3006 Massachusetts Ave., N.W.
Washington, D.C., 20008 Dr. R. Moir
U.S.A. Associate Director
Scientific and Technical Programs
Ms Sonia Vitoria Meat Hygiene Division
Brazilian Embassy Food Production and Inspection Branch
3006 Massachusetts Ave., N.W. Agriculture Canada
Washington, D.C., 20008 Ottawa, Ontario K1A 0Y9
U.S.A.
Dr. F. Tittiger
Observer Chief
Meat Safety
Dr. Leo Bick Meat Hygiene Division
Director Food Production and Inspection Branch
Associagao Brasileira das Industrias Agriculture Canada
de Alimentagao (ALICA) Ottawa, Ontario K1A 0Y9
Avenida 9 de Julho 3452
Sao Paulo, SP Brasil Mr. John F. Riou
Director
CANADA Bureau of Field Operations
Health Protection Branch
Head of Delegation Health and Welfare Canada
Ottawa, Ontario K1A OL2
Mr. I.E. Erdman
Chief DENMARK
Evaluation Division DANEMARK
Bureau of Microbial Hazards DINAMARCA
Health Protection Branch
Health and Welfare Canada Delegate
Ottawa, Ontario K1A 0L2 Mr. Kaj Haaning
Senior Veterinary Officer
Delegates Veterinary Services Laboratory
Postbox 93
Dr. B.E. Brown DK 4100 Ringsted
Scientific Evaluator
Evaluation Division ECUADOR
Bureau of Microbial Hazards EQUATEUR
Health Protection Branch ECUADOR
Health and Welfare Canada
Ottawa, Ontario K1A OL2 Delegate

Dr. D.S. Clark Ms Teresa Nuques de Guzman

Director Jefe Dpto Microbiology Sanitaria
Bureau of Microbial Hazards National Institute of Hygiene
Health Protection Branch Leopoldo Izquieta Perez
Health and Welfare Canada Guayaquil
Ottawa, Ontario, K1A 0L2

Ms K. Miedzybrodzka
Project Officer
Program Development and
Evaluation Division
Field Operation Directorate
Health Protection Branch
Health and Welfare Canada
Ottawa, Ontario K1A OL2
ALINORM 85/13 - 28 -
APPENDIX I

FINLAND GREECE
'FINLANDE GRECE -
FINLANDIA GRECIA
Head of Delegation Delegates
Dr. Jorma Himn Ms Angelique Assimakopoulos
Head of the Department of Food Hygiene Laboratoire Général de Chimie de l'Etat
National Veterinary Institute 16 rue An. Tsoha
Helsinki Athènes 602
Delegates Mr. John Papadakis
Professeur de l'Haute Ecole d'hygiène
Dr. Pekka Pakkala d'Athènes
Chief Inspector Av. Alexandras
National Board of Health Athènes 602
Helsinki 00530 53
INDIA
Dr. Erkki Petaja INDE
Director of Customs Laboratory
P.O. Box 512 Delegates
00101 Helsinki 10
Mr. D.N. Rao
FRANCE Chairman
FRANCIA The Marine Products
Export Development Authority
Delegates Ministry of Commerce
Cochin
Professor Leclerc Henri
Directeur de l'Unité 146 INSERM Mr. M. P. Haran
Secretariat d'Etat de la Santé B139 Resident Director
Villeneuve d'Arcq The Marine Products
59651 Cedex Export Development Authority
New York
Ms Poirier Danielle
Vétérinaire inspecteur JAPAN
Ministère de l'Agriculture JAPON
Directeur de la Qualité
Service Vétérinaire d'hygiène alimentaire Delegates
44-46 Boulevard de Grenell
75015 Paris D.V.M. Kunio Morita
Technical Officer
Mr. Pierre Veit Veterinary Sanitation Division
Inspecteur de la Répression des fraudes Environmental Health Bureau
et du contróle de la Qualité Ministry of Health and Welfare
Secretariat d'Etat chargé de la Tokyo
consommation
Direction de la Consommation et de la Mr. Tsutomu Nakamura
Répression des fraudes Technical Adviser
13 rue St. Georges Japan Milk Industry Association
75009 Paris Tokyo
GERMANY (FED.REP. OF) Mr. Tohur Tomita
ALLEMAGNE (REP.FED.) Technical Adviser
ALEMANIA (REP. FED.) Japan Milk Industry Association
Tokyo
Delegate
Mr. Norihiko Matsuda
Dr. Paul Teufel Assistant Director
Wissenschaftlicher Angestellter Research Laboratory
Bundesgesundheitsamt Japan Canner Association
Postfach 3300 13 Tokyo
D-1000 Berlin 33
 - 29-

ALINORM 85/13
APPENDIX I

JAPAN (CONT.) NORWAY

JAPON NORVEGE
NORUEGA
Mr. Masahiko Fukuda
Technical Adviser Delegates
The Japan Soft Drink Bottler's
Association Mr. Knut Framstad
Tokyo Directorate of Health
P.O. Box 8128 Dep.
MEXICO Oslo 1
MEXIQUE
Mr. John Race
Delegate Norwegian Codex Alimentarius Committee
P.O. Box 8139 Dep.
Sr. Alfonso Vizcarra Quinonez Oslo 1
Secretary Tecnico del Comite de
Normas Park Productos Agropecuarios Ms Marianne Christie
Secretaria de Agricultural The National Quality Control Authority
Mexico City for Processed Fruits and Vegetables
Ministry of Agriculture
NETHERLANDS Gladengvn 3 B
PAYS-BAS Oslo 6
PAISES BAJOS
Mr. P. Haram
Head of Delegation Head of . Division
Ministry of Fisheries
Mr. K. Blichli P.O. Box 8118 Dep.
Ministry of Welfare Oslo 1
Health and Cultural Affairs
Leidschendam Mr. R. Jgirgense
Director
Delegate The Official Norwegian Quality Control
Institute for Canned Fish Products
Mr. J.B.G. Samson P.O. Box 329
First Secretary (Agriculture) Stavanger 4001
Royal Netherlands Embassy
4200 Linnean Avenue, N.W. Mr. H. Blokhus
Washington, D.C. 20008 Chief Inspector
U.S.A. Directorate of Fisheries
P.O. Box 185
NEW ZEALAND Bergen 5001
NOUVELLE-ZELANDE
NUEVA ZELANDIA Mr. J. Gjerde
Head of Section
Head of Delegation Directorate of Fisheries
P.O. Box 185
Dr. W.A. Royal Bergen 5001
Director
Meat Division SENEGAL (REP.)
Ministry of Agriculture and Fisheries
Private Bag Delegate
Wellington
Dr. Mame Thierno Aby Sy
Mrs. M.J. Riordan Chief Medical Officer
Food Technologist Food and Applied Nutrition Division
Public Health Division Chief of the Technical Secretariat of
Department of Health the Codex Alimentarius National
P.O. Box 5013 Committee
Wellington Ministry of Health
Dakar
 - 30-
ALINORM 85/13
APPENDIX I

SWEDEN UNITED KINGDOM (CONT.)

SUEDE
SUECIA Dr. J.E.L. Corry
Senior Scientific Officer
Delegate Food Science Division
Professor Torsten Nilsson Ministry of Agriculture, Fisheries and
Head of Hygiene Department Food
The National Food Administration 65 Ronney Street
Uppsala S-75126 London SW1P 3RD

SWITZERLAND Dr. A.C. Band-Parker

SUISSE Scientific Adviser
SUIZA Colworth House
Sharebrook
Head of Delegation Bedford MX44 1LQ

Dr. H. Illi Mr. R.H. Thorpe

Section of Bacteriology Head of Microbiology Department
Federal Office of Public Health Campden Food Preservation Research
Berne CH-3008 Association
Chipping Campden
Delegate Gloucestershire GL55 6LD

Dr. J.C. de Man UNITED STATES OF AMERICA

P.O. Box 88 ETATS-UNIS D'AMERIQUE
1814 La Tour-de-Peilz ESTADOS UNIDOS DE AMERICA

TUNISIA Representative
TUNISIE
TUNEZ Dr. George J. Jackson
Chief
Delegate Food and Cosmetics Microbiology Branch
Division of Microbiology
Dr. Zmerli Raouf Food and Drug Administration
Vaérinaire 200C Street, S.W.
Institut -ational de normalisation et Washington, D.C., 20204
de propriété industrielle (I.N.NOR.P.I.)
10 bis rue Ibn Jazar (Lafayette) Alternate Representative
Tunis
Dr. Robert W. Weik
TURKEY Bureau of Foods
TURQUIE Food and Drug Administration
TURQUIA 200C Street, S.W.
Washington, D.C., 20204
Delegate
Government Advisors
Dr. Nazmi Demir
Counselor of Agriculture Mr. E. Spencer Garrett II
Embassy of the Republic of Turkey Laboratory Director
2523 Massachusetts Avenue, N.W. National Seafood Inspection Laboratory
Washington, D.C., 20008 National Marine Fisheries Service
U.S.A. PO Drawer 1207
Pascagoula, MS 38533
UNITED KINGDOM
ROYAUME-UNI Dr. George P. Hoskin
REINO UNIDO Biologist
Microanalytical Branch
Delegate Division of Microbiology
Food and Drug Administration
Dr. R.H.G. Charles 200C Street, S.W.
Senior Medical Officer Washington, D.C. 20204
Department of Health and Social Security
Alexander Fleming House
Elephant and Castle
London SE1 6BY
 -31 -
ALINORM 85/13
APPENDIX I
UNITED STATES OF AMERICA (CONT.) Dr. Stanley Green
Staff Officer
Mr. Barry Wentz Microbiology Division
Microbiologist Science, FSIS
Food and Cosmetics Microbiology. U.S. Department of Agriculture
Branch Washington, D.C., 20250
Division of Microbiology
Food and Drug Administration Dr. F. Leo Kauffman
200C Street, S.W. Food and Drug Administration
Washington, D.C. 20204 200C Street, S.W.
Washington, D.C., 20204
Dr. Joseph W. Lepak
Assistant to the Director Dr. J.E. Kvenberg
Division of Microbiology Assistant to the Director
Food and Drug Administration Division of Microbiology
200C Street, S.W. Food and Drug Administration
Washington, D.C. 20204 200C Street, S.W.
Washington, D.C., 20204
Dr. Joseph M. Madden
Microbiologist Mr. Donald A. Kautter
Food and Cosmetics Microbiology Microbiologist
Branch Food and Drug Administration
Division of Microbiology 200C Street, S.W.
Food and Drug Administration Washington, D.C., 20204
200C Street, S.W.
Washington, D.C. 20204 Mr. Howard Magwire
National Supervisor
Dr. Thomas Mulvaney Egg Products
Chief Poultry Division
Processing Section Agricultural Marketing Service
Division of Food Technology U.S. Department of Agriculture
Food and Drug Administration Washington, D.C. 20250
200C Street, S.W.
Washinton, D.C., 20204 Ms Rosanna Mentzer Morrison
Economist
Mr. Stephen H. Spinak Economic Research Service
Staff Officer U.S. Department of Agriculture
Canned Products Branch Washington, D.C., 20250
Processed Products Inspection
Division Mr. Fred A. Phillips
U.S. Department of Agriculture Special Assistant for Low Acid Canned Foods
Washington, D.C., 20250 Food and Drug Administration
200C Street, S.W.
Dr. D. Archer Washington, D.C., 20204
Deputy Director
Food and Drug Administration Ms Tanya Roberts
Division of Microbiology Economist
200C Street, S.W. Economic Research Service
Washington, D.C., 20204 U.S. Department of Agriculture
Washington, D.C., 20250
Dr. James R. Brooker
Program Leader Dr. Sanford Miller
Fishery Products Research Director
Department of Commerce NOAA Bureau of Foods
Washington, D.C., 20235 Food and Drug Administration
200C Street, S.W.
Mr. H. Guy Fugate Washington, D.C., 20204
Staff Officer
Microbiology Division Mr. Clyde Takaguchi
Science, FSIS Consumer Safety Officer
U.S. Department of Agriculture Division of Food and Color Additives
Washington, D.C., 20250 Food and Drug Administration
200C Street, S.W.
Washinton, D.C., 20204
ALINORM 85/13
APPENDIX I
UNITED STATES OF AMERICA (CONT.) Dr. J.C. Olson
Private Consultant
Industry Advisors 4982 Sentinel Drive
Bethesda, Md. 20016
Mr. L.M. Beacham
Research Services Mr. J.A. Roser
National Food Processors Association Manager
1133 20th Street, N.W. Technical Service and Development
Washington, D.C., 20036 American Can, Canada, Inc.
P.O. Box 38
Ms Gloria E.S. Cox 391 Victoria Avenue North
Chief Hamilton, Ontario L8N 3VI
Executive Officer
Cox and Cox Investments Mr. Carl J. Ross
12006 Auth Lane Manager
Silver Spring, Md. Technical Services and Regulatory Affairs
Canadian Canners Limited
Mr. Cleve Denny Research Center
Director 1101 Walker's Line
Research Services Burlington, Ontario, L7N 204
National Food Processors Association
1401 New York Ave., N.W., Suite 400 Dr. Glenn G. Slocum
Washington, D.C., 20005 Private Consultant
4204 Dresden Street
Mr. William V. Eisenberg Kensington, Md. 20895
Private Consultant
6408 Tone Drive Mr. J.A. Stock
Bethesda, Md. 20817 Manager
Specifications
Dr. Harold B. Hubbard Division of the Continental Group of
Chief Canada Ltd.
Food Control Continental Can Company of Canada
Pan American Health Organization Research and Technical Service Laboratory
525 3rd Street, N.W. 191 New Toronto Street
Washington, D.C. Toronto, Ontario, M8V 2E7
Mr. Robert R. Jule Mr. Hugh W. Symons
Associate Director Commission Member
Container and Packaging Technology International Institute of Refrigeration
Section 1700 Old Meadow Road
Metal Container Research Division McLean, VA 22102
American Can Company
Barrington Technical Center Mr. Steve Taylor
433 N. Northwest Highway Associate Professor
Barrington, IL 60010 Food Research Institute
University of Wisconsin
Dr. Richard V. Lechowich 1925 Willow Drive
Manager Madison
Microbial Research Wisconsin
General Foods Corporation
250 North Street Mr. Michael G. Teeter
White Plains, NY, 10625 Vice President
Canadian Food Processors Association
Dr. Roy Martin 130 Albert Street
National Fisheries Institute Suite 1409
1101 Connecticut Avenue Ottawa, Ontario K1P 5G4
Washinton, D.C., 20036
Mr. Dale A. Tulloch
Dr. Andrew B. Moore Vice President
Food and Nutrition Science Associates National Dairy Council of Canada
Grocery Manufacturers of America 141 Laurier Avenue W.
1010 Wisconsin Avenue, N.W. Suite 704
Washington, D.C., 20007 Ottawa, Ontario K1P 5J3
 - 33 -
ALINORM 83/15
APPENDIX I
UNITED STATES OF AMERICA (CONT.) FAO PERSONNEL
PERSONNEL DE LA FAO
Mr. Gary Yingling PERSONAL DE LA FAO
President
Food and Drug Law Institute FAO Liaison Officers and Rapporteurs
1200 N.H. Avenue, N.W
Suite 380 Mr. J.M. Hutchinson
Washington, D.C., 20036 Food Standards Officer
Joint FAO/WHO Food Standards Programme
OBSERVER COUNTRIES Food and Agriculture Organization of
PAYS OBSERVATEURS the United Nations
PAISES OBSERVADORES Via delle Terme di Caracalla
00100 Rome, Italy
SOUTH AFRICA
AFRIQUE DU SUD Mrs Barbara Dix
SUDAFRICA Food Standards Officer
Joint FAO/WHO Food Standards Programme
Mr. Jan H. Venter Food and Agriculture Organization of
Second Secretary (Economic) the United Nations
Embassy of South Africa Via delle Terme di Caracalla
4801 Massachusetts Avenue, N.W. 00100 Rome, Italy
Suite 350
Washington, D.C., 20016 WHO Liaison Officer

INTERNATIONAL ORGANIZATIONS Dr. A. Koulikovskii

ORGANISATIONS INTERNATIONALES Food Hygienist
ORGANIZACIONES INTERNACIONALES Veterinary Public Health
Division of Communicable Diseases
COUNCIL OF EUROPEAN COMMUNITIES (CEC/CCE) World Health Organization
1211 Geneva 27
Mr. Luigi Cisnetti Switzerland
Administrator
General Secretariat of the Council of
European Communities
Rue de la Loi 170
Brussels 1048
Belgium

COMMISSION OF THE EUROPEAN COMMUNITIES (EEC)

Mr. G. Vos
Principal Administrator
General Directorate of the Domestic
Market and Industrial Affairs
Commission of the European Communities
Rue de la Loi 200
Brussels 1049
Belgium

INTERNATIONAL ORGANIZATION FOR STANDARDS (ISO)

Mrs J. Gantois
Technical Secretary
Sub-Committee on Microbiology
Geneva
Switzerland
 - 34 -
ALINOR; 85/13
APPENDIX II

REPORT ON THE STATE OF WORK OF

THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
IN THE FIELD OF MICROBIOLOGY

FOOD PRODUCTS

1. GENERAL MICROBIOLOGY SUB-COMMITTEE - ISO/TC 34/SC 9

Six International Standards are now published:

ISO 4831-78 - Microbiology - General guidance for the enumeration of coliforms -

Most probable number technique at 30 ° C

ISO 4832-78 - Microbiology - General guidance for the enumeration of coliforms -

Colony count technique at 30 °C

ISO 4833-78 - Microbiology - General guidance for the enumeration of micro-organisms

- Colony count technique at 30 ° C

• ISO 6579-81 - Microbiology - General guidance on methods for the detection of

'Salmonella

ISO 6887-83 - Microbiology - General guidance for the preparation of dilutions

for microbiological examination

ISO 6888-83 - Microbiology - General guidance for enumeration of Staphylococcus

aureus - Colony count technique

Five draft standards are at the state of ballot:

DIS 7251 General guidance for the enumeration of presumptive Escherichia

coli - o Most probable number - Technique after incubation at 35°C
- o
or 37 C then 45 C

DIS 7402 General guidance for enumeration of Enterobacteriaceae without

resuscitation - Most probable number technique at 35 °C or 37 ° C
and colony count technique at 35 ° C or 37 ° C

DIS 7667 Agricultural food products - Standard layout for methods of

microbiological examination

DIS 7937 General guidance for enumeration of presumptive Clostridium

perfringens - Colony count technique at 35° to 37 0 C

DIS 7218 General guidance for microbiological analysis

TWO draft proposals are still being considered by the Sub-Committee:

DP 7932 - General guidance for enumeration of presumptive Bacillus cereus -

Colony count technique

DP 7954 - General guidance for detection and enumeration of yeasts and moulds

Detection and enumeration of yeasts and moulds, enumeration of Bacillus cereus, general
guidance for the microbiological analysis are considered with a-TiTiT-Tirt5T.
 - 35 -

ALINORM 85/13
APPENDIX II

The future programme of work contains also:

General guidance for microbiological analysis of preserves
(convenor : Canada)

Enumeration of Vibrio parahaemolyticus

(convenor : France)

Revision of ISO 6579 on Salmonella with reconstitution of dehydrated products

(convenor : M. READ)

Preparation of sample for the microbiological analysis

(convenor : M. KITCHELL)

Enumeration of Enterobacteriaceae with resuscitation

(convenor : M. VAN SCHOTHORST)

Campylobacter

Yersinia enterocolitica

Enumeration of low numbers of Clostridium perfringens

(the enquiry shows its necessity)

The next meeting of ISO/TC 34/SC 9 should be held near March 1984.

2. SPECIFIC MICROBIOLOGY

2.1 Cereals and cereal products - Sub-Committee ISO/TC 34/SC 4

One draft proposal is considered:

DP 7698 - Enumeration of micro-organisms after incubation at 30 °C - Colony count

technique

2.2 Milk and milk products - Sub-Committee ISO/TC 34/SC 5

Five draft proposals are considered in liaison with IDF and AOAC:

DP 5541/1 - Enumeration of coliforms - Part 1 : Most probable number technique

DP 5541/2 - Enumeration of coliforms - Part 2 : Colony count technique

DP 7889 - Yogurt - Enumberation of characteristic micro-organisms - Colony

count technique at 37 ° C

DP 8198 - Casein and casemates - Enumeration of micro-organisms - Colony

count technique at 30 °C

DP 8261 - General guidance for preparation of samples, primary dilutions,

initial suspensions and further dilutions for microbiological
examination
 - 36 -

ALINORM 85/13
APPENDIX II

2.3 Meat and meat products - Sub-Committee ISO/TC 34/SC 6

Three standards are published:

ISO 3565-75 - Detection of Salmonellae (Reference method)

ISO 3811-79 - Detection and enumeration of presumptive coliform bacteria and

presumptive Escherichia coli (Reference method)

ISO 5552-79 - Detection and enumeration of Enterobacteriaceae (Reference methods)

One draft standard is at the state of ballot:

DIS 6649 - Detection and enumeration of Clostridium perfringens (Reference method)

One draft proposal is considered:

DP 6563 - Treatment of a primary sample for microbiological analysis

 - 37 -

ALINORM 85/13
APPENDIX III

REPORT OF THE WORKING GROUP ON TI-E VISUAL AND

TEARDOWN INSPECTION CF CANS FOR DEFECTS

1. The Formation of the Working Group and Its Mandate

The need for more definitive information concerning defects commonly found in
cans (the two and three piece sanitary can) and instructions for the tear-down
evaluation of double seams arose from different sources. First there is the need
for further clarification and detail for the following sections of the Code of
Hygienic Practice for Low-Acid and Acidified Low-Acid Canned foods

7.4.2 Inspection of empty product containers,

7.4.7 Closing operations,
7.4.8 Inspection of closures,
7.4.8.1 Inspection for gross defects,
7.4.8.1.2 Inspection of can seams,
7.4.8.1.4 Closure defects,
8.2.2 Container closure recorcis,
11 End Product Specifications

In addition to guidance with respect to the visual and tear-down examination

guidance is also required as to appropriate sampling plans and acceptable
incidences of defects with respect to the present state of the art. The Working
Group responsible for the preparation of the Draft Code of Hygienic Practice for
the Salvaging of Damaged Canned Products also expressed a need for the same
information for sections 7.1.3 and 7.2.5 of that Code. Finally, in reply to an
expressed need in the report of the Working Group formed to examine the Annex C
to the International Code of Hygienic Practice for Processed Meat Products,
Sampling and Inspection Procedures for Microbiological Examination of Meat
Products in Hermetically Sealed Containers (Alinorm 81116, Appendix II) the Food
Hygiene Committee accepted the offer of the U.S.A. delegation to prepare a
working document on the tear-down inspection of double seams for presentation at
the next session.

During the past year there has been a serious problem involving defects found in
canned salmon produced in both Canada and the United States which has had
international involvement. During the investigation of this problem certain things
became apparent, such as, differences in nomenclature used to identify specific
defects, differences in the classification as to the seriousness of the defects, a
variety of methods used to test and analyze canned foods, differences in the
interpretation of results of tests and analyses, and whet level of these defects
could be reasonably expected given the prisent state of the art. The differences
and disagreements not only existed between countries but also within countries.
There was definitely a need for at least a common agreement. Therefore, the
three countries involved in this problem, Canada, the United Kingdom and the
United States, each with a long history in canning technology, decided to try to
resolve these disagreements and differences. Early in the discussion between the
three countries it became apparent that this problem was shared by other countries
and that the best forum would be the Codex Alimentarius through the Food
Hygiene Committee.
 - 38 -

ALINORM 85/13
APPENDIX III

In view of the foregoing the Chairman of the Food Hygiene Committee requested
an ad hoc Working Group composed of the following countries; Canada, the
Netherlands, Norway, the Republic of West Germany, the United States of America
and the United Kingdom. The group is to be chaired by Canada. The working
Group met in Ottawa, Canada from 11 Nov to 14 Nov. 1982, Inclusive. The
following delegates were present:

Canada - Mr. I.E. Erdman, (chairman), Health & Welfare Canada

Dr. B.E. Brown, (rapporteur), Health & Welfare Canada
Dr. D. Clark, Health & Welfare Canada
Mr. R. Burke, Health & Welfare Canada
Dr. K. Devlin, Health & Welfare Canada
Mr. J. Mercer, Health & Welfare Canada
Ms. Hélène Couture, Health & Welfare Canada
Dr. F. Tittiger, Agriculture Canada
Mr. J. Donald, Agriculture Canada
Mr. B. Lingeman, Fisheries and Oceans Canada
Dr. G. Jarvis, Health & Welfare Canada
Mr. D. Laitin, Continental Can of Canada
Mr. J.A. Roser, American Can Canada Inc.
Mr. M. Teeter, Canadian Food Processors Association
Mr. D. Gardner, T.J. Lipton Inc.

Norway - Mr. Olav C. Sundsvold, The Official Norwegian Quality Control

Institute for Canned Fish Products

U.S.A. - Dr. G.J. Jackson, U.S. Food and Drug Administration

Dr. T.R. Mulvaney, U.S. Food and Drug Administration
Mr. S.H. Spinak, U.S. Dept. of Agriculture
Mr. C.B. Denny, the National Food Processors Association

United Kingdom - Dr. R.H.G. Charles, Dept. of Health and Social Services
Dr. A. Tolan, Ministry of Agriculture, Fisheries and Food

The following topics were discussed by the Working Group:

1. Definitions for Defect Classification

Class I (critical) Defect

Class II (major) Defect
Class III (minor) Defect

2. Visual Defects

Nomenclature
Classification

Laboratory Examination
Methods and Interpretation
Incidence of Infection by Defect Type
Health Hazard Cqnsiderations
 - 39 -
ALINORM 85/13
APPENDIX III

4. Evaluation of Container Integrity

Vacuum/Pressure Leak -Test

Tear-Down Evaluation

5. Lot Evaluation

Sampling Plans and Acceptance Criteria

Standards and/or Guidelines

6. Investigations

7. Salvage

Definitions for Defect Classification

Class I (critical) Defects are defects which provide evidence that

(a) the container has lost its hermetic seal (e.g., holes, fractures, 'punctures,
product leakage, etc.,) or (b) evidence that there is, or has been, microbial growth
in the can contents.

Class II (major) Defects are defects which result in cans which do

not show signs of having leaked, but are of such magnitude that they may leak.

Class III (minor) Defects are defects which result in cans whicll do
not show signs of having leaked, and are not likely to result in leakage.

Visual Defects

The defects were grouped according to either the origin of the defect or the
part of the can affected. No attempt was made to list all alternative names for
each defect. Instead a pictoral record of each defect was compiled into a manual
with the appropriate classification given to each defect.

The following defects are shown in the manual:

Tin plate or coating defects,

Dirty, stained or smeared defects,
Rusted can defects,
Dented cans body
side seam
double seam
Panelling Defects
Buckling defects
Punctured/fractured/cut cans
Cable cuts
Defects involving the double seam
 - 40 -

ALINORM 85/13
APPENDIX III

For some of the defects the classification depends upon

the extent to which
It Is present and in such cases this is shown in the
pictures. Not all the defects
which can be encountered are shown in the manual
but it is believed that most of
those commonly occurring are represented. The manual
is being prepared to assist
the inspector in identifying and classifying defects found
on the visual examination
of canned foods.

The proper visual examination of a can for defects requires

the removal of
the label. This, of course, would not be necessary for
lithographed cans. The
Working Group recognized that label removal may impose economic penalties
restrictions to inspections, however for proper inspection it should and
be done. It will
have to be left to the discretion of
the agency having jurisdiction whether the
labels should be removed in the inspection of any
particular lot.

Each defect found during the inspection shall be identified

and classified as
to its seriousness as given in the manual. The results of the
examination shall be
recorded. In some instances a defect may be classified
as a II or even a III upon
visual examination but after destructive examination
be found to be classed higher
as a I or II.

The question as to whether only the most serious defect on

any can should be
scored (recorded) or if all unrelated defects be
scored was discussed. First there is
the question of related and unrelated defects. For example
a can may be swollen
and have a cut-over with some evidence of leakage through
the cut-over.
reasonable to assume that the swelling resulted from microbial contaminationIt is
the cut-over and that only the most serious defect need via
be recorded, that is either
the swelling or the leakage. However there is merit
in also recording the presence
of the cut-over since is, the primary cause and would indicate
corrective action.
There is also the question of the unrelated or
independent defects, should only the
most serious defect be scored or all defects. The Working Group would like
guidance from the Food Hygiene Committee in these matters.

A manual has been presented to the Working Group and

it agreed on the title
and on the scope of that manual.

Title: "Manual for Ex-Cannery Visual Screening Examination

of Low-Acid
Canned Foods for Container Integrity."

Scope: "This manual is for the use in the ex-cannery visual examination
of low-
acid foods in hermetically sealed rigid metal containers. The
examina-
tion is to determine whether or not further examination
of a lot should
be carried out. Lots failing may be eligible for salvage,
but considera-
tion for salvage falls outside the scope of this manual."

3. Laboratory Examination

Methods adopted should be within the capability of a relatively unsophisti-

cated microbiological laboratory with the ability to open containers and
inoculum aseptically. Ih keeping with the definition transfer
for commercial sterility of
food, both the presence of viable organisms and
growth must be established. In
 - 41 -

ALINORM 85/13
APPENDIX III

some instances this may be accomplished by establishing that the viable organisms
are present In sufficient numbers to be incompatible with the product and its
processing. In many Instances growth may have progressed to the point of
autosterilization and no viable organisms can be found using conventional methods
therefore other observations are required. Another problem Is the ability to
differentiate between Incipient and post-processing spoilage.

3.1 Methodsfeind Interpretatiori

The laboratory examination of the contents should include at least the

following:

Test for the presence of viable organisms using at least two different media
capable of supporting aerobic and anaerobic growth, for example PEZ media and
cooked meat media. It is also recommended that either streak or pour plates be
prepared using suitable media and incubated aerobically and anaerobically. The
latter procedure may permit a more rapid method for showing the presence of
viable organisms, specially when densities are relatively large. There is the added
benefit of the possibility of obtaining an estimate of the density asl well as some
leads to identification.

Direct microscopic examination of the contents of either a dried, stained

smear or wet mount by phase contrast can be informative when the contents have
relatively large cellular densities. There is the limitation that this procedure does
not differentiate between viable and dead cells.

Appearance and odour of the product should be assessed. Microscopic growth

often produces changes in the appearance and/or odour of a food. The presence of
off-odours, physical changes in the food such as liquefaction, curdling, precipita-
tion, etc. as well as the presence of gas should be noted and may be indicative of
microbial growth.

Changes in pH of the food should be noted. Often microbial growth induces

changes in the pH of its media, therefore any significant change in the pH of a
particular food should be noted.

Laboratory examination should not be limited to the contents but should

include the container (can). The container should be tested for leaks and the seams
torn down and examined.

While many methods for the detection of viable organisms have been
published and are in use, they all depend upon the aseptic inoculation of specific
medie which permits the resuscitation, germination, and outgrowth of vegetative
cells and spores in general and obligate anaerobes in particular. The quantity of
Inoculum used (about 1 to 3 g) is small in comparison with the can contents. While
such a technique may be adequate to detect the presence of viable organisms in the
can contents suspected of being contaminated, It cannot be used u a test of
sterility, that is the absence of viable organisms.

There remains much to be accomplished in the interpretation of the results.

What constitutes evidence of the presence of viable organisms in a food? If 2 or 3
tubes of each media are inoculated, must all tubes for both media be positive or
 - 42 -

ALINORM 85/13
APPENDIX III

can less be accepted? What evidence is required to verify that there has been
microbial growth or that the organisms found are capable of growing In the food.
These problems have yet to be addressed.

3.2 Incidence of Contamination (Infection) by Defect Type

A measure of the seriousness of a can defect Is whether it will result in

contamination (infection) of the contents. This principle has been applied in the
Campden procedure developed for the sorting and assessment of lots of canned
salmon suspected of having unacceptable levels of defects. A resurnd of some of
the analyses of defect cans found in the investigation of the canned salmon
problem in Canada and the U.K. was presented by the Canadian delegation. The
entire report is attached as appendix 2.

3.3 Health Hazard Considerations

This topic was not discussed during this meeting and will be a subject for
discussion at the next meeting.

4. Evaluation of Container Inte rit

In both the U.K. and North America a mechanical sorting system involving
double dud detectors and check weighers have been used to salvage lots of canned
salmon believed to have unsatisfactory levels of can defects. A dud detector can
reject cans having centre depths of the ends below a prescribed minimum. In
double dud detection this is applied to both can ends. The check weigher is also set
to reject cans having a gross weight below a prescribed minimum. The basis for
this is that a can which has a defect which results in the loss of the integrity would
leak and loose some if not all of the vacuum applied at the time of seaming and/or
would loose some of the product resulting in a loss of weight. A decrease in or loss
of internal vacuum usually results in a decrease in the can end centre depth. The
working group agreed that while such a system may be very useful in certain cases
It can not be said to be a reliable general method for checking container integrity.
During the testing of canned salmon cans having a hole in the body (index fault)
were seen in which there had been little or no loss of weight nor had there been
sufficient decrease in the end plate centre depths to result in rejection by the
sorting system.

Four, reliable methods presently employed in the industry to detect leaks in

metal containers were discussed:

1) Helium leak test;

2. Dye leak test;
Vacuum leak test;
Pressure leak test.

1. Helium Leak Test

Although this method is quite sensitive, capable of detecting microleaks, it is

expensive and requires special handling.
 - 43 -
ALINORM 85/13
APPENDIX III

Dye Leak Test

This method involves the application of a detectable dye (by colour of

fluorescence, etc.) around the outside of a seam then pulling a vacuum on the can
and observing whether and where there is dye penetration into the interior. This
has been used to plot routes of entry of microorganisms into cans.

Vacuum Leak Test

This is the most popular method for testing integrity of cans after filling,
seaming and processing. Details of the method, including construction of the
required apparatus have been published by the National Food Processors Associa-
tion in 1972. For testing the can is opened at one end, the contents removed and
the can thoroughly cleaned and dried. A small amount of water is placed in the can
and a vacuum drawn on the interior by means of a gasketed Plexiglas cover which
permits observation of the can interior. As the amount of vacuum is increased so
is the pressure differential between the interior and exterior of the can. The can is
rotated so that the water placed inside passes over the interior of the seams at
each vacuum level applied. Leaks are observed by the formation al air bubbles,
The value of the Plexiglas is that it allows the Interior of the can surface to be
observed.

Pressure Leak Test

In modern can manufacturing facilities all cans are pressure tested for leaks
st the time of manufacture. The process involves the application and maintenance
of a pressure of air to the interior of a can resulting in a pressure differential
between the can interior and exterior. Leaks are detected either by the failure to
maintain an applied pressure or by immersion of the can in water and watching for
the appearance of air bubbles. The procedure is used in testing the integrity of
cans after filling, seaming and processing and like in the vacuum leak test, the can
is opened at one end, emptied, cleaned and dried. The opening in one end must be
carefully done so as to permit sealing in a bung through which the air is introduced
to create the pressure. Pressures of up to 20 psig are used for most cans, although
some of the larger cans tend to bulge at pressures in excess of 15 psig.

There was no agreement reached by the Working group as to which method

was or is preferred. It was agreed that the helium leak test apparatus is most
precise but not suited for routine investigations. The pressure and vacuum methods
are reported to be of equal reliability.

For some defects occurring to the double seams, tear-down examinations

should be carried out to determine whether the defect is class I or II. The extent
to which tear-down examinations are applied will depend upon the nature of the
defects. More frequent tear-down examinations may have to be made on
aluminium cans and containers having soldered end seams. The Working Group did
not deal with a specific method for tearing down seam's. The delegation from the
U.S.A. will present a report on this subject at the next meeting of the Food
Hygiene Committee.
 - 44 -
ALINORM 85/13
APPENDIX III

5. Lot Evaluation

1. Sampling Plans and Acceptance Criteria

In order to evaluate the condition of quality of a lot, a sampling plan is

required. The type of plan used should be In keeping with why the lot Is being
evaluated. That for assessing a potential public health hazard may be more severe
than that for organoleptic quality. Different sampling plans may have to be used
for the following:

Product quality not involving a public health hazard;

Examination for compliance to net weight regulations;
Health hazards including non-compliance with public health regulations,
and this would include examination for container integrity.

The economic aspects of sampling plans must also be taken into considera-
tion. There is the cost of the product in the sample which can be considerable
specially in those situations in which the sample size is large, the product is
expensive and that destructive analyses are involved. There is also the additional
storage and handling costs which may result from any delay in reaching a decision
as to whether the product can be distributed. Such additional costs can be very
important where the trading profit is a small percentage of the selling price.

Sampling plans have to be applicable to many situations, but at least cover

the following:

1. Monitoring

This activity, commonly used by regulatory agencies, is also employed by

buyers in assessing the incoming quality of their purchases. In this type of
examination no particular problem is anticipated. Rather it is a periodic check to
see that regulatory requirements or specifications are being met. After consider-
able discussion the following plan given in Table 3 was devised and is recommended
as a screening or first stage examination of lots of unknown quality.

Table 1
Monitoring Sampling Plan
Routine Minimum Sampling and Limits

Defect 2 3
Sample Size Accept Retain' AQL ROL
(n) (Ac) (Re) Pa = 0.95 Pa = 0. 05

Class! 240 0 1 0.2/1000 12/1000

Class!! 240 5 6 11/1000 44/1000

Class III 240 NO LIMITS PROPOSED AT TI-US TIME

(Notes:
 Table - Analysis of Defect Containing Canadian Canned Salmon

I II III IV V VI II III IV V_I

Number (7) Viable Leaked at Product Direct (ONE) Appearance Viable Leaked st Product Total DME Total
Observed Organisme <25" of Ng Dry Microscopic »poises 25" of NI Dry
No. 1 No. 1 No. Z No. I No. II No. 'No. No. No. 1 No. No. 1
v
A. 1. Droops 22 1 4.5 10 45.4 1 4.5 5 22.7 3 13.6 1 10 0 11 50.0 1 12 54.5
2. Spurs 95 1 1.1 12 12.5 1 1.1 10 10.5 16 16.8 1 . 12 0 13 13.7 5 18 18.9
3. K.D.E. (1) 54 0 0 4 7.4 0 0 6 11.1 12 22.2 0 4 0 4 7.4, 3' 9 16.7
Total 171 2 1,1 26 15.2 __,2 1.1 21 12.3 29 17.0 2 26 0 28 14.411 39 22.8
S. 1. 1.D.F. 127 22 1 4.5 7 31.8 0 0 1 4.5 5 22.7

1 .0.,
1 6 0 7 31.8 7 31.8
2. Cut-Over 34 4 11.8 23 67.6 10 29.4 23 67.6 1 2.9 4 20 0 24 70.6 26 74.5
3. 1.17. (3) 4 3 75.0 4 100.0 2 50.0 3 75.0 1 25.0 3 1 0 4 100.0 4 100.0
Total 60 8 13.3 34- 56.7 12 20.0 27 45.0 7 11.7 8 27 0 35 58.3 37 61.7

C. S.S.P. (4) 4 2 50.0 1 25.0 2 ma 3 75.0 1 25.0 2 0 1 3 75.0 0 3 75.0

_
D. no1ed (5) 24 8 33.3 18 75.0 11 45.8 14 58.3 1 4.2 8 10 0 18 75.0 2 20 83.3

L. Blown (6) 25 13 52.0 12 48.0 8 32.0 21 84.0 6 24.0 13 4 4 21 84.0 3 24 96.0

29.9 43 15.1 13 67 6 106 32,3 tg 124 43 . 2

Total 264 33 11.6 91 32.0 35 12.3 85

- Knocked Down Curl (End), in U.K. called Torn Droop Evidence of contamination - presence of viable organisms.

- Knocked Down Flange Evidence can leaked - leaked at <25" of Hg

- product dry
- Index Fault. in U.K. called Cut Down Flange Presumptive evidence of contamination - presence of microbial cells,
direct microscopic examination
- Side Seam Fault
Holed include Fractures, Punctures, etc.
Blown, includes Swollen Leakers
(7) Judged most serious defect present.
(8) For the 4 S.S.?.; when analysed in laboratory 3 were shown
to be blown and have been counted ln that category. the
fourth one leaked and should bave been counted in E.
 - 45 -

ALINORM 85/13
APPENDIX III

The term "retain" is used rather than the conventional "reject" because
lots which are retained because the number of defects found exceeds the
acceptable limit may be salvageable. This will depend upon the nature and
incidence of defects.

The term "AOL" means acceptable quality level and lots having that
level would by the sampling plan be accepted 95% of the time.

The term "ROL" means retention quality level and lots having that level
would by the sampling plan be accepted 5% or retained 95% of the time.)

The choice of a 240 can sample size represents a compromise between the
economic and the hazard aspects. While it only assures retention of lots having for
1.2 Class I defects per 100 cans 95% of the time, a relatively high defect
level, it is capable of detecting and hence retaining lots having 3 Class I defects
per thousand cans, (see the OC curves in figure 1), at least 50% of the time. The
smaller the sample size the more lots which may be inspected for the same cost.

Lots retained as a result of examination by this sampling plan my have to be

examined in greater depth employing a more rigorous sampling plan. Retained lots
may be salvaged subject to the provisions contained in the Codex Alimentarius
Principles for Salvage of Low-Acid Canned Foods presently at step 3.

Investigational

This applies to lots in which a problem is known or suspected. Usually the

problem is confined to specific defects or attributes and more information is
required as to the extent of the problem. Generally sampling plans for investiga-
tion require larger sample sizes than for monitoring plans, specially in cases where
attribute sampling plans as opposed to variables sampling plans are required. The
acceptance criteria should be adjusted to be in keeping with the specific problem
and the degree of concern. No single plan was recommended by the Working Group
since the plan will depend upon the needs of the investigation.

Post-Salvage

Sampling plans under this heading would be applied to lots which have been
salvaged and the object is to obtain assurance that the salvage procedures have
been effective. Since the reasons for -the salvage and the concerns will vary, it is
not possible to derive a single sampling plan to meet all contingencies. Because
the recovered product should be relatively defect free and depending upon the
degree of concern the sampling plans will have to be more rigorous (higher sample
numbers) in order to detect low defect levels.

Theoretically the cans for a sample should be drawn at random from the lot.
This is seldom, If ever, feasible under operating conditions. Therefore, It is
recommended that the sample be selected in a manner-to be representative of the
lot.
 Figure 1 Operating Characteristic (0.C.)Curves for Monitoring Sampling Plan

0.C.earemajar WrJeloo ea., c,„r

[ I

■
gait

C •0

Id

Ca a
0
0001
a • i•l
77-irrn , to
04
I II I I
..
Owly
t
ca 0 es. • ,

fie.sa eqr Pr i "yeem 40 \

 -. 48 -
ALINORM 85/13
APPENDIX III

Small lots present a problem. Generally the sample size should not exceed
10% of the lot size, hence the monitoring plans should not be used for lots having
fewer than 2400 cans. For small lots specific plans should be devised.

Complete visual examination of labelled canned foods requires the removal of

the label. Lithographed cans are, of course, exempt, for obvious reasons. In some
circumstances visual inspection of canned foods may be effectively carried out
without label removal, but this will be dictated by the situation at the time and the
degree of concern. Some products are completely overwrapped, e.g., cans of
sardines, and these must be removed to permit inspection. There is an economic
aspect to the removal of the label. If the examination is non-destructive, i.e.,
visual, then many if not all of the cans in the sample will be judged to be sound and
hence could be returned and put into distribution if and when the lot is cleared.
While re-labelling may only involve the extra cost of the label and the labour for
the canner, it does present a problem when lots are inspected away from the
primary producer, e.g., imported canned foods. While it is recommended that all
labels should be removed to permit visual examination of the complete can surface
for the presence of defects, the decision should remain with the agency having
jurisdiction.

The question as to what constitutes e lot was discussed. The Codex

Alimentarius Code of Practice for Low-Acid and Acidified Low-Acid Canned
Foods, Section 7.4.10, recommends that each container should be permanently
marked with a code identifying at least the establishment, the product contained,
the year and day of the year the product was packed. Preferably sampling should
be applied to single code lots, that is lots which have the same code. When product
is in distribution, specially imported product, segregation of the product into code
lots is not always economically feasible. Therefore a lot may have to be
designated by the persons responsible for carrying out the inspection or by the
owner of the product. Such lots may well contain more than one code lot, however,
they should be limited to the same product, same container size and preferably
from the same cannery.

In all cases where lots have been examined and evaluated complete records
should be made and kept. This is particularly important where lots have been
retained so that interested parties may be informed as to why the lot was retained.

Separate discussions on items 6, Investigations and 7, Salvage were not held.

Where applicable these were discussed in conjunction with other topics.
 - 50 -

ALINORM 85/13
APPENDIX III
ANNEX . I

Holed cans include those that are fractured, punctured or leaking. (Leaking
cans are also included in categories 1,2 and 3.)

Blown cans include swollen cans.)

In the Canadian study 230,000 cans representing 94 lots (day codes) from 17
canneries were visually examined for the presence of defects. Of a total of 344
cans found to have abnormalities, 284 were judged to have major defects and these
were subject to the following analyses:

Presence of viable organisms in the contents;

Direct microscopic examination of the contents;
pH of contents (unfortunately this was carried out on only a small portion of
the contents of the 284 cans);
Observation of physical appearance and smell of the contents;
Vacuum leak test;
Centre depth of both ends prior to opening for examination of contents;
Gross weight;
Double seam heights and thicknesses;
Tear down examination of both double seams for overlap, tightness and
juncture ratings - particular attention was paid to double seam defects and
any points where leaks were detected during the vacuum leak test.

The results of the analyses 1, 2, 3, 4 and 5 are summarized in Table 2. To

facilitate comparison, the defects have been grouped as for Table 1.
 - 49 -

ALINORM 85/13
APPENDIX III
ANNEX I

Incidence of contamination (Infection) by defect type

The infection rates derived by the U.K. were based upon the microbiological
analyses of the contents of 178 cans of salmon which were judged to have "serious"
visual defects. The results are summarized in Table 1.

*Table 1 Infection Rates by Defect Type

Defect Total Infected- Per Cent

Infected

1. Severe Double Seam Fauits BO 4 .5

2. Side Seam Faults 27 4 15

3. K.D.F., K.D.E., C.D.F. 50 30 60

4. Holed 16 5 31
5. Blown 5 4 80
6. Total 178 47 26
(Notes on the above defects

1. Included in the severe double seam faults are the following:

Droops exceeding 50% of the double seam height;

Leaking droops;
Spurs (Vees) exceeding 50% of double seam height;
Leaking Spurs (Vees);
Torn Droops (this defect is called a knocked down end or curl in North
America);
Leaking Torn Droops.

2. Side Seam Faults include those that were leaking.

3. The defects included in this category are:

K.D.F. - knocked down.flange including those that were leaking;

K.D.E. - knocked down end including those that were leaking, (this is
different from what Is called a K.D.E. in North America and which in
the U.K. Is called a torn droop);
- cut down flange including those that were leaking, (this is
called an Index fault in North America).

* Data Obtained from the summary report of assesment of efficiency of automatic sorting
procedure for U.S. Canned Salmon By The Camden Food Preservation Research Association,
Chipping Campden, England.
 - 51 -
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APPENDIX III
ANNEX I

Viable Organisms

The Canadian results show a lower incidence of infection (recovery of viable

organisms) than do the U.K. results, with only 11.6% (33) of the 284 defect cans
being positive for the presence of viable organisms as compared to 26% (47) of the
178 defect cans in the U.K. study. A comparison by defect groups is varied with
group A (severe double seam faults) having only 1.1% infected compared to 5% in
the U.K. study (Table 1) and group B with only 13.3% compared to 60%. Similarly
the blown/swollen cans, group E were 52% infected compared to 80%. The
Incidence of infection for holed cans appears to be about the same with 33%
compared to 31%. The Canadian study revealed a considerably higher incidence of
infection with cans having side seam faults, that is 50% compared to 15%.

Loss of Container Integrity

The presence of viable organisms in the contents cannot always be used as

evidence of either underprocessing or post-processing contamination. Interpreta-
tion is dependent upon the type of organisms found, the type of product and the
extent of heat processing it has received. Because canned salmon receives
extensive heat treatment to ensure that the bones are sufficiently softened it is
reasonable to assume that the product should be free of viable mesophiles. Any
underprocessing of canned salmon which could lead to the possible survival of
botulinum spores would be evidence in the condition of the bones in that they would
not be soft. Thus if viable microorganisms are found in the product and the bones
are soft it is reasonable to assume that post processing contamination has taken
place. There is an additional stipulation that in order to comply with the
international definition of the term "commercial sterility" that growth or the
potential for growth in the product should be established for any viable organisms
found.

Frequently no viable organisms are found in product in which there is other

evidence of microbial growth or that the container has leaked. Conventional
methods used to establish the presence of viable organsims use relatively small
amounts of inoculum (1 to 5 g) and are incapable of detecting low numbers of
viable organisms. Low densities of organisms can result due to lack of growth at
the time the product is tested Or by autosterilization. Therefore other evidence
should be sought to help establish contamination and growth by microorganisms or
leakage of the can. This was done in the Canadian study. In addition to the
presence of viable organisms, cans containing dry product were judged as having
letiked and thus capable of becoming infected and those which leaked at vacuums
below 25" of Hg were judged as capable of leaking and depending upon the hygienic
conditions capable of being infected. The physical state or smell of the product
can often be indicative that microbial growth had taken place, for example rotten,
putrid or sour odours, product liquified or otherwise physically altered indicative of
proteolysis, etc.

Normally the direct microscopic examination (D.M.E.) of the fluid portion in

sound canned salmon shows no or very few microbial cells and then usually a few
micrococci. The presence of significant numbers of microbial cells, specially rods,
In the fluid portion can be taken as evidence of contamination and growth. Further
 - 52 -
ALINORM 85/13
APPENDIX III
ANNEX I

confirmation is a co-incident change in pH from the normal range although

microbial growth is not always accompanied by detectable changes in pH. Since
both viable and dead cells will be seen in the direct microscopic examination, their
presence could be due to incipient and/or post processing contamination. In the
Canadian study, results of the D.M.E. were taken into consideration.

In Table 2 the number of cans having each defect are listed. For each defect
the number of cans having: viable organisms, leaked during the vacuum leak test,
dry product, microbial cells in direct microscopic examination and non-normal
organoleptic appearance are listed followed by the percentage based on the total
number of that defect. Again there is considerable variation in the results for each
defect. For each category the defects can be ranked from the lowest to the
highest incidence and the rankings for all 5 categories totalled. With this
aggregate rank score, group A has the lowest with a total score of 7 followed by
group B with 12, then group D with 16 and finally groups C and E both with 20.

While the aggregate scores gives a means of evaluating the seriousness of the
defects, it was observed that many cans were positive for more than one test. This
can produce a bias, giving more emphasis to some defects. To circumvent this the
data was re-evaluated with the view to determine how many of the defect cans
were in fact defective. For this purpose a defective is defined as a can having an
abnormality (defect) which provides evidence that there has been loss of the
hermetic seal or that there has been microbial contamination or spoilage of the
contents. Thus in order to be called a defective, a can must have shown the
presence of viable organisms in the contents or leaked at under 25" of Hg during
the vacuum leak test or contained dry product or the contents showed a positive
count upon D.M.E. The results of the re-evaluation are given in the right hand side
of Table 2. In the re-evaluation only the most serious positive test was counted,
for example If the product was dry and viable organisms were found it was only
scored under viable organisms. The order for the tests is, first viable organisms,
then leaking at under 25" of Hg, followed by dry product and finally having a
positive D.M.E. As can be seen in Table 2 the cans were scored by defect for the
first three tests which were then totalled giving a total number of defectives for
each. The percentage was calculated and is given. Finally the cans were scored
for D.M.E. which were added to the previous totals and again percentages
calculated. The reason for separating the D.M.E. results from the others is that
these cans showed only a positive D.M.E. It is interesting that no cans were found
whose contents showed organoleptic changes indicative of microbial growth that
were not positive for at least one of the other tests.

The incidence of defectives overall is 37.3% when only the first three tests
were considered and 43.7% if a positive direct microbial count is included. The
significance of a defective can is that it had become contaminated as indicated by
a presence of viable mesophilic organisms or that it leaked as evidenced by dry
product or that it could have leaked as evident by leaking during the vacuum leak
test. It is believed that the incidence of defectives is more meaningful than the
Incidence of Infection since the chance that a can which leaks during the critical
post-processing handling due to some physical defect will become infected is
largely dependent upon the extent of the leakage and the hygienic conditions
existing at the time.
 - 53 -

ALINORM 85/13
APPENDIX III
ANNEX I

The Incidence of defectives gives a measure of the seriousness of the defects

more In keeping with the physical nature of the defect than does the incidence of
Infection. Group A defects have the lowest, as was the case with that of infection,
however the spread of values within the group is greater. Group B is still second
lowest with 58.3% defectives compared to 13.3% for infected. From the results it
is obvious that both the cut-over and the index fault produce considerably higher
proportion of defectives and If being grouped should be put with group D, holed.
Since knocked down flanges are similar to knocked down curls (torn droops) and
since their incidences of defectives are in the lower range it would appear logical
to put these in group A, that is If grouping is beneficial. It was surprising that the
defects such as holed/fractured/punctured should show such a low infection rate in
both studies. When the incidence of defectives is considered, the 75% level is more
consistent with what would be expected from such defects.
 - 54 -
ALINORM 85/13
APPENDIX IV

DRAFT CODE OF HYGIENIC PRACTICE FOR THE COLLECTING,

PROCESSING AND MARKETING OF NATURAL MINERAL WATER
(Retained at Step 6)

SECTION I - FIELD OF APPLICATION

This code recommends appropriate general techniques for collecting natural mineral
water, its treatment, bottling, packaging, storage, transport, distribution and sale for
direct consumption, so as to guarantee a safe, healthy and wholesome product.

SECTION II - DEFINITIONS

2.1 For the purposes of this code the following expressions have the meaning stated:

2.1.1 Natural mineral waters - all waters meeting the requirements of the European
standard for Natural Mineral Waters (CAC/RS 108-1979).

2.1.2 Adequate - sufficient to accomplish the intended purpose of this code.

2.1.3 Cleaning - the removal of soil, food residues, dirt, grease or other
objectionable matter.

2.1.4 Contamination - the occurrence of any objectionable matter in the product.

2.1.5 Disinfection - the reduction, without adversely affecting the natural

mineral water, by means of hygienically satisfactory chemical agents and/
or physical methods, of the number of micro-organisms to a level that will
not lead to harmful contamination of natural mineral water.

2.1.6 Establishment - any building(s) or area(s) in which natural mineral water

is handled after collection and the surroundings under the control of the
same management.

2.1.7 Handling of natural mineral water - any manipulation with regard to

collecting, treating, bottling, packaging, storing, the transport,
distribution and sale of natural mineral water.

2.1.8 Food Hygiene - all measures necessary to ensure the safety, soundness and
wholesomeness of hatural mineral water at all stages from its
production or manufacture until its final consumption.

2.1.9 Packaging Material - any containers such as cans, bottles, cartons, boxes,
cases, or wrapping and covering material such as foil, film, metal paper
and wax-paper.

2.1.10 Pests - any animals capable of directly or indirectly contaminating natural

mineral water.

2.1.11 Containers - any bottle, carton, can or other container to be filled with
natural mineral water, properly labelled and intended for sale.

2.1.12 Aquifers - any solid permeable mass of rocks (layer) containing natural
mineral water.

2.1.13 Spring - any natural mineral water discharging genuinely from the ground.
 - 55 - ALINORM 85/13
APPENDIX IV

SECTION III - PRESCRIPTIONS OF THE RESOURCES OF

NATURAL MINERAL WATERS

A. Protection of alimentary reservoirs and aquifers

3.1 Authorization

Any spring, well or drilling intended for the collection of natural mineral water
should be approved by the official authority having jurisdiction for this region.

3.2 Determination of the genesis of natural mineral water

As far as it is methodologically possible in each case, a precise analysis should

be carried out on the origin of natural mineral waters, the period of their residence
in the ground before being collected and their chemical and physical qualities.

3.3 Perimeter of protection

If possible areas wherein natural mineral water might be polluted or its chemical
and physical qualities otherwise deteriorated should be determined by a hydrologist.
Where indicated by hydrogeological conditions and considering the risks of pollution
and physical, chemical and biochemical reactions, several perimeters with separate
dimensions may be provided for.

3.4 Protective measures

All possible precautions should be taken within the protected perimeters to avoid
any pollution of, or external influence on, the chemical and physical
qualities of natural mineral water.
It is recommended that regulations be established fór the disposal of liquid, solid
or gaseous waste, the use of substances that might deteriorate natural mineral
water (by agriculture e.g.) as well as for any possibility of accidental deterioration
of natural mineral water by natural occurrences such as a change in the hydro-
,geological conditions. Particular consideration should be given to the following
potential pollutants: bacteria, viruses, fertilizers, hydrocarbons, detergents,
pesticides, phenolic compounds, toxic metals, radioactive substances and other
soluble organic or inorganic substances. Even where nature provides apparently
sufficient protection against surface pollution, potential hazards should be taken
into consideration, such as mining, hydraulic and engineering facilities etc.

E. Hygiene prescriptions for the collection of natural mineral water

3.5 Extraction

The withdrawal of natural mineral water (from springs, galleries, genuine or drilled
wells) must be performed in conformity with the hydrogeological conditions in such
a manner as to prevent any other than the natural mineral wáter from entering, or,
should there be pumping facilities, prevent any extraneous water from entering by
reducing the supply. The natural mineral water thus collected or pumped should be
protected in such a way that it will be safe from pollution whether caused by
natural occurrence or actions of neglect or ill will.

3.6 Materials

The pipes, pumps or other possible devices coming into contact with natural mineral
water and used for its collection should be made of such material as to guarantee
that the original qualities of natural mineral water will not be changed.
 ALINORM 85/13 - 56 -
APPENDIX IV

3.7 Protection of the extraction area

In the immediate surroundings of springs and

wells, precautionary measures should be
taken to guarantee that no pollutant whatsoever can enter the extraction
Ls, an area surrounding the source within area, that
a radius of about 60 m. The extraction
areas to be established therefore should at least be identical with
the areas
allocated at the time of construction. These extraction areas should
be inaccessible
to non-authorized people by providing adequate devices (e.g. enclosure).
Any use not
aiming at the collection of natural mineral water should be forbidden
in these areas.
3.8 The exploitation of natural mineral water

The condition of the extraction facilities, areas of extraction and

perimeters of protection as well as the quality of the natural mineral
water should periodically be checked. To control the stability, of the
chemical and physical particulars of the natural mineral water derived -
besides the natural variations - automatic measurements of the typical
characteristics of water should be carried out and notified (e.g,
electrical, conductance, temperature, content of carbon dioxide) or
frequent partial analyses should be done.

Maintenance of extraction facilities

3.9 Technical aspects

Methods and procedures for maintaining the extraction facilities should be hygienic
and not be a potential health hazard to humans or a source of contamination to
natural mineral water. From the hygiene standpoint, servicing of the extraction
installations should meet the same standards as those required for the bottling or
treatment.

3.10 Equipment and reservoirs

Equipment and reservoirs used for extraction of natural mineral water should be
constructed and maintained in order to minimize all hazards to human health and
to avoid contamination.

3.11 Storage at the point of extraction

The quantity Of natural mineral water stored at the point of extraction should be as
low as possible. The storing should furthermore guarantee protection against
contamination or deterioration.

Transport of natural mineral water

3.12 Means of transport, piping and reservoirs

Any vehicle, piping or reservoir used in the processing of natural mineral water
from its source to the bottling facilities, the latter included, should comply with
the necessary requirements and be made of inert material such as ceramic and
stainless steel which prevents any deterioration, be it by water, handling, servicing
or disinfection; it should allow easy cleaning.

3.13 Maintenance of vehicles and reservoirs

Any vehicle or reservoir should be properly cleaned and if necessary disinfected

 - 57- ALINORM 85/13
APPENDIX IV

and kept in good repair so as not to present any danger of contamination to natural
mineral water and of deterioration of the essential qualities of natural mineral
water.

SECTION IV - ESTABLISHMENT FOR /TREATMENT7 AND BOTTLING OF

NATURAL MINERAL WATER - DESIGN AND FACILITIES

4.1 Location

Establishments should be located in areas which are free from objectionable odours,
smoke, dust or other contaminants and are not subject to flooding.

4.2 Roadways and areas used by wheeled traffic

Such roadways and areas serving the establishment which are within its boundaries
or in its immediate vicinity should have a hard paved surface suitable for 'wheeled
traffic. There should be adequate drainage and provision should be made for
protection of the extraction area in accordance with sub-section 3.7 where
appropriate and to allow for cleaning. Adequate road signals may be provided to
call the attention of road users to the existence of a natural mineral water
extraction area.

4.3 Buildings and Facilities

4.3.1 Type of construction

Buildings and facilities should be of sound construction in
accordance with the, provisions of Sub-section 3.7 and maintained
in good repair. -
4.3.2 Disposition of holding facilities

Rooms for recreation, for storing or packaging of raw material and areas
for the cleaning of containers to be re-used should be apart from the •
bottling areas to prevent the end-product from being contaminated. Raw
and packaging materials and any other additions which come into contact
with natural mineral water should be stored apart from other material.

4.3.3 Adequate working space should be provided to allow for satisfactory

performance of all operations.

4.3.4 The design should be such as to permit easy and adequate cleaning and to
facilitate proper supervision Of natural mineral water hygiene.

4.3.5 The buildings and facilities should be designed to provide separation by

partition, location or other effective means between those operations which
may cause cross-contamination.

4.3.6 Buildings and facilities should be designed to facilitate hygienic

operations by means of a regulated flow in the process from the arrival of
the natural mineral water at the premises to the finished product, and
should provide for appropriate temperature conditions for the process and
the product.

4.3.7 Natural mineral water handling, storing and bottling areas

- Floors, where appropriate, should be of water-proof, non-absorbent,

washable, non-slip and non-toxic materials, without crevices, and should
be easy to clean and disinfect. Where appropriate, floors should slope
sufficiently for liquids to drain to trapped outlets.
 - 58 -

ALINORM 85/13
APPENDIX IV

Walls, where appropriate, should be of Water-proof, non-absorbent,

Washable and non-toxic materials and should be light coloured. Up to a
height appropriate for the operation they should be smooth and without
crevices, and should be easy to clean and disinfect. Where appropriate,
angles between walls, between walls and floors, and between walls and
and ceilings should be sealed and coved to facilitate cleaning.

Ceilings should be so designed, constructed and finished as to prevent

the accumulation of dirt and minimize condensation, mould development
and flaking, and should be easy to clean.

Windows and other openings should be so constructed as to avoid

accumulation of dirt and those which open should be fitted with screens
Screens should be easily movable for cleaning and kept in good repair.
Internal window sills, if present, should be sloped to prevent use as
shelves.

Doors should have smooth, non-absorbent surfaces and, where appropriate,

be self-closing and close fitting.

Stairs, lift cages and auxiliary structures such as platforms, ladders,

chutes, should be so situated and constructed as not to cause
contamination to food. Chutes should be constructed with inspection
and cleaning hatches.

Piping for natural mineral water lines should be independent of potable

and non-potable waters.

4.3.8 In natural mineral water handling areas all overhead structures and fittings
should be installed in such a manner as to avoid contamination directly or
indirectly of natural mineral water and raw materials by condensation and
drip, and should not hamper cleaning operations. They should be insulated
where appropriate and be so designed and finished as to prevent the
accumulation of dirt and to minimize condensation, mould development and
flaking. They should be easy to clean.

4.3.9 Living quarters, toilets and areas where animals are kept should be
completely separated from and should not open directly on to natural
mineral water handling areas.

4.3.10 Where appropriate, establishments should be so designed that access can be

controlled.

4.3.11 The use of material which cannot be adequately cleaned and disinfected,
such as wood, should be avoided unless its use .would clearly not be a
source of contamination.

4.3.12 Canalisation, drainage lines

Canalisation and drainage and used water lines as well as any possible
waste storage area within the protected perimeter should be built and
maintained in such a manner as not to present any risk whatsoever of
polluting aquifers and springs.

4.3.13 Fuel storage area

Any storage area or tank for the storing of fuel's such as coal or
hydrocarbons should be designed, protected,.controlled and maintained
in such a manner as not to present a risk of aquifers and springs being
polluted during the storage and manipulation of these fuels.
 - 59-
ALINORM 85/13
APPENDIX IV

4.4 Hygiene Facilities

4.4.1 Water supply

4.4.1.1 An ample supply of potable water in compliance with Section 7.3 of the
Codex 'Code of Practice - General Principles of Food Hygience (CAC/RCP1 1969
Rev. 1) under adequate pressure and of suitable temperature should be
available with adequate facilities for its storage, where necessary, and
distribution, and with adequate protection against contamination. The
standards of potability should not be less than those contained in the
latest edition of "International Standards of Drinking Water" (WHO).

4.4.1.2 Natural mineral water, potable water, non potable water for steam production
or for refrigeration or any other use should be carried in completely
separate lines with no cross connection between them and without back
siphonage. It would be desirable that these lines be identified by
different colours. Steam used in direct contact with natural
mineral water and natural mineral water contact surfaces should
contain no substances which may be hazardous to health or may
contaminate the food.

4.4.2 Effluent and waste disposal

Establishments should have an efficient effluent and waste disposal system

which should at all times be maintained in good order and repair. All
effluent lines (including sewer systems) should be large enough to carry
peak loads and should be so constructed as to avoid contamination of potable
water supplies.

4.4.3 Changing facilities and toilets

Adequate, suitable and conveniently located changing facilities and toilets

should be provided in all establishments. Toilets should be so designed as
to ensure hygienic removal of waste matter. These areas should be well lit,
ventilated and where appropriate heated, and should not open directly on
to natural mineral water handling areas. Hand washing facilities with warm
or hot and cold water, a suitable hand-cleaning preparation, and with
suitable hygienic means of drying hands, should be provided adjacent to
toilets and in such a position that the employee must pass them when
returning to the processing area. Where hot and cold water are available
mixing taps should be provided. Where paper towels are used, a sufficient
number of dispensers and receptacles should be provided near to each
washing facility. Care should be taken that these receptacles for used
paper towels are regularly emptied. Taps of a non-hand operable type are
desirable. Notices should be posted directing personnel to wash their
hands after using the toilet.

4.4.4 Hand washing facilities in natural mineral water processing areas

Adequate and conveniently located facilities for hand washing and drying
should be provided wherever the process demands. Where appropriate,
facilities for hand disinfection should also be provided. Warm or hot and
cold water and a suitable hand-cleaning preparation should be provided.
Where hot and cold water are available mixing taps should be provided.
There should be suitable hygienic means of drying hands. Where paper
towels are used, a sufficient number of dispensers and receptacles should
- be provided adjacent to each washing facility. Taps of a non-hand
operable type are desirable. The facilities should be furnished with
- properly trapped waste pipes leading to drains.
 — 60—

ALINORM 85/13
APPENDIX IV

4.4.5 Disinfection facilities

Where appropriate, adequate facilities for cleaning and disinfection of

working implements and equipment should be provided. These facilities
should be constructed of corrosion resistant materials, capable of being
easily cleaned, and should be fitted with suitable means of supplying hot
and cold water in sufficient quantities.

4.4.6 Lighting

Adequate natural or artificial lighting should be provided throughout the

establishment. Where appropriate, the lighting should not alter colours
and the intensity should not be less than:

540 lux (50 foot candles) at all inspection points

220 lux (20 foot candles) in work rooms
110 lux (10 foot Candles) in other areas.

Light bulbs and fixtures suspended over natural mineral water in any stage
of production should be of a safety type and protected to prevent don-
tamination of natural mineral water in case of breakage.

4.4.7 Ventilation

Adequate ventilation should be provided to prevent excessive heat, Steam

condensation and dust and to remove contaminated air. The direction of the
air flow should never be from a dirty atea to a clean area. Ventilation
openings should be provided with a screen or other protecting enclosure of
non-corrodible material. Screens should be easily removable for Cleaning.

4.4.8 Facilities for storage of waste and inedible material

Facilities should be provided for the storage of waste and inedible material
prior to removal from the establishment. These facilities should be
designed to prevent access to waste or inedible material by pests and to
avoid contamination of natural mineral water, potable water, equiPment,
buildings or roadways on the premises.

4.5 Equipment and Utensils

4.5.1 Materials

All equipment and utensils used in natural mineral water handling areas and
which may contact the natural mineral water should be made of material
which does not transmit toxic substances, odour or taste, is non-abSorbent,
is resistant to corrosion and is capable of withstanding repeated cleaning
and disinfection. Surface should be smooth and free from pits and crevices.
The use of wood and other materials which cannot be adequately cleaned and
disinfected should be avoided except when their use would clearly not be
a source of contamination. The use of different materials in such a way
that contact corrosion can occur should be avoided.

• 4.5.2 Hygienic design, construction and installation

4.5.2.1 All equipment and utensils should be so designed and constructed aS to

prevent hygienic hazards and permit easy and thorough cleaning and
disinfection.
 - 61 - ALINORM 85/13
APPENDIX IV

SECTION V - ESTABLISHMENT: HYGIENE REQUIREMENTS

5.1 Maintenance

The buildings, equipment, utensils and all other physical facilities of the
establishment, including drains, should be maintained in good repair and in an
orderly condition. As far as practicable, rooms should be kept free from steam,
vapour and surplus water.

5.2 Cleaning and Disinfection

5.2.1 Cleaning and disinfection should meet the requirements of this code. For
further information on cleaning and disinfection procedures see Annex I,
Revised Recommended International Code of Practice - General Principles of
Food Hygiene (CAC/RCP 1-1969, Rev. 1. 11979)).

5.2.2 To prevent contamination of natural mineral water, all equipment and

utensils should be cleaned as frequently as necessary and disinfected
whenever circumstances demand.

5.2.3 Adequate precautions should be taken to prevent natural mineral water from
being contaminated during cleaning or disinfection of rooms, equipment or
utensils, by water and detergents or by disinfectants and their solutions.
Detergents and disinfectants should be suitable for the purpose intended
and should be acceptable to the official agency having jurisdiction. Any
residues of these agents on a surface which may come in contact with
natural mineral water should be removed by thorough rinsing with water in
coLpliance with 7.3 of the Recommended International Code of Hygienic
Practice - General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 1
(1979)) before the area or equipment is again used for handling
natural mineral water.
5.2.4 Either immediately after cessation of work for the day or at such other
times as may be appropriate, floors, including drains, auxiliary sructures
and walls of natural mineral water handling areas should be thoroughly
cleaned.

5.2.5 Changing facilities and toilets should be kept clean at all times.

5.2.6 Roadways and yards in the immediate vicinity of and serving the premises
should be kept clean.

5.3 Hygiene Control Programme

A permanent cleaning and disinfection schedule should be drawn up for each

establishment to ensure that all areas are appropriately cleaned and that critical
areas, equipment and material are designated for special attention. A single
individual, who should preferably be a permanent member of the staff of the
establishment and whose duties should be independent of production, should be
appointed to be responsible for the cleanliness of the establishment. He should
have a thorough understanding of the significance of contamination and the hazards
involved. All cleaning personnel should be well-trained in cleaning techniques.

5,4 Storage and Disposal of Waste

Waste material should be handled in such a manner as to avoid contamination of natural

mineral water or potable water. Care should be taken to prevent access to waste by
pests. Waste should be removed from the natural mineral water handling and other
working areas as often as necessary and at least daily. Immediately after disposal
of the waste, receptacles used for storage and any equipment which has come into
APPEMDIX IV. - 62 -

contact With the waste should be cleaned and disinfected. The waste storage area
should al,so'be cleaned and disinfected.

5.5 .1 ExclusicWof Animals

Animals that are uncontrolled or that could be a hazard to health should be excluded
from establishments.

5.6 Pest Control

5.6.1 There should be an effective and continuous programme for the control of
pests. Establishments and surrounding areas should be regularly examined
for evidence of infestation.

5.6.2 Should pests gain entrance to the establishment, eradication measures should
be instituted. Control measures involving treatment with chemical, physical
or biological agents should only be undertaken by or under direct
supervision of personnel who have a thorough understanding of the potential
hazards to health resulting from the use of these agents, including those
hazards which may arise from residues retained in the natural mineral water.
Such measures should only be carried out in accordance with the
recommendations of the official agency having jurisdiction.

5.6.3 Pesticides should only be used if other precautionary measures cannot be

used effectively. Before pesticides are applied, care should be taken to
safeguard natural mineral water, equipment and utensils from contamination.
After application, contaminated equipment and utensils should be thoroughly
cleaned to remove residues prior to being used again.

5.7 Storage of Hazardous Substances

5.7.1 Pesticides or other substances which may represent a hazard to health should
be suitably labelled with a warning about their toxicity and use. They
should be stored in locked rooms or cabinets used only for that purpose and
dispensed and handled only by authorized and properly trained personnel or
by persons under strict supervision of trained personnel. Extreme care
should be taken to avoid contaminating natural mineral water.

5.7.2 Except when necessary for hygienic or processing purposes, no substance

which could contaminate natural mineral water should be used or stored in
natural mineral water handling areas.

5.8 PerSónal Effects and Clothing

Personal effects and clothing should not be deposited in natural mineral water
handling areas.

SECTION VI - PERSONNEL HYGIENE AND HEALTH REQUIREMENTS

6.1 Hygiene Training

Managers of establishments should arrange for adequate and continuing training of

all natural mineral water handlers in hygienic handling of natural water
and in person hygiene so that they understand the precautions necessary to prevent
to prevent contamination of natural mineral water. Instruction should include
relevant parts of this Code.
6.2 Medical Examination
Persons who come in contact with natural mineral water in the course of their
work should have a medical examination prior to employment if the official
agency having jurisdiction, acting on medical advice, considers that this is
 ALINORM 85/13
- 63 - APPENDIX IV

necessary, whether because of epidemiological considerations or the medical

history of the prospective natural mineral water handler. Medic a l examination
of natural mineral water handler should be carried out at other times when
clinically Dr epidemiologically indicated.

6.3 Communicable Diseases

The management should take care to ensure that no person, while known or suspected
to be suffering from, or to be a carrier of a disease likely to be transmitted
through food or while afflicted with infected wounds, skin infections, sores or with
diarrhoea, is permitted to work in any natural mineral water handling area in any
capacity in which there is any likelihood of such a person directly or indirectly
contaminating natural mineral water with pathogenic micro-organisms. Any
person so affected should immediately report to the management that he is ill.

6.4 Injuries'

Any person who has a cut or wound should not continue to handle natural mineral
water or natural mineral water contact surfaces until the injury is completely
protected by a waterproof covering which is firmly secured, and which is conspicuous
in colour. Adequate first-aid facilities should be provided for this purpose.

6.5 Washing of Hands

Every person, while on duty in a natural Mineral water handling area, should wash his
hands frequently and thoroughly with a suitable hand cleaning preparation under running_
warm water in compliance with Section 7.3 of the Codex Code of Practice - General
Principle of Food Hygiene (CAC/RCP 1-1969 Rev. 1 (1979)). Hands should always be washed
before commencing work, immediately after using the toilet, after handling
contaminated material and whenever else necessary. After handling any material
which might be capable of transmitting disease, hands should be washed and
disinfected immediately. Notices requiring hand-washing should be displayed. There
should be adequate superv„ision to ensure compliance with this requirement.

6.6 Personal Cleanliness

Every person engaged in a natural mineral water handling area should maintain a high
degree of personal cleanliness while on duty, and should at all times while so. -
engaged wear suitable protective clothing including head covering and footwear, all
of which articles should be cleanable unless designed to be disposed of and should
be maintained in a clean condition consistent with the nature of the work in which
the person is engaged. Aprons and similar items should not be washed on the floor.
During periods where natural mineral water is manipulated by hand, any jewellery
that cannot be adequately disinfected should be removed from the hands. Personnel
should not wear any insecure jewellery when engaged in natural mineral water •
handling.

6.7 Personal Behaviour

Any behaviciur which could result in contamination of natural mineral:water, .- .s1.10 as

eating, use of tobacCo, chewing (e.g. - gum, sticks, betel nuts, etc.) or unhygienic
practices such as spitting, should be prohibited in natural mineral water handling •
areas.

6.8 Visitors

Precautions should be taken to prevent visitors to natural mineral water handling

areas from contaminating the product. These may include the use of protective clothing.
Visitors should observe the provisions recommended in paragraphs 5.8,.6.3, 6 .4 and
6.7 of this code.
 - 64-
ALINORM 85/13
APPENDIX IV

6.9 Supervision

Responsibility for ensuring compliance by all personnel with all requirements of

Sections 6.1 - 6,8,inclusive should be specifically allocated to competent
supervisory personnel.

SECTION VII - ESTABLISHMENT: HYGIENIC PROCESSING REQUIREMENTS

7.1 Raw Material Requirements

To guarantee a good and stable quality of natural mineral water, certain criteria
should be monitored regularly, e.g.

7.1.1 Spring discharge, temperature of the natural mineral water;

7.1.2 Appearance of the natural mineral Water;

7.1.3 Odour and taste of the natural mineral water;

7.1.4 The conductance of natural mineral water or any other adequate parameter;

7.1.5 The microbiological flora.

7.2 Should there be a perceptible lack in meeting the standards, the necessary
corrective measures are immediately to be taken.

7.3 Treatment

The treatment may include decantation, filtratión, airing and where necessary
application or offtake of carbon dioxide (CO2).

7.3.1 Processing should be supervised by technically competent personnel.

7.3.2 All steps in the production process, including packaging, should be

performed without unnecessary delay and under conditions which will prevent
the possibility of contamination, deterioration, or the development of
pathogenic and spoilage micro-organisms.

7.3.3 Rough treatment of containers should be avoided to prevent the possibility

of contamination of the processed product.

7.3.4 Methods of preservation and necessary controls should be such as to protect

against contamination or development of a public hea4h hazard and against'
deterioration within the limits of good commercial practice.

7.3.5 All contaminated equipment which has been in contact with raw materials
should be thoroughly cleaned and disinfected prior to being used in contact
with the end-products.

7.4 Packaging material and containers

7.4.1 All packaging material should be stored in a clean and sanitary manner.
The material should be appropriate for the product to be packed and for
the expected conditions of storage and should not transmit to the product
objectionable substances beyond the limits acceptable to the official
agency having jurisdiction. The packaging material should be sound and
should provide appropriate protection from contamination. Only packaging
material required for immediate use should be kept in the packing or
filling area.
 65-
ALINORM 85/13
APPENDIX IV

7.4.2 Product containers should not have been used for any purpose that may lead
to contamination of the product. Used containers, also new containers if
there is a possibility that they have been contaminated, should be cleaned
and disinfected. When chemical disinfectant is used, the container should
be rinsed as prescribed under 5.2.3. Containers should be well drained
after rinsing. Used and, when necessary, unused containers should be
inspected immediately before filling.

7.5 Filling and Sealing of Containers

7.5.1 Packaging should be done under conditions that preclude the introduction of
contaminants into the product.

7.5.2 The methods, equipment and material used for sealing should guarantee a
tight and impervious sealing and not damage the containers nor deteriorate
the chemical, bacteriological and organoleptic qualities of natural
mineral water.

7.6 Packaging of Containers

The packaging of containers should protect the latter from contamination and
damage and allow appropriate handling and storing.

7.7 . Lot Identification

Each container shall be permanently marked in code or in clear to identify the

producing factory and the lot. A lot is a quantity of food produced under identical
conditions, all packages of which should bear a lot number that identifies the
production during a particular time interval, and usually from a particular "line"
or other critical processing unit.

7.8 Processing and Production Records

Permanent, legible and dated records of pertinent processing and production details
should be kept concerning each lot. These records should be retained for a period
that exceeds the shelf life of the product, but unless a specific need exists they
need not be kept for more than two years. Records should also be kept of the initial
distribution by lot.

7.9 Storage and Transport of the End-Product

The end-product should be stored and transported under such conditions as will
preclude contamination with and/or proliferation of micro-organisms and protect
against deterioration of the product or damage to the container. During storage,
periodic inspection of the end-product . should take place to ensure that only natural
mineral water which is fit for human consumption is despatched and that end-product
specifications should be complied with when they exist.

7.10 Sampling and Laboratory Control Procedure

The following are intended as guidelines for testing the water at the source and at
critical control points:

Natural mineral water should contain no parasites and should be free from:
 - 66 -
ALINORM 85 / 13
APPENDIX IV

Incubation Method
Temperature

Coliforms 37 ° C 5 (x250 ml) 0 )

Faecal streptococci 37o c 5 (x250 ml) 0 0 )

Spore-forming ) ISO method if
sulphite-reducing ) they exist;
anaerobic bacteria 42 ° C 5 (x250 ml) 0 0 ) otherwise to
Pseudomonas ) be elaborated.
aeruginosa 42 ° C 5 (x250 ml) 0 0 )

Aerobic microbial counts; the maximum permissible total aerobic counts per
millilitre at 20-22 0 C and 37 ° C depend on the unique characteristics of the
source and should be fixed by the authority having jurisdiction.

SECTION VIII - END-PRODUCT SPECIFICATIONS

After bottling natural mineral water should be free from:

Incubation
c m Method
Temperature

Coliforms 37°C 5 (x250 ml) ) As for European

Aerobic microbes ) Regional
capable of multi- ) Standard
plying on x 10 ) (See Annex I)
diluted plate )
count agar 42 ° C 5 (x250 ml) 0 0 )
 - 67 - ALINORM 85/13
APPENDIX V

PROPOSED DRAFT AMENDMENT TO THE RECOMMENDED INTERNATIONAL CODE OF PRACTICE

FOR EGG PRODUCTS (CAC/RCP 15-1976) (AT STEP 3)
SECTION 2 - DEFINITIONS

Add:

Egg Products The content of eggs, as whole egg or only the yolk or only egg albumen or
a mixture of yolk and albumen in liquid, frozen or dried form, single or
in combination with other foods or drinks to a minimum content of 50%
egg product.

SECTION 3 - RAW MATERIAL REQUIREMENTS

Add new Sub-sections 3.3 and 3.4 as follows:

3.3 Handling In-shell Cracked Eggs on the Farm

3.3.1 Thin-shelled or hair cracked eggs or cracked eggs with shell membranes
intact should be carefully handled and packed in a separate container to prevent
breakage before delivery to the breaking plant.

3.3.2 If there is a danger that this type of egg will break during the transport
to the egg-breaking plants the following procedure should be followed.

3.3.3 Only clean hair cracked eggs (not washed) or clean cracked eggs (not
washed) with shell membranes intact may be broken on the farm.

3.3.4 This procedure should be in accordance with Section 4, Sub-section 4.4.4.1.

3.3.5 Egg products collected on the farm may not be strained nor be separated
into egg-yolk and egg-albumen.

3.3.6 This egg product should be collected in clean and, if necessary,

disinfected containers with suitable closures and should be chilled in accordance
with Sub-section 4.4.4.4, Section 4. This procedure should preferably be
performed in a separate room. The room used for the operation should be in
accordance with the requirement set forth in Sub-section 4.1.1.

3.3.7 All measures should be taken to protect the product from contamination.

3.3.8 The egg products should be collected and transported from the farm where
they are produced as soon as possible only to the egg product plant and
transported at a temperature between 0-5°C.

3.4 Handling In-shell Cracked Eggs at the Packing Station

3.4.1 The same procedures should be followed as prescribed in Sub-sections

3.3.2, 3.3.3, 3.3.4, 3.3.5, 3.3.6, 3.3.7 and 3.3.8.

Change present Sub-section 3.3 - Transportation to Sub-section 3.5 - Transportation.

SECTION 4 - PLANT, FACILITIES AND OPERATING REQUIREMENTS

Sub-section 4.4.4.1

Add the following (new indent):

After breaking, a centrifuge may be used to remove the last part of the egg albumen
out of the egg shells, but only eggs that have been washed with the method
described in Sub-section 4.4.4.2 may be centrifuged.

Sub section 4.4.4.5.1

- ,Add the following (new indent):

Egg product received from the farms or packing stations should be pasteurized in
the plant.
 - 68-

ALINORM 85/13
APPENDIX VI

THE MICROBIOLOGICAL SAFETY

OF

IRRADIATED FOOD '

Report of a meeting of the Board of the International Committee

on Food Microbiology and Hygiene (ICFMH) of the International
Union of Microbiological Societies (IUMS) * with participation
of WHO, FAO and IAEA, held in Copenhagen on 16 December 1982.

* The IUMS is a Non-Governmental Organization in official relationships with WHO.

 - 69 -
ALINORM 85/13
APPENDIX VI
I - INTRODUCTION

At ate request of FAO and WHO, this subject was considered at a meeting of
the Board of the International Committee on Food Microbiology and Hygiene (ICFMH) of
the International Union of Microbiological Societies (IUMS) on 16 December 1982. The
Board met at the Royal Veterinary and Agricultural University in Copenhagen. A list
of those present is given in Annex A.

The Chair was taken by Professor Mossel and Dr. Charles was asked to write
the Report.

Professor Mossel opened the meeting and welcomed and thanked the participants,
He described the role of ICFMH and its relationship to IUMS.

II - GENERAL DISCUSSION
,c
Dr. Kaferstein presented the views of FAO and WHO. These organizations hope
that irradiation of food, by reducing contamination with pathogenic micro-organisms
and food loss from spoilage, would contribute to achieving Health for All by the
Year 2000 by improving both food safety and nutrition. This could only be done if
irradiation of food did not of itself create a health hazard. The Joint FAO/IAEA/WHO
Expert Committee on the Wholesomeness of Irradiated Food (JECFI) (3) concluded in 1980
that the irradiation of any food commodity up to an overall average dose of 10 kGy
(1Mrad) presents no toxicological hazard and does not introduce special nutritional
or microbiological problems. However,.concerns about the effects of irradiation on
micro-organisms in food had been raised by Dr. Charles and others at the Food Hygiene
Committee of the Codex Alimentarius Commission in 1979 (ALINORM 79/13A and ANNEX B to
this Report). Was the Board able to say if these microbiological concerns were
justified or if sufficient scientific research had given results which could alleviate
these concerns? It was important that a definitive answer should be given, since the
International Organizations did not want to promote irradiation of food and then have
to change their minds after its widespread use for several years.

Mr. Hutchinson briefly described the Codex Alimentarius procedure, including the
roles of the Food Additives Committee and the Food Hygiene Committee. In 1979 this last
had noted that the upper limit of 10kGy (1Mrad) established by the Codex Recommended
International General Standard for Irradiated Foods (4) represented sub-lethal low dose
irradiation,which raised certain concerns related to microbiological aspectsandpublichealth
considerations. Among these concerns were increased radiation resistance and increased
pathogenicity associated with genetic changes of surviving micro-organisms, and
destruction of vegetative cells only preventing competitive growth of spoilage
micro-organisms prior to the outgrowth of resistant organisms, e.g., Clostridium
botulinum spores. The Food Hygiene Committee had appointed an ad hoc Working Group,
but this had only looked at the problem caused by the suppression of spoilage flora,
which if felt,necessitated special care in handling irradiated food to ensure
refrigerated conditions of storage and transport in order to preclude the growth of
pathogens. The FAO and WHO now wanted an opinion from geneticists about the possibility
of a public health hazard from radiation induced mutation in surviving organisms.

In reply, Professor Mossel presented - a paper for discussion by the Board

(see ANNEX C to this Report). He stated that the problem of genetic mutation had
already been reviewed in 1975 by Ingram and Farkas and that they had not been able
to identify a hazard. He himself subsequently reviewed the evidence and substantiated
their concludions. He agreed that there could be a problem due to suppression of
spoilage organisms, but this was no greater than arose with other methods of partial
preservation, e.g., pasteurisation, salting, vacuum packing. Following all these
procedures, safety depended on proper temperature control of the treated food.

Professor Elias stated that he had provided the Boaid with copies of all
current relevant literature, including 65 reprints of papers published since 1980.
All this work had still not identified any hazard, but FAO and WHO needed positive
evidence and assurance that hazardous mutations had not occurred, Professor Mossel
stated that these doubts had at first been expressed in Karlsruhe in 1960; this had
led to the following action: there was initially the literature search by Ingram and
 - 70-
ALINORM 85/13
APPENDIX VI

Farkas confirmed by Professor Mossel himself in 1977. Direct research on genetics of

irradiated micro-organisms has been performed by Professor Idziak in Canada. ,Further
direct research was being carried out in Professor Mossel's laboratory. The
concluiion was that shifts in the surviving flora were similar to those which occur
after other sub-lethal treatment and if changes in attributes of micro-organisms
occured, these were all towards reduction in the hazards to health. These changes did
not make the micro-organisms unidentifiable or even significantly more difficult to
identify.

On behalf of the Joint FAO/IAEA Division, of Isotope and Radiation Applications

of Atomic Energy for Food and Agricultural Development, •Dr. Farkas expressed the
IAEA's view that the conclusions of the 1974 FAO/IAEA Consultant's Meeting on the
Microbiological Aspects of Food Irradiation, and the statements of the 1976 and 1980
reports of the Joint FAO/IAEA/WHO Expert Committee on the Wholesomeness of Irradiated
Food (JECFI) regarding the microbiological safety of irradiated foods are still valid
(2) (3) and no evidence has been found which shows the contrary. Furthermore, the
Codex Recommended International General Standard for Irradiated Foods and the
Recommended Code of Hygienic Practice for the Operation of Radiation Facilities
used for the Treatment of Foods (4) properly cover the food hygiene aspects of the
process. Nevertheless, as recommended by the 1980 JECFI, codes of technological
practice will be prepared for various food groups and the Food Preservation Section
of the IAEA has already contracted out technical.papers to this end. These codes
will be further developed following consultation with the Codex Officers in charge
of the General Standard of Irradiated Foods (now under revision) and the codes will
contain guidelines for the handling, irradiation and storage of foods treated with
sub-sterilising doses.

He pointed out that other adverse influences on micro-organisms, i.e., heating,

drying and ultra violet irradiation would also induce mutation. There was no evidence
of undesirable effects arising from the irradiation of medical products or as a result
of food irradiation which was already taking place in some countries, e.g., Japan,
though this was relatively limited in amount. Professor Elias pointed out that this
provided an answer to a problem indicated by Mr. Hutchinson (see ANNEX B to this
Report) that the problems were difficult to investigate because nobody, as far as he
knew, had studied all the surviving flora or irradiated foods. Dr. Farkas, however,
agreed with Mr. Hutchinson's point that it was not possible for food microbiologists
to study the full range of mutation of the heterogeneous micro-flora in food.

Mr. Hutchinson pointed out that the more widespread use of irradiation which
would allow the general clearance of the technique for use in food processing would
lead to a more extensive knowledge of the effects of irradiation on surviving microbial
flora than had been obtained from the present relatively limited experience of food
irradiation.

Professor Mossel said that his group has used the most modern means of analytical
microbiology to study as fully as possible all changes in the composition and
determinative traits of' the micro-flora surviving after irradiation of food and that
no adverse effects had been found.

Dr. Corry informed the Board that she had herself studied irradiation of micro-
organisms and had in addition received the views of Dr. T.A. Roberts of the Meat
Research Institute at Bristol, which she summarised. These all support the views
of Dr. Farkas and Professor Mossel that changes in the properties of microbes
tend to result in less rather than more virulent strains and that there is no more
difficulty in identifying the surviving micro-flora by standard microbiological
techniques than in an unirradiated population. It also needed to be remembered that
there is no selective pressure to encourage the continual survival in foods of strains
of increased virulence. Repeated expossure of survivors to sub-lethal radiation has
often been shown to select populations with enhanced resistance to radiation, but there
is no evidence that this can occur in the practical situation. Indeed, similar
increased resistance to other factors, such as heat, has been induced by comparable
methods in the laboratory (Corry and Roberts 1970 J.appl.Bact. 33 733-737). Exposure
to sunlight, ultra violet irradiation etc. must also cause mutation in microbes, yet
there is no evidence that mutants thus produced pose any particular hazard. Professor
Skovgaard pointed out that thousands of tons of feed for experimental animals are
 - 71 -
ALINORM 85/13
APPENDIX VI

irradiated every year, some sterilised and some pasteurised, and no problems have been
identified. Professor Elias asked if there was a risk of increased mycotoxin production
as there was some published experimental evidence of this. Professor Mossel stated that
the increase in mycotoxin production is more than balanced by the decrease in the number
of mycotoxin-producing organisms. Dr. Farkas added that this increase in mycotoxin
production is due to the reduction in concentration of these organisms and not to
genetic mutation; the same result can be obtained by reducing the innoculum size.

Dr. Charles pointed out that food of animal origin was normally cooked before
consumption and that this heat treatment was sufficient to destroy pathogens derived
from the food animals, such as Salmonella, Campylobacter and Yersinia. Irradiation of
the raw food would not affect spore bearing organisms present in the food, nor would it
prevent recontamination from a food handler, e.g., with Staphylococcus aureus or hepatitis
virus. Infection from these sources could only be prevented by adequate heat treatment
and the observance of other established hygienic precautions in the preparation and
storage of food. The consumer might well ask why it was then necessary to irradiate
the food, since irradiation did not provide any safeguard that could not be provided
by thorough cooking and irradiated food still had to be cooked and to be subject to
normal hygienic precautions. Furthermore, if there was any health risk due to the
induction of genetic mutations in micro-organisms, the mutagenic effects of irradiation
would be added to those of other unavoidable processes such as cooking.

The Board gave a firm and definitive reply that total reliance could never be
placed on kitchen hygiene, recontamination could occur after cooking, refrigeration
might be inadequate and in some cases, e.g., on a resting stomach, illness could occur
following the ingestion of very small numbers of micro-organisms. The use of ionising
radiation to reduce the numbers of vegetative forms of pathogens on raw food would
reduce the load of pathogens entering the food chain and complement the other hygienic
measures in reducing yet further the hazards of microbial foodborne disease. Not only
does irradiation of food create another barrier to the transmission of pathogenic
organisms through food, especially Gram negative organisms, but the survivors of
irradiation are usually more sensitive to heat, drying etc.
Dr. Corry and Dr. Bartl pointed out that modern methods of farming tend to
increase the load of Gram negative organisms in food animals, emphasising the need for
a process such as irradiation to reduce this load early in the food chain. Dr. Corry
also pointed out that Clostridium perfringens, although a spore former, was usually
present almost entirely as vegetative cells in meat, and that radiation would therefore
have a significant effect on their numbers. It was also observed by Dr.Farkas that,while
low dose irradiation did not eliminate either spores or viruses,it would reducetheirrmmbers.

III - CONCLUSIONS

The Board agreed with the views expressed in Professor Mossel's paper (see
ANNEX C to this Report). It had noted the concern of the Codex Committee on Food
Hygiene but, after analysing the scientific knowledge to date, it was.
satisfied that there was no cause for concern. Irradiation induced genetic mutation'
of pathogens in food did not create an increased hazard to health and in the.13oard's •
opinion there would.be,no qualitative difference between the kind of mutation inchiced*
by ionizing irradiation and that induced by any other paateuiization/partial - preservation
methods such as' heat treatment or vaccum drying.

Modern food handling technology was adequate to control problems created by

suppression of spoilage micro-organisms. Food irradiation was an important addition
to the methods of control of foodborne pathogens and did not present any additional
hazards to health.
 -

ALINORM 85/13 - 72 -
APPENDIX VI

IV - REFEREÑCES

Report of an FAO/IAEA Consultants' Meeting on Microbiological Aspects of Food

Irradiation, 16-19 December 1974, Vienna. (Document available on request from
Food Preservation Section, International Atomic Energy Agency, A-1011 Vienna,
P.O. Box 590, Austria).

WHO Technical Report Series No. 604 2977.

WHO Technical Report Series No. 659 1981
General Standard for Irradiated Foods
Code of Hygienic Practice for the Operation of Radiation Facilities
Used for the Treatment of Foods. (CAC/RCP 19 1979).
-

-0 •

1'
 - 73-
ALINORM 85/13
APPENDIX VI
ANNEX A
LIST OF 'PARTICIPANTS
Mr. V. Bartl, Counsellor at Large ICFMH, Laboratory of Hygiene, Safaricova 14, Prague 2,
Czechoslovakia

Mrs. Barbro Blomberg, Regional Officer for Food Safety, WHO Regional Office for Europe,
Scherfigsvej 8, UK 2100 Copenhagen, Denmark

Mr. Robert H.G. Charles, Department of Health and Social Security, Alexander Fleming
• House, Elephant and Castle, London SE1 6BY, England

Dr. Janet Corry, Ministry of Agriculture, Fisheries and Food, Food Science Division,
65 Romney Street, London SW1P 3RD, England

Professor Dr. P.S. Elias, Project Director, International Project in the Field of Food
Irradiation, Federal Research Centre for Nutrition, Postfach 3640, 7500
Karlsruhe 1, West Germany

Dr. J. Farkas, Project Director, International Facility for Food Irradiation Technology,
c/o Pilot Plant for Food Irradiation, P.O. Box 87, 6700 AB Wageningen,
the Netherlands

Mr. J.M. Hutchinson, Food Standards Officer, FAO/WHO Food Standards Programme, Via delle
Terme di Caracalla, 00100 Rome, Italy

Dr. F.K. Kgferstein, Responsible Officer, Food Safety Environmental Hazards and Food
Protection, Division of Environmental Health, World Health Organization,
1211 Geneva 27, Switzerland

Dr. A. Koulikovskii, Food Hygienist, Veterinary Public Health, Division of Communicable

Diseases, World Health Organization, 1211 Geneva 27, Switzerland

Professor D.A.A. Mossel, President of ICFMH, Department of the Science of Food of

Animal Origin, University of Utrech, Biltstraat 172, 3572 B.P. Utrecht,
the Netherlands

Professor Niels Skovgaard, Secretary and Treasurer to I.C.F.M.H., Royal Veterinary and
Agricultural University, Billowsvej 13, 1870 Copenhagen V, Denmark

Professor Dr. G. Terplan, Lehrstuhl fUr Hygiene und Technologie der Milch, Ludwig-
Maximilians-Universitlit MUnchen, 8000 MUnchen 40, Schellingstrasse 10/III,
West Germany

Mr. Bjarne Underdal, Professor of Veterinary Microbiology, Norges VetérinEerhOgskole,

Postbox 8146, Oslo 1, Norway
ALINORM 85/13
APPENDIX VI - 74 -
ANNEX B

CONCERNS REGARDING THE MICROBIOLOGICAL SAFETY OF FOOD

(Summarized by the FAO/WHO Secretariat of the Codex Alimentarius Commission)

The following is the substance of an FAO/WHO Inter-Secretariat letter written by

the Secretariat of the Codex Committee on Food Hygiene:

"The use of short wave irradiation to produce mutation in micro-organisms is a

well-known technique and has been used in a variety of the lower fungi and in bacteria
to produce, for instance biochemical "markers" so that genetic segregation and
recombination can be followed both through mitotic and meiotic cycles. Pontecorvo and
his co-workers made an extensive study of the genetics of Aspergillus nidulans using
mutants which were for the most part obtained by U.V. and X7irradiation (1). Macdonald
and Hutchinson used the same techniques to study recombination in Aspergillus niger and
penicillin producing strains of P. chrysogenum (2), (3) and (4).

Irradiation produced a wide number of mutations for requirements for amino-

acids, nucleotides and vitamins in otherwise prototroph species and also some strains
which were resistant to inhibitors such as acriflavin.

To obtain the highest number of mutants, irradiation doses were adjusted to

ensure near total kill of the cells (in the above cases fungal conidia) - in the small
percentage surviving the rate of mutation was very high. These techniques were
designed to select specific mutants but the irradiation must have induced many others
which fell outside the scope of the screening techniques used.

The use of irradiation to produce microbial strains for industrial purposes is

of course also well-known; mutation by U.V. and X-irradiation has given strains which
produce enormously increased yields of penicillin by comparison with the parent strains
and there are many other examples of the same kind: many vitamins and amino-acids are
produced micro-biologically by mutated strains. In some cases the normal metabolic
path ways are blocked and there is an accumulation of the desired end-products. In all
cases, screening of mutations has been designed to select only the strains required.
Many other mutations both morphological and biochemical are produced in an irradiation
programme which obviously go unnoticed and the way in which they have mutated cannot
be recorded.

The connection between this kind of directed irradiation and the ultra-short
wave irradiation used in the sterilizing of foods hinges on the following factors, in
the opinion of the Secretariat:

Maximum permissible doses of 10 MeV given in the Revised General Standard for
Irradiated Foods obviously cannot guarantee total kill of micro-organisms
present in a food.

Among the survivors of irradiation there is likely to be a high mutation rate.

Among mutations, there is a possibility of inducing genetic changes which may

be deleterious to haman health.

When the General Standard for Irradiated Foods was examined by the Codex
Committee on Food Hygiene, there was considerable concern expressed on a number of
issues. A resumé of these concerns expressed by delegations in full Committee appears
in paragraph 20 of the Report which reads as follows:

"It was noted that the upper limits of irradiation set by the Joint Expert
Committee on Food Irradiation (JECFI) which encompassed the eight specified
foods in the Draft General Standard for Irradiated Foods at Step 8, as referred
to the Food Hygiene Committee, was established to represent toxicological safety.
The Food Hygiene Committee noted that this upper limit also represented sub-
lethal, low-dose irradiation, which raised certain concerns related to
microbiological aspects and public considerations. Among these concerns involving
 - 75 - ALINORM 85/13
APPENDIX VI
ANNEX B
sub-lethal doses of irradiation were increased radiation resistance and
increased pathogenicity associated with genetic changes of surviving micro-
organisms, and destruction of vegetative cells only, preventing competitive
growth of spoilage micro-organisms prior to outgrowth of C. botulinum spores".

The ad hoc Working croup of the Committee which examined the Standard in
detail made the following more general comments:

"The Working Group noted with some concern that the irradiation processes
could lead to microbiological health hazards that are not of much significance
with current food technology. The concern is that the irradiation, particularly
when it is used to extend shelf life or to reduce or eliminate certain pathogens
will alter the current microbial ecology of foods and may therefore result in
the growth of pathogens to hazard levels without the concomitant development
of normal spoilage flora. While the foods currently proposed for irradiation
have codes of practice specifying that such foods should be held under
sufficiently refrigerated conditions as to preclude growth of pathogens,
extra care will have to be used with these irradiated foods to assure freedom
from such hazards when irradiated. Foods which do not have specific codes of
practice may well be proposed for such irradiation processes, and even where
such codes do exist, there is not automatic assurance that such codes will
always be followed. Therefore, irradiation proposals should be specifically
associated with codes of hygienic practice for each commodity. This could
most easily be done by close collaboration with the Food Hygiene Committee
and specific commodity committees".

The Codex Committee on Food Hygiene has raised problems which are very difficult
to investigate because no body as fa r as is known, has studied the surviving flora of
irradiated foods and to identify the full range of mutants produced by irradiation of
foods or even to select those with increased pathogenicity or toxin 'production would be
impossible.

The concern of the Codex Committee on Food Hygiene is a subject on which experts ,
should give an opinion. If necessary a Code of Practice could perhaps be elaborated
which would give advice on how irradiated foods could be handled in the household, in
restaurants and catering establishments to ensure that the greatest precautions
possible are taken against possible outgrowth on foods of micro-organisms which
survive irradiation.

REFERENCES

Pontecorvo G. et al 1953. The Genetics of Aspergillus nidulans. Advances in

Genetics, Vol. V, 141-238

Hutchinson, J. 1958. A first five marker linkage group identified by mitotic

analysis in the asexual Aspergillus Niger. Microb. Genet. Bull. 14 and 16.

Macdonald, K.D., Hutchinson, J.M. and Gillet, W.A. 1963.

"Isolation of auxotrophs of Penicinium chrysogenum and their penicillin yields"

"Heterokaryon studies and the genetic control of penicillin and chrysogenin

production in Penicillium chrysogenum"

"Formation and segregation of heterozygous diploYds between a wild-type strain

and derivatives of high penicillin yield in Penicillium chrysogenum"
J. Gen. Microbiol. 33 No. 3, 365-394

"Heterozygous diplons of Penicillium chrysogenum and their segregation Patterns".

Macdonald, K.D., Hutchinson, J.M. and Gillet, W.A. Genetica 36 (1965), 378-397

Report of the 16th Session of the Codex Committee on Food Hygiene 1979.
ALINORM 79/13A, paras 15-21 and APPENDIX VI.
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ALINORM 85/13
APPENDIX VI
ANNEX C

HEALTH HAZARDS OF MICROBIOLOGICAL NATURE INHERENT TO

FOODS IRRADIATED AT A LEVEL OF BELOW 10 KGY

Respected colleagues on the staff of FAO and WHO have requested the Committee's
Expert advice with respect to some facets of the microbiological wholesomeness of foods,
irradiated at the 4 10 kGy level for either radicidation or radurization purposes.
Clearly it is beyond the Committee's competence to deal at large with the discussions
which have unfortunately been raging for almost three decennia now: one group
advocating food irradiation as a marvel, the other depicting it as a monster, the latter
as a result of post-Hiroshima public paranoia of irrational fear for nuclear energy.
I suggest that we limit our advice to one specific aspect: are there conclusive or
at least persuasive data to support the verdict that irradiated foods present no
particular problems of a microbiological nature that can interfere with their acceptance
from the point of view of protection of the consumer against health risks.

In essence, I am generally opposed to applying the risk vs. benefit analysis

approach to problems of public health. Nonetheless, in the case of food irradiation,
and more specifically when considering radicidation of foods, there is a spectacular
benefit that we cannot and should not ignore. Unwarranted complacency has for too long
allowed raw foods of animal origin, such as pork, chicken and veal to be marketed in a
microbiological condition that can best be described as: perennial occurence of at
least one infective unit of Salmonella, Campylobacter or Yersinia per 100 cm2 .of every
commodity sold to the public. If this status of human food is compared to that of
petfoods which are required to be 'specific pathogen free' the divergence is at least
surprising. Fortunately, irradiation of prepacked portions of such meats with about
5 kGy is a promising approach to alleviating the problem. It should therefore,
definitely be considered for approval, together with other suitable decontamination
procedures (1) by health administrators. In addition a recent outbreak in Norway in
which over 120 patients were recorded who had contracted salmonellosis due to the
consumption of foods spiced with Brazilian pepper, containing Salmonella oranienburg
indicates another area of consumer protection that merits the attention of Health
Administrators (2). In summary, radicidation is a very effective tool for intervention
in some areas of microbiological safety of foods - a measure of prevention which is
long overdue (3).

As stressed before, the benefits of radicidation should not include such a

state of euphoria that caution with respect to perilous side effects is neglected.
What then are the real microbiological hazards menacing food radicidation and, by the
same token radurisation. The main concern has been the emergence of mutants that (i)
are of unprecedented pathogenicity or virulence; (ii) cannot be identified because of
loss of their determinative traits. This subject was most carefully reviewed, about
1975 by the late Professor M. Ingram and Dr. J. Farkas (4). These authors could not
substantiate claims of this nature. I was invited to review their evidence - in fact
a superfluous assignment, which I nonetheless accepted because the discipline of
Science should be truth and not authority. As expected, I found no fault with Ingram
and Farkaesdissertation. On the contrary, I substantitated their conclusions by
paying particular attention to the methodological aspects of the problem (5). It is
a well established practice to monitor foods processed for safety by the use of
"marker" (index and indicator) organisms. The use of marker organisms for this
purpose has been defended in an academic and eloquent and hence convincing way by
Sir Graham Wilson (6). Since then many public health bacteriologists have recognized
the merits of, and adopted this invaluable diagnostic tool. If marker organisms are
properly used for the assessment of adequate processing for safety all identified and
supposed risks of microbiological nature can be eliminated (7). My conclusion of 1977
therefore was that consumers and public health authorities alike can be reassured that
no microbiological hazards endanger the process of food irradiation at the 4 10 kGy
'level, used for radicidation or radurisation. Since 1977 I have not become aware of
any new experimental evidence to the contrary. While carefully monitoring the
literature in this area, as a part of our research on the ecological aspects of food
processing for safety in general (1).
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APPENDIX VI
ANNEX C

Another consideration is that radicidation and radurisation might change the

microbial community structure of fresh foods so that pathogens art able to multiply
to dangerous levels before the nórmal association flora develop and metabolise
sufficiently to spoil the food. I know of no evidence to show that this risk is
any greater that that posed by foods treated by e.g., heat where the same flora shift
occurs.

In Spite of all this, it would be utterly unwise not to listen attentively to

colleagues who apparently are concerned abOut this matter - despite the reassurance
expressed in the literature quoted before. It would be equally wrong not to be
prepared to carry out additional research when_really,tequired. However, in the latter
case both the nature of the problem, the experimental approach to be followed and the
Public Health impact of such data - reassuring or alarming - Should be most accurately
defined. If we fail to do precisely the latter in this Forum, we risk adding a
perennial fruitless discussion to our deplorable failure so far to protect the consumer
against food transmitted disease. I am convinced that if this situation were continued
this would greatly detract from the prestige Of Food Microbiology, a branch of Science
this Committee is supposed to foster instead of frustrating.

REFERENCES D,A.A. Mossel

Mossel, D.A.A. and vat Netten, P. 1982. Whither protection of the consumer
against enteropathogenic bacteria on fresh meats and poultry by processing for
safety. In: Food Irradiation Now. The Hague Martints Nijhoff. pp. 2-, 19.

Weekly Epidemiological Record 57, 329, 1982.

3 Mossel, D.A.A. and Kampelmacher, E.H. 1981. Prevention of salmonellosis.

Lancet I 208.

Ingram, M. and Farkas, J. 1977. Microbiology of foods pasteurised by ionising

radiation. Acta Alimentaria 6, 123-185.

Mossel, D.A.A. 1977. Health protection aspects of foód irradiation at

pasteurization level. Acta Alimentaria 6 253-262.

Wilson, G.S. 1935. Medical Research Council London, Special Report No. 206.

Mossel, D.A.A. 1981. Conform test for cheese and other foods. Lancet II,
1425.