Guidelines For The Interpretation of Microbiological Analysis of RTE Foods

Guidance Note
No.3
Guidelinesfor the
Interpretation of
Results of
Microbiological
Analysis of Some
Ready-To-Eat
Foods Sampled
at Point of Sale
fsai-guidance note 3 v3-15029 29/6/01 4:08 PM Page 3 Derek ALPHA:Desktop Folder:FSAI:FSAI-Guidance Note 3-15029:
Guidelines for the Interpretation of Results
of Microbiological Analysis
of Some Ready-To-Eat Foods
Sampled at Point of Sale
Published by:
Food Safety Authority of Ireland
Abbey Court
Lower Abbey Street
Dublin 1
Tel:+353 1 8171 300 Fax:+353 1 8171 301
Email:info@fsai.ie Website:www.fsai.ie
2001
Applications for reproduction should be made to the FSAI Information Unit
ISBN 0-9539183-5-1
Other Food Safety Guidance Notes available from
the Food Safety Authority of Ireland:
Guidance Note No 1 Inspection of a Food Business (2000)
ISBN 0-9539183-2-7
Guidance Note No 2 Classification of Food (2001)
ISBN 0-9539183-3-5
INTRODUCTION 1
BACKGROUND 2
MICROBIOLOGICAL CRITERIA 2
GUIDELINES FOR MICROBIOLOGICAL ENFORCEMENT 3
READY-TO-EAT FOODS 4
INTERPRETATION OF GUIDELINES 4
REVISED GUIDELINES 4
MICROBIOLOGICAL QUALITY LEVELS 5
INDICATOR ORGANISMS 6
PATHOGENS 7
TABLE 1:GUIDELINES FOR THE MICROBIOLOGICAL QUALITY 8
OF SOME READY-TO-EAT FOODS AT POINT OF SALE
TABLE 2: AEROBIC COLONY COUNT CATEGORIES FOR 9
DIFFERENT TYPES OF READY-TO-EAT FOODS
REFERENCES 11
ACKNOWLEDGEMENTS 12
Contents
The Food Safety Authority of Ireland Act, 1998, facilitated the establishment of the Food
Safety Authority of Ireland (FSAI) to perform the functions assigned to it by this Act. The
principal function of the Authority shall be to take all reasonable steps to ensure that:
(a) food produced in the State (whether or not distributed or marketed in the State),
and
(b) food distributed or marketed in the State,
meets the highest standards of food safety and hygiene reasonably attainable and it shall, in
particular, take all reasonable steps to ensure that such food complies:
1) with any relevant food legislation in respect of food safety and hygiene standards, or
2) in the absence of any such legislation, with the provisions of generally recognised
standards or codes of good practice aimed at ensuring the achievement of high
standards of food hygiene and food safety.
The FSAI believes that Guidance Notes have a major role to play in helping both the
regulators and the food industry achieve a higher degree of compliance with Regulations
and with good practice generally. A good, well prepared, Guidance Note must, if it is to
achieve these objectives, provide regulators and industry alike with clear guidance towards
the application of the relevant legislation. While a Guidance Note is not, of course, a
substitute for the Regulations, the FSAI believes that adherence to it should make
compliance easier by providing the basis for a high degree of consistency in application of
those Regulations.
We hope this series of Guidance Notes will meet the aims we have set out here and that
they will contribute to the development of the high standards we aim to achieve in the food
inspection services.
Introduction
1
Background
The Microbiology Sub-committee of the Food Safety Authority of Ireland has undertaken a
review of the microbiology guidelines for some ready-to-eat foods sampled at point of sale
as they appear in the 1995 report of the former Food Safety Advisory Committee
1
.
The 1995 guidelines were adapted from guidelines published by the UK Public Health
Laboratory Service (PHLS) in 1992
2
. The revision and expansion of the PHLS guidelines in
1996
3
and subsequent revision in 2000
4
, have necessitated the current review by the
Microbiology Sub-committee.The following guidelines draw heavily on those of the PHLS.
This document does not purport to have any legal standing.The microbiological criteria
listed in Table 1 are not statutory standards. Revisions to these guidelines will continue to
be made as experience is gained of their value in practice and as additional information
becomes available.
In addition to these guidelines for ready-to-eat foods sampled at point of sale, there is a
supporting document that contains relevant material
5
.The supporting document broadly
describes the approach to establishing microbiological criteria and food sampling plans for
all foods sampled at any point in the food chain. It also includes a summary of the
microbiological criteria (standards and guidelines) as listed in current EU legislation.
Microbiological Criteria
Microbiological criteria are essentially of three types: guidelines, standards and
specifications.These terms were originally defined by Codex Alimentarius
6
and have since
been redefined both by Codex and other international organisations. They can be described
as follows:
A microbiological guidelineis a criterion which relates to the microbiological
condition of the food sample that is applied at any stage of food processing and
retailing. It aids in identifying situations requiring attention for food safety or quality
reasons. Guidelines arise from many sources - the food industry, enforcement
agencies and, national and international committees, and are especially applied to
indicator organisms. While guidelines may be written in law they are not legally
enforceable, but serve to provide assistance to enforcement agencies in interpreting
whether producers are complying with the general policy in relation to standards.
2
Guidelines can both complement legally enforceable standards and provide a
benchmark in the situations where standards are not considered necessary. A
persistent and widespread breach of the guidelines could be an indication of
poor manufacturing or handling practice. Guidelines also provide a benchmark against
which unacceptable microbial contamination of food can be identified. Guideline
levels for microbiological hazards are proposed as a mechanism to identify
the maximum level of contamination that is reasonably acceptable and to
provide a trigger for remedial action when these levels are exceeded.
An adverse health effect is not an inevitable consequence of consumption of foods
containing microorganisms above the guideline levels. However, the presence of
microorganisms above the guideline levels does indicate that human exposure to
particular micro-organisms may occur at undesirable and preventable levels.
A microbiological standardis a microbiological criterion contained in a law where
compliance is mandatory. The food industry must ensure full compliance with these
standards which are monitored by enforcement agencies.
A microbiological specificationis a microbiological criterion applied to raw
materials, ingredients or the end-product which is used in a purchase agreement.
Specifications are set by purchasers and are usually more stringent than
microbiological standards in order to provide an extra margin of safety.
Guidelines for Microbiological Enforcement
The purpose of these guidelines is to provide authorised officers with assistance in
determining the microbiological quality of various ready-to-eat foods sampled at point of
sale. Traditionally, in enforcement situations, microbiological examination has played an
important role in evaluating the microbiological safety of food. Food inspection services
generally rely on the examination of single food samples rather than statistically based
sampling plans. The results from single sample examination may provide evidence that food
hygiene regulations have been contravened or provide the basis for additional inspection
and/or food sampling. They may also give valuable baseline data (usually where samples form
part of a specific survey) which can be used for trend analysis. Where there is routine
sampling, the choice of food to be sampled will vary according to the local need, and the
occurrence of cases and outbreaks of foodborne illness in the area or nationally.
3
Ready-to-Eat Foods
All composite foods purchased by or supplied to a consumer for their consumption and
which do not require significant further processing other than re-heating or completion of
a cooking process are included in the ready-to-eat category. If not consumed immediately,
these foods usually require refrigeration to ensure shelf-life. There is considerable variation
in the composition of ready-to-eat foods. They range from those containing some
ingredients that are uncooked, such as sandwiches, to those that are cooked immediately
prior to being provided to the consumer. A list of the more common ready-to-eat foods
and their categories are outlined in Table 2. Excluded categories include low water activity
foods and other ambient temperature stable foods such as jams, canned food, cured food
and food preserved by pH reduction (including pickled foods).
Interpretation of Guidelines
The figures given in Table 1 are guidelines and not statutory microbiological standards.
These guidelines have no legal standing. They are intended for use by food examiners and
authorised officers. They may be used to monitor the microbiological quality of a food. The
microbiological criteria used in the guidelines can be of prime importance in deciding if a
food is unfit or in reinforcing other observations, such as breaches in operational hygiene,
and providing reasons to suspect a food may not meet sound public health and hygiene
standards. It should be noted that the specification of a criterion for a particular organism
does not imply that all foods should be examined for that organism as a matter of routine.
Authorised officers should be aware that a number of EU directives contain microbiological
criteria for a variety of foodstuffs. Some of these criteria may apply to ready-to-eat foods
sampled at point of sale. For convenience, these directives and their criteria are
summarised in the supporting document.To ensure correct application of these criteria,the
current legislation must be read. In addition, it should be noted that the European
Commissions Scientific Committee on Veterinary Measures Relating to Public Health has
recently evaluated the legal standards and has expressed an opinion on possible changes
7
.
Revised Guidelines
The following changes have been included in the revised guidelines:
1. The term aerobic plate count has been renamed aerobic colony count and is based
on incubation at 30
o
C for 482h.
4
2. Five categories of ready-to-eat foods have been identified (Table 2). To avoid
confusion with the 21 EU categories
8
(designated by the numbers 1-21) from the
guidelines on Article 14 of Directive 89/397/EEC, the five ready-to-eat categories in
this document are designated by the upper case letters A to E. The first four
categories are based on a range of aerobic colony counts expected according to
the type of product and the processing it has received. The fifth category refers to
certain fermented foods for which guidelines for aerobic colony counts may not be
applicable. Only foods for which sufficient microbiological data exist are listed in
Table 2. When a food which is not listed is submitted for analysis, the food should
be assessed as to which of the five categories it best fits into - based on the type of
product, the processing it has received and the potential for microbial growth
during storage.
3. Four quality levels remain, but the term fairly satisfactory has been renamed
acceptable. Hence, the four categories are satisfactory,acceptable,
unsatisfactory, and unacceptable/potentially hazardous (see below).
4. New or modified criteria have been included for Enterobacteriaceae,Escherichia coli,
Listeria spp.,E.coli O157 and other verocytotoxigenic producing E.coli (VTEC), Vibrio
cholerae,V.parahaemolyticus,Clostridiumperfringens,Bacillus cereusand other pathogenic
Bacillusspp. (see sections on indicator organisms and pathogens).
Microbiological Quality Levels
The classification of satisfactory means that the test results indicate good
microbiological quality.
The classification of acceptable is suggested to take account of the limitations in
microbiological sampling, handling, testing and wide confidence limits in enumeration.
Due to these factors, some samples will fall between what is considered satisfactory
and unsatisfactory.
Samples in the unsatisfactory category indicate that the acceptability threshold has
been exceeded. Further sampling may be necessary and the authorised officer may
wish to carry out a detailed inspection of premises, food production and handling
processes to determine whether hygiene practices for food production or handling
are inadequate. The judgement of the authorised officer and the observation of
trends will indicate the level of response. In general, the ready-to-eat guidelines are
similar to or less stringent than the microbiological standards in the relevant EU
Directives
5
. If an authorised officer suspects that the product may be in breach of
5
the legal criteria, they are advised to consult the relevant directive and inform the
relevant authorised officer under the directive in force. There are examples where
the ready-to-eat guidelines are more stringent than the criteria in the EU Directives.
As these examples only relate to the unsatisfactory category and not to the
unacceptable/potentially hazardous category, the issue of possible withdrawal under
the ready-to-eat guidelines should not arise (see definition of the
unacceptable/potentially hazardous category).
The numbers quoted under the heading unacceptable/potentially hazardous
represent a potential health hazard to those consuming such food. Samples falling in
the unacceptable/potentially hazardous category should prompt a rapid response
by the authorised officer and a detailed assessment should take place. Product
withdrawal should be an option to be considered in this category only.
Indicator Organisms
Enterobacteriaceaeare included in the revised guidelines as they are useful indicators
of hygiene and post-processing contamination of heat processed foods. Coliforms
have been the traditional indicator group in this context. Coliforms are those
members of the Enterobacteriaceaethat ferment lactose and include Enterobacter,
most Escherichia,Klebsiellaand Citrobacter. Tests for coliform bacteria will only detect
organisms capable of fermenting lactose. If large numbers of non-lactose-fermenting
bacilli are present, reliance on tests for coliform bacteria may lead to falsely
reassuring results. In addition, many food pathogens do not ferment lactose.
Enterobacteriaceaeis a broader term and includes Escherichia spp., Citrobacter spp.,
Enterobacter spp.,Proteus spp.,Salmonella enterica spp.,Shigella spp., and Yersinia spp..
Thus, examining a sample for the presence of members of the family
Enterobacteriaceaeinstead of coliforms may give a better indication of the likelihood
of the presence of pathogens, as well as providing more accurate information about
the handling and storage of the foodstuff. It should be noted that this test is not
applicable to fresh fruit, vegetables and salad vegetables.
The criteria for Escherichia coli (total) and Listeriaspp.(total) have been modified.
Quantitative quality levels in the unacceptable/potentially hazardous column
have been deleted (Table 1). Additionally, Listeriaspp. has been modified to include
L.monocytogenesbecause of the changes to the quantitative criteria for
L.monocytogenes(see below).
6
7
Pathogens
E.coli O157 and other VTEC have been included.
Vibrio choleraehas been included because the European Commission has made
several decisions in response to the isolation of this organism from various imported
ready-to-eat foods, mainly fishery products and, fruits and vegetables. Vibrio cholerae
O1 and O139 are the two serogroups responsible for disease. V.parahaemolyticusin
seafood has been retained, but the quantitative quality levels have been modified.
The quantitative quality levels for Listeria monocytogeneshave been modified and the
classification of unsatisfactory is now not applicable in this case. The value of 10
2
cfu/g at point of sale/consumption represents a potential risk to health according to
a number of recent opinions and published reports
6
. It is recognised that some
serotypes/phage types of L.monocytogenesmay rarely be associated with human
infection, however their presence reflects an inadequate level of hygiene.
The European Commission is currently drafting a decision on the control of
L.monocytogenesin ready-to-eat foods. This decision will include zero tolerance for
some ready-to-eat foods and will take precedence over these guidelines.
The Clostridiumperfringensquantitative quality level for the satisfactory category is
now <20 cfu/g to bring it in line with the levels for other gram positive pathogens.
The microbiological criteria have been altered for the Bacillus cereusand other
pathogenic Bacillusspp. to take account of the minimum infective dose (of >10
5
/g) in
the case of the diarrhoeal disease. In the case of the emetic disease, the minimum
number of cells required in a food to produce the minimum intoxication dose is also
>10
5
/g. When present in foods, B.cereusis usually at concentrations of <10
3
/g.
Bacillusspecies other than B.cereus, notably those of the B.subtilus-licheniformis group,
have also been implicated in outbreaks of food poisoning from meat and pastry
products and, meat or seafood rice dishes. This group is now included in the revised
guidelines. Initial isolation and enumeration procedures are similar to those for
B.cereusand biochemical tests are necessary for confirmation.
Table 1:Guidelines for the Microbiological Quality
of some Ready-To-Eat Foods at Point of Sale
Food Category
(see Table 2)
Criterion
Satisfactory Acceptable
Microbiological quality
(cfu per gram unless otherwise stated) (a)
Unsatisfactory
(b)
Unacceptable/
potentially
hazardous
(c)
8
(a) For a detailed explanation of the categories of microbiological quality see page 6.
(b) Further sampling may be necessary and the authorised officer may wish to initiate a detailed inspection by the
relevant authorised officer of premises,food production and handling processes to determine whether hygiene
practices for food production or handling are inadequate.
(c) Product withdrawal should be an option to be considered in this category only.
(d) Guidelines for aerobic colony counts may not apply to certain fermented foods - e.g. salami, soft cheese and
unpasteurised yoghurt. These foods fall into Category E (see Table 2). Acceptability is based on appearance,
smell, texture and the levels or absence of indicator organisms or pathogens.
(e) On occasion some strains may be pathogenic.
(f) Enterobacteriaceae are indicators of hygiene and of post-processing contamination of heat processed foods.
They are not applicable to fresh fruit, vegetables and salad vegetables.
(g) Relevant to seafood only.
(h) Not detected in 25g for certain long shelf-life products under refrigeration, such as soft ripened cheese,
vacuum packed pat and sliced meats.
(i) If the Bacilluscounts exceed 10
4
per gram, the organism should be identified.
N/A Denotes not applicable.
Aerobic colony count (d)
30
o
C / 48h
A <10
3
10
3
-<10
4
>10
4
N/A
B <10
4
10
4
-<10
5
>10
5
N/A
C <10
5
10
5
-<10
6
>10
6
N/A
D <10
6
10
6
-<10
7
>10
7
N/A
E N/A N/A N/A N/A
Indicator organisms(e)
A-E Enterobacteriaceae(f) <100 100-<10
4
>10
4
N/A
A-E Escherichia coli (total) <20 20-<100 >100 N/A
A-E Listeriaspp. (total) <20 20-<100 >100 N/A
Pathogens
A-E Salmonellaspp Not detected Detected
in 25g in 25g
A-E Campylobacter spp. Not detected Detected
in 25g in 25g
A-E E.coli O157 & other VTEC Not detected Detected
in 25g in 25g
A-E Vibrio cholerae Not detected Detected
in 25g in 25g
A-E Vibrio parahaemolyticus (g) <20 20-<100 100-<10
3
>10
3
A-E L.monocytogenes <20 (h) 20-<100 N/A >100
A-E Staphylococcus aureus <20 20-<100 100-<10
4
>10
4
A-E Clostridiumperfringens <20 20-<100 100-<10
4
>10
4
A-E Bacillus cereus& other
pathogenic Bacillusspp. (i) <10
3
10
3
-<10
4
10
4
-<10
5
>10
5
9
Table 2:Aerobic Colony Count Categories for Different Types of Ready-To-Eat Foods
Food Group Product Category
(A-E)
Dairy cheese E
ice-cream, milk shakes (non-dairy) B
ice lollies, slush and sorbet B
yogurt/frozen yogurt (natural) E
Dessert cakes, pastries, slices and desserts - with dairy cream C
cakes, pastries, slices and desserts - without dairy cream B
cheesecake E
mousse/dessert A
tarts, flans and pies B
trifle C
Meat beefburgers A
ham - raw (e.g. Parma) E
kebabs B
meat meals (shepherds/cottage pie/casseroles) B
meat pies (steak and kidney, pastry) A
meat, sliced (beef, pork, poultry) C
meat, sliced (cooked ham, tongue) D
pork pies A
poultry (unsliced) B
salami and fermented meat products E
sausage roll A
sausages (smoked) E
scotch egg A
Ready-to-Eat pasta/pizza B
Meals meals (other) B
Sandwiches and with cheese E
Filled Rolls with salad E
without salad D
Savoury bean curd E
bhaji (onion, spinach, vegetable) A
cheese-based bakery products B
fermented foods E
flan/quiche B
homous, tzatziki and other dips D
mayonnaise/dressings B
pat (meat, seafood or vegetable) C
samosa B
satay C
spring rolls C
10
Table 2:Aerobic Colony Count Categories for Different Types of Ready-To-Eat Foods
Food Group Product Category
(A-E)
Seafood crustaceans (crab, lobster, prawns) C
herring and other raw pickled fish A
molluscs and other shellfish (cooked) D
other fish (cooked) C
seafood meals C
smoked fish D
taramasalta D
Vegetable coleslaw C
fruit and vegetables (dried) C
fruit and vegetables (fresh) E
prepared mixed salads and crudits D
rice C
vegetables and vegetable meals (cooked) B
11
References
1 Food Safety Advisory Committee (1995). Microbiological Standards Limits and
Guidelines for Foods. Report to the Minister for Health and the Minister for
Agriculture, Food and Forestry (Stationary Office, Dublin). Report No. 21,April 1995.
2 Public Health Laboratory Service (1992). Provisional microbiological guidelines
for some ready-to-eat foods sampled at point of sale. Notes for PHLS examiners.
PHLS Microbiological Digest 9:98-99.
3 Public Health Laboratory Service (1996). Microbiological guidelines for some
ready-to-eat foods sampled at the point of sale:an expert opinion from the PHLS.
PHLS Microbiology Digest 13, (1), 41-43.
4 Public Health Laboratory Service (2000). Guidelines for the microbiological
quality of some ready-to-eat foods at the point of sale. Comm Dis Public Health 3,
(3), 163-167. http://www.phls.co.uk/publications/CDPHvol3/No3/cdph0300.pdf
5 Microbiology Sub-committee (2001). Material Relevant to Guidelines for the
Interpretation of Results of Microbiological Analysis of Some Ready-To-Eat Foods
Sampled at Point of Sale. Food Safety Authority of Ireland.
6 Codex Alimentarius Commission (1981). Report of the 17th Session of the
Codex Committee on Food Hygiene,Washington DC. 17-21 November 1980.
ALINORM 81/13 Appendix II. Codex Alimentarius Commission, FAO Rome.
7 Scientific Committee on Veterinary Measures relating to Public Health
(1999). Opinion on L.monocytogenes. European Commission. Health & Consumer
Protection Directorate-General. Directorate B - Scientific Health Opinions.
http://europa.eu.int/comm/food/fs/sc/scf/out63
_
en.pdf
8 Guidance Note No.2,Classification of Food (2001). Food Safety Authority
of Ireland.
12
Acknowledgements
The Food Safety Authority of Ireland is most grateful for the advice and co-operation
of the Public Health Laboratory Service Environmental Surveillance Unit of the
Communicable Disease Surveillance Centre at Colindale, London, UK in the
preparation of these Guidelines. The FSAI is particularly grateful for the
categorisation of foods (Table 2) which is the result of the work of that Unit.
Notes
Notes
Notes
Food Safety Authority of Ireland
Abbey Court, Lower Abbey Street,
Dublin 1
dars Sbhilteachta Bia na hireann
Cirt na Mainistreach, Srid na Mainistreach ocht.,
Baile tha Cliath 1
Telephone:+353 1 817 1300
Facsimile:+353 1 817 1301
E-mail:info@fsai.ie
Website:www.fsai.ie
ISBN 0-9539183-5-1

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