Guidelines for Assessing the Microbiological Safetyof Ready-to-Eat Foods Placed on the Market

Authorship

These guidelines for assessing the microbiologicalsafety of ready-to-eat foods have been revised andwritten by a Health Protection Agency Working Groupand chaired by Professor Eric Bolton.

Working Group members • Professor Eric Bolton (Chair)

HPA Regional Microbiology Network• Dr Christine Little (Secretariat)

HPA Centre for Infections• Dr Heather Aird

HPA Regional Microbiology Network• Ms Melody Greenwood

Microtech Services (Wessex) Ltd• Dr Jim McLauchlin

HPA Regional Microbiology Network• Dr Richard Meldrum

NPHS Wales• Dr Susanne Surman-Lee

HPA Regional Microbiology Network• Dr Grahame Tebbutt

HPA Regional Microbiology Network• Dr Kathie Grant

HPA Centre for Infections

AcknowledgementsDrs Robert Mitchell and Satnam Sagoo (HPA Centre forInfections) for their contribution at an earlier time tothe revision of these guidelines.

Further informationFor further information on these guidelines, pleasecontact Dr Jim McLauchlin, HPA Regional MicrobiologyNetwork,e-mail: jim.mclauchlin@hpa.org.uk orFWELabs@hpa.org.uk

CitationHealth Protection Agency. Guidelines for Assessing theMicrobiological Safety of Ready-to-Eat Foods. London:Health Protection Agency, November 2009.

Abbreviations

ACC Aerobic colony countBRC British Retail ConsortiumCFA Chilled Food Associationcfu/g Colony forming units per gramEC European CommissionEN European NormEU European UnionFBO Food business operatorFSA Food Standards Agencyg GramGHP Good hygiene practiceHACCP Hazard analysis and critical control point HPA Health Protection AgencyHUS Haemolytic uraemic syndromeIBS Irritable bowel syndromeISO International Organization for StandardizationKg KilogramLACORS Local Authorities Co-ordinators

of Regulatory ServicesMAP Modified atmosphere packagingMg MilligramMPN Most probable numberNPHS National Public Health Service for WalesTTP Thrombotic thrombocytopaenic purpuraUHT Ultra high temperatureUK United KingdomVT VerocytotoxinVTEC Verocytotoxin-producing Escherichia coliYrs Years

Table of contents

Section 1. Introduction 41.1 Purpose of the guidelines 41.2 Scope of the guidelines 41.3 Intended use of the guidelines 41.4 Commission Regulation on microbiological criteria for foodstuffs 5

Section 2 Pathogens 62.1 Introduction 62.2 Detection of pathogenic micro-organisms in ready-to-eat food 62.2.1 Campylobacter species (thermotolerant) 62.2.2 Escherichia coli O157 and other verocytotoxin-producing E. coli (VTEC) 62.2.3 Salmonella species 62.2.4 Shigella species 62.2.5 Vibrio cholerae 72.3 Enumeration of pathogenic micro-organisms in ready-to-eat food 72.3.1 Bacillus cereus 82.3.2 Bacillus species (other pathogenic Bacillus) 82.3.3 Clostridium perfringens 82.3.4 Listeria monocytogenes 82.3.5 Staphylococcus aureus and other coagulase-positive staphylococci 92.3.6 Vibrio parahaemolyticus 102.4 Foodborne pathogens and risk of disease 102.5 Specialist and reference tests 10

Section 3 Hygiene Indicator Organisms 123.1 Introduction 123.2 Enterobacteriaceae 123.3 Escherichia coli 123.4 Listeria species 12

Section 4 Aerobic Colony Counts 144.1 Introduction 144.2 ACC levels in various ready-to-eat foods 14

Section 5 Supplementary Advice on Use of the Guidelines 155.1 Microbiological methodology 155.2 Environmental samples 16

Section 6 Tables 16Table 1 Guidance on the interpretation of results for detection of bacterial pathogens

(the hazard) in ready-to-eat foods placed on the market 17Table 2 Guidance on the interpretation of results for enumeration of bacterial pathogens (the hazard)

in ready-to-eat foods placed on the market 18Table 3 Major features of foodborne diseases due to selected pathogens 22Table 4 Guidance on the interpretation of results for hygiene indicator organisms in ready-to-eat

foods placed on the market 24Table 5 Guidance on the interpretation of results for aerobic colony count levels in various ready-to-eat

foods and components placed on the market 26

Glossary 28

References 30

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SECTION 1

Introduction

1.1 Purpose of the guidelines In pursuit of the Health Protection Agency’s (HPA) goal ofpreventing and reducing the incidence and consequencesof infection1, the HPA examines foods from Local and PortHealth Authorities to help safeguard consumer health.These foods include samples submitted for surveillanceand monitoring, for official control purposes, and thosetested as part of outbreak investigations. From this workthe HPA has accumulated a wealth of data both on themicrobiological results and, crucially, on theirinterpretation. This information was captured andpromulgated in three previous sets of these guidelines2-4

for practical use by Food Examiners and Local AuthorityEnforcement Officers. These revised guidelines supersedethose previously issued and have a different emphasisfocusing on public health and consumer protection.Additional information on the bacteria that causefoodborne disease and those that act as hygieneindicators, on interpretation of test results, comments onpoor practices that are likely to have contributed toadverse results and suggested appropriate public healthactions, are now included.

The use of microbiological criteria as risk managementtools should only be applied when they can be shown tobe effective and can contribute to the provision of safeproducts5-7. Microbiological testing alone cannotguarantee the safety of food and microbiological criteriashould be used to support Good Hygienic Practice (GHP)and Hazard Analysis and Critical Control Point (HACCP)systems. The food industry has a duty to ensure thatmicro-organisms are eliminated or minimized to the extentthat they cannot cause harm to human health8, andofficial controls are in place to audit compliance by foodbusiness operators (FBOs)9.

1.2 Scope of the guidelines Food within the scope of the revised guidelines includesready-to-eat food sampled within the retail chain, e.g.retail, wholesale, distribution and food service sectors (asdefined by Regulation (EC) No. 178/200210). This includesfood components, such as herbs and spices, where theyare added to foods without further cooking or processing.The guidelines for pathogens also apply to food poisoninginvestigations in all settings including domesticenvironments. Criteria are also applied for bacteria thatindicate possible poor hygiene and/or substandardpractices. In some circumstances these guidelines may alsobe used to assess more fully the safety and quality of foodtaken from the producer’s premises. Although potablewater is now defined as food this matrix is not addressed

in these guidelines as there is relevant legislation andguidance that covers this commodity11-14. For some ready-to-eat foods (sampled from production and/or onthe market) statutory criteria exist and these food safety orprocess hygiene criteria are laid down in Regulation (EC)No. 2073/2005 (as amended) including sampling plans,analytical methods, and corrective actions15,16.

Local Authorities and Port Health Authorities areresponsible for food safety checks on imported foods atpoints of entry (e.g. Border Inspection Posts and otherdesignated Points of Entry). The revised guidelines alsoapply to ready-to-eat imported food, including both thosesourced from within the European Union (EU) as well asfrom countries outside of the EU.

These guidelines do not take precedence overmicrobiological criteria within European or nationallegislation (see section 1.4) but serve to complementlegally enforceable standards and provide an indication ofthe microbiological safety for foods where standardscurrently do not exist. Investigative action is required toidentify and rectify the cause for those foodstuffs notcompliant with microbiological food safety criteria and/orwhere there is a perceived risk to public health. Theseguidelines should therefore not be used to interpret theresults of microbiological parameters which are part ofstatutory regulations. To safeguard public health, however,additional tests on ready-to-eat foods not covered by theregulations may be considered appropriate. Food samplestaken at producer premises as part of inspections by localenforcement officers would be expected to givesatisfactory results for all parameters and any deviationshould be investigated.

1.3 Intended use of the guidelines These guidelines are for use by Food Examiners andenforcement officers in identifying situations requiringinvestigation for public health or food safety reasons, andare applicable to the following types of samples:• Samples collected during predefined sampling

programmes such as the Local Authorities Co-ordinatorsof Regulatory Services (LACORS)/HPA national microbiological food studies17;

• Samples taken at or during food inspections;• Samples taken to confirm previous adverse findings in

order to determine the scale of microbiological contamination;

• Samples collected during investigations of suspected outbreaks of disease;

• Samples submitted after complaints.

All of the types of samples listed above are usually singlesamples and are not associated with any formal samplingplan. Any follow up studies which require testing under theregulations should be done in accordance with the

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requirements of the regulations. Follow up testing is bestdone in conjunction with advice from a Food Examiner18,19

or other appropriately qualified food microbiologist toensure that the most appropriate testing, which mayinclude environmental sampling, is performed.

When using the microbiological criteria within theseguidelines, the food type concerned (including its intrinsicproperties such as pH and water activity, and extrinsicproperties such as temperature, packaging, and gascomposition), the key processing factors, storagetemperature, and shelf-life, should all be considered as well as the sampling framework and selection ofmicrobiological tests.

1.4 Commission Regulation onmicrobiological criteria for foodstuffs European or national regulations are a legal requirementand compliance is mandatory. Microbiological criteria inthe EU have been harmonised in Community legislation bythe European Commission (EC) Regulation onmicrobiological criteria for foodstuffs ([EC] No. 2073/2005[as amended]) which came into force in January 200615,16.This supports the Regulation on the Hygiene of Foodstuffs([EC] No. 852/2004) that also applies from January 20068,and the General Food Law Regulation ([EC] No. 178/2002)that came into force in February 2002, although certainkey provisions applied only from January 200510.In addition, the Regulation laying down specific rules forfood of animal origin ([EC] No. 853/200420) containscriteria for marine biotoxins, for live bivalve molluscs, andraw milk. Interpretative documents relating to theRegulation on microbiological criteria for foodstuffs havebeen produced by the Food Standards Agency (FSA)21 andthe Chilled Food Association (CFA) / British RetailConsortium (BRC)22. A definition of standard terms has alsobeen published by the CFA23. These Regulations apply toall FBOs involved in the production and handling of food.

Two types of microbiological criteria are set out inRegulation (EC) No. 2073/2005 (as amended) and includecriteria for both pathogens and indicator organisms:• Food safety criteria defining the acceptability of a

product or a batch. They are applicable to foodstuffsplaced on the market and throughout the shelf-life ofthe food.

• Process hygiene criteria defining the acceptability of the process. These apply only during the manufacturingprocess.

Failure to meet the criteria alone is not an offence but thespecific corrective action must be carried out to complyfully with the Regulation. Microbiological criteria areintended to assist with validating and verifying HACCP-based food safety management systems.

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Campylobacter, the potentially fatal consequence of thisdisease particularly in the young and the elderly give it ahigh public health significance. It is estimated that VTECinfection is the cause of approximately 70% of the cases ofrenal failure in children35. The consumption of very lownumbers of viable VTEC in food is sufficient to causeinfection36.

Not all cases of VTEC are foodborne (Table 3) and differenttransmission routes can occur within the same outbreak.Most infections in the United Kingdom (UK) are due to asingle serotype of VTEC, i.e. O157, but other serotypeshave been associated with sporadic cases of illness oroutbreaks of foodborne disease. In continental Europe andAustralia, infections from a broader range of VTECserotypes are reported. The other serotypes of VTEC thathave been associated most frequently with disease inhumans include O26, O103, O111 and O14537,38.

2.2.3 Salmonella species Salmonella infection is caused by ingestion of viablebacteria. Infection occurs in all age groups, however hostfactors may increase the susceptibility to infection, forexample treatment to reduce the acidity of the stomach,are more vulnerable to infection. The infectious dose forSalmonella species is usually quite large32. However, datafrom outbreaks has shown that consumption of lownumbers of Salmonella in food together with the mode ofdelivery of the bacterium to the gastrointestinal tract cancause infection and this is particularly evident with high fat/ low water activity foods, such as chocolate, fermentedmeats, cheese and snacks, in which the organism cansurvive for long periods of time39-51. Application of goodhygiene and temperature and time control during food preparation is also important to prevent cross-contamination and multiplication in foods oringredients that are able to support its growth24,52-54.

Around 2,500 serotypes of Salmonella have beendescribed. These serotypes can be further characterisedusing specialist methods to identify strains. TypingSalmonella species in this way is essential for national andinternational surveillance and identification ofoutbreaks24,44-49,55,56. The emergence of new Salmonellastrains or strains that have anti-microbial drug resistancecontributes to the concern regarding imported food. Anti-microbial drug resistant Salmonella infections areassociated with an increased hospitalization rate,morbidity, and mortality57.

2.2.4 Shigella species Shigellosis is caused by ingestion of viable bacteria andmost cases in the UK are due to Shigella sonnei. Infectiondue to other Shigella species including Sh. flexneri, Sh.

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Pathogens

2.1 Introduction Examination for the presence of pathogens in ready-to-eatfood products contributes to food safety24-30. However, thepathogens listed in Tables 1 to 3 are not equally applicableto all food groups. Interpretation of results should also bebased on knowledge of the food product and theproduction process and care must be taken wheninterpreting results obtained in the absence of thisinformation. The significance of the pathogenic micro-organisms in ready-to-eat foods is discussed in thefollowing sections and tables.

2.2 Detection of pathogenic micro-organisms in ready-to-eat food

Detection of the foodborne pathogenic bacteria shown inTable 1 in ready-to-eat food represents an unacceptablerisk to health regardless of the number of bacteria present.The pathogens listed in Table 1 should not be found inready-to-eat food that has been adequately prepared.Table 1 details the likely cause of contamination along withthe suggested actions if the pathogen is detected in ready-to-eat food.

2.2.1 Campylobacter species (thermotolerant)

This is the most common cause of bacterialgastrointestinal infections in the UK. Most cases of diseaseare sporadic and the outbreaks of foodborne infection thatdo occur are difficult to identify. The route of transmissionfor the majority of infections remains unidentified. Theconsumption of low numbers of Campylobacter in food issufficient to cause infection31,32.

Disease is caused by the ingestion of viable thermotolerantCampylobacter species. The most common species ofCampylobacter isolated from cases of foodborne diseaseare C. jejuni and C. coli but illness has also been associatedwith other thermotolerant species. Campylobacter speciesare unable to grow in food, they are killed by heat and areduction in numbers has also been observed followingfreezing of contaminated foodstuffs. Cross contaminationof ready-to-eat foods in the food preparation environmentis an important route of transmission33,34.

2.2.2 Escherichia coli O157 and other verocytotoxin-producing E. coli (VTEC)

The most important Escherichia coli from a food safetyperspective are the verocytotoxin-producing E. coli (VTEC).Despite the relatively low number of cases of VTECinfection compared with that of Salmonella and

SECTION 2

boydii and Sh. dysenteriae also occur. In contrast to themost common foodborne pathogenic agents, shigellosis isexclusively a human disease. The majority of cases in theUK are acquired as a result of person-to-person spread andoccasionally by eating food contaminated by infected foodhandlers, or through the consumption of vegetable or fruitcrops irrigated with untreated water or contaminated byinfected crop workers. Illness can result following theingestion of very low numbers of viable bacteria (as low as10 cells depending on host susceptibility) and it istherefore easily spread from person to person particularlyamongst young children32. Infection can occur in all agesand there is an association between infection and travel toareas where hygiene is poor.

2.2.5 Vibrio choleraeCholera is caused by the ingestion of viable Vibriocholerae. Two serogroups of V. cholerae, O1 and O139have been identified as causing outbreaks. Cholera is anextremely virulent disease that affects both children andadults. It is associated with a rapid onset of severediarrhoea. Case fatality rates of 1-10% have been reportedand this is dependent largely on access to healthcare andtreatment by proper rehydration.

Foodborne transmission occurs through consumption ofcrops cultivated in, or irrigated by, untreated water,through washing or handling foods which receive nofurther processing or by the consumption of raw orundercooked seafood. Foods that are commerciallyimported from countries where V. cholerae is endemichave been, albeit rarely, implicated in outbreaks of choleraand the potential for foodborne transmission fromimported food remains. In the UK, all cases are associatedwith foreign travel particularly to the Indian sub-continent.Food produced under good manufacturing practices poseonly a negligible risk for cholera transmission and thebacterium is killed by adequate cooking.

2.3 Enumeration of pathogenic micro-organisms in ready-to-eat food

Although low numbers of the pathogens listed in Table 2probably represent a low risk, their presence can suggestfault(s) in the production and/or subsequent handlingwhich, if not controlled, could lead to an unacceptableincrease in risk. Contamination by the pathogens listed inTable 2 should always be investigated with an urgency ofresponse which is proportional to the level ofcontamination and type of food as shown in Table 2. In addition, pathogenic bacteria are often unevenlydistributed in foods and the levels of contamination found,and therefore the subsequent interpretation placed onthem, may vary between sub-samples. The detection oflow numbers of these organisms in ready-to-eat foods

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which are thought to be associated with food poisoningoutbreaks or which are consumed by more vulnerablegroups warrants further investigation by the enforcementauthority in consultation with the Food Examiner.Vulnerable people are generally more susceptible to theseinfections and are at greater risk of developing moreserious disease.

2.3.1 Bacillus cereusLarge numbers of Bacillus cereus are needed to causeillness either by releasing toxin into the food prior toconsumption (emetic syndrome) or by producing adifferent toxin or toxins in the gut after eating the food(diarrhoeal syndrome). The emetic syndrome is particularlyassociated with farinaceous products such as rice andpasta dishes. A wider range of foods have been implicatedwith the diarrhoeal syndrome including meat products,soups, vegetables, puddings and sauces.

Bacillus cereus is a diverse group of bacteria which arewidespread in the environment, therefore all foods andfood ingredients are likely to be contaminated by thespores of this bacterium. The spores may survive thecooking process, hence people are frequently exposed tolow numbers of B. cereus through food without becomingill. Minimum growth temperatures for B. cereus varybetween 4°C and 12°C with an upper limit of around50°C although some psychrotrophic strains occur. Not allstrains produce toxins that cause either the emetic ordiarrhoeal disease. The emetic and diarrhoeal toxins aredistinct; the emetic toxin is pre-formed in food and is bothacid and heat stable. Hence foods can be toxic in theabsence of viable B. cereus.

2.3.2 Bacillus species (other pathogenic Bacillus)

Illness is caused by the Bacillus subtilis group (including B.subtilis, B. licheniformis, B. pumilis and B. amyloliquifaciens)and occurs less frequently than B. cereus gastroenteritis.Symptoms are similar to those from B. cereus and includeacute-onset vomiting often followed by diarrhoea, as well asdiarrhoea accompanied infrequently by vomiting. Illness isstrain and possibly species dependent. Illness follows theconsumption of a wide variety of poorly stored cookedfoods containing large numbers of Bacillus (105 to 109 cfu/gor more) and includes food prepared from poultry, meat,vegetables, and farinaceous products such as rice andbread. The temperature range for growth is similar to B.cereus (see section 2.3.1). The exact mechanisms andtoxins produced by this group are less well understood thanfor B. cereus but some may be associated with preformedtoxin, and some with viable organisms. Not all of the B.subtilis group have the potential to cause disease, indeedsome natural fermentations which rely on production ofvery high levels of these bacteria result in safe products.

Spices and spice products such as pepper and curry pasteoften carry a significantly high load of Bacillus species,usually in the spore form. Although these are not normallyregarded as ready-to-eat foods they may be added to aready-to-eat food as a garnish or seasoning, albeit as a verysmall proportion of the finished product. However,depending on the nature of the food to which they areadded, outgrowth is possible and may then pose a healthrisk. Levels in spices exceeding 106 cfu/g are thereforeregarded as unsatisfactory. If high levels of Bacillus spp. arefound in ready-to-eat foods, the possibility that spices suchas pepper have been added after the main cookingprocess, for example to the egg mayonnaise or mashedpotato topping, should be investigated.

2.3.3 Clostridium perfringensClostridium perfringens is found in the gut and thusindicates faecal contamination although spores commonlyoccur in the environment. It is uncommon to detect thisorganism in properly handled ready-to-eat foods. Illness iscaused by the ingestion of large numbers of viablevegetative bacteria, which sporulate in the lower smallintestine and produces enterotoxin which causesdiarrhoea. This enterotoxin is not produced in foods.Spores are common in the environment and may survivethe cooking process such that low level contamination ofthe final product may occasionally occur. Control isachieved by preventing spore germination and growth infood and rapid cooling, adequate cold storage andadequate reheating of food are of paramount importance.C. perfringens will grow between 15°C and 52°C withvirtually no growth below 12°C. Not all C. perfringensproduce enterotoxin and these non-toxigenic isolates(irrespective of the numbers of bacteria present) will notproduce foodborne disease. However the presence ofhigh numbers of non-toxigenic C. perfringens in aready-to-food is unsatisfactory and indicates poorprocessing, particularly during cooling.

2.3.4 Listeria monocytogenesIllness is caused by the ingestion of live bacteria. Listeriamonocytogenes occurs commonly in the environment andin raw foods, and consequently will occur in some foodproduction environments. Growth of this bacteriumfollowing both post-process contamination of cooked orprocessed foods or in raw foods probably represents thegreatest risk for disease transmission. L. monocytogenescan grow between <0°C to 45°C, albeit slowly atrefrigeration temperatures. The bacterium is killed byadequate cooking. Unrefrigerated foods and those chilledfor extended periods are at increased risk of allowingsignificant growth, particularly if chilled temperatures aresuboptimal. Vulnerable groups (pregnant women, theimmunosuppressed, the elderly, and many patients in

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hospitals) are at particular risk of infection, henceconsumption of low levels of L. monocytogenes may be ofgreater risk when eaten by these groups.

In refrigerated high risk foods such as soft ripened cheese,pâté, smoked fish, and cooked sliced meat, where there isa potential for growth during storage, and in foods likely tobe served to vulnerable groups (such as those served inhospital), the presence of L. monocytogenes at any levelmay be of public health significance and should beinvestigated. For these high risk food products and toassess the public health significance it is thereforerecommended that an enrichment method be used, inaddition to enumeration, to ensure that there is anabsence of the bacterium in 25g portions of these foods (Table 2).

Food safety criteria for L. monocytogenes in Regulation(EC) No. 2073/2005 (as amended)16 are applicable tothree categories of ready-to-eat foods: absence of L. monocytogenes in 25g is required in some foods, e.g.ready-to-eat foods intended for infants and those forspecial medical purposes; while for other ready-to-eatfoods (including those able to support growth or not of L. monocytogenes) L. monocytogenes should not exceed102 cfu/g within the shelf-life. However investigation onpublic health grounds may be justified in products withlevels of less than 102 cfu/g, especially in high risk foods,those likely to be consumed by vulnerable groups andthose which are defined in Regulation (EC) No. 2073/2005that do not support the growth (based on a shelf life ofless than 5 days) but where growth may occur under poortemperature and time control.

2.3.5 Staphylococcus aureus and other coagulase-positive staphylococci

Illness due to Staphylococcus aureus is caused byenterotoxins which are preformed in food. Only some S.aureus contain enterotoxin genes and therefore have thepotential to cause food poisoning. Although most cases ofinfection are due to S. aureus, other coagulase-positiveStaphylococcus species (e.g. S. intermedius) can alsoproduce enterotoxins and cause foodborne disease.

Adequate cooking will kill the bacterium, however someprotection is afforded in dry, high-fat and high-salt foods.Staphylococcal enterotoxins are heat-stable and can survivesome normal cooking processes including boiling, henceactive toxin can be present in the absence of viableorganisms. Most coagulase-positive staphylococci growbetween 7°C and 48°C with no growth at refrigerationtemperatures. Many people carry S. aureus andcontamination of foods after processing by food handlerscan occur. Toxin production starts at 10°C and storage offoods below this should prevent its development.

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In foods such as ripened cheeses and fermented meatproducts, S. aureus levels are highest 2–3 days after initialproduction and may reduce significantly during storage. If levels exceed 105 cfu/g at any time during the life of afood, there is a risk of sufficient enterotoxin to cause illnessthat will remain in the food product regardless ofsubsequent recoverable levels of this organism. Howevercheese products sampled at retail with coagulase-positivestaphylococci levels in excess of 103 cfu/g should beregarded with suspicion and further investigation iswarranted, for example by arranging for checks of theproducer’s test records. If levels exceed 104 cfu/g, isolatesshould be sent to the Reference Laboratory for enterotoxingene testing. If levels exceed 105 cfu/g in any product or ifthe food is associated with possible staphylococcal foodpoisoning, the food (if available) should be tested forenterotoxin and the strain for enterotoxin gene detection.

The only food safety criterion for staphylococci inRegulation (EC) No. 2073/2005 (as amended) is for anabsence of staphylococcal enterotoxins in cheese, milkpowder and whey powder in product placed on themarket during their shelf life16. This Regulation has processhygiene criteria with limits of between 10 and 105

coagulase positive staphylococci/g in cheese, milk andwhey powder during manufacture, and if values of >105

cfu/g are detected, the batch should be tested forstaphylococcal enterotoxins. However, since assays forenterotoxin detection are not rapid, can be insensitive forsome food matrices and do not detect all types ofstaphylococcal enterotoxins, public health actions shouldnot be delayed pending results.

2.3.6 Vibrio parahaemolyticus Vibrio parahaemolyticus is a marine bacterium found incoastal and estuarine waters. It is a rare cause of illness in the UK and is most frequently associated with the ingestion of live Vibrio parahaemolyticus in uncooked imported seafood or ingestion of foods cross-contaminated with seafood. Growth has beenreported between 14°C and 40°C and therefore does not occur in seafood stored at proper refrigerationtemperatures; however freezing does not destroy theorganism but it is killed by most heat treatments. Many isolates appear unable to produce the toxinresponsible for causing the disease.

2.4 Foodborne pathogens and risk of diseaseFurther details on some of these pathogens including themost common foods associated with them and thesettings or locations most frequently associated withoutbreaks of disease are provided in Table 3. This tablealso identifies the most common routes of transmission,known host risk factors for more severe infection, the

symptoms and possible consequences of infection, andtheir frequency as a cause of human illness in the UK.

Foodborne diseases of microbiological origin can becaused by a variety of agents, which gain entry by thegastrointestinal tract. Symptoms of foodborne disease,which are not necessarily confined to diarrhoea andvomiting, are caused by viable organisms and/or by thetoxins that they produce. The risk of disease from theseagents varies depending on the pathogen, the dose, thehost and the properties of the food matrix. Host riskfactors include age, immune status, underlying debilitatingdisease or stress factors, and the physiological state of thestomach and upper small intestine at the time of exposureto the agent. For these reasons a minimum infectious dosecannot be defined, although the risk of disease at lowexposure for some agents is small.

The presence of foodborne agents that may cause illnessin ready-to-eat foods is a significant risk to consumerhealth and their absence is of paramount importance.With the exception of the aerobic and anaerobic bacterialspores, detection of foodborne pathogenic agents at anylevel is of concern and should be investigated with anurgency of response proportionate to the level ofcontamination and risk to consumers. Although lownumbers of pathogens, such as coagulase-positivestaphylococci, C. perfringens, B. cereus, and L. monocytogenes, in ready-to-eat products probablyrepresent a very low risk to immunocompetent people,they are more significant for the immunocompromisedand vulnerable groups. Low levels may be due to naturalcontamination of raw materials used in those foods, butusually their presence suggests faults in the production orsubsequent handling of food which could lead to anunacceptable increase in risk. There may also be a need foraction when detecting low numbers of these organisms inready-to-eat foods because there is variation in hostsusceptibility and interstrain differences in thepathogenicity of these bacteria.

2.5 Specialist and reference testsSpecialist and reference tests are available for manyfoodborne pathogens and their toxins, the results of whichwill provide considerable added value to those from initialtests and to epidemiological investigations. Specialist orreference tests are performed for:• Verification of the microbiological results from the

primary laboratory;• Identification of rare or unusual pathogens; • Comparative (fingerprinting or typing) analyses for strain

characterisation to establish likely relationships betweencultures from samples collected during outbreaks and at different times or from different places in the food chain;

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• Detection of toxins, and/or the potential to produce a toxin;

• Distinction, where possible, between non-pathogenic and pathogenic variants of the same species;

• Assessment of the likely disease severity;• Detection of additional bacterial pathogens as well as

viruses (e.g. norovirus) and parasites.

Tests for Cronobacter (Enterobacter) sakazakii, Clostridiumbotulinum neurotoxin, staphylococcal enterotoxins, Bacillustoxins, histamine and shellfish toxins, norovirus andparasites are usually only available at national orinternational reference laboratories. Given the specialistand complex nature of some of these tests, results maynot be available as quickly as primary tests. Hence publichealth actions and interventions should not be delayedpending the results of specialist and reference tests.

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(depending on the type of product) are set by Regulation(EC) No. 2073/2005 (as amended)16.

3.3 Escherichia coli Escherichia coli belongs to the Enterobacteriaceae familyand is used as a faecal indicator to assess the hygienestatus of a food product. Escherichia coli are killed by theheat processes used in food production and should bereadily removed from the factory, equipment and surfacesby appropriate cleaning procedures. Occasional strains arepathogenic; these are rarely found in ready-to-eat foodsalthough not all can be recovered by currently availabledetection laboratory methods. Specialist methods todetect pathogenic strains are required when illness is suspected.

Escherichia coli may sometimes be found in soft, mould-ripened or washed-rind cheese made from raw milk.Although Regulation (EC) No. 2073/2005 (as amended)has no criteria for E. coli in cheese made from raw milk16 itis recommended that these cheese types be routinelytested for E. coli and investigation undertaken if a changein trend is detected. It is also recommended that a riskassessment is performed to assess the need for periodicmonitoring for VTEC O157. Tests should be urgentlyapplied where there is epidemiological evidence linkingVTEC infection with specific foods (please refer to Table 1and section 2.2.2 for information on VTEC O157).

3.4 Listeria species Listeria spp. are able to grow at normal refrigerationtemperatures but are killed by temperature regimes suchas 70°C for two minutes. These organisms show a greaterresistance to heat than the Enterobacteriaceae. In foodsthat have undergone such a heat treatment the presenceof Listeria spp. indicates undercooking or post processcontamination. Their presence can be used as an indicatorto assess the hygienic status of a food product. Listeriaspp. are also environmental contaminants that can survivein both food processing premises and on equipment ifinappropriate hygiene measures are used. These organismsare less sensitive to the cleaning procedures used in foodprocessing environments than many other bacteria.

The term Listeria spp. is fully inclusive of all Listeria spp.,including L. monocytogenes. The occurrence of thesebacteria at any level may therefore be of significance incertain refrigerated high risk foods (e.g. soft ripenedcheese, pâté, smoked fish, cooked sliced meats) due to thepotential for growth during storage in some of theseproducts. For these products it is therefore recommendedthat an enrichment method be used, in addition toenumeration, to check that there is an absence of Listeriaspp. in 25g of food (Table 4).

/ / 12

Hygiene IndicatorOrganisms

3.1 Introduction The presence of indicator bacteria in ready-to-eat food,although not inherently a hazard, can be indicative of poorpractice that may be one or more of the following: • poor quality of raw materials or food components;• undercooking;• cross-contamination;• poor cleaning; • poor temperature and time control.

Indicator bacteria may be associated with an increasedlikelihood of the presence of pathogens58. Indicatororganisms are useful in the assessment of food productsafety because they tend to be present in higher numbersthan most pathogens and are relatively quick and easy to identify.

There are a number of recommended actions listed inTable 4 that could be taken in response to anunsatisfactory result for indicator bacteria. Several foodsfrom the same premises with borderline levels of indicatorsshould prompt further investigation. It is recommendedthat any proposed actions should be discussed with a Food Examiner.

3.2 Enterobacteriaceae The Enterobacteriaceae family is a group of bacteria that isused to assess the general hygiene status of a foodproduct. This group includes species that originate fromthe intestinal tract of animals and humans, as well asplants and the environment. All Enterobacteriaceae arekilled by the heat processes used in food production andshould be readily removed from the factory, equipmentand surfaces by appropriate cleaning procedures. Theirpresence in heat treated foods therefore signifiesinadequate cooking or post-processing contamination.High levels of these bacteria are expected in some foodcommodities such as salad vegetables. The use ofsanitising rinses may reduce but not entirely remove these organisms.

Some Enterobacteriaceae can contribute to the formationof histamine (scombrotoxin) in foods such as scombroidfish (e.g. mackerel and tuna) and occasionally somecheeses if these are not processed properly and/or storedat an adequate refrigeration temperature. Ingestion of fishwith high histamine levels is toxic, and maximumpermissible levels of <200 or <400 mg/kg of histamine

SECTION 3

G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 13

spoilage organisms such as psychrotrophic pseudomonads;a lower refrigeration temperature will reduce the rate ofgrowth further and help to extend shelf-life. As theduration of storage increases the aerobic colony count alsoincreases; this will also occur if refrigeration temperaturesare poorly controlled or if the food is frequently taken inand out of refrigeration.

An ACC of less than 106 cfu/g is usually associated with amixed flora. Above this level there is usually a predominantorganism, and the acceptability and organoleptic quality ofthe food will depend on which type of organismpredominates. In meat products for example the florafrequently consists almost entirely of lactic acid bacteria(mainly lactobacilli and streptococci), which can grow wellat refrigeration temperatures. Spoilage will eventuallyoccur at a level of around 109 cfu/g due to the productionof lactic acid. If the predominant organism or group oforganisms consists of Gram-negative bacteria, spoilage islikely to be noticeable at 107 – 108 cfu/g; pseudomonadstend to produce taints, discolouration, and slime whilstother Gram-negative bacteria frequently produce slime.Yeasts may cause spoilage at slightly lower levels (106 –107 cfu/g) due to acid and gas production. If high levels ofBacillus spp. are found this may be due to the addition ofpepper or other spices after any heat treatment;investigations of the full preparation process is needed. If ACCs are high it is therefore important to identify thepredominant organism type in order to fully interpret thesignificance of the level. Tests by the laboratory forcatalase and oxidase production and a Gram stain areusually sufficient to achieve the differentiation needed tointerpret results.

For raw, ready-to-eat food commodities such as saladvegetables, ACCs are likely to be much higher, between106 and 108 cfu/g. This will tend to limit their shelf-life asspoilage may occur relatively rapidly and will usually bevisible. This also applies to products such as rice or pastasalads containing raw vegetables. If products are dried(e.g. herbs), the ACC per gram appears to increase due tothe volume of water being removed. Raw meat and fish,eaten untreated or cold smoked, will also have ACCs ofaround 106 – 107 cfu/g, whereas marinated products arelikely to have lower counts due to the acidity of themarinade unless they have been spoiled. Some foodcommodities such as fermented meats, fish, vegetablesand most types of cheese are produced by adding startercultures of bacteria; the predominant organisms aretherefore the starter bacteria and other bacteria are usuallypresent only in low numbers due to the acidity producedduring the fermentation.

/ / 14

Aerobic ColonyCounts

4.1 Introduction The Aerobic Colony Count (ACC), also known as the TotalViable Count or Standard Plate Count, is an indicator ofquality, not safety, and cannot directly contribute towardsa safety assessment of ready-to-eat food.

4.2 ACC levels in various ready-to-eat foodsACCs can be used as part of a general quality assessmentincluding that of extended shelf-life foods; as such it canbe used as part of a programme of shelf-life testing carriedout by the food producer: • If an ACC is above the expected level, a determination of

the constituent organisms and their level is needed before any follow-up investigation is instigated;

• High counts may suggest quality issues and possible poor temperature control and these should be investigated.

Immediate action in response to high ACCs is not usuallywarranted except for shelf-stable canned or bottled foodproducts immediately after opening (Category 1, Table 5).The level will depend initially on the type and duration ofprocessing that the food has received during production(see Table 5). Thereafter the level will depend on the wayit is handled and stored. For example, immediately after apasteurisation heat process, products will normally have anACC of below 104 cfu/g, whilst a more rigorous heatprocess such as grilling, roasting or baking will result incounts below 103 cfu/g. For canned products that aremicrobiologically stable at ambient temperature, viablemicro-organisms are usually absent but occasionallythermotolerant spores may survive, depending on theseverity of the heat process. Products that have received adrying process will be stable whilst remaining dry, but maycontain relatively high numbers of bacteria that canmultiply following rehydration.

Microbes are inevitably introduced during slicing,packaging, portioning and other manipulations but thisshould be minimised by good hygiene, both of personneland of equipment. The type of packaging may theninfluence the rate of microbial growth, for examplevacuum packaging will retard the growth of obligateaerobic organisms due to the exclusion of oxygen. Thetemperature of refrigeration for non-ambient stableproducts also influences the microbial growth rate; storagebelow 8°C will prevent growth of most foodbornepathogens (with the notable exceptions of Listeriamonocytogenes and Yersinia enterocolitica) but not of

SECTION 4

type of packaging, and the culturability of injuredorganisms will also contribute further to the variation ofreproducibility between microbiological results. Resultsshould therefore be interpreted in context taking suchfactors into consideration. Criteria for other agentsincluding viruses and enteric parasites are currentlyexcluded; however as European Standard methods (EN)become available these may be included in the future.

5.2 Environmental samplesThese guidelines do not include microbiological criteria forand interpretation of microbiological results fromenvironmental samples. Sampling the food environmentwill be the subject of additional HPA guidance. However,taking appropriate and targeted environmental samples isrecommended in these guidelines for unsatisfactory resultson ready-to-eat foods and should also be considered forborderline values. Testing the food environment makes apositive and additional contribution to food safety.

As a guide environmental sampling is useful in thefollowing situations: • In an outbreak/incident investigation, environmental

samples should be taken as soon as possible as part of the primary sampling exercise. Detection of pathogensin environmental samples is important because it may provide the only evidence to link a particular premise toan outbreak of infection;

• For hygiene indicators during an investigation into poormicrobiological results or during an inspection of apremises especially where there are concerns about thepotential for cross contamination;

• As part of the follow-up to assess the effectiveness of deep cleaning of premises which have been shown to be contaminated with pathogens.

G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 15

SECTION 5

This diversity of food products and the productionmethods used means that a good understanding of theproduct type is needed in order to fully interpret the ACC.Guidance is given in Table 5 but careful considerationshould be given to the type of food being tested andwhether it is truly ready-to-eat or an ingredient thatrequires a further heating process before consumption.The stage of shelf-life should also be considered; ifsampled at the point of production ACCs are likely tocategorise foods as “satisfactory”, whereas if sampled atthe end of shelf-life an ACC can normally be expected toapproach the upper “borderline” limit. If used correctlyACCs can provide useful information about the generalquality and remaining shelf-life of the food in question, andthus highlight potential problems of storage and handlingsince production; however they are not deemed a priorityin a risk based analysis.

SupplementaryAdvice on Use of the Guidelines

5.1 Microbiological methodology Laboratory methods that allow rapid and accuratedetection, identification and quantification ofmicrobiological hazards enhance the ability to monitor and investigate contamination throughout the food chain.Methods are defined for Official Control sampling15,16,20,59.However for public health investigations and for reasons ofincreased speed or sensitivity, different methods (as well assample sizes) may be utilised as long as they have beenvalidated according to internationally acceptable protocolsand their use authorised by the Competent Authority.

The interpretation of laboratory results in foodmicrobiology is often the most difficult and complexaspect of the examination process. Users of theseguidelines should be aware that the precision andreproducibility of many microbiological tests depends onmany factors, some of which are outside the control of thelaboratory. Sampling itself is the greatest contributoryfactor to the variability of a result for a particular sample asmicro-organisms are not usually homogenously distributedin a contaminated foodstuff. The sample matrix itself, the

/ / 16

Tables

SECTION 6

G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 17

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/ / 18

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e,C

onfir

mat

ion

ofid

entit

y,m

olec

ular

typi

ng

Repo

rted

aspr

esum

ptiv

eB.

cere

usun

less

asso

ciat

edw

ithan

outb

reak

inve

stig

atio

nw

hen

conf

irmat

ion

and

typi

ngar

epe

rfor

med

Repo

rted

,if

pres

ent,

aspr

esum

ptiv

eB.

cere

us

Not

alls

trai

nspr

oduc

ega

stro

inte

stin

aldi

seas

e.C

onfir

mat

ion

ofid

entit

y,m

olec

ular

typi

ng

Hig

hle

vels

occu

rin

spec

ific

ferm

ente

dpr

oduc

tsan

ddo

not

repr

esen

ta

publ

iche

alth

risk

Repo

rted

aspr

esum

ptiv

eBa

cillu

ssp

p.un

less

asso

ciat

edw

ithan

outb

reak

inve

stig

atio

nw

hen

conf

irmat

ion

and

typi

ngar

epe

rfor

med

Repo

rted

,if

pres

ent,

aspr

esum

ptiv

eBa

cillu

ssp

p.

Tab

le2

.Gui

danc

eon

the

inte

rpre

tatio

nof

resu

ltsfo

ren

umer

atio

nof

bact

eria

lpat

hoge

ns(t

heha

zard

)in

read

y-to

-eat

food

spl

aced

onth

em

arke

t

G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 19

Clo

stri

diu

mp

erfr

ing

ens

List

eria

mo

no

cyto

gen

es

>104

10-

≤104

<10

>102

10-

≤102

c

<10d

Hig

h

Mod

erat

e

Low

Hig

h

Mod

erat

e

Low

UN

SATI

SFA

CTO

RY:

Pote

nti

ally

inju

rio

us

toh

ealt

han

d/

or

un

fit

for

hu

man

con

sum

pti

on

b

BORD

ERLI

NE

SATI

SFAC

TORY

UN

SATI

SFA

CTO

RY:

Pote

nti

ally

inju

rio

us

toh

ealt

han

d/

or

un

fit

for

hu

man

con

sum

pti

on

b

BORD

ERLI

NE

SATI

SFAC

TORY

Stro

ngev

iden

cefo

rpo

orpr

oces

sing

,pa

rtic

ular

lydu

ring

cool

ing

perio

daf

ter

cook

ing,

the

use

ofle

ftov

erfo

od,o

rfr

omst

ocks

and

grav

ies

Like

lyev

iden

cefo

rpo

orpr

oces

sing

part

icul

arly

cool

ing

Stro

ngev

iden

cefo

rpo

orpr

oces

sing

,en

viro

nmen

talo

rcr

oss-

cont

amin

atio

ndu

ring

prod

uctio

nor

atpo

int

ofsa

le,p

oor

tem

pera

ture

cont

rolo

rin

appr

opria

tele

ngth

ofsh

elf-

life

Like

lyev

iden

cefo

rpo

orpr

oces

sing

and/

orpo

orqu

ality

raw

mat

eria

ls

Imm

edia

tely

revi

ewte

mpe

ratu

rean

dtim

eco

ntro

ls.T

ake

inve

stig

ativ

esa

mpl

esof

food

and

the

food

prep

arat

ion

envi

ronm

ent.

Risk

will

incr

ease

prop

ortio

nalt

oth

ele

vels

dete

cted

and

the

likel

ihoo

dof

subs

eque

ntgr

owth

inth

eab

senc

eof

appr

opria

tele

vels

ofco

ntro

l.Re

view

tem

pera

ture

and

time

cont

rols

part

icul

arly

cool

ing

and

stor

age

prac

tices

inpl

ace

topr

even

tgr

owth

.Con

side

rta

king

inve

stig

ativ

esa

mpl

esof

food

and

the

food

prep

arat

ion

envi

ronm

ent.

N/A

Imm

edia

tein

vest

igat

ion

of:t

hefo

odor

igin

,pro

duct

ion

proc

ess

and

envi

ronm

ent.

Take

inve

stig

ativ

esa

mpl

esof

food

and

envi

ronm

enta

lmon

itorin

g.

Risk

will

incr

ease

prop

ortio

nalt

oth

ele

vels

dete

cted

and

the

likel

ihoo

dof

subs

eque

ntgr

owth

unde

rno

rmal

stor

age

cond

ition

s.Re

view

qual

ityof

raw

mat

eria

ls,f

ood

prep

arat

ion

envi

ronm

ent

(incl

udin

gcl

eani

ng),

cook

ing,

tem

pera

ture

and

shel

flif

eco

ntro

ls.

Con

side

rta

king

inve

stig

ativ

esa

mpl

esof

food

and

envi

ronm

enta

lmon

itorin

g.In

refr

iger

ated

high

risk

food

sw

here

ther

eis

apo

tent

ialf

orgr

owth

durin

gst

orag

e,an

din

food

slik

ely

tobe

serv

edto

vuln

erab

legr

oups

(suc

has

that

serv

edin

hosp

ital)

the

pres

ence

ofL.

mon

ocyt

ogen

esat

any

leve

lmay

beof

sign

ifica

nce

and

shou

ldbe

inve

stig

ated

.

N/A

Con

firm

atio

nof

iden

tity,

typi

ng,

path

ogen

icity

(tox

inge

nede

tect

ion)

Refe

ris

olat

esas

soci

ated

with

anou

tbre

akin

vest

igat

ion

Refe

ris

olat

esfo

rco

nfirm

atio

nof

iden

tity,

sero

typi

ng,

mol

ecul

arty

ping

.

Con

side

rre

ferr

alof

isol

ates

,pa

rtic

ular

lyw

here

asso

ciat

edw

ithpe

rsis

tent

cont

amin

atio

nor

aspa

rtof

outb

reak

inve

stig

atio

ns.

For

food

sin

high

risk

cate

gorie

sc,

refe

ris

olat

esfo

rre

fere

nce

test

ing.

Regu

latio

n(E

C)

No.

2073

/200

5(a

sam

ende

d)co

ntai

nsm

icro

biol

ogic

alcr

iteria

for

som

esp

ecifi

cfo

od/

L.m

onoc

ytog

enes

com

bina

tions

and

the

requ

irem

ents

tobe

com

plie

dw

ithby

FBO

s.

/ / 2 0

Stap

hyl

oco

ccu

sau

reu

san

do

ther

coag

ula

se-p

osi

tive

stap

hyl

oco

cci

Vib

rio

par

ahae

mo

lyti

cus

>104

20-

≤10

4

<20

>103

20-

≤10

3

<20

Hig

h

Mod

erat

e

Low

Hig

h

Mod

erat

e

Low

UN

SATI

SFA

CTO

RY:

Pote

nti

ally

inju

rio

us

toh

ealt

han

d/

or

un

fit

for

hu

man

con

sum

pti

on

b

BORD

ERLI

NE

SATI

SFAC

TORY

UN

SATI

SFA

CTO

RY:

Pote

nti

ally

inju

rio

us

toh

ealt

han

d/

or

un

fit

for

hu

man

con

sum

pti

on

b

BORD

ERLI

NE

SATI

SFAC

TORY

Stro

ngev

iden

cefo

rpo

orha

ndlin

gan

dte

mpe

ratu

reco

ntro

l.

Like

lyev

iden

cefo

rpo

orha

ndlin

g,pr

oces

san

dte

mpe

ratu

reco

ntro

l.

Stro

ngev

iden

cefo

rpo

orpr

oces

sing

.

Like

lyev

iden

cefo

rpo

orpr

oces

sing

orcr

oss-

cont

amin

atio

n.

Imm

edia

tely

revi

ewfo

odha

ndlin

gas

wel

las

tem

pera

ture

and

time

cont

rols

.Tak

ein

vest

igat

ive

sam

ples

offo

od,f

ood

prep

arat

ion

envi

ronm

ent

and

food

hand

lers

.

Risk

will

incr

ease

prop

ortio

nalt

oth

ele

vels

dete

cted

and

the

likel

ihoo

dof

subs

eque

ntgr

owth

inth

eab

senc

eof

appr

opria

tele

vels

ofco

ntro

l.Re

view

hand

ling

asw

ella

spr

oces

sing

cont

rols

,es

peci

ally

ifth

ere

oppo

rtun

ities

for

grow

thof

stap

hylo

cocc

idur

ing

proc

essi

ngor

mat

urat

ion

ofth

epr

oduc

t.C

onsi

der

taki

ngin

vest

igat

ive

sam

ples

offo

od,f

ood

prep

arat

ion

envi

ronm

ent

and

food

hand

lers

.

N/A

Imm

edia

tein

vest

igat

ion

ofth

efo

odor

igin

,rev

iew

cook

ing

and

subs

eque

ntte

mpe

ratu

rean

dtim

eco

ntro

ls.T

ake

inve

stig

ativ

esa

mpl

esof

proc

esse

d(c

ooke

d)fo

od,r

awfo

odco

mpo

nent

s(p

artic

ular

lym

arin

epr

oduc

ts)

and

the

food

prep

arat

ion

envi

ronm

ent.

Risk

will

incr

ease

prop

ortio

nalt

ole

vels

dete

cted

.Fo

odm

ayno

tbe

com

eha

zard

ous

prov

ided

appr

opria

tele

vels

ofco

ntro

lare

appl

ied.

Con

side

rta

king

inve

stig

ativ

esa

mpl

esof

proc

esse

d(c

ooke

d)fo

ods,

raw

food

com

pone

nts

(par

ticul

arly

mar

ine

prod

ucts

)an

dth

efo

odpr

epar

atio

nen

viro

nmen

t.

N/A

Not

alls

trai

nsar

eca

pabl

eof

prod

ucin

gto

xin

and

caus

ing

dise

ase.

Con

firm

atio

nof

iden

tity,

typi

ng,p

atho

geni

city

(tox

inge

nede

tect

ion)

ofis

olat

es,C

onsi

der

ente

roto

xin

dete

ctio

nin

food

and

food

rem

nant

sfr

omca

ses

ofsu

spec

ted

food

pois

onin

g,or

whe

rehi

ghle

vels

(>10

5cf

u/g)

may

have

occu

rred

atan

yst

age

inth

efo

odch

ain.

Con

side

rre

ferr

alof

isol

ates

,pa

rtic

ular

lyw

here

asso

ciat

edw

ithou

tbre

akin

vest

igat

ions

orw

here

ther

eis

die

off

ofth

eba

cter

ium

durin

gst

orag

e.Re

gula

tion

(EC

)N

o.20

73/2

005

(as

amen

ded)

cont

ains

mic

robi

olog

ical

crite

riafo

rso

me

spec

ific

food

/co

agul

ase-

posi

tive

stap

hylo

cocc

icom

bina

tions

and

the

requ

irem

ents

tobe

com

plie

dw

ithby

FBO

s

Con

firm

atio

nof

iden

tity,

typi

ng

Con

side

rre

ferr

alof

isol

ates

,pa

rtic

ular

lyw

here

asso

ciat

edw

ithou

tbre

akin

vest

igat

ions

a,So

me

read

y-to

-eat

food

sar

eta

ken

asO

ffic

ialC

ontr

olsa

mpl

es,p

leas

ere

fer

toth

efo

odsa

fety

orpr

oces

shy

gien

ecr

iteria

inRe

gula

tion

(EC

)N

o.20

73/2

005

(as

amen

ded)

for

mic

robi

olog

ical

crite

riaan

dsa

mpl

ing

plan

s.b,

Regu

latio

n(E

C)

No.

178/

2002

,Art

icle

14Fo

odsa

fety

requ

irem

ents

.Not

appl

icab

leto

food

sfe

rmen

ted

with

Baci

llus

spp.

c,D

etec

ted

in25

gby

enric

hmen

tfo

rhi

ghris

kfo

ods

capa

ble

ofsu

ppor

ting

the

grow

thof

L.m

onoc

ytog

enes

such

asso

me

soft

ripen

edch

eese

s,sl

iced

mea

ts,s

mok

edfis

han

dpâ

tés.

d,N

otde

tect

edin

25g

byen

richm

ent

for

high

risk

food

sca

pabl

eof

supp

ortin

gth

egr

owth

ofL.

mon

ocyt

ogen

es.

G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 21

Haz

ard

Bac

illu

sce

reu

s

Bac

illu

ssp

p.(

oth

erp

ath

og

enic

Bac

illu

s)

Cam

pyl

ob

acte

rsp

p.

(th

erm

oto

lera

nt)

Clo

stri

diu

mp

erfr

ing

ens

Esch

eric

hia

coli

O15

7(a

nd

oth

erve

rocy

toto

xin

-p

rod

uci

ng

E.co

li(V

TEC

))

Foo

dty

pes

mo

sto

ften

asso

ciat

edw

ith

hu

man

infe

ctio

ns

Coo

ked

rice

(em

etic

synd

rom

e)C

ooke

dm

eats

,po

ultr

yan

dve

geta

bles

,so

ups,

spic

es(d

iarr

hoea

lsy

ndro

me)

Coo

ked

mea

ts,

poul

try

and

vege

tabl

es

Poul

try,

red

mea

t,m

ilkan

dda

irypr

oduc

tsm

ade

with

unpa

steu

rised

milk

orpo

st-

past

euris

atio

nco

ntam

inat

edm

ilk,u

ntre

ated

drin

king

wat

er

Coo

ked

mea

t,gr

avy

and

stoc

k

Und

erco

oked

beef

,milk

and

dairy

prod

ucts

mad

ew

ithun

past

euris

edm

ilkor

post

-pa

steu

risat

ion

cont

amin

ated

milk

,sal

adve

geta

bles

,un

trea

ted

drin

king

wat

er

Mic

rob

iolo

gic

alR

isk

Cat

ego

ry

Com

mer

cial

cate

ring

Com

mer

cial

cate

ring

Con

sum

ptio

nof

food

prep

ared

outs

ide

the

hom

eBa

rbec

ues

Con

sum

ptio

nof

untr

eate

dw

ater

/milk

onho

liday

(e.g

.far

m,

cott

age,

cara

van

site

)

Com

mer

cial

and

inst

itutio

nalc

ater

ing

Pre-

scho

ol/

nurs

erie

sZo

onot

ic(p

ettin

gfa

rms)

Dom

estic

hom

eIn

stitu

tiona

lset

tings

Con

sum

ptio

nof

untr

eate

dw

ater

/milk

onho

liday

(e.g

.far

m,

cott

age,

cara

van

site

)

Maj

or

rou

tes

of

tran

smis

sio

n

Food

born

e

Food

born

e

Food

born

eC

ross

-con

tam

inat

ion

Zoon

otic

Wat

erbo

rne

Food

born

e,N

on-f

oodb

orne

infe

ctio

n(i.

e.pe

rson

-to-

pers

onan

dan

tibio

tic-

asso

ciat

edin

fect

ions

occu

rin

elde

rly)

Food

born

eC

ross

-con

tam

inat

ion

Envi

ronm

enta

lexp

osur

ePe

rson

-to-

pers

onZo

onot

icW

ater

born

e

Kn

ow

nh

ost

risk

fact

ors

for

seve

rein

fect

ion

Unk

now

n

Unk

now

n

Age

(<5

yrs

or>6

0yr

s)Re

duce

dim

mun

est

atus

Ant

acid

trea

tmen

t

Mos

tpe

ople

are

prob

ably

susc

eptib

le

Age

(<5

yrs

(HU

S)or

>60

yrs

(TTP

))

Sym

pto

ms,

seve

rity

and

seq

uel

aea

Vom

iting

(em

etic

synd

rom

e)D

iarr

hoea

(dia

rrho

eals

yndr

ome)

Usu

ally

mild

and

shor

t-liv

ed,

last

s~

1da

y

Vom

iting

and

diar

rhoe

aU

sual

lym

ildan

dsh

ort-

lived

,las

ts~

1da

y

Dia

rrho

ea,h

eada

che,

abdo

min

alpa

in;

usua

llyla

sts

2-7

days

Irrita

ble

bow

elsy

ndro

me

(IBS)

mos

tco

mm

onse

quel

ae,r

eact

ive

arth

ritis

,G

uilla

in-B

arré

synd

rom

e

Dia

rrho

ea,a

bdom

inal

pain

;U

sual

lym

ildan

dsh

ort-

lived

,la

sts

~1

day,

but

diar

rhoe

alo

nger

and

mor

ese

vere

inel

derly

Deh

ydra

tion

inse

vere

case

s

Dia

rrho

ea,v

omiti

ng,a

bdom

inal

pain

,ha

emor

rhag

icco

litis

,las

ts2

wee

ksin

unco

mpl

icat

edca

ses,

can

befa

tal;

Hae

mol

ytic

Ura

emic

Synd

rom

e(H

US)

,Th

rom

botic

Thro

mbo

cyto

paen

icPu

rpur

a(T

TP)

No

.of

rep

ort

edh

um

anca

ses

inU

Kin

20

07

b

Man

yfo

odbo

rne

infe

ctio

nsar

eno

tre

port

ed

Man

yfo

odbo

rne

infe

ctio

nsar

eno

tre

port

ed

57,8

15

73 1,14

9

Tab

le3

.Maj

orfe

atur

esof

food

born

edi

seas

esdu

eto

sele

cted

path

ogen

s

/ / 2 2

List

eria

mo

no

cyto

gen

es

Salm

on

ella

spp

.(n

on

Typ

hi/

Para

typ

hi)

Shig

ella

spp

.

Stap

hyl

oco

ccu

sau

reu

san

do

ther

coag

ula

se-

po

siti

vest

aph

ylo

cocc

i

Vib

rio

cho

lera

e

Vib

rio

par

ahae

mo

lyti

cus

Hig

hris

kfo

ods,

such

assl

iced

mea

ts,p

âté,

soft

chee

se,

sand

wic

hes,

smok

edfis

h

Eggs

,pou

ltry,

pork

,bee

f,da

irypr

oduc

ts,s

eeds

,he

rbs,

sala

dve

geta

bles

,ch

ocol

ate

Sala

dve

geta

bles

Proc

esse

dm

eats

,po

ultr

y,fis

h,sh

ellfi

sh,a

ndda

irypr

oduc

ts.

Impo

rted

seaf

ood,

untr

eate

ddr

inki

ngw

ater

Impo

rted

seaf

ood

Hos

pita

lsan

dth

eco

mm

unity

Con

sum

ptio

nof

food

prep

ared

outs

ide

the

hom

eFo

reig

ntr

avel

Pre-

scho

ols

/nu

rser

ies

Inst

itutio

nals

ettin

gsFo

reig

ntr

avel

Com

mer

cial

and

inst

itutio

nalc

ater

ing

Fore

ign

trav

elpa

rtic

ular

lyto

the

Indi

ansu

bcon

tinen

t

Vario

us

Food

born

eC

ross

-con

tam

inat

ion

Food

born

eC

ross

-con

tam

inat

ion

Pers

on-t

o-pe

rson

Zoon

otic

Pers

on-t

o-pe

rson

Food

born

e

Food

born

eFo

odha

ndle

rsC

ross

-con

tam

inat

ion

Wat

erbo

rne

Food

born

e

Food

born

e

Age

(>60

yrs)

,Pr

egna

ncy

New

born

infa

nts

Imm

unos

uppr

essi

onA

ntac

idtr

eatm

ent

Redu

ced

imm

une

stat

us

Age

(<5

yrs)

Mos

tpe

ople

are

susc

eptib

le

Mos

tpe

ople

are

prob

ably

susc

eptib

le

Mos

tpe

ople

are

prob

ably

susc

eptib

le

Non

-inva

sive

:dia

rrho

ea,f

ever

,hea

dach

e,m

uscl

epa

inIn

vasi

ve:f

ever

and

seve

resy

stem

icin

fect

ions

poss

ible

(sep

ticae

mia

and

men

ingi

tis,a

ndm

isca

rria

ge).

Hig

hca

sefa

talit

yra

te.

Dia

rrho

ea,v

omiti

ng,a

bdom

inal

pain

,fe

ver;

last

sse

vera

lday

sto

3w

eeks

,and

inse

vere

case

sde

ath;

Sept

icae

mia

and

infla

mm

atio

nof

the

abdo

min

alw

all,

reac

tive

arth

ritis

Dia

rrho

ea,v

omiti

ng,b

acill

ary

dyse

nter

y;la

stav

erag

eof

4to

7da

ys;

HU

S,To

xic

meg

acol

on.

Nau

sea

and

vom

iting

,las

t1

–2

days

,m

aybe

very

acut

eA

bdom

inal

cram

psan

ddi

arrh

oea

Col

laps

ein

very

seve

reca

ses

Dia

rrho

ea,v

omiti

ng,s

ever

ede

-hyd

ratio

n,le

gcr

amps

Dia

rrho

ea

261

13,8

02

1,63

8c

Man

yfo

odbo

rne

into

xica

tions

are

not

repo

rted

47d

41

a,Th

eTa

ble

isno

tin

clus

ive

and

feat

ures

,oth

erth

anth

atde

scrib

edm

ayoc

cur

but

are

gene

rally

cons

ider

edun

com

mon

.b,

Dat

apr

ovid

edby

Hea

lthPr

otec

tion

Agen

cy,H

ealth

Prot

ectio

nSc

otla

nd,C

omm

unic

able

Dis

ease

Surv

eilla

nce

Cen

tre

Nor

ther

nIre

land

c,M

ost

case

sid

entif

ied

are

pers

on-t

o-pe

rson

d,A

llfo

reig

ntr

avel

asso

ciat

ed

G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 2 3

Hyg

ien

eIn

dic

ato

r

Ente

rob

acte

riac

eaea

Esch

eric

hia

colib

,c,d

Resu

lt(c

fu/g

)

>104

102

-≤1

04

<102

>102

20-

≤102

<20

Inte

rpre

tati

on

UN

SATI

SFAC

TORY

BORD

ERLI

NE

SATI

SFAC

TORY

UN

SATI

SFAC

TORY

BORD

ERLI

NE

SATI

SFAC

TORY

Co

mm

ent

Mem

bers

ofth

isgr

oup

occu

rin

the

envi

ronm

ent

asw

ella

sth

egu

tof

hum

ans

and

anim

als.

Thei

rpr

esen

ceat

thes

ele

vels

sugg

ests

anov

eral

lpoo

rge

nera

lhyg

iene

stat

usof

afo

odpr

oduc

t.Th

ese

bact

eria

are

not

relia

ble

indi

cato

rsof

cont

amin

atio

nby

faec

alpa

thog

ens

ina

food

.

Inte

rpre

tin

conj

unct

ion

with

test

resu

ltsfr

omot

her

mic

robi

olog

ical

para

met

ers

but

dete

ctio

nin

seve

ralf

oods

orot

her

area

sof

the

food

prod

uctio

nen

viro

nmen

tsh

ould

bein

vest

igat

ed.

Orig

inat

esfr

omth

ein

test

inal

trac

tof

man

and

anim

als

indi

catin

gco

ntam

inat

ion

and

grow

th(d

epen

ding

onth

ele

veld

etec

ted)

atso

me

stag

eof

the

proc

ess.

The

dete

ctio

nof

E.co

lica

nsi

gnify

aris

kth

atfa

ecal

path

ogen

sar

epr

esen

t.Re

sults

shou

ldbe

inte

rpre

ted

inco

njun

ctio

nw

ithte

stre

sults

from

othe

rm

icro

biol

ogic

alpa

ram

eter

s.Re

peat

edor

wid

espr

ead

dete

ctio

nin

seve

ralf

oods

oren

viro

nmen

tals

ites

high

light

san

incr

ease

dfo

odsa

fety

risk.

Alth

ough

E.co

lish

ould

not

bede

tect

edin

read

y-to

-eat

food

s,lo

wle

vels

may

occa

sion

ally

befo

und.

Repe

ated

orw

ides

prea

dde

tect

ion

inse

vera

lfoo

dsor

area

sof

the

food

prod

uctio

nen

viro

nmen

tsu

gges

tsan

incr

ease

dfo

odsa

fety

risk.

Like

lyC

ause

Poor

hygi

ene

due

toun

derc

ooki

ng,o

rcr

oss

cont

amin

atio

nfr

omra

wm

eat,

food

hand

lers

orfo

odco

ntac

tsu

rfac

esas

wel

las

poor

tem

pera

ture

and

time

cont

rol.

Poss

ible

evid

ence

ofpo

orhy

gien

edu

eto

unde

rcoo

king

,or

cros

sco

ntam

inat

ion

from

raw

mea

t,fo

odha

ndle

rsor

food

cont

act

surf

aces

asw

ella

spo

orte

mpe

ratu

rean

dtim

eco

ntro

l.

N/A

Poor

hygi

ene

due

toun

derc

ooki

ng,o

rcr

oss

cont

amin

atio

nfr

omra

wfo

odes

peci

ally

mea

t,fo

odha

ndle

rsor

food

cont

act

surf

aces

asw

ella

spo

orte

mpe

ratu

rean

dtim

eco

ntro

l.

Poss

ible

evid

ence

ofpo

orhy

gien

edu

eto

unde

rcoo

king

,or

cros

sco

ntam

inat

ion

from

raw

food

espe

cial

lym

eat,

food

hand

lers

orfo

odco

ntac

tsu

rfac

es,a

sw

ella

spo

orte

mpe

ratu

rean

dtim

eco

ntro

l.

N/A

Sug

ges

ted

Act

ion

s(N

ot

excl

usi

ve)

Revi

ewco

okin

gan

dal

lhyg

iene

proc

edur

esin

clud

ing

clea

ning

.Ta

kein

vest

igat

ive

sam

ples

offo

odan

dun

dert

ake

envi

ronm

enta

lm

onito

ring

offo

odpr

epar

atio

nen

viro

nmen

t.

Revi

ewco

okin

gan

dal

lhyg

iene

proc

edur

esin

clud

ing

clea

ning

.C

onsi

der

taki

ngin

vest

igat

ive

sam

ples

offo

odan

dth

efo

odpr

epar

atio

nen

viro

nmen

t.Ac

tion

shou

ldbe

prop

ortio

nalt

oth

ele

vels

dete

cted

.

Regu

latio

n(E

C)

No.

2073

/200

5(a

sam

ende

d)co

ntai

nsm

icro

biol

ogic

alcr

iteria

for

som

esp

ecifi

cfo

od/

Ente

roba

cter

iace

aeco

mbi

natio

nsan

dth

ere

quire

men

tsto

beco

mpl

ied

with

byFB

Os

Revi

ewco

okin

gan

dal

lhyg

iene

proc

edur

esin

clud

ing

clea

ning

.Ta

kein

vest

igat

ive

sam

ples

offo

odan

dun

dert

ake

envi

ronm

enta

lm

onito

ring

ofth

efo

odpr

epar

atio

nen

viro

nmen

t.

Revi

ewco

okin

gan

dal

lhyg

iene

proc

edur

esin

clud

ing

clea

ning

.C

onsi

der

taki

ngin

vest

igat

ive

sam

ples

offo

odan

dth

efo

odpr

epar

atio

nen

viro

nmen

t.Ac

tion

shou

ldbe

prop

ortio

nalt

ole

vels

dete

cted

.

Regu

latio

n(E

C)

No.

2073

/200

5(a

sam

ende

d)co

ntai

nsm

icro

biol

ogic

alcr

iteria

for

som

esp

ecifi

cfo

od/

E.co

lico

mbi

natio

nsan

dth

ere

quire

men

tsto

beco

mpl

ied

with

byFB

Os

Tab

le4

.Gui

danc

eon

the

inte

rpre

tatio

nof

resu

ltsfo

rhy

gien

ein

dica

tor

orga

nism

sin

read

y-to

-eat

food

spl

aced

onth

em

arke

t

/ / 2 4

List

eria

spp

.(n

ot

L.m

on

ocy

tog

enes

)>1

02

10-

≤10

2e

<10

f

UN

SATI

SFAC

TORY

BORD

ERLI

NE

SATI

SFAC

TORY

With

very

rare

exce

ptio

ns,s

peci

esot

her

than

L.m

onoc

ytog

enes

are

not

path

ogen

icto

hum

ans.

Det

ectio

nof

othe

rLi

ster

iasp

ecie

sat

this

leve

lsi

gnifi

esa

risk

that

L.m

onoc

ytog

enes

coul

dm

ultip

lyin

the

food

.Lis

teria

can

grow

,alb

eit

slow

ly,a

tre

frig

erat

ion

tem

pera

ture

s,an

dits

pres

ence

info

ods

with

anex

tend

edsh

elf

life

atth

isle

vels

ugge

sts

follo

w-u

pac

tion.

Rem

edia

lac

tion

shou

ldbe

take

nfo

rfo

ods

likel

yto

beco

nsum

edby

vuln

erab

legr

oups

inw

hom

the

risk

oflis

terio

sis

isin

crea

sed,

e.g.

food

sse

rved

inho

spita

ls

May

beco

me

apr

oble

mes

peci

ally

info

ods

capa

ble

ofsu

ppor

ting

grow

thof

List

eria

(see

abov

e).R

emed

iala

ctio

nsh

ould

beta

ken

for

food

sin

tend

edto

befe

dto

vuln

erab

legr

oups

inw

hom

the

risk

oflis

terio

sis

isin

crea

sed,

e.g.

food

sse

rved

inho

spita

ls.

Stro

ngev

iden

cefo

rpo

orpr

oces

sing

,or

poor

tem

pera

ture

cont

roli

nclu

ding

subo

ptim

alop

erat

ion

ofre

frig

erat

ors,

orov

erex

tens

ion

ofsh

elf

life.

Poss

ible

evid

ence

for

poor

proc

essi

ngor

poor

qual

ityra

wm

ater

ials

.Ind

icat

epr

oces

sha

sth

epo

tent

ialt

oal

low

cont

amin

atio

nby

L.m

onoc

ytog

enes

.

N/A

Revi

ewfa

ctor

yhy

gien

e(in

clud

ing

clea

ning

)to

geth

erw

ithte

mpe

ratu

rean

dsh

elf

life

cont

rols

.Ta

kein

vest

igat

ive

sam

ples

offo

odan

dth

efo

odpr

epar

atio

nen

viro

nmen

t,pa

rtic

ular

lypl

ant

and

mac

hine

ry.C

onsi

der

send

ing

isol

ates

for

refe

renc

ete

sts

Revi

ewqu

ality

ofra

wm

ater

ials

,fa

ctor

yhy

gien

e(in

clud

ing

clea

ning

),te

mpe

ratu

rean

dsh

elf

life

cont

rols

.Con

side

rta

king

inve

stig

ativ

esa

mpl

esof

food

and

the

food

prep

arat

ion

envi

ronm

ent,

part

icul

arly

plan

tan

dm

achi

nery

.C

onsi

der

send

ing

isol

ates

for

refe

renc

ete

sts.

Actio

nsh

ould

bepr

opor

tiona

lto

leve

lsde

tect

ed

a,Th

ecr

iterio

nlis

ted

for

Ente

roba

cter

iace

aedo

esno

tap

ply

tofr

esh

frui

tan

dsa

lad

vege

tabl

esor

food

that

cont

ains

fres

hfr

uit

and

vege

tabl

esas

ingr

edie

nts

e.g.

sand

wic

hes,

asth

ese

food

type

sca

nco

ntai

nhi

ghle

vels

ofEn

tero

bact

eria

ceae

aspa

rtof

thei

rno

rmal

mic

ro-f

lora

.The

crite

rion

does

not

appl

yto

chee

ses

ripen

edus

ing

acu

lture

ofH

afni

aal

veio

rPr

oteu

svu

lgar

is.

b,So

me

read

y-to

-eat

food

sar

eta

ken

asO

ffic

ialC

ontr

olsa

mpl

es,p

leas

ere

fer

toth

efo

odsa

fety

orpr

oces

shy

gien

ecr

iteria

inRe

gula

tion

(EC

)N

o.20

73/2

005

(as

amen

ded)

for

mic

robi

olog

ical

crite

riaan

dsa

mpl

ing

plan

s.c,

Acco

rdin

gto

Regu

latio

n(E

C)

No.

2073

/200

5(a

sam

ende

d)th

elim

itfo

rE.

coli

inliv

ebi

valv

em

ollu

scs

and

live

echi

node

rms,

tuni

cate

san

dga

stro

pods

plac

edon

the

mar

ket

durin

gth

eir

shel

f-lif

e(e

.g.r

awoy

ster

sin

tend

edto

beea

ten

raw

)is

230

MPN

/100

gfle

shan

din

tra-

valv

ular

liqui

d(f

ood

safe

tycr

iterio

n)us

ing

ISO

TS16

649-

3.d,

Crit

erio

ndo

esno

tap

ply

toch

eese

sm

ade

from

raw

milk

e,D

etec

ted

in25

gby

enric

hmen

tfo

rhi

ghris

kfo

ods

capa

ble

ofsu

ppor

ting

the

grow

thof

List

eria

spp.

such

asso

me

soft

ripen

edch

eese

,slic

edm

eats

,sm

oked

fish

and

pâté

f,N

otde

tect

edin

25g

byen

richm

ent

for

high

risk

food

sca

pabl

eof

supp

ortin

gth

egr

owth

ofLi

ster

iasp

p.

G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 2 5

Tab

le5

.Gui

danc

eon

the

inte

rpre

tatio

nof

resu

ltsfo

rae

robi

cco

lony

coun

tle

vels

inva

rious

read

y-to

-eat

food

san

dco

mpo

nent

spl

aced

onth

e

1 2 3 4 5 6 7 8 9 10 11 12 13

Foo

dC

ateg

ory

Am

bien

tst

able

cann

ed,b

ottle

d,ca

rton

edan

dpo

uche

dfo

ods

imm

edia

tely

afte

rre

mov

alfr

omco

ntai

ner

Food

sco

oked

imm

edia

tely

prio

rto

sale

orco

nsum

ptio

n

Coo

ked

food

sch

illed

but

with

min

imum

hand

ling

prio

rto

sale

orco

nsum

ptio

n;ca

nned

past

euris

edfo

ods

requ

iring

refr

iger

atio

n

Bake

ryan

dco

nfec

tione

rypr

oduc

tsw

ithou

tda

irycr

eam

,pow

dere

dfo

ods

Coo

ked

food

sch

illed

but

with

som

eha

ndlin

gpr

ior

tosa

leor

cons

umpt

ion

Non

-fer

men

ted

dairy

prod

ucts

and

dairy

dess

erts

,m

ayon

nais

ean

dm

ayon

nais

eba

sed

dres

sing

s,co

oked

sauc

es

Food

mix

edw

ithdr

essi

ngs,

dips

,pas

tes

Exte

nded

shel

flif

efo

odpr

oduc

tsre

quiri

ngre

frig

erat

ion

Raw

read

y-to

-eat

mea

tan

dfis

h,co

ldsm

oked

fish

Pres

erve

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Glossary

Aerobic – conditions in which oxygen is present

Anaerobic – conditions in which oxygen is absent.

Antimicrobial resistance - the ability of micro-organisms of certain species to survive or even to grow in the presenceof a given concentration of an antimicrobial agent, that is usually sufficient to inhibit or kill micro-organisms of thesame species (Directive 2003/99/EC60).

aw – the water activity (aw) of a food is a measure of availability of water for the metabolic activity and growth ofmicro-organisms.

Batch - a group or set of identifiable products obtained from a given process under practically identical circumstancesand produced in a given place within one defined production period (Regulation (EC) No. 2073/2005).

Borderline – test results that are not unsatisfactory but are also not satisfactory, are on the upper limit of acceptabilityand which indicate the potential for development of public health problems and of unacceptable risk.

Bacterial spores (endospores) - exist in a free state and are a tough, dormant form that are very resistant todesiccation, heat, and a variety of chemical and radiation treatments that are otherwise lethal to vegetative bacteria.The genera of Gram-positive bacteria, Bacillus and Clostridium, produce endospores which are released from a bacterial cell.

Competent authority - the central authority of a Member State competent for the organisation of official controls orany other authority to which that competence has been conferred (Regulation (EC) No. 882/2004).

Contamination – the presence or introduction of a hazard (Regulation (EC) No. 852/2004).

Disease – any change from a normal physiological state or function.

Emetic – causes vomiting.

Fermentation – conversion of a carbohydrate, such as sugar, by micro-organisms into an acid or an alcohol.

Flora - the bacteria and other micro-organisms that normally are found in a food.

Food business operator - the natural or legal persons responsible for ensuring that the requirements of food law aremet within the food business under their control (Regulation (EC) No. 178/2002).

Food examiner - a person who possesses the requisite qualifications and experience to carry out examinations for thepurposes of the Food Safety Act18.

Food safety criterion – criterion defining the acceptability of a product or a batch of foodstuff applicable to productsplaced on the market (Regulation (EC) No. 2073/2005).

Foodborne outbreak - an incidence, observed under given circumstances, of two or more human cases of the samedisease and/or infection, or a situation in which the observed number of cases exceeds the expected number andwhere the cases are linked, or are probably linked, to the same food source (Directive 2003/99/EC60).

Imported food – non-UK produced foods which are imported from other countries within or outside the EuropeanUnion. Import means the release for free circulation of food or the intention to release food for free circulation(Regulation (EC) No. 882/2004).

Microbiological criterion – criterion defining the acceptability of a product, a batch of foodstuffs or a process, based on the absence, presence or number of micro-organisms, and / or on the quantity of their toxins / metabolites,per unit(s) of mass, volume, area or batch (Regulation (EC) No. 2073/2005).

Modified atmosphere packaging (MAP) – removal of air from a food package and replacement with a strictlycontrolled gaseous mixture of carbon dioxide, oxygen, and/or nitrogen, and then hermetically sealed.

Morbidity – effect of disease.

Mortality – death as a result of disease.

Official control - any form of control that the competent authority or the Community performs for the verification ofcompliance with feed and food law, animal health and animal welfare rules (Regulation (EC) No. 882/2004).

G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 2 9

Pasteurisation – a form of heat treatment that kills vegetative pathogens and spoilage microorganisms in milk andother foods e.g. for milk a common pasteurisation process is 71.7°C for 15 seconds.

Pathogen – a micro-organism that has the capacity to cause disease, i.e. has the property of pathogenicity.

pH – the relative acidity or alkalinity of a food.

Potable water - water intended for drinking or use in food preparation.

Process hygiene criterion – criterion indicating the acceptable functioning of the production process. Such acriterion is not applicable to products placed on the market. It sets an indicative contamination value above whichcorrective actions are required in order to maintain the hygiene of the process in compliance with food law (Regulation(EC) No. 2073/2005).

Psychrotroph - a micro-organism that can grow at temperatures between -1°C and 5°C and have an optimum growthtemperature in the mesophilic range (20-30°C)

Ready-to-eat food – food intended by the producer or the manufacturer for direct human consumption without theneed for cooking or other processing effective to eliminate or reduce to an acceptable level micro-organisms ofconcern (Regulation (EC) No. 2073/2005).

Retail – the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer,and includes distribution terminals, catering operations, factory canteens, institutional catering, restaurants and othersimilar food service operations, shops, supermarket distribution centres and wholesale outlets (Regulation (EC) No.178/2002).

Risk - a function of the probability of an adverse health effect and the severity of that effect, consequential to ahazard (Regulation (EC) No. 178/2002).

Risk assessment - a scientifically based process consisting of four steps: hazard identification, hazard characterisation,exposure assessment and risk characterisation (Regulation (EC) No. 178/2002).

Sample - a set composed of one or several units or a portion of matter selected by different means in a population orin an important quantity of matter, which is intended to provide information on a given characteristic of the studiedpopulation or matter and to provide a basis for a decision concerning the population or matter in question orconcerning the process which has produced it (Regulation (EC) No. 2073/2005).

Satisfactory – test results indicating good microbiological quality

Shelf-life – the period preceding the “Use by” or the minimum durability date (Directive 2000/13/EC61).

Sporulation – the process by which some bacteria are able to produce endospores to enhance their survival underadverse conditions (see bacterial spores).

Symptoms – manifestation or evidence of disease.

Thermotolerant – able to survive high temperatures.

Toxin – a poisonous substance with the capacity to cause disease.

Unsatisfactory – for pathogens, test results at levels which indicate a product that is potentially injurious to healthand/or unfit for human consumption and require immediate remedial action. For hygiene indicators, test results thatrequire remedial action.

Vegetative bacteria – a bacterial cell which is capable of actively growing; multiplication occurs by division of the cellinto two.

Viable - capable of living, developing, or germinating in favourable environmental conditions.

Vulnerable groups – population of persons more susceptible or more likely to develop foodborne disease, sometimesof greater severity; these groups include pregnant women, the elderly, young babies, children and people withweakened immune systems.

Zoonosis - any disease and/or infection which is naturally transmissible directly or indirectly between animals andhumans (Directive 2003/99/EC60).

Zoonotic agent – any virus, bacterium, fungus, parasite or other biological entity which is likely to cause a zoonosis(Directive 2003/99/EC60).

/ / 3 0

References

Health Protection Agency. Health Protection Agency - Corporate Plan 2004-2009. April 2004. Available from:http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1197021714519.

Public Health Laboratory Service. Provisional microbiological guidelines for some ready-to-eat foods sampled at point ofsale. Notes for PHLS food examiners. PHLS Microbiology Digest 1992; 9: 98-9.

Public Health Laboratory Service. Microbiological guidelines for some ready-to-eat foods sampled at the point of sale:an expert opinion from the PHLS. PHLS Microbiology Digest 1996; 13: 41-3.

Public Health Laboratory Service. Guidelines for the microbiological quality of some ready-to-eat foods sampled at thepoint of sale. Communicable Disease & Public Health 2000; 3: 163-7. Available from:www.hpa.org.uk/cdph/issues/CDPHVol3/no3/guides_micro.pdf.

Mitchell, R.T. Practical Microbiological Risk Analysis. How to Assess, Manage and Communicate Microbiological Risks inFoods. Chandos Publishing (Oxford) Limited, Oxford, 2000.

European Food Safety Authority. Opinion of the Scientific Panel on Biological Hazards on microbiological criteria andtargets based on risk analysis, The EFSA Journal 2007; 462: 1-29.

European Commission. Discussion paper on strategy for setting microbiological criteria for foodstuffs in Communitylegislation. SANCO/1252/2001 Rev. 11. 8 March 2005. Available from:http://ec.europa.eu/food/food/biosafety/salmonella/discussion_paper_en.pdf.

European Commission. Regulation (EC) No. 852/2004 of the European Parliament and of the Council of 29 April 2004on the hygiene of foodstuffs. Official Journal of the European Communities 2004; L139: 1–54. Available from: eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:226:0003:0021:EN:PDF

European Commission. Regulation (EC) No. 882/2004 of the European Parliament and of the Council of 29 April 2004on official controls performed to ensure verification of compliance with feed and food law, animal health and animalwelfare rules. Official Journal of the European Communities 2004; L191: 1–52. Available from: eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:191:0001:0052:EN:PDF.

European Commission. Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authorityand laying down procedures in matters of food safety. Official Journal of the European Communities 2002; L31: 1–24.Available from: eur-lex.europa.eu/pri/en/oj/dat/2002/l_031/l_03120020201en00010024.pdf.

The Water Supply (Water Quality) Regulations 2000, SI 3184. Available from: www.opsi.gov.uk/SI/si2000/20003184.htm.

The Water Supply (Water Quality) Regulations 2000 (Amendment) Regulations 2007, SI 2734. Available from:http://www.opsi.gov.uk/si/si2007/pdf/uksi_20072734_en.pdf.

The Natural Mineral Water, Spring Water and Bottled Drinking Water (England) Regulations 2007, SI 2785. Availablefrom: http://www.opsi.gov.uk/si/si2007/uksi_20072785_en_1.

The Natural Mineral Water, Spring Water and Bottled Drinking Water (England) (Amendment) Regulations 2009.Available from: http://www.opsi.gov.uk/si/si2009/pdf/uksi_20091598_en.pdf.

European Commission. Regulation (EC) No. 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs.Official Journal of the European Union 2005; L338: 1-26. Available from: europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2005/l_338/l_33820051222en00010026.pdf.

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European Commission. Regulation (EC) No. 1441/2007 of 5 December 2007 amending Regulation (EC) No 2073/2005on microbiological criteria for foodstuffs. Official Journal of the European Union 2007; L322: 12-29. Available from: eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:322:0012:0029:EN:PDF.

Health Protection Agency. Food Sampling. National microbiological food studies carried out by the Health ProtectionAgency and the Local Authorities Co-ordinators of Regulatory Services. Available from:http://www.hpa.org.uk/webw/HPAweb&Page&HPAwebAutoListName/Page/1191942150074?p=1191942150074.

The Food Safety (Sampling and Qualifications) Regulations 1990 SI 2463. Available from:http://www.opsi.gov.uk/si/si1990/Uksi_19902463_en_1.htm.

Health Protection Agency. Requirements of Food Examiners, Expert Witnesses and Witnesses of Fact acting for/or onbehalf of the Health Protection Agency. National Standard Method QSOP 50 Issue 1. Available from: http://www.hpa-standardmethods.org.uk/documents/qsop/pdf/qsop50.pdf.

European Commission. Regulation (EC) No. 853/2004 of the European Parliament and of the Council of 29 April 2004laying down specific hygiene rules for food of animal origin. Official Journal of the European Communities 2004; L139:55–205. Available from: europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2004/l_226/l_22620040625en00220082.pdf.

Food Standards Agency. General Guidance for Food Business Operators. EC Regulation No. 2073/2005 MicrobiologicalCriteria for Foodstuffs. 26 February 2009. Available from:http://www.food.gov.uk/multimedia/pdfs/ecregguidmicrobiolcriteria.pdf.

Chilled Food Association / British Retail Consortium. Guidance on the Practical Implementation of the EC Regulation onMicrobiological Criteria for Foodstuffs. Ed 1.2. December 2006. Available from: http://www.chilledfood.org/.

Chilled Food Association. Glossary of definitions of industry, legal and technical terms (W 1.0 (v2.7)). 14 September 2007. Available from: http://www.chilledfood.org/.

Little, C.L., Surman-Lee, S., Greenwood, M., Bolton, F.J., Elson, R., Mitchell, R.T., Nichols, G.N., Sagoo, S.K., Threlfall, E.J.,Ward, L.R., Gillespie, I.A., O’Brien, S.J. Public health investigations of Salmonella Enteritidis in catering raw shell eggs,2002 – 2004. Letters in Applied Microbiology 2007: 44: 595-601.

Elviss, N.C., Little, C.L., Hucklesby, L., Sagoo, S., Surman-Lee, S., de Pinna, E., Threlfall, E.J. Microbiological study of freshherbs from retail premises uncovers an international outbreak of salmonellosis. International Journal of FoodMicrobiology 2009: Available from: doi:10.1016/j.ijfoodmicro.2009.01.015.

Willis, C., Little, C.L., Sagoo, S., de Pinna, E., Threlfall, J. Assessment of the microbiological safety of edible dried seedsfrom retail premises in the United Kingdom with a focus on Salmonella spp. Food Microbiology 2009: Available from:doi:10.1016/j.fm.2009.05.007.

Meldrum, R.J., Little, C.L., Sagoo, S.K., Mithani, V., McLauchlin, J., de Pinna, E. Microbiological quality of salad vegetablesand sauces from kebab take-away restaurants in the United Kingdom. Food Microbiology 2009; 26: 573-7.

Sagoo, S.K., Little, C.L., Ward, L., Gillespie, I.A., Mitchell, R.T. Microbiological study of ready-to-eat salad vegetables fromretail establishments uncovers a national outbreak of salmonellosis. Journal of Food Protection 2003; 66: 403-9.

Little, C.L., Sagoo, S.K., Gillespie, I.A., Grant, K., McLauchlin, J. Prevalence and level of Listeria monocytogenes and otherListeria species in selected retail ready-to-eat foods in the UK. Journal of Food Protection 2009; 72: 1869-77.

Willis, C., Greenwood, M. Wessex Shopping Basket Survey - a structured approach to local food sampling. InternationalJournal of Environmental Health Research 2003; 13: 349-59.

Black, R. E., Levine, M.M., Clements, M.L., Hughes, T.P., Blaser, M.J. Experimental Campylobacter jejuni infection inhumans. Journal of Infectious Diseases 1988; 157: 472-9.

Kothary, M.H., Babu, U.S. Infective dose of foodborne pathogens in volunteers: A review. Journal of Food Safety 2001;21: 49-73.

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Pearson, A.D., Greenwood, M.H., Donaldson, J., Healing, T.D., Jones, D.M., Shahamat, M., Feltham, R.K.A., Colwell, R.R.Continuous source outbreak of campylobacteriosis traced to chicken. Journal of Food Protection 2000; 63: 309-14.

Yoda, K., Uchhimura, M. An outbreak of Campylobacter jejuni food poisoning caused by secondary contamination incooking practice at a high school. Japanese Journal of Infectious Diseases 2006; 59: 408-9.

Fitzpatrick, M. Haemolytic uraemic syndrome and E. coli O157. British Medical Journal 1999; 318: 684-5.

Tilden, J.Jr, Young W., McNamara, A.M., Custer, C., Boesel, B., Lambert-Fair, M.A., Majkowski, J., Vugia, D., Werner, S.B.,Hollingsworth, T. and Morris, J.G.Jr. A new route of transmission for Escherichia coli: infection from dry cured salami.American Journal of Public Health 1996; 86: 1142-5.

World Health Organisation. Zoonotic Non-O157 Shiga Toxin-Producing Escherichia coli (STEC). Report of a WHOScientific Working Group Meeting. Berlin, Germany. WHO/CRS/APH/98.8, 1998.

European Food Safety Authority. Scientific Opinion of the Panel on Biological Hazards on a request from EFSA onmonitoring of verotoxigenic Escherichia coli (VTEC) and identification of human pathogenic VTEC types. The EFSAJournal 2007; 579: 1-61. Available from:http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/biohaz_op_ej579_vtec_en.pdf?ssbinary=true.

Gill, O.N., Sockett, P.N., Bartlett, C.L.R., Vaile, M.S.B., Rowe, B., Gilbert, R.J., Dulake, C., Murrell, H.C., Salmaso, S. Outbreakof Salmonella Napoli infection caused by contaminated chocolate bars. Lancet 1983; i: 574-7.

Rowe, B., Begg, N.T., Hutchinson, D.N., Dawkins, H.C., Gilbert, R.J., Jacob, M., Hales, B.H., Rae, F.A., Jepson, M. SalmonellaEaling infections associated with consumption of infant dried milk. Lancet 1987; ii: 900-3.

Unicomb, L.E., Simmons, G., Merritt, T., Gregory, J., Nicol, C., Jelfs, P., Kirk, M., Tan, A., Thomson, R., Adamopoulos, J.,Little, C.L., Currie, A., Dalton, C.B. Sesame seeds products are high risk for Salmonella contamination: Three outbreaksassociated with tahini. Epidemiology & Infection 2005; 133: 1065-72.

Craven, O.C., Mackel, D.C., Baine, W.B., Barker, W.H., Gangarosa, E.J. International outbreak of Salmonella Eastbourneinfection traced to contaminated chocolate. Lancet 1975; 1: 788-92.

Connor, C. Defying a reputational crisis – Cadbury’s Salmonella scare: Why are customers willing to forget and forgive?Corporate Reputation Review 2009; 12: 64-82.

Danyluk, M.D., Jones, T.M., Abd, S.J., Schlitt-Dittrich, F., Jacobs, M., Harris, L.J. Prevalence and amounts of Salmonellafound on raw California almonds. Journal of Food Protection 2007; 70: 820-7.

Kirk, D.M., Little, C.L., Lem M., Fyfe, M., Tan, A., Threlfall, J., Paccagnella, A., Lightfoot, D., Genobile, D., Li, H., McIntyre,L., Crawford, C., Ward, L., Brown, D.J., Surman, S., Fisher, I.S.T. An outbreak due to peanuts in their shell caused bySalmonella enterica serotypes Stanley and Newport—sharing molecular information to solve international outbreaks.Epidemiology & Infection 2004; 132: 571-7.

Killalea, D., Ward, L.R., Roberts, D., de Louvois, J., Sufi, F., Stuart, JM, Wall, P.G., Susman, M., Schwieger, M., Sanderson,P.J., Fisher, I.S.T., Mead, P.S., Gill, O.N., Bartlett, C.L.R., Rowe, B. International epidemiological and microbiological studyof outbreak of Salmonella Agona infection from a ready to eat savoury snack-I: England and Wales and the UnitedStates. British Medical Journal 1996; 313: 1105-7.

Cowden, J.M., O'Mahony, M., Bartlett, C.L.R., Rana, B., Smyth, B., Lynch, D., Tillett, H. A national outbreak of SalmonellaTyphimurium DT 124 caused by contaminated salami sticks. Epidemiology & Infection 1989; 103: 219-25.

Hedberg, C.W., Korlath, J.A., D’Aoust, J-Y., White, K.E., Schell, W.L., Miller, M.R., Cameron, D.N., MacDonald, K.L.,Osterholm, M.T. A multistate outbreak of Salmonella Javiana and Salmonella Oranienburg infections due to theconsumption of contaminated cheese. Journal of the American Medical Association 1992; 268: 3203-7.

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G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 3 3

Van Duynhoven, Y.T.H.P., Isken, L.D., Borgen, K., Besselse, M., Soethoudt, K., Haitsma, O., Mulder, B., Notermans, D.W.,Jonge, R.D., Kock, P., van Pelt, W., Stenvers, O., van Steenbergen, J. A prolonged outbreak of Salmonella Typhimuriuminfection related to an uncommon vehicle: hard cheese made from raw milk. Epidemiology & Infection 2009; Availableon-line from: doi:10.1017/S0950268809002337.

Uesugi, A.R., Danyluk, M.D., Harris, L.J.. Survival of Salmonella Enteritidis Phage Type 30 on inoculated almonds stored at-20, 4, 23 and 35°C. Journal of Food Protection 2006; 69: 1851-7.

Bell, C., Kyriakides, A. Salmonella. A practical approach to the organism and its control in foods. 2002. Blackwell ScienceLtd., Oxford, UK.

Humphrey, T.J., Martin, K.W., Whitehead, A. Contamination of hands and work surfaces with Salmonella Enteritidis PT4during the preparation of egg dishes. Epidemiology & Infection 1994; 113: 403-9.

Bradford, M.A., Humphrey, T.J., Lappin-Scott, H.M. The cross-contamination and survival of Salmonella Enteritidis PT4 onsterile and non-sterile foodstuffs. Letters in Applied Microbiology 1997; 24: 261-4.

Gillespie, I.A., O'Brien, S.J., Adak, G.K., Ward, L.R., Smith, H.R., 2005. Foodborne general outbreaks of SalmonellaEnteritidis phage type 4 infection, England and Wales, 1992-2002: where are the risks? Epidemiology & Infection 2005;133: 795-801.

Pezzoli, L., Elson, R., Little, C.L., Yip, H., Fisher, I., Yishai, R., Anis, E., Valinsky, L., Biggerstaff, M., Patel, N., Mather, H.,Brown, D.J., Coia, J.E., van Pelt, W., Nielsen, E.M., Ethelberg, S., Hampton, M., Threlfall, J. Packed with Salmonella -Investigation of an international outbreak of Salmonella Senftenberg infection linked to contamination of pre-packedbasil. Foodborne Pathogens & Disease 2008; 5: 661-8.

Fisher, I.S.T., Jourdan-Da, S.N., Hächler, H., Weill, F-X, W., Schmid, H., Danan, C., Kérouanton, A., Lane, C., Dionisi, A.M.,Luzzi, I. Human infections due to Salmonella Napoli: a multicountry, emerging enigma recognized by the Enter-netinternational surveillance network. Foodborne Pathogens & Disease 2009; 6: 613-9.

Mølbak, K. Human health consequences of antimicrobial drug-resistant Salmonella and other foodborne pathogens.Clinical Infectious Diseases 2005; 41: 1613–20.

Roberts, D., Greenwood, M. Isolation and enrichment of microorganisms, p 131-192. In Roberts, D., Greenwood, M.(eds) Practical Food Microbiology. 2003. Blackwell Publishing Ltd., Oxford, UK.

European Commission. Guidance document on official controls, under Regulation (EC) No 882/2004, concerningmicrobiological sampling and testing of foodstuffs. 13 November 2006. Available from:http://ec.europa.eu/food/food/controls/foodfeed/sampling_testing.pdf.

European Commission. Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 onthe monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing CouncilDirective 92/117/EEC. Official Journal of the European Union 2003; L325: 31-40. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:325:0031:0040:EN:PDF.

European Commission. Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on theapproximation of the laws of the Member States relating to labelling , presentation and advertising of foodstuffs.Official Journal of the European Communities 2000; L109: 29–42. Available from: http://eur-lex.europa.eu/pri/en/oj/dat/2000/l_109/l_10920000506en00290042.pdf.

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