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Guidance on the Practical Implementation of the
EC Regulation on Microbiological Criteria for Foodstuffs
EDITION 1.2 6 DECEMBER 2006
Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
Published by Chilled Food Association Ltd, P.O. Box 6434, Kettering, NN15 5XT, UK © 2006 Chilled Food Association Ltd Typeset in Arial 10 ISBN-13 978-1-901798-13-5 ISBN-10 1-901798-13-5 Enquiries concerning reproduction should be sent to the Chilled Food Association Ltd at P.O. Box 6434, Kettering, NN15 5XT, UK [email protected], www.chilledfood.org
CFA publishes information and expresses opinions in good faith, and seeks to ensure that the information and opinions it provides are correct, but accepts no
liability for any error or omission in any such information or opinion, including any information or opinion contained in this document. The information contained
herein is to assist with the understanding of the EC Regulation on Microbiological Criteria for Foodstuffs. It is not a definitive interpretation of the law which only the courts can provide. Information and opinion herein are not substitutes for specific
legal or other professional advice.
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Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
FOREWORD This guidance is intended to help food business operators (manufacturers and retailers) to understand the requirements of the Commission Regulation on Microbiological Criteria for Foodstuffs (‘the Regulation’), providing additional detail to that given in the Food Standards Agency’s own guidance documents. The purpose of the Regulation is to protect public health and provide harmonised reference points for Food Business Operators (FBOs). It relates to the General Food Law (178/2002/EC) that obliges FBOs to withdraw or recall unsafe food from the market. It states that safety is ensured by a preventative approach such as employing good hygiene practices and use of Hazard Analysis and Critical Control Point (HACCP) principles. This guidance assumes FBOs have working knowledge of this approach. The Regulation generally relates to finished manufactured foods and not to ingredients or raw materials used to manufacture that food. However, FBOs producing/supplying raw materials may be affected by the Regulation through the application of criteria and corrective actions required by their customers’ food safety management plans. With the exception of raw minced meat, meat preparations, certain meat products intended to be cooked and mechanically separated meat, the Regulation does not specify the frequency of sampling/testing, and it is for the FBO to decide the appropriate level of sampling/testing to help validate and verify their food safety management systems, e.g. HACCP. This guidance document is separated into two parts: Part A is an overview of the requirements of the Regulations. Part B provides interpretation of Annex I (the microbiological criteria) for both food safety
and process hygiene. The tables in this section are taken directly from the regulation and include relevant footnotes for clarity. The interpretations appear below the table in blue text.
The guidance has been prepared by the Chilled Food Association with support from: British Retail Consortium British Frozen Food Federation British Meat Processors Association Campden and Chorleywood Food Research Association Food Standards Agency Health Protection Agency Provision Trade Federation This guidance will be updated as required in light of practical experience.
6 December 2006 Version 1.2
The Regulation provides for further criteria to be added in the future and businesses must ensure that they are aware of any changes.
The issuing organisations seek to ensure the information and guidance they provide is correct, but accept no liability in respect thereof. Such information and guidance are not substitutes for specific
legal or other professional advice.
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Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
Contents Page Part A – Overview of the Requirements of the Regulations 4 1. The Purpose Of Microbiological Criteria 4 2. The Purpose of Microbiological Testing 4 3. The Legal Context 4 4. Requirements For Food Business Operators 5 5. Recommendations For Food Business Operators 6 6. Definitions 9 7. Sampling Plans and Frequencies 9 Part B – Interpretation of Annex I of the Regulations (The Criteria)
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8. Food Safety Criteria Index
11
Ready-to-eat foodsMinced meat and meat preparationsMeat and products thereof Milk and dairy products Infant Formula and dried dietary foods for infants for special medical purposesEgg ProductsFishery Products and Shellfish Produce
16 22 25 27 28
29 30 32
Process Hygiene Criteria Index
33 9.
Meat and products thereof Milk and dairy productsInfant formula and dried dietary foods for infants for special medical purposes Egg ProductsFishery Products and Shellfish Produce
36 45 48
49 50 51
Figures
1. Decision Tree Showing Application of Listeria monocytogenes (Lm) Criteria for ready-to-eat foods other than infant foods and foods for special medical purposes
17
2. Sampling rules for poultry carcases 43
Tables
1. Sampling frequencies for red meat carcases 38 2. Sampling frequencies for poultry slaughterhouses 41
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Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
PART A - OVERVIEW OF THE REQUIREMENTS OF THE REGULATIONS 1. The Purpose of Microbiological Criteria Microbiological criteria are intended to give some degree of assurance that food is safe and of suitable quality, and that it will remain so to the end of its shelf life provided it is handled appropriately. The EC Regulation on Microbiological Criteria for Foodstuffs requires FBOs to use the criteria given in the Regulation when carrying out validation and verification checks as part of food safety management systems based on HACCP principles. It should be noted that it is not an offence per se to breach the criteria set out in the Regulations. 2. The Purpose of Microbiological Testing The safety of food is neither guaranteed nor controlled by microbiological testing. Microbiological testing can be used to validate and monitor processes and verify Critical Control Points (CCPs) identified through HACCP. Microbiological testing of final product alone cannot be relied upon to demonstrate product safety and may be insufficient to demonstrate due diligence. The EC Regulation on Microbiological Criteria for Foodstuffs simply requires food business operators to ensure their products comply with microbiological criteria, testing against microbiological criteria as appropriate “when they are validating or verifying the correct functioning of their procedures based on HACCP principles and good hygiene practice.” It is important to note that the Regulations are not intended to create additional testing requirements since validating/verification testing is a standard part of HACCP. The Regulation should also not lead to an increased reliance on or positive release. 3. The Legal Context The Commission Regulation on Microbiological Criteria for Foodstuffs (2073/2005/EC), hereafter referred to as “the Regulation”, applies from 1 January 2006. The Regulation is pursuant to the Regulation on the Hygiene of Foodstuffs (Regulation No. 852/2004/EC) and to the General Food Law (Regulation No. 178/2002/EC). The Regulation on Microbiological Criteria for Foodstuffs is subject to future review in order to take account of developments in microbiology and food safety. A copy of the Regulation and any future amendments to it can be obtained from the Europa website at: www.europa.eu.int/eur-lex. The Regulation is implemented locally through Food Hygiene (No. 2) Regulations 2005 in the constituent countries of the UK. This implementing legislation includes, for example, requirements for FBOs to put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles and to take the measures laid down in paragraphs (2) to (4) of Article 7 of the Microbiological Criteria Regulation when the results of testing against the Food Safety Criteria are unsatisfactory.
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Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
4. Requirements for Food Business Operators The following are minimum legal requirements:
• There is an obligation within 178/2002/EC to withdraw or recall unsafe food from the
market. • If the Food Safety Criteria given in Annex I, Chapter 1 of the Regulation are not met,
the product is deemed as ‘unsatisfactory’. Under 178/2002/EC there is an obligation on the Brand Owner to withdraw unsafe food from the market and to notify the Competent Authority. Further action may include product recall by the Brand Owner. This would be agreed on a case by case basis in consultation with the Competent Authority.
• Food Business Operators must analyse trends in the test results. • When a trend towards unsatisfactory results is found, or if the Process Hygiene Criteria
given in Annex I, Chapter 2 of the Regulation are exceeded then appropriate investigation and corrective action is required. Corrective action is to include the actions specified in the Annex I of the Regulation (see pages 17-52 of this guidance) together with other corrective actions defined in the Food Business Operator’s HACCP-based procedures and other actions necessary to protect the health of consumers. In addition, the Food Business Operator shall take measures to find the cause of the unsatisfactory results in order to prevent the recurrence of the unacceptable microbiological contamination. Those measures may include modifications to the HACCP-based procedures or other food hygiene control measures in place. Environmental monitoring can form part of the investigatory action undertaken to prevent a reoccurrence of an exceedance. No notification is required in the case of a Process Hygiene Criterion being exceeded.
• A food management preventative approach such as employing good hygiene practices
and a system based on HACCP principles must be in place. Food testing against the appropriate criteria should be undertaken, if appropriate, when verifying or validating HACCP.
• The Regulation stipulates a minimum frequency of sampling and testing for carcases,
minced meat, meat preparations, meat products covered in Annex I of the Regulation that are intended to be eaten cooked and mechanically separated meat. For more details of these requirements see Part B of this document section 8 (Food Safety Criteria) and section 9 (Process Hygiene Criteria).
• Where there are no frequencies defined by the Regulation (all except carcases, minced
meat, meat preparations, meat products covered in Annex I of the Regulation that are intended to be eaten cooked and mechanically separated meat), sampling and testing frequencies should be determined by the Food Business Operator based on HACCP principles. Evidence to support the sampling/testing regime should be held on file and available on request to the Competent Authority.
• Raw minced meat, raw meat preparations and raw poultry meat products intended to
be cooked must be clearly labelled by the manufacturer informing the consumer of the need for thorough cooking prior to consumption.
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Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
• If official control testing (for example by a Port Health Authority) is conducted on a product from outside the EU the Food Safety Criteria will be used as a minimum requirement.
• Alternative methods to those prescribed in the Regulation may be used as long as
those methods provide equivalent results validated against the reference method given in Annex I of the Regulation. Alternative methods must be:
a. validated against the reference method, and if a commercial kit, certified by a
third party using an internationally accepted protocol, i.e. ISO 16140 or a similar protocol Or
b. validated by an internationally accepted protocol and authorised by the Competent Authority.
• Environmental monitoring is one important tool when investigating why hygiene criteria
and/ or food safety criteria are not met. • Processing areas and equipment used in the manufacture of ready-to-eat foods must
be monitored for Listeria monocytogenes. • Processing areas and equipment used in the manufacture of dried infant formula and
related products must be monitored for Enterobacteriaceae.
5. Recommendations for Food Business Operators In addition to the legal obligations Food Business Operators should also consider the following: • Sampling of the production and processing environment is required to monitor hygiene
in relation to ready-to-eat foods. Listeria spp is considered a suitable hygiene indicator for Listeria monocytogenes. If Listeria spp are detected the particular species must be identified. Aerobic colony counts can be useful in validating factory cleaning procedures.
• Laboratories carrying out official controls must be accredited. FBOs should use an
appropriately accredited laboratory to conduct microbiological testing. Laboratories should take part in relevant external proficiency testing schemes.
6. Selected Definitions Batch This is defined in Article 2 (e) of the Regulation for the microbiological criteria for foodstuffs (2073/2005/EC) as a group or set of identifiable products obtained from a given process under practically identical circumstances and produced in a given place within one defined production period. The food business operator must define the batch. Batch size is a key point to consider in any risk management action.
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Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
Brand Owner The Brand Owner is a Food Business Operator and is the person or organisation that has legal responsibility for the product. For the purpose of this guidance document, for pre-packed products, this would normally be the brand on the food package. Competent Authority For the purpose of the microbiological criteria for foodstuffs Regulation, in the UK the Competent Authority is the Food Standards Agency. Enforcement is undertaken on its behalf by the Local Authority, Port Health Authority and the Meat Hygiene Service. Egg Products Directive (853/2004/EC) defines egg products as “processed products resulting from the processing of eggs, or of various components or mixtures of eggs, or from the further processing of such processed products”. They may be liquid, concentrated, dried, crystallized, frozen, quick frozen or coagulated. Food for Infants Means food intended to meet fully or partially the nutritional requirements of children under the age of 12 months. It includes both infant formulae and follow-on formulae as defined in Directive 91/321/EC. Food Business Operator (FBO) A FBO is defined in the General Food Law Regulation (178/2002/EC) as the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control. Meat Preparations "Meat Preparations", as defined in Regulation 853/2004/EC, means fresh meat, including meat that has been reduced to fragments, which has had foodstuffs, seasonings or additives added to it or which has undergone processes insufficient to modify the internal muscle fibre structure of the meat and thus to eliminate the characteristics of fresh meat. Meat Products "Meat Products", as defined in Regulation 853/2004/EC, means processed products resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat. Minced Meat "Minced Meat", as defined in Regulation 853/2004/EC, means boned meat that has been minced into fragments and contains less than 1% salt.
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Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
Placing on the Market The General Food Law Regulation (178/2002/EC) defines Placing on the Market as: “The holding of food or feed for the purpose of sale, including offering for sale or any other form or transfer, whether free of charge or not, and sale, distribution, and other forms or transfer themselves.” In practice this means food is placed on the market if it has left the control of the primary manufacturer. Product Recall Means any measure aimed at achieving the return of the product that has already been supplied to or made available to consumers. Product Withdrawal Means any measure aimed at preventing the distribution, display or offer of a product. Proficiency Testing The determination of laboratory testing performance by means of interlaboratory test comparisons. Ready-to-eat Food Means food intended by the producer or the manufacturer for direct human consumption without the need for cooking or other processing effective to reduce to an acceptable level or eliminate microorganisms of concern. For the purpose of this guidance ready-to-eat means food intended by the producer or the manufacturer for direct human consumption without the need for cooking or reheating. For example, ready meals labelled to be reheated are outside the scope of the Regulation. Smoked salmon, sandwiches and products not requiring such processing prior to consumption are within the scope of the Regulation. Reference Method This refers to the laboratory method in Annex I of the Regulation, which is normally international, i.e. an EN/ISO standard. Shelf life As defined in the Regulations as “Either the period corresponding to the period preceding the “use by” or the minimum durability date”. In practice this means the period during which the product maintains its microbiological safety and sensory qualities at a specific storage temperature. It is based on identified hazards for the product, heat or other preservation treatments, packaging method and other inhibitory or inhibiting factors that may be used.
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Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
Small Establishments and Slaughterhouses Small minced meat and meat preparation establishments produce up to an average 2 metric tonnes a week. Small poultry meat establishments hand fewer than 7,500,000 birds a year. Small red meat slaughterhouses handle fewer than 25,000 livestock units a year. Terms Used in the Criteria Tables The following definitions apply to the criteria tables (sections 8 and 9) when the detection (presence/absence) of specific pathogens is being tested for (i.e. a two-class sampling plan): Limit m: This is the maximum acceptable level Sampling Plan n: The number of samples from the batch which are tested Sampling Plan c: The number of samples that are allowed to exceed m The following definitions apply to the criteria tables (sections 8 and 9) when enumeration of the microorganism being tested for is required (i.e. a three-class sampling plan): Limit m: This level is the target normally achieved using HACCP and good
hygienic practice. Limit M: This is the maximum acceptable level Sampling Plan n: The number of samples from the batch which are tested Sampling Plan c: The number of samples that are allowed to have results between m
and M 7. Sampling Plans and Frequencies The Regulation gives sampling plans to which the criteria in its Annex (I) are to be applied. Testing or sampling frequencies are defined in the Regulation for minced meat, meat preparations and mechanically separated meat. For all other product types, the Food Business Operator should determine sampling and microbiological testing frequency. HACCP principles must be applied when manufacturing all products. The management of the microbiological risks at each stage of manufacturing process must be considered.
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Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
Key stages include: • Ingredients/ raw material • Factory - design, hygiene of equipment and people • Manufacturing process targeting appropriate organism/s • Packaging • Storage temperature and shelf life • Intended use • Food safety studies related to similar products More information on the practical application of HACCP can be found in CFA’s ‘Best Practice Guidelines for the Production of Chilled Food’. Microbiological testing may be appropriate at certain stages to verify that the HACCP is adequate, operational and effectively in control. Monitoring raw materials and factory hygiene may also be important. Final product microbiological testing against microbiological criteria is often used to verify that the overall process is in control. When deciding the frequency of microbiological tests against criteria the following should be considered. For example for raw materials: • The microbiological hazards and risks associated with the raw material. • Knowledge and confidence in the supplier/ producer of the raw material. • The risk associated with the volume of the raw material used. • Historical data. The supplier/ producer of the raw material should be producing using HACCP principles, which should minimise the risks, associated with the raw materials. The more confidence you have in the raw material supplier/ producer the less testing is required. Confidence can be achieved by: • Auditing the supplier/ producer and their HACCP including their microbiological checks
and/ or
• Increasing the frequency of checks until sufficient historical data is available. Microbiological testing can be used to verify a HACCP plan. As the HACCP plan is more established and more satisfactory test results are obtained the frequency of testing may be reduced based on historical data. If anything significant is changed in the production of the product such as raw material source, formulation or processing, the HACCP should be reviewed and it may be appropriate to increase test frequency. It is the view of the Food Standards Agency that where testing is not part of validation or verification of procedures based on HACCP principles then there is no requirement to conduct such additional testing under the Regulation and the specific requirements of Annex I of the Regulation do not apply. More information on sampling and testing can be found in CFA’s ‘Microbiological Testing and its Interpretation Guidance’, ISBN-13 978-1-901798-10-4.
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Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
PART B – INTERPRETATION OF ANNEX I (THE CRITERIA)
The Regulation sets Food Safety Criteria and Process Hygiene Criteria, which are detailed in sections 8 and 9, respectively. 8. Food Safety Criteria Index Criteria have been set for Escherichia coli, Enterobacter sakazakii, Listeria monocytogenes, Salmonella spp, Staphylococcus enterotoxin and histamine. The following is an index of the microbiological criteria tables taken from Annex I Chapter 1 of the Regulation. The tables have been separated so that each section can be referred to in isolation. Some product examples have been given to assist in deciding which tables are relevant. Ready to Eat Foods Criterion No.
Organism and Food Category Examples (not an exhaustive list)
1.1 Listeria monocytogenes in ready-to-eat foods intended for infants and special medical purposes
Ready-to-eat baby foods Ready-to-eat foods intended for infants less than 12 months old Ready-to-eat dietary food for special medical purposes for infants less than 6 months old
1.2 L. monocytogenes in ready-to-eat foods able to support the growth of L.monocytogenes other than those in 1.1.
Chilled ready-to-eat products with more than 5 days life Pre-packed delicatessen products Pre-packed sliced cooked meat Smoked salmon Pate Soft Cheese
1.3 L. monocytogenes in ready-to-eat foods unable to support the growth of L.monocytogenes other than those in 1.1.
Ice cream Yoghurt Hard Cheese Products with a pH of less than 4.4, e.g. coleslaw Products with shelf life of less than 5 days e.g. sandwiches and some unpackaged delicatessen products if prepared in store
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Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
Minced Meat and Meat Preparations Criterion No.
Organism and Food Category Examples (not an exhaustive list)
1.4
Salmonella in minced meat and meat preparations intended to be eaten raw
Steak tartare
1.5 Salmonella in minced meat and meat preparations made from poultry meat intended to be cooked
Chicken/Turkey Mince Turkey kebabs Chicken nuggets if not fully cooked by the manufacturer
1.6 Salmonella in minced meat and meat preparations made from other species than poultry intended to be cooked
Minced beef, sausages, burgers, minced lamb kebabs, minced pork
1.7 Salmonella in Mechanically separated meat (MSM)
Meat and Products Thereof
Criterion No.
Organism and Food Category Examples (not an exhaustive list)
1.8 Salmonella in meat products intended to be eaten raw, excluding products where the manufacturing process or the composition of the product will eliminate the Salmonella risk
Salami Parma ham Cold smoked duck
1.9
Salmonella in meat products made from poultry meat intended to be eaten cooked
Turkey bacon
1.10 Salmonella in gelatine and collagen
Milk and Dairy Products
Criterion No.
Organism and Food Category Examples (not an exhaustive list)
1.11
Salmonella in cheeses, butter and cream made from raw milk or milk that has undergone a lower heat-treatment than pasteurisation
Roquefort, Brie de Meaux
1.12 Salmonella in milk powder and whey powder
Dried milk powder
1.13 Salmonella in ice cream, excluding products where the manufacturing process or the composition of the product will eliminate the Salmonella risk
Ice cream made from unpasteurised ingredients
1.21 Staphylococcal enterotoxins in cheeses, milk powder and whey powder, as referred to in the coagulase-positive staphylococci criteria in Chapter 2.2 of Annex I of the Regulation
Cheese, excluding processed cheese and non fermented cheese.
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Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
Infant Formula and dried dietary foods for infants for special medical purposes Criterion No.
Organism and Food Category Examples (not an exhaustive list)
1.22 1.23
Salmonella and Enterobacter sakazakii in dried infant formulae and dried dietary foods for special medical purposes intended for infants below 6 months of age, as referred to in the Enterobacteriaceae criterion in Chapter 2.2 of Annex I of the Regulation
Egg Products Criterion No.
Organism and Food Category Examples (not an exhaustive list)
1.14 Salmonella in egg products, excluding products where the manufacturing process or the composition of the product will eliminate the Salmonella risk
Unpasteurised liquid egg
1.15 Salmonella in ready-to-eat foods containing raw egg, excluding products where the manufacturing process or the composition of the product will eliminate the Salmonella risk
Mayonnaise and meringues made with unpasteurised egg
Fishery Products and Shellfish Criterion No.
Organism and Food Category Examples (not an exhaustive list)
1.16 Salmonella in cooked crustaceans and molluscan shellfish
Mussels, prawns, shrimp, lobster, crab
1.17 Salmonella in live bivalve molluscs and live echinoderms, tunicates and gastropods
Oysters, clams, sea urchins, winkles, whelks
1.24 E.coli in live bivalve molluscs and live echinoderms, tunicates and gastropods
Oysters, clams, sea urchins, winkles, whelks
1.25 Histamine in fishery products from fish species associated with a high amount of histidine
Tuna, mackerel, sardines, mahi mahi
1.26 Histamine in fishery products which have undergone enzyme maturation treatment in brine, manufactured from fish species associated with a high amount of histidine
Anchovies
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Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
Produce Criterion No.
Organism and Food Category Examples (not an exhaustive list)
1.18 Salmonella in sprouted seeds (ready-to-eat)
Cress, ready-to-eat beansprouts
1.19 Salmonella in pre-cut fruit and vegetables (ready-to-eat)
Prepared ready-to-eat salads, prepared ready-to-eat fruit
1.20 Salmonella in unpasteurised fruit and vegetable juices (ready-to-eat)
Freshly squeezed unpasteurised juices
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Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
The Food Safety Criteria
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Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
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Food Safety - Ready-to-eat foods: infant foods and foods for special medical purposes There are very specific criteria requirements for Listeria monocytogenes in ready-to-eat foods intended for infants and for special medical purposes:
Sampling
plan Limits Food category and criterion number Microorganisms/ their
toxins, metabolites
n C M M
Analytical reference method
Stage where the criterion applies
1.1 Ready-to-eat foods intended for infants and ready-to eat foods for special medical purposes
Listeria monocytogenes 10 0 Absence in 25 g
EN/ISO 11290-1
Products placed on the market during their shelf-life
The Regulation states that regular testing against the criterion is not useful in normal circumstances for the following ready-to-eat foods: • those which have received heat treatment or other processing effective to eliminate L. monocytogenes, when recontamination is not possible after this treatment (e.g. products heat-treated
in their final package) • fresh, uncut and unprocessed vegetables and fruits, excluding sprouted seeds • bread, biscuits and similar products • bottled or packed waters, soft drinks, beer, cider, wine, spirits and similar products • sugar, honey and confectionery, including cocoa and chocolate products • live bivalve molluscs Interpretation of Requirements: Positive release testing for L.monocytogenes is not required. Results indicating the presence of L. monocytogenes in 25g of these products are considered to be an unacceptable food safety risk and products must be withdrawn from the market and the competent authority notified. The sampling plan given above may be revised if the food business operator can demonstrate by historical documentation and data that effective HACCP based procedures are in place. A preventative approach such as environmental monitoring should be demonstrated.
Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
17
Figure 1: Decision tree showing the application of Listeria monocytogenes criteria for ready-to-eat foods other than infant foods and foods for special medical purposes
For all ready-to-eat foods not designed for infants or for special medical purposes the decision tree below can be used to identify the type of criteria applicable. The specific criteria can be found in the appropriate later sections of this guidance.
Is the product ready-to-eat? i.e. intended by the producer or the manufacturer for direct human consumption without the need for cooking or other processing effective to
eliminate or reduce to an acceptable level microorganisms of concern → NO → No criterion for L. monocytogenes applies
↓ YES
YES
↓
Is the product one of the following? [i.e. referred to in footnote 4 of the Regulation] • Product which has received heat treatment or other processing to eliminate L.
monocytogenes, when recontamination is not possible • Fresh, uncut and unprocessed vegetables and fruit (excluding sprouted seeds) • Bread, biscuits and similar products • Bottled or packed waters, soft drinks, beer, cider, wine, spirits and similar products • Sugar, honey, confectionery, including cocoas and chocolate products • Live bivalve molluscs
→ → No criterion for L. monocytogenes applies
↓ NO
↓
Is the product: • pH < 4.4 or • aW <0.92 or • pH < 5.0 and an aW <0.94 or • shelf life of <5 days or • frozen at <-12ºC
→ YES →
Product is unable to support the growth of L. monocytogenes.
Limit of 100 cfu/g applies when placed on the market throughout shelf life
↓ NO
YES
↓
Are scientific/modelling, historical or other data (e.g. end of life testing) available to demonstrate that the product will not support the growth of L. monocytogenes? → → Limit of 100 cfu/g applies when placed on the market throughout
shelf life ↓
NO ↓
Is data available to show that L. monocytogenes will not exceed 100 cfu/g at the end of shelf life under expected storage conditions? → YES →
Establish shelf life to ensure that limit of 100 cfu/g not exceeded when placed on the market throughout shelf life under expected
storage conditions ↓
NO
↓
EITHER carry out studies to show that L. monocytogenes will not exceed 100 cfu/g at the end of shelf life under expected storage conditions, OTHERWISE a limit of 0 cfu/25g applies before the food has left the immediate control of the producing FBO
Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
18
Food Safety - Ready-to-eat foods able to support the growth of Lm
Sampling plan
Limits Food category and criterion number Microorganisms/ their toxins,
metabolites n c m M
Analytical reference method
Stage where the criterion applies
5 0 100 cfu/g EN/ISO 11290-2
Products placed on the market during their shelf-life 1.2 Ready-to-eat foods able to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes
Listeria monocytogenes
5 0 Absence in 25 g
EN/ISO 11290-1
Before the food has left the immediate control of the food business operator, who has produced it
The criterion of 100 cfu/g applies if the manufacturer is able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit 100 cfu/g throughout the shelf-life. The operator may fix intermediate limits during the process that should be low enough to guarantee that the limit of 100 cfu/g is not exceeded at the end of the shelf-life. The criterion of absence in 25g applies to products before they have left the immediate control of the producing food business operator, when he is not able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit of 100 cfu/g throughout the shelf-life. Article 3.2 of the Regulation states: "As necessary the food business operators responsible for the manufacture of the product shall conduct studies in accordance with Annex II in order to investigate compliance with the criteria throughout the shelf life" Annex II states: – "specifications for physico-chemical characteristics of the product, such as pH, aw, salt content, concentration of preservatives and the type of packaging system, taking into account the
storage and processing conditions, the possibilities for contamination and the foreseen shelf-life; and – consultation of available scientific literature and research data regarding the growth and survival characteristics of the micro-organisms of concern. When necessary on the basis of the above-mentioned studies, the food business operator shall conduct additional studies, which may include: – predictive mathematical modelling established for the food in question, using critical growth or survival factors for the micro-organisms of concern in the product; – tests to investigate the ability of the appropriately inoculated micro-organism of concern to grow or survive in the product under different reasonably foreseeable storage conditions; – studies to evaluate the growth or survival of the micro-organisms of concern that may be present in the product during the shelf-life under reasonably foreseeable conditions of distribution,
storage and use. The above-mentioned studies shall take into account the inherent variability linked to the product, the micro-organisms in question and the processing and storage condition.
Interpretation of Requirements:
To determine how to apply the criteria for these products refer to page 17 Figure 1 (Decision Tree Showing Application of Listeria monocytogenes (Lm) Criteria for Ready-to-eat foods other than Infant Foods and Foods for Special Medical Purposes) The Food Business Operator (manufacturer and/or brand owner) should decide the testing frequency based on HACCP principles, testing should be used to verify HACCP. Positive release testing for L.monocytogenes is not required.
This criterion applies in general to chilled ready-to-eat foods. (continued…)
Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
19
The exclusions listed in the Regulation under criterion 1.1 apply, i.e.: • those which have received heat treatment or other processing effective to eliminate L. monocytogenes, when recontamination is not possible after this treatment
(e.g. products heat-treated in their final package) • fresh, uncut and unprocessed vegetables and fruits, excluding sprouted seeds • bread, biscuits and similar products • bottled or packed waters, soft drinks, beer, cider, wine, spirits and similar products • sugar, honey and confectionery, including cocoa and chocolate products • live bivalve molluscs Additional products that will not support the growth of L. monocytogenes also include foods with: • a pH ≤4.4 or • an aw ≤0.92 • a shelf life of less than 5 days • a pH ≤5.0 and an aw ≤ 0.94 Frozen foods at less than -12oC will not support the growth of L. monocytogenes. n = the number of samples to be taken from a given process under practically identical circumstances and produced in a given place within one defined production period. Samples can be composited together. Results indicating that levels of L. monocytogenes are more than 100 cfu/g are considered to be an unacceptable food safety risk and products must be withdrawn from the market and the Competent authority notified. If L. monocytogenes is detected in 25g or at levels of no more than 100 cfu/g, in product either before dispatch from the manufacturing site or when already on the market, there must be evidence to demonstrate that the level will not exceed 100cfu/g within the shelf life under expected storage conditions (see next page). If this evidence is available notification is not required. The section on studies, whilst applicable to a range of different microorganisms in foods is of most relevance to L.monocytogenes (particularly criteria 1.2 and 1.3) in the context of these criteria. Manufacturers of ready-to-eat foods should understand how L.monocytogenes behaves in their product, as determined by the products formulation, storage conditions, packaging and shelf life. The factors deemed to be critical in controlling development of L.monocytogenes must be identified, controlled and monitored (e.g. in a hard cheese, salt, moisture, pH and acidity are likely to be the most significant factors restricting growth of L.monocytogenes. Tolerances and limits for these parameters should be specified and controlled. Effective HACCP, good hygienic procedures and environmental monitoring for Listeria spp are a critical component of Listeria management.
(continued…)
Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
20
Should Lm be found to be present in a ready-to-eat food there are is a hierarchy of options available to manufacturers to determine how L.monocytogenes would behave in the product:
1. Historical data Historical data provides the best indication of the behaviour of an organism in food. When present, Listeria has usually contaminated the product from the environment. In a factory environment, natural contaminants are likely to be stressed and will grow slower than those that have been grown for use in inoculation studies (as is the case in models and challenge testing). Data on the levels of Listeria present throughout and at the end of shelf life can be used to assess its potential for growth. For example, if Listeria was detected in a cooked meat product at the beginning of shelf life at a level of <10 cfu/g, and end of life data on a representative sample from the same batch showed levels remained at no more than 100 cfu/g, then the data help demonstrate that from a Listeria perspective the product remains safe over its shelf life. Under such circumstances, a low level (e.g. <10 cfu/g) detection during shelf life should not need to be notified, withdrawn or recalled.
This approach is considered to be the most valid providing that end of life samples have either followed the normal route of distribution, storage and retail, (e.g. sampling from the shelf for retail products) or have been stored at temperatures closely simulating those conditions. The limitation of this method is that for most of the time Listeria should be absent in product; it can therefore be difficult, or take time to acquire such data. It also provides no information on safe shelf life for new products, particularly if a new product is introduced that is significantly different from those usually produced at the manufacturing site.
2. Outbreak and scientific data Much information is available in the scientific literature researching growth of organisms in foods. These data may be used to support the safety of a product over its life. The main disadvantage is that it may be difficult to find information that closely resembles the formulation, processing and storage conditions of the product in question. However, it may be possible to demonstrate through these data that the product type in question has not previously been linked to an outbreak. Such data may support the safety of a particular product/product group but is not a replacement for HACCP, an effective Listeria management/monitoring plan, and the establishment of a safe shelf life using the studies detailed here.
3. Predictive Mathematical Modelling Predictive models enable the user to enter key physicochemical factors such as the pH, water activity (primarily defined by the salt content) of the product in question, and its storage temperature. A prediction is then obtained showing how, over time the organism would be expected to grow. The main disadvantage of predictive models is that they are developed based on growth of organisms in broths, which is frequently faster than growth in real food systems, which can result in predicted shelf lives being shorter than may be achieved in reality, particularly in low acid, high water activity products.
Predictive models are cheap or free, failsafe and quick to use. However, they need some interpretation in their use. A number of models are available, e.g. Growth Predictor, which is freely available at: http://www.ifr.ac.uk/Safety/GrowthPredictor/default.html. In Growth Predictor, the water activity is directly linked to salt, which can affect accuracy when predicting growth in products where the water activity is predominantly influenced by sugar or low moisture.
4. Challenge testing Challenge tests are not required to be carried out if any of the above information is available. Challenge testing is the process of inoculating the organism of interest into the product in question and observing its growth over time, by monitoring at selected time intervals. This MUST be conducted in an appropriately accredited laboratory. To conduct a challenge test well requires expert knowledge to ensure that the strains chosen are relevant, the inoculum is correctly applied with minimal interference to the product’s characteristics and ensuring that the inoculum is fully recoverable. A well-conducted challenge test can provide more accurate information than models about an organism’s behaviour in a specific food product. Key disadvantages of challenge testing are that a change in formulation may require a repeat challenge test if the formulations are significantly different, the status of inoculated cells will not be the same as in reality (i.e. not stressed) therefore growing quicker than in reality and that the test assumes that the product is contaminated during production, whereas HACCP/GMP are designed to prevent/minimise contamination.
(continued…)
Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
21
Food Safety - Ready-to-eat foods unable to support the growth of Lm
Sampling plan Limits Food category and criterion number Microorganisms/ their toxins, metabolites n c m M
Analytical reference method
Stage where the criterion applies
1.3 Ready-to-eat foods unable to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes
Listeria monocytogenes
5 0 100 cfu/g EN/ISO 11290-2
Products placed on the market during their shelf-life
The Regulations state that regular testing against the criterion is not useful in normal circumstances for the following ready-to-eat foods: • those which have received heat treatment or other processing effective to eliminate L. monocytogenes, when recontamination is not possible after this treatment (e.g. products heat-treated
in their final package) • fresh, uncut and unprocessed vegetables and fruits, excluding sprouted seeds • bread, biscuits and similar products • bottled or packed waters, soft drinks, beer, cider, wine, spirits and similar products • sugar, honey and confectionery, including cocoa and chocolate products • live bivalve molluscs Products with pH ≤ 4.4 or aw ≤ 0.92, products with pH ≤ 5.0 and aw ≤ 0.94, products with a shelf-life of less than 5 days are automatically considered to belong to this category. Other categories of products can also belong to this category, subject to scientific justification.
Interpretation of Requirements:
To determine how to apply the criteria for these products refer to page 17 Figure 1 (Decision Tree Showing Application of Listeria Monocytogenes (Lm) Criteria for Ready-to-eat foods other than Infant Foods and Foods for Special Medical Purposes) The Food Business Operator (manufacturer and/or brand owner) should decide the testing frequency based on HACCP principles, testing should be used to verify HACCP. Positive release testing for L.monocytogenes is not required. This criterion applies to products that will not support the growth of L.monocytogenes but in which this organism could survive at levels of more than 100 cfu/g.
As stated in the Regulation products belonging to in this category include foods with:
• a pH ≤4.4 or • an aw ≤0.92 • a shelf life of less than 5 days • a pH ≤5.0 and an aw ≤ 0.94
Levels of L. monocytogenes of more than 100 cfu/g isolated in product are considered to be a food safety risk. Such products must be withdrawn from the market and competent authority must be notified.
(continued…)
Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
22
Food Safety - Minced Meat and Meat Preparations
Sampling plan
Limits Food category and criterion number Microorganisms/ their toxins,
metabolites n c m M
Analytical reference method
Stage where the criterion applies
1.4 Minced meat and meat preparations intended to be eaten raw
Salmonella 5 0 Absence in 25 g
EN/ISO 6579 Products placed on the market during their shelf-life
1.5 Minced meat and meat preparations made from poultry meat intended to be eaten cooked
Salmonella 5 0 From 1.1.2006 Absence in 10 g
From 1.1.2010
Absence In 25 g
EN/ISO 6579 Products placed on the market during their shelf-life
1.6 Minced meat and meat preparations made from other species than poultry intended to be eaten cooked
Salmonella 5 0 Absence in 10 g
EN/ISO 6579 Products placed on the market during their shelf-life
1.7 Mechanically separated meat (MSM)
Salmonella 5 0 Absence in 10 g
EN/ISO 6579 Products placed on the market during their shelf-life
Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
23
Sampling frequencies for minced meat, meat preparations and mechanically separated meat The food business operators of slaughterhouses or establishments producing minced meat, meat preparations or mechanically separated meat shall take samples for microbiological analysis at least once a week. The day of sampling shall be changed each week to ensure that each day of the week is covered. In the case of sampling for Salmonella analyses of minced meat, meat preparations and carcases, the frequency can be reduced to fortnightly if satisfactory results have been obtained for 30 consecutive weeks. The salmonella sampling frequency may also be reduced if there is a national or regional salmonella control programme in place and if this programme includes testing that replaces the above-described sampling. The sampling frequency may be further reduced if the national or regional salmonella control programme demonstrates that the salmonella prevalence is low in animals purchased by the slaughterhouse. However, when justified on the basis of a risk analysis and consequently authorised by the competent authority, small slaughterhouses and establishments producing minced meat and meat preparations in small quantities may be exempted from these sampling frequencies. The definition for mechanically separated meat (MSM) refers to MSM produced with the techniques referred to in Chapter III, paragraph 3, in section V of Annex III of Regulation No 853/2004/EC of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin. Note: MSM is the same as mechanically recovered meat. (MRM). Interpretation of Requirements:
Unlike the criteria for other product types the testing frequencies for minced meat and meat preparations are a statutory requirement under the microbiological criteria for foodstuffs Regulation for Food Business Operators. A minimum of one batch of one product type of minced meat or meat preparation must be sampled once a week per production site. Establishments producing minced meat and meat preparations in small quantities (e.g. premises not requiring approval) are exempt from these sampling frequencies.
The day of the week sampling takes place must be changed each week so that all production days are sampled over time.
During the course of producing the batch to be tested, 5 separate samples must be taken spaced out across the production run. This is so that a representative sample of the batch is obtained. A representative sample of a batch cannot be taken at retail level. Samples can be combined and tested for Salmonella spp unless the transitional derogation is in place (see next page). This means that a total sample size of 125g (5 x 25g samples) and 50g (5 x 10g samples) must be tested using 1:10 dilution detailed in the reference method.
Minced Meat and Meat preparations intended to be eaten raw: Salmonella must not be detected in 25g from any of the 5 samples. If Salmonella is detected (i.e. confirmed) the product must be withdrawn or recalled from sale (see section 5 - Selected Definitions), and the Competent Authority notified,
Minced Meat and Meat preparations intended to be eaten cooked:
Until 1st January 2010 Salmonella must not be detected from any of the 5 samples each of 10g. If Salmonella is detected(i.e. confirmed) the product should be withdrawn from sale (see section 5 - Selected Definitions) and the Competent Authority notified unless a Transitional Derogation is in place and the product is on the home market (see below).
(continued…)
If sa
tisfa
ctor
y S
alm
onel
la re
sults
(Sal
mon
ella
not
det
ecte
d) a
re o
btai
ned
for 3
0 co
nsec
utiv
e w
eeks
the
frequ
ency
of t
estin
g ca
n be
redu
ced
from
wee
kly
to fo
rtnig
htly
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
From
1st J
anua
ry 2
010,
for m
ince
d m
eat a
nd m
eat p
repa
ratio
ns m
ade
from
pou
ltry
mea
t, S
alm
onel
la m
ust n
ot b
e de
tect
ed in
25g
from
any
of t
he 5
sam
ples
test
ed
and
from
that
dat
e th
ere
is n
o lo
nger
a re
quire
men
t to
labe
l with
coo
king
inst
ruct
ions
. Unt
il th
at d
ate,
all
min
ced
mea
t and
mea
t pre
para
tions
mus
t be
clea
rly la
belle
d by
the
man
ufac
ture
r ind
icat
ing
the
need
for t
horo
ugh
cook
ing
prio
r to
cons
umpt
ion.
The
pro
visi
on o
f coo
king
inst
ruct
ions
suf
ficie
nt to
ach
ieve
thor
ough
coo
king
sa
tisfie
s th
is re
quire
men
t.
The
Tran
sitio
nal D
erog
atio
n (g
rant
ed u
ntil
31st D
ecem
ber 2
009)
allo
ws
cont
inue
d sa
le o
f min
ced
mea
t, m
eat p
repa
ratio
ns a
nd m
eat p
rodu
cts
inte
nded
to b
e co
oked
pr
ovid
ed n
o m
ore
than
one
of t
he 5
sam
ples
test
s po
sitiv
e fo
r Sal
mon
ella
(the
sam
ples
mus
t the
refo
re b
e te
sted
sep
arat
ely)
and
:
Pro
duct
s pr
oduc
ed u
nder
the
Tran
sitio
nal D
erog
atio
n an
d th
ose
not p
rodu
ced
unde
r the
Der
ogat
ion
are
allo
wed
to b
e pr
oduc
ed w
ithin
the
sam
e pr
oduc
tion
area
at
the
sam
e tim
e.
• P
rodu
ct p
rodu
ced
unde
r the
Der
ogat
ion
mus
t bea
r a 's
peci
al m
ark'
and
can
onl
y ta
ke a
dvan
tage
of t
he d
erog
atio
n in
the
coun
try w
here
it is
pro
duce
d an
d so
ld. E
xpor
ted
prod
uct m
ust n
ot b
ear t
he s
peci
al m
ark.
The
test
ing
frequ
ency
can
be
furth
er re
duce
d if
ther
e is
a n
atio
nal o
r reg
iona
l Sal
mon
ella
con
trol p
rogr
amm
e in
pla
ce th
at d
emon
stra
tes
that
the
prev
alen
ce o
f sa
lmon
ella
in th
e an
imal
s/m
eat u
sed
to p
rodu
ce m
ince
d m
eat a
nd m
eat p
repa
ratio
ns is
low
(See
k ad
vice
from
the
Com
pete
nt A
utho
rity)
.
All
min
ced
mea
t and
mea
t pre
para
tions
mus
t be
clea
rly la
belle
d by
the
man
ufac
ture
r ind
icat
ing
the
need
for t
horo
ugh
cook
ing
prio
r to
cons
umpt
ion.
Eith
er th
e pr
ovis
ion
of c
ooki
ng in
stru
ctio
ns s
uffic
ient
to a
chie
ve th
orou
gh c
ooki
ng o
r a s
tate
men
t tha
t the
pro
duct
requ
ires
cook
ing
is c
onsi
dere
d to
be
suita
ble.
• Th
at th
e pr
oduc
t lab
el in
clud
es th
e fo
llow
ing
‘spe
cial
mar
k’ in
dica
ting
that
the
prod
uct i
s pr
oduc
ed u
nder
the
dero
gatio
n:
24
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
25
Food
Saf
ety
- Mea
t and
pro
duct
s th
ereo
f
Sam
plin
g pl
an
Lim
its
Food
cat
egor
y an
d cr
iteri
on n
umbe
r M
icro
orga
nism
s/ th
eir
toxi
ns,
met
abol
ites
n C
m
M
Ana
lytic
al
refe
renc
e m
etho
d
Stag
e w
here
the
crite
rion
app
lies
1.8
Mea
t pro
duct
s int
ende
d to
be
eate
n ra
w, e
xclu
ding
pro
duct
s whe
re
the
man
ufac
turin
g p
roce
ss o
r th
e co
mpo
sitio
n of
the
prod
uct
will
elim
inat
e th
e sa
lmon
ella
risk
Salm
onel
la
5 0
Abs
ence
in 2
5g
EN/IS
O 6
579
Prod
ucts
pla
ced
on th
e m
arke
t dur
ing
thei
r she
lf lif
e
1.9
Mea
t pro
duct
s mad
e fr
om p
oultr
y m
eat i
nten
ded
to b
e ea
ten
cook
ed
Salm
onel
la
5 0
From
1.1
.200
6 A
bsen
ce
in 1
0 g
Fr
om 1
.1.2
010
Abs
ence
In
25
g
EN/IS
O 6
579
Prod
ucts
pla
ced
on th
e m
arke
t dur
ing
thei
r she
lf lif
e
1.10
G
elat
ine
and
colla
gen
Salm
onel
la
5 0
Abs
ence
in
25
g EN
/ISO
657
9 Pr
oduc
ts p
lace
d on
the
mar
ket d
urin
g th
eir s
helf-
life
Inte
rpre
tatio
n of
Req
uire
men
ts:
The
Food
Bus
ines
s O
pera
tor (
man
ufac
ture
r and
/or b
rand
ow
ner)
sho
uld
deci
de th
e te
stin
g fre
quen
cy b
ased
on
HA
CC
P p
rinci
ples
, tes
ting
shou
ld b
e us
ed to
ver
ify
HA
CC
P. P
ositi
ve re
leas
e te
stin
g fo
r Sal
mon
ella
is n
ot re
quire
d.
Not
e th
at th
ere
is n
o S
alm
onel
la c
riter
ion
for r
eady
-to-e
at fo
ods
cont
aini
ng b
oth
prod
ucts
of p
lant
orig
in a
nd p
roce
ssed
pro
duct
s of
ani
mal
orig
in.
1.8
Mea
t pro
duct
s in
tend
ed to
be
eate
n ra
w:
Sal
mon
ella
mus
t not
be
dete
cted
in 2
5g. I
f Sal
mon
ella
is d
etec
ted(
i.e. c
onfir
med
) th
e pr
oduc
t mus
t be
with
draw
n or
reca
lled
from
sal
e (s
ee s
ectio
n 5
- Sel
ecte
d D
efin
ition
s), a
nd th
e C
ompe
tent
Aut
horit
y no
tifie
d.
(con
tinue
d…)
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
1.9
Mea
t pro
duct
s m
ade
from
pou
ltry
mea
t int
ende
d to
be
eate
n co
oked
:
Unt
il 1st
Jan
uary
201
0 S
alm
onel
la m
ust n
ot b
e de
tect
ed fr
om a
ny 1
of 5
10g
sam
ples
. If S
alm
onel
la is
det
ecte
d (i.
e. c
onfir
med
) the
pro
duct
may
be
with
draw
n fro
m
sale
(see
sec
tion
5 - S
elec
ted
Def
initi
ons)
and
the
Com
pete
nt A
utho
rity
notif
ied
unle
ss a
Tra
nsiti
onal
Der
ogat
ion
is in
pla
ce in
the
man
ufac
turin
g co
untry
. The
Tr
ansi
tiona
l Der
ogat
ion
(whi
ch m
ay b
e gr
ante
d un
til 3
1st D
ecem
ber 2
009)
allo
ws
cont
inue
d sa
le o
f mea
t pro
duct
s in
tend
ed to
be
cook
ed p
rovi
ded
no m
ore
than
1 o
f 5
sam
ples
test
s po
sitiv
e fo
r Sal
mon
ella
and
that
:
• P
rodu
ct p
rodu
ced
with
the
'spe
cial
mar
k' c
an o
nly
take
adv
anta
ge o
f the
der
ogat
ion
in th
e co
untry
whe
re it
is p
rodu
ced
and
sold
. Whe
re th
e 's
peci
al
mar
k' a
ppea
rs o
n th
e pa
ckag
ing
of e
xpor
ted
prod
uct t
he d
erog
atio
n is
not
ava
ilabl
e ov
erse
as a
nd th
e hi
gher
Sal
mon
ella
sta
ndar
d is
app
licab
le. E
xpor
ted
prod
uct m
ust n
ot b
ear t
he s
peci
al m
ark.
• Th
at th
e pr
oduc
t lab
el in
clud
es th
e fo
llow
ing
‘spe
cial
mar
k’ in
dica
ting
that
the
prod
uct i
s pr
oduc
ed u
nder
the
dero
gatio
n:
From
1st J
anua
ry 2
010
Sal
mon
ella
mus
t not
be
dete
cted
in 2
5g fr
om a
ny 1
of 5
sam
ples
test
ed.
Unt
il 1st
Jan
uary
201
0 al
l the
se m
eat p
rodu
cts
mus
t be
clea
rly la
belle
d by
the
man
ufac
ture
r ind
icat
ing
the
need
for t
horo
ugh
cook
ing
prio
r to
cons
umpt
ion.
The
pr
ovis
ion
of c
ooki
ng in
stru
ctio
ns s
uffic
ient
to a
chie
ve th
orou
gh c
ooki
ng o
r a s
tate
men
t tha
t the
pro
duct
requ
ires
cook
ing
is c
onsi
dere
d to
be
suita
ble.
26
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Food
Saf
ety
– M
ilk a
nd D
airy
Pro
duct
s
Sam
plin
g pl
an
Lim
its
Food
cat
egor
y an
d cr
iteri
on n
umbe
r M
icro
orga
nism
s/ th
eir
toxi
ns,
met
abol
ites
n C
m
M
Ana
lytic
al
refe
renc
e m
etho
d
Stag
e w
here
the
crite
rion
app
lies
1.11
C
hees
es, b
utte
r and
cre
am
mad
e fr
om ra
w m
ilk o
r milk
th
at h
as u
nder
gone
a lo
wer
he
at-tr
eatm
ent t
han
past
euris
atio
n*
Salm
onel
la
5 0
Abs
ence
in
25
g EN
/ISO
657
9 Pr
oduc
ts p
lace
d on
the
mar
ket d
urin
g th
eir s
helf-
life
1.12
M
ilk p
owde
r and
whe
y po
wde
r*
Salm
onel
la
5 0
Abs
ence
in
25
g EN
/ISO
657
9 Pr
oduc
ts p
lace
d on
the
mar
ket d
urin
g th
eir s
helf-
life
1.13
Ic
e cr
eam♦
, exc
ludi
ng
prod
ucts
whe
re th
e m
anuf
actu
ring
proc
ess o
r the
co
mpo
sitio
n of
the
prod
uct
will
elim
inat
e th
e sa
lmon
ella
ris
k
Salm
onel
la
5 0
Abs
ence
in
25
g EN
/ISO
657
9 Pr
oduc
ts p
lace
d on
the
mar
ket d
urin
g th
eir s
helf-
life
1.21
C
hees
es, m
ilk p
owde
r and
w
hey
pow
der,
as re
ferr
ed to
in
the
coag
ulas
e-po
sitiv
e st
aphy
loco
cci c
riter
ia in
C
hapt
er 2
.2 o
f thi
s Ann
ex
Stap
hylo
cocc
al
ente
roto
xins
5
0 N
ot d
etec
ted
in 2
5g
Euro
pean
sc
reen
ing
met
hod
of th
e C
RL
for M
ilk
♣
Prod
ucts
pla
ced
on th
e m
arke
t dur
ing
thei
r she
lf-lif
e
* E
xclu
ding
pro
duct
s w
hen
the
man
ufac
ture
r can
dem
onst
rate
to th
e sa
tisfa
ctio
n of
the
com
pete
nt a
utho
ritie
s th
at, d
ue to
the
ripen
ing
time
and
a w o
f the
pro
duct
whe
re a
ppro
pria
te, t
here
is
no sa
lmon
ella
risk
. ♦
Onl
y ic
e cr
eam
s con
tain
ing
milk
ingr
edie
nts.
♣ R
efer
ence
: Hen
neki
nne
et a
l., J.
AO
AC
Inte
rnat
. Vol
. 86,
No
2, 2
003.
In
terp
reta
tion
of R
equi
rem
ents
: Th
e Fo
od B
usin
ess
Ope
rato
r sho
uld
deci
de th
e te
stin
g fre
quen
cy b
ased
on
HA
CC
P p
rinci
ples
, tes
ting
shou
ld b
e us
ed to
ver
ify H
ACC
P.
1.11
/ 1.1
2 –
A h
eat t
reat
men
t low
er th
an p
aste
uris
atio
n w
ould
be
less
than
71.
7°C
for 1
5 se
cond
s or
the
ther
mal
equ
ival
ent.
Pro
duct
s ex
clud
ed fo
r thi
s fo
od c
ateg
ory
are
thos
e pr
oduc
ts in
whi
ch it
is s
how
n by
robu
st s
cien
tific
evi
denc
e th
at S
alm
onel
la c
anno
t sur
vive
. If
the
resu
lts o
btai
ned
exce
ed th
e ab
ove
crite
ria th
ey a
re u
nsat
isfa
ctor
y an
d th
e af
fect
ed p
rodu
ct m
ust b
e w
ithdr
awn
from
the
mar
ket.
The
Com
pete
nt A
utho
rity
mus
t al
so b
e no
tifie
d.
27
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Food
Saf
ety
- Inf
ant F
orm
ula
and
drie
d di
etar
y fo
ods
for s
peci
al m
edic
al p
urpo
ses
inte
nded
for i
nfan
ts
Sa
mpl
ing
plan
L
imits
Fo
od c
ateg
ory
and
crite
rion
num
ber
Mic
roor
gani
sms/
thei
r to
xins
, m
etab
olite
s n
c m
M
Ana
lytic
al
refe
renc
e m
etho
d
Stag
e w
here
the
crite
rion
app
lies
1.22
D
ried
infa
nt fo
rmul
ae a
nd d
ried
diet
ary
food
s for
spec
ial m
edic
al
purp
oses
inte
nded
for i
nfan
ts b
elow
6
mon
ths o
f age
, as r
efer
red
to in
the
Ente
roba
cter
iace
ae c
riter
ion
in
Cha
pter
2.2
of t
his A
nnex
Salm
onel
la
30
0
Abs
ence
in 2
5 g
EN/IS
O
6579
Prod
ucts
pla
ced
on th
e m
arke
t dur
ing
thei
r she
lf-lif
e
1.23
Drie
d in
fant
form
ulae
and
drie
d di
etar
y fo
ods f
or sp
ecia
l med
ical
pu
rpos
es in
tend
ed fo
r inf
ants
bel
ow
6 m
onth
s of a
ge, a
s ref
erre
d to
in th
e En
tero
bact
eria
ceae
crit
erio
n in
C
hapt
er 2
.2 o
f thi
s Ann
ex
Ente
roba
cter
saka
zaki
i 30
0
Abs
ence
in 1
0 g
ISO
/DTS
2296
4
Prod
ucts
pla
ced
on th
e m
arke
t dur
ing
thei
r she
lf-lif
e
Inte
rpre
tatio
n of
Req
uire
men
ts:
The
Food
Bus
ines
s O
pera
tor s
houl
d de
cide
the
test
ing
frequ
ency
bas
ed o
n H
AC
CP
prin
cipl
es, t
estin
g sh
ould
be
used
to v
erify
HAC
CP
. If
the
resu
lts o
btai
ned
exce
ed th
e ab
ove
crite
ria th
ey a
re u
nsat
isfa
ctor
y an
d th
e af
fect
ed p
rodu
ct m
ust b
e w
ithdr
awn
from
the
mar
ket.
The
Com
pete
nt A
utho
rity
mus
t al
so b
e no
tifie
d.
28
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Food
Saf
ety
- Egg
Pro
duct
s
Sam
plin
g pl
an
Lim
its
Food
cat
egor
y an
d cr
iteri
on n
umbe
r M
icro
orga
nism
s/ th
eir
toxi
ns,
met
abol
ites
n c
m
M
Ana
lytic
al
refe
renc
e m
etho
d
Stag
e w
here
the
crite
rion
app
lies
1.14
Eg
g pr
oduc
ts, e
xclu
ding
pr
oduc
ts w
here
the
man
ufac
turin
g pr
oces
s or t
he
com
posi
tion
of th
e pr
oduc
t w
ill e
limin
ate
the
salm
onel
la
risk
Salm
onel
la
5 0
Abs
ence
in
25g
EN
/ISO
657
9 Pr
oduc
ts p
lace
d on
the
mar
ket d
urin
g th
eir s
helf-
life
1.15
R
eady
-to-e
at fo
ods
cont
aini
ng ra
w e
gg,
excl
udin
g pr
oduc
ts w
here
the
man
ufac
turin
g pr
oces
s or t
he
com
posi
tion
of th
e pr
oduc
t w
ill e
limin
ate
the
salm
onel
la
risk
Salm
onel
la
5 0
Abs
ence
in
25
g or
ml
EN/IS
O 6
579
Prod
ucts
pla
ced
on th
e m
arke
t dur
ing
thei
r she
lf-lif
e
Inte
rpre
tatio
n of
Req
uire
men
ts:
The
Food
Bus
ines
s O
pera
tor s
houl
d de
cide
the
test
ing
frequ
ency
bas
ed o
n H
AC
CP
prin
cipl
es, t
estin
g sh
ould
be
used
to v
erify
HAC
CP
. If
the
resu
lts o
btai
ned
exce
ed th
e ab
ove
crite
ria th
ey a
re u
nsat
isfa
ctor
y an
d th
e af
fect
ed p
rodu
ct m
ust b
e w
ithdr
awn
from
the
mar
ket.
The
Com
pete
nt A
utho
rity
mus
t al
so b
e no
tifie
d.
29
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Food
Saf
ety
- Fis
hery
pro
duct
s an
d sh
ellfi
sh
Sa
mpl
ing
plan
L
imits
Fo
od c
ateg
ory
and
crite
rion
num
ber
Mic
roor
gani
sms/
thei
r to
xins
, m
etab
olite
s n
c m
M
Ana
lytic
al
refe
renc
e m
etho
d
Stag
e w
here
the
crite
rion
app
lies
1.16
C
ooke
d cr
usta
cean
s and
m
ollu
scan
shel
lfish
Sa
lmon
ella
5
0 A
bsen
ce
in 2
5 g
EN/IS
O 6
579
Prod
ucts
pla
ced
on th
e m
arke
t dur
ing
thei
r she
lf-lif
e
1.17
Li
ve b
ival
ve m
ollu
scs a
nd
live
echi
node
rms,
tuni
cate
s an
d ga
stro
pods
Salm
onel
la
5 0
Abs
ence
in 2
5g
EN/IS
O 6
579
Prod
ucts
pla
ced
on th
e m
arke
t dur
ing
thei
r she
lf-lif
e
1.24
Li
ve b
ival
ve m
ollu
scs a
nd
live
echi
node
rms,
tuni
cate
s an
d ga
stro
pods
E. c
oli*
1
♦
0 <2
30 M
PN /
100g
of f
lesh
an
d in
tra-
valv
ular
liqu
id
ISO
TS
1664
9-3
Prod
ucts
pla
ced
on th
e m
arke
t dur
ing
thei
r she
lf-lif
e
1.25
Fi
sher
y pr
oduc
ts fr
om fi
sh
spec
ies a
ssoc
iate
d w
ith a
hig
h am
ount
of h
istid
ine♣
His
tam
ine
9
♠
2 10
0
mg/
kg
200
mg/
kg
HPL
C♥
Pr
oduc
ts p
lace
d on
the
mar
ket d
urin
g th
eir s
helf-
life
1.26
Fi
sher
y pr
oduc
ts w
hich
hav
e un
derg
one
enzy
me
mat
urat
ion
treat
men
t in
brin
e,
man
ufac
ture
d fr
om fi
sh
spec
ies a
ssoc
iate
d w
ith a
hig
h am
ount
of h
istid
ine♣
His
tam
ine
9
2 20
0
mg/
kg
400
mg/
kg
HPL
C♥
Pr
oduc
ts p
lace
d on
the
mar
ket d
urin
g th
eir s
helf-
life
(c
ontin
ued…
)
30
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Food
Saf
ety
- Fis
hery
pro
duct
s an
d sh
ellfi
sh
* E.
col
i is u
sed
here
as a
n in
dica
tor o
f fae
cal c
onta
min
atio
n.
♦ A
poo
led
sam
ple
com
pris
ing
a m
inim
um o
f 10
indi
vidu
al a
nim
als.
♣ P
artic
ular
ly fi
sh sp
ecie
s of t
he fa
mili
es: S
com
brid
ae, C
lupe
idae
, Eng
raul
idae
, Cor
yfen
idae
, Pom
atom
idae
, Sco
mbr
esos
idae
. ♠
Sing
le s
ampl
es m
ay b
e ta
ken
at re
tail
leve
l. In
suc
h a
case
the
pres
umpt
ion
laid
dow
n in
Arti
cle
14(6
) of
Reg
ulat
ion
No
178/
2002
/EC
, a
ccor
ding
to w
hich
the
who
le b
atch
sho
uld
be
deem
ed u
nsaf
e, sh
all n
ot a
pply
. ♥
Ref
eren
ces:
1. M
alle
P.,
Val
le M
., B
ouqu
elet
S. A
ssay
of b
ioge
nic
amin
es in
volv
ed in
fish
dec
ompo
sitio
n. J.
AO
AC
Inte
rnat
. 199
6, 7
9, 4
3-49
. D
uflo
s G.,
Der
vin
C.,
Mal
le P
., B
ouqu
elet
S. R
elev
ance
of m
atrix
eff
ect i
n de
term
inat
ion
of b
ioge
nic
amin
es in
pla
ice
(Ple
uron
ecte
s pla
tess
a) a
nd w
hitin
g (M
erla
ngus
mer
lang
us).
J. A
OA
C
Inte
rnat
. 199
9, 8
2, 1
097-
1101
. H
ista
min
e in
fish
ery
prod
ucts
from
fish
spec
ies a
ssoc
iate
d w
ith a
hig
h am
ount
of h
istid
ine:
–
satis
fact
ory,
if th
e fo
llow
ing
requ
irem
ents
are
fulfi
lled
1.
th
e m
ean
valu
e ob
serv
ed is
≤m
2.
a
max
imum
of c
/n v
alue
s obs
erve
d ar
e be
twee
n m
and
M
3.
no v
alue
s obs
erve
d ex
ceed
the
limit
of M
, –
unsa
tisfa
ctor
y, if
the
mea
n va
lue
obse
rved
exc
eeds
m o
r mor
e th
an c
/n v
alue
s are
bet
wee
n m
and
M o
r one
or m
ore
of th
e va
lues
obs
erve
d ar
e >M
.
Inte
rpre
tatio
n of
Req
uire
men
ts:
The
Food
Bus
ines
s O
pera
tor s
houl
d de
cide
the
test
ing
frequ
ency
bas
ed o
n H
AC
CP
prin
cipl
es, t
estin
g sh
ould
be
used
to v
erify
HAC
CP
. If
the
resu
lts o
btai
ned
exce
ed th
e ab
ove
crite
ria th
ey a
re u
nsat
isfa
ctor
y an
d th
e af
fect
ed p
rodu
ct m
ust b
e w
ithdr
awn
from
the
mar
ket.
The
Com
pete
nt A
utho
rity
mus
t al
so b
e no
tifie
d.
31
Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
Food Safety - Produce
Sampling plan
Limits Food category and criterion number Microorganisms/ their toxins,
metabolites n c m M
Analytical reference method
Stage where the criterion applies
1.18 Sprouted seeds (ready-to-eat)*
Salmonella 5 0 Absence in 25 g
EN/ISO 6579 Products placed on the market during their shelf-life
1.19 Pre-cut fruit and vegetables (ready-to-eat)
Salmonella 5 0 Absence in 25 g
EN/ISO 6579 Products placed on the market during their shelf-life
1.20 Unpasteurised fruit and vegetable juices (ready-to-eat)
Salmonella 5 0 Absence in 25 g
EN/ISO 6579 Products placed on the market during their shelf-life
* Preliminary testing of the batch of seeds before starting the sprouting process or the sampling to be carried out at the stage where the highest probability of finding Salmonella is expected.
Interpretation of Requirements: The Food Business Operator should decide the testing frequency based on HACCP principles, testing should be used to verify HACCP. Ready-to-eat products included in this category are taken to be washed and ready-to-eat. Products requiring washing prior to consumption are not included in this category. If the results obtained exceed the above criteria they are unsatisfactory and the affected product must be withdrawn from the market. The Competent Authority must also be notified.
32
Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
33
9. Process Hygiene Criteria Index Criteria have been set for aerobic colony count, Enterobacteriaceae, Salmonella, E.coli, and coagulase positive Staphylococci. The following is an index of the microbiological criteria tables taken from Annex I Chapter 2 of the Regulation. The tables have been separated so that each section can be referred to in isolation. Some product examples have been given to assist in deciding which tables are relevant. Meat and products thereof Criterion No.
Organism and Food Category Examples (not an exhaustive list)
2.1.1 2.1.3
Aerobic Colony Count, Enterobacteriaceae and Salmonella on carcases of cattle, sheep, goats and horses
Whole or split, before chilling or cutting
2.1.2 2.1.4
Aerobic Colony Count, Enterobacteriaceae and Salmonella on carcases of pigs
Before chilling and cutting
2.1.5 Salmonella on poultry carcases of broilers and turkeys
Whole, after chilling
2.1.6 Aerobic Colony Count and E. coli in minced meat
See definition
2.1.7 Aerobic Colony Count and E. coli in mechanically separated meat (MSM)
2.1.8 E.coli in meat Preparations Burgers, raw sausages Milk and Dairy Products Criterion No.
Organism and Food Category Examples (not an exhaustive list)
2.2.1 Enterobacteriaceae in pasteurised milk and other pasteurised liquid dairy products
2.2.2 E.coli in cheeses made from milk or whey that has undergone heat treatment
2.2.3 Coagulase-positive staphylococci in cheese made from raw milk
2.2.4 Coagulase-positive staphylococci in cheeses made from milk that has undergone a lower heat treatment than pasteurisation and ripened cheeses made from milk or whey that has undergone pasteurisation or a stronger heat treatment
2.2.5 Coagulase-positive staphylococci in ripened soft cheeses (fresh cheeses) made from milk or whey
Guidance on the Practical Implementation of the EC Regulation on Microbiological Criteria for Foodstuffs – edition 1.2, Dec2006
34
that has undergone pasteurisation or a stronger heat treatment
2.2.6 E.coli in butter and cream made from raw milk or milk that has undergone a lower heat treatment than pasteurisation
2.2.7 Enterobacteriaceae and coagulase-positive staphylococci in milk powder and whey powder
2.2.8 Enterobacteriaceae in ice cream and frozen dairy desserts
Arctic roll, pavlova, cheesecake, frozen yogurt, tiramisu.
Infant formula and dried dietary food for infants for special medical purposes Criterion No.
Organism and Food Category Examples (not an exhaustive list)
2.2.9 Enterobacteriaceae in dried infant formulae and dried dietary foods for special medical purposes intended for infants below 6 months of age
Egg Products Criterion No.
Organism and Food Category Examples (not an exhaustive list)
2.3.1 Enterobacteriaceae in egg products See definition Fishery Products and Shellfish Criterion No.
Organism and Food Category Examples (not an exhaustive list)
2.4.1 E.coli and coagulase-positive staphylococci in shelled and shucked products of cooked crustaceans and molluscan shellfish
Oysters, clams, winkles
Produce Criterion No.
Organism and Food Category Examples (not an exhaustive list)
2.5.1 E.coli in pre-cut fruit and vegetables (ready-to-eat)
Prepared ready-to-eat salads, prepared ready-to-eat fruit
2.5.2 E.coli in unpasteurised fruit and vegetable juices (ready-to-eat)
Freshly squeezed unpasteurised juices
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
The
Proc
ess
Hyg
iene
Crit
eria
35
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Proc
ess
Hyg
iene
- M
eat a
nd p
rodu
cts
ther
eof
Sa
mpl
ing
plan
L
imits
Fo
od c
ateg
ory
and
crite
rion
num
ber
Mic
roor
gani
sms
n c
m
M
Ana
lytic
al
refe
renc
e m
etho
d
Stag
e w
here
the
crite
rion
app
lies
Act
ion
in c
ase
of u
nsat
isfa
ctor
y re
sults
Aer
obic
col
ony
coun
t
3.
5 lo
g cf
u/cm
2
daily
m
ean
log
5.0
log
cfu/
cm2
daily
m
ean
log
ISO
483
3 C
arca
ses a
fter d
ress
ing
but b
efor
e ch
illin
g Im
prov
emen
ts in
slau
ghte
r hyg
iene
an
d re
view
of p
roce
ss c
ontro
ls
2.1.
1 C
arca
ses o
f ca
ttle,
shee
p,
goat
s and
hor
ses
Ente
roba
cter
iace
ae
1.5
log
cfu/
cm2
daily
m
ean
log
2.5
log
cfu/
cm2
daily
m
ean
log
ISO
215
28-2
C
arca
ses a
fter d
ress
ing
but b
efor
e ch
illin
g Im
prov
emen
ts in
slau
ghte
r hyg
iene
an
d re
view
of p
roce
ss c
ontro
ls
Aer
obic
col
ony
coun
t
4.
0 lo
g cf
u/cm
2
daily
m
ean
log
5.0
log
cfu/
cm2
daily
m
ean
log
ISO
483
3 C
arca
ses a
fter d
ress
ing
but b
efor
e ch
illin
g Im
prov
emen
ts in
slau
ghte
r hyg
iene
an
d re
view
of p
roce
ss c
ontro
ls
2.1.
2 C
arca
ses o
f pig
s
Ente
roba
cter
iace
ae
2.0
log
cfu/
cm2
daily
m
ean
log
3.0
log
cfu/
cm2
daily
m
ean
log
ISO
215
28-2
C
arca
ses a
fter d
ress
ing
but b
efor
e ch
illin
g Im
prov
emen
ts in
slau
ghte
r hyg
iene
an
d re
view
of p
roce
ss c
ontro
ls
The
limits
(m a
nd M
) app
ly o
nly
to sa
mpl
es ta
ken
by th
e de
stru
ctiv
e m
etho
d. T
he d
aily
mea
n lo
g is
cal
cula
ted
by fi
rst t
akin
g a
log
valu
e of
eac
h in
divi
dual
test
resu
lt an
d th
en c
alcu
latin
g th
e m
ean
of th
ese
log
valu
es.
Sam
plin
g pl
an: s
ee s
ectio
n on
nex
t pag
e
(con
tinue
d…)
36
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Proc
ess
Hyg
iene
- M
eat a
nd p
rodu
cts
ther
eof (
cont
inue
d)
Sam
plin
g ru
les f
or c
arca
ses o
f cat
tle, p
igs,
shee
p, g
oats
and
hor
ses
The
dest
ruct
ive
and
non-
dest
ruct
ive
sam
plin
g m
etho
ds,
the
sele
ctio
n of
the
sam
plin
g si
tes
and
the
rule
s fo
r st
orag
e an
d tra
nspo
rt of
sam
ples
are
des
crib
ed i
n st
anda
rd I
SO 1
7604
(M
icro
biol
ogy
of fo
od a
nd a
nim
al fe
edin
g st
uffs
– C
arca
se sa
mpl
ing
for m
icro
biol
ogic
al a
naly
sis)
.
Five
car
case
s sha
ll be
sam
pled
at r
ando
m d
urin
g ea
ch sa
mpl
ing
sess
ion.
Sam
ple
site
s sho
uld
be se
lect
ed ta
king
into
acc
ount
the
slau
ghte
r tec
hnol
ogy
used
in e
ach
plan
t.
Whe
n sa
mpl
ing
for a
naly
ses o
f Ent
erob
acte
riace
ae a
nd a
erob
ic c
olon
y co
unts
, fou
r site
s of e
ach
carc
ase
shal
l be
sam
pled
. Fou
r tis
sue
sam
ples
repr
esen
ting
a to
tal o
f 20
cm² s
hall
be o
btai
ned
by th
e de
stru
ctiv
e m
etho
d. W
hen
usin
g th
e no
n-de
stru
ctiv
e m
etho
d fo
r thi
s pu
rpos
e, th
e sa
mpl
ing
area
sha
ll co
ver a
min
imum
of 1
00 c
m² (
50 c
m² f
or s
mal
l rum
inan
t car
case
s) p
er s
ampl
ing
site
.
Whe
n sa
mpl
es a
re ta
ken
from
the
diff
eren
t sam
plin
g si
tes o
n th
e ca
rcas
e, th
ey sh
all b
e po
oled
bef
ore
exam
inat
ion.
Gui
delin
es fo
r sa
mpl
ing
Mor
e de
taile
d gu
idel
ines
on
the
sam
plin
g of
car
case
s, in
par
ticul
ar c
once
rnin
g th
e sa
mpl
ing
site
s, m
ay b
e in
clud
ed in
the
guid
es to
goo
d pr
actic
e re
ferr
ed to
in A
rticl
e 7
of R
egul
atio
n N
o 85
2/20
04/E
C o
f the
Eur
opea
n Pa
rliam
ent a
nd o
f the
Cou
ncil
of 2
9 A
pril
2004
on
the
Hyg
iene
of F
oods
tuff
s.
Sam
plin
g fr
eque
ncie
s for
car
case
s
The
food
bus
ines
s ope
rato
rs o
f sla
ught
erho
uses
shal
l tak
e sa
mpl
es fo
r mic
robi
olog
ical
ana
lysi
s at l
east
onc
e a
wee
k. T
he d
ay o
f sam
plin
g sh
all b
e ch
ange
d ea
ch w
eek
to e
nsur
e th
at e
ach
day
of th
e w
eek
is c
over
ed.
The
sam
plin
g fr
eque
ncy
of c
arca
ses
for E
nter
obac
teria
ceae
and
aer
obic
col
ony
coun
t ana
lyse
s m
ay b
e re
duce
d to
fortn
ight
ly te
stin
g if
satis
fact
ory
resu
lts a
re o
btai
ned
for s
ix c
onse
cutiv
e w
eeks
. If a
ny su
bseq
uent
resu
lts e
xcee
d M
, the
n sa
mpl
ing
freq
uenc
y sh
ould
retu
rn to
wee
kly.
How
ever
, whe
n ju
stifi
ed o
n th
e ba
sis
of a
risk
ana
lysi
s an
d co
nseq
uent
ly a
utho
rised
by
the
com
pete
nt a
utho
rity,
sm
all s
laug
hter
hous
es p
rodu
cing
sm
all q
uant
ities
may
be
exem
pted
from
th
ese
sam
plin
g fr
eque
ncie
s.
37
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Tabl
e 1:
Sam
plin
g fr
eque
ncy
for r
ed m
eat c
arca
sses
Sam
plin
g fr
eque
ncie
s
Cat
egor
y A
vera
ge a
nnua
l thr
ough
put o
f ca
ttle,
pig
s sh
eep,
goa
ts,
hors
es
- liv
esto
ck u
nits
1In
itial
Fre
quen
cy
Red
uced
Fre
quen
cy if
resu
lts a
re s
atis
fact
ory
Ente
roba
cter
iace
ae a
nd A
CC
: 5
carc
ases
onc
e a
wee
k fo
r 6 w
eeks
for e
ach
spec
ies
(6 x
5 =
30
sam
ples
/ spe
cies
)
Ente
roba
cter
iace
ae a
nd A
CC
: 5
carc
ases
onc
e ev
ery
2 w
eeks
for e
ach
spec
ies,
Standard establishments
1 O
ver 2
5,00
0 a
year
(25,
000
= 50
0 x
50 w
eeks
) Sa
lmon
ella
: 5
carc
ases
onc
e a
wee
k fo
r 30
wee
ks, f
or e
ach
spec
ies
(30
x 5
= 15
0 sa
mpl
es/s
peci
es)
Salm
onel
la:
5 ca
rcas
es o
nce
ever
y 2
wee
ks, f
or e
ach
spec
ies
Ente
roba
cter
iace
ae a
nd A
CC
: 5
carc
ases
onc
e a
wee
k fo
r 2 w
eeks
for e
ach
spec
ies
(5 x
2 =
10
sam
ples
/ spe
cies
)
Ente
roba
cter
iace
ae a
nd A
CC
: 5
carc
ases
onc
e ev
ery
4 w
eeks
2 B
elow
25,
000
but o
ver 7
,500
a
year
(7,5
00 =
150
x 50
wee
ks)
Salm
onel
la:
5 ca
rcas
es o
nce
ever
y 4
wee
ks,
Ente
roba
cter
iace
ae a
nd A
CC
: 5
carc
ases
onc
e a
wee
k fo
r 2 w
eeks
per
spe
cies
(5 x
2 =
10
sam
ples
/ spe
cies
)
Ente
roba
cter
iace
ae a
nd A
CC
: 5
carc
ases
on
one
day
ever
y 12
wee
ks, f
or e
ach
spec
ies
3 B
elow
7,5
00 b
ut o
ver 1
,500
a
year
(1,5
00 =
30
x 50
wee
ks)
Salm
onel
la:
not
requ
ired
Ente
roba
cter
iace
ae a
nd A
CC
: 5
cons
ecut
ive
carc
ases
of e
ach
spec
ies
hand
led.
(5 s
ampl
es p
er s
peci
es)
Ente
roba
cter
iace
ae a
nd A
CC
: 5
cons
ecut
ive
carc
ases
of e
ach
spec
ies,
1 y
ear a
fter t
he la
st
test
for t
hat s
peci
es.
Small establishments
4 B
elow
1,5
00 c
attle
, pig
s sh
eep,
go
ats,
hor
ses
a ye
ar
(ex-
low
thro
ughp
ut)
Salm
onel
la:
not
requ
ired
The
mea
t dat
abas
e w
ww
.ukm
eat.o
rg is
use
ful f
or c
alcu
latio
n of
tren
d re
sults
.
38
1 1
solip
ed; 1
adu
lt bo
vine
ani
mal
; 2
othe
r bov
ine
anim
als;
5 s
win
e of
ove
r 100
kg li
ve w
eigh
t; 7
oth
er s
win
e; 1
0 sh
eep
or g
oats
; 20
lam
bs o
r pig
lets
of u
nder
15k
g liv
e w
eigh
t.
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Proc
ess
Hyg
iene
- M
eat a
nd p
rodu
cts
ther
eof (
cont
inue
d)
Sa
mpl
ing
plan
L
imits
Fo
od c
ateg
ory
and
crite
rion
num
ber
Mic
roor
gani
sms
n c
m
M
Ana
lytic
al
refe
renc
e m
etho
d
Stag
e w
here
the
crite
rion
ap
plie
s A
ctio
n in
cas
e of
uns
atis
fact
ory
resu
lts
2.1.
3 C
arca
ses o
f cat
tle,
shee
p, g
oats
and
ho
rses
Salm
onel
la
50
2 A
bsen
ce in
the
area
te
sted
per
car
case
EN
/ISO
657
8 C
arca
ses a
fter d
ress
ing
but
befo
re c
hilli
ng
Impr
ovem
ents
in sl
augh
ter h
ygie
ne,
revi
ew o
f pro
cess
con
trols
and
orig
in
of a
nim
als
2.1.
4 C
arca
ses o
f pig
Sa
lmon
ella
50
5
Abs
ence
in th
e ar
ea
test
ed p
er c
arca
se
EN/IS
O 6
579
Car
case
s afte
r dre
ssin
g bu
t be
fore
chi
lling
Im
prov
emen
ts in
slau
ghte
r hyg
iene
an
d re
view
of p
roce
ss c
ontro
ls, o
rigin
of
ani
mal
s and
of t
he b
iose
curit
y m
easu
res i
n th
e fa
rms o
f orig
in
2.1.
5 Po
ultry
car
case
s of
broi
lers
and
turk
eys
Salm
onel
la
50
7 A
bsen
ce in
25
g of
a
pool
ed sa
mpl
e of
nec
k sk
in
EN/IS
O 6
579
Car
case
s afte
r chi
lling
Im
prov
emen
ts in
slau
ghte
r hyg
iene
an
d re
view
of p
roce
ss c
ontro
ls, o
rigin
of
ani
mal
s and
bio
secu
rity
mea
sure
s in
the
farm
s of o
rigin
For p
oint
s 2.1
.3 –
2.1
.5 m
=M
The
50 sa
mpl
es a
re d
eriv
ed fr
om 1
0 co
nsec
utiv
e sa
mpl
ing
sess
ions
in a
ccor
danc
e w
ith th
e sa
mpl
ing
rule
s and
freq
uenc
ies l
aid
dow
n in
this
Reg
ulat
ion
The
num
ber o
f sam
ples
whe
re th
e pr
esen
ce o
f sal
mon
ella
is d
etec
ted.
The
c v
alue
is su
bjec
t to
revi
ew in
ord
er to
take
into
acc
ount
the
prog
ress
mad
e in
redu
cing
the
salm
onel
la p
reva
lenc
e.
Mem
ber S
tate
s or r
egio
ns h
avin
g lo
w sa
lmon
ella
pre
vale
nce
may
use
low
er c
val
ues e
ven
befo
re th
e re
view
Inte
rpre
tatio
n A
fter e
ach
sam
plin
g se
ssio
n, th
e re
sults
of t
he la
st te
n sa
mpl
ing
sess
ions
(50
resu
lts) a
re a
sses
sed,
e.g
. a m
ovin
g w
indo
w -
afte
r 10
wee
ks n
ew re
sults
are
pr
oduc
ed.
The
se re
sults
sho
uld
then
be
used
to d
eter
min
e w
heth
er th
e pr
oces
s hy
gien
e cr
iteria
hav
e be
en m
et.
(c
ontin
ued…
)
39
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Sam
plin
g ru
les f
or c
arca
ses o
f cat
tle, p
igs,
shee
p, g
oats
and
hor
ses
The
dest
ruct
ive
and
non-
dest
ruct
ive
sam
plin
g m
etho
ds,
the
sele
ctio
n of
the
sam
plin
g si
tes
and
the
rule
s fo
r st
orag
e an
d tra
nspo
rt of
sam
ples
are
des
crib
ed i
n st
anda
rd I
SO 1
7604
(M
icro
biol
ogy
of fo
od a
nd a
nim
al fe
edin
g st
uffs
– C
arca
se sa
mpl
ing
for m
icro
biol
ogic
al a
naly
sis)
.
Whe
n sa
mpl
ing
for S
alm
onel
la a
naly
ses,
an a
bras
ive
spon
ge sa
mpl
ing
met
hod
shal
l be
used
. The
sam
plin
g ar
ea sh
all c
over
a m
inim
um o
f 100
cm
² per
site
sele
cted
.
Whe
n sa
mpl
es a
re ta
ken
from
the
diff
eren
t sam
plin
g si
tes o
n th
e ca
rcas
e, th
ey sh
all b
e po
oled
bef
ore
exam
inat
ion.
Sam
plin
g ru
les f
or p
oultr
y ca
rcas
es
See
note
for c
riter
ion
2.1.
5 ab
ove,
rega
rdin
g sa
mpl
e nu
mbe
rs.
For t
he S
alm
onel
la a
naly
ses,
a m
inim
um o
f 15
carc
ases
sha
ll be
sam
pled
at r
ando
m d
urin
g ea
ch s
ampl
ing
sess
ion
and
afte
r chi
lling
. A p
iece
of a
ppro
xim
atel
y 10
g fr
om n
eck
skin
sha
ll be
ob
tain
ed fr
om e
ach
carc
ase.
On
each
occ
asio
n th
e ne
ck sk
in sa
mpl
es fr
om th
ree
carc
ases
shal
l be
pool
ed b
efor
e ex
amin
atio
n in
ord
er to
form
5 x
25
g fin
al sa
mpl
es.
Gui
delin
es fo
r sa
mpl
ing
Mor
e de
taile
d gu
idel
ines
on
the
sam
plin
g of
car
case
s, in
par
ticul
ar c
once
rnin
g th
e sa
mpl
ing
site
s, m
ay b
e in
clud
ed in
the
guid
es to
goo
d pr
actic
e re
ferr
ed to
in A
rticl
e 7
of R
egul
atio
n N
o 85
2/20
04/E
C o
f the
Eur
opea
n Pa
rliam
ent a
nd o
f the
Cou
ncil
of 2
9 A
pril
2004
on
the
Hyg
iene
of F
oods
tuff
s.
Sam
plin
g fr
eque
ncie
s for
car
case
s
The
food
bus
ines
s ope
rato
rs o
f sla
ught
erho
uses
shal
l tak
e sa
mpl
es fo
r mic
robi
olog
ical
ana
lysi
s at l
east
onc
e a
wee
k. T
he d
ay o
f sam
plin
g sh
all b
e ch
ange
d ea
ch w
eek
to e
nsur
e th
at e
ach
day
of th
e w
eek
is c
over
ed.
In t
he c
ase
of s
ampl
ing
for
Salm
onel
la a
naly
ses
of c
arca
ses,
the
freq
uenc
y ca
n be
red
uced
to
fortn
ight
ly i
f sa
tisfa
ctor
y re
sults
hav
e be
en o
btai
ned
for
30 c
onse
cutiv
e w
eeks
. If
any
su
bseq
uent
resu
lts e
xcee
d M
, the
n sa
mpl
ing
freq
uenc
y sh
ould
retu
rn to
wee
kly.
The
sal
mon
ella
sam
plin
g fr
eque
ncy
may
als
o be
redu
ced
if th
ere
is a
nat
iona
l or r
egio
nal s
alm
onel
la c
ontro
l pr
ogra
mm
e in
pla
ce a
nd if
this
pro
gram
me
incl
udes
test
ing
that
repl
aces
the
abov
e-de
scrib
ed sa
mpl
ing.
The
sam
plin
g fr
eque
ncy
may
be
furth
er re
duce
d if
the
natio
nal o
r reg
iona
l sal
mon
ella
co
ntro
l pro
gram
me
dem
onst
rate
s tha
t the
salm
onel
la p
reva
lenc
e is
low
in a
nim
als p
urch
ased
by
the
slau
ghte
rhou
se.
How
ever
, whe
n ju
stifi
ed o
n th
e ba
sis
of a
risk
ana
lysi
s an
d co
nseq
uent
ly a
utho
rised
by
the
com
pete
nt a
utho
rity,
sm
all s
laug
hter
hous
es p
rodu
cing
sm
all q
uant
ities
may
be
exem
pted
from
th
ese
sam
plin
g fr
eque
ncie
s.
40
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Tabl
e 2:
Sam
plin
g fr
eque
ncy
for p
oultr
y sl
augh
terh
ouse
s
Sa
mpl
ing
freq
uenc
ies
C
ateg
ory
Ave
rage
ann
ual t
hrou
ghpu
t of
turk
eys
and
broi
lers
Initi
al F
requ
ency
R
educ
ed F
requ
ency
if re
sults
are
sat
isfa
ctor
y
Standard establishments
1 O
ver 7
,500
,000
a y
ear
(7,5
00,0
00 =
150
,000
x 5
0 w
eeks
)
Salm
onel
la:
5 ca
rcas
es o
nce
a w
eek
for 3
0 w
eeks
, for
eac
h sp
ecie
s
(30
x 5
= 15
0 sa
mpl
es/s
peci
es)
Salm
onel
la:
5 ca
rcas
es o
nce
ever
y 2
wee
ks, f
or e
ach
spec
ies
(30
x 5
= 15
0 sa
mpl
es)
2 B
elow
7,5
00,0
00 b
ut o
ver
1,00
0,00
0 a
year
(1,0
00,0
00 =
20,
000
x 50
w
eeks
)
Salm
onel
la:
5 ca
rcas
es o
nce
ever
y 4
wee
k fo
r eac
h sp
ecie
s
3 B
elow
1,0
00,0
00 b
ut o
ver
150,
000
a ye
ar
(150
,000
= 3
,000
x 5
0 w
eeks
)
Salm
onel
la:
not r
equi
red
Small establishments
4 B
elow
150
,000
a y
ear
(ex-
low
thro
ughp
ut)
Salm
onel
la:
not r
equi
red
41
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Sa
mpl
ing
plan
L
imits
Fo
od c
ateg
ory
and
crite
rion
num
ber
Mic
roor
gani
sms
n c
m
M
Ana
lytic
al
refe
renc
e m
etho
d
Stag
e w
here
the
crite
rion
app
lies
Act
ion
in c
ase
of u
nsat
isfa
ctor
y re
sults
Aer
obic
col
ony
coun
t75
2 5x
105
cfu/
g 5x
106
cfu/
g IS
O 4
833
End
of th
e m
anuf
actu
ring
proc
ess
Impr
ovem
ents
in p
rodu
ctio
n hy
gien
e an
d im
prov
emen
ts in
sele
ctio
n an
d/or
or
igin
of r
aw m
ater
ials
2.1.
6 M
ince
d m
eat
E. c
oli
5 2
50 c
fu/g
50
0 cf
u/g
ISO
166
49-1
or
2
End
of th
e m
anuf
actu
ring
proc
ess
Impr
ovem
ents
in p
rodu
ctio
n hy
gien
e an
d im
prov
emen
ts in
sele
ctio
n an
d/or
or
igin
of r
aw m
ater
ials
Aer
obic
col
ony
coun
t 5
2 5x
105
cfu/
g 5x
106
cfu/
g IS
O 4
833
End
of th
e m
anuf
actu
ring
proc
ess
Impr
ovem
ents
in p
rodu
ctio
n hy
gien
e an
d im
prov
emen
ts in
sele
ctio
n an
d/or
or
igin
of r
aw m
ater
ials
2.1.
7 M
echa
nica
lly se
para
ted
mea
t (M
SM)
E. c
oli
5 2
50 c
fu/g
50
0 cf
u/g
ISO
166
49-1
or
2
End
of th
e m
anuf
actu
ring
proc
ess
Impr
ovem
ents
in p
rodu
ctio
n hy
gien
e an
d im
prov
emen
ts in
sele
ctio
n an
d/or
or
igin
of r
aw m
ater
ials
2.1.
8 M
eat p
repa
ratio
ns
E. c
oli
5 2
500
cfu/
g or
cm
2
5000
cf
u/g
or
cm2
ISO
166
49-1
or
2
End
of th
e m
anuf
actu
ring
proc
ess
Impr
ovem
ents
in p
rodu
ctio
n hy
gien
e an
d im
prov
emen
ts in
sele
ctio
n an
d/or
or
igin
of r
aw m
ater
ials
A
erob
ic c
olon
y co
unt:
this
crit
erio
n do
es n
ot a
pply
to m
ince
d m
eat p
rodu
ced
at re
tail
leve
l whe
n th
e sh
elf-
life
of th
e pr
oduc
t is l
ess t
hen
24 h
ours
. E.
col
i is u
sed
here
as a
n in
dica
tor o
f fae
cal c
onta
min
atio
n.
Thes
e cr
iteria
app
ly to
mec
hani
cally
sepa
rate
d m
eat (
MSM
) pro
duce
d w
ith th
e te
chni
ques
refe
rred
to in
Cha
pter
III,
para
grap
h 3,
in se
ctio
n V
of A
nnex
III o
f Reg
ulat
ion
No
853/
2004
/EC
of
the
Euro
pean
Par
liam
ent a
nd o
f the
Cou
ncil
of 2
9 A
pril
2004
layi
ng d
own
spec
ific
hygi
ene
rule
s for
food
of a
nim
al o
rigin
.
(con
tinue
d…)
42
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Sam
plin
g fr
eque
ncie
s for
min
ced
mea
t, m
eat p
repa
ratio
ns a
nd m
echa
nica
lly se
para
ted
mea
t Th
e fo
od b
usin
ess
oper
ator
s of
sla
ught
erho
uses
or e
stab
lishm
ents
pro
duci
ng m
ince
d m
eat,
mea
t pre
para
tions
or m
echa
nica
lly s
epar
ated
mea
t sha
ll ta
ke s
ampl
es fo
r mic
robi
olog
ical
ana
lysi
s at
leas
t onc
e a
wee
k. T
he d
ay o
f sam
plin
g sh
all b
e ch
ange
d ea
ch w
eek
to e
nsur
e th
at e
ach
day
of th
e w
eek
is c
over
ed.
As
rega
rds
the
sam
plin
g of
min
ced
mea
t and
mea
t pre
para
tions
for E
. col
i and
aer
obic
col
ony
coun
t ana
lyse
s, th
e fr
eque
ncy
may
be
redu
ced
to fo
rtnig
htly
test
ing
if sa
tisfa
ctor
y re
sults
are
ob
tain
ed fo
r six
con
secu
tive
wee
ks. I
f any
subs
eque
nt re
sults
exc
eed
M, t
hen
sam
plin
g fr
eque
ncy
shou
ld re
turn
to w
eekl
y.
How
ever
, whe
n ju
stifi
ed o
n th
e ba
sis
of a
ris
k an
alys
is a
nd c
onse
quen
tly a
utho
rised
by
the
com
pete
nt a
utho
rity,
sm
all s
laug
hter
hous
es p
rodu
cing
sm
all q
uant
ities
may
be
exem
pted
fro
m
thes
e sa
mpl
ing
freq
uenc
ies.
A
repr
esen
tativ
e sa
mpl
e of
a b
atch
can
not b
e ob
tain
ed a
t ret
ail l
evel
. Sam
plin
g sh
ould
take
pla
ce a
s ea
rly a
s po
ssib
le in
the
prod
uctio
n ch
ain.
In
terp
reta
tion
Figu
re 2
: Sam
plin
g ru
les
for p
oultr
y ca
rcas
es
Fo
r the
Sal
mon
ella
ana
lyse
s, a
min
imum
of 1
5 ca
rcas
es s
hall
be s
ampl
ed a
t ran
dom
dur
ing
each
sam
plin
g se
ssio
n an
d af
ter c
hillin
g.
1
2
3 4
5 6
7 8
9
10
11
12
13
14
15
↓ ↓
↓ ↓
↓ ↓
↓ ↓
↓ ↓
↓ ↓
↓ ↓
↓ A
pie
ce o
f app
roxi
mat
ely
10g
from
nec
k sk
in s
hall
be o
btai
ned
from
eac
h ca
rcas
e. O
n ea
ch o
ccas
ion
the
neck
ski
n sa
mpl
es fr
om 3
car
case
s sh
all b
e po
oled
bef
ore
exam
inat
ion
in o
rder
to fo
rm 5
x 2
5g fi
nal s
ampl
es.
↓ ↓
↓ ↓
↓ ↓
↓ ↓
↓ ↓
↓ ↓
↓ ↓
↓
30g
30g
30g
30g
30g
↓ ↓
↓ ↓
↓ 25
g 25
g 25
g 25
g 25
g Sa
mpl
e 1
Sam
ple
2 Sa
mpl
e 3
Sam
ple
4 Sa
mpl
e 5
43
Afte
r eac
h sa
mpl
ing
sess
ion,
the
resu
lts o
f the
last
ten
sam
plin
g se
ssio
ns (5
0 re
sults
) are
ass
esse
d, e
.g. a
mov
ing
win
dow
- af
ter 1
0 w
eeks
new
resu
lts a
re
prod
uced
. T
hese
resu
lts s
houl
d th
en b
e us
ed to
det
erm
ine
whe
ther
the
proc
ess
hygi
ene
crite
ria h
ave
been
met
.
(con
tinue
d…)
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Inte
rpre
tatio
n of
the
test
resu
lts
Unl
ike
the
crite
ria fo
r oth
er p
rodu
ct ty
pes
the
test
ing
frequ
enci
es fo
r car
case
s, m
ince
d m
eat a
nd m
eat p
repa
ratio
ns a
re a
sta
tuto
ry re
quire
men
t for
Foo
d B
usin
ess
Ope
rato
rs p
rodu
cing
thes
e pr
oduc
ts.
The
limits
giv
en re
fer t
o ea
ch s
ampl
e un
it te
sted
. Whe
n te
stin
g ca
rcas
es th
e te
stin
g is
car
ried
out o
n po
oled
sam
ples
and
the
limits
refe
r to
resu
lts fr
om 5
0 sa
mpl
es.
The
test
resu
lts d
emon
stra
te th
e m
icro
biol
ogic
al q
ualit
y of
the
proc
ess
test
ed.
44
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Proc
ess
Hyg
iene
- M
ilk a
nd d
airy
pro
duct
s Sam
plin
g pl
an
Lim
it Fo
od c
ateg
ory
and
crite
rion
num
ber
Mic
roor
gani
sms
n c
m
M
Ana
lytic
al
refe
renc
e m
etho
d
Stag
e w
here
the
crite
rion
app
lies
Act
ion
in c
ase
of u
nsat
isfa
ctor
y re
sults
2.2.
1 Pa
steu
rised
milk
and
oth
er
past
euris
ed li
quid
dai
ry
prod
ucts
Ente
roba
cter
iace
ae
5 2
<1
cfu/
ml
5 cf
u/m
l IS
O 2
1528
-1
End
of th
e m
anuf
actu
ring
proc
ess
Che
ck o
n th
e ef
ficie
ncy
of h
eat-
treat
men
t and
pre
vent
ion
of
reco
ntam
inat
ion
as w
ell a
s the
qua
lity
of ra
w m
ater
ials
Th
e cr
iterio
n do
es n
ot a
pply
to p
rodu
cts i
nten
ded
for f
urth
er p
roce
ssin
g in
the
food
indu
stry
. 2.
2.2
Che
eses
mad
e fr
om m
ilk o
r w
hey
that
has
und
ergo
ne
heat
trea
tmen
t
E. c
oli
5 2
100
cfu/
g 1
000
cfu/
g IS
O 1
6649
- 1 o
r 2
At t
he ti
me
durin
g th
e m
anuf
actu
ring
proc
ess w
hen
the
E.
coli
coun
t is e
xpec
ted
to b
e hi
ghes
t
Impr
ovem
ents
in p
rodu
ctio
n hy
gien
e an
d se
lect
ion
of ra
w m
ater
ials
E. c
oli i
s use
d he
re a
s an
indi
cato
r for
the
leve
l of h
ygie
ne.
For
chee
ses
whi
ch a
re n
ot a
ble
to s
uppo
rt th
e gr
owth
of
E.co
li, th
e E.
coli
coun
t is
usua
lly th
e hi
ghes
t at t
he b
egin
ning
of
the
ripen
ing
perio
d, a
nd f
or c
hees
es w
hich
are
abl
e to
sup
port
the
grow
th o
f E.c
oli,
it is
nor
mal
ly a
t the
end
of t
he ri
peni
ng p
erio
d.
Not
e: ‘H
eat t
reat
men
t’ is
pas
teur
isat
ion
or a
ny lo
wer
hea
t tre
atm
ent t
han
past
euris
atio
n. P
aste
uris
atio
n is
ach
ieve
d by
mea
ns o
f a tr
eatm
ent:
(i)
invo
lvin
g a
high
tem
pera
ture
for
a s
hort
time
(at l
east
71.
7°C
for
15
seco
nds)
or
a lo
w te
mpe
ratu
re f
or a
long
tim
e (a
t lea
st 6
3°C
for
30
min
utes
) or
any
oth
er ti
me-
tem
pera
ture
co
nditi
ons t
o ob
tain
equ
ival
ent e
ffec
t;
(ii)
suff
icie
nt to
ens
ure
that
the
prod
ucts
show
a n
egat
ive
reac
tion
to a
n al
kalin
e ph
osph
atas
e te
st im
med
iate
ly a
fter h
eat t
reat
men
t.
(c
ontin
ued…
)
45
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Proc
ess
Hyg
iene
- M
ilk a
nd d
airy
pro
duct
s (c
ontin
ued)
Sam
plin
g pl
an
Lim
it Fo
od c
ateg
ory
and
crite
rion
num
ber
Mic
roor
gani
sms
n c
m
M
Ana
lytic
al
refe
renc
e m
etho
d
Stag
e w
here
the
crite
rion
app
lies
Act
ion
in c
ase
of u
nsat
isfa
ctor
y re
sults
2.2.
3 C
hees
es m
ade
from
raw
m
ilk
Coa
gula
se-p
ositi
ve
stap
hylo
cocc
i 5
2 10
4
cfu/
g 10
5 cf
u/g
EN/IS
O 6
888-
2
2.2.
4 C
hees
es m
ade
from
milk
th
at h
as u
nder
gone
a lo
wer
he
at tr
eatm
ent t
han
past
euris
atio
n an
d rip
ened
ch
eese
s mad
e fr
om m
ilk o
r w
hey
that
has
und
ergo
ne
past
euris
atio
n or
a st
rong
er
heat
trea
tmen
t
Coa
gula
se-p
ositi
ve
stap
hylo
cocc
i 5
2 10
0 cf
u/g
1000
cf
u/g
EN/IS
O 6
888-
1 or
2
At t
he ti
me
durin
g th
e m
anuf
actu
ring
proc
ess w
hen
the
num
ber o
f st
aphy
loco
cci i
s ex
pect
ed to
be
high
est
Impr
ovem
ents
in p
rodu
ctio
n hy
gien
e an
d se
lect
ion
of ra
w m
ater
ials
. If v
alue
s gr
eate
r tha
n 10
5 cfu
/g a
re d
etec
ted,
the
chee
se b
atch
has
to b
e te
sted
for
stap
hylo
cocc
al e
nter
otox
ins.
2.2.
5 U
nrip
ened
soft
chee
ses
(fre
sh c
hees
es) m
ade
from
m
ilk o
r whe
y th
at h
as
unde
rgon
e pa
steu
risat
ion
or
a st
rong
er h
eat t
reat
men
t
Coa
gula
se-p
ositi
ve
stap
hylo
cocc
i 5
2 10
cf
u/g
100
cfu/
g EN
/ISO
688
8-1
or 2
En
d of
the
man
ufac
turin
g pr
oces
s
Impr
ovem
ents
in p
rodu
ctio
n hy
gien
e. If
va
lues
gre
ater
than
105 c
fu/g
are
det
ecte
d,
the
chee
se b
atch
has
to b
e te
sted
for
stap
hylo
cocc
al e
nter
otox
ins.
Excl
udin
g ch
eese
s whe
re th
e m
anuf
actu
rer c
an d
emon
stra
te, t
o th
e sa
tisfa
ctio
n of
the
com
pete
nt a
utho
ritie
s, th
at th
e pr
oduc
t doe
s not
pos
e a
risk
of st
aphy
loco
ccal
ent
erot
oxin
s. If
an u
nsat
isfa
ctor
y co
agul
ase-
posi
tive
stap
hylo
cocc
i cou
nt is
obt
aine
d an
d th
e pr
oduc
t is
sent
for
ente
roto
xin
test
ing,
it is
adv
isab
le to
hol
d th
e ba
tch
conc
erne
d (i.
e. n
ot
rele
ase
onto
the
mar
ket)
until
the
ente
roto
xin
resu
lts a
re o
btai
ned.
If s
taph
yloc
occa
l ent
erot
oxin
is p
rese
nt, t
he b
atch
wou
ld th
en p
rese
nt a
n un
acce
ptab
le r
isk
to h
uman
he
alth
and
mus
t not
be
plac
ed o
nto
the
mar
ket (
see
Food
Saf
ety
Crit
erio
n 1.
21).
For c
hees
es w
hich
are
not
abl
e to
sup
port
the
grow
th o
f S.a
ureu
s e.
g. h
ard
chee
se, t
he S
.aur
eus
coun
t is
usua
lly th
e hi
ghes
t at t
he b
egin
ning
of t
he ri
peni
ng p
erio
d,
and
for c
hees
es w
hich
are
abl
e to
sup
port
the
grow
th o
f S.a
ureu
s, e
.g. s
oft c
hees
es, i
t is
norm
ally
at t
he e
nd o
f the
ripe
ning
per
iod.
(con
tinue
d…)
46
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Proc
ess
Hyg
iene
- M
ilk a
nd d
airy
pro
duct
s (c
ontin
ued)
Sam
plin
g pl
an
Lim
it Fo
od c
ateg
ory
and
crite
rion
num
ber
Mic
roor
gani
sms
n c
M
M
Ana
lytic
al
refe
renc
e m
etho
d
Stag
e w
here
the
crite
rion
app
lies
Act
ion
in c
ase
of u
nsat
isfa
ctor
y re
sults
2.2.
6 B
utte
r and
cre
am m
ade
from
raw
milk
or m
ilk th
at
has u
nder
gone
a lo
wer
hea
t tre
atm
ent t
han
past
euris
atio
n
E. c
oli
5 2
10
cfu/
g 10
0 cf
u/g
ISO
166
49- 1
or
2 En
d of
the
man
ufac
turin
g pr
oces
s
Impr
ovem
ents
in p
rodu
ctio
n hy
gien
e an
d se
lect
ion
of ra
w m
ater
ials
E. c
oli i
s use
d he
re a
s an
indi
cato
r for
the
leve
l of h
ygie
ne.
Ente
roba
cter
iace
ae
5 0
<10
cfu/
g IS
O 2
1528
- 1
End
of th
e m
anuf
actu
ring
proc
ess
Che
ck o
n th
e ef
ficie
ncy
of h
eat
treat
men
t and
pre
vent
ion
of
reco
ntam
inat
ion
The
crite
rion
does
not
app
ly to
pro
duct
s int
ende
d fo
r fur
ther
pro
cess
ing
in th
e fo
od in
dust
ry.
2.2.
7 M
ilk p
owde
r and
whe
y po
wde
r
Coa
gula
se-p
ositi
ve
stap
hylo
cocc
i 5
2 10
cf
u/g
100
cfu/
g EN
/ISO
688
8-1
or 2
En
d of
the
man
ufac
turin
g pr
oces
s
Impr
ovem
ents
in p
rodu
ctio
n hy
gien
e. If
va
lues
gre
ater
than
105 c
fu/g
are
de
tect
ed, t
he b
atch
has
to b
e te
sted
for
stap
hylo
cocc
al e
nter
otox
ins.
If a
n un
satis
fact
ory
coag
ulas
e-po
sitiv
e st
aphy
loco
cci c
ount
is o
btai
ned
and
the
prod
uct i
s sen
t for
ent
erot
oxin
test
ing,
it is
adv
isab
le to
hol
d th
e ba
tch
conc
erne
d (i.
e. n
ot re
leas
e on
to th
e m
arke
t) un
til th
e en
tero
toxi
n re
sults
are
obt
aine
d. If
stap
hylo
cocc
al e
nter
otox
in is
pre
sent
, the
bat
ch w
ould
then
pre
sent
an
unac
cept
able
risk
to h
uman
hea
lth a
nd m
ust n
ot b
e pl
aced
ont
o th
e m
arke
t (se
e Fo
od S
afet
y C
riter
ion
1.21
).
(con
tinue
d…)
47
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Proc
ess
Hyg
iene
- M
ilk a
nd d
airy
pro
duct
s (c
ontin
ued)
,
Infa
nt fo
rmul
a an
d dr
ied
diet
ary
food
s fo
r inf
ants
for s
peci
al m
edic
al p
urpo
ses
Sam
plin
g pl
an
Lim
its
Food
cat
egor
y an
d cr
iteri
on n
umbe
r M
icro
-org
anis
ms
n c
m
M
Ana
lytic
al
refe
renc
e m
etho
d St
age
whe
re th
e cr
iteri
on a
pplie
s A
ctio
n in
cas
e of
uns
atis
fact
ory
resu
lts
2.2.
8 Ic
e cr
eam
(onl
y ic
e cr
eam
s co
ntai
ning
milk
ingr
edie
nts)
an
d fr
ozen
dai
ry d
esse
rts
Ente
roba
cter
iace
ae
5 2
10
cfu/
g 10
0 cf
u/g
ISO
215
28- 2
En
d of
the
man
ufac
turin
g pr
oces
s Im
prov
emen
ts in
pro
duct
ion
hygi
ene
2.2.
9 D
ried
infa
nt fo
rmul
ae a
nd d
ried
diet
ary
food
s for
spec
ial
med
ical
pur
pose
s int
ende
d fo
r in
fant
s bel
ow 6
mon
ths o
f age
Ente
roba
cter
iace
ae
10
0
Abs
ence
in 1
0 g
ISO
215
28- 1
En
d of
the
man
ufac
turin
g pr
oces
s Im
prov
emen
ts in
pro
duct
ion
hygi
ene
to m
inim
ise
cont
amin
atio
n. If
En
tero
bact
eria
ceae
are
det
ecte
d in
an
y of
the
sam
ple
units
, the
bat
ch h
as
to b
e te
sted
for E
. sak
azak
ii an
d Sa
lmon
ella
In
terp
reta
tion
of th
e te
st re
sults
Th
e lim
its g
iven
refe
r to
each
sam
ple
unit
test
ed.
The
test
resu
lts d
emon
stra
te th
e m
icro
biol
ogic
al q
ualit
y of
the
proc
ess
test
ed.
If E
nter
obac
teria
ceae
are
det
ecte
d in
any
of t
he s
ampl
e un
its th
e ba
tch
mus
t be
test
ed fo
r E. s
akaz
akii
and
Sal
mon
ella
. As
requ
ired
in F
ood
Saf
ety
Crit
eria
1.2
2 an
d 1.
23, i
f the
resu
lts o
btai
ned
exce
ed th
e cr
iteria
for E
. sak
azak
ii an
d S
alm
onel
la th
ey a
re u
nsat
isfa
ctor
y an
d th
e af
fect
ed p
rodu
ct m
ust b
e w
ithdr
awn
from
the
mar
ket.
Th
e C
ompe
tent
Aut
horit
y m
ust a
lso
be n
otifi
ed.
48
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
. Proc
ess
Hyg
iene
- Eg
g pr
oduc
ts Sa
mpl
ing
plan
L
imits
Fo
od c
ateg
ory
and
crite
rion
num
ber
Mic
ro-o
rgan
ism
s
n c
m
M
Ana
lytic
al
refe
renc
e m
etho
d
Stag
e w
here
the
crite
rion
app
lies
Act
ion
in c
ase
of u
nsat
isfa
ctor
y re
sults
2.3.
1 Eg
g pr
oduc
ts
Ente
roba
cter
iace
ae
5 2
10
cfu/
g or
m
l
100 cf
u/g
or m
l IS
O 2
1528
-2
End
of th
e m
anuf
actu
ring
proc
ess
Che
cks o
n th
e ef
ficie
ncy
of th
e he
at tr
eatm
ent
and
prev
entio
n of
reco
ntam
inat
ion
Inte
rpre
tatio
n of
the
test
resu
lts
The
limits
giv
en re
fer t
o ea
ch s
ampl
e un
it te
sted
. Th
e te
st re
sults
dem
onst
rate
the
mic
robi
olog
ical
qua
lity
of th
e pr
oces
s te
sted
.
49
Gui
danc
e on
the
Prac
tical
Impl
emen
tatio
n of
the
EC R
egul
atio
n on
Mic
robi
olog
ical
Crit
eria
for F
oods
tuffs
– e
ditio
n 1.
2, D
ec20
06
Proc
ess
Hyg
iene
- Fi
sher
y pr
oduc
ts a
nd s
hellf
ish
Sam
plin
g pl
an
Lim
it Fo
od c
ateg
ory
and
crite
rion
nu
mbe
r M
icro
orga
nism
s
n c
m
M
Ana
lytic
al
refe
renc
e m
etho
d
Stag
e w
here
the
crite
rion
app
lies
Act
ion
in c
ase
of u
nsat
isfa
ctor
y re
sults
E. c
oli
5 2
1 cf
u/g
10 c
fu/g
IS
O T
S 16
649-
3 En
d of
the
man
ufac
turin
g pr
oces
s
Impr
ovem
ents
in p
rodu
ctio
n hy
gien
e 2.
4.1
Shel
led
and
shuc
ked
prod
ucts
of c
ooke
d cr
usta
cean
s and
m
ollu
scan
shel
lfish
C
oagu
lase
-pos
itive
st
aphy
loco
cci
5 2
100
cfu/
g 1
000
cfu/
g EN
/ISO
68
88-1
or 2
En
d of
the
man
ufac
turin
g pr
oces
s
Impr
ovem
ents
in p
rodu
ctio
n hy
gien
e
Inte
rpre
tatio
n of
the
test
resu
lts
The
limits
giv
en re
fer t
o ea
ch s
ampl
e un
it te
sted
. Th
e te
st re
sults
dem
onst
rate
the
mic
robi
olog
ical
qua
lity
of th
e pr
oces
s te
sted
.
50
Guidance on the Practical Im
plementation of the EC
Regulation on M
icrobiological Criteria for Foodstuffs – edition 1.2, D
ec2006
Process Hygiene - Produce
Sampling
plan L
imits
Food category and criterion num
ber M
icroorganisms
n c
m
M
Analytical
reference m
ethod
Stage where the
criterion applies A
ction in case of unsatisfactory results
2.5.1 Pre-cut fruit and vegetables (ready-to-eat)
E. coli 5
2 100
cfu/g 1 000 cfu/g
ISO 16649-
1 or 2 M
anufacturing process
Improvem
ents in production hygiene, selection of raw
materials
2.5.2 U
npasteurised fruit and vegetable juices (ready-to-eat)
E. coli 5
2 100
cfu/g 1 000 cfu/g
ISO 16649-
1 or 2 M
anufacturing process
Improvem
ents in production hygiene, selection of raw
materials
Interpretation of the test results The lim
its given refer to each sample unit tested.
The test results demonstrate the m
icrobiological quality of the process tested.
51