brc/cfa guidance on the mcr - chilled food association by chilled food association ltd, p.o. box...

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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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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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

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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

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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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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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http://www.europa.eu.int/eur-lex


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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• 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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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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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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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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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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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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Minced Meat and Meat Preparations Criterion No.


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.


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.


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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Infant Formula and dried dietary foods for infants for special medical purposes Criterion No.


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.


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.


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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Produce Criterion No.


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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The Food Safety Criteria

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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.


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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


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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



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…)


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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…)


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…)

http://www.ifr.ac.uk/Safety/GrowthPredictor/default.html










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



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…)


22

Food Safety - Minced Meat and Meat Preparations

Sampling plan


metabolites n c m M



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


1.6 Minced meat and meat preparations made from other species than poultry intended to be eaten cooked



1.7 Mechanically separated meat (MSM)




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


Food Safety - Produce

Sampling plan


metabolites n c m M



1.18 Sprouted seeds (ready-to-eat)*



1.19 Pre-cut fruit and vegetables (ready-to-eat)



1.20 Unpasteurised fruit and vegetable juices (ready-to-eat)



* 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


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.


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.


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


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.


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.


2.3.1 Enterobacteriaceae in egg products See definition Fishery Products and Shellfish Criterion No.


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.


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.

http://www.ukmeat.o/

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

brc/cfa guidance on the mcr - chilled food association by chilled food association ltd, p.o. box...

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