Checklist of issues to be considered by food business operators when implementing Commission Regulation 1. General requirements 2. Sampling foodstuffs and testing against the relevant criteria 2.1 Validation and verification of procedures based on HACCP principles and GHP 2.2 Sampling frequencies 2.3 Sample numbers/sampling plans 2.4 Submission of samples to the laboratory 2.5 Laboratory and laboratory methods 2.6 Interpretation and trending of results 2.7 Follow-up action in the event of unsatisfactory results 2.8 Environmental monitoring 3. Determination of the ready-to-eat status of the foodstuff 4. Instructions for use 5. Shelf-life studies 6. Documentation and records Page 1 of 15
1. General requirements Key point: Food business operators must take measures, as part of their procedures based on HACCP principles and good hygiene practices, to ensure compliance with the relevant microbiological criteria. Detailed information is provided in Part A, Section 2 and Part B, Section 1 of FSAI GN No. 26. Article 3.1 Article 3.1 Have you identified the process hygiene and/or the food safety criteria which are relevant to your foodstuffs? NOTE 1 Have you implemented measures, as part of your food safety management system, to ensure your foodstuffs are complying with the relevant criteria? Have you identified microbiological hazards other than those addressed in Commission Regulation which may also influence the safety of your foodstuffs? Have you implemented measures, as part of your food safety management system to ensure these additional hazards are controlled? NOTE 1: To determine whether a food safety criterion for Listeria monocytogenes applies, food business operators must determine the ready-to-eat status of their foodstuff. This is addressed in section 3 of this checklist. Page 2 of 15
2. Sampling foodstuffs and testing against the relevant criteria 2.1 Validation and verification of procedures based on HACCP principles and GHP Key point: Commission Regulation requires food business operators to perform testing, as appropriate, against the relevant microbiological criteria when they are validating or verifying the correct functioning of their procedures based on HACCP principles and GHP. Detailed information is provided in Part B, Section 3 of FSAI GN No. 26 Article 4.1 When validating your food safety management system, did you sample foodstuffs and test them against the relevant criteria? NOTE 2 If no, did you validate the food safety management system by other means? Article 4.1 When verifying the correct functioning of the food safety management system, do you sample foodstuffs and test them against the relevant criteria? NOTE 3 If no, do you verify the food safety management system by other means? NOTE 2: Validation means obtaining evidence that the procedures based on HACCP principles and GHP are effective, i.e. will the procedures, when implemented, control the hazards and ensure the end products are safe? NOTE 3: Verification is the application of methods, procedures, tests and other evaluations to determine compliance with the procedures based on HACCP principles and GHP i.e. are you doing what you say you are doing? Page 3 of 15
2.2 Sampling frequencies Key point: Sampling frequencies are specified in Commission Regulation for carcases, minced meat, meat preparations and mechanically separated meat. For all other foodstuffs the sampling frequency must be determined by the food business operator. Detailed information is provided in Part B, Section 3.3 of FSAI GN No. 26 Annex I, Chapter 3, Section 3.2 Annex I, Chapter 3, Section 3.2 s applicable to food business operators in slaughterhouses and establishments producing minced meat, meat preparations or mechanically separated meat: Are you following the minimum sampling frequencies specified in Annex I, Chapter 3, Section 3.2? If no, is your establishment exempt from these sampling frequencies based on a risk analysis and has this exemption been authorised by the competent authority? s applicable to food business operators in other establishments: Article 4.2 Have you undertaken a risk assessment to determine the appropriate sampling frequency? Has the risk assessment considered the following? NOTE 4: i) The microbial hazard(s) of concern in the foodstuffs ii) The susceptibility of the population consuming the food iii) The intended use of the foodstuff iv) Nature of the business v) Results from environmental monitoring vi) Food safety management system (e.g. how it has been validated and verified) Are you periodically reviewing the appropriateness of this sampling frequency & amending where appropriate? NOTE 4: These parameters are not specified in legislation; however, it is recommended that they are taken into consideration. Page 4 of 15
2.3 Sample numbers/sampling plans Key point: A sampling plan is specified in Commission Regulation for each microbiological criterion. It includes a value for n, i.e. the number of samples to be obtained from the production batch being sampled. Detailed information is provided in Part B, Section 3.4 of FSAI GN No. 26 Article 5.1 For each foodstuff, have you described your production batch? Have you documented this description? Can you justify the reasoning for this description to your enforcement officer? Are you taking the appropriate number of samples (n) from the production batch being sampled (i.e. as a minimum, are you following the sampling plan specified in Annex I of the Regulation for each relevant criterion)? NOTE 5 NOTE 5: Article 5.3 of the Regulation permits the food business operator to reduce the number of sample units set out in the sampling plan (i.e. n ) if it can be demonstrated to the satisfaction of the competent authority, by historical documentation, that effective HACCP-based procedures are in place. So in theory a single sample could be obtained. However, the FSAI does not recommend this practice, as the likelihood of detecting a pathogen in a single sample is minimal, particularly when the contamination rate is low. Furthermore, the Regulation states (Article 5.4) if the aim of testing is to specifically assess the acceptability of a certain batch of foodstuffs or a process, the sampling plan set out in the Regulation must be respected as a minimum. This does not preclude a food business operator from using a more stringent sampling plan. Page 5 of 15
2.4 Submission of samples to the laboratory Annex I, Chapter 3, Section 3.2 Are you clearly labelling the samples so that n samples from the same production batch are identifiable by the laboratory? NOTE 6 Regarding carcass samples: Are these samples transported to the laboratory in accordance with ISO 17604? NOTE 6: This is necessary, as the results of these samples must be interpreted together. Page 6 of 15
2.5 Laboratory and laboratory methods [NOTE 7] Key point: It is the responsibility of the food business operator to ensure the laboratory is using the correct analytical method. Specific requirements are laid down in Article 5.1 and 5.5 of Commission Regulation (EC) No 2073/2005. Detailed information is provided in Part B, Section 3.5 of FSAI GN No. 26. Article 5.1 and Annex I Article 5.5, paragraph 3 Article 5.5, paragraph 3 Article 5.5, paragraph 4 Is the laboratory testing the foodstuff using the most recent version of the analytical reference method specified in Annex I of the Regulation? If the laboratory is using an alternative method, has it been validated against the most recent version of the analytical reference method specified in Annex I of the Regulation? If the alternative method is a proprietary (rapid) method, is it also certified by a third party in accordance with the protocol set out in ISO 16140 or other internationally accepted similar protocols? If the laboratory is using an analytical method other than those validated and certified as described in the last two questions, has its use been authorised by the competent authority? Is the laboratory accredited to conduct the analytical method for the required food matrix? NOTE 8 NOTE 7: For further information please consult the following documents available in the Resources and Publications section of www.fsai.ie 1. Fact sheet: Best Practice for Testing Foods when Assessing Compliance with the Microbiological Criteria Specified in Commission Regulation (EC) 2073/2005 2. List of: Alternative Methods - Food Safety Criteria Alternative Methods - Process Hygiene Criteria NOTE 8: Although not a legal requirement, the FSAI strongly recommends that the laboratory is accredited to conduct the analytical method for the required food matrix. Page 7 of 15
2.6 Interpretation and trending of results Key point: Food business operators must interpret the results for each criterion as outlined in Annex 1 of Commission Regulation. They must also analyse the trend in their test results. Detailed information is provided in Part B, Sections 3.6 & 3.7 of FSAI GN No. 26 Relevant table of Annex I Article 9 Article 9 Are you interpreting the results in accordance with Annex I of the Regulation? Are you trending the microbiological results, e.g. by plotting the results on a graph (trending is applicable to criteria where microbiological limits relate to the quantification of a microorganism, toxin or metabolite)? Where the results trend towards unsatisfactory, are you taking action to prevent the occurrence of microbiological risk? Page 8 of 15
2.7 Follow-up action in the event of unsatisfactory results Key point: In the event of an unsatisfactory result for either a process hygiene or a food safety criterion, food business operators must take specific actions. These actions are laid down in Article 7 of Commission Regulation. Detailed information is provided in Part B, Section 3.8 of FSAI GN No. 26 Article 7.4 Article 7.1 Article 7.1 In the event of an unsatisfactory result for a process hygiene criterion: Are you taking the corrective action defined in Annex I, Chapter 2 for that criterion? Are you taking measures to find the cause of the unsatisfactory result in order to prevent recurrence? Are you taking any other corrective actions defined in your HACCP-based procedures and any other actions necessary to protect the health of consumers? NOTE 9 In the event of an unsatisfactory result for a food safety criterion: Article 7.2 Article 7.1 Article 7.1 Are you withdrawing or recalling the foodstuff from the market in accordance with Article 19 of Regulation 178/2002? NOTE 10 or If the product is on the market but has not reached retail level, is the product submitted to further processing to eliminate the hazard? NOTE 11 Are you taking measures to find the cause of the unsatisfactory result in order to prevent recurrence? Are you taking any other corrective actions defined in your HACCP-based procedures and any other actions necessary to protect the health of consumers? NOTE 9 NOTE 9: The food safety management system should be reviewed and amended if necessary. This may include amendments to microbiological sampling and testing. NOTE 10: Please refer to FSAI GN No. 10 - Product Recall and Traceability (Revision 2) available in the Resources and Publications section of www.fsai.ie NOTE 11: If the batch is used for purposes other than those for which it was originally intended, certain stipulations apply: This use must not pose a risk for public or animal health This use must be decided within the framework of procedures based on HACCP and GHP This use must be authorised by the competent authority Page 9 of 15
2.8 Environmental monitoring Key Point: Article 5.2 of Commission Regulation lays down mandatory requirements for environmental monitoring in businesses manufacturing: i) ready-to-eat foods, which may pose a Listeria monocytogenes risk for public health and ii) dried infant formulae or dried foods for special medical purposes intended for infants below six months, which pose a Cronobacter spp. (Enterobacter sakazakii) risk. Detailed information is provided in Part B, Section 5 of FSAI GN No. 26 Article 5.2, Paragraph 1 and 2 Is your food product a RTE food which may pose a L. monocytogenes risk to public health? NOTE 12 If yes, do you take samples from the processing and equipment areas of your factory for Listeria monocytogenes as part of a routine sampling scheme in accordance with ISO 18593? i.e. environmental monitoring programme Article 5.2, Paragraph 1 and 3 Do you manufacture dried infant formulae or dried foods for special medical purposes intended for infants below six months which pose an Enterobacter sakazakii (Cronobacter spp.) risk? If yes, do you take samples from the processing and equipment areas of your factory for Enterobacteriaceae as part of a routine sampling scheme in accordance with ISO 18593? i.e. environmental monitoring programme NOTE 12: For further information please refer to the FSAI report The Control and Management of Listeria monocytogenes Contamination of Food available in the Resources and Publications section of www.fsai.ie Page 10 of 15
3 Determination of the ready-to-eat status of the foodstuff Key Point: The producer or manufacturer has to decide whether the food is ready-to-eat or not-ready-to-eat. A ready-to-eat food is one which is intended by the producer or manufacturer to be consumed without the need for cooking or further processing to eliminate or reduce microorganisms of concern to an acceptable level. Further information is provided in Part B, Section 2 of FSAI GN No. 26 Is the food intended to be cooked by the consumer/customer before eating, to ensure its safety? Example: Raw meat If yes, the food is likely to be not-ready-to-eat and you should indicate this clearly in the product specification and/or HACCP plan NOTE 13 Is the food intended to be reheated by the consumer/customer before eating, for palatability purposes? NOTE 14 Examples: Soups, custards, some ready meals, etc. If yes, the food is likely to be ready-to-eat and you should indicate this clearly in the product specification and/or HACCP plan Is the food intended to be eaten directly by the consumer/customer without the need for cooking or reheating? Examples: Cooked ham, cheese, coleslaw, yogurt, pasteurised milk, etc. If yes, the food is likely to be ready-to-eat and you should indicate this clearly in the product specification and/or HACCP plan Will the food be subjected to further processing in the food chain and is this processing intended to eliminate or reduce the level of microorganisms to an acceptable level? If yes, the food is likely to be not-ready-to-eat and you should indicate this clearly in the product specification and/or HACCP plan NOTE 13: These foods would be considered non-rte when placed on the market if: AND The foodstuff is labelled, as required, with cooking instructions (addressed in section 4 of this checklist) These cooking instructions are validated to ensure the microorganisms of concern will be eliminated or reduced to an acceptable level. NOTE 14: Reheating conducted for palatability purposes and not for food safety purposes. Page 11 of 15
4 Instructions for use Key point: Requirements regarding instructions for use are laid down in Article 3 of Directive 2000/13/EC and Article 6 of Regulation. The objective of these instructions is to enable consumers make appropriate use of the foodstuff. Detailed information is provided in Part B, Section 6 of FSAI GN No. 26 Legal basis Article 3, Directive 2000/13/EC NOTE 15 Article 6, Regulation (EC) No 2073/2005 Pre-packed foods: Have you given instructions for use on the product label when it would be impossible to make use of the food in the absence of such instructions (e.g. cooking instructions)? Loose foods: i) Minced meat and meat preparations which are made from species other than poultry and are intended to be eaten cooked: Are instructions provided to inform the consumer of the need for cooking prior to consumption (e.g. via accompanying documentation or point of sale notices)? NOTE 16 ii) All other loose foods: Where ambiguity could arise over the necessity to cook prior to consumption, have you provided cooking instructions to inform the consumer of the need for cooking prior to consumption (e.g. via accompanying documentation or point of sale notices)? NOTE 17 NOTE 15: DIRECTIVE 2000/13/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. Article 3 requires that instructions for use shall be indicated in a manner which will enable appropriate use to be made of the foodstuff (i.e. if cooking instructions are required they must be provided). NOTE 16: Since 1 st January 2010, minced meat, meat preparations and meat products which are i) made from poultry and ii) intended to be eaten cooked, have been exempt from these labelling requirements. On that date stricter criteria were introduced for these foodstuffs. NOTE 17: Although not a legal requirement, the provision of cooking instructions is strongly recommended where ambiguity could occur. Page 12 of 15
5 Shelf-life studies Key point: Article 3.2 of Regulation requires the food business operator responsible for the manufacture of the product to conduct studies in accordance with Annex II in order to investigate compliance with the criteria throughout the shelf-life. In particular, this applies to ready-to-eat foods that are able to support the growth of L. monocytogenes and that may pose a L. monocytogenes risk for public health. Further information is provided in Part B, Section 4 of FSAI GN No. 26. Article 3.2 If you manufactured the product, have you carried out shelf-life studies to investigate compliance with the relevant food safety criteria under reasonably foreseeable conditions of distribution, storage and use? If yes, did these shelf-life studies include any or all of the following: Did you determine the characteristics of your product including ph, water activity, salt content, concentration of preservatives and the type of packaging system, taking into account the storage and processing conditions, and the possibilities for contamination of the product and the effect on the desired shelf-life? Annex II Did you consult any available scientific documents and/or research data on the microbiological hazards associated with your food, after establishing the characteristics of your product? Did you carry out any predictive mathematical modelling of the identified microbiological hazards associated with your food and its characteristics? Did you carry out any laboratory tests to investigate the ability of identified pathogens to grow or survive in your product under different reasonably foreseeable storage conditions? i.e. challenge tests Did you carry out any laboratory tests to investigate the ability of identified pathogens of concern that may be present in your product during the desired shelf-life under reasonably foreseeable conditions of distribution, storage and use? i.e. durability tests SANCO/1628/2008 ver. 9.3 (26112008) If you are manufacturing a ready-to-eat food able to support the growth of L. monocytogenes, were the previously mentioned shelf-life studies conducted using the approach outlined in the EC guidance documents? Note 18 For all other foodstuffs, were the previously mentioned shelf-life tests conducted using a best practice approach e.g. FSAI Guidance Note 18 (Revision 1)? Note 19 Did the shelf-life studies take other relevant microbiological hazards into consideration (i.e. microbiological hazards which may influence the safety of your product other than those addressed in Commission Regulation (EC) No. 2073/2005)? Did you apply a margin of safety to the shelf-life established under reasonably foreseeable conditions of distribution, storage and use? Do you verify the product shelf-life as part of a regular review of your food safety management system? Page 13 of 15
Note 18: The European Commission has published two guidance notes related to shelf-life studies for L. monocytogenes in RTE foods. The first guidance note on Listeria monocytogenes Shelf-Life Studies for Readyto-Eat Foods under Regulation of 15 November 2005 on Microbiological Criteria for Foodstuffs is designed for food business operators producing RTE foods: To demonstrate to the satisfaction of the competent authority that the products will comply with the Community Regulation until the end of the shelf-life To understand the range of different approaches available to help establish a safe product shelf-life in relation to L. monocytogenes and to decide the appropriate approach for their products To classify their products into RTE foods in which growth of L. monocytogenes can occur or in RTE foods in which growth of L. monocytogenes will not occur during their shelf-life. The second guidance note Technical Guidance Document on Shelf-Life Laboratory Durability and Challenge Studies for Listeria monocytogenes in Ready-to-Eat Foods was prepared by the EU Community Reference Laboratory (CRL) for L. monocytogenes in collaboration with a working group consisting of 10 laboratories, including 9 National Reference Laboratories (NRL s) for L. monocytogenes. It is a technical guidance document which is basically intended for laboratories conducting shelf-life studies for L. monocytogenes in RTE foods, in collaboration with food business operators and it provides recommendations on how to select, implement and perform the tests required. It describes the microbiological procedures for determining growth of L. monocytogenes using challenge tests and durability studies in the frame of the application of the Regulation (EC) No. 2073/2005. Note 19: Link to FSAI Guidance Note No. 18 - Validation of Product Shelf-Life (Revision 1) Page 14 of 15
6. Documentation and records Key point: FBOs should retain appropriate documents/records, as necessary, to demonstrate compliance with Commission Regulation. These documents/records should be made available to the competent authority on request. Can you provide evidence that the relevant food safety and process hygiene criteria were taken into consideration when developing the HACCP-based procedures? Can you provide evidence that GHP and HACCP-based procedures were i) validated, ii) implemented appropriately and iii) routinely verified to ensure compliance with the relevant food safety and process hygiene criteria? Have you documented the RTE status of each foodstuff? Have you documented your sampling and testing programme for foodstuffs? This should include: The description of a batch The sampling frequency (where sampling frequencies are not specified in the Regulation, it should include details of the risk assessment undertaken to determine the appropriate frequency) The sampling plan The laboratories accreditation and analytical method used by the laboratory Interpretation of the test results Trend analysis Action to be taken in the event of unsatisfactory results Action taken to prevent the occurrence of microbiological risk Shelf-life studies Have you documented your environmental monitoring programme? This should include: Sampling procedure Sampling frequency (and the risk assessment undertaken to determine the appropriate frequency) Sample sites Sampling time The laboratories accreditation and analytical method used by the laboratory The action to be taken in the event of a positive result Trending of results Have you ensured that all records/documentation are available if required by the relevant competent authorities to demonstrate compliance with the Regulation? Page 15 of 15