Business Compliance with the Requirements of Regulation 2073/ Shelf Life Studies Training Workshop. Dr. Karl McDonald Dr.

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1 Business Compliance with the Requirements of Regulation 2073/ Shelf Life Studies Training Workshop Dr. Karl McDonald Dr. Mary Friel

2 Under Article 3.2 of the Regulation... There is a requirement for FBOs responsible for the manufacture of food products to carry out studies to investigate compliance of those products with the food safety criteria set out in the Reg throughout the products shelf-life (SL). In particular these SL studies maybe required for RTE food which may support the growth of Listeria monocytogenes (L. mono) and pose a risk to public health. In other words if you produce a food especially a RTE food with a defined shelf-life will any of the food safety criteria defined in the regulation be exceeded? You need to be in a position to answer that question and be in a position to defend the products shelf-life if questioned.

3 Characteristics of your Product Often called intrinsic and extrinsic properties Intrinsic Quality of raw materials Food formulation & composition Salt level Water activity ph Presence of preservatives Others Extrinsic GHP & GMP HACCP Processing Storage temperature Packaging Consumer practices Others

4 Characteristics of your Product Example: Chilled Pre-Packaged, Ready-to-Eat Cooked Sliced Ham Ingredients: Pork (95%), Salt, Sugar, Stabiliser (Sodium Polyphosphate), Antioxidant (Sodium Ascorbate), Preservative (Sodium Nitrite) Instructions for use: Keep refrigerated below 5 C and once opened use within 48 hours and/or by the use by date, whichever comes first. Intrinsic Approved supplier agreed spec Boned vac packed Irish Pork Legs ph = 5.8 Salt level = 2% Water activity (Aw) = 0.98 Preservative = Sodium Nitrite (max 150ppm) Extrinsic Storage temperature = 5C Processing: Cooked 70C/2 min i.e. D-6 process Cooled to <5C / 2hrs Sliced i.e. following cooking & cooling MAP Desired Shelf-life > 5 <5C Consumer Practices: Store at 7C

5 Consultation of Scientific Literature (1) Consult available scientific data to understand what may be the microbiological hazards associated with your food. Three basic questions need to be answered to begin this process: Using Example of Cooked Ham: Has similar products been associated with the presence of pathogens and/or outbreaks of food borne illness? e.g. Using Rapid Alert System for Food and Feed (RASFF) - YES What pathogens were associated? e.g. Using RASFF - L. mono and in some cases Salmonella Are those pathogens a risk for your product? Possibly, but further assessment is required

6 Consultation of Scientific Literature (2) Example: Does the intrinsic and extrinsic properties of my cooked ham allow the growth/survival of L. mono if present? Yes Example: Characteristics From Regulation (EC) No. 2073/2005 Products are not considered to support the growth of L. monocytogenes if : ph is no more than 4.4, or aw is no more than 0.92, or ph is no more than 5.0 and the aw is no more than 0.94 Shelf life of less than 5 days

7 Consultation of Scientific Literature (2) Reference: FSAI GN 18 on Validation of Product Shelf-Life (Revision 1)

8 Consultation of Scientific Literature (3) Historical Data: FBOs have legal obligation to maintain records Historical data can comprise records, built up over time Historical data can be used as supporting evidence Comprises information from GMP/GHP and HACCP, such as: Process validation, verification and monitoring e.g. temperature, ph Ingredients traceability and microbiological quality testing Environmental monitoring data from processing areas and equipment Supplier records Final product testing Cooked Ham Example: Listeria species has been isolated from environmental monitoring of the FBOs processing area. Recontamination of the product is possible as slicing and packaging is done after cooking

9 Conclusions so far... Example: Chilled Pre-Packaged, Cooked Sliced Ham The ph, aw and salt level suggest L. mono may grow if present The proposed shelf-life is > 5days i.e. > 5 day rule in Regulation Product receives cooking sufficient to destroy L. mono But post process contamination possible following cooking Storage temp is <5C but consumer practices, store at 7C Cooked ham products have been associated with outbreaks of L. mono foodborne illness Historical data shows possible risk of L. mono Conclusion: Possible that L. mono may be present in the cooked ham at the point of sale and could grow to levels > 100 cfu/g before end of shelf-life, further assessment required to determine appropriate shelf-life.

10 So what next for the FBO? There are 3 broad options available: The shelf-life must be declared as < 5 days OR The FBO must show that L. mono is absent (not detectable) in the product at end of manufacturing i.e. zero tolerance OR The FBO must show that the count for L. mono does not exceed 100 cfu/g at any time during the proposed shelf life i.e. > 5 days target shelf-life 12 days. To do this Annex II of the Regulation outlines three additional studies which can be used: Predictive Microbiology Durability Tests Challenge Tests. Cooked Ham Example: In this case the the FBO wants to give the product a shelf-life of > 5 days so additional studies are required as outlined above.

11 Predictive Microbiology The behaviour of L. mono should it be present in cooked ham, can be predicted using appropriate commercially-available predictive microbiology models. Predictive microbiology is quick, efficient and cost effective Useful in product development to give estimation of the shelf-life Useful to identify areas where challenge testing maybe required Useful if shelf-life determined, but food subject to minor change. However: Data used in models normally from lab media rather than foods Normally developed assuming microbial responses are consistent Which is why models often don't predict survival / growth of pathogens in foods. Predictive microbiology provides accurate information if interpreted by trained microbiologists with appropriate skills and experience. Where an FBO does not have skills/ expertise to use these models it should seek advice.

12 Cooked Ham Example: Time to Reach 100cfu/g Growth of Listeria monocytogenes at 7C under anaerobic conditions in ground ham Approx time to exceed 100 cfu/g is about 9 days assuming 10 cfu/g present at start of shelf-life and no lag phase Source: Pathogen Modeling Program (PMP)

13 Durability Tests: i.e. shelf-life trials Lab testing to determine the growth of selected organisms in a naturally contaminated food under reasonably foreseeable conditions (RFC) of distribution, storage and use i.e. typically used by Irish FBOs for shelf-life determination However, durability studies are generally not useful for determining the growth of pathogens in foods, as there's no guarantee they will be naturally present If these tests are used to assess L. mono growth in e.g. cooked ham replicate samples should be taken over the desired shelf-life with allowances given for a reasonable degree of product abuse i.e. temperature A plot of number of L. mono over time would give an indication of whether it would grow to a > 100 cfu/g by the end of shelf-life.

14 Durability Tests: i.e. shelf-life trials Cooked Ham Example: Results under reasonably foreseeable conditions of distribution, storage and use i.e. 7C Batch LM Sal LM Sal LM Sal LM Sal LM Sal Day 1 Day 5 Day 9 Day 12 Day 15 1 Abs Abs NT NT Abs Abs NT NT Abs Abs 2 Abs Abs NT NT Abs Abs NT NT Abs Abs 3 Abs Abs NT NT Abs Abs NT NT Abs Abs ph, salt, Aw of product also monitored and TVC, E. coli, coliforms No significant difference or changes in ph, Aw and salt day 1 to day 15 No growth of pathogens seen at Day 15 But TVC counts (not shown) at day 12 and sensory analysis indicate that the product has spoiled so shelf-life < 12 days The assigned shelf-life from these studies only relevant to the product formulation/storage conditions used and should not be extrapolated.

15 Challenge Tests Designed to check if product formulation and storage conditions control pathogen growth during desired shelf-life if present in the ingredients or contaminated the food during manufacture Food inoculated with pathogen, at specific level. Food is then treated under RFC of distribution, storage and use by FBO and survival and growth of inoculated pathogen measured e.g. as with durability studies a plot of no of L. mono over time gives an indication if growth to >100 cfu/g by end of shelf-life. Challenge tests don't estimate shelf life, but indicate if shelf-life is safe Advantages: provides data to questions not answered from other shelf-life studies e.g. What happens if L. mono contaminates cooked ham after cooking at slicing stage? In practice challenge testing is required if all other methods of assessing safety have been exhausted or if no data available for the food Disadvantages: costly, very specific, complex, experience required.

16 Conclusions: Shelf-Life Studies Based on all the shelf-life studies undertaken by the FBO: Description of Intrinsic & Extrinsic Characteristics Consultation of Scientific Literature Predictive Mathematical Modelling Laboratory Tests Durability & Challenge Tests Cooked Ham Example: Based on the collected data the FBO has determined that the shelf-life should be no longer than 9 days and challenge tests were not required.

17 Conclusions Shelf-life of foods is ensured by preventative approach incorporating product and process design, application of GHP/GMP and HACCP Microbiological criteria where applicable must be used in validation/verification of HACCP and other control measures Determined shelf-life unique to food and conditions tested and should not be extrapolated to other foods and conditions Assigning correct shelf-life key to commercial success of new foods and should be done in the early stages of new product development.

18 Additional Issues Now there are some additional questions which should be examined by the FBO before assigning the SL to the product: If you are manufacturing a RTE food able to support the growth of L. mono, were the previously mentioned SL studies conducted using the approach outlined in the EC guidance documents? For all other foodstuffs, were the previously mentioned SL tests conducted using a best practice approach e.g. FSAI Guidance Note 18 (Revision 1)? Did the SL 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)? Was a margin of safety applied to the SL established under reasonably foreseeable conditions of distribution, storage and use? e.g. If we take the cooked ham example the FBO decides to apply a Margin of Safety to the product, so labels it with a 7 day SL in the form of a useby-date Did you verify the product SL as part of a regular review of your food safety management system?

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