1. Microbiological Criteria - an introduction Jens Kirk Andersen The National Food Institute Technical University of Denmark

2. 2DTU Food, Technical University of Denmark No of human cases in Denmark:

3. 3DTU Food, Technical University of Denmark Sampling Testing Made decision on the result

4. 4DTU Food, Technical University of Denmark 4 pages that changed the world: 1997:

5. 5DTU Food, Technical University of Denmark

6. 6 Microbiological Criterion (Codex, 1997) : A criterion defining the acceptability of a product or a food lot, based on the absence or presence, or number of microorganisms including parasites, and/or quantity of their toxins/metabolites, per unit(s) of mass, volume, area or lot

7. 7DTU Food, Technical University of Denmark Microbiological criterium consists of: The microorganism Analytical method Sampling plan Acceptable limit/limits The food for which the criterion applies The place in the food chain where it applies Action on failure to meet the criterion Codex, 1997

8. 8DTU Food, Technical University of Denmark Codex, 1997: Food safety is assured by GHP and HACCP Microbiological criteria should be based on science Developed in a transparent fashion Meet the requirements for fair trade Setting of Microbiological Criteria is a Risk Management task

9. 9DTU Food, Technical University of Denmark Application of MC (Codex, 1997) : Where no other more effective tools are available When they are expected to improve the degree of protection offered to the consumer

10. 10DTU Food, Technical University of Denmark We realized that we were not performing according to this structured approach We needed to re-think New EU legislation was evolved

11. 11DTU Food, Technical University of Denmark Sampling uncertainty “Even if you search you shall not always find” Example: Testing 300 samples and finding all negative does not guarantee absence But evidence of prevalence is below 1% - with a probability of 0.95 Conclusion: You cannot rely on end-product testing MC should be used for verification of food safety control systems

12. 12DTU Food, Technical University of Denmark The purpose of an MC is to reduce the risk of the consumer Step 1: Hygiene-based MC - Hygiene parameter, E. coli, TVC etc. Step 2: Hazard-based MC - Pathogenic microorganisms Step 3: Risk-based MC - Directly (mathematically) related to consumer risk – outcome 3 steps in this hierarchy:

13. 13DTU Food, Technical University of Denmark Proces hygiene criteria –Hygiene parameters –3-class plans –Reaction: Improvement of hygiene + review of HACCP Relation to risk is weak EU microbiological criteria

14. 14DTU Food, Technical University of Denmark EU microbiological criteria Food safety criteria –Pathogenic microorganisms –2-class plans –Dramatic reaction when non-complience: Withdrawal Recall Relation to risk is stronger

15. 15DTU Food, Technical University of Denmark Towards a risk-based approach: Work has been going on for several years The term “risk-based” is being used increasingly in Codex Committee on Food Hygiene

16. 16DTU Food, Technical University of Denmark There must be a link between the level of hazard in a food, and the risk for the consumer Therefore it should be possible to translate the Level of Protection into a Microbiological Criterion

17. 17DTU Food, Technical University of Denmark ALOP Human PO Food Chain FSO Meal/RTE MC

18. 18DTU Food, Technical University of Denmark The missing link: The transition from Performance Objective to Microbiological Criterion? –A challenge for years! Two examples on how to do this is presented in by examples 5a and 5b

19. 19DTU Food, Technical University of Denmark Alternative approach The principle is simple: 1.Take a sample 2.Do the testing 3.Use the result to model the risk 4.Compare the risk to the average (baseline) risk 5.Acceptability is defined by the relative risk An example on this approach is also being presented by example 4

20. 20DTU Food, Technical University of Denmark Thank you for your attention