Microbiological Criteria an introduction Jens Kirk Andersen The

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

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

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

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

5 DTU Food, Technical University of Denmark

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 6 DTU 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 7 DTU 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 8 DTU 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 9 DTU 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 10 DTU 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 11 DTU Food, Technical University of Denmark

The purpose of an MC is to reduce the risk of the consumer 3 steps in this hierarchy: 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 12 DTU Food, Technical University of Denmark

EU microbiological criteria • Proces hygiene criteria –Hygiene parameters – 3 -class plans –Reaction: Improvement of hygiene + review of HACCP • Relation to risk is weak 13 DTU 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 14 DTU 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 15 DTU 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 16 DTU Food, Technical University of Denmark

Human ALOP Meal/RTE FSO Food Chain 17 PO MC DTU 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 5 a and 5 b 18 DTU Food, Technical University of Denmark

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

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