1. SMMSS - Support to Modernisation of Mongolia Standardisation System Food Chain Risk Assessment and Management - Seminar on Food Safety Ulaanbaatar / Mongolia 3 – 7 November 2014 Peter Steinbüchel - Nov. 2014 - RiA 1

2. SMMSS - Support to Modernisation of Mongolia Standardisation System Hazard: – “ A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect “ (Codex Alimentarius Commission) - “A condition or physical situation with a potential for an undesirable consequence “ Peter Steinbüchel - Nov. 2014 - RiA 2

3. SMMSS - Support to Modernisation of Mongolia Standardisation System Risk: – a situation involving exposure to danger – the possibility that something unpleasant will happen is the chance, high or low, that any hazard will actually cause somebody harm. Peter Steinbüchel - Nov. 2014 - RiA 3

4. SMMSS - Support to Modernisation of Mongolia Standardisation System Risk vs Hazard: – Hazard: something with the potential to cause harm. likelihood Risk: the likelihood of occurrence and the consequences magnitude of consequences of a specified hazard being realized Peter Steinbüchel - Nov. 2014 - RiA 4

5. SMMSS - Support to Modernisation of Mongolia Standardisation System For example, working alone away from your office can be a hazardrisk of personal danger hazard. The risk of personal danger may be high. --- hazard Electric cabling is a hazard. If it has snagged on a sharp object, the exposed wiring places it in a 'high-risk' a 'high-risk' category. Peter Steinbüchel - Nov. 2014 - RiA 5

6. SMMSS - Support to Modernisation of Mongolia Standardisation System hazards There are many hazards associated with food that can and do result in injury and harm to human health. Millions of people worldwide suffer from some sort of "food poisoning" each year. Peter Steinbüchel - Nov. 2014 - RiA 6

7. SMMSS - Support to Modernisation of Mongolia Standardisation System Uncontrolled application of agricultural chemicals, environmental contamination, use of unauthorized additives, microbiological hazards and other abuses of food along the food chain can all contribute to the potential of introducing or failing to reduce hazards related to food. Peter Steinbüchel - Nov. 2014 - RiA 7

8. SMMSS - Support to Modernisation of Mongolia Standardisation System With increased awareness of the effects of food hazards on human health, the increasing importance and rapid growth of world food trade and the demand by consumers for a safe food supply, analysis of the risks associated with food has become more important than ever before. Peter Steinbüchel - Nov. 2014 - RiA 8

9. SMMSS - Support to Modernisation of Mongolia Standardisation System Risk assessment is a quantitative evaluation quantitative evaluation of information potential health hazards on potential health hazards from exposure to various agents. It involves four interrelated steps: Peter Steinbüchel - Nov. 2014 - RiA 9

10. SMMSS - Support to Modernisation of Mongolia Standardisation System 1.Identification of the hazard and comprehension of the danger it represents, the impact in terms of human health and the circumstances under which the danger is present (hazard identification) Peter Steinbüchel - Nov. 2014 - RiA 10

11. SMMSS - Support to Modernisation of Mongolia Standardisation System 2. Qualitative and/or quantitative evaluation of the adverse effects of the hazard on human health (hazard characterization) 3. Qualitative and/or quantitative evaluation of the likely degree of consumption or intake of the hazardous agent (exposure assessment) Peter Steinbüchel - Nov. 2014 - RiA 11

12. SMMSS - Support to Modernisation of Mongolia Standardisation System 4.Integration of the first three steps into an likely estimate of the likely adverse effect in the target population (risk characterization). Peter Steinbüchel - Nov. 2014 - RiA 12

13. SMMSS - Support to Modernisation of Mongolia Standardisation System The entire risk assessment process requires the use of sound and scientifically derived information and the application of established scientific procedures carried out in a transparent manner. a degree of uncertainty Unfortunately, sound scientific data are not always available for the qualitative and quantitative evaluations necessary for an absolutely sure final decision; consequently a degree of uncertainty must be factored into the decision. Peter Steinbüchel - Nov. 2014 - RiA 13

14. SMMSS - Support to Modernisation of Mongolia Standardisation System The importance of risk assessment lies not only in its capacity for estimating human risk, but also in its function as a framework for organizing data as well as for allocating responsibility for analysis. The risk assessment process can include a variety of models for reaching conclusions; for example, the concept of acceptable daily intake (ADI) may be considered a component of risk assessment. Peter Steinbüchel - Nov. 2014 - RiA 14

15. SMMSS - Support to Modernisation of Mongolia Standardisation System Bacterial pathogens: not sufficient data for a quantitative risk assessment available; the many uncertainties associated with how and when an organism may express its pathogenic potential are one of the reasons; Qualitative assessment is then the only current alternative. Peter Steinbüchel - Nov. 2014 - RiA 15

16. SMMSS - Support to Modernisation of Mongolia Standardisation System FAO/WHO consultations had difficulty with quantitative microbiological risk assessment, and one recommendation is to establish an FAO/WHO Expert Committee on Microbiological Risk Assessment. Peter Steinbüchel - Nov. 2014 - RiA 16

17. SMMSS - Support to Modernisation of Mongolia Standardisation System Chemical risk assessment is a fairly well established process and in general permits the assessment of risks from long-term chronic exposure to a chemical. It includes the assessment of food additives, residues of pesticides and other agricultural chemicals, residues from veterinary drugs, chemical contaminants from any source and natural toxins such as mycotoxins and ciguatoxin. Peter Steinbüchel - Nov. 2014 - RiA 17

18. SMMSS - Support to Modernisation of Mongolia Standardisation System Commissioning a targeted risk assessment – aflatoxins example Peter Steinbüchel - Nov. 2014 - RiA 18

19. SMMSS - Support to Modernisation of Mongolia Standardisation System Commissioning a targeted risk assessment – aflatoxins example Peter Steinbüchel - Nov. 2014 - RiA 19

20. SMMSS - Support to Modernisation of Mongolia Standardisation System Commissioning a targeted risk assessment – aflatoxins example Peter Steinbüchel - Nov. 2014 - RiA 20

21. SMMSS - Support to Modernisation of Mongolia Standardisation System The naturally occurring mycotoxins, aflatoxins, are considered to be carcinogenic to humans, and the initial risk assessment by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) resulted in the recommendation to take management actions to reduce aflatoxin intake to the lowest practicable levels. Peter Steinbüchel - Nov. 2014 - RiA 21

22. SMMSS - Support to Modernisation of Mongolia Standardisation System After additional scientific data became available, and several risk management options were considered, the Codex Committee on Food Additives and Contaminants (CCFAC) commissioned a targeted risk assessment to JECFA: to evaluate the potency of these contaminants, to link these potency estimates to intake estimates and to estimate the impact of different standards, i.e. maximum limits, on the overall cancer risk. Peter Steinbüchel - Nov. 2014 - RiA 22

23. SMMSS - Support to Modernisation of Mongolia Standardisation System The outcome of the potency estimates and the evaluation of the impact of different standards assist the risk manager in the decision making process to set regulatory limits for these contaminants in the food supply. Peter Steinbüchel - Nov. 2014 - RiA 23

24. SMMSS - Support to Modernisation of Mongolia Standardisation System Thank you very much for your attention Peter Steinbüchel - Nov. 2014 - RiA 24