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2. Consumers, Health, Agriculture and Food Executive Agency Risk assessment with regard to food and feed safety Risk analysis Why risk assessment in the EU? How, who? Example 2

3. Consumers, Health, Agriculture and Food Executive Agency Risk analysis principle (Codex Alimentarius) 3 Risk assessment Hazard identification and characterisation Exposure assessment Risk characterisation Risk management Measures e.g. (legal) standards Control and evaluation of results Risk communication

4. Consumers, Health, Agriculture and Food Executive Agency Risk analysis principle (Codex Alimentarius) The three activities are independent. This means that different persons (or organisations) are responsible, and a system of transfer of information must exist between the different parties. Risk assessment Experts on toxicology, chemical analysis, nutrition, food production Risk management Policy officers, legal officers, sampling and analysis Risk communication All experts 4

5. Consumers, Health, Agriculture and Food Executive Agency Interactions between risk assessment and risk management..recent examinations of risk assessment and risk analysis methodology have paid much closer attention to the influence of risk management on the risk assessment process. Although it is desirable to separate the functional activities of risk assessment from those of risk management in order to ensure scientific independence, it is acknowledged that risk managers should communicate and interact with risk assessors during the process to establish the scope of the analysis, particularly during problem formulation (also known as risk profiling). Thus, the relationship between risk assessment and risk management is an interactive, often iterative, process 5

6. Consumers, Health, Agriculture and Food Executive Agency Role of risk assessment in the EU Regulation 178/2002 Article 34Identification of emerging risks … the EFSA has information leading it to suspect an emerging serious risk, it shall request additional information from the Member States, other Community agencies and the Commission…. Article 50Rapid alert system RASFF … to the existence of a serious direct or indirect risk to human health deriving from food or feed, this information … Article 53Emergency measures for food and feed of Community origin or imported from a third country …from a third country is likely to constitute a serious risk to human health, animal health or the environment,… Article 56Crisis unit...identifies a situation involving a serious direct or indirect risk to human health deriving from food and feed,.. There is however no regulation or guideline in the EU on how to determine whether such serious risk exists! The risk analysis approach as described by the Codex Alimentarius is to be followed 6

7. Consumers, Health, Agriculture and Food Executive Agency Risk assessment method ENVIRONMENTAL HEALTH CRITERIA 240 Principles and methods for the risk assessment of chemicals in food (EHC 240, 2009) Chapter 1: Introduction Chapter 2: Risk Assessment and its Role in Risk Analysis Chapter 3: Chemical Characterization, Analytical Methods and the Development of Specifications Chapter 4: Hazard Identification and Characterization: Toxicological and Human Studies Chapter 5: Dose-Response Assessment and Derivation of Health-Based Guidance Values Chapter 6: Dietary Exposure Assessment of Chemicals in Food Chapter 7: Risk Characterization Chapter 8: Maximum Residue Limits for Pesticides and Veterinary Drugs Chapter 9: Principles Related to Specific Groups of Substances 7

8. Consumers, Health, Agriculture and Food Executive Agency Risk assessment: hazard identification 8 1.Its objective is to define the level where the chemical become “hazardous”. This level is expressed by means of guidance levels, e.g. Acute Reference Dose, Acceptable Daily Intake, Tolerable Daily Intake, or Virtual Safe Dose; 2.These values are based on the toxicological evaluation of various studies, and the levels are derived by international or national risk assessment organisations (JECFA/WHO, EFSA,..). 3.The health based guidance levels are published in various documents (e.g. Toxicological Monographs, Opinions). These can be found on the Internet.

9. Consumers, Health, Agriculture and Food Executive Agency Risk assessment: Exposure 9 For the exposure assessment, information is needed of Rate of consumption of relevant foods The quantity of food ingested can be found in consumption inquiries, statistics from food producers, interviews with consumers, and Available data of international organisations, e.g. GEMS-FOOD, EFSA-PRIMO Concentration of chemical in these foods To be defined by sampling and analysis, e.g. monitoring programs and surveys, or to be taken c.q. estimated from data in scientific reports

10. Consumers, Health, Agriculture and Food Executive Agency Consumption data: EFSA-PRIMO 10

11. Consumers, Health, Agriculture and Food Executive Agency Calculation of the exposure 11 Exposure (intake) equals Q x C, where Q is intake of a food item, and Ci is the concentration in that item. If the chemical is detected in different food items, total exposure is the sum of exposure from all items. If the variation of the rate of consumption and the variation in concentrations in the foods are known, the calculation can be repeated with different rates and different concentrations. The outcome will show the variation of exposure within the population. This approach is called “probabilistic modelling” (Monte Carlo)

12. Consumers, Health, Agriculture and Food Executive Agency Risk assessment: risk characterisation 12 For the risk characterisation the exposure is to be compared to a health based guidance value. When the exposure exceeds the health based guidance value, it is assumed that a health risk exists. The risk assessor will decide whether a “serious” health risk exists. That statement and its reasoning is to be communicated to the risk manager and/or the exposed population. It is the responsibility of the risk manager to decide whether measures to reduce the risk are needed.

13. Consumers, Health, Agriculture and Food Executive Agency Example: tin in drinking water 1/2 13 Due to an error in coatings of conduit pipes, levels of 200 mg of tin were detected per L stagnant drinking water. Is there a health risk for the consumer? PTWI: EFSA n.a., JECFA 14 mg/kg.week (2005) Intake adult:2 L/day * 200 mg/L equals 400 mg/day -> 400/60*7 equals 47 mg/kg.week Intake child:1 L/day * 200 mg/L equals 200 mg/day -> 200/15*7 equals 93 mg/kg.week

14. Consumers, Health, Agriculture and Food Executive Agency Example: tin in drinking water 2/2 The risk assessment is presented to the risk managers. At..date.. tin was detected in stagnant drinking water of private houses in …region … Levels up to 200 mg per Liter were determined. As it was found, that the tin is coming from coatings inside the conduit pipes, it must be assumed that the contamination exists already for a period of years. The exposure to tin by average adults and children exceeds the Tolerable Weekly Intake presented by JECFA-WHO in 2005. So it is concluded that a health risk for the general public in..region.. exists. What should be done? What can be done? What measures are feasible? Other suggestions or statements? 14

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