Risk-Benefit assessment of foods in a European perspective
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1 Risk-Benefit assessment of foods in a European perspective Hans Verhagen, Head, Risk Assessment and Scientific Assistance Department LIFE WOULD BE PRETTY DULL WITHOUT RISK voluntary risk taking and its pleasures * Three dominant discourses: 1.Self improvement 2. Emotional engagement 3. Control *Lupton & Tulloch, Health, Risk and Society, 4 [2002]
2 2 2 LIFE WOULD BE PRETTY DULL WITHOUT RISK Pufferfish (fugu) Gall bladder: tetrodotoxin (neurotoxin) Emerging risk: Vibrio spp in Northern Waters and detection of tetrodotoxin in European bivalves (UK, NL, BE) EFSA 2017 Opinion 3 2
3 CHEMICALS IN FOOD Macronutrients Micronutrients Contaminants Natural toxins Non-nutrients 4 DIETARY REFERENCE VALUES - average requirement (AR) - population reference intake (PRI) 3
4 DIETARY REFERENCE VALUES DIETARY REFERENCE VALUES 4
5 DIETARY REFERENCE VALUES Example: vit C PRI 110mg Source: ERNA 8 DIETARY REFERENCE VALUES Population distribution versus intake 5
6 DIETARY REFERENCE VALUES Population distribution versus intake DIETARY REFERENCE VALUES Population distribution versus intake 6
7 RISK-BENEFIT NICOTINIC ACID 100 Requirement 10 Flushing % Incidence Cholesterol lowering Hepatotoxicity Nicotinic acid daily intake Courtesy: Prof. A. Renwick 12 FOLIC ACID FORTIFICATION OF FLOUR Neural Tube Defects (benefit) Masking B12-deficiency (risk) Colorectal Cancer (benefit and risk) Folate deficiency (benefit) 7
8 FOLIC ACID FORTIFICATION OF FLOUR (70 µg/100 G) Public health burden (modelling) Neural tube defects Incidence (#) Incidence (%) DALYs % 5474 B 12 deficiency 53 1 % - 53 Colorectal Cancer % 2217 FOLIC ACID FORTIFICATION OF FLOUR Public health burden (DALYs) 70 μg 140 μg 280 μg 420 μg NTD B CRC Total
9 FOLIC ACID FORTIFICATION OF FLOUR Public health burden (DALYs) (sensitivity analysis / uncertainty*) 70 μg 140 μg 280 μg 420 μg NTD B CRC Total *different cut-off cancer EFFECTS VERSUS ABSENCE OF EFECTS Nutrition / epidemiology: effective dose levels Toxicology: ineffective (= safe) dose levels 9
10 RISK-BENEFIT ASSESMENT Compare effects with effects Compare effects with absence of effects Megaloblastic anaemia PRI 330 μg 10
11 Risk not accepted Food and nutrition Medicine Risk accepted Risk a neccesity Economics and Marketing-Finance 20 Risk Benefit characteristics 1. Problem formulation: at least 2 scenario s 2. A common currency to describe the health impacts 3. Tiered approach 11
12 RISK-BENEFIT & RISK RANKING & RISK-RISK 22 RISK-BENEFIT & RISK RANKING & RISK-RISK 12
13 RISK-BENEFIT & RISK RANKING & RISK-RISK unsafe food unhealthy diet 2004/2006 RISK-BENEFIT & RISK RANKING & RISK-RISK Comparing health loss and potential health gain by healthy diet and unsafe food in the Netherlands Factor DALY s Deaths Cases / year / year / year Diet composition # 245,000 13,000 ca. 40,000 Bodyweight 215,000 7,000 ca. 40,000 Healthy diet > 350,000 Micro-organisms 1,000-4, x10 3 Allergens ca. 1,000 < 1 ca. 32,000 Chemicals 500-1, Food safety 2,500-6,000 # dietary composition (5 factors) 25 13
14 BIOLOGICAL RELEVANCE Effect under consideration No 1. Is the effect in itself a(n) adverse/positive effect? Yes 2.Is the effect directly or indirectly linked to a(n) adverse/ beneficial outcome? No No Yes Is the size of the effect relevant for the assessment Yes Irrelevant Relevant 26 WEIGHT OF EVIDENCE APPROACH WEIGHT OF EVIDENCE CONCLUSION Three basic steps of weight of evidence assessment Integrate the evidence Weigh the evidence Assemble the evidence Assess consistency across lines of evidence Assess the relevance and reliability of each line of evidence LINES OF EVIDENCE Identify, filter and organise the evidence Includes preliminary consideration of relevance and reliability AVAILABLE INFORMATION 27 14
15 UNCERTAINTY IN RISK ASSESSMENT Uncertainty? Don t scientists know everything? 28 PROMETHEUS PROmoting METHods for Evidence Use in Scientific assessments 29 15
16
17 32 Life would be pretty dull... without risk - benefit Thank you Hans Verhagen Head of Department - Risk Assessment & Scientific Assistance (RASA) Via Carlo Magno 1A Parma - Italy Tel: Cell: hans.verhagen@efsa.europa.eu 17
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