Risk assessment of mycotoxins: the EFSA approach. Katleen Baert Scientific officer, EFSA

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1 Risk assessment of mycotoxins: the EFSA approach Katleen Baert Scientific officer, EFSA International Conference The burden of Mycotoxins on animal and human health Rome, 15 December 2017

2 RECEIPT OF A REQUEST EU Commission EU Parliament Member States EFSA self mandate EFSA receives a question

3 RECEIPT OF A REQUEST EU Commission EU Parliament Member States EFSA self mandate EFSA receives a question EFSA s scientists evaluate, assess, advise

4 THE SCIENTIFIC PANELS Plant health Plant protection GMO Nutrition Animal feed Food Packaging Animal health & welfare Food additives Biological hazards Chemical contaminants

5 RISK ASSESSMENT OF MYCOTOXINS HAZARD IDENTIFICATION & CHARACTERISATION EXPOSURE ASSESSMENT RISK CHARACTERIZATION

6 HAZARD IDENTIFICATION AND CHARACTERISATION Aim: identification of reference point Toxicokinetics in experimental animals, farm animals and humans Toxicity in experimental animals Observations in humans Adverse effects in farm animals, fish, horses and pets Mode of action

7 HAZARD CHARACTERISATION Critical effect-> reference point NOAEL/LOAEL 7

8 BENCHMARK DOSE (BMD) 8

9 WHAT S NEW IN UPDATED BMD GUIDANCE Revised section on how to apply the BMD approach in practice, with model averaging now recommended as the preferred method for BMD calculations Default models for BMD analysis have been reviewed and a new criterion introduced. A new flow chart and template provide a step-by-step guide for performing and reporting a BMD analysis 9

10 HAZARD CHARACTERISATION ~ HUMANS Health-based guidance value Apply uncertainty factor(s) to reference point Tolerable Daily Intake (TDI) Chronic toxicity Acute Reference Dose (ARfD) Acute toxicity Margin of exposure (MOE) Substances that are genotoxic and carcinogenic Substances for which no safe level can be identified MOE = Reference point Dietary exposure estimate Dose that causes low but measurable response BMDL: benchmark dose lower confidence limit for a specific response 10

11 HAZARD CHARACTERISATION ~ HUMANS Health-based guidance value Apply uncertainty factor(s) to reference point Tolerable Daily Intake (TDI) Chronic toxicity Acute Reference Dose (ARfD) Acute toxicity Substances that are genotoxic and carcinogenic Substances for which no safe level can be identified 11

12 HAZARD CHARACTERISATION ~ HUMANS Health-based guidance value Apply uncertainty factor(s) to reference point Tolerable Daily Intake (TDI) Chronic toxicity Acute Reference Dose (ARfD) Acute toxicity Margin of exposure (MOE) Substances that are genotoxic and carcinogenic Substances for which no safe level can be identified MOE = Reference point Dietary exposure estimate Dose that causes low but measurable response BMDL: benchmark dose lower confidence limit for a specific response 12

13 HAZARD CHARACTERISATION ~ HUMANS Health-based guidance value Apply uncertainty factor(s) to reference point Tolerable Daily Intake (TDI) Chronic toxicity Acute Reference Dose (ARfD) Acute toxicity Margin of exposure (MOE) Substances that are genotoxic and carcinogenic Substances for which no safe level can be identified MOE = Reference point Dietary exposure estimate Dose that causes low but measurable response BMDL 10 : benchmark dose lower confidence limit for an increase of tumour incidence of 10% > => low concern 13

14 HAZARD CHARACTERISATION ~ ANIMALS USE OF REFERENCE POINT NOAEL/LOAEL BMDL 14

15 EXPOSURE ASSESSMENT Chemical Occurrence Exposure Assessment Food consumption 15

16 COLLECTION OF OCCURRENCE DATA EFSA does not generate occurrence data but collect existing data through data calls Food and feed industry European countries Research institutes/ Universities 16

17 FOOD AND FEED CONSUMPTION FOOD consumption Comprehensive Food Consumption Database The most recent data within the country The most complete/detailed data currently available in EU FEED consumption External databases Literature data 17

18 RISK CHARACTERISATION Humans Comparison of health-based guidance value and dietary exposure Calculation of margin of exposure (MOE) Animals Comparison of reference point and dietary exposure 18

19 LACK OF KNOWLEDGE; A RISKY ISSUE Le doute n'est pas une condition agréable, mais la certitude est ridicule Voltaire 19

20 LACK OF KNOWLEDGE; A RISKY ISSUE How to take the uncertainties into account in a way that allows a clear and transparent conclusion regarding the risk? Recommendations Lack or limited occurrence data Validated analytical methods Methods with sensitivity in low µg/kg range Certified reference materials Studies on influence of food/feed processing Incomplete toxicological databases Limitations in animal consumption data 20

21 RECEIPT OF A REQUEST EU Commission EU Parliament Member States EFSA self mandate EFSA receives a question EFSA s scientists evaluate, assess, advise Adoption and communication

22 EFSA S RECENT RISK ASSESSMENTS ON MYCOTOXINS Nivalenol Sterigmatocystin 2013 HBGV ZEA + MF Ergot alkaloids Citrinin Phomopsins 2014 Modified mycotoxins Beauvericin and enniatins 2017 Deoxynivalenol + MF Zearalenone + MF HBGV NIV + MF HBGV T2 & HT2 + MF Moniliformin MF: modified forms; HBGV: health-based guidance value; ZEA: zearalenone; NIV: nivalenol 22

23 MODIFIED MYCOTOXINS Modified forms of mycotoxins comprise all metabolites of the parent molecule which are formed in the fungus, infested plant and mammalian organism. Appropriate and feasible to set a group HBGV? Parent compound as marker for presence and toxicity of parent compound and modified forms? Zearalenone T-2 & HT-2 toxin Nivalenol Fumonisins B1 and B2 23

24 ONGOING AND FUTURE ACTIVITIES Appropriateness to set a group HBGV for certain mycotoxins and their modified forms : fumonisins Diacetoxyscirpenol (4,15-DAS) in feed and food Fumonisins and their modified forms in feed Effect on public health of a possible increase of the maximum level for aflatoxin total in peanuts 24

25 Thank you for your attention

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