IAFP European Symposium 2018 Session Integrating Scientific Risk Assessment in the Prioritization and Management of Chemical Contaminants in Foods and Raw Materials Fri, 27 April 1 27.04.2018 GSc, NRC - IFSAS Paracelsus 1493 - 1541 “What is there that is not poison? All things are poison and nothing is without poison. Solely the dose determines that a thing is not a poison." 2 27.04.2018 GSc, NRC - IFSAS 1
Risk Assessment Paradigm Risk Assessment Risk Management Exposure assessment Risk Hazard Risk management identification characterization decisions Hazard characterization (Adapted from EPA Office of Research and Development) 3 27.04.2018 GSc, NRC - IFSAS Some of Today’s Challenges Analytical sensitivity Risk vs hazard based assessments Risk assessment should inform risk- & quality management Regulation, international vs local Prioritization Protection of consumers 4 27.04.2018 GSc, NRC - IFSAS 2
Presenters & Presentations Integrating Scientific Risk assessment in the Prioritization and Management of Chemical Contaminants in Foods and Raw Materials 1. Gabriele Scholz , Nestlé Research Center, Lausanne, Switzerland Application Example of a Global Scientific Tool for the Assessment and Prioritization of Chemical Hazards in Food Raw Materials 2. Tilemachos Goumperis , European Food Safety Authority, Parma, Italy A Methodology for Risk Evaluation of Chemical Contamination in Food 3. Paul Hanlon , Abbott Nutrition, Columbus, OH An Industry Approach to Integrate Scientific Risk Assessment to Prioritize Chemical Contaminants 5 27.04.2018 GSc, NRC - IFSAS Application Example of a Global Scientific Tool for the Assessment and Prioritization of Chemical Hazards in Food Raw Materials Gabriele Scholz Gabriele.Scholz@rdls.nestle.com Chemical Food Safety Group Nestlé Research Center, Lausanne, CH 3
Outline Context Context Objectives for tool development Objectives for tool development Tool Tool Case of 3-MCPD Case of 3-MCPD Conclusions Conclusions 7 27.04.2018 GSc, NRC - IFSAS Context Risk assessment Quality management • RA authorities • Ensure compliance with legal limits (raw (EFSA, JECFA, other) materials) set by Regulatory authorities (EC, codex, national…) - if available • Occurrence / analytical data • Specifications (RMPS) • Consumer total dietary exposure • Process control (HACCP) • Toxicity - Safe levels of exposure • Originally based on ‘hazard’ Risk of exceeding safe exposure levels in Supply chain focus (raw materials) populations / sub-populations 8 27.04.2018 GSc, NRC - IFSAS 4
Context Context Objectives for tool development Objectives for tool development Tool Tool Case of 3-MCPD Case of 3-MCPD Conclusions Conclusions 9 27.04.2018 GSc, NRC - IFSAS Objectives Nestlé global approach To define a global, harmonised and consistent strategy to manage chemical contaminants in raw materials that is scientifically sound and defendable • Global • Raw materials • Based on scientific principles of risk assessment Output: Tool for the prioritisation of chemicals to be managed in raw materials, entailing the use of decision trees • Severity Combined in a • Risk (likelihood to cause harm) significance matrix 10 27.04.2018 GSc, NRC - IFSAS 5
Context Context Objectives for tool development Objectives for tool development Tool Tool Case of 3-MCPD Case of 3-MCPD Conclusions Conclusions 11 27.04.2018 GSc, NRC - IFSAS Tool Development Food safety authorities EFSA, JECFA Health Health based based opinions guidance guidance Analytic Analytic values values al data al data Analytical data Nestlé internal database Consum Consum ption ption Food consumption RM categories mapped to FoodEx2 categorisation GEMS cluster diet intakes Excel spreadsheet 12 27.04.2018 GSc, NRC - IFSAS 6
Tool: Excel Spreadsheet Health Based Guidance Value Consumption Analytical data 13 27.04.2018 GSc, NRC - IFSAS Decision tree Risk (Likelihood to Cause Harm) Per contaminant X raw material (RM) Safety Target (ST) • Concentration in RM considered safe for lifetime exposure in the context of an average diet (taking into account other sources of exposure) Risk (decision tree) • Based on total exposure and contribution of RM category to the HBGV • Level and frequency of exceeding the Safety Target high medium low negligible 14 27.04.2018 GSc, NRC - IFSAS 7
Definitions Concentration in Safety Target (ST) Safety Target (ST) raw material • The ST refers to the level of a given chemical in a specific food raw material (expressed in mg/kg of raw material) consumed in the context of an average global diet, that can be ingested (orally) on a daily basis over a lifetime without an appreciable health risk. Dose on a body Health Based Guidance Values (HBGV): TDI, ADI Health Based Guidance Values (HBGV): TDI, ADI weight basis • The tolerable daily intake (TDI) is an estimate of the amount of a substance in food or drinking water which is not added deliberately (e.g contaminants) and which can be consumed over a lifetime without presenting an appreciable risk to health (EFSA glossary). 15 27.04.2018 GSc, NRC - IFSAS Severity Criteria for setting the severity • Chronic exposure (not acute), oral route (not inhalation or injection) • Carcinogenicity, reproductive and developmental toxicity • Structural changes/ functional damage in critical organs or systems • Mutagenicity/ absence of a threshold • Reversibility • Evidence in humans/ plausibility for human effect α β γ δ 16 27.04.2018 GSc, NRC - IFSAS 8
Risk and Severity are combined in the Significance Matrix For any combination of contaminant X raw material Trigger investigation • Local assessment • Analysis • Mitigation… Consideration in: severity • HACCP studies • Surveillance/ monitoring programs • Raw material purchasing specifications N L M H likelihood to cause harm 17 27.04.2018 GSc, NRC - IFSAS Context Context Objectives for tool development Objectives for tool development Tool Tool Case of 3-MCPD Case of 3-MCPD Conclusions Conclusions 18 27.04.2018 GSc, NRC - IFSAS 9
Application: 3-MCPD and its esters Issue • 3-MCPD esters were identified in vegetable fats & oils (palm oil) • Database on levels mainly in vegetable fats and oils • Humans are exposed via food • 3-MCPD esters (‘bound’) are a source of exposure to 3-MCPD (‘free’) • 3-MCPD is toxic to kidney and testes in rodents • Non-genotoxic (threshold mechanism) • Dose response characterization available • Health Based Guidance Value(s) established (TDI) • Human exposure may exceed TDI in certain populations, particularly formula-fed infants Need to manage 19 27.04.2018 GSc, NRC - IFSAS Application: 3-MCPD and its esters EFSA (2017) Group TDI = 2 g/kg bw/day Health Health based based JECFA (2016) guidance guidance Analytic Analytic values values PMTDI = 4 g/kg bw/day al data al data Analytical data Nestlé internal database consump consump tion tion (n 1’400) Food consumption RM categories mapped to FoodEx2 categorisation GEMS cluster diet intakes Excel spreadsheet 20 27.04.2018 GSc, NRC - IFSAS 10
‘Safety Targets’ for 3-MCPD Safety Targets critically depend on the HBGV applied TDI = TDI = 2 µ g/kg bw/day 4 µ g/kg bw/day Raw material Dietary intake Fraction of Safety Target Safety Target category (daily average) TDI allocated (mg/kg) (mg/kg) Fats * 38 g 43.6 % 1.375 2.75 Miscellaneous 35 g 3 % 0.10 0.21 * Applicable to all edible fats & oils (from vegetable and animal sources), global / average / adult intake scnario 21 27.04.2018 GSc, NRC - IFSAS Evaluation against Analytical Data Nestlé analytical data EFSA reported analytical data Vegetable fats and oils 500 1275 µg/kg 2750 µg/kg 450 400 350 Frequency 300 250 200 p95 150 100 50 (EFSA, 2016) 0 bin (ug/kg) 22 27.04.2018 GSc, NRC - IFSAS 11
Consequences Analytics • Method development • Data generation Engagement with suppliers • Understanding formation • Mitigation studies • Communication of objectives with suppliers Monitoring 23 27.04.2018 GSc, NRC - IFSAS Context Context Objectives for tool development Objectives for tool development Tool Tool Case of 3-MCPD Case of 3-MCPD Conclusions Conclusions 24 27.04.2018 GSc, NRC - IFSAS 12
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