IAFP European Symposium 2018 Session Integrating Scientific Risk - - PDF document

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IAFP European Symposium 2018 Session Integrating Scientific Risk - - PDF document

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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

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IAFP European Symposium 2018

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Session Integrating Scientific Risk Assessment in the Prioritization and Management of Chemical Contaminants in Foods and Raw Materials Fri, 27 April

27.04.2018 GSc, NRC - IFSAS 2

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."

27.04.2018 GSc, NRC - IFSAS

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Risk Assessment Paradigm

Exposure assessment Hazard identification Hazard characterization Risk characterization Risk management decisions

(Adapted from EPA Office of Research and Development)

Risk Assessment Risk Management

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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

27.04.2018 GSc, NRC - IFSAS

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Presenters & Presentations

Integrating Scientific Risk assessment in the Prioritization and Management

  • f 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

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

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Outline

Context Context Objectives for tool development Objectives for tool development Tool Tool Case of 3-MCPD Case of 3-MCPD Conclusions Conclusions

Context

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Risk assessment

  • RA authorities

(EFSA, JECFA, other)

  • Occurrence / analytical data
  • Consumer total dietary exposure
  • Toxicity - Safe levels of exposure
  • Risk of exceeding safe exposure levels in

populations / sub-populations

Quality management

  • Ensure compliance with legal limits (raw

materials) set by Regulatory authorities (EC, codex, national…) - if available

  • Specifications (RMPS)
  • Process control (HACCP)
  • Originally based on ‘hazard’
  • Supply chain focus (raw materials)

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Context Context Objectives for tool development Objectives for tool development Tool Tool Case of 3-MCPD Case of 3-MCPD Conclusions Conclusions

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Objectives

Nestlé global approach

  • Global
  • Raw materials
  • Based on scientific principles of risk assessment

To define a global, harmonised and consistent strategy to manage chemical contaminants in raw materials that is scientifically sound and defendable

  • Severity
  • Risk (likelihood to cause harm)

Output: Tool for the prioritisation of chemicals to be managed in raw materials, entailing the use of decision trees Combined in a significance matrix

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Context Context Objectives for tool development Objectives for tool development Tool Tool Case of 3-MCPD Case of 3-MCPD Conclusions Conclusions

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Tool Development

Excel spreadsheet

Consum ption Consum ption

Analytic al data Analytic al data

Health based guidance values Health based guidance values

Food safety authorities EFSA, JECFA

  • pinions

Food consumption RM categories mapped to FoodEx2 categorisation GEMS cluster diet intakes Analytical data Nestlé internal database

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Tool: Excel Spreadsheet

Health Based Guidance Value Consumption Analytical data

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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
  • f 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

negligible low medium high

Decision tree

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Definitions

Safety Target (ST) Safety Target (ST)

  • 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.

Health Based Guidance Values (HBGV): TDI, ADI Health Based Guidance Values (HBGV): TDI, ADI

  • 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).

Concentration in raw material Dose on a body weight basis

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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

δ γ α β

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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:
  • HACCP studies
  • Surveillance/ monitoring programs
  • Raw material purchasing specifications

N L M H severity likelihood to cause harm

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Context Context Objectives for tool development Objectives for tool development Tool Tool Case of 3-MCPD Case of 3-MCPD Conclusions Conclusions

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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

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Application: 3-MCPD and its esters

Excel spreadsheet

consump tion consump tion

Analytic al data Analytic al data

Health based guidance values Health based guidance values

EFSA (2017) Group TDI = 2 g/kg bw/day JECFA (2016) PMTDI = 4 g/kg bw/day Food consumption RM categories mapped to FoodEx2 categorisation GEMS cluster diet intakes Analytical data Nestlé internal database (n  1’400)

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‘Safety Targets’ for 3-MCPD

Safety Targets critically depend on the HBGV applied

Raw material category Dietary intake (daily average) Fraction of TDI allocated Safety Target (mg/kg) Safety Target (mg/kg) Fats * 38 g 43.6 % 1.375 2.75 Miscellaneous 35 g 3 % 0.10 0.21

TDI = 2 µg/kg bw/day TDI = 4 µg/kg bw/day * Applicable to all edible fats & oils (from vegetable and animal sources), global / average / adult intake scnario

Evaluation against Analytical Data

Nestlé analytical data

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50 100 150 200 250 300 350 400 450 500 Frequency bin (ug/kg)

Vegetable fats and oils

1275 µg/kg 2750 µg/kg p95

(EFSA, 2016)

EFSA reported analytical data

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Consequences

Analytics

  • Method development
  • Data generation

Engagement with suppliers

  • Understanding formation
  • Mitigation studies
  • Communication of objectives with suppliers

Monitoring

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Context Context Objectives for tool development Objectives for tool development Tool Tool Case of 3-MCPD Case of 3-MCPD Conclusions Conclusions

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Summary & Conclusions

Development of a tool that allows to integrate risk assessment in the management of chemical contaminants

 Results are consistent with published information (exposure, severity, risks), need verification with newly generated data  Globally & locally applicable to all kinds of chemical contaminants, not only 3-MCPD (flexibility)  Outcome is used as an input to management of chemical contaminants (justification for monitoring, mitigation, investigation, HACCP studies, setting of specifications…)

Limitations

  • Limited applicability to process related contaminants (if not occurring in RMs)
  • Currently out of scope: small children, allergens, packaging materials

3-MCPD

  • ‘Safety Targets’ for 3-MCPD may serve as an input to define a limit (Nestlé specific, or even a general
  • ne) that is defendable from the safety perspective

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Publication(s)

2017: In preparation:

  • Tool for infant foods
  • Results for 3-MCPD

including a statistical approach to consider analytical data variability and ingestion over time

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Acknowledgement

Project team

Nestle Research Center

  • Paolo Mazzatorta (PM)
  • Thomas Stroheker
  • Gabriele Scholz
  • Yong Joo Chung
  • Benoît Schilter
  • Richard Stadler

Nestlé Quality Management

  • Pascal Volery

Chemical contaminant experts in Nestlé Product Technology Centers (NPTCs) and Quality Assurance Centers (NQACs)