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Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Addressing Chemical Risks through Risk-based Regulatory Measures:
Domestic and International Perspectives13th Symposium of the Scientific Committee of the Belgian Food Safety Agency
Chemical Risks in the Food Chain: Challenges for the Risk Assessor and Risk Manager
23 November 2017
Brussels, Belgium
Prof. Samuel Godefroy, Ph.D.Full Professor, Food Risk Analysis and Regulatory Policies
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Outline
Management of Chemicals Based on their Mode of Introduction
Drivers of Change
Considerations for Future Directions
2
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
How Do Chemicals Get into Food? …… Risk Management depends on the mode of introduction
Chemicals may find their way into the food supply chain: As a result of deliberate addition / introduction, resulting in a technical effect:
o E.g. additives, pesticides, processing aids, etc. As a result of ubiquitous presence in the environment
o From natural sources • E.g. natural toxins, Cd
o From man-made/industrial sources: • E.g. PCBs, Dioxins, mercury & other heavy metals etc.
As a result of deliberate and unlawful introduction: o Food fraud
As a result of process-induced occurrence: o Acrylamide, ethylcarbamate
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Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Managing the Risks for Chemicals in Food
Ensure that Chemical hazards are not present in food at LEVELS that lead to adverse health effects to humans
HAZARD: potential for a chemical or other pollutant to cause human illness or injury (inherent toxicity of a compound)
RISK: a measure of the probability that damage to health and/or the environment will occur as a result of a given hazard
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Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Applying Codex Risk Analysis Paradigm5
Risk CommunicationDialogue with All Stakeholders
Risk AssessmentWHO & FAO
Scientific Advice & Information Analysis
Risk ManagementCodex & Member
StatesRegulation & Control
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Risk Management Applied to Chemicals in Canada
Managing the risks relies on a combination of measures :
Industry action to prevent introduction of hazards (which may be supported by Government guidance)
Consumer action : following advice, informed choice
Regulator’s measures: Rules, Regulations and other requirements e.g. : Maximum
limits for specific hazards in food, control measures to ensure consistency of prevention measures and optimum protection Surveillance and monitoring of effectiveness of measures
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Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Chemicals Added/Introduced Deliberately to the Food Supply…7
… with an Intended Technical Effect
Food packaging materials / chemicals: with or without contact
Food Additives: Become components / ingredients of the food
Processing aids: e.g., Carcass rinses, immobilized enzymes
Agrochemical interventions: Pesticides, veterinary drugs, leave residues based on method of application
Incidental additives: e.g., food surface sanitizers
Higher levels of innovation
Premarket oversight : Mandatory approval processes : additives, pesticides, veterinary drugs
Codex guidance for additives, pesticides and veterinary drugs
General Guidance with no Mandatory Approval
Negative decisions for substances that are known to have deleterious health effects, even at low doses : e.g. genotoxic carcinogens
Level of oversight depends on
probability of exposure
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Ubiquitous Chemicals Entering the Food Supply:Man-made or Natural Sources
8
Man-made chemicals accumulating in the environment
Food may be the major source of exposure : PCBs, Dioxins and Furans, mercury as well as Flame retardants
Incidents related to deliberate or accidental introduction due to poor practices have resulted in major food safety crisis or in Food Safety Incidents: Belgian Dioxin crisis in 1999 and Irish pork crisis in 2008, Contaminated feed lots in British Columbia
Contaminated Foods as a result of Natural Toxin Presence / Accumulation
Risk Management:
Action to curb accumulation: industrial ban / Control reservoirs of introduction
Prevention of « point of introduction » incidents – particularly for feed
Specifically Designed Practices to reduce occurrence: Temperature, Humidity Control, etc.
Codes of Practice to reduce likelihood of introduction
ALARA principle : As Low as Reasonably Achievable approach
Regulatory Measures : Control measures to limit introduction - possible MLs in specific commodities
Consumption advice where applicable
Active surveillance and monitoring of reduction of exposure: Environment, Food and Human monitoring (Biomonitoring)
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Canadian SpecificityHigh Range Transport Chemicals: POPs, Mercury, Banned
Pesticides (DDT) Accumulation in the North and contamination of Environment
and Food Sources
Indigenous Population : First Nations Specific Dietary Patterns, Different Food sources : Seal, Bear,
etc.
The Answer: Regular Monitoring, Consumption Advice, Involvement of Communities
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Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
10
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Drivers of Change of Food Chemical Safety Management
Food Security Imperatives: Reduction of Food Waste and Food Loss
Access to New Sources of Protein : Addressing Innovation
Need to Address Changes in Methods and Approaches
Food Fraud as a Prevalent Threat
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Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Food Security : An On-going ChallengeBy 2050 the World
Population will reach an estimated
9.6 Billion individuals
UN report 2013: World population prospects: the 2013 Revision –Highlights and advance tables, Working paper N0 ESA/P/WP228, UN Department of Economic and Social Affairs, Population Division, NY
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Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Areas of Population Growth =Areas Suffering from Food Security Issues
13
Current 7.2 Billion will grow by one third (1/3) Highest areas of growth will be
witnessed in developing nationso e.g. Sub-Saharan Africa has one of
the highest levels of fertility Same areas currently suffering
from malnutrition and hunger will be subject to highest population growth Added Food Security Challenge
The Global Hunger Index map, 2013. Source: von Grebmer et al. (2013). Original publication International Food Policy Research Institute
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
World Hunger Index Map14
The Global Hunger Index map, 2013. Source: von Grebmer et al. (2013). Originally Published by the International Food Policy Research Institute
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Reduction of Food Loss and Waste NeededInefficiencies in the Food Value Chain, resulting in food safety concerns
from production to availability, result in major food losses
Currently about 30% of food production is lost and/or wasted worldwide –some estimates put this at 50% UK House of Commons (2013) Global Food Security. First Report of
Session 2013-14 (Vol. I) London: International Affairs Committee
Eliminating food loss and waste is expected to feed 870 million undernourished people worldwide Da Silva, JG. (2013), Food Losses mean hunger, the Think-Eat-Save Reduce your
footprint campaign of the save food initiative, partnership between UNEP – FAO and Messe Dusseldorf
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Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
An Opportunity to Support Food SecurityReduction and/or Elimination of Food Loss and Waste can be an opportunity to support Food Security through:Enhanced Food Chemical Safety Enhanced Natural Toxin Management Addressing Innovation in Food Production Practices
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Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Address Innovation in Food Production Practices Reduction of food waste can be achieved
through innovative interventions Packaging applications, additives, processes
Novel sources of protein may address food shortages Insect sources, etc.
Novel processes of food production to address climate challenges may require review and approval / acceptance
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Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Major Food Chemical Safety Challenge: Fraud
Food Fraud is as old as Food Production for
Commercial Purposes
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Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Food Fraud : An Attempt to Define the IssueNo formal definition in most regulatory frameworks
Notions included in Food Fraud:
Deliberate act
Aims for economic gain in an illicit manner
Meant to be hidden / not to be discovered
Misrepresents the food product to consumers
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Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Definitions found in the Literature / Regulation UK FSA A dishonest act or omission, relating to the production or supply of food, which is intended for personal gain or to cause loss to another party.
EU Commission Food Fraud NetworkInternational violation of the rules covered by Regulation 882/2004, which are applicable to the production of food and feed, motivated by the prospect of economic or financial gain.
ISOFood fraud is the fraudulent, intentional substitution or addition of a substance in a product, for the purpose of increasing the apparent value of the product or reducing the cost of its production. This includes dilution of products with increased quantities of an already present substance, to the extent that such dilution poses a known or possible health risk to consumers, as well as the addition or substitution of substances, in order to mask dilution.
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Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
“Economically Motivated Adulteration”
One of the most recent definitions of “Economically Motivated Adulteration” (EMA) – US FDA
The fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the
product, or reducing the cost of its production, i.e. for economic gain.
Includes dilution of products with increased quantities of an already-present substance, e.g. watering down milk or juice or the addition / substitution of
substances in order to mask dilution
21
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Food Fraud within the “Codex Mandate”22
Protection of Consumers’
Health
Ensuring Fair Practices in the
Food Trade
Food Safety Food Quality
FOOD FRAUD Food Fraud is meant to impact food quality but can have significant impacts on food safety
It ceases to be “hidden”
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Current Regulatory Framework 23
REACTIVE- Prohibition of Adulteration &
Misrepresentation of Food- Support to Enforcement
- General Penalties for Contravention to Adulteration & Misrepresentation
GENERAL PROVISIONS- Specific Penalties for Food Fraud
- More Specific Provisions Targeting Food Fraud
PREVENTIVE- General Requirements on GMP
- Specific Requirements of Preventive Controls, e.g. VACCP
M o r e S p e c i f i c f r o m R e a c t i v e t o P r e v e n t i v e
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Expected Evolution of Food Fraud Regulatory ManagementWould Likely Follow the Evolution and Progress of Food Safety Hazard Management
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AFTERPreventive Approach :
▪ Mandatory requirements for vulnerability analysis and identification
of weaknesses▪ Mandatory measures to address weaknesses through controls and
mitigation▪ Less reliance on end-product testing
but on enhanced process management
BEFOREReactive Measures based on:
▪ Consumer complaints▪ Competitors’ complaints▪ End-product testing
▪ Random sampling and testing
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Need to Move the Needle Towards Preventive Controls25
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
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Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Requirements of Changes in Risk Assessment Methodologies
Chemicals detected in foods at low levels and requiring attention
More Chemicals do not have full toxicological data, yet need to evaluated in conjunction with food production
New methodologies in risk assessment are being developed
Notion of Threshold of Toxicological Concern (TTC) used appropriately in Risk Assessment and Risk Management
Better use of tools related to foresight of Toxicity based on Structure
27
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
28
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Importance of Collaborative Efforts To Leverage Efforts and Avoid Duplication in Food Chemical
Risk AssessmentsTo support convergence in Food Chemical Risk Assessment
Outcomes e.g. Common Stance on Issues (BPA etc..)To Address Emerging Issues and New Scientific Findings
Collectively To Develop Common / Harmonized Guidance To Address Shortages In Risk Assessment CapacityTo Address Gaps in Food Chemical Risk Analysis In Risk Assessment : New Generation Toxicology, Consumption
Information, Food Monitoring In Risk Management / Communication: Studies and Methodologies to
Assess Impacts for Proposed Measures e.g. socio-economic impacts
29
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science
Intersectoral Collaboration & Capacity Building Needed30
Food Risk Analysis &Regulatory Excellence Platform
Département Sciences des alimentsDepartment of Food Science