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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



Outline

Management of Chemicals Based on their Mode of Introduction

Drivers of Change

Considerations for Future Directions

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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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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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Applying Codex Risk Analysis Paradigm5

Risk CommunicationDialogue with All Stakeholders

Risk AssessmentWHO & FAO

Scientific Advice & Information Analysis

Risk ManagementCodex & Member

StatesRegulation & Control



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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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



Ubiquitous Chemicals Entering the Food Supply:Man-made or Natural Sources

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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)



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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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 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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Areas of Population Growth =Areas Suffering from Food Security Issues

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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



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



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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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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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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Major Food Chemical Safety Challenge: Fraud

Food Fraud is as old as Food Production for

Commercial Purposes

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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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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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“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

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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”



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



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



Need to Move the Needle Towards Preventive Controls25



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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

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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

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Intersectoral Collaboration & Capacity Building Needed30

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