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30th December 2022 by foodfraudadvisors

Food Safety Hazards from Food Fraud (EMA)

Updated 31st December, 2022

Are you confident in your FSMA preventive controls for hazards from food fraud?

This post is for you if your company manufactures food in the USA or exports food to the USA.

Food companies in the USA must comply with food safety regulations that require them to identify and address hazards from economically motivated adulteration (EMA), a type of food fraud.

In this post you can learn what EMA is and how to identify food safety hazards from EMA.  You can also discover what type of preventive controls are best for EMA hazards.

Definitions

EMA is short for economically motivated adulteration which is a type of food fraud.  Other types of food fraud include counterfeiting, making false claims (for example, fake ‘organic’ food) and species substitution (for example, selling cheap white fish labelled as snapper).

“Economically motivated adulteration (EMA) occurs when someone intentionally leaves out, takes out, or substitutes a valuable ingredient or part of a food. EMA also occurs when someone adds a substance to a food to make it appear better or of greater value.” (US FDA)

FSMA denotes the Food Safety Modernization Act (USA). is a set of rules for food manufacturers. Under the rules, food manufacturers must assess food safety hazards and implement preventive controls. The US Food and Drug Administration (FDA) is responsible for the enforcement of the rules.  If your company is outside the USA but exports to the USA, you must also comply with the FSMA rules.

Hazards are chemical, physical and biological agents that may be present in food and that are capable of causing harm to consumers of the food.  (Find the official FDA definition here)

Preventive controls are procedures and systems that are designed to ensure that food safety hazards are prevented or minimized to an acceptable level.

Rules for food fraud (USA)

FSMA requires that preventive controls are implemented by food manufacturers to prevent hazards to human health.  The relevant regulation is called the FSMA Final Rule for Preventive Controls for Human Food, and is commonly known as the Preventive Controls Rule.

The Preventive Controls Rule requires food manufacturers to identify and control hazards that could arise from:

  • natural occurrences (for example, some raw meat products naturally contain certain human pathogens);
  • unintentional contamination (for example food may be accidentally contaminated with a pesticide during a pest control treatment), and
  • economically motivated adulteration (EMA).

After food manufacturers have identified the hazards, they must minimize or prevent the hazards by creating and implementing preventive controls in their food manufacturing operations. These are procedures and systems that are documented and that include monitoring, corrective actions systems and verification activities.  The preventive controls form part of the food manufacturer’s food safety plan.

Learn more about the preventive controls rule on the FDA’s preventive controls guidance webpage.

A separate part of the FSMA rules also requires food manufacturers to create and implement systems to prevent intentional, malicious adulteration.  The FDA calls this type of adulteration Intentional Adulteration (IA). It is different from economically motivated adulteration.  Intentional adulteration prevention is also known as food defense.  Click here to learn more about food defense.

Hazards are chemical, physical and biological agents that may be present in food and that are capable of causing harm to consumers of the food

Examples of hazards from economically motivated adulteration (EMA)

Economically motivated adulteration (EMA) is a subset of food fraud.   Food fraud includes many types of deception carried out for the purposes of economic gain.  It includes activities such as mislabeling (for example, making false claims about the geographical origin of a food product) and other fraudulent activities that do not involve the adulteration of food.

Economically motivated adulteration is a type of food fraud in which a person has added a substance to food to enhance its apparent value or profitability.  Often the added substance will boost the apparent quality or appearance of the food, other times the substance will be a diluent, which dilutes or replaces the genuine material with a cheaper material, thereby increasing the profitability of the resulting mix.

Food businesses are required by law to about hazards that may be in their products and must create and implement systems that will prevent, minimize or eliminate those hazards.  The systems must be documented in a food safety plan.

Economically motivated food fraud (EMA) happens when food fraud perpetrators add materials to increase the apparent value of the food or to extend its shelf life in an undeclared or unlawful manner.  Materials that are added to make food or ingredients seem bigger, or heavier include water and other liquids, or fillers and bulking agents, such as starches, husks or sawdust.  Adulterants that are added to make food look better include unauthorised colorants, glosses and glazes.  Adulterants that extend shelf life include non-approved preservatives.

The food safety risks from such adulterations include acute or chronic chemical poisoning, allergenic reactions, and microbial illnesses from pathogens introduced during the adulteration processes.

Example: Unauthorized color in turmeric

A significant proportion of powdered turmeric traded worldwide contains unsafe levels of lead.  Researchers in Bangladesh have confirmed that the lead is added to the spice in the form of toxic lead chromate which has an intense yellow-gold color, the color favoured by turmeric traders and buyers as an indicator of freshness and quality.  Curry powder, cumin and cinnamon have also been affected.  A survey of more than 1496 samples of 50 spices from 41 countries found that 50% of the spice samples had detectable lead, and more than 30% had lead concentrations greater than 2 ppm, a level that is 200 times higher than the recommended maximum lead content of candy in the USA.  Lead is a potent neurotoxin that damages organs including the brain.

Example: Undeclared peanuts in chopped hazelnuts

Peanuts are cheaper than most other nuts which makes them an attractive ‘filler’ or bulking agent in chopped nuts, powdered nuts and nut pastes.  When a food fraud perpetrator adds peanuts to a tree nut product, they gain more profit than if they sold a pure paste or powder.  In Germany in 2017, authorities found bulk quantities of chopped hazelnuts adulterated with 8% chopped peanuts.  The chopped hazelnuts were sold as ‘pure’ hazelnuts and did not declare any peanut ingredients on the label.  Because peanuts are a regulated human food allergen, their presence in the hazelnut product presented a serious food safety hazard.

 

How to identify hazards from economically motivated adulteration (EMA)

Follow the five steps below to identify hazards from EMA food fraud for your food manufacturing preventive controls plan.

  1. For each raw material that your company purchases to use in the food manufacturing process, investigate whether economically motivated adulteration is likely to occur within the supply chain.  Ask yourself: could adulterants be present in the raw material when it is purchased?  Learn how to investigate susceptibility to food fraud here.
  2. For each raw material and each finished product your company makes, also investigate whether economically motivated adulteration could occur inside your manufacturing facility or storage areas.  This is sometimes known as ‘insider activity’.
  3. After you have understood whether adulteration is likely to occur for each raw material, make a list of adulterants that could be added to each of the susceptible foods.   Historical records of past incidences of food fraud provide the best indication of the types of adulterants that can be expected in different foods and ingredients.  This page has a list of databases you can use to find historical records. .
  4. For each possible adulterant, make a note of whether it could be hazardous to human health if present in the food.  As an example, olive oil is commonly adulterated with (non-olive) vegetable oils.  That type of adulteration is unlikely to be hazardous and as such it would not require a preventive control under the FSMA rules*.   Document your decisions and justifications for such.
  5. Add the economically motivated hazards you have identified to your company’s food safety plan.  Implement preventive controls for each hazard.  Supplier approvals programs are commonly used for control of economically motivated hazards in incoming raw materials.

Need to learn more about food fraud prevention?  Visit our online training school.  Courses start at just US$29.

*Even if not strictly required under FSMA rules, it is always a good idea to prevent any type of food fraud from affecting your products.  This will protect your company and brand as well as your consumers’ health.

 

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Filed Under: Adulteration, Regulatory Tagged With: economically motivated adulteration, FSMA

11th August 2022 by Karen Constable

Food Safety Standards Compared (2022)

 

food vulnerability assessment

 

When it comes to food fraud, each food safety standard has slightly different food fraud requirements. For example, some standards require food businesses to include counterfeiting in their vulnerability assessments, while others don’t; some standards specify that vulnerability assessments must be performed on ingredients, while others state they should be done on finished products.

Confused? We are here to help.  Read on to find out which standards have what requirements, and get recommendations for creating a great food fraud prevention (VACCP) program.

Background

Food safety standards are standards that describe requirements for food and related businesses.  The requirements aim to ensure that food and food-related goods are safe for consumers and customers.  The correct term for such standards is food safety management systems standards (FSMS).

There are food safety standards for all types of operations within the food supply chain, including:

  • growing and packing fresh produce;
  • manufacture of food and food ingredients;
  • buying and selling food (“brokers”);
  • storage and transport of food;
  • manufacture or converting of packaging materials;
  • manufacture of animal feed or pet food;
  • services such as cleaning, laundry, or pest control for food businesses.

The over-arching aim of all food safety standards is to keep consumers safe, but most standards also have secondary aims. Some of the most popular food safety standards were developed by food retailing groups, and these standards were written to protecting the retailers’ brands as well as keeping consumers safe. Other standards were developed to help food businesses understand best practices and gain a way to demonstrate their excellence through independent certifications.  Some standards include quality parameters, while others only address food safety issues.

There are dozens of internationally accepted food safety management system standards, each with slightly different requirements.  This can make it difficult to know which standards are ‘better’ or more suitable for your food company.

To solve this problem, a standard for food safety standards was created by the GFSI (Global Food Safety Initiative).  The GFSI assesses and approves food safety standards using a process called benchmarking. The aim of GFSI benchmarking is to define best practice in food safety standards and provide a way to compare and align different food safety standards.

Among the dozens of food safety standards, some are benchmarked by the GFSI (Global Food Safety Initiative), while others are not.  Benchmarked standards usually have more requirements and more rigorous expectations than non-benchmarked standards.  The auditing and certification processes for benchmarked standards are typically more time-consuming and often more expensive than for non-benchmarked standards.

Food Fraud in Food Safety Standards

Food fraud prevention activities are an important part of all food safety management systems because food fraud can pose a risk to food safety.  Some food safety standards have separate, stand alone requirements for food fraud prevention activities, while others do not.  Standards that are GFSI-benchmarked all include explicit, separate food-fraud-related requirements. Other standards rely on the hazard analysis elements of the food safety system to identify and control hazards from food fraud.

The GFSI requires all benchmarked standards to require food companies to do a vulnerability assessment for food fraud and create a mitigation plan for food fraud prevention.  Most GFSI-benchmarked standards also include details about which materials should be assessed and which types of food fraud need to be managed.

Non-GFSI standards vary in how they require a food company to approach food fraud.  Some specify or recommend a VACCP program, which is based on food fraud vulnerability assessment activities. Others, like AIB, require that food fraud risks be considered in the supplier approvals processes.  The regulations of the USA Food Safety Modernization Act (FSMA) require that food businesses identify hazards from economically motivated adulteration type food fraud and implement preventive controls to minimise the risks.

Among the most well-known standards there are some notable differences. For example, the SQF Food Safety Code requires food businesses to assess and manage risks from counterfeit-type food fraud, while the BRC Food Safety Standard only requires businesses to assess the risks from adulteration or substitution activities. BRC requires horizon scanning activities, while the SQF and IFS standards explicitly mention food fraud training.

Below you will find a table that compares the current food fraud requirements of each of the major food safety standards.

Table 1.  Food fraud requirements of major food safety standards, 2022. 

Click here to open or download a pdf version of this table

  AIB* BRC* FSSC* GlobalGAP* IFS* SQF*
Food types to include in food fraud prevention activities Ingredients (implied)

 

 

Raw materials

 

 

Products and processes

 

 

Unclear

 

 

Raw materials,

ingredients,

packaging,

outsourced processes

Raw materials,

Ingredients,

finished products

 

Food fraud types

 

 

 

Economically motivated adulteration (only)

 

 

Adulteration,

substitution

(only)

 

 

Any type where consumer health is at risk (in definition, Appendix A)

 

Unclear, however counterfeit or non-foodgrade packaging or propagation materials are included as examples

 

Substitution, mislabelling, adulteration, counterfeiting

 

 

Substitution, mislabelling, dilution, counterfeiting

 

 

Vulnerability assessments explicitly required? Risk assessment (implied, Appendix A) Yes Yes Risk assessment Yes Implied (Edition 9)
Mitigation plan required?

 

 

– Mitigation activities are to be included in the vulnerability assessment Yes Yes Yes Yes
Does packaging need to be included in the vulnerability assessment? Yes

(implied)

 

Yes

(see 3.5.1.1)

 

Yes

(as per food fraud definition, Appendix A)

Yes

 

 

Yes

 

 

Implied

(primary packaging is a ‘raw material’)

Is a separate food fraud procedure explicitly required? – – Yes – Implied

(“responsibilities shall be defined”)

Implied

(“methods and responsibilities shall be documented”)

Is training in food fraud explicitly mentioned? – Implied

(Clause 5.4.1)

– – Yes

(Clause 3.3.4)

Yes
Is an annual review explicitly required? – Yes – – Yes Yes
Other

 

 

– Horizon scanning for developing threats must be done (Clause 5.4.1) – – Criteria for vulnerability assessments must be defined

(4.20.2)

Food safety risks from food fraud must be specified (2.7.2.2)

*  The full names of the standards are as follows:

AIB International Consolidated Standards for Inspection of Prerequisite and Food Safety Programs, 2023 (NEW!)

BRCGS Food Safety, Issue 9 (NEW!)

FSSC 22000, Version 5.1

GlobalG.A.P. Integrated Farm Assurance (IFA), Version 5.4-1

IFS Food, Version 7

SQF Food Safety Code, Edition 9

Takeaways

Among the major food safety management system standards, there are small but significant differences between food fraud prevention requirements.  Key differences include whether finished products or ingredients are to be assessed, which types of food fraud must be included and the presence/absence of requirements related to horizon scanning and training.

If that all seems confusing, don’t despair…

Recommendations for a robust and compliant food fraud prevention program (VACCP)

At Food Fraud Advisors we have been working at the intersection of food fraud and food safety since the very beginning!  Creating a robust and compliant food fraud program can take time and effort but it isn’t complicated.  Follow the steps below to get started:

  1. Carefully read the food fraud clauses of the standard you are/will be certified to.
  2. Pay attention to the food types and the food fraud types that are mentioned in your standard. HINT: you may need to check the definitions or glossary.
  3. Create a robust vulnerability assessment (here’s how) and a mitigation plan for identified vulnerabilities.
  4. Whether or not it is explicitly required in your standard, we recommend you create a food fraud prevention procedure that defines the methods, responsibilities and criteria for food fraud prevention.
  5. You should also conduct training for all relevant staff and ensure that the food fraud system is reviewed at least annually.

Get a complete guide to the food fraud requirements of all the major food safety standards from us, the food fraud experts, here.

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Filed Under: Consultancy, Food Fraud, Learn, Vulnerability Assessments Tagged With: 2.5.4, 2.7.2, 4.20, 5.4.1, 5.4.2, AF16.1, AF16.2, audit, BRC, BRC Issue 9, economically motivated adulteration, food fraud consultant, food safety standard, GFSI, HACCP, SQF Edition 9

14th September 2021 by Karen Constable

How To Do a Vulnerability Assessment for Food Fraud

Updated 30th December 2022

What is a vulnerability assessment?

 

A vulnerability assessment is a risk-assessment-style evaluation of a food’s vulnerability to food fraud.

A food fraud vulnerability assessment is a documented assessment that identifies vulnerabilities to food fraud and explains how those vulnerabilities were identified.

Vulnerability assessments are also done to assess the threat of a malicious attack on food.  Malicious attacks include attacks conducted for extortion, ideological reasons or terrorism. We call these issues of food defense. To learn more about vulnerability assessments for food defense (intentional adulteration), click here.

Why ‘vulnerability’ and not ‘risk’? 

 

  • A risk is something that has occurred before and will occur again. A risk can be quantified using existing data.
  • A vulnerability is a weakness that can be exploited.  A vulnerability can lead to a risk.

Food fraud is difficult to estimate and quantify, so we use the word vulnerability rather than risk.

Why do a vulnerability assessment?

 

  1. To protect consumers: Food that is vulnerable to food fraud presents significant risks to consumers.  Food that is adulterated or diluted   [Read more…]

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Filed Under: Food Fraud, Learn, VACCP, Vulnerability Assessments Tagged With: 2.7.2, 5.4.2, audit, BRC, checklist, economically motivated adulteration, EMA, food fraud, FSSC 22000, FSSC version 5, risk assessment, SQF, SQF Edition 9, template, VACCP

24th July 2021 by foodfraudadvisors

Acronym Decoder

BRC: British Retail Consortium.  A group of British companies that publish guidance and standards for food manufacturers, including a food safety standard that is also commonly referred to as BRC.

CoOL or COOL: Country of Origin Labelling.

EMA: Economically motivated adulteration or substitution. EMA is a subset of food fraud and is defined as the fraudulent, intentional substitution or addition of a substance, or dilution of a substance for the purposes of economic gain.  Non-EMA food fraud includes black market importation and trading of food and alcoholic beverages for the purposes of avoiding duty and taxes.

DEFRA: The Department for Environment, Food and Rural Affairs, a United Kingdom government department responsible for food production and standards as well as environmental and agricultural responsibilities.

FDA:  Food and Drugs Administration.  The FDA is the name of a regulatory body in a number of countries, including USA, Philippines and India.

FSA: Food Standards Agency, a United Kingdom government regulatory body.

FSMA: Sometimes pronounced ‘Fizzmah’.  Stands for Food Safety Modernisation Act (United States of America).

FSSC 22000: A food safety management system standard similar to ISO 22000 but with extra requirements incorporated to meet the requirements of a GFSI standard.

GFSI: Global Food Safety Initiative.  The GFSI is a group of food companies whose mission is to harmonize, strengthen, and improve food safety management systems around the globe.  The GFSI provides direction and approval to organizations that create food safety management systems, so a GFSI-approved food safety standard is one that represents international best practice.  Well known GFSI standards include BRC, FSSC 22000 and SQF.

GMO: Genetically Modified Organism.

HACCP:  HACCP is a set of principles designed to control and prevent food safety risks during food production.  The principles of HACCP are codified (written down) by the Food and Agriculture Organization of the United Nations (FAO).  Download the 2020 revision of the HACCP Code here.

HARCP: Hazard Analysis Risk-based Preventive Control.  HARCP = food safety as legislated by the United States.  This acronymn being used by some in the USA when talking about the requirements of the recently enacted Food Safety Modernisation Act (FSMA) in that country.  HARCP is claimed to differ from HACCP by including requirements for preventive controls.  Read more about HARCP here.

IA: Intentional Adulteration.  Within the US Food Safety Modernisation Act (FSMA), Intentional Adulteration specifically refers to malicious adulteration that is intended to cause widescale harm.  Learn more about intentional adulteration here.

ISO 22000:  ISO is the International Organization for Standardization.  They have thousands of standards across many different businesses, products and systems.  ISO 22000 is the ISO standard for food safety management systems.  Like other major food safety management systems it is based on the principles of HACCP.

NSF:  a pseudo-government organization head-quartered in the United States that is active in the area of food safety and sanitation.

SQF:  Safe Quality Food Institute.  The Safe Quality Food Institute owns and publishes a group of food safety standards also known as SQF that is a GFSI – approved standard.

USP: United States Pharmacopeial Convention.  USP is a non-profit organization that creates identity and purity standards for food ingredients and food chemicals, as well as for medical drugs.

TACCP: Threat Assessment Critical Control Point.  TACCP = prevention of malicious threats to food.

VACCP: Vulnerability Assessment Critical Control Point.  VACCP = food fraud prevention.  Learn more about TACCP and VACCP here.

Learn about Vulnerability Assessments, what they are and how to do them, here.

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Filed Under: Learn Tagged With: acronyms, auditing, BRC, economically motivated adulteration, EMA, FDA, food safety, food safety standard, FSSC, GFSI, HACCP, intentional adulteration, TACCP, VACCP

31st January 2021 by foodfraudadvisors

Preventing food fraud: testing is not the answer

Fraudulently adulterated food is receiving a lot of attention at the moment. While it is widely acknowledged that food fraud is a large and expensive problem requiring urgent action there is not a lot of practical advice available about exactly what actions food businesses should take to prevent, deter and detect food fraud. And, although published advice about direct action is rare, there is plenty of commentary that discusses the issue in general terms, including one very common refrain: food testing is not the answer.

Food safety hang-ups

One of the reasons we so often hear that testing is not the answer is that many food fraud commentators come from a food safety and quality assurance background. As such, our unwillingness to rely on testing for food fraud can be explained in part by our familiarity with food safety systems. Within the realms of food safety, testing can achieve nothing on its own; the prevention of risks and control of hazards is much more effective and efficient, with testing used simply to verify that the system is working.

For those who are less familiar with food safety systems, let’s take a closer look. For the sake of simplicity, imagine a hypothetical food safety system that is designed solely to prevent the growth of a pathogenic microorganism in salami. If the system relied solely on testing, one would have to take a sample from every pack of salami, test for pathogens and then discard packs which were found to be contaminated. A missed test could have deadly consequences. Worse still, the sampling itself could lead to contamination. A better way is to use preventive control methods to stop hazards before they arise and carefully monitor critical operations in the production process so that the finished product is safe. This combination of prevention and monitoring is the basis for every modern food safety system. Within those systems the food must still be tested to verify that the system is working but in fact every piece of salami that is consumed without causing illness is a form of ongoing verification.

Dairy Processing

Fraudulently adulterated food is very different from accidentally contaminated food. It usually doesn’t make people sick and can rarely be identified as fraudulent by the consumer. People who adulterate food for financial gain aim to avoid detection and for that reason adulterated food rarely causes acute illness. In fact, the Chinese government is currently assuring its citizens that the large volumes of counterfeit baby formula within that market are safe to consume. There have been instances of fraudulent food that caused illness and death, including the melamine milk scandal in China and toxic mineral oil passed off as olive oil in Spain. In another famous case, a carcinogenic industrial dye was used to make paprika powder appear fresher. In each of these cases it was some time before the link between illness and adulterated food was found.

Criminals are smarter than Salmonella.

The prevention of microbial contamination and growth in food can be achieved in a few simple steps using well-understood methods; Salmonella hasn’t figured out how to outsmart a thermal kill step yet. But people who seek to make money from adulterating food have much more imagination than your average bacterium. While there are only about 120 food borne pathogens known to man, there are almost unlimited ways to tamper with food, meaning many different types of controls are required. Unfortunately, any effective control method can be discovered and then outsmarted by a clever fraudster, making reliance on prevention a risky proposition. And the worst part is that no matter how effective a fraud prevention system is, at the end of the day it is indistinguishable from an ineffective fraud prevention system to the naked eye; without very frequent testing there is no way to know the system is working.

More testing?

Testing is a key element of effective fraud prevention. I envisage a day when every food manufacturer tests vulnerable raw materials before they are used in production, where every supermarket has the technology to verify that their food is authentic before they place it on their shelves and where even local restaurants will have access to cheap and fast authenticity testing. Testing holds the answers to many of our current food fraud challenges.  However, testing can be expensive, time consuming and much less effective than we would like.

Pesticide residue in food

A key challenge to the efficacy of testing is that when it comes to food fraud we can never be sure of the adulterant that might be present. Many currently available test methods are targeted for a particular adulterant, and are not designed to detect adulterants that are unexpected. Non-targetted tests are rapidly being developed but there are still relatively few that have been properly validated, a process that requires expensive cross-testing against other methods such as botanical testing, DNA-based methods and classical chemistry.

In less than five years, claim the makers of new rapid testing technology, we will be able to hold a scanner in our hand that can tell us the entire molecular makeup of our food. I think we will have to wait a little longer than that; food is complex and a huge amount of research will be required before we can properly interpret the results of complex molecular ‘scans’ of every food on the planet. But testing is an important tool in our fight to ensure an authentic food supply, and that’s a goal worth striving for.

Read about the latest food fraud analytical technologies here.

Are you ready to start testing for food fraud? Use our testing checklist to find out.

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Filed Under: Food Fraud, VACCP Tagged With: authentic food, authenticity, detection, economically motivated adulteration, EMA, food fraud, food safety

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