Tag Archives: undeclared allergens

Guangtao Zhang, Ph.D., director of the Mars Global Food Safety Center

Complexity of Food Allergen Management Requires Global Collaboration

By Maria Fontanazza
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Guangtao Zhang, Ph.D., director of the Mars Global Food Safety Center

Undeclared allergens continue to be a big cause of food recalls. For allergen management practices to be effective within food companies, there must be a shared responsibility between food manufacturers, government agencies, regulators and consumers, says Guangtao Zhang, Ph.D., director of the Mars Global Food Safety Center. In a Q&A with Food Safety Tech, Zhang discussed key concerns related to undeclared allergens in food as well as the research that Mars is conducting to improve allergen management.

Food Safety Tech: The presence of undeclared allergens continues to be a hazard in the food safety space. Specific to peanut detection, what challenges is the industry facing?

Guangtao Zhang, Ph.D., director of the Mars Global Food Safety Center
Guangtao Zhang, Ph.D., director of the Mars Global Food Safety Center. All images courtesy of Mars.

Guangtao Zhang, Ph.D.: As food materials become more varied and complicated, food allergen management becomes increasingly complex. Robust, accurate and sensitive detection methods are essential to ensure consumer safety as well as compliance with regulatory standards for allergens in the food supply chain.

When you look at the regulatory aspects, detection methods go hand in hand. Firstly, there is a need to ensure that current standard detection methods used in regulatory control of consumer goods are validated for a range of complex food matrices to ensure neither over- nor under-estimation of allergen content occurs within a food supply chain. This is important because underestimation of allergen poses a significant food safety hazard to consumers, while overestimation of allergen can result in unnecessary product recalls, driving up product costs and food waste.

Secondly, validation and monitoring of the effectiveness of cleaning and handling practices in areas of potential cross contamination with allergen containing materials depend on reliable and robust quantitative food allergen test methods for their success. The more robust the testing protocols, the more we can improve our understanding of the risks associated with cross contamination of food allergens, potentially reducing the frequency of accidental contamination events.
It is also important to note that whilst the most common cause of undeclared allergen in the global food supply chain is through accidental contamination in raw materials or finished products, this is not the only method by which undeclared allergen may be found in a product.

For example, peanut flour may be used in economically motivated adulteration (EMA) food fraud cases. In 2018 the European Commission estimated that the cost of food fraud for the global food industry is approximately €30 billion every year. Due to its high protein content, peanut flour has been used as a bulking agent to raise the overall protein content of e.g., wheat flour, thus raising the ‘quality’, and therefore price, of lower value goods. The ability to effectively quantify peanut traces within complex products therefore has the potential to enable consumers of food products to further trust the safety of the food they eat.

ELISA (Enzyme linked immunosorbent assay) is the method used most frequently for peanut allergen detection in the food manufacturing industry because of its sensitivity and ease of use. However, it has disadvantages in certain settings. It is not currently validated for complex food matrices, as it is believed that the effects of both food matrices and food processing could result in an underestimation of peanut concentrations in thermally processed foods, leading to false negatives, as well as overestimation in complex food matrices, leading to false positives which are a potential food safety hazard to consumers.

Food Safety Tech: Tell us about the research that the Mars Global Food Safety Center is doing to help the industry with effective methods for peanut quantification.

Zhang: At the Mars Global Food Safety Center (GFSC) we believe that everyone has the right to safe food and that we have a responsibility to generate and share insights to help solve for global food safety challenges. We also know we can’t tackle these alone, which is why we collaborate with external partners. One of our focus areas is advancing understanding and knowledge sharing in peanut allergen detection. As part of that work, we are exploring methods of improving food safety via the development of advanced analytical methods to detect peanut allergen content, in the hopes that it will enable the food industry to expand on current preventative management protocols, including early detection methodologies, for faster response to future food allergen contamination events.

As part of our latest published research, we investigated the accuracy and sensitivity of ELISA-based test methods on raw and cooked wheat flour, wheat flour-salt and wheat flour-salt-oil matrices, which are common ingredients in the food industry. 10 ppm peanut was doped into each matrix during sample preparation. Recovery testing demonstrated that in all matrices the current industry standard ELISA method overestimated results with recoveries ranging from 49.6 to 68.6 ppm.
These findings prompted the development of a new confirmatory method based on liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) for peanut quantification. When subjected to the same validation testing programme the HPLC-MS/MS technique was demonstrably more accurate and sensitive, with a limit of quantification of 0.3 ppm and the detected peanut concentration ranging from 6.8 to 12.8 ppm for samples doped with 10 ppm peanut.

This work is a first step in the development of a new standard method for peanut detection in complex food matrices and could ultimately inform safer manufacturing Quality & Food Safety (Q&FS) processes across global supply chains to help ensure safe food for all.

Mars GFSC Lab Food Integrity Team
The Lab Food Integrity Team at the Mars Global Food Safety Center.

Food Safety Tech: What projects are researchers at the Center working on to enhance allergen management as a whole?

Zhang: A successful allergen management program depends on rigorous control of allergenic foods and ingredients from all other products and ingredients at every step of the food production process, from raw material development to the delivery of final products. This means that for allergen management practices to be effective, they must be a shared responsibility between food manufacturers, government agencies, regulators and consumers.

At the Mars GFSC, we take a precompetitive approach to research, knowledge sharing and collaborations—this means we openly share insights and expertise to help ensure safe food for all. This is important in driving forward innovations, helping unlock solutions that may not have previously been possible.

We have shared our latest work both through an open access publication in Food Additives & Contaminants: Part A but also directly with regulatory bodies such as the FDA in the hopes of advancing knowledge in both food safety risk management and allergen management in complex flour-based media within global supply chains. In addition to this, this research contributes to a wider Food Safety Best Practice whitepaper focused on food allergen risk management currently under draft by the Mars GFSC, which will be published in collaboration with Walmart Food Safety Collaboration Center and the Chinese Institute of Food Science and Technology (CIFST) later this year.

We believe that global collaborations such as this are essential to improving food allergen management and mitigating food safety risks. Communication, training and knowledge sharing are core principles of the Mars GFSC and as such form a large part of our ongoing activities in this space. For example, we have hosted Food Allergen Management workshops in collaboration with Danone and Romer Labs focused on helping to raise awareness of current and future food allergen trends. At one such event in 2019, 100 participants from 16 food companies came together to promote food allergen management in the industry and ensure that the next generation of food integrity testing capability is relevant, practical, and directly applicable to the real-world problems experienced by manufacturers and processors throughout the supply chain.

Representatives of the Mars GFSC have also shared our insights externally at a number of international conferences as well as during a Food Enterprise Food Allergen Management Seminar on topics including effective allergen management procedures, our guiding principles for allergen managements at Mars, and shared our approach to encourage and share knowledge with other manufactures in this area.

We continue to support requests for technical insights, for example providing insights during a global consultation session on General Principles for Labeling of Prepackaged Food. This resulted in the addition of characterization requirements for possible allergenic substances, promoting the use of a recognizable naming system in ingredient lists that contain allergen warnings.

Food Safety Tech: Can you comment on additional work your team is doing in the area of food fraud?

Zhang: Food allergen risk management forms only one part of our wider food integrity focus at the Mars GFSC. We are committed to helping ensure food authenticity in an increasingly complex, global food supply chain through collaboration with global partners to develop new and improved tools and analytical methods that help protect the integrity of raw materials and finished products.

We have collaborated with researchers at Michigan State University to develop a Food Fraud Prevention Cycle roadmap (Introducing the Food Fraud Prevention Cycle (FFPC): A dynamic information management and strategic roadmap) which answered questions such as how to detect food fraud, how to start a food fraud prevention program, what to do in terms of testing, how much testing is enough, and how to measure success. Our intention in publishing this research was that the adoption of a holistic and all-encompassing information management cycle will enable a globally harmonized approach and the continued sharing of best practices across industry partners.

More recently, we completed an international collaboration tackling rice adulteration together with Queen’s University Belfast (QUB), Agilent Technologies, International Atomic Energy Agency (IAEA), China National Center for Food Safety Risk Assessment (CFSA), and Zhejiang Yangtze Delta Institute of Tsinghua University (Yangtze Delta). This work successfully developed a two-tier testing program, capable of rapidly screening the geographical origins of rice within the global supply chain (Food Fingerprinting: Using a two-tiered approach to monitor and mitigate food fraud in rice). By developing a tiered system, we could ensure that manufacturers use the right techniques for the right occasion, to maximize the information available in investigating food fraud at the best value. As part of this work, we have helped develop hands-on training in Ghana and inform best practice guidance to help build the foundations of a strong food safety culture in rice authenticity across the global supply chain.

Recall

Q3 Food Recalls Drop More than 10%, 2021 Could See Lowest Recall Levels in a Decade

By Maria Fontanazza
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Recall

FDA food recalls fell more than 11% and USDA recalls increased by just one recall in Q3. If this decreased activity continues, 2021 food recalls could fall to their lowest levels in more than a decade.

The drop in recalls is good news, but food companies remain challenged in maintaining and implementing effective employee training. “Health and safety risks related to the coronavirus, combined with labor shortages, mean that companies must double down on training, communication, and accountability, particularly in cases where employees have never worked in food manufacturing,” according to Sedgwick’s Q3 update on U.S. recalls. “All the right protocols and procedures can be in place, but without a skilled workforce and commitment to continuous improvement, no number of written policies and procedures will prove effective. Companies and their quality and safety teams must be ready, willing, and able to embrace new technologies and evolve with new regulatory guidance as the industry innovates.”

FDA Recalls: Notable Numbers (Q3 2021)

  • Recall activity dropped from 106 recalls in Q2 to 94 recalls (11.3% decline)
  • Prepared foods and produce were top categories for recalls, with 13 events each
  • Recalls affected 2.4 million units, a nearly 70% drop from Q2 (7.9 million units)
  • 33% of recalls were Class I
  • Undeclared allergens was leading cause of recall, with milk being the main cause
  • Bacterial contamination came in second for amount of recalls at 25, followed by quality concerns at 11 recalls

USDA Recalls: Notable Numbers (Q3 2021)

  • Recalls increased from 12 to 13 events (quarter-over-quarter)
  • Number of pounds increased from 207,000 pounds to 10.7 million pounds (due to a single recall of ready-to-eat poultry products that affected almost 9 million pounds)
  • Bacterial contamination was the top cause of recalls—Listeria, Salmonella, and E.coli were the named pathogens of concern
  • Eight recalls were due to undeclared allergens
  • Poultry products the most impacted product category

In November alone, there were nine recalls as a result of foreign matter contamination. Learn more about the strategies companies should implement to prevent and detect foreign materials during Food Safety Tech’s upcoming virtual event, “Food Safety Hazards: Physical Hazards”. | Thursday, December 16 at 12 pm ET.

Recall

Q2 Food Recalls Increase 20%, Undeclared Allergens and Quality Top Cause

By Food Safety Tech Staff
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Recall

For the 23rd quarter in a row, undeclared allergens were the top cause of food recalls and accounted for 45% of them in Q3 2021, according to Sedgwick’s latest Recall Index report. Within allergens, undeclared milk was the leading cause and prepared foods remained the leading category.

“Companies need to concentrate on the basics through the second half of 2021 and final emergence from the COVID-19 pandemic,” the report states. “Amid supply chain pressures, high consumer demand and worker health and safety concerns arising from the coronavirus, food businesses are rightfully focused on their ability to maintain and conduct their core operations in safe manner while delivering quality, safe products to customers.”

FDA Recalls: Notable Numbers (Q2 2021)

  • 106 recalls affecting 7.9 million units
  • 5.8 million units (nearly 69%) impacted by recalls were due to one nut recall
  • 19 recalls were a result of quality issues
  • 18 recalls were a result of foreign material contamination
  • 11 recalls were a result of bacterial contamination—6 from Listeria; 4 Salmonella; and 1 E. coli

USDA Recalls: Notable Numbers (Q2 2021)

  • Recalls increased from 10 (Q1) to 12, but numbers still low compared to 2019 quarterly averages
  • Units impacted dramatically dropped nearly 83% to 207,322 units
  • Undeclared allergens were top cause of recalls, accounting for nearly 42%
    • Soy milk and eggs were main allergens, but first recall of food products due to sesame also occurred
  • Other recall reasons were quality (2), lack of inspection (2), bacterial contamination (2) and foreign material contamination (1)
  • Beef products (93,551 pounds) most impacted category, followed by fish (46,804 pounds)

The report also pointed out that heavy metal regulation will have increased emphasis, as FDA has made it a priority as a result of a report released by Congress earlier this year indicating the presence of dangerous toxic heavy metals found in baby foods.

Recall

Q3 Food and Beverage FDA Recalls Up 34% Over Q2, USDA Recalls at Record Low

By Food Safety Tech Staff
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Recall

It is being speculated that the short-term decline in the number of food and beverage recalls this year is due to less regulatory oversight as a result of the COVID-19 pandemic. During Q3, FDA food recall activity was up 34% compared to last quarter, but this increase is actually a sign of things returning to normal on the side of regulatory oversight activities, according to the latest Q3 Recall Index from Stericycle.

FDA Food Recalls: Notable Numbers (Q3 2020)

  • Undeclared allergens: 56 recalls, accounting for nearly 53% of all recalls; the top cause of an FDA food recalls for the 13th consecutive quarter
  • Bacterial contamination: Accounting for 62% of recalled units, this was the top cause of recalled units with Salmonella being the most common contaminant (the pathogen was responsible for 17 out of 24 recalls)
  • Foreign materials, quality and mislabeling were the other reasons for recalls

USDA Recalls: Notable Numbers (Q3 2020)

  • Undeclared allergens: Top cause of recalls; 6 recalls accounted of nearly 70% of all recalled pounds
    • A single meat and poultry recall affected more than 242,000 pounds (63%) of all recalled pounds
  • The average recall affected 38,000 pounds
  • Over the last three quarters, recalls have been at record low levels
    • Quarterly recall activity is averaging 8.3 recalls a quarter versus an average quarterly volume of more than 30 recalls over the last five years
Recall

Undeclared Allergens, Bacterial Contamination Top Q1 2020 Recalls

By Food Safety Tech Staff
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Recall

The COVID-19 crisis has led to supply chain management challenges for food manufacturers and processors, ingredient suppliers and vendors, and regulators. In its Q1 2020 Recall Index, experts from Stericycle advise that companies use this time to take a closer look at their supply chain processes and reevaluate their recall plan.

Watch two complimentary on-demand webinars: COVID-19 in the Food Industry: Enterprise Risk Management and the Supply Chain |
COVID-19 in the Food Industry: Mitigating and Preparing for Supply Chain Disruptions
“Companies in the food industry have their work cut out for them during this outbreak and for months after,” the report states. “But the key is to focus intensely on the basics. It’s too easy to assume food safety protocols and quality controls are followed as strictly and uniformly as they always are. Use this time wisely to recheck your supply chain, review your food-safety processes and update your recall plan.”

FDA Recalls: Notable Numbers (Q1 2020)

  • 141 recalls affecting more than 8.8 units
  • Undeclared allergens: 39.7% of recalls. The top cause of recalls for the 11th consecutive quarter
  • Bacterial contamination: 58.1% of recalls by number of impacted units
  • Nearly 20% of fresh and processed food recalls impacted products distributed nationwide

USDA Recalls: Notable Numbers (Q1 2020)

  • 6 recalls impacting 22,500 pounds of product
    • More than half of recalled pounds were a result of lack of inspection
  • Recalls dropped nearly 79%
  • Undeclared allergens: 4 recalls
Production line, NiceLabel

Farm-to-Fork Transparency: How Digitized Labeling Can Prevent a Major Allergen Recall

By Lee Patty
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Production line, NiceLabel

For consumers and brands alike, the damaging impact of mislabeling or neglecting to clearly outline an allergen can be colossal. Therefore, to prevent a health and business disaster, best practices around allergen labeling must be top of mind. Luckily, technology can help, and the farm-to-fork transparency provided by a centralized and digitized modern label management system can ensure organizations improve responsiveness and accuracy while reducing costs beyond those saved by mitigating recalls.

No one wants to face a recall, but have you done enough to prevent one from happening to you? More than 650 food products were recalled last year in the United States alone. And one of the leading causes might just be the easiest to prevent: Undeclared allergens.

According to the Q2 2019 Stericycle Recall Index, undeclared allergens are the leading cause of U.S. food recalls, accounting for 48.4% of food recalls from the FDA and 62.9% of food pounds recalled by the USDA. This statistic becomes more alarming considering that roughly 11% of US adults have a food allergy, according to JAMA.

Enacted in 2004, the Food Allergen Labeling and Consumer Protection Act (FALCPA) stipulates that all packaged food regulated under the Federal Food Drug and Cosmetic Act (FFD&C) comply by listing major food allergens. “Major allergens” refers to milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans, and for nuts and shellfish, the species must be declared.

For brands, the damaging impact of mislabeling or neglecting to clearly outline an allergen can be colossal, resulting in costly recalls or litigation. However, the impact to consumers can be even greater when one small mistake can cause serious illness, or worse, death. To prevent a health and business nightmare, best practices around allergen labeling must be top of mind.

However, with constantly changing legislation, this can be easier said than done. For instance, in a move that outpaced the FDA, Illinois issued a state law requiring sesame labeling. And in the UK, Natasha’s Law was recently introduced, requiring companies to label all food ingredients on fresh pre-packaged food after 15-year-old Natasha Ednan-Laperouse died of a sesame allergy from a sandwich that didn’t list all the ingredients.

The need for optimal allergen labeling is clear, so how can organizations ensure allergens are clearly labeled on their products and meet existing standards while preparing for future requirements?

Though the underlying principle behind a clear label is simple, the process of designing such labels can be multifaceted and difficult to streamline—especially if labels are designed, printed and managed by separate users across a franchise or store network. And this challenge is multiplied further when products reach across international boundaries. But technology can help, and the farm-to-fork transparency provided by a centralized and digitized modern label management system can ensure organizations improve responsiveness and accuracy while reducing costs beyond those saved by mitigating recalls.

Disorganized Sprawl: A Major Hurdle to Effective Labeling

When implemented properly, modern label management can cost-effectively centralize labeling, reducing inefficiencies and human error. However, before this can happen, there are a few common roadblocks that may make standardizing the labeling process challenging.

One issue may be a sprawl of legacy equipment that is not integrated into a cohesive network. For instance, a legacy labeling system may only support certain label printers while certain manufacturers of direct marking equipment may only support their own propriety brand of printers. In another sense, a lack of standardization can also make it difficult to efficiently integrate labeling with other business solutions like manufacturing execution systems (MES) and enterprise resource planning (ERP) systems.

A damaging impact of sprawl is adoption of a wide range of different labeling applications across various facilities. This will result in inconsistent label formatting, the need to create the same label multiple times, and the need to accommodate different systems and printers. Consequences of this may be a lack of centralized storage when everything is saved locally, complex user training encompassing many software programs, an increased burden on IT, and a great deal of extra administration and human intervention to maintain and update labels.

Another problem with a disorganized ecosystem for labeling is that quality assurance inevitably suffers because tracing a label’s history or implementing standardized approval processes can be difficult or impossible. To accurately track labeling, it’s necessary to have a production log stating where and when labels were produced and who produced them. Having such a log and using it effectively requires centralization or else it can become difficult to track different versions or enforce universal approval processes for altering templates.

Implementing Modernized Labeling to Improve QA

Modern label management systems can help suppliers and manufacturers standardize and control marking packaging or label production across an entire organizational ecosystem. These solutions feature a central, web-based document management system and provide a reliable storage space for label templates and label history. This will enable changes and updates to be tracked centrally, so local facilities can access uniform and accurate templates to produce labels.

An ideal label management system can also interface with a multitude of direct marking and labeling printers, even if they are from different manufacturers, and it can integrate labeling and direct marking with a business system’s master data, which eliminates manual data entry errors. This decreases upfront capital expenditures in more costly efforts to standardize equipment, provides a system that is easy to integrate with partners, saves costs generated from having to discard product or rework labels, and increases a company’s ability to implement unified, organization-wide labeling processes.

Centralized Labeling is Easily Delivered Through Cloud

To many, the thought of migrating legacy labeling to a centralized system or investing a large sum of resources into centralizing labeling may seem inordinate or daunting. However, cloud technology makes migrating to a modern label management system feasible for organizations of all sizes.

With the cloud, designing labels and ensuring quality assurance becomes far more accessible. Additionally, the software-as-a-service (SaaS) model doesn’t require the capital investments or operations and maintenance upkeep associated with costly IT infrastructure and is easily scalable depending on business needs. This is a game changer for small to medium sized businesses who can now benefit from a centralized labeling system because of the cloud.

The Benefits of a “Single-source-of-truth”

In addition to other benefits, integrating a modern label management solution with other business systems allows users to access a “single-source-of-truth.” This allows for enforceable, specific user roles with logins for each user as well as traceability and transparency across all factories that produce products. The traceability from being able to monitor a “single-source-of-truth” is a critical component to farm-to-fork transparency because it can provide an accurate production log overviewing label versions and changes, so companies can pinpoint the locations and causes of labeling inaccuracies and fix them instantly.

A modern label management system also enables organizations to nimbly respond to new regulatory requirements because alterations only need to be made in one location, new templates can be previewed before going to production, and nutrition and allergen functionality can be easily formatted so that it is clear and stands out to the consumer. This increases labeling consistency and accuracy, and saves time when rules change and when new products need to be incorporated during a merger or acquisition.

Futureproofing and Ensuring Consumer Safety with Allergen Labeling

In today’s world, food and beverage manufacturers must rise to the challenge of changing regulations while meeting the call of shifting customer demands and integrating themselves within greater business ecosystems and extended supply chains. In the case of allergen labeling, this may mean preparing labels for different countries, which have varying standards for labeling allergens like sesame, royal jelly, bee pollen, buckwheat and latex, or ensuring labels can be altered quickly when new products are rolled out or when bodies like the FDA revamp standards.

Companies that implement modern label management solutions position themselves to adapt to competition and regulations quickly, implement solutions that can easily be integrated with partners in a supply chain, and streamline quality control. This can help improve productivity, reduce labeling errors, increase collaboration, and prevent product recalls. But most importantly, it helps ensure the safety of consumers everywhere.

Recall

Undeclared Allergens Top Cause of FDA and USDA Food Recalls

By Food Safety Tech Staff
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Recall

Stericycle released its Q3 2019 Recall Index last month. The following are the key takeaways:

FDA Food Recalls

  • Recalled food units increased 319.5% to 8.8 million
  • 21.5% had nationwide distribution
  • Top food categories
  • Prepared foods: 24
    • Produce: 19
    • Flavoring: 14
    • Seafood: 12
  • Undeclared allergens were the top cause at 35.5%
  • Foreign material were top cause of units impacted at 47%

USDA Recalls

  • Decreased 25% to 24
  • Affected 537,000 pounds
  • Top Categories
    • Poultry: 33%
    • Beef: 21%
    • Pork: 12.5%
    • Seafood: 4.2%
  • However, this category came out on top for recalls by pound, at 22.6% of recalled pounds
  • Top Reasons
    • Undeclared allergen: 37.5%
    • Bacterial contamination: 21%
    • Foreign material: 17%
Recall

FDA Food Recalls Up Nearly 93% Since 2012

By Food Safety Tech Staff
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Recall

Over the past five years, the food and beverage industry has seen a big increase in the units recalled—a 92.7% spike in FDA recalls and an 83.4% increase in recalled pounds by USDA since 2012, according to Stericycle’s quarterly recall index. The firm cites technological advances in food testing, factory farming and more automation in food production as the main contributors to the high numbers.

During Q4 2017, bacterial contamination and undeclared allergens led the pack in food recall causes. According to Stericycle, back in 2012, about 28% of FDA food recalls were a result of bacterial contamination, while undeclared allergens accounted for 35% of pounds of food recalled by USDA. During Q4 2017, 44% of food recalls (based on units) were from bacterial contamination, followed by undeclared allergens (31%), mislabeling (13%), and quality (10%). Among the top categories for recalls were prepared foods (20%, nuts and seeds (16%), produce (15%) and baked goods (12%). In addition, nearly 50% of the USDA recalled pounds were a result of lack of inspection.