Tag Archives: labeling

magnifying glass

Avoiding Total Recalls: Regulatory Labeling for the Food and Beverage Industry

By Josh Roffman
No Comments
magnifying glass

In recent memory, no time has more effectively demonstrated the challenges facing the food and beverage industry than spring 2018. In addition to a widely publicized recall of romaine lettuce, several other companies have instituted noteworthy product recalls. For example:

While demoralizing for food and beverage manufacturers, these recalls may also be an unavoidable part of doing business. Plants are grown outdoors, livestock lives outdoors, and no method of sterilization or disinfection is perfect. This is why regulations exist, such as FSMA or EU 1169, so that when recalls do occur, companies can efficiently find and eliminate their contaminated products, and then find the point in the supply chain where the contaminants were introduced.

Despite their necessity, food labeling and packaging regulations represent a huge challenge for food and beverage (F&B) manufacturers—and these challenges don’t exist in a vacuum. The labeling and packaging process is already a huge challenge, which includes customer requirements such as branding, cultural and linguistic localization, 2-D barcodes, and more. How can F&B companies enmesh their regulatory requirements with these existing challenges without adding to the complexity and expense of the entire undertaking?

Challenges of the Regulatory Environment

Since 2011, FSMA has been changing the way that F&B manufacturers produce, package, ship and sell food. In a departure with previous tradition, government inspectors no longer form the first line of defense against contaminated or mislabeled food. Rather, food producers and manufacturers themselves must bear the responsibility to implement procedures that prevent foodborne illness.

In short, FSMA will force F&B manufacturers to implement full transparency and traceability within their supply chains. Artwork and product labeling must be used to support these endeavors—ideally, one would be able to scan the barcode on a food package to instantly determine its origin as well as the chain of distributors that it passed through in order to reach your hands. Right now, the industry standard is well below this benchmark.

Right now, a seven-day timeline is the best-case scenario for traceability throughout the F&B supply chain. Although the endpoints of the supply chain—grocery stores and restaurants—may use modern digital records, you’ll find growers and transportation companies still using Excel and paper records.

In the meantime, a new European Union regulation known as EU 1169 went into effect in December 2016. It made a number of changes to food labeling laws, creating a uniform standard for nutritional facts information. Manufacturers must meet minimum standards for legibility, attain a minimum font size, and notify consumers about potential allergens.

Purely by coincidence, a new FDA food labeling law has also recently gone into effect. Announced in May 2016, this rule will update serving sizes found on most food packaging, alert consumers to added sugars, and more. Although these rules were originally slated to take effect in 2018, they’ve been delayed to 2020 for companies with more than $10 million in revenue, and delayed to 2021 for smaller F&B manufacturers.

To encapsulate, F&B manufacturers must now adjust to the following factors:

  • The FDA is becoming much more serious about preventing foodborne illnesses
  • To this extent, it’s begun to demand instant traceability from F&B manufacturers
  • In addition, the EU will force manufacturers to update their nutritional labeling
  • Manufacturers must update their nutritional labels in the United States as well—but differently

Barcodes and labeling already pose a complicated challenge for manufacturers, causing product recalls and packaging write-offs. Putting additional regulation on top of that solves problems in one sense, by making recalls less likely, but also creates problems in another sense—by putting pressure on artwork and labeling departments that are already overworked. After all, regulations alone aren’t the only sources of change and challenge when it comes to labeling and packaging.

Other Stressors on Labeling and Packaging within F&B Manufacturers

Changing consumer tastes, changing marketing methods, and changing technologies all play their role in adding stress to the job of labeling and packaging within the F&B manufacturing industry.

  • New Branding Needs. Packaging drives 36% of purchase decisions, which means that new and eye-catching label designs are always a must. Good design is subjective, however, and tastes change. For example, most Americans are now driven towards brands that are driven towards social and environmental causes. In other words, many F&B manufacturers may soon reorient their product artwork design to reflect this new concern.
  • International Expansion. If EU 1169 is a concern for you, it probably means that you’re selling into countries where English isn’t the only language. It’s easy to make missteps in this realm. For example, it’s possible to accidentally approve poorly translated copy, or to approve copy that’s in the wrong language entirely.
  • New Technologies. In addition to the UPC, many brands are now incorporating 2-D barcodes (such as QR codes), which provide product information when scanned by a smartphone. Although these codes are supposed to provide more information to consumers, only 34% of consumers actually scanned them as of 2014. The challenge for the labeling department is to make these codes more useful and user-friendly.

These new techniques, regions and branding requirements pose challenges. Think about the possibility of approving the right logo for the wrong country, approving out-of-date artwork, or substituting an FDA-compliant label for one that should comply with EU-1199. These things will happen, and they will necessarily lead to recalls. Here’s the question: How do you structure your artwork and labeling departments to minimize these risks?

Minimize Risks with Standardized, Centralized Labeling and Artwork Management

The secret to producing compliant labeling with up-to-date branding and correct localization is to create a system that gives you as little choice as possible. In other words, you should not find yourself wandering through a nest of file folders wondering which asset is the most up-to-date or find yourself developing separate label templates for each separate region you sell into.

Instead, your labeling and packaging artwork should be able to integrate with other business applications and content libraries to ensure your accessing the correct, most up-to-date approved content and assets. In an ideal world, if you start creating a label and select “Spain” as your target market, your labeling solution would immediately retrieve the relevant content for that target market. With the right kind of integrated, dynamic, data-driven solution you can be confident that you’ll only be dealing with complete with approved Spanish-language content for your packaging and your labeling. You would have peace of mind that your solution would generate an EU 1199-compliant nutrition label template, auto-populated with the appropriate nutrition facts. Additionally, if this label is intended for food sold only by a particular supermarket chain, you would feel confident that your solution would retrieve all of the correct content, images and barcodes required for that brand.

Improve Traceability by Replacing Sources of Confusion with Sources of Truth

To ensure accuracy and consistency, your labeling solution should integrate with your “sources of truth,” namely your ERP systems, but also potentially including your manufacturing execution systems, warehouse management systems, and more. You should be able to leverage existing business processes and vital data sources to drive labeling—to avoid replication of data and potential error, and instead automate and streamline your processes.

Recalls may be a fact of life, but using the right labeling and packaging solution will let you narrow their scope—and trace contamination to its source within a much faster window. The fastest solve for this problem involves creating a true “closed loop” for artwork and labeling—a comprehensive, integrated and automated solution to provide accurate and consistent labeling.

Katy Jones, Foodlogiq
FST Soapbox

3 Ways to Make Transparency a Successful Business Strategy

By Katy Jones
1 Comment
Katy Jones, Foodlogiq

Transparency. It’s been top of mind for years. But because of the shift in public’s interest in healthy ingredients and where they come from, businesses are responding by making transparency part of their strategic business initiatives. This includes providing a complete list of ingredients, known allergens and their nutritional information. They also want to know where and how products are sourced and handled. If this information isn’t available, it creates an air of distrust with today’s savvy consumers.

FoodLogiQ, FoodSafety Tech
EXCLUSIVE VIDEO: Food Safety Tech recently spoke with Katy Jones about consumer preferences and their expectations during a product recall. Watch the video

This information is becoming increasingly mandatory, not just because of FSMA and other regulations but because customers are demanding it. With globalization and increased imports from foreign suppliers, regulations as well as consumer expectations for food quality and safety has dramatically risen in the past few years. It is now one of the most critical ways you can earn consumer trust and loyalty. Here are three ways to incorporate transparency into your business plan.

1. Supplier Engagement Makes Good Business Sense

To offer transparency to customers, you must engage with your suppliers. You can’t offer your consumers the transparency they are demanding if you are not getting the information from your suppliers. Plus, it is critical to know who your suppliers’ suppliers are to mitigate risk.

Leveraging a supplier management technology solution will save you time by automating processes such as supplier onboarding and will help you keep track of documents, certificates and audits that you require.

It also helps support supplier communications so you can establish an open dialogue, which is critical when problems arise. You can’t expect a supplier to fulfill your requirements around safety and brand promise if you aren’t open about your expectations. It’s a two-way relationship that can make a huge difference in your business.

FoodLogiQ’s recent survey, “A Food Company’s Guide to What Consumers Care About in the Age of Transparency” (click to enlarge)

2. Label Transparency

FoodLogiQ recently published a survey that revealed supply chain transparency by food companies is a critical driver in consumer purchasing decisions and brand loyalty. Fifty-four percent of respondents want as much information as possible on the label, and nearly 40% want country of origin, allergen alerts and GMOs all identified on the label.

In this survey, those who identify as “caring deeply about the quality of food they eat,” are overwhelmingly in favor of more transparent labeling, with 86% of that demographic expecting country of origin, allergen alerts and genetically modified ingredients to be noted, and they ask that “as much information as possible” be included on the label (or menu) itself.

If a brand doesn’t provide this information, consumers will look elsewhere for it. This puts companies in a vulnerable position.

3. Building a Transparent Culture and Backing Marketing Claims

Food safety professionals and the marketing department are now working together to communicate their transparent farm-to-fork story. This cross-departmental collaboration will not only meet business goals but the teamwork strengthens the overall business.

To maintain a positive reputation, it starts with being open and honest, and engaging your customers in an authentic way. And once a brand establishes itself as being transparent, consumers are more open to trying other products from that company. Building a culture of transparency that is focused on safety and quality can be an incredible marketing advantage and give food companies an edge over competitors.

A recall, stock withdrawal or a report of a foodborne illness can wreak havoc on a business. But the worst thing you can do is hide it. If a brand has ever been under fire for false information, low-quality ingredients or a major recall, consumers know. They are more informed about your products through their online research and social media. It is better for consumers to receive this information directly from the brand than through a third-party site.

If a company is faced with a recall, it is important to involve multiple business units that each have a stake in resolving the issues as quickly as possible. Include the marketing department in your food safety plan and preventative controls so if you are faced with a recall, you have a communication plan in place.

How to Meet Transparency Business Goals

For food companies to provide this transparency, protect their brand image and earn their customers’ trust, they need full end-to-end supply chain traceability technology to modernize their processes and access real-time data. Centralizing your data creates a single source of truth to make data-informed decisions and remain compliant, all while empowering consumers to make safer, more informed decisions about the food they eat.

The good news is that food companies making transparency a priority are being rewarded by customer loyalty, as consumers are willing to pay more for those products. The previously mentioned survey revealed that 88% of respondents—from all demographics, Millennials to Boomers—were willing to pay more for healthier foods including those that are GMO-free, have no artificial coloring/flavors and are deemed all natural.

Transparency transcends all categories: From restaurant menus to labels on consumer package goods. So no matter what business you are in, implement these strategies to systematically impact on your bottom line and keep your food chain safe.

Gluten free

FDA Project Finds Gluten-Free Labeled Products Meeting Standards

By Food Safety Tech Staff
No Comments
Gluten free

Accurate labeling of gluten-free products is a big deal for consumers who have celiac disease, as they can suffer potentially serious health issues when they eat gluten. FDA set standards for the labeling of gluten-free products in August 2013 (with a compliance date of August 5, 2014) and recently announced results of a sampling assignment that was conducted to assess compliance with the final rule.

Of the 702 samples taken from 250 products labeled as “gluten-free”, FDA found that more than 99.5% of the samples to be in compliance with the agency’s requirement.

“Of the total number tested, five samples from one product source contained gluten in excess of the regulatory limit of 20 parts per million (ppm), for a product-based rate of compliance with that requirement greater than 99.5 percent. A voluntary recall was conducted to address concerns related to the violative samples. In addition to carrying out the recall, the manufacturer conducted an extensive root cause analysis and immediately implemented additional corrective actions to prevent recurrence.” ­ – FDA

The analytical results are available on FDA’s website.

Dagan Xavier, Label Insight

Food Transparency Movement Driving Changes in Labeling

By Maria Fontanazza
No Comments
Dagan Xavier, Label Insight

Recently the Grocery Manufacturers Association (GMA) and the Food Marketing Institute (FMI) announced an initiative to reduce the amount of confusion that consumers experience regarding the “sell by”, “use by” and other date-specific labeling on food packaging. It is also part of an effort to reduce food waste.

The new initiative is completely voluntary, but GMA and FMI are hoping that retailers and manufacturers adopt the standard by the summer of 2018. It streamlines the labeling terminology to two simple phrases:

  • BEST If Used By”. Describes product quality, indicating the date by which the product may not taste or perform as expected but it is still safe to consume
  • USE By”. Applies to highly perishable products and/or products that have a food safety concern over a period of time that warrants a date by which the products should either be consumed or discarded

A variety of factors well beyond “sell by”/”use by” dates contribute to consumer confusion. The following Q&A is a brief discussion with Dagan Xavier, co-founder and vice president, customer intelligence at Label Insight on the impact of incorrectly labeling products (erosion of brand trust) and the challenge food companies face in providing transparent information on their products.

Food Safety Tech: How is the demand for transparency both from consumers and regulators changing the food product labeling landscape?

Dagan Xavier, Label Insight
Dagan Xavier, Label Insight

Dagan Xavier: Transparency sounds easy, but in reality, it is complex. For companies, managing compliance and consumer demands is not cut and dry.

Thankfully, brands and consumers are usually on the same page. But there are times when it’s not the case—and that causes trust issues. For one, brands need to use specific, compliant wording. That wording can sometimes be more complex than a preferred consumer-friendly phrasing. For example, USDA’s proposed labeling of GM-containing products refers to them as “genetically engineered.” Except, consumers are far more familiar with the term “genetically modified.”

Regardless of these nuances, regulations around transparency are in place to help consumers. The regulations set clear definitions about what products or ingredients can or cannot qualify for a labeling claim.

We currently live at a time where there is a general distrust of the food industry from consumers. Having strict regulations in place that add factual meaning behind claims is incredibly important. Meaningful and understandable claims, logos, and certifications are slowly beginning to help build trust back up from consumers.

FST:  What challenges are food companies facing in labeling their products?

Xavier: One of the biggest hurdles companies face in labeling is fitting as much information as possible on the package. Between mandatory components (like allergens, nutrients, ingredients) and desired content (marketing copy and images), something almost always gets left off. What gets left off? It tends to be sourcing facts, “Made in America” logos, and other data that consumers find valuable but rank lower on a brand’s priority list.

In reality, 100% complete product information is nearly impossible to fit within the confined space of most product packaging.

The good news is that according to a recent study by Label Insight, most consumers (88%) say they would be interested in accessing a complete set of product information digitally.

SmartLabel (an initiative by the Grocery Manufacturers Association) is an easy solution. SmartLabels save companies space on their packaging, while still allowing them to communicate all product information with consumers digitally.

Most consumers (79%) say they are very likely or somewhat likely to use SmartLabel technology if it was offered by a brand. 44% say they would trust a brand more if it participated in the GMA SmartLabel initiative.

FST: Related to labeling, what are the complicating factors when a company is producing organic, GMO-free, gluten free, etc.—especially when working with suppliers?

Xavier: Having a trusting relationship and open communication with suppliers is key.

Because regulations around organic and gluten-free are so stringent here in the United States, brands need to rely on their suppliers to have ongoing robust certification audits, inspections, documentation and renewal programs.

We expect regulations around GMO-containing products to follow suit.

For companies with dozens of suppliers, it can get tricky managing the documentation of certifications. This is especially complicated if suppliers are overseas and their audits are not delivered through the same certifying agencies that retailers or importers would like.

Adding logos and certifications to packages can be expensive and add risk to brands if a supplier falls out of compliance. In the end, it is important for both brands and suppliers to have robust documentation and a good communication channel. This ensures that all information on-pack is always the most accurate information for consumers and retailers.

Organic, NonGMO, Natural, Labeling

Achieving Transparency in Organic and Natural Product Claims

By Lori Carlson
No Comments
Organic, NonGMO, Natural, Labeling

Consumer preference for organic and “all natural” foods remains on the rise, according to market trend research and retailer sales.1,2 The Organic Trade Association (OTA) recorded $40 billion in U.S. organic food sales for 2015, stating that sales have nearly doubled since 2008.3 Pair this with $21 billion in sales for Q1 2016 for non-GMO labeled foods and $1.6 billion in 2015 gluten-free sales and, it is hard to ignore this thriving market sector, which seeks to support consumers in their quest for fresh, healthy and transparently-labeled foods.4,5

As a result of these trends, the industry is experiencing a surge in natural food and beverage start-up companies as well as the acquisition of organic and natural product companies by manufacturing giants such as Campbell Soup Co., Danone and General Mills, Inc. But in complex—and especially global—supply chains, achieving transparency comes with hurdles for verifying product claims  such as “all-natural”, non-GMO, antibiotic-free, and other nutrient content or functional claims.

Organic and other natural food manufacturers are under increasing regulatory and consumer scrutiny for tracing claims back to the source for all ingredients. Failing to verify the authenticity or identity preservation (IP) status of materials, maintain chain of custody and ensure the accuracy of labels can have devastating consequences for a manufacturer, including regulatory action and consumer fraud class action law suits.6 It’s not just consumers demanding the “right to know” where food comes from, but manufacturers must also push this sentiment back through their supply chain to drive transparency for ensuring safety, brand protection and verifying product claims.

With the goal of meeting consumer demands for healthy food products, improved transparency in food production and clean labels, how can organic, non-GMO and natural food manufacturers stay ahead of the curve when it comes to ensuring that product claims provide the value consumers seek?

Consider the following tasks for achieving transparency in organic and natural product claims.

Analyze Your Ingredients for Risk

Get to know the pitfalls, which can affect the integrity of product claims. Many of these stem from cross contamination, authenticity or mislabeling issues for sourced materials. To prevent these pitfalls, analyze each ingredient for supply chain risks. Identifying potential risks, which may affect the integrity of claims creating liability for misbranding, is a critical step in achieving transparency.

For example, is there a potential for cross contamination from a non-organic source? This is a common risk where a supplier engages in the co-production of organic and non-organic materials. A lack of segregation and clear product identification during transportation, storage and processing activities can lead to commingling or cross-contamination, which affects material integrity and thus, any downstream product claims. Ensuring suppliers and the manufacturer have clear measures in place for segregation is an important consideration when determining risk.

Or, consider adulteration from a non-authentic material, which can affect the integrity of the claim. Identifying vulnerabilities within the supply chain is necessary to reduce opportunities for perpetrating food fraud. Materials such as organic products and some natural ingredients are at greater risk for fraud where limited availability is an issue and/or the material is a high-value commodity or product. Mislabeling, counterfeit production or economically motivated adulteration, such as the substitution or dilution of ingredients in a sourced material, has a significant impact on downstream product claims.

Unverified packaging and labels are other sources of risk with the potential to affect the integrity of product claims. Ensure your supplier’s labeling practices include controls to verify the correct packaging and labels when producing IP materials or other ingredients with nutrient content or functional claims.

With a clear understanding of material risks, what attributes of an ingredient should be prioritized, tested and/or verified when considering the integrity of finished product claims?

Once material risks are analyzed, establish clear specifications for raw materials, which are agreed upon between the supplier and manufacturer. This serves as the basis for verifying material claims and subsequently, downstream product claims. Where specifications are in place, material verification may be performed through a variety methods including: testing, mass balance, COA review and audits. Verifying materials against agreed upon specifications not only supports due diligence in product claims but also brings manufacturers closer to their suppliers, steering us towards the next task.

Get to Know Your Suppliers

At the heart of food production transparency is the relationship a manufacturer has with its suppliers. Even the simplest of manufactured foods have a handful of ingredients, which are typically sourced through a global supply chain network. Due to the seasonality of produce or supply chain risks such as market fluctuations, business disruptions, natural disasters, or transportation failures; manufacturers can’t rely on a single supplier for the sourcing of a particular ingredient.

This leads to reliance on multiple suppliers, which may be geographically dispersed. Sourcing from multiple suppliers—especially when this occurs for multiple ingredients across multiple products—can create hurdles to relationship building for enhanced transparency due to time and resource constraints for acquiring first-hand knowledge of a supplier’s operation. Thus, proactive supply chain management, which enables a manufacturer to learn about the supplier’s history and operation, is essential for transparency.

This can be accomplished by establishing supplier approval criteria to provide a baseline for getting to know your supplier and establish minimum criteria for sourcing. Building upon this, is the use of approved suppliers to solidify the relationship and develop out a stable supply chain network. And finally, it is best practice to visit the supplier’s site to learn more about operational practices and the people responsible for ensuring material specifications and identity status are consistently achieved.

Apply Supply Chain Management Best Practices

Effective management of suppliers to prevent or reduce risks, which can lead to mislabeling and false claims, relies on the risk assessment conducted for materials and suppliers, applied controls (e.g., segregation) and verification that the supplier’s controls consistently ensure material integrity.

GFSI benchmarked schemes paved the way for enhanced supply chain management and risk mitigation when it comes to sourcing materials to ensure food safety and legal status. Some schemes additionally require controls and verification activities such as the validation of health claims or verification of nutrient content to provide a framework for helping manufacturers develop a system, which ensures product integrity. For food sold in the United States, a GFSI-based system is now reinforced by the  FSMA Preventive Controls rule, which requires supply chain-applied controls to mitigate material risks along with additional controls to ensure that food is not adulterated or misbranded under the U.S. Food, Drug and Cosmetic (FD&C) Act.

It is important to note that while the FSMA Preventive Controls rule regulates most processors and manufacturers, organic raw agricultural commodities (RAC’s), dietary supplements and unprocessed meats are not covered by the rule as they are covered by other U.S. food regulations. Since these products may be included in organic and natural product formulations, manufacturers may want to consider applying a Preventive Controls methodology to their supply chain or pursue certification to a recognized food safety standard such as a GFSI benchmarked scheme where this is not already in place.

Simplify Your Supply Chain

Complex supply chains reduce visibility, add latency into monitoring, and increase opportunities for contamination or fraud.7,8

Simplifying your supply chain can take a variety of forms such as the sourcing of local or domestic materials.

Continue reading the article by clicking on page 2 below.

Senate Deal Requires Nationwide GMO Labeling

By Food Safety Tech Staff
3 Comments

The U.S. Senate Committee on Agriculture, Nutrition, and Forestry has come to an agreement on the first-of-its-kind nationwide mandatory labeling of food products that contain genetically modified organisms (GMOs).  Although the deal requires labeling on far more products than those required under the Vermont GMO labeling law (which goes into effect July 1), the way in which disclosure of genetically engineered ingredients is revealed on food products is not as straightforward as it seems.  Under the bill, disclosure methods of GMOs on labeling includes on the actual packaging; an electronic/digital link that a consumer can scan with a smartphone to retrieve more information online; or a phone number in which a consumer can call to get more information. Thus, companies are not required to include all of the information on the product label.

The Center for Food Safety estimates that 75% of processed foods contain genetically engineered ingredients.The Senate Agriculture Committee praises the bill as a “win for consumers”, but there are industry folks who disagree. “While we are pleased this proposal will finally create a national, mandatory GMO disclosure system, protects organic labels, and will cover more food than Vermont’s groundbreaking GMO labeling law, we are disappointed that the proposal will require many consumers to rely on smart-phones to learn basic information about their food.,” said Gary Hirshberg, chairman of Stonyfield Farm and advocacy group Just Label It in a release.

The National Bioengineered Food Disclosure Standard is available on the Senate Agriculture Committee’s website.

Health Canada Approves GMO Salmon, Sparks More Outcry

By Food Safety Tech Staff
No Comments

Following a “thorough and rigorous” scientific review process, Health Canada announced the approval of GMO salmon, also known as AquAdvantage Salmon, last week. The salmon is developed by Massachusetts-based AquaBounty Technologies, Inc. According to a release from Health Canada, the AquAdvantage Salmon underwent safety and nutrition assessments by both Health Canada for use as food and by the Canadian Food Inspection Agency for use as livestock feed. The assessments found the salmon to be “as safe and nutritious as” traditional salmon.

The approval was met with distain by several groups, including Friends of the Earth, which called the approval “irresponsible and disappointing” in a news release.

“This approval also comes despite the Canadian Department of Fisheries and Oceans draft risk assessment that questions the health and welfare of AquaBounty Technologies Inc.’s genetically modified salmon. The draft risk assessment concluded that AquaBounty’s GMO salmon are not only ‘more susceptible to Aeromonas salmonicida, a type of disease-causing bacteria,’ but exhibit ‘diminished growth rates’ and ‘widely varied performance.’”  –Friends of the Earth news release

More than 60 grocery store chains have committed to keeping GMO salmon off their shelves, including Trader Joe’s, Costco, Whole Foods, Aldi, Target and Safeway.

Traceability: Leveraging Automation to Satisfy FSMA Requirements

By Dr. Christine Paszko
No Comments

In America’s food supply chain, food is sourced globally. Since ingredients often come from multiple countries, inspection and quality control is challenging, as regulations, policies and processes differ in each country. Product management begins with the suppliers, from the fields where the foods are grown, to the pesticides and fertilizers used, to harvesting, washing, shipping, storing, and processing (manufacturers), and finally, to packaging and delivery to consumers.

Figure 1. LIMS will facilitate FSMA by providing complete traceability from farm to table, in addition to accelerating collaboration, communication and providing operational insight.
Figure 1. LIMS will facilitate FSMA by providing complete traceability from farm to table, in addition to accelerating collaboration, communication and providing operational insight. (Click to enlarge)

Figure 1 shows each step of the product management process can introduce contamination due to unsafe practices or other risks. As such, test data and traceability must begin in the field and end when the final product is delivered to the consumer. The Laboratory Information Management System (LIMS) captures all information to ensure that quality data is effectively managed, communicated, and easily and quickly accessible in the event of a contamination issue. The LIMS allows producers to provide authorities with the required sampling and testing documentation to prove compliance.

U.S. consumers expect their food products to be affordable, consistent, safe and unadulterated. Consumers have seen numerous food recalls in the news, and it has shaken their confidence. The CDC estimates that about one in six Americans (or 48 million people) get sick, 128,000 are hospitalized, and approximately 3,000 die of foodborne diseases each year. Global food directives for international food initiatives include CODEX, ISO (International Standards Organization), and the Global Food Safety Initiative (GFSI).

The U.S. Government has implemented various food safety programs, from Hazard Analysis & Critical Control Points (HACCP) to FSMA in order to identify and correct potential contamination in the food supply. In fact, one of the primary focuses of FSMA is preventive action based on risk assessment.

The food landscape has changed significantly, especially over the past decade, as consumers demand year-round fresh fruits, vegetables and juices, along with more exotic foods. The fact that U.S. food is globally sourced has resulted in numerous challenges in quality assurance, shipping, traceability, labeling, storage, blending, testing, and reporting.

Use LIMS to track and manage information in a relational SQL Server LIMS database
Use LIMS to track and manage information in a relational SQL Server LIMS database. (Click to enlarge)

For example, upon reading the labeling on an apple juice can, it is not uncommon to learn the juice has been possibly sourced from numerous countries including the United States, China, Brazil, Argentina, Chile and many other countries from the European Union. Oftentimes, labels state that ingredients may come from some of the countries listed, but it does not specify what percentage comes from each country or exactly from which country the product was sourced. Figure 2 shows how LIMS can track and manage this information in a relational SQL Server LIMS database.

A similar scenario is true for tracking hamburger meat: The meat that was used to make burgers can come from multiple ranches and hundreds of cows. Many consumers don’t understand why their food/beverage is blended in large ton batches, and producers want to reach the required final product specifications, while offering a consistent product and experience to the consumer. Blending has become commonplace in the food industry, and it makes traceability much more challenging. The same is true in blending different meats, for example regulators have found pork in products marked 100% beef, this has led to the use of molecular tests to determine if meat has been adulterated.

FSMA and Traceability

FSMA focuses on a preventive approach rather than reaction and response to foodborne outbreaks. A central focus is on traceability, involving a complete understanding of the complex food chain and conducting testing at the key control points that can introduce contamination. It is important to understand the source of all the raw ingredients that make up a final product as well as the details of where they are sourced, the CoA (Certificate of Analysis) report, other test results, and all associated documentation. These elements are especially important, because each region of the world has different approved testing methods and is challenged with different potential contaminants and processes. As a result, food manufacturers must manage a significant amount of information on all raw materials that they receive, along with the associated paperwork, which includes the CoA, confirmatory test data, and all plant, production and final product test data.

Case example. As operations scale, so does the testing. In order to manage all the testing, most laboratories turn to LIMS and laboratory automation to manage high throughput screening. A client that was performing nearly 1,000 Listeria tests per day was using an automated microbiological screening platform to complete this testing. They were struggling to hire more resources to manage and run the instrument, as the time was short and the increased sample volume was imminent. The goal was to automate testing from the nine plants that were submitting samples to the main laboratory, such that the entire process could be automated from the laboratory knowing how many samples were coming from each plant and from deploying pre-configured worklists to upload to the instruments. The instruments would then run the samples and send the result back into the LIMS. This integration alone saved more than six hours per day. In addition, the electronic data transfer was fast and error-free, and since the data was imported into the LIMS, any positives were automatically flagged in real time. This approach allows immediate action.

In addition, all data from shelf life studies and additional testing on the food product (i.e., pesticide testing, environmental testing for Listeria sp., mold, yeast, etc., formulations, and blending) can be managed in the LIMS, one centralized database.

How LIMS Supports FSMA

Over the years some manufacturers have relied on less-robust tools to manage and maintain testing data, from multiple Excel spreadsheets to paper log books. Challenges with using these tools include data corruptions, data loss, typographical errors, and accidental or malicious data changes. These systems are often costly, especially from a resource standpoint (i.e., data errors, hours spent interacting with the data for calculations, tracking samples, and manual report creation alone). In addition, creating reports for regulating authorities can be time-consuming and because there is no control over changes to the Excel sheets or logbooks, there is typically no audit trail, and because the data is not in the database, querying the data can be very difficult.

A quality LIMS will ensure that the organization is bullet-proof when it comes time for regulatory audits. It also provides a complete and secure solution to manage, track and monitor batches of product from farm to table. LIMS not only helps clients manage their regulatory compliance goals, but it also facilitates communication across the organization and provides laboratory intelligence that gives buyers insight into the best suppliers to purchase from, based on final product specification, consistency and pricing. Managers can also better understand when it is time to outsource testing based on workload data, allowing them to maximize their resources and profitably through more efficient operations. The system also accelerates communication: As soon as testing is completed, reports can be automatically emailed and alerts sent to cell phones, if any issues arise.

When dealing with perishable products, time is of the essence, LIMS save time. Table 1 lists just a few of major benefits of the LIMS in FSMA regulatory compliance.

Process/Requirement Advantage
Sample tracking and management Integrated barcode support (both 1D and 2D), manage all batch data, tests, from raw materials, in process testing to final packaged product testing
21 CFR Part 11 Compliance with electronic signature requirements
CoA Easily, automatically generate the CoA report once testing is completed, validated and approved
Specification Management Manage final product, supplier and customer specifications and pricing
Document Management Link all paperwork to Work Order for ready access and retrieval
Full Chain of Custody Automatically generated and linked to the order
Records data and all paperwork associated with product All paperwork that arrived with the raw ingredients, CoA, and shipping documentation or additional test data
Records all test results Automatic data import from instruments as well as hand entered data
Shelf-life Studies Setup, manage and track all aspects of shelf life studies
Formulations and Blending Manage and track as components and specifications for final product blends, and leverage predictive tools for optimal purchase options from suppliers
Audit Trail Track actions in the system and generate a report of all audits made to any result data
CAPAs (Corrective and Preventative Actions) Track and manage open CAPAs in the LIMS, and tie to testing results for easy management to increase customer satisfaction
Traceability back to the source (farm, country) and  forward to the store that it was shipped to, with key data (lot number, ship date, etc.) Users can view all components and associated test results, along with any notes on the final product, back to the supplier and forward to locations that offer the product to the consumer
Employee Training Manage employee training records and view Standard Operating Procedures online to ensure access to work instruction and provide evidence for audits
Instrument Management Manage all quality control data on the instruments used in the testing, as well as documented calibration data, maintenance, any repairs, or any issues. Users can link the PDF manual in the LIMS
Enterprise integration (ERP, SAP, SCADA, MES, SAS JMP) Data sharing allows users with permissions access to data when they need it, so that they can quickly view and monitor information they need to perform their job. Users can also view data with integrated statistical tools to view trends that may not be readily evident
Table I

A LIMS is a critical tool to the success of food companies. It organizes and securely manages all aspects of food testing, facilitates regulatory compliance, enhances communication within the organization, and maximizes productivity. Many food producers are concerned about protecting their brand and providing a high quality, consistent, and safe product to consumers while operating efficiently and at a profit. An LIMS allows them to meet these goals.

Paul Dewsbury, B.Sc.
In the Food Lab

Is that Pricey Wine the Real Deal? Using IRMS to Detect Fraud

By Paul Dewsbury
No Comments
Paul Dewsbury, B.Sc.

By Paul Dewsbury, B.Sc.

Upon conducting some online research to find a nice bottle of wine to bring to a party, I became distracted by a story about the world’s most expensive wine, priced at an eye-watering $195,000. With just a few clicks, I uncovered stories about auctioning a single bottle of wine for more than $300,000, and a case of 114 bottles selling for a record $1.6 million. Some of the reasons for the huge sums invested in pricey wines include rarity, social status of owner (aka famous), vintage, and perhaps most importantly, region and vineyard.

Ever the analytical chemist, I wondered, how do buyers identify whether that the extravagant bottle of wine they’re purchasing is the real thing? Perhaps the serious wine collectors out there could benefit from having an isotope ratio mass spectrometer (IRMS) in their cellar! But seriously, could IRMS play a role in authenticity testing?

Testing for Authenticity and Geographic Origin of Wine

Increasingly, fraud surrounding the provenance of wine has become a problem. Last year, a man was sentenced to 10 years in prison for selling millions of dollars of counterfeit wine. He not only created fake labels, but he also mixed and blended lower-priced wines to imitate the taste and character of rare and much more expensive wines.

An article published last year about the authenticity and geographic origin of wine discusses the results of investigating the stable isotope composition (C and O) of wine samples.1 The authors claim to have found significant isotope variations within samples from the same country as well as between samples from different countries.

¹³C and Simultaneous ¹⁸O and ²H Isotope Analysis in Ethanol with Thermo Scientific DELTA V Isotope Ratio Mass Spectrometers is also a useful resource, as it defines the configuration required for such testing. The method demonstrates excellent results and could be quite suitable for origin testing of wine. Isotopic analysis of wine has become a widespread tool to evaluate the quality, authenticity and origin of labeled products. This application note shows the ability and performance of the analysis of ethanol with combustion and with a high temperature carbon reduction technique in combination with a DELTA V IRMS. With this configuration, the ethanol can be analyzed for oxygen and carbon isotope composition. The analysis allows for the quantification of exogenous sugar added during the fermentation process, which is used to increase the alcohol content of the wine. This control is also needed for the detection of frauds, such as mislabeling regarding both ingredients and origin.

Most laboratories will seek alternative or complimentary techniques for authenticating wine. A few months ago, I blogged about using an ion chromatography method to verify the authenticity of your wine. I was also captivated by the poster, Related Seasonal and Geographical Differences in Wine from California’s Central Coast, which describes how a high performance liquid chromatography coupled to mass spectrometry (LC-MS) configuration was successfully implemented to analyze several wine varieties from different areas to show simultaneous detection and relative quantification of the wine’s components.

Wine authenticity is a fascinating subject, and I will leave you with this unbelievable but true story. In 1989, a bottle of 1787 Château Margaux from Thomas Jefferson’s wine collection was valued at more than $500,000 by its owner, William Sokolin, a New York wine merchant. At a dinner, it was accidentally knocked over and broke. What’s more,  the insurers paid $225,000 for the loss of the wine.

And to get back to where I started—I went to the supermarket and picked up a cheap bottle of wine. I don’t think anyone was the wiser, either.

References

1. Horacek, M., Papesch, W., Ogrinc, N., Magdas, A., Wunderlin, D., and
Misurovic, A. (2014). Control of Authenticity and Geographic Origin of Austrian, Slovenian,Romanian, Montenegrin and Argentinean wine, Geophysical Research Abstracts, 14. Retrieved from: http://www.josephinum.at/fileadmin/content/BLT/Puplikationen/1444-00_E.pdf.

Does Your Company Really Understand GMO Labeling?

By Maria Fontanazza
No Comments

Consumers want to know what’s in their food, from artificial sweeteners and high-fructose corn syrup to dyes and pesticides. The latest hot-button issue surrounds foods made from genetically modified organisms (GMO) and the demand for companies to indicate on labeling whether a product contains GMOs.

In a recent Q&A with Food Safety Tech, James Cook, Food Scientific and Regulatory Affairs Manager at SGS, briefly discusses the challenges and misconceptions surrounding GMOs and labeling.

Food Safety Tech: What are the biggest challenges food companies face in communicating that their products are GMO-free?

James Cook: The biggest challenge for a company is to determine what words or phrases can be used concerning the regulations and/or laws of country that the product will be received into. Companies want to use GMO free, a terminology recognized by consumers, which is actually prohibited in certain locations such as the European Union (EU), and discouraged by the FDA.

FST: How has public (consumer) awareness of this issue complicated matters?

Cook: There is a diverse difference in dealing with the consumers in the EU that have a clear knowledge and unfortunately outrage to GMOs, and the consumers from the United States, where some have no idea what GMOs are.

FST: Are there misconceptions among consumers that present additional challenges to food companies?

Cook: The biggest misconceptions are: Everything created by humankind is evil, food crops have never changed, and the government and the industry are lying. Another misconception is that in the future, we will have enough food to feed the world population, without making significant changes in the way we produce food.   

FST: What are the most critical developments regarding state and federal labeling laws that we need to know about?

Cook: At this time, the Vermont law is the only breakthrough for the requirement [of] GMO labeling in the United States. If some non-government organization obtains passage of their bill through U.S Congress then this law will not come into effect. If this law becomes effective, we will have many states issuing and passing a similar law, as their consumers will want to know why this is required in Vermont but not in their states.

On April 16 Cook will be offering more insight on the topic during a GMO Labeling webinar. Register for the webinar now.

FST: Where do you see the GMO issue headed over the next year or so?

Cook: We will have some sort of GMO labeling law in the United States. Whether this law only affects one state or all of the U.S. is still unknown. Even if this is not solved, more locations in the United States will continue to ban the growing of GMO crops. Eventually these bans will make it into the courts, because you are dictating to a farmer what crops they can grow and sell.  

FST: What key questions will you address during the GMO Labeling webinar?

Cook: What does my company need to do in order to verify to a Non-GMO program?
Does one have to review the entire supply chain in order to prove the product is GMO free?
Why isn’t GMO product just labeled as such in the USA?
Why the vast difference of GMO policies between EU and USA?

 

Related Content: Expanding GMO Labeling Requirements in the U.S.