More than 60 percent of FDA recalls are due to labeling issues. Most of these errors relate to allergens. Processors inadvertently put the wrong label on products, a change in the ingredients (undeclared allergens) doesn’t show up on the label, or the label doesn’t include a complete list of allergens. But the label includes more than just allergens.


FDA requires five basic pieces of information on a food label: product identity, net contents, nutrition facts, ingredients/allergens and a signature line with the processor’s/distributor’s/importer’s contact information.

A labeling-related recall may be initiated for a number of reasons that have nothing to do with allergens. “Wrong ingredient deck, expiration declaration and labels not being current,” offers Warren Gilbert, owner of FSS Corp.-Food Safety Specialists.

“Improper or missing date, lot, ‘best by,’ machine code, etc.,” adds Mark Breunig, Videojet regional product manager. “Virtually every food product requires a code at the time of manufacture. While the specific code contents may change, the requirement for the code to be on the product and for it to be correct does not. Any improper or missing code can result in returned, rejected or recalled product.”

Carole Besnard, Luceo Inspection marketing manager, lists some other problems from an inspection viewpoint that often pop up:

  • Missing or incorrect information including quantity, price and promotional stickers
  • Improper position (e.g., bad position and orientation of information or products within the package or  misalignment of the top film)
  • A poor-quality barcode that can’t be read by retailer scanners
  • Food spoilage due to inadequate package sealing.

“Sealing is a critical control point in food security that can be difficult to master,” says Besnard. “Rigid or flexible packaging conditioned in a modified atmosphere is becoming widespread in our daily life in response to our requirements for freshness, extended shelf life or simply practical considerations.”

Modified atmosphere packaging guarantees it is hermetically sealed from the outside environment, irrespective of the technology used to create it. It is not only an essential safeguard against health risks, the sealing is the first line of defense to stresses that occur throughout the product’s lifecycle (crating, transportation and shelving). The slightest sealing defect can compromise an entire package, allowing the product to develop anaerobes (mold, bacteria, etc.) that can contaminate food, says Besnard.

Allergen-related recalls

According to FDA, most allergen-related recalls are for bakery products, followed by snacks, candies, dairy and dressing, while the most common allergen recalls are for milk, wheat and soy (in descending order). Typically, these recalls are caused by the use of the wrong package or an incorrect label. How can processors and their employees avoid these mix-ups?

“First-off inspection is a simple check and signoff for all changeovers or startups,” says Gilbert. “It all goes back to the verification and validation process. Labeling inventories also can be a big problem, if it is not managed correctly.”

When rolls of film with printed ingredient statements are used, processors must confirm the labeling is correct at the beginning and end of each roll. “Film manufactured at the packaging manufacturing site often involves splicing multiple rolls together,” explains Stephanie Lopez, president, AIB International - certification services. “And when those rolls get spliced, there is the opportunity for incorrect rolls to get spliced together.”1

Internal operational changes can wreak havoc, too. “Each time the coding requirements change, there is an opportunity for an error,” adds Breunig. “Manufacturers should choose a coding solution that reduces operator interaction to minimize errors. They also should employ automated strategies such as barcodes and networked job input to further reduce the opportunity for input errors.”

A machine vision system can catch many mistakes before they get to the loading dock. For example, Luceo’s solutions inspect, identify, trace and reject products that display contaminated seals or do not conform to visual appearance specifications, says Besnard. Luceo’s ThermoSecure software/hardware system checks for the presence, position and orientation of the label; coherence of information; required product information (use-by date, barcode, weight/price, etc.); and correlates the top, bottom and side labels.

The ThermoSecure software also inspects and tracks all packaging, and archives important production data and images to prevent the reworking  of defective packaging, complaints or product recalls due to packaging integrity problems. The system prevents risk of a product mix-up at the start of every new batch by matching the product to information on the label. Usually, the system is placed at the end of a line after the weighing and metal detection stations.

The second-most common cause for allergen recalls is incorrect terminology in the ingredient list. For example, “contains butter” is not an appropriate allergen listing, whereas “contains milk” is. “One way to mitigate the inaccurate terminology is to create and manage print jobs centrally,” suggests Videojet’s Breunig. “Rather than creating codes and messages for each production run, line operators can select from a menu of print jobs. This enables a one-time creation and review process to assure the correct terminology is used.”

Incorrect, outdated or damaged data files in computerized onsite printing systems also can be a source of labeling errors. How can these issues be remedied? “Certain marking and coding solutions are available with ‘code assurance’ software designed to ensure the right code is applied in the right location on the right product,” adds Breunig.

These solutions begin with centralized message management and printing control. Code accuracy issues can be detected with scanners positioned throughout the production line. Whether the code is printed directly on the product/package or label, the technology that drives the data to the printers should allow the automatic setup of multiple printers with the correct code, says Breunig.

According to Jean-Christophe Calmejane, vice president North America, Lascom Solutions, another relevant issue that seems to come up frequently is the lack of a standard format for ingredient specification sheets.

Australian and European processors often have specification sheets geared to national standards with a clear recommendation on the way data should be presented. This makes including the specification sheet within PLM (product lifecycle management) and batch systems much easier, and if an ingredient change adds an allergen, it’s much faster and easier to pick up on the change.

“But in the US, this is usually not the case,” says Calmejane. “Each company has its own template, and that makes it difficult to find the allergen and microbiological information related to the raw material specification from the supplier.”

With a lack of continuity and/or connectivity between raw materials specifications, the final formula may not accurately reflect all its ingredients, making mistakes on the label a distinct possibility. For example, if a processor creates a new formula by dragging and dropping a strawberry purée into a dairy product, milk should  appear on the final product label as an allergen, according to Calmejane.

Plus, if a formula change includes an allergen, the old, non-allergen labels should be destroyed, says AIB’s Lopez.

Software solutions can help

PLM software can help processors organize their products and manufacturing worldwide. For instance, when Monin, a worldwide premium syrup manufacturer with R&D centers in the US, France and Malaysia, needed some help with global product management and development, it chose Lascom Solutions PLM.

“Monin is the brand of choice for creative beverage professionals. Our strong, proactive innovation strategy, covering 140 countries, is one of the key factors in our continued success,” says Gislene Da Silva Razavet, R&D group director of Monin. “But our global product development and management operations expose us to complex regulatory [liabilities]. Lascom PLM helps us manage these operations quickly and effectively.”

“Labeling is normally one of the last activities in the packaging operation, but it reflects the status and condition [and genealogy] of the products,” says Maryanne Steidinger, director, software and product marketing, Schneider Electric. “At a minimum, the label should identify the lot, location/plant and  date of the product’s production. By tracking and documenting labels, manufacturers can add an extra measure of quality control to their production.”

In the past, barcode readers were used to verify the correct label was applied to the correct lot; custom- or purpose-built software did the real-time (or off-line) comparison of lots to packaged products. Newer systems use MES (management execution system) software to verify the correct label is associated with each lot. If a split or quarantine occurs, the software chronicles which lots were affected and which products were split into a separate lot. This information then becomes part of the “as-built” record of the work order (or batch record) the software tracks.

For serialized lots, MES software tracks not only the applied barcode, but also the actual serial numbers applied to the lots. The collective serial numbers/sequences become part of the record showing which products are within a single lot or batch.

Today’s vision systems are capable of 100 percent inspection in real time and can provide control and/or tie into the MES. Continuous inspection allows the immediate detection and withdrawal of defective packaging, explains Luceo’s Besnard. Data-driven inspection systems also can indicate printing or labeling problems. Once these trends have been identified, the volume of rejects tends to decrease and, in some cases, disappear altogether.

With a real-time vision system, each packaging item is individually controlled, and defective products are removed one by one from the production line. In addition, the system can identify any drift in production so it can be corrected immediately.

“Manufacturing intelligence [MI] platforms can be configured to require in-process traceability checks and label verification,” says Eric Weisbrod, InfinityQS technical services manager. “The software application is connected to a database that stores all the information related to products, such as container type, size, color and material; closure type and color; front and back label; ingredient statement; and any other item critical to traceability.”

When an operator sets up a line to run a specific product, the container and packaging information can be retrieved to ensure the correct packaging and labeling are being used. At various stages of production, the operator addresses a number of questions related to various characteristics of the product, including the traceability or identification number of the labels being used. After the operator enters this number—manually or with a barcode scanner—the software compares the entry to the number associated with the product in the database and provides immediate feedback with either a green “Passed” screen or a red “Failed” screen. These messages can be further customized to specify results such as “Passed Front Label Inspection” and “Failed Back Label Inspection,” says Weisbrod.

If the red failure screen appears, a number of other automated actions occur, continues Weisbrod. First, the failure is recorded into the manufacturer’s database to ensure accurate records for audits and continuous improvement efforts. Second, an email can be sent immediately to supervisors and quality managers to make them aware of nonconformances across operations. The operator also can be required to enter assignable cause information to explain why the product is nonconforming, such as noting if the label is for a different size of container or the wrong promotion is displayed. Then, the operator would also enter which corrective actions were taken to fix the issue, such as changing the label reel and removing all mislabeled products.

MI software can also address allergen concerns from two different perspectives. For example, the database for a cookie manufacturer would note which cookies contained allergens in their ingredient lists and ensure the proper labels were used during packaging. These verifications can use a single traceability number identifying the label/package and/or can request specific verbiage, such as “contains dairy,” to be utilized. In addition, the software can ask operators to confirm specific, regulated cleaning and sanitization steps were completed to ensure all allergens were removed when a line is converted from allergen-containing to non-allergen products.

Labeling is an important part of any track-and-trace effort. In fact, FDA commissioned the Institute of Food Technologists (IFT) to coordinate and conduct the product tracing pilots required by Section 204 of FDA’s FSMA 2, including an evaluation of the costs and benefits to industry and consumers. The pilots for three ingredients (chicken, peanuts and crushed red pepper) were used to demonstrate the effectiveness of track-and-trace with electronic recordkeeping and labeling practices.3


1 Top Best Practices for Your Allergen Control Program, [E-Book] Co-produced by TraceGains, Inc and AIB International:

2 Product Testing, FDA website(Information available related to Product Tracing under the FDA Food Safety Modernization Act (FSMA))

3 “Pilot Projects for Improving Product Tracing along the Food Supply System Final Report,” FDA/IFT,

For more information:

Warren Gilbert, FSS Corp.-Food Safety Specialists, 262-745-7881,

Mark Breunig, Videojet, 866-430-5621,,

Carole Besnard, Luceo Inspection, 713-338-2925,

Stephanie Lopez, AIB International, 785-706-0114,

Maryanne Steidinger, Schneider Electric, 949-727-3200,,

Jean-Christophe Calmejane, Lascom Solutions, 858-452-1300,,