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Undeclared Allergens - Potential Failure Point 1: Purchasing

Denis Storey
May 11, 2020

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Undeclared allergens can wreak havoc on a food manufacturer’s reputation. Not only can these undeclared allergens pose a life-threatening risk to the public, but the resulting Class I recall can tarnish the food manufacturer’s reputation – temporarily or permanently – depending on the severity and frequency. One potential point of failure that could lead to undeclared allergens making it to the marketplace happens in purchasing.

Stephanie Lopez, Vice President, Food Safety Services Innovation, AIB International, shared her expertise on three potential failure points: purchasing, receiving, and packing. This article will highlight possible failure point No. 1: Purchasing. 

In addition to the gauge or weight of packaging materials, size of the gusset, or color specifications for the graphics, specifications for packaging material also require any allergen statements that would be on the packaging during purchasing. Typically, the artwork or graphic department is involved in developing the specifications. They need to be aware that the ingredients statement is a critical legal and food safety component of an allergen control program.

Food Allergen Labeling Consumer Protection Act Compliance

The label must comply with the Food Allergen Labeling Consumer Protection Act (FALCPA).

“The key element of that act is that all allergens are declared in plain language. For example, if your product contains whey, the word ‘milk,’ which is the plain language alternative, must be declared. If your product contains albumen, the plain language word of ‘egg’ must appear on your packaging,” Lopez explained. But there is some flexibility in these declarations. For more information, refer to the FALCPA FAQs

Non-compliance with FALCPA can result in “civil sanctions, criminal penalties, or both under the Federal Food, Drug, and Cosmetic Act if one of its packaged food products does not comply with the FALCPA labeling requirements. FDA may also request the seizure of food products where the label of the product does not conform to FALCPA’s requirements. Also, the FDA is likely to request that a food product containing an undeclared allergen be recalled by the manufacturer or distributor.”

Cross-Departmental Collaboration

When spec’ing out packaging, make sure anyone familiar with the act is involved. Typically, this includes representatives from Research & Development (R&D), Quality Assurance (QA), Purchasing, and the Art department.

Problem Area

One area that can pose problems in purchasing is when you need to make revisions to existing packaging. For example, if adjustments are made to the formula on a current product to contain soy flour, it’s essential to communicate it to the packaging manufacturer. Two elements must be covered:

  1. Ensure the packaging supplier destroys any old stock on hand and provides evidence to confirm it.

  2. Ensure the packaging supplier eradicates any obsolete printing plates and, again, offers documentation to prove it.

“The fear here is that they may have some obsolete materials that may accidentally be used again and would inadvertently not declare the allergen that is now in your product. Typically, this is a conversation between your purchasing or procurement group and the packaging manufacturer,” Lopez added.

Next up, Potential Failure Point No. 2: Receiving.

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