Food Allergens and FSMA

Most of you probably know a person that has an allergy reaction to specific food. It is estimated that approximately 3% of US population has some sort of food allergy.

Food allergens are defined as substances that cause chemical reaction to individuals with immune system that doesn’t tolerate this substance.

In U.S. there are 8 major food allergens – Wheat, Soy, Egg, Milk, Tree nuts, Peanuts, Fish and Shellfish. Across the world this list changes as many food allergies are geographically motivated.

Over the years’ food manufacturing companies adopted many safeguards and Allergen Management Programs to avoid cross contact to foods that are not supposed to contain any allergens. Some of the elements of these Programs include proper production scheduling, changeover procedures or allergen storage in a manner to avoid cross contact.

Allergen hazard is an essential part of HACCP plans and most companies conduct risk assessment related to allergens that are present in their manufacturing system.

New regulation (Food Safety Modernization Act) or FSMA requires companies to consider allergens while conducting risk assessment of their process and ingredients. Based on this hazard analysis company may decide that hazards associated with allergens are controlled through Allergen Preventive Control.

While cross contact of allergens to non – allergenic foods is not a significant issue, allergens remain number one cause for food recalls. It is because of product labeling and not declaring allergens on product labels.

There are a few main reasons for this non – conformance:

1) Ingredient Substitutions – using different ingredient in lieu of regular ingredient due to inventory shortage. Keep in mind that each ingredient substitution must be carefully analyzed for allergen content and label adjustment made as needed. 

2) Lack of proper label verification procedures – labels made years ago and not reviewed on periodic basis. As time goes by your ingredient supplier might have changed their product content and added an allergen that you’re not aware of. It is critical to review ingredients labels as they are received and make sure their content has not changed.

 3) Product labeled with labels leftovers from previous production run – with high speed manufacturing process, packing personnel may not have enough time to read every single label. It is essential that the company has proper product changeover procedures that include label reconciliation after each product run. Label color coding may also be helpful.

As always, training is the key to prevent undesirable situations and potential food safety issues.

Many of these issues can be revealed during internal audits and including label verification in your routine inspections might be useful.

At the other hand not too many 3rd party audit schemes require the auditor to verify product labeling during the audit.

SQF has recognized the problem and with new code revision (issue 8) label verifications will be an integral part of SQF facility audit.

Let’s hope more audit schemes adopts similar approach as SQFI and with time, companies change the way they handle product labeling. With current practices consumer safety and your company liability is at risk.

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