Food Allergen Controls

Features - Safety

A Top Priority of Risk Management

December 10, 2013

With the prevalence of food allergies continuously rising in the U.S. and unlabeled allergens a top recall issue, legislation and guidelines have become a top priority for a number of federal agencies: USDA has increased its focus on allergens in its inspections; FDA is requiring food allergen controls for labeling in the Food Safety Modernization Act (FSMA), and CDC recently published guidelines for food allergy controls in school. (See Legislative Update, page 6)



As described in the FSMA Proposed Rule for Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, the most common cGMP-related problem resulting in a recall is that of mislabeling (i.e., undeclared allergen). During the period 1999-2003, labeling problems accounted for 34 percent of recalls due to undeclared major food allergens. In a 2008-2009 follow-up review, labeling problems accounted for 43 percent of recalls due to undeclared major food allergens. Because there is no cure, the only option for those with food allergies is to avoid the food, and to do so, they have to rely on food labels being complete, clear, and accurate. Thus, for consumer safety, manufacturers need to have controls to ensure that labels declare all the food allergens that are intended to be present, the correct label is applied to the product, and cross-contact of unintended food allergens is prevented.

As such, Proposed §117.135(d)(2)(ii) would require that food allergen controls for labeling of finished food prevent application of the wrong label to a food, use of wrong packaging, and use of packaging with an incorrect allergen declaration. Additionally, the rule proposes the revision of several provisions of cGMP part 110 to explicitly address cross-contact, make it clear that cGMPs require protection against cross-contact, and ensure that they continue to address health concerns related to allergens.

Proposed Revisions.

To identify the cGMP to be revised, detail the proposed requirement, clarify the reasoning for the requirement, and explain the proposed revisions and associated action(s), FDA created a table outlining these for each proposed revision. For example, the cGMP § 110.10(b) & (b)(9) Cleanliness is revised in Section XI.E.1. FDA’s reasoning for the revision is that “Poor hygiene may result in the transfer of food allergens from persons working in direct contact with food, food-contact surfaces, and food-packaging materials to food.”

The requirements for action are:

  • All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against cross-contact and contamination of food.
  • All such persons must take any other necessary precautions to protect against the cross-contact of food.

Although FDA notes that the table does not include all requirements for allergen controls, stating that readers should visit for the complete rule, the details of the table do provide a great deal of information and a good starting point in preparing for implementation of the final FSMA rules related to allergens. The table is available at; November/December 2013, Online Extras.


9 Steps to Reduce Allergen Risk

Following are nine key areas of allergen risk in plants and best practice methods for reducing risk in each.

1. R&D

  • Limit use of allergen ingredients in new products.
  • Formulate product to add allergens at end of processing steps.
  • Minimize reformulations which add new allergens to existing products.

2. Engineering & System Design

  • Ensure all equipment is accessible/cleanable; re-engineer existing systems for cleanout and inspection access.
  • Isolate allergen addition points.
  • Dedicate recoup/refeed systems and production systems; install parallel modules for units not cleanable.
  • Eliminate cross over and poor product containment points.

3. Raw Materials

  • Ensure vendors and contractors are aware of allergen requirements; survey suppliers‘ allergen risks.
  • Identify potential sources of ingredient cross-contact.
  • Obtain fully disclosed ingredient lists, including subcomponents.
  • Mandate vendor communication of any raw material substitutions.

4. Labeling & Packaging

  • Ensure label reflects the current formula.
  • Review graphics on “new & improved” packages and all packaging label changes.
  • Recheck label accuracy when an ingredient change/substitution is made.
  • Appropriately manage excess packaging inventory.
  • Do not use precautionary labeling in lieu of GMPs.
  • Ensure packaging material vendor understands risk of mixed material and incorrect press set-ups.
  • Prevent the use of outdated or incorrect materials.

5. Production Scheduling

  • Dedicate production systems.
  • Allow time for a thorough cleanout between runs.
  • Incorporate allergen strategy into scheduling system, such as producing non-allergenic products on clean lines, prior to production of allergenic products.
  • Lengthen run times/minimize change-overs.

6. Rework Practices

  • Clearly label all rework.
  • Control rework—like into like only.
  • Dedicate rework systems.
  • Post instructions on the use of rework with other operator instructions.
  • Promptly report any misuse of rework which could result in mislabeling.
  • Audit rework periodically to ensure proper identification and use.

7. Sanitation

  • Standardize cleanout procedures and train employees.
  • Allow enough time for complete sanitation processes.
  • Disassemble equipment for manual clean when needed, and dedicate equipment that is difficult to clean.
  • Inspect all contact surfaces.
  • Label all systems, containers, and tools.

8. Marketing & Consumer Testing

  • Whenever possible, avoid allergen ingredients in new products or reformulations.
  • Drop marginally performing products that have high allergen risk.
  • Test products with consumer allergy labeling.

9. Human Error/Employee Awareness

  • Routinely train all employees, including temporary workers and new hires.
  • Ask food-allergic employees and outside speakers to share their experiences.
  • Join food allergy associations.
  • Brainstorm for high-risk areas in your plant, and post awareness posters.
  • Discuss the financial impact of cross contamination.

Source: Practical Approaches to Preventing Allergen Exposure in Food Products on a Daily Basis, General Mills, 2006 AOAC Annual Meeting. Originally printed in QA, July/August 2009.


The author is Editor of QA magazine. She can be reached at