[Best Practices] Tips for Prevention of Allergenic Cross Contamination

The FDA is currently evaluating its food GMP regulations to ensure that they take today‘s technologies and food safety hazards into account. Among the recommendations for updates is the addition of new requirements for allergen control.

 According to a 2006 AOAC Annual Meeting presentation, Practical Approaches to Preventing Allergen Exposure in Food Products on a Daily Basis, by General Mills technical representatives, there are nine key areas of allergen risk in plants which process allergenic product. Following are those nine areas and best practice methods for reducing risk in each.

1. R&D

• Limit use of allergen ingredients in new products
• Formulate 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/contractors are aware of allergen re-quirements; survey supplier’s allergen risk
• 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 out-dated or incorrect materials (i.e. employ use of bar code scanners)

5. Production Scheduling

• Dedicate production systems
• Allow for thorough clean-out time 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 changeovers

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 oper-ator instructions
• Promptly report any misuse of rework which could result in mislabeling
• Audit rework periodically to ensure proper  identification and use

7. Sanitation

• Standardize clean-out 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 hire
• 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

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Allergen Laws
Around the World.
With today’s ever-increasing reliance on the global supply chain, it is important that manufacturers know the allergen laws of countries with which they conduct business. As compiled from the Food Allergy & Anaphylaxis Alliance (www.foodallergyalliance.org), a few of these include:

Europe. European Union regulations state that allergens that must be declared in packaged food are cereals containing gluten, crustaceans, egg, fish, peanut, tree nuts, soybean, milk, celery, mustard, sesame seed, lupine, mollusks, sulfur dioxide and sulfites of more than 10 mg/kg or 10 mg/liter. In addition, all ingredients must be listed in descending order of weight, unless they are exempt processing aids; ingredients must be declared by their legal name or customary/accurate name if no legal name exists; additives are listed by name, serial number or both; single-ingredient foods, such as fresh fruits and vegetables, and foods sold for immediate consumption do not have to list an ingredient statement, nor are ingredients of flavorings required to be listed individually.
Canada. The Canadian Food Inspection Agency regulates packaged food labeling requiring that priority allergens must be listed by name, except for oils (only peanut oil must be specified), fats, colors and flavors. Labeling exemptions also include seasonings, flavorings, colors, hydrolyzed plant protein, lecithin, starch, some items that compose less than 5 percent to 10 percent of the product, sources of cross-contact during processing, and sources of domestic oils (except peanut, which must be declared). It is recommended that the plant source be identified by the common name for each of the following foods: hydrolyzed plant protein, flour, gluten, starch, and modified starch. New food labeling regulations are currently under review by Health Canada.
Australia. Food Standards Australia New Zealand (FSANZ) regulates packaged and unpackaged foods in Australia and New Zealand. Under the 2002 FSANZ Food Standards Code, crustaceans, egg, fish, milk, tree nuts, sesame seed, peanut, soy, gluten-containing cereals and products derived from them must be named on the ingredient list, without exception. The cutoff for all other component ingredients is 5 percent, and ingredients are to be listed in descending order of weight.