Allergen Rules Nothing to Sneeze At: Get a Head Start on Meeting Upcoming FDA Requirements

Editor’s Note: This is the second of a two part series. the first article, “Managing Allergen Labeling Challenges,” was published on p. 49 of the October/November issue.

With additional regulations in the FDA’s 2004 Food Allergen Labeling and Consumer Protection Act set to go into effect in the not-so-distant future, there are ways that food processors can get a head start on complying.

Food businesses will have to employ enterprise business systems to manage and disclose the presence of protein-based allergens for products they make, move and store. Pending voluntary guidelines target the prevention of environmental cross-contamination. Protein-based food allergens can be introduced into normally allergen-free food products when a product containing no such allergens is processed on the same manufacturing line after a food product containing milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat or soybeans, without the necessary level of cleaning processing equipment between production runs.

Consider a hypothetical cookie manufacturer who makes peanut butter cookies and sugar cookies. When demand dictates, both kinds of cookies may end up being made on the same day, one after the other – likely with some or all of the same production equipment.

Imagine the potential for allergen cross-contamination if the first production run of the day on a shared processing line is for peanut butter cookies. As the dough leaves mixing, passes through shaping, moves into an oven, then to packaging, peanut residue remains on each piece of equipment.

The upcoming FDA regulations will encourage food processors to enact practices that support voluntary and mandatory compliance, including the addition of more sophisticated sanitation and changeover procedures. This includes having instructions in place to increase employee awareness about when and how to clean equipment between production runs.

Also, food processors will soon require the identification of allergen properties for all foods at every step of processing, as well as product lots going into inventory. Enterprise business systems will need to allow food processors to clearly define ingredients with allergen properties and describe how to manage work in process inventory (e.g., intermediate recipes such as producing peanut butter cookie dough) and finished food products (e.g., packaged peanut butter cookies). Product formulas and process routes will also need to identify points where cross-contamination could occur when products share processing equipment. Operator instructions regarding the movement and steps to support disclosure of allergens and prevent cross-product contamination should be provided.

Clear operational instructions can also help prevent cross-contamination during the handling of rework material (e.g., broken peanut butter cookies).

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