Tracking Food Allergens

Jan. 1, 2005
The U.S. Food Allergen Labeling and Consumer Protection Act (FALCPA) goes into effect on Jan. 1, 2006, and requires food processing and manufacturing companies to list on their packaging labels the eight most common food allergens that may be contained in a product.

These eight are milk, eggs, peanuts, tree nuts, fish, shellfish, soy and wheat. About 11 million Americans suffer from food allergies, with an average of 250 people dying and another 30,000 requiring treatment each year.

In order for manufacturers to comply with this regulation, product documentation and product change control must be improved. Steve Phelan is one of three founders of Formation Systems (, a privately held software company headquartered in Southborough, Mass. The company was formed in 1995 when the founders, fresh from a sale of their previous business, were looking for new opportunities. “We realized that no one had a design-to-manufacture software product targeted at the process industries. People there were using spreadsheets and lab notebooks. This was not the best way to document products for sharing information, not to mention providing storage and retrieval so product information is available as a corporate asset,” Phelan says.

Formation Systems’ Optiva product manages the entire product development process, from concept to market, for process manufacturers, including those in the food and beverage, consumer packaged goods and specialty chemical industries. The software provides functions that enable companies to meet FALCPA requirements, including ingredient tracking down to the raw material level, automated allergen checks and automated generation of label content.

“Optiva automates the process of identifying food ingredients for not only those ingredients used internally, but also those used by our suppliers, allowing us to accurately reflect every ingredient on our product labels, no matter their source,” says Herb Rau, quality control director of Barber Foods (, Westbrook, Maine. “Creating accurate ingredient and allergen information used to be a tedious process that took hours of manual work for each product, but Optiva now does it automatically, saving time and money while dramatically reducing the chance of errors. Utilizing the Optiva solution will make ongoing compliance with government regulations easier.”

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