Exceptions to the law are highly refined oil derived from an allergen or a food ingredient that, although it is derived from an allergen, has proved by petition to and approval of the FDA to contain no allergen protein. Some ingredients exempted from the allergen labeling law are hydrogenated soybean oil and modified food starch.
It appears that every day there is yet another recall of a food product because of an undeclared allergen. In the Reportable Food Registry’s annual report, the FDA noted that 69 of the 229 (30.1%) food safety entries were for undeclared allergens.6 Including other intolerances (undeclared sulfites) brings the total to 80 reports, 34.9% of the food safety entries. Bakery products were identified in 17.5% of the undeclared allergen intolerance reports, and a milk allergen was identified in 29% of the reports.
So what is a supplier, manufacturer, or retailer supposed to do? Should a supplier list all the allergens possible under a “may contain” statement? While the FDA and the U.S. Department of Agriculture do not prohibit the use of such advisory statements, the agency does acknowledge that this practice should be reserved for those situations when the allergen may still be in the product, even if good manufacturing practices and other industry best practices are followed. Both agencies believe the indiscriminate use of “may contain” statements does not help those who are allergic to spot specific allergens and that these statements should only be used when all other methods have been tried and have failed.
The FDA Guide
In 2001, the FDA developed its inspection guide, giving the industry insights into what areas to address in an allergen control program.7 The agency broke the inspection into the following areas: product development, receiving, equipment, processing, finished product testing, and labeling. The list of areas to investigate should help any firm, big or small, to develop an allergen control program. The methods can apply to any product.
In product development, a company must identify the sources of allergens in the product. Are all ingredients and sub-ingredients for the product identified? For ingredients such as vitamins, spices, flavorings, and colors, are any carriers allergens? Does your product contain juice clarified using isinglass, a fish allergen? Are there going to be any processing aids or rework? Will there be any dust or potential transfer of ingredients from one line to the next? What else is being made on the product line of this new item? Does the packaging material have any releasing agent that could be a food allergen (for example, foil with wheat-releasing agent)?
In the Reportable Food Registry’s first annual report, the FDA noted that 69 of the 229 (30.1%) food safety entries were for undeclared allergens. Including other intolerances (undeclared sulfites) brings the total to 80 reports, 34.9% of the food safety entries.
Receiving: It is necessary to separate raw materials that are allergens from other materials. They must be properly identified and stored separately to prevent cross-contamination. If bulk tanks are used, are they only used for one material, or are they cleaned out and used to store other materials? What does the raw material declare as allergens, and is there a “may contain” statement on its label? How will the raw material label information be transferred to the information on the finished good? How often is this checked and verified?