FDA has finalized its labeling rules for foods containing allergens—including milk, eggs, peanuts and shellfish—which would allow food manufacturers to qualify for a labeling exemption, if they can prove an ingredient is modified so it no longer presents a risk to consumers with allergies.

In some cases, an ingredient derived from a major food allergen may be produced in a way to eliminate the allergenic proteins in the ingredient so it is not a risk for food-allergic individuals. Or, a major food allergen is used as an ingredient or a component of an ingredient so the level of allergenic protein in a finished food product is below a certain level, so the food will not pose a risk to food-allergic individuals.

Under FALCPA, manufacturers that want an exemption from the labeling requirement for a specific ingredient must submit:

-a petition that provides scientific information demonstrating that an ingredient derived from a major food allergen “does not cause an allergic response that poses a risk to human health”


-a notification providing scientific information demonstrating that the ingredient “does not contain allergenic protein” (or providing information that there has been a previous determination through a premarket approval process under section 409 of the FD&C Act that the ingredient does not cause an allergic response that poses a risk to human health).

FDA says the final guidance describes the types of submissions that will help the agency evaluate ingredients to see if they meet the standards in the Food Allergen Labeling and Consumer Protection Act. Manufacturers that can demonstrate to FDA that an ingredient qualifies for an exemption will not need to place on the food label an allergen declaration for that ingredient.

 The final guidance can be found on the FDA website