|Markets||United States of America|
|Organization||U.S. Federal Register|
On Oct. 28, 2020 the Food and Drug Administration has proposed exempting an ingredient derived from a major food allergen (as milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans) from the labeling requirement if the allergenic proteins protein has been eliminated or altered to the point where it no longer poses a risk to a person. FALCPA (Food Allergen Labeling and Consumer Protection Act of 2004) provides two mechanisms through which such ingredients may become exempt. An ingredient may obtain an exemption through submission and approval of a petition containing scientific evidence that demonstrates that the ingredient “does not cause an allergic response that poses a risk to human health”. Alternately, an ingredient may become exempt through submission of a notification containing scientific evidence showing that the ingredient “does not contain allergenic protein” or 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”. The public comment period ends December 28, 2020.