FDA outlines when firms do not need to label major food allergens

By Elizabeth Crawford contact

- Last updated on GMT

FDA outlines when firms do not need to label major food allergens

Related tags: Food allergy

Manufacturers do not need to label major food allergens if they can prove to FDA prior to distribution that the production process eliminates allergenic proteins from the product or that the allergen is in such a low amount that it does not pose a risk, the agency says in guidance published June 18.

The guidance​ outlines two options for obtaining an exception for labeling a major food allergen: a petition and a notification. If the agency does not approve either of these then, according to the Food Allergen Labeling and Consumer Protection Act of 2004, manufacturers must label with the common name the presence of milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans. 

FDA acknowledges that labeling already is unnecessary if an ingredient from a major food allergen does not contain protein from the allergenic food. For example, highly refined oil from a major allergen does not need to be labeled. If, however, protein is present, manufacturers should consult with FDA about whether a petition or notification is the best way to obtain an exemption and what specific scientific evidence should be included.

Generally speaking, manufacturers seeking an exemption should opt for a petition if allergenic proteins are present, but are in such low doses that they do not pose a threat, according to the guidance.

A notification is a better bet if the ingredient contains proteins from a major food allergen, but not the allergenic proteins, the guidance says.

What to include

Regardless whether a manufacturer chooses to submit a notification or petition, both methods must describe:

  • The ingredient, including its name, the food allergen from which it is sourced, chemical and biological properties, related food standards, its compensation and batch-to-batch variations and methods for determining its composition.
  • The preparation of the ingredient, such as physical, temperature and chemical treatments, growth conditions and bioengineering process.
  • The protein’s characterization, including the amount present and variation amounts.
  • The ingredient’s application, such as the amount to be used in products.

Petitions also must include expected consumption levels by different consumer groups and clinical evidence via oral provocation studies, skin prick tests or in vitro studies that show there is no allergenic reaction risk.

Notifications also must include proof the ingredient does not contain the allergenic protein, according to the guidance, which suggests in vivo or in vitro clinical data.

Related topics: Regulation

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