FDA Issues Request for Information on Food Allergens

December 13, 2012

FDA Issues Request for Information on Food Allergens


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The agency is seeking public comments on safe thresholds for the top 8 allergens. Deadline is February 7, 2013.

The U.S. Food and Drug Administration (FDA) is looking for public comments on the eight major food allergens. Specifically, the agency aims to receive public comments related to performing a risk assessment that will help to establish regulatory thresholds.

Published in the Federal Register, the call for comments focuses on the eight major food allergens identified in the Food Allergen Labeling and Consumer Protections Act (FALPCA) of 2004: milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts and soybeans.

(NFCA Note: Gluten is not included on the list of major allergens; however, the FDA has already proposed a safe threshold for gluten: 20 parts per million (ppm). A final rule on this threshold has yet to be passed. To NFCA’s knowledge, the FDA has not indicated any impact or connection between this call for comments and the pending final rule on gluten-free labeling.)

According to an announcement from the FDA:

“If safe thresholds can be established, the FDA could:

  • more effectively determine the appropriate corrective action to unintentional allergen contamination issues;
  • better evaluate petitions and notifications for exemptions from allergen labeling;
  • better respond to situations where undeclared allergens are found in foods;
  • consider how thresholds might be used to improve consumer choices in the marketplace, while protecting sensitive consumers”

Individuals and stakeholders have until February 7, 2013, to submit their comments.

To submit comments electronically, go to http://www.regulations.gov :

1. Choose “Submit a Comment” from the top task bar
2. Enter in the “Keyword” space: docket number FDA-2012-N-0711
3. Select “Search”

To submit your comments to the docket by mail, use the following address:

The Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852