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HHS/FDA RIN: 0910-AF07 Publication ID: Fall 2003 
Title: ●Food Labeling: Food Allergen Ingredient Labeling 
Abstract: The purpose of this rulemaking is to reduce mortality and morbidity by providing sensitive individuals with additional food allergen information to help them protect themselves from serious allergic reactions, including life-threatening anaphylactic shock. The eight most common food allergens are: 1) peanuts; 2) soybeans; 3) milk; 4) eggs; 5) fish; 6) crustacea (e.g., lobster, crab, shrimp); 7) tree nuts (e.g., almonds, chestnuts, macadamia nuts, pecans, walnuts, hazelnuts or filberts, cashews, brazil nuts, pistachios, pine nuts); and 8) wheat. The rule would propose to require that foods that contain certain protein ingredients include information on the label in plain English terms that clearly identifies the presence of these ingredients. The agency is also proposing to require food allergen labeling on spices, flavors, noncertified colors and incidental additives found in foods as ingredients that contain certain allergic proteins. Currently, section 403(i) of the Federal Food, Drug, and Cosmetic Act allows spices, flavors and noncertified colors used as ingredients of foods to be declared collectively on the label without naming each one. Federal regulations at 21 C.F.R. 101.100(a)(3) exempt incidental additives from ingredient declaration on the label if they are present in the food at an insignificant amount and do not have any technical or functional effect in the finished food. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 101 
Legal Authority: 21 USC 321 ; 21 USC 331; 21 USC 342; 21 USC 343; 21 USC 371 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  To Be Determined   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Rhonda Rhoda Kane
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Room 4D008, HFS-820,
College Park, MD 20740
Phone:240 402-1803
Fax:301 436-2636
Email: rhonda.kane@fda.hhs.gov

 
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