TABLE 1-1Selected Laws and Regulations Related to New Ingredients Added to Infant Formulas

Country or OrganizationRegulations (Reference)Identifying Terms
United StatesFederal Food, Drug, and Cosmetic Act (21 U.S.C. §301)Food additive, Substances Generally Recognized as Safe (GRAS)
Food Additive (21 C.F.R. §170, 171, and 172)Food Additive
GRAS (21 C.F.R. §182, 184, and 186)GRAS
CanadaFood and Drugs Regulations (Canada, 2001)Food additive, novel food
European UnionEuropean Communities (Infant Formulae and Follow-on Formulae) Regulations, 1998 (FSAI, 1999)Established by generally accepted scientific data
Council Directive 89/107/EEC (EEC, 1989)Food additive
European Parliament and Council Directive 94/34/EC (EEC, 1994)Food additive
Regulation EC No. 258/97 (EC, 1997)Novel foods, novel food ingredients
Council Directive 90/220/EEC (EEC, 1990)Genetically modified organisms

From: 1, Introduction and Background

Cover of Infant Formula
Infant Formula: Evaluating the Safety of New Ingredients.
Institute of Medicine (US) Committee on the Evaluation of the Addition of Ingredients New to Infant Formula.
Washington (DC): National Academies Press (US); 2004.
Copyright 2004 by the National Academy of Sciences. All rights reserved.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.