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E. L. LIEN, Wyeth Nutrition, PO Box 8299, Philadelphia, PA 19101 and E. Underwood. European regulations currently permit several routes for innovative modifications of infant formula. These routes include: 1. filing as a novel food, if appropriate, 2. submission of a nutritional substance file to amend the approved list of components that may be added to infant formula (and other foods for particular nutritional uses), and 3. modification of the 1991 European infant formula regulation. In 1993 the European Scientific Committee for Food gave an opinion that Long Chain Polyunsaturated fatty acids (LCPs) could be added to infant formula providing that the content was similar to that of European breast milk. Following this opinion, the European Directive on infant formula was amended to permit the addition of LCPs. Specific restrictions were stipulated regarding the levels and ratios of both n-3 and n-6 families, the most relevant of which are docosahexaenoic acid (DHA, C22:6 n-3) and arachidonic acid (AA, C20:4 n-6). The sources were not specified. Any LCPs that were added prior to the introduction of the novel foods regulation in 1997 were reviewed by the appropriate National Regulatory Authorities of individual EU member states. The addition of LCPs to infant formula was initiated in the mid-1990s and is supported by a large body of preclinical and clinical safety data. In addition to the general information concerning safety, manufacturers addressed specific issues in such areas as prostaglandin formation, immune function and oxidation. In conclusion a multifaceted approach must be developed to ensure modifications to infant formulas provide a safe and nutritious substitute for human milk if breast-feeding is not an option.
Session 44, Evaluating the safety of bioactive components for infant formula
2005 IFT Annual Meeting, July 15-20 - New Orleans, Louisiana |