BFAD Fda Regulation No. 001-C (1982)

(NAR) VOL. II NO. 4 / OCTOBER - DECEMBER 1991

[ BFAD FDA REGULATION NO. 001-C s. 1982, October 01, 1982 ]

GUIDELINES FOR THE OPEN-DATE MARKING OF INFANT FOOD

1 Scope This open-date marking guideline applies to infant food in powdered form (also referred to as infant formula) intended for use, where necessary, as a substitute for human milk in meeting the normal nutritional requirements of infants. 2 Definitions For the purpose of this guideline the following definitions shall apply: 2.1 Infant formula is a product based on milk of cow of animals, (including fish) or plant origin, which have proved to be suitable for infant feeding. 2.2 The term "Infant" means a person not more than 12 months of age. 3 Requirements All products covered by this guideline shall prominently indicate in their label/package a "Best before" date at which time any of the following specified limits is expected to be reached: 3.1 Maximum moisture content — 3.5% 3.2 Maximum Vitamin C — 90% of label claim but not lower than 30 mg/100mg sample. 3.3 Minimum percent solubility — 80% 4 Date of Effectivity For products covered by this guideline, full compliance to the Open-Date Marking regulation shall be on January 1983.

Adopted: 1 Oct. 1982(SGD.) CATALINA C. SANCHEZ (SGD.) J. C. AZURIN

Acting Administrator Minister of Health Re-issued: 7 Oct. 1991

(SGD.) QUINTIN L. KINTANAR, M.D., Ph.D. Director Assistant Secretary for Standards and Regulation