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

[ 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

Acting Administrator

(SGD.) J. C. AZURIN

Minister of Health

Re-issued: 7 Oct. 1991

(SGD.) QUINTIN L. KINTANAR, M.D., Ph.D.

Director

Assistant Secretary for Standards and Regulation