QuestionsQuestions (BFAD FDA REGULATION NO. 001-E s. 1982)
It is titled “BFAD FDA REGULATION NO. 001-E s. 1982” and was issued by BFAD (Bureau of Food and Drugs, now FDA) with adoption dated 8 November 1982. The document shows signatures of the BFAD Acting Administrator and the Minister of Health.
It provides guidelines for the open-date marking of dried dairy milk powder intended for direct consumption that are relatively stable under ambient conditions.
It requires labels to show the “Best before” date—i.e., the date when specified limits for a particular product are expected to be reached (not necessarily the same as an expiration date).
The guideline covers: (1) whole milk powder, (2) skimmed milk powder, and (3) filled milk powder.
Whole milk powder is the product resulting from removal of water from whole milk, or by recombining skimmed milk powder with anhydrous milk fat.
Skimmed milk powder is the product resulting from removal of fat and water from milk; it contains lactose, milk proteins, and milk minerals in the same relative proportions as in the fresh milk from which it is derived.
Filled milk powder is produced by recombining skimmed milk powder constituents with acceptable vegetable oils.
They must prominently indicate in their labels the “Best before” date at which time any specified limits for a particular product are expected to be reached.
The maximum moisture content is 4.5%.
The minimum percent solubility is 80%.
Full compliance was required on April 1983 for products covered by the guideline.
The regulation was adopted on 8 November 1982; it indicates when the guidelines were officially adopted under the stated authority.
The document shows signatures of the BFAD Acting Administrator (Catalina C. Sanchez) and the Minister of Health (J. C. Azurin), and later indicates the re-issue with the Director and Assistant Secretary for Standards and Regulation (Quintin L. Kintanar, M.D., Ph.D.). This implies joint/oversight authority over standards and health regulation.
It would violate the requirement that all products covered by the guideline must prominently indicate the “Best before” date on their labels.
It includes both: it sets quality expectations/limits (maximum moisture content 4.5% and minimum solubility 80%) and requires labeling of the “Best before” date linked to when those limits are expected to be reached.