Issuing authorities and signatories
- The regulation is issued under the BFAD and FDA framework as BFAD FDA Regulation No. 001-E s. 1982.
- The acting administrator signatory is Catalina C. Sanchez.
- The minister of health signatory is J. C. Azurin.
- The standards and regulation signatory is Quintin L. Kintanar, M.D., Ph.D., as Director and Assistant Secretary for Standards and Regulation.
Scope and coverage
- The guidelines cover the open-date marking of dried dairy milk products intended for direct consumption.
- The covered products are relatively stable under ambient conditions.
- The covered product types are:
- whole milk powder.
- skimmed milk powder.
- filled milk powder.
- The required marking applies to all products covered by this guideline.
Definitions of covered milk powders
- Whole milk powder is the product from removal of water from whole milk or by recombining skimmed milk powder with anhydrous milk fat.
- Skimmed milk powder is the product from removal of fat and water from milk and 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 the product from recombining skimmed milk powder constituents with acceptable vegetable oil(s).
Labeling and open-date marking rules
- All products covered by this guideline must prominently indicate on their labels a Best before date.
- The Best before date must indicate the time when specified limits for a particular product are expected to be reached.
- The labeling requirement is mandatory for every product within the covered categories:
- whole milk powder.
- skimmed milk powder.
- filled milk powder.
Product limits referenced by the labeling
- For dried milk, the maximum moisture content is 4.5%.
- For dried milk, the minimum percent solubility is 80%.
- The Best before date on the label must correspond to when these specified limits are expected to be reached for that product.
Compliance timing and transitory implementation
- Full compliance with the open-date marking regulations applies beginning April, 1983 for products covered by the guideline.