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FDA REGULATORY REQUIREMENTS ON REGISTRATION OF REGULATED

PRODUCTS (e.g. wine)

FDA Authorizations

1. License to Operate – for Establishments (e.g. food manufacturer/food importers)


2. Certificate of Product Registration – for Food Products (e.g. wine)

A Certificate of Product Registration is an authorization covering a particular product


which serves as the registrant’s marketing authority in connection with the activity/ies
as permitted in the License to Operate.

Alcoholic beverages, such as wine, whether local manufactured or imported, is classified


under Category II.

Registration Requirements for Category II Products


1. Completely filled out Assessment Slip
2. Notarized Application Letter
3. Product Information
a. List of ingredients
b. Finished product specification
4. One sample in commercial presentation
5. One actual loose label
6. Certificate of analysis of the finished product
7. Flow diagram of the method of manufacture, packaging, and quality control
8. Packaging certification of suitability for food use
9. Shelf-life analysis
10. Justification of label claims

Additional Requirement for Alcoholic Beverages (e.g. wine)

Methanol may be present provided it shall be derived from natural alcohol fermentation
and not added (Memorandum Circular No. 13 s. 1989)

Philippine Standards on Wine

Under SAO No. 357 series of 1978 (Standardization of Wines)

Types:
1. Dry/Semi-Dry/Sweet
2. Fortified and unfortified
3. Sparkling/Still/Carbonated
4. Red and white
5. Special/Medicinal
6. Basi

General Requirements:

1. Ethyl alcohol content: 7% to 16% by volume (except for fortified wine)


2. Free from added coloring matter
3. Free from any ingredient injurious to health
4. Manufactured in premises built and maintained under hygienic conditions
5. Alcohol content:
a. Dry/Semi-Dry/Sweet: 7% to 16%
b. Fortified: 18% to 22%
6. Total acidity (tartaric): 0.4 to 1.5 g/100ml
7. Volatile acids (acetic): 0.08 to 0.12 g/100ml
8. Regular sugar: 0.1 to 9.6% (by weight)
9. Marking
a. Name of the product
b. Country of origin
c. Ethyl alcohol content (% of alcohol by vol. or proof)
d. Name and address of the manufacturer
e. Contents in ml
f. List of ingredients (for special or medicinal wines)

Under Philippine National Standard for Tropical Fruit Wines (PNS/FDA 30: 2010)

General Requirements:

1. Alcohol content (ethyl alcohol): 7% to 24% (v/v)


a. Methanol may be present, provided it shall be derived from the alcohol
fermentation process and not added.
2. PH: 3.0 to 4.0
3. Total acidity: 0.6% to 0.9%
4. Soluble solids: greater than or equal to 8.0% (m/m) at 20 degrees C
5. Volatile acidity (acetic): less than or equal to 0.14 g/100 ml
6. Labeling
a. Name of the product
b. Complete list of ingredients and food additives
c. Content by volume (metric system)
d. Name and address of the manufacturer, packer and/or distributor
e. Lot or code number identifying product lot
f. Open date marking (“best/consume before” or “use by date”)
7. The words “Product of the Philippines” or the country of origin
8. Alcoholic strength (percentage by volume)
9. Direction for use
10. Storage instructions
11. Additional requirements:
a. Pictorial presentation of the product and/or the raw material/s used
should be indicated on the label.

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