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Presented by:
Pilar Marilyn M. Pagayunan
Product Services Division
Food and Drug Administration 
Philippines
Outline
A. Food and Drug Administration (FDA)
B. FDA Authorizations
1. License to Operate
2. Certificate of Product Registration
C. Product Classification of Wine
D. Registration Requirements for Wine
E. Philippine Standards on Wine
FDA’s Mandate  
Regulatory agency mandated to ensure 
safety, efficacy, purity, and quality of 
regulated products (e.g. food, drugs, 
cosmetics, medical devices, diagnostic 
reagents and household hazardous 
substances).
FDA Regulatory Requirements
I. Licensing of establishments
II. Registration of regulated 
products
FDA Authorizations
1. License to Operate           Establishments
(e.g. food manufacturer /
food importers)
2. Certificate of Product 
Registration                Food products 
(e.g. wine)
License to Operate (LTO)
An approval issued by FDA 
to an establishment prior 
to engaging in the 
manufacture, importation, 
exportation, sale, 
distribution, promotion or 
advertisement of food 
products.
Certificate of Product Registration (CPR)
An authorization covering a 
particular product which 
serves as the registrant’s 
marketing authority in 
connection with the 
activity/ies as permitted in 
the LTO. 
Product Classification of Wine
Alcoholic beverages , 
such as wine, is classified 
under Category II.
Locally manufactured / 
Imported 
CATEGORY II
Alcoholic Beverages
Foods for Special dietary Use (not for general 
use)
Foods for Infants and children     
Herbal Tea
Ethnic Food  (with indigenous ingredient) 
Food Additives
Food Supplements 
Transgenic Food
Registration Requirements for 
Category II Products
Completely filled up Assessment Slip
Notarized Application Letter
Product Information
List of ingredients
Finished product specification 
• One sample in commercial presentation
• One actual loose label
Certificate of analysis of the finished product
Flow diagram of the method of manufacture, packaging and quality 
control
Packaging certification of suitability for food use
Shelf‐life analysis
Justification of label claims 
For Imported Products
Original copy of the Certificate of Free Sale (CFS) 
issued by the government regulatory agency in the 
country of origin or equivalent.
The CFS should state that the specific product/s applied for 
registration are freely sold in the country of origin and fit for 
human consumption.
Additional Requirement for 
Alcoholic Beverages (e.g. wine)
Methanol Content (Memorandum Circular No.13 s. 1989)
Methanol may be present provided it shall be derived from 
natural alcohol fermentation and not added.
Phil. Standards on Wine
1. Standard Administrative Order No. 357 series 1978 
(Standardization of Wines)
2. Philippine National Standard/FDA 30:2010 
(Phil. National Standard for Tropical Fruit Wines)
Standards Administrative Order 
No.357 series 1978
Types:
1. Dry / Semi‐Dry / Sweet
2. Fortified & Unfortified
3. Sparkling / Still / Carbonated
4. Red & White
5. Special / Medicinal
6. Basi
General Requirements 
(SAO No.357 s.1978)
Ethyl alcohol content: 7 to 16% by volume (except for 
fortified wine)
Free from added coloring matter
Free from any ingredient injurious to health
Manufactured in premises built & maintained under 
hygienic conditions
General Requirements 
(SAO No.357 s.1978)
Alcohol content
a. Dry / Semi‐Dry/ Sweet:  7% to 16%
b. Fortified : 18% to 22%
Total Acidity (Tartaric): 0.4 to 1.5 g/100ml
Volatile Acids (Acetic): 0.08 to 0.12 g/100ml
Reducing Sugar: 0.1 to 9.6 % (by weight)
G e n e ra l R e q u ire m e n t s
(SAO No.357 s.1978)
Marking
Name of the product
Country of origin
Ethyl alcohol content (% alcohol by vol. or proof)
Name & address of the manufacturer
Contents in mL
List of ingredients (for special or medicinal wines)
Philippine National Standard for 
Tropical Fruit Wines (PNS/FDA 30:2010)
Alcohol content (ethyl alcohol): 7% to 24% (v/v)
Methanol may be present, provided it shall be derived from 
the alcohol fermentation process & not added.
pH : 3.0 to 4.0
Total Acidity : 0.6% to 0.9%
Soluble Solids: > 8.0% (m/m) at 20 oC
Volatile Acidity (Acetic): < 0.14 g/100 mL
Philippine National Standard for 
Tropical Fruit Wines (PNS/FDA 30:2010)
Labeling
Name of the product
Complete list of ingredients & food additives
Content by volume (metric system)
Name & address of the manufacture, packer &/or 
distributor
Lot or code number identifying product lot
Open date marking (“Best/Consume Before” or “Use by” 
date)
Philippine National Standard for 
Tropical Fruit Wines (PNS/FDA 30:2010)
The words “Product of the Philippines” or the country of 
origin
Alcoholic strength (percentage by volume)
Direction for use
Storage instructions
Additional requirements:
Pictorial presentation of the product and/or the raw 
material/s used should be indicated on the label. 
THANK YOU!
Asian Food Regulation Information Service is a resource for the
food industry. We have the largest database of Asian food
regulations in the world – and it’s FREE to use.
We publish a range of communication services (free and paid), list
a very large number of food events and online educational
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We look forward to hearing from you soon!
www.asianfoodreg.com
admin@asianfoodreg.com

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