Professional Documents
Culture Documents
GENERAL REQUIREMENTS:
Note: All photocopied documents shall be verified against the original copy.
b. Petitioner should be one of the Incorporators. If the petitioner is not the owner/ incorporator,
copy of Secretary Certificate/ Board Resolution/ Authorization Letter/ Special Power of Attorney
must be submitted
2. Proof of Registration
a. If Single Proprietorship, valid Certificate of Business Name Registration with the Department of
Trade and Industry
Note:
1. If the DTI or SEC has a different Business Address, copy of valid Mayors Business
Permit or Barangay Clearance must be submitted.
2. If the Corporate Name is different from the Business Name, copy of amendment of SEC
Registration must be submitted
3. DTI Certificate or SEC Registration must indicate the actual activity/ purpose.
4. In case of change of ownership, copy of Deed of Sale must be submitted.
b. Transfer Certificate of Title (TCT) if owned and notarized Certificate of Occupancy (if owned by
one of the incorporators)
c. Clearance from the Condominium/ Building Administration allowing the use of the unit for
business purposes as necessary
b. Transfer Certificate of Title (TCT) if owned and notarized Certificate of Occupancy (if owned by
one of the incorporators)
Photocopy of Notarized valid Contract of Lease of the space/building occupied (if the space/bldg. is not
owned)
6. Photocopy of Notarized Fixed Asset & Operating Capital or Financial Statement, if applicable.
8. Floor Plan/ Lay out with dimension (office and/or warehouse; manufacturing plant)
9. Tentative list of food products to be manufactured or distributed identified based on its classification
(local or imported) and category (Annex L) (Low/medium/high risk).
10. Facsimile of Proposed Label (for local manufacturer) / sample label of product to be imported or a
digital image of the document in an FDA-approved file type.
SPECIFIC REQUIREMENTS:
A. FOOD REPACKER:
Photocopy of notarized valid contract/ agreement with the manufacturer (limits on products to be
repacked stated in the main AO), with attached LTO of the manufacturer
1. Photocopy of Foreign Agency Agreement duly authenticated by the Territorial Philippine Consulate
D. FOOD MANUFACTURER
1. Organizational Chart Indicating qualification of key personnel in production and quality control:
a. Educational Background;
b. Trainings Attended;
7. Quality control procedures / sanitation standard operating procedures enforced in the plant:
a. Working Area;
b. Equipment;
c. Personnel;
d. Pest Control Program
8. Certification with current laboratory analysis (from FDA recognized laboratories)
a. Source Water
For plant within Metro Manila: photocopy of recent MWSS / Maynilad water bill and/or
satisfactory results of potability test performed by either:
DOH Laboratory
Laboratories of Water Supplier
Laboratories Accredited by DOH as per A.O. 26-A s. 1994
b. Finished Products compliance with standard Please see Annexes I and J for the specific test
parameters to be conducted.
For bottled water, please see Annex N or refer to AO 18-A s. 1993 or its latest revision/
amendments for additional tests results to be submitted;
c. Packaging certification of suitability for food use;
10. HACCP Program - the establishment shall follow the generic format listed as Annex A-1
b. Any one of the following documents for the status of Manufacturer issued by the Regulatory/ Health
Authority from the country of origin:
Note: In the absence of a Regulatory/ Health Authority from the country of origin, attestation by a
recognized association which should be duly authenticated by the Philippine Consulate.
F. FOOD EXPORTER:
b. Valid notarized Distributorship Agreement or Letter of Appointment with FDA licensed Supplier/
Manufacturer to distribute their products outside the Philippines;
G. WHOLESALER
Valid License to Operate (LTO) of Manufacturer and/or Repacker (tolling/ repacking activity and
specific product should be indicated in the LTO)
H. ADDITIONAL REQUIREMENTS:
1. Premises:
A signage in front of the business bearing the registered name;
A well-ventilated area with concrete, tile or wooden flooring, provide with office fixtures such
as but not limited to table, chairs, cabinets, computers etc.;
A suitable and proper place for adequate storage of food products, with considerations to its
proper storage conditions, i.e. needing refrigeration, cold room, provided with wooden or steel
pallets
APP
PLICATION
N FOR AUT
THORIZAT
TION
HE MATTER O
IN TH OF PETITION OF:
O
_______________________________
_____
(N
Name of Owner/IIncorporator) 2x2
2
Piccture
TO OPEN
O A FOOD E
ESTABLISHME
ENT
MORRE PARTICULA
ARLY AS A: (Owwner)
( ) Manufactureer ( ) Distributtor ( ) Repackker
( ) Importer ( ) Exporterr ( ) Wholeesaler
x----------------------------------------------------x
COM
MES NOW the undersigned Applicant
A to the Food and Drugg Administration, Alabang, Mu
untinlupa City, respectfully allleges:
FIRS
ST thaat the p
petitioner is of legaal age, married/single,
m Filipino Citizen an
nd residing at
____
_______________________________________
__________________________
_____________ __________________________
__;
FOUURTH - That thhe petitioner heereby agrees to change the buusiness name orr corporate nam me of the establlishment in the event that therre is a
similar or name regiistered with thee Food and Drug
g Administratioon or if it is rulees later that it iss misleading;
WHEEREFORE, thhe petitioner resspectfully prayss that he/she bee granted licensse to operate saaid establishmennt after inspecttion thereof andd after
comp
pliance with thee Food and Drug Administratio
on requirementss, rules and reg
gulations.
Resspectfully subm
mitted:
________
__________________________
__________________
SIGNATU
URE OVER PRIN
NTED NAME OF APPLICANT
( ) NEW ESTABLISHMENT
( ) PRESENTLY OPERATING
I. Name of Owner:__________________________________________________________________________________________
( ) Single Proprietorship ( ) Corporation
( ) Partnership ( ) Association
IV. List of Food and Food Products to be manufactured; repacked and/or exporter/ imported.
Country of Origin:_________________________________________________
VIII. Personnel: List No. of Technical Employees and their scholastic attainment, who are directly involved in manufacturing
/repacking.
IX. Are the Products produced or manufactured for export ( ) Yes ( ) No or for local domestic consumption? ( ) Yes ( ) No.
If for export, state name of country to which is exported:___________________________________________________________
________________________________________________________________________________________________________
I declared under oath that the foregoing statement composed of two (2) pages are true, correct and complete to
the best of my knowledge and belief.
Respectfully submitted:
A. HACCP Team
Name Designation Qualification/Expertise HACCP Training
Regular Renewal:
1. Renewal shall be on or before the issuance date
2. Submit latest Financial Statement duly signed by a CPA or latest BIR
Automatic Renewal:
There shall be automatic renewal of the LTO when the following conditions are satisfied:
1. The application is filed before the expiration date of the license;
2. The prescribed renewal fee is paid upon filing of the application; and
3. A sworn statement indicating no change or variation whatsoever in the establishment is attached to the
application.
ANNEX C
CHANGE OF OWNERSHIP
1. Official letter regarding the change of ownership
2. Notarized accomplished Petition Form
3. Photocopy of Business Name Registration
a. For single proprietorship registration from the Department of Trade & Industry (DTI)
b. For corporation / partnership, registration from Securities & Exchange Commission (SEC)
and Articles of Incorporation
Note: If the registered address with DTI/SEC is different from the address of the establishment
to licensed, submit a photocopy of Business/Mayors Permit
4. ID picture of the owner / authorized representative
5. Photocopy of Contract / Agreement with Manufacturer reflecting the new owner
6. Photocopy of Deed of Sale / Transfer of Rights
7. Photocopy of Dissolution Papers from SEC (for corporation/partnership)
8. Photocopy of Financial Statement duly notarized or received by Bureau of Internal Revenue (BIR)
9. Surrender original License to Operate (LTO)
ANNEX D
Low Risk (LR) Category Food that is unlikely to contain pathogenic microorganisms and will not
normally support their growth due to food characteristics or type
The following list, but not limited to, shows food products identified by FDA based from CODEX GSFA
and FAO Risk Categories:
C. PROCESSED FRUITS, VEGETABLE AND EDIBLE FUNGI (including mushrooms and fungi, roots
and tubers, pulses and legumes, and aloe vera) SEAWEEDS, AND NUTS AND SEEDS
D. CONFECTIONERY
1. Cocoa products and Chocolate products including imitations and chocolate substitutes
a. Cocoa mixes (powders) and cocoa mass/ cake
b. Cocoa mixes (syrups)
c. Cocoa-based spreads, including fillings
d. Cocoa and chocolate products, including tablea; and imitation chocolate, chocolate
substitute products
2. Confectionery including hard and soft candy, nougats, marzipans, etc. other than in LR D.1
3. Chewing gum
4. Decorations (e.g. for fine bakery wares, sugar flowers), toppings (non-fruit), and sweet sauces
E. CEREAL-BASED PRODUCTS, derived from cereal grains, from roots and tubers, pulses, legumes and
pith or soft core of palm tree, excluding bakery wares in Letter G below
2. Brown sugar excluding products under LR H.1.c (soft white sugar, etc.)
3. Sugar solutions and syrups, also (partially) inverted, including treacle and molasses, excluding
products under H.1.c (soft white sugar, etc.)
4. Other sugars and syrups (e.g. xylose, maple syrup, sugar toppings), including coconut sugar
5. Honey
6. Table-top sweeteners, including those containing high-intensity sweeteners
7. Salads (e.g. macaroni salad, potato salad) and sandwich spreads excluding cocoa- and nut-based,
spreads under MR/HR Letter B.8 and D.1.c (peanut butter/ cocoa-based spreads)
K. READY-TO-EAT SAVOURIES
1. Snacks potato-, cereal- or starch-based (from roots and tubers, pulses and legumes), including
chips and crunchies
2. Processed nuts, including coated nuts and nut mixtures (with e.g. dried fruits)
3. Chicharon
4. Snacks fish-based
*As listed in the latest Codex General Standard for Food Additives (GSFA)
2. MEDIUM TO HIGH RISK CATEGORY
Medium to High Risk (MR/HR) Category Food that may contain pathogenic Micro-organisms and/or may
support their growth and toxin formation
FOOD PRODUCTS
A. DAIRY PRODUCTS and ANALOGUES, excluding products under Fats, Oils and Fat Emulsions
2. Fermented and renneted milk products (plain), excluding dairy-based drinks in A.1.b
a. Fermented milks (plain)
g. Fermented milk (plain), not heat-treated after fermentation
h. Fermented milks (plain), heat-treated after fermentation
b. Renneted milk (plain)
B. PROCESSED FRUITS, VEGETABLES and EDIBLE FUNGI (including mushrooms and fungi,
roots and tubers, pulses and legumes, and aloe vera) seaweeds, and nuts and seeds
1. Dried Fruits and vegetable plain/ sun-dried (including mushrooms and fungi, roots and tubers,
pulses and legumes, and aloe vera) seaweeds, and nuts and seeds
2. Canned or bottled (pasteurized) or retort pouch fruit and vegetable preserve in juice, syrup, brine
3. Fruit-based desserts, gelatin (including water-based fruit flavored desserts, i.e. gels)
4. Fermented fruit products
5. Fruit fillings for pastry
6. Fermented vegetable products (including mushrooms and fungi, roots and tubers, pulses and
legumes, and aloe vera) and seaweed products, excluding fermented soybean products MR/HR
Letter E.1 and E.2 (fermented soybeans and fermented soybean curd) and LR Letters I.9.b. 1) to
3) (soybean sauces)
8. Vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe
vera), seaweed, and nut and seed purees, spreads (e.g. peanut butter)
E. CEREAL-BASED PRODUCTS, derived from cereal grains, from roots and tubers, pulses, legumes
and pith or soft core of palm tree Soybean products
G. PROCESSED MEAT AND MEAT PRODUCTS, INCLUDING POULTRY AND GAME (to be
included even if jurisdiction is with NMIS)
1. Processed fish and fish products, including molluscs, crustaceans and echinoderms
a. Frozen fish, fish fillets and fish products, including molluscs, crustaceans and echinoderms
b. Frozen battered fish, fish fillets and fish products, including molluscs, crustaceans and
echinoderms; including value added products (battered, marinated, smoked, spiced, fish and
squid balls preparations)
c. Frozen minced and creamed fish products, including molluscs, crustaceans and echinoderms
d. Cooked and/or fried fish and fish products, including molluscs, crestaceans and echinoderms
e. Smoked, dried, fermented, and/or salted fish and fish products, including molluscs,
crustaceans and echinoderms
2. Semi-preserved fish and fish products, including molluscs, crustaceans and echinoderms
a. Fish and fish products, including molluscs, crustaceans and echinoderms marinated and/or
in jelly
b. Fish and fish products, including molluscs, crustaceans and echinoderms pickled and/or in
brine
c. Salmon substitutes, caviar and other fish roe products
d. Semi-preserved fish and fish products, including molluscs, crustaceans and echinoderms
(e.g. fish paste), excluding products under MR/HR Letter H.2.a to c above
3. Fully preserved, including canned or fermented fish and fish products, including molluscs,
crustaceans and echinoderms
1. Egg products
a. Liquid egg products
b. Frozen egg products (e.g. frozen eggs, frozen egg whites, frozen egg yolks)
c. Dried and/or heat coagulated egg products (e.g. dried eggs, dried egg whites, dried egg
yolks)
2. Preserved eggs, including alkaline, salted and canned eggs (salted eggs, century eggs)
3. Egg-based desserts (e.g. custard)
1. Infant formula, follow-on formula and formula for special medical purposes for infants
2. Complementary foods for infants and young children
3. Dietetic foods intended for special medical purposes (excluding products under MR/HR Letter
I.1)
4. Dietetic formula for slimming purposes and weight reduction
5. Dietetic foods (e.g. supplementary foods for dietary use) excluding products under MR/HR
Letter I.1 to 4 and Letter K, Food supplements)
6. Weaning foods for infants and growing children
7. Dietetic foods for special medical purpose
8. Dietetic formulas for weight control
J. BOTTLED WATER
K. FOOD SUPPLEMENT/ HERBAL FOOD/ HERBAL DIETARY SUPPLEMENTS
Additional requirements for Food Supplements may apply as necessary such as:
1. Technical specifications of an ingredient or ingredients
2. Computation of % RENI, elemental Content of Compounds, test results, and others as applicable
3. Test Results of Physical, chemical, microbiological, heavy metals, pesticide residues, MRLs and
other contaminants and for nutrient analysis, etc. as applicable per product formulation depending on
active or main ingredient, ..
4. Rationale
5. Scientific study
6. Pertinent regulations (local and international)as part of the justification
7. Certificates (membership to an association, quarantine, free sale, etc.)
8. Other supporting documents
9. Vitamin/ Mineral Assay
10. Safety Data (toxicity study, LD50)
11. General Test for steroids and alkaloids
12. If applicable, test for the absence of synthetic substances such as:
Manufacturer Distributor/Wholesaler Importer Exporter Wholesaler Manufacturer Distributor/Wholesaler Importer Exporter Wholesaler
PRODUCT INFORMATION PRODUCT INFORMATION
Brand name and Product Brand name and Product
Name : Name :
Product Classification Product Classification
(Category/Code) : (Category/Code) :
List of Products : List of Products :
Number of Products Applied : Number of Products Applied :
Packaging Types and Sizes : Packaging Types and Sizes :
Registration Number (FR) : __________________ Validity: ___________________________________ Registration Number (FR) : __________________ Validity: __________________________________
Applicant Company : Applicant Company :
Manufacturer : Manufacturer :
Repacker : Repacker :
Distributor : Distributor :
Others (Pls. specify) : Others (Pls. specify) :
Number of Samples : __________________ Loose Labels:_______________________________ Number of Samples : __________________ Loose Labels:_______________________________
APPLICATION DETAILS APPLICATION DETAILS
Food Bottled Food Bottled
Application Type Category I Category II Application Type Category I Category II
Supplement Water Supplement Water
Initial Initial
Renewal Renewal
Renewal with Surcharge Renewal with Surcharge
Re-application (OLD RSN:_______________) Re-application (OLD RSN:_______________)
No. of CPR Validity Applied for (year/s) No. of CPR Validity Applied for (year/s)
OTHER REQUESTS OTHER REQUESTS
Amendment of CPR Provisional Permit to Market (PPM) Amendment of CPR Provisional Permit to Market (PPM)
Re-issuance/Reconstruction of CPR Export Certificate Re-issuance/Reconstruction of CPR Export Certificate
Referral to ACB Others, pls. specify Referral to ACB Others, pls. specify
[[COMPANY LETTERHEAD]]
The Director/OIC
Center for Food Regulation and Research
Food and Drug Administration
Civic Drive, Filinvest Corporate City,
Alabang, Muntinlupa City
Sir/Madam:
In accordance with R.A. 9711 and other related issuances, we (company name) _______, having
LTO number ___ issued on ___ valid until ____, wish to apply for the registration of our product/s:
PRODUCT/S* TYPE OF REGISTRATION**
INITIAL RE-APPLICATION RENEWAL
Along with this application are the documents listed in the checklist of requirements for registration
and the representative sample of our products.
We categorically declare that all data and information submitted in connection with this application
as well as other submission in the future are true and correct.
We further agree and bind ourselves to all approved formulations, labeling, technical specifications,
information or changes in this application. Any changes thereof in the approved formulation,
labelling, technical specifications, or any deviations on any information given will first have to be
cleared and approved by FDA.
Date: ___________________
Company Name:
_____________________________
By:
______________________________
Indicate Authority
(e.g whether owner / proprietor / partner or duly
authorized representative of the company)
PRODUCT INFORMATION
Company Name: _____________________________________________________________________________
Address: ____________________________________________________________________________________
Product Classification: _________________________________________________________________________
BRAND NAME PRODUCT NAME DESCRIPTION OF DESCRIPTION OF SUPPLIER NAME AND ADDRESS
PRODUCT PACKAGING
MANUFACTURER DISTRIBUTOR
_______________________________
(Print Name over Signature)
ANNEX E-3
Undertaking
AFFIDAVIT OF UNDERTAKING
2. The applicant company has a valid License to Operate as an importer or manufacturer, with LTO
no.____
3. The said products to be registered contain ingredients and additives that are permitted for use in
human food and in accordance with relevant regulations issued by FDA.
4. As duly authorized person of ______________________________________, he
(company name)
is responsible and accountable for the quality, safety and the truth in the labelling declaration of the
said food product.
5. With regards to the labeling, he undertakes to indicate his company name and address by stick-on
labelling or by other means of labeling of the products in market, for imported food products
6. He further undertakes to inform in writing and seek approval from the FDA when in case there are
changes in any circumstances or specification, formulation, information labeling
7. He binds to all approved formulations, labeling, technical specifications, information or changes for
this application. Any changes thereof in the approved formulation, labelling, technical
specifications, or any deviations on any information given will first have to be cleared and approved
by FDA.
*changes in the formulation
_______________________________
(Print Name over Signature)
ANNEX F
3. Actual loose labels and labeling materials and/ a digital image in an FDA-approved
format;
ANNEX G
1. Letter requesting for the amendment of a valid unexpired CPR specifically reflecting the
change requested;
_______________________________
(Print Name over Signature