Licensing Requirements for
Food Establishments
 The Dept. of Health through the FDA is mandated
to ensure the safety of all food processing and
product packaging activities, to develop and issue
appropriate authorizations in the form of a license
and certificate or registration that covers
establishments, facilities engaged in production
and distribution of products.
FDA Authorizations
1. License to Operate (LTO)
2. Certificate of Product Registration (CPR)
Section 13. Principal Responsibility of Food
Business Operators.
Food business operators shall ensure that:
food satisfies the requirements of food law relevant to
their activities in the food supply chain; and
control systems are in place to prevent, eliminate or
reduce risks to consumers.
A sole proprietorship, a partnership, a corporation, an
institution, an association, or an organization engaged
in any of the activities of the following establishments
are being licensed by FDA:
 Manufacturer
 Trader
 Distributor
Engaged in any and all operations involved in
the production of health (food) products
including
preparation,
processing,
compounding, formulating, filling, packing,
repacking, altering, ornamenting, finishing and
labeling with the end view of its storage, sale or
distribution.
• Involves in the process of packaging or changing
of container, wrapper (that may include or not a
changing of label) in furtherance of distribution of
food.
• A manufacturer that conducts contract
manufacturing where conditions of the contract
are defined, agreed and controlled; and all
aspects of contracted work are specified to
obtain quality product/s conforming to agreed
standards.
• A registered owner of food and food products
and/or procure raw materials and packaging
component, quality control standards and
procedures,
but
subcontracts
the
manufacture of such products to a licensed
manufacturer.
• Distributes raw materials, ingredients, and or
finished products into local destination by
crossing international borders for further
distribution to the other establishment or
outlets.
• Distributes raw materials, ingredients, and or
finished products outside of origin by
crossing international borders for further
distribution to the other establishment or
outlets.
• Procures pre-packaged food products
and/or
raw
materials
from
local
establishment and locally distributes in
commercial quantity or wholesale basis.
Primary
Activities:
Other
Activities:
Manufacturer
Distributor
Trader
Repacker
Importer
Toll Manufacturer
Wholesaler
Importer of Raw
Materials for Own
Use
Importer of Raw Materials
for Own Use
Exporter of Own Products
Exporter
Exporter of Own
Products
Administrative Order 2020-017
Revised Guidelines on the Unified Licensing
Requirements and Procedures of the FDA
INITIAL LTO
1. Accomplished ePortal form with Declaration of
Undertaking
2. Proof of Business Name Registration
3. Business permit (as applicable)
4. Proof of Income (Latest audited Financial
Statement with Balance Sheet)
5. Payment of Fees
Renewal of LTO
1. Accomplished ePortal form with
Declaration of Undertaking
2. Payment of Fees
Variation
1. Accomplished ePortal form with Declaration of
Undertaking
2. Documentary requirements depending on the
variation (refer to Annex C of AO 2020-017)
3. Payment of Fees
For medium and large manufacturers, the
following documents shall be presented to the
FDA inspector:
1) Risk Management Plan (RMP)
2) Site Master File (SMF)
Criteria for Automatic Renewal of LTO:
I. The application is filed before the expiration date
of the license;
II. The prescribed renewal fee is paid upon filing of
the application; and
III. A sworn statement indicating no change or
variation whatsoever in the establishment is
attached to the application
VARIATION
1. Major: changes that may affect significantly and/or
directly the aspects of safety and quality of
products, which shall be approved only upon
compliance to requirements and inspection.
2. Minor: changes in administrative matters and/or
changes with minimal impact on or not critical to
safety and quality of products.
MAJOR VARIATION
Major Variation
Transfer of Location of
Manufacturing Plant
Expansion of Manufacturer
and/or Additional Product
Line or Change of
Manufacturing Activity
Application
Form

Business
Permit

Reflecting the
new address
Updated Site
Mater File
To be presented
during inspection
Payment

-
To be presented
during inspection


MINOR VARIATION
Minor Variation
Application
Form
Business Registration/
Business Permit
Transfer of Location of
Offices

Change of Distributor
Activity
Transfer/Addition of
Warehouse
Change of Ownership
Other document/s
Payment

Reflecting the new address
-


-
Contract Agreement to
prove activity



Reflecting the new address
-



Reflecting the new
ownership
• Any proof on the
transfer of ownership

MINOR VARIATION
Minor Variation
Application
Form
Business
Registration/
Business Permit

reflecting the new
name
Change of Business Name

Zonal Change in Address

-
Change of Qualified
Personnel

-
Change of Authorized Person

Other document/s
Payment
-


Certificate of Zonal change

Certificate of Attendance on
Seminar on Food Safety,
GMP or HACCP
Updated contact Details



Establishment
Type
Capitalization
MANUFACTURER/Repacker/
Trader/Toll Manufacturer
250K and below
over 250K but below 500K
500K but below 1M
1M but below 5M
5M but below 10M
10M but below 20M
20M but below 50M
50M and above
DISTRIBUTOR (Wholesaler,
Importer, Exporter)
VARIATION
Fee (LRF excluded)
INITIAL
RENEWAL
(2 years validity) (5 years validity)
1,000
1,500
2,000
4,000
6,000
10,000
20,000
30,000
2,500
3,750
5,000
10,000
15,000
25,000
50,000
75,000
8,000
20,000
500
LRF (Legal
Research Fee):
an amount
equivalent
to one
percent (1%) of
the fee imposed
but in no case
lower than ten
(10) pesos
Surcharge and Penalty
• An application for renewal of an LTO
received after its date of expiration shall be
subject to a surcharge or penalty equivalent
to twice the renewal licensing fee and an
additional 10% per month or a fraction
thereof of continuing non-submission of
such application up to a maximum of 120
days.
Turned Initial
• An application for renewal of license filed after
120 days shall be considered expired and the
application shall be subject to a fee equivalent
to the total surcharge or penalty plus the
initial filing fee and the application shall
undergo the initial filing.
For technical inquiries:
Send your e-mail to: cfrr@fda.gov.ph
For issuance of user account or reporting of eportal issues:
Send your e-mail to fdac@fda.gov.ph
Contact FDA Action Center at:
Landline: 02 8821 1176, 02 8821 1177, 02 8821 1220
02 8821 1162, 02 8821 1159
Mobile: 0961-6804447, 0961-7709691, 0961-6845994