Republic of the Philippines  
Department of Health  
OFFICE OF THE SECRETARY  
 
 
Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila ● Trunk Line 651 -7800 local 1108, 1111 to 13  
  Direct Line: 711 -9502 to 03 Fax: 743 -1829 ● URL: http://www.doh.gov.ph ; e-mail: ftduque@doh.gov.ph  
 
 
 
DRAFT AS OF 20  APRIL 2022  
 
ADMINISTRATIVE ORDER  
No.  - ________  
 
SUBJECT:  Revised Rules and Regulations on the Licensing of Food 
Establishments and Registration of Processed Food, and  Other 
Food Products, and for Other Purposes Repealing Administrative 
Order 2014 -0029  
 
 
I. RATIONALE  
 
Administrative Order (AO) No. 2014 -0029 was issued on 08 September 2014 to 
effectively strengthen the food control system and implement risk -based food control strategies 
by setting the rules and regulations for the issuance of License to Operate (LTO) and Certificate 
of Product Registration (CPR) to food establishments.  
 
Consistent with the objective of Republic Act (RA) No. 8792 or the Electronic 
Commer ce Act of 2000 in promoting the universal use of electronic transactions in the 
government, the electronic registration (e -registration) is now being adopted to streamline the 
application and evaluation process for registration of processed  food products.  
 
In view of the passing of Republic Act (RA) No. 11032, otherwise known as the Ease 
of Doing Business and Efficient Government Service Delivery Act of 2018 has led to the 
issuance of FDA Circular (FC) No. 2021 -012 to support the implementation of the eSer vices 
Portal System for LTO application of Food Establishments and FC No. 2020 -033 which 
provided a more user -friendly E -Registration System attuned with the requirements of the RA 
No. 11032.  
 
 
II. OBJECTIVES  
 
This Order aims to:  
 
1. Amend certain provisions of AO 2014 -0029 in the licensing of food establishments and 
registration of food products to adop t the new system of application  aligned with 
existing national laws, programs, policies and consistent with adopted international 
standards and best practices.  
 
2. Comply with the objectives of RA No. 8792 or the “Electronic Commerce Act of 2000” 
and any other relevant laws.  
  
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 3. To align with the requirements of ASEAN Sectoral Mutual Recognition Arrangement 
(MRA) for Inspection and Certification Systems on Food Hygiene for Prepared 
Foodstuff Products.  
 
 
III. SPHERE OF APPLICATION  
 
            This Administrative Order shall not cover fresh or raw food derived from plant, animal, 
fisheries and aquaculture products or foods in the primary production and post -harvest stages 
of the supply chain which are under the regulatory jurisdictio n of the Department of 
Agriculture. However, consistent with the ASEAN Harmonized Tariff Nomenclature, products 
which undergo pre -treatment process after post -harvest, i.e. brining, smoking, including 
physical preparation such as cutting and trimming (redu ction of extraneous materials such as 
peels, stems, fins & scales, or other non -edible parts) which may significantly alter the original 
nature of the food product after harvest and post -harvest treatment, shall be under the 
jurisdiction of the FDA. This s hall not cover imported and locally produced foods in the 
primary production and post-harvest  stages of food supply chain including minimal 
transformation of plant and animal foods after primary production such as removal of field heat 
for fruits, slaughte r of animals, sorting, grading and cutting of fresh plant and animal foods, 
icing and freezing, and milling and storage of grain which are under the jurisdiction of 
Department of Agriculture.  
 
             This Administrative Order shall cover imported and  locally produced processed and 
prepackaged foods under the jurisdiction of the FDA as defined in the RA  10611 or the Food 
Safety Act of 2013.  
 
          This shall also not cover Food businesses such as, but not limited to, activities in 
slaughter -houses , poultry dressing plants, fish ports, wet markets, supermarkets, school 
canteens, restaurants without manufacturing activity of prepacked foods , catering 
establishments, water refilling stations, street food sale, including ambulant vending, food 
kiosk of prepared foods, which are under the purview of the Local Government Unit (LGU).  
 
IV. DEFINITION OF TERMS  
 
           The Definition of Terms is specified in Annex A of this Issuance.   
 
V. GUIDELINES  
 
A. Guidelines for Licensing of Food Establishments  
 
1. General Principles  
 
 
a. Classification of establishments based on activities shall be defined by the current 
issuance from the Food and Drug Administration. The FDA shall issue 
authorization to food business operators based on compliance with current 
guidelines on food hygiene an d risk classification of food products. Risk 
classification of food products (Annex B) shall be updated by FDA subject to prior 
consultation with stakeholders.  
  
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 b. All FDA -covered food business operators shall:  
 
i. secure a License to Operate (LTO) before engag ing in food 
manufacturing, importation, exportation, sale, offer for sale, 
distribution, transfer and where applicable the use, testing, promotion, 
advertisement, and/or sponsorship of food products.  
ii. comply with the general principles of food hygiene inclu ding general 
requirements on sanitation, and as appropriate for the food business 
operator, comply with the relevant standards and requirements of the 
Code of Good Manufacturing Practice (GMP), HACCP, Good Storage 
Practice (GSP), Good Distribution Practice  (GDP), or the Sanitary 
Standard Operating Procedures (SSOP) to ensure safety and quality of 
products.  
iii. comply with relevant laws that address the nutritional quality of food 
and food products, such as the RA 8172 (ASIN Law) and RA 8976 
(Food Fortification  Act).  
iv. comply with the provisions of RA 9711, RA 10611, RA 3720 as 
amended by E.O. 175 ( Foods, Drugs and Devices, and Cosmetics Act) , 
RA 7394 ( Consumer Act of the Philippines) , and Presidential Decree 
No.856 ( Code on Sanitation of the Philippines)  to ensur e food quality 
and safety.  
v. comply with the regulatory requirements of the importing country 
before engaging in food export; and  
vi. allow inspection of their premises to verify compliance based on 
existing requirements.  
 
c. The activities allowed under a single l icense are summarized in Table 4  under 
Annex C . 
 
d. All applications for a License to Operate shall be accepted by the FDA only when 
all the requirements including payment of prescribed fees have been completed.  
 
e. An entity, natural or juridical person, applying for LTO as a food manufacturer, 
distributor, importer, exporter, wholesaler, trader or repacker shall be issued the 
LTO per establishment, regardless of the ownership, only when they have complied 
with all t he necessary requirements and if consistency in manufacture and/or 
distribution of safe and quality products are demonstrated.   
 
f. Food business operators shall first apply for an initial LTO following the existing 
licensing requirements and prescribed fees as per current FDA regulations.  
 
g. Application for initial CPR shall be filed once the FDA -LTO is approved.  
 
h. The LTO and CPR shall  be a requirement before a food establishment can join food 
trade and exhibitions, market research or testing of unregi stered processed food 
products. For foreign exhibitors may join local food expositions or exhibit prior 
issuance of an LTO to their consi gnees.   Note, however, that the sample of the 
products imported for the exhibition shall be secured with BOC Clearance by 
complying with the requirements listed in Annex F of this order.   
  
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 i. Applicants must prove their capability and capacity to assure food safety and 
quality through compliance with GMP, GDP, GSP, HACCP, and/or other food 
industry best practices recognized by the Food and Agriculture Organization of the 
World Health Organization, as appropriate.  
 
j. All FDA -licensed food establishments shall be primarily responsible for 
determining the regulatory requirements of the importing country before engaging 
in food export.  
 
k. Only one licensed establishment shall operate at a given address or facility. 
Establishments engaged in the same activity are not allowed to share the same 
address or facility, regardless of ownership.  
 
l. The inclusion of virtual offices shall be allowed on ly when coupled with a physical 
address.  
 
m. For affiliated companies with different activities, sharing of facilities may be 
allowed provided that each establishment shall secure a license accordingly.   
 
n. Valid LTO shall be displayed in a conspicuous place in the establishment or 
business office or premises. Failure to display the valid LTO shall be grounds for 
revocation of the LTO.  
 
o. Changes of Business Information  of the establishment, such as but not limited to: 
location, business name and owner, additional or reduction in the product lines, 
inclusion or deletion of any activities/products shall prior notification to FDA by 
filing an application for LTO variation.  
 
p. For assignment and transfer of pending applications, existing licenses, if there is a 
change in ownership while the application is in process, the application shall be 
considered terminated. The new owner or the new regulatory officer shall file for 
initial application.  
 
q. For licensed establishments with revoked/ cancelled/ suspended LTO resulting 
from violations as stated in this Order and/or in RA 9711 and/or o ther relevant food 
regulations,  after due process, shall not be allowed to re -apply for a new LT O using 
the same company/owner/business name for a period of three (3) years.  
 
2. Specific Guidelines for Manufacturers including Traders  
  
a. A single LTO shall be issued to manufacturing plants in different locations within 
the same municipality/city producing  a single product at different processing stages 
indicating their respective addresses. In this instance, the principal office address 
shall be reflected at the front page of the LTO while the other address/es at the back 
page thereof or secondary page app ended thereto.  
 
b. A food manufacturer producing different products at different locations within the 
same municipality/city shall be issued separate licenses for each location.  
  
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 c. Imported and locally -sourced raw materials covered by RA 89 76 and its IRR, and 
RA 8172 for  own use of manufacturers shall comply with the requirements such as 
results of analysis and other documents as deemed necessary.  
 
d. A licensed salt manufacturer or repacker may engage in manufacturing or repacking 
of other food products within th e same address under a single license. Similarly, a 
licensed food manufacturer or repacker may engage in manufacturing or repacking 
of iodized salt and distribute it accordingly, subject to compliance of technical 
requirements and subsequent monitoring.    
 
e. Manufacturers may engage in any activity it is able to satisfy the requirements for, 
including processing;  
  
f. Packer or Repacker may engage in any activity it is able to satisfy the requ irements 
for, except processing.  
 
g. For bottled drinking water, the stan dards and GMP requirements as stated in 
Administrative Order No.18 -A s.1993 or its amendment shall be followed.  
 
h. A food business operator  without a food manufacturing facility and contracts the 
services of a licensed food manufacturer to toll -manufacture i ts products shall 
secure an LTO as Trader.  
  
i. A trader may engage in any activity it is able to satisfy the requirements for,  except 
processing or packaging.  
 
 
3. Specific Guidelines for Distributor (Importer/Exporter/Wholesaler)  
a. Food distributors (importer, exporter, and/or wholesaler) utilizing or sharing one 
office with another establishment shall not be allowed regardless of ownership. For 
establishments using the same location, further distinction as to room/unit/level/ or 
building number shall be specifi ed in the address.  
  
b. For distributors, all warehouses and depots shall be declared in the LTO.  
 
c. Importers shall comply with the applicable law, rules and regulations. Importers of 
raw materials covered by RA 8976 and its IRR, and RA 8172 shall comply with  the 
requirements prior to importation.  
 
d. A distributor (importer, exporter or wholesaler) may engage in manufacturing or 
repacking provided that an LTO as manufacturer or repacker is secured.  
 
e. Exporters should satisfy the requirements of the importing cou ntry prior to export.  
 
f. Distributors (importer, exporter, wholesaler) engaged in online distribution using 
internet -based platform shall secure applicable LTO prior to engaging in 
importation, exportation, sale, offer for sale, distribution, transfer, and where 
applicable, using,  testing, promoting, advertising, and/or sponsorship of food 
product/s.   
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g. A consolidator/indenter/middleman engaging in any distributor  activity except 
limited to representation shall likewise secure an LTO as distributor.  
 
h. Distributors with a license for  a specific activity may engage in other distributor 
activities it is able to satisfy the requirements for.  
 
i. Distributors activities may be applied for by a manufacturer or distributor, at the 
same time as the license or later added as an amendment after l icensing  
 
4. Inspection and Certificate of Compliance  
 
a. The FDA -Regional Field Office (RFO) will verify documentary requirements based 
on current licensing requirements submitted during the filing of application and 
technical documents based on guidelines on food hygiene during inspection prior to 
issuance of a  License to Operate as a Food Manufacturer.  
  
b. Manufacturers shall be subjected to pre -licensing inspection following the FDA 
quality manual. All other establishments shall be inspected at any time within the 
validity of its LTO.  
 
c. A certificate of compliance (COC) shall be issued following a risk -based approach 
or HACCP depending on the level of risks and complexity of production, among 
others.  
 
d. Recommendation letter (RL) may be issued to establishments instead under the 
following conditions:  
 
i. The establishment is applying for renewal provided that the criteria stated in 
RA 9711, Book II, Art. I Sec.3. A. (2) are duly satisfied . 
ii. The establishment is applying for variations that does not require 
inspection .  
 
If the licensed establishment is not inspected or fails to conform with existing 
rules and regulation upon inspection within the validity of its LTO, the 
establishment is not qualified for its automatic renewal. In addition, a GMP 
Certificate, requiring at least one year of operation in g ood stan ding, is likewise 
disqualified.  
 
e. The FDA reserves the right to conduct inspection of food establishments for any of 
the following purposes: routine; spot check; post -market surveillance of products ; or 
action  on any report of food -borne illness or complaints received by FDA.   Upon 
validation of non -compliance to FDA safety and quality standards, the FDA CFRR 
Director shall revoke the LTO and CPR immediately, following due process.  
 
f. For warehouse/s in location/ s other than the address covered by the issued LTO, the 
concerned RFO shall coordinate with respective regions to forward a copy of the 
inspection report per warehouse address/es. Addition of warehouse and/or cold 
storage  shall be filed as a LTO variation and is subject to inspection depending on the 
risk of the products.   
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g. The FDA may conduct inspections in collaboration with the LGUs and any agency or 
office under the DOH, DA and DILG.  
 
5. Requirements  
 
The requirements for issuance of LTO and its amendments are specified in 
Administrative Order No. 2020 -0017 “Revised Guidelines on the Unified Licensing 
Requirements and Procedures of the Food and Drug Administration Repealing 
Administrative Order No. 2016 -0003” or its latest amendment.  
 
6. Validity of the LTO  
 
a. Unless revoked, the LTO shall have the following validity period:  
 
i. An initial license issued shall be valid for two (2) years; and  
ii. A renewal license shall be valid for five (5) years.   
  
7. Process of Application  
 
          The process of application is as prescribed by current FDA regulations and shall be 
guided by the following:  
 
a. A Certificate of Compliance (COC) per post -inspection, or Recommendation Letter 
(RL) if post -licensing inspection applies, shall be issued by the FDA inspectorate in the 
respective regions. Should a site inspection or pre -licensing inspection be required, the 
inspection shall be scheduled with the applicant before the COC is issued.  
 
b. However, in the course of  RFO evaluation, monitoring, inspection and spot 
checking, upon finding of any violation in the compliance and other requirements by 
the FDA and its implemented laws, such as the FDA Act of 2009  and other relevant 
laws, the RFO shall submit a report of violation to serve as basis for the motu propio  
action of the Director of the Regional Field Office; ” as per Book 1 Article VIII of the 
IRR of RA 9711 under Section 7 (g). Hence, the RFO upon verifi cation/inspection that 
the food establishment has not complied with the requirement has the power to 
recommend for disapproval and sign the proper action by the Director of the RFO.  
 
c. Approval or disapproval of applications with COCs shall be signed by the Director 
of the Center for Food Regulation and Research under the authority of the FDA Director 
General.  
 
d. The notice of disapproval of applications for license shall clearly state the reason for 
disapproval.  
 
B. Guidelines in the Registration of Processed Food Products  
 
1. General Principles  
 
a. All processed food products including food additives, food supplements (FS) and 
bottled water, shall first be registered with the FDA before these are distributed,  
8 
 supplied, sold or offered for sale or use and advertised,  among other marketing or 
promotional activities.  
 
b. Only one (1) Certificate of Product Registration CPR shall be issued to a product 
that has multiple packaging sizes provided that it meets all of the following 
conditions:  
i. The same brand name;  
ii. The same product name/ variant;  
iii.The same product formulation/ same ingredients in the same order of 
proportion; and  
iv. The same label information, except net weight.  
 
 
c. Likewise, regardless of the packaging sizes, only one (1) CPR shall be issued to a 
product that has labels with multiple models  and/or multiple suggested recipes on the 
pack provided that it meets all of the following conditions:  
i. The same brand name;  
ii. The same product name/ variant;  
iii. The same product formulation/same ingredients in the same order of proportion; 
and 
iv. The same label information except net weight.  
 
d. The company should secure permission from the FDA through amendment applications 
(i.e. additional packaging design) for any additional label design or other label changes 
prior to use in advert isement, promotion, and commercial distribution.   
 
e. Should a product fail to meet the requirements for product registration, applicable 
product standards, and labeling regulations, a Letter of Denial shall be sent 
electronically through the e -registration system and through registered email. A 
maximum of six (6) months shall be given to comply and file for re -application. Beyond 
this date, it shall be treated as INITIAL and the prescribed fee shall be paid.   
 
f. All product applications shall undergo pre -assessment to determine completeness of the 
submitted documentary requirements based on the issued guidelines for pre -assessment 
or its amendment thereof . 
 
g. Food establishments with License to Operate (LTO) activity as Importer/Distributor, 
Trader, and Manufacturer shall be regarded as the Market Authorization Holder 
(MAH). The MAH shall be primarily responsible for the filing of CPR applications 
using its own account, ensuring quality and safety and continued compliance of the 
product with applicable ru les and regulations of the FDA.   
 
h. CPR shall be secured by the respective distributor, trader, exporter, repacker or 
manufacturer for each imported and locally manufactured raw materials, ingredients 
and food additives which are intended to be sold, offered  for sale or use or for 
distributed to other food establishments and food business operators for further 
processing and/or for institutional use.   
 
Food manufacturers or traders who directly import raw materials, ingredients, and 
food additives to be used for the production of their own products or by their toll - 
9 
 manufacturers need not secure a CPR provided that their LTO has an approved 
activity as an importer of raw materials for their own use. The finished products that 
use these imported raw materials sh all be registered with the FDA.  
 
i. Should the FDA -licensed food manufacturer/importer use or source out local 
ingredients and food additives, it shall be purchased from FDA -licensed 
establishments.  
 
j. The registration requirements for food establishments intending to export products are 
the same. However, food establishments with the intention to export shall comply 
with all the regulatory standards and requirements of the importing country, including 
the labelling requirements.  
 
k. A previously registered pr oduct initially for local distribution shall be allowed to be 
exported using the same CPR as long as the following conditions are met and 
labelling and standards of the importing country are likewise met:  
i. The same brand name;  
ii. The same product name/ variant ; 
iii. The same product formulation/ same ingredients in the same order of 
proportion; and  
iv. The same label information except net weight.  
 
Filing of amendment applications (i.e. additional packaging design) to FDA shall be 
made and labels in the language of the importing country shall likewise be submitted.  
 
l. Only food additives listed in the latest Codex Stan 192 -1995 known as the General 
Standards for Food Additives (GSFA) and/or the latest FDA Listing of Food Additives 
and/or approved pharmaceutical excipients list intended for processed foods products 
including FS in pharmaceutical dosage form such as tablet, soft gel capsule and capsule 
shall be issued a CPR.  
 
m. Validity of CPR will be 2 years minimum to 5 years’ maximum for initial and 5 years 
for renewal; prov ided that upon renewal, its MAH conforms with the pertinent 
standards and requirements including labeling regulations.   
 
n. The FDA may require additional documents on products that are considered high risk 
food provided that the reason for the additional req uirements is to address  uncertainties 
on safety as deemed necessary to ensure quality and safety.   
 
i. For medium and high risk food products including for “institutional use only” 
with standard of identity (e.g. Infant Formula, Milk Supplement, Foods for 
Infants and Young Children, Foods for Special Medical Purposes, Foods for 
Special Dietary Uses, FS, bottled water, etc.), the corresponding Certificates of 
Analysis for assessment of compliance to such standards must be uploaded. In 
addition, these product s should conform to the chemical and microbiological 
parameters and nutritional requirements based on existing Codex standards, 
national and FDA regulations.  
  
10 
 o. In case there is a health issue other than the growth of pathogenic microorganisms or 
other food safety related incidents (e.g. chemical contamination or adulteration), FDA 
has the option to impose other requirements through regulatory issuances.  
 
p. In addition to the requirements in the proceeding sections, the FDA may conduct 
inspection of the manufacturing or processing plant or verification of documents 
submitted or may require additional documents or evidence to ascertain the safety 
and/or quality of the product.  
 
q. If the company has several plants in one or different cities/towns/provinces 
manufacturing the same product, each plant shall apply for separate registration of the 
product.  
 
2. Quality and Safety Standard  
 
a. Food products shall be evaluated based on the technical documents submitted for safety 
and quality. Only those food establishments with products that have complied with the 
requirements and meet the standards for food safety, quality, and labeling, including 
relevant standards set by the FDA/Codex for specific food categories, as applicable, 
will be issued a CPR.  
 
b. All p rocessed and prepackaged food products shall comply with the relevant 
appropriate/ applicable quality and safety standards, if any.  
 
c. Imported food products must come from countries with an equivalent food safety 
regulatory system with the FDA. Hence, the f ollowing are hereby recognized as 
equivalent:  
i. Certificate of Registration with GMP Compliance or its equivalent  
ii.Valid Sanitary Phyto -Sanitary Certificate or Health Certificate  
iii. ISO 22000 Certificate or FSSC Certificate  
iv. HACCP Certificate  
v. Certificate of Free Sale  
 
d. All certificates of analysis submitted must be issued within twelve (12) months from 
the date of filing of the application or the date of payment.  
 
e. For FS, the physical, chemical, and microbiological analysis, Stability Data of the 
finished product and Safety Data (e.g. LD50 or toxicity tests as applicable to products 
with herbs and botanical ingredients not included in Official Pharmacopoeias and 
Generally Recognized as Safe (GRAS) list or other applicable test procedures or reports 
to assess potential toxicity) must be attached to establish safety and/or address 
uncertainties on safety of the product.  
 
f. For food products covered by Republic Act No. 81 72 otherwise known as “ An Act for 
Salt Iodization Nationwide (ASIN)”  and Republic Act No. 8976 or the  “Philippine 
Food Fortification Act of 2000” , the Certificate of Analysis attesting its conformity to 
prescribed fortification levels must be uploaded. Lev els of iodine must conform to the 
latest acc eptable level of fortification based on FDA Circular 2013 -007 or its 
amendment.  
  
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 3. Product Claims and Labeling  
 
a. Except for FS, no food samples shall be submitted to the FDA provided that the labels 
of primary and secondary packaging (if any) are clear and bear the complete label 
information.  
 
b. Food supplements shall not have curative claims or therapeutic claims. Ot her claims 
shall be reviewed in accordance with existing and relevant labeling guidelines.  
 
c. Advertising and promotional materials of food establishments and food business 
operators shall not make curative or therapeutic claims.  
 
d. Nutrition and Health Claims  declared on the product labels must be supported by 
relevant documents (e.g. scientific research, etc.) following Bureau Circular 2007 -002 
(Guidelines in the Use of Nutrition and Health Claims in Food).  
 
e. Label Exhaustion (e.g. Labels of products covered b y Milk Code reflecting the old FR 
Number) can be requested provided that there is a letter of justification and the 
inventory with the target date for consumption is clearly stated. Approval of such a 
request shall be subject to review. Request for label e xhaustion shall not be considered 
for food products with an issued Report of Violation by the FDA.  
 
f. In cases of exhaustion of existing labels permitted by the FDA, the use of a provisional 
sticker label shall only be allowed for a maximum period of 6 month s. All information 
should be accurate and legible. The sticker must be durable, i.e. cannot be easily 
removed from the label or packaging.   
 
4. Requirements  
 
The requirements for issuance of Certificate of Product Registration and its amendments 
are specified in Annex E of this Issuance.  
 
5. Validity of the Registration   
 
Unless revoked within the validity period, the CPR shall be valid for 2 years minimum to 
5 years maximum for initial (except for FS) and 5 years for renewal.   Maximum years of 
validi ty for initial registration of FS shall be based on A.O. 50 s. 2001 or the latest.  
 
6. Registration Process  
 
    The procedure for CPR application shall follow the Electronic Registration System as 
prescribed in FDA Circular 2020 -033 “Procedure for the Use  of Electronic Registration System 
for Prepackaged Processed Food Products” or its latest amendment thereof.   
7. Grounds for Disapproval of Applications  
    The following shall be grounds for disapproval of an application:  
a. Failure to submit complete documentary requirements.   
12 
 b. Failure to meet the appropriate standards, existing rules and regulations, guidelines or 
requirement documents or inspection of the food establishment's offices and premises.  
c. Failure to respond to notice of deficiency or to submit  documents within prescribed 
timeline.  
d. Misrepresentations, false entries, or withholding any relevant data contrary to the 
provisions of the law, these Rules and Regulations or appropriate standards.  
e. Such other analogous grounds or causes as determined by the FDA.  
D. Fees and Other Charges  
     Initial and renewal application fees and other charges shall be collected as may be allowed 
by the existing rules on fees and charges or surcharges.   
 E. Post -Market Surveillance and Product Monitoring  
      Post-Market Surveillance and product monitoring shall be conducted by the FDA based on 
the risks presented by food products.  Samples of products shall be collected for testing, and 
routine or spot checking of food establishments shall be conducted o n a regular basis.  Food -
borne illnesses and epidemiological data shall be studied as a basis for planning or instituting 
measures to reduce food -borne outbreaks.  Risk communication in collaboration with other 
stakeholders shall be heightened to reduce th e risk of food borne illnesses brought about by 
food products.  Risk management plan or food safety plan as well as attendance to food safety 
seminars or training shall be required food business operators to ensure continuous compliance 
with food safety st andards.  
 
VI. PENALTY CLAUSE  
 
Any establishment or processed prepackaged food product found to be in violation of 
any provision of this issuance shall be a ground for disapproval of application, suspension, 
revocation or cancellation of LTO, CPR or any authorization pursuant to Section 4, Article 
1, Book II of the Implementing Rules and Regulations (IRR) of RA No. 9711.  
 
Notwithstanding the preceding paragraph, nothing in this section shall restrict the FDA 
in imposing the penalty and sanctions as prescr ibed under RA No. 10611 and its IRR.  
 
 
VII. SEPARABILITY CLAUSE  
 
             If any part or provision of this Order is rendered invalid by any court of law or 
competent authority, the remaining parts or provisions not affected shall remain valid and 
effective.  
 
 
VIII.  REPEALING CLAUSE   
 
         Administrative Order No. 2014 -0029 or the “Rules and Regulations on the Licensing 
of Food Establishments and Registration of Processed Food, and Other Food Products, and  
13 
 for Other Purposes” and other related issuanc es inconsistent or contrary to the provisions of 
this Administrative Order are hereby repealed, amended, or modified accordingly.  
 
 
IX. EFFECTIVITY  
 
          This Order shall take effect fifteen (15) days from the date of its publication in the 
Official Gazette or in any national newspaper of general circulation, with three (3) certified 
copies to be filed with the Office of the National Administrativ e Register (ONAR) of the UP 
Law Center.  
 
 
 
 
 
     FRANCISCO T. DUQUE III, MD, MSc  
                                                                                  Secretary of Health  
 
 
Office  Food and Drug Administration  Office of the Secretary  
 
 
Initial   
 
 
DR. OSCAR G. GUTIERREZ, JR., MPA  
Officer -In-Charge, Director General   
 
 
ATTY. FATIMA P. LAPERAL  
Head Executive Assistant  
Date    
 
 
 
Keywords  Licensing, Registration, Certificate of Product Registration, License to Operate  
Related issuances, laws, 
directives from other 
government agencies  FDA Circular No.2021 -012 “Guidelines for the Use of the Food and Drug Administration (FDA) 
eServices Portal System for License to Operate (LTO) Application of Food Traders and Food 
Distributors Including Wholesaler s, Importers, and Exporters of Processed Food Products, Food 
Supplements, Bottled Water, and Iodized Salt”, FDA Circular No.2020 -033“Procedure for the Use of 
the Modified Electronic Registration System for Raw Materials and Prepackaged Processed Food 
Produ cts Repealing FDA Circular No. 2016 -014 “Procedure for the Use of Electronic Registration 
System for Prepackaged Processed Food Products”   
1 
 Annex A  
 
Definition of Terms  
 
For the purpose of this issuance the following terms are defined:  
 
A. Activity  refers to either processing, packaging, repackaging, trading, import, wholesale, 
export, sale, promotion, or offer for sale, of a food product.  
 
B. Advertising  refers to the business of conceptualizing, presenting or making available to 
the public, through a ny form of mass media, fact, data or information about the attributes, 
features, quality or availability of food and its related products for the purpose of promoting 
its sale or distribution and enhancing economic activity.  
 
C. Authorization  refers to the pe rmission embodied in a document granted by a regulatory 
agency to a natural or juridical person who has submitted an application for a food business 
operation from primary production, post -harvest handling, distribution, processing, 
manufacture, importatio n, exportation, sale, and offer for sale, transfer and preparation for 
human consumption. The authorization can take the form of a permit, license, certificate of 
registration and certificate of compliance or exemption or any similar document.  
 
D. Bottled Wat er means water that is placed in a sealed container or package and is offered 
for sale for human consumption as drinking water.  
 
E. Certificate of Product Registration (CPR)  is an authorization issued by the FDA for 
specific health products after evaluation and approval of submitted registration 
requirements.  
 
F. Contaminant  refers to any substance not intentionally added to food which is present in 
such food as a result of the production (including operations carried out in crop industry, 
animal husbandry and veterinary medicine) post -harvest handling, manufacturing, 
processing, preparation, treatment, packing, packaging, transport or holding of such food 
as a result of environm ental contamination.  
 
G. Control  measure  refers to any action and activity that can be used to prevent or eliminate 
food safety hazard or to reduce it to an acceptable level.  
 
H. Distribute  means the delivery or sale of any health product for purposes of distrib ution in 
commerce, except that such term does not include the manufacture or retail of such product.  
 
I. Distribution  means any activity where a food product is stored by an establishment and/or 
transported to another establishment, with the intention of poss ible further retail.   
 
J. Distributor/Importer/Exporter refers to any establishment that imports or exports raw 
material, ingredients and/or finished products for wholesale distribution to other 
establishments or outlets. If the distributor/importer/exporter sells to the general public, it 
shall be considered a retailer. Further, in addition to the existing activities of the distributor, 
similar or parallel activities in other locations, i.e. importers with branches in the regions 
and issues invoice, shall be covered by the original authorization and therefore subject to  
2 
 the same responsibilities and corresponding sanctions if violations are committed from the 
other declared locations.  
 
K. Distributor/Wholesaler  refers to any establishment that procures raw materi als, and/or 
finished products from local establishments for local distribution on a wholesale basis.  
 
L. Establishment  means a sole proprietorship, a partnership, a corporation, an institution, an 
association, or an organization engaged in the manufacture, im portation, exportation, sale, 
offer for sale, distribution, donation, transfer, use, testing, promotion, advertising, or 
sponsorship of health products, including the facilities and installation needed for its 
activities.  
 
M. Export  refers to distribution outside of origin by crossing international borders.  
 
N. Food  refers to any substance or product whether processed, partially processed or 
unprocessed that is intended for human consumption. It includes drinks, chewing gum, 
water and o ther substances which are intentionally incorporated into the food during its 
manufacture, preparation and treatment.  
 
O. Food additive  refers to any substance not normally consumed as a food by itself and not 
normally used as a typical ingredient of the food , whether or not it has nutritive value, the 
intentional addition of which to food for a technological (including organoleptic) purpose 
in the manufacture, processing, preparation, treatment, packing, packaging, transport or 
holding of such food results, o r may be reasonably expected to result (directly or indirectly), 
in it or its by -products becoming a component of or otherwise affecting the characteristics 
of such foods. The term does not include contaminants or substances added to food for 
maintaining o r improving nutritional qualities.  
 
P. Food -borne illnesses  refer to diseases, usually either infectious or toxic in nature, caused 
by agents that enter the body through the ingestion of food.  
 
Q.  Food business  refers to any undertaking, whether public or priva te, which carries out any 
of the activities related to, or any of the stages of the food supply chain.  
 
R. Food Business Operator  refers to a person engaged in the food business including one’s 
agents and is responsible for ensuring that the requirements of t he Food Safety Act of 2013 
are met by the food business under one’s control. It can be classified as manufacturer, 
repacker, distributor, importer, exporter or trader.  
 
S. Food / Dietary Supplement  refers to a processed food product intended to supplement the  
diet that bears or contains one or more of the following dietary ingredients: vitamins, 
mineral, amino acid, herb, or other dietary substance of botanical, animal, artificial or 
natural origin to increase the total daily intake in amounts conforming to th e latest 
Philippine recommended energy and nutrient intakes or internationally agreed minimum 
daily requirements. It is usually in the form of capsules, tablets, liquids, gels, powders or 
pills and is not represented for use as a conventional food or as th e sole item of a meal or 
diet or a replacement for drugs and medicines.  
  
3 
 T. Fortification  means the addition of nutrients to processed foods or food products at levels 
above the natural state.  
 
U. Good Manufacturing Practice (GMP)  refers to a quality assurance s ystem aimed at 
ensuring that products are consistently manufactured, packed or held to quality standards 
appropriate for the intended use. It is thus concerned with both manufacturing and quality 
control procedures.  
 
V. Good Distribution Practice (GDP) or Goo d Storage Practice (GSP)  refers to a part of 
the quality assurance system where appropriate procedures for sanitary handling of food 
on storage and distribution are established. Storage and transportation of finished food 
should be under conditions that wi ll protect food against physical, chemical, and microbial 
contamination as well as against deterioration of the food and the container. Warehouses 
are kept free from rodents, insects, birds and other pests.  
 
W. Hazard Analysis and Critical Control Points (HAC CP) refers to a science -based system 
which identifies, evaluates and controls hazards which are significant for food safety at 
critical points during a given stage in the food supply chain.  
 
X. Import  refers to the distribution into a local destination by cro ssing international borders. 
In case of imported food products, the manufacturer’s representative or, in his absence, the 
importer shall be deemed the manufacturer taking full accountability to ensure quality and 
safety of imported food products locally di stributed.   
 
Y. Ingredients  is any substance including food additive, used as a component in the 
manufacture or preparation of a food and present in the final product in its original or 
modified form.  
 
Z. Inspection  refers to the examination of food, food production facilities or establishments, 
and the management and production systems of food businesses, including the examination 
of documents, finished product testing and registration, and of the origin and destina tion of 
production inputs and outputs to verify compliance with legal requirements by an agency 
mandated to perform food safety regulatory and /or enforcement functions. Label refers to 
the display of written, printed or graphic matter upon the immediate c ontainer, tag, 
literature or other suitable material affixed thereto for the purpose of giving information as 
to identify components, ingredients, attributes, directions for use, specifications and such 
other information as may be required by law or regula tions.  
 
AA. Licensing  means the process of approval of an application to operate or establish an 
establishment prior to engaging in the manufacture, importation, exportation, sale, offer for 
sale, distribution, transfer, and where applicable the use, testing, promotion, advertisement, 
and/or sponsorship of health products.  
 
BB. Local Government Unit (LGU)  shall mean the city or municipality, provincial or 
regional government unit which issues the Sanitary Permit in compliance with the National 
Sanitation Code of th e Philippines and the Mayor’s Permit.   
 
CC. Manufacturer  means an establishment engaged in any and all operations involved  in 
the production of health products including preparation, processing, compounding,  
4 
 formulating, filling, packaging, repacking, altering, ornamenting, finishing and labeling 
with the end in view of its storage, sale or distribution. Likewise, it may also manufacture 
as a commissary for products intended for institutional use and for distribution in its various 
outlets. It shall be allowed to import raw materials or finished products as ingredients or 
additives for their own use to manufacture registered products. A trader, on the other hand, 
shall be categorized as a manufacturer in which its products are manufactured by a licensed 
manufacturing facility, otherwise termed as toll -manufacturer. In such a case, the trader 
owns the formulation of the product. A trader may also import its own raw materials which 
shall be processed by its toll manufacturer.  
 
DD. Monitoring  refers to the syste matic gathering of data through the sampling of 
commodities as well as monitoring of food -borne diseases, collation and interpretation of 
collected data.  
 
EE. Packaging  refers to an activity where a product is contained AND SEALED with the 
intention of storage  and/or transport.  
 
FF. Packer/repacker  means any establishment that repacks a finished product into smaller 
quantities in a separate container and/or secondary packaging, including but not limited to 
relabeling, stickering and bundling for promo packs with th e end view of storage, 
distribution, or sale of the product.   Repacker is any establishment engaged in the process 
of packaging or changing of container, wrapper (that may include changing of label) from 
a bulk material to retail packaging sizes in further ance of distribution of food. Note that 
packaging may refer to either the primary packaging that is directly attached to the food 
product (sachet/blister then box) or the secondary packaging containing the wrapped food 
(aluminum foil then box). Another lay er, tertiary packaging (box of 12 to box of 6), i.e. 
bulk boxing, or shrink wrap (not part of repacking) shall be considered as bundle packing 
or bundling. Therefore, if the establishment is importing food products that will be 
packed/boxed locally, the es tablishment must secure an LTO as Repacker/Importer of Raw 
Materials for Own Use.  Food Distributors bundling (no re -labelling, no repacking, with at 
least 6 -month expiration period) of products for promo or donation may be allowed. 
Stickering for additiona l information on labels is likewise an allowed activity for the 
licensed food distributor.  
 
GG. Permit  refers to a form of authorization that is issued by the FDA to an establishment 
that has complied with the application requirements.  
 
HH. Processing  refers to any action that substantially alters the initial raw materials or 
product or ingredients including, but not limited to, heating, smoking, curing, maturing, 
drying, marinating, extraction, extrusion, freezing, fermentation or a combination of tho se 
processes intended to produce/manufacture food.   
 
II. Raw materials  are all substances that are employed in the processing of a finished product, 
packed in bulk containers and not labelled as a finished product. Raw Materials or 
ingredients would have produ ct specifications that comply with the client requirements and 
not necessarily a single component.  
  
5 
 JJ. Repackaging  refers to a manufacturing activity where a food product is taken out of a 
larger or bulk packaging and again contained with the intention of fur ther storage, transport 
and distribution.   
 
KK. Retailer  means any establishment which sells or offers to sell any health product directly 
to the general public.  
 
LL. Risk  refers to a function of the probability of an adverse health effect and the severity of 
the effect, consequential to a hazard(s) in food.  
 
MM.  Salt Iodization  refers to the addition of iodine to salt intended for human consumption 
in accordance with the specifications as to form, fortificant type, method, manner and 
composition as may be prescribed b y the FDA.   
 
NN. Source  refers to any establishment able to supply food products to another establishment 
through further importation, wholesale or export.   
 
OO. Trader  means any establishment which is a registered owner of food and food products 
and/or procure th e raw materials and packing components, quality control standards and 
procedures, but subcontracts the manufacture of such products to a licensed manufacturer. 
In addition, a trader may also engage in the distribution and/or marketing of its products. 
A trader may only subcontract to a licensed manufacturer that is likewise authorized to toll -
manufacture the particular product based on an approved LTO variation. and that such an 
agreement should be binding in writing.  
 
PP.  Toll Manufacturer  refers to the 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 the agreed 
standards.  
 
QQ. Wholesal e refers to local distribution of pre -packaged food products in commercial 
quantities.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
1 
  
ANNEX B  
 
PROCESSED FOOD PRODUCTS CLASSIFICATION   
ACCORDING TO MICROBIOLOGICAL RISK   
 
The following list, but not limited to, shows food products identified by FDA based from the 
Codex Alimentarius General Standard for Food Additives (GSFA) and the UN Food and Agriculture 
Organization (FAO) Risk Categories:  
 
 
A. LOW RISK FOODS  
 
Low Risk (LR) Foods – Foods that are unlikely to contain pathogenic 
microorganisms and will not normally support their growth because of food 
characteristics and foods that are unlikely to contain harmful chemicals.  
 
 
Table 1. List of Low Risk Food Product s 
LOW RISK FOOD PRODUCTS  
A. FATS, OILS AND FAT EMULSIONS  
1. Butter oil, anhydrous milkfat, ghee   
2. Vegetable oils and fats  
3. Animal fats (lard, tallow, fish oil and other animal fats)  
4. Fat emulsions mainly of type oil -in-water, including mixed and/or flavored products based on fat 
emulsion    
5. Fat emulsions mainly of type water -in-oil (butter, fat spreads, margarine dairy fat spreads and 
blended spreads)  
6. Fat-based desserts excluding dairy -based desserts  
B. PROCESSED FRUITS, VEGETABLE AND EDIBLE FUNGI (including mushrooms and  fungi, roots 
and tubers, pulses and legumes, and aloe vera) SEAWEEDS, AND NUTS AND SEEDS  
1. Dehydrated fruits or vegetables, including candied fruits (mechanically dried)  
2. Jams, jellies, marmalades (pastry, topping, filling, coconut spreads)  
3. Dehydrated Vegetable protein products   
4. Fruits or vegetables  in vinegar, oil or brine  
5. Fruit -based spreads (e.g. chutney) excluding jams, jellies and marmalades  
6. Fruit preparations, including pulp, purees , fruit toppings and coconut milk  
7. Cooked  fruits  
8. Frozen vegetables (including mushrooms and  fungi, roots and tubers, pulses and legumes, and aloe 
vera) seaweeds, and nuts and seeds  
9. Vegetable (including mushrooms and fungi, roots and tubers, pulses and legum es, and aloe vera), 
seaweed, and nut and seed in pulps and preparations (e.g. vegetable desserts and  sauces, candied 
vegetables) other than food in HR Letter B.2 (Vegetable purees, spreads – peanut butter)  
10. Cooked or fried vegetables(including mushrooms and  fungi, roots and   tubers, pulses and legumes, 
and aloe vera), and seaweeds  
C. CONFECTIONERY  
1. Confectionery including hard and  soft candy, nougats, marzipans, etc. other than in MR Letter D 
(cocoa products and chocolate products)   
2. Chewing gum  
3. Decorations (e.g. for fine   bakery wares, sugar flowers), toppings (non -fruit), and sweet sauces  
 
 
  
2 
 LOW RISK FOOD PRODUCTS (continued)  
D. 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 F below  
1. Flours, starches (including soybean powder) and flour mixes  
2. Breakfast cereals including  rolled oats   
3. Pasta and noodles and like products (e.g. rice paper, rice vermicelli, soybean pastas  and noodles)  
a. Fresh  pastas and noodles and like products  
b. Dried pastas and noodles and like  products  
c. Pre-cooked pastas and noodles and like  products  
4. Cereal and  starch based desserts (e.g. rice pudding, tapioca pudding, native delicacies)  
5. Batters (e.g. for breading or batters for fish  or poultry)  
6. Pre-cooked or processed rice products, including rice cakes (Oriental type only)  
7. Soybean products (excluding soybean -based seasonings and condiments under LR Letter H 
(seasonings, condiments and sauces)  
a. Soybean -based beverages  
b. Soybean -based  film 
c. Soybean curd (tofu)  
d. Semi -dehydrated soybean curd  
     i. Thick gravy -stewed semi -dehydrated soybean  curd 
     ii. Deep fried semi -dehydrated soybean curd  
            iii. Semi -dehydrated soybean curd, other than in LR Letter D.7. d. i) a nd 7.d.ii  
e. Dehydrated soybean curd (kori tofu)  
f. Other soybean protein products  
E. PROCESSED MEAT AND  MEAT PRODUCTS, INCLUDING POULTRY AND  GAME   
Edible casings (e.g. sausage casings)  
F. BAKERY WARES AND BAKERY RELATED PRODUCTS  
1. Bread and ordinary bakery wares and mixes   
a. Breads and rolls – yeast -leavened breads and specialty breads, soda breads  
b. Crackers, excluding sweet crackers   
c. Other ordinary bakery products (e.g. bagels, pita, English muffins)  
d. Bread -type products, including bread stuffing and bread  crumbs  
e. Steamed bread and buns  
f. Mixes for bread and ordinary bakery wares  
2. Fine bakery wares (sweet,   salty or savory) and mixes – Mixes for fine bakery wares (e.g. cakes, 
pancakes)  
G. SWEETENERS, INCLUDING HONEY   
1. Refined and raw sugars   
a. White sugar, dextrose anhydrous, dextrose monohydrate, fructose   
b. Powdered sugar, powdered dextrose  
c. Soft white sugar, soft brown sugar, glucose syrup, dried glucose syrup, raw cane sugar  
     i. Dried glucose syrup used to manufacture sugar  confectionery  
     ii. Glucos e syrup used to manufacture sugar confectionery  
d. Lactose   
e. Plantation or  mill white sugar   
2. Brown sugar excluding products under LR Letter G.1.c (soft white sugar, etc.)  
3. Sugar solutions and syrups, also (partially) inverted, including treacle and molasses, excluding 
products under G.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   
H. SALT, SPICES, SOUPS, S AUCES, SALADS AND PROTEIN PRODUCTS   
1. Salt and salt substitutes  
2. Herbs, spices, seasonings and condiments (e.g. seasoning for instant noodles)  
3. Vinegars  
4. Mustards  
5. Soups and broths – Mixes for soups and broths   
6. Sauces and like products   
a. Mixes for sauces and gravies  
b. Clear sauces (fish sauce)  
7. Yeast and like products   
3 
 8. Soybean -based seasonings and condiments   
a. Fermented soybean paste (e.g. miso)  
b. Soybean sauce  
                   i. Fermented soybean sauce  
                   ii. Non -fermented soybean sauce  
                          iii. Other soybean sauces  
9. Protein products other than from soybeans, marinades   
I.  I. BEVERAGES, excluding dairy products  
       1. Non -alcoholic (“soft”) beverages  
a. Non-alcoholic (“soft”) beverages without herbal ingredients  (e.g. Coffee, coffee 
substitutes, tea, and other hot cereal and grain beverages)  
b. Non- alcoholic (“soft”) beverages with herbal ingredients  (e.g. Herbal tea or Tea blends)  
      2. Alcoholic beverages, including alcohol -free and low -alcoholic counterparts  
a. Beer and malt beverages  
b. Cider and perry  
c. Grape wines  
                   i. Still grape wine  
                   ii. Sparkling and semi -sparkling grape wines  
            iii. Fortified grape wine, grape liquor wine, and sweet grape wine  
d. Wines (other than grapes)  
e. Mead  
f. Distilled spirituous beverages containing more than 15% alcohol  
g. Aromatized alcoholic beverages (e.g. beer, wine and spirituous cooler -type beverages, low -
alcoholic refreshers)  
J. READY -TO-EAT SAVOURIES  
1. Snacks – potato -, cereal - or starch -based (from roots and tubers, pulses and legumes), including 
chips and crunchies  
2. Chicharon  
3. Snacks – fish-based   
K. FOOD ADDITIVES  
 
B. MEDIUM RISK FOODS  
 
Medium Risk (MR) Foods  – Foods that may contain pathogenic microorganisms but will not 
normally support their growth because of food characteristics; or food that is unlikely to contain 
pathogenic micro -organisms because of food type or processing, but may support the formation  
of toxins or the growth of pathogenic microorganisms.  
 
Table 2. List of Medium Risk Food Products  
MEDIUM RISK FOOD PRODUCTS  
A.   DAIRY PRODUCTS and ANALOGUES, excluding products under Fats, Oils and Fat Emulsions  
1. Condensed milk and analogues (plain) (evaporated/reconstituted milk)  
a. Condensed milk (plain)  
b. Beverage whiteners   
2. Milk powder and cream powder and powder analogues (plain)  
3. Milk products for specific age groups or target population (e.g. children above 3 years; pregnant 
women)  
B. FROZEN DESSERTS   
1. Non-Dairy based (e.g. sherbet, sorbet)  
2. Edible ices – popsicles   
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  
1. Tomato products  
2. Frozen fruits  
3. Canned or bottled (pasteurized) or retort pouch fruit and vegetable preserve in juice, syrup, brine  
4. Fruit -based desserts, gelatin (including water -based fruit flavored desserts, i.e. gels)  
5. Fermented fruit products   
4 
 6. Fruit fillings for pastry  
7. Fermented vegeta ble products (including mushrooms and fungi, roots and tubers, pulses and 
legumes, and aloe vera) and seaweed products, excluding fermented soybean products MR Letter 
E.1 and E.2 (fermented soybeans and fermented soybean curd) and LR Letters H.8.b. 1 to 3 
(soybean sauces)  
8. Vegetable protein products (canned and frozen)  
D. CONFECTIONERY /Cocoa products and Chocolate products including imitations and chocolate 
substitutes   
1. Cocoa mixes (powders) and cocoa mass/ cake   
2. Cocoa mixes (syrups)  
3. Cocoa -based spreads, including fillings  
4. Cocoa and chocolate products, including “tablea” ; and imitation chocolate, chocolate substitute 
products  
E. CEREAL -BASED PRODUCTS, derived from cereal grains, from roots and tubers, pulses, legumes and 
pith or soft core of palm tree – Soybean products  
1. Fermented soybeans (e.g. natto, tempe)  
2. Fermented Soybean curd   
F. PROCESSED MEAT AND MEAT PRODUCTS, INCLUDING POULTRY AND GAME   
1. Processed meat, poultry and game products in whole or cuts  
a. Non-heat treated processed meat, poultry and game products (cured, fermented, chilled)   
                     i. Cured (including salted) non -heat treated processed meat, poultry and game products  
ii. Cured (including salted) and dried non -heat treated processed meat, poultry and 
game products  
                            iii. Fermented non -heat treated processed meat, poultry and game products  
2. Processed comminuted  meat, poultry and game products   
a. Non-heat treated processed meat, poultry and game products (cured, fermented, chilled)  
                    i. Cured (including salted) non -heat treated processed meat, poultry and game produ  
ii. Cured (including salted) and dried non -heat treated processed meat, poultry and game 
products (jerky, shredded beef/ pork)   
iii. Fermented non -heat treated processed meat, poultry and game products  
G. PROCESSED FISH AND FISH PRODUCTS, INCLUDING MOLLUSCS, CRUSTACEANS AND 
ECHINODERMS   
1. Processed fish and fish products, including mollusks, crustaceans and echinoderms  
a. Smoked, dried, fermented, and/or salted fish and fish products, including mollusks, 
crustaceans and echinoderms  
2. Semi -preserved fish and fish products, including mollusks, crustaceans and echinoderms  
a. Fish and fish products, including mollusks, crustaceans and echinoderms – marinated 
and/or in jelly  
b. Fish and fish products, including mollusks, 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 mollusks, crustaceans and echinoderms 
(e.g. fish paste), exclud ing products under MR Letter G.2.a to c above  
H. EGG AND EGG PRODUCTS   
1. Preserved eggs, including alkaline, salted and canned eggs (salted eggs, century eggs)  
2. Egg-based desserts (e.g. custard)  
I. BAKERY WARES AND BAKERY RELATED PRODUCTS  fine bakery wares (sweet, salty or savory) 
and mixes  
1. Cakes, cookies, pies, pastries, doughnuts, sweet rolls, scones, muffins, waffles – plain / without 
filling  
2. Frozen dough  
J. SALT, SPICES, SOUPS, SAUCES, SALADS AND PROTEIN PRODUCTS   
1. Soups and broths Ready -to-eat soups and  broths, including canned, bottled and frozen   
2. Sauces and like products   
a. Emulsified sauces and dips (e.g. mayonnaise, salad dressing, onion dips)  
b. Non-emulsified sauces (ketchup, cheese sauce, cream sauce, brown gravy)  
3. Salads (e.g. macaroni salad, potato sa lad) and sandwich spreads excluding cocoa - and nut -based, 
spreads under HR Letter B.2 (peanut butter)and MR D.3 (cocoa -based spreads including fillings)    
5 
 K. BEVERAGES, excluding dairy products  
1. Non-alcoholic (“soft”) beverages  
a. Fruit and vegetable juices - (fruit juice, vegetable juice, concentrates for fruit juice, 
concentrates for vegetable juice)  
b. Fruit and vegetable nectars (fruit nectar, vegetable nectar, concentrates for fruit nectar, 
concentrates for vegetable nectar)  
c. Water -based flavored drinks, inclu ding “sport,” “energy,” or “electrolyte” drinks and 
particulated drinks   
      i. Carbonated water -based flavored drinks  
      ii.Non -carbonated water -based flavored drinks, including punches, ades and jelly drinks  
             iii. Concentrates (liquid or solid) for water -based flavored drinks  
d. Powdered cocoa drink mixes (cocoa)   
L. L. FOOD SUPPLEMENT/ HERBAL FOOD/ HERBAL DIETARY SUPPLEMENTS    
1. Vitamins and minerals  
2. Amino acids  
M. READY -TO-EAT SAVOURIES  
Processed nuts, including coated nuts and nut mixtures (with e.g. dried fruits)    
 
 
C. HIGH RISK FOOD    
 
High Risk (HR) Food – foods that may contain pathogenic microorganisms and will support 
the formation of toxins or the growth of pathogenic microorganisms and foods that may contain 
harmful chemicals.  
 
Table 3. List of High Risk Food Products  
HIGH RISK FOOD PRODUCTS  
A.   DAIRY PRODUCTS and ANALOGUES, excluding products under Fats, Oils and Fat Emulsions  
1. Milk and dairy -based drinks   
a. Milk (plain) and buttermilk (plain)  
b. Dairy -based drinks, flavored and/or fermented (e.g. chocolate milk, cocoa, eggnog, 
drinking yoghurt, whey -based drinks)  
2. Fermented and renneted milk products (plain), excluding dairy -based drinks in HR A.1.b  
a. Fermented milks (plain)  
                   i. Fermented milk (plain), not heat -treated after fermentation  
                   ii. Fermented milks (plain), heat -treated after fermentation  
b. Renneted milk (plain)  
3. Cream (plain) and the likes (cream analogs)  
a. Pasteurized cream (plain)  
b. Sterilized and UHT creams, whipping and whipped creams, and reduced fat creams (plain)  
c. Clotted cream (plain)  
d. Cream analogues  
4. Cheese and analogs  
a. Unripened cheese  
b. Ripened cheese  
                   i. Ripened cheese, includes rind  
                   ii. Rind of ripened cheese  
                   iii. Cheese powder (for reconstitution; e.g. for cheese sauces)  
c. Whey cheese  
d. Processed cheese  
                   i. Plain processed cheese  
                   ii. Flavored processed cheese, inc luding those containing fruits, vegetables, meat, etc  
e. Cheese analogues  
f. Whey protein cheese  
5. Dairy -based desserts (e.g. pudding, fruit or flavored yoghurt)  
6. Whey and whey products, excluding whey cheeses    
6 
 a. Liquid whey and whey products  
b. Dried whey and whey products  
7. Milk for manufacture  
8. Dairy -based frozen desserts (e.g. ice cream)  
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. 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)  
C. CONFECTIONERY  
Chocolate with nuts   
D. BAKERY WARES AND BAKERY RELATED PRODUCTS  
1. Fine bakery products with fillings: meat, milk, poultry, cream, other perishable foods; icings; and 
coatings  
2. Cookies with nuts  
E. PROCESSED MEAT AND MEAT PRODUCTS, INCLUDING POULTRY AND GAME   
1. Processed meat, poultry and game products in whole or cuts  
a. Heat -treated processed meat, poultry and game products (canned)  
b. Frozen processed meat, poultry and game products (marinated pork/ beef/ chicken cuts)  
2. Processed comminuted  meat, poultry and game products   
a. Heat -treated processed meat, poultry and game products (canned)  
b. Frozen processed meat, poultry and game products (nuggets, patties, dumplings, salami, 
meat loaf, hotdog)  
F.    F. PROCESSED FISH AND FISH PRODUCTS, INCLUDING MOLLUSCS, CRUSTACEANS AND 
ECHINODERMS   
1. Processed fish and fish products, including mollusks, crustaceans and echinoderms  
a. Frozen fish, fish fillets and fish products, including mollusks, crustaceans and echinoderms  
b. Frozen battered fish, fish fillets and fish products, including mollusks, crustaceans and 
echinoderms; including value added products (battered, marinated, smoked, spiced, fish 
and squid balls preparations)  
c. Frozen minced and cre amed fish products, including mollusks, crustaceans and 
echinoderms  
d. Cooked and/or fried fish and fish products, including mollusks, crustaceans and 
echinoderms  
                                     i. Cooked fish and fish products  
                     ii. Cooked mollusks, crustaceans and echinoderms  
                     iii. Fried fish and fish products, including mollusks, crustaceans and echinoderms  
2. Fully preserved, including canned or fermented fish and fish products, including m ollusks, 
crustaceans and echinoderms   
G. EGG AND EGG PRODUCTS   
1. Liquid egg products  
2. Frozen egg products (e.g. frozen eggs, frozen egg whites, frozen egg yolks)  
3. Dried and/or heat coagulated egg products (e.g. dried eggs, dried egg whites, dried egg yolks and 
powdered egg products)  
 
H. FOODSTUFFS INTENDED FOR PARTICULAR NUTRITIONAL USES  
 
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 HR Letter H.1)  
4. Dietetic formula for slimming purposes and weight reduction  
5. Dietetic foods (e.g. supplementary foods for dietary use) excluding products under HR Letter H.1 to 
4 and Letter J, Food supplements)  
6. Weaning foods for infants and growing children  
7. Dietetic foods for special medical purpose  
8. Dietetic formulas for weight control  
I. BOTTLED WATER / ICE  
J.  J. FOOD SUPPLEMENT/ HERBAL FOOD/ HERBAL DIETARY SUPPLEMENTS    
7 
 1. Herbs and botanicals and/or products with other nutritional substances and/or combination as Food 
Supplement  
2. Herbs and botanicals and/or Products with other nutritional substances and/or combination as 
Conventional Food Products (Excluding products under LR Letter I.1.b)  
K. NOVEL / NEW INNOVATIONS in FOOD  
New in the international or local market   
 
As listed in the Codex General Standard for Food Additives (GSFA) latest revision.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
1 
 ANNEX C  
 
ACTIVITIES ALLOWED UNDER A SINGLE LICENSE  
 
 
Primary Activity  Activities that may be added to LTO  
Manufact
urer/ 
Toll-
Manufact
urer Repacker  Exporter 
of Own 
Products  Importer 
of RM for 
Own Use  Exporter 
Not Own 
Products  Importer 
Not Own 
Products  Wholesal
er  
Not Own 
Products  
Manufacturer/  
Toll-
Manufacturer  n/a       
Repacker   n/a      
Trader         
Distributor - 
Importer       n/a  
Distributor - 
Exporter      n/a   
Distributor - 
Wholesaler        n/a 
 
Legend:  
    = may be added to LTO  
     = cannot be added to existing LTO and will require a new LTO  
n/a  = Not applicable, existing activity  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
1 
 ANNEX D  
 
Requirements for Application of License to Operate  
 
 
A. Requirements for Initial Licensing  – The following are the requirements for 
application by an establishment:  
 
1. Accomplished Integrated Application Form as prescribed by current FDA 
regulations;  
2. Proof of Payment of Fees as prescribed by current FDA regulations;  
3. Proof of Business Registration  
a. If Single Proprietorship: Valid Certificate of Business Name Registration with 
the Department of Trade and Industry indicating the same name, address and 
ownership as the establishment applying for a license;  
b. If a Corporation or Partnership:  
i. Valid Regi stration with Securities and Exchange Commission (SEC) 
indicating the same name, address, and ownership as the establishment 
applying for a license;   
ii. Articles of Incorporation; and   
iii. Other pertinent documents, as applicable;  
c. If a Cooperative: Certi ficate of Cooperative Development Authority (CDA) 
indicating the same name, address, and ownership as the establishment 
applying for a license;  
4. If the business name and/or and address is different from the registered name and/or 
address in the DTI -, SEC -, or CDA -issued certificate, the following shall be 
submitted in addition to the documents specified above as applicable:  
a. If a Corporation or Partnership, SEC Certificate must reflect “Doing business 
under the name and style of (Name of Establishment)  
b. Valid Mayor's Business Permit or Barangay Business Permit indicating the 
same name, address and ownership as the establishment applying for a license;  
5. Proof of Occupancy (per facility and/or address declared as part of the 
establishment);  
a. If the facility and/or address declared as part of application is not owned  by 
the applicant:  
i.  Notarized valid Contract of Lease of the space or building occupied; 
and 
ii.  If the applicant is engaged in distribution (i.e. third -party logistics):  
              - Duly notarized warehousing agreement;  
      b. If the facility and/or address declared as part of application is owned  by the 
applicant:  
             - Copy of Transfer Certificate of Title;  
6. Product List  
a. The list of food products to be manufactured, pr ocessed with proposed brand 
name per product  
b. The list of products to be distributed, sold, or offered for sale or use, as 
appropriate, including the following information per product:   
i. Business name and address of direct source;  
ii.Business name and address of facility where the product is last packaged, 
if different from source;   
2 
 iii. Business name and address of facility where product is last processed, if 
different from last packaging site and direct source;  
iv. If product is to be imported, a unique global product identification  
number;  
7. Location Map – a graphic illustration indicating the address, landmarks, immediate 
environment, type of building, and Global Positioning System (GPS) coordinates (if 
available) for each facility and/ or address declared part of the e stablishment;   
8. Floor plan/ layout with dimensions  
9. Specific requirements – The following are the requirements for application in 
addition to the General Requirements (Nos. 1 -8 above) as applicable:  
a. Manufacturer/Processor  
i. Description of the products to be manufactured (e.g. list of     
ingredients, physico -chemical, and/or microbiological specifications)  
ii. Description of manufacturing process or food processing/preparation, 
including a flowchart with quality control points, a s appropriate to the 
size of operation  
iii. Quality control procedures, as appropriate to the size of operation  
iv. Results of analysis of Finished Product /s showing compliance with 
applicable standards  
v. Facsimile of proposed product label, compliant with FDA stand ards 
b. Repacker  
 
i. Description of the product to be repacked (e.g. name of product, 
physico -chemical, and/or microbiological specifications)  
ii. Description of repacking process, including a flowchart with quality 
control points   
iii. Quality control procedures  
iv. Photocopy of duly notarized valid contract or  agreement with the 
manufacturer, and, as appropriate, the License to Operate (LTO) of the 
manufacturer where the product will be sourced for repacking  
v. Facsimile of proposed label, compliant with FDA labeling 
requirements  
c. Importer -Distributor of Raw Materials/Finished Products/ Ingredients/ 
Additives  for Distribution and/or Retail  
 
i. Each item declared in the list of food product(s) to be imported must 
be identified in any of the following:    
 Pro forma invoice,   
 Foreign agency agreement,   
 Appointment letter, or   
 Distributorship agreement  
ii. All establishments from which the applicant sources its imports must 
be supported by at least one of the following documents issued by the 
health or regulatory authority of the co untry of origin or of source:  
 Valid manufacturer’s certificate of registration with GMP 
compliance, or its equivalent,   
 Valid Sanitary Phyto -sanitary Certificate or Health 
Certificate,   
 Valid ISO 22000 Certification,   
 Valid HACCP Certificate, or   
3 
  Certificate of Free Sale  
 
iii.  All certification issued by a private organization should be attested by 
a recognized business association or chamber of commerce.  
iv.  Appropriate test result or certificate of analysis routinely conducted in 
the country of origin o r source that would indicate or show safety of the 
product.   For test or analysis conducted in the Philippines, the applicant 
shall be guided by appropriate FDA standards as published in the FDA 
Website in addition to the recognition or accreditation of la boratories.  
d. Distributor -Exporter  
 
i. Any of the following documents issued to the applicant by the 
establishment from which it sources the products it exports:  
 Valid notarized distributorship agreement; or   
 Letter of appointment between FDA -licensed manufacturer 
and exporter  
ii. Copy of valid CPR if already registered by the FDA -licensed   
manufacturer  
e. Distributor -Wholesaler  
i. Any of the following documents issued to the applicant by the 
establishment from which it sources the products it sells:  
 Valid notarized distributorship agreement; or  
 Letter of appointment between the applicant and FDA -
licensed source   
ii. Valid Certificate(s) of Product Registration if  already registered by the 
FDA -licensed source  
f. Food Trader  
 Valid and notarized toll manufacturing and/or repacking 
agreement with FDA -licensed toll manufacturer and/or 
repacker.  
 
B. Requirements for Renewal of a License  
 
1. Regular renewal  
 
a. Accomplished Integrated Application Form as prescribed by current FDA 
regulations;  
b. Proof of Payment of Fees as prescribed by current FDA regulations; and  
c. Requirements in support of amendments, if applicable, included in the renewal 
application, including Scanned Application Letter stating the intended changes 
(indicate chang es/ amendments to be made);   
2. Automatic renewal – where there is no need for inspection or re -submission of 
requirements as required for initial applications, automatic renewal may be granted 
only if the following conditions are met:  
 
a. Submission of an affidavit of undertaking for automatic renewal with a sworn 
statement indicating no change or variation or, as applicable, no violation of 
FDA rules and regulations or non -compliance to the requirements of GMP 
have been committed   
4 
 b. The application for renewa l was filed before the expiration date of the license; 
and 
c. The prescribed renewal fee was paid upon filing of the application.  
 
C. Requirements for Amendment of a License  
 
1. The following changes are equivalent to an initial licensing application  and must 
satisfy all applicable requirements as specified in Section V Part A and Section V 
Part B or Part C, of main text of this Issuance, and surrender the previously issued 
license:  
 
a. Change of Ownership  
b.  Change of Location of Manufacturing Site or Distribution Office  
2. The following amendments must satisfy applicable requirements and upon approval, 
LTO will be re -issued:  
 
a. Change of Business Name  
i. Accomplished Integrated Application Form as prescribed by 
current FDA regulations;   
ii. Scanned Application Letter stating the intended changes 
(indicate changes/ amendments to be made);  
iii. New Business Name registration from DTI/SEC. If registered 
address with DTI/ SEC is different from the address of the 
establishment, a photocopy of Business/ Mayor’s Permit; and  
iv. Proof of Payment of Fees as prescribed by current FDA 
regulations  
b. Additional Product Line(s), for manufacturers  
 
i. Accomplished Integrated Application Form as prescribed by 
current FDA regulations;   
ii. Scanned Application Letter stating the intended changes (indicate 
changes/ amendments to be made);  
iii. Compliance to GMP verified during inspection; and  
iv. Proof of Payment of Fees as prescribed by current FDA 
regulations  
c. Additional activity(ies):  
 
i. Accomplished Integrated Application Form as prescribed by current 
FDA regulations;   
ii. Scanned Application Letter stating the intended changes (indicate 
changes/ amendments to be made);  
iii. Compliance to GMP verified during inspection; if for additional 
activity as Toll  Manufacturer for a Licensed Food Manufacturer; 
and 
iv. Proof of Pa yment of Fees as prescribed by current FDA regulations  
d. Addition of Sources:  
 
i. Accomplished Integrated Application as prescribed by current FDA 
regulations;    
5 
 ii. Scanned Application Letter stating the intended changes (indicate 
changes/ amendments to be made);  
iii. Scanned List of new sources, its address, name and address of the 
manufacturer (in cases when source is not directly the 
manufacturer), distributorship agreement or contract agreement, as 
applicable;  
iv. Scanned copy of any of the following original documents issued to 
the source by the Phil FDA (local) or the regulatory or health 
authority from the country of origin (for imported) per source:  
 Valid manufacturer’s certificate of registration with GMP 
compliance, or its equivalent,   
 Valid Phytosanitary Certifica te/ Health Certificate,   
 Valid ISO 22000 Certification,   
 Valid HACCP Certificate, or  
 Certificate of Free Sale; and  
v. Proof of Payment of Fees as prescribed by current FDA regulations  
3. The following amendments must be made known to the FDA through notification:  
 
a. Deletion of activity(ies);  
b. Deletion of Source(s);  
c. Deletion of Warehouse Address; and  
d. Deletion of Manufacturing Plant Address  
4. Requirements for notification of amendments are as follows:  
 
a. Accomplished Integrated Application Form and Notarized Declaration page in 
the FDA website as prescribed by current FDA regulations;   
b. Scanned Application Letter stating the intended changes (indicate changes/ 
amendments to be made); and  
c. Proof of Payment of Fees as prescribed by current FDA regulations  
5. The foll owing amendments must be made known to FDA through notification, 
submission of applicable Proof of Occupancy, and payment of appropriate fees:  
 
a. Addition of Warehouse Address not involving transfer of location  
b. Any change  requiring modification of the submitted Proof of Occupancy  
6. All other changes not identified previously, including but not limited to, the 
following:  
 
a. Change in Distribution Agreement not previously covered;  
b. Change of Manufacturing Process; and  
c. Change of Quality Control Procedure  
 
Must be reflected in the appropriate document that was required during initial 
application and shall be submitted during renewal;  
7. Amendments requiring notification must be made known to the FDA within 30 
calendar days of effect.  
8. Amendments requiring satisfaction of initial licensing requirements must to do so 
within 60 calendar days of effect.  
9. Amendments taking effect within 90 days prior to expiration of a current license 
must be declared along with the renewal, and must pay the corresponding fees as  
prescribed by current FDA regulations.   
6 
  
D. Re -issuance of a License – for additional original copies  
 
1. Accomplished Integrated Application Form as prescribed by current FDA 
regulations; and  
 
2. Proof of Payment of Fees as prescribed by current FDA regulations.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
1 
 ANNEX E  
 
Requirements for Application of Certificate of Product Registration  
 
 
A. Requirements for Initial Registration  – The follo wing are the requirements for      
product registration:  
 
1. Accomplished Food Product Online Application Form as prescribed by current 
FDA regulations;  
 
2. Proof of Payment of Fees as prescribed by current FDA regulations;  
 
3. Clear and complete loose labels or artworks, as applicable, of all packaging sizes, 
or equivale nts as defined by FDA regulations except for bulk raw materials, 
ingredients and food additives intended for further processing or for distribution to 
establishments/ manufacturers for further processing;  
 
4. Pictures of the product in all angles and in diffe rent packaging sizes, and from at 
least two different perspectives allowing visual recognition of a product as the same 
with the one being registered , as applicable;  
  
5. For food supplement, a sample in actual commercial presentation shall be 
submitted.   
  
6. As applicable, documents to substantiate claims, such as technical, nutritional or 
health studies or reports, market -research studies, Certificate of Analysis (E.g. 
physical, chemical, microbiological and nutrient analysis of the finished product), 
quantita tive analysis and computations, scientific report or studies published in 
peer-reviewed scientific journals, certificates or certification to support use of 
logo/seal on Sangkap Pinoy, Halal, and Organic (Certificate Number and Certifying 
Body), or Kosher food, Intellectual Property Office (IPO) Certificate/Trademark 
Registration and in compliance with current labelling regulations.   
 
7. Source Documents  
 
a. For locally produced products, Certificate of Distributorship or 
Appointment letter or Memorandum of Agreement from each supplier  
b. For imported products Foreign Agency Agreement or Certificate of 
Distributorship or Appointment letter or Proforma Invoice or 
Memorandum of Agreement from each supplier  
c. For imported products Certificate of Registration with GMP  
Compliance or its equivalent or Valid Sanitary Phyto -Sanitary 
Certificate or Health Certificate or ISO 22000 Certificate or FSSC 
Certificate or HACCP Certificate or Certificate of Free Sale issued by 
the Regulatory/ Health Authority/ Attested by recognize d Association 
or duly authenticated by the Philippine Consulate from the country of 
origin.   
2 
 8. In addition to the requirements for initial registration, any of the following 
documents or the prevailing guidelines or policies may be required for the 
followi ng products, as necessary:  
8.1 Ice  
Parameters  Method of 
Determination  Value  Units of 
Measurement  
Total coliform  Multiple Tube 
Fermentation 
Technique (MTFT)  < 1.1  MPN/100 mL  
Chromogenic 
substrate test 
(Presence -Absence)  Absent  
 
< 1.1   
 
MPN/100 mL  
Membrane Filter 
(MF) Technique   
< 1 Total coliform 
colonies/ 100 
mL 
Fecal coliform  Multiple Tube 
Fermentation 
Technique (MTFT)  < 1.1  MPN/100 mL  
Membrane Filter 
(MF) Technique  < 1 Fecal coliform 
colonies/100 
mL 
Chromogenic 
substrate test 
(Presence -Absence)  < 1.1  MPN/100 mL  
Heterotrophic Plate 
Count  ● Pour Plate  
● Spread Plate  
● Membrane 
Filter 
Technique  < 500  CFU/mL  
 
Chemical Constituents  Max. Accept. Level (MAL)  
Arsenic  0.05 mg/L  
Cadmium  0.003 mg/L  
Lead  0.01 mg/L  
Nitrate  50 mg/L  
Benzene  0.01 mg/L  
 
Physical -Chemical Constituents  Max. Accept. Level (MAL)  
Color    
 Apparent  10 Color Units  
True  5 Color Units  
Turbidity  5 NTU  
Iron 1.0 mg/L  
Manganese  0.4 mg/L  
pH 6.5 – 8.5 
 
5 – 7  
3 
 (for product water that 
undergone reverse osmosis or 
distillation process)  
Sulfate  250 mg/L  
Total Dissolved Solids (TDS)  500 mg/L  
 
<10 (for product water that 
undergone reverse osmosis or 
distillation process)  
 
  Directly from the source:  
Radiological Constituents  Activity Level (Bq/L)  
Gross Alpha activity  0.1 (excluding radon)  
Gross Beta  1.0 
Radon  11 (MCL)  
  
8.2 Food Supplement  
a. Technical specifications of an ingredient  
b. Computation for conversion of vitamins and elemental minerals  
c. Certificate of Analysis (Vitamins/Minerals Assay)  
d. Scientific Study  
e. Certificates (membership to an association, quarantine, free sale, 
etc.) 
f. Safety data (Toxicity Study, LD50) with corresponding conclusion 
on safety (ex. Cert ificate for Absence of TSE/BSE)  
g. Stability Data / Shelf -life Study  
h. Standards for the following tests shall be based on AO 184 s. 2004 
or its future amendments:  
 
i. For Dried plants (limits for adults):  
 
Heavy Metals  Unit Limits  
Lead  ppm maximum 10  
Cadmium  ppm maximum 0.3  
Arsenic  ppm maximum 0.3  
Mercury  ppm maximum 0.5  
 
ii. For untreated plant material  harvested under acceptable 
hygienic conditions intended for further processing:  
 
Microorganisms  Unit Limits  
Escherichia coli  cfu/g  negative  
Moulds 
propagules  cfu/g  maximum 105 
Staphylococcus  cfu/g  negative   
4 
  
iii. Plant materials that will undergo pre-treatment (e.g. with 
boiling water as used for herbal teas and infusions):  
 
Microorganisms  Unit Limits  
Aerobic bacteria  cfu/g  maximum 107 
Yeast and moulds  cfu/g  Maximum 104 
Escherichia coli  cfu/g  negative  
Salmonellae  cfu/g  negative  
Staphylococcus  cfu/g  negative  
Other 
Enterobacteria  cfu/g  maximum 104 
 
iv. The following tests and standards shall be required to 
determine the quality of the finished product:  
 
 Moisture Content – not more than 10%  
 pH 
 Microbial Limits  shall be based on the following:  
 
        For Solid Products  
Microorganisms  Unit Limits  
Aerobic bacteria  cfu/g  maximum 104 
Yeast and moulds  cfu/g  maximum 103 
Escherichia coli  cfu/g  negative  
Salmonellae  cfu/g  negative  
Staphylococcus  cfu/g  negative  
Other 
Enterobacteria  cfu/g  maximum 102 
 
        For Liquid Products  
Microorganisms  Unit Limits  
Aerobic bacteria  cfu/g  maximum 102 
Yeast and moulds  cfu/g  maximum 102 
Escherichia coli  cfu/g  negative  
Salmonellae  cfu/g  negative  
Staphylococcus  cfu/g  negative  
Other 
Enterobacteria  cfu/g  maximum 102 
  
5 
  
8.3 Low Risk food products   
a. Certificate of Analysis of finished product to determine 
compliance with Food Fortification Law, RA 8976, RA 8172, 
and F.M. 2011 -028 for 3 -MCPD  
 
8.4 Medium and High risk food products  
Any of the following documents, as may be applicable, shall be 
submitted:  
a. Certificate of Analysis of finished product to determine 
compliance with applicable Codex Standards, Philippine 
National Standards, Food Fortification Law, RA 8976, RA 8172, 
and other standards (e.g. infant formula, milk supplement, other 
foods for infants and young children, foods for special medical 
purposes, foods for special dietary uses);  
b. Certificate of Analysis to determine compliance with FDA 
Circular No. 2013 -010 (Revised Guidelines for the Assessment 
of Microbiological Quality of Processed Foods) and its future 
amendments;”  
c. Relevant validated scientific studies (peer reviewed and/or 
published) to support the use of products for specific purposes 
(e.g.  foods for special medical purposes, foo ds for special dietary 
uses); and/or  
d. Validated scientific researches or studies published in peer -
reviewed scientific journals to support declaration of health and 
nutrition claims, and other relevant supporting documents.   
 
B. Requirements for Renewal Regist ration  
 
1. Accomplished Application Form as prescribed by current FDA regulations;  
 
2. Proof of Payment of Fees as prescribed by current FDA regulations;  
 
3. Clear and complete loose labels or artworks, as applicable, of all packaging sizes, 
or equivalents as defined by FDA regulations except for bulk raw materials, 
ingredients and food additives intended for further processing or for distribution to 
establishments/ manufacturers for further processing.   
 
4. For regular renewal of applications initially approved i n the old E -Registration, the 
application shall be filed in the Modified E -Registration Version by starting a new 
case number and by selecting "Renewal" as the type of application. The applicant 
shall accomplish the online application form, upload revised labels, indicate the 
correct case number and use the same user account to automatically transfer initially 
submitted documents from the old portal.  
 
 
  
6 
  
C. Automatic Renewal of CPR  
 
 
1. Accomplished Online Application Form as prescribed by FDA regulations  
 
2. Proof of payment of fees as prescribed by current FDA regulations  
 
3. A sworn statement indicating no change in or variation whatsoever in the product 
is attached to the application  
 
4. Renewal of the CPR may be automatic provided that the following conditions a re 
met:  
 
a. The application for renewal shall be filed within 90 calendar days before the 
date of its expiration;   
b. The prescribed automatic renewal fee must be paid; and  
c. There is no condition stated on the previously issued Certificate of Product 
Registration. Compliance to remarks on previously issued CPR processed 
under modified E -Registration Version 2 requires CPR amendment that 
automatically disqualifies the product for automatic renewal registration.  
d. There is no change and/or variation (no CP R amendment, no label changes, 
no changes in the data entry, no changes that entail initial application) in the 
product  
 
5. Requests for amendment shall not be allowed to be filed simultaneously with an 
application for automatic renewal.   
 
6. Below shall be the specific cases wherein the Automatic Renewal will not apply:  
 
a. If the application for registration is filed after the expiry date of the CPR but 
within 120 calendar days, the application shall not be qualified for automatic 
renewal and is subject to corresponding surcharges prescribed in 
Administrative Order 50 s.2001 or the latest (this will be considered under 
Regular Renewal).  
b. If the application is filed after 120 days from the expiry date of the CPR, the 
application shall undergo the initial filin g and evaluation procedure. A new 
CPR will be issued.  
c. If the application has undergone any changes from the previously approved 
application, it shall not be qualified for automatic renewal.  
d. If there are any changes in product formulation (reformulation), t his is treated 
as an application for initial registration.  
e. No application for renewal shall be accepted unless the prescribed renewal 
fee is paid.  
f. If within the 5 -year validity, a violation on the product and label was 
monitored, there will be correspondin g sanctions as indicated in Section XI 
of RA 9711 and CPR will be revoked/ cancelled if not complied within the 
period of 6 months. Food establishment will file for an initial application.  
  
7 
 7. For automatic renewal of applications initially approved in the old E -Registration, 
the application shall be filed in the Modified E -Registration Version by starting a 
new case number and by selecting "Renewal" as the type of application. The 
applicant must accomplish the online application form, indicate the correct c ase 
number and use the same user account to automatically transfer initially submitted 
documents from the old portal.  
 
D. Amendments to the Product Registration  
 
1. The following changes are equivalent to an initial registration application:  
 
a. Change in manufacturer or repacker and change in manufacturer’s or 
repacker’s address shall be treated as initial registration; and   
b. Change of product formulation.  
 
2. Notification of Amendments  
 
a. Condition:  
i. There must be no changes in product that is an indication for initial 
product registration  
b. The following amendments must be made known to FDA through 
notification:  
 
i.  Change/ Additional Packaging Size  
ii.  Extension/ Change in Shelf -life 
iii.  Change in/Additional Commercial Presentation (i.e. Packaging Size)  
iv.  Change in/ Additional Packaging Design  
v.  Change in/ Additional Supplier  
vi.  Exportation of previously registered product initially for local   
distribution   
vii. Other cases as declared in succeeding FDA issuances     
 
3. Requirements for notification of amendments in Section G.2 above, are as follows:  
 
a. Accomplished Integrated Application Form as prescribed by current FDA 
regulations;   
b. Scanned Application Letter stating the intended changes (indicate changes/ 
amendments to be made);   
c. Proof of Payment of Fees as prescribed by current FDA regulations;  
d. Clear and complete loose labels or artworks, as applicable, of all packaging 
sizes, or equivalents, reflecting the change/s, as defined by FDA regulations 
or reflecting compliance to labeling requirements of importing  country, in 
the case mentioned in Section G.2.2.4 (e.g. label reflecting the language of 
importing country); and/or  
e. Stability study results with conclusion to support extension or change in 
shelf -life. 
f. Any of the following: Foreign Agency Agreement, Certi ficate of 
Distributorship, Appointment Letter, Memorandum of Agreement, or 
Proforma Invoice; and  
g. Other documents to substantiate the intended change/s   
8 
  
 
4. Transfer of Ownership of a Registered Product:  
 
a. Conditions  
 
i. There must be no changes in the product that is an indication for initial 
product registration; and  
ii.The new owner must have a valid License to Operate from the FDA  
 
b. Requirements  
 
i. 4.2.1 Accomplished Integrated Application Form as prescribed by 
current FDA regulations;  
ii. 4.2.2 Scanned Application Letter stating clearly the intended changes 
(indicate changes/ amendments to be made);  
iii. 4.2.3 Proof of Agreement between previous and current owners of the 
product transferring ownership/ Deed of Sale;  
iv. 4.2.4 Clear and complete loose labels or artworks, as applicable, of all 
packaging sizes, or equivalent as defined by FDA regulations; and  
v. 4.2.5 Proof of Payment of Fees as prescribed by current FDA regulations  
 
5. Change in/ Additional Packaging Type or Packaging Material  
 
a. Conditions  
 
i. There must be no changes in the product that is an indication for initial 
product registration  
ii. This is independent of the change in product description/ design.  
 
b. Requirements  
 
i. Accomplished Integrated Application Form as prescribed by current FDA 
regulations;  
ii. Complete labeling materials of the previously approved label and the 
proposed new/ additional presentation of packaging for comparison. (All 
information on the label including the design should be the same);  
iii. Proof of suitability of packagi ng material for food, including stability of 
the product in the new packaging;  
iv. Clear and complete loose labels or artworks, as applicable, of all 
packaging sizes, or equivalent as defined by FDA regulations; and  
v. Proof of Payment of Fees as prescribed by cu rrent FDA regulations  
 
6. Change in Product Description/ Name:  
 
a. Conditions  
 
i. There must be no changes in the product that is an indication for initial 
product registration  
ii. This is independent of the change in packaging material or packaging type   
9 
  
 
b. Requirements  
 
i.  Accomplished Integrated Application Form as prescribed by current FDA 
regulations;  
ii.  Scanned Application Letter stating the intended changes, including 
justification for the change (indicate changes/ amendments to be made and 
the name should describe the true identity of the product);  
iii.  Clear and complete loose labels or artworks, as appli cable, of all 
packaging sizes, or equivalent as defined by FDA regulations; and  
iv. Proof of Payment of Fees as prescribed by current FDA regulations  
 
7. Change in Brand Name  
 
a. Accomplished Integrated Application Form as prescribed by current FDA 
regulations;  
 
b. Scanned Application Letter stating the intended changes (indicate changes/ 
amendments to be made);  
 
c. New product label, reflecting the change  
 
d. Authority from the source or the owner of the brand (if imported)  
 
e. IPO registration, if available  
 
f. Proof of Payment of Fees as prescribed by current FDA regulations  
 
8. Change in Business Name  
 
a. Accomplished Integrated Application Form as prescribed by current FDA 
regulations;  
 
b. Scanned Application Letter stating the intended changes (indicate changes/ 
amendments to be made);  
 
c. License to Operate reflecting the new business/ company name  
 
d. New labeling materials, reflecting the change; and   
 
e. Proof of Payment of Fees as prescribed by current FDA regulations  
 
9. Change in Importer/ Distributor/Trader  
 
a. Accomplished Integrated  Application Form as prescribed by current FDA 
regulations;  
 
b. Scanned Application Letter stating the intended changes (indicate changes/ 
amendments to be made);   
10 
  
c. Termination of agreement;  
 
d. Deed of Assignment/ Agreement of new manufacturer/ importer/ distrib utor 
or Appointment letter  
 
e. New labeling materials, reflecting the change/s  
 
f. Proof of Payment of Fees as prescribed by current FDA regulations  
 
10. Amendments requiring notification must be made known to the FDA within 30 
calendar days of effect.  Change in Business/ Company Address (Not Applicable or 
Manufacturer and Repacker)  
 
a. Filing of Amendment shall be filed at most 6 months prior to expiration of 
the Certificate of Product Registration.  
b. For amendment of applications initially approved in the old E -Registration 
or manual system, accomplish the initial application and amendment forms 
and upload both initial and amendment requirements.  
 
E. Printing of Certificate of Product Registration  
 
      If the application filed in the Modified E -Registrati on Version 2 is approved, a system -
generated email notification shall be sent to the applicant's registered email. The applicant 
can download and print the system -generated CPR by opening the case number in the Inbox 
of the E -Registration account holder.  
 
F. Exhaustion of Registered Products  
 
     For a company with a request for closure but still having a product with valid CPR, a letter 
requesting exhaustion of the registered product indicating the inventory of stocks with the 
target date for consumption shall be submitted. This is subject to approval .  
 
G. Cancellation of CPR  
 
     The E -Registration account holder may cancel the CPR of a product application filed in the 
Modified E -Registration Version 2 by opening the case number in the Inbox folder. Sel ect "I 
want to cancel this authorization" as the type of action and proceed with the application to end 
the process.  
 
 
 
 
 
 
 
 
 
 
  
1 
 ANNEX F  
 
Requirements for Application of Import Permit  
 
 
 
The following are the requirements for Import Permit:  
 
1. Application Letter stating the purpose of importations, products to be imported and 
their quantity.  
  
2. Notarized Affidavit of Undertaking (see sample below)  
 
a. Certificate of Analysis (E.g. physical, chemical, microbiological and nutrient 
analysis of the finished product) or Certificate of Free Sale issued by the 
Regulatory/ Health Authority/ Attested by recognized Association or duly 
authenticated by the Philippine Consulate from the country of origin.  
 
3. Proforma or Commercial Invoice  
 
4. If available, these  documents may be attached to the application dossier: Packing 
List, Airway Bill or Bill of Lading  
 
5. Valid License to Operate issued by FDA -CFRR  
 
6. Proof of Payment of Fees as prescribed by current FDA regulations;