Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
DRAFT (February 6, 2014)
ADMINISTRATIVE ORDER
No. 2014-________________
SUBJECT: Rules and Regulations on the Licensing of Food Establishments and Food
Business Operators and Registration of Processed Food, and Other Food
Products, and For Other Purposes
I. Rationale/Background
Effective national food control systems are essential to protect the health and safety
of consumers. They are also critical to assure the safety and quality of food entering
international trade and to ensure that imported food conforms to the national safety and
quality standards requirements. The global environment for food trade places emphasis on
strengthening food control systems and to implement and enforce risk-based food control
strategies.1 The food regulatory agencies are responsible for setting food safety standards,
regulating food establishments and food business operators as well as the products they
manufacture, offer for sale, or distribute, by conducting inspections to ensure compliance to
standards, and maintaining a strong regulatory enforcement program to deal with those that
do not comply with the provisions of the law.
The Department of Health (DOH) through the Food and Drug Administration (FDA)
is mandated by Republic Act (RA) No. 10611, otherwise known as the Food Safety Act of
2013, to bear the specific responsibility of ensuring the safety of all food processing and
product packaging activities, among others (Section 18), and to develop and issue
appropriate authorizations in the form of a license and certificate or registration that would
cover establishments, facilities engaged in production and distribution of products (Section
28).
The Food and Drug Administration Act of 2009 (Republic Act No. 9711) reaffirmed
that the State shall adopt, support, establish, institutionalize, improve and maintain
structures, processes, mechanisms and initiatives that are aimed, directed and designed to
protect and promote the right to health of the Filipino people (Sec.3). Further, Section 7
affirms the FDA Act as amendment to Republic Act No.3720 prohibiting the manufacture,
importation, exportation, sale, offering for sale, distribution, transfer, or retail of any food
products; or the operation of establishment by any natural or juridical person without the
License to Operate from the FDA (Section 7(k)).
Presidential Decree No. 856, otherwise known as the Code of Sanitation of the
Philippines states under Section 14 that “No person or entity shall operate a food
establishment for public patronage without securing a permit from the local health office.”
Moreover, under Section 15, it states that “No person shall be employed in any food
establishment without a Health Certificate issued by the local health authority.”
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Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
1
FAO/WHO Assuring Food Safety and Quality: Guidelines for Strengthening National
Food Control Systems
Republic Act No. 7394, otherwise known as The Consumer Act of the Philippines,
also declares that the State shall ensure safe and good quality of food and regulate their
production, sale distribution and advertisement to protect the health of the consumer. It
further mandates the DOH to develop and provide standards on safety and quality of food,
among others, and to strengthen the FDA.
Therefore, the FDA through the Center for Food Regulation and Research (CFRR)
shall implement a performance-based food safety control management system which shall
include, among others: a) the development of food standards and regulations; b) post-market
monitoring; c) enforcement of Hazard Analysis Critical Control Points (HACCP) and other
risk-based control measures; d) strong participation in Codex and other international
standard setting bodies, e) communication of risks and development of interactive exchange
among stakeholders; f) establishment and strengthening of food laboratories; g) development
of a database on food-borne illness and epidemiological data; h) strengthening R&D
capabilities food safety and quality standards; and i) certification of food safety inspectors.
Consistent with this mandate, the FDA will ensure food safety through the
imposition of food quality standards in the country. Thus, the issuance of this
Administrative Order on the Licensing of Food Establishments, and Registration of
Processed Food to issue appropriate authorizations in the form of a permit, license and
certificate of registration or compliance that would cover establishments, facilities engaged
in production, post-harvest handling, processing, packing, holding or producing food for
consumption in accordance with the mandated issuances of regulatory agencies issuing such
authorizations.
This Administrative Order is hereby issued, consistent with the abovementioned
Laws and Regulations, to guide the food industry and the public in ensuring safety of food
and food products in the furtherance of public health.
II. Objectives
The objective for issuing this Administrative Order is to provide guidelines and
policies, on the following:
1. The issuance of License to Operate (LTO) to food establishments and food business
operators engaged in the manufacture or processing and distribution, i.e. import,
export or wholesale, or trade and repacking of processed food and food products, by
issuing the License to Operate,
2. The issuance of the Certificate of Product Registration (CPR) to FDA-licensed
establishments before processed food and other food products are sold, offered for
sale or use, distributed or supplied, among other marketing and promotional
activities, and
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Department of Health
OFFICE OF THE SECRETARY
3. Adoption of risk-based classification of food establishments and food products
III. Scope and Coverage
This Administrative Order is issued to cover food establishments and food business
operators engaged in the manufacture and distribution, i.e. import, export or wholesale, or
trade and repacking, of processed food and food products.
This Administrative Order shall not cover fresh or raw food derived from fresh plant,
animal, fisheries and aquaculture products or foods in the primary production and postharvest stages of the supply chain under the Department of Agriculture. It shall likewise not
cover food businesses such as, but not limited to, activities in slaughterhouses, dressing
plants, fish ports, wet markets, supermarkets, school canteens, restaurants, catering
establishments, water refilling stations, street food sale, including ambulant vending which
are under the purview of the Local Government Units (LGUs).
IV. Definition of Terms
The following terms are defined for clarity:
1. Advertising refers to the business of conceptualizing, presenting or making available to
the public, through any 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.
2. Authorization refers to the permission 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, importation, exportation, sale, and offer for sale, distribution,
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.
3. Bottled Water means water that is placed in a sealed container or package and is offered
for sale for human consumption as drinking water.
4. Certificate of Product Registration (CPR) is an authorization issued by the FDA for
specific health products after evaluation and approval of submitted registration
requirements.
5. 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 environmental contamination.
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6. 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.
7. Distribute means the delivery or sale of any health product for purposes of distribution in
commerce, except that such term does not include the manufacture or retail of such
product.
8. Distributor/Importer/Exporter refers to any establishment that imports or exports raw
materials, ingredients and/or finished products for its own use or for wholesale
distribution to other establishments or outlets. If the distributor/importer/exporter sells to
the general public, it shall be considered a retailer.
9. Distributor/ wholesaler refers to any establishment that procures raw materials, and/or
finished products from local establishments for local distribution on wholesale basis.
10. Establishment means a sole proprietorship, a partnership, a corporation, an institution, an
association, or an organization engaged in the manufacture, importation, 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.
11. 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 other substances which are intentionally incorporated into the food during its
manufacture, preparation and treatment.
12. Food safety standards refer to the formal documents containing the requirements that
foods or food processors have to comply with to safeguard human health. They are
implemented by authorities and enforced by law; and are usually developed and
published under the auspices of a national standards body.
13. 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, or 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 or improving nutritional qualities.
14. 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: vitamin,
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 the 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 the sole item of a meal or
diet or a replacement for drugs and medicines.
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15. Fortification means the addition of nutrients to processed foods or food products at
levels above the natural state.
16. 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.
17. Food Business refers to any undertaking, whether public or private, that carries out any
of the activities related to, or any of the stages of the food supply chain.
18. 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 the Food Safety Act of
2013 are met by the food business under one’s control.
19. Food Hygiene (hereinafter referred to as hygiene) refers to the measures and conditions
necessary to control hazards that could lead to food-borne illnesses and to ensure fitness
for human consumption of a food of plant or animal origin taking into account its
intended use.
20. Food Law refers to the laws, regulations and administrative provisions governing food in
general, donated food and food safety at any stage of production, processing, distribution
and preparation for human consumption.
21. Food Safety refers to the assurance that food will not cause harm to the consumer when
it is prepared or eaten according to its intended use.
22. Food Quality includes all other attributes that influence the value of a product to the
consumer which includes its color, flavor, texture, origin and processing method of the
food.
23. Food Supply Chain refers to all stages in the production of food from primary
production, post-harvest handling, distribution, processing and preparation for human
consumption.
24. Good Manufacturing Practice (GMP) refers to a quality assurance system aimed at
ensuring that products are consistently manufactured, packed, repacked or held to quality
standards appropriate for the intended use. It is thus concerned with both manufacturing
and quality control procedure.
25. Good Distribution Practice (GDP) or Good Storage Practice (GSP) refers to a part of
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 will 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.
26. Hygienic practices refer to all practices regarding the conditions and measures necessary
to ensure the safety and suitability of food at all stages of the food chain.
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Department of Health
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27. Hazard Analyses and Critical Control Points (HACCP) refer 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.
28. Ingredient 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.
29. 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 destination of production inputs and outputs to verify compliance with legal
requirements by an agency mandated to perform food safety regulatory and/or
enforcement functions.
30. Label refers to the display of written, printed or graphic matter upon the immediate
container, 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 regulations.
31. 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.
32. Licensing, Regulation and Enforcement Division (LRED) shall mean the division under
the Center for Health Development in charge of licensing, regulation and enforcement of
DOH-FDA rules and regulations. LRED may also mean RLED.
33. 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 the Philippines and the Mayor’s Permit.
34. Manufacturer means an establishment engaged in any and all operations involved in the
production of health products including preparation, processing, compounding,
formulating, filling, packaging, repacking, altering, ornamenting, finishing and labeling
with the end in view of its storage, sale or distribution. A trader shall be categorized as
manufacturer. They may also manufacture products for institutional use. In case of
imported food products, the manufacturer’s representative or, in his absence, the
importer shall be deemed the manufacturer.
35. Micro, Small and Medium Enterprise (MSME) refers to food businesses as defined
within the classification of industries by the Department of Trade and Industry (DTI).
36. Monitoring refers to the systematic gathering of data through the sampling of
commodities as well as monitoring of food-borne diseases, collation and interpretation of
collected data.
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37. Permit refers to a form of authorization that is issued by the FDA to an establishment
that has complied with the application requirements.
38. 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
those processes intended to produce/ manufacture food.
39. Raw materials are all substances that are employed in the processing of a finished
product, packed in bulk containers and not labeled as finished product. Raw Materials or
ingredients would have product specifications that comply with the client requirements
and not necessarily a single component.
40. Repacker means any establishment engaged in the process of packaging or changing of
container, wrapper (that may include or not a changing of label) from a bulk material to
retail packaging sizes in furtherance of distribution of food.
41. Retailer means any establishment which sells or offers to sell any health product directly
to the general public.
42. Risk refers to a function of the probability of an adverse health effect and the severity of
that effect, consequential to a hazard(s) in food.
43. Salt Iodization refers to the addition of iodine to salt intended for human consumption in
accordance with specifications as to form, fortificant type, method, manner and
composition as may be prescribed by the FDA.
44. Trader means any establishment which is a registered owner of food and food products
and/or procure the raw materials and packing components, quality control standards and
procedures, but subcontracts the manufacture of such product to a licensed manufacturer.
In addition, a trader may also engage in the distribution and/or marketing of its products.
45. Toll Manufacturer refers to the manufacturer that conduct 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.
V. General Guidelines
The FDA shall be guided by the following risk categorization or classification of
food businesses and major risk factors on food safety when conducting food establishment
inspections and when evaluating food products for registration:2
1.
High Risk food are food products that may contain pathogenic microorganisms and
will support formation of toxins or growth of pathogenic microorganisms. Examples
are raw meat, fish, oysters, poultry and milk. Other examples include tofu, fresh
filled pasta, meat pies, frankfurters, salami, cooked rice and lasagne (these foods
pose a particularly high risk if they are not processed or cooked adequately).
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FAO/UN Guidelines for Risk Categorization of Food and Food Establishment Applicable to
ASEAN Countries
2.
Medium-risk food are food products that may contain pathogenic microorganisms
but will not normally support their growth due to food characteristics; or food that is
unlikely to contain pathogenic microorganisms due to food type or processing but
may support formation of toxins or growth of pathogenic microorganisms. Examples
are fruits and vegetables, orange juice, canned meats, pasteurised milk, dairy
products, ice cream, peanut butter and milk-based confectionery.
3.
Low-risk food are food products that is unlikely to contain pathogenic
microorganisms and will not normally support their growth due to food
characteristics. Examples are grains and cereals, bread, carbonated beverages, sugarbased confectionery, alcohol and fats and oils.
The following major risk factors shall be taken into consideration or into account:2
1.
Type of Food and Intended Use by Consumers or Customers. The type of food
handled by a food business is important in identifying the hazards that are likely to
be present. Some foods are more likely to be contaminated with pathogenic
microorganisms and to support their growth. Whether or not the food is prepackaged or intended to be ‘ready-to-eat’ is also important in determining the
severity of the risk. Ready-to-eat food can present a greater risk of causing foodborne illness as it is not intended for further heat processing. Heat processing can
destroy any pathogens present in the food.
2.
Activity of the Food Business Operators. The amount of handling and whether or
not the food is intended to be ready-to-eat are considered to play an important role in
determining the potential risk of a food business. Whether or not the food is
packaged/ pre-packaged is also considered. Businesses that are extensively handled
or even transported are more likely to be contaminated with pathogenic bacteria
when exposed to abused or inappropriate storage condition, such that the storage or
shelf life is reduced. If a food business handles unpackaged food the risk of
contamination is more likely than if the food is pre-packaged prior to handling by the
food business. Again if the food is intended to be ready-to-eat and will not receive
further heat processing, it presents a greater risk of causing foodborne illness.
3.
Method of Processing. Processing steps that reduce the level of microorganisms
through the application of a well-established pathogen reduction step (such as
sterilization, preservation, cooking and pasteurisation) reduce the risk of microbial
hazards. Processes that significantly reduce the microbial population (pathogen
reduction steps) and are performed by the food business before sale are considered
low risk.
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Department of Health
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2
4.
FAO/UN Guidelines for Risk Categorization of Food and Food Establishment
Applicable to ASEAN Countries
Consumer or Customer Base. The number of individuals potentially exposed to a
food hazard is an important determinant in assessing the severity of the risk
presented by the food business. The number of persons exposed will, in all but fully
automated processes, be related to the number of employees required for production.
A business producing a large amount of food is likely to employ more people and,
therefore, the business size is used to approximate the size of the exposed population.
Food businesses catering directly to customers, such as children under the age of
five, the elderly, pregnant women and people with an illness is another factor to
consider. These groups are vulnerable to food-borne illness and can become very ill
from consuming food that is contaminated with low doses of pathogenic bacteria.
The implementation of this Administrative Order shall be guided by the following:
A. License to Operate (LTO)
1. All food establishment shall secure a LTO as food manufacturer and shall be classified
as follows:
1.1.
Large, and medium food establishments, using the DTI classification shall
apply for LTO at the FDA in Alabang; or to their nearest respective regional
offices/ Center for Health Development.
1.2.
Small establishments and Microenterprise food manufacturers, using the DTI
classification, shall apply for LTO at the FDA-DOH or to their nearest
respective regional offices/ Center for Health Development Offices.
2. All applications for a License to Operate shall be accepted by the FDA only when all the
requirements have been completed.
3. The manufacture, importation, exportation, sale, offering for sale or use, distribution, or
wholesale of any processed food or processed food products by any food establishment
or food business operators, as the case maybe, without the License to Operate (LTO) and
CPR issued by the FDA is prohibited
4. The LTO shall be a requirement before a food establishment or food business operator
can join food trade and exhibitions, market research or testing of unregistered processed
food products.
5. Food establishment and food business shall apply for both LTO and CPR/s during the
initial application. After which, additional CPR application may be filed by an FDAlicensed establishment and food business operator.
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6. 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
only when they have complied with all the requirements and have demonstrated their
capability and capacity to assure food safety and quality.
7. No application for initial or renewal of LTO shall be accepted or approved unless the
prescribed fee is paid.
8. A food business operator with LTO as food distributors, i.e. as importer, exporter or
wholesaler, may engage in manufacturing or repacking provided that a LTO as
manufacturer (repacker) shall be secured also from the FDA.
9. All FDA-licensed food establishments and food business operators shall be primarily
responsible for determining the regulatory requirements of the importing country before
engaging in food export.
10. Food manufacturing or processing plant shall be covered by a single LTO
notwithstanding their distance or different locations within one locality/municipality/city
but with one product, at different stages of operation/ process indicating their address in
the license. 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
appended thereto.
11. When a food manufacturing or processing plant carries an entirely different and
complete stage of operation for different products in different locations but within one
municipality/city, in which case, each shall be covered by separate licenses. Food
manufacturing establishments utilizing or sharing one facility shall not be allowed
regardless of ownership.
12. Any establishment applying for a license to the FDA as food distributor (importer,
exporter, wholesaler) utilizing or sharing one office shall not be allowed regardless of
ownership.
13. For offices of distributors, all warehouses and depots shall be declared. Sharing of
offices by different distributors shall not be allowed.
14. Licensing of food manufacturers shall be issued only by the FDA if the food business
operators are able to demonstrate consistency in production of safe and good quality
products.
B. Certificate of Product Registration (CPR)
1. All processed food products such as food additives, food supplements and bottled water,
shall first be registered with the FDA before they are distributed, supplied, sold or
offered for sale or use and advertised, among other marketing or promotional activities.
2. Only applications with a complete set of requirements shall be accepted and processed
for the order of payment.
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3. Only one CPR per product shall be issued regardless of the packaging size provided that
all specifications and information are the same and the only difference is the net weight.
If one product has multiple packaging sizes but with the same formulation, the same
ingredients in the same order of proportion bearing one brand and product name, and
label design except for recipes and models, this shall be covered by one CPR.
4. The CPR shall be approved and issued only when all the requirements have been
complied and the safety standards set by the FDA has been met.
5. The registration requirements for food establishments intending to export products are
the same. However, food establishments with intention to export, shall comply with all
the regulatory standards and requirements of the importing countries, including the
labeling requirements.
6. Food products shall be evaluated for safety and quality, as well as compliance to
labelling regulation prior to issuance of CPR.
7. 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 category, as applicable, will be given
CPR.
8. Should a product fail to meet the requirements on food safety, and quality, applicable
product standards, and labeling regulations, a Letter of Denial shall be issued. The
applicant shall be given a maximum of six (6) months to comply.
9. The company should secure permission from FDA in writing for any additional label
design or other label changes prior to use in advertisement, promotion, and commercial
distribution.
10. Imported and local manufactured raw materials intended to be sold, offered for sale or
use or for distribution to other food establishments and food business operators and
consumers shall secure a CPR for each raw material, ingredients and food additives..
However, raw materials intended for further processing by the local
manufacturer/importer need not secure CPR.
11. When a CPR is granted to a food manufacturer/importer, all individual ingredients as
part of the FDA-registered product formulation, may be imported without a CPR.
However, should the FDA-licensed food manufacturer/importer use or source out local
ingredients, it shall only purchase from FDA-licensed establishment.
12. Products covered by separate laws (e.g. RA 8172 and RA 8976) requiring the
submission of Certificate of Analysis (COA) shall be complied with.
13. Validity of Certificate of Product Registration (CPR) will be 2 years minimum to 5 years
maximum for initial and 5 years for renewal; provided that upon renewal, its holder
conforms with the pertinent standards and requirements including labeling regulations.
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14. Only food additives listed in the latest Codex General Standards for Food Additives
(GSFA) and/or the latest FDA Listing of Food Additives and/or approved
pharmaceutical excipients list intended for Food Supplement in pharmaceutical dosage
form such as tablet, softgel capsule and capsule shall be issued a CPR.
15. The FDA may request for additional documents on products that are considered high risk
food provided that the reason for the additional requirements is to address uncertainties
on safety.
16. No food samples shall be submitted to FDA provided that the labels are clear and bears
the complete label information. However, for food supplements, it is necessary to submit
product samples in commercial presentation.
17. Food supplements shall not have curative claims or therapeutic claims. Other claims
shall be in accordance to existing and relevant labeling guidelines.
18. Other than the food supplement labels, advertising and promotional materials of food
establishments and food business operators shall not make curative or therapeutic claims
without scientific data or clinical trials to substantiate such claims.
19. Specialized high risk products such as, but not limited to, infant formula, milk
supplement, foods for infants and young children, foods for special medical purposes
and foods for special dietary uses shall be required to submit additional requirements as
deemed necessary.
20. 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.
21. 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.
C.
Quality and Safety Standard
1.
All processed Food Products shall comply with the relevant appropriate / applicable
quality and safety standards, if any.
2.
Food establishments or food business operators shall be required to conform with the
General Principles of Food Hygiene, including general requirements on sanitation, and
as appropriate for the food establishment or food business operation, comply with the
relevant standards and requirements of the code of Good Manufacturing Practice,
HACCP, Good Storage Practice, Good Distribution Practice, or the Sanitary Standard
Operating Procedures.
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3.
Food establishments shall be required to comply, as appropriate, with the requirements
of the ASIN Law and Food Fortification Law, and other issuances related to them and
to other food quality and safety standards as adopted or determined by the FDA.
D. Inspection and Certificate of Compliance
1.
The FDA/CHD may verify documents submitted to FDA and conduct risk-based
approach audit during pre-licensing inspection for the purpose of preparing or
issuing the Certificate of Compliance.
2.
The FDA may conduct inspection in collaboration with the LGUs and any agency or
office under the DOH, DA and DILG.
E. Food Legislation
1.
FDA-licensed food establishments or food business operators shall comply with
relevant laws that address nutritional quality of food and food products, such as the RA
8172 (ASIN Law) and RA 8976 (Food Fortification Act).
2.
Food business operators shall comply with the provisions of RA No. 9711, RA No.
10611, RA No. 3720 as amended by E.O. 175, RA No. 7394, and Presidential Decree
No. 856 to ensure food quality and safety.
VI. Requirements and Guidelines on Application for LTO and CPR
A.
License to Operate
1.
The food business operator or the food establishment FDA may apply for the
following License to Operate based on the type of the food business operation:
1.1.
1.2.
1.3.
LTO as Food Manufacturer, including Toll Manufacturer or Repacker
1.1.1. Large, Medium and Small
1.1.2. Microenterprise
LTO as Food Distributor (DTI classification does not apply)
1.2.1. Importer
1.2.2. Exporter
1.2.3. Wholesaler
LTO as Food Trader, that enters into contract with a FDA-licensed Toll
Manufacturer
2. Requirements for LTO Application
2.1.
Initial. The following are the requirements for initial application:
2.1.1. General Requirements
2.1.1.1. Proof of Business Registration
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a. If Single Proprietorship, Valid Certificate of Business
Name Registration with the Department of Trade and
Industry
b. If a Corporation or Partnership, Valid Registration with
SEC and Articles of Incorporation and other pertinent
documents
c. If a Cooperative, Certificate of Cooperative Development
Authority (CDA)
If the Business Name is different from the Corporate Name,
SEC Certificate must reflect "Doing business under the
name and style of (Name of Establishment)
If the business name and address is different from the
registered name and address in the DTI or Security and
Exchange Commission or SEC), a Valid Mayor's Business
Permit or Barangay Business Permit shall be submitted.
2.1.1.2. Duly Notarized Accomplished Application and Order of
Payment with ID picture (size: 2x2 inch) of applicant
(ANNEX A).
Persons who signs on behalf of the
establishment or company owner shall present a notarized
certificate of authority.
The Tax Identification Number (TIN) of the owner shall be
reflected on the petition form.
2.1.1.3. Proof of Occupancy (for offices and warehouses), such as
notarized valid Contract of Lease of the space/building
occupied if the space/building is not owned, Copy of
Transfer Certificate of Title (TCT) if owned, duly notarized
warehousing agreement (3rd party logistics)
2.1.1.4. Location Map (indicate location, landmarks, immediate
environment, type of building) and GPS
2.1.1.5.
List of food products to be manufactured, processed,
distributed, sold, or offered for sale or use, as the case may
be
NOTE: Pre-licensing inspection and a Certificate of Compliance (COC) shall
be issued, following a risk-based approach or HACCP/GMP requirements
depending on the level of risks and complexity of production, among others
(Section V.D.2.). The conduct of inspection shall be covered by Quality
Manual.
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Republic of the Philippines
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OFFICE OF THE SECRETARY
In lieu of the COC, for the microenterprise food manufacturer, Sanitary
Permit (establishment) and Health Certificate (food handlers), as appropriate,
which are issued after inspection or examination by the LGU sanitary
inspectors or health facilities may be accepted by the FDA.
However, the FDA reserve the right to inspect at any in time as routine, spot
check, post-market surveillance of the product, or to act on any report of
food-borne illness or complaints the FDA receives. Upon validation of noncompliance to FDA safety and quality standards, the FDA CFRR Director
shall revoke the LTO and CPR immediately, following due process.
2.1.2.
Specific Requirements
2.1.2.1. Manufacturer/Processor
2.1.2.1.1. Comprehensive/short Product description to be
manufactured (e.g. list of Ingredients, physicochemical and/or microbiological specifications)
2.1.2.1.2. Comprehensive/short
description
of
manufacturing
process
or
food
processing/preparation, including a flowchart
with quality control points, as appropriate to the
size of operation (Annex 3, outline/guide)
2.1.2.1.3. Comprehensive/short quality control procedures,
as appropriate to the size of operation (Annex 4,
outline/guide)
2.1.2.1.4. Facsimile of proposed product label, compliant
with FDA standards
The microenterprise food manufacturer may freely seek
assistance from the FDA field Food and Drug Regulation
Officer through the FDA-DOH/CHD offices.
Manufacturers shall comply with relevant law, rules and
regulations, such as the RA 8172 (ASIN Law) and RA 8976
(Food Fortification Act).
2.1.2.2. Repacker
2.1.2.2.1.
2.1.2.2.2.
2.1.2.2.3.
2.1.2.2.4.
Comprehensive description of manufacturing
process, including a flowchart with quality
control points
Quality control procedures
Product Description to be repacked
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
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Department of Health
OFFICE OF THE SECRETARY
2.1.2.2.5.
Facsimile of proposed label, compliant with
FDA standards
2.1.2.3. Importer of Raw Materials/Finished Product Ingredients or
Additives for Distribution or Retail
2.1.2.3.1. Any of the following: pro forma invoice,
foreign agency agreement, appointment letter,
or distributorship agreement
2.1.2.3.2. Any of the following scanned original copy of
the original following documents issued to the
manufacturer by the regulatory or health
authority in country of origin: valid
manufacturer’s certificate of registration with
GMP compliance, or its equivalent, valid
Phytosanitary Certificate or Health Certificate,
valid ISO 22000 Certification, or valid HACCP
Certificate or Certificate of Free Sale as
applicable. All certification issued by a private
organization should be attested by a recognized
business association or chamber of commerce.
2.1.2.3.3. Appropriate test result or certificate of analysis
routinely conducted in the country of origin or
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 laboratories.
FDA-licensed food manufacturers shall be allowed to import raw materials or finished
products as ingredients or additives for their own use to manufacture registered food
products.
Importers shall comply with applicable law, rules and regulations, such as the RA
8172 (ASIN Law) and RA 8976 (Food Fortification Act).
2.1.2.4. Distributor/Exporter
2.1.2.4.1 Valid notarized distributorship agreement or letter
of appointment between FDA-licensed importer manufacturer
and exporter
2.1.2.4.2 Copy of valid CPR
2.1.2.5. Distributor/Wholesaler
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Department of Health
OFFICE OF THE SECRETARY
For wholesaling of locally procured raw materials in bulk or
finished products, valid notarized Distributorship Agreement
or Letter of Appointment with FDA-licensed food
establishment.
Valid Certificate(s) of Product Registration
2.1.2.6. Food Trader
Valid and notarized toll manufacturing and/or repacking
agreement with FDA-licensed toll manufacturer and/or
repacker
Note: For Bottled drinking water, the Standards and Good Manufacturing Practice
(GMP) requirements as stated in Administrative Order No. 18-A s. 1993 or the
Philippine National Standard for Bottled Drinking Water are still in effect.
2.2.
Requirements for LTO Renewal
2.2.1. Regular renewal. The FDA shall determine the continued compliance
by the establishment with the standards and requirements of FDA
through inspection.
2.2.2. Automatic renewal – where there is no need for inspection or resubmission of requirements as required for initial applications, may be
granted only if the following conditions are met:
2.2.2.1. 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
2.2.2.2. The application for renewal was filed before the expiration
date of the license; and
2.2.2.3. The prescribed renewal fee was paid upon filing of the
application based on assessment form as shown in the
official receipt.
3.
Requirements on LTO Amendments
The following are the requirements for amending information and other circumstances
of LTO:
3.1. Change of Business Name
3.1.1. Notarized accomplished amendment application form with id picture of
the owner
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Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
3.1.2. Photocopy of business name registration or a digital image of the
document (1024 x768 pixels)
3.1.2.1. For single proprietorship registration from the Department of
Trade & Industry (DTI)
3.1.2.2. For corporation / partnership, registration from Securities &
Exchange Commission (SEC) and Articles of Incorporation. If
the registered address with DTI/SEC is different from the address
of the establishment to be licensed, a photocopy of
Business/Mayor’s Permit shall be submitted
3.1.3. Surrender original License to Operate (LTO)
3.2. Change of Ownership
3.2.1. Notarized accomplished Petition Form with ID picture of the owner
3.2.2. Photocopy of Business Name Registration
3.2.2.1. For single proprietorship registration from the Department of
Trade & Industry (DTI)
3.2.2.2. For corporation / partnership, registration from Securities and
Exchange Commission (SEC) and Articles of Incorporation. If
the registered address with DTI/SEC is different from the address
of the establishment to be licensed, a photocopy of
Business/Mayor’s Permit shall be submitted.
3.2.3. Photocopy of Contract / Agreement with Manufacturer reflecting the new
owner
3.2.4. Photocopy of Deed of Sale or Transfer of Rights
3.2.5. Photocopy of Dissolution Papers from SEC (for corporation/partnership)
3.2.6. Surrender original License to Operate (LTO)
3.3 Addition or Deletion of Activities/ Classification/ Sources/ Products
3.3.1. Notarized accomplished Amendment Application Form with ID picture of
the owner / authorized representative
3.3.2. List of Added Activities/products with the corresponding process flow,
revised plant layout and results of analysis in case of additional products
Note: For deletion, a letter notifying the FDA will suffice.
3.3.3. List of new sources, as applicable
3.3.4. Specific sources or products to be deleted, as applicable
3.4 Changes In The Existing or Opening or Closure Of Warehouse/ Office/ Branch
3.4.1. Notarized accomplished Amendment Application Form with ID picture of
the owner/authorized representative
3.4.2. Photocopy of Business Name Registration under new address, when
applicable
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Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
3.4.2.1. For single proprietorship registration from the Department of
Trade & Industry (DTI)
3.4.2.2. For corporation / partnership, registration from Securities &
Exchange Commission (SEC) and Articles of Incorporation. If the
registered address with DTI/SEC is different from the address of the
establishment to be licensed, submit a photocopy of Business/Mayor’s
Permit
3.4.3. Photocopy of Contract / Agreement with Manufacturer reflecting the new
owner, when applicable.
3.5. Change of Business Information
No change in the previously approved circumstances of the application 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 be effected unless with prior notification to FDA through
amendment.
3.6. Assignment and Transfer of Pending Applications, Existing Licenses
If there is a change in ownership while application is on process, the
application shall be considered terminated and documents shall be returned to the
authorized representative of the company. The new owner or the new regulatory
officer shall comply with the requirements for initial application including
attendance to QPIRA.
3.7. Lost or Destroyed LTO
A lost or destroyed LTO shall be replaced by the FDA upon submission of a
letter of request and payment of prescribed fee. A certified photocopy of the original
LTO kept by FDA shall be issued temporarily for a period of 3 months.
4. Approval and Validity of the LTO
4.1. The Director of the CFRR shall sign the LTO.
4.2. Unless revoked, the LTO shall have the following validity period:
4.2.1. Initial LTO issued shall be valid for one (1) year.
4.2.2. Renewed LTO shall be valid for two (2) years.
4.3. 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 ground for
revocation of the LTO.
5. Licensing Process
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Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
5.1. All applications shall be received by the FDA or the CHD through the PAIR
system or by the LRED/RLED for evaluation by the CFRR or FDA/LRED/RLED, as
applicable.
5.2. A Certificate of Compliance 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 Certificate of
Compliance is issued.
5.3. 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.
However, upon finding, in the course of its evaluation, monitoring, inspection and
spot checking, of any violation in the compliance and other requirements required by
the FDA and its implemented laws, such as the FDA Act of 2009, these Rules and
Regulations, and other relevant laws, to submit a report to serve as basis for the motu
proprio action of the Director of the Regional Field Office; as per Book I Article
VIII of IRR of RA 9711 under Section 7 (g). Hence, the RFO upon
verification/inspection that the food establishment has not complied with the
requirement have the power to disapprove and sign the proper action by the Director
of the RFO.
5.4. The notice of disapproval of applications for license shall clearly state the reason
for disapproval.
B. Certificate of Product Registration
An application may be filed with the FDA in Alabang or respective FDA/CHD
Office having jurisdiction over the establishment.
1.
Initial Registration
The following requirements for CPR application shall be submitted electronically to
FDA via http://fda.gov.ph or through the PAIR Unit:
1.1. Product Information Sheet duly accomplished and submitted online (See Annex
B)
1.2. Notarized application letter with Affidavit of Undertaking
1.3. Copy of valid License to Operate with the list of all products or variants and list
of sources, as the case may be, and their manufacturer and country/location
1.4. Clear and complete loose labels of all packaging sizes (may be scanned/
electronic copy/ies)
1.5. Pictures of the product in all angles and in different packaging sizes, as
applicable, except for food supplement, a sample in actual commercial
presentation shall be submitted.
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Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
1.6. As applicable, documents to substantiate claims, such as technical, nutritional or
health studies or reports, Certificate of Analysis, quantitative analysis and
computations, scientific or report or studies published in peer-reviewed scientific
journals, certificates or certification to support use of logo/seal on Sangkap
Pinoy, Halal, Organic, or Kosher food
2.
Renewal of CPR
The FDA shall determine the continued compliance of the food establishments to the
FDA standards and requirements specific for the registered food product or food category
during renewal of the CPR. Renewal of the CPR may be automatic provided that the
following conditions are met: a) The application shall be filed before the expiration date of
the registration; b) The prescribed renewal fee must be paid prior to filing of the application;
If there is no condition stated at the back of the issued Certificate of Product Registration.
However, in case there is a condition, an acknowledgment letter from FDA indicating the
condition stated in the CPR had been complied, should be submitted.
Any application filed as automatic renewal registration shall be submitted with the
FDA at least 90 days before the date of its expiration with the submission of the following
requirements:
2.1 Notarized letter of application from manufacturer/importer/distributor indicating
that there is no change in formulation, specification and labeling of the product,
and there was no unresolved violation, penalties or sanction pending with the
FDA.
2.2 Photocopy of valid License to Operate, reflecting the source(s) of the product;
2.3 Scanned copy of the actual and complete loose labels and labeling materials
including all packaging sizes or a digital image in an FDA-approved format;
2.4 Original CPR for verification.
Request for amendment shall not be allowed to be filed simultaneously with an
application for automatic renewal.
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 days, the application shall not be qualified for automatic renewal
and is subject to corresponding surcharges (this will be considered under
Regular Renewal with the same FR number).
b.
If the application is filed after 120 days from the expiry date of the CPR, the
application shall undergo the initial filing and evaluation procedure. It will be
issued a new CPR.
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Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
c.
If there are any changes in product formulation (reformulation), this is treated
as an application for initial registration.
d.
No application for renewal shall be accepted unless the prescribed renewal
fee is paid.
e. If within the 5 year validity, a violation on the product and label was
monitored, there will be corresponding 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.
3. Requirements on Amendments of the CPR
Assignment or transfer of a valid CPR or of a pending application for renewal
thereof shall be considered an amendment to the CPR so long as the assignee or transferee is
also a valid LTO holder and shall submit a sworn statement of acceptance including the
responsibility/liability for the product assigned or transferred.
Change in manufacturer/ repacker shall be treated as initial registration. For CPRs
reflecting the product’s packaging size, an amendment will be required for any additional
packaging size provided that all information in the previously approved label is retained.
3.1 The following are the general requirements when applying for amendment of the
CPR:
3.1.1. Letter of Application
3.1.2. Application and Order of Payment Form for CPR (ANNEX C), duly
accomplished and paid
3.1.3. Original CPR
3.1.4. Label/labeling materials of the registered-product
3.1.5. Copy of valid License to Operate
3.2 The following are the specific requirements depending on the amendment:
3.2.1 Change in Brand Name
3.2.1.1 New product label, reflecting the change
3.2.1.2 Authority from the source or the owner of the brand (if
imported)
3.2.1.3 IPO registration, if available
3.2.2 Change in product description
3.2.2.1 Reason or justification for change in the product description
(may be part of the letter of application)
3.2.2.2 New product label, reflecting the change
3.2.3 Change in Packaging Material
3.2.3.1 Statement of no changes in formulation
3.2.3.2 Reason or Justification for the change (may be part of the
letter of application)
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Department of Health
OFFICE OF THE SECRETARY
3.2.3.3
3.2.4
3.2.5
3.2.6
3.2.7
3.2.8
3.2.9
Data or information on the suitability of packaging material
to the product for food, including stability of the product in
the new packaging, and
3.2.3.4 New labeling materials
Change in Business Name
3.2.4.1 Proof of change in business name, e.g. License, Certificate
3.2.4.2 New labeling materials, reflecting the change
Change in Importer/Distributor
3.2.5.1 Termination of agreement/ Deed of assignment
3.2.5.2 Agreement of new manufacturer/ importer/ distributor or
Appointment letter
3.2.5.3 Copy of LTO, reflecting the change in LTO and its
attachment
3.2.5.4 New labeling materials, reflecting the change
Change in address of establishment
3.2.6.1 Proof of change in address, e.g. License, Certificate
3.2.6.2 New labeling materials, reflecting the change
Change/Additional Packaging Size
3.2.7.1 New labeling materials, reflecting the change
Extension of Shelf-life (for Food Supplements)
3.2.8.1 Stability data/ studies to support extension of shelf life
Change in Packaging Design (for Food Supplements)
3.2.9.1 New labeling materials, reflecting the change
4. Reissuance for lost or damaged CPR
Reissuance of a new or reconstruction of a CPR shall be issued after submission of
the following requirements:
4.1
4.2
4.3
Letter of request, indicating that there were no changes in circumstances of
the CPR that would render it invalid
Affidavit of loss
Payment of the prescribed fee
5. Registration Process
The Director General of the FDA, upon the recommendation of the Center Director
for Food, shall further promulgate the rules and regulations on the procedure for registration:
a. The applicant company shall upload and accomplish the online Product Information
Sheet from the FDA Website. FDA shall acknowledge receipt of duly accomplished
Product Information Sheet thru online. The applicant will be given a maximum of 10
working days to pay online or at FDA Cashier.
b. Before issuance of CPR, compliance of the product with applicable standards,
requirements and regulations shall be evaluated based on the submitted requirements.
After evaluation, FDA shall issue the Certificate of Product Registration within 90
working days upon filing of applications.
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c. If the product does not conform with applicable standards, requirements or regulations,
a Letter of Denial shall be issued. The applicant shall be given 6 months to reapply by
submitting the deficiencies and the complete set of documents. Otherwise, the
application is considered as initial.
VII. Grounds for Disapproval of Applications
The following shall be grounds for disapproval of an application:
1. Failure to submit complete or correction to documentary requirements.
2. Failure to meet the appropriate standard or requirement evaluation of documents or
inspection of the food establishment offices and premises.
3. Failure to respond to notice of deficiency or to submit documents on time.
4. Misrepresentations, false entries, or withheld any relevant data contrary to the provisions
of the law, these Rules and Regulations or appropriate standards.
5. Such other analogous grounds or causes as determined by the FDA.
VIII. Capacity Building
The DOH-FDA in collaboration with the LGU shall conduct capacity building on
food safety to be conducted in strategic regions in the country
IX. 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.
X. Post-Market Surveillance and Product Monitoring
Post-Market Surveillance and product monitoring shall be conducted by the FDA
based on the risks presented by the food products. Samples of products shall be collected
for testing, and routine and spot checking of food establishments or food business operators
shall be conducted. Food-borne illnesses and epidemiological data shall be studied as basis
for planning or instituting measures to reduce food-borne outbreaks. Risk communication in
collaboration with other stakeholders shall be heightened to reduce the 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 from food borne operators
or food establishments to ensure continuous compliance to food safety standards.
XI. Transition Period
Within six (6) months after the signing of this Administrative Order, the FDA shall
streamline the national process and system of licensing and registration in the country with
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other government agencies to ensure increased protection of the health and welfare of
consumers, and availability of processed food and food products in the market.
XII. Separability Clause
If any part or term of provision of this order shall be declare invalid or unenforceable
the validity or enforceability of the remaining portions or provisions shall not be affected
and this order shall be construed as if it did not contain the particular invalid or enforceable
part, term or provision.
XIV. Repealing Clause
All other administrative issuances, bureau circulars and memoranda and other
regulations inconsistent with this Order are hereby withdrawn, repealed and /or revoked
accordingly.
XV.
Effectivity
This Order shall take effect 15 days after its publication in an official gazette or in a
newspaper of general circulation.
ENRIQUE T. ONA, MD, FPCS, FACS
Secretary of Health
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Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
LIST OF ANNEXES
A
Application and Order of Payment Form for Initial LTO Application
B
Template for Product Information Sheet
C
Application and Order of Payment Form for CPR
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Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
ANNEX A
Application and Order of Payment Form for Initial LTO Application
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Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
ANNEX B
Template for Product Information Sheet
Product Information
Brand Name – if applicable
____________________________________________________________________
Product Name
____________________________________________________________________
Complete Company Name and address – as listed in the LTO
_____________________________________________________________________
Contact Number(s)
____________________________________________________________________
E-mail address:
____________________________________________________________________
Country of origin (if imported)
____________________________________________________________________
Complete Name and Address of the Supplier (if not directly sourced from the manufacturer)
_____________________________________________________________________
Complete Name and Address of Manufacturer (if imported)
____________________________________________________________________
Ingredients list:(list all specific name of the ingredients in descending order) – if applicable
1.
2.
3.
PRODUCT SPECIFICATIONS:
Physical description:
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
Chemical and/or Microbiological specifications:
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
Shelf life declaration (indicate if actual or accelerated)
____________________________________________________________________
Packaging material type/ name and Description of Product as Packed :
____________________________________________________________________
Storage condition requirement:
_____________________________________________________________________
Food application (e.g preservative, nutrient, emulsifier, bakery ingredient) – function of the
food material
_____________________________________________________________________
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Department of Health
OFFICE OF THE SECRETARY
Usage: (especially for food additives with limits) – if applicable
_____________________________________________________________________
Source of allergen / ingredient allergen (if any):
____________________________________________________________________
Lot Code and Interpretation:
____________________________________________________________________
Open Date Marking (e.g. Date of Manufacture, Expiration Date) – if applicable:
____________________________________________________________________
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Department of Health
OFFICE OF THE SECRETARY
Annex C
Application and Order of Payment Form for CPR
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