DRAFT Food Regulation Feb 6, 2014.pdf

Republic of the Philippines

Department of Health

OFFICE OF THE SECRETARY

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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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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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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 post-

harvest 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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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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2FAO/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, sugar-

based 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 pre-

packaged 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 food-

borne 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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2FAO/UN Guidelines for Risk Categorization of Food and Food Establishment

Applicable to ASEAN Countries

4. 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 FDA-

licensed 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. LTO as Food Manufacturer, including Toll Manufacturer or Repacker

1.1.1. Large, Medium and Small

1.1.2. Microenterprise

1.2. LTO as Food Distributor (DTI classification does not apply)

1.2.1. Importer

1.2.2. Exporter

1.2.3. Wholesaler

1.3. 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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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 non-

compliance 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, physico-

chemical 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. Comprehensive description of manufacturing

process, including a flowchart with quality

control points

2.1.2.2.2. Quality control procedures

2.1.2.2.3. Product Description to be repacked

2.1.2.2.4. 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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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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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 re-

submission 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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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



3.2.2.2. 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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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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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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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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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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3.2.3.3 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

3.2.4 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

3.2.5 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


3.2.6 Change in address of establishment

3.2.6.1 Proof of change in address, e.g. License, Certificate


3.2.7 Change/Additional Packaging Size


3.2.8 Extension of Shelf-life (for Food Supplements)

3.2.8.1 Stability data/ studies to support extension of shelf life

3.2.9 Change in Packaging Design (for Food Supplements)


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 Letter of request, indicating that there were no changes in circumstances of

the CPR that would render it invalid

4.2 Affidavit of loss

4.3 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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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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ANNEX A

Application and Order of Payment Form for Initial LTO Application




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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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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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Annex C

Application and Order of Payment Form for CPR

DRAFT Food Regulation Feb 6, 2014.pdf

Documents

Transcript of DRAFT Food Regulation Feb 6, 2014.pdf