I. Rationale/Background

Effective national food control systems are essential to protect the health and safety of consumers. The global environment for food trade places emphasizes on strengthening food control systems and to implement and enforce risk-based food control strategies.

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 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.

The FDA through the Center for Food Regulation and Research (CFRR), per RA 9711, 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. It 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 international food safety measures, FDA is adopting a risk-based approach on product and establishment risk categorization focusing on preventive, rather than corrective strategies. Consistent with this mandate, the FDA shall 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 packing, holding or producing food for consumption in accordance with the mandated issuances of regulatory agencies issuing such authorizations.

II. Objectives

1. Adoption of risk-based classification of food establishments and food products as published by the Food and Agriculture Organization of the United Nations;

2. The issuance of License to Operate (LTO) to food establishments engaged in the manufacture or processing and distribution, i.e. import, export or wholesale, or trade and repacking of processed food and food products, and

3. 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.

III. Scope and Coverage

This Administrative Order covers food establishments engaged in the manufacture and/or distribution, (i.e. import, export and/or wholesale) trade and/or repacking of processed food and food products.

This Administrative Order shall not cover fresh or raw food derived from plant, animal, fisheries and aquaculture products or foods in the primary production and post-harvest stages of the supply chain under the Department of Agriculture. It shall likewise not cover food businesses such as, but not limited to, activities in slaughter-houses, poultry dressing plants, fish ports, wet markets, supermarkets, school canteens, restaurants, 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

For the purpose of this issuance the following terms are defined:

1. Activity refers to either processing, packaging, repackaging, trading, import, wholesale, export, sale, promotion, or offer for sale, of a food product.
2. 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.
3. 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, postharvest handling, distribution, processing, manufacture, importation, exportation, sale, and offer for sale, transfer and preparation for human consumption. The authorization can take the form of a permit, license, certificate of registration and certificate of compliance or exemption or any similar document.
4. Bottled Water means water that is placed in a sealed container or package and is offered for sale for human consumption as drinking water.
5. Certificate of Product Registration (CPR) is an authorization issued by the FDA for specific health products after evaluation and approval of submitted registration requirements.
6. 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) postharvest handling, manufacturing, processing, preparation, treatment, packing, packaging, transport or holding of such food as a result of environmental contamination.
7. 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.
8. 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.
9. Distribution means any activity where a food product is stored by an establishment and/or transported to another establishment, with the intention of possible further retail.
10. 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.
11. Distributor/wholesaler refers to any establishment that procures raw materials, and/or finished products from local establishments for local distribution on wholesale basis.
12. 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.
13. Export refers distribution outside of origin by crossing international borders.
14. 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.
15. 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.
16. Food-home 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, which 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/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.
20. Fortification means the addition of nutrients to processed foods or food products at levels above the natural state.
21. 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.
22. 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.
23. 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.
24. Import refers to the distribution into a local destination by crossing international borders.
25. 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.
26. 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.
27. 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.
28. 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.
29. 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.
30. 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 labelling 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.
31. 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.
32. Packaging refers to an activity where a product is contained AND SEALED with the intention of storage and/or transport.
33. Packer refers to food manufacturer engaged in packaging food products not previously packaged.
34. Permit refers to a form of authorization that is issued by the FDA to an establishment that has complied with the application requirements.
35. 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 producer/manufacture food.
36. Raw materials are all substances that are employed in the processing of a finished product, packed in bulk containers and not labelled as finished product. Raw Materials or ingredients would have product specifications that comply with the client requirements and not necessarily a single component.
37. Repackaging refers to a manufacturing activity where a food product is taken out of a larger or bulk packaging and again contained with the intention of further storage, transport and distribution.
38. 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.
39. Retailer means any establishment which sells or offers to sell any health product directly to the general public.
40. 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.
41. 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.
42. Source refers to any establishment able to supply food products to another establishment through further importation, wholesale or export.
43. 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.
44. 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.
45. Wholesale refers to local distribution of pre-packaged food products in commercial quantity.

V. Guidelines for Licensing of Food Establishments

A. General Principles

1. Risk classification of establishments shall be defined by the current issuance from the Food and Drug Administration, and consistent with the current guidelines of the Food and Agriculture Organization of the United Nations. The FDA shall issue authorization based on risk categorization of food establishments and food products. Food establishments classified as high risk shall be the priority for inspection. (Annex A)
2. All food establishment shall secure a License to Operate (LTO) before engaging in food manufacturing, importation, exportation, sale, offer for sale, distribution, transfer and where applicable the use, testing, promotion, advertisement, and/or sponsorship of food products.
3. The following indicates the activities allowed to under a single license and Table 4 in Annex B summarizes the hierarchies of activities: a. A manufacturer may engage in any activity it is able to satisfy the requirements for, including processing;
   b. A packer or repacker may engage in any activity it is able to satisfy the requirements for, except processing;
   c. A trader may engage in any activity it is able to satisfy the requirements for, except processing or packaging;
   d. A distributor is not allowed to engage in processing and/or packaging;
   e. A distributor with a license for a specific activity may engage in other distributor activities it is able to satisfy the requirements for;
   f. Distributor activities may be applied for by a manufacturer or distributor, at the same time as the license or later added as an amendment after licensing; and
   g. Multiple facilities within the same address engaged in different activities in the manufacture and distribution of a single product may be associated to a single license.
4. All applications for a License to Operate shall be accepted by the FDA only when all the requirements have been completed.
5. Food establishment shall first apply for LTO initial application. Once the FDALTO is secured, CPR initial application should be filed.
6. The LTO shall be a requirement before a food establishment can join food trade and exhibitions, market research or testing of unregistered processed food products.
7. 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 necessary requirements.
8. Applicants must prove their capability and capacity to assure food safety and quality through compliance with Good Manufacturing Practice, Good Distribution Practice, Good Storage Practice, Hazard Analysis and Critical Control Points, and/or other best industry practices recognized by the Food and Agriculture Organization and the World Health Organization, as appropriate.
9. All FDA-licensed food establishments shall be primarily responsible for determining the regulatory requirements of the importing country before engaging in food export.
10. Licensing of food establishments shall be issued only by the FDA if these are able to demonstrate consistency in manufacture and/or distribution of safe and quality products.
11. Only one licensed establishment should operate at a given address or facility. Establishments engaged in the same activity are not allowed to share the same address or facility, regardless of ownership.
12. 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.
13. No application for initial or renewal of LTD shall be accepted or approved unless the prescribed fee is paid.
14. For changes 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.
15. For 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.
16. For licensed establishments with revoked/cancelled/ suspended LTO resulting from violations as stated in this Order and/or in RA 9711 and/or other relevant food regulations, and after due process, shall not be allowed to re-apply for a new LTO for a period of three (3) years and from using the same of business name.
17. 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).
18. 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.

B. Specific Guidelines for Manufacturers including Traders:

1. 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.
2. 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.
3. 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. However, for raw materials covered by Republic Act (RA) 8976 (Food Fortification Act) and its IRR and other related issuances including RA 8172 (ASIN Law), these shall comply with the requirements set forth upon importation, such as results of analysis and/or inspection and others as deemed necessary.
4. 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 or their amended version shall be followed.

C. Specific Guidelines for Distributor (Importer/Exporter/ Wholesaler)

1. Any establishment applying for a license to the FDA as food distributor (importer, exporter, wholesaler) utilizing or sharing one office with another establishment shall not be allowed regardless of ownership.
2. For offices of distributors, all warehouses and depots shall be declared. Sharing of offices by different distributors shall not be allowed.
3. Importers shall comply with applicable law, rules and regulations, such as the RA 8172 (ASIN Law) and RA 8976 (Food Fortification Act).
4. An establishment 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. Application requirements as listed in succeeding sections relative to this activity shall be submitted to the FDA.
5. Exporters should satisfy the requirements of the importing country prior to export.

D. Requirements

The requirements for issuance of License to Operate and its amendments are specified in Annex C of this Issuance.

E. Validity of the LTO

1. Unless revoked, the LTO shall have the following validity period:

a. An initial license issued shall be valid for two (2) years
b. A renewed license shall be valid for five (5) years.

F. Process of Application - The process of application is as prescribed by current FDA regulations and shall be guided by the following:

1. A Certificate of Compliance shall be issued by the FDA inspectorate in the respective regions. Should a site inspection or pro-licensing inspection be required, the inspection shall be scheduled with the applicant, before the Certificate of Compliance is issued.
2. 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, œUpon 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.
3. The notice of disapproval of applications for license shall clearly state the reason for disapproval.

VI. Guidelines in the Registration of Processed Food Products

A. General Principles

1. All processed food products including food additives, food supplements and bottled water, shall first be registered with the FDA before these are distributed, supplied, sold or offered for sale or use and advertised, among other marketing or promotional activities.
2. Only one (1) Certificate of Product Registration CPR shall be issued to a product that has multiple packaging sizes provided that it meets all of the following conditions:

a. The same brand name;
b. The same product name/variant;
c. The same product formulation/ingredients in the same order of proportion; and
d. The same label information, except net weight.

3. Likewise, regardless of the packaging sizes, only one (1) CPR shall be issued to a product that has multiple artwork design and/or multiple suggested recipes on the pack provided that it meets all of the following conditions:

a. The same brand name;
b. The same product name/variant;
c. The same product formulation/ingredients in the same order of proportion; and
d. The same label information except net weight.

4. The company should secure permission from FDA through notification for any additional label design or other label changes prior to use in advertisement, promotion, and commercial distribution.
5. Should a product fail to meet the requirements for product registration, 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 and file for re-application.
6. Imported and locally manufactured raw materials, ingredients and food additives which are 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 by the importer or distributor.

a. However, local food manufacturers who directly import and use raw materials, ingredients and food additives for their own use or for further processing to manufacture a processed food product, need not secure a CPR for the raw materials, ingredients and food additives.

7. As stated in Item 6 above, when a CPR is granted to a food manufacturer/importer, all individual ingredients as part of the FDAregistered product formulation, may be imported without a CPR. However, should the FDA-licensed food manufacturer/importer use or source out local ingredients and food additives, it shall only purchase from FDA-licensed establishments.
8. 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 country, including the labelling requirements.
9. A previously registered product initially for local distribution shall be allowed to be exported using the same CPR as long as the following conditions are met and labelling and standards of importing country are likewise met: a. The same brand name;
   b. The same product name/variant;
   c. The same product formulation/ingredients in the same order of proportion; and
   d. The same label information except net weight. Notification to FDA shall be made and labels in the language of the importing country shall likewise be submitted.
10. 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, soft gel capsule and capsule shall be issued a CPR.
11. 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.
12. The FDA may require 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 as deemed necessary through a separate issuance. a. High risk products include but not limited to the following: infant formula, milk supplements, foods for infants and young children, foods for special medical purposes, and foods for special dietary uses.
13. 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.
14. 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.

B. Quality and Safety Standard

1. Food products shall be evaluated based on the technical documents submitted for safety and quality. Only those food establishments with products that have complied with the requirements and meet the standards for food safety, quality, and labeling, including relevant standards set by the FDA/Codex for specific food category, as applicable, will be issued a CPR.
2. All processed Food Products shall comply with the relevant appropriate/ applicable quality and safety standards, if any.
3. 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.
4. 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. Products covered by separate laws (e.g. RA 8172 and RA 8976) requiring the submission of Certificate of Analysis (COA) shall be complied with.

C. Product Claims and Labeling

1. 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.
2. Food supplements shall not have curative claims or therapeutic claims. Other claims shall be in accordance to existing and relevant labeling guidelines.
3. 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.

D. Requirements

The requirements for issuance of Certificate of Product Registration and its amendments are specified in Annex D of this Issuance.

E. Validity of the Registration

Unless, revoked within the validity period, the CPR shall be valid for 2 years minimum to 5 years maximum for initial and 5 years for renewal.

F. 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:

1. Issuance of CPR shall be based on compliance of the product with applicable standards, requirements and regulations.
2. 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. Inspection and Certificate of Compliance

1. The FDA/CHD will verify documents submitted and conduct inspection prior to licensing dependent on the safety risk of the products being handled by the establishment.
2. The FDA may conduct inspection in collaboration with the LGUs and any agency or office under the DOH, DA and DILG.
3. 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. The conduct of inspection shall be covered by Quality Manual.
4. 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.
5. The FDA reserve the right to inspect at any time as routine, spot check of food establishment, or 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.

VIII. 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.

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 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.

XIII. Repealing Clause

All other administrative issuances, bureau circulars and memoranda and other regulations inconsistent with this Order are hereby withdrawn, repealed and for revoked accordingly.

XIV. Effectivity

This Order shall take effect 15 days after its publication in an official gazette or in a newspaper of general circulation.

(SGD) ENRIQUE T. ONA, MD, FPCS, FACS
Secretary of Health