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DRAFT FOR COMMENTS AS OF 10 JULY 2014 1 2 ADMINISTRATIVE ORDER 3 No. 2014-________________ 4 5 6 SUBJECT: Rules and Regulations on the Licensing of Food Establishments and 7

Registration of Processed Food, and Other Food Products, and For 8 Other Purposes 9

10 I. Rationale/Background 11

12 Effective national food control systems are essential to protect the health and safety of 13 consumers. They are also critical to assure the safety and quality of food entering 14 international trade and to ensure that imported food conforms to the national safety 15 and quality standards requirements. The global environment for food trade places 16 emphasis on strengthening food control systems and to implement and enforce risk-17 based food control strategies.1 The food regulatory agencies are responsible for setting 18 food safety standards, regulating food establishments and food business operators as 19 well as the products they manufacture, offer for sale, or distribute, by conducting 20 inspections to ensure compliance to standards, and maintaining a strong regulatory 21 enforcement program to deal with those that do not comply with the provisions of the 22 law. 23

24 The Department of Health (DOH) through the Food and Drug Administration (FDA) 25 is mandated by Republic Act (RA) No. 10611, otherwise known as the Food Safety 26 Act of 2013, to bear the specific responsibility of ensuring the safety of all food 27 processing and product packaging activities, among others (Section 18), and to 28 develop and issue appropriate authorizations in the form of a license and certificate or 29 registration that would cover establishments, facilities engaged in production and 30 distribution of products (Section 28). 31

32 The Food and Drug Administration Act of 2009 (Republic Act No. 9711) reaffirmed 33 that the State shall adopt, support, establish, institutionalize, improve and maintain 34 structures, processes, mechanisms and initiatives that are aimed, directed and 35 designed to protect and promote the right to health of the Filipino people (Sec.3). 36 Further, Section 7 affirms the FDA Act as amendment to Republic Act No.3720 37 prohibiting the manufacture, importation, exportation, sale, offering for sale, 38 distribution, transfer, or retail of any food products; or the operation of establishment 39 by any natural or juridical person without the License to Operate from the FDA 40 (Section 7(k)). 41

42 Presidential Decree No. 856, otherwise known as the Code of Sanitation of the 43 Philippines states under Section 14 that “No person or entity shall operate a food 44 establishment for public patronage without securing a permit from the local health 45 office.” Moreover, under Section 15, it states that “No person shall be employed in 46 any food establishment without a Health Certificate issued by the local health 47 authority.” 48 1FAO/WHO Assuring Food Safety and Quality: Guidelines for Strengthening National Food Control 49 Systems 50

 

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Republic Act No. 7394, otherwise known as The Consumer Act of the Philippines, 1 also declares that the State shall ensure safe and good quality of food and regulate 2 their production, sale distribution and advertisement to protect the health of the 3 consumer. It further mandates the DOH to develop and provide standards on safety 4 and quality of food, among others, and to strengthen the FDA. 5

6 Therefore, the FDA through the Center for Food Regulation and Research (CFRR) 7 shall implement a performance-based food safety control management system which 8 shall include, among others: a) the development of food standards and regulations; b) 9 post-market monitoring; c) enforcement of Hazard Analysis Critical Control Points 10 (HACCP) and other risk-based control measures; d) strong participation in Codex and 11 other international standard setting bodies, e) communication of risks and 12 development of interactive exchange among stakeholders; f) establishment and 13 strengthening of food laboratories; g) development of a database on food-borne illness 14 and epidemiological data; h) strengthening R&D capabilities food safety and quality 15 standards; and i) certification of food safety inspectors. 16 17 Consistent with this mandate, the FDA will ensure food safety through the imposition 18 of food quality standards in the country. Thus, the issuance of this Administrative 19 Order on the Licensing of Food Establishments, and Registration of Processed Food 20 to issue appropriate authorizations in the form of a permit, license and certificate of 21 registration or compliance that would cover establishments, facilities engaged in 22 packing, holding or producing food for consumption in accordance with the mandated 23 issuances of regulatory agencies issuing such authorizations. 24

25

26 II. Objectives 27 28 The objective for issuing this Administrative Order is to provide guidelines and 29 policies on the following: 30 31

1. Adoption of risk-based classification of food establishments and food products 32 as published by the Food and Agriculture Organization of the United Nations; 33 34

2. The issuance of License to Operate (LTO) to food establishments engaged in 35 the manufacture or processing and distribution, i.e. import, export or 36 wholesale, or trade and repacking of processed food and food products, and 37 38

3. The issuance of the Certificate of Product Registration (CPR) to FDA-licensed 39 establishments before processed food and other food products are sold, offered 40 for sale or use, distributed or supplied, among other marketing and 41 promotional activities. 42

43 44 III. Scope and Coverage 45 46 This Administrative Order covers food establishments engaged in the manufacture 47 and/or distribution, (i.e. import, export and/or wholesale) trade and/or repacking of 48 processed food and food products. 49

50

 

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This Administrative Order shall not cover fresh or raw food derived from plant, 1 animal, fisheries and aquaculture products or foods in the primary production and 2 post-harvest stages of the supply chain under the Department of Agriculture. It shall 3 likewise not cover food businesses such as, but not limited to, activities in slaughter-4 houses, poultry dressing plants, fish ports, wet markets, supermarkets, school 5 canteens, restaurants, catering establishments, water refilling stations, street food sale, 6 including ambulant vending which are under the purview of the Local Government 7 Units (LGUs). 8 9 10 IV. Definition of Terms 11 12 The terms in this Issuance are as defined by Republic Acts 3720, 7394, 8172, 8976, 13 9711, 10611, the respective Implementing Rules and Regulations, and other laws 14 relevant to the regulation of food establishments and food products. In case of 15 conflict between definitions from different laws, the definition provided by a current 16 provision of the more recent Republic Act is to be observed. In case of lack of 17 definition, it shall be as defined by the Food and Drug Administration and/or the 18 Department of Health. 19

20 For the purpose of this issuance the following terms are defined: 21 22 1. Activity refers to either processing, packaging, repackaging, trading, import, 23

wholesale, export, sale, promotion, or offer for sale, of a food product. 24 25

2. Advertising refers to the business of conceptualizing, presenting or making 26 available to the public, through any form of mass media, fact, data or information 27 about the attributes, features, quality or availability of food and its related 28 products for the purpose of promoting its sale or distribution and enhancing 29 economic activity. 30 31

3. Authorization refers to the permission embodied in a document granted by a 32 regulatory agency to a natural or juridical person who has submitted an 33 application for a food business operation from primary production, post-harvest 34 handling, distribution, processing, manufacture, importation, exportation, sale, and 35 offer for sale, transfer and preparation for human consumption. The authorization 36 can take the form of a permit, license, certificate of registration and certificate of 37 compliance or exemption or any similar document. 38

39 4. Bottled Water means water that is placed in a sealed container or package and is 40

offered for sale for human consumption as drinking water. 41 42 5. Certificate of Product Registration (CPR) is an authorization issued by the FDA 43

for specific health products after evaluation and approval of submitted registration 44 requirements. 45

46 6. Distribution means any activity where a food product is stored by an 47

establishment and/or transported to another establishment, with the intention of 48 possible further retail. 49 50

 

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7. Distributor/Importer/Exporter refers to any establishment that imports or exports 1 raw materials, ingredients and/or finished products for its own use or for 2 wholesale distribution to other establishments or outlets. If the 3 distributor/importer/exporter sells to the general public, it shall be considered a 4 retailer. 5

6 8. Distributor/ wholesaler refers to any establishment that procures raw materials, 7

and/or finished products from local establishments for local distribution on 8 wholesale basis. 9

10 9. Establishment means a sole proprietorship, a partnership, a corporation, an 11

institution, an association, or an organization engaged in the manufacture, 12 importation, exportation, sale, offer for sale, distribution, donation, transfer, use, 13 testing, promotion, advertising, or sponsorship of health products, including the 14 facilities and installation needed for its activities. 15

16 10. Food refers to any substance or product whether processed, partially processed or 17

unprocessed that is intended for human consumption. It includes drinks, chewing 18 gum, water and other substances which are intentionally incorporated into the 19 food during its manufacture, preparation and treatment. 20

21 11. Food Additive refers to any substance not normally consumed as a food by itself 22

and not normally used as a typical ingredient of the food, whether or not it has 23 nutritive value, the intentional addition of which to food for a technological 24 (including organoleptic) purpose in the manufacture, processing, preparation, 25 treatment, packing, packaging, transport or holding of such food results, or may be 26 reasonably expected to result (directly or indirectly), in it or its by-products 27 becoming a component of or otherwise affecting the characteristics of such foods. 28 The term does not include contaminants or substances added to food for 29 maintaining or improving nutritional qualities. 30 31

12. Food Business Operator refers to a person engaged in the food business including 32 one’s agents and is responsible for ensuring that the requirements of the Food 33 Safety Act of 2013 are met by the food business under one’s control. 34 35

13. Food/ Dietary Supplement refers to a processed food product intended to 36 supplement the diet that bears or contains one or more of the following dietary 37 ingredients: vitamin, mineral, amino acid, herb, or other dietary substance of 38 botanical, animal, artificial or natural origin to increase the total daily intake in 39 amounts conforming to the latest Philippine recommended energy and nutrient 40 intakes or internationally agreed minimum daily requirements. It is usually in the 41 form of capsules, tablets, liquids, gels, powders or pills and is not represented for 42 use as a conventional food or as the sole item of a meal or diet or a replacement 43 for drugs and medicines. 44 45

14. Fortification means the addition of nutrients to processed foods or food products 46 at levels above the natural state. 47

48 15. Good Manufacturing Practice (GMP) refers to a quality assurance system aimed at 49

ensuring that products are consistently manufactured, packed, repacked or held to 50

 

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quality standards appropriate for the intended use. It is thus concerned with both 1 manufacturing and quality control procedure. 2

3 16. Good Distribution Practice (GDP) or Good Storage Practice (GSP) refers to a part 4

of quality assurance system where appropriate procedures for sanitary handling of 5 food on storage and distribution are established. Storage and transportation of 6 finished food should be under conditions that will protect food against physical, 7 chemical, and microbial contamination as well as against deterioration of the food 8 and the container. Warehouses are kept free from rodents, insects, birds and other 9 pests. 10

11 17. Hazard Analyses and Critical Control Points (HACCP) refer to a science-based 12

system which identifies, evaluates and controls hazards which are significant for 13 food safety at critical points during a given stage in the food supply chain. 14

15 18. Ingredient is any substance including food additive, used as a component in the 16

manufacture or preparation of a food and present in the final product in its original 17 or modified form. 18 19

19. Inspection refers to the examination of food, food production facilities or 20 establishments, and the management and production systems of food businesses, 21 including the examination of documents, finished product testing and registration, 22 and of the origin and destination of production inputs and outputs to verify 23 compliance with legal requirements by an agency mandated to perform food 24 safety regulatory and/or enforcement functions. 25

26 20. Label refers to the display of written, printed or graphic matter upon the 27

immediate container, tag, literature or other suitable material affixed thereto for 28 the purpose of giving information as to identify components, ingredients, 29 attributes, directions for use, specifications and such other information as may be 30 required by law or regulations. 31 32

21. License to Operate (LTO) is an authorization issued by the FDA to an 33 establishment to grant permission to undertake a trade or carry out a business 34 activity, such as manufacturing, importation, exportation, sale, offering for sale, 35 distribution, or transfer of food products. 36

37 22. Licensing means the process of approval of an application to operate or establish 38

an establishment prior to engaging in the manufacture, importation, exportation, 39 sale, offer for sale, distribution, transfer, and where applicable the use, testing, 40 promotion, advertisement, and/or sponsorship of health products. 41

42 23. Manufacturer means an establishment engaged in any and all operations involved 43

in the production of health products including preparation, processing, 44 compounding, formulating, filling, packaging, repacking, altering, ornamenting, 45 finishing and labelling with the end in view of its storage, sale or distribution. A 46 trader shall be categorized as manufacturer. They may also manufacture products 47 for institutional use. In case of imported food products, the manufacturer’s 48 representative or, in his absence, the importer shall be deemed the manufacturer. 49

50

 

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24. Monitoring refers to the systematic gathering of data through the sampling of 1 commodities as well as monitoring of food-borne diseases, collation and 2 interpretation of collected data. 3

4 25. Packaging refers to an activity where a product is contained AND SEALED with 5

the intention of storage and/or transport. 6 7

26. Packer refers to food manufacturer engaged in packaging food products not 8 previously packaged. 9

10 27. Processing refers to any action that substantially alters the initial raw materials or 11

product or ingredients including, but not limited to, heating, smoking, curing, 12 maturing, drying, marinating, extraction, extrusion, freezing, fermentation or a 13 combination of those processes intended to produce/ manufacture food. 14

15 28. Raw materials are all substances that are employed in the processing of a finished 16

product, packed in bulk containers and not labelled as finished product. Raw 17 Materials or ingredients would have product specifications that comply with the 18 client requirements and not necessarily a single component. 19

 20 29. Repacker means any establishment engaged in the process of packaging or 21

changing of container, wrapper (that may include or not a changing of label) from 22 a bulk material to retail packaging sizes in furtherance of distribution of food. 23

24 30. Retailer means any establishment which sells or offers to sell any health product 25

directly to the general public. 26 27 31. Risk refers to a function of the probability of an adverse health effect and the 28

severity of that effect, consequential to a hazard(s) in food. 29 30 32. Salt Iodization refers to the addition of iodine to salt intended for human 31

consumption in accordance with specifications as to form, fortificant type, 32 method, manner and composition as may be prescribed by the FDA. 33 34

33. Source refers to any establishment able to supply food products to another 35 establishment through further importation, wholesale or export. 36

37 34. Trader means any establishment which is a registered owner of food and food 38

products and/or procure the raw materials and packing components, quality 39 control standards and procedures, but subcontracts the manufacture of such 40 product to a licensed manufacturer. In addition, a trader may also engage in the 41 distribution and/or marketing of its products. 42

43 35. Toll Manufacturer refers to the manufacturer that conduct contract manufacturing 44

where conditions of the contract are defined, agreed and controlled; and all 45 aspects of contracted work are specified to obtain quality product/s conforming to 46 the agreed standards. 47

 48 36. Wholesale refers to local distribution of pre-packaged food products in 49

commercial quantity. 50

 

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V. Guidelines for Licensing of Food Establishments 1 2

A. General Principles 3 4 1. Risk classification of establishments shall be defined by the current 5

issuance from the Food and Drug Administration, and consistent with the 6 current guidelines of the Food and Agriculture Organization of the United 7 Nations. 8

9 2. All food establishment shall secure a License to Operate (LTO) before 10

engaging in food manufacturing, importation, exportation, sale, offer for 11 sale, distribution, transfer and where applicable the use, testing, promotion, 12 advertisement, and/or sponsorship of food products. 13

14 3. Hierarchy of Activities – Table 1 indicates the activities allowed to under a 15

single license: 16 17 a. A manufacturer may engage in any activity it is able to satisfy the 18

requirements for, including processing; 19 b. A packer or repacker may engage in any activity it is able to satisfy the 20

requirements for, except processing; 21 c. A trader may engage in any activity it is able to satisfy the 22

requirements for, except processing or packaging; 23 d. A distributor is not allowed to engage in processing and/or packaging; 24 e. A distributor with a license for a specific activity may engage in other 25

distributor activities it is able to satisfy the requirements for; 26 f. Distributor activities may be applied for by a manufacturer or 27

distributor, at the same time as the license or later added as an 28 amendment after licensing; and 29

g. Multiple facilities within the same address engaged in different 30 activities in the manufacture and distribution of a single product may 31 be associated to a single license. 32

33 Table 1 Hierarchy of Activities – ‘Y’ is indicated for default activities covered by the 34 license, ‘a’ is indicated for activities that may be added after licensing as an amendment, ‘N’ 35 is indicated for activities not allowed. 36 License to Operate as Manufacturer License to Operate as Distributor

Activity Manufacturer Packer Repacker Trader Importer Wholesaler Exporter

Processing Y a a N N N N Packaging Y Y N N N N N Repackaging a a Y N N N N Import for processing Y a N a N a a

Import for distribution N N N a Y a a

Wholesale N N N a Y Y a Export a a a a a a Y Distribution Y Y Y Y Y Y Y

37

 

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1 4. All applications for a License to Operate shall be accepted by the FDA 2

only when all the requirements have been completed. 3 4 5. Food establishment shall first apply for LTO initial application. Once the 5

FDA-LTO is secured, CPR initial application should be filed. 6 7 6. The LTO shall be a requirement before a food establishment can join food 8

trade and exhibitions, market research or testing of unregistered processed 9 food products. 10

11 7. An entity, natural or juridical person, applying for LTO as a food 12

manufacturer, distributor, importer, exporter, wholesaler, trader or 13 repacker shall be issued the LTO only when they have complied with all 14 the necessary requirements. 15

16 8. Applicants must prove their capability and capacity to assure food safety 17

and quality through compliance with Good Manufacturing Practice Good 18 Distribution Practice, Good Storage Practice, Hazard Analysis and Critical 19 Control Points, and/ or other best industry practices recognized by the 20 Food and Agriculture Organization and the World Health Organization, as 21 appropriate. 22

23 9. All FDA-licensed food establishments shall be primarily responsible for 24

determining the regulatory requirements of the importing country before 25 engaging in food export. 26

27 10. Licensing of food establishments shall be issued only by the FDA if these 28

are able to demonstrate consistency in manufacture and/or distribution of 29 safe and quality products. 30

 31 11. Only one licensed establishment should operate at a given address or 32

facility. Establishments engaged in the same activity are not allowed to 33 share the same address or facility, regardless of ownership. 34

35 12. Valid LTO shall be displayed in a conspicuous place in the establishment 36

or business office or premises. Failure to display the valid LTO shall be 37 ground for revocation of the LTO. 38

39 13. No application for initial or renewal of LTO shall be accepted or approved 40

unless the prescribed fee is paid. 41 42 14. For changes of Business Information, no change in the previously 43

approved circumstances of the application of the establishment, such as 44 but not limited to: location, business name and owner, additional or 45 reduction in the product lines, inclusion or deletion of any 46 activities/products, shall be effected unless with prior notification to FDA 47 through amendment. 48

49

 

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15. For assignment and Transfer of Pending Applications, Existing Licenses, 1 if there is a change in ownership while application is on process, the 2 application shall be considered terminated and documents shall be returned 3 to the authorized representative of the company. The new owner or the 4 new regulatory officer shall comply with the requirements for initial 5 application including attendance to QPIRA. 6

7 16. For licensed establishments with revoked/ cancelled/ suspended LTO 8

resulting from violations as stated in this Order and/or in RA 9711 and/or 9 other relevant food regulations, and after due process, shall not be allowed 10 to re-apply for a new LTO for a period of three (3) years and from using 11 the same of business name. 12

13 17. FDA-licensed food establishments or food business operators shall comply 14

with relevant laws that address nutritional quality of food and food 15 products, such as the RA 8172 (ASIN Law) and RA 8976 (Food 16 Fortification Act). 17

18 18. Food business operators shall comply with the provisions of RA No. 9711, 19

RA No. 10611, RA No. 3720 as amended by E.O. 175, RA No. 7394, and 20 Presidential Decree No. 856 to ensure food quality and safety. 21

22 B. Specific Guidelines for Manufacturers including Traders: 23

24 1. Food manufacturing or processing plant shall be covered by a single LTO 25

notwithstanding their distance or different locations within one 26 locality/municipality/city but with one product, at different stages of 27 operation/ process indicating their address in the license. In this instance, 28 the principal office address shall be reflected at the front page of the LTO 29 while the other address/es at the back page thereof or secondary page 30 appended thereto. 31

32 2. When a food manufacturing or processing plant carries an entirely 33

different and complete stage of operation for different products in different 34 locations but within one municipality/city, in which case, each shall be 35 covered by separate licenses. Food manufacturing establishments utilizing 36 or sharing one facility shall not be allowed regardless of ownership. 37

 38 3. FDA-licensed food manufacturers shall be allowed to import raw materials 39

or finished products as ingredients or additives for their own use to 40 manufacture registered food products. However, for raw materials covered 41 by Republic Act (RA) 8976 (Food Fortification Act) and its IRR and other 42 related issuances including RA 8172 (ASIN Law), these shall comply with 43 the requirements set forth upon importation, such as results of analysis 44 and/or inspection and others as deemed necessary. 45

 46 4. For Bottled drinking water, the Standards and Good Manufacturing 47

Practice (GMP) requirements as stated in Administrative Order No. 18-A 48 s. 1993 or the Philippine National Standard for Bottled Drinking Water are 49 still in effect. 50

 

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1 C. Specific Guidelines for Distributor (Importer/ Exporter/ Wholesaler) 2

3 1. Any establishment applying for a license to the FDA as food distributor 4

(importer, exporter, wholesaler) utilizing or sharing one office with 5 another establishment shall not be allowed regardless of ownership. 6 7

2. For offices of distributors, all warehouses and depots shall be declared. 8 Sharing of offices by different distributors shall not be allowed. 9

10 3. Importers shall comply with applicable law, rules and regulations, such as 11

the RA 8172 (ASIN Law) and RA 8976 (Food Fortification Act). 12 13

4. An establishment with LTO as food distributors, i.e. as importer, exporter 14 or wholesaler, may engage in manufacturing or repacking provided that a 15 LTO as manufacturer (repacker) shall be secured also from the FDA. 16 Application requirements as listed in succeeding sections relative to this 17 activity shall be submitted to the FDA. 18

19 5. Exporters should satisfy the requirements of the importing country prior to 20

export. 21 22 D. Requirements for Initial Licensing – The following are the requirements for 23

application by an establishment: 24 25 1. Accomplished Integrated Application Form as prescribed by current FDA 26

regulations; 27 2. Proof of Payment of Fees as prescribed by current FDA regulations; 28 3. Proof of Business Registration 29

a. If Single Proprietorship: Valid Certificate of Business Name 30 Registration with the Department of Trade and Industry indicating the 31 same name, address and ownership as the establishment applying for a 32 license; 33

34 b. If a Corporation or Partnership: 35

i. Valid Registration with Securities and Exchange Commission 36 (SEC) indicating the same name, address, and ownership as the 37 establishment applying for a license; 38

ii. Articles of Incorporation; and 39 iii. Other pertinent documents, as applicable; 40

41 c. If a Cooperative: Certificate of Cooperative Development Authority 42

(CDA) indicating the same name, address, and ownership as the 43 establishment applying for a license; 44

45 4. If the business name and/or and address is different from the registered 46

name and/or address in the DTI-, SEC-, or CDA-issued certificate, the 47

 

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following shall be submitted in addition to the documents specified above 1 as applicable: 2 3 a. If a Corporation or Partnership, SEC Certificate must reflect “Doing 4

business under the name and style of (Name of Establishment) 5 6 b. Valid Mayor's Business Permit or Barangay Business Permit indicating 7

the same name, address and ownership as the establishment applying 8 for a license; 9

10 5. Proof of Occupancy (per facility and/or address declared as part of the 11

establishment); 12 13

a. If the facility and/or address declared as part of application is not 14 owned by the applicant: 15

i. Notarized valid Contract of Lease of the space or building 16 occupied; and 17

ii. If the applicant is engaged in distribution (i.e. third-party 18 logistics): 19

- Duly notarized warehousing agreement; 20 b. If the facility and/or address declared as part of application is owned 21

by the applicant: 22 - Copy of Transfer Certificate of Title; 23

24 6. Product List – 25

a. The list of food products to be manufactured, processed with proposed 26 brand name per product 27

28 b. The list of products to be distributed, sold, or offered for sale or use, as 29

appropriate, including the following information per product: 30 31

i. Business name and address of direct source; 32 ii. Business name and address of facility where the product is last 33

packaged, if different from source; 34 iii. Business name and address of facility where product is last 35

processed, if different from last packaging site and direct 36 source; 37

iv. If product is to be imported, a unique global product 38 identification number; 39

40 7. Location Map – a graphic illustration indicating the address, landmarks, 41

immediate environment, type of building, and Global Positioning System 42 (GPS) coordinates (if available) for each facility and/ or address declared 43 part of the establishment; 44

45 8. Floor plan/ layout with dimensions 46

47 9. Specific requirements – The following are the requirements for application 48

in addition to the General Requirements (Nos. 1-7 above) as applicable: 49 50

 

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a. Manufacturer/Processor 1 2

i. Description of the products to be manufactured (e.g. list of 3 ingredients, physico-chemical, and/or microbiological 4 specifications) 5

ii. Description of manufacturing process or food 6 processing/preparation, including a flowchart with quality 7 control points, as appropriate to the size of operation 8

iii. Quality control procedures, as appropriate to the size of 9 operation 10

iv. Results of analysis of Finished Product /s showing compliance 11 with applicable standards 12

v. Facsimile of proposed product label, compliant with FDA 13 standards 14

15 b. Repacker 16

17 i. 9.2.1 Description of the product to be repacked (e.g. name of 18

product, physico-chemical, and/or microbiological 19 specifications) 20

ii. 9.2.2. Description of repacking process, including a flowchart 21 with quality control points 22

iii. 9.2.3 Quality control procedures 23 iv. 9.2.4 Photocopy of duly notarized valid contract or agreement 24

with the manufacturer, and, as appropriate, the License to 25 Operate (LTO) of the manufacturer where the product will be 26 sourced for repacking 27

v. 9.2.5 Facsimile of proposed label, compliant with FDA 28 labelling requirements 29

30 c. Importer-Distributor of Raw Materials/Finished Products/ Ingredients/ 31

Additives for Distribution and/or Retail 32 33

i. Each item declared in the list of food product(s) to be imported 34 must be identified in any of the following: 35

36 Pro forma invoice, 37 Foreign agency agreement, 38 Appointment letter, or 39 Distributorship agreement 40

41 ii. All establishments from which the applicant sources its imports 42

must be supported by at least one of the following documents 43 issued by the health or regulatory authority of the country of 44 origin or of source:: 45 Valid manufacturer’s certificate of registration with GMP 46

compliance, or its equivalent, 47 Valid Sanitary Phyto-sanitary Certificate or Health 48

Certificate, 49

 

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Valid ISO 22000 Certification, 1 Valid HACCP Certificate, or 2 Certificate of Free Sale 3

4 iii. All certification issued by a private organization should be 5

attested by a recognized business association or chamber of 6 commerce. 7

8 iv. Appropriate test result or certificate of analysis routinely 9

conducted in the country of origin or source that would indicate 10 or show safety of the product. For test or analysis conducted in 11 the Philippines, the applicant shall be guided by appropriate 12 FDA standards as published in the FDA Website in addition to 13 the recognition or accreditation of laboratories. 14

15 d. Distributor-Exporter 16

17 i. Any of the following documents issued to the applicant by the 18

establishment from which it sources the products it exports: 19 20

Valid notarized distributorship agreement; or 21 Letter of appointment between FDA-licensed manufacturer 22

and exporter 23 24

ii. Copy of valid CPR if already registered by the FDA-licensed 25 manufacturer 26

27 e. Distributor-Wholesaler 28

29 i. Any of the following documents issued to the applicant by the 30

establishment from which it sources the products it sells: 31 32

Valid notarized distributorship agreement; or 33 Letter of appointment between the applicant and FDA-34

licensed source  35 36

ii. Valid Certificate(s) of Product Registration if already 37 registered by the FDA-licensed source 38

39 f. Food Trader 40

41 Valid and notarized toll manufacturing and/or repacking 42

agreement with FDA-licensed toll manufacturer and/or 43 repacker. 44

45 46 47 48 49

 

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E. Requirements for Renewal of a License 1 2 1. Regular renewal 3

a. Accomplished Integrated Application Form as prescribed by current 4 FDA regulations; 5

b. Proof of Payment of Fees as prescribed by current FDA regulations; 6 c. Requirements in support of amendments, if applicable, included in the 7

renewal application, including Scanned Application Letter stating the 8 intended changes (indicate changes/ amendments to be made); and 9

10 2. Automatic renewal – where there is no need for inspection or re-11

submission of requirements as required for initial applications, automatic 12 renewal may be granted only if the following conditions are met: 13

14 a. Submission of an affidavit of undertaking for automatic renewal with a 15

sworn statement indicating no change or variation or, as applicable, no 16 violation of FDA rules and regulations or non-compliance to the 17 requirements of GMP have been committed 18

b. The application for renewal was filed before the expiration date of the 19 license; and 20

c. The prescribed renewal fee was paid upon filing of the application. 21 22

F. Requirements for Amendment of a License 23 24 1. The following changes are equivalent to an initial licensing application 25

and must satisfy all applicable requirements as specified in Section V Part 26 A and Section V Part B or Part C, of this Issuance, and surrender the 27 previously issued license: 28 a. Change of Ownership 29 b. Change of Location of Manufacturing Site or Distribution Office 30

31 2. The following amendments must satisfy applicable requirements and upon 32

approval, LTO will be re-issued: 33 34

a. Change of Business Name 35 i. Accomplished Integrated Application Form as prescribed by 36

current FDA regulations; 37 ii. Scanned Application Letter stating the intended changes 38

(indicate changes/ amendments to be made); 39 iii. New Business Name registration from DTI/SEC. If registered 40

address with DTI/ SEC is different from the address of the 41 establishment, a photocopy of Business/ Mayor’s Permit; and 42

iv. Proof of Payment of Fees as prescribed by current FDA 43 regulations 44

 

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1 b. Additional Product Line(s), for manufacturers 2

i. Accomplished Integrated Application Form as prescribed by 3 current FDA regulations; 4

ii. Scanned Application Letter stating the intended changes 5 (indicate changes/ amendments to be made); 6

iii. Compliance to GMP verified during inspection; and 7 iv. Proof of Payment of Fees as prescribed by current FDA 8

regulations 9 10

c. Additional activity(ies): 11 i. Accomplished Integrated Application Form as prescribed by 12

current FDA regulations; 13 ii. Scanned Application Letter stating the intended changes 14

(indicate changes/ amendments to be made); 15 iii. Compliance to GMP verified during inspection; if for 16

additional activity as Toll Manufacturer for a Licensed Food 17 Manufacturer; and 18

iv. Proof of Payment of Fees as prescribed by current FDA 19 regulations 20

21 d. Addition of Sources: 22

i. Accomplished Integrated Application as prescribed by current 23 FDA regulations; 24

ii. Scanned Application Letter stating the intended changes 25 (indicate changes/ amendments to be made); 26

iii. Scanned List of new sources, its address, name and address of 27 the manufacturer (in cases when source is not directly the 28 manufacturer), distributorship agreement or contract 29 agreement, as applicable; 30

iv. Scanned copy of any of the following original documents 31 issued to the source by the Phil FDA (local) or the regulatory or 32 health authority from the country of origin (for imported) per 33 source: 34 Valid manufacturer’s certificate of registration with GMP 35

compliance, or its equivalent, 36 Valid Phytosanitary Certificate/ Health Certificate, 37 Valid ISO 22000 Certification, 38

Valid HACCP Certificate, or 39 Certificate of Free Sale; and 40

v. Proof of Payment of Fees as prescribed by current FDA 41 regulations 42

43 3. The following amendments must be made known to the FDA through 44

notification: 45 a. Deletion of activity(ies); 46

 

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b. Deletion of Source(s); 1 c. Deletion of Warehouse Address; and 2 d. Deletion of Manufacturing Plant Address 3 4

4. Requirements for notification of amendments are as follows: 5 a. Accomplished Integrated Application Form as prescribed by current 6

FDA regulations; 7 b. Scanned Application Letter stating the intended changes (indicate 8

changes/ amendments to be made); and 9 c. Proof of Payment of Fees as prescribed by current FDA regulations 10 11

5. The following amendments must be made known to FDA through 12 notification, submission of applicable Proof of Occupancy, and payment of 13 appropriate fees: 14 a. Addition of Warehouse Address not involving transfer of location 15 b. Any change requiring modification of the submitted Proof of 16

Occupancy 17 18

6. All other changes not identified previously, including but not limited to, 19 the following: 20 a. Change in Distribution Agreement not previously covered; 21 b. Change of Manufacturing Process; and 22 c. Change of Quality Control Procedure, 23 24 Must be reflected in the appropriate document that was required during 25 initial application and shall be submitted during renewal; 26 27

7. Amendments requiring notification must be made known to the FDA 28 within 30 calendar days of effect. 29 30

8. Amendments requiring satisfaction of initial licensing requirements must 31 to do so within 60 calendar days of effect. 32 33

9. Amendments taking effect within 90 days prior to expiration of a current 34 license must be declared along with the renewal 35

36 G. Re-issuance of a License – for additional original copies 37

38 1. Accomplished Integrated Application Form as prescribed by current FDA 39

regulations; and 40 2. Proof of Payment of Fees as prescribed by current FDA regulations. 41

42 43 44

 

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H. Validity of the LTO 1 2 1. Unless revoked, the LTO shall have the following validity period: 3

a. An initial license issued shall be valid for two (2) years 4 b. A renewed license shall be valid for five (5) years. 5 6

I. Process of Application – The process of application is as prescribed by 7 current FDA regulations and shall be guided by the following: 8 9 1. A Certificate of Compliance shall be issued by the FDA inspectorate in the 10

respective regions. Should a site inspection or pre-licensing inspection be 11 required, the inspection shall be scheduled with the applicant, before the 12 Certificate of Compliance is issued. 13

14 2. Approval or disapproval of applications with COCs shall be signed by the 15

Director of the Center for Food Regulation and Research under the 16 authority of the FDA Director General. 17

18 However, “Upon finding, in the course of its evaluation, monitoring, 19 inspection and spot checking, of any violation in the compliance and other 20 requirements required by the FDA and its implemented laws, such as the 21 FDA Act of 2009, these Rules and Regulations, and other relevant laws, to 22 submit a report to serve as basis for the motu proprio action of the Director 23 of the Regional Field Office;” as per Book I Article VIII of IRR of RA 24 9711 under Section 7 (g). Hence, the RFO upon verification/inspection 25 that the food establishment has not complied with the requirement have the 26 power to disapprove and sign the proper action by the Director of the RFO. 27

28 3. The notice of disapproval of applications for license shall clearly state the 29

reason for disapproval. 30  31  32

VI. Guidelines in the Registration of Processed Food Products 33 34

A. General Principles 35 36 1. All processed food products including food additives, food supplements 37

and bottled water, shall first be registered with the FDA before these are 38 distributed, supplied, sold or offered for sale or use and advertised, among 39 other marketing or promotional activities. 40

41 2. Only one (1)Certificate of Product Registration CPR shall be issued to a 42

product that has multiple packaging sizes provided that it meets all of the 43 following conditions: 44 a. The same brand name; 45 b. The same product name/ variant; 46 c. The same product formulation/ ingredients in the same order of 47

proportion; and 48 d. The same label information, except net weight. 49

 

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1 3. Likewise, regardless of the packaging sizes, only one (1) CPR shall be 2

issued to a product that has multiple artwork design and/or multiple 3 suggested recipes on the pack provided that it meets all of the following 4 conditions: 5 a. The same brand name; 6 b. The same product name/ variant; 7 c. The same product formulation/ ingredients in the same order of 8

proportion; and 9 d. The same label information except net weight. 10

11 4. The company should secure permission from FDA through notification for 12

any additional label design or other label changes prior to use in 13 advertisement, promotion, and commercial distribution. 14

15 5. Should a product fail to meet the requirements for product registration, 16

applicable product standards, and labeling regulations, a Letter of Denial 17 shall be issued. The applicant shall be given a maximum of six (6) months 18 to comply and file for re-application. 19

20 6. Imported and locally manufactured raw materials, ingredients and food 21

additives which are intended to be sold, offered for sale or use or for 22 distribution to other food establishments and food business operators and 23 consumers shall secure a CPR for each by the importer or distributor. 24 25 a. However, local food manufacturers who directly import and use raw 26

materials, ingredients and food additives for their own use or for 27 further processing to manufacture a processed food product, need not 28 secure a CPR for the raw materials, ingredients and food additives. 29

30 7. As stated in Item 6 above, when a CPR is granted to a food 31

manufacturer/importer, all individual ingredients as part of the FDA-32 registered product formulation, may be imported without a CPR. However, 33 should the FDA-licensed food manufacturer/importer use or source out 34 local ingredients and food additives, it shall only purchase from FDA-35 licensed establishments. 36 37

8. The registration requirements for food establishments intending to export 38 products are the same. However, food establishments with intention to 39 export, shall comply with all the regulatory standards and requirements of 40 the importing country, including the labelling requirements. 41

42 9. A previously registered product initially for local distribution shall be 43

allowed to be exported using the same CPR as long as the following 44 conditions are met and labelling and standards of importing country are 45 likewise met: 46

47 a. The same brand name; 48 b. The same product name/ variant; 49

 

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c. The same product formulation/ ingredients in the same order of 1 proportion; and 2

d. The same label information except net weight. 3 4

Notification to FDA shall be made and labels in the language of the 5 importing country shall likewise be submitted. 6 7

10. Only food additives listed in the latest Codex General Standards for Food 8 Additives (GSFA) and/or the latest FDA Listing of Food Additives and/or 9 approved pharmaceutical excipients list intended for Food Supplement in 10 pharmaceutical dosage form such as tablet, soft gel capsule and capsule 11 shall be issued a CPR. 12

13 11. Validity of Certificate of Product Registration (CPR) will be 2 years 14

minimum to 5 years maximum for initial and 5 years for renewal; provided 15 that upon renewal, its holder conforms with the pertinent standards and 16 requirements including labeling regulations. 17 18

12. The FDA may require for additional documents on products that are 19 considered high risk food provided that the reason for the additional 20 requirements is to address uncertainties on safety as deemed necessary 21 through a separate issuance. 22 23 a. High risk products include but not limited to the following: infant 24

formula, milk supplements, foods for infants and young children, foods 25 for special medical purposes, and foods for special dietary uses. 26

27 13. In case there is a health issue other than the growth of pathogenic 28

microorganisms or other food safety related incidents (e.g. chemical 29 contamination or adulteration), FDA has the option to impose other 30 requirements through regulatory issuances. 31

32 14. In addition to the requirements in the proceeding sections, the FDA may 33

conduct inspection of the manufacturing or processing plant or verification 34 of documents submitted or may require additional documents or evidence 35 to ascertain the safety and/or quality of the product. 36 37

B. Quality and Safety Standard 38 39 1. Food products shall be evaluated based on the technical documents 40

submitted for safety and quality. Only those food establishments with 41 products that have complied with the requirements and meet the standards 42 for food safety, quality, and labeling, including relevant standards set by 43 the FDA/Codex for specific food category, as applicable, will be issued a 44 CPR. 45 46

2. All processed Food Products shall comply with the relevant appropriate/ 47 applicable quality and safety standards, if any. 48

 

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1 3. Food establishments or food business operators shall be required to 2

conform with the General Principles of Food Hygiene, including general 3 requirements on sanitation, and as appropriate for the food establishment 4 or food business operation, comply with the relevant standards and 5 requirements of the code of Good Manufacturing Practice, HACCP, Good 6 Storage Practice, Good Distribution Practice, or the Sanitary Standard 7 Operating Procedures. 8

9 4. Food establishments shall be required to comply, as appropriate, with the 10

requirements of the ASIN Law and Food Fortification Law, and other 11 issuances related to them and to other food quality and safety standards as 12 adopted or determined by the FDA. Products covered by separate laws 13 (e.g. RA 8172 and RA 8976) requiring the submission of Certificate of 14 Analysis (COA) shall be complied with. 15

16 C. Product Claims and Labeling 17 18

1. No food samples shall be submitted to FDA provided that the labels are 19 clear and bears the complete label information. However, for food 20 supplements, it is necessary to submit product samples in commercial 21 presentation. 22

23 2. Food supplements shall not have curative claims or therapeutic claims. 24

Other claims shall be in accordance to existing and relevant labeling 25 guidelines. 26

27 3. Advertising and promotional materials of food establishments and food 28

business operators shall not make curative or therapeutic claims without 29 scientific data or clinical trials to substantiate such claims. 30

31 D. Requirements for Initial Registration – The following are the requirements 32

for a product registration: 33 34 1. Accomplished Integrated Application Form as prescribed by current FDA 35

regulations; 36 2. Proof of Payment of Fees as prescribed by current FDA regulations; 37 3. Clear and complete loose labels or artworks, as applicable, of all 38

packaging sizes, or equivalents as defined by FDA regulations except for 39 bulk raw materials, ingredients and food additives intended for further 40 processing or for distribution to establishments/ manufacturers for further 41 processing; 42

4. Pictures of the product in all angles and in different packaging sizes, and 43 from at least two different perspectives allowing visual recognition of a 44 product as the same with the one being registered, as applicable; 45

5. For food supplement, a sample in actual commercial presentation shall be 46 submitted. 47

6. As applicable, documents to substantiate claims, such as technical, 48 nutritional or health studies or reports, market-research studies, Certificate 49 of Analysis, quantitative analysis and computations, scientific report or 50

 

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studies published in peer-reviewed scientific journals, certificates or 1 certification to support use of logo/seal on Sangkap Pinoy, Halal, Organic, 2 or Kosher food and in compliance with current labelling regulations.. 3

4 E. Requirements for Renewal Registration 5

6 1. Accomplished Integrated Application Form as prescribed by current FDA 7

regulations; 8 2. Proof of Payment of Fees as prescribed by current FDA regulations; 9 3. Requirements in support of amendments included in the renewal 10

application (not applicable for automatic renewal); and 11 4. Clear and complete loose labels or artworks, as applicable, of all 12

packaging sizes, or equivalents as defined by FDA regulations except for 13 bulk raw materials, ingredients and food additives intended for further 14 processing or for distribution to establishments/ manufacturers for further 15 processing. 16

17 F. Automatic Renewal of CPR 18

19 1. Renewal of the CPR may be automatic provided that the following 20

conditions are met: 21 a. The application shall be filed before the expiration date of the CPR; 22 b. The prescribed automatic renewal fee must be paid prior to filing of the 23

application; and 24 c. If there is no condition stated at the back of the issued Certificate of 25

Product Registration. However, in case there is a condition, a scanned 26 copy of the acknowledgment letter from FDA indicating the condition 27 stated in the CPR had been complied, should be submitted. 28

29 2. Any application filed as automatic renewal registration shall be submitted 30

with the FDA within 90 days before the date of its expiration. 31 32 3. Request for amendment shall not be allowed to be filed simultaneously 33

with an application for automatic renewal. 34 35 4. Below shall be the specific cases wherein the Automatic Renewal will not 36

apply: 37 38

a. If the application for registration is filed after the expiry date of the 39 CPR but within 120 days, the application shall not be qualified for 40 automatic renewal and is subject to corresponding surcharges (this will 41 be considered under Regular Renewal with the same FR number). 42

43 b. If the application is filed after 120 days from the expiry date of the 44

CPR, the application shall undergo the initial filing and evaluation 45 procedure. It will be issued a new CPR. 46

47 c. If there are any changes in product formulation (reformulation), this is 48

treated as an application for initial registration. 49

 

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1 d. No application for renewal shall be accepted unless the prescribed 2

renewal fee is paid. 3 4 e. If within the 5 year validity, a violation on the product and label was 5

monitored, there will be corresponding sanctions as indicated in 6 Section XI of RA 9711 and CPR will be revoked/ cancelled if not 7 complied within the period of 6 months. Food establishment will file 8 for an initial application. 9

10 G. Amendments to the Product Registration 11

12 1. The following changes are equivalent to an initial registration application: 13

a. Change in manufacturer or repacker shall be treated as initial 14 registration; and 15

b. Change of product formulation. 16 17

2. Notification of Amendments 18 19 a. Condition 20

There must be no changes in product that is an indication for initial 21 product registration 22 23

b. The following amendments must be made known to FDA through 24 notification: 25

i. Change/ Additional Packaging Size 26 ii. Extension/ Change in Shelf-life 27

iii. Change in Packaging Design/ Additional Packaging Design 28 iv. Exportation of previously registered product initially for local 29

distribution 30 31

3. Requirements for notification of amendments in Section G.2 above, are as 32 follows: 33 34 a. Accomplished Integrated Application Form as prescribed by current 35

FDA regulations; 36 b. Scanned Application Letter stating the intended changes (indicate 37

changes/ amendments to be made); 38 c. Proof of Payment of Fees as prescribed by current FDA regulations; 39 d. Clear and complete loose labels or artworks, as applicable, of all 40

packaging sizes, or equivalents, reflecting the change/s, as defined by 41 FDA regulations or reflecting compliance to labeling requirements of 42 importing country, in the case mentioned in Section G.2.2.4 (e.g. label 43 reflecting the language of importing country); and/or 44

e. Stability study results with conclusion to support extension or change 45 in shelf-life. 46 47 48 49

 

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4. Transfer of Ownership of a Registered Product, or of a pending 1 application: 2 3 a. Conditions 4

i. There must be no changes in the product that is an indication 5 for initial product registration; and 6

ii. The new owner must have a valid License to Operate from the 7 FDA 8 9

b. Requirements 10 i. 4.2.1 Accomplished Integrated Application Form as prescribed 11

by current FDA regulations; 12 ii. 4.2.2 Scanned Application Letter stating clearly the intended 13

changes (indicate changes/ amendments to be made); 14 iii. 4.2.3 Proof of Agreement between previous and current owners 15

of the product transferring ownership; 16 iv. 4.2.4 Clear and complete loose labels or artworks, as 17

applicable, of all packaging sizes, or equivalent as defined by 18 FDA regulations; and 19

v. 4.2.5 Proof of Payment of Fees as prescribed by current FDA 20 regulations 21

22 5. Additional Packaging Type or Change in Packaging Material: 23

24 a. Conditions 25

i. There must be no changes in the product that is an indication 26 for initial product registration 27

ii. This is independent of the change in product description/ 28 design. 29

30 b. Requirements 31

i. Accomplished Integrated Application Form as prescribed by 32 current FDA regulations; 33

ii. Complete labeling materials of the previously approved label 34 and the proposed new/ additional presentation of packaging for 35 comparison. (All information on the label including the design 36 should be the same); 37

iii. Proof of suitability of packaging material for food, including 38 stability of the product in the new packaging; 39

iv. Clear and complete loose labels or artworks, as applicable, of 40 all packaging sizes, or equivalent as defined by FDA 41 regulations; and 42

v. Proof of Payment of Fees as prescribed by current FDA 43 regulations 44

45 46 47 48 49 50

 

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6. Change in Product Description/ Name: 1 a. Conditions 2

i. There must be no changes in the product that is an indication 3 for initial product registration 4

ii. This is independent of the change in packaging material or 5 packaging type 6

7 b. Requirements 8

i. Accomplished Integrated Application Form as prescribed by 9 current FDA regulations; 10

ii. Scanned Application Letter stating the intended changes, 11 including justification for the change (indicate changes/ 12 amendments to be made and the name should describe the true 13 identity of the product); 14

iii. Clear and complete loose labels or artworks, as applicable, of 15 all packaging sizes, or equivalent as defined by FDA 16 regulations; and 17

iv. Proof of Payment of Fees as prescribed by current FDA 18 regulations 19

20 7. Change in Brand Name 21

a. Accomplished Integrated Application Form as prescribed by current 22 FDA regulations; 23

b. Scanned Application Letter stating the intended changes (indicate 24 changes/ amendments to be made); 25

c. New product label, reflecting the change 26 d. Authority from the source or the owner of the brand (if imported) 27 e. IPO registration, if available 28 f. Proof of Payment of Fees as prescribed by current FDA regulations 29 30

8. Change in Business Name 31 a. Accomplished Integrated Application Form as prescribed by current 32

FDA regulations; 33 b. Scanned Application Letter stating the intended changes (indicate 34

changes/ amendments to be made); 35 c. Proof of change in business name, e.g. License, Certificate 36 d. New labeling materials, reflecting the change; and 37 e. Proof of Payment of Fees as prescribed by current FDA regulations 38 39

9. Change in Importer/ Distributor 40 a. Accomplished Integrated Application Form as prescribed by current 41

FDA regulations; 42 b. Scanned Application Letter stating the intended changes (indicate 43

changes/ amendments to be made); 44 c. Termination of agreement/ Deed of assignment; 45 d. Agreement of new manufacturer/ importer/ distributor or Appointment 46

letter 47 e. New labeling materials, reflecting the change/s 48 f. Proof of Payment of Fees as prescribed by current FDA regulations 49

 

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1 10. Amendments requiring notification must be made known to the FDA 2

within 30 calendar days of effect. 3 4

11. Amendments requiring satisfaction of initial licensing requirements must 5 do so within 60 calendar days of effect. 6

7 12. Amendments taking effect within 90 days prior to expiration of a current 8

license must be declared along with the renewal 9 10

H. Re-issuance of a Registration – for additional original copies: 11 12 1. Accomplished Integrated Application Form as prescribed by current FDA 13

regulations; and 14 2. Proof of Payment of Fees as prescribed by current FDA regulations 15

16 I. Validity of the Registration 17

18 1. Unless, revoked within the validity period, the CPR shall 19

be valid for 2 years minimum to 5 years maximum for initial and 5 years 20 for renewal. 21 22

J. Registration Process 23 24

The Director General of the FDA, upon the recommendation of the Center 25 Director for Food, shall further promulgate the rules and regulations on the 26 procedure for registration: 27 28 1. Issuance of CPR shall be based on compliance of the product with 29

applicable standards, requirements and regulations. 30 31 2. If the product does not conform with applicable standards, requirements or 32

regulations, a Letter of Denial shall be issued. The applicant shall be 33 given 6 months to reapply by submitting the deficiencies and the complete 34 set of documents. Otherwise, the application is considered as initial. 35

36 37

VII. Inspection and Certificate of Compliance 38 39

A. The FDA/CHD will verify documents submitted and conduct inspection 40 prior to licensing dependent on the safety risk of the products being handled 41 by the establishment. 42

43 B. The FDA may conduct inspection in collaboration with the LGUs and any 44

agency or office under the DOH, DA and DILG. 45 46 C. Pre-licensing inspection and a Certificate of Compliance (COC) shall be 47

issued, following a risk-based approach or HACCP/GMP requirements 48 depending on the level of risks and complexity of production, among others. 49 The conduct of inspection shall be covered by Quality Manual. 50

 

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1 D. In lieu of the COC, for the microenterprise food manufacturer, Sanitary 2

Permit (establishment) and Health Certificate (food handlers), as 3 appropriate, which are issued after inspection or examination by the LGU 4 sanitary inspectors or health facilities may be accepted by the FDA. 5

6 E. The FDA reserve the right to inspect at any time as routine, spot check, post-7

market surveillance of the product, or to act on any report of food-borne 8 illness or complaints the FDA receives. Upon validation of non-compliance 9 to FDA safety and quality standards, the FDA CFRR Director shall revoke 10 the LTO and CPR immediately, following due process. 11

 12 13

VIII. Grounds for Disapproval of Applications 14 15

The following shall be grounds for disapproval of an application: 16 17 1. Failure to submit complete or correction to documentary requirements. 18 2. Failure to meet the appropriate standard or requirement evaluation of 19

documents or inspection of the food establishment offices and premises. 20 3. Failure to respond to notice of deficiency or to submit documents on time. 21 4. Misrepresentations, false entries, or withheld any relevant data contrary to 22

the provisions of the law, these Rules and Regulations or appropriate 23 standards. 24

5. Such other analogous grounds or causes as determined by the FDA. 25 26 27 IX. Fees and Other Charges 28 29 Initial and renewal application fees and other charges shall be collected as may be 30 allowed by the existing rules on fees and charges or surcharges. 31 32 33 X. Post-Market Surveillance and Product Monitoring 34 35 Post-Market Surveillance and product monitoring shall be conducted by the FDA 36 based on the risks presented by the food products. Samples of products shall be 37 collected for testing, and routine and spot checking of food establishments or food 38 business operators shall be conducted. Food-borne illnesses and epidemiological data 39 shall be studied as basis for planning or instituting measures to reduce food-borne 40 outbreaks. Risk communication in collaboration with other stakeholders shall be 41 heightened to reduce the risk of food borne illnesses brought about by food products. 42 Risk management plan or food safety plan as well as attendance to food safety 43 seminars or training shall be required from food borne operators or food 44 establishments to ensure continuous compliance to food safety standards. 45 46 47 48 49 50

 

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XI. Transition Period 1 2 Within six (6) months after the signing of this Administrative Order, the FDA shall 3 streamline the national process and system of licensing and registration in the country 4 with other government agencies to ensure increased protection of the health and 5 welfare of consumers, and availability of processed food and food products in the 6 market. 7 8 9 XII. Separability Clause 10 11 If any part or term of provision of this order shall be declare invalid or unenforceable 12 the validity or enforceability of the remaining portions or provisions shall not be 13 affected and this order shall be construed as if it did not contain the particular invalid 14 or enforceable part, term or provision. 15 16 17 XIII. Repealing Clause 18 19 All other administrative issuances, bureau circulars and memoranda and other 20 regulations inconsistent with this Order are hereby withdrawn, repealed and /or 21 revoked accordingly. 22

23 24

XIV. Effectivity 25 26 This Order shall take effect 15 days after its publication in an official gazette or in a 27 newspaper of general circulation. 28 29 30 31 32 ENRIQUE T. ONA, MD, FPCS, FACS 33 Secretary of Health 34 35 36