ANNEX A

Requirements for License to Operate (LTO) – OPENING/ INITIAL GENERAL REQUIREMENTS: Note: All photocopied documents shall be verified against the original copy. 1. Notarized Accomplished Application for Authorization Form (Annex A-1)

Note: a. Notarized Certificate authorizing the person who signed in behalf of the establishment/ company,

if he/she is not the owner or one of the incorporators as registered with DTI/SEC b. Petitioner should be one of the Incorporators. If the petitioner is not the owner/ incorporator,

copy of Secretary Certificate/ Board Resolution/ Authorization Letter/ Special Power of Attorney must be submitted

2. Proof of Registration

a. If Single Proprietorship, valid Certificate of Business Name Registration with the Department of Trade and Industry

b. If Corporation or Partnership, valid Registration with Securities and Exchange Commission

(SEC) and Articles of Incorporation or Partnership c. If Cooperative, valid Certificate from Cooperative Development Authorities and by laws

Note: 1. If the DTI or SEC has a different Business Address, copy of valid Mayor’s Business

Permit or Barangay Clearance must be submitted. 2. If the Corporate Name is different from the Business Name, copy of amendment of SEC

Registration must be submitted 3. DTI Certificate or SEC Registration must indicate the actual activity/ purpose. 4. In case of change of ownership, copy of Deed of Sale must be submitted.

3. Proof of Occupancy – Office

a. Valid notarized Contract of Lease / Sub-Lease/ Certificate of Occupancy

b. Transfer Certificate of Title (TCT) if owned and notarized Certificate of Occupancy (if owned by one of the incorporators)

c. Clearance from the Condominium/ Building Administration allowing the use of the unit for business purposes – as necessary

4. Proof of Occupancy – Warehouse or Stock Room

a. Valid notarized Contract of Lease / Sub-Lease/ Certificate of Occupancy

b. Transfer Certificate of Title (TCT) if owned and notarized Certificate of Occupancy (if owned by one of the incorporators)

c. Valid notarized Warehousing Agreement (Third Party Logistics)

5. Proof of Occupancy – Manufacturer

Photocopy of Notarized valid Contract of Lease of the space/building occupied (if the space/bldg. is not owned)

6. Photocopy of Notarized Fixed Asset & Operating Capital or Financial Statement, if applicable. 7. Location Plan/Site (Indicate size, location, immediate environment, type of building)

8. Floor Plan/ Lay out with dimension (office and/or warehouse; manufacturing plant)

9. Tentative list of food products to be manufactured or distributed identified based on its classification

(local or imported) and category (Annex L) (Low/medium/high risk).

10. Facsimile of Proposed Label (for local manufacturer) / sample label of product to be imported or a digital image of the document in an FDA-approved file type.

SPECIFIC REQUIREMENTS: A. FOOD REPACKER:

Photocopy of notarized valid contract/ agreement with the manufacturer (limits on products to be repacked stated in the main AO), with attached LTO of the manufacturer

B. FOOD IMPORTER FOR RAW MATERIALS

1. List of sources of raw materials 2. List of materials to be imported

C. FOOD IMPORTER FOR FINISHED PRODUCTS IN BULK:

1. Photocopy of Foreign Agency Agreement duly authenticated by the Territorial Philippine Consulate

2. Photocopy of Certificate of Status of Manufacturer (cGMP Certificate) issued by a Government

Health Agency Duly authenticated by the Territorial Philippine Consulate.

D. FOOD MANUFACTURER 1. Organizational Chart Indicating qualification of key personnel in production and quality control:

a. Educational Background; b. Trainings Attended;

2. List of Products and brands to be manufactured/repacked;

3. List of production equipment with specification;

4. List of quality control facilities and equipment (if any);

5. Flowchart of manufacturing process with emphasis on identification of critical control points;

6. Detailed description of manufacturing process;

7. Quality control procedures / sanitation standard operating procedures enforced in the plant: a. Working Area; b. Equipment; c. Personnel; d. Pest Control Program

8. Certification with current laboratory analysis (from FDA recognized laboratories)

a. Source Water For plant within Metro Manila: photocopy of recent MWSS / Maynilad water bill and/or satisfactory results of potability test performed by either:

DOH Laboratory Laboratories of Water Supplier Laboratories Accredited by DOH as per A.O. 26-A s. 1994

b. Finished Product’s compliance with standard Please see Annexes I and J for the specific test parameters to be conducted.

For bottled water, please see Annex N or refer to AO 18-A s. 1993 or its latest revision/ amendments for additional tests results to be submitted;

c. Packaging certification of suitability for food use; 9. Name and address of suppliers of raw materials and packaging materials 10. HACCP Program - the establishment shall follow the generic format listed as Annex A-1

E. IMPORTER OF FINISHED PRODUCTS: a. Any one of the following from each supplier:

Foreign Agency Agreement/ Certificate of Distributorship/ Appointment Letter Proforma Invoice;

b. Any one of the following documents for the status of Manufacturer issued by the Regulatory/ Health Authority from the country of origin:

1) Certificate of Registration of Manufacturer and its conformity with GMP from Regulatory/ Health Authority or its equivalent; 2) Phytosanitary Certificate; 3) Certificate of Free Sale; 4) HACCP Plan/Certificate as applicable;

Note: In the absence of a Regulatory/ Health Authority from the country of origin, attestation by a recognized association which should be duly authenticated by the Philippine Consulate.

F. FOOD EXPORTER:

a. Valid License to Operate (LTO) of Supplier/ Manufacturer;

b. Valid notarized Distributorship Agreement or Letter of Appointment with FDA licensed Supplier/

Manufacturer to distribute their products outside the Philippines;

c. List of food products with registration numbers and validities.

G. WHOLESALER

a. Locally Procured Raw Materials in Bulk and Finished:

a.1 Valid License to Operate (LTO) of Supplier/ Manufacturer; a.2 Valid notarized Distributor Agreement or Letter of Appointment with FDA licensed Supplier/ Manufacturer to distribute their products outside the Philippines a.3 List of food products with registration numbers and validities

b. Subcontracts to a Licensed Manufacturer/ Repacker:

Valid License to Operate (LTO) of Manufacturer and/or Repacker (tolling/ repacking activity and

specific product should be indicated in the LTO)

H. ADDITIONAL REQUIREMENTS: Food Trader/Distributor (Importer/Exporter/Wholesaler) 1. Premises:

A signage in front of the business bearing the registered name; A well-ventilated area with concrete, tile or wooden flooring, provide with office fixtures such

as but not limited to table, chairs, cabinets, computers etc.; A suitable and proper place for adequate storage of food products, with considerations to its

proper storage conditions, i.e. needing refrigeration, cold room, provided with wooden or steel pallets

2. Record of distribution and sales:

A file of invoices issued to customers; An updated inventory of stocks whether computerized or in logbook indicating, among others:

the name and address of client; control number of product; date and quantity received from the supplier/s, and date and quantity delivered.

3. Other additional requirements

Pest control system; SOP on good distribution, good storage, system of recall and disposal of damage & expired

products; A file of documents consisting among others:

o Valid certificate of product registration for the food products; o Proforma invoices for every shipment (if applicable) or official invoice issued by suppliers; o Copies of BOC clearances issued by FDA (if applicable)

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INFORMATION SHEET (FOOD MANUFACTURING AND PROCESSING ESTABLISHMENT)

( ) NEW ESTABLISHMENT ( ) PRESENTLY OPERATING

I. Name of Owner:__________________________________________________________________________________________ ( ) Single Proprietorship ( ) Corporation ( ) Partnership ( ) Association

II. Name of Establishment:_____________________________________________________________________________________

III. (a) Address of the Food Establishment:_________________________________________________________________________ ____________________________________________________________________________________________________________ (b) Postal Address if different from (a)_________________________________________________________________________ ____________________________________________________________________________________________________________ (c) Telephone Number(s)____________________________________________________________________________________ IV. List of Food and Food Products to be manufactured; repacked and/or exporter/ imported.

V. List of Equipments and Machineries (For Manufacturer & Repacker Only)

VI. If a License, a State name and address of Licensing Firm: Name:___________________________________________________________________________________________________ Address:_________________________________________________________________________________________________ VII. Source(s) of raw materials to be used:

(a) Local ( ) Yes ( ) No (b) Imported ( ) Yes ( ) No

Country of Origin:_________________________________________________

(c) Imported Finished Product in bulk from the repacking:

( ) Yes ( ) No Country of Origin:_________________________________________________ VIII. Personnel: List No. of Technical Employees and their scholastic attainment, who are directly involved in manufacturing

/repacking.

IX. Are the Products produced or manufactured for export ( ) Yes ( ) No or for local domestic consumption? ( ) Yes ( ) No. If for export, state name of country to which is exported:___________________________________________________________ ________________________________________________________________________________________________________ I declared under oath that the foregoing statement composed of two (2) pages are true, correct and complete to the best of my knowledge and belief. Respectfully submitted: ___________________________ __________________________ _________________________ Print Name and Sign Above Title Date

ANNEX A-2

Hazard Analysis Critical Control Point (HACCP) Program

A. HACCP Team Name Designation Qualification/Expertise HACCP Training

B. Product Description and Intended Use Product Name Common Name Ingredients List Product Specification Method of Preservation Packaging Method and Materials Used Storage Condition Distribution Method Shelf Life Intended Use Customer Preparation Special Labeling

C. Hazard Analysis Worksheet D. HACCP Plan

(1) Critical Control Point (CCP)

(2) Significant Hazard(s)

(3) Critical

Limits for each

Preventive Measure

(4) (5) (6) (7) (8) Corrective Action (s)

(9) Records

(10) Verification

Monitoring What How Frequency Who

Prepared by:

Reviewed by:

Approved by:

ANNEX B

Requirements for the Renewal of LTO Regular Renewal:

1. Renewal shall be on or before the issuance date 2. Submit latest Financial Statement duly signed by a CPA or latest BIR

Automatic Renewal: There shall be automatic renewal of the LTO when the following conditions are satisfied:

1. The application is filed before the expiration date of the license; 2. The prescribed renewal fee is paid upon filing of the application; and 3. A sworn statement indicating no change or variation whatsoever in the establishment is attached to the application.

ANNEX C

Requirements for Amendment of License to Operate

CHANGE OF BUSINESS NAME 1. Official letter regarding the change of business name 2. Notarized accomplished Amendment Application Form 3. Photocopy of Business Name Registration OR a digital image of the document in an FDA-

approved file type and at least 1024 x768 pixels in size a. For single proprietorship registration from the Department of Trade & Industry (DTI) b. For corporation / partnership, registration from Securities & Exchange Commission (SEC)

and Articles of Incorporation Note: If the registered address with DTI/SEC is different from the address of the establishment

to licensed, submit a photocopy of Business/Mayor’s Permit 4. ID picture of the owner/authorized representative 5. Surrender original License to Operate (LTO) CHANGE OF OWNERSHIP 1. Official letter regarding the change of ownership 2. Notarized accomplished Petition Form 3. Photocopy of Business Name Registration a. For single proprietorship registration from the Department of Trade & Industry (DTI) b. For corporation / partnership, registration from Securities & Exchange Commission (SEC)

and Articles of Incorporation Note: If the registered address with DTI/SEC is different from the address of the establishment

to licensed, submit a photocopy of Business/Mayor’s Permit 4. ID picture of the owner / authorized representative 5. Photocopy of Contract / Agreement with Manufacturer reflecting the new owner 6. Photocopy of Deed of Sale / Transfer of Rights 7. Photocopy of Dissolution Papers from SEC (for corporation/partnership) 8. Photocopy of Financial Statement duly notarized or received by Bureau of Internal Revenue (BIR) 9. Surrender original License to Operate (LTO)

ANNEX D

CLASSIFICATION OF PROCESSED FOOD PRODUCTS

A. LOW RISK CATEGORY Low Risk (LR) Category – Food that is unlikely to contain pathogenic microorganisms and will not

normally support their growth due to food characteristics or type The following list, but not limited to, shows food products identified by FDA based from CODEX GSFA

and FAO Risk Categories: List of Low Risk Category Food Products

FOOD PRODUCTS A. FROZEN DESSERTS

1. Non-Dairy based (e.g. sherbet, sorbet) 2. Edible ices

B. FATS, OILS AND FAT EMULSIONS

1. Butter oil, anhydrous milkfat, ghee 2. Vegetable oils and fats 3. Animal fats (lard, tallow, fish oil and other animal fats) 4. Fat emulsions mainly of type oil-in-water, including mixed and/or flavored products based on fat

emulsion 5. Fat emulsions mainly of type water-in-oil (butter, fat spreads, margarine dairy fat spreads and

blended spreads) 6. Fat-based desserts excluding dairy-based desserts

C. PROCESSED FRUITS, VEGETABLE AND EDIBLE FUNGI (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera) SEAWEEDS, AND NUTS AND SEEDS

1. Dehydrated fruits or vegetables, including candied fruits (mechanically dried) 2. Jams, jellies, marmalades (pastry, topping, filling, coconut spreads) 3. Dehydrated Vegetable protein products 4. Tomato products 5. Frozen fruits 6. Fruits or vegetables in vinegar, oil or brine 7. Fruit-based spreads (e.g. chutney) excluding jams, jellies and marmalades 8. Fruit preparations, including pulp, purees, fruit toppings and coconut milk 9. Cooked fruits 10. Frozen vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and

aloe vera) seaweeds, and nuts and seeds 11. Vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera),

seaweed, and nut and seed in pulps and preparations (e.g. vegetable desserts and sauces, candied vegetables) other than food in MR/HR Letter B.8 (Vegetable purees, spreads – peanut butter)

12. Cooked or fried vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), and seaweeds

D. CONFECTIONERY

1. Cocoa products and Chocolate products including imitations and chocolate substitutes a. Cocoa mixes (powders) and cocoa mass/ cake b. Cocoa mixes (syrups) c. Cocoa-based spreads, including fillings d. Cocoa and chocolate products, including “tablea”; and imitation chocolate, chocolate

substitute products 2. Confectionery including hard and soft candy, nougats, marzipans, etc. other than in LR D.1 3. Chewing gum 4. Decorations (e.g. for fine bakery wares, sugar flowers), toppings (non-fruit), and sweet sauces

E. CEREAL-BASED PRODUCTS, derived from cereal grains, from roots and tubers, pulses, legumes and

pith or soft core of palm tree, excluding bakery wares in Letter G below

1. Flours, starches (including soybean powder) and flour mixes 2. Breakfast cereals including rolled oats 3. Pasta and noodles and like products (e.g. rice paper, rice vermicelli, soybean pastas and noodles)

a. Fresh pastas and noodles and like products b. Dried pastas and noodles and like products c. Pre-cooked pastas and noodles and like products

4. Cereal and starch based desserts (e.g. rice pudding, tapioca pudding, native delicacies) 5. Batters (e.g. for breading or batters for fish or poultry) 6. Pre-cooked or processed rice products, including rice cakes (Oriental type only) 7. Soybean products (excluding soybean-based seasonings and condiments under Cat 1 LR Letter I

(seasonings, condiments and sauces) a. Soybean-based beverages b. Soybean-based film c. Soybean curd (tofu) d. Semi-dehydrated soybean curd

i. Thick gravy-stewed semi-dehydrated soybean curd ii. Deep fried semi-dehydrated soybean curd

iii. Semi-dehydrated soybean curd, other than in Cat 1LR E.7.d.i) and 7.d.ii) e. Dehydrated soybean curd (kori tofu) f. Other soybean protein products

F. PROCESSED MEAT AND MEAT PRODUCTS, INCLUDING POULTRY AND GAME

Edible casings (e.g. sausage casings)

G. BAKERY WARES AND BAKERY RELATED PRODUCTS

1. Bread and ordinary bakery wares and mixes a. Breads and rolls – yeast-leavened breads and specialty breads, soda breads b. Crackers, excluding sweet crackers c. Other ordinary bakery products (e.g. bagels, pita, English muffins) d. Bread-type products, including bread stuffing and bread crumbs e. Steamed bread and buns f. Mixes for bread and ordinary bakery wares

2. Fine bakery wares (sweet, salty or savory) and mixes a. Cakes, cookies, pies, pastries, doughnuts, sweet rolls, scones, muffins, waffles – plain /

without filling b. Mixes for fine bakery wares (e.g. cakes, pancakes)

H. SWEETENERS, INCLUDING HONEY

1. Refined and raw sugars a. White sugar, dextrose anhydrous, dextrose monohydrate, fructose b. Powdered sugar, powdered dextrose c. Soft white sugar, soft brown sugar, glucose syrup, dried glucose syrup, raw cane sugar

i. Dried glucose syrup used to manufacture sugar confectionery ii. Glucose syrup used to manufacture sugar confectionery

d. Lactose e. Plantation or mill white sugar

2. Brown sugar excluding products under LR H.1.c (soft white sugar, etc.) 3. Sugar solutions and syrups, also (partially) inverted, including treacle and molasses, excluding

products under H.1.c (soft white sugar, etc.) 4. Other sugars and syrups (e.g. xylose, maple syrup, sugar toppings), including coconut sugar 5. Honey 6. Table-top sweeteners, including those containing high-intensity sweeteners

I. SALT, SPICES, SOUPS, SAUCES, SALADS AND PROTEIN PRODUCTS

1. Salt and salt substitutes 2. Herbs, spices, seasonings and condiments (e.g. seasoning for instant noodles) 3. Vinegars 4. Mustards

5. Soups and broths a. Ready-to-eat soups and broths, including canned, bottled and frozen b. Mixes for soups and broths

6. Sauces and like products

a. Emulsified sauces and dips (e.g. mayonnaise, salad dressing, onion dips) b. Non-emulsified sauces (ketchup, cheese sauce, cream sauce, brown gravy) c. Mixes for sauces and gravies d. Clear sauces (fish sauce)

7. Salads (e.g. macaroni salad, potato salad) and sandwich spreads excluding cocoa- and nut-based,

spreads under MR/HR Letter B.8 and D.1.c (peanut butter/ cocoa-based spreads)

8. Yeast and like products

9. Soybean-based seasonings and condiments a. Fermented soybean paste (e.g. miso) b. Soybean sauce

1) Fermented soybean sauce 2) Non-fermented soybean sauce 3) Other soybean sauces

10. Protein products other than from soybeans, marinades

J. BEVERAGES, excluding dairy products

1. Non-alcoholic (“soft”) beverages a. Fruit and vegetable juices - (fruit juice, vegetable juice, concentrates for fruit juice,

concentrates for vegetable juice) b. Fruit and vegetable nectars (fruit nectar, vegetable nectar, concentrates for fruit nectar,

concentrates for vegetable nectar) c. Water-based flavored drinks, including “sport,” “energy,” or “electrolyte” drinks and

particulated drinks 1) Carbonated water-based flavored drinks 2) Non-carbonated water-based flavored drinks, including punches and ades 3) Concentrates (liquid or solid) for water-based flavored drinks

d. Coffee, coffee substitutes, tea, herbal infusions, and other hot cereal and grain beverages e. Powdered cocoa drink mixes (cocoa)

2. Alcoholic beverages, including alcohol-free and low-alcoholic counterparts

a. Beer and malt beverages b. Cider and perry c. Grape wines

1) Still grape wine 2) Sparkling and semi-sparkling grape wines 3) Fortified grape wine, grape liquor wine, and sweet grape wine

d. Wines (other than grape) e. Mead f. Distilled spirituous beverages containing more than 15% alcohol g. Aromatized alcoholic beverages (e.g. beer, wine and spirituous cooler-type beverages, low-

alcoholic refreshers)

K. READY-TO-EAT SAVOURIES

1. Snacks – potato-, cereal- or starch-based (from roots and tubers, pulses and legumes), including chips and crunchies

2. Processed nuts, including coated nuts and nut mixtures (with e.g. dried fruits) 3. Chicharon 4. Snacks – fish-based

*As listed in the latest Codex General Standard for Food Additives (GSFA)

2. MEDIUM TO HIGH RISK CATEGORY Medium to High Risk (MR/HR) Category – Food that may contain pathogenic Micro-organisms and/or may support their growth and toxin formation

FOOD PRODUCTS

A. DAIRY PRODUCTS and ANALOGUES, excluding products under Fats, Oils and Fat Emulsions

1. Milk and dairy-based drinks a. Milk (plain) and buttermilk (plain) b. Dairy-based drinks, flavored and/or fermented (e.g. chocolate milk, cocoa, eggnog, drinking

yoghurt, whey-based drinks)

2. Fermented and renneted milk products (plain), excluding dairy-based drinks in A.1.b a. Fermented milks (plain)

g. Fermented milk (plain), not heat-treated after fermentation h. Fermented milks (plain), heat-treated after fermentation

b. Renneted milk (plain)

3. Condensed milk and analogues (plain) (evaporated/reconstituted milk) a. Condensed milk (plain) b. Beverage whiteners

4. Cream (plain) and the likes (cream analogs) a. Pasteurized cream (plain) b. Sterilizeed and UHT creams, whipping and whipped creams, and reduced fat creams (plain) c. Clotted cream (plain) d. Cream analogues

5. Milk powder and cream powder and powder analogues (plain)

6. Cheese and analogs a. Unripened cheese b. Ripened cheese

1) Ripened cheese, includes rind 2) Rind of ripened cheese 3) Cheese powder (for reconstitution; e.g. for cheese sauces)

c. Whey cheese d. Processed cheese

1) Plain processed cheese 2) Flavored processed cheese, including those containing fruits, vegetables, meat, etc

e. Cheese analogues f. Whey protein cheese

7. Dairy-based desserts (e.g. pudding, fruit or flavored yoghurt) 8. Whey and whey products, excluding whey cheeses

a. Liquid whey and why products b. Dried whey and whey products

9. Milk for manufacture

10. Dairy-based frozen desserts (e.g. ice cream) B. PROCESSED FRUITS, VEGETABLES and EDIBLE FUNGI (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera) seaweeds, and nuts and seeds

1. Dried Fruits and vegetable – plain/ sun-dried (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera) seaweeds, and nuts and seeds

2. Canned or bottled (pasteurized) or retort pouch fruit and vegetable preserve in juice, syrup, brine 3. Fruit-based desserts, gelatin (including water-based fruit flavored desserts, i.e. gels) 4. Fermented fruit products 5. Fruit fillings for pastry

6. Fermented vegetable products (including mushrooms and fungi, roots and tubers, pulses and

legumes, and aloe vera) and seaweed products, excluding fermented soybean products MR/HR Letter E.1 and E.2 (fermented soybeans and fermented soybean curd) and LR Letters I.9.b. 1) to 3) (soybean sauces)

7. Vegetable protein products (canned and frozen)

8. Vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweed, and nut and seed – purees, spreads (e.g. peanut butter)

E. CEREAL-BASED PRODUCTS, derived from cereal grains, from roots and tubers, pulses, legumes and pith or soft core of palm tree – Soybean products

1. Fermented soybeans (e.g. natto, tempe) 2. Fermented Soybean curd

F. BAKERY WARES AND BAKERY RELATED PRODUCTS

1. Fine bakery products with fillings, icings, coatings 2. Frozen cakes, pastries and pies G. PROCESSED MEAT AND MEAT PRODUCTS, INCLUDING POULTRY AND GAME (to be included even if jurisdiction is with NMIS)

1. Processed meat, poultry and game products in whole or cuts a. Non-heat treated processed meat, poultry and game products (cured, fermented, chilled)

1) Cured (including salted) non-heat treated processed meat, poultry and game products 2) Cured (including salted) and dried non-heat treated processed meat, poultry and game

products 3) Fermented non-heat treated processed meat, poultry and game products

b. Heat-treated processed meat, poultry and game products (canned) c. Frozen processed meat, poultry and game products (marinated pork/ beef/ chicken cuts)

1. Processed comminuted meat, poultry and game products a. Non-heat treated processed meat, poultry and game products (cured, fermented, chilled)

1) Cured (including salted) non-heat treated processed meat, poultry and game products 2) Cured (including salted) and dried non-heat treated processed meat, poultry and game

products (jerky, shredded beef/ pork) 3) Fermented non-heat treated processed meat, poultry and game products

b. Heat-treated processed meat, poultry and game products (canned) c. Frozen processed meat, poultry and game products (nuggets, patties, dumplings, salami,

meat loaf, hotdog)

H. PROCESSED FISH AND FISH PRODUCTS, INCLUDING MOLLUSCS, CRUSTACEANS AND ECHINODERMS

1. Processed fish and fish products, including molluscs, crustaceans and echinoderms a. Frozen fish, fish fillets and fish products, including molluscs, crustaceans and echinoderms b. Frozen battered fish, fish fillets and fish products, including molluscs, crustaceans and

echinoderms; including value added products (battered, marinated, smoked, spiced, fish and squid balls preparations)

c. Frozen minced and creamed fish products, including molluscs, crustaceans and echinoderms d. Cooked and/or fried fish and fish products, including molluscs, crestaceans and echinoderms

1) Cooked fish and fish products 2) Cooked molluscs, crustaceans and echinoderms 3) Fried fish and fish products, including molluscs, crustaceans and echinoderms

e. Smoked, dried, fermented, and/or salted fish and fish products, including molluscs,

crustaceans and echinoderms

2. Semi-preserved fish and fish products, including molluscs, crustaceans and echinoderms a. Fish and fish products, including molluscs, crustaceans and echinoderms – marinated and/or

in jelly b. Fish and fish products, including molluscs, crustaceans and echinoderms – pickled and/or in

brine c. Salmon substitutes, caviar and other fish roe products d. Semi-preserved fish and fish products, including molluscs, crustaceans and echinoderms

(e.g. fish paste), excluding products under MR/HR Letter H.2.a to c above

3. Fully preserved, including canned or fermented fish and fish products, including molluscs, crustaceans and echinoderms

I. EGG AND EGG PRODUCTS

1. Egg products a. Liquid egg products b. Frozen egg products (e.g. frozen eggs, frozen egg whites, frozen egg yolks) c. Dried and/or heat coagulated egg products (e.g. dried eggs, dried egg whites, dried egg

yolks)

2. Preserved eggs, including alkaline, salted and canned eggs (salted eggs, century eggs) 3. Egg-based desserts (e.g. custard)

I. FOODSTUFFS INTENDED FOR PARTICULAR NUTRITIONAL USES

1. Infant formula, follow-on formula and formula for special medical purposes for infants 2. Complementary foods for infants and young children 3. Dietetic foods intended for special medical purposes (excluding products under MR/HR Letter

I.1) 4. Dietetic formula for slimming purposes and weight reduction 5. Dietetic foods (e.g. supplementary foods for dietary use) excluding products under MR/HR

Letter I.1 to 4 and Letter K, Food supplements) 6. Weaning foods for infants and growing children 7. Dietetic foods for special medical purpose 8. Dietetic formulas for weight control

J. BOTTLED WATER K. FOOD SUPPLEMENT/ HERBAL FOOD/ HERBAL DIETARY SUPPLEMENTS

1. Vitamins and minerals 2. Amino acids 3. Herbs and botanicals 4. Products with other nutritional substances

L. NOVEL / NEW INNOVATIONS in FOOD

- New in the international or local market - Energy drinks

ANNEX E

Requirements for Certificate of Product Registration INITIAL/ REGULAR RENEWAL

For Low Risk Category:

1. Completely filled up Assessment Slip 2. Application Letter with Product List for Locally manufactured products 3. A copy of valid FDA License to Operate (Source: FDA DATABASE) 4. Completely filled-up Product List 5. One sample in commercial presentation OR a digital image of the product and its packaging at least

1024 x 768 pixels in size, and in an FDA-approved file type 6. One (1) actual loose label attached in the documents (for locally manufactured)

OR a digital image of the product and its packaging at least 1024 x 768 pixels in size, and in an FDA-approved file type

7. For imported products: a. one (1) actual loose label attached in the documents with sticker reflecting the complete

name and address of the Importer OR a digital image of the product and its packaging at least 1024 x 768 pixels in size, and in an FDA-approved file type

b. Notarized Affidavit of Undertaking with product list for imported products

For Medium Risk, High Risk

1. Completely filled up Assessment Slip (for Food) 2. Application Letter 3. A copy of valid FDA License to Operate (Source: FDA DATABASE) 4. Product Information:

List of ingredients in decreasing order of proportion. For additives, with prescribed limit, the amount must be indicated

Safety certificate from flavor supplier Finished product specifications – Physical, Chemical and Microbiological

5. One (1) sample label in facsimile or commercial presentation 6. Labels and labeling materials used in the product (to be attached in the documents) 7. Estimated shelf-life, parameters used and methods for determining shelf life complete with the

following: a. Product name, Batch number, Production date and dates of analysis; b. Tabulated data and results in terms of physical, chemical and/or microbiological; c. Conclusion as to the shelf life of the product; d. Name and signature of the authorized technical personnel or FDA-accredited third party

laboratory analyst.

8. Science-based justification of label nutritional or functional claims (if applicable) 9. For imported products:

a. One (1) actual loose label attached in the documents with sticker reflecting the complete name and address of the Importer

b. Certificate of Analysis of the finished product from manufacturer OR recognized laboratory from country of origin OR Philippine FDA recognized laboratory. Indicate the analytical method used. Submit test results that are critical to the product

c. Flow diagram of method of manufacture, packaging and quality control from manufacturer or the exporting country

d. Packaging certification of suitability for food use from a foreign health regulatory agency

NOTE: All documents must be secured in blue folder according to the checklist of requirements and FDA-MC 2013-001-A. FOR FOOD SUPPLEMENT:

2. Completely filled up Assessment Slip (for Food); 3. A copy of valid FDA License to Operate ( Source: FDA DATABASE ) 4. Product Information:

a. List of ingredients in decreasing order of proportion. For additives, with prescribed limit, the amount must be indicated;

b. Safety certificate from flavor supplier. 5. One (1) sample label in facsimile or commercial presentation; 6. Estimated shelf life, parameters used and methods for determining shelf life complete with the

following: a. Product name, Batch number, Production date and dates of analysis; b. Tabulated data and results in terms of physical, chemical and/or microbiological; c. Conclusion as to the shelf life of the product; d. Name and signature of the authorized technical personnel or FDA-accredited third party

laboratory analyst. 7. Science-based justification of label claims (if applicable); 8. For imported products:

One (1) actual loose label attached in the documents with sticker reflecting the complete name and address of the Importer and Source/Manufacturer

For renewal application, copy of existing Certificate/s of Product Registration (CPR)

Additional requirements for Food Supplements may apply as necessary such as:

1. Technical specifications of an ingredient or ingredients 2. Computation of % RENI, elemental Content of Compounds, test results, and others as applicable 3. Test Results of Physical, chemical, microbiological, heavy metals, pesticide residues, MRL’s and

other contaminants and for nutrient analysis, etc. as applicable per product formulation depending on active or main ingredient, ..

4. Rationale 5. Scientific study 6. Pertinent regulations (local and international)—as part of the justification 7. Certificates (membership to an association, quarantine, free sale, etc.) 8. Other supporting documents 9. Vitamin/ Mineral Assay 10. Safety Data (toxicity study, LD50) 11. General Test for steroids and alkaloids 12. If applicable, test for the absence of synthetic substances such as:

Aspirin Paracetamol Dipyrone Phenylbutazone Pyrazolone Corticosteroid Anabolic Steroids Gonadal Hormone

Ephedrine & Pseudo-ephedrine Fenfluramine Phetatermine Methamphetamine Vitamin B Complex Pesticide Residue

ANNEX E-1 Assessment Slip

FOOD AND DRUG ADMINISTRATION CENTER FOR FOOD REGULATION AND RESEARCH C P R A S S E S S M E N T S L I P

FOOD

DATE: RSN:

Applicant Company : _______________________________________________________ Address/Tel no. : _______________________________________________________ LTO No./Validity : _______________________________________________________ Manufacturer Distributor/Wholesaler Importer Exporter Wholesaler PRODUCT INFORMATION

Brand name and Product Name : Product Classification (Category/Code) :

List of Products :

Number of Products Applied :

Packaging Types and Sizes :

Registration Number (FR) : __________________ Validity: ___________________________________

Applicant Company :

Manufacturer :

Repacker :

Distributor :

Others (Pls. specify) :

Number of Samples : __________________ Loose Labels:_______________________________APPLICATION DETAILS

Application Type Category I Category II Food

Supplement Bottled Water

Initial Renewal Renewal with Surcharge Re-application (OLD RSN:_______________) No. of CPR Validity Applied for (year/s)

OTHER REQUESTS

Amendment of CPR Provisional Permit to Market (PPM) Re-issuance/Reconstruction of CPR Export Certificate Referral to ACB Others, pls. specify

PAYMENT DETAILS

EVALUATOR CASHIER Fee : Amount :

Surcharge : OR Number :

TOTAL : Date Issued :

Evaluated by : Received by :

RECEIPT DETAILS

Name :

Signature : KJFSLFJASKFJALDFJLAFJLSKDJFLAKSJDFLJASKDFJALSD

FOOD AND DRUG ADMINISTRATION CENTER FOR FOOD REGULATION AND RESEARCH C P R A S S E S S M E N T S L I P

FOOD

DATE: RSN:

Applicant Company : _______________________________________________________ Address/Tel no. : _______________________________________________________ LTO No./Validity : _______________________________________________________ Manufacturer Distributor/Wholesaler Importer Exporter Wholesaler PRODUCT INFORMATION

Brand name and Product Name : Product Classification (Category/Code) :

List of Products :

Number of Products Applied :

Packaging Types and Sizes :

Registration Number (FR) : __________________ Validity: __________________________________

Applicant Company :

Manufacturer :

Repacker :

Distributor :

Others (Pls. specify) :

Number of Samples : __________________ Loose Labels:_______________________________ APPLICATION DETAILS

Application Type Category I Category II Food

Supplement Bottled Water

Initial Renewal Renewal with Surcharge Re-application (OLD RSN:_______________) No. of CPR Validity Applied for (year/s)

OTHER REQUESTS

Amendment of CPR Provisional Permit to Market (PPM) Re-issuance/Reconstruction of CPR Export Certificate Referral to ACB Others, pls. specify

PAYMENT DETAILS

EVALUATOR CASHIER Fee : Amount :

Surcharge : OR Number :

TOTAL : Date Issued :

Evaluated by : Received by :

RECEIPT DETAILS

Name :

Signature : KJFSLFJASKFJALDFJLAFJLSKDJFLAKSJDFLJASKDFJALSD

ANNEX E-2

Application Form for Product Registration

[[COMPANY LETTERHEAD]] The Director/OIC Center for Food Regulation and Research Food and Drug Administration Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City Sir/Madam: In accordance with R.A. 9711 and other related issuances, we (company name) _______, having LTO number ___ issued on ___ valid until ____, wish to apply for the registration of our product/s:

PRODUCT/S* TYPE OF REGISTRATION** INITIAL RE-APPLICATION RENEWAL *Provide additional row/s if more than one product is applied, **Check the type or registration if applied

Along with this application are the documents listed in the checklist of requirements for registration and the representative sample of our products. We categorically declare that all data and information submitted in connection with this application as well as other submission in the future are true and correct. We further agree and bind ourselves to all approved formulations, labeling, technical specifications, information or changes in this application. Any changes thereof in the approved formulation, labelling, technical specifications, or any deviations on any information given will first have to be cleared and approved by FDA. Date: ___________________ Company Name: _____________________________ By: ______________________________

Indicate Authority (e.g whether owner / proprietor / partner or duly authorized representative of the company)

PRODUCT INFORMATION

Company Name: _____________________________________________________________________________ Address: ____________________________________________________________________________________ Product Classification: _________________________________________________________________________

BRAND NAME

PRODUCT NAME

DESCRIPTION OF

PRODUCT

DESCRIPTION OF

PACKAGING

SUPPLIER NAME AND ADDRESS

MANUFACTURER DISTRIBUTOR

_______________________________ (Print Name over Signature)

ANNEX E-3

Undertaking

AFFIDAVIT OF UNDERTAKING ____________________________of legal age, ______________________________ (name of applicant) (position in the company) and/or duly authorized representative or _____________________________________ (name of company and address) _____________________________, after having sworn in accordance with law, hereby declare that:

1. The aforementioned company has imported food products from ________________________ : see attached product list (country of origin)

2. The applicant company has a valid License to Operate as an importer or manufacturer, with LTO no.____

3. The said products to be registered contain ingredients and additives that are permitted for use in human food and in accordance with relevant regulations issued by FDA.

4. As duly authorized person of ______________________________________, he (company name)

is responsible and accountable for the quality, safety and the truth in the labelling declaration of the said food product.

5. With regards to the labeling, he undertakes to indicate his company name and address by stick-on labelling or by other means of labeling of the products in market, for imported food products

6. He further undertakes to inform in writing and seek approval from the FDA when in case there are changes in any circumstances or specification, formulation, information labeling

7. He binds to all approved formulations, labeling, technical specifications, information or changes for this application. Any changes thereof in the approved formulation, labelling, technical specifications, or any deviations on any information given will first have to be cleared and approved by FDA. *changes in the formulation

8. He executed this affidavit to confirm the truth of the foregoing.

_____________________________at _________________________________ (Date) (Place of the Executor) _____________________________________ (Affiant) Subscribed and sworn to before me this ______day of _____________ issued on _________ at __________________ Notary Public

PRODUCT INFORMATION Company Name: _____________________________________________________________________________ Address: ____________________________________________________________________________________ Product Classification: _________________________________________________________________________

BRAND NAME

PRODUCT NAME

DESCRIPTION OF

PACKAGING

COUNTRY OF ORIGIN (for

imported products)

SUPPLIER NAME AND ADDRESS

MANUFACTURER DISTRIBUTOR

_______________________________ (Print Name over Signature)

ANNEX F

Requirements for Automatic Renewal of CPR

1. Notarized letter of application from manufacturer/importer/distributor indicating that there is no change in formulation, specification and labeling of the product;

2. Photocopy of valid License to Operate, reflecting the source(s) of the product;

3. Actual loose labels and labeling materials and/ a digital image in an FDA-approved format;

4. Original CPR for validation.

5. Compliance with FDA Memorandum Circular Nos. 2013-001 and 2013-001-A

ANNEX G

Requirements for Amendment of CPR

1. Letter requesting for the amendment of a valid unexpired CPR specifically reflecting the change requested;

2. Necessary documents to support the desired change (i.e., amended Articles of Incorporation; agreement with a third party like toll manufacturers, disengagement letter signed by all parties, etc.);

3. Payment of amendment fee;

4. Sample of Revised Label.

ANNEX H

AFFIDAVIT OF UNDERTAKING for RAW MATERIAL, INGREDIENT AND / OR FOOD ADDITIVE LISTING

____________________________of legal age, ______________________________ (name of applicant) (position in the company) and/or duly authorized representative or _____________________________________ (name of company and address) _____________________________, after having sworn in accordance with law, hereby declare that:

1. The aforementioned company will utilize in its manufacturing activities and/or import the raw materials, ingredients and/or food additives: see attached material list

2. The applicant company has a valid License to Operate as an importer / manufacturer, with LTO no.____

3. The said products are not adulterated or misbranded, and contain ingredients and additives that are permitted for use in human food and in accordance with relevant regulations issued by FDA

4. As duly authorized person of the ______________________________________ (company name)

he has undertaken to be responsible and accountable for the quality, safety and the truth in the labelling declaration of the said food product

5. Attached herewith are the Certificate of Analysis or Material Safety Data Sheet of the said raw materials, ingredients and/ or food additives

6. These Food Additives are listed in the Latest Codex General Standard for Food Additives and/or the Latest Phil FDA List of Food Additives

7. He furthermore understands and agrees that the products may be subjected to FDA laboratory examination at any time to verify the products safety, quality and conformity with labelling claims

8. He executed this affidavit to confirm the truth of the foregoing.

_____________________________at _________________________________ (Date) (Place of the Executor) _____________________________________ (Affiant) Subscribed and sworn to before me this ______day of _____________ issued on _________ at __________________ Notary Public

MATERIAL LIST Company Name: _____________________________________________________________________________ Address: ____________________________________________________________________________________ Product Classification: _________________________________________________________________________

PRODUCT NAME

DESCRIPTION OF

MATERIAL

DESCRIPTION OF

PACKAGING

COUNTRY OF

ORIGIN

SUPPLIER NAME AND ADDRESS

MANUFACTURER DISTRIBUTOR

_______________________________ (Print Name over Signature