list of annexes - Food and Drug Administration Philippines

Transcription

Annexes to the Draft AO on Food Licensing and Registration
30 October 2013
LIST OF ANNEXES
A
Classification of Processed Food Products
B
Checklist of Requirements for Initial Application for a License to Operate as
Food Establishment
C
Requirements for Automatic Renewal of LTO
D
Requirements for Amendment of LTO
E
Application and Order of Payment Form for Initial LTO Application
F
Requirements for Application for Certificate of Product Registration (CPR)
G
Requirements for Amendment in CPR
H
Application and Order of Payment Form for CPR
I
Summary of Current Food Standards
19
ANNEX A
Classification of Processed Food Products
The following list, but not limited to, shows food products identified by FDA based from
CODEX GSFA and FAO Risk Categories:
A.
LOW RISK FOODS
Low Risk (LR) Foods – Foods that are unlikely to contain pathogenic
microorganisms and will not normally support their growth because of food
characteristics and foods that are unlikely to contain harmful chemicals.
Table 1. List of Low Risk Food Products
LOW RISK FOOD PRODUCTS
A. FATS, OILS AND FAT EMULSIONS
1.
2.
3.
4.
5.
6.
Butter oil, anhydrous milkfat, ghee
Vegetable oils and fats
Animal fats (lard, tallow, fish oil and other animal fats)
Fat emulsions mainly of type oil-in-water, including mixed and/or flavored products based on fat emulsion
Fat emulsions mainly of type water-in-oil (butter, fat spreads, margarine dairy fat spreads and blended
spreads)
Fat-based desserts excluding dairy-based desserts
B. 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.
2.
3.
4.
5.
6.
7.
8.
Dehydrated fruits or vegetables, including candied fruits (mechanically dried)
Jams, jellies, marmalades (pastry, topping, filling, coconut spreads)
Dehydrated Vegetable protein products
Fruits or vegetables in vinegar, oil or brine
Fruit-based spreads (e.g. chutney) excluding jams, jellies and marmalades
Fruit preparations, including pulp, purees, fruit toppings and coconut milk
Cooked fruits
Frozen vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera)
seaweeds, and nuts and seeds
9. Vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera),
seaweed, and nut and seedin pulps and preparations (e.g. vegetable desserts and sauces, candied
vegetables) other than food in HR Letter B.8 (Vegetable purees, spreads – peanut butter)
10. Cooked or fried vegetables(including mushrooms and fungi, roots and tubers, pulses and legumes, and
aloe vera), and seaweeds
C. CONFECTIONERY
1.
Confectionery including hard and soft candy, nougats, marzipans, etc. other than in MR (cocoa products
and chocolate products)
2. Chewing gum
3. Decorations (e.g. for fine bakery wares, sugar flowers), toppings (non-fruit), and sweet sauces
D. 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 F below
1.
2.
3.
Flours, starches (including soybean powder) and flour mixes
Breakfast cereals including rolled oats
Pasta and noodles and like products (e.g. rice paper, rice vermicelli, soybean pastas and noodles)
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4.
5.
6.
7.
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
Cereal and starch based desserts (e.g. rice pudding, tapioca pudding, native delicacies)
Batters (e.g. for breading or batters for fish or poultry)
Pre-cooked or processed rice products, including rice cakes (Oriental type only)
Soybean products (excluding soybean-based seasonings and condiments under LR Letter I (seasonings,
condiments and sauces)
a. Soybean-based beverages
b. Soybean-based film
c. Soybean curd (tofu)
d. Semi-dehydrated soybean curd
1) Thick gravy-stewed semi-dehydrated soybean curd
2) Deep fried semi-dehydrated soybean curd
3) Semi-dehydrated soybean curd, other than in LRD.7.d.1) and 7.d.2)
e. Dehydrated soybean curd (kori tofu)
f. Other soybean protein products
E. PROCESSED MEAT AND MEAT PRODUCTS, INCLUDING POULTRY AND GAME
Edible casings (e.g. sausage casings)
F. 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
Mixes for fine bakery wares (e.g. cakes, pancakes)
G. 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
1) Dried glucose syrup used to manufacture sugar confectionery
2) Glucose syrup used to manufacture sugar confectionery
d. Lactose
e. Plantation or mill white sugar
2.
3.
Brown sugar excluding products under LRG.1.c (soft white sugar, etc.)
Sugar solutions and syrups, also (partially) inverted, including treacle and molasses, excluding products
under G.1.c(soft white sugar, etc.)
Other sugars and syrups (e.g. xylose, maple syrup, sugar toppings), including coconut sugar
Honey
Table-top sweeteners, including those containing high-intensity sweeteners
4.
5.
6.
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I. SALT, SPICES, SOUPS, SAUCES, SALADS AND PROTEIN PRODUCTS
J.
1.
2.
3.
4.
5.
Salt and salt substitutes
Herbs, spices, seasonings and condiments (e.g. seasoning for instant noodles)
Vinegars
Mustards
Soups and broths
Mixes for soups and broths
6.
Sauces and like products
a. Mixes for sauces and gravies
b. Clear sauces (fish sauce)
7.
Yeast and like products
8.
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
9.
Protein products other than from soybeans, marinades
BEVERAGES, excluding dairy products
1. Non-alcoholic (“soft”) beverages
Coffee, coffee substitutes, tea, herbal infusions, and other hot cereal and grain beverages
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.
2.
3.
Snacks – potato-, cereal- or starch-based (from roots and tubers, pulses and legumes), including chips and
crunchies
Chicharon
Snacks – fish-based
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B.
MEDIUM RISK FOODS
Medium Risk (MR) Foods – Foods that may contain pathogenic micro-organisms but will
not normally support their growth because of food characteristics; or food that is unlikely to
contain pathogenic micro-organisms because of food type or processing, but may support the
formation of toxins or the growth of pathogenic micro-organisms.
Table 2. List of Medium Risk Food Products
MEDIUM RISK FOOD PRODUCTS
A. DAIRY PRODUCTS and ANALOGUES, excluding products under Fats, Oils and Fat Emulsions
1.
Condensed milk and analogues (plain) (evaporated/reconstituted milk)
a. Condensed milk (plain)
b. Beverage whiteners
2.
Milk powder and cream powder and powder analogues (plain)
B. FROZEN DESSERTS
1.
2.
Non-Dairy based (e.g. sherbet, sorbet)
Edible ices – popsicles
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.
2.
3.
4.
5.
6.
7.
8.
Tomato products
Frozen fruits
Canned or bottled (pasteurized) or retort pouch fruit and vegetable preserve in juice, syrup, brine
Fruit-based desserts, gelatin (including water-based fruit flavored desserts, i.e. gels)
Fermented fruit products
Fruit fillings for pastry
Fermented vegetable products (including mushrooms and fungi, roots and tubers, pulses and legumes, and
aloe vera) and seaweed products, excluding fermented soybean products MR Letter E.1 and E.2 (fermented
soybeans and fermented soybean curd) and LR Letters I.8.b. 1) to 3) (soybean sauces)
Vegetable protein products (canned and frozen)
D. CONFECTIONERY
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
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.
2.
Fermented soybeans (e.g. natto, tempe)
Fermented Soybean curd
F. PROCESSED MEAT AND MEAT PRODUCTS, INCLUDING POULTRY AND GAME
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
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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
2.
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
H. PROCESSED FISH AND FISH PRODUCTS, INCLUDING MOLLUSCS, CRUSTACEANS AND
ECHINODERMS
1.
Processed fish and fish products, including molluscs, crustaceans and echinoderms
a. 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 Letter H.2.a to c above
I. EGG AND EGG PRODUCTS
1.
2.
Preserved eggs, including alkaline, salted and canned eggs (salted eggs, century eggs)
Egg-based desserts (e.g. custard)
J. BAKERY WARES AND BAKERY RELATED PRODUCTS
Fine bakery wares (sweet, salty or savory) and mixes
a. Cakes, cookies, pies, pastries, doughnuts, sweet rolls, scones, muffins, waffles – plain / without filling
b. Frozen dough
K. SALT, SPICES, SOUPS, SAUCES, SALADS AND PROTEIN PRODUCTS
1. Soups and broths
Ready-to-eat soups and broths, including canned, bottled and frozen
2.
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)
3.
Salads (e.g. macaroni salad, potato salad) and sandwich spreads excluding cocoa- and nut-based, spreads
under HR Letter B.8 (peanut butter) and MR D.1.c (cocoa-based spreads)
L. 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. Powdered cocoa drink mixes (cocoa)
24
M. FOOD SUPPLEMENT/ HERBAL FOOD/ HERBAL DIETARY SUPPLEMENTS
1.
2.
Vitamins and minerals
Amino acids
N. READY-TO-EAT SAVOURIES
Processed nuts, including coated nuts and nut mixtures (with e.g. dried fruits)
C. HIGH RISK FOOD
High Risk (HR) Food – foods that may contain pathogenic microorganisms and will support
the formation of toxins or the growth of pathogenic microorganisms and foods that may
contain harmful chemicals.
Table 3. List of High Risk Food Products
HIGH RISK 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 HR A.1.b
a. Fermented milks (plain)
1) Fermented milk (plain), not heat-treated after fermentation
2) Fermented milks (plain), heat-treated after fermentation
b. Renneted milk (plain)
3.
Cream (plain) and the likes (cream analogs)
a. Pasteurized cream (plain)
b. Sterilized and UHT creams, whipping and whipped creams, and reduced fat creams (plain)
c. Clotted cream (plain)
d. Cream analogues
4.
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
5.
6.
Dairy-based desserts (e.g. pudding, fruit or flavored yoghurt)
Whey and whey products, excluding whey cheeses
a. Liquid whey and why products
25
b.
Dried whey and whey products
7.
Milk for manufacture
8.
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.
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)
D. CONFECTIONERY
Chocolate with nuts
F. BAKERY WARES AND BAKERY RELATED PRODUCTS
1.
2.
Fine bakery products with fillings: meat, milk, poultry, cream, other perishable foods; icings; and coatings
Cookies with nuts
G. PROCESSED MEAT AND MEAT PRODUCTS, INCLUDING POULTRY AND GAME
1.
Processed meat, poultry and game products in whole or cuts
a. Heat-treated processed meat, poultry and game products (canned)
b. Frozen processed meat, poultry and game products (marinated pork/ beef/ chicken cuts)
2. Processed comminuted meat, poultry and game products
a. Heat-treated processed meat, poultry and game products (canned)
b. 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
2.
Fully preserved, including canned or fermented fish and fish products, including molluscs, crustaceans and
echinoderms
I. EGG AND EGG PRODUCTS
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)
26
J. FOODSTUFFS INTENDED FOR PARTICULAR NUTRITIONAL USES
1.
2.
3.
4.
5.
6.
7.
8.
Infant formula, follow-on formula and formula for special medical purposes for infants
Complementary foods for infants and young children
Dietetic foods intended for special medical purposes (excluding products under HR Letter J.1)
Dietetic formula for slimming purposes and weight reduction
Dietetic foods (e.g. supplementary foods for dietary use) excluding products under HR Letter J.1 to 4 and
Letter K, Food supplements)
Weaning foods for infants and growing children
Dietetic foods for special medical purpose
Dietetic formulas for weight control
J. BOTTLED WATER
K. FOOD SUPPLEMENT/ HERBAL FOOD/ HERBAL DIETARY SUPPLEMENTS
1.
2.
L.
Herbs and botanicals
Products with other nutritional substances
NOVEL / NEW INNOVATIONS in FOOD
New in the international or local market
*As listed in the latest Codex General Standard for Food Additives (GSFA)
27
ANNEX B
Checklist of Requirements for Initial Application for a License to Operate as Food
Establishment
I. GENERAL REQUIREMENTS
1. Notarized Accomplished Petition Form with ID picture (size: 2x2 inch) of petitioner
Note:
a. Notarized Certificate authorizing the person who signed in behalf of the establishment/
company, if he/she is not the Owner
b. If Corporation, the petitioner should be one of the Incorporators. If he/she is not one of
the incorporator, copy of Secretary Certificate/ Board Resolution/ Authorization Letter/
Special Power of Attorney must be submitted
2. Photocopy of Notarized Fixed Asset & Operating Capital or Financial Statement, whichever
is applicable (For Manufacturer).
1.
3. Photocopy of Business Name Registration (as applicable)
a. Securities and Exchange Commission and Articles of Incorporation (for
corporation/partnership)
b. Department of Trade and Industry (for single proprietorship)
c. Cooperative Development Authority (for cooperative)
Note:
 If the registered address with DTI/SEC is different from the address of the
establishment to be licensed, submit a photocopy of the Business/Mayor’s
Permit.
 If the establishment adopts another business name/style different from the
corporation name, the business/trade name shall be indicated in the SEC
registration certificate.
d. Law or chartered establishments
4. Proof of Occupancy (for Office and Warehouse)
a. Notarized valid
2. Contract of Lease of the space/building occupied if the space/building is
not owned.
b. Copy of Transfer
3.
Certificate of Title (TCT) if owned.
c. Valid notarized
4. warehousing agreement (3rd party logistics)
5. Location Map (indicate location, landmarks, immediate environment, type of building)
6. List of food products to be manufactured/repacked/distributed
28
II. SPECIFIC REQUIREMENTS
A. FOOD MANUFACTURER/FOOD REPACKER
1. Flowchart and detailed description of manufacturing process with emphasis on
identification of quality control points
2. Quality control procedures / sanitation standard operating procedures enforced in the plant:
3.1 Working Area 3.3
Personnel
3.2 Equipment
3.4
Pest Control Program
3. Product Description (e.g. list of Ingredients, physico-chemical and/or microbiological
specifications)
4. Photocopy of notarized valid contract/ agreement with the manufacturer (for Food Repacker
only)
5. Photocopy of the License to Operate (LTO) of the Manufacturer/Source (for Food Repacker
only)
Note:
For the initial requirements for bottled water processor, refer to A.O 18-A s. 1993.
6. Facsimile of proposed label in compliance with latest mandatory labeling requirements
B. FOOD IMPORTER OF RAW MATERIALS IN BULK for
manufacturing/repacking/further processing OR FINISHED PRODUCTS
1. Any one of the following:
 Proforma Invoice
 Foreign Agency Agreement
 Appointment Letter
 Distributorship Agreement
2. Any one of the following documents for the status of Manufacturer issued by the
Regulatory/ Health Authority from the country of origin (scanned original copy):
 Valid Certificate of Registration of Manufacturer and its conformity with GMP from
Regulatory/ Health Authority or its equivalent
 Valid Phytosanitary Certificate/Health Certificate
 Valid ISO 22000 Certification
 Valid HACCP Certificate as applicable
Note:
Certification issued by private organization should be attested by a recognized association.
3. Certificate of Analysis (COA) for specific products in Annex J, Summary of Food
Standards and current FDA issuance on Microbiological Standards for Food
C. DISTRIBUTOR EXPORTER
1. Valid notarized Distributorship Agreement or Letter of Appointment with FDA licensed
Supplier/ Manufacturer to distribute their products outside the Philippines
2. Copy of valid CPR/CPR
29
E. DISTRIBUTOR WHOLESALER
For Locally Procured Raw Materials in Bulk and Finished Products
1. Valid notarized Distributorship Agreement or Letter of Appointment with FDA licensed
Supplier/ Manufacturer to distribute their products within the Philippines
2. Copy of valid CPR/CPR
F. FOOD TRADER
1. Valid License to Operate (LTO) of Manufacturer and/or Repacker (tolling/ repacking
activity, client, and specific product classification should be indicated in the LTO)
2. Valid notarized Toll Manufacturing and/or Repacking Agreement with FDA licensed Toll
Manufacturer and/or Repacker
III. ADDITIONAL REQUIREMENTS – as applicable
1. For Salt Importer
For Distribution (Iodized Salt) – Certificate of Analysis for the presence of iodine
conducted by the Manufacturer/Supplier in conformance with RA 8172 (ASIN Law)
For Iodization – Valid LTO of the Manufacturer and notarized Memorandum of Agreement
(MOA) with FDA-licensed Manufacturer
2. For Staple Products (Wheat Flour, Cooking Oil and Rice Premixes) Importer
For Distribution – Certificate of Analysis for the presence of fortificant (vitamin A and/or
Iron), conducted by the Manufacturer/Supplier in conformance with RA 8976 (Phil. Food
Fortification Act)
For Fortification – Valid LTO of the Manufacturer and notarized Memorandum of
Agreement (MOA) with FDA-licensed Manufacturer
30
ANNEX C
Requirements for Automatic Renewal of LTO
1. Affidavit of Undertaking for Automatic Renewal
2. Automatic Renewal Assessment Form
3. Official Receipt
31
ANNEX D
Requirements for Amendment of LTO
CHANGE OF BUSINESS NAME
1.
Notarized accomplished Amendment Application Form with ID picture of the
owner/authorized representative
2. Photocopy of Business Name Registration OR a digital image of the document in an FDAapproved 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
3. Surrender original License to Operate (LTO)
CHANGE OF OWNERSHIP
1.
2.
3.
4.
5.
6.
7.
Notarized accomplished Petition Form with ID picture of the owner / authorized
representative
Photocopy of Business Name Registration
a. For single proprietorship registration from the Department of Trade & Industry (DTI)
(SEC)
establishment
Photocopy of Contract / Agreement with Manufacturer reflecting the new owner
Photocopy of Deed of Sale / Transfer of Rights
Photocopy of Dissolution Papers from SEC (for corporation/partnership)
Photocopy of Financial Statement duly notarized or received by Bureau of Internal
Revenue (BIR)
Surrender original License to Operate (LTO)
ADDITION OR DELETION OF ACTIVITIES/ CLASSIFICATION/ SOURCES/ PRODUCTS
1.
2.
3.
4.
Notarized accomplished Amendment Application Form
List of Activities/ products with the corresponding process flow, revised plant layout and
results of analysis in case of additional products
List of new sources
Specific sources or products to be deleted
CHANGES IN THE EXISTING OR OPENING OR CLOSURE OF WAREHOUSE/ OFFICE/
BRANCH
1. Notarized accomplished Amendment Application Form with ID picture of the owner /
32
2.
4.
authorized representative
Photocopy of Business Name Registration under new address
b. For single proprietorship registration from the Department of Trade & Industry (DTI)
(SEC)
establishment
Photocopy of Contract / Agreement with Manufacturer reflecting the new owner
33
ANNEX E
Application and Order of Payment Form for Initial LTO Application
34
ANNEX F
Requirements for Application for Certificate of Product Registration
Duly accomplished Product Information Sheet via online containing pertinent information
about the company and complete information about the product.
a) Notarized application letter with Affidavit of Undertaking
b) Copy of valid License to Operate with list of products and list of sources (it
should be clear that the list of sources would include the manufacturer and the
list of products would mean same process design if different flavors – can be
included in the database so as not to crowd the LTO)
c) Clear and complete loose labels of all packaging labels
d) Picture of the products (all sides, all packaging sizes as applicable)
e) Justification of label claims, as applicable
 Certificate of Analysis
 Computation
 Certification to support declaration (i.e. Halal, Organic, Kosher logos)
 Clinical/Scientific studies (validated, peer-reviewed and published in
scientific journal/s to support claims)
 Safety studies/scientific data literature
Note:
Requirements b, c, d, and e could just be uploaded
35
TEMPLATE
Application Letter for Product Registration of Food Product/Raw Material/
Ingredient/ Food Additive
[[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 the following raw material/s, ingredients and food additives:
PRODUCT/S*
TYPE OF REGISTRATION*
INITIAL
RE-APPLICATION
RENEWAL
*Check the type or registration if applied
Along with this application is the Affidavit of Undertaking, copy of our valid LTO.
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 bind ourselves to all safety and quality issues that may arise from these
products.
Date: ___________________
Company Name:
_____________________________
By:
______________________________
Indicate Authority
(e.g whether owner / proprietor / partner or duly
authorized representative of the company)
36
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 will import/ manufacture the food product/raw
material/ ingredient/ food additives to be supplied, distributed and offered for sale to
food establishments, food manufacturers, food processors or customers with the
following details on Product Information:
Product Information
Brand Name – if applicable
____________________________________________________________________
Product Name
____________________________________________________________________
Complete Company Name and address – as listed in the LTO
_____________________________________________________________________
Contact Number(s)
____________________________________________________________________
E-mail address:
____________________________________________________________________
Country of origin (if imported)
____________________________________________________________________
Complete Name and Address of the Supplier (if not directly sourced from the manufacturer)
_____________________________________________________________________
Complete Name and Address of Manufacturer (if imported)
____________________________________________________________________
Ingredients list:(list all specific name of the ingredients in descending order) – if applicable
1.
2.
3.
PRODUCT SPECIFICATIONS:
Physical description:
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
Chemical and/or Microbiological specifications:
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
Shelf life declaration (indicate if actual or accelerated)
37
____________________________________________________________________
Packaging material type/ name and Description of Product as Packed :
____________________________________________________________________
Storage condition requirement:
_____________________________________________________________________
Food application (e.g preservative, nutrient, emulsifier, bakery ingredient) – function of the
food material
_____________________________________________________________________
Usage: (especially for food additives with limits) – if applicable
_____________________________________________________________________
Source of allergen / ingredient allergen (if any):
____________________________________________________________________
Lot Code and Interpretation:
____________________________________________________________________
Open Date Marking (e.g. Date of Manufacture, Expiration Date) – if applicable:
____________________________________________________________________
2. The applicant company has a valid License to Operate as an importer / distributor or
manufacturer, with LTO No.____ and valid until __________________
3. The said product is not adulterated or misbranded, and contain ingredients and
additives that are permitted for use in human food and in accordance with applicable
standards, rules and regulations issued by the FDA.
4. As duly authorized person of the ____________________________________
(company name)
the undersigned has undertaken to be responsible and accountable for the quality,
safety of the said food material and shall promptly inform the FDA on any quality or
safety issue and concern, including results of laboratory analysis or decision to
voluntarily recall or withdraw the product.
5. For the Food Additives, these are listed in the Latest Codex General Standard for
Food Additives and/or the Latest Philippine FDA List of Food Additives or other
standards recognized by the FDA.
6. He furthermore agrees to post-market surveillance, including inspection of
establishment, collection of product samples and laboratory examination.
7. He executed this affidavit to confirm the truth of the foregoing.
_____________________________at _____________________________________
(Date)
(Place of the Executor)
___________________________
(Affiant)
Valid Government-issued Identification No.
Place and Date Issued
Subscribed and sworn to before me this ______day of _____________ issued on
_________ at __________________
Notary Public
38
ANNEX G
Requirements for Amendment in CPR
General Requirements:
1. Application and Order of Payment Form
2. Original Certificate of Product Registration (CPR)
3. Old labeling materials
Additional Requirements:
Change in Brand Name
 Authority from the source or the owner of the brand (if imported)
 IPO registration, if available
 New labeling materials
Change in product description
 Technical justification of the proposed change
 Proposed label
Change in Packaging Material
 Sworn Statement of no changes in formulation
 Justification for the Change
 Stability data of the product in the new packaging
 Suitability of packaging material to the product
Change in Business Name
 LTO indicating change in business name
 New labeling materials reflecting the new business name
Change in Importer/Distributor
 Termination of agreement/ Deed of assignment
 Agreement of new manufacturer/ importer/ distributor or Appointment letter
 Copy of LTO and its attachments (reflecting pertinent changes)
Change in address of establishment based on zoning
 LTO indicating the change in address
 New labeling materials reflecting the new address
Change/Additional Packaging Size
Extension of Shelf-life (for Food Supplements)
 Stability data/ studies to support extension of shelf life
Change in Packaging Design (for Food Supplements)
39
Annex H
Application and Order of Payment Form for CPR
40
Annex I
Summary of Current Food Standards
MINIMUM REQUIREMENT FOR ANALYSIS OF FINISHED PRODUCT
PROCESSED FOOD
1. Beverages
a) Alcoholic
ANALYSIS REQUIRED
Alcoholic Content (%)
Spirit/Liquor
% alcohol = 40% min.
Fruit Wines(not under Tropical Fruit wines)
% alcohol = label claim
Presence of methanol
Methanol may be present in
alcoholicbeverages provided that it
shall bederived from the natural
alcoholfermentation process and
not added.
Color (CoA from supplier)
Preservative:
Sodium Benzoate
Vit. C (if enriched)
GMP
(MC No. 13 s. 1989)
(PLEASE SEE ALSO
SPECIFIC STANDARDS
FOR TROPICAL FRUIT
WINES (PNS/FDA
30:2010); COCONUT
LAMBANOG (PNS/BAFPS
47:2011; and Standard
Administrative Orders for
DISTILLED SPIRITS, #51,
page 24)
b) Non-alcoholic
Fruit Flavored
Juice Drink
Concentrate
Tonic Drink
STANDARDS
0.1%, maximum
12mg/100 ml, minimum
c) Wines
(Standards
Administrative Order
No. 357 s. 1978)
Alcohol Content (%), as ethyl
alcohol:
Dry or semi-dry or sweet wine 7 to 16
Fortified wine
18 to 22
Total Acidity, as tartaric acid,
g/100ml
Volatile Acids, as acetic acid,
g/100ml
Reducing Sugar, % by weight
2. Bagoong
(AO No. 128 s. 1970)
(Fish & Shrimp)
0.4 to 1.5
0.08 to 0.12
0.1 to 9.6
Fish Bagoong:
Total Solids
Protein
NaCl
40%, minimum
12.5%, minimum
20 to 25%
Shrimp Bagoong:
Total Solids
Protein
NaCl
35%, minimum
10%, minimum
20 to 25%
41
PROCESSED FOOD
3. Patis
Total Solids
pH
Titratable Acidity as acetic acid
Color(CoA from supplier)
Na Benzoate (if added)
STANDARDS
32%, minimum
20 to 25%
8% (min. for special-domestic, export)
4.5% (min. for regular-domestic)
6% (min. regular for export)
25%, minimum
4, maximum
0.7 – 1.2%
GMP
0.1%, maximum
Total soluble solids
Titratable Acidity as acetic acid
25%, minimum
1.2%, minimum
GMP
Aflatoxin
Fat content
20 ppb, maximum
55%, maximum
(AO No. 232 s. 1974)
Fat
Moisture
Sodium benzoate (if added)
80%, minimum
16.5%, maximum
0.1% (by weight of product)
8. Mayonnaise
Fat
65%, minimum
(AO No. 154 s. 1971)
Nitrate
Nitrite
GMP
500 ppm, maximum
200 ppm, maximum
10. Noodles, Sago
Borax
Negative
11. Snack Foods
Aflatoxin (corn based)
GMP
20 ppb, maximum
12. Vinegar
(AO No. 134 s. 1970)
Acidity
Permanganate Oxidation No.
(Glacial acetic acid)
4%, minimum
2, minimum
(prohibited use in/as vinegar)
(AO No. 325 s. 1977)
4. Banana Sauce
(AO No. 123-A s. 1985)
5. Tomato Catsup
(AO No. 233 s. 1974)
6. Peanut Butter
(AO No. 228 s. 1974)
and other
peanut products
7. Margarine
ANALYSIS REQUIRED
Total Solids
NaCl
Protein
(AO No. 235 s. 1975)
9. Meat & Meat
Products
(MO No. 1 1985)
13. Coffee
(AO No. 136-A & 136-B s.
1985)
Caffeine
Instant
Soluble with added carbohydrates
Decaffeinated
Moisture
Ash
Instant and Decaffeinated
Soluble
Water-insoluble solids
2 to 6%
1.3%, minimum
0.3%, maximum
6%, maximum
6 to 15%
4 to 15 %
42
PROCESSED FOOD
ANALYSIS REQUIRED
Instant and Decaffeinated
Soluble
pH
Arsenic
Lead
14. Honey
(BAFPS PNS)
15. Soy Sauce
Glucose
Sucrose
Micro: E. coli; Y&M
60%, minimum
10%, maximum
Total Nitrogen(BAFPS PNS)
3 MCPD(3-monochloropropane1,2-diol)(MC 4 s. 2002)
0.4%, minimum
1 ppm, maximum
PNS 274:1993 (DTI-BPS)
pH
%Salt, as NaCl
%Total Solids (excluding NaCl), min
%Total Nitrogen, minimum
%Amino Nitrogen, minimum
Total Halophilic Yeast Count,
cfu/mL, maximum
16. Fats & Oils
Lard
STANDARDS
0.5%, maximum
1.5%, maximum
4.7 to 5.5
0.1 ppm, maximum
0.3 ppm, maximum
Fermented
0.6
0.20
Hydrolyzed
4.3 to 5.0
15 to 25
5
0.4
0.14
20
Blend
0.6
0.20
Saponification number
Iodine number
192 – 198
52 - 65
Edible oil
Safonification number
Iodine Number
Free Fatty Acids
constant value for specific oil
17. Jams and
Jellies
Soluble Solids
Sodium Benzoate
65%, minimum
0.1%, maximum
(AO No. 239 s. 1975)
(if utilized, the limit is as indicated)
18. Taho, Tofu,
Tokwa
19. Milk & Dairy Products
CaSO4 (raw material)
Food grade
pH
Protein
Fat
Milk Solids
Milk Fat
Moisture
6.0, minimum
26 to 28%
28%
95%, minimum
26%, minimum
5%, maximum
(AO No. 231 s. 1974)
(AO No. 132 s. 1970)
a) Milk Powder,
Whole Milk Powder
Full Cream Milk
43
PROCESSED FOOD
b) Non-fat Milk
Powder, Skim Milk
Powder
pH
Protein
Fat
Solids
Moisture
STANDARDS
6.0, minimum
35%, minimum
4.5%, maximum
95%, minimum
5%, maximum
c) Skim Milk or
Skimmed Milk
Milk Fat
Milk Solids-not-fat
0.5%
8.5%, minimum
d) Party Skimmed
Milk Powder
Milk Solids
Milk Fat
Moisture
95%, minimum
1.5% to 26%
5%, maximum
e) Buttermilk
Milk Solids-not-fat
8.5%, minimum
f) Buttermilk Powder
Butterfat
Total Milk Solids
Moisture
4.5%, minimum
95%, minimum
5%, minimum
g) Butter
Milk Fat
Milk Solids-not-fat
Moisture
80%, minimum
2%, maximum
16%, minimum
h) Low-fat Milk
Milk Fat
0.5% to 2%
i) Sweetened
Condensed Milk
(Whole, Full
Cream)
Total Milk Solids
Milk Fat
28%, minimum
8.5%, minimum
j) Evaporated
Skimmed Milk,
Unsweetened
Condensed
Skimmed Milk
Milk Solids
20%, minimum
k) Sweetened
Condensed
Skimmed Milk
Milk Solids
24%, minimum
l) Flavored Milk
Drink
pH
6.0, minimum
GMP
Butterfat
18%, minimum
pH
Butterfat
6.0, minimum
18 to 30%
FOR CREAMS:
a) Cream
b) Light Cream
ANALYSIS REQUIRED
44
PROCESSED FOOD
c) Whipping Cream
ANALYSIS REQUIRED
Milk Fat
STANDARDS
30%, minimum
d) Light Whipping
pH
Butterfat
6.0, minimum
30 to 36%
e) Heavy Cream
pH
Butterfat
6.0, minimum
36%. minimum
Total Oil
Non-fat Milk Solids (means the
product resulting from fluid
skimmed milk from which a
considerable portion of water has
been removed)
3%, minimum
8.5%, minimum
b) Evaporated Filled
Milk, Unsweetened
Condensed Milk
Total Oil
Non-fat Milk Solids
6%, minimum
20%, minimum
c) Sweetened
Condensed Filled
Milk
20. Dried Fruits and
Vegetables
21. Herbal Food Products
Food Supplements
Ready-to-drink
Total Oil
Non-fat Milk Solids
7%, minimum
22%, minimum
Sodium metabisulfite
200 ppm, maximum
FOR FILLED MILK:
a) Filled Milk
Sodium Benzoate
GMP
Pesticide residue**
shall conform to the limits as defined
in FAO/WHO Codex Alimentarius
(if applicable or when plant source is
exposed to pesticides)
For Dried plants
(limits for adults)
For untreated plant
materials harvested
under acceptable
hygienic conditions
intended for further
processing
0.1%, maximum
Total Aflatoxin**
Aflatoxin B1**
20 ppb
10 ppb by ELISA or Liq Chrom
Heavy metals:**
Lead (Pb)
Cadmium
Arsenic
Mercury
10 ppm, maximum
0.3 ppm, maximum
0.3 ppm, maximum
0.5 ppm, maximum
Microbiological Limits:**
Escherichia coli, cfu/g
Mould propagules, cfu/g
Staphylococcus, cfu/g
Negative
105, maximum
Negative
45
PROCESSED FOOD
Plant materials that
will undergo pretreatment (e.g. with
boiling water as
used for herbal teas
and infusions)
ANALYSIS REQUIRED
Microbiological Limits:**
Aerobic bacteria, cfu/g or mL
Yeasts & molds, cfu/g or mL
Escherichia coli, cfu/g or mL
Salmonella spp./ 25g
Staphylococcus aureus, cfu/g
Other Enterobacteriaceae, cfu/g
STANDARDS
10 , maximum
104, maximum
Negative
Negative
Negative
104, maximum
7
* For Food Supplement s with chemical components such as vitamins and minerals, heavy metals
analyses are not required.
** Reference: AO 184 s. 2004 – Guidelines on Registration of Traditionally-Used Herbal Products
PROCESSED FOOD
22. Cheese
ANALYSIS REQUIRED
(AO No. 200-A s. 1973)
23. Squid ball
Fishball
STANDARDS
a) Cheddar
b) Pasteurized Process (PP) Cheese
c) PP Cheese Food
d) PP Cheese Spread
e) Cream Cheese
f) Cottage Cheese
g) Low Fat Cottage Cheese
Fat (min.)
Dry basis
50%
47%
23%
20%
33%
4%
0.5to 2%
Borax
Negative
Moisture (max.)
39%
43%
44%
55%
55%
80%
82.5%
24. Bottled Water
(AO 18-A s. 1993)
Source Water
Source Water OR
Finished Product
Microbiological Parameters:
Coliform Count
MPN<2.2/100 ml
Provided that no sample shall
contain MPN of 9.2/100 ml
Heterotrophic Plate Count
300 cfu/ml, maximum
Toxic Contaminants:
Arsenic (As)
Cadmium (Cd)
Cyanide
Chromium (Cr)
Lead (Pb)
Mercury (Hg)
Selenium
Max. Accept. Level (MAL)
0.05 ppm
0.01 ppm
0.01 ppm
0.05 ppm
0.05 ppm
0.001 ppm
0.01 ppm
46
PROCESSED FOOD
ANALYSIS REQUIRED
Phenolic substances
Volatile Organic Compound:
Carbon Tetrachloride
Benzene
Trihalomethane
Pesticides & related subs.:
Carbamates, organo-chlorine,
& oranophos-phates
Herbicides, fungicides, PCP
Finished Product
a) Purified/Distilled
b) Mineral
c) Distilled / Purified /
Mineral
STANDARDS
0.001 ppm
0.005 ppm
0.005 ppm
0.01 ppm
0.1 ppb
0.5 ppb
Radionuclides (every 4 yrs):
Gross Alpha Activity
Gross Beta Activity
0.1 Bq/L
1.0 Bq/L
Physico-chemical Properties:
pH
TDS
Conductivity
Turbidity
Guide LevelMAL
5–7
9
<10
500
<5 uS/cm
1 NTU
pH
TDS
Conductivity
TDS for Spring water
6.5 – 8.5
>200
>200 uS/cm
>100
Mineral (as labeled)
Calcium
Magnesium
Sodium
Potassium
Chloride
Sulfate
100 ppm
30 ppm
20 ppm
10 ppm
25 ppm
25 ppm
Contaminants:
Nitrates
Nitrites
Iron
Manganese
Copper
Zinc
Aluminum
Fluoride
Organic Material (mgO2/L)
Surfactants
9
1000
500
50 ppm
175 ppm
12 ppm
200 ppm
250 ppm
Guide LevelMAL
25 ppm
45 ppm
Not detected
0.1 ppm
0.3 ppm
1.0 ppm
0.05 ppm
0.1 ppm
0.1 ppm
1.0 ppm
0.5 ppm
5.0 ppm
0.05 ppm
0.2 ppm
0.8 ppm2.0 ppm
(Flouridated water)
2.0 ppm
5.0 ppm
Not detected
2.0 ppm
(as lauryl sulfate)
47
PROCESSED FOOD
ANALYSIS REQUIRED
Microbiological parameters:
(5 samples)
Coliforms, MPN/100m
Fecal Streptococci, cfu/100mL
Pseudomonas aeruginosa,
cfu/100mL
Heterotrophic Plate Count,
cfu/mL
 Distilled/Purified
 Mineral
STANDARDS
ncmM
5
5
5
1
1
0
5
5
1
1
0
0
0
103
104106
1*
1**
105
* shall not be E.coli
** more samples should be
analyzed, considered defective
lot is another set of 5 samples
yield at least one positive sample
n number of samples tested
c maximum number of samples
>m but not more than M
m guide level
M maximum acceptable level
25. Ice
(DOH-AO No. 2007-0012)
Per Annex A – Minimum
requirement
Microbiological Parameters:
Total Coliform
 Multiple Tube Fermentation
Technique (MTFT)
 Chromogenic substrate test
(Presence-Absence)
 Membrane Filter (MF)
Technique
Fecal Coliform
 Multiple Tube Fermentation
Technique (MTFT)
 Membrane Filter (MF)
Technique
 Chromogenic substrate test
(Presence-Absence)
Heterotrophic Plate Count
 Pour Plate
 Spread Plate
 Membrane Filter Technique
<1.1 MPN/100ml
Absent
<1.1 MPN/100ml
<1 Total coliform colonies/100ml
<1.1 MPN/100ml
<1 Fecal coliform colonies/100ml
<1.1 MPN/100ml
<500 CFU/ml
Chemical Constituents:
Arsenic
Cadmium
Lead
Nitrate
Benzene
0.05 mg/L
0.003 mg/L
0.01 mg/L
50 mg/L
0.01 mg/L
Physical-Chemical Properties:
Color
Apparent: 10 color units
48
PROCESSED FOOD
ANALYSIS REQUIRED
(Visual Comparison Colorimetric)
Turbidity
Iron
Manganese
pH
STANDARDS
True: 5 color units
5 NTU
1.0 mg/L
0.4 mg/L
6.5 to 8.5 mg/L
5 to 7 mg/L (for product water that
undergone reverse osmosis or distillation
process)
Sulfate
Total Dissolved Solids (TDS)
250 mg/L
500 mg/L
<10 mg/L (for product water that
undergone reverse osmosis or distillation
process)
Radiological Constituents:
Gross Alpha Activity
Gross Beta
Radon
26. Fortified Foods
Products
Voluntary Fortification
27. Shelf-stable, Chilled
and Frozen Corned
Beef
(PNS 891:1993 UDC)
0.1 (excluding radon) Bq/L
1.0 Bq/L
11 (MCL) Bq/L
AO No. 4-A s. 1995 – Guidelines
on Micronutrient Fortification of
Processed Food
Check label claim
Check label claim
Coliform
Escherichia coli
Salmonella
Molds and Yeasts Count
Aerobic Plate Count
Nitrite
28. Dry Base Mixes for
Soups and Sauces
Water Activity (aw)
(AO 2005-0018 PNS for
Ethnic Food Products)
Microbiological requirements:
Standard Plate Count, cfu/g
Coliform count , cfu/g
Yeasts & Molds Count, cfu/g
Salmonella, in 25g sample, &
tested only for products
containing meat, poultry
and seafood product
ingredients
Contaminants:
Lead
Aflatoxin, for products containing
0 cfu/g
Negative
Negative
0
1,000,000 cfu/g
Shelf-stable: 50 ppm, maximum
Chilled/Frozen: 125 ppm, max.
0.6, maximum
ncmM
5 2
5 3
5 3
5 0
10,000
10
100
0
1,000,000
1,000
10,000
n = no. of samples to be analyzed
c = no. of tolerable samples exceeding m
but not M
m = minimum count
M = maximum count
0.1 mg/kg
10 mcg/kg
peanuts
49
PROCESSED FOOD
29. Sweet Preserves
(Sugar palm,
Jackfruit, Banana,
Legumes, Coconut
& Halo-halo)
(AO No. 2005-0018)
ANALYSIS REQUIRED
Contaminants:
Lead
Tin, for products in cans
STANDARDS
0.1 ppm, maximum Pb
250 ppm, maximum Sn
Sodium / Potassium metabisulfite
350 ppm
Commercial Sterility
Commercially Sterile
30. Nata de Coco in
Syrup
Sulfites
28 ppm, maximum
(PNS 1219:1994)
Acidified Nata de Coco:
Aerobic Plate Count
Yeasts and Molds Count
Sorbates (if utilized, the limit is as indicated)
Benzoate (if utilized, the limit is as indicated)
100 cfu/g, maximum
10 cfu/g, maximum
1000 ppm, maximum
200 ppm, maximum
Low Acid Nata de Coco:
Commercial Sterility Test
Pass
31. Thermally Processed
Fish Products
Histamine
20 mg/100g, maximum
(PNS/BFAD 06:2006
ICS 67.120.30)
Heavy Metal Contaminants:
Lead
Tin
Mercury
0.5 ppm, maximum Pb
250 ppm, maximum Sn
0.1 ppm, maximum Hg
32. Dried, Salted Fish
(PNS/BFAD 04:2006)
Commercial Sterility (BC 01-A)
Physico-Chemical Requirements:
Water Activity (aw)
Salt Content, NaCl
Pass
0.78
12%, minimum
(may vary provided that the prescribed
awis not exceeded)
Histamine Content
Standard Plate Count, cfu/g
Yeasts & Molds Count, cfu/g
Total Coliforms, MPN/g
Escherichia coli
Staphylococcus aureus, MPN/g
200 ppm edible portion, maximum
ncmM
5 2
5 2
5 2
5 2
5 2
100,000
1,000
10
---
500,000
10,000
100
11
1,000
n = no. of samples to be analyzed per
volume product
c = no. of samples that may exceed m
butnot M
m = maximum count achievable under
GMP
M = maximum count beyond which
product safety/quality may be
affected
50
PROCESSED FOOD
33. Mango Beverage
(PNS/BFAD 09:2007)
ANALYSIS REQUIRED
Minimum content for fruit
ingredient:
Puree
Nectar
Juice
Juice Drink
Flavored Juice Drink
100%
25%, minimum
10%, minimum
5%, minimum
1%, minimum
Soluble Solids
Ethanol Content
20%
3 g/kg
Microbiological Limits:
Standard Plate Count
Yeasts and Molds Count
Coliform Count
Escherichia coli
1,000 cfu/g. maximum
50 cfu/g, maximum
10 cfu/g, maximum
Negative
pH
Titratable Acidity, as %citric acid
Soluble Solids, at 20oC
CalamansiDalandan
2.0, min.
2.5, min.
4.5%, min.
0.7%, min.
6.0%, min.
7.0%, min.
Ethanol Content
3 g/kg, maximum
Water activity (aW)
Moisture Content
Fat Content
Free Fatty Acid, as oleic acid
Peroxide Value , meq/kg
0.40 at 25oC, maximum
4.0%, maximum
35.0%, maximum
0.25%, maximum
5.0%, maximum
Water activity (aW)
Moisture Content
Sulphites
15%, maximum
3,000 ppm, maximum
Water activity (aW)
Moisture Content
Sulphites
15%, maximum
3,000 ppm, maximum
Moisture Content
Free Fatty Acid
8%, maximum
0.50% (as oleic acid), maximum
Moisture Content
Fine and Extra Fine
Medium and Coarse
Other Cuts (special)
3%, maximum
3.8%, maximum
4.5%, maximum
Oil Content
62% (mass/mass)
34. Citrus Beverage
(PNS/BFAD 11:2007)
STANDARDS
35. Banana Chips
(PNS/BFAD 13:2007)
36. Dried Mango
(PNS/BFAD 15:2007)
37. Dried Tropical Fruits
(PNS/BFAD 16:2007)
38. Pancit Canton
(PNS/BFAD 18:2008)
39. Desiccated Coconut
(PNS/BAFPS 25:2007)
51
PROCESSED FOOD
ANALYSIS REQUIRED
STANDARDS
Microbiological Analyses:
Salmonella
Total plate count
Coliform
Yeast
Molds
Escherichia coli
Negative in 25 grams
5,000 cfu/g, maximum
50 cfu/g, maximum
100 cfug, maximum
100 cfu/g, maximum
< 3 MPN/g (Not detected ≈ 0)
Sulfur dioxide
200 mg/kg
Alcohol Content
Methanol content (per BFAD MC
13 s. 1989)
pH
Titratable Acidity (as %Lactic acid)
Soluble solids
Volatile Acidity (as %Acetic acid)
Total Phenol (as mg gallic acid/mL)
12%, minimum
a) Negative – if added
b) Present – if derived from the
natural alcohol fermentation
process (for fruit wines)
3.2, minimum
0.67% (w/v), maximum
8.0°Bx, minimum
0.034% (w/v), maximum
1.48 mg/mL, minimum
Food Additives:
Benzoates (as benzoic acid)
Sulphites (as residual SO2)
1000 ppm, maximum
200 ppm, maximum
Water activity (aW) at 25oC
Moisture content
Fat content
Free fatty acid as oleic acid
Peroxide value
Aflatoxin
0.60, maximum
3.0%, maximum
23%, maximum
0.5%, maximum
5.0%, maximum
20 ppb
40. Basi
(PNS/BFAD 20:2009)
41. Chichacorn
(PNS/BFAD 22:2010)
42. PurpleYam(Ube)Jam
(Halaya)
(PNS/FDA 24:2010)
pH
Low-acid purple yam jam
Acidified purple yam jam
aw controlled purple yam jam
aw controlled low-acid purple
yam jam
aw
Low-acid purple yam jam
Acidified purple yam jam
aw controlled purple yam jam
aw controlled low-acid purple
yam jam
> 4.6
< 4.6
None required
> 4.6
> 0.90
> 0.85
< 0.85
0.86 – 0.90
52
PROCESSED FOOD
ANALYSIS REQUIRED
Commercial Sterility (BC 01-A)
STANDARDS
Pass
43. Smoked Fish
(PNS/FDA 26:2010)
44. Processed Pili Nut
Products
(PNS/FDA 28:2010)
45. Tropical Fruit Wines
(PNS/FDA 30:2010)
46. Distilled fermented
coconut sap
(Coconutlambanog)
Histamine Content
200 ppm, maximum
SPC/APC, cfu/g
Salmonella/25g
Escherichia coli, MPN/g
Staph aureus (coagulase+), cfu/g
ncmM
5 2
5 0
5 3
5 2
Aflatoxin
500,000
-<500
10,000
volume product
butnot M
m = maximum count achievable under
GMP
M = maximum count beyond which
product safety/quality may be
affected
10 ppb (parts per billion = microgram per
kilogram)
Moisture content
Water activity (aW), at 25oC
Fat content
Free fatty acid
Peroxide value, as oleic acid
% Alcohol
pH
Total acidity
% Soluble Solids at 20oC
Volatile acidity as acetic acid
4.0%, maximum
0.70
70%, maximum
1.0%, maximum
10 meq/kg, maximum
7.0 to 24.0% (v/v)
3.0 to 4.0
0.6 to 0.9%
8.0%, minimum (m/m)
0.14 g/100mL, maximum
% Alcohol, as ethyl alcohol
30%, minimum
Methanol
The methanol content shall be in
accordance with the provisions of
BFAD M.C. No.13 s.1989: Methanol
may be present in alcoholic
beverages provided that it shall be
derived from the natural alcohol
fermentation process and not added.
Titratable acidity, as acetic acid
0.3%, maximum
0.60, maximum
(PNS/BAFPS 47:2011)
47. Ethnic Flour-based
Confectioneries
100,000
0
11
100
53
PROCESSED FOOD
(Pulvoron, Piaya,
Barquillos) (PNS/FDA
32:2011)
ANALYSIS REQUIRED
Yeasts and Molds Count, cfu/g
Coliforms, MPN/g
STANDARDS
ncmM
5 2
5 2
10
10
1,000
100
volume product
butnot M
m = guide level
M = maximum level
48. Ethnic Milk-based
Confectioneries
(Yema, Pastillas)
(PNS/FDA 34:2011)
0.85, maximum
Salmonella per 25g
Coliforms, MPN/g
SPC/ APC, cfu/g
ncmM
5 2
5 0
5 2
5 2
100
0
<1.8
10,000
10,000
100
1,000,000
volume product
butnot M
m = guide level
M = maximum level
49. VIRGIN COCONUT OIL STANDARD
(PNS/BAFPS 22:2004 ICS 67.200.10)
1. Fatty Acid Profile
Common Name
Caproic acid
Caprylic acid
Capric acid
Lauric acid
Myristic acid
Palmitic acid
Palmitoleic acid
Stearic acid
Oleic acid
Linoleic acid
Linolenic acid
2.
3.
4.
5.
Composition
C 6:0
C 8:0
C 10:0
C 12:0
C 14:0
C 16:0
C 16:1
C 18:0
C 18:1
C 18:2
C 18:3
C 24:1
(%)
ND – 0.7
4.6 – 10.0
5.0 – 8.0
45.1 – 53.2
16.8 – 21
7.5 – 10.2
ND
2.0 – 4.0
5.0 – 10.0
1.0 – 2.5
ND – 0.2
ND
Moisture
- 0.20 %
Free Fatty Acid (FFA) as lauric acid, max - 0.20 %
Peroxide Value, max
- 3.0 meq/kg oil
Food Additives
- none permitted
54
6. Contaminants (Matter volatile at 105ºC)
- 0.20 %
7. Heavy Metals, mg/kg, max
 Iron (Fe)
5.0
 Copper (Cu)
0.40
 Lead (Pb)
0.10
 Arsenic (As)
0.10
8. Quality Requirements
 Color (colorless)
 Sediment Free
 With natural fresh coconut scent
 Free from rancid odors or tastes
9. Required Micro Analysis for VCO (Reference: Philippine Pharmacopoeia)
 Total Aerobic Plate Count- 100 cfu/mL max
 Molds and Yeast
- 10 cfu/mL max
 Salmonella
- negative
 E. coli
- negative
 Staphylococcus aureus - negative
55
50. STANDARD FOR FERMENTED MILKS
(PNS/BFAD 08.2007 ICS 67.100.10)
Composition
Fermented
Milk
Milk Proteina , %
(w/w),
minimum
Milk Fat (% m/m)
Titratable Acidity, %
expressed as %
lactic
acid (% m/m),
minimum
Ethanol, % (vol/w),
Minimum
Sum
of
microorganisms
constituting
the
starter
culture (cfu/g, total),
minimum
Labeled
microorganismsb
(cfu/g,
total),
minimum
Yeast (cfu/g, total),
Minimum
a
b
Kefir
Kumys
2.7
Yogurt/Alternate
Culture Yogurt/
Acidophilus Milk
2.7
2.7
-
<10
0.3
<15
0.6
<10
0.6
<10
0.7
-
-
-
0.5
10,000,000
1,000,000
1,000,000
-
-
-
-
10,000
10,000
Protein content is 6.387 multiplied by total Kyeldahl nitrogen determined
Applies where a constant claim is made in the labeling that refers to the
presence of a specific microorganism (other than those specified in
definition for the product concerned) that has been added as a supplement
to the specific starter culture
56
51. STANDARD ADMINISTRATIVE ORDERS (SAOs) FOR DISTILLED SPIRITS
CHEMICAL
COMPOSITION
% Ethyl alcohol
content
Total Solids, %
(w/v)
Total Ash, %
(w/v)
BRANDY
SAO # 358
s. 1978
32.5%, minimum
(free from added
coloring except
caramel prepared
from sugar)
1.0%, maximum
SAO # 257
s. 1976
50 grams per 100
L of absolute
alcohol, maximum
Esters as ethyl
acetate
Brandy – 20
grams
Blended/ Fruit/
Compounded
Brandy – 8 grams
per 100L of
absolute alcohol,
minimum
30 – 350 grams
per 100L of
absolute alcohol
Furfural (per
100L of
absolute
alcohol)
5 grams per 100L
of absolute
alcohol, maximum
Aldehydes as
acetaldehyde
(per 100L of
absolute
alcohol)
Copper (as Cu)
---
VODKA
SAO # 258
s. 1976
25o proof – 42.85
30o proof – 40.01
35o proof – 37.15
0.005%, maximum
0.02%, maximum
Volatile acids
as acetic acid
Higher alcohols
as amyl alcohol
RUM
Heavy: 25-60
Medium: 11-24
Light: 5-10
mg per 100 mL
of 100 proof
Heavy: 56-565
Medium: 13-55
Light: 0.6-12
mg per 100 mL
of 100 proof
Heavy: 114-238
Medium: 36-136
Light: 0-35
per 100 L of
absolute alcohol
Heavy: 1-5.4
Medium: 0.6 –
0.9
Light: 0-0.5
Per 100 L of
absolute alcohol
Heavy: 17-19
Medium: 8-16
Light: 0-7
mg per 100 mg
proof
Heavy: 11-14
Medium: 7-10
Light: 3-6
ppm Tannins
WHISKEY
SAO # 259
s. 1976
32.5% , minimum
(free from added
coloring except
caramel prepared
from sugar)
0.2%, maximum
(free from
sediment or
suspended matter)
2 grams per mg
100 mL of 100
proof, maximum
0.02%, maximum
10 grams mg per
100 mL of 100
proof, maximum
Malt Whiskey –
20 grams
Straight/ Blended/
Compounded
Whiskey – 8 grams
Per 100 L of
absolute alcohol,
minimum
30 – 350 grams,
per 100L of
absolute alcohol
0.03 (v/v),
maximum
40 grams,
maximum
100 L absolute
alcohol
Nil
5 grams per 100 L
of absolute alcohol,
maximum
2 grams as
acetaldehyde, mg
per 100 ml of 100
proof, maximum
60 grams per 100 L
of absolute alcohol,
maximum
10 gram ppm,
maximum
57
52. WHITE SUGAR (PNS 1098:1993, from DTI-BPS)
Table 1. Physico-chemical requirements
Characteristic
Sucrose, % mass at
27°C, minimum
Moisture, % mass,
maximum
Ash, Conductometric
% mass, maximum
Color in ICUMSA*
Units, maximum
Reducing Sugar, %
mass, maximum
Sediment: mg/kg,
maximum
SO2 mg/kg, maximum
Taste and Odor
Bottler’s
Grade
99.9
Refined
Premium
Grade
99.8
Mill/ Factory
White
Standard
Grade
99.7
0.04
0.04
0.08
0.1
0.015
0.03
0.09
0.1
35
50
150
150
0.04
0.04
0.08
0.1
2
10
30
30
6
20
Shall not
produce floc
when 500mL of
10.5° Brix
solution at a pH
of 2.5 and 3.5
gas volume is
allowed to stand
10 days at room
temperature
Shall not
produce floc
when one
gallon 54° Brix
solution at a pH
of 1.5 is allowed
to stand 10
days at room
temperature
20
Not required
20
Not required
99.5
No obvious objectionable taste or odor in dry form or in
10% sugar solution odorless water
*ICUMSA – International Commission for Uniform Methods of Sugar Analysis
Table 2. Microbiological requirements for Bottler’s and Premium Grade
Refined White Sugars
Microorganism
Mesophilic Bacteria
Yeast and Mold
Thermophilic spores
Maximum Level cfu/10g
200
10
150
58
Table 3. Contaminants Limits for White Sugar
Contaminant
Lead
Arsenic
Copper
Total Heavy Metals (expressed as
lead)
Maximum Level mg/kg
Bottler’s
Refined/ Mill/ Factory White
Grade
Sugar
0.5
0.5
0.5
0.5
1.5
2.0
5.0
Not required
53. COCONUT FLOUR (PNS/BAFPS 75:2010)
Table 1 – Physical Characteristics
Parameters
Color
-Premium Class (Superior quality)
-Class I (Good quality)
-Class II (Fair quality)
Odor
Particle size
-Premium Class (Superior quality)
-Class II (Fair quality)
Characteristics
White to creamy white
Very light brown
Very light brown to brown
Typical nutty odor
Fine – 0.15 to 0.20 mm sieve
Medium – 0.21 to 0.25 mm sieve
Medium – 0.21 to 0.25 mm sieve
Table 2 – Chemical Composition
Chemical Composition
Moisture
Ash
Protein
Fat
Total dietary fiber
Carbohydrates
Free fatty acid – as lauric acid
–as oleic acid
Peroxide value, meq
Value (%) (dry weight basis)
≤ 5.0
4.0 to 6.0
10.0 to 19.0
10.0 to 12.0
40.0 to 60.0
50.0 to 70.0
< 0.20
0.01 to 0.02
< 3.0
59
Table 3 – Microbiological Characteristics
Parameters
Aerobic Plate Count, cfu/g
Coliform, cfu/g
Escherichia coli, MPN/100g or cfu/g
Staphylococcus aureus, cfu/g
Salmonella, per 25g
Level or Limit
≤ 10,000
≤ 50
Negative
Negative
Negative
≤ 100
54. COCONUT SAP SUGAR (PNS/BAFPS 76:2010)
Table 1 – Physical Characteristics
Parameters
Color
-Premium class (Superior quality)
-Class II *
Odor
Taste
Others
Quality Characteristics
Light yellow to Cream
Light brown to brown
(see note below)
Sweet scent; pleasant nutty
aroma
Sweet
Free from filth and extraneous
matters
Table 2 – Chemical Properties
Parameters
Water activity, aW
-Premium class (Superior quality)
-Class II *
Glucose
Fructose
Sucrose
Ash
Value (%)
< 0.5
0.5 to 0.7
(see note below)
2.0 to 3.0
1.0 to 4.0
78.0 to 89.0
≤ 2.4
60
Table 3 – Microbiological Characteristics
Parameters
Aerobic Plate Count, cfu/g
Coliform, cfu/g
Escherichia coli, MPN/100g or cfu/g
Salmonella, per 25g
Level or Limit
<10
<10
Negative
Negative
<10
*Note: Class II – This class includes coconut sap sugar that does not qualify under
Premium class or Class I in terms of Color and Water Activity (aW) but still
meets the other Physical, Chemical and Microbiological requirements
indicated above.
55. OTHERS (For the updated levels on specific food products, supplemental
to FDA Circular No. 2010 – 008 entitled “Adoption of the Codex Standards
on Food Contaminants in Processed Food” will be issued soon)
CONTAMINANTS
RESTRICTION/MAXIMUM
LEVEL OF USE
250 ppm
Tin (Sn)
Mercury (Hg)
0.4 ppm (fish)
0.5 ppm (herbal)
Lead (Pb)
Milk
Vegetable/Fruit
Fruit Juice
Meat
Composite/Filled Chocolate
Shellfish
Herbal
0.5 ppm
1.0 ppm
0.3 ppm
0.5 ppm
1.0 ppm
10 ppm
10 ppm
NATURALLY OCCURRING TOXICANTS
Histamine
Aflatoxin
Paralytic Shellfish
100 ppm
20 ppb (max)
80 ug/100g
61
FOOD ADDITIVES
(Please see BC 2006- 0016 – Updated list of Food Additives @ www.fda.gov.ph
or latest Codex Alimentarius General Standards for Food Additives [GSFA] @
www.codexalimentarius.net)
Benzoic acid & its K and Na Salts
Nitrate of K & Na (meat)
Nitrite of NA (meat)
Sorbic acid & its K, Ca & Na salts
Caffeine in cola type beverages
0.1%
500 ppm
200 ppm
0.3%
200 ppm
SO2 & other sulfite in Dried fruits
and vegetables
Apricots/Peaches/Nectarines
Pears
Apples
Cabbage
Potatoes
Carrots
2000 ppm
1000 ppm
800 ppm
750-1000 ppm
200-250 ppm
200-250 ppm
NON-PERMISSIBLE FOOD ADDITIVES
Borax
Formalin
Rhodamine (coloring)
Coumarin (in vanilla)
Bromate
62
56. FOOD FORTIFICATION
IODINE LEVELS - SALT
Sampling Point
Type of Container/Package
Bulk (>2 kg)
Retail (< 2 kg)
Production Site
-------------------20 to 70mg/kg-------------------
Port of Entry*
-------------------20 to 70mg/kg-------------------
Retail Site
-------------------20 to 70mg/kg-------------------
*For imported iodized salt; also at importer’s/distributor’s warehouse.
MANDATORY FOOD FORTIFICATION (Staple products)
As per RA 8976 - Rule VI (IRR)
1. All rice, except brown rice and locally produced glutinous rice, to be fortified
with iron.
Fortificant
Iron
Ferrous Sulfate
Minimum Acceptable Level
Maximum Tolerable Level
60 mg Fe/kg raw rice
90 mg Fe/kg raw rice
2. Refined sugar for human consumption to be fortified with Vitamin A.
Fortificant
Vitamin A
Retinol palmitate
5.0 mg/kg
30.0 mg/kg
3. Wheat flour to be fortified with Vitamin A and Iron.
Fortificant
Vitamin A
Retinol Palmitate/
acetate
Iron
Elemental Iron
(electrolytic, H
reduced, particle size
should be < 50
microns)
3.0 mg/kg as retinol
6.5 mg/kg as retinol
70.0 mg Fe/kg
105 mg Fe/kg
Ferrous Sulfate or
Ferrous Fumarate
50.0 mg/kg
75.0 mg Fe/kg
4. Cooking Oil for human consumption to be fortified with Vitamin A except for
export.
63
Forificant
Vitamin A
Retinol Palmitate
12.0 mg RE/L
23 mg RE/L
64

list of annexes - Food and Drug Administration Philippines

Transcription

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