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CFRR Electronic Registration User Manual
FOREWORD
Application of all processed food products through the electronic
registration system is an outgrowth of the electronic registration
for raw materials and low risk food products which started on
December 2014. Following its release, an improved version of
the system that will cater/cover all submissions was developed
alongside with the enhancements which were incorporated for
faster transactions and submissions.
A glance through the pages of this manual will show you that it
consists largely of guidelines, food product classification, and
list of references including frequently asked questions on
registration and labelling concerns. But, rest assured that every
effort has been made to laymanize this manual. Stakeholders and
readers alike will find this a gold mine of information. For
instance, it provides a road map of how the applicant should go
about their submission. It cites examples or scenarios that
applicants will encounter in the course of their transaction with
FDA. Moreover, it is a compendium of the resources or
references the stakeholders could use when familiarizing with
FDA processes, policies and regulations.
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Suggested Citation:
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TABLE OF CONTENTS
Foreword …………………………………………….…………. 2
Table of Contents ………………………………………………. 4
Introduction, Uses and Applications …………………………. 5
Terminology ……………………………………………………. 7
General Guidelines in the Registration of Food Products…… 10
Classification of Processed Food Products 15
Low Risk ………………………………………………… 16
Medium Risk ……………………………………………. 34
High Risk …………………………………………….….. 45
Electronic Registration Guidelines and Procedure 60
Initial Application ………………………………………. 64
Reapplication ……………………………………………. 93
Amendment Application ……………………………….. 95
Renewal Application ……………………………………. 117
Re-Issuance ……………………………………………… 123
Cancellation ……………………………………………... 125
Roles and Responsibilities of Food Business Operators …….. 131
Annexes…………………………………………………………. 133
References ……………………………………………………… 214
FAQ ……………………………………………………………... 219
Help and Contact Details ……………………………………… 225
Committee on the Creation of CFRR
Electronic Registration User Manual ………………….. 226
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This manual has been prepared by the Food and Drug Administration –
Center for Food Regulation and Research and is intended to be used guide
and provide adequate information and minimize error during filling and
securing of Certificate of Product Registration (CPR) Application.
The User Manual contains all detailed information for the user to make
full understanding of the Electronic Registration System. This manual
includes Step by Step Procedures for Initial, Renewal, Re-Application and
Amendment of Certificate of Product Registration, General Guidelines on
Registration and relevant FDA issuances on registration-related matters.
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TERMINOLOGY
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TERMINOLOGY
“Blister pack label” means a label affixed to or printed on the strip or blister pack.
The strip/blister pack needs to be repacked in another container or accompanied with
a catch cover where label can display information.
“Complementary Food” means any food except milk substitutes, whether
manufactured or locally prepared, suitable as a complement to breastmilk to satisfy
the nutritional requirements of infants.
“Food for Special Medical Purposes” refers to a category of foods for special
dietary uses which are specially processed or formulated and presented for the
dietary management of patients and may be used under medical supervision
(adopted from Codex Stan 180-1991).
“Food/Dietary Supplement” means a processed food product intended to
supplement the diet that contains one or more of the following dietary ingredients:
vitamin, mineral, amino acid, herb, or other dietary substance of botanical, animal,
artificial or natural origin to increase the total daily intake in amounts conforming to
the latest Philippine recommended energy and nutrient intakes or internationally
agreed minimum daily requirements. It is usually in the form of capsules, tablets,
liquid, gels, powders or pills and not represented for use as a conventional food or as
the sole item of a meal or diet or a replacement for drugs and medicines.
“Formulated Complementary Foods for Older Infants and Young Children”
refers to foods that are suitable for use during the complementary feeding period.
These foods are specifically formulated with appropriate nutritional quality to
provide additional energy and nutrients to complement the family foods derived
from the local diet by providing those nutrients which are either lacking or are
present in insufficient quantities.
“High Risk Food Products” means foods that contain pathogenic microorganisms
and will support the formation of toxins or the growth of pathogenic
microorganisms; and foods that may contain harmful chemicals.
“Infant Formula” means one of the breastmilk substitutes formulated industrially
in accordance with applicable Codex Alimentarius Commission (CAC) standards
(Adopted from A.O. 2006-0012).
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TERMINOLOGY
“Low Risk Food Products” means 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.
“Medium Risk Food Products” means foods that may contain pathogenic
microorganisms but will not normally support their growth because of food
characteristics; or food that is unlikely to contain pathogenic microorganisms
because of food type or processing, but may support the formulation of toxins or the
growth of pathogenic microorganisms.
“Milk Supplement” product name shall be used in place of “follow-up” formula. It
means a food intended for use as a liquid part of the complementary food for the
infant from the 6th month on and for young children; (adopted from Codex Stan
156-1987 stated that designated name is allowed in accordance with national usage).
“Processed Cereal-Based Foods” are prepared primarily from one or more milled
cereals, which should constitute at least 25% of the final mixture on a dry weight
basis. The four categories distinguished are: (1) Products consisting of cereals which
are or have to be prepared for consumption with milk or other appropriate nutritious
liquids; (2) Cereals with an added high protein food; (3) Pasta and (4) Rusks and
Biscuits.
“Stability Studies” refers to the real time and accelerated studies/testing undertaken
on primary batches according to a prescribed stability protocol to establish or
confirm the re-test period of a substance or shelf-life of a finished product.
Accelerated Stability Studies
Studies designed to increase the rate of chemical degradation or physical change of a
finished product by using exaggerated storage conditions as part of the formal
stability studies. (Data from these studies, in addition to long term stability studies,
can be used to assess longer term chemical effects at non-accelerated condition and
to evaluate the effect of short term excursions outside the label storage conditions
such as might occur during shipping.
Real Time Stability Studies
Stability studies under the recommended storage condition for the re-test period or
shelf life proposed (or approved) for labelling.
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A. FATS, OILS 1. Butter oil, The milk fat products anhydrous milk fat,
AND FAT Anhydrous Milk anhydrous butter oil and butter oil ar e
EMULSIONS Fat, Ghee products derived exclusively from milk and/
or products obtained from milk by a process
Definition: that almost completely removes water and
Includes all fat- non-fat solids.
based products
that are derived Ghee is a pr oduct obtained exclusively
from vegetable, from milk, cream or butter by a process that
animal or marine almost completely removes water and non-
sources, or their fat solids; it has a specially developed
mixtures. flavour and physical structure.
2. Vegetable oils Edible fats and oils obtained fr om edible Virgin olive oil,
and Fats plant sources. Products may be from a single cottonseed oil,
plant source or marketed and used as blended peanut oil, and
Fats & Oils oils that are generally designated as edible, vanaspati
Coconut, Palm, cooking, frying, table or salad oils. Virgin
Soybean and Corn oils ar e obtained by mechanical means
Oil—covered by: (e.g. pressing or expelling), with application
of heat only so as not to alter the natural
Republic Act 8976 composition of the oil. Virgin oils are
on Food suitable for consumption in the natural state.
Fortification Cold pressed oils are obtained by mechanical
means without application of heat.
3. Animal fats All animal fats and oils should be derived Tallow and partially
(lard, tallow, fish from animals in good health at the time of defatted beef or
oil and other slaughter and intended for human pork fatty tissue
animal fats) consumption.
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A. FATS, OILS 4. Fat emulsions Includes fat-based counterparts of dairy- Imitation milk (a fat
AND FAT mainly of type oil- based foods excluding dessert products. The -substituted milk
EMULSIONS in-water, fat portions of these products are derived produced from non-
(continued) including mixed from sources other than milkfat (e.g. fat milk solids by
Definition: and/or flavored vegetable fats and oils). addition of
Includes all fat- products based on vegetable fats
based products fat emulsion (coconut, safflower
that are derived or corn oil)); non-
from vegetable, dairy whipped
animal or marine cream; non-dairy
sources, or their toppings; and
mixtures. vegetable cream
5. Fat emulsions
Include all emulsified products excluding fat Margarine (a
mainly of type-based counterparts of dairy products and spreadable or fluid
water-in-oil dairy desserts. water-in-oil
(butter, fat emulsion produced
spreads, Butter is a fatty pr oduct consisting of a mainly from edible
margarine dairy
primarily water-in-oil emulsion derived fats and oils)
fat spreads and
exclusively from milk and/or products
blended spreads)
obtained from milk. Products derived
from butter:
Includes fat spreads (emulsions principally “butterine,” a
of the type water and edible fats and oils), spreadable butter
Margarine
dairy fat spreads (emulsions pr incipally of blend with
AO No. 232 s. the type water-in-milkfat), and blended vegetable oils
1974 spreads (fat spr eads blended with higher
amounts of milkfat) Examples include Blends of butter and
margarine (a spreadable or fluid water-in-oil margarine; and
emulsion produced mainly from edible fats minarine (a
and oils); products derived from butter (e.g. spreadable water-in-
“butterine,” a spreadable butter blend oil emulsion
with vegetable oils) blends of butter and produced principally
margarine; and minarine (a spreadable water- from water and
in-oil emulsion produced principally from edible fats and oils
water and edible fats and oils that are not that are not solely
solely derived from milk). Also includes derived from milk).
reduced fat-based products derived from
milkfat or from animal or vegetable fats, Three-quarter fat
including reduced-fat counterparts of butter, butter, three-quarter
margarine, and their mixtures (e.g. three- fat margarine, or
quarter fat butter, three-quarter fat three-quarter fat
margarine, or three-quarter fat butter- butter-margarine
margarine blends). blends.
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B. PROCESSED 1. Dehydrated Candied fruits includes glazed fr uits (fr uit Cocktail
FRUITS, fruits or treated with a sugar solution and dried), (maraschino)
VEGETABLE vegetables, candied fruit (dried glazed fruit immersed in cherries, candied
AND EDIBLE including candied a sugar solution and dried so that the fruit is citrus peel, candied
FUNGI fruits covered by a candy-like sugar shell), and citrons (e.g. used in
(including (mechanically crystallized fruit is prepared (dried glazed holiday fruitcakes),
mushrooms and dried) fruit rolled in icing or granulated sugar and and mostarda di
fungi, roots an Dried Tropical dried). frutta
tubers, pulses and Fruits
legumes, and aloe PNS/BFAD
vera) 16:2007
SEAWEEDS,
AND NUTS AND Dried Mango
SEEDS PNS/BFAD
15:2007
2. Jams, jellies, Jams, pr eser ves and conser ves ar e thick, Orange marmalade,
marmalades spreadable products prepared by boiling grape jelly, and
(pastry, topping, whole fruit or pieces of fruit, fruit pulp or strawberry jam
filling, coconut puree, with or without fruit juice or
spreads) concentrated fruit juice, and sugar to thicken,
and to which pectin and fruit pieces may be
Jams and Jellies added.
AO No. 239 s.
1975 Jelly is a clear spr eadable pr oduct
prepared similarly to jam, except that it is has
a smoother consistency and does not contain
Sweet Preserves fruit pieces.
(Sugar palm,
Jackfruit, Banana, Marmalade is a thick spr eadable fr uit
Legumes, Coconut slurry prepared from whole fruit, fruit pulp or
puree (usually citrus), and boiled with sugar
& Halo-halo)
to
PNS/BFAD thicken, to which pectin and fruit pieces and
02:2005 fruit peel pieces may be added.
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7. Cooked fruits Fruit that is steamed, boiled, baked, or fried, Baked apples, fried
Banana Chips with apple rings, and peach
or without a coating, for presentation to the dumplings (baked
PNS/BFAD peaches with a sweet
13:2007 consumer. dough covering)
8. Frozen vegetables Fresh vegetables ar e gener ally fr ee of Quick-frozen corn,
(including mushrooms quick-frozen French-
and fungi, roots and additives. However, fresh vegetables that are
tubers, pulses and coated or cut or peeled for presentation to fried potatoes, quick
legumes, and aloe vera) the consumer may contain additives frozen peas, and quick
seaweeds, and nuts and frozen whole
seeds processed tomatoes
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10. Cooked or Vegetables that are steamed, boiled, baked, Simmered beans,
fried vegetables or fried, with or without a coating, for pre-fried potatoes,
(including presentation to the consumer. fried okra, and
mushrooms and vegetables boiled
fungi, roots and down in
tubers, pulses and soy sauce
legumes, and aloe (tsukudani)
vera), and
seaweeds
C. 1. Confectionery Includes all types of products that primarily Rolled, shaped and
CONFECTIONER including hard contain sugar and their dietetic counterparts and filled sweetened
Y and soft candy, may or may not contain cocoa. Includes hard candy).
nougats, candy (Products made fr om water and sugar
(simple syrup), colour and flavour that may or Caramels (containing
marzipans, may not have a filling, their dietetic counterparts, sugar syrup, fats,
etc. other than in and products that may or may not contain cocoa), colour and flavour)
MR (cocoa soft candy (Pr oducts include soft, chewy
products and products such as caramels (containing sugar syrup, Toffees and
chocolate fats, colour and flavour) and their dietetic chocolate-flavoured
products) counterparts; products that may or may not contain caramels
cocoa and milk (e.g. toffees and chocolate-
flavoured caramels); jelly-based candies (e.g. jelly Jelly-based candies
Ethnic Flour- beans, jellied fruit paste covered in sugar, (e.g. jelly beans,
based made from gelatin, pectin, colour and flavour); jellied fruit paste
Confectioneries and licorice. Also included are halwa teheniaa and covered in sugar,
(Pulvoron, Piaya, oriental specialties, such as sweet bean jelly made from gelatin,
Barquillos) (yokan) and agar jelly for mitsumame), and pectin, colour and
nougats and marzipans (Nougats consist of roasted flavour)
PNS/FDA 32:2011 ground nuts, sugar and cocoa and their dietetic
counterparts, that may be consumed as is, or may Licorice
be used as a filling for chocolate products within
the scope of food categories and Marzipan consists Sweet bean jelly and
of almond paste and sugar and their dietetic agar jelly for
counterparts, that may be shaped and coloured for mitsumame
direct consumption. Ube Bars
2. Chewing gum Product made from natural or synthetic gum Bubble gum and
base containing flavours, sweeteners other gum
(nutritive or non-nutritive), aroma products.
compounds, and other additives. Includes
bubble gum and other gum products.
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5. Batters (e.g. for Products containing flaked or ground cereal Includes breading
breading or or grain that when combined with other for tempura batter.
batters for fish or ingredients (e.g. egg, water, milk) are used as
poultry) a coating for fish or poultry. Products are
usually sold as dry mix of the cereal or grain
component.
6. Pre-cooked or Products prepared from rice that is soaked, drained, Japanese mochi,
processed rice steamed, kneaded and shaped into cake forms. Korean teuck
products, including Would also include processed rice and enriched
rice cakes (Oriental rice products, such as pre-cooked products that are
type only) sold canned, chilled or frozen; and processed rice
products sold in retort pouches.
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D. CEREAL- 7. Soybean Includes dried, cooked, fried or fermented soybean Dried, cooked, fried
BASED products products, and soybean curd products. or fermented
PRODUCTS, (excluding soybean products,
derived from soybean-based Soybean-based beverages - Products and soybean curd
cereal grains, from seasonings and prepared from dried soybeans that are soaked products
roots and tubers, condiments under in water, pureed, boiled and strained, or
pulses, legumes LR Letter I prepared from soybean flour, soybean
(seasonings, concentrate, or soybean isolate. In a number of Soybean-based
and pith or soft countries this category includes products beverage powder
core of palm tree, condiments and referred to as soybean milk. Soybean-based
excluding bakery sauces) beverages may be consumed as is, or used to
wares in Letter F prepare other soybean products. Also includes
below. soybean products, such as soybean-based
beverage powder, which is sold as is, for
reconstitution, or as a mix containing a
Definition: coagulant that can be reconstituted by the
Includes consumer for preparation of home-made soft
unprocessed and tofu.
various processed
forms of cereal Soybean-based film - Film formed on the
and cereal-based surface of boiling soybean-based beverage that
products. is dried. It may be deep-fried or softened in
water prior to use in soups or poached food.
Also known as fuzhu or yuba.
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E. PROCESSED 1. Edible casings Casings or tubing prepared from collagen, Sausage casings
MEAT AND (e.g. sausage cellulose, or food-grade synthetic material or
MEAT casings) from natural sources (e.g. hog or sheep
PRODUCTS, intestines) that contain the sausage mix.
INCLUDING
POULTRY AND
GAME
F. BAKERY 1. Bread and Includes categories for bread and ordinary
WARES AND ordinary bakery bakery wares and for sweet, salty and
BAKERY wares and mixes savoury fine bakery wares.
RELATED
PRODUCTS
Breads and rolls – yeast - leavened breads
and specialty breads, soda breads.
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F. BAKERY 1. Bread and Steamed bread and buns - Oriental-style Includes filled
WARES AND ordinary bakery leavened wheat or rice products that are dumplings and
BAKERY wares and mixes cooked in a steamer. Products may be steamed bun with
RELATED made with or without filling. In China, meat, jam or other
PRODUCTS products without filling are called steamed filling (manjyu).
bread (mantou), and those with filling are
called steamed buns (baozi or bao).
Twisted rolls of various shapes (huajuan)
may also be prepared.
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I. SALT, 1. Salt and salt Includes salt and salt substitutes used as
SPICES, SOUPS, substitutes seasoning for food.
SAUCES,
SALADS AND Iodized Salt Salt - Primarily food-grade sodium
PROTEIN chloride. Includes table salt, iodized and
Republic Act 8172
PRODUCTS fluoride iodized salt, and dendritic salt.
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5. Soups and Includes ready-to-eat soups and mixes. The Ready-to-eat soups
broths finished products may be water- (e.g. and mixes,
consommé) or milk-based (e.g. chowder). consommé and
Ethnic Food chowder
Products – Dry Mixes for soups and broths - Concentrated
base mixes for soup to be reconstituted with water and/or Includes bouillon
soups and sauces. milk, with or without addition of other powders and cubes;
PNS/BFAD optional ingredients (e.g. vegetables, meat, powdered and
01:2005 noodles). condensed soups
(e.g. mentsuyu); and
stock cubes and
powders
6. Sauces and like Includes ready-to-eat sauces, gravies and
products dressings, and mixes to be reconstituted
before consumption. The ready-to eat
products are divided into sub-categories for
emulsified and non-emulsified products,
Patis whereas the sub-category for the mixes
(AO No. 325 s. encompasses both emulsified and non-
1977) emulsified sauce mixes.
a. Mixes for sauces and gravies - Includes mixes for
Concentrated product, usually in powdered cheese sauce,
form, to be mixed with water, milk, oil or hollandaise sauce,
other liquid to prepare a and salad dressing
finished sauce or gravy. (e.g. Italian or ranch
dressing)
7. Yeast and like Includes baker’s yeast and leaven used in the Includes the Oriental
products manufacture of baked goods. products koji (rice
or wheat malted
with A. oryzae) used
in the production of
alcoholic beverages
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I. SALT, 8. Soybean-based Includes products that are derived from Fermented soybean
SPICES, SOUPS, seasonings and soybeans and other ingredients intended for paste and soybean
SAUCES, condiments use as seasonings and condiments. sauces
SALADS AND
PROTEIN Soy Sauce a. Fermented soybean paste (e.g. miso) - includes dou jiang
PRODUCTS
FDA Memorandum The product is made of soybeans, salt, water (China), doenjang
No. 2011-028 and other ingredients, using the process of (Republic of Korea),
fermentation. The product includes dou jiang or miso (Japan)
(China), doenjang (Republic of Korea), or
miso (Japan), which maybe used in the
preparation of soups or dressings, or as a
seasoning.
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J. BEVERAGES, 1. Non-alcoholic This major category is divided into the broad Includes ready-to-
excluding dairy (“soft”) beverages: categories of non-alcoholic and alcoholic drink products (e.g.
products Coffee, coffee beverages: Coffee, coffee substitutes, tea, canned), and their
substitutes, tea, herbal infusions, and other hot cereal and mixes and concentrates
herbal infusions, grain beverages
and other hot Chicory-based hot
cereal and grain beverages (postum),
beverages rice tea, mate tea, and
mixes for hot coffee
and tea beverages (e.g.
Coffee instant coffee, powder
AO No. 136-A & for hot cappuccino
beverages)
136-B s. 1985
Treated coffee beans
for the manufacture of
coffee products are
also included
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J. BEVERAGES, 2. Alcoholic bever- g. Aromatized alcoholic beverages (e.g. Aromatized wine, cider
excluding dairy ages, including beer, wine and spirituous cooler-type and perry; aperitif wines;
products alcohol-free and beverages, low-alcoholic refreshers) - americano; batidas (drinks
low-alcoholic Includes all non-standardized alcoholic made from cachaça, fruit
counterparts beverage products. Although most of juice or coconut milk and,
these products contain less than 15% optionally, sweetened
alcohol, some traditional non- condensed milk); bitter
standardized aromatized products may soda and bitter vino;
contain up to 24% alcohol. clarea (also claré or clary;
a mixture of honey, white
wine and spices; it is
closely related to hippo-
cras, which is made with
red wine); jurubeba alco-
holic drinks (beverage
alcohol product made
from the Solanum panicu-
latum plant indigenous to
the north of Brazil and
other parts of South
America); negus (sangria;
a hot drink made with port
wine, sugar, lemon and
spice); sod, saft, and
sodet; vermouth; zurra (in
Southern Spain, a sangria
made with peaches or
nectarines; also the Span-
ish term for a spiced wine
made of cold or warm
wine, sugar, lemon, or-
anges or spices); amazake
(a sweet low-alcoholic
beverages (<1% alcohol)
made from rice by koji;
mirin (a sweet alcoholic
beverage (<10% alcohol)
made from a mixture of
shoochuu (a spirituous
beverage), rice and koji);
“malternatives,” and pre-
pared cocktails (mixtures
of liquors, liqueurs, wines,
essences, fruit and plant
extracts, etc. marketed as
ready-to-drink products or
mixes). Cooler-type bev-
erages are composed of
beer, malt beverage, wine
or spirituous beverage,
fruit juice(s), and soda
water (if carbonated)
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K. READY-TO- 1. Snacks – potato- Includes all savoury snacks, with or without Potato chips, pop-
EAT SAVOUR- , cereal- or starch- added flavourings, but excludes unsweetened corn, pretzels, rice
IES based (from roots crackers. crackers (senbei),
and tubers, pulses flavoured crackers
and legumes), (e.g. cheese-
including chips flavoured crackers),
and crunchies bhujia (namkeen;
snack made of a
Fried Corn Snacks mixture of flours,
maize, potatoes, salt,
(Chichacorn)
dried fruit, peanuts,
PNS/BFAD spices, colours, fla-
22:2010 vours, and antioxi-
dants), and papads
(prepared from
soaked rice flour or
from black gram or
cow pea flour,
mixed with salt and
spices, and formed
into balls or flat
cakes).
2. Chicharon
3. Snacks – fish- This describes savoury crackers with fish,
based fish products or fish flavouring.
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A. DAIRY 1. Condensed milk Includes all types of dairy products that are Includes products
PRODUCTS and and analogues derived from the milk of any milking animal based on skim, part-
ANALOGUES, (plain) (e.g. cow, sheep, goat, buffalo). In this skim, low-fat and
excluding (evaporated/ category, a “plain” product is one that is not whole milk, blends
products under reconstituted flavoured, nor contains fruit, vegetables or of
Fats, Oils and Fat milk) other non-dairy ingredients, nor is mixed evaporated skimmed
Emulsions with other non-dairy ingredients, unless milk and vegetable
Milk and Milk permitted by relevant standards. Analogues fat, and blends of
Definition: Products are products in which milk fat has been sweetened
Includes all types partially or wholly replaced by vegetable fats condensed skimmed
of dairy products AO No. 132 s.
or oils. milk and
that are derived 1970 vegetable fat.
from the milk of
any milking
animal (e.g. cow, 1.a. Condensed Condensed milk is obtained by partial Includes partially
sheep, milk (plain) removal of water from milk to which sugar dehydrated milk,
goat, buffalo). In may have been added. For evaporated milk, evaporated milk,
this category, a the water removal may be accomplished by sweetened
“plain” product is Milk and Milk heating. condensed milk, and
one that is not Products
khoa (cow or
flavoured, nor AO No. 132 s. 1970 buffalo milk
contains fruit, concentrated by
vegetables or boiling)
other non-dairy
ingredients, nor is
mixed with other 1.b. Beverage Milk or cream substitute consisting of a Includes condensed
non-dairy whiteners vegetable fat-water emulsion in water with milk analogues,
ingredients, unless milk protein and lactose or blends of evaporated
permitted by vegetable proteins for use in beverages such skimmed milk and
relevant as coffee and tea. Also includes the same vegetable fat and
standards. type of products in blends of sweetened
Analogues are powdered form. condensed skimmed
products in which milk and vegetable
milk fat has been fat.
partially or wholly
replaced by
vegetable fats
or oils.
2. Milk powder Milk powder and cream powder (plain): Milk Includes casein and
and cream powder products obtained by partial removal of water caseinates.
and powder from milk or cream and produced in a
analogues (plain) powdered form.
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6. Fruit fillings Includes the ready-to-eat products and mixes. Includes cherry pie
for pastry Includes all type of fillings excluding purees filling and raisin
(LR Letter B.6). These fillings usually filling for oatmeal
include whole fruit or fruit pieces. cookies.
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8. Vegetable
protein products
(canned and
frozen)
D. Cocoa products and Chocolate products including imitations and chocolate
CONFECTIONERY substitutes
Definition: a. Cocoa mixes Includes a variety of products that are Includes drinking
Includes all cocoa (powders) and used in the manufacture of other chocolate powder;
and chocolate cocoa mass/ cake chocolate products or in the preparation breakfast cocoa; cocoa
products of cocoa-based beverages. dust (fines), nibs, mass,
press cake;
chocolate liquor; cocoa
mixes (powders for
preparing the hot
beverage); cocoa-sugar
mixture; and dry mixes
for sugar-cocoa
confectionery.
b. Cocoa mixes Products that may be produced by adding Includes chocolate
(syrups) a bacterial amylase to cocoa liquor. syrup used to prepare
chocolate milk or hot
chocolate.
c. Cocoa-based Products in which cocoa is mixed with Includes cocoa butter,
spreads, including other ingredients (usually fat-based) to fillings for bonbons and
fillings prepare a spreadable paste that is used as chocolates, chocolate
a spread for bread or as a filling for fine pie filling, and nut-
bakery wares. chocolate based spreads
for bread (Nutella-type
product).
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D. d. Cocoa and Chocolate is produced from cocoa nibs, Includes bonbons, cocoa
CONFECTIONERY chocolate mass, press cake, powder, or liquor with or butter confectionery
products, without addition of sugar, cocoa butter, (composed of cocoa
Definition: including aroma or flavouring substances, and butter, milk solids and
Includes all cocoa “tablea”; sugar), white chocolate,
and optional ingredients (e.g. nuts). chocolate chips (e.g. for
and chocolate imitation
baking), milk chocolate,
products chocolate, cream chocolate, sweet
chocolate chocolate, bitter
substitute chocolate, enrobing
products chocolate, chocolate
covered in a sugar-based
“shell” or with coloured
Ethnic Milk- decorations, filled
Based chocolate (chocolate
Confectioneries with a texturally distinct
PNS/FDA 34:2011 center and external
coating, excluding flour
confectionery and pastry
products of category
MR Letter J.a and
chocolate with added
edible ingredients,
yema, pastillas
E. CEREAL- 1. Fermented The product is prepared from soybeans that Includes products such
BASED soybeans (e.g. have been steamed and fermented with as dou chi
PRODUCTS, natto, tempe) certain fungi or bacteria (starter). (China), natto (Japan),
derived from cereal and tempe (Indonesia).
grains, from roots
and tubers, pulses,
legumes and pith
2. Fermented The product is prepared by forming
or soft core of palm Soybean curd soybean curd into a loaf during the
tree – Soybean fermentation process.
products
F. PROCESSED 1. Processed meat, poultry and game products in whole or cuts
MEAT AND
MEAT 1.a. Non-heat This category describes several treatment
PRODUCTS, treated processed methods (e.g. curing, salting, drying,
INCLUDING meat, poultry and pickling) that preserve and extend the shelf
POULTRY AND game products life of meats.
GAME (cured, fermented,
chilled)
1.a.1. Cured Salted products are treated with sodium Includes bacon (cured,
(including salted) chloride. Dry cured (dry pickled) products dry-cured, immersion-
non-heat treated are prepared by rubbing salt directly on the cured, pump-cured);
processed meat, meat surface. Wet pickle cured products are side bacon; corned beef;
marinated beef; and
poultry and game prepared by submerging the meat in a brine different types of
products solution. Pump cured products are prepared Oriental pickled
by injecting brine into the meat. Curing products: miso-pickled
may also be achieved by meat (miso-zuke), koji-
addition of additives. Smoked products are pickled meat (koji-
also included here. zuke), and soy sauce-
pickled meat (shoyu-
zuke).
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2.c. Salmon Roe is usually produced by washing, salting and Includes salted
substitutes, caviar allowing to ripen until transparent. The roe is then salmon roe (sujiko),
and other fish roe packaged in glass or other suitable containers. The processed, salted
products term “caviar” refers only to the roe of the sturgeon salmon roe (ikura),
species (e.g. beluga). Caviar substitutes are made
of roe of various sea and freshwater fish (e.g. cod cod roe, salted cod
and herring) that are roe (tarako) and
salted, spiced, dyed and may be treated with a lumpfish caviar.
preservative.
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1.b. Frozen
dough
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2.b. Non- Include water-, coconut milk-, and milk- Includes barbecue
emulsified sauces based sauces, gravies and dressings. sauce, tomato ketchup,
(ketchup, cheese cheese sauce,
sauce, cream Worcestershire sauce,
Oriental thick
sauce, brown Worcestershire sauce
gravy) (tonkatsu sauce), chilli
sauce, sweet and sour
Banana Sauce dipping sauce, and
white (cream-based)
AO No. 123-A s. sauce (sauce consisting
1985 primarily of milk or
cream, with little
added fat (e.g. butter)
Tomato Catsup and flour, with or
AO No. 233 s. without seasoning or
1974 spices), banana sauce,
tomato catsup.
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Citrus Beverage
PNS/BFAD
11:2007
1.d. Powdered
cocoa drink mixes
(cocoa)
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PNS/BFAD
08:2007
(Fermented
Milks)
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A. DAIRY 4.a. Unripened Unripened cheese, including fresh cheese, is cream cheese
PRODUCTS and cheese ready for consumption soon after (rahmfrischkase, an
ANALOGUES, manufacture. uncured, soft
excluding spreadable cheese)
mozzarella and
products under scamorza cheeses and
Fats, Oils and paneer (milk protein
Fat Emulsions coagulated by the
addition of citric acid
Definition: from lemon or lime
juice or of lactic acid
Includes all types from whey, that is
of dairy products strained into a solid
that are derived mass, and is used in
from the milk of vegetarian versions of,
any milking e.g. hamburgers).
animal (e.g. cow, Includes the whole
unripened cheese and
sheep, goat, unripened cheese rind
buffalo). In this (for those unripened
category, a cheeses with a “skin”
“plain” product is such as mozzarella).
one that is not Most products are
flavoured, nor plain, however, some,
contains fruit, such as cottage cheese
vegetables or and cream cheese, may
be flavoured or
other non-dairy contain ingredients
ingredients, nor is such as fruit,
mixed with other vegetables or meat.
non-dairy
ingredients,
unless permitted 4.b. Ripened cheese Ripened cheese is not ready for consumption Includes ripened
by relevant soon after manufacture, but is held under cheese that may be
standards. such time and temperature conditions so as soft (e.g.
Analogues are to allow the necessary biochemical and camembert), firm
products in which physical changes that characterize the (e.g. edam, gouda),
milk fat has been specific cheese. Includes cheese in brine, hard (e.g. cheddar),
partially or which is a ripened semi-hard to soft cheese, or extra-hard.
wholly replaced white to yellowish in colour with a compact
by vegetable fats texture, and without actual rind that has been
or oils. preserved in brine until presented to the
consumer.
4.b.1) Ripened Refers to ripened (including mould-ripened) Includes blue
cheese, includes cheese, including rind, or any part thereof, cheese, brie, gouda,
rind such as cut, shredded, grated or sliced acteal, hard grating
cheese. cheese, and Swiss
cheese.
4.b.2) Rind of The rind of the cheese is the exterior portion
ripened cheese of the cheese mass that initially has the same
composition as the interior portion of the
cheese, but which may dry after brining and
ripening.
4.b.3) Cheese Dehydrated product prepared from a variety Includes spray-dried
powder (for or processed cheese. cheese.
reconstitution; e.g.
for cheese sauces)
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A. DAIRY 4.c. Whey cheese A solid or semi-solid product obtained by Includes the whole
PRODUCTS and concentration of whey with or without the cheese and the rind
ANALOGUES, addition of milk, cream or other materials of of the cheese.
excluding milk origin, and moulding of the
products under concentrated product.
Fats, Oils and
Fat Emulsions 4.d. Processed Product with a very long shelf life obtained
cheese by melting and emulsifying cheese. Includes
products manufactured by heating and
Definition: emulsifying mixtures of cheese, milkfat, milk
Includes all types protein, milk powder, and water in different
of dairy products amounts. Products may contain other added
that are derived ingredients, such as aromas, seasonings and
from the milk of fruit, vegetables and/or meat. Product may be
any milking spreadable or cut into slices and pieces. The
animal (e.g. cow, term “processed” does not mean cutting,
sheep, goat, grating, shredding, etc. of cheese.
buffalo). In this
category, a “plain”
product is one that 4.d.1) Plain Processed cheese product that does not Includes American
is not flavoured, processed cheese contain added flavours, seasonings, fruit, cheese, requeson.
nor contains fruit, vegetables and/or meat.
vegetables or
other non-dairy 4.d.2) Flavored Processed cheese product that contains added Includes actealed
ingredients, nor is processed cheese, flavours, seasonings, fruit, vegetables and/or cheese spread with
mixed with other including those meat. vegetables, pepper
non-dairy containing fruits, jack cheese, cheddar
ingredients, unless vegetables, meat, cheese spread with
permitted by etc wine, and cheese
relevant standards. balls (formed
Analogues are processed cheese
products in which coated in nuts, herbs
milk fat has been or spices).
partially or wholly
replaced by 4.e. Cheese Products that look like cheese, but in which Includes imitation
vegetable fats or analogues milkfat has been partly or completely cheese, imitation
oils. replaced by other fats. cheese mixes, and
imitation cheese
powders.
4.f. Whey protein Product containing the protein extracted from Includes ricotta
cheese the whey component of milk. These products cheese.
are principally made by coagulation of whey
proteins.
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2.b. Frozen pro- Includes raw, partially cooked and fully Includes frozen
cessed meat, poul- cooked comminuted or mechanically hamburger patties;
try and game deboned meat products that have been fro- frozen breaded or
products (nuggets, zen. battered chicken
patties, dump- fingers.
lings, salami,
meat loaf, hotdog)
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F. PROCESSED 1. Processed fish and fish products, including molluscs, crustaceans and
FISH AND FISH echinoderms
PRODUCTS,
INCLUDING 1.a. Frozen fish, Fresh, including partially cooked, fish Includes frozen or
MOLLUSCS, fish fillets and fish subjected to freezing or quick-freezing at sea deep frozen clams,
CRUSTACEANS products, including and on land for further processing. cod fillets, crab,
AND molluscs, finfish, haddock,
ECHINODERM crustaceans and hake, lobster,
S echinoderms minced fish, prawns
and shrimp; frozen
fish roe; frozen
surimi; and frozen
whale meat.
1.b. Frozen battered Uncooked product prepared from fish or fish Includes frozen raw
fish, fish fillets and portions, with dressing in eggs and bread breaded or batter-
fish products, crumbs or batter. coated shrimp; and
including molluscs, frozen or quick-
crustaceans and frozen breaded or
echinoderms; battercoated fish
including value fillets, fish portions
added products and fish sticks (fish
(battered, fingers).
marinated, smoked,
spiced, fish and
squid balls
preparations)
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F. PROCESSED 1. Processed fish and fish products, including molluscs, crustaceans and echino-
FISH AND FISH derms
PRODUCTS,
INCLUDING 1.d.2) Cooked mol- Cooked products include steamed, boiled or Includes cooked
MOLLUSCS, luscs, crustaceans any other cooking method except frying see crangon crangon
CRUSTACEANS and echinoderms HR Letter F.1.d.3). and crangon vulgar-
AND ECHINO- is (brown shrimp;
DERMS cooked shrimp,
clams and crabs.
1.d.3) Fried fish Ready-to-eat products prepared from fish or Includes ready-to-
and fish products, fish portions, with or without further dressing eat fried surimi,
including mol- in eggs and bread crumbs or batter, that are fried calamari, and
luscs, crustaceans fried, baked, roasted or barbecued, and then fried soft-shell
and echinoderms packaged or canned with or without sauce or crabs.
oil.
2. Fully preserved, Products with extended shelf life, manufac- Includes canned
including canned tured by pasteurizing or steam retorting and tuna, clams, crab,
or fermented fish packaging in vacuum-sealed air-tight con- fish roe and sar-
and fish products, tainers to ensure sterility. Products may be dines; gefilte fish
including mol- packed in their own juice or in added oil or balls; and surimi
luscs, crustaceans sauce. (heat-pasteurized).
and echinoderms
PNS/BFAD
06:2006 ICS
67.120.30
(Thermally Pro-
cessed Fish Prod-
ucts)
PNS/FDA 36:2014
(Salt Fermented
Fish and Shrimps
[Bagoong])
G. EGG AND a. Liquid egg The purified whole egg, egg yolk or egg
EGG PRODUCTS products white is pasteurized and chemically pre-
served (e.g. by addition of salt).
b. Frozen egg The purified whole egg, egg yolk or egg Includes frozen
products white is pasteurized and frozen. eggs, frozen egg
whites, frozen egg
yolks
c. Dried and/or Sugars are removed from the purified whole Includes dried eggs,
heat coagulated egg, egg yolk or egg white, which is then dried egg whites,
egg products pasteurized and dried. dried egg yolks
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D.C. 2008-0006
(Amendments to
Department
Circular No. 2007-
0276 dated 07
December 2007,
Re: Guidelines for
the Labeling of
Breastmilk
substitutes, infant
formula, other
related products,
foods and
beverages, and
other related
products within the
scope of E.O. 51,
otherwise known as
the “Milk Code”,
and to Department
Circular No. 2007-
272 dated
December 2007,
Re: Containers and
Labels of Milk
Products within the
Scope of EO 51
otherwise Known
as “Milk Code”.)
Codex Stan 156- Follow-up formulae:
1987 (Codex Food intended for use as a liquid part of the
Standard for Follow complementary feeding of infants (aged at least 6
-Up Formula) months) and for young children (aged 1-3 years).
They may be ready-to-eat or in a powdered form to
be reconstituted with water. Products, other than
those under formulae for special medical purposes
intended for infants, may be soy based hydrolysed
protein and/or amino acid-based, or milk-based.
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2. Complementary Foods that are intended for infants 6 months Includes cereal-,
foods for infants and of age and older, and for progressive fruit, vegetable-, and
young children adaptation of infants and children to ordinary meatbased “baby
food. Products may be ready-to-eat or in foods” for infants,
Codex Stan 73-1981 powder form to be reconstituted with water, “toddler foods,” and
(Codex Standard for milk, or other suitable liquid. “junior foods”;
Canned Baby Foods) acteal flour, biscuits
and rusks for
Codex Stan 074-1981, children.
Rev. 1-2006 (Codex
Standard for
Processed Cereal-
Based Foods for
Infants and Young
Children)
CAC/GL 8-1991
(Guidelines on
Formulated
Complementary
Foods for Older
Infants and Young
Children)
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8.Dietetic formulas
for weight control
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ASEAN GL
Minimising Risk of
Transmission TSE
TMHS V1.0
(1Oct14)
ANNEX III
ASEAN GL on
Limits of
Contaminations
TMHS V1.0
(13Nov14) (1)
Pharm'l Excipient
6th
PNS/BAFPS
22:2004 (Virgin
Coconut Oil
2015 Philippine
Dietary Reference
Intake
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J. FOOD
SUPPLEMENT/
HERBAL
FOOD/
HERBAL
DIETARY
SUPPLEMENTS
Office Order
No.22 s.1991
(Guidelines for
the Classification
of Vitamins and
Minerals as Drug
or as Food)
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pg. 17 of
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Mode of Payment:
BancNet Online (with additional fee of Php 15.00. Please
refer to FDA Advisory No. 2015-021
LandBank of the Philippines (with additional fee of
Php 40.00
You may check the status of the application under the “Task” column
of the company account dashboard.
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Step 1: Access the online portal (E-registration system) thru the FDA website
(http://ww2.fda.gov.ph) and click “E-Portal” as shown in the image above.
The Company Account Holder should use the account of the Market Authorization
Holder (MAH) of the product being applied for registration. The MAH shall be
primarily responsible for the filing and secur ing of CPR applications, safety
and continuing compliance of the product with applicable rules and regulations of
FDA. Once approved, the MAH and/or the manufacturer of this product will be
reflected in the CPR.
Step 2: Provide the Username and Password of the MAH then click “Login”.
Step 3: Click “New Case” and choose “Food Product Registration (Initial
Application Form)” under the Electronic Registration folder. Select “Start Case”
to begin a new application.
Please read and understand the declaration. This declaration conveys binding
agreement of the applicant with the FDA to provide accurate information, affirm
full responsibility for the safety of the product being registered, and comply with
all applicable rules and regulations.
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Fill out all necessary information in capital letters, except for Trademark,
Corporate De Facto (e.g. GmbH) and e-mail address. Please read all the notes
indicated after the data entries.
All data entries with red asterisk (*) are mandatory fields. The application will not
proceed to the next step upon clicking “Continue” if not all mandatory fields are
filled out.
Vitamins and Minerals and Amino Acids are under Medium Risk Food Product
and categorized as: MRM1. Vitamins and minerals as Food Supplement and
MRM2. Amino Acids as Food Supplement.
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Food Supplement Products with herbs and botanicals and product with other
nutritional substances (plant or animal origin) and/or combination are under High
Risk Food Product and categorized as HRK1.HRK1.
Indicate the true nature or a more appropriate product description such as:
Product Name: Swiss Choco Hazelnut Flavored Ice Cream
(Chocolate Ice Cream Infused with Hazelnut
Flavor and Milk –Choco Coated Biscuits,
Glazed with Chocolate Ripple
Brand Name: SWISSE ICE CREAM ®
Products such as Foods for Special Medical Purpose shall be declared as:
Product Name: Low Lactose Formula for Special Medical Purpose Intended
for Infants from 0-12 Months (For Lactose Intolerance)
Brand Name : ALTA VITA ®
Product Name: Meal Replacement Shake Powder - Vanilla Flavor
Brand Name: VITA E-LITE®
For Products that are exclusive for Export or for Institutional Use, declare it after
the product name in the data entry.
Example:
MENTHOL CANDY (FOR EXPORT MARKET ONLY)
SOY SAUCE (FOR INSTITUTIONAL USE ONLY)
INFANT FORMULA (FOR EXPORT TO MALAYSIA)
Products for Institutional Use are classified according to their risk categorization.
Example:
Product: MAYONNAISE (FOR INSTITUTIONAL USE ONLY)
Type of Food Product: Medium Risk Food Product
Food Categorization: MRK2a. Emulsified sauces and dips
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For products formulated for an intended age group, special medical purpose, or
special dietary use, include the target population in the product name:
Example:
INFANT FORMULA ( 0 TO 6 MONTHS)
FORMULA FOR SPECIAL MEDICAL PURPOSES INTENDED FOR
INFANTS 0-6 MONTHS – FOR THE DIETARY MANAGEMENT OF LOW
BIRTHWEIGHT INFANTS
MILK SUPPLEMENT (FROM 6-12 MONTHS)
CEREAL FOR INFANTS – BROWN RICE WITH BANANA (6+ MONTHS)
BISCUIT AND CEREAL IN ONE – FORMULATED COMPLEMENTARY
FOOD FOR OLDER INFANTS AND YOUNG CHILDREN
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Product Name should indicate the true nature of the product (e.g. Vitamin A, B1 &
C plus Minerals) and shall be specific and not generic. Also, the word “Food/
Dietary Supplement” and its product form (e.g. tablet, capsule, syrup, granules,
liquid, gummies, powder) must be part of the product name.
The declaration of the company name and address should be consistent with the
declaration in the valid LTO.
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If the product is imported and not directly sourced from the manufacturer, click
“No” in the field of “Directly Sourced?”, upload Documentary Requirements
and indicate the complete name and address of the supplier as well as the
complete name and address of the manufacturer.
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4. Choose “Yes” if the product is directly sourced and “No” if otherwise. If the
product is directly sourced, it was imported directly from the manufacturer in
the country of origin of the product. If not, the product was imported through a
“middle-man” or the supplier.
Example:
Directly Sourced:
Manufacturer: USA — > Importer: Philippines
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5. Click the “Choose File” to attach ANY of the following scanned copy of the
original documents issued by the regulatory or health authority of the country
of origin or of source: Valid Manufacturer’s Certificate of Registration with
GMP compliance or its equivalent, Valid Sanitary Phyto-sanitary Certificate or
Health certificate, Valid ISO 22000 Certification, Valid HACCP Certificate, or
Certificate of Free Sale.
6. For Directly sourced products, declare the complete name and address of the
Manufacturer.
For products NOT directly sourced, declare the complete name and address of the
supplier and the manufacturer.
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3. Click the “Choose File” to attach ANY of the following scanned copy of the
original documents issued to the applicant by the establishment from which it
sources the products it sells: Valid notarized distributorship agreement, or
Letter of appointment between the applicant and the FDA-licensed source
4. If the product is not directly sourced, declare the complete name and address
of the supplier and manufacturer.
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5. If the product is directly sourced, declare the complete name and address of the
manufacturer.
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3. Click the “Choose File” to attach ANY of the following scanned copy of the
original documents. For products sourced from supplier/manufacturer, upload
the scanned copy of the Valid and notarized toll manufacturing and/or
repacking agreement with FDA-licensed toll manufacturer and/or repacker.
4. If the product is not directly sourced, declare the complete name and address
of the supplier and manufacturer.
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Please refer to CODEX Advisory list of nutrient compounds for use in Infant
Formula and Formula for Special Medical Purposes Intended for Infants and Milk
Supplements.
Please refer to Bureau Circular 2006-016, Administrative Order 88a. S. 1984 and
GSFA for List of Approved Food Additives and its functional category.
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Indicate the recommended usage per day or Direction for Use. (e.g. 1 tbsp. once a
day, 1 tablet once a day, Dissolve 1 sachet in a glass of water).
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Ensure the completeness and accuracy of the details for the parameters and
specifications (Physical, Chemical and Microbiological) in coherence with the
Local and International Standards (e.g. Philippine National Standards,
Administrative Orders, and other relevant issuances).
Bottled Drinking Water: Please refer to A.O. 18-A s. 1993 for the parameters and
standard of bottled drinking water.
Food for Special Dietary Uses and food for Special Medical Purposes: Please
refer to applicable CODEX Standards.
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For products with different and/or multiple packaging material and shelf life,
please use “semi-colon” to separate/delineate declaration in the data entry.
Example:
Shelf Life Declaration (in Months): 6; 12
Packaging Material Type/Name: PLASTIC PACK; ALUMINUM FOIL
PACK
The declared packaging material in the data entry should be specific and consistent
with the submitted pictures of the product.
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Nutrition and health claims shall be covered by Bureau Circular 2007-002 and
CODEX Guidelines for Use of Nutrition and Health Claims under
CAC/GL 23-1991 and supported by research conducted for the product. Upload
the Documentary Requirements for justification.
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“Label_(Case Number)”
For products with multiple labels, the product label shall be named following the
format:
Also, submit pictures of the product in all angles and in different packaging sizes,
and from at least two different perspectives allowing visual recognition of a
product as the same with the one being registered.
Note: When scanning documents for upload, preferably use the 150 x 150 dpi
setting. Check clarity of the label infor mation befor e uploading the labels and
pictures of the product. Please be reminded that you may only upload documents
in .PNG and .PDF format.
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*See Annex G for the list of critical documents and reference standards for Medium and High Risk
Food Products (i.e. Infant Formula, Milk Supplement/Follow-Up Formula, Foods for Special
Medical Purposes, Foods for Special Dietary Uses, Cereal-based Foods for Infants & Young
You may only upload a single document in this step per Documentary require-
ment. If you need to upload more documents, click “Continue” to proceed to the
next step where you may review and upload additional documents.
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Please be reminded that only 25MB is allotted per product application. This
includes all the documents uploaded during initial application, amendment
application and reapplication.
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Payment can be made thru FDA Cashier, Land Bank and BancNet. Validity of
Initial Application of Food Supplement is two (2) to five (5) years, while
Automatic and Regular Renewal is up to five years. The fees generated are based
on Administrative Order 50 s. 2001.
You may review all your input in the data entries. Click “Open” to view the
Order of Payment Form then pr int two copies of this document. Click “Next
Step” and choose “Continue” to assign this application to FDA Cashier.
Payment Options:
1. Payment thru Land Bank (FDA Memorandum Circular 2013-046) and use
FDA Food Clearing Account #: 0392-2220-22
2. Payment thru BancNet online (FDA Advisory 2015-021)
3. FDA Cashier
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Personal delivery to the Food and Drug Action Center (FDAC), formerly
Public Assistance, Information and Receiving (PAIR) Unit, at 4th floor of
Civic Prime Building.
Delivery via a registered courier reflecting the company’s complete name and
address on the sender information; and “FDA Center for Food Regulation and
Research (E-Registration Application)” with address at “Civic Drive, Filinvest
City, Alabang, Muntinlupa City 1781” as the receiver information.
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Transitory Provisions
The E-Registration shall be accessible for applications for r egistr ation of raw
materials or ingredients, low risk, medium risk and high risk pr e-packaged
processed food products starting 11 June 2016.
Repealing Clause
FDA Circular 2014-029 and other issuances inconsistent with this Cir cular
are hereby repealed.
Separability Clause
If any provision of this Circular be declared as invalid or unenforceable, the
validity and enforceability of the remaining portions or provisions shall remain in
full force and effect.
Effectivity
E-registration of all pr e-packaged processed food products shall take full effect
on 01 August 2016 following publication in two (2) newspaper s of national
circulation and submission to the University of the Philippines Office of the
National Administrative Register (ONAR).
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These shall be treated as initial under the E-Registration System. The initial
application fee shall be waived and a reapplication fee shall be charged after
due evaluation, provided that the application was filed within six (6) months
from the date of receipt of the Letter of Denial with the following records for
verification:
1.Issued Letter of Denial reflecting the product being applied for.
2.Two (2) copies of the system generated Order of Payment consistent with
the previously applied years of validity.
II. For Applications for Registration of Low Risk food products and Raw
Materials Previously Denied via the E-Registration System:
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7. Click “Continue”.
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Step 1: Click “Inbox” and look for the case number to be applied as amendment.
Step 2: Double click the “Case Number” to start the application.
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Step 3: Read and understand the Declaration and choose “Amendment” as type of
action.
Step 4: Click “Continue” button to proceed.
PRODUCT SUMMARY
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SINGLE APPLICATION
EXAMPLE: CHANGE IN BRAND NAME
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PAYMENT PROCEDURE
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After payment, you can monitor your application by logging in your account.
Look for the “Participated”.
Double click the “Case Number”.
Click the “Information” button located in the upper most part of the
application.
As shown in the picture above, the type of amendment applications applied were
“Change in Brand Name, Change in Product Name and Change In/Additional
Packaging Design”.
Provide the data entry with all the changes to be made.
Upload the new product label by clicking “Choose File”.
Click the “Next” button to proceed.
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Once the amendment application is done, you can view the summary table to
check if your application was approved or denied.
Log in your account.
Click the “Inbox” and look for the case number applied as amendment.
Right click the “Case Number”.
MULTIPLE AMENDMENT
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Select the “Attach” button to upload other documents to support the proposed
design.
Click the “Next” button to proceed.
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Select the “Attach” button to upload other documents to support the proposed
design.
Click the “Next” button to proceed.
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• Select the "Attach" button to upload the requirement as per Administrative Or-
der 2014-0029(Letter of intent and New product label reflecting the change,
termination agreement/deed of assignment, Agreement of new manufacturer/
importer/distributor or Appointment letter).
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Click "Change in Company Name" (To generate payment, since there is no op-
tion on E-portal in this case).
• Select the "Attach" button to upload the requirement as per Administrative Or-
der 2014-0029 (Letter of intent and New product label reflecting the change in
manufacturers’ name, proof of change in NAME of the manufacturer, and Cer-
tificates as per FDA Circular 2016-007 from the manufacturer reflecting its
new NAME).
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Select the "Attach" button to upload the requirement as per Administrative Or-
der 2014-0029 (Letter of intent, new product label reflecting the change in
LTO Number and Valid LTO).
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The issued CPR from manual registration process must have at least four (4)
months remaining validity upon application. Otherwise, apply for renewal first.
Proceed to payment options to forward your application to the Evaluator.
After payment, you can monitor your application by logging in your account.
Look for the “Participated” and click your application.
Select the “Information” button located in the upper most part of the
application.
Click “Process Map” to monitor or check the development of your
application.
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4. Once the details are confirmed, click the “Continue” button to proceed.
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Click “Continue”.
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PROCEDURE:
1. Double click the Case Number due for “CANCELLATION”
2. Drop down “Type of Action” button and select “I want to cancel this
authorization”.
3. Once “I want to cancel this authorization” is selected, click and select the
“Continue” button.
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4. Once the details are confirmed, click the “Continue” button to proceed.
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Example:
Self-initiated testing of contaminants of products, assessment and verification of
capability of sources to produce quality and safe raw materials or finished goods,
vigilance along the food chain on where hazards may occur and acting on to
mitigate, eliminate the hazard (e.g. observance of the optimal temperature in
delivery of frozen goods, manner of stacking of deliverymen that prevents denting
of canned acidic products, etc.).
Example:
Maintenance of records (Invoices, Certificate of Free Sale) from where the raw
materials/imported products came from and where the finished food products will
be distributed or delivered.
Example:
The company must notify FDA Center for Food Regulation and Research through
submission of letter explaining the nature of the risk or non-compliance and the
initial steps conducted to contain the hazard or potential risk to consumers. In
cases where the unsafe or non-compliant food product may have reached the
consumer, the company must be proactive in withdrawing the product and
informing the consumer of the reason for such withdrawal.
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ANNEX
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PNS/BFAD 01:2005 Ethnic Food Products: Dry Base Mixes for Soups and Sauces
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PNS/FDA 38:2015 Fish Sauce (Patis) and Fish Flavoured Sauce – Specifications
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ANNEX
ANNEX B.
B. SUMMARY
SUMMARY OF
OF CURRENT
CURRENT FOOD
FOOD STANDARDS
STANDARDS
As of October 2017
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ANNEX
ANNEX B.
B. SUMMARY
SUMMARY OF
OF CURRENT
CURRENT FOOD
FOOD STANDARDS
STANDARDS
As of October 2017
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ANNEX
ANNEX B.
B. SUMMARY
SUMMARY OF
OF CURRENT
CURRENT FOOD
FOOD STANDARDS
STANDARDS
As of October 2017
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ANNEX
ANNEX B.
B. SUMMARY
SUMMARY OF
OF CURRENT
CURRENT FOOD
FOOD STANDARDS
STANDARDS
As of October 2017
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The labels of all food additives sold by retail shall bear the information re-
quired by sub-sections a.1 to a.6 of this section, as applicable to the food addi-
tive being labelled.
A. The name of each food additive present shall be printed. The name shall
be specific and not generic and shall indicate the true nature of the food
additive. Where a name has been established for a food additive in a Co-
dex list of additives, that name shall be used. In other cases the common or
usual name shall be listed or, where none exists, an appropriate descriptive
name shall be used.
1) If two or more food additives are present, their names shall be given in
the form of a list. The list shall be in the order of the proportion by
weight which each food additive bears to the total contents of the con-
tainer, the food additive present in the greatest proportion by weight
being listed first. Where one or more of the food additives is subject to
a quantitative limitation in a food covered by a Codex standard, the
quantity or proportion of that additive may be stated. If food ingredi-
ents are part of the preparation, they shall be declared in the list of in-
gredients in descending order of proportion.
2) In the case of mixtures of flavourings, the name of each flavouring
present in the mixture need not be printed. The generic expression
“flavour” or “flavouring” may be used, together with a true indication
of the nature of the flavour. The expression “flavour” or “flavouring”
may be qualified by the words “natural”, “nature-identical”,
“artificial”, or a combination of these words, as appropriate. This pro-
vision does not apply to flavour modifiers, but does apply to “herbs”
and “spices”, wherein generic expressions may be used where appro-
priate.
3) All food additives shall carry an expiration date which shall signify
that beyond this date the effectivity of the additive for its intended use
is diminished.
4) The words “For Food Use” or a statement substantially similar thereto
shall appear in a prominent position on the label.
5) The words “For Food Use” or a statement substantially similar thereto
shall appear in a prominent position on the label.
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C. Net contents
The net contents shall be declared in either the metric (Système Interna-
tional Units) or avoirdupois or both systems of measurement as required by
the country in which the food additive is sold. This declaration shall be
made in the following manner:
1) for liquid food additives, by volume or weight;
2) for solid food additives, other than those sold in tablet form, by weight;
3) for semi-solid or viscous food additives, either by weight or volume;
4) for food additives sold in tablet form, by weight together with the num-
ber of tablets in the package.
E. Country of Origin
The country of origin of a food additive shall be declared if its omission is
likely to mislead or deceive the consumer.
When a food additive undergoes processing in a second country which
changes its chemical or physical nature, the country in which the pro-
cessing is performed shall be considered to be the country of origin for
the purposes of labelling.
F. Lot Identification
Each container shall be marked in code or in clear to identify the producing
factory and the lot.
The labels of all food additives sold other than by retail shall bear the infor-
mation required by Sub-sections C.1.a to C.1.f, as applicable to the food addi-
tive being labeled; except that, where the food additives in non-retail containers
are solely destined for further industrial processing, the required information,
other than that described in Sub-sections C.1.a to C.1.f, may be given on the
documents relating to the sale.
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Bee Pollen and or Propolis This product contains bee pollen and or
propolis and may cause severe allergic
reaction including fatal and anaphylactic
reaction to susceptible individuals . Asthma
and allergic sufferers may be at greater risk .
Caffeinated Beverages (e.g. Excessive intake of caffeine may cause
energy and sports drinks ) sleeplessness, palpitation and other similar
side effects. Not recommended for children,
pregnant and lactating women, people who
may have heart problems and/or those
sensitive to caffeine”
FSMP – with polydextrose Statement to the effect that
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Additional Reqt’s:
-A statement that the product is not to be used for parenteral
administration.
-A prominent statement indicating whether the product is or is not
intended as the sole source of nutrition.
-The statement “For the dietary management of ___” with
specific disease, disorder or medical condition for w/c the product
is intended and for w/c it has been shown to be effective.
-Adequate precautions, known side effects, contraindication and
product-drug interaction, as applicable.
-Rationale for the use of the product and a description of the
properties or characteristics that make it useful.
-Specific age group if the product is formulated for this age group
-Feeding instruction, including method of administration and
serving size.
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Additional Provisions:
The label shall not make reference to the rate or amount of
weight loss which result from the use of the food or to
reduction in hunger or an increase in the sense of satiety.
Statement on the importance of maintaining an adequate
fluid intake when the product is used.
If there is sugar alcohol in excess of 20 g, a statement on
the label that the food may have a laxative effect.
Statement that the food maybe useful in weight control
only as a part of an energy-controlled diet.
The label shall bear a prominent statement recommedning
that if the food is used for more than 6 weeks, medical
advice should be sought.
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Additional Provisions:
The label shall not make reference to the rate or amount of
weight loss which result from the use of the food or to
reduction in hunger or an increase in the sense of satiety.
Statement on the importance of maintaining an adequate
fluid intake when the product is used.
If there is sugar alcohol in excess of 20 g, a statement on
the label that the food may have a laxative effect.
Statement that the food maybe useful in weight control
only as a part of an energy-controlled diet.
The label shall bear a prominent statement recommedning
that if the food is used for more than 6 weeks, medical
advice should be sought.
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-Other statements:
On the lowermost level, bold and prominent:
“Infants six months onwards should be given fresh,
indigenous, and natural foods in combination with
continued breastfeeding”
At the uppermost level, bold and prominent, font type: Arial,
font size: 1/6 of the biggest letter on the label:
English: “THIS PRODUCT MAY CONTAIN
PATHOGENIC MICROORGANISMS AND MUST BE
PREPARED AND USED APPROPRIATELY”
Filipino: “ANG PRODUKTONG ITO AY MAAARING
MAGKAROON NG MIKROBYO NA NAGDUDULOT NG
SAKIT AT DAPAT IHANDA AT GAMITIN NG TAMA”
OR
English: “THERE IS LIKELIHOOD THAT
PATHOGENIC MICROORGANISMS WILL BE IN THIS
PRODUCT WHEN IT IS PREPARED AND USED
INAPPROPRIATELY”
Filipino: “ANG PRODUKTONG ITO AY MAAARING
MAGKAROON NG MIKROBYO NA NAGDUDULOT NG
SAKIT KAPAG HINDI TAMA ANG PAGHAHANDA AT
PAGGAMIT”
-Complete name and address of the manufacturer/packer/repacker/
distributor/importer/exporter
-Country of origin
-Lot identification number
-Food Registration (F.R.) Number
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REFERENCES
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REFERENCES
2015 Philippine Dietary Reference Intake
Standards of Quality and Requirements for the Processing, Packaging
A.O. No. 18-A S. 1993
and Labeling of Bottled Drinking Water
Revised 2001 Schedule of Fees and Charges for the Corresponding
A.O. No. 50 2001
Services Rendered by the Bureau of Food and Drugs
A.O. No. 88-A s 1984 Regulatory Guidelines Concerning Food Additives
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REFERENCES
ANNEX III ASEAN GL on Limits of Contaminations TMHS V1.0(13Nov14) (1)
ASEAN Guidelines on Stability Study and Shelf-Life of Traditional Medicines and Health Sup-
plements.
B.C. No. 2007-002 Guidelines in the Use of Nutrition and Health Claims in Food
Codex Standard for Labelling of and Claims for Foods Special Medi-
Codex Stan 180-1991
cal Purposes
Codex Stan 181-1991 Standard for Formula Foods for Use in Weight Control Diets
Codex Standard for Formula Foods for Use in Very Low Energy Diets
Codex Stan 203-1995
for Weight Reduction
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REFERENCES
Amendments to Department Circular No. 2007-0276 dated 07 Decem-
ber 2007, Re: Guidelines for the Labeling of Breastmilk substitutes,
infant formula, other related products, foods and beverages, and other
D.C. 2008-0006 related products within the scope of E.O. 51, otherwise known as the
“Milk Code”, and to Department Circular No. 2007-272 dated De-
cember 2007, Re: Containers and Labels of Milk Products within the
Scope of EO 51 otherwise Known as “Milk Code”.
A Guide to Food Labelling and Advertisements—A publication of the Agri-Food and Veterinary
Authority, Singapore
Office Order No.22 Guidelines for the Classification of Vitamins and Minerals as Drug or
s.1991 as Food
PDR For Herbal Medicines 4th Ed
Pharm'l Excipient 6th
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REFERENCES
Philippine National Standard for Mango Beverage Products – Specifi-
PNS/BFAD 09:2007
cation
Philippine National Standard for Citrus Beverage Products – Specifica-
PNS/BFAD 11:2007
tion
PNS/BFAD 13:2007 Philippine National Standard for Banana Chips – Specification
PNS/BFAD 15:2007 Philippine National Standard for Dried Mango Products – Specification
PNS/BFAD 16:2007 Philippine National Standard for Dried Tropical Fruits – Specification
Philippine National Standard for Flour Sticks (Pancit Canton) – Speci-
PNS/BFAD 18:2008
fication
Philippine National Standard for Sugar Cane Wine (Basi) – Specifica-
PNS/BFAD 20:2009
tion
Philippine National Standard for Fried Corn Snacks (Chicharon) –
PNS/BFAD 22:2010
Specification
Philippine National Standard for Purple Yam (Ube) Jam (Halaya) –
PNS/FDA 24:2010
Specification
PNS/FDA 26:2010 Philippine National Standard for Smoked Fish – Specification
Philippine National Standard for Processed Pili Nut Products – Speci-
PNS/FDA 28:2010
fication
PNS/FDA 30:2010 Philippine National Standard for Tropical Fruit Wines – Specification
Philippine National Standard for Ethnic flour-based confectioneries
PNS/FDA 32:2011 (Polvoron,
Piaya and Barquillos) – Specification
Philippine National Standard for Ethnic milk-based confectioneries
PNS/FDA 34:2011 (Pastillas
and Yema) – Specification
Philippine National Standard for Salt Fermented Fish and Shrimps
PNS/FDA 36:2014
(Bagoong)
Recommended Energy and Nutrient Intakes (RENI)
REGULATION (EC) No 1924/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUN-
CIL of 20 December 2006 on nutrition and health claims made on foods
Republic Act 8172 An Act for Salt Iodization Nationwide (ASIN) Law
An Act Establishing the Philippines Food Fortification Program and
Republic Act 8976
for other Purposes
SAO # 257 s. 1976 Standardization of Rum
The Adopted Negative List of Active Ingredients (Animal or Plant) for Traditional Medicines
A Guide on Nutrition and Health Claims - Expert Committee On Nutrition, Health Claims And Ad-
vertisement - Malaysia
Make effective Use of Nutrition Information on Food labels - Ministry Of Health Malaysia
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2. How much does registration cost/fee and how many years is the validity of a CPR?
>> Fees and charges will be computed by the system based on the number of years (2, 3, 4 or 5
years validity) applied for and type of product. You may refer to A.O. 50 s. 2001 for the schedule
of fees. Payment may be made through the FDA Cashier by presenting your printed Order of
Payment form. Payments through Bancnet Online and Landbank Oncoll are also accepted.
4. How do I secure a username and password for E-Registration? Can I use one username and
password for all companies I am handling?
>> The CFRR E-Registration User Account and Password is company-specific. An authorized
representative handling multiple companies must secure a separate user account and password
for each respective company. You must secure a notarized authorization letter from the company
(with a valid License to Operate Number) being represented or the company account holder.
Send the request for a User Account to info@fda.gov.ph following the format specified below
with the scanned notarized authorization letter:
SUBJECT: CFRR:E-Registration
BODY: Email Address:
Last Name:
First Name:
Middle Name:
Company Name:
cont...
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5. The cashier cannot view my case number during payment. What should I do?
>> The application was not forwarded to the cashier. To forward the application, go to
the DRAFT section in your e-registration account and click the continue button after
generating the Order of Payment Form. If the case number is already in the Participat-
ed, the forwarding was successfully made.
In reapplication, click the case number of the denied application in the Inbox and a ques-
tion “Would you like to reapply” will pop up. Click “yes” and upload the documents/
compliance to your denial.
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8. What will be the proof that my applications under Notification of Amendment is ap-
proved or disapproved?
>> Applications under Notification of Amendment will not print a CPR unless it is
Amendment Data Capture (The existing CPR is from manual). Once the case number
is already in the inbox on your account, you can click the case number and view the
Amendment Summary Table which reflects the result of your application. If the appli-
cation is disapproved, you can see the remarks or reason for its disapproval on the
right side of the table.
9. Where can I categorize my product if it is in conventional form and has herbs, botani-
cals and other nutritional substances?
>> There is a new Food Categorization in the system under High Risk HRK2: Herbs
and botanicals and/or Products with other nutritional substances and/or combination
as Conventional Food Product. This new categorization is not yet specified in the An-
nex A of FDA Circular No.2016-014 and Administrative Order No.2014-0029 Annex
A.
10. How can we reach the CFRR Registration Section for other inquiries?
>> You may call us at 857-1992, or send an email to cfrr_lrd@fda.gov.ph. You may
also inquire through our Official Facebook Page https://www.facebook.com/
FDAPhilippines/.
12. I have sent additional documents to info@fda.gov.ph so the evaluator can attach it,
but my application was denied.
>> Sending additional files to info@fda.gov.ph does not guarantee approval of your
application unless CFRR has notified you to submit compliance documents. Before
sending additional files, be sure that you have received a notification from the con-
cerned evaluator. Also, you must submit the said additional files within the timeline as
mentioned in the notification received. Make sure that all attachments are complete
before finishing the case/application.
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14. How can we transfer the ownership of our CPR to another company?
>> Should there be no changes in the product, this will not be applied as initial appli-
cation. The new owner must apply for an Amendment using their own E-Registration
account, changing its Company Name, Company Address, License to Operate (LTO)
Number and its validity from the former owner to their own. The former owner must
CANCEL their existing CPR in the E-Registration System to be able to proceed with the
Amendment (Change in Company Name). Letter of intent declaring the agreement/
termination and transfer must be attached upon the application. Also, all documents
needed including the label with new importer’s/distributor’s name must be attached
under the name of the new owner.
15. How can I apply for an additional supplier or manufacturer of the same product?
>> Addition of Supplier can be applied through CPR amendment, however, Addition of
Manufacturer of the same product should be applied as INITIAL.
16. What documents are needed to be presented to BOC for the release of our shipment?
>> You just have to present the company’s License To Operate and the Certificate of
Product Registration of the shipment.
17. What are the products that need to secure Certificate of Product Registration in the
Philippines?
>> All processed food and food products including food additives, food supplements
and bottled water manufactured and/or distributed (i.e. for import, export and/or
wholesale), for trade and/or repacked are required to secure a Certificate of Product
Registration before these are sold, offered for sale or use, distributed or supplied,
among other marketing and promotional activities as per R.A. 9711 and A.O. 2014-
0029.
18. Do I need to secure a CPR for the Raw Materials that I will import for my own use as
manufacturer?
>> Food establishments with License to Operate as Manufacturer and Trader which
directly import and use raw materials, ingredients and food additives for their own use
or for further processing to manufacture a processed food product, need NOT secure a
CPR.
19. What level of Vitamins and Herbs are allowed for a product to be registered as a Food
Supplement?
>> Vitamins levels are computed by RDA/% RENI, as per Office Order 22 s.1991.
The maximum limit in Water Soluble Vitamins should be ≤150% RDA/RENI while Fat
Soluble Vitamins should be ≤105% RDA/RENI. On the other hand, Herbals and Bo-
tanicals require justification for the safety. If applicable, tests for toxicity study (e.g.
LD50 Toxicity Test) must be submitted.
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20. Do I need to declare the nutrition information in %RENI even if the products are im-
ported vitamins and minerals food supplement?
>> Yes, because the Office Order 22 s.1991, which sets the limit for vitamins and
minerals to be classified as Food Supplement is also applicable to imported vitamins
and minerals food supplement products
22. What will I do if I file for Amendment/Reapplication/Renewal using a new case num-
ber?
>> Only one case number shall be used for each application. If there is an instance
that a new case number was made of that same product, either one of the following
must be done:
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CONTACT FDA
For correspondence:
Your opinion matters. We want to hear from you regarding our user’s
documentation If you have feedback about how we can make our documentation
better or easier to use, please send us your feedback directly at info@fda.gov.ph
with subject: CFRR-User Manual Feedback.
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MEMBERS
www.fda.gov.ph
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CFRR Electronic Registration User Manual
2017 | 228
CFRR Electronic Registration User Manual
2017 | 229