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CFRR Electronic Registration User Manual

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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.

Overall, this manual will provide guidance to both its existing


stakeholders/clients and new applicants. It is designed to address
the issues and concerns regarding food classification, step by
step application using the new system and the things to be
expected from the food business operators.

With its publication, I hope that this electronic registration user


manual will bridge the gap between CFRR and its stakeholders.

NELA CHARADE G. PUNO, RPh


Director General
Food and Drug Administration

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CFRR Electronic Registration User Manual

Copyright © 2016 by the Center for Food Regulation and Research,


Food and Drug Administration, Department of Health.

All rights reserved. Reproduction and/or dissemination of material in


this booklet for educational and other non-commercial purposes are
authorized without any prior written permission from the CFRR,
FDA-DOH provided that the source is fully acknowledged.
Reproduction of material in this handbook for resale or other
commercial purposes is prohibited without written permission from
the CFRR, FDA-DOH. Applications for such permission should be
addressed to: Pilar Marilyn M. Pagayunan, Director IV of Center for
Food Regulation and Research.

Suggested Citation:

Center for Food Regulation and Research, Food and Drug


Administration, Department of Health. (2017). CFRR Electronic
Registration User Manual.

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CFRR Electronic Registration User Manual

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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CFRR Electronic Registration User Manual

INTRODUCTION, USES and


APPLICATION

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INTRODUCTION, USES and


APPLICATION

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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General Guidelines in the Registration of


Food Products

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General Guidelines in the Registration of Food Products


1. Requirements for registration are based on the requirements indicated in
Administrative Order 2014-0029 and FDA Circular 2016-014:
A. Proof of payment or fees as prescribed by current FDA regulations;
B. Clear and complete loose labels or artworks, as applicable, of all packaging
size, or equivalents as defined by FDA regulations except of bulk raw
materials, ingredients and food additives intended for further processing or for
distribution to establishments/manufacturers for further processing;
C. 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, as applicable;
D. For food supplement, a sample in actual commercial presentation shall be
submitted.
E. For food products with label claims: as applicable, documents to substantiate
claims, such as technical, nutritional or health studies or reports, market
research studies, Certificate of Analysis, quantitative analysis and
computations, scientific report or studies published in peer-reviewed scientific
journals, certificates or certification to support use of logo/seal on Sangkap
Pinoy, halal, Organic, or Kosher food and in compliance with current labelling
regulations.
F. Additional requirements for food supplement are the following:
*Certificate of Analysis for physico-chemical and microbiological parameters
*Shelf life study with stability data containing relevant information on the crit-
ical parameters of the finished product, period conducted, conclusion, and
signed/verified by competent technical staff to support shelf life declaration.
*Safety data (Acute Oral Toxicity Test (LD-50 Test, Heavy Metals Test, other
cytoxicity tests, safe history of use or other tests to assess potential toxicity
as applicable)
2. All food additives must conform with the Updated List of Food Additives and/or
latest General Standard for Food Additives based on Bureau Circular 2006-016 and
Administrative Order 2014-0029. Food flavours must be listed in Flavors and
Extracts Manufacturers Association (FEMA) or International Organization of the
Flavor Industry (IOFI) Generally Recognized As Safe Lists based on
B.C. 2006-016 or latest FDA Regulation on Food Additives.

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General Guidelines in the Registration of Food Products


3. Based on FDA Circular 2016-007, additional requirements for imported prod-
ucts include ANY of the following scanned copy of the or iginal documents:
(1) Foreign Agency Agreement or (2) Certificate of Distributorship or
(3) Appointment letter or (4) Proforma Invoice or (5) Memorandum of Agreement
from the supplier.
and ANY of the following documents issued by the Regulator y/ Health Author -
ity/Internationally Recognized Certifying Body:
(1) Certificate of Registration with GMP Compliance or its equivalent or (2) Valid
Sanitary Phyto-Sanitary Certificate or (3) Health Certificate or (4) ISO 22000
Certificate or (5) FSSC Certificate or (6) HACCP Certificate or (7) Certificate of
Free Sale issued to the Manufacturer.
In case, the Certificate of Free Sale is issued by the Chamber of Commerce or trade
association, this should be duly authenticated by the Philippine Consulate from the
country of origin.
4. Food products with standards of identity should conform with the specification in
the corresponding standards thru submission of Certificate of Analysis. Refer to
Annex A for the List of Philippine National Standards. For the analysis required
(both AO) see Annex B. Summary of Current Food Standards.
5. Medium and high risk food products should conform with the microbiological
parameters as indicated in Annex c (Revised Guidelines for the Assessment of Mi-
crobiological Quality of Processed Foods).
6. Processed food products containing food additives with restricted levels (e.g. nitrite
in meat products) should not exceed the maximum levels allowed in the Updated
List of Food Additives (B. C. 2006-016) or FDA latest Regulation on Food
Additives. A Certificate of Analysis on the level of such restricted food additive in
the finished product must be submitted.
7. Thermally processed food products packed in hermetically sealed containers
(e.g. can, bottle) should submit Tests Results for Commercial Sterility.
8. Labels of food products applying for registration should conform to the current
labelling guidelines based on Administrative Order 2014-0030. Refer to Annex D
(Rules and Regulations Governing the Labeling of Prepackaged Food Products).

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General Guidelines in the Registration of Food Products


The mandatory labelling requirements are:
 Brand name
 Product name
 List of ingredients including common name and function of food additives
 Net weight
 Complete name and address of manufacturer, packer, distributor, trader or
importer. For imported products, country of origin should be declared.
 Nutrition labelling (nutrition facts)
 Expiration date/use by date/consume before date
 Lot identification code
 Allergen information as applicable
 Storage instruction/Instruction for use as applicable.
 % alcohol for alcoholic beverages only
 Country of origin (for imported products only)
 English translation if Foreign language is used
 Additional labelling requirements for food supplements: Mandatory declaration
of “Food Supplement” and NO APPROVED THERAPEUTIC CLAIMS based
on Bureau Circular 2 s. 1999 (bold, Arial, font size 14 and all capital letters).
Food products for export should conform with the labelling requirements of the
importing country.
 Additional labelling requirements apply to specific products with standards of
identity or Philippine National Standards.
 Additional precaution/caution statements are declared on the label. Refer to
Annex E.
If labels of processed food products bear any health and nutrition claims, these
should comply with the Guidelines for Health and Nutrition Claims based on the
Codex Guidelines on Health and Nutrition Claims for Use in Food as adopted thru
Bureau Circular 2007-002 (Annex F).
9. For food products requiring the use of salt as an ingredient, it is mandatory to use
iodized salt for local food products intended for local distribution based on
Republic Act 8172 (ASIN Law).

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General Guidelines in the Registration of Food Products


10. The following staple food products should be fortified with Vitamin A and/or iron
-based on Republic Act 8976 and must submit the Certificate of Analysis and
compliant label as additional requirements in the registration:
*Cooking Oil-Vitamin A
*Wheat Flour-Iron and Vitamin A
*Sugar-Vitamin A
*Rice-Vitamin A
11. Voluntary fortification of processed food products must conform with
AO 04 s. 1995.
12. The following high risk food products should conform with the corresponding
Codex Standards:
 Infant Formula: Codex Standard for Formula for Special Medical Purposes
Intended for Infants and Infant Formula (Codex STAN 72-1981 Rev. 2006)
 Follow up Formula or Milk Supplement: Codex Standard for Follow
 Up Formula (Codex STAN 156-1987)
 Cereal-based Foods for Older Infants and Young Children: Codex Standard for
Processed Cereal-based Foods for Older Infants and Young Children (Codex
STAN 074-1981 Revised 2006)
 Formulated Complementary Foods for Infants and Young Children (Codex GL
-9-1991 Revised 2013)
 Canned Baby Foods: Codex Standard for Canned Baby Foods (Codex STAN
73-1981)
 Foods for Special Medical Purposes: Codex Guidelines for the Labeling and
Claims of Foods for Special Medical Purposes (Codex STAN 180-1991)
 Foods for Special Dietary Uses: Codex Standard for the Labeling of Prepack-
aged Foods for Special Dietary Uses (Codex STAN 146-1985 )
 Formula Foods for Weight Control Diets: Codex Standard for Formula Foods
for Weight Control Diets)
The complete documentary and labeling requirements for the above high risk
foods are presented in Annexes G and H.

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Risk Classification of Food Products

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Risk Classification of Food Products


LOW RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

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.

Lard is fat r ender ed fr om the fatty tissue


of swine. Edible beef fat is obtained from
Lard fresh bovine fatty tissue covering the
AO No. 231 s. abdominal cavity and surrounding the kidney
1974 and heart, and from other compact,
undamaged fat tissues. Such fresh fat
obtained at the time of slaughter is the
“killing fat.” Prime beef fat (premiere jus or
oleo stock) is obtained by low-heat rendering
(50-55oC) of killing fat and selected fat
trimmings (cutting fat). Secunda beef fat is a
product with typical beef fat odour and taste
obtained by rendering (60-65oC) and
purifying beef fat. Rendered pork fat is fat
obtained from the tissue and bones of swine.

Edible tallow (dr ipping) is pr oduced by


the rendering of fatty tissue (excluding
trimmings and cutting fat), attached muscles
and bones of bovine animals or sheep.

Fish oils ar e der ived fr om suitable sour ces


such as herring, sardines, sprat, and
anchovies.

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Risk Classification of Food Products


LOW RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

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.

6. Fat-based Includes fat-based counterparts of dairy- Ice cream-like


desserts excluding based desserts. Includes ready-to-eat product made with
dairy-based products and their mixes. Also includes non- vegetable fats
desserts dairy fillings for desserts. An example is an
ice cream-like product made with vegetable
fats.

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LOW RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

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.

Purple Yam (Ube) Includes dietetic counterparts made with non


Jam (Halaya) -nutritive high-intensity sweeteners.
PNS/FDA 24:2010
3. Dehydrated
Vegetable Protein
products
4. Fruits or Includes pickled products such as pickled Includes pickled
vegetables in plums, mango pickles, lime pickles, pickled plums, mango
vinegar, oil or gooseberries, and pickled watermelon rind. pickles, lime
brine pickles, pickled
gooseberries, and
pickled watermelon
rind
5. Fruit-based Includes all other fruit-based spreads, such Includes apple
spreads (e.g. as apple butter and lemon curd. Also includes butter, lemon curd,
chutney) condiment-type fruit products such as mango mango chutney and
excluding jams, chutney and raisin chutney. raisin chutney
jellies and
marmalades

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LOW RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES
B. PROCESSED 6. Fruit Fruit pulp is not usually intended for
FRUITS, preparations, direct consumption. It is a slurry of lightly
VEGETABLE including pulp, steamed and strained fresh fruit, with or
AND EDIBLE purees, fruit without added preservatives.
FUNGI toppings and
(including coconut milk Fruit puree (e.g. mango puree, prune puree) Mango puree, prune
mushrooms and is produced in the same way, but has a puree
fungi, roots an smoother, finer texture, and may be used as
tubers, pulses and fillings for pastries, but is not limited to this
legumes, and aloe use.
vera)
SEAWEEDS, Fruit sauce (e.g. pineapple sauce or Pineapple sauce or
AND NUTS AND strawberry sauce) is made from boiled fruit strawberry sauce
SEEDS pulp with or without added sweeteners and
may contain fruit pieces. Fruit sauce may be
used as toppings for fine bakery wares and
ice cream sundaes.
Fruit syrup (e.g. blueberry syrup) is a more Blueberry syrup
liquid form of fruit sauce that may be used as
a topping e.g. for pancakes.
Coconut milk and coconut cr eam ar e
products prepared using a significant amount
of separated, whole, disintegrated macerated
or comminuted fresh endosperm (kernel) of
coconut palm and expelled, where most
filterable fibers and residues are excluded,
with or without coconut water, and/or with
additional water. Coconut milk and coconut
cream are treated by heat pasteurization,
sterilization or ultrahigh temperature (UHT)
processes. Coconut milk and coconut cream
may also be produced in concentrated or
skim (or “light”) forms. Examples of
traditional foods in this sub-category are:
tamarind concentrate (clean extract of
tamarind fruit with not less than 65% total
soluble solids), tamarind powder (tamarind
paste mixed with tapioca starch), tamarind
toffee (mixture of tamarind pulp, sugar, milk
solids, antioxidants, flavours, stabilizers and
preservatives), and fruit bars (a mixture of
fruit (mango, pineapple, or guava) pulp
mixed with sugar, flavours and
preservatives, dried into a sheet).

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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LOW RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES
B. PROCESSED 9. Vegetable Includes all fresh vegetables (Fresh
FRUITS, (including vegetables ar e gener ally fr ee of additives.
VEGETABLE mushrooms and However, fresh vegetables that are coated or
AND EDIBLE fungi, roots and cut or peeled
FUNGI tubers, pulses and for presentation to the consumer may contain
(including legumes, and aloe additives) and processed vegetables
mushrooms and vera), (Includes all forms of processing other than
fungi, roots an seaweed, and nut peeling, cutting and surface treating fresh
tubers, pulses and and seedin pulps vegetables).
legumes, and aloe and preparations
vera) SEAWEEDS, (e.g. vegetable
AND NUTS AND desserts and
SEEDS sauces, candied
vegetables) other
than food in HR
Letter B.8
(Vegetable purees,
spreads – peanut
butter)

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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C. 3. Decorations Includes ready-to-eat icings and frostings for


CONFECTIONERY (e.g. for fine cakes, cookies, pies and bread and flour
bakery wares, confectionery, as well as mixes for these
sugar flowers), products.
toppings (non-
fruit), and sweet
Also includes sugar- and chocolate-based
sauces
coatings for baked goods.

Sweet sauces and toppings include


butterscotch sauce for use, e.g. on ice cream.

D. CEREAL- 1. Flours, starches The basic milled products of cereal grains,


BASED (including soybean roots, tubers, pulses, pith or softy core of
PRODUCTS, powder) and flour palm tree or legumes sold as such or used as
derived from mixes ingredients (e.g. in baked goods).
cereal grains,
from roots and durum wheat flour,
Wheat Flour b.1. Flour is produced from the milling of
tubers, pulses, self-rising flour,
grain, cereals and tubers (e.g. cassava) and
Republic Act 8976 enriched flour,
legumes and pith pith or soft core of palm tree. Includes flour
or soft core of instantized flour,
pastes for bread and flour confectionery, corn flour, corn
palm tree,
PNS-BAFPS flour for bread, pastries, noodles and pasta,
excluding bakery 75:2010 Coconut and flour mixes meal, bran, farina,
wares in Letter F Flour roasted soybean
below. Examples include: durum wheat flour, self- flour (kinako),
rising konjac flour (devil’s
flour, enriched flour, instantized flour, corn tongue jelly powder,
Definition: flour, corn meal, bran, farina, roasted konnayaku-ko), and
Includes soybean flour (kinako), konjac flour (devil’s maida (refined
unprocessed and tongue jelly powder, konnayaku-ko), and wheat flour) and
various processed maida (refined wheat flour) and sago flour. sago flour.
forms of cereal
and cereal-based Coconut Flour
products. b.2. Starch is a glucose polymer occurring in
granular form in certain plant species,
notably seeds (e.g. cereals, pulses, corn,
wheat, rice, beans, peas) and tubers (e.g.
tapioca, potato). The polymer consists of
linked anhydro-alpha-D-glucose units.
Native starch is separated by processes that
are specific for each raw material.

2. Breakfast Includes all ready-to-eat, instant, and regular Includes granola-


cereals including hot breakfast cereal products. Examples type breakfast
rolled oats include: granola-type breakfast cereals, cereals, instant
instant oatmeal, farina, corn flakes, puffed oatmeal, farina, corn
wheat or rice, multi-grain (e.g. rice, wheat flakes, puffed wheat
and corn) breakfast cereals, breakfast cereals or rice, multi-grain
made from soy or bran, and extruded-type (e.g. rice, wheat and
breakfast cereals made from grain flour or corn) breakfast
powder. cereals, breakfast
cereals made from
soy or bran, and
extruded-type
breakfast cereals
made from grain
flour or powder.

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D. CEREAL- 3. Pasta and This food category was revised, with the
BASED noodles and like understanding that there would be few, if any
PRODUCTS, products (e.g. rice additives needed in dried pastas and noodles.
derived from paper, rice Includes all pasta, noodle and similar
cereal grains, from vermicelli, products. Includes unboiled
roots and tubers, soybean pastas noodles, and “skins”
pulses, legumes and noodles)
Fresh pastas and noodles and like or crusts for spring
and pith or soft products rolls, wontons, and
core of palm tree, Pancit Canton
excluding bakery - Products that are untreated (i.e. not shuo mai.
PNS/BFAD heated, boiled, steamed, cooked, pre-
wares in Letter F
18:2008 gelatinized or frozen) and are not
below.
dehydrated. These products are intended
to be consumed soon after preparation.
Definition:
Includes Dried pastas and noodles and like Includes dried forms
unprocessed and products of: spaghetti, bean
vermicelli, rice
various processed Products that are untreated (i.e. not heated, vermicelli, macaroni,
forms of cereal boiled, steamed, cooked, pre-gelatinized or and rice noodles.
and cereal-based frozen) and are dehydrated.
products.
Pre-cooked pastas and noodles and like Pre-cooked, chilled
products gnocchi to be heated
prior to consumption
Products that are treated (i.e. heated,
boiled, steamed, cooked, pre-gelatinized or Heat-and-serve frozen
dinner entrees
frozen). These products may be sold containing spaghetti,
directly to the consumer (e.g. pre-cooked, macaroni or noodles;
chilled gnocchi to be heated prior to canned spaghetti and
consumption), or may be the starch meatballs entrée
component of prepared meals (e.g. heat- Includes instant
and-serve frozen dinner entrees containing noodles (sokuseki-
spaghetti, macaroni or noodles; canned men; e.g. pre-cooked
spaghetti and meatballs entrée). Also ramen, udon, rice
includes instant noodles (sokuseki-men; noodles), that are pre-
e.g. pre-cooked ramen, udon, rice noodles), gelatinized, heated and
dried prior to sale to
that are pre-gelatinized, heated and dried the consumer.
prior to sale to the consumer.
4. Cereal and Dessert products containing cereal, starch or Includes rice pudding,
semolina pudding, tapioca
starch based grain as the main ingredient. Also includes pudding, rice flour
desserts (e.g. rice cereal- or starch based fillings for desserts. dumplings (dango), a
pudding, tapioca steamed yeast-fermented
pudding, native wheat flour dough dessert
(musipan), and a starchy
delicacies) pudding based dessert
PNS-FDA 32-2011 (namagashi).
Flour –based Cassava Cake, polvoron,
Confectioneries barquillos, piaya

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.

Soybean curd (tofu) - Soybean curd is prepared


from dried soybeans that are soaked in water,
pureed, and strained to produce soybean-based
beverage, which is then made into a curd with
a coagulant, and placed in a mould. Soybean
curds may be of a variety of textures (e.g. soft,
semi-firm, firm).

Semi-dehydrated soybean curd - Soybean curd


that has been pressed while being moulded into
blocks so that some moisture has been
removed, but so that it is not completely dried.
Semi-dehydrated soybean curd typically
contains 62% water, and has a chewy texture.

Thick gravy-stewed semi- dehydrated


soybean curd – Partially dehydrated soybean
curd that is cooked (stewed) with a thick sauce
(e.g. miso sauce). The partially dehydrated
soybean curd typically absorbs the sauce, and
so regains its original texture.

Deep fried semi-dehydrated soybean curd -


Partially dehydrated soybean curd that is deep-
fried. It may be consumed as such, or cooked
(e.g. stewed in sauce) after frying

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D. CEREAL- 7. Soybean Semi-dehydrated soybean curd, other Miso sauce


BASED products than in LRD.7.d.1) and 7.d.2) -
PRODUCTS, (excluding Partially dehydrated soybean curd
derived from soybean-based prepared other than by stewing in thick
cereal grains, from seasonings and (e.g. miso) sauce or by deep frying.
roots and tubers, condiments under Includes grilled products and mashed
pulses, legumes LR Letter I products that may be combined with
and pith or soft (seasonings, other ingredients (e.g. to make a patty or
core of palm tree, condiments and a loaf).
excluding bakery sauces)
wares in Letter F Dehydrated soybean curd (kori tofu) -
below. Soybean curd from which all moisture
has been removed through the process of
Definition: freezing, aging, and dehydrating. It may
Includes be reconstituted with water or sauce for
unprocessed and consumption, or is used directly in
various processed prepared dishes. It may also be deep-fried
forms of cereal or simmered in sauce.
and cereal-based
products. Other soybean protein products - Other
products from soybeans composed mainly of
soybean protein such as extruded, textured,
concentrated, and isolated soybean protein.

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.

Crackers, excluding sweet crackers – The Includes soda


term “cracker” refers to a thin, crisp wafer, crackers, rye crisps,
usually of unsweetened dough. and matzohs.

Other ordinary bakery products - Includes Bagels, pita, English


all other ordinary bakery wares, such as muffins, cornbread
cornbread and biscuits. The term “biscuit” and biscuits
in this category refers to a small cake of
shortened bread, leavened with baking
powder or baking soda. It does not refer to
the British “biscuit,” which is a “cookie”
or “sweet cracker”.
Bread-type products, including bread e.g. for biscuits
stuffing and bread crumbs - Includes
bread-based products such as croutons,
bread stuffing and stuffing mixes, and
prepared doughs.

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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.

Mixes for bread and ordinary bakery Includes French


wares - Includes all the mixes containing bread mix, tin bread
the dry ingredients to which wet mix, panettone mix,
ingredients (e.g. water, milk, oil, butter, ciabatta mix, among
eggs) are added to prepare a dough for others.
baked goods.

2. Fine bakery Includes sub-categories for ready-to-eat


wares (sweet, products as well as mixes for preparing fine
salty or savory) baked goods.
and mixes
Includes cake mix,
a. Mixes for fine bakery wares (e.g. cakes, flour confectionery
pancakes) - Mixes containing the dr y mix, pancake mix,
ingredients to which wet ingredients (e.g. pie mix, and waffle
water, milk, oil, butter, eggs) are added to mix.
prepare a dough for fine baked goods.

G. 1. Refined and Nutritive sweeteners, such as fully or (e.g. hard or soft


SWEETENERS, raw sugars partially purified sucrose (derived from sugar candies).
INCLUDING beet and sugar cane), glucose (derived from
HONEY Refined Sugars starch), or fructose.
Republic Act 8976
Definition: White sugar, dextrose anhydrous,
Includes all dextrose monohydrate, fructose - White
standardized sugar is purified and crystallized sucrose
sugars, non- with a polarisation of not less than 99.7oZ.
standardized Dextrose anhydrous is purified and
products and crystallized D-glucose without water of
natural crystallization. Dextrose monohydrate is
sweeteners. purified and crystallized D-glucose with
one molecule of water of crystallization.
Fructose is purified and crystallized D-
fructose.

Powdered sugar, powdered dextrose -


Powdered sugar (icing sugar) is finely
pulverized white sugar with or without
added anticaking agents. Powdered
dextrose (icing dextrose) is finely
pulverized dextrose anhydrous or dextrose
monohydrate, or a mixture of the two, with
or without added anticaking agents.

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G. 1. Refined and Soft white sugar, soft brown sugar,
SWEETENERS, raw sugars glucose syrup, dried glucose syrup, raw
INCLUDING cane sugar – Soft white sugar is fine grain
HONEY Refined Sugars purified, moist sugar, that is white in
colour. Soft brown sugar is fine grain
Republic Act 8976 moist sugar that is light to dark brown in
Definition:
Includes all colour. Glucose syrup is a purified
standardized concentrated aqueous solution of nutritive
sugars, non- saccharides derived from starch and/or
standardized inulin. Dried glucose syrup is glucose
products and syrup from which water has been partially
removed. Raw cane sugar is partially
natural purified sucrose crystallized from partially
sweeteners. purified cane juice without further
purification.

Dried glucose syrup used to


manufacture sugar confectionery -
Dried glucose syrup used to
manufacture candy products.
Glucose syrup used to manufacture
sugar confectionery – glucose syrup
used to manufacture candy products.
Lactose – A natural constituent of milk
normally obtained from whey. It may be
anhydrous, or contain one molecule of
water of crystallization, or be a mixture
of both forms.

Plantation or mill white sugar - Pur ified


and crystallized sucrose with a polarisation
of not less than 99.5 oz.

2. Brown sugar Includes large-grain, brown or yellow lump Demerara sugar


excluding sugars, such as Demerara sugar.
products under
LRG.1.c (soft
white sugar, etc.)
3. Sugar solutions Includes co-products of the sugar refining Includes treacle and
and syrups, also process, invert sugar (equimolar mixture of molasses high
(partially) inverted, glucose and fructose produced from the fructose corn syrup,
including treacle and
molasses, excluding hydrolysis of sucrose), and other sweeteners, high fructose inulin
products under G.1.c such as high fructose corn syrup, high syrup and corn sugar
(soft white sugar, fructose inulin syrup and corn sugar.
etc.)
4. Other sugars and Includes all types of table syrups, syrups for Includes xylose,
syrups (e.g. xylose, fine bakery wares and ices, and decorative maple syrup, sugar
maple syrup, sugar sugar toppings. toppings
toppings), including
coconut sugar
Caramel syrup,
Coconut Sap Sugar flavoured syrups
PNS/BAFPS 76:2010
Coloured sugar
crystals for cookies

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G. 5. Honey Honey is the natur al sweet substance Includes wildflower


SWEETENERS, produced by honeybees from the nectar of
INCLUDING Honey and clover
blossoms or secretions of plants. The honey.
HONEY
honeybees collect the nectar or secretions,
transform it by combination with specific
Definition:
Includes all substances of the bees’ own, and store it in a
standardized honeycomb to ripen and mature.
sugars, non-
standardized 6. Table-top Includes products that are preparations of Acesulfame
products and sweeteners, high-intensity sweeteners and/or of polyols potassium, sorbitol
natural including those which may contain other additives and/or
sweeteners. containing high-
intensity nutritive ingredients, such as carbohydrates.
sweeteners
These products, which are sold to the final
consumer, may be in powder, solid (e.g.
tablets or cubes), or liquid form.

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.

Salt substitute - Salt substitutes are


seasonings with reduced sodium content
intended to be used on food in place of
salt.

2. Herbs, spices, This category describes items whose use is


seasonings and intended to enhance the aroma and taste of
condiments (e.g. food.
seasoning for
instant noodles) Herbs and spices ar e usually der ived fr om Includes basil,
botanical sources, and may be dehydrated, oregano and thyme.
and either ground or whole.
Spices may also be found as blends in Includes cumin and
powder or paste form. Examples of spice caraway seeds.
blends include chilli seasoning, chilli paste,
curry paste, curry roux, and dry cures or rubs
that are applied to external surfaces of meat
or fish.

Condiments include seasonings such as Includes seasonings


meat tenderizers, onion salt, garlic salt, such as meat
Oriental seasoning mix (dashi), topping to tenderizers, onion
sprinkle on rice (furikake, containing, e.g. salt, garlic salt,
dried seaweed flakes, sesame seeds and Oriental seasoning
seasoning), and seasoning for noodles. The mix (dashi), topping
term “condiments” as used in the Food to sprinkle on rice,
Category System does not include condiment seasoning for
sauces (e.g. ketchup, mayonnaise, mustard) noodles
or relishes.

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I. SALT, 3. Vinegars Liquid produced from fermentation of Includes cider


SPICES, SOUPS, ethanol from a suitable source (e.g. wine, vinegar, wine
SAUCES, AO No. 134 s. cider). vinegar, malt
SALADS AND 1970 vinegar, spirit
PROTEIN vinegar, grain
PRODUCTS vinegar, raisin
vinegar, and fruit
(wine) vinegar

4. Mustards Condiment sauce prepared from ground, Includes Dijon


often defatted mustard seed that is mixed into mustard, and “hot”
a slurry with water, vinegar, salt, oil and mustard (prepared
other spices and refined. from seeds with
hulls)

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)

b. Clear sauces (fish sauce) - Includes thin, Includes oyster


non-emulsified clear sauces that may be sauce, and Thai fish
water-based. These sauces may be used as sauce (nam pla).
condiments or ingredients rather than as
finished gravy (for use e.g. on roast beef).

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.

b. Soybean sauce - A liquid seasoning


obtained by fermentation of soybeans, non-
fermentation (e.g. hydrolysis) of soybeans, or
by hydrolysis of vegetable protein.

Fermented soybean sauce - A clear, non-


emulsified sauce made of soybeans, cereal,
salt and water by the fermentation process.

Non-fermented soybean sauce - which is


also known as non-brewed soybean sauce,
may be produced from vegetable proteins,
such as defatted soybeans that are acid-
hydrolyzed (e.g. with hydrochloric acid),
neutralized (e.g. with sodium carbonate),
and filtered.

Other soybean sauce - Non-emulsified


sauce made from fermented soybean sauce
and/or non-fermented soybean sauce, with
or without sugar, with or without
caramelization process.

9. Protein Includes, for example, milk protein, cereal Includes vegetable


products other protein and vegetable protein analogues or protein analogues,
than from substitutes for fu (a mixture of
soybeans, standard products, such as meat, fish or milk. gluten (vegetable
marinades protein) and flour
that is sold dried
(baked) or raw, and
is used as an
ingredient, e.g. in
miso soup) and
proteinaceous meat
and fish substitutes.

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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

2. Alcoholic The alcohol-free and low-alcoholic


beverages, counterparts are included in the same
including alcohol- category as the alcoholic beverage.
free and low-
alcoholic a. Beer and malt beverages – Alcoholic Ale, brown beer, weiss
counterparts beverages brewed from germinated barley beer, pilsner, lager
(malt), hops, yeast, and water. beer, oud bruin beer,
Obergariges
Alcoholic Einfachbier, light beer,
MC No. 13 s. 1989 table beer, malt liquor,
porter, stout, and
barleywine
Standard
Administrative
Orders (SAOs) for b. Cider and perry - Fr uit wines made Cider bouche
DISTILLED from apples (cider) and pears (perry).
SPIRITS
c. Grape wines - Alcoholic bever age Spumante, and
obtained exclusively from the partial or “cold duck” wine
Brandy complete alcoholic fermentation of fresh
SAO # 358 s. 1978 grapes, whether crushed or not, or of grape
must (juice).
Rum
SAO # 257 s. 1976 Still grape wine - Gr ape wine (white,
red, rosé, or blush, dry or sweet) that may
contain up to a maximum 0.4g/100 ml
Vodka (4000 mg/kg) carbon dioxide at 20oC.
SAO # 258 s. 1976
Sparkling and semi-sparkling grape
Whiskey wines - Gr ape wines in which
SAO # 259 s. 1976 carbonation is produced during the
fermentation process, either by bottle
Wines fermentation or closed tank fermentation.
Also includes carbonated wine whose
Standards carbon dioxide is partially or totally of
Administrative exogenous origin.
Order No. 357 s.
1978

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J. BEVERAGES, 2. Alcoholic Fortified grape wine, grape liquor Includes grape dessert
excluding dairy beverages, wine, and sweet grape wine - Gr ape wine
products including alcohol- wines produced either by: (i) the
free and low- fermentation of grape must (juice) of
alcoholic high sugar concentration; or (ii) by
counterparts the blending of concentrated grape
juice with wine; or (iii) the mixture of
Basi fermented must with alcohol.
PNS/BFAD d. Wines (other than grape) - Rice wine (sake), and
20:2009 Includes wines made from fruit other sparkling and still fruit
than grapes, apples and pears and from wines
Tropical Fruit other agricultural products, including
Wines grain (e.g. rice). These wines may be
PNS/FDA 30:2010 still or sparkling.
e. Mead - Alcoholic liquor made from Honey wine
Coconut fermented honey, malt and spices, or
Lambanog PNS/ just of honey.
BAFPS 47:2011
f. Distilled spirituous beverages Includes aperitifs, brandy
containing more than 15% alcohol - (distilled wine), cordials,
Includes all distilled spirituous liqueurs (including
beverages derived from grain (e.g. corn, emulsified liqueurs),
bagaceira belha (grappa from
barley, rye, wheat), tubers (e.g. potato), Portugal; bagaceira is a drink
fruit (e.g. grapes, berries) or sugar cane distilled from bagaço
that contain greater than 15% alcohol. (pressed skins, seeds and
stalks of the grapes)), eau de
vie (a brandy), gin, grappa
(Italian brandy distilled from
the residues of pressed wine),
marc (brandy distilled from
grape or apple residue), korn
(grain spirit (schnapps) of
Germany, usually derived
from rye (Roggen),
sometimes from wheat
(Weizen) or both (Getreide);
also labelled as Kornbrantt or
Kornbranttwein), mistela
(also mistelle (France) and
jeropico (South Africa);
unfermented grape juice
fortified with grape alcohol),
ouzo (Greek spirit drink
flavoured with aniseed), rum,
tsikoudia (grape marc spirit
from Crete), tsipouro (grape
marc spirit from certain
regions in Greece),
wienbrand (style of grape
brandy devised by Hugo
Asbach, Rudesheim,
Germany; literally, “burnt
wine”), cachaça (Brazilian
liquor made from fermented
distilled sugar cane juice),
tequila, whiskey, and vodka

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CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

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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CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

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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CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

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.

Milk and Milk


Products
AO No. 132 s. 1970

Milk and cream powder analogues: Products Includes imitation


based on a fat-water emulsion and dried for dry cream mix and
use other than as a beverage whitener (LR blends of skimmed
Letter A.1.b) milk and vegetable
fat in powdered
form.

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CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

B. FROZEN 1. Non-Dairy Includes water-


DESSERTS based (e.g. based frozen
sherbet, sorbet) desserts, confections
and novelties, such
2. Edible ices – as fruit sorbet,
popsicles “Italian”-style ice,
and flavoured ice.

C. PROCESSED 1. Tomato Includes tomato


FRUITS, products catsup, tomato
VEGETABLE puree, tomato sauce,
AND EDIBLE Tomato Catsup tomato paste,
FUNGI AO No. 233 s. 1974 canned tomatoes
(including and spaghetti sauce.
mushrooms and Spaghetti Sauce
fungi, roots and and Spaghetti
tubers, pulses Sauce variants
and legumes, and PNS 247:1993
aloe vera)
SEAWEEDS,
AND NUTS AND
SEEDS 2. Frozen fruits Fruit that may or may not be blanched prior Includes frozen fruit
to freezing. The product may be frozen in a salad and frozen
Definition: juice or sugar syrup. strawberries
Includes all forms
of processing
other than peeling, 3. Canned or Fully preserved product in which fresh fruit Includes canned
cutting and bottled is cleaned and placed in cans or jars with fruit salad, and
surface treating (pasteurized) or natural juice or sugar syrup (including applesauce in jars
fresh fruits and retort pouch fruit artificially sweetened syrup) and heat-
vegetables. and vegetable sterilized or pasteurized.
preserve in juice,
syrup, brine

4. Fruit-based Includes the ready-to-eat products and mixes. Includes fruit-


desserts, gelatin This category does not include fine bakery flavoured gelatine,
(including water- wares containing fruit (MR Letter J.a), fruit- rote gruze, frutgrod,
based fruit flavoured fruit compote, nata
flavored desserts, edible ices (MR Letter B.2), or fruit- de coco, and
i.e. gels) containing frozen dairy desserts (HR Letter mitsumame
A.5). (gelatine-like dessert
of agar jelly, fruit
pieces and syrup).

5. Fermented fruit Type of pickled product produced by Includes fermented


products preservation in salt by lactic acid plums
fermentation.

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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CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

C. PROCESSED 7. Fermented Fermented vegetables are a type of Includes red pepper


FRUITS, vegetable products pickled product, formed by the action of paste, fermented
VEGETABLE (including lactic acid bacteria, usually in vegetable products
AND EDIBLE mushrooms and the presence of salt. (some tsukemono other
FUNGI fungi, roots and than category LR Letter
(including tubers, pulses and B.4), kimchi (fermented
mushrooms and legumes, and aloe Chinese cabbage and
fungi, roots and vera) and seaweed vegetable preparation),
tubers, pulses roducts, excluding and sauerkraut
and legumes, and fermented (fermented cabbage).
aloe vera) soybean products Excludes fermented
SEAWEEDS, MR Letter E.1 soybean products that
AND NUTS AND and E.2 are found in food
SEEDS (fermented categories MR Letter
soybeans and E.1 (fermented
Definition: fermented soybeans (e.g. natto and
Includes all forms soybean curd) and tempe)), MR Letter E.2
of processing LR Letters I.8.b. (fermented soybean
other than peeling, 1) to 3) (soybean curd), LR Letter I.8.a
cutting and sauces) (fermented soybean
surface treating paste e.g. miso), I.8b.1
fresh fruits and (fermented soybean
vegetables. sauce), and I.8b.3 (other
soybean sauce).

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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CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

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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CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

F. PROCESSED 1. Processed meat, poultry and game products in whole or cuts


MEAT AND
MEAT 1.a. Non-heat treated processed meat, poultry and game products (cured,
PRODUCTS, fermented, chilled)
INCLUDING
POULTRY AND 1.a.2) Cured The meat cuts may be cured or salted as Includes dried salt pork,
GAME (including salted) described for category MR Letter F.1a.1, dehydrated meat,
and dried non- and then dried, or they may only stuffed loin, Iberian
heat treated be dried. Drying is achieved either in hot ham, and prosciutto-
processed meat, air or in vacuum. type ham.
poultry and game
products
1.a.3) Fermented products are a type of pickled Includes potted beef and
Fermented non- product produced by the action of lactic pickled (fermented)
heat treated acid bacteria in the presence of salt. pig’s feet.
processed meat,
poultry and game
products
2. Processed comminuted meat, poultry and game products

2.a. Non-heat This category describes several treatment


treated processed methods (e.g. curing, salting, drying,
meat, poultry and pickling) that preserve and
game products extend the shelf life of comminuted and
(cured, fermented, mechanically deboned meat products.
chilled)
2.a.1) Cured Salted products are treated with sodium Includes chorizos (spicy
(including salted) chloride. Dry cured (dry pickled) pork sausages),
non-heat treated products are prepared by rubbing salt salami-type products,
processed meat, directly on the meat surface. Wet pickle salchichon, tocino
poultry and game cured products are prepared by (fresh, cured sausage),
products submerging the meat in a brine pepperoni, and smoked
solution. Pump cured products are sausage.
prepared by injecting brine into the meat.
Curing may also be achieved by addition
of additives. Also includes smoked
products.
2.a.2) Cured The comminuted or mechanically Includes pasturmas,
(including salted) deboned products may be cured or salted dried sausages, cured
and dried non- as described for category MR Letter and dried sausages, beef
heat treated F.2.a.1, and then dried, or they may only jerky, Chinese sausages
processed meat, be dried. Drying is achieved either in hot (including traditional
poultry and game air or in vacuum. cured or smoked pork
products (jerky, sausage), and
shredded beef/ sobrasada.
pork)
2.a.3) Fermented products are a type of pickled Includes certain types of
Fermented non- product produced by the action of lactic sausages that may be
heat treated acid bacteria in the presence of salt. fermented.
processed meat,
poultry and game
products

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CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES
G. PROCESSED 1. Processed fish and fish products, including molluscs, crustaceans and
FISH AND FISH echinoderms
PRODUCTS,
INCLUDING 1.a. Smoked, Smoked fish are usually prepared from fresh Includes salted
dried, fermented, deep frozen or frozen fish that are dried anchovies, shrimp, and
MOLLUSCS, shad; smoked chub,
CRUSTACEANS and/or salted fish directly or after boiling, with or without
and fish products, salting, by exposing the fish to freshly- cuttlefish and octopus;
AND fish ham; dried and
ECHINODERM including generated sawdust smoke. Dried fish are salted species of the
S molluscs, prepared by exposing the fish to sunlight or Gadidae species;
crustaceans and drying directly or after boiling in a special smoked or salted fish
echinoderms installation; the fish may be salted paste and fish roe;
prior to drying. Salted fish are either rubbed cured and smoked
Dried, Salted Fish with salt or placed in a salt solution. This sablefish, shad, and
manufacturing process is different from that salmon; dried shellfish,
PNS/BFAD dried bonito
04:2006 described in food category MR Letter G.2.d (katsuobushi), and
for marinated and pickled fish. Cured fish is boiled, dried fish
prepared by salting and then smoking fish. (niboshi); bagoong,
Smoked Fish squid ball, fish ball
PNS/FDA 26:2010
2. Semi-preserved Includes products treated by methods such as
fish and fish marinating, pickling and partial cooking that
products, have a limited shelf life.
including
molluscs,
crustaceans and
echinoderms
2.a. Fish and Marinated products are manufactured by Includes
fish products, soaking the fish in vinegar or wine with or rollmops” (a type of
including without added salt and spices. They are marinated herring),
molluscs, packaged in jars or cans and have a limited sea eel
crustaceans and shelf life. Products in jelly may be (dogfish) in jelly
echinoderms – manufactured by tenderizing fish products by and fish aspic.
marinated and/or cooking or steaming, adding vinegar or wine,
in jelly salt and preservatives, and solidifying in a
jelly.
2.b. Fish and Pickled products are sometimes considered a Includes different
fish products, type of marinated product. Pickling results types of Oriental
including from the treatment of the fish with a salt and pickled products: koji-
molluscs, vinegar or alcohol (e.g. wine) solution. pickled fish (koji-
zuke), lees-pickled fish
crustaceans and (kasu-zuke), miso-
echinoderms – pickled fish
pickled and/or in (misozuke), soy sauce-
brine pickled fish (shoyu-
zuke), and vinegar-
pickled fish (su-zuke);
pickled whale meat;
and pickled herring
and sprat.

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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CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

G. PROCESSED 2.d. Semi- Includes fish or


FISH AND FISH preserved fish and crustacean pates and
PRODUCTS, fish products, traditional Oriental
INCLUDING including fish paste.
MOLLUSCS, molluscs,
CRUSTACEAN crustaceans and
S AND echinoderms (e.g.
ECHINODERM fish paste),
S excluding
products under
MR Letter H.2.a
to c above

H. EGG AND 1. Preserved eggs, Includes traditional


EGG including alkaline, Oriental preserved
PRODUCTS salted and canned products, such as
eggs (salted eggs, salt-cured duck eggs
century eggs) (Hueidan), and
alkaline treated
“thousand-year-old-
eggs” (pidan).

2. Egg-based Includes ready-to-eat products and products Includes custard


desserts (e.g. to be prepared from a dry mix. fillings for fine
custard) bakery wares (e.g.
pies).
I. BAKERY 1. Fine bakery wares (sweet, salty or savory) and mixes
WARES AND
BAKERY 1.a. Cakes, Cakes, cookies and pies (e.g. fruit-filled or Includes butter cake,
RELATED cookies, pies, custard types): The term “sweet cracker” or cheesecake, fruit-
PRODUCTS pastries, “sweet biscuit” used in this category refers to filled cereal bars,
doughnuts, sweet a cookie-like product that may be pound cake
rolls, scones, eaten as a dessert. (including
muffins, waffles – kasutera), moist
plain/without cake (type of
filling starchy dessert
(namagashi)),
western cakes,
moon cakes, sponge
cake, fruitfilled
pies (e.g. apple pie),
oatmeal cookies,
sugar cookies and
British
“biscuits” (cookies
or sweet crackers).

Other fine bakery products (e.g. doughnuts, Includes pancakes,


sweet rolls, scones, and muffins): Includes waffles,
products that may be eaten as a dessert or as filled sweet buns
breakfast. (anpan), Danish pastry,
wafers or cones for ice
cream, flour
confectionery, and
trifles.

1.b. Frozen
dough

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CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

J. SALT, 1. Soups and Includes ready-to-eat soups and mixes. The


SPICES, SOUPS, broths finished products may be water- (e.g.
SAUCES, consommé) or milk-based (e.g. chowder).
SALADS AND
PROTEIN Ready-to-eat Water- or milk-based products consisting of Includes Water- or
PRODUCTS soups and broths, vegetable, meat or fish broth with or without milk-based products
including canned, other ingredients (e.g. vegetables, meat, consisting of
bottled and frozen noodles). vegetable, meat or
fish broth with or
without other
ingredients (e.g.
vegetables, meat,
noodles).
2. Sauces and like Includes ready-to-eat sauces, gravies and
products dressings, and mixes to be reconstituted
before consumption.
2.a. Emulsified Sauces, gravies, dressings based and dips, at Includes salad dressing
sauces and dips least in part, on a fat- or oil-in water (e.g. French, Italian,
(e.g. mayonnaise, emulsion. Greek, ranch style), fat
salad dressing, -based sandwich
spreads (e.g.
onion dips) mayonnaise with
mustard), salad cream,
Mayonnaise and fatty sauces and
snack dips (e.g. bacon
AO No. 235 s. and cheddar dip, onion
1975 dip).

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.

3. Salads (e.g. Includes prepared


macaroni salad, salads, milk-based
potato salad) and sandwich spreads,
sandwich spreads non-standardized
excluding cocoa- mayonnaise-like
and nut-based, sandwich spreads,
spreads under HR and dressing for
Letter B.8 (peanut coleslaw (cabbage
butter) and MR salad).
D.1.c (cocoa-based
spreads)

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K. BEVERAGES, 1. Non-alcoholic (“soft”) beverages


excluding dairy
products 1.a. Fruit and Fruit juice: Fruit juice is the unfermented but Includes orange
vegetable juices - fermentable liquid obtained from the edible juice, apple juice,
(fruit juice, part of sound, appropriately mature and fresh black currant juice,
vegetable juice, fruit or of fruit maintained in sound lemon juice, orange-
concentrates for condition by suitable means. mango juice and
fruit juice, coconut water.
concentrates for
vegetable juice) Vegetable juice is the liquid unfermented but Includes products
fermentable product intended for direct that may be based
Mango Beverage consumption obtained by mechanical on a single
PNS/BFAD expression, crushing, grinding, and/or vegetable (e.g.
09:2007 sieving of one or more sound fresh carrot) or blends of
vegetables or vegetables preserved vegetables (e.g.
exclusively by physical means. carrots, celery)
Citrus Beverage
PNS/BFAD Concentrates for vegetable juice: Prepared Includes carrot juice
11:2007 by the physical removal of water from concentrate.
vegetable juice. Sold in liquid, syrup and
frozen forms for the
preparation of a ready-to-drink juice by
addition of water.
1.b. Fruit and Fruit and vegetable nectars are beverages
vegetable nectars produced from purees, juices, or
(fruit nectar, concentrates of either, blended with water
vegetable nectar, and sugar, honey, syrups, and/or sweeteners.
concentrates for
fruit nectar, Fruit nectar is the unfermented but Includes pear nectar
concentrates for fermentable product obtained by adding and peach nectar.
vegetable nectar) water with or without the addition of sugar,
honey, syrups, and/or sweeteners to fruit
Mango Beverage juice, concentrated fruit juice, fruit purees or
PNS/BFAD concentrated fruit purees, or a mixture of
09:2007 those products.

Vegetable nectar: Product obtained by


adding water with or without the addition of
sugar, honey, syrups, and/or sweeteners to
vegetable juice or concentrated vegetable
juice, or a mixture of those products.

Concentrates for fruit nectar: Prepared by the Includes pear nectar


physical removal of water from fruit nectar concentrate and
or its starting materials. Sold in liquid, syrup peach nectar
and concentrate.
frozen forms for the preparation of a ready-
to-drink nectar by addition of water.

Concentrates for vegetable nectar: Prepared


by the physical removal of water from
vegetable nectar. Sold in liquid, syrup and
frozen forms for
the preparation of ready-to-drink nectars by
addition of water.

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MEDIUM RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES
K. 1.c. Water- Includes all
BEVERAGES, based flavored carbonated and non-
excluding dairy drinks, including carbonated varieties
products “sport,” “energy,” and concentrates;
or “electrolyte” products based on
drinks and fruit and vegetable
particulated juices; and coffee-,
drinks tea- and herbal-based
drinks.
1.c.1. Includes water-based flavoured drinks with Includes gaseosa
Carbonated water added carbon dioxide with nutritive, non- (water-based drinks
-based flavored nutritive and/or intense with added carbon
drinks sweeteners and other permitted food dioxide, sweetener,
additives. and flavour), and
Citrus Beverage sodas such as colas,
pepper-types, root
PNS/BFAD beer, lemon-lime, and
11:2007 citrus types, both diet/
light and regular
types. Also, includes
so-called “energy”
drinks that are
carbonated and
contain high levels of
nutrients and other
ingredients (e.g.
caffeine, taurine,
carnitine).

1.c.2. Non- Include water-based


carbonated water- flavoured drinks without
based flavored added carbon dioxide,
drinks, including fruit and vegetable juice
-based drinks (e.g.
punches and ades almond, aniseed,
coconut-based drinks,
and ginseng drink), fruit
flavoured ades (e.g.
lemonade, orangeade),
squashes (citrus-based
soft drinks), capile
groselha, lactic acid
beverage, ready-to-drink
coffee and tea drinks
with or without milk or
milk solids, and herbal-
based drinks (e.g. iced
tea, fruit-flavoured iced
tea, chilled canned
cappuccino drinks) and
“sports” drinks
containing electrolytes.
Also, includes so-called
“energy” drinks that are
non-carbonated and
contain high levels of
nutrients and other
ingredients (e.g.
caffeine, taurine,
carnitine).

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MEDIUM RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

K. 1.c.3) Include powder, syrup, liquid and frozen Includes fountain


BEVERAGES, Concentrates concentrates for the preparation of syrups (e.g. cola
excluding dairy (liquid or solid) carbonated or non-carbonated water-based syrup), fruit syrups
products for water-based non-alcoholic beverages by addition of water for soft drinks,
flavored drinks or carbonated water. frozen or powdered
concentrate for
Mango Beverage lemonade and iced
tea mixes.
PNS/BFAD
09:2007

Citrus Beverage
PNS/BFAD
11:2007
1.d. Powdered
cocoa drink mixes
(cocoa)

L. FOOD 1. Vitamins and Includes vitamin and mineral supplements in


SUPPLEMENT/ minerals unit dose forms such as capsules, tablets,
HERBAL powders, solutions,
FOOD/ Guidelines for the etc.
HERBAL Classification of
DIETARY Vitamins and
SUPPLEMENTS Minerals as Drug
or as Food
Office Order No.
22 s. 91
2. Amino acids

M. READY-TO- Processed nuts, Includes processed


EAT including coated pili nuts
SAVOURIES nuts and nut
mixtures (with e.g.
Definition: dried fruits)
Includes all types
of savoury snack Processed Pili
foods. Nuts
(PNS/FDA
28:2010)
N. ICE PNS on Drinking Tube ice, cube,
Water AO 2017- block
0010

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HIGH RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

A. DAIRY 1. Milk and dairy-based drinks


PRODUCTS and
ANALOGUES, 1.a. Milk (plain) Includes plain fluid products only. Includes
excluding and buttermilk reconstituted plain milk that contains only
products under (plain) dairy ingredients.
Fats, Oils and (A.O. No. 132 s.
Fat Emulsions 1970) Milk (plain): Fluid milk obtained from
milking animals (e.g. cows, sheep, goats,
Definition: buffalo).
Includes all types
of dairy products Buttermilk (plain): Buttermilk is the nearly
that are derived milkfat-free fluid remaining from the butter-
from the milk of making process (i.e. the churning fermented
any milking or non-fermented milk and cream).
animal (e.g. cow, 1.b. Dairy-based Includes all ready-to-drink flavoured and Includes hot chocolate,
sheep, goat, drinks, acteale and/ aromatized milk-based fluid beverages and chocolate malt drinks,
buffalo). In this or fermented (e.g. their mixes, excluding mixes for cocoa strawberry-flavoured
category, a “plain” chocolate milk, (cocoa-sugar mixtures, MR Letter D.a.) yoghurt drink, lactic
product is one that acid bacteria drinks,
cocoa, eggnog, and lassi (liquid
is not flavoured, drinking yoghurt,
nor contains fruit, obtained by whipping
whey-based drinks) curd from the lactic
vegetables or acid fermentation of
other non-dairy milk, and mixing with
ingredients, nor is PNS/BFAD sugar or synthetic
mixed with other 08:2007 sweetener).
non-dairy (Fermented
ingredients, unless Milks)
permitted by
relevant standards. 2. Fermented and Includes all plain products based on skim,
Analogues are renneted milk part-skim, low-fat and whole milk.
products in which products (plain),
milk fat has been excluding dairy-
partially or wholly based drinks in
replaced by HR Letter A.1.b
vegetable fats or Codex Stan 243-
oils. 2003 (Codex
Standards for
Fermented Milks)
2.a. Fermented Includes all plain products, including fluid
milks (plain) fermented milk, acidified milk and cultured
milk.
PNS/BFAD
08:2007
(Fermented Milks)
2.a.1) Fermented Includes fluid and non-fluid plain products Includes yoghurt.
milk (plain), not
heat-treated after
fermentation

PNS/BFAD
08:2007
(Fermented
Milks)

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HIGH RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

A. DAIRY 2.a.2) Fermented Products similar to that in HR Letter


PRODUCTS and milks (plain), heat- A.2.a.2), except that they have been heat-
ANALOGUES, treated after treated (e.g. sterilized or pasteurized) after
excluding fermentation fermentation.
products under PNS/BFAD
Fats, Oils and 08:2007
Fat Emulsions (Fermented
Milks)
Definition:
2.b. Renneted milk Plain, coagulated milk produced by the Includes curdled
Includes all types
(plain) action of milk coagulating enzymes. milk.
of dairy products
that are derived
3. Cream (plain) Cream is a fluid dairy product, relatively high Includes all plain
from the milk of
and the likes in fat content in comparison to milk. fluid, semi-fluid and
any milking (cream analogs) semi-solid cream
animal (e.g. cow,
(A.O. No. 132 s. and cream analogue
sheep, goat,
1970) products.
buffalo). In this
category, a “plain” 3.a. Pasteurized Cream subjected to pasteurization by Includes milk
product is one that cream (plain) appropriate heat treatment or made from cream and “half-
is not flavoured, pasteurized milk. and-half.”
nor contains fruit,
vegetables or 3.b. Sterilized and Includes every cream, regardless of fat Includes whipping
other non-dairy UHT creams, content, which has undergone a higher heat- cream, heavy cream,
ingredients, nor is whipping and treatment than pasteurization. Also includes whipped pasteurized
mixed with other whipped creams, pasteurized creams with a reduced fat cream, and whipped
non-dairy and reduced fat content, as well as every cream intended for cream-type dairy
ingredients, unless creams (plain) whipping or being whipped. toppings and
permitted by (A.O. No. 132 s. fillings.
relevant standards. 1970)
Analogues are
products in which 3.c. Clotted cream Thickened, viscous cream formed from the Includes sour cream
milk fat has been (plain) action of milk coagulating enzymes. (cream subjected to
partially or wholly lactic acid
replaced by fermentation
vegetable fats or achieved as
oils. described for
buttermilk (HR
Letter A.1.a).
3.d. Cream Cream substitute consisting of a vegetable fat Includes instant
analogues -water emulsion in liquid or powdered form whipped cream
for use other than as a beverage whitener toppings and sour
(MR Letter A.1.b) cream substitutes.
4. Cheese and Cheese and cheese analogues are products
analogs that have water and fat included within a
coagulated milk protein structure.
(A.O. No. 200-A s.
1973)
4.a. Unripened Unripened cheese, including fresh cheese, is Includes cottage
cheese ready for consumption soon after cheese (a soft,
manufacture. unripened, coagulated
curd cheese), creamed
cottage cheese (cottage
cheese covered with a
creaming mixture),

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HIGH RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

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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CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

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.

5. Dairy-based Includes ready-to-eat flavoured dairy dessert Includes flavoured


desserts (e.g. products and dessert mixes. Includes frozen yoghurt (a milk
pudding, fruit or dairy confections and novelties, and dairy- product obtained by
acteale yoghurt) based fillings. fermentation of milk
and milk products to
which flavours and
ingredients (e.g.
fruit, cocoa, coffee)
have been added)
that may or may not
be heat-treated after
fermentation.

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HIGH RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES
A. DAIRY 5. Dairy-based Also includes ice cream
PRODUCTS and desserts (e.g. (frozen dessert that may
ANALOGUES, pudding, fruit or contain whole milk, skim
excluding acteale yoghurt) milk products, cream or
butter, sugar, vegetable oil,
products under egg products, and fruit,
Fats, Oils and cocoa, or coffee), ice milk
Fat Emulsions (product similar to ice
cream with reduced whole
Definition: or skim milk content, or
made with nonfat milk),
Includes all types jellied milk, frozen
of dairy products flavoured yoghurt, junket
that are derived (sweet custard-like dessert
from the milk of made from flavoured milk
any milking set with rennet), dulce de
animal (e.g. cow, leche (cooked milk with
sugar and added ingredients
sheep, goat, such as coconut or
buffalo). In this chocolate),butterscotch
category, a “plain” pudding and chocolate
product is one that mousse. Includes traditional
is not flavoured, milk-based sweets prepared
nor contains fruit, from milk concentrated
vegetables or partially, from khoa (cow or
other non-dairy buffalo milk concentrated
by boiling), or chhena (cow
ingredients, nor is or buffalo milk, heat
mixed with other coagulated aided by acids
non-dairy like citric acid, lactic acid,
ingredients, unless malic acid, etc), sugar or
permitted by synthetic sweetener, and
relevant standards. other ingredients (e.g.
Analogues are maida (refined wheat flour),
products in which flavours and colours (e.g.
peda, burfee, milk cake,
milk fat has been gulab jamun, rasgulla,
partially or wholly rasmalai, basundi).
replaced by
vegetable fats or
oils.

6. Whey and whey Includes a variety of whey-based


products, products in liquid and powdered forms.
excluding whey
cheeses
6.a. Liquid whey Whey is the fluid separated from the
and whey product curd after coagulation of milk, cream,
skimmed milk or buttermilk with milk
coagulating enzymes during the
manufacture of cheese, casein or similar
products. Acid whey is obtained after the
coagulation of milk, cream, skimmed
milk or buttermilk, mainly with acids of
the type used for the manufacture of
fresh cheese.
6.b. Dried whey Whey powders are prepared by spray- or
and whey roller-drying whey or acid whey from
products which the major portion of the milkfat
has been removed.

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HIGH RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

A. DAIRY 7. Milk for


PRODUCTS and manufacture
ANALOGUES,
excluding 8. Dairy-based
products under frozen desserts
Fats, Oils and (e.g. ice cream)
Fat Emulsions
B. PROCESSED 1. Dried Fruits Products in which the natural water content Includes dried
FRUITS, and vegetable – has been reduced below that critical for potato flakes and
VEGETABLES plain/ sun-dried growth for microorganisms without affecting dried lentil.
and EDIBLE (including the important nutrients. The product may or Examples of
FUNGI mushrooms and may not be intended for rehydration prior to Oriental dried
(including fungi, roots and consumption. Includes vegetable powders products include:
mushrooms and tubers, pulses and that are obtained from drying the juice, such dried sea tangle
fungi, roots and legumes, and aloe as tomato powder and beet powder. (kelp; kombu), dried
tubers, pulses vera) seaweeds, sea tangle with
and legumes, and and nuts and seeds seasoning
aloe vera) (shiokombu), dried
seaweeds, and seaweed (tororo-
nuts and seeds kombu), dried gourd
strips (kampyo),
PNS/FDA dried laver (nori),
28:2010 and dried
(Processed Pili laminariales
Nut Products) (wakame).

PNS/BFAD 2. Vegetable Products prepared by treating raw vegetables Includes pickled


cabbage, pickled
15:2007 (Dried (including with salt solution excluding fermented
cucumber, olives,
mushrooms and soybean products.
Mango) pickled onions,
fungi, roots and
mushrooms in oil,
tubers, pulses and marinated artichoke
PNS/BFAD legumes, and aloe hearts, achar, and
16:2007 (Dried vera), seaweed, piccalilli.
Tropical Fruits) and nut and seed – Examples of Oriental-
purees, spreads style pickled
(e.g. peanut vegetables include:
butter) tsukemono such as rice
bran pickled
vegetables (nuka-
zuke), koji-pickled
vegetables (koji-zuke),
sake lees-pickled
vegetables (kasu-
zuke), miso-pickled
vegetables (miso-
zuke), soybean sauce-
pickled vegetables
(shoyu-zuke), vinegar-
pickled vegetables
(suzuke) and brine-
pickled vegetables
(shio-zuke). Other
examples include:
pickled ginger, pickled
garlic, and chilli
pickles.

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HIGH RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES
C. CONFEC- Chocolate with Masareal (Sugar,
TIONERY nuts nuts, milk)
D. BAKERY 1. Fine bakery
WARES AND products with
BAKERY RE- fillings: meat,
LATED PROD- milk, poultry,
UCTS cream, other
perishable foods;
icings; and coat-
ings
2. Cookies with
nuts
E. PROCESSED 1. Processed meat, poultry and game products in whole or cuts
MEAT AND
MEAT PROD- 1.a. Heat-treated Includes cooked (including cured and Includes cured,
UCTS, INCLUD- processed meat, cooked, and dried and cooked), heat-treated cooked ham; cured,
ING POULTRY poultry and game (including sterilized) and canned meat cuts. cooked pork shoul-
AND GAME products (canned) der; canned chicken
meat; and meat piec-
es boiled in soy
sauce (tsukudani).
A.O. No. 154 s.
1971 (Meat and 1.b. Frozen pro- Includes raw and cooked meat cuts that have Includes whole
Meat Products) cessed meat, poul- been frozen. chickens, frozen
try and game chicken parts, and
PNS 891:1993 products frozen beef steaks.
UDC (Shelf- (marinated pork/
stable, Chilled beef/ chicken
cuts)
and Frozen
Corned 2. Processed comminuted meat, poultry and game products
Beef)
2.a. Heat-treated Includes cooked (including cured and Includes pre-grilled
processed meat, cooked, and dried and cooked), heat-treated beef patties; foie gras
poultry and game (including sterilized) and canned comminut- and pates; brawn and
products (canned) ed products. head cheese; cooked,
cured chopped meat;
chopped meat boiled in
soy sauce (tsukudani);
canned corned beef;
luncheon meats; meat
pastes; cooked meat
patties; cooked salami-
type products; cooked
meatballs; saucises de
actealed; breakfast
sausages; brown-and-
serve sausages; and
terrines (a cooked
chopped meat mix-
ture).

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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HIGH RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

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)

1.c. Frozen minced Uncooked product prepared from minced fish


and creamed fish pieces in cream-type sauce.
products, including
molluscs,
crustaceans and
echinoderms
1.d. Cooked and/or Includes all ready-to-eat cooked products as
fried fish and fish described in the sub-categories.
products, including
molluscs,
crustaceans and
echinoderms
1.d.1) Cooked fish Cooked products include steamed, boiled or Includes fish
and fish products any other cooking method except frying (see sausage; cooked fish
HR Letter F.1.d.3). The fish may be whole, products boiled
Smoked Fish – in portions or comminuted. down in soy sauce
PNS/FDA 26:2010 (tsukudani); cooked
surimi product
(kamaboko); crab-
flavoured cooked
kamaboko product
(kanikama); cooked
fish roe; cooked
surimi; cooked, tube
-shaped surimi
product (chikuwa);
and cooked fish and
lobster paste (surimi
-like products.

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CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

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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Risk Classification of Food Products


HIGH RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES
H. 1. Infant formula, Infant formulae: A human milk substitute for
FOODSTUFFS follow-on formula infants (aged no more than 12 months) that is
INTENDED and formula for specifically formulated to provide the sole
FOR special medical source of nutrition during the first months of
PARTICULAR purposes for life up to the introduction of appropriate
NUTRITIONAL infants complementary feeding. Product is in a liquid
USES CAC/GL 10-1979 form, either as a ready-to-eat product, or is
(Advisory List of reconstituted from a powder.
Nutrient Products, other than those under formulae for
Compounds for Use special medical purposes intended for infants,
in Foods for Special may be, actealed protein and/or amino acid-
Dietary Uses based,or milk-based.
Intended for Infants
and Young
Children)

E.O 51 (Milk Code)

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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HIGH RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

H. Codex Stan 72- Formulae for special medical purposes


FOODSTUFFS 1981 (Standard intended for infants:
INTENDED for Infant Foods for special dietary use that are
FOR Formulas for specially processed or formulated and
PARTICULAR Special Medical presented for the dietary management of
NUTRITIONAL Purposes Intended infants and may be used only under medical
USES for Infants) supervision. They are intended for the
exclusive or partial feeding of infants with
limited or impaired capacity to take, digest,
absorb or metabolize ordinary infant
formulae or certain nutrients contained
therein, or who have other special medically
determined nutrient requirement, whose
dietary management cannot be achieved only
by modification of the normal diet, by other
foods for special dietary uses, or by a
combination of the two.

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)

3.Dietetic foods Foods for special dietary use that are


intended for specially processed or formulated and
special medical presented for the dietary management of
purposes patients and may be used only under medical
(excluding supervision. They are intended for the
products under exclusive or partial feeding of patients with
HR Letter H.1) limited or impaired capacity to take, digest,
absorb or metabolize ordinary foods or
Codex Stan 180- certain nutrients contained therein, or who
1991 (Codex have other special medically-determined
Standard for nutrient requirement, whose dietary
Labelling of and management cannot be achieved only by
Claims for Foods modification of the normal diet, by other
Special Medical foods for special dietary uses, or by a
Purposes) combination of the two.

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HIGH RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES
H. 4.Dietetic formula Formula foods that when presented as “ready Includes products
FOODSTUFFS for slimming -to-eat” or when prepared in conformity with with reduced caloric
INTENDED purposes and the directions for use are specifically content such as
FOR weight reduction presented as replacements for all or part of those that are low in
PARTICULAR the total daily diet. sugar and/or fat,
NUTRITIONAL Codex Stan 203- sugar- or fat-free, or
USES 1995 (Codex contain sugar and/
Standard for or fat-substitutes.
Formula Foods for
Use in Very Low
Energy Diets for
Weight Reduction)

Codex Stan 181-


1991 (Standard for
Formula Foods for
Use in Weight
Control Diets

5.Dietetic foods Products of high nutritional content, in liquid


(e.g. or solid form (e.g. protein bars), to be used
supplementary by individuals as part of a balanced diet to
foods for dietary provide supplemental nutrition. Products are
use) excluding not intended to be used for purposes of
products under weight loss or as part of a medical regimen.
HR Letter H.1 to 4
and Letter I, Food
supplements)

Codex Stan 203-


1995 (Codex
Standard for
Formula Foods for
Use in Very Low
Energy Diets for
Weight Reduction)

Codex Stan 181-


1991
6.Weaning foods for
infants and growing
children

Codex Stan 074-1981,


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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HIGH RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

H. 7.Dietetic foods Foods for special dietary use that are


FOODSTUFFS for special medical specially processed or formulated and
INTENDED purpose presented for the dietary management of
FOR patients and may be used only under medical
PARTICULAR Codex Stan 180- supervision. They are intended for the
NUTRITIONAL 1991 (Codex exclusive or partial feeding of patients with
USES Standard for limited or impaired capacity to take, digest,
Labelling of and absorb or metabolize ordinary foods or
Claims for Foods certain nutrients contained therein, or who
Special Medical have other special medically-determined
Purposes) nutrient requirement, whose dietary
management cannot be achieved only by
Codex Stan 146- modification of the normal diet, by other
1995 (General foods for special dietary uses, or by a
Standard for the combination of the two.
Labelling of and
Claims for
Prepackaged Foods
for Special Dietary
Uses)

8.Dietetic formulas
for weight control

Codex Stan 203-1995


(Codex Standard for
Formula Foods for
Use in Very Low
Energy Diets for
Weight Reduction)

Codex Stan 181-1991


(Standard for Formula
Foods for Use in
Weight Control Diets)

I. BOTTLED Bottled Water means water that is placed in a Includes drinking


WATER sealed container or package and is offered for water, natural water,
sale for human consumption as drinking artesian water, well
A.O. 18-A s. 1993 water, spring water,
water. mineral water, purified
water, carbonated or
sparkling water, and
fluorinated water.

J. FOOD 1. Herbs and


SUPPLEMENT/ botanicals
HERBAL
FOOD/
HERBAL 2. Products with
DIETARY other nutritional
SUPPLEMENTS substances
Regulations:
The Adopted
Negative List of
Active Ingredients
(Animal or Plant)
for Health
Supplements

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HIGH RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES
J. FOOD
SUPPLEMENT/
HERBAL FOOD/
HERBAL
DIETARY
SUPPLEMENTS
The Adopted
Negative List of
Active Ingredients
(Animal or Plant)
for Traditional
Medicines

ASEAN GL
Minimising Risk of
Transmission TSE
TMHS V1.0
(1Oct14)

ASEAN GP for the


Use of Additives &
Excipients in
TMHS V2.0
(1Oct14)

ANNEX III
ASEAN GL on
Limits of
Contaminations
TMHS V1.0
(13Nov14) (1)

B.C. No. 02 s. 1999


(Additional
Labelling
Requirement for
Food Supplements)

B.C. No. 16 s. 2004


(Guidelines on
Probiotics)

B.C. No. 17 s. 2004


(Taheebo/Pau
d’arco/Lapacho)

Pharm'l Excipient
6th

PNS/BAFPS
22:2004 (Virgin
Coconut Oil
2015 Philippine
Dietary Reference
Intake

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Risk Classification of Food Products


HIGH RISK FOOD PRODUCTS
CATEGORY FOOD STUFF DESCRIPTORS/DEFINITION EXAMPLES

J. FOOD
SUPPLEMENT/
HERBAL
FOOD/
HERBAL
DIETARY
SUPPLEMENTS

PDR For Herbal


Medicines 4th Ed

Office Order
No.22 s.1991
(Guidelines for
the Classification
of Vitamins and
Minerals as Drug
or as Food)

K. NOVEL / New in the


NEW international or
INNOVATIONS local market
in FOOD

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Electronic Registration Guidelines and


Procedure

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STEP-BY-STEP PROCEDURE FOR INITIAL APPLICATIONS

pg. 17 of

 Please see the succeeding pages for the Guidelines


on filling out the application form

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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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Open the product application, click “Information” button and choose


“Process Map” on the drop-down list to check the status of the
application .

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Guidelines on Filling out the Initial Application Form

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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Guidelines on Filling out the Initial Application Form
Step 4: Click “Yes, I agree” then “Continue” to proceed to the initial application
form. Declining the declar ation shall mean for feitur e of the oppor tunity to
proceed with E-registration.

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Guidelines on Filling out the Initial Application Form
All information filled out by the applicant during the process will be reflected
exactly in the final output (either CPR or Letter of Denial). Thus, it is imperative
for the client to be strictly cautious and diligent in filling out all required
information.

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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Guidelines on Filling out the Initial Application Form

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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Guidelines on Filling out the Initial Application Form
The declaration of the Brand Name and Product Name should be consistent with
the submitted label. Product name shall indicate the true nature of the food and
shall normally be specific; not generic.

Example of wrong data entry:

Declaration on the label: Declaration on the application:


Brand Name: ABC Brand Name: ABC
Product Name: Menthol Candy Product Name: MENTHOL

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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Guidelines on Filling out the Initial Application Form
Brand Name should not be misleading, confusing and likely create erroneous
impression regarding its character or nature in any respect. For those Brand Name
with a registered Trade Mark or with an IPO certificate, the symbol ™ or ® must
be declared and a Trade Mark or IPO Certificate must be submitted.

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.

Example of Wrong Data Entry:


Declaration on the valid LTO:
Company Name: COOKIES CORP.
Company Address: BLK 15, LOT 3, SALCEDO VILLAGE,
MAKATI CITY

Declaration on the Application:


Company Name: COOKIES CORPORATION
Company Address: B 15, L 3, SALCEDO VILL. MAKATI

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Guidelines on Filling out the Initial Application Form

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Guidelines on Filling out the Initial Application Form

 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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For companies with LTO activity as IMPORTER/DISTRIBUTOR
1. Choose the option “Importer Wholesaler Distributor” as the company
activity, consistent with the License to Operate (LTO) number declared in the
data entry under Food Product Application Form.

2. Select the option “Imported” in the Type of Source.

3. Determine the correct “Country of Origin” of the product being imported.


Refer to the guide statement regarding the definition of the country of origin.

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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For companies with LTO activity as IMPORTER/DISTRIBUTOR
Not Directly Sourced:
Manufacturer: USA —> Supplier: China —> Importer: Philippines

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.

7. Click “Next” to continue.

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For companies with LTO activity as DISTRIBUTOR/
WHOLESALER
1. Choose the option “Distributor Wholesaler” as the company activity,
consistent with the License to Operate (LTO) number declared in the data
entry under Food Product Application Form.

2. Choose if the product is Directly Sourced or not.

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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For companies with LTO activity as DISTRIBUTOR/
WHOLESALER

5. If the product is directly sourced, declare the complete name and address of the
manufacturer.

6. Click “Next” to continue.

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For companies with LTO activity as TRADER
1. Choose the option “Trader” as the company activity, consistent with the Li-
cense to Operate (LTO) number declared in the data entry under Food Product
Application Form.

2. Choose if the product is Directly Sourced or not.

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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For companies with LTO activity as TRADER
5. If the product is directly sourced, declare the complete name and address of the
manufacturer.

6. Click “Next” to continue.

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For companies with LTO activity as MANUFACTURER

1. Choose the option “Manufacturer” as the company activity, consistent with


the License to Operate (LTO) number declared in the data entry under Food
Product Application Form.

2. Click “Next” to continue.

For Applications with Multiple Suppliers

1. Declare the complete name and address of the suppliers separated by


semicolon (;).

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Guidelines on Filling out the Initial Application Form

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Guidelines on Filling out the Initial Application Form
For Wine products, declare the grape variety/ies used.

Flavors – declare the classification as, “Natural”, “Artificial”, “Nature identical”


and “Flavors (Combination of Natural and Nature Identical)”.

Coloring substances – declare common name or as “Food Color(s)” or “Colors”


for those derived from or identical with substances derived from plant materials,
and the common name of the “Artificial Color(s)” for coal-tar dyes or other
synthetic chemical compounds

In case of reformulation, apply for an initial registration for the reformulated


product. Reformulation includes the increase or decrease in the amount of existing
ingredients of a product, or addition of new ingredient/s or deletion of existing
ingredients of the product.

Click “Continue” to proceed to the next step.

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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Guidelines on Filling out the Initial Application Form
The complete list of ingredients and amount per serving (e.g. capsule, tablet, ml,
sachet, stick, gummies, softgel, mg, g) must be declared. It should be stated as:
- Form/Chemical Nature for Vitamins and Minerals
- Common Name (Scientific name) and Plant Part used for Herbs and Botanicals
- Common name (Scientific name) of Plant/Animal source and part used for
Product with other nutritional substances (plant or animal origin).

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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Guidelines on Filling out the Initial Application Form

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).

Examples of Chemical Parameters:


Moisture content, Water activity, pH, Heavy metals such as lead, mercury,
arsenic, cadmium.

Examples of declaration of Chemical Specifications:


Not more than 10%, Minimum of 10 ppm, etc.

Examples of Microbiological Parameters:


Coliforms, Total Plate Count, Salmonella spp., Yeast & Molds, E . Coli. ;
Commercial Sterility , S. A ureus

Examples of Microbiological Specifications:


Maximum 10 cfu/g, <100 cfu/mL, etc.
MAL 10,000 cfu/ml ;

Click “Continue” to proceed to the next step.

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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Guidelines on Filling out the Initial Application Form

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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Guidelines on Filling out the Initial Application Form

Follow the nutrition labelling based on A.O. 2014-0030.


For products formulated for an intended purposes (e.g. special medical purpose or
special dietary use) follow the nutrition labelling based on specific Codex
Standards (e.g. per 100ml or per 100g).
Note: For products covered by the milk code, infant formula, milk supplement follow D.C.
2008-0006 and for mineral/mineralized water follow A.O. 18A s. 1993.

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Guidelines on Filling out the Initial Application Form

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Guidelines on Filling out the Initial Application Form

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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Guidelines on Filling out the Initial Application Form

Upload clear and complete loose labels or artworks, as applicable, of all


packaging sizes, or equivalents as defined by FDA regulations. The product label
shall be named following the for mat:

“Label_(Case Number)”

Example: “Label_36252.pdf” or “ Label_36252.png”

For products with multiple labels, the product label shall be named following the
format:

“Label1_(Case Number)” and “Label2_(Case Number)”.

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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Guidelines on Filling out the Initial Application Form

If there is IPO, Trademark and other logo/seal, Certification must be submitted.


The Certificate of Analysis should be recent (issued six months from the date of
application).

*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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Guidelines on Filling out the Initial Application Form
The submitted Stability Data should indicate:
1. Conclusion Parameters Used
2. Methodology (This should declare the following: product name, batch number,
production date, dates of analysis, tabulated data results in terms of physical
and chemical properties, and name and signature of the QA Analyst and QA
Manager. (Accelerated Shelf Life Study until 6 mos. can be accepted for
Initial Application and Real Time Shelf Life Study for Renewal Applications.)
Upload Certificate of Analysis reflecting the Physical, Chemical, and
Microbiological properties of the finished product with Nutrient Analysis and
Heavy Metals as applicable.
Upload LD-50 Toxicity Test to justify the safety of the product, as applicable )
e.g. food supplements)

 Click “Attach” to upload: Other Documentary Requirements, Substantiation


of Claims and Product Label (Labeling Artwork, Box, Blister Pack, Sachet,
Stick).

For Food Supplements: The word “FOOD SUPPLEMENT” and “NO


APPROVED THERAPEUTIC CLAIMS” must be declared on the principal
display panel. The precaution: “For Adult Use only. Not recommended for
children, pregnant and lactating women” should be declared if the product is not
intended for children nor pregnant women. The uploaded label should not contain
therapeutic claims and unnecessary images/photographs that is not part of the
ingredients and will likely create erroneous impression regarding its character or
nature in any respect. The phrase Nutrition Facts should be used instead of
Supplement Facts.

Please be reminded that only 25MB is allotted per product application. This
includes all the documents uploaded during initial application, amendment
application and reapplication.

Click “Continue” to proceed to the next step.

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Guidelines on Filling out the Initial Application Form
PAYMENT PROCEDURES

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

You may review this Order of Payment Form by clicking “Generated


Documents” in the drop down list of “Information” button.

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Guidelines on Filling out the Initial Application Form
One (1) sample of Food Supplement in commercial presentation should be
submitted to the Food and Drug Administration (Civic Drive, Filinvest City,
Alabang 1781 Muntilupa City) within ten (10) days upon payment of assessed fee
through following means:

 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.

Guidelines on proper packing of Food Supplement Samples for


transport via courier:
 For Fragile Items:
 Use fillers like crumpled newspaper or air-cellular cushioning material such
as bubble wrap, to fill void spaces and prevent movement inside the box
during shipping.
 Wrap individual items with cushioning material and position them away
from other items and the sides, corners, top and bottom of the outer
container.
 For glass bottles containing liquid, wrap in a plastic bag to prevent from
leaking.
 Mark “FRAGILE” on the shipment box.
 Consolidate small parts or spillable granular products in a strong sealed
container, such sift-proof plastic bag, before packaging in a sturdy outer box.
(e.g. samples in a carton box with blister pack, aluminium pouch, PET &
HDPE plastic bottle, sachet)
 For multiple items, wrap each item individually and separate with corrugated
inserts or other divider materials as appropriate.
 Fill empty space completely within the box to avoid contents from moving
during transit which can cause damage to both contents and box.
 Fix the shipment label securely on the top surface of the shipment box. This
will help to keep shipment in an upright position, as much as possible, during
transit.
 Apply tape evenly across flaps and seams to both top and bottom of the outer
box.

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FDA Circular 2016-014: Procedure for the use of Electronic Registration


(E-Registration) System for Pre-packaged Processed Food Products

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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Guidelines on Reapplication
I. For Applications for Registration of Medium and High Risk Food
Products Previously Denied under the PAIR System:

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:

1. Access the online portal through https://ww2.fda.gov.ph. Provide the company


-specific Username and Password, and double click on the specific product in
the Inbox folder.
2. Select the type of application from the drop-down menu after the
“Declaration”.

3. Choose “Yes, I would like to reapply”.


Reapplication can be done within six (6) months from the date of receipt of the
Letter of Denial.
If Reapplication was not filed after six months or was DENIED, application will
be turned Initial.

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Guidelines on Reapplication

4. Click “Attach” to upload each document to comply to specific deficiency stated


in the Letter of Denial (Example: Certificate of Analysis of 3MCPD for soy
sauce, Vitamin A for cooking oil, Food Supplement label with phrase “NO
APPROVED THERAPEUTIC CLAIMS”).
 Note: If the application is denied under the PAIR System, initial requirements
must be submitted in addition to reapplication documents. This application is
termed as “REAPPLICATION DATA CAPTURE” and will only be used for
product applications previously filed from PAIR unless specified in this
manual.
Reminder: Submit a clear and readable copy of your compliance in ".PNG" or
".PDF" format not exceeding 2MB in size per file.

6. Select “Open” to download Order of Payment. Follow instructions as indicated.

7. Click “Continue”.

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Guidelines on Amendment
 For amendment application from previously approved CPR under the
PAIR System, initial requirements must be submitted in addition to docu-
ments. This application is termed as “AMENDMENT DATA CAPTURE”
and will only be used for product applications previously filed from PAIR
unless specified in this manual.

 All amendment applications (Approved or Denied) will be automatically sent in


the company’s account inbox.

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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Guidelines on Amendment

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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Guidelines on Amendment
PRODUCT SUMMARY

The summary of your previous application will appear.


Step 5: Click “Continue” button to proceed to amendment form.

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Guidelines on Amendment
AMENDMENT FORM

Step 6: Click the type of amendment to be applied.


You can click multiple options depending on the changes applicable to your
application. Payment is based on the number of amendments to be applied.

SINGLE APPLICATION
EXAMPLE: CHANGE IN BRAND NAME

 Click “Change in Brand Name”


 Enter the new Brand Name.
 Select the “Next” button to proceed.

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Guidelines on Amendment

 Click the “Attach” button to upload the requirements as per Administrative


Order No.2014-0029 (New product label reflecting the change, Authority from
the Source or the owner of the brand, if imported, IPO registration, if
available).
 If the application is “Amendment Data Capture” and the previously
approved CPR is with remarks (e.g. “Declare expiry date in prescribed
format” ) the label to be submitted should be compliant.
 Click the “Next” button to proceed.

PAYMENT PROCEDURE

 Follow the description of “Order of Payment”.


 Click the “Next Step” button to proceed.

You may also pay the amendment fee thru BancNet.

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AMENDMENT

 Select the “Continue” button to forward your application to the cashier.


Upon payment of the corresponding fee, the cashier will forward your application

 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.

 To monitor your application, click “Process Map”.


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AMENDMENT
MULTIPLE AMENDMENT

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.

 Select the “Attach” button to upload the requirements as per Administrative


Order No.2014-0029. (New product label reflecting the change and
justification for the change, Authority from the Source or the owner of the
brand, if imported and IPO registration, if applicable.
 Click the “Next” button to proceed.

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AMENDMENT
AMENDMENT SUMMARY TABLE

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”.

 Select “Summary” button.

MULTIPLE AMENDMENT

 The Product Information Summary will appear.


 The “Amendment Summary Table” is located at the bottom part of Product
Information Summary. This table will show the result of your amendment
application if Approved or Denied.
 Once approved, you can claim your amended CPR to the releasing unit of
PAIR.

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OTHER TYPES OF AMENDMENT
1. CHANGE IN PRODUCT DESCRIPTION/NAME

 Click “Change in Product Name”.


 Enter the new Product Name/Description.
 Click the “Next” button to proceed.

 Select the “Attach” button to upload the requirements as per Administrative


Order No.2014-0029 (New product label reflecting the change and
justification for the change).
 Click the “Next Step” button to proceed.

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OTHER TYPES OF AMENDMENT
2. CHANGE IN BUSINESS NAME

 Click “Change in Company Name”.


 Enter the new Company Name.
 Click the “Next” Step button to proceed.

 Select the “Attach” button to upload the requirements as per Administrative


Order No.2014-0029 (New product label reflecting the change, termination of
agreement/ Deed of assignment, Agreement of new manufacturer/importer/
distributor or Appointment letter).
 Click the “Next Step” button to proceed.

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OTHER TYPES OF AMENDMENT
3. CHANGE IN/ADDITIONAL PACKAGING MATERIAL

 Click “Change in Packaging Material and/or Additional Packaging Type”.


 Enter the new Packaging Material and/or Additional Packaging Type.
 If applicable, click “Change in Packaging in Commercial Presentation”
given that there will be changes in size, presentation or description.
 Enter the new Packaging in Commercial Presentation.
 Select “Change or Extension of Shelf Life” since there is change or
additional packaging material.
 Enter the new or additional Shelf Life.
 Click the “Next” button to proceed.

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OTHER TYPES OF AMENDMENT
NOTE: If the amendment is to add packaging material, commercial presentation or
shelf life declaration, re-type the existing information and use semi-colon (;) in the
data entry to delineate the new one .
Example:
CARTON BOX; FOIL POUCH
TY; 30 GRAMS IN FOIL POUCH
24 MONTHS; 12 MONTHS

 Click the “Attach” button to upload the requirements as per Administrative


Order No.2014-0029 (Complete labelling materials of the previously approved
label and the proposed new/additional presentation of packaging for
comparison [All information on the label including the design should be the
same], Proof of suitability of packaging material for food, including stability of
the product in the new packaging and clear and complete loose labels or
artworks).
 Select the “Next” button to proceed.

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OTHER TYPES OF AMENDMENT
4. CHANGE IN PACKAGING PRESENTATION

 Click “Change of Packaging in Commercial Presentation”.


 Enter the new description including the size or SKU of Packaging in
Commercial Presentation.
 Select the “Next” button to proceed.

If the amendment is to add commercial presentation, re-type the existing


information and use semi-colon (;) in the data entry to delineate the new one
(Example: TY; 30 GRAMS IN FOIL POUCH)

 Click the “Attach” button to upload the requirements as per Administrative


Order No.2014-0029 (New product label reflecting the change).
 Select the “Next” button to proceed.

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OTHER TYPES OF AMENDMENT
5. CHANGE OR EXTENSION OF SHELF LIFE

 Click “Change or Extension in Shelf Life”.


 Enter the new or additional Shelf Life.
 Click the “Next” button to proceed.

 Selct the “Attach” button to upload the requirements as per Administrative


Order No.2014-0029 (Stability study results with conclusion to support
extension or change in shelf life).
 Click the “Next” button to proceed.

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OTHER TYPES OF AMENDMENT
6. CHANGE OR ADDITIONAL DESIGN

 Click “Change in/Additional Packaging Design”.


 Upload the new product label by clicking the “Choose File” button.
 Click the “Next” button to proceed.

The amendment “Exportation of previously registered product initially for local


distribution” will be under Change or Additional Design.

 Select the “Attach” button to upload other documents to support the proposed
design.
 Click the “Next” button to proceed.

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OTHER TYPES OF AMENDMENT
7. CHANGE OR ADDITIONAL SUPPLIER

 Click “Change in Company Name”.


 Enter the new or additional Supplier’s Name and/or Address.
 Click the “Next” button to proceed.
This type of amendment is only applicable provided that the manufacturer is the
same. If the amendment is to add new supplier, re-type the existing information
and use semi-colon (;) in the data entry to delineate the new one .

 Select the “Attach” button to upload other documents to support the proposed
design.
 Click the “Next” button to proceed.

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OTHER TYPES OF AMENDMENT
8. TRANSFER OF OWNERSHIP OF A REGISTERED PRODUCT

• Click "Change in Company Name" (To generate payment, since there is no


option on E-portal in this case).

• Enter the new Company name .

• Select the "Attach" button to upload the requirement as per Administrative


Order 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).

• Click the "Next" button to proceed.

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OTHER TYPES OF AMENDMENT
9. CHANGE IN BUSINESS/COMPANY ADDRESS

• Click "Change in Company Name" (To generate payment, since there is no


option on E-portal in this case).

• Enter The Existing Company name.

• 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).

• Click the "Next" button to proceed.

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OTHER TYPES OF AMENDMENT
10. CHANGE IN MANUFACTURERS’ NAME & ADDRESS

 Click "Change in Company Name" (To generate payment, since there is no op-
tion on E-portal in this case).

 Enter The Existing Company name.

• 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).

• Click the "Next" button to proceed.

 Note: Change in Manufacturer’s Address is automatically an INITIAL


APPLICATION.

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OTHER TYPES OF AMENDMENT
11. CHANGE IN LTO NUMBER

• Click "Change in Company Name" (To generate payment, since there is no


option on E-portal in this case).

• Enter The Existing Company name.

 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).

• Click the "Next" button to proceed.

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OTHER TYPES OF AMENDMENT
12. NOTIFICATION CHANGE IN PRODUCT SPECIFICATIONS

• Click "Change in Company Name" (To generate payment, since there is no


option on E-portal in this case)

• Enter The Existing Company name.

 Select the "Attach" button to upload the requirement as per Administrative


Order 2014-0029 (Letter of intent, and new product specifications or Certifi-
cate of Analysis).

• Click the "Next" button to proceed.

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Guidelines in the Payment of Issued Certificate of Product
Registration from Manual Process to E-Registration (Renewal
and Amendment Application)

 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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RENEWAL of CPR
Renewal in E-registration is the action of extending the period of validity of the
existing Certificate of Product Registration (CPR) with the following conditions:
a. No change/s in the product formulation; and
b. No change/s in manufacturer or re-packer.
 Renewal of registration is strictly five-year duration starting on the date of
expiration of the CPR. The client should tick “5 YEARS” for the validity of
the CPR.
 Renewal application should be filed THREE (3) months prior to
expiration date.
 A surcharge of 50% of renewal fee is collected if renewal registration is
submitted within three (3) months after the expiration of the CPR. Application
for renewal filed beyond the third month after expiration of CPR shall be
considered as initial application. Corresponding surcharges shall be made
accordingly.
 For renewal application from previously approved CPR under the PAIR
System, initial requirements must be submitted in addition to renewal
documents. This application is termed as “RENEWAL DATA CAPTURE”
and will only be used for product applications previously filed from PAIR
unless specified in this manual.

PROCEDURE FOR E-REG “RENEWAL”


1. Double click the Case Number due for “RENEWAL”
2. Look for “Type of Action” button and select “RENEWAL” from the drop
down box.

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RENEWAL of CPR
3. Once “Renewal” is selected, click then select the “Continue” button.

Details of existing Certificate of Product Registration (CPR) can be viewed.

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RENEWAL of CPR
Details of existing Certificate of Product Registration (CPR) can be viewed.

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RENEWAL of CPR
Details of existing Certificate of Product Registration (CPR) can be viewed.

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RENEWAL of CPR
Details of existing Certificate of Product Registration (CPR) can be viewed

4. Once the details are confirmed, click the “Continue” button to proceed.

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RENEWAL of CPR

5. Follow directions as indicated (DOWNLOADING of Order of Payment).


6. Click “Next Step” and “Continue” button to finish task.

Task can be viewed or reviewed by clicking “Previous Step”.

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RE-ISSUANCE OF CPR IN ELECTRONIC REGISTRATION

 In Type of Action, choose “Re-issuance”.


 Click “Next”.

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RE-ISSUANCE OF CPR IN ELECTRONIC REGISTRATION

 Type the number of CPR copies.

 Download a copy of the Order of Payment by clicking “Open”.


 Follow the instructions as indicated.
 Click “Next Step”

 Click “Continue”.

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CANCELLATION OF CPR IN ELECTRONIC REGISTRATION

Cancellation or “I want to cancel this authorization” in E-registration is the


invalidation (null and void) of the existing Certificate of Registration (CPR) due to
reasons below:
A. Product has become non-existent;
B. Product is no longer manufactured by/distributed/traded/imported.

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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CANCELLATION OF CPR IN ELECTRONIC REGISTRATION
Details of existing Certificate of Product Registration (CPR) can be viewed

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CANCELLATION OF CPR IN ELECTRONIC REGISTRATION
Details of existing Certificate of Product Registration (CPR) can be viewed

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CANCELLATION OF CPR IN ELECTRONIC REGISTRATION
Details of existing Certificate of Product Registration (CPR) can be viewed.

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CANCELLATION OF CPR IN ELECTRONIC REGISTRATION
Details of existing Certificate of Product Registration (CPR) can be viewed.

4. Once the details are confirmed, click the “Continue” button to proceed.

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CANCELLATION OF CPR IN ELECTRONIC REGISTRATION
Details of existing Certificate of Product Registration (CPR) can be viewed.

5. Task is done once “Finish” button is clicked.

Task can be viewed or reviewed through clicking “Previous Step” prior to


“Finish”.

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Post-CPR Approval Duties and


Responsibilities of Food Establishments

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Duties and Responsibilities of Food Establishments


Ensure that the food product, along the food chain, is not and will not be
adulterated, contaminated, misbranded and misleading.

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.).

Ensure the traceability of the food products through proper documentation


and observance, at the minimum, of the “one-step-backward and one-step-
forward” approach .

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.

In cases that the company detects non-compliances of their own products to


food safety standards of the Food and Drug Administration (e.g. level of
contaminants, quality standards, etc.), the company must immediately report
to FDA the appropriate action to address the potential food safety issue.

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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ANNEX A. LIST OF CURRENT PHILIPPINE NATIONAL


STANDARDS
PNS Number Title

PNS/BFAD 01:2005 Ethnic Food Products: Dry Base Mixes for Soups and Sauces

PNS/BFAD 02:2005 Ethnic Food Products: Sweet Preserves


Recommended Code of Practice for the Processing and Handling of
PNS/BFAD 03:2006
Sweet Preserves
PNS/BFAD 04:2006 Ethnic Food Products: Dried, Salted Fish
Recommended Code of Practice for the Processing and Handling of
PNS/BFAD 05:2006
Dried Fish
PNS/BFAD 06:2006 Thermally Processed Fish Products

PNS/BFAD 08:2007 Standard for Fermented Milks

PNS/BFAD 09:2007 Mango Beverage Standard


Recommended code of practice for the processing and handling of
PNS/BFAD 10:2007
mango beverage products
PNS/BFAD 11:2007 Citrus Beverage Standard
Recommended code of practice for the Processing and Handling of
PNS/BFAD 12:2007
Citrus Beverage Products
PNS/BFAD 13:2007 Banana chips – Specification
Recommended Code of Practice for the Processing and Handling of
PNS/BFAD 14:2007
Banana Chips
PNS/BFAD 15:2007 Dried Mango Products – Specification

PNS/BFAD 16:2007 Dried Tropical Fruits – Specification


Recommended Code of Practice for the Processing and Handling of
PNS/BFAD 17:2007
Dried Tropical Products
PNS/BFAD 18:2008 Flour Sticks (Pancit Canton) – Specification
Recommended Code of Practice for the Processing and Handling of
PNS/BFAD 19:2008
Flour Sticks (Pancit Canton)
PNS/BFAD 20:2009 Sugar Cane Wine (Basi) – Specifications
Recommended Code of Practice for the Processing and Handling of
PNS/BFAD 21:2009
Sugar Cane Wine
PNS/BFAD 22:2010 Fried Corn Snacks (Chichacorn)
Recommended Code of Practice for the Processing and Handling of
PNS/BFAD 23:2010
Fried Corn Snacks

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ANNEX A. LIST OF CURRENT PHILIPPINE NATIONAL


STANDARDS

PNS Number Title

PNS/FDA 24:2010 Purple Yam (Ube) Jam (Halaya)


Recommended code of practice for the processing and handling of
PNS/FDA 25:2010
purple yam jam
PNS/FDA 26:2010 Smoked Fish – Specifications
Recommended Code of Practice for the Processing and Handling of
PNS/FDA 27:2010
Smoked Fish
PNS/FDA 28:2010 Processed Pili Nut Products – Specifications
Recommended Code of Practice for the Processing and Handling of
PNS/FDA 29:2010
Processed Pili Nut Products
PNS/FDA 30:2010 Tropical Fruit Wines – Specifications
Recommended Code of Practice for the Processing and Handling of
PNS/FDA 31:2010
Tropical Fruit Wines
Ethnic Flour-based Confectioneries (Pulvoron, Piaya, Barquillos) –
PNS/FDA 32:2010
Specifications

Recommended Code of Practice for the Processing and Handling of


PNS/FDA 33:2010
Ethnic Flour-based Confectioneries (Pulvoron, Piaya, Barquillos)

Ethnic Milk-based Confectioneries (Yema, Pastillas) – Specifica-


PNS/FDA 34:2011
tions

Recommended Code of Practice for the Processing and Handling of


PNS/FDA 35:2011
Ethnic Milk-based Confectioneries (Yema, Pastillas)

PNS/FDA 36:2014 Salt Fermented Fish and Shrimps (Bagoong) – Specifications

Recommended Code of Practice for the Processing and Handling of


PNS/FDA 37:2014
Salt Fermented Fish and Shrimps (Bagoong)

PNS/FDA 38:2015 Fish Sauce (Patis) and Fish Flavoured Sauce – Specifications

Recommended Code of Practice for the Processing and Handling of


PNS/FDA 39:2015
Fish Sauce (Patis) and Fish Flavoured Sauce
PNS/FDA 40:2015 Banana Ketchup – Specifications
Recommended Code of Practice for the Processing and Handling of
PNS/FDA 41:2015
Banana Ketchup
*Copy of documents may be purchased from the Bureau of Philippine Standards, Department of Trade and Industry

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As of October 2017
(NOTE: For the Methods of Analysis of PNS products, please see the specific standards as referred to
in this document.)

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As of October 2017

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ANNEX B.
B. SUMMARY
SUMMARY OF
OF CURRENT
CURRENT FOOD
FOOD STANDARDS
STANDARDS
As of October 2017

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ANNEX B.
B. SUMMARY
SUMMARY OF
OF CURRENT
CURRENT FOOD
FOOD STANDARDS
STANDARDS
As of October 2017

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As of October 2017

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ANNEX B.
B. SUMMARY
SUMMARY OF
OF CURRENT
CURRENT FOOD
FOOD STANDARDS
STANDARDS
As of October 2017

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B. SUMMARY
SUMMARY OF
OF CURRENT
CURRENT FOOD
FOOD STANDARDS
STANDARDS
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As of October 2017

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ANNEX C. REVISED GUIDELINES FOR THE ASSESSMENT


OF MICROBIOLOGICAL QUALITY OF PROCESSED FOODS

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OF MICROBIOLOGICAL QUALITY OF PROCESSED FOODS

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OF MICROBIOLOGICAL QUALITY OF PROCESSED FOODS

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OF MICROBIOLOGICAL QUALITY OF PROCESSED FOODS

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OF MICROBIOLOGICAL QUALITY OF PROCESSED FOODS

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OF MICROBIOLOGICAL QUALITY OF PROCESSED FOODS

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OF MICROBIOLOGICAL QUALITY OF PROCESSED FOODS

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OF MICROBIOLOGICAL QUALITY OF PROCESSED FOODS

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OF MICROBIOLOGICAL QUALITY OF PROCESSED FOODS

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OF MICROBIOLOGICAL QUALITY OF PROCESSED FOODS

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OF MICROBIOLOGICAL QUALITY OF PROCESSED FOODS

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ANNEX D. RULES AND REGULATIONS GOVERNING THE


LABELING OF PREPACKAGED FOOD PRODUCTS

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LABELING OF PREPACKAGED FOOD PRODUCTS

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LABELING OF PREPACKAGED FOOD PRODUCTS

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LABELING OF PREPACKAGED FOOD PRODUCTS

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LABELING OF PREPACKAGED FOOD PRODUCTS
Table 1. Class Names for Use in Ingredients Listing
CLASS NAMES
NAME OF CLASSES
for Use in Ingredients Listing
‘Oil’ together with either the term
‘vegetable’ or ‘animal’, qualified by
Refined oils other than olive* the term ‘hydrogenated’ or ‘partially-
hydrogenated’, as appropriate
‘Fat’ together with either, the term
‘vegetable’ or ‘animal’, as appropriate
Refined fats* provided that for animal fat the specif-
ic animal source must be declared (i.e.
pork, beef)
Starches, other than chemically modified starches Starch
All species of fish where the fish constitutes an
ingredient of another food and provided that the
Fish
labeling and presentation of such food does not
refer to a specific species of fish
All types of poultry meat where such meat consti-
tutes an ingredient of another food and provided
Poultry meat
that the labeling and presentation of such a food
does not refer to a specific type of poultry meat
All types of cheese where the cheese or mixture of
cheeses constitutes an ingredient of another food
and provided that the labeling and presentation of Cheese
such food does not refer to a specific type of
cheese
All spices and spice extracts not exceeding 2% by
weight either singly or in combination in the food ‘Spice’, ‘spices’, or ‘mixed spices’, as
appropriate
All herbs or parts of herbs not exceeding 2% by
weight either singly or in combination in the food ‘Herbs’ or ‘mixed herbs’, as appropriate

All types of gum preparations used in the manufac-


ture of gum base for chewing gum Gum base

All types of sucrose Sugar


Anhydrous dextrose and dextrose monohydrate
‘Dextrose’ or ‘glucose’
All types of caseinates Caseinates
Milk products containing a minimum of 50% of
milk protein (m/m) in dry matter** Milk Protein

Press, expeller or refined cocoa butter Cocoa Butter


All crystallized fruit not exceeding 10% of the
weight of the food
Crystallized Fruit

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LABELING OF PREPACKAGED FOOD PRODUCTS
Labeling of Food Additives
The following provisions of the Guidelines of Codex Standard for Food Additives
Labeling (General Standard for the Labeling of Food Additives when Sold as such
– CODEX STAN 107-1981) are hereby adopted:
1. Mandatory Labeling of Prepackaged Food Additives Sold by Retail

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.

Details of the food additive:

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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B. Instructions on storage and use
Adequate information shall be given about the manner in which the food
additive is to be kept and is to be used in food.

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.

D. Name and Address


The name and address of the manufacturer, packer, distributor, importer,
exporter of the food additive shall be declared.

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.

2. Mandatory Labelling of Prepackaged Food Additives Sold Other than by


Retail

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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ANNEX E. CAUTION/ADVISORY STATEMENTS


In case a product contains one of the following ingredients, the corresponding cau-
tion statement shall be declared as additional labelling requirements.

INGREDIENTS/ CAUTION STATEMENT


COMPONENTS

Aspartame Phenylketonurics : Contains Phenylalanine

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

Lactitol, maltitol, maltitol syrup, “excessive consumption of the food containing


xylitol, mannitol (alone or in these substances may have a laxative effect”
combination)
³ 10 g/100 g

Sorbitol, erythritol, isomalt,


polydextrose (alone or in
combination) ³ 25 g/100 g

Ginkgo Biloba Ginkgo Biloba : It is advised that Ginkgo


Biloba should not be taken for 6 months or
longer and it should not be used with warfarin
and other thrombolytic agents.

Glucomannan (konjac mannan) Warning of choking to be given for people with


1 g of glucomannan per swallowing difficulties or when ingesting with
quantified portion inadequate fluid intake — advice on taking
plenty of water to ensure the substance reaches
the stomach.
Take 1-2 glasses of water, before meals and in
the context of an energy-restricted diet

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ANNEX E. CAUTION/ADVISORY STATEMENTS

INGREDIENTS/ CAUTION STATEMENT


COMPONENTS
Guar Gum Warning of choking to be given for people with
swallowing difficulties or when ingesting with
a daily intake of 10 g of guar inadequate fluid intake — advice on taking
gum. plenty of water to ensure that the substance
reaches the stomach

High dose of Vitamin C - Adverse effects of high intake of Vitamin C


Beyond tolerable upper limit may contribute to common complaints such as
diarrhea, nausea, abdominal cramps and
disturbances due to the osmotic effect of
unabsorbed Vitamin C in the gastrointestinal
tract and kidney stone formation in patients
with pre-existing hyperoxaluria.

Hydroxypropyl methylcellulose Warning of choking to be given for people with


(HPMC)- swallowing difficulties or when ingesting with
4 g of HPMC as part of the meal. inadequate fluid intake — advice on taking
plenty of water to ensure that the substance
reaches the stomach

Kava ‘Use in moderation.’ ‘May cause drowsiness.’

Royal Jelly Warning : This product may not be suitable for


asthma and allergy sufferers

Taheebo/Pau d’arco/Lapacho ‘This product is not intended to diagnose, treat,


cure and prevent disease’, ‘Maximum daily
intake up to 3 cups per day only, ‘Should not be
taken with aspirin, ticlopidine, ginko biloba,
ginseng, warfarin & heparin’, ‘Should not be
taken by pregnant or breast-feeding mother’,
‘Should not be taken at least one week before
contemplated operation’, ‘Stop intake of this
product in the event of nausea, vomiting,
diarrhea, skin pallor, bruises and nose bleeding’.

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ANNEX F. CODEX GUIDELINES ON HEALTH AND


NUTRITION CLAIMS

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NUTRITION CLAIMS

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NUTRITION CLAIMS

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NUTRITION CLAIMS

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NUTRITION CLAIMS

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NUTRITION CLAIMS

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NUTRITION CLAIMS

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NUTRITION CLAIMS

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ANNEX G. EVALUATION OF HIGH RISK FOOD PRODUCTS

Foods for Special Medical Purposes


Related Codex Stan 180-1991
Reference
Standards Codex Stan 192-1995
Critical Scientific studies indicating safety and benefits of the product for
Documents intended medical condition

Certificate of Analysis to Support Nutrition Facts


Labelling -Nutrition Labelling: Energy, Vitamins and Minerals per 100 g or
Requirement per 100 ml of the food as sold or as applicable, per serving as
s suggested for consumption
-Osmolality or osmolarity and/or acid base balance when
appropriate
-Nature of the animal or plant proteins or protein hydrolysates
-Modification of the content or nature of proteins, fats or
carbohydrates, other nutrients with rationale for such modification
-USE UNDER MEDICAL SUPERVISION shall be declared in
bold in an area separated from other written, printed or graphic
information
-Additional warning statement in bold letters if the product poses a
health hazard when it is consumed by individuals who do not
have the disease.

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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Infant Formula Milk Supplement/


Follow Up Formula
Related Codex Stan 72-1981 Rev. 2007 Codex Stan 156-1987
Reference CAC/GL 10-1979
Standards
CAC/GL 10-1979 CAC/GL 10-1979
Codex Stan 192-1995 Codex Stan 192-1995
D.C. 2008-0006 D.C. 2008-0006
Critical Certificate of Analysis Certificate of Analysis
Documents (Energy, Protein, Total Fat, (Energy, Protein, Total Fat,
Linolenic Acid, Total Linolenic Acid, Total
Carbohydrates per 100g, Carbohydrates, Vitamins and
Vitamins and Minerals, Trace Minerals, Trace Minerals and
Minerals and Other Other Substances, Optional
Substances, Lauric/Mystiric/ Ingredients – suitable for 6
Trans Fatty Acids per 100 mos onwards and
kcal, Optional Ingredients – scientifically proven,
Taurine, DHA, Contaminants, Additives, Microbioligical
Microbiological Tests, Test Tests, Test Results to Support
Results to Support Nutrition Nutrition Facts)
Facts)
Vitamins and Minerals
Vitamins and Minerals should should be included in the
be included in the Codex Codex Advisory List of
Advisory List of Nutrient Nutrient Compounds for Use
Compounds for Use In Foods In Foods for Infants and
for Infants and Young Young Children (CAC/GL 10
Children (CAC/GL 10-1979) -1979)

Food additives must conform Food additives must conform


with Codex Stan 72-1981 Rev. with Codex Stan 156-1987
2007
Must not be treated by
ionizing radiation
Labelling See Annex 1 for complete See Annex 1 for complete
Requirements summary of D.C. 2008-0006 summary of D.C. 2008-0006

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Foods for Special Dietary Uses


Related Codex Stan 146-1985
Reference
Standards Codex Stan 192-1995
Critical  Scientific studies indicating safety and suitability of the
Documents product to specific disease and disorder to which it is
intended

 Certificate of Analysis to Support Nutrition Facts

Labelling  Product Name: The designation “Special dietary” or


Requirements “Special dietetic” or an appropriate equivalent term shall
be declared; characterizing essential feature but not the
condition shall be stated in appropriate description near
the product name.
 List of ingredients
 Nutrition labeling: Energy, Protein, CHO, Fats, Vitamins
and Minerals per 100 g or per 100 ml of the food as sold,
or as applicable, per serving as suggested for consumption
 Net content
 Storage instruction for opened food
 Claims should conform with Guidelines on Health and
Nutrition Claims
 Claims on prevention, alleviation, treatment, or cure of a
disease, disorder or particular physiological condition are
not allowed.
 Advise statement indicating that advice from a qualifed
medical person is needed. (e.g. USE ONLY UNDER
MEDICAL SUPERVISION)

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ANNEX G. EVALUATION OF HIGH RISK FOOD PRODUCTS

Cereal-Based Foods for Infants & Young Children

Related Codex Stan 074-1981, Rev. 1-2006


Reference
Standards CAC/GL 10-1979
Codex Stan 192-1995
Critical Certificate of Analysis
Documents (Energy, Protein, Carbohydrates, Lipids, Minerals – Critical:
Sodium and Calcium, Vitamins – A B1, D, per 100 kcal
Microbiological Tests)
Labelling  Product Name: Dry Cereal for Infants (andor Young
Requirements Children), Rusks or Biscuits for Infants (and/or Young
Children)
 List of ingredients
 Nutrition labeling-energy, vitamins and minerals shall be
expressed per 100 g or per 100 ml of the food as sold and
where appropriate per specified quantity (per serving) as
suggested for consumption)
 Date marking and Storage Instructions; Date marking (best
before) shall be declared by date, month and year in
uncoded numerical sequence except for products with
shelf life of more than 3 months, the month and year will
suffice.
 Information for Utilization-Direction for use, storage
keeping before and after opening
 Other information-age group; statement indicating when
precisely to begin complementary feeding should be made
in consulation with a health worker.
 Additional statement (bold, in the lowermost level of the
information display panel): Infants six months onwards
should be given fresh, indigenous and natural food in
combination with continued breast feeding.

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ANNEX G. EVALUATION OF HIGH RISK FOOD PRODUCTS

Canned Baby Foods


Related Codex Stan 73-1981 amended 1989
Reference
Standards Codex Stan 192-1995
Critical  Certificate of Analysis
Documents (to support Nutrition Facts, Sodium Content and ,
Microbiological Tests)

 Food additives must conform with Codex Stan 73-1981


amended 1989

 Must not be treated by ionizing radiation

Labelling  Product Name: Indicate the major or characterizing


Requirements ingredient with words suitable to indicate consistency or
intended use.
 List of ingredients
 Nutrition labeling: Energy, Protein, CHO, Fats, Vitamins
and Minerals per 100 g, and per serving size as suggested
for consumption
 Date marking and storage instructions: Date marking (best
before) shall be declared by date, month and year in
uncoded numerical sequence except for products with shelf
life of more than 3 months, the month and year will suffice.
 Information for Utilization: Direction for use, storage
keeping before and after opening
 Net Content

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ANNEX G. EVALUATION OF HIGH RISK FOOD PRODUCTS

Formula Foods for Weight Control Diets


Related Codex Stan 181-1991
Reference
Standards Codex Stan 192-1995
Critical Certificate of Analysis to Support Nutrition Facts

Labelling  Product name: Meal Replacement for Weight Control


Requirements  List of ingredients
 Nutrition labeling: Energy, Protein, CHO, Fats, Vitamins
and Minerals per 100 g or per 100 ml of the food as sold or
as applicable, per serving as suggested for consumption
 Date Marking
 Storage Instructions for opened and unopened food
If direction for use indicate that the food should be combined
with other ingredients, the nutritive value of the final
combination should be declared.

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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ANNEX G. EVALUATION OF HIGH RISK FOOD PRODUCTS

Complementary Foods for Older Infants and Young Children


Related Reference CAC/GL 8-1991
Standard/s Codex Stan 192-1995
CAC/GL 10-1979
Critical Documents Certificate of Analysis to support Nutrition Facts
Labelling Require- Product Name:
ments Indicate that the food is a Formulated Complementary
Food for Older Infants and Young Children. The major
source of protein and the age from which the product is
recommended for use shall appear in close proximity to
the name of the food.
List of Ingredients
Nutrition labelling:
Energy, Protein, CHO, Fats, Vitamins and Minerals per
100g, and per feeding suggested for consumption.
 Directions for use preferably accompanied by graph-
ical representations.
 Storage keeping and date markings
 Suggested number of feedings per day.
 In case that addition of water is needed, the directions
for the preparations shall include a precise statement
that: (a) where the food contains non-heat-processed
basic ingredients, the food must be adequately boiled
in a prescribed amount of water (b) where the food
contains heat-processed basic ingredients: (i) the food
requires boiling or (ii) can be mixed with boiled wa-
ter that has been cooled.
 Other information- age group; statement indicating
when precisely to begin complementary feeding
should be made in consultation with a health worker
 Additional Statement (bold, in the lowermost level of
the information display panel):
Infants six months onwards should be given fresh,
indigenous and natural food in combination with
continued breast feeding.

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ANNEX G. EVALUATION OF HIGH RISK FOOD PRODUCTS

Formula Foods for Weight Control Diets


Related Codex Stan 181-1991
Reference
Standards Codex Stan 192-1995
Critical Certificate of Analysis to Support Nutrition Facts

Labelling  Product name: Meal Replacement for Weight Control


Requirements  List of ingredients
 Nutrition labeling: Energy, Protein, CHO, Fats, Vitamins
and Minerals per 100 g or per 100 ml of the food as sold or
as applicable, per serving as suggested for consumption
 Date Marking
 Storage Instructions for opened and unopened food
If direction for use indicate that the food should be combined
with other ingredients, the nutritive value of the final
combination should be declared.

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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ANNEX H. SUMMARY OF LABELLING GUIDELINES FOR BREASTMILK


SUBSTITUTES, INFANT FORMULA, FOLLOW UP FORMULA/MILK SUPPLE-
MENTOTHER MILK PRODUCTS, FOODS AND BEVERAGES, AND OTHER
RELATED RODUCTS WITHIN THE SCOPE OF E.O. 51 (“MILK CODE”) AS
PER D.C. 2008-0006

PRINCIPAL -Product name shall be “Infant Formula”, “Formula for Special


DISPLAY Medical Purposes Intended for Infants” or “Milk Supplement” or
PANEL Follow-up Formulas in accordance with relevant Codex Standards
-Source of Protein
-“Infant Formula Based on Cow’s Milk” (if cow’s milk is the only
protein source)
-“Contains No Milk or Milk Products” or equivalent phrase (if the
product does not contain milk or any milk derivative”
-It shall be contrary to public policy to use as brand name and/or trade
mark or any word or set of words that may be considered as
nutritional, healthful, and superlative and other terms of similar
import.
-Net Content and Drained Weight (SI Unit)
-Primary Messages
a. At the center uppermost level; In bold, all capital letters, font
type: Arial, font size: 1/3 of the size of the biggest letter on the
label:
English: “BREASTMILK IS THE BEST FOR BABIES UP TO
2 YEARS OF AGE AND BEYOND”
Filipino: “ANG GATAS NG INA ANG PINAKAMABUTI
PARA SA BATA HANGGANG 2 TAON O HIGIT PA”

b. At the center lowermost level; In bold, all capital letters, font


type: Arial, font size: 1/3 of the size of the biggest letter on the
label:
English: “IMPORTANT NOTICE: THERE IS NO
SUBSTITUTE FOR BREASTMILK”
Filipino: “MAHALAGANG PAALALA: WALANG
ANUMANG GATAS ANG PWEDENG IPALIT SA GATAS
NG INA”
INFORMATIO -List of ingredients in descending order of proportion
N PANEL -Declaration of Nutritive Value
Per 100 grams and per specified quantity of the food as suggested
per consumption: Energy in calories (kcal) and/or kilojoules
(kJ); Protein, Carbohydrates, and Fat in grams
Per 100 grams and per specified quantity of the food as suggested
per consumption or per 100 calories (100 kilojoules): V itamins
and Minerals, Choline for infant formula, and any optional
ingredients listed in the codex standards of infant formula and
milk supplement (follow-up formula)

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ANNEX H. SUMMARY OF LABELLING GUIDELINES FOR BREASTMILK


SUBSTITUTES, INFANT FORMULA, FOLLOW UP FORMULA/MILK SUPPLE-
MENTOTHER MILK PRODUCTS, FOODS AND BEVERAGES, AND OTHER
RELATED RODUCTS WITHIN THE SCOPE OF E.O. 51 (“MILK CODE”) AS
PER D.C. 2008-0006
INFORMATION -If shelf – life is < 3 months, declare the expiration date in the
PANEL sequence day, month, and year. If shelf – life is ≥ 3 months, the
month and year will do. The month must be declared in word.
-Storage instructions shall be declared near the date marking
-Directions for appropriate preparation and use of the product
including its storage and disposal after preparation
-Clear graphic illustration of the method of preparation
-Warning about health hazards of inappropriate preparation,
storage and use

-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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ANNEX H. SUMMARY OF LABELLING GUIDELINES FOR BREASTMILK


SUBSTITUTES, INFANT FORMULA, FOLLOW UP FORMULA/MILK SUPPLE-
MENTOTHER MILK PRODUCTS, FOODS AND BEVERAGES, AND OTHER
RELATED RODUCTS WITHIN THE SCOPE OF E.O. 51 (“MILK CODE”) AS
PER D.C. 2008-0006

INFORMATION Secondary Messages


PANEL At the uppermost level; In bold, all capital letters, font type:
Arial, font size: 1/6 of the size of the biggest letter
on the label:

English: “The Use of Infant Formula/Milk


Supplements must only be upon the advice of
a health professional”

Filipino: “Ang paggamit ng gatas na ito ay dapat sang-


ayon sa payo ng Doctor o health professional”

English: “The unnecessary and improper use of this


product may be dangerous to your child’s
health”

Filipino: “Ang maling paggamit ng gats na ito ay


maaaring makasama sa kalusugan ng bata”

Additional Labelling Information for Milk Supplements/Follow Up Formula:


“Milk Supplement shall not be introduced until six months of life”. age”

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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

A.O. No. 123-A s. 1985 Standards of Banana Sauce


Regulation Prescribing the Standards of Identity and Quality of Milk
A.O. No. 132 s. 1970
and Milk Products (B-4.12-01) Department of Health
Regulation Prescribing the Standard of Identity and Quality of Vine-
A.O. No. 134 s. 1970
gar (B-4.9 Condiments, Sauces, Seasonings) Department of Health
Standard For Instant Coffee; Standard for Soluble Coffee with Added
A.O. No. 136-A & 136-B
Carbohydrates Republic of the Philippines Ministry of Health BU-
s.1985
REAU OF FOOD AND DRUGS
Regulation B-4 Definition and Standards of Identity for Foods;
A.O. No. 154 s. 1971 A.14 Meat and Meat Products. A.14.01 Sausages Department of
Health
Regulation B-4 Definitions & Standards of Identity for Foods, B-4.5
A.O. No. 200-A s. 1973
Cheese and Cheese Products
Regulation B-4 Definitions and Standards for Food B-4.15 Fats
A.O. No. 231 s. 1974
and Oils B-4.15-02 Lard
Regulation B-4 Definitions and Standards for Food, B-4.18 Marga-
A.O. No. 232 s. 1974
rine
Regulation B-1 Definitions and Standards for Food B-1.6 Condi-
A.O. No. 233 s. 1974
ments, Sauces, Seasoning B-1.9-01 Tomato Catsup (Catsup)
Regulation B-4 Definition and Standards of Identity of Foods:
4.6 Dressings for Food
A.O. No. 235 s. 1975
4.6.01 Mayonnaise (Mayonnaise Dressing and Mayonnaise Salad
Dressing)
Regulation B-4 Definition and Standards of
A.O. No. 239 s. 1975 Food, B-4.13 Jams (Fruit Preserves), B-4.13-02 Jellies (naming the
fruit)
Regulation B-4 Definition and Standard for Foods, 4.9 Condiments,
A.O. No. 325 s. 1977 Sauces and Seasonings, 4.9-04 Standard of Identity and Quality for
Patis
A.O. No. 357 s. 1978 Standards for Wines
Rules and Regulations on the Licensing of Food Establishments and
A.O. No. 2014-0029 Registration of Processed Food, and Other Food Products, and for
Other Purposes
Revised Rules and Regulations Governing the Labeling of Pre-
packaged Food Products Further Amending Certain Provisions of
A.O. No. 2014-0030 Administrative Order No. 88-B s. 1984 or the “Rules and Regulations
Governing the Labeling of Pre-packaged Food Products Distributed
in the Philippines,” and For Other Purposes

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REFERENCES
ANNEX III ASEAN GL on Limits of Contaminations TMHS V1.0(13Nov14) (1)

ASEAN GL Minimising Risk of Transmission TSE TMHS V1.0 (1Oct14)

ASEAN GP for the Use of Additives & Excipients in TMHS V2.0(1Oct14)

ASEAN Guidelines on Stability Study and Shelf-Life of Traditional Medicines and Health Sup-
plements.

B.C. No. 02 s. 1999 Additional Labelling Requirement for Food Supplements

B.C. No. 16 s. 2004 Guidelines on Probiotics

B.C. No. 17 s. 2004 Taheebo/Pau d’arco/Lapacho

B.C. No. 2006-016 Updated List of Food Additives

B.C. No. 2007-002 Guidelines in the Use of Nutrition and Health Claims in Food

Advisory Lists of Nutrient Compounds for Use in Foods for Special


CAC/GL 10-1979
Dietary Uses intended for Infants and Young Children
Guidelines on Formulated Complementary Foods for Older Infants
CAC/GL 8-1991
and Young Children

CAC/GL 23-1997 Guidelines for Use of Nutrition and Health Claims

CODEX STAN 73-1981 CODEX STANDARD FOR CANNED BABY FOODS

CODEX STANDARD FOR INFANT FORMULA AND FORMU-


CODEX STAN 72-1981,
LAS FOR SPECIAL MEDICAL PURPOSES INTENDED FOR IN-
REV. 2007
FANTS
Codex Stan 074-1981, Codex Standard for Processed Cereal-Based Foods for Infants and
Rev. 1-2006 Young Children
General Standard for the Labelling of and Claims for Prepackaged
Codex Stan 146-1995
Foods for Special Dietary Uses

Codex Stan 156-1987 Codex Standard for Follow-Up Formula

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

Codex Stan 243-2003 Codex Standards for Fermented Milks

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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”.

Adopting a National Code of Marketing of Breastmilk Substitutes,


E.O 51 Breastmilk Supplements, and Related Products. It will Take Effect
30 Days after Publication in the Official Gazette
FDA Circular No. 2016- Procedure for the use of Electronic Registration (E-Registration) Sys-
014 tem for Prepackaged Processed Food Products
FDA Circular No. 2016- Notification of Sources for Raw Materials, Low Risk, Medium Risk
007 and High Risk Prepackaged Processed Food Products
FDA Memorandum No.
2011-028 Safety of Soy Sauce in the Philippines: CODEX Limit on 3 MCPD

A Guide to Food Labelling and Advertisements—A publication of the Agri-Food and Veterinary
Authority, Singapore

MC No. 13 s. 1989 Standards for Alcohols

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

PNS/BAFPS 22:2004 Virgin Coconut Oil

Philippine National Standards for Spaghetti Sauce and Spaghetti


PNS 247:1993
Sauce Variants
Philippine National Standard for Shelf-stable, Chilled and Frozen
PNS 891:1993 UDC
Corned Beef
Philippine National Standard for Distilled Fermented Coconut Sap
PNS/BAFPS 47:2011
(Coconut Lambanog)
Philippine National Standard for Coconut Sap Sugar – Grading and
PNS/BAFPS 76:2010
Classification
Philippine National Standard for Ethnic Food Products – Dry Base
PNS/BFAD 01:2005
Mixes for Soups and Sauces
Philippine National Standard for Ethnic Food Products – Sweet Pre-
PNS/BFAD 02:2005
serves
Philippine National Standard for Ethnic Food Products – Dried, Salted
PNS/BFAD 04:2006
Fish - Specifications
Philippine National Standard for Ethnic Food Products - Thermally
PNS/BFAD 06:2006
Processed Fish Products - Specification

PNS/BFAD 08:2007 Philippine National Standard for Fermented Milks – Specification

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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

SAO # 358 s. 1978 Standardization of Brandies

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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FREQUENTLY ASKED QUESTIONS

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FREQUENTLY ASKED QUESTIONS


1. What are the requirements to secure a CPR?
>> You may refer to FDA Circular No. 2016-014 dated 12 August 2016, Procedure for the Use
of Electronic (E-Registration) System for Pre-Packaged Processed Food Products prior to filing
for registration. You will also need to upload a scanned copy of the following documents in the
system during application:
a. Compliant labels in accordance with the prevailing labelling guidelines stipulated in Ad-
ministrative Order No. 2014-0030.
b. Pictures of the product in all angles from at least two different perspectives allowing visual
recognition of a product as the same with the one being registered ures of the product in all
angles.
c. As applicable, documents to substantiate claims, such as technical, nutritional or health
studies or reports, market-research studies, Certificate of Analysis, quantitative analysis
and computations, scientific report or studies published in peer-reviewed scientific journals,
certificates or certification to support use of logo/seal on Sangkap Pinoy, Halal, Organic, or
Kosher food and in compliance with current labelling regulations.
d. Applicable Certificates of Analysis (e.g. microbiological tests)

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.

3. How long is the processing time/release of CPR?


>> If the application is applied as initial, the processing timeline is 114 calendar days, while
amendment, renewal, and reapplications are prioritized and has a timeline of 57 calendar days.
You may track the applications through the Process Map function of the E-Registration System.

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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4. cont.
The issued CFRR E-Registration User Account will be sent to the e-mail address you pro-
vided in the request. Be sure to check the Spam folder of your e-mail if you have not
received a reply within 3 working days.
You may also use your E-LTO User Account and Password for E-Registration by having it
validated through a request sent via email to info@fda.gov.ph following this format:
SUBJECT: CFRR:E-Registration (Re-validate)
BODY: Email Address:
Last Name:
First Name:
Middle Name:
Company Name:
User Account:
Password:
The User Account and Password has a validity of 2 years. You will need to renew these by
sending a request via email to info@fda.gov.ph following this format:
SUBJECT: CFRR:E-Registration (Renewal of User Account & Password)
BODY: Email Address:
Last Name:
First Name:
Middle Name:
Company Name:
User Account:
Password:
You may refer to FDA Circular 2016-014 for other details and format of documents re-
quired in securing a User Account and Password for E-Registration.

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.

6. Why do I have a new Case number for my Amendment/Reapplication if my initial ap-


plication is already in the E-Registration?
>> A new case number will be generated if the amendment/ reapplication was done by
clicking new case. This procedure is for Data Capture only wherein it is intended for
applications with existing CPR from manual (Integrated Application Form). You may
view previously approved and denied applications/case numbers in the Inbox of your E-
Registration account. Click the specific case number to be amended and choose
“Amendment” as type of application.

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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7. How can I use the remaining validity of the CPR of an existing product applied by oth-
er company if I will be the new Importer?
>> (From Electronic Registration) this will fall under Amendment Change in Import-
er. The new Importer must apply for CPR as amendment and must declare the current
FR number and its validity. Attach all the documents stipulated in AO 2014-0029 An-
nex D and other documents needed. Please ensure the completeness and correctness of
the documents since the old Importer is required to cancel the CPR of the product in
their account by clicking the case number in their inbox and choose “Cancellation” as
type of application.

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/.

11. What will I do to know the status of the application?


>> Open the case, go to information, and click process map.

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.

13. What are the requirements for food supplements?


>> Same as the requirements for conventional food products as stipulated in the Ad-
ministrative Order 2014-0029 with the addition of stability study, Certificate of Analy-
sis (COA) of the finished product and as applicable, safety data (e.g. LD-50 Toxicity
Test). For food supplements containing herbs which are not listed in any official
pharmacopeia and substances with no established safe levels.

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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

21. How do I apply for Amendment/Reapplication/Renewal in the e-Registration System?


>> To apply for amendment/reapplication/ renewal, access the online portal through
https://www.fda.gov.ph. Provide the company-specific Username and Password, and
double click on the Case Number you wish to apply for amendment/reapplication/
renewal in the Inbox folder. Select the type of application from the drop-down menu
after the “Declaration”. Provide the required information completely and accurately.
DO NOT cr eate new case number .

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:

A.) If the Amendment/Renewal application using a new case is recommended for


denial, the evaluator will advise the client through the Notice of Deficiency (NOD)
that once he/she re-applies for renewal or re-amend, he/she shall use the previously
approved case number. However, the denied re-application should be filed under INI-
TIAL.
B.) If the Amendment/Reapplication/Renewal using a new case is recommended for
approval, the evaluator will inform the client to cancel the previously approved case
number before proceeding to the new case number. Also, please be informed that all
documents attached from the previously approved application must be seen in the
new case.

23. How do I submit Food Supplement actual product sample?


>> For initial applications, a sample in actual commercial presentation shall be sub-
mitted. Bring the sample to FDAC and submit it to Letters. Acknowledgement Receipt
will be issued upon submission indicating the Document Tracking number. You may
refer to FDA Circular 2016-014 for the complete details.

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CONTACT FDA

For correspondence:

Food and Drug Administration


Civic Drive, Filinvest City,
Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900


Telephone +63 2 857 1991 to 93
Fax +63 2 807 0751
E-mail info@fda.gov.ph
Website www.fda.gov.ph

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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COMMITTEE ON THE CREATION OF


THE CFRR E-REGISTRATION USER
MANUAL
PILAR MARILYN M. PAGAYUNAN, MBA
Director IV, Center for Food Regulation and Research
Chairperson

HELENA S. ALCARAZ, MSc


Chief, Licensing and Registration Division
Vice-Chairperson

MEMBERS

LICENSING AND REGISTRATION DIVISION


JOAN MARIE C. ALCAZAR GEORGIA D. VALENCIA
Food-Drug Regulation Officer III Food-Drug Regulation Officer III
ELANE V. MALALAY, MSc MARICEL S. ROSAROSO
Nutritionist-Dietitian III Nutritionist-Dietitian III
GLADDYS B. ADRIANO MARIA LUISA G. CORPUZ
Food-Drug Regulation Officer II Food-Drug Regulation Officer II
ROEDER JON S. JAREÑO MARY JOY L. PAULIN
Food-Drug Regulation Officer II Food-Drug Regulation Officer II
HANNAH MARGARET M. RABAJA GEONNA MARICE D. SANTOS
Food-Drug Regulation Officer II Food-Drug Regulation Officer II
GIAN ARKIAL I. CLARIDAD HONEY LEE C. ESTEFANI
Food-Drug Regulation Officer I Food-Drug Regulation Officer I
JEHIEL JAHAZIEL A. SERRANO GIVINIA J. TUASON
Food-Drug Regulation Officer I Food-Drug Regulation Officer I
CHARLOTTE REYNA G. WOLFERT NOELSON J. INION
Food-Drug Regulation Officer I Administrative Aide VI

PRODUCT RESEARCH AND STANDARDS DEVELOPMENT DIVISION


MA. THERESA C. CERBOLLES
Food-Drug Regulation Officer IV
MA. RONITA SJ. YASOÑA
Food-Drug Regulation Officer II
FOOD SAFETY UNIT
TIMOTHY MOISES C. MENDOZA
Food-Drug Regulation Officer III
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Food and Drug Administration


Department of Health

Civic Drive Filinvest City, Alabang


1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900


Fax +63 2 807 0751
Email info@fda.gov.ph

www.fda.gov.ph

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