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ADMINISTRATIVE ORDER
No. 2014
-
0030
Presented by:
Charina
May T. Tandas
FDRO III, FDA
-
CFRR
-
LRD
Revised Rules and Regulations Governing
the Labelling of Pre-packaged Food
Products Further Amending Certain
Provisions of Administrative Order No.88B s. 1984 or the Rules and Regulations
Governing the Labeling of Prepackaged
Food Products Distributed in the
Philippines, and For Other Purposes
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OBJECTIVES
A. Promulgate rules and regulations on the revised labelingguidelines of prepackaged food products in order to
protect the consumer against hazards to health andsafety and provide information and education tofacilitate sound choice in the proper exercise of theirrights
B. Establish provisions on the exemption to the
requirements of labeling of prepackaged food productswhich are, in accordance with the practice of trade, to beprocessed, labeled, or repacked in substantial quantitiesat establishments other than those where originallyprocessed or packed.
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SCOPE
This Order covers the labeling of allprepackaged food products, including food
supplements, whether locally manufactured
or imported into the Philippines
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GENERAL PROVISIONS Prepackaged food shall not be described or presented on any
label or in any labeling in a manner that is false, misleading or
deceptive or is likely to create erroneous impression regardingits character in any respect.
Prepackaged food shall not be described or presented on any
label or in any labeling by words, pictorial or other devices
that might be confused, or in such a manner as to lead the
purchaser or consumer to suppose that the food is connected
with such other product.
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DEFINITION OF TERMS
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Definition of Terms
Brand Name-refers to the name appropriated by themanufacturer, repacker, distributors, trader or importerto distinguish its product in the market
Bulk food materials-refers to raw materials,ingredients, and food additives that are packed inwholesale containers either for food industry use for
further processing or institutional use or food service orcatering business or generally not intended forcommercial distribution.
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Definition of Terms
Country of manufacture/Country of origin-
the country in which the processing isperformed
Directions/Instruction for use-the relevant
information regarding the reconstitution,preparation and consumption of a food product
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Definition of Terms
Expiry or expiration Date/Use by Date/Consume before(Recommended last consumption Date)-the date which signifies the end
of the estimated period under any stated storage condition, after which theproduct will not have the quality attributes normally expected by theconsumers. After this date the food should not be regarded as marketable
Food allergen-any food or ingredient known to cause hypersensitivity thatcontains protein, peptide derived from any of, but not limited to the
following: milk, egg, fish, tree nuts, wheat, peanuts and soybean
Food authorization Number-the number assigned to a particularregistered food product as proof that it is permitted or authorized by theFDA
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A display of written, printed or
graphic matter upon the immediate
container of any article and a
requirement made by or underauthority of existing law that any
word, statement , or other
information appearing on the label
shall not be considered to be
complied with unless such word,statement or other information also
appears on the outside container or
wrapper of the retail package of
such article or is easily legible
through the outside container orwrapper
Definition of Terms
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Principal display panel-
the part which, eitherthrough design or general
use, is presented or shown
to the consumer under
customary conditions ofdisplay for retail sale.
Definition of Terms
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Information panel-the partimmediately contiguous to the
principal display panel
In the case of rectangular,cylindrical or four-sided (tetra-
pak) containers, any of thesides adjacent to the principaldisplay panel except the
bottom side which serves asthe base of package.
Definition of Terms
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Definition of Terms
Nutrition facts/declaration-a standardized statement
or listing of the nutrient content of a food
Nutrition labelling-a description intended to inform
the consumer of the nutritional properties of a food
Primary Food Commodity-means food of plant oranimal origin that has not undergone any means of
processing
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Definition of Terms
Processed Food-means the product resulting from theapplication of physical, chemical or biologicalprocesses to a primary food commodity intended fordirect sale to the consumer, for direct use as aningredient in the manufacture of food or for furtherprocessing.
Storage condition-refers to the prevailing specifiedtemperature range, humidity and other environmentalfactors within which optimal stability of the foodproduct is ensured based on laboratory data.
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Mandatory Label Information on
prepackaged food products
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Comparison of Mandatory Labeling Requirements
Administrative Order No. 88-B Administrative Order No. 2014-030
1. Name of the Food 1. Product Name/Name of the Food
2. Use of Brand Name and/or
Trademark
2. List of Ingredients 3. Complete List of Ingredients
3. Net Contents and Drained Weight 4. Net Contents and Drained Weight
4. Name and Address of Manufacturer,
Packer and Distributor
5. Name and Address of Manufacturer,
Repacker, Packer, Importer, Trader
and Distributor
5. Lot Identification 6. Lot Identification
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Comparison of Mandatory Labeling Requirements
Administrative Order No. 88-B Administrative Order No. 2014-030
6. Nutrition Information (not
mandatory)
7.Nutrition Facts/Nutrition
Information/ Nutritive Value
(mandatory)
8. Expiry or Expiration Date/ Use-by-
date/Consume before Date
9. Storage Condition (as applicable)
10. Food Allergen Information (with
ingredient )
11. Direction/Instruction(s) for Use
(as applicable)
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1. Product Name/Name of the Food
The name shall indicate the true nature
of the food and shall normally be specificand not generic.
The type of packing medium, form or style shall appear on the
label for better understanding e.g. type of packing medium, form or
style, condition (canned ex. Peas in brine) or type of treatment
The name of the food shall be presented in bold type letters in a
size reasonably related to the most prominent printed matter (e.g.
trade mark or brand name)
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2. Use of Brand Name and/or Trademark
If an establishment has a registered brand name or trade mark, it
shall be mandatory to indicate but may not be declared if the product
will be used for further processing
Any brand name or trade mark used shall be placed in conjunction
with the product and must not be misleading, deceptive, confusing,
or is likely to create erroneous impression regarding its character or
nature in any respect
Identical brand name may be allowed provided that it is authorized
by the same brand owner.
AO No. 2005-0016 (Subject: General Policies and Guidelines
Governing Brand Names of Products) applies
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Brand Name or
Trademark
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Brand
Product name
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Except for single ingredient food, a complete list of ingredients shall bedeclared in descending order of proportion on either the principaldisplay panel or information panel.
The list of ingredient shall be proceeded by an appropriate title
(e.g. ingredients:______)
Added water shall be declared in the list of ingredients if such a declarationwould result in a better understanding of the products composition
Where an ingredient is itself the product of two or more ingredients,such a compound ingredient may be declared as such provided that it is
accompanied by the list, in brackets, of its ingredients in descendingorder of proportion.
Where a compound ingredient constitutes less than 5% of the food, theingredient need not be declared except food additives which serve atechnological function in the finished product
3. Complete List of Ingredients
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Provisions in A.O 88B s.1984 on flavors,smoke flavors and colors still applies
Specific name, not a collective (generic)name shall be used for an ingredientand unless a general class name wouldbe more informative (refer to Table 1Annex A)
Food additives shall be declared bytheir common name and theirfunctional categories as provided byBureau Circular No. 2006-016 or in thelatest amendment by the FDA
3. Complete List of Ingredients
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NAME OF CLASSES CLASS NAMES
Refined oils other than olive* Oil together with either the term vegetable or
animal, qualified by the term hydrogenated or
partially-hydrogenated, as appropriate
Refined fats*
Fat together with either, the term vegetable oranimal, as appropriate provided that for animal fat the
specific 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 labeling and presentation of such
food does not refer to a specific species of fish
Fish
All types of poultry meat where such meat
constitutes an ingredient of another food and
provided that the labeling and presentation of
such a food does not refer to a specific type of
poultry meat
Poultry meat
ANNEX A
Table 1. Class names for Use in Ingredients Listing
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The net content shall be declared using the metric
system of measurement or SI (International
System of Units) on either the principal displaypanel or the information panel.
For liquid foods, by volume;
For solid foods, by weight, except that whensuch foods are sold by number, a declaration of
count shall be made
For semi-solid or viscous foods, either by
weight or volume.
4. Net Content and Drained Weight
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Foods packed in a liquid medium normally discarded beforeconsumption shall carry a declaration of drained weight.Liquid medium means water, aqueous solutions of sugarand salt, fruit and vegetable juices, in canned fruits andvegetables only or vinegar, either singly or in
combination. (Note: oil in canned or bottled fish are notnormally discarded)
The declaration of contents shall appear in conspicuous andlegible bold face print or type in distinct contrast to othermatters on the panel where it is declared.
For multi unit retail packages, a statement of the quantity ofcontents, include the number of individual units and in
parenthesis the total quantity of contents of the multi unitpackage.
Ex. 20 x 10g sachets (net weight 200g)
No more provision on non-declaration of count if it canbe clearly seen on the label
4. Net Content andDrained Weight
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5.Name and Address of Manufacturer, Repacker,Packer, Importer, Trader andDistributor
The name and address of the manufacturer, repacker, packer,importer, trader or distributor of the food shall be declared on thelabel of locally manufactured products
If a manufacturer has plant in many cities and/or towns, thecorporate head office address would suffice provided every foodpackage has a code/mark to identify the processing plant where it
was produced If the prepackaged food is not manufactured by the person or company
whose name appears on the label, the name must be qualified byManufactured For or Packed For or similar expression
For imported products, the complete name and address of importerand the country of origin shall be declared
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Country Of Origin
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5. Name and Address of
Manufacturer, Importer and/or
Distributor
In the case of products carrying foreign brands or manufactured
under license by a foreign company, the name or name andaddress of the foreign company, if declared, shall be in letters of
type size not bigger than those used for the local company.
When a food undergoes processing in a second country
which changes its nature, the second country in which the
processing is performed shall be considered to be the
country of origin for the purpose of labeling
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6. Lot Identification CodeLot is food produced during a period oftime and under more or less the samemanufacturing conditions as indicated by
a specific code.
The lot identification code shall beembossed or otherwise permanentlymarked on immediate individual
packages or containers.
Prepackaged foods in multi-unit retailpackages may be exempted from therequirements of lot identification codeonly when sold together with theprimary packaging (e.g. candies withsurface area less than 10 cm2
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7. Storage Condition For products that need special
storage condition other than normal
room temperature, the storagecondition shall be printed clearly,
conspicuously and indelibly on all
product label or labeling
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8. Expiry or Expiration Date/ Use-by-date/ Consume
before Date (Recommended last consumption date)
Shall be printed clearly, conspicuously and legibly on allproduct labels (except alcoholic beverages)
Prescribed Format: Day, Month, Year
e.g. Expiry Date: 01 January 2012 or 01Jan 12
Note:(Other terms: Use by, consume before, recommended last consumption date)
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Sample Date marking
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9. Food Allergen Information
Food allergeninformation on the
label of productscontaining the belowlisted ingredients (butnot limited to)shall beindicated clearly,
conspicuously andindelibly
Must be located belowthe List of Ingredients
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Allergen
a. Cereal containing gluten, i.e. wheat, rye, barley, oat spelt
or their hybridized strain and products of these;
b. Crustaceans and products of these;c. Eggs and egg products;
d. Fish and fish products;
e. Peanuts, soybeans and products of these;
f. Milk and Milk Products (lactose included);g. Tree nut and nut products;
h. Sulphite in concentrations of 10mg/kg or more
i. Such other ingredient as may be included by FDA
through appropriate issuance (sources can be US FDA,
Codex WHO, other international references).
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10. Direction/ Instruction(s) for Use
Shall also be printed,
where applicable or as
necessary to ensurecorrect utilization of
the food
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11. Nutrition Facts/Nutrition Information/Nutritive Value
Presented in tabulated form through the declaration of protein,
carbohydrates (including dietary fiber and sugar), fat (including
saturated fats, trans fat and cholesterol), sodium, energy value or
calories (10 nutrients)
Locally manufactured food products intended for local
consumption shall also indicate the corresponding Recommended
Energy and Nutrient Intake (RENI) values in actual percentage
expressed in whole numbers
For computation of %RENI value, the basis would be the
Philippine Recommended Energy and Nutrient Intake for male
adults 19-29 years old. For products with specific target age
group, RENI values for the said group shall be used and indicated
on the label.
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Nutrition Facts Actual nutrient values or content must be consistent with the nutrient
label declarations. However in consideration of the stability of the
vitamins and nutrients, the nutrient content of a food shall in no case
be lower than 80% of the value for the nutrient declared on the label atany point in time within the expected shelf life of the product. Further,
where a standard has been set by a special law for a particular
product, compliance is mandatory
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Nutrients Analytical Tolerance*
For energy, fat and carbohydrates Min.80% of the declared
nutrient value on label and
max 120% of the declared
nutrient value on the label
For other nutrients: protein, fiber,
vitamins and minerals
Min 80% of the declared
nutrient value on the label
Nutrition facts
The following tolerance limits shall be applied in nutrient labeldeclaration ,provided that no related nutrition and health claims are
made
% refers to the ratio between the nutrient level from actual analytical result and the declared level multiplied by
100
The values used in nutrient declaration should be weighted average
valuesderived from data specifically obtained from analyses of products
which are representative of the product being labeled.
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Nutrition FactsServing size:
No. of servings per container/pack:
Amount per serving: % RENI*
Energy (kcal)
Total fat
Saturated Fat **(g)
Trans fat (g)
Cholesterol (mg)
Sodium (mg)
Total Carbohydrates (g)
Dietary Fiber (g)
Sugar (g)
Total Protein (g)200pmespecially energy drink)
Specific Labelling Requirements BasedOn A Standard / Regulation
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IRR for Products covered by E.O. 51 (i.e infant
formula, milk supplement) D.O. 2008-06 Labelling Requirement
Breastmilk is the best for babies up to 2 years of
age
The improper use of breastmilk substitute maybe
dangerous to your childs health
Specific Labelling Requirements BasedOn A Standard / Regulation
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Other declarations on the label
Other declarations on the label shall besubstantiatedsuch as Halal, Kosher, Organic,
etc.
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Additional Information
A sticker maybe allowed to reflect the Food
Authorization Number which consists of LTONumber and FR Number
FAN Number maybe printed either on the PDP or
IP
Note: proposed e-registration is system generated
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Guidelines in the Use of Nutrition andHealth Claims in Food (B.C 2007-02)
Adopts Codex Alimentarius CommissionGuidelines for Use of Nutrition and HealthClaim
(CAC/ GL 23-1997, Amended 2012
Nutrition and Health Claims
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any representation which states, suggests or
implies that a food has particular nutritional
properties including but not limited to the
energy value and to the content of vitamins
and minerals
Nutrition Claims
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1. Nutrient Content Claim
describes the level of a nutrient contained in a food
(e.g. Source of Calcium, Low Calorie, Low Fat)
2. Nutrient Comparative Claim
comparesthe nutrient levels and/or energy value of two
or more food
(e.g. reduced, less than, fewer)
Nutrition Claims
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means any representation that
states, suggests, or implies that a
relationshipexists between a food
or a constituent of that food andhealth.
Health Claims
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COMPONENT CLAIM
CONDITIONS
not less than)
Vitamins and
Minerals
Source
High
15% of RENI per 100 g
(solids)
7.5% of RENI per 100mL
(liquids)
Or 5% of RENI per 100
kcal (12% of RENI per 1
MJ)
2 times the value forsource
Criteria for the claims
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COMPONENT CLAIM
CONDITIONS
not more than)
Sugars Free
0.5 g per 100 g (solids)
0.5 g per 100mL
(liquids)
Sodium
Low
Very Low
Free
0.12 g per 100 g
0.04 g per 100 g
0.005 g per 100 g
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1. Nutrient Function Claim
describes the physiological role of the nutrient in growth,
development and normal functions of the body.
2. Other Function Claim
concern specific beneficial effects of the consumption of foods for
their constituent, in the context of the total diet on normal
functions or biological activities of the body.
3. Reduction of Disease Risk Claims
relates to the consumption of a food or food constituent, in the
context of the total diet, to the reduced risk of developing a disease
or health related condition
Health Claims
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Details of the food additive:
1. The name of each food additive present shall be printed.The name shall be specific and not generic and shallindicate the true nature of the food additive. Where a namehas been established for a food additive in a Codex list ofadditives, that name shall be used.
1. If two or more food additives are present, their names shallbe given in the form of a list. The list shall be in the order ofthe proportion by weight which each food additive bears tothe total content of the container
Annex BLabelling of Food Additives
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Labelling of Food Additives
3. In the case of mixtures of flavourings, the name of eachflavouring present in the mixture need not be printed. Thegeneric expression flavour or flavouring may be used,together with a true indication of the nature of the flavour.
4. All food additives shall carry an expiration date which shallsignify that beyond this date the affectivity of the additive forits intended use is diminished
5. The words FOR FOOD USE or a statement substantiallysimilar thereto shall appear in a prominent position on thelabel
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Labelling of Food Additives
Instructions on storage and use
Net contents
Name and Address
Country of Origin
Lot Identification
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Misleading
Declarations/Representation/Prohibited Claims
Any of the following whether directly or indirectly stated shall constitute as
misleading, deceptive and untruthful declarations
That the food because of the presence or absence of certain dietaryproperties, is adequate or effective in theprevention, cure, mitigation or
treatment of any disease or symptom of any disease
That a balanced diet of ordinary foods cannot supply adequate amount of
nutrients
That the food has dietary properties when such properties are of no
significant value or need in human nutrition
That a synthetic vitamin in a food is superior to natural vitamin
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Misleading Claims... Claims which highlight the absence or addition of any food additive or nutrient
supplement, if the addition of such food additive or nutrient supplement is notpermitted or prohibited
Claims on the absence of beef or pork or its derivatives or lard or added alcohol areprohibited if the food does not contain such ingredient
Claims on the absence of any substance when the food does not contain suchingredient
Claims that a product is superiorto any other existing product of the same kind thatcannot be substantiated
Claims stating that any given food will provide an adequate source of all essentialnutrients, except in the case of well-defined products for which a Codex standardregulates such claims as admissible claims or where FDA have accepted, throughan issuance that the product to be an adequate source of all essential nutrients.
Claims as to the suitability of a food for use in theprevention, alleviation, treatmentor cure of a disease, disorder or particular physiological condition unless
a. they are in accordance with Codex standards or guidelines
b. In the absence of a guidelines, permitted by FDA
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Misleading Claims
Meaningless claims including incomplete
comparatives and superlatives (ex. No. 1)
Claims as to good hygienic practice such as
wholesome, healthful or sound
Use of photographs and graphic representations
Use of names and places
Such analogous cases as determined by FDA
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EXEMPTIONS FROM THE LABELING
REQUIREMENTS
Food materials to be served in restaurants or to be served in airline
catering, which are not labeled and prepackaged available to the
consumer (e.g. Schools, cafeterias, trains, airplanes and retail stores) and
for immediate consumption
Bulk food materials (including raw materials, ingredients and processed
food products) for further processing or repacking or for catering or food
service use and not intended for retail sale, on condition that these are
properly identified as may be appropriate and product specifications are
provided in supporting documents
Foods in primary packages with available label space of less than 10 cm2
(e.g. Pack of gum, individually wrapped candies), provided that the
secondary packaging contains all the required information
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Violations and Sanctions
Any violation of the provisions of this Administrative
order shall render the food product misbranded underRA 9711, and such misbranded food products and theresponsible person shall be subject to actions and
penalties available to the FDA as provided under
Republic Act No. 3720 as amended by ExecutiveOrder No. 175 and further amended by Republic Act9711 and its implementing rules and regulations
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TRANSITORY PROVISIONS
For products with existing valid CPR, a non-extindible
period of twelve (12) months for exhaustion of old labels
will be allowed
For products with pending renewal application, a non-
extnedible period of twelve (12) months for exhaustion of
old labels will be allowed; compliant labels must
however be submitted
For new products and products with pending initial
application, compliance to these guidelines is mandatory
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TRANSITORY PROVISIONS
After 12 months from the effectivity of this Order, non-
compliant products shall thereafter be deemed
misbranded and appropriate sanctions against the
violating establishment shall be imposed
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Repealing Clause Provisions of AO No. 88B s. 1984 and
issuances which are inconsistent to those
reflected hereon are modified and/or
repealed accordingly
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Separability Clause
If any part or provision of this Revised AO
be declared invalid or unconstitutional, suchinvalidity or unconstitutionality shall not
affect the other provisions which shall
remain in full force and effect
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EFFECTIVITY
Shall take effect immediately upon approval andpublication in Newspapers of general circulation
Posted last 16 September 2014 (Effective 1 October 2015)
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