updates on food labelling-paft presentation-21 feb

7/25/2019 Updates on Food Labelling-PAFT Presentation-21 Feb

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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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