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1K views20 pagesAdministrative Order No. 2014 0030
Uploaded by
Dia MontecastroCopyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF or read online on Scribd
/ 20
Republic of the Philippines
Department of Health
en ji) OFFICE OF THE SECRETARY
, oi,
eee SEP 08 2014
ADMINISTRATIVE ORDER .
NO. 2014 — 0030
L
SUBJECT: Revised Rules And Regulations Governing The Labeling of
Prepackaged Food Products Further Amending Certain
Provisions of Administrative Order No. 88-B.
“Rules and Regulations Governing the Labeling of Pre-
ackaged Food Products Distributed in the ines.” and
For Other Purposes
RATIONALE
Administrative Order No. 88-B series of 1984 was promulgated governing the
Rules and Regulations for the Labelling of Pre-packaged Food Products Distributed
in the Philippines to establish standards and quality measures for food; to
implement the policy of the State to ensure safe and good quality supply of food;
and to regulate the production, sale and traffic of the same to protect the health of
the people.
‘With the increasing trade of prepackaged food in the country, its safety must at all
times be assured. One effective national food safety and control system is consumer
information about the food product through its label.
Product label is the most readily available material to inform the consumer about
the product contents, shelf life and traceability, among others. It protects against
dishonest or misleading advertising or promotion, and facilitates sound choice to
acquire the knowledge necessary to be an informed consumer.
Accordingly, with the aim to provide coherence in the Food and Drug
Administration’s regulatory system for food establishments and prepackaged food
products, this Order is hereby issued amending for this purpose certain provisions
of Administrative Order No. 88-B s. 1984 or the “Rules and Regulations Governing
the Labeling of Prepackaged Food Products Distributed in the Philippines” and for
other purposes,
I, OBJECTIVES
A. To promulgate rules and regulations on the revised labeling guidelines of
prepackaged food products in order to protect the consumer against hazards to
health and safety and provide information and education to facilitate sound
choice in the proper exercise of their rights
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aS B. To establish provisions on the exemption to the requirements of labeling of
prepackaged food products which are, in accordance with the practice of trade, to be
processed, labeled, or repacked in substantial quantities at establishments other than
those where originally processed or packed
Il. SCOPE
This Order covers the labeling of all prepackaged food products, including food
supplements, whether locally manufactured or imported into the Philippines.
IV. DEFINITION OF TERMS
For the purpose of this labeling regulation, the term:
1, Brand Name refers to the name appropriated by the manufacturer, repacker,
distributors, trader or importer to distinguish its product in the market.
2. Bulk Food Materials refers to raw materials, ingredients, and food additives that are
packed in wholesale containers either for food industry use for further processing or
institutional use or food service or catering business or generally not intended for
commercial distribution.
3. Container means any form of packaging material which completely or partially
enclosed the food and includes wrappers. A container may enclose the food as a
single item or several units or types of prepackaged food when such is presented for
sale to the consumer. .
4. Country of Manufacture/Country of Origin means the country in which the
processing is performed shall be considered to be the country of origin for the
purposes of labeling (CODEX STAN 1-1985, Amended 2010)
5. Directions/Instructions for Use refers to the relevant information regarding the
reconstitution, preparation and consumption of a food product.
6. Expiry or Expiration Date/Use-by-date/ Consume Before (Recommended last
consumption date) means the date which signifies the end of the estimated period
under any stated storage condition, after which the product will not have the quality
attributes normally expected by the consumers. After this date the food should not be
regarded as marketable.
7. Food means any processed substance, which is intended for human consumption and
includes drinks for human beings, beverages, chewing gum and any substance which
have been used as an ingredient in the manufacture, preparation or treatment of food.
Food Additive means any substance not normally consumed as a food by itself and
not normally used as a typical ingredient of the food, whether or not it has nutritive
value, the intentional addition of which to food for a technological (including
organoleptic) purpose in the manufacture, processing, preparation, treatment, packing,
packaging, transport or holding of such food results, or may be reasonably expected to
result (directly or indirectly), in it or its by-products becoming a component of or
Page 2 of 15 otherwise affecting the characteristics of such foods. The term does not include
contaminants or substances added to food for maintaining or improving nutritional
qualities. (Codex GSFA 2013)
9, Food Allergen is any food or ingredient knowa to cause hypersensitivity that contains
protein, peptide derived from any of, but not limited to, the following: milk, egg, fish
(eg, bass, flounder, or cod), crustacean shellfish (e.g., erab, lobster, or shrimp), tree
nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.
10. Food Authorization Number means the number assigned to a particular registered
food product as proof that it is permitted or authorized by the Food and Drug
Administration (FDA) to be manufactured, imported, exported, sold, offered for sale,
distributed, transferred, promoted, advertised, and/or used in sponsorship activities.
This refers to both the license to operate (LTO) and the food registration (FR)
numbers.
11. Food Standard is a regulatory guideline that defines the identity of a given food
product (i.e. its name and the ingredients used for its preparation) and specifies the
minimum quality factors and, when necessary, the required fill of container. It may
also include specific labeling requirements other than or in addition to the labeling
requirements generally applicable to all prepackaged foods.
12. Information Panel means that part of the label immediately contiguous to the
principal display panel and in the case of rectangular, cylindrical or four-sided (tetra-
pack) containers, any of the sides adjacent to the principal display panel except the
bottom side which serves as the base of package.
13. Ingredient means any substance, including a food additive, used as a component in
‘the manufacture or preparation of food and present in the final product (in its original
or modified form).
14, Label means a display of written, printed or graphic matter upon the immediate
container of any article and a requirement made by or under authority 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 or wrapper.
15. Labeling means any written, printed or graphic matter (1) upon any article or any of
its container or wrappers or (2) accompanying the packaged food.
16. Lot refers to quantity of food produced under essentially the same conditions during a
particular production schedule,
17. Lot identification code refers to a specific code indicating food produced during a
period of time and under more or less the same manufacturing condition,
18, Medium Chain Triglycerides (MCT) are medium chain fatty acid esters of glycerol,
containing 6 to 12 carbon atoms and are constituents of coconut and palm kernel oils.
Page 3 of 15
ZKy MCTs are more easily digested, absorbed, and metabolized than long-chain
triglycerides.
19. Nutrition facts/ declarations mean a standardized statement or listing of the nutrient
content of a food.
20. Nutrition Labeling is a description intended to inform the consumer of the nutritional
properties of a food.
21. Prepackaged means packaged or made up in advance in a container, ready for sale to
the consumer, or for catering purposes.
22. Primary Food Commodity means food of plant or animal origin that has not
undergone any means of processing,
23. Principal Display Panel means that part of the label which, either through design or
general use, is presented or shown to the consumer under customary conditions of
display for retail sale.
24, Processed Food means the product, resulting from the application of physical,
chemical or biological processes to a “primary food commodity” intended for direct
sale to the consumer, for direct use as an ingredient in the manufacture of food or for
further processing.
25. Processing Aid means a substance or material not including apparatus or utensils, and
not consumed as a food ingredient by itself, intentionally used in the processing of
raw materials, foods or its ingredients, to fulfill a certain technological purpose during
treatment or processing and which may result in the non-intentional but unavoidable
presence of residues or derivatives in the final product,
26. Product Name refers to the name of the food that indicates the true nature of the food
and shall normally be specific and not generic.
27. Spices which include dried aromatic plants, refers to natural dried component or
mixture used in food for flavoring, seasoning, and imparting aroma. The term applies
equally to spices in the whole, broken or ground form.
28. Storage Condition refers to the prevailing specified temperature range, humidity and
other environmental factors within which optimal stability of the food product is
ensured based on laboratory data.
GENERAL RULES AND REGULATIONS,
‘A. Prepackaged Food shail not be described or presented in any label or labeling in a
manner that is false, misleading or deceptive or is likely to create erroneous
impression regarding its character in any respect.
B, Prepackaged Food shall not be described or presented in any label or labeling by
words, pictorial or other devices which refer to or are suggestive either directly ot
indirectly, of any other product with which such food might be confused, or in such
Page 4 of 15, VI.
4 manner as to lead the purchaser or consumer to suppose that the food is
connected with such other product. :
Food packages shall be labeled with the required information, of which shall be
contained in the principal display or information panel.
Every word, figure or statement required to be placed on the label or labeling shall
be printed legibly with such conspicuousness and in such terms as to render it
likely to be understood under customary condition of purchase and use.
FE. Where the label of a food package is so small that it prevents the use of letters of
the prescribed size or where it concems secondary or optional information, letters
of proportionately reduced size may be used provided the prescribed particulars are
visible and legibly shown and the designated label space is proportional to the size
of the package. For other small packages that will not be able to accommodate
label information, only the brand name and product name may be indicated.
However, these shall not be sold separately or not for retail sale.
Claims on the label and labeling materials regarding nutrition and health shall
follow the Guidelines in the Use of Nutrition and Health Claims in Food (Bureau
Circular 2007-002), Codex Guidelines for Use of Nutrition and Health Claims
(CACIGL 23-1997) and Codex General Guidelines on Claims (CAC/GL 1-1979
revised in 1991) and their subsequent amendments in so far as it does not conflict
with existing laws,
Claims other than health and nutrition not covered under the Guidelines in the Use
of Nutrition and Health Claims in Food (Bureau Circular 2007-002), Codex
Guidelines for Use of Nutrition and Health Claims (CAC/GL 23-1997) and Codex
General Guidelines on Claims (CAC/GL 1-1979 revised in 1991) and their
subsequent amendments shall be evaluated based on submitted substantiation.
SPECIFIC RULES AND REGULATIONS
A. Mandatory Label Information
‘The labels of all prepackaged food shall bear the following minimum mandatory
information:
1. Product Name/ Name of the Food
The product name shall be specific and not generic and shall indicate the true
nature of the food.
a, Where a product name or names have been established for a particular
food in a Food Standard, any one of the names shaill be used.
b. In other cases, a common or usual product name, or in the absence
thereof, an appropriate descriptive product name which is not misleading,
deceptive, or confusing shall be used.
c. A “coined” or “fanciful” name may be used provided it is not misleading,
deceptive or confusing and it accompanies one of the names specified in
(@) and (b). :
4. For the consumer's better understanding of the true nature and condition of
the food, there shall appear in the label cither in conjunction with, or in
close proximity to the product name of the food, such additional words or
phrases, as necessary, to state the type of packing medium, form or style,
Page 5 of 1S 2
3
and the condition or type of treatment it has undergone (c.g. dried, freeze-
dried, concentrated, smoke, reconstituted, etc.).
fe, The product name/name of the food shall be presented prominently on the
principal display panel in bold type letters and shall be in a size reasonably
related to the biggest printed matter on such panel, e.g,, trade mark or
brand name.
Use of Brand Name and/or Trademark
a. If an establishment has a registered brand name of trade mark, it shall be
mandatory for the holder or owner of the same to indicate such correct
brand name or trade mark in the label of its product, but may not be
declared if the product will be used for further processing,
b. Any brand name or trade mark used shall be placed in conjunction with the
product name referred in item 1 above and must not be misleading,
deceptive, confusing, or is likely to create erroneous impression regarding
its character or nature in any respect.
c. No brand name shall be aliowed that is identical to those already registered
with the Food and Drug Administration in the same product classification
or those that is offensive, obscene, scandalous or otherwise contrary to
public morals based on AO No.2005-0016 entitled “General Policies and
Guidelines Governing Brand Names of Products for Registration with the
Bureau of Food and Drug” which shall remain as basis unless amended by
future issuances.
d. Identical brand name may be allowed provided that it is authorized by the
same brand owner.
Complete List of Ingredients
a, Except for single ingredient food a complete list of ingredients shall be
declared on the label.
b, The list of ingredients shall be headed or preceded by an appropriate title
which consists of or includes the term ‘ingredient.”
c. The complete list of ingredients shall be declared in descending order of
proportion on either the principal display panel or information panel.
4. Added water shall also be declared in the list of ingredients except when
the water forms part of an ingredient such as brine, syrup or broth used in a
compound food and declared as such in the list of ingredients. Water or
other volatile ingredients that evaporate in the course of manufacture need
not be declared.
€. Where an ingredient is itself the product of two or more ingredients, such a
compound ingredient may be declared, as such, in the list of ingredients,
provided that it is immediately accompanied by the list, in brackets, of its
ingredients in desconding order of proportion (mm/m).
£ Where a compound ingredient constitutes less than 5% of the food, the
ingredients, other than food additives which serve a technological function
in the finished product, need not be declared.
g. A specific name, not a collective (generic) name shall be used for an
ingredient and unless a general class name would be more informative and
Page 6 of 15 not in conflict with other existing regulations or standards the class names
in attached Table 1 Annex A may be used.
h. Flavors and flavoring substances whether in any of the category below
shall also be declared as part of the list of ingredients. Flavor as classified
shall be declared as “Natural Flavor(s)”, “Nature — identical flavor(s)” or
“Artificial Flavor(s),” respectively. In the case of combination of Natural
Flavors and Nature — identical flavors it shall be declared as such or
simply as “Flavors.”
1) Natural flavors — flavoring substance derived through appropriate
physical processes from spices, herbs, fruits or fruit juices, vegetable
‘or vegetable juices, edible yeast, bark, bud, root, leaf of plant
materials, meat, fish, poultry, eggs, dairy products or fermentation
products thereof,
2) Nature — identical flavoring substance ~ substances chemically derived
from aromatic materials or obtained synthetically, which are
chemically identical to substances present in natural products intended
for human consumption.
3) Artificial flavoring substances — substances that impart flavor but
which have not been identifie« natural products or natural sources of
flavorings.
i. Any pyroligneous acid or other artificial smoke flavors used es an
ingredient in a food shall be declared as artificial flavor or artificial smoke
flavor. Provided that, no representation may be made, either directly or
implied, that a food flavored with pyroligneous acid or other artificial
smoke flavor has been smoked or has a true smoke flavor, or that a
seasoning sauce or similar product containing pyroligneous acid or other
artificial smoke flavor and used to season or flavor other food will result in
a smoked product or one having a true smoked flayor.
Coloring substances shall be declared by their common name or as “Food
Color(s)" or “Color(s)" for those that are derived from or identical with
substances derived from plant materials, and as “Artificial Color(s)” for
coal-tar dyes or other synthetic chemical compounds.
k. Food additives shall be declared by their common name and their
functional categories as provided under Bureau Circular No. 2006-016 or
in the latest amendment by the FDA.
1. Processing aids and food additives carried over into food (from another
food that was used as an ingredient) at levels less than those required to
achieve technological function, need not be declared in the list of
ingredients.
4, Net Contents and Drained Weight
2, The net content shall be declared using the metric system of measurement
or “SI” (Intemational System of Units) on either the principal display
panel or the information panel and in parallel to the base of the package
‘The Declaration shall be made in the following manner:
1) For liquid foods, by volume;
2) For solid foods, by weight, except that when such foods are sold by
number, a declaration of count shall be made;
Page 7 of 1S
\Y 3) For semi-solid or viscous foods, either by we
Foods packed in a liquid medium normally discarded before consumption
shall carry a declaration of drained weight. For the purposes of this
requirement, liquid medium means water, aqueous solutions of sugar and
salt, fruit and vegetable juices, in canned fruits and vegetables only or
vinegar, either singly or in combination.
¢. For multi-unit retail packages, a statement of the quantity of contents on
the outside package shall include the number of individual units, the net
content of each individual unit, and in parenthesis the total quantity of
contents of the multi-unit package.
A multi-unit retail package may thus be properly labeled:
“20x 10 g sachets (net wt. 200 g)" or
“6 x 300 ml bottles (1.8 L or 1000 ml)”
5. Name and address of Manufacturer, Repacker, Packer, Importer, Trader
and Distributor
a. The name and address of the manufacturer, repacker, packer, importer,
trader or distributor of the food shall be declared on the label of locally
manufactured products.
If a manufacturer has plant in many cities and/or towns, the corporate head
office address would suffice provided every food package has # code/mark
to identify the processing plant where it was produced.
b. If the prepackaged food is not manufactured by the person or company
whose name appears on the label, the name must be qualified by
“Manufactured for” or “Packed for” or similar expression.
¢. For imported products, the complete name and address of importer and the
country of origin shall be declared.
4. In the case of products carrying foreign brands or manufactured under
license by a foreign company, the name and address of the foreign
‘company, shall be in letters of type and size not bigger than those used for
the local company.
©. When @ 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 purposes of labeling.
6. Lot Identification
The lot identification code shall be embossed or otherwise permanently
marked individually on the immediate packages “or containers. For
Prepackaged foods in multi-units retail packages such as candies with surface
area less than 10 cm? the same may be exempted from the requirements of lot
identification code only when sold together with the primary packaging.
Page 8 of 15
ye 7. Storage Condition
For products that need special storage condition other than normal room
temperature, the storage condition shall be printed clearly, conspicuously and
indelibly on all product label or labeling.
8. Expiry or Expiration Date/ Use-by-date/ Consume Before Date
(Recommended last consumption date)
Expirationlexpiry date shall be printed clearly, conspicuously and legibly on
all product labels (except alcoholic beverages) in the following order: Day,
Month, Year. The declaration of day and year are numerical while the
declaration of month must be in words to avoid confusion (e.g. Expiry date: 01
January 2012 or O1an12).
9. Food Allergen Information
Food allergen information on the label of products containing the following
ingredients but not limited to those listed below shall be indicated clearly,
conspicuously and indelibly, located directly below the List of Ingredients
(e.g. Contains food allergen: egg; or “Allergen Information: may contain”
J “Manufactured in equipment that processes"; or similar expression)
The following ingredients known to cause hypersensitivity shall always be
declared:
a, Cereal containing gluten, ic, wheat, rye, barley, oat, spelt or their
hybridized strain and produets of these;
b. Crustaceans and products of these;
c. Eggs and eggs products;
d. Fish and fish products;
e. Peanuts, soybeans and products of these;
£. Milk and milk products (lactose included);
g. Tree nut and nut products;
h. Sulphite in concentrations of JOmg/kg or more
i, Such other ingredient as may be included by FDA through appropriate
issuance
10, Direction/ Instruction(s) for Use shall also be printed, where applicable or as
necessary to ensure correct utilization of the food.
11. Nutrition Facts / Nutrition Information/ Nutritive Value
a. The nutrition facts shall be presented in tabulated form as shown in Figure
1 through the declaration of protein, carbohydrates (including dietary fiber
and sugar), fat (including saturated fat, trans fat and cholesterol), sodium,
energy value ot calories. Added Vitamin A, iron and iodine for the
products covered by the Food Fortification Program or vitamins and
minerals and/or other nutrients like fatty acids and linolenic acids for other
products claimed to contain such, shall also be included in the tabulation.
b. All nutrient quantities shall be declared in relation to the average or usual
serving in terms of slices, pieces or a specified weight or volume.
cc. The declaration of nutrients ean also be expressed either in unit per serving
or % RENI or both.
Page 9 of 1S
Q v 1) Carbohydrates, protein, fats (cholesterol expressed in mg), sugar and
dietary fiber, shall be expressed in nearest Gram (g). Energy values
shall be expressed in Calories (kcal). Sodium shall be declared in mg
2) Vitamins and minerals shall be expressed in Milligram (mg) or
Microgram (meg ot
