Republic of the Philipphes

Department of Health
OFFICE OF THE SECRETARY
Building 1, San Lazaro Compound, Rizal Avenue
Sta. Cruz, Manila, Philippines
Tel. Nos. (632) 711-9502,711-9503 and 781-4362; Telefax No. (632) 743-1829

09 January 2008

DEPARTMENT CIRCULAR
No. 2008- QOO(p

TO ALL MILK COMPANIES AND OTHERS CONCERNED

SUBJECT: Amendments to Department Circular No. 2007-0276 dated

07 December 2007, Re: Guidelines for the Labeling of
breastmilk substitutes, infant formula, other milk 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. 2007-0272 dated 17 December
2007, Re: Containers and Labels of Milk Products within
the Scope of EO 51 otherwise known as the "Milk Code"

I. Rationale

It is a common knowledge that the two leading causes of infant mortality-

diarrheal diseases and malnutrition- are often rooted in improper and artificial feeding
practices. Only 33.50 percent of infants less than 6 months old are exclusively
breastfed but exclusive breastfeeding is very low for 4-5 months at 16 percent. The
median duration of exclusive breastfeeding in the Philippines is very short for only
less than a month. The decline of breastfeeding, compounded by inappropriate
complementary feeding practices, is a cause for alarm because of the consequent
undernutrition and risk for childhood mortality and morbidity. Thus, the Philippines
has adopted the Global Strategy for infant and young child feeding jointly developed
by the WHO and UNICEF, to promote exclusive breastfeeding and timely and
adequate complementary feeding with continued breastfeeding as stated in the
Administrative Order (AO) No. 2006-0012, "Revised Implementing Rules and
Regulations (RIRR) of Executive Order No. 51, Otherwise known as the "Milk
Code," Relevant International Agreements, Penalizing Violations Thereof and for
Other Purposes".

As provided for in Rule VII of AO No. 2006-0012, the containers and labels
shall be designed to provide the necessary information about the appropriate use of
the products within the scope of the Code and in such a way as not to undermine, or
equate it to, breastfeeding. Likewise, the BFAD is mandated to enforce the necessary
rules and regulations on the informational requirements that should be reflected in the
containers and labels.
II. Objectives

The objectives of this Order are the following:

1. To set a standard labeling for breastmilk substitutes, infant formula,

other milk products, foods and beverages, and other related products
within the scope of E.O. 51, which will be used in the evaluation and
screening ofthe labeling materials/containers of the said products;

2. To guide the milk companies as defined in AO No. 2006-0012;

manufacturers, importers, exporters, owners, distributors of other milk
products, foods and beverages, and other related products within the
scope of the Code.

III. Scope and Coverage

These guidelines apply to the labeling of the following products: breastmilk

substitutes, including infant formula, other milk products, foods and beverages,
including bottled-fed complementary foods, when marketed or otherwise represented
to be suitable, with or without modification, for use as a partial or total replacement of
breastmilk; feeding bottles and teats. It also applies to their quality and availability,
and to information concerning their use.

IV. Definition of Terms

Breastmilk substitute - means any food being marketed or otherwise

represented as partial or total replacement of breastmilk whether or not
suitable for that purpose (adopted from EO 51);

Complementary - means any food except milk substitutes, whether

manufactured or locally prepared, suitable as a complement to breastmilk to
satisfy the nutritional requirements of infants.

Container - means any form of packaging of products for sale as a normal

retail unit, including wrappers (adopted from AO 88-B s. 1984);

Expiration date- It is the date which signifies the end of the estimated shelf
life of the product under a storage condition beyond which the quality of the
product is significantly impaired. After this date, the food should not be
regarded as marketable (adopted from FDA Regulation No. 001 s. 1982);

Food for Special Medical Purposes - is 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);

Halal food - defined by FAO/WHO as food permitted under Islamic Law

(adopted from Codex CAC/GL 24-1997);

2
 ..

Health Claim - means any representation that states, suggests, or implies that a
relationship exists between a food or a constituent of that food and health;
(adopted from Codex CAC/GL 23-1997, Rev. 1-2004);

Healthful (adj)- means good for one's wellness. Healthy is a positive

descriptive of a person's physical state; healthful of something that favorably
affects or promotes that state (Adopted from Roget's New Millenium,
Thesaurus);

Infant - shall refer to a person within the age bracket of 0-12 months (adopted
from AO 2006-0012);

Irifant Formula -means one of the breastmilk substitutes formulated

industrially in accordance with applicable Codex Alimentarius Commission
(CAC) standards (adopted from AO 2006-0012);

Label - means any tag, brand, pictorial or other descriptive matter, written,
printed, stenciled, marked embossed of impressed on, or attached to a
container of any product within the scope ofthe code (adopted from AO 88-B.
s. 1984);

Lot - refers to a quantity of food produced under essentially the same

conditions during particular production schedule; (adopted from A.O. 88-B s.
1984)

Milk Company -shall refer to the owner, manufacturer, distributor, of infant

formula, follow-up milk, milk formula, milk supplement, breastmilk substitute
or replacement, or by any other description of such nature, including their
representatives who promote or otherwise advance their commercial interests
in marketing those products (adopted from AO 2006-0012);

Milk supplement -this 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)

Natural and indigenous food- means locally grown or produced food which
are neither artificial nor processed (adopted from AO 2006-0012);

Nutrition Claim -means 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 protein, fat and carbohydrates, as well as
the content of vitamins and minerals. However, The mention of these nutrients
in the list of ingredients and the qualitative and quantitative nutritive
value/nutrition information declaration in the information panel as part of
mandatory labeling do not constitute nutrition claims; (adopted from Codex
CAC/GL 23-1997, Rev. 1-2004);

3
 Nutritional (ad))- nutritious, nourishing, nutritive, food etc. ; of or relating to
or providing nutrition (Adopted from Encarta World English Dictionary);

Products within the Scope ofthe Code -shall pertain to breastmilk substitutes
and infant formula, including bottle-fed complementary foods as well as teats
and other commodities, which intend to replace or substitute, in whole or in
part, breastmilk and breastfeeding (adopted from AO 2006-0012);

Other Milk Products, Foods and beverages -refers to any provision or drink
marketed as a partial or total replacement of breastmilk (adopted from AO
2006-0012);

Other Related Products- refers to all materials used to administer breastmilk

substitutes; such as, but not limited to, feeding bottles, teats and other artificial
feeding paraphernalia; (adopted from AO 2006-0012);

Shelf-life - means the period wherein the product retain an acceptable level of
eating quality from a safety and organoleptic point of view (labuza, 2002);

Superlative- relating to, or constituting the degree of grammatical comparison

that denotes an extreme or unsurpassed level or extent; surpassing all others
like supreme ; very high quality like excellent (Adopted from Merriam
Webster Dictionary)

V. General Guidelines

1. All breastmilk substitutes, infant formula, other milk products, foods and
beverages, and other related products within the scope of E.O. 51, that are to
be advertised, imported and exported must have the approval of BFAD and
must be covered with a Certificate of Product Registration (CPR). In
particular, their label must conform to these guidelines and be in accordance
with the pertinent rules provided for in the Revised Implementing Rules and
Regulations (RIRR) ofE.O. 51.

2. All breastmilk substitutes, infant formula, other milk products, foods and
beverages, and other related products within the scope of E.O. 51 that are to
be exclusively exported and will not be distributed in the Philippines, the
labelling specifications may be in accordance with the labeling regulations of
the country of destination. However, in case a product is to be distributed in
the Philippines and abroad, the label must conform to these guidelines and be
in accordance with the pertinent rules provided for in the Revised
Implementing Rules and Regulations (RIRR) ofE.O. 51.

3. Any information, whether in text or graphical form, which are not mentioned
in these guidelines may be a ground for the denial of the label applied for.

4
 4. All breastmilk substitutes, infant formula, other milk products, foods and
beverages, and other related products within the scope of E.O. 51 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 regarding
its character in any respect.

5. All breastmilk substitutes, infant formula, other milk products, foods and
beverages, and other related products within the scope of E.O. 51 shall not be
described or presented on any label or in any labeling by words, pictorial or
other devices to be suitable to be used in the prevention, alleviation, treatment
or cure of a disease, disorder, or particular physiological condition.

6. Food products with special dietary needs or special medical purposes must be
in accordance with the Codex STAN 180-1991 and Codex STAN 72-1981
Revised 2007 in addition to the requirements of E.O. 51 and RIRR.

7. Consistent with Rule VI of AO 2006-0012, all health and nutrition claims for
food products within the scope of the Code are absolutely prohibited except
those provided in item V no. 6 ofthese guidelines.

8. The approved label of all food products within the scope ofthe Code shall not
be construed as an authority or approval for advertising, promotion, or
marketing materials and activities, the latter shall be subject to specific lAC
approval.

VI. Specific Guidelines

The label of all food products within the scope of the Code shall contain the
following information (See the sample label attached herein as "Annex 1"):

A. The principal display panel shall contain the following:

1. Product and Brand Name (Name of the Food)

(i) The product name shall be "Infant Formula," Formula for

Special Medical Purposes Intended for Infants" or "Milk
Supplement" or other food standard names in accordance with
relevant Codex Standards.
(ii) The sources of protein in the product shall be clearly shown on
the label
(iii) If cow's milk is the only source of protein, the product may be
labeled "Infant Formula Based on Cows' Milk.
(iv) A product which contains neither milk or any milk derivative
shall be labeled "contains no milk or milk products" or an
equivalent phrase.

(v) It shall be contrary to public policy to use as brand name

and/or trade mark any word or set of words that may be

5
 considered as nutritional, healthful, and superlative and other
terms of similar import.

2. Net Contents and Drained Weight

Net Contents

(i) The net contents shall be declared in the metric system

("System International" units).

(ii) The net contents shall be declared in the following manner:

- for liquid foods, by volume;

- for solid foods, by weight;
- for semi-solid or viscous foods, either by weight or
volume.

Drained Weight

(i) Foods packed in a liquid medium normally discarded before

consumption may carry a declaration of drained weight.

3. The primary messages

The principal panel of each container/label shall contain the

following messages:

(i) 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 0
HIGIT PA"

This message shall be printed bold in all capital letters at the

center uppermost level of the principal display panel, the font type
is Aria! and font size of which must be one-third (1/3) ofthe size
of the biggest letter on the label.

(ii) ENGLISH: "IMPORTANT NOTICE: THERE IS NO

SUBSTITUTE FOR BREASTMILK"

FILIPINO: "MAHALAGANG PAALALA: WALANG

ANUMANG GATAS ANG PWEDENG IPALIT
SA GATAS NG INA"

This message shall be printed bold in all capital letters at the

center lowermost level of the principal display paneL the font type
is Aria! and font size of which must be one-third (l /3) of the size
of the biggest letter on the label.

6
B. The information panel shall contain the following:

1. List of ingredients

A complete list of ingredients shall be declared in descending order of

proportion except in the case of added vitamins and minerals. Added
vitamins and minerals shall be arranged as separate groups (indicating the
specific nature/chemical name), respectively, and within these groups the
vitamins and minerals need not be listed in descending order of proportion.

All ingredients shall be printed on the information panel. There shall

be no elaboration of ingredients and nutrient contents on the principal and
information panel.

The specific name shall be declared for ingredients of animal or plant

origin and for food additives. In addition, appropriate class name for these
ingredients and additives may be included on the label.

2. Declaration ofNutritive Value

The declaration of nutritive value or nutrition information shall be

printed containing the following information in the following order:

2.1. the amount of energy, expressed in calories (kcal) and/or kilojoules

(kJ), and the number of grammes of protein, carbohydrates and fat per
100 grammes of the food as sold as well as per specified quantity of
the food as suggested for consumption;
2.2. the total quantity of each vitamin, mineral, (and choline for infant
formula), and any optional ingredients as listed in the codex standards
of infant formula and milk supplement (follow-up formula) per 100
grammes of the food as sold as well as per specified quantity of the
food as suggested for consumption when prepared according to the
instructions on the label. In addition, the declaration per 100 calories
(or per 100 kilojoules) is permitted.

3. Date Marking and Storage Instructions

3.1. Expiration Date

(i) For products with a shelf-life of less than three (3) months, the
expiration date shall be declared by the day, month, and year
sequence.

(ii) For products with shelf-life of three (3) months or more, the
month and year will suffice.

(iii) The day and year may be declared in numerals but the month
must be declared in word so as not to confuse the consumer.

7
 3.2. Storage Instructions

(i) Any condition for the storage of the food shall be indicated if
the validity of the date depends thereon. The storage
instructions shall be declared in close proximity to the date
marking.

(ii) Adequate directions for the appropriate preparations and use of

the product, including its storage and disposal after
preparation, i.e. that formula remaining after feeding should be
discarded, shall appear on the label and in any accompanying
leaflet.

(iii) The label shall carry clear graphic instructions illustrating the
method of preparation ofthe product.

(iv) The directions should be accompanied by a warning about the

health hazards of inappropriate preparation, storage and use.

(v) Storage instructions of opened food products within the Scope

of the Code shall be included to ensure that the opened product
maintains its wholesomeness and nutritive value. A warning
should be included on the label if the food is not capable of
being stored after opening or is not capable of being stored in
the container after opening.

(vi) Storage and disposal instructions for the use of the product
including its storage and disposal after preparation, i.e. formula
remaining after feeding shall be discarded, shall appear on the
label.

(vii) Adequate instructions regarding the storage of the product after

the container has been opened, shall appear on the label.

4. Information for Utilization

Directions as to the preparation and use of the food, its storage and
keeping after the container has been opened shall appear on the label.

i. The label must bear the instructions for use. Products in powder
form and concentrated liquids shall be directed to be prepared
with safe and previously boiled water before feeding.

ii. Adequate directions for the appropriate preparations and use of

the product, including its storage and disposal after preparation,
i.e. that formula remaining after feeding should be discarded,
shall appear on the label and in any accompanying leaflet.

iii. The label shall carry clear graphic instructions illustrating the
method of preparation of the product.

8
 IV. Information that infants over six months of age should receive
indigenous, fresh and natural complementary foods in
combination with continued breastfeeding. Such statement
shall be:

·'Infants six months onwards should be given fl·esh, indigenous,

and natural foods Ill combination with continued
breastfccd i ng"

'fhis message shall be printed bold and prominent on the

lowermost level ofthe information display panel of the label.

v. The health hazards of (the use) unnecessary or improper use of

infant formula and other related products including information
that powdered infant formula may contain pathogenic
microorganisms and must be prepared and used appropriately.

"ENGLISH: "THIS PRODUCT MAY CONTAIN

PATHOGENIC MICROORGANISMS AND MUST BE
PREPARED AND USED APPROPRIATELY"

"FILIPINO: ANG PRODUKTONG ITO AY MAARING

MAGKAROON NG MIKROBYO NA NAGDUDULOT NG
SAKIT AT DAPAT IHANDA AT GAMITIN NG TAMA."

Alternatively, the following can be reflected

"ENGLISH: THERE IS LIKELIHOOD THAT

PATHOGENIC MICROORGANISMS WILL BE IN THIS
PRODUCT WHEN IT IS PREPARED AND USED
INAPPROPRIATELY"

"FILIPINO: ANG PRODUKTONG ITO AY MAARING

MAGKAROON NG MIKROBYO NA NAGDUDULOT NG
SAKIT KAPAG HINDI TAMA ANG PAGHAHANDA AT
PAG~GAMIT"

'T'his message shall be printed bold in all capital letters at the

uppermost level of the inf(mnation display panel, the font
type is Arial and font size of which must be one-six ( l /6) of
the size of the biggest letter on the label.

5. Name and Address

The complete name and address of either manufacturer, packer/repacker,

distributor, importer, exporter of the food shall be declared.

9
6. Country of Origin

1. The country of origin of the food shall be declared.

11. When a food undergoes processing in a second country which

changes its nature, the country in which the processing is
performed shall be considered to be the country of origin for
the purpose of labeling.

7. Lot Identification

The lot identification number shall be embossed or otherwise permanently

marked on the label/container.

8. Food Registration (F.R.) Number

The Food Registration No. of the product shall be reflected on the label
except on certain situations as may be allowed by BFAD.

9. Secondary Messages

The information display panel of each container/label shall contain the

following messages in both English and Filipino languages:

(i) > "The Use of Infant Formula/Milk Supplements must only be

upon the advice of a health professional"
> Ang paggamit ng gatas na ito ay dapat sang-ayon sa payo ng
Doctor o health professional"

(ii) > "The unnecessary and improper use of this product may be
dangerous to your child's health"
> Ang maling paggamit ng gatas na ito ay maaaring
makasama sa kalusugan ng bata

These messages shall be printed bold, font type Arial and font size 1/6 size
of the biggest letter at the uppermost level of the information display panel.

10. Required Language

The language to be used in the declaration of all other information must be

in English and maybe written in both English and Pilipino, except for products
intended to be exported in which case English and/or the language acceptable to
the country of destination may be used.

10
VII. Transitory Provisions

By August 1, 2008 all labels must be fully compliant to these guidelines. Any
product within the scope of the Code which labels are not compliant to these
guidelines after said non-extendible deadline shall be subject to recall and the
appropriate sanctions as provided by existing laws and pertinent statutes shall be
exacted on the erring firms.

VIII. Miscellaneous Provisions

I. Milk companies as defined in AO No. 2006-0012; manufacturers,

owners, importers, exporters, distributors of other milk products, foods and beverages;
and other related products within the scope of the Code that may be affected by these
guidelines should submit a copy of their new label!s for purposes of amending their
valid CPR.

2. Upon presentation of a certification duly issued by the appropriate

entity or institution, and in accordance with the Islamic law, Halal logo may be
allowed to be printed in the label/container for products within the scope of the Code.

IX. Repealing Clause

All orders, issuances, rules and regulations or parts thereof inconsistent with
these guidelines are hereby repealed and modified accordingly.

X. Separability Clause

If for any reason, any part or provision of these guidelines is declared invalid
or unconstitutional, such invalidity or unconstitutionality shall not affect the other
provisions which shall remain in full force and effect.

XI. Effectivity

These guidelines shall take effect immediately.

FRANC
s

11
 Annex 1

BREASTMILK IS THE BEST FOR BABIES UP TO 2 YEARS OF AGE

OR BEYOND
ANG GATAS NG INA ANG PINAKAMABUTING PAGKAIN 'NG BATA
HANGGANG 2 TAON 0 HIGIT PA

BRAND NAME
Powdered Infant Formula

Net Wt. 500 grams

IMPORTANT NOTICE: THERE IS NO SUBSTITUTE FOR BREASTMILK

MAHALAGANG PAALALA: WALANG ANUMANG GATAS NA
PWEDENG IPALIT SA GATAS NG INA
Government Warnings:

• The use of Infant Formula/Milk Supplement must only be

upon the advice of a health professional.
Ang paggamit ng galas na ito ay dapat sang-ayon sa payo ng
Doctor o health worker.

• The unnecessary or improper use of this product may be

dangerous to your child's health.
Ang Maling Paggamit ng galas na ito ay maaaring makasama sa
kalusugan ng bata.

• THERE IS LIKELIHOOD THAT PATHOGENIC

MICROORGANISMS WILL BE IN THIS PRODUCT WHEN IT
IS PREPARED AND USED INAPPROPRIATELY.
ANG PRODUKTONG ITO A Y MAAARING MAGKAROON NG
MIKROBYO NA NAGDUDULOT NG SAKIT KAPAG HINDI
, TAMA ANG PAGHAHANDA AT PAG-GAMIT.
Ingredients: Non-fat milk, lactose, Vegetable oils (coconut oil, soy oil), whey
protein concentrate, Minerals (potassium citrate, ferrous sulfate, zinc sulfate), Vitamins:
(Ascorbic acid, niacinamide, vitamin A palmitate), Nucleotides: (Cytidine 5-
monophosphate, disodium guanosine,5-monophosphate, disodivm uridine 5-
monophospate, adenosine monophospahate)
Nutrition Facts Directions for Use: One scoop= 10 gms

D
Average Analysis : Per100g Before preparing the formula, clean all utensils:
• Energy .................. 500 kcal 1. Wash hands and all feeding utensils well.
• Protein .................. 12 g 2. Boil all feeding utensils (cap, bottle etc)
60% whey ............. 8.5 g for 5 minutes
40% casein ............ 3.8 g 3. Boil fresh water for 30 minutes then cool before putting

D
• Carbohydrate ......... 56 g into the bottle the correct amount.
• Fat.. ..................... 25 g Preparing the formula:
Linoleic acid ........... 400 mg 1. Mix 1 scoop of formula to 70 ml of safe and previously'
Linolenic acid ......... 350 mg boiled water.
• Vitamins: 2.1f preparing more than one feed, refrigerate and use within

D
Vitamin A. ............. 12001U 24 hours
Vitamin D ............. 3001U 3. Throw away any left over in the bottle after feeding the baby.
• Minerals: Use this product within 1 month after
Calcium ............... 350 mg opening the can. Store in cool dry place.
Iron ..................... 6.2 mg

D
Zinc ..................... 4.5 mg Expiry Date: 30 December 2006.
• Nucleotides:
CMP Product of U.S.A.
UMP Imported and distributed by: _ _ _ _ __

Lot identification no. - - - - -

Food Registration (FR) No. _ _ _ __

"Infants six months onwards should be given fresh, indigenous, and

natural foods in combination with breastfeeding"