Philippines Infant Formula Regulation

In Philippines, infant formula must be in accordance with the Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Codex Stan 72-1981 Revised 2007) in addition to the requirements in the 1987 Executive Order 51 or “Milk Code” and its implementation rules RIRR.

contents 

1. Competent authorities

  • Department of Health (DOH)
  • Philippines Food and Drug Administration (PFDA)

2. Main regulations

Executive Order No.51 (known as the Milk Code) (1986-10-28)
National Code of Marketing of Breast milk Substitutes, Breast milk Supplements and related products

Administrative Order No.2006-0012 (abbreviated to RIRR) (2006-05-15)
Revised Implementing Rules and Regulations of Executive Order No. 51

Administrative Order No.18 S.1997 (2004-05-07)

Labelling of infant formula “breast milk supplement “or “follow-on formula”

Department Circular No.2008-0006 (2008-01-09)

Amendments to Department Circular No. 2007-0276 dated 07 December 2007, Re: Guidelines for the Labeling of Breast milk substitutes, infant formula, other related products, foods and beverages, and other related products within the scope of E.O. 51 and to Department Circular No. 2007-272 dated December 2007, Re: Containers and Labels of Milk Products within the Scope of E.O. 51

Department Circular No.2009-0228 (2009-08-17)

Guidelines for the Monitoring of Milk Code Activities

Bureau Circular No.2006-016 (2006-10-18)

Updated List of Food Additives

Administrative Order No.2014-0029 (2014-09-08)

Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and Other Food Products, and For Other Purposes

FDA Memorandum Circular No.2013-001 (2013-01-02)

Guidelines on the Submission of LTO and CRP Application with Electronic Copy (E-Copy)

3. Marketing of infant formula

The marketing of infant formula is of particular concern to the Philippines government due to the low rate of breastfeeding rate there. In the Philippines, the 2003 National Demographic and Health Survey showed that only 16% of Filipino infants are breastfed exclusively at the age of 4-5 months, leading to under nutrition. It is an underlying cause in 64% of the deaths of children. Malnourished children are less healthy, less intelligent and more vulnerable to infections and illness. The situation before the implementation of the Milk Code was even worse.

Therefore, in 1986, the Milk Code was issued to ensure the safety and adequate nutrition for infants by protecting and promoting breastfeeding and ensuring the proper use of breast milk substitutes and supplements on the basis of providing adequate information and through appropriate marketing and distribution. Under the regulation, no advertising, promotion or other marketing materials, whether written, audio or visual, for infant formula products shall be printed, published, distributed, exhibited and broadcast unless such materials are duly authorized and approved by the Inter-Agency Committee (IAC); Manufacturers and distributors shall not be permitted to give, directly or indirectly, samples and supplies of infant formula products or gifts of any sort to any member of the public, including families members, hospitals and other health institutions as well as personnel within the health care system. After the implementation rules of the Milk Code were issued and revised in 2006. The revision reiterates that no advertising, promotions, sponsorships, or marketing materials and activities for breast milk substitutes intended for infants and young children up to 24 months shall be allowed as they tend to convey messages that undermine breast milk or exaggerate the function of breast milk substitutes. The IAC reviews all marketing materials and requires all approved ad or marketing info to bear the messages both in English and in Filipino. The following shall not be included in advertising, promotional and marketing materials:

  • Texts, pictures, illustrations or information which discourage or tend to undermine the benefits or superiority of breastfeeding or which idealize the use of breast milk substitutes and supplements. Therefore, no pictures of babies and children together with their mothers, fathers, siblings, grandparents, other relatives or caregivers shall be used in the advertisement.
  • No terms like “humanized”, maternalized”, “close to mother’s milk” or similar words;
  • Pictures or text that idealizes the use of infant and milk formula.

Each container/label shall contain such message in both Filipino and English languages:

  • The words or phrase “Important Notice”or “Government Warning”or other equivalent;
  • A statement of the superiority of breastfeeding;
  • A statement that there is no substitute for breast milk;
  • A statement that the product shall be used only on the advice of a health worker as to the need for its use and proper methods of use;
  • Instruments for appropriate preparation, and a warning against the health hazards of inappropriate preparation, and
  • The health hazard 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.

On 17 Aug 2009, the DOH especially released the Department Circular No.2009-0228 to monitor the Milk Code Activities as a survey showed the breastfeeding data was still unsatisfactory. 84% of infants are not exclusively breastfed at 4-5 months of age and 50% stop exclusive breastfeeding at only 3 weeks. The strong explanation made by DOH is that manufacturers and distributors of infant formula and other breast milk substitutes have taken, over the past 20 years, advantage of the loopholes and gaps in the Milk Code to massively undermine breastfeeding in the Philippines.

4. Labelling of infant formula

According to Department Circular No.2008-0006, infant formula should not be described or presented on any label or in any labelling in a manner that if false, misleading or deceptive or is likely to create erroneous impression regarding its character in any respect.

Infant formula 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.

The label of infant formula should include:

A.   The principal display panel shall contain the following information:

1) Product and brand name

The product name shall be “infant formula,” Formula for Special Medical Purposes Intendeds for Infants” or “Milk Supplement” or other food standard names in accordance with relevant Codex Standards.

The source of protein in the product shall be clearly shown on the label

If cow’s milk is the only source of protein, the product may be labeled “Infant Formula Based on Cow’s Milk”.

2) Net contents and 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 GARAS NG INA ANG PINAKAMABUTI PARA SA BATA HANGGANG 2 TAON O HIGIT PA”

This message shall be printed bold in all capital letters at the center uppermost level of the principal display panel, the front type is Arial and front size of which must be one-third (1/3) of the size of the biggest letter on the label.

ii)            ENGLISH: “IMPORTANT NOTICE: THERE IS NO SUBSTITUTE FOR BREASTMILK ”

FILIPINO: “MAHALAGANG PAALALA: WALANG ANUMANG GATAS AND PWEDENG IPALIT SA GATAS NG ING”

This message shall be printed bold in all capital letters at the center lowermost level of the principal display panel, the front type is Arial and front size of which must be one-third of the size of the biggest letter on the label

B. The information panel shall contain the following:

1) List of ingredients

A complete list of ingredients shall be declared in descending order based on relative concentrations 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 on specific ingredients or nutrient content on the principal and information panel.

The specific name shall be declared for ingredients of animals 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 of nutrient values

The declaration of nutrient value or nutritional information shall be printed containing the following information in the following order:

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 the specified quantity of the food as suggested for consumption;

The total quantity of each vitamin, mineral, choline, 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 (0r per 100 kilojoules) is permitted.

3) Date marking and storage instructions

Expiration date

For products with a shelf life of less than 3 months, the expiration date shall be declared by the day, month, and year sequence. For products with shelf life of 3 months or more, the month and the year will suffice.The day and year may be declared in numerals but the month must be declared in word so as not to confuse the consumer.

Storage instructions

Any condition for the storage of the food shall be indicated if the use-by-date is affected by these conditions. The storage instructions shall be declared in close proximity to the date marking.

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.

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

The directions shall be accompanied by a warning about the health hazards of inappropriate preparation, storage and use.

Storage instructions of opened food products shall be included to ensure that the open 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 containers after opening.

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.

Adequate instructions regarding the storage of the product after the container has been opened shall appear on the label.

4) Usage Information  

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 should bear directions on correct preparation methods.

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.

iv). Information that infants over six months of age should receive nor-processed, fresh and natural complementary foods in combination with continued breastfeeding should be included. Such statement should read

“infants six months onwards should be given fresh, non-processed and natural foods in combination with continued breastfeeding”

This message shall be printed bold and prominent on the lowermost level of the information display panel of the label.

The health hazards associated with unnecessary or improper use of infant formula including information that powdered infant formula may contain pathogenic microorganisms and must be prepared and used appropriately.

“ENGLISH: “THIS PRODUCT MAY CONTAIN PATHOGENIC MICROORGANISOMS AND MUST BE PREPARED AND USED APRROPRIATELY””

“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 PREPRAED AND USED INAPPROPRIATELY”

“FILIPINO: ANG PRODUKTON ITO AY MAARING MAGKAROON NG MIKROBYO NA NAGDUDULOT NG SAKIT KAPAG HINDI TAMA ANG PATHAHANDA AT PAG-GAMIT”

This message shall be printed bold in all capital letters at the uppermost level of the information display panel, the font type is Arial and front size of which must be one-six of the size of the biggest letter on the label.

5) Name and address

The complete name and address of the manufacturer or packer/repacker, distributor, importer, exporter of the food shall be declared.

6) Country of origin

i). the country of origin of the food shall be declared.

ii). When a food undergoes processing in a second country which changes its nature, the country in which the processing is performed shall be considered as 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

It shall be labeled except in certain situations as may be allowed by FDA.

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 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, front type Arial and front 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 Filipino.

At the end of Department Circular No.2008-0006, there is a sample label attached for your reference.

5. Food additives that can be used in infant formula products

Infant formula is classified in to 13.1 food categories according to the Bureau Circular No.2006-016.

There are 75 food additives with different functions allowed to be used in infant formula products if applied within certain limit.

Food additive

 

Function

Max level

ACETYLATED DISTARCH ADIPATE

INS: 1422

Bulking Agent, Emulsifier, Stabilizer, Thickener

25000mg/kg

ACETYLATED DISTARCH PHOSPHATE

 

ulking Agent, Emulsifier, Stabilizer, Thickener

25000mg/kg

AGAR

INS: 406

Bulking Agent, Emulsifier, Filler, Stabilizer, Thickener

GMP

ALGINIC ACID

INS: 400

Bulking Agent, Emulsifier, Stabilizer, Thickener

300mg/kg

ALLURA RED AC

 

Colour

50mg/kg

ALPHA-AMYLASE (ASPERGILLUS ORYZAE VAR.)

INS: 1100

Adjuvant, Enzyme, Flour Treatment Agent

GMP

AMMONIUM ALGINATE

INS: 403

Emulsifier, Thickener, Stabilizer

300mg/kg

ASCORBIC ACID

INS: 300

Antioxidant, Colour Retention Agent

50mg/kg

ASCORBYL ESTERS

 

Antioxidant

10000mg/kg

AZORUBINE

 

Colour

50mg/kg

BEET RED

 

Colour

GMP

BRILLIANT BLACK PN

 

Colour

50mg/kg

BRILLIANT BLUE FCF

 

Colour

50mg/kg

BROWN HT

 

Colour

50mg/kg

50mg/kg

INS: 404

Antifoaming Agent, Emulsifier, Stabilizer, Thickener

300mg/kg

CALCIUM ASCORBATE

INS: 302

Antioxidant

50mg/kg

CALCIUM CARBONATE

 

Anticaking Agent, Acidity Regulator, Colour, Emulsifier, Stabilizer

GMP

CALCIUM CITRATE

INS: 333

Acidity Regulator,Antioxidant, Emulsifier,  Firming Agent, Sequestrant

GMP

CALCIUM HYDROXIDE

INS: 526

Acidity Regulator, Firming Agent

GMP

CARAMEL COLOUR, CLASS I

INS: 150a

Colour

GMP

CAROB BEAN GUM

 

Emulsifier, Stabilizer, Thickener

10000mg/kg

CAROTENOIDS

 

Colour

50mg/kg

CARRAGEENAN

INS: 407

Emulsifier, Filler, Stabilizer, Thickener

3000mg/kg

CHLOROPHYLLS

 

Colour

Colour

CITRIC ACID

INS: 330

Acidity Regulator, Antioxidant, Sequestrant

GMP

CURCUMIN

 

Colour

50mg/kg

DIACETYLTARTARIC AND FATTY ACID ESTERS OF GLYCEROL

 

Emulsifier, Sequestrant, Stabilizer

GMP

DISTARCH PHOSPHATE

INS: 1412

Bulking Agent, Emulsifier, Stabilizer, Thickener

25000mg/kg

GELLAN GUM

INS: 418

Thickener, Stabilizer

GMP

GUAR GUM

INS: 412

Bulking Agent, Emulsifier, Stabilizer, Thickener

10000mg/kg

GUM ARABIC

INS: 414

Bulking Agent, Emulsifier, Filler, Stabilizer, Thickener

10000mg/kg

HYDROXYPROPYL STARCH

 

Bulking Agent, Emulsifier, Stabilizer, Thickener

25000mg/kg

INDIGOTINE

 

Colour

50mg/kg

ISOMALT

 

Anticaking Agent, Bulking Agent, Emulsifier, Glazing Agent, Sweetener

GMP

KARAYA GUM

INS: 416

Bulking Agent, Emulsifier, Stabilizer, Thickener

GMP

KONJAC FLOUR

 

Emulsifier, Stabilizer, Thickener

GMP

LACTIC ACID (L-, D- and Dl-)

INS: 270

Acidity Regulator

GMP

LACTITOL

INS: 966

 

GMP

LECITHIN

 

Antioxidant, Emulsifier, Stabilizer

3000mg/kg

MAGNESIUM CHLORIDE

 

Colour Retention Agent, Firming Agent

GMP

MALTITOL and MALTITOL SYRUP

INS: 965

Bulking Agent, Emulsifier, Stabilizer, Sweetener, Thickener

GMP

MANNITOL

INS: 421

 

GMP

MICROCRYSTALLINE CELLULOSE

 

Anticaking Agent, Bulking Agent, Emulsifier, Foaming Agent, Stabilizer, Thickener

GMP

MONO- AND DIGLYCERIDES

 

Antifoaming Agent, Bulking Agent, Emulsifier, Stabilizer, Thickener

5000mg/kg

PECTINS (AMIDATED AND NON-AMIDATED)

 

Emulsifier, Stabilizer, Thickener

10000mg/kg

PHOSPHATED DISTARCH PHOSPHATE

 

Bulking Agent, Emulsifier, Stabilizer, Thickener

60000mg/kg

PONCEAU 4R

 

Colour

50mg/kg

POTASSIUM ALGINATE

INS: 402

Emulsifier, Stabilizer, Thickener

300mg/kg

POTASSIUM ASCORBATE

 

Antioxidant

50mg/kg

POTASSIUM CARBONATE

INS: 501i

Acidity Regulator, Stabilizer

GMP

POTASSIUM CHLORIDE

INS: 508

Stabilizer, Thickener

GMP

POTASSIUM DIHYDROGEN CITRATE

 

Acidity Regulator, Antioxidant, Emulsifier, Sequestrant, Stabilizer

GMP

POTASSIUM HYDROGEN CARBONATE

INS: 501ii

Acidity Regulator, Raising Agent, Stabilizer

GMP

POWDERED CELLULOSE

INS: 460ii

Anticaking Agent, Bulking Agent,Emulsifier, Stabilizer, Thickener

GMP

PROCESSED EUCHEUMA SEAWEED

INS: 407a

Stabilizer, Thickener

1000mg/kg

QUINOLINE YELLOW

 

Colour

50mg/kg

SILICON DIOXIDE (AMORPHOUS)

INS: 551

Anticaking Agent, Filler

10000mg/kg

SODIUM ALGINATE

INS: 401

Bulking Agent, Emulsifier, Stabilizer, Thickener

300mg/kg

SODIUM ASCORBATE

INS: 301

Antioxidant, Colour Retention Agent

50mg/kg

SODIUM CARBONATE

INS: 500i

Anticaking Agent, Acidity Regulator, Raising Agent, Stabilizer

GMP

SODIUM DIHYDROGEN CITRATE

 

Acidity Regulator, Antioxidant, Emulsifier, Sequestrant, Stabilizer

GMP

SODIUM HYDROGEN CARBONATE

INS: 500ii

Acidity Regulator, Anticaking Agent, Raising Agent, Stabilizer

GMP

SODIUM HYDROXIDE

INS: 524

Acidity Regulator

GMP

SORBITOL (INCLUDING SORBITOL SYRUP)

INS: 420

Bulking Agent, Emulsifier, Humectant, Sequestrant, Stabilizer, Sweetener, Thickener

GMP

YELLOW FCF

 

Colour

GMP

TARA GUM

 

Thickener, Stabilizer

1000mg/kg

TARTRAZINE

 

Colour

50mg/kg

TITANIUM DIOXIDE

 

Colour

GMP

TOCOPHEROLS

 

Antioxidant

30mg/kg

TOCOPHEROLS

 

Antioxidant

10000mg/kg

TRIPOTASSIUM CITRATE

 

Acidity Regulator, Antioxidant, Emulsifier, Sequestrant, Stabilizer

GMP

TRISODIUM CITRATE

 

Acidity Regulator, Antioxidant, Emulsifier, Sequestrant, Stabilizer

GMP

Thickener, Stabilizer

 

Thickener, Stabilizer

GMP

XANTHAN GUM

 

Thickener, Stabilizer

GMP

XYLITOL

INS: 967

Bulking Agent, Emulsifier, Humectant, Stabilizer, Sweetener, Thickener

GMP

6. Registration of products with PFDA

Under Administrative Order No.2014-0029, companies involved in the importation, exportation, trading, and distribution of processed food in the Philippines need to obtain a license to operate (LTO) and certificate of product registration (CPR) from the PFDA prior to placing the products on the market. PFDA adopts risk-based classification of food products which are subject to different registration requirements, dossiers and procedures (Detailed dossiers and procedures are clearly listed here at the website of PFDA). There are three risk degrees for food products, including low, medium and high. Infant formula products are classified as high risk foods.

For imported food products, the importer or an agent in Philippines will undertake the product registration responsibility; however some documentation or samples need to be provided by the overseas exporter. Only products with a valid CRP issued by PFDA will be allowed for sale in the Philippines.