1. Definition & classification
As per National Code of Marketing of Breastmilk Substitutes, Breastmilk Supplement and Other Related Products (The Milk Code) and Department Circular No.2008-0006:
infant formula refers to breastmilk substitute formulated industrially in accordance with applicable Codex Alimunterius standards, to satisfy the normal nutritional requirements of infants up to between four to six months of age, and adapted to their physiological characteristics. Infant formula may also be prepared at home in which case it is described as "home-prepared";
milk supplement, which shall be used in place of follow-up formula, refers to food intended for use as a liquid part of the complementary food for the infant from the 6th month on and for young children.
2. Competent authority
Department of Health (DOH)
DOH is the executive department of the Philippine government which is responsible for ensuring the access to basic public health services by all Filipinos through the provision of quality health care as well as the regulation for all health services and products.
Philippines Food and Drug Administration (PFDA)
PFDA is a health regulatory agency under DOH responsible for licensing, monitoring, and regulation of cosmetics, drugs, foods, household hazardous products, medical devices and electromagnetic radiation emitting devices, pesticides, tobacco and related products, and vaccines, for safety, efficacy, and quality in the Philippines.
3. Market access approval
3.1 License to operate (LTO)
Under Administrative Order No.2014-0029 Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and Other Food Products, and For Other Purposes, companies involved in the importation, exportation, trading, and distribution of processed food in the Philippines need to obtain a License to Operate (LTO). The LTO application procedure and requirements can be found in Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration.
3.2 Certificate of product registration (CPR)
Under Administrative Order No.2014-0029 Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and Other Food Products, and For Other Purposes, all processed food products are required to secure a Certificate of Product Registration (CPR) before they are sold, offered for sale or use, distributed, or supplied. The CPR application procedure can be found in FDA Circular No. 2016-014 Procedure for the Use of Electronic Registration (E-Registration) System for Prepackaged Processed Food Products.
4. Product compliance
4.1 Product requirements
The Philippines adopts risk-based classification of food products. Infant formula is classified into high-risk food products.
Milk Supplement (Follow-up Formula)
FDA Circular No.2013-010 Revised Guidelines for the Assessment of Microbiological Quality of Processed Foods
The labeling of infant formula shall comply with Department Circular No.2008-0006, where the labeling rules, items and samples for infant formula are provided. In principle, infant formula shall not be described or presented on any label by words, pictures or other devices that it is suitable to be used in the prevention, alleviation, treatment or cure of a disease, disorder, or particular physiological condition.
Besides, Administrative Order No.18 S.1997 was formulated to address the issue of using the term "Breast Milk Supplement" or "Follow-on Formula" on product labels.
In addition, as per Guidelines in the Use of Nutrition and Health Claims in Food, nutrition and health claims shall not be permitted for foods for infants and young children except where specifically permitted by relevant Codex standards or national legislation.