On July 14, 2025, the Philippines Food and Drug Administration (FDA) issued FDA Circular No. 2025-004, formally adopting the revised Codex Standard for Follow-Up Formula for Older Infants and Product/Drink for Young Children (CXS 156-1987) as technical regulation.
The new regulation harmonizes national standards with international requirements while ensuring continued compliance with the Philippines' National Code of Marketing of Breastmilk Substitutes (Executive Order No. 51). The FDA emphasized that this adoption aims to keep pace with advances in composition, quality factors, and purity requirements for follow-up formula and products for young children.
1. Product scope
The circular applies to all manufacturers, distributors (importers, exporters, wholesalers), and traders of follow-up formula for older infants and product/drink for young children in liquid or powdered form. Key definitions include:
Follow-up formula for older infants: Products manufactured as breastmilk substitutes for infants aged 6-12 months when complementary feeding is introduced.
Product/drink for young children: Products manufactured for children aged 12-36 months as part of their diversified diet.
2. General Requirements
The Philippine FDA will automatically adopt the revised Codex Standard for Follow-Up Formula for Older Infants and Product/Drink for Young Children (CXS 156-1987) and all subsequent revisions and amendments, provided they align with existing national laws.
Furthermore, all Food Business Operators (FBOs) engaged in the manufacture, importation, exportation, sale, distribution, promotion, or advertising of these products must first obtain a License to Operate (LTO) before applying for a Certificate of Product Registration (CPR).
Additionally, these products must adhere to several other key domestic regulations, including:
Executive Order No. 51 (The Milk Code of the Philippines) and its Implementing Rules and Regulations (IRR).
Compliance with general guidelines for labeling and other relevant food safety regulations.
3. Implementation timeline
The circular provides a structured transition period for existing manufacturers. Companies with CPRs expiring within five years must file new applications complying with the revised standards after their original registration expires. For existing label stocks, manufacturers may exhaust current inventory within a maximum six-month period, provided they submit detailed inventory reports to the FDA.
The regulation includes automatic adoption of future Codex standard revisions unless otherwise prescribed by the FDA, ensuring continued alignment with international standards. A monitoring and review clause mandates evaluation within three years to assess the policy's objectives, impact, and effectiveness.
For food manufacturers operating in the Philippines market, this regulatory update represents a significant alignment with international standards while maintaining strong protections for breastfeeding promotion. Companies should begin preparing for compliance requirements, particularly regarding compositional standards and labeling restrictions.
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