On June 29, 2026, the Food and Drug Administration (FDA) of the Philippines released for public comment a draft policy provisionally entitled “Guidelines on the Adoption of the Regulatory Sandbox for the Implementation of Regulations for the Licensing of Establishments Engaged in Refilling Activity of Certain Cosmetics and Household/Urban Hazardous Substances (HUHS).”
The draft proposes a 12-month regulatory sandbox with a two-track approach, easing License to Operate (LTO) and other access requirements for compliant pilot establishments engaged in refilling activities, allowing such activities to be piloted under controlled conditions. The commenting period shall commence upon the date of posting of this announcement until 24 July 2026. All comments should be submitted in MS Word format via email to cchuhsrr-policy@fda.gov.ph using the attached “Template for Comments”.
Background
The Philippine Department of Health previously issued Administrative Order (AO) No. 2024-0008 regulating the refilling activity of cosmetic and HUHS products. To mainstream refilling stations, help address plastic-waste and other environmental concerns, and leave room for industry innovation in a controlled and flexible manner, the FDA's draft introduces a “regulatory sandbox” mechanism that allows enterprises to pilot refilling operations under defined conditions during the sandbox period. The FDA had earlier advanced the linkage of relevant License to Operate (LTO) procedures through, among others, FDA Advisory No. 2025-0512.
Key Points of the Draft
- Scope: establishments engaged in the refilling activity of certain cosmetics and HUHS products;
- Sandbox duration: a 12-month pilot period is proposed;
- Two-track mechanism: for establishments engaged in refilling that meet the pilot conditions, License to Operate (LTO) and other access requirements are eased to facilitate compliant pilots;
- Controlled piloting: activities are conducted under defined conditions during the sandbox period, balancing innovation with product safety/consumer protection;
- Objective: to mainstream refilling stations, reduce packaging waste, and align with environmental objectives.
CIRS Reminder
If adopted, the draft would provide a new compliance pathway for enterprises engaged in cosmetic (and HUHS) refilling activities in the Philippines. CIRS Group offers the following reminders:
- Determine whether your business is in scope: verify whether the refilling activities your enterprise intends to conduct fall within the “certain cosmetics/HUHS” categories listed in the draft;
- Watch the two-track access conditions: assess against the draft’s specific conditions and documentation requirements for LTO easing whether your business qualifies;
- Use the consultation window: relevant enterprises may submit comments to the FDA during the draft’s comment period on the pilot scope, qualification conditions, and regulatory requirements;
- Coordinate with existing rules: note the linkage with AO No. 2024-0008 (refilling guidelines) and relevant FDA advisories (e.g., No. 2025-0512).
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Our Services
- ASEAN Cosmetics Notification
- ASEAN Cosmetics Formula/Label Review
- ASEAN Cosmetics Regulatory Compliance Consultation
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