On July 23, 2026, the Food and Drug Administration (FDA) submitted a notification (G/TBT/N/PHL/370) to the World Trade Organization (WTO) regarding the “Guidelines on the Adoption of a Regulatory Sandbox for the Implementation of Regulations on the Licensing of Establishments Engaged in Refilling Activity of Certain Cosmetics and Household/Urban Hazardous Substances (HUHS) Products” (amending Administrative Order No. 2024-0008).
The guidelines propose introducing a “regulatory sandbox” mechanism for the refilling (refill/bulk-filling) of cosmetics and HUHS products, allowing enterprises to pilot-test innovative refilling models in a controlled, time-bound environment and to use the findings to refine risk-based regulatory rules.
The final date for comments on the notification is July 31, 2026. The notification will take effect fifteen (15) days after its publication in a newspaper of general circulation and its filing with the University of the Philippines Office of the National Administrative Register; the proposed date of entry into force is yet to be determined.
Policy Background and Objective
The Philippine Department of Health previously issued Administrative Order No. 2024-0008 as an enabling regulatory policy, intended to promote and mainstream refilling systems for cosmetics and HUHS products while safeguarding public health through safety, efficacy, and quality standards. However, regulatory impact assessments and related consultations revealed several barriers:
- Disproportionate compliance costs faced by micro, small, and medium enterprises (MSMEs);
- Limited scope of permissible refilling operations;
- Restrictions on subcontracting and franchising.
These barriers may hinder the promotion of refilling systems and constrain the expansion of refilling operations.
Key Points of the Regulatory Sandbox Mechanism
A regulatory sandbox allows participants to pilot-test innovative products or services with regulatory relief or flexibility in a controlled, time-bound environment, with the aim of accumulating evidence to support sound regulatory design for new technologies. This approach has already been used in the Philippines across several sectors, such as the financial products and services, the Department of Health, and the Philippine Health Insurance Corporation (benefits and payment reforms).
The proposed policy aims to:
- establish a regulatory sandbox framework for the refilling of certain cosmetics and HUHS products, accommodating the varying levels of technological readiness of innovative refilling models;
- gather empirical data to inform the development of risk-proportionate regulations for refilling models.
CIRS Reminder
This notification reflects the Philippines’ active response to the “refill / refill-packaging” business model for cosmetics and other products, as well as to the trends of circular economy and sustainable packaging. CIRS Group reminds relevant exporting enterprises to note the following points:
- Follow up on the notification review: The final date for comments on this notification is July 31, 2026. Comments may be submitted to the comment-handling authority designated in the notification — the Bureau of Philippine Standards (BPS) at bps@dti.gov.ph;
- Anticipate regulatory trends: The Philippines’ plan to implement licensing for refilling activities through a regulatory sandbox reflects its clear support for innovative business models such as refilling and the circular economy. While regulatory flexibility increases, the compliance requirements for refilling operations may be further refined; relevant enterprises should assess whether their own business models are suitable for the sandbox framework.
- Keep abreast of regulatory developments: Enterprises already present in or seeking to enter the Philippine market should continuously monitor subsequent revisions to relevant policies and regulations and the progress of regulatory sandbox projects, and make compliance preparations in advance.
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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