Philippines Develops Guidelines on Cosmetics Refilling Licensing

On May 21, 2024, Philippines Food and Drug Administration (FDA) published the Guidelines on the Licensing of Establishments Engaged in Refilling Activity of Certain Cosmetics and Household/Urban Hazardous Substances (HUHS) Products (the Guidelines). It shall take effect 15 days after its publication in the Official Gazette or in a newspaper of general circulation, and upon filing at the Office of the National Administrative Register (ONAR) of the UP Law Center.¹

The application of single-use plastics has revolutionized product packaging, offering reusability and convenience. However, the improper disposal and misuse of these plastics have contributed to environmental deterioration. To address this issue, there are calls to establish refilling stations for certain cosmetics and household/urban hazardous substances (HUHS) products. In response, the FDA issued the Guidelines to regulate companies intended to provide refilling service of these products. In terms of cosmetics, the Guidelines covers general requirements for cosmetics refilling, and primary obligations for cosmetic refillers.

Requirements for Cosmetics Refilling

Before conducting refilling activities, cosmetic refillers shall secure a License to Operate (LTO). Following that, they should apply for a major variation to add the refilling activity to their existing LTO, and upon approval, apply for an additional major variation to include the details of refilling stations. To ensure the approval, cosmetic refillers and their refilling stations shall comply with the following requirements: 

Cosmetic refillers and their refilling stations are subject to FDA monitoring and inspection prior to engaging in refilling activities, and during the LTO's validity period. Each refilling station shall prominently display a copy of the LTO, including the page with the station's address. Additionally, a copy of the CPN of the product for refill is required. 

Obligations for Cosmetic Refillers

The Guidelines specifies the obligations of cosmetic refillers engaged in refilling activities. To be specific, cosmetic refillers shall:

1. Only refill FDA-notified cosmetics, and ensure their safety, efficacy, quality, and traceability;

2. Provide ongoing training to their personnel on refilling activities, and ensure that only trained employees perform the refilling;

3. Ensure the emptied product container is suitable, sanitized, and safe for refilling, and conduct appropriate sampling and retention of refilled products for quality, safety, and efficacy testing;

4. Inform consumers about the refilled product at the time of product dispensing, including but not limited to safety information, the reuse frequency of the emptied product container, and proper disposal methods;

5. Conduct information campaigns to raise consumer awareness about refilling activities and refilled products. Provide information that includes but is not limited to safety information, the reuse frequency of the emptied product container, and proper disposal methods;

6. Coordinate with the FDA regarding post-marketing surveillance matters;

7. Promptly undertake necessary measures if the cosmetic for refill has been withdrawn due to health and safety concerns;

8. Notify the FDA if they and/or their refilling stations cease operations, or discontinue the previously approved refilling activities.

Other Noteworthy Points

In refilling stations, companies are strictly prohibited to conduct the on-site refilling of the primary container and dispenser of finished bulk cosmetics, or prepare customized products. Customized products are defined as those that can be prepared on-site according to consumer preferences, or require further mixing, dilution, and/or other methods that alter the formulation of the notified product. In addition, companies are forbidden to resell or repackage refilled cosmetics.

Once the Guidelines takes effect, the FDA shall issue implementing rules or guidelines for the provisions stated herein, including a pilot implementation lasting not more than six months. Following the effective date of these implementing rules and guidelines, affected stakeholders will be granted with a transitional period of not more than six months to comply with the new guidelines.

Further Reading

• Philippines FDA Proposes New Requirements for LTO Application

• Philippines Consults on Cosmetics Recall Guidelines