On October 8, 2026, the Food and Drug Administration (FDA) of the Department of Health of the Philippines issued Advisory No. 2026-1607 and Advisory No. 2026-1608, announcing the recall of two BB creams after post-marketing surveillance sampling found that the products contained Butylphenyl methylpropional and Cyclotetrasiloxane. The market authorization holders have ceased distribution and cancelled the product notifications concerned, and neither advisory provides for a transitional selling period.
Background and Basic Information
Cosmetics in the Philippines are managed under a notification system. Post-marketing surveillance falls to the FDA's Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHHSRR), with the Food and Drug Administration Act of 2009 (Republic Act No. 9711) as the regulatory basis. Under the ASEAN Cosmetic Directive (ACD), the Philippine list of prohibited ingredients remains aligned with ASEAN Annex II, and both substances involved this time are expressly listed in Annex II.
It is worth noting that this recall introduces no new prohibition or restriction requirements, but constitutes enforcement of the existing ban against products already on the market-the ASEAN compliance transition period for the two substances expired nearly two years ago.
Prohibited Substances Detected
Citing the prohibited entries of Annex II of the ASEAN Cosmetic Directive, the two advisories classify the two substances as prohibited cosmetic ingredients:
- Butylphenyl methylpropional, entry No. 1666 of Annex II, commonly known in the industry as "Lilial" , has long been widely used as a fragrance ingredient;
- Cyclotetrasiloxane, entry No. 1388 of Annex II, known as the Cyclic siloxane D4, is commonly used as a volatile silicone oil to adjust skin feel.
The potential health risks listed in the advisories include skin sensitization and allergic reactions (contact dermatitis), endocrine disruption, and reproductive toxicity (effects on fertility and fetal development), as well as long-term environmental effects arising from persistence, bioaccumulation, and toxicity (PBT).
Comparison of the Regulatory Progress on the Two Substances in Major Markets
- EU: Butylphenyl methylpropional was added to Annex II of the EU Cosmetics Regulation by Commission Regulation (EU) 2021/1902, and its use has been prohibited since March 1, 2022;
- ASEAN: the ASEAN Cosmetic Committee incorporated the prohibited substances set out in that regulation and other documents into Annex II of the ASEAN Cosmetic Directive, with a 24-month grace period; since November 21, 2024, only compliant products may be sold on the market;
- China: on January 12, 2026, the National Medical Products Administration (NMPA) issued the Announcement on Incorporating 18 Standard Development and Revision Projects, Including the Limits of Aerobic Plate Count in Eye Cosmetics, Lip Cosmetics and Children's Cosmetics, into the Safety and Technical Standards for Cosmetics (2015 Edition) (No. 6 of 2026), adding Butylphenyl methylpropional and Cyclotetrasiloxane to the List of Prohibited Cosmetic Ingredients, effective from January 1, 2028; cosmetics produced or imported before the implementation date may be sold until the end of their shelf life. For Cyclotetrasiloxane, an impurity exemption applies: where its presence as an impurity is technically unavoidable, it must be less than 0.1% (w/w) in the cosmetic product.
CIRS Reminder
- When exporting to the ASEAN market, companies must comply with the control requirements already in force there: the transition periods for the two substances have ended, and product formulations containing the substances concerned carry compliance risks; companies should make corresponding disposal arrangements.
- For silicone-oil raw materials, attention should be paid to potential carry-over of D4: the substance may be an intentionally added formulation component, or may be present as an impurity accompanying raw materials such as the cyclic siloxanes D5 and D6; companies need to identify and assess such cases.
- Keep track of international control timelines in parallel: Butylphenyl methylpropional and Cyclotetrasiloxane will be controlled in China from 2028; companies may adjust their product portfolios early to meet the forthcoming regulatory requirements.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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