Recently, the Food and Drug Administration of the Philippines (FDA) issued Advisory No. 2026-0699, ordering the recall of a 100ml batch of skin-lightening cleanser + toner after the prohibited substance hydroquinone was detected in the product. Hydroquinone is listed in Annex II of the ASEAN Cosmetic Directive (ACD) and in Philippine cosmetic regulations as a prohibited substance.
CIRS Group has compiled the key points of the incident and the regulatory requirements on hydroquinone for the reference of relevant enterprises.
Recall Incident Review
Health risks: when applied to the skin, Hydroquinone may cause rashes and facial swelling; long-term use can lead to adverse reactions such as ochronosis (bluish-black or grey-blue discoloration of the skin);
Response measures: the Philippine FDA requires distributors/retailers to immediately remove and stop selling the affected batch, and consumers should stop using the product and handle it in accordance with the advisory.
Regulatory Requirements on Hydroquinone in Cosmetics
Hydroquinone is a skin-depigmenting/skin-lightening active ingredient. Due to its potential health risks, it is strictly restricted or prohibited in cosmetics across most major markets. According to Global CosIng, independently developed by CIRS Group:
ASEAN (including the Philippines): Hydroquinone is listed in Annex II (list of prohibited substances) of the ASEAN Cosmetic Directive (ACD) and may not be used as a cosmetic ingredient; the Philippine FDA enforces the rules accordingly;
China: Hydroquinone is listed as a prohibited substance in the Safety and Technical Standards for Cosmetics (STSC) and may not be added to cosmetics;
EU: EU: Hydroquinone is listed in Annex II/1339 of Regulation (EC) No 1223/2009 and is generally prohibited as a cosmetic ingredient, except for the specific exception under Annex III, entry 14, for professional artificial nail systems up to 0.02% in the finished product.
Therefore, the illegal addition of Hydroquinone to skin-whitening/anti-spot cosmetics is a common issue and an enforcement focus across major global markets.
CIRS Reminder
This recall once again shows that skin-whitening/anti-spot products are a high-risk category for cosmetic regulators worldwide. CIRS Group offers the following reminders:
- Strict formula compliance: skin-whitening/anti-spot products must ensure they do not contain prohibited substances such as hydroquinone — be particularly alert to the risks of “raw-material carry-over” and “undeclared addition”;
- Raw-material supplier audit: strengthen the qualification audit and incoming inspection of skin-whitening ingredients (e.g., kojic acid, niacinamide, vitamin C derivatives, plant extracts), and request purity and impurity reports where necessary;
- Consistency between label and notification: ensure that the ingredient list on the label, the registration/notification dossier, and the actual formula are mutually consistent, so as to avoid “detected-but-undeclared” violations;
- Track target-market regulations: regulatory requirements for hydroquinone differ across markets (e.g., restricted in some scenarios) — export-oriented companies should confirm the compliance requirements of each individual market;
- Stay informed: Philippine FDA and other ASEAN regulators continue to intensify enforcement against the illegal addition of ingredients in skin-whitening products; relevant companies should keep abreast of recall and sampling-inspection information.
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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