Quality & complianceOfficial

AEMPS recalls Smilekit teeth whitening pen batch over excess hydrogen peroxide

🇪🇸 AEMPS · Thu 22 Oct 2026

Spain's regulator says French tests found 7.6% hydrogen peroxide in the TEMU-sold cosmetic, against a 0.1% limit for oral products.

The Spanish Agency for Medicines and Medical Devices (AEMPS) has announced that batch 20250620 of the cosmetic Smilekit Teeth Whitening pen is to be withdrawn from sale and recalled. Marketing of the batch has ceased. The notice carries the reference COS, 22/2026.

The measures follow analyses by French authorities, which found hydrogen peroxide at 7.6%. The maximum permitted level for oral products, covering hydrogen peroxide present or released, is 0.1%. AEMPS says the product therefore fails the requirements of Regulation (EC) No 1223/2009 on cosmetic products.

The product is sold through the TEMU platform. The company responsible for placing it on the market is France Effie Cosmeceuticals Technology Co. Ltd, listed at an address in Paris. AEMPS learned of the case through an alert in the EU's Safety Gate rapid alert system and has informed the health authorities of Spain's autonomous communities so they can circulate the information.

AEMPS advises anyone who has a unit of the product not to use it. It asks people aware of any incident linked to a cosmetic to report it through its NotificaCS portal. The notice does not describe any specific adverse events.

What it means for your team

  • Cosmetics teams should note that the recall rests on a clear numerical breach: 7.6% hydrogen peroxide against the 0.1% limit for oral products under Regulation (EC) No 1223/2009.
  • Online marketplace sales do not remove responsible-person obligations. Product-safety teams should check whether similar whitening products sold via e-commerce channels are being monitored.
  • The case came through Safety Gate and French testing, which shows how national surveillance results can trigger recalls in other EU states.
  • Any adverse reactions linked to cosmetics can be reported in Spain through NotificaCS.

Official source: AEMPS ↗

Article written by VigiEye from the official source (AEMPS). AI-assisted; check the source before acting.

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