Teeth whitening products recalled in Spain after peroxide levels far exceed legal limit

Two home teeth-whitening products have been pulled from sale in Spain after tests found substances at concentrations above the limits allowed for oral cosmetic products.

Spain’s Agency for Medicines and Health Products (AEMPS) has ordered the sale to stop, products to be removed from the market and affected units to be recovered in a nationwide recall.

The warning concerns specific batches of 7D White Teeth Whitening Strips and Teeth Whitening Pen, both marketed by Success Courier S.L.

Which teeth whitening products are affected?

Consumers who use these products at home are being advised to check the batch number printed on the packaging.

The recall covers:

• 7D White Teeth Whitening Strips – batch T125218
• Teeth Whitening Pen – batch T125186

AEMPS says both products were intended for home use. However, laboratory testing found problems with ingredients in both products, with the most striking result involving the whitening pen.

Tests on Teeth Whitening Pen batch T125186 found hydrogen peroxide at a concentration of 8.1 per cent. For oral cosmetic products, the maximum permitted concentration is 0.1 per cent.

That means the level found in the affected whitening pen was 81 times the permitted limit.

Whitening strips also failed safety limits

Testing on 7D White Teeth Whitening Strips batch T125218 also found concentrations above the levels allowed under European cosmetic rules. The analysis detected 6-methylcoumarin at 0.05 per cent, compared with a maximum permitted level of 0.003 per cent.

Hydrogen peroxide was also found at a concentration of more than 0.9 per cent, compared with the maximum permitted level of 0.1 per cent for the relevant oral product category. AEMPS says these concentrations do not comply with the requirements set out under European Regulation (EC) 1223/2009 covering cosmetic products.

Why is hydrogen peroxide used in teeth whitening?

Hydrogen peroxide is widely associated with teeth-whitening products because of its bleaching properties. European rules place strict limits on its use in oral cosmetic products and products containing more than 0.1 per cent and up to 6 per cent hydrogen peroxide can fall under a different set of conditions, including requirements involving dental professionals and restrictions on use by people under 18.

Products intended for ordinary consumer use at home therefore cannot simply contain whatever concentration is used in professional whitening treatments. The rules are designed to control how much hydrogen peroxide consumers can be exposed to through cosmetic products used on the teeth and inside the mouth.

What should customers do now?

Anyone who has either of the affected products should check the batch number before using it.

Consumers with T125218 7D White Teeth Whitening Strips or T125186 Teeth Whitening Pen should not use the product.

AEMPS advises customers to return affected units to the place where they were bought or contact the company responsible to arrange their return. Retailers have also been told to check products on their shelves and bathroom cupboards. Any affected units should be removed from sale and the company responsible contacted.

AEMPS warning follows European alert

AEMPS says it became aware of the problem through two alerts submitted through the European Safety Gate notification system. Spain’s health authorities have also been informed so the withdrawal can be communicated across the autonomous communities.

No general withdrawal of every product sold under these names has been announced. The AEMPS notice specifically identifies batch T125218 of the whitening strips and batch T125186 of the whitening pen.

Anyone who has bought one of these products should therefore check the lot number rather than assuming every pack is affected. If they do have one of the affected products, take it back to the shop where you bought it for a full refund.

Consumers can also report an incident involving a cosmetic product through the AEMPS reporting system.