HPRA issues safety warning to consumers on teeth whitening products

Almost 7,000 illegal units detained in 2025 

The HPRA is warning consumers to exercise caution when purchasing teeth whitening products, following new figures which show that illegal and potentially unsafe products, containing high levels of hydrogen peroxide, are entering the Irish market through online sales. Due to potential harmful side effects from hydrogen peroxide, the HPRA advises consumers to consult a dentist before considering teeth whitening - especially if they  have existing dental or medical conditions.

The HPRA states that in 2025, it detained 6,849 units of teeth whitening products and was involved in removing 105 website URLs connected to the sale and supply of non-EU compliant teeth whitening products. These products, typically sold as strips or gels, are often marketed online, including through social media platforms.

Hydrogen peroxide is the active bleaching ingredient used in teeth whitening kits and gels. While effective, it is tightly regulated in the E U to protect consumer health. Higher concentrations of hydrogen peroxide in teeth-whitening products are associated with an increased risk of adverse effects.  A common side effect of teeth whitening is sensitivity; however, hydrogen peroxide may cause inflammation, pain, gum irritation and chemical burns when concentrations are too high.

Lisa Byrne, Cosmetic Product Manager at HPRA explained: “Millions of teeth whitening kits have been sold across the world to consumers looking to brighten their smiles. However, we have noticed an increase in the number of teeth whitening products - being sold directly to consumers online - containing hydrogen peroxide levels far above the legal EU limit, sometimes as high as 15% - 40%, well above the EU permissible limit of 6%. High levels of hydrogen peroxide, without appropriate dental supervision, may cause chemical burns to the gums, tooth sensitivity, damage to dental restorations as well as increasing the risk of long-term oral health complications” 

“Consumer safety is our priority. Always consult a dental professional before using hydrogen peroxide for teeth whitening, especially if you have pre-existing dental or medical conditions. Always check labels carefully, avoid unregulated online sellers, and seek advice from qualified healthcare professionals, “she concludes.

The HPRA is the competent authority overseeing the safety and compliance of cosmetic products in Ireland - including teeth whitening products - in line with EU* regulations where the following limits apply to teeth whitening and oral  care cosmetic products:

• Up to 0.1% hydrogen peroxide: The maximum permitted concentration of hydrogen peroxide in oral products sold directly to the consumer is 0.1%. These products can be sold directly to consumers and are considered safe when used as intended.
• More than 0.1% and up to 6% hydrogen peroxide:  Tooth whitening products containing or releasing between 0.1% - 6% hydrogen peroxide can’t be sold directly to consumers. A registered dentist must supply them and supervise the first use.
• Above 6% hydrogen peroxide: These products are prohibited in the EU and must not be made available.

HPRA tips for safer use of teeth whitening products

• All teeth whitening products sold in the EU must include specific safety information on the labels*. The product must also display the name and EU/EEA address of the Responsible Person^. Items without this information may not meet EU safety standards and should not be used.
• Always consult a dentist first if you are considering teeth whitening, particularly if you have existing dental or medical conditions. 
• Only purchase products from reputable, trusted outlets supplying EU compliant products. Products sold through unknown platforms or through unofficial channels may not meet safety standards or comply with EU regulations. 
• Teeth whitening products should not be used on under 18’s. 
• If you experience a serious reaction, report it directly to the HPRA at hpra.ie/report.

The HPRA has a regulatory role in relation to the sale and supply of cosmetics in Ireland. This includes investigating non-compliance with EU regulations and monitoring reported undesirable effects and adverse reactions to products. To protect consumer health, it monitors the market in collaboration with the HSE’s National Environmental Health Service to identify and address safety and quality issues, undertaking investigations as appropriate when there are product safety concerns. Consumer reports of serious undesirable effects associated with cosmetic products play a vital role in helping the HPRA identify potential public health and safety concerns.

ENDS 

For further information

Káno Communications: (01) 679 8600   

Sinéad Brassil/Eoghan Dowling: (086) 057 9298/(083) 450 5356

Notes to editor 

European Union vs US

Hydrogen peroxide levels in teeth whitening products are tightly regulated in the European Union to protect consumer health. Products with hydrogen peroxide levels above 6% are prohibited in the EU and must not be made available. 

The U.S. Food and Drug Administration (FDA) and the American Dental Association (ADA) do not enforce a strict federal percentage cap for hydrogen peroxide in teeth whitening products. Instead, products are regulated based on their classification (Cosmetic vs. Drug), labelling compliance, and intended use. Generally, concentrations of hydrogen peroxide up to 15% can be found on the market in America as cosmetics, products with levels of 15% - 40% are considered medical devices or medicines.

Cosmetic products

A "cosmetic" is any product used to clean, protect, perfume, keep in good condition and change the appearance of skin, hair, nails or teeth. Cosmetics include beauty preparations (make-up, perfume, skin cream, nail polish), grooming aids (soap, shampoo, shaving cream, deodorant, toothpaste) and skincare products (moisturisers, serums and suncreams). 

*The below are required on labels are mandated under EU cosmetic safety rules (EU Cosmetics Regulation (EC) No. 1223/2009) for any product containing 0.1%–6% hydrogen peroxide: 

• Contains hydrogen peroxide. 
• Avoid contact with eyes. Rinse immediately if product comes into contact with them. 
• Concentration of H2O2 present or released indicated in percentage terms. 
• Not to be used on a person under 18 years of age. 
• To be only sold to dental practitioners. 
• For each cycle of use, the first use to be only done by dental practitioners or under their direct supervision if an equivalent level of safety is ensured. Afterwards to be provided to the consumer to complete the cycle of use. 

^ The Responsible Person (RP) is the entity or person responsible for ensuring that the cosmetic product they place on the market is safe for use and complies with the Cosmetic Product Regulation. The RP can be an individual or a legally registered company and they must be located in the European Economic Area (EEA) or Northern Ireland.  For more information see our webpage on the Responsible Person for cosmetic products.

The Dental Council of Ireland has published information on teeth whitening for dental practitioners on their website. For more information see the Dental Council of Ireland's website.