Electric toothbrushes, irrigators and whitening devices

• Directive 2014/35/EU — Low Voltage
• Directive 2014/30/EU — EMC
• Regulation (EC) No 1223/2009 — Cosmetics for whitening gels
• Regulation (EU) 2017/745 — MDR for some dental devices
• Regulation (EU) 2023/1542 — Batteries

Who has to appoint one

Manufacturers and sellers outside the Union placing oral care appliances on the EU market. Whitening kits split the product: the device follows the electrical rules while the gel is a cosmetic with its own responsible person, safety report and CPNP notification.

Thresholds and exemptions

Hydrogen peroxide content decides legality for whitening products: above 0.1% and up to 6% they may only be sold to dental practitioners for first use, and above 6% they may not be placed on the market for tooth whitening at all.

What must appear on the label

CE marking, manufacturer and EU representative details, model and batch number, rated voltage, the WEEE symbol and battery markings. For the gel, the full cosmetic labelling including the peroxide concentration and the practitioner restriction where applicable.

Marketplace fields

Marketplaces routinely remove whitening kits exceeding the peroxide limits, and this is one of the most enforced cosmetic restrictions in online retail.

Documentation you must hold

EU declaration of conformity and technical file for the appliance. For the gel: the Product Information File, the safety report signed by a qualified assessor, CPNP notification and evidence of the peroxide concentration. Battery, WEEE and packaging registrations.

Standards and testing

EN 60335-2-52 for oral hygiene appliances, EMC testing, IEC 62133 for the cell, and for the gel stability, compatibility and analytical verification of the peroxide content.

Language requirements

Instructions and warnings in the language of each member state, including the cosmetic warnings on the gel.

When it applies

Before placing on the market, with CPNP notification preceding the first sale of the gel.

How long records are kept

Ten years for the appliance documentation and the Product Information File for ten years after the last batch.

What happens if you do not comply

Withdrawal and fines. Peroxide above the permitted limits is treated as a serious cosmetic infringement with criminal exposure in several member states.

Who enforces it

Market surveillance authorities, cosmetics competent authorities, WEEE registers and customs.

Where the boundary lies

A whitening kit is two regulated products in one box, and sellers frequently comply with the electrical rules while ignoring the cosmetic ones. LED devices sold with the gel do not change the classification of the gel.

Questions we are asked

Can we sell a 12% peroxide whitening kit online?

No. Above 6% hydrogen peroxide or equivalent, tooth whitening products may not be placed on the market at all in the Union.

Does the gel need its own responsible person?

Yes, a cosmetics responsible person under Article 4 of Regulation 1223/2009, which is a different role from the electrical economic operator.