Household appliances
EU Declaration of Conformity for Electric Toothbrushes: requirements and checklist
By Ing. Jaroslav Křepelka, Owner, DoC solutions s.r.o. · Updated 22 September 2026
The brush handle runs on a small battery, but the charging base plugs into the mains, so the Low Voltage Directive applies to the set and the household appliance standards EN 60335-1 and EN 60335-2-52 are the reference. App-connected models add the Radio Equipment Directive.
This page covers rechargeable electric toothbrushes, sonic brushes and oral irrigators with a mains charger or adapter.
Checklist: what your electric toothbrush declaration must contain
- Model of the handle and of the charging base or adapter, as marked on each
- Name and postal address of the manufacturer (and of the authorised representative, if appointed)
- The statement that the declaration is issued under the sole responsibility of the manufacturer
- Low Voltage Directive 2014/35/EU and EMC Directive 2014/30/EU, or RED 2014/53/EU instead for Bluetooth models
- RoHS Directive 2011/65/EU
- The harmonised standards applied, with year and amendments
- Place and date of issue, name and function of the signatory, and the signature
Which EU legislation applies
| Legislation | Applies? | In the DoC? | Notes |
|---|---|---|---|
| Low Voltage Directive2014/35/EU | Applies | In the DoC: Yes | The mains-powered charging base or adapter brings the set within the 50–1000 V AC range. |
| EMC Directive2014/30/EU | Applies | In the DoC: Yes | Motor drive and inductive charging electronics. |
| Radio Equipment Directive2014/53/EU | Depends on model | In the DoC: Yes | For Bluetooth models; RED then replaces the LVD and EMC Directives. Models that communicate over the internet through the app and process personal data (brushing habits) must also meet Delegated Regulation (EU) 2022/30 since 1 August 2025. |
| RoHS Directive2011/65/EU | Applies | In the DoC: Yes | Restriction of hazardous substances in electrical and electronic equipment. |
| Batteries Regulation(EU) 2023/1542 | Applies | In the DoC: No | From 18 February 2027 portable batteries in appliances must be removable and replaceable by the end user. Appliances designed to operate primarily in wet environments and intended to be washed or rinsed may instead be designed for replacement by independent professionals, but only where that is required for the safety of the user and the appliance (Article 11(2)). |
| Standby and off-mode ecodesignDirective 2009/125/EC + Regulation (EU) 2023/826 | Depends on model | In the DoC: Yes | Tooth-brushing appliances are listed in Annex II, but the regulation only covers equipment that depends on mains power to work as intended. A brush that runs on its battery is usually outside it; a corded oral irrigator is inside. |
| WEEE Directive2012/19/EU | Applies | In the DoC: No | Producer registration in every EU country where you sell and the crossed-out wheeled bin symbol. |
Typical harmonised standards
A harmonised standard gives presumption of conformity only in the version cited in the Official Journal of the EU. Always check the current list for each directive before you issue or update a declaration (European Commission: harmonised standards); the versions below are the ones commonly used at the time of writing, and the right selection depends on your product.
Electrical safety (LVD)
- EN 60335-1:2012 + A11:2014 + A13:2017 + A1:2019 + A14:2019 + A2:2019 + A15:2021Household and similar electrical appliances — general requirements (cited with a restriction on part of clause 20.2)
- EN 60335-2-52:2003 + A1:2008 + A11:2010 + A12:2019Particular requirements for oral hygiene appliances
- EN 62233:2008Measurement of electromagnetic fields of household appliances with regard to human exposure
EMC
- EN 55014-1:2017 + A11:2020EMC for household appliances and similar apparatus — emission
- EN 55014-2:1997 + A1:2001 + A2:2008EMC for household appliances and similar apparatus — immunity (the edition cited in the Official Journal)
- EN 61000-3-2:2014 and EN 61000-3-3:2013Harmonic currents and voltage fluctuations
Bluetooth models (RED)
- ETSI EN 300 328 V2.2.22.4 GHz wideband transmission systems
- ETSI EN 301 489-1 and EN 301 489-17 V3.3.1EMC for radio equipment
Hazardous substances (RoHS)
- EN IEC 63000:2018Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances
Already have a declaration for your electric toothbrush?
A certification expert checks it against everything on this page and tells you exactly what to fix. Written report in 48 hours, €99 per product (excl. VAT).
Common mistakes in electric toothbrush declarations
The LVD is left out because the brush is battery-powered
The set includes a mains charger or adapter, so the LVD and the EN 60335 series apply. Only a brush supplied without any mains part could argue otherwise.
Only the handle is identified
The charging base or adapter is part of the product and needs to be identified in the declaration and covered by the tests.
Battery removability ignored
From 18 February 2027 the Article 11 rules apply. The wet-environment exception only allows replacement by independent professionals where this is needed for safety, and the justification belongs in the technical file.
Bluetooth model declared under LVD and EMC
App-connected brushes are radio equipment and need RED with its radio standards.
EMC immunity standard cited in a version the Official Journal does not list
EN 55014-2:1997 with A1 and A2 is the edition cited in the Official Journal. Testing to the newer EN 55014-2:2015 is fine technically, but on its own it does not give presumption of conformity, so the technical file should show how the immunity requirements are met.
What you need besides the declaration
- Technical documentation
- Test reports against EN 60335-1 and EN 60335-2-52 (including water ingress), EMC and EMF reports, battery data, risk assessment and RoHS documentation. Keep it for 10 years.
- Marking and instructions
- CE marking, crossed-out wheeled bin, model, ratings, manufacturer name and contact address, and use, cleaning and battery instructions in the local language, including information on battery removal.
- Economic operator in the EU
- An importer, authorised representative or responsible person established in the EU (Article 4 of Regulation (EU) 2019/1020).
- Producer registration
- WEEE and battery producer registration in every EU country where you sell.
No EU presence yet? We can act as your EU authorised representative or responsible person.
Frequently asked questions
Does the Low Voltage Directive apply to an electric toothbrush?
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Yes, when it is supplied with a mains charging base or adapter. The household appliance standards EN 60335-1 and EN 60335-2-52 are the harmonised references.
Must the toothbrush battery be user-replaceable from 2027?
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Article 11 of the Batteries Regulation requires user-replaceable batteries from 18 February 2027, but washable appliances used in wet environments may be designed for replacement by independent professionals where this is needed for safety.
Is an electric toothbrush a medical device?
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Not normally. Oral hygiene appliances for everyday cleaning are household appliances; medical claims would change that.
What does MyCECheck check on a toothbrush declaration?
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Whether the LVD, EMC (or RED) and RoHS are cited with the right EN 60335 parts and versions, whether handle and charger are identified, and the battery and economic-operator obligations. Written report within 48 hours.
Already have a declaration for your electric toothbrush?
A certification expert checks it against everything on this page and tells you exactly what to fix. Written report in 48 hours, €99 per product (excl. VAT).