(fra kommisjonsforordningen)

(1) Article 11 of Regulation (EU) 2023/1542 sets out generic requirements for end-user removability and replaceability of portable batteries incorporated into products which are placed on the market but also includes a list of derogations for certain products for which portable batteries only need to be made removable and replaceable by independent professionals, instead of by end-users. 

(2) It is necessary to include certain wearable devices into the scope of derogation already given to wet appliances to provide legal certainty. Wearables are portable electronic devices that are worn on the body and often have sensors and connectivity to collect and transmit data. Their use has increased significantly since Regulation (EU) 2023/1542 was adopted. Examples of wearables include smartwatches, fitness trackers, smart glasses or other electronic devices integrated into clothing and other accessories. The guidelines in Commission’s Notice C/2025/214 provide guidance on what constitutes a wet appliance. 

(3) The miniaturization of wearable devices and the portable batteries powering them may result in situations where the battery is so tightly encapsulated in its receptacle that its removal may create a non-negligible risk of damage or piercing of the battery. Where the nature of the product hinders its redesign (anatomic or ergonomic considerations), it is justified that such small batteries be removable and replaceable only by independent professionals. 

(4) Regulation (EU) 2025/2509 of the European Parliament and of the Council establishes that, as of 1 August 2030, electric toys with batteries that constitutes small parts are to be designed in a way as to ensure that the battery cannot be accessed without the use of a tool, and that where the size or nature of the toy so requires, a rechargeable battery may instead be made inaccessible, and removable or replaceable only by independent professionals. Until such date, it is appropriate to ensure that a temporary derogation is provided in accordance with Article 11(4) of Regulation (EU) 2023/1542. 

(5) In the case of wireless thermometer probes specifically designed for food contact, it is considered that the end-user removability of portable batteries would present a considerable safety risk for end-users during normal operation in case the probe’s sealing would be damaged and leaked chemicals from the battery would contaminate food. 

(6) Products falling in the scope of Article 1 of Directive 2014/34/EU are specifically designed to operate in potentially explosive environments. End-user removability of any portable battery contained in such products could result in a violation of the safety requirements for the users provided for in that Directive. 

(7) On-body delivery systems incorporate small portable batteries to administer medication subcutaneously. End-user removability of such batteries could result in improper functioning of the device and in a false administration of medication, which could be a safety risk for the user. 

(8) Telematics devices intended for roof mounted installation in agricultural and construction machinery and designed to be exposed to harsh vibrations, dust and wet conditions during their normal use are usually maintained by certified personnel having access to the necessary training and tools. Therefore, end-user removability of portable batteries incorporated in such devices could result in safety risks for end users. 

(9) Regulation (EU) 2023/1542 should therefore be amended accordingly,