§3 REMOVABILITY AND REPLACEABILITY BY INDEPENDENT PROFESSIONALS

Concept of independent professionals Article 3(23) of Regulation (EU) 2023/1542 provides a definition of ‘independent operators’, but not of ‘independent professionals’ that Article 11 refers to. Some clarifications are therefore proposed to address the concept of ‘independent professionals’ in Article 11(2) and (5). These are drawn and adapted from specifications established in other EU law, namely Annex II of Regulation (EU) 2023/1670 (7). ‘Independent professionals’ are to be understood as independent operators who have the technical competence and qualification to repair the product where the battery is integrated into, and conduct their business on commercial basis and/or in commercial premises. If removability and replaceability interventions are carried out on individual cells within a battery pack of LMT batteries, the ‘independent professional’ is to be understood to have the technical competence to render the battery operating as intended again. If removability and replaceability actions are carried out on products subject to battery type-approval under Regulation (EU) No 168/2013 and Regulation (EU) 2018/858, independent professionals are to be understood as ‘independent operators’ as defined in Regulation (EU) No 168/2013 (8) and Regulation (EU) 2018/858 (9). Compliance with the above points could be demonstrated by a reference to an official registration system as professional repairer (when such system exists in the Member States concerned), or by registration with, or training/certification by, the manufacturer of the product where the battery is integrated in (when required by national legislation). In all cases, battery removal and replacement (both at pack or cell level) should be performed according to the safety information on the use, removal and replacement of batteries provided by the product manufacturer. Partial derogations from the main rule Article 11(2) establishes derogations from the removability and replaceability requirements set out in Article 11(1) for portable batteries incorporated in products to be removable and replaceable by end users. For certain products where it is necessary to ensure the safety of the product user, it is sufficient that portable batteries can be replaced and removed by independent professionals with commercially available tools. This includes products specifically designed to operate primarily in a wet environment and certain professional medical imaging and radiotherapy devices and in vitro diagnostic medical devices. These derogations are discussed in more detail below. Appliances specifically designed to operate in a wet environment Appliances specifically designed to operate primarily in an environment that is regularly subject to splashing water, water streams or water immersion, and that are intended to be washable or rinseable, may be designed in such a way as to make the battery removable and replaceable only by independent professionals. Recital (39) of Regulation (EU) 2023/1542 specifies that ‘this derogation should only apply when it is not possible, by way of redesign of the appliance, to ensure the safety of the end-user and the safe continued use of the appliance after the end-user has correctly followed the instructions to remove and replace the battery’. Therefore, the following indicators are therefore all relevant for interpreting and applying the criteria for the applicability of a derogation for an appliance operating in a wet environment: (i) ‘specifically’: the appliance is designed with the main purpose to operate in the environment described; (ii) ‘primarily’: the environment described is the primary environment of the appliance, as Recital 39 explicitly specifies, ‘for the majority of the active service of the appliance’. In other words, not just an environment in which the device may only coincidentally or accidentally operate; (iii) ‘washable or rinseable’: the appliance is intended to be washable or rinseable; (iv) ‘compromising safety’: there is evidence in the product documentation when placing the product on the market that battery replaceability and removability by end-users would compromise the safety of the user or the appliance; (v) ‘no way to redesign’: there is evidence in the product documentation when placing the product on the market that there is no way to redesign the appliance with the current state of the art technology, without severely affecting the health and safety of the end-user or the performance and functionality of the product. The Ingress Protection (IP) rating system defined in standard IEC 60529 (specifically, the second numeral related to water, as depicted in Figure 1) offers an indicative guide to identify the environment referred to in the above-mentioned criteria. Nevertheless, an IP rating grades resistance of an enclosure against the intrusion of dust or liquids; it is not limited only to appliances that operate in a certain primary environment for a given part of their active service, nor does it establish whether redesign is possible or not. As such, the IP rating alone is considered as sufficient to demonstrate the compliance with the above-mentioned criteria. Specifically, the case of ‘splashing water’ referenced in Article 11 of Regulation 2023/1542 is equivalent to an IPX4 rating (class number 4 described in Figure 1 below), the case of ‘water streams’ is equivalent to IPX5 and IPX6 (classes number 5 and number 6), and the case of ‘water immersion’ is equivalent to an IPX7 rating (class number 7). On points (ii) and (iii), a representative example of products primarily operating in such environment can be oral hygiene appliances (e.g., toothbrushes as in IEC 60335-2-52), and shavers, hair clippers and epilators (as in IEC 60335-2-8). At the same time, point (iv) indicates that there may still be appliances used in wet environment that incorporate batteries that are removable and replaceable by end-users, as long as this does not compromise safety. Examples of such appliances include toothbrushes and shavers powered by portable batteries of general use. 0 No protection 1 Protected against vertically falling water drops Vertically falling drops shall have no harmful effects 2 Protected against vertically falling water drops when enclosure titled up to 15 degrees Vertically falling drops shall have no harmful effects when the enclosure is titled at any angle up 15 degrees on either side of the vertical 3 Protected against spraying water Water sprayed at an angle up to 60 degrees on either side of the vertical shall have no harmful effects 4 Protected against splashing water Water splashed against the enclosure from any direction shall have no harmful effects 5 Protected against water jets Water projected in jets against the enclosure from any directions shall have no harmful effects 6 Protected against powerful water jets Water projected in powerful jets against the enclosure from any directions shall have no harmful effects 7 Protected against the effects of temporary immersion in water Ingress of water in quantities causing harmful effects shall not be possible when the enclosure is temporarily immersed in water under standardized conditions of pressure and time 8 Protected against the effects of continuous immersion in water Ingress of water in quantities causing harmful effects shall not be possible when the enclosure is continuously immersed in water under conditions which shall be agreed between manufacturer and user, but which are more severe than for numeral 7 9 Protected against high pressure and temperature water jets Water projected at high pressure and high temperature against the enclosure from any direction shall not have harmful effects Medical devices and in-vitro diagnostic medical devices Professional medical imaging and radiotherapy devices, which are medical devices as defined in Article 2 (1) of Regulation (EU) 2017/745 (10), and in-vitro diagnostic medical devices, as defined in Article 2 (2) of Regulation (EU) 2017/746 (11), may be designed in such a way as to make portable batteries removable and replaceable only by independent professionals. Additional derogations In addition to the above-mentioned derogations already included in Article 11(2), the Commission is empowered to adopt delegated acts by adding further products to be exempted from the removability and replaceability requirements laid down in Article 11(1). Such delegated acts are to be adopted only on account of market developments and technical and scientific progress, and provided there are scientifically grounded concerns over the safety of end-users removing or replacing the portable battery, or where there is a risk that the removal or the replacement of the battery by end-users would be in violation of any product safety requirements provided for by applicable EU law. In order to follow a structured approach in considering which candidate products to be included in a delegated act under the above-mentioned empowerment, the Commission will regularly publish calls for application. When the first call is published, applicants wishing to demonstrate that candidate products fulfil the conditions laid out in Article 11(4) will have the possibility to submit evidence, for a period of three months, to explain that the requirement on the removability and replaceability of portable batteries by the end-user poses risks to the safety of the end-user or risks the violation of any product safety requirements provided for in applicable EU law. Applicants will be required to submit an application form with the following information: — company name, address and contact details of the applicant — product category — technical documentation supporting the case for a derogation — other relevant information The Commission will assess the documentation on the candidate products for additional derogations and, if justified, will propose adopting a delegated act under Article 11(4) in due course. Given that this empowerment has been granted to the Commission on account of market development and technical and scientific progress, the Commission intends to periodically repeat the exercise explained above. This could lead to the adoption of further delegated acts with additional derogations.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07