Question écrite de
M. Tiemo WÖLKEN
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Commission européenne
Subject: Dangers of button cell batteries for children
Button cell batteries, in particular those of up to 20mm in size, can pose a significant health risk to children and adolescents. If swallowed, they can remain stuck in the oesophagus, where they cause severe chemical burns that can be fatal.
1. What measures is the Commission planning to prevent this risk, and does the Commission intend to enact a regulation under Article 11(4) of Regulation 2023/1542 on batteries and waste batteries or to make use of the EU's harmonised product legislation to make battery compartments safer?
2. Does the Commission intend, if necessary together with market watchdogs, to ascertain the safety of button cell packaging and to look into ways of improving packaging safety?
3. Does the Commission intend to promote the development of safe alternatives and provide consumers with proper information about risks?
Submitted: 19.12.2024
Answer given by Ms Roswall on behalf of the European Commission
(11 March 2025)
The empowerment conferred to the Commission in the Batteries Regulation (1) is meant to make more flexible the generic provision (2) requiring that portable batteries incorporated into products be removable and replaceable by the end-user.
Instead, it sets a number of situations where those batteries should be made removable and replaceable by independent professionals2, as it is already the case with products listed in Article 11(2).
The Commission will launch (3) a call for applications for further derogations to be added to those already in Article 11(2) notably to ensure the safety of the user and the appliance. If justified, additional products will be added in Article 11(2) via a delegated act.
It is also important to note that according to the Toy Safety Directive (4) and harmonised standard EN 62115 (5), small batteries in electric toys and parts of electric toys containing small batteries shall not be removable/accessible without the aid of a tool.
The safety of button batteries (6) is not addressed in any sectorial EU legislation, except for button batteries used in toys, and therefore falls under the General Product Safety Regulation (GPSR) (7). The GPSR is reinforcing product safety obligations for economic operators.
There are no standards cited in the Official Journal of the EU covering the safety of button batteries on the risk of ingestion by children, except for toys.
Businesses and authorities therefore often rely on standard EN IEC 60086-4:2019 (8), requiring that lithium button cells with a diameter greater than/equal to 16mm to be packaged in child-resistant packaging.
Also, the EU Safety Gate Portal provides information on risks posed by button batteries (9).
1 ∙ ⸱ Article 11(4) of Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and waste batteries, amending
Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC, OJ L 191, 28.7.2023, p. 1-117. 2 ∙ ⸱ In paragraph 1 of the same Article. 3 ∙ ⸱
Following the adoption of the Guidelines Commission guidelines to facilitate the harmonised application of provisions on the removability and replaceability of portable batteries and LMT batteries in Regulation (EU) 2023/1542 — https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C_202500214 4 ∙ ⸱ Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys, OJ L 170, 30.6.2009, p. 1-37. 5 ∙ ⸱ Electric Toys — Safety — supporting the safety requirements of the directive. 6 ∙ ⸱ Especially the risk of ingestion by children. 7 ∙ ⸱
Applicable since December 2024, Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC, OJ L 135, 23.5.2023, p. 1-51. 8 ∙ ⸱ This standard is not cited in the Official Journal of the European Union (OJEU) and therefore it does not grant presumption of safety under the GPSR but can serve as element to prove safety of button batteries. 9 ∙ ⸱
https://ec.europa.eu/safety-gate/#/screen/pages/buttonBattery