The Biweekly Pulse: 10th – 21st February 2025

This blog was originally posted on 26th February, 2025. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

Check out what’s hot in our regulatory world with The Pulse! Your biweekly source for global regulatory insights.

This week’s trending sources in C2P

1. EU: Comprehensive EU Toolbox for Safe and Sustainable E-commerce, Commission Communication, February 2025
2. UK: Recyclability Assessment Methodology for Packaging Waste, Guidance Document, Revised, February 2025
3. UK: Regulatory Position on Extended Producer Responsibility for Packaging (pEPR) – Producer Data Requirements, Guidance Document, February 2025

What is our Content Team talking about?

French Landmark Bill on PFAS Ban Adopted at Second Reading

by Dieudonné Ymedji

On 20 February 2025, the French Parliament took a bold and necessary step toward addressing the environmental and health risks posed by perfluoroalkyl and polyfluoroalkyl substances (PFAS) also known as “forever chemicals” because of their capacity to build up in the environment and people’s bodies. 

In line with the European Union’s Chemicals Strategy for Sustainability, which aims to phase out harmful chemicals and promote safer alternatives, the approved text:

• Gradually bans PFAS use in three categories of consumer goods, including cosmetics, clothing textiles (except protective clothing for security and civil protection professionals) and ski waxes;
• Contributes to improving information on the presence and risks of these substances and introduces measures to ensure the decontamination of sites;
• Provides for an interministerial action plan for financing the decontamination of water intended for human consumption managed by local authorities responsible for public drinking water and sanitation services;
• Introduces a tax on manufacturers whose activities result in PFAS discharge (i.e, €100 per 100 grams PFAS discharged)

Article 1 of the adopted text establishes a comprehensive ban on the manufacturing and marketing of various products that contain PFAs above a specified concentration level, which will be determined through a future regulatory decree. The ban will take effect for cosmetic products and clothing textiles starting in 2026. Subsequently, a broader restriction will be enforced in 2030, which will extend to all types of textiles, including those used in furnishings. However, there will be exemptions for certain industrial textiles and specific materials deemed “necessary for essential uses.” The criteria for which industrial textiles will qualify for this exemption will also be clarified in an upcoming decree, ensuring a careful balance between environmental safety and the practical needs of the industry.

The new measures will be promulgated by the French president and published in the national official journal in the coming days.

What are our Knowledge Partners talking about?

European Commission Publishes Guidance on EU Batteries Regulation Removability Requirements

by Cooley

New European Commission (EC) guidance on the European Union Batteries Regulation 2023/1542 has been published, which is relevant to anyone who places products containing batteries on the EU market. The new guidance sheds light on the challenging Article 11 requirement that portable batteries be ‘readily removable and replaceable by the end user at any time during the lifetime of the product’.

Background

The EU Batteries Regulation requires that products containing batteries be designed to ensure the batteries are removable and replaceable by the end user, unless an exemption applies. There are two very narrow exemptions for:

• Products designed to be operated in an environment that is regularly subject to splashing water, water streams or water immersion (known as the ‘wet environment exemption’).
• Certain limited categories of medical devices must be designed for removability.

These exemptions are “partial” because products that qualify for them must still be designed to allow for battery replacement by an independent professional. There also is a very narrow exemption for certain limited categories of products which require a continuous power supply for safety or data integrity reasons. This is a “full” exemption, meaning that products that qualify do not need to have batteries that can be removed and replaced by either end users or independent professionals.

In practice, the exemptions will only apply to a very small number of products – meaning for the overwhelming majority of products containing batteries placed on the EU market, the battery will need to be removeable and replaceable by the end user. This requirement poses significant technical challenges and potential safety concerns for manufacturers, particularly as the Batteries Regulation specifies that the use of heat or solvents to remove and replace batteries will not be permissible.

Key points

Given the challenging requirements of the Batteries Regulation, manufacturers have been eagerly awaiting guidance from the EC on the Article 11 removability and replaceability requirements. We have summarized our key takeaways from this guidance below.

No damage

The guidance specifies that, ‘The replaceability of portable … batteries means that the battery can be removed and replaced with another battery without damaging or destroying the battery or the device where it is incorporated’. This language goes beyond the requirements in the Batteries Regulation, which only specifies that removal should not damage the device. The additional requirement that removal should not damage the battery creates further design complexities, especially for products containing delicate batteries (such as pouch cells) or using one-time fixings.

Tools

The Batteries Regulation requires that removal be possible using ‘commonly available’ and not proprietary tools. To assist with interpreting this term, the guidance refers to standard EN 45554:2020e, which clarifies that ‘proprietary tools’ means tools not available for purchase by the general public, or which cannot be licensed under fair, reasonable and non-discriminatory terms.

Mobile phones and tablets

Mobile phones and tablets subject to disassembly and repair requirements under the Ecodesign Framework (Directive 2009/125/EC) should comply with those requirements, rather than the removability and replaceability requirements under the Batteries Regulation. However, these products must still comply with other requirements under the Batteries Regulation, such as the due diligence policy requirements, labelling obligations and conformity assessment procedures.

Independent professionals

‘Independent professionals’ are defined 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’.

‘Parts-pairing’

‘Parts-pairing’ – a practice whereby software is used to identify if appropriate batteries are fitted to a product by use of a unique identifier – will not be permitted. The guidance suggests that this is because parts-pairing can impede repairs. It also suggests that this is a complete ban, which will be disappointing for many manufacturers that had sought recognition in the guidance that the use of software should be permitted to prevent the use of unsafe or incompatible replacement batteries. Software features can be used to notify consumers that a nonoriginal battery is being used, as long as the software features do not affect the device functionality or user experience.  

Wet environment exemption

It is clear that the EC is intending the available exemptions to be interpreted narrowly, giving examples of shavers, hair clippers, epilators and electric toothbrushes as types of products that will fall within the wet environment partial exemption. The guidance notes that manufacturers relying on this exemption will need to ensure that product technical documentation includes ‘evidence’ that designing for removability by an end user would compromise the safety of the user or the product, and that there is no way to redesign the product without ‘severely affecting the health and safety of the end user, or the performance and functionality of the product’. There is no guidance given on what level of detail would be required. The Ingress Protection (IP) rating is specified as not being sufficient in itself to justify the wet environment exemption.

Medical device exemption

Despite extensive lobbying from industry stakeholders, many medical devices will be subject to the removability and replaceability requirements. The situation for medical devices is complex, and companies designing medical devices containing batteries should read the guidance carefully to determine whether their products may be able to benefit from an exemption. Full or partial exemptions may apply to implantable medical devices, and certain medical imaging, radiotherapy and in vitro diagnostic devices.

Continuity of power supply exemption

The EC has again taken a narrow approach to the types of products which could benefit from this exemption, giving examples of smoke or gas alarms, carbon monoxide alarms designed for at least 10 years of uninterrupted operation, and ‘batteries whose main function is to power a volatile memory itself or deliver backup functions in the internal clock of a device, such as CMOS (Complementary Metal-Oxide Semiconductor) batteries found in digital cameras, processors, sensors, and medical devices’. Hardware used by the digital payments industry also is mentioned as potentially exempt.

Next steps

The removability and replaceability requirements apply from 18 February 2027, so manufacturers need to start making design decisions now in order to ensure their products will comply with these new requirements.

The EC has also launched a process to consider whether there should be any further derogations to the removability and replaceability requirements. Submissions are due by 30 April 2025. Based on our involvement in the legislative process to date, we expect that any further derogations will be extremely limited in scope, and that evidential requirements will be very high. In practice, it is likely to be challenging for manufacturers to make the case for an exemption, especially if there are other similar products in the market that have been (re)designed for removability and replaceability of the battery. For this reason, we recommend that manufacturers fully consider potential routes to compliance, including the possibility of adopting new technical and design solutions.

What are our clients asking about?

“In Japan, is it mandatory to have material identification/recycling symbols on the battery packaging?”

Answered by Andrew O’Neill

In Japan, the labeling requirements for battery packaging are governed by the Act on the Promotion of Effective Utilization of Resources. This Act mandates that certain rechargeable batteries, specifically nickel-cadmium, nickel-metal hydride, small sealed lead-acid, and lithium-ion batteries, must display appropriate recycling symbols to facilitate proper collection and recycling. These provisions are detailed in Chapter VII, Articles 24 and 25 of the Act, which pertain to “Specified Labeled Products.” 

For non-rechargeable batteries, such as alkaline or zinc-carbon types, the Act does not impose specific labeling requirements. However, manufacturers and importers are encouraged to provide appropriate disposal information to promote environmental responsibility.

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