March Regulatory Update

Battery

EU: European Commission Guidance on EU Batteries Regulation Removability Requirements published

2025-02-19

It is focused on the application of provisions on the removability and replaceability of portable batteries and LMT batteries included in Article 11 of the Regulation (EU) 2023/1542. There is an open process to propose further exemptions ("derogations") until April 30, 2025.

The European Commission (EC) published on January 10, 2025, a guidance on the European Union Batteries Regulation 2023/1542. It is focused on Article 11, and the challenging requirement that portable batteries be ‘readily removable and replaceable by the end user at any time during the lifetime of the product’.

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 is also 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, that is, 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. This requirement poses significant technical challenges and potential safety concerns for manufacturers, mainly because the Batteries Regulation specifies that the use of heat or solvents to remove and replace batteries will not be permissible.

Key aspects of the guidance:

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 additional requirement 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 non-original battery is being used, as long as the software features do not affect the device functionality or user experience.

Wet environment exemption

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

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 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 February 18, 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 initiated a process to consider whether there should be any further derogations to the removability and replaceability requirements. Submissions are due by April 30, 2025 (link provided below). The expectation is that the additional 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.

"This commentary is a summary of an article published by Cooley, one of the world’s leading law firms for innovative companies."

Electrical Safety

Brazil: INMETRO published Portaria 25/2025 on New Procedures for Granting Registration

2025-03-03

It entered into force on January 17, 2025. It changes criteria and procedures for product registration. It establishes the criteria for the initiation of the administrative process of suspension and cancellation of registration, as well as reinforces deadlines and other conditions of this process.

On January 17, 2025, INMETRO/CONMETRO published Portaria No. 57 to amend Portaria No. 258 on Procedures for Granting Registration and for Charging the Fee for Products Subject to Mandatory Conformity Assessment.

This Portaria modifies the criteria and procedures for registering products requiring mandatory conformity assessment. It updates Portaria No. 258/2020, establishing new rules for suspending and canceling registrations while reinforcing deadlines and compliance conditions.

The main changes and provisions are:

1. Suspension of Registration can occur if:

• The product poses risks to safety, health, or the environment.

• The product lacks clear and accurate labeling or information.

• It fails to meet regulatory requirements or loses its conformity certificate.

• There are irregularities in the registration process.

2. Cancellation of Registration will be applied when:

• The product has irreversible safety issues.

• The manufacturer continues production or sales during the suspension.

• Fraud or false documentation is detected.

• The product is banned from the national market.

3. Enforcement and Penalties:

• Inmetro may prohibit sales and require product recalls.

• Non-compliance may lead to sanctions under Law No. 9.933/1999.

• Affected companies can present a defense and appeal within 10 days.

• Public warnings will be issued if a product poses health or safety risks.

Chile: New Protocol published for Saws (Safety Certification)

ENEC Scheme - New Version for OD ECS 040-1 Summary of Testing

Peru: New Technical Standards on Electronic Equipment, EV Batteries and Others approved

Thainland: Several Industrial Standards released

2025-02-27

They entered into force through February, 2025.They cover Hand-held Tools, Electrical Accessories and OLED panels.

On 7 February 2025, the Ministry of Industry of Thailand released several Industrial Product Standards, such as:

• TIS 62841-4(5)-2567: Electric Motor-Operated Hand-Held Tools, Transportable Tools and Lawn and Garden Machinery – Safety – Part 4-5: Particular Requirements for Grass Shears;

complies with the requirements of IEC 62841-1:2014 on Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery - Safety - Part 1: General requirements.
applies to hand-held electric grass shears with a cutting width of up to 200 mm;
It does not apply to hedge trimmers, which are covered under IEC 62841-4-2;

• TIS 62841-4(6): Electric Motor-Operated Hand-Held Tools, Transportable Tools And Lawn And Garden Machinery - Safety – Part 4-6: Particular Requirements For Garden Blowers, Garden Vacuums And Garden Blower/Vacuums.

This standard specifies safety requirements for electric motor-operated hand-held and backpack :
- garden blowers;
- garden vacuums;
- garden blower/vacuums
• The standard does not apply to:
- Walk-behind garden blowers and vacuums;
- Robotic garden blowers and vacuums;
- Vacuum cleaners for indoor use, for water suction cleaning or animal care;
- Indoor blowers designed primarily for indoor use or animal care

• TIS 60799: Electrical Accessories - Cord Sets and Interconnection Cord Sets.

This industrial product standard defines requirements for:
- Cord sets and interconnection cord sets for household and similar general purpose equipment.
It does not apply to:
- Cord sets designed specifically for industrial applications (those conforming to IEC 60309).
- Cord extension sets.

• TIS 62922: Performance requirements for OLED panels and sheets used for general lighting purposes

Performance Characteristics: The document outlines performance characteristics, including:
- Input power requirements
- Initial and maintained photometric characteristics
- Reliability
- Information for designing control equipment
Testing and Marking: It sets conditions for general declarations, test environments, and marking of products.
Excluded Aspects: The current version of the standard does not cover lifespan (operating life and maintenance factors), with the intention to address this in future updates.

Energy Efficiency

Malaysia: Energy Efficiency and Conservation Act (EECA) 2024 - Guidelines on Energy-Using Product published

2025-03-04

The Guidelines for the implementation of EECA came into operation on January 1, 2025. For the new energy using products intended to be sold in Malaysia, manufacturers and importers shall obtain a Certificate of Efficiency (COE).

The Suruhanjaya Tenaga (ST, Energy Commission) published on December 30, 2024, the Guidelines on Energy-Using Product GP/ST/No.50/2024. They are to specify the detail requirement on:

(a) the energy-using product;
(b) the energy efficiency criteria, testing methodology;
(c) the minimum energy performance standards;
(d) the energy efficiency rating table and calculation method for each of energy products;
(e) the methodology of calculation of the energy efficiency rating; and
(f) the Energy Efficiency Labeling requirement and specification.

There is a new process of Energy Efficiency requirement in Malaysia according to the Energy Efficiency and Conservation Act (EECA) 2024, which came into effect on Jan 1, 2025. Under this Act, for the new energy using products intended to be sold in the Malaysian market, manufacturers and importers shall obtain a Certificate of Efficiency (COE).

The products below are regulated as Energy-Using Products under EECA:

• Television;
• Domestic Fan;
• Refrigerator;
• Lamp;
• Air-Conditioner;
• Washer;
• Rice Cooker;
• Microwave Oven;
• Freezer; and
• Electric Oven.

The scope of regulated products under EECA includes domestic, commercial, and industrial products, as specified in the attachment.

Starting from February 24, 2025, ST has developed temporary measures to cater for COE application. There is no separate application required for COE. Applicants may apply for a COE by applying for a Certificate of Approval (COA) through the ePermit system. Applicants shall follow the procedures detailed in the Guideline for the Approval of Electrical Equipment 2024 and submit the document as listed in the Guideline for the Approval of Electrical Equipment 2024 (From Page 43 onwards).

Montenegro: Energy Efficiency Labelling of Air Conditioners, Pravilnik No. 112/2025

Recognition of the energy efficiency accreditation in Brazil (INMETRO) for the regulations in Honduras renewed

USA: Implementation of Energy Efficiency Rules on household appliances postponed

Telecommunications

Brazil: ANATEL Act 2105/2025 on IoT technologies published

2025-02-26

It entered into force on February 14, 2025, and its application will be mandatory as of August 13, 2025. It updates the technical requirements for Mobile Phones and Terminal Access Stations (ETA).

It was published on February 14, 2025. Now it allows some IoT technologies as 5G NB-NTN, 5G RedCap , and 4G LTE Cat 1bis.

Brazil: ANATEL published and approved the Frequency Band Allocation and Distribution Plan

EU: Harmonised Standards for Radio Equipment under Directive 2014/53/EU amended

Indonesia: Amendment Published - Use of Radio Frequency Spectrum Based on Class Permits

Indonesia: Regulation on Foreign Test lab recognition published

2025-02-20

It was published on January 15, 2025. It updates the criteria and list of Recognized Foreign Testing Labs. Some DEKRA labs are new in the list (new addresses). Their test reports for the scope registered are accepted for telecommunications equipment certification until end of 2026.

The Minister of Communication and Digital Affairs of the Republic of Indonesia (KOMDIGI) published on January 15, 2025, Regulation Kempen no. 13 of 2025.

It includes the list of Recognized Foreign Testing Labs whose test reports are accepted for the telecommunications equipment certification within Indonesia, as well as the scope for each recognized lab and the general criteria to be eligible to be included in the list. This acceptance will end on December 31, 2026.

The details can be found on the regulation.

26	DEKRA Certification, Inc.	405, Glenn Drive Suite 12 Sterling, Virginia, United States	Non-HKT	RF, EMC, Electrical Safety
27	DEKRA Testing and Certification Co., Ltd (Guangzhou)	DEKRA House, No.3, Qiyuan Road, Science City, Hi-tech Industrial Development Zone, Huangpu District, Guangzhou, Guangdong Province, 10663, China	HKT & Non-HKT	RF, EMC, Electrical Safety
28	DEKRA Testing and Certification Co., Ltd (HsinChu 1)	1. No. 372, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County 310, Taiwan	Non-HKT	1. RF, EMC, Electrical Safety
28	DEKRA Testing and Certification Co., Ltd (HsinChu 1)	2. No. 372-2, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County 310, Taiwan	Non-HKT	2. RF, EMC
29	DEKRA Testing and Certification Co., Ltd (Linkou)	1. No. 5-22, Ruishukeng, Linkou Dist., New Taipei City 24451, Taiwan	Non-HKT	RF, EMC
		2. No, 26, Huaya 1st Rd., Guishan Dist., Taoyuan City		RF, EMC
		3. No. 6, Lane 75, Wenlin St., Linkou Dist., New Taipei City		RF, EMC
		4. No. 85, Wenlin St., Linkou Dist., New Taipei City		EMC
30	DEKRA Testing & Certification, S.A.U	1. Severo Ochoa, 2, 29590 Malaga, Spain	Non-HKT	RF, EMC, Electrical Safety
		2. Severo Ochoa, 6, 29590 Malaga, Spain		RF, EMC, Electrical Safety
		3. Severo Ochoa, 8, 29590 Malaga, Spain		RF, EMC, Electrical Safety
		4. Margarita Salas Boulevard, 26, 29590 Malaga, Spain		RF, EMC

Mexico: Agreement approving Technical Provision IFT 016-2024 on Specifications for Generic Low Power Radio Equipment (DRBP) published

2025-02-19

It will enter into force on November 3, 2025. It covers devices that make use of frequency bands of the radio spectrum in the range of 30 MHz to 3 GHz.

On February 7, 2025, the Mexican Federal Telecommunications Institute (IFT) published an agreement approving Technical Provision 016-2024 on Low Power Radiocommunication Devices (DRBP) that make use of frequency bands of the radio spectrum in the range of 30 MHz to 3 GHz.

It sets the specifications and testing requirements for all low-power radio communications devices, equipment or products that can make use of frequency bands of the radio spectrum within the range of 30 MHz to 3 GHz, in particular 30-40.02, 40.02-40.98, 40.98-50, 54-72, 72-73, 76-88, 74.6-74.8, 75.2-75.4, 74-76, 88-108, 143.6-144, 144-148, 148-149.9, 149.9-150.05, 156.7625-156.7875, 156.8125-156.8375, 161.9375-161.9625, 161.9875-162.0125, 174-216, 216-220, 220-225, 312-322, 399.9-400.15, 406.1-430, 430-440, 470-608, 614-698, 698-806, 806-902, 902-928, 928-960, 1427-1518, 1710-1780, 1780-1850, 1850-1920, 1880-1900, 1920-1930, 1930-2000, 2000-2025, 2110-2200, 2290-2300, 2300-2400, 2400-2483.5, 2483.5-2500 y 2500-2690 MHz.

Excluded from the scope are the radio spectrum frequency bands classified as protected spectrum and those identified for distress, security, search, or rescue communications whose application is not consistent with using these bands under the provisions of the National Frequency Allocation Table.

The DRPB are classified as:

• Generic: All DRBPs capable of transmitting in the frequency range of the field of application, except those that, due to their specific characteristics.
• Wireless microphones: DRBPs intended for transmitting sound, specifically, voice, excluding hearing assistance devices and microphones that use DECT technology. This category includes In-Ear monitoring systems, wireless systems for tourist guides and WMAS.
• Hearing assistance devices: Radio communication devices allow people with hearing disabilities to hear sounds and conversations better.
• Wireless alarms: DRBPs that send an alert signal to a system or person in another location when a condition is met or a specific situation occurs.

Section 7 indicates the technical specifications for each DRPB category; meanwhile, Section 8 sets the testing methods.

Labelling must comply with the Guidelines for approving products, equipment, and devices intended for telecommunications and broadcasting.

Non-compliance will be sanctioned as per the Federal Telecommunications and Broadcasting Law.

The Agreement enters into force on November 3, 2025.

Mexico: Agreement approving Technical Provision IFT-017-2023 for Radio Equipment using Digital Modulation Techniques published

2025-02-19

It will enter into force on November 7, 2025. It covers equipment operating in the bands 5150-5250 MHz, 5250-5350 MHz, 5470-5600 MHz, 5650-5725 MHz, 5725-5850 MHz, and 5925-6425 MHz.

On February 10, 2025, the Mexican Federal Telecommunications Institute (IFT) published an agreement approving Technical Provision IFT-017-2023 for radio equipment using digital modulation techniques and operating in the bands 5150-5250 MHz, 5250-5350 MHz, 5470-5600 MHz, 5650-5725 MHz, 5725-5850 MHz, and 5925-6425 MHz.

It sets the specifications, testing and conformity assessment procedure for radiocommunication systems products that use wireless access in local area radio networks and radiocommunication equipment that use the digital modulation technique and that operate in any or all of the following bands classified as free spectrum: 5150 MHz-5250 MHz, 5250 MHz-5350 MHz, 5470 MHz-5600 MHz, 5650 MHz-5725 MHz, 5725 MHz-5850 MHz and 5925 MHz-6425 MHz.

For the 5725-5850 MHz band, the Technical Provision also applies to all hybrid radiocommunication products that use digital and frequency hopping modulation. However, the requirements only apply to the digital modulation part with the frequency hopping modulation turned off, so the part corresponding to frequency hopping must be evaluated following Technical Provision IFT-008-2015.

Section 4 describes the technical specifications for the products in scope, Section 5 sets the testing methods, Section 6 provides the operation of the equipment, and Section 8 establishes the conformity assessment procedure.

Labelling must comply with the Guidelines for approving products, equipment, and devices for telecommunications and broadcasting.

Non-compliance will be sanctioned as per the Federal Telecommunications and Broadcasting Law.

The Agreement enters into force on November 7, 2025. Upon its entry into force, it will repeal the specifications and testing methods related to the 5725–5850 MHz frequency band for digital modulation equipment and the digital modulation part of hybrid equipment under the previous IFT-008-2015 regulation.

Saudi Arabia: Frequency Spectrum Regulations for Radio Services and Applications published

Other news

#2095 Product Certification Checklist - Version 17 published

2025-02-20

A new version for the checklist has been published and shall be used for all new projects.

You can download the WORD file from AM-System by clicking on below link.

Link

All changes in comparison to the previous version are highlighted in the tracking version – also available via the link.

The checklist is used for projects leading to CB, DEKRA Mark, KEMA-KEUR, HAR, ENEC, ENEC+, CCA/NTR, GCC, GAC – RoHS, EE LATAM, AOC, DTC, IECQ, Oman LV certification.

DEKRA visited the Saudi Standards, Metrology and Quality Organization (SASO) and the Saudi Electricity Company (SEC) to discuss new opportunities for cooperation

2025-03-04

DEKRA is already recognized by SASO as designated Certification Body and accredited as Saudi Quality Mark (SQM) Certification body. The DEKRA laboratory in Wenzhou (Mainland China) is included on the list of independent testing laboratories recognized by the SEC.

Recently, Cesar Valencia, Vice President of DEKRA Product Certification & Global Market Access Business Line, Yusuf Albaity, General Manager of DEKRA Saudi Arabia, and Chen Kaiyi, Deputy Technical Support Manager of DEKRA China Certification & Certificate Service Product Testing, visited the Saudi Standards, Metrology and Quality Organization (SASO) and Saudi Electricity Company (SEC) to deepen the partnership and explore new cooperation opportunities.

Saudi Standards, Metrology and Quality Organization (SASO)

SASO certification is an important part of DEKRA's global market access services. Since 2021, DEKRA China has been recognized by the Saudi Standards, Metrology and Quality Organization (SASO) as its designated certification body, and we have been committed to providing customers with low-voltage electrical equipment, such as household appliances, lighting products, electrical components and other product certification services, to help Chinese enterprises smoothly enter the Saudi market.

In addition, as a SASO-accredited Saudi Quality Mark (SQM) certification body, DEKRA can provide SQM certification services. SQM certification is used to ensure that products entering the Saudi market meet the quality and safety requirements. It was initially only mandatory for non-electrical products but, since 2020, it is also mandatory for some electrical products such as plugs, wall switches, drag strips, etc.

The DEKRA team made a special visit to SASO, and the two sides focused on discussing the latest standards of the "SASO Technical Specifications for Communication and Information Technology Equipment", and had in-depth exchanges on the details of cooperation on the Saudi Quality Mark (SQM) certification to ensure that the products meet the quality and safety requirements of the Saudi market.

Saudi Electricity Company (SEC)

As Saudi Arabia's power construction has entered a period of rapid development, the Saudi Electricity Company (SEC) has purchased a large number of power equipment from many domestic and foreign enterprises. In order to assist these companies' products to enter the Saudi market smoothly, DEKRA has started the laboratory qualification application process since July 2023, and successfully entered the list of independent testing laboratories recognized by the SEC in December 2024.

This approval means that the low-voltage switchgear and control equipment can be successfully entered into the Saudi market and used in SEC engineering projects after the completion of the tests in the DEKRA Wenzhou low-voltage laboratory.

During the visit to the SEC, DEKRA said that it looks forward to further strengthening communication and collaboration with the SEC, and carrying out in-depth cooperation in many fields such as power equipment testing, technical standard formulation, and market access. DEKRA emphasized that it will give full play to its professional advantages in the field of testing and certification, and work with the SEC to build a long-term, stable, mutually beneficial and win-win partnership to jointly promote the high-quality development of Saudi Arabia's power industry.

This visit further strengthens DEKRA's cooperation with SASO and SEC, and lays a solid foundation for cooperation in more fields in the future. DEKRA will continue to uphold the concept of "safety and sustainable development", with the world's leading testing and certification experience, to provide better services for the Saudi market, help Saudi Arabia achieve the "Vision 2030", and jointly explore new opportunities in the Saudi market.

Each country and region in the world has its own regulations and product approval processes, and this complexity is undoubtedly a challenge for exporters to enter new markets. DEKRA Global Market Access Services provides a global market access program to help your products reach markets in more than 200 countries and regions around the world.

IAF Mandatory document for the Use of Information and Communication Technology (ICT) for Conformity Assessment Purposes (IAF MD4:2025 issue 3) published