2026 New Regulation Alert: How Maternal and Infant Small Appliances Meet Certification Requirements in the US, EU, GCC, Japan, and Australia

For manufacturers and importers of maternal and infant small appliances, 2026 is undoubtedly a critical year for compliance. The US Consumer Product Safety Commission (CPSC), EU CE certification system, Gulf Cooperation Council (GCC) G-Mark certification, Japan PSE certification, and Australia SAA (RCM) certification have successively been updated, significantly raising the safety and quality access thresholds. These new regulations are not merely procedural adjustments; they directly determine whether brands can successfully enter core overseas markets and, more importantly, affect consumers' trust in the brands. According to data from the China Chamber of Commerce for Import and Export of Machinery and Electronic Products, in the fourth quarter of 2025, the export volume of maternal and infant small appliances failing to meet new international certifications dropped by 42% year-on-year (Source: "2025-2030 China Maternal and Infant Small Appliances Industry Development Analysis Report"） With the full implementation of various new regulations in 2026, this gap will continue to widen. Below, we analyze the key points of new regional regulations and practical adaptation plans focusing on two core products: baby bottle sterilizers and warmers.

US CPSC: Mandatory Electronic Filing and Certificate System Innovation

The revised 16 CFR Part 1110 standard by the US Consumer Product Safety Commission (CPSC) will take effect on July 8, 2026, covering all categories of maternal and infant small appliances such as food processors, bottle warmers, and breast pumps. Compared with the 2018 version, it has added two core mandatory requirements with significantly enhanced regulatory granularity. First, electronic filing (eFiling) fully replaces paper filing. The old regulation only encouraged digital filing, while the new regulation clearly requires all imported and domestically produced products to submit compliance data through the CPSC's dedicated platform, including 12 core items such as unique traceability codes, batch-wise material test reports, production process flowcharts, and laboratory qualification certificates. Data must be synchronized in real time and retained for at least 5 years. Products entering through US foreign trade zones have a grace period until January 8, 2027, after which they will be directly detained. Second, certificate content is mandatorily upgraded. The old version only required marking product models and certification standards, while the new regulation requires supplementing risk assessment reports, component supplier information, and sampling test data of the past 3 months, all of which must be signed and confirmed by a CPSC-recognized third-party laboratory.

The core of electronic filing lies in full-process traceability, which is particularly strict for products in direct contact with infants such as bottle sterilizers and warmers. According to the CPSC compliance guidelines issued by the Guangdong Sub-Administration of General Administration of Customs (Source: Announcement of Guangdong Sub-Administration of General Administration of Customs) export enterprises must connect their production management systems to the CPSC platform as required to achieve automatic synchronization of compliance data. In practice, enterprises must generate a unique traceability code for each batch of bottle sterilizers, linking full-chain material test reports and UVC lamp sterilization performance test data, with all information completely archived in the electronic filing certificate. This is not only a mandatory requirement of the new regulation but also one of the core indicators for obtaining the CHCT certification from China Household Electrical Appliances Research Institute (CHEARI) Testing & Certification Co., Ltd. — CHEARI, affiliated with the China Household Electrical Appliances Research Institute, is a national recognized third-party authoritative testing and certification institution, focusing on safety testing, standard formulation, and certification services for household appliances and maternal-infant products. Its CHCT maternal-infant appliance certification is an important reference for domestic export enterprises to align with international standards (Source: CHEARI Official Website), which can effectively avoid manual filing errors.

The cost of non-compliance is sufficient for enterprises to lose access to the US market. In a recall case announced by the CPSC in early January 2026, a brand's bottle warmer was recalled due to excessive temperature control deviation, resulting in a loss of 2.3 million US dollars for a single batch, including sales volume, rectification costs, and fines . Compared with the 2018 old regulation, the CPSC has added multiple rigid requirements for the special control of bottle sterilizers and warmers: In terms of electrical safety, the old regulation only tested leakage protection, while the new regulation clearly requires bottle warmers to be equipped with dual dry-burn protection devices (temperature control sensors installed on the heating plate and the kettle body respectively), with a deviation between the actual temperature and the set value ≤ ±5℃ in constant temperature mode (referring to the T/CAS501.3—2021 group standard) to eliminate scald risks; Bottle sterilizers (especially UV models) need to supplement UVC wavelength testing to ensure the sterilization wavelength is in the core range of 253.7nm, and provide a 1000-hour continuous operation stability report. In terms of small component control, the old regulation only restricted the size of swallowable components, while the new regulation requires buttons of bottle warmers, door latches of sterilizers, and other components to pass a 50N pull test (no detachment), and prohibits the use of magnetic components in non-functional areas to avoid accidental ingestion and intestinal injury by children. In terms of traceability, there was no mandatory requirement in the old regulation, while the new regulation requires "one-code penetration" — consumers can scan the code to query the full-process information such as the temperature calibration record of the bottle warmer and the batch information of the UVC lamp of the sterilizer, which is simultaneously connected to the US national product quality and safety traceability platform.

EU CE Certification: Upgrade of EN 12586:2025 Standard, Strengthening Chemical and Mechanical Safety Requirements

The new EN 12586:2025 standard issued by the European Committee for Standardization (CEN) will replace the 2007+A1:2011 version and be officially enforced across the EU starting from April 2026. This update completely revolutionizes the safety requirements for maternal and infant small appliances, especially for products containing plastic or rubber components, and clearly divides the testing process into two sectors: mechanical safety and chemical safety.

Compared with the 2007+A1:2011 old version, the EN 12586:2025 standard has more targeted requirements for bottle sterilizers and warmers, and achieves full-category coverage for the first time (Source: CEN Official Announcement). In terms of chemical safety, the old regulation only controlled 8 heavy metals, while the new regulation adds 11 controlled substances. Food-contact kettles of bottle warmers, inner liners and gaskets of sterilizers need to focus on testing phthalates (DBP, DEHP), bisphenol A (BPA), etc. Among them, silicone rubber gaskets need additional migration substance testing; the upper limit of formaldehyde migration is reduced from 1.5mg/L to 0.75mg/L, and material supply chain traceability certificates must be provided, such as the material origin and test report of the stainless steel inner liner of the sterilizer (Source: Zhejiang Council for the Promotion of International Trade 2026 Foreign Trade New Regulations). The "Supplementary Guide to Chemical Substance Control for Maternal and Infant Appliances" released by the German Association of Electrical Engineers (VDE) in 2025 further clarifies that the total phthalate content of plastic components of bottle warmers must be ≤ 0.1mg/kg, and this data has been cited by the EU EN standard as a reference basis (Source: VDE Official Website). In terms of mechanical safety, there was no restriction on magnetic components in the old regulation, while the new regulation requires the magnetic force of a single magnet in the magnetic suction door of the sterilizer to be ≤ 0.5T, and combined magnets must pass a separation test; both bottle warmers and sterilizers are prohibited from built-in button batteries, the power interface must be "tool-removable", and the impact resistance test strength of the shell is increased by 30% (to simulate no damage from daily collisions). In terms of testing procedures, the old regulation allowed batch testing of similar products, while the new regulation requires separate testing for different capacity models of bottle warmers and different sterilization mode models of sterilizers, and adds a 1000-time daily use cycle test (such as repeated heating of bottle warmers and start-stop sterilization of sterilizers). At the same time, sterilizers need to supplement antibacterial effect testing, with a killing rate of ≥ 99.9% for Escherichia coli and Staphylococcus aureus.

In response to the EU's new EN 12586:2025 standard, enterprises need to optimize their supply chains in combination with the maternal-infant appliance evaluation requirements issued by CHEARI. According to the public technical guidelines of CHEARI's Health Appliance Testing Center, the gaskets of sterilizers should be made of glue-free food-grade silicone to control migration substance risks from the source; the temperature control system of bottle warmers must pass 1000-cycle use verification, and the temperature control deviation must be lower than the standard limit to meet both the EU new regulation and CHCT certification requirements. Meanwhile, enterprises need to cooperate with authoritative laboratories such as TÜV Rheinland and Intertek to optimize the fixing structure of UVC lamps, conduct magnetic separation tests and antibacterial tests in accordance with the WS/T 650—2019 standard, ensuring that the killing rate of Escherichia coli and Staphylococcus aureus meets the standards. According to the disclosure at CHEARI's 2024 Annual Maternal and Infant Appliance Technology Forum, the core pain points for domestic enterprises in the initial adaptation to the new EN standard are mainly the failure of antibacterial testing and insufficient temperature control accuracy, which require targeted optimization to improve compliance pass rates.

GCC G-Mark Certification: Localization Adaptation and High-Temperature Environment Optimization

For the GCC market, the new version of G-Mark certification (revised version of GCC Technical Regulation BD-142004-01) implemented in 2026 has added multiple localized mandatory requirements compared with the old regulation, and strengthened full-process control. At the basic testing level, the old regulation only covered electrical safety and material environmental protection, while the new regulation adds three mandatory items: high-temperature adaptation, sand and dust protection, and energy efficiency labeling. Among them, electrical safety must meet normal operation under ±15% voltage fluctuation to adapt to the power grid characteristics of the GCC region. In terms of high-temperature environment adaptation, there was no clear testing standard in the old regulation, while the new regulation requires portable maternal and infant small appliances to pass a 72-hour continuous operation test at 50℃ (shell deformation ≤ 2%), and batteries must have no leakage risk at 60℃; it also adds a 45℃ high-temperature storage test to simulate the use safety in unair-conditioned indoor environments in summer. In terms of traceability and labeling, the old regulation only required marking the G-Mark, while the new regulation requires affixing the GCC Conformity Tracking Symbol (GCTS) with a QR code. Scanning the code should display test reports, production dates, local after-sales service point information, etc., and Arabic manuals must be provided separately, with bilingual stickers not allowed as a substitute. In addition, GCC countries have added differentiated requirements, such as Saudi Arabia requiring additional salt spray testing for products sold in coastal areas, and the UAE requiring energy efficiency rating certificates (mandatory affixing starting from 2026).

The extreme high-temperature environment in the GCC region places extremely high requirements on the stability of bottle warmers and sterilizers, which need to carry out localized adaptation in strict accordance with the technical regulations of the Gulf Standardization Organization (GSO) (Source: GSO Official Technical Document）; Supplementary Basis: Intertek GCC Compliance Guide). In practice, the kettle body of the bottle warmer should be made of high-temperature resistant PP material, pass the 72-hour continuous operation test at 50℃, and control the shell deformation within the new regulation limit. Meanwhile, optimize the battery protection structure to ensure no leakage risk at 60℃; Bottle sterilizers need to be equipped with high-density sand and dust protection filters to prevent sand and dust from affecting the operation of core components, and for coastal areas in Saudi Arabia, additional salt spray testing must be completed. Manuals must be printed in Arabic separately, specifying high-temperature use time limits and sand and dust cleaning processes, and bilingual stickers are prohibited — this is also a mandatory requirement for obtaining G-Mark certification. In addition, the updated UL 1642 standard by Underwriters Laboratories (UL) in 2026 puts forward supplementary requirements for the high-temperature stability testing of built-in lithium batteries in maternal and infant appliances, clarifying that the battery cycle life must be ≥ 500 times at 60℃. This standard has been adopted by the GCC countries as a reference for battery component compliance (Source: UL Official Website ).

All products passing G-Mark certification must be marked with the GCC Conformity Tracking Symbol (GCTS), a G-Mark with a QR code that links to test reports and manufacturer information. Importers should note that there may be differences in special requirements among GCC countries — for example, Saudi Arabia requires additional special testing for electrical products used in coastal humid areas.

Japan PSE Certification: Mandatory Japanese Authorized Representative System and Dual-Track Certification Control

Japan implements dual mandatory requirements of PSE certification (Electrical Appliance and Material Safety Law Certification) + METI filing for maternal and infant small appliances. Starting from December 25, 2025, a mandatory Japanese Authorized Representative system has been added. Non-compliant products will be prohibited from being sold on Japanese e-commerce platforms, and the control of bottle sterilizers and warmers covers the entire chain of electrical safety, labeling specifications, and traceability management.

PSE certification implements a dual-track control system: Bottle sterilizers and warmers, which involve heating functions, are classified as low-risk electrical products and require circular PSE certification, which can be self-declared by enterprises in accordance with corresponding standards. However, if the product has wireless functions (such as Bluetooth control), additional TELEC certification (Technical Conformity Mark) is required to comply with the frequency and power limits of Japan's Radio Law. In terms of core technical requirements, electrical safety must comply with the JIS C 60335-2-14 standard. Bottle warmers need to be equipped with reliable dry-burn protection devices, with a power-off response time ≤ 15 seconds and a shell temperature rise ≤ 60℃; UV bottle sterilizers must comply with photobiological safety standards, with an irradiance of 200-280nm wavelength ≤ 0.003W/m² to avoid UV leakage risks. In terms of chemical safety, food-contact components must comply with the requirements of Japan's Ministry of Health, Labour and Welfare Notification No. 370, with BPA migration ≤ 0.04mg/L, and heavy metal (lead, cadmium) migration ≤ 0.05mg/kg and 0.01mg/kg respectively.

The core point of the 2025 new regulation is the implementation of the Japanese Authorized Representative system: All cross-border enterprises selling products with the PSE mark must designate a legal person or individual in Japan as the authorized representative, responsible for submitting METI filings, reporting product safety accidents, and handling consumer complaints. In terms of labeling and traceability, products must be marked with the circular PSE mark and certification number, and the nameplate information must be completely consistent with the METI filing and sales channel information; it is recommended to simultaneously access Japan's product safety traceability system, allowing consumers to query product batches, test reports, and the contact information of the Japanese Authorized Representative. In terms of testing and filing procedures, PSE certification testing must be completed first, and then the Japanese Authorized Representative submits filing materials to the Ministry of Economy, Trade and Industry (METI). Only after the filing is approved can customs clearance and sales be carried out, and the consistency of certificates, reports, and nameplate information must be ensured throughout the process.

Australia SAA Certification (RCM System): High-Risk Classification Control and Multi-Standard Integration

Maternal and infant small appliances in Australia need to obtain SAA certification and be included in the RCM (Regulatory Compliance Mark) compliance system. Bottle sterilizers and warmers are classified as Level 3 high-risk electrical appliances, mandating safety certification, EMC testing, food-contact material testing, and database registration. Without compliance certificates, customs clearance and shelf sales cannot be completed.

Core certification standards and technical requirements integrate multi-dimensional control: Safety standards comply with AS/NZS 60335.2.15:2020. Bottle warmers need to be equipped with dual redundant thermostats, with a power-off response temperature ≤ 150℃ after thermostat failure and a handle temperature rise ≤ 50℃; Steam sterilization bottle warmers must have a waterproof rating ≥ IPX4, a power-off response time ≤ 0.5 seconds when the lid is opened, and a ground continuity ≤ 0.1Ω. EMC testing is based on AS/NZS CISPR 14.1:2020, with conducted disturbance (150kHz-30MHz) limit ≤ 60dBμV, radiated disturbance (30MHz-1GHz) limit ≤ 30dBμV/m, and voltage flicker testing must also be passed. Food-contact safety complies with AS/NZS 4029:2018. Lead migration of sterilization trays, kettles, and other components ≤ 0.05mg/kg, cadmium migration ≤ 0.01mg/kg. The use of food-grade PP/Tritan materials can exempt some heavy metal tests. In terms of sterilization performance, sterilizers must comply with the AS/NZS 4187:2014 standard, with a killing rate of ≥ 99.99% for Escherichia coli and Staphylococcus aureus. UV models additionally need to meet the IEC 62471 photobiological safety requirements.

Compliance procedures must strictly follow Australian local rules: Applications must be submitted to recognized laboratories such as SAI Global, providing circuit diagrams, English manuals, key component lists, and samples, while completing three tests: safety, EMC, and food-contact. After passing the tests, obtain the SAA certificate and EMC report, and the Australian importer completes the registration in the EESS Electrical Safety Database and ACMA Database. Only after registration is approved can the RCM mark be affixed (size ≥ 3mm). It should be noted that RCM registration must be operated by the Australian importer; manufacturers cannot handle it independently. Existing CB reports (including Australian deviation tests) can shorten the SAA review time to 1 week. Sterilizers with drying functions need additional verification of hot air circulation uniformity, with a cavity temperature difference ≤ 15℃.

Five Practical Compliance Strategies for 2026

With the full tightening of new regulations in the five core markets, passive rectification will lead to missed market opportunities. Combining the CHEARI CHCT certification process, customs export compliance guidelines of various countries, and industry best practices, enterprises need to build a full-chain response plan from three aspects: R&D, supply chain, and management system to ensure compliance implementation:

1.Embed compliance design in the early R&D stage, focusing on core product pain points: Establish a cross-departmental team of "compliance + R&D + testing", align with the five major standards of CPSC, EN 12586:2025, GSO, PSE, SAA, and CHEARI CHCT certification requirements, and formulate a special compliance plan. For bottle warmers, prioritize high-precision temperature sensors, conduct 1000-cycle constant temperature tests in advance, and design a dual dry-burn protection structure (independent temperature control chip + mechanical temperature control switch) to adapt to Australia's AS/NZS 60335.2.15 and Japan's JIS standards; For bottle sterilizers, select UVC lamps with a core sterilization wavelength of 253.7nm, install magnetic separation protection devices, and reserve sand and dust protection interfaces and IPX4 waterproof structures to meet GCC sand and dust, Australian waterproof, and Japanese photobiological safety requirements. Simultaneously establish a "new regulation difference comparison table" to clarify the differences in formaldehyde limits, sterilization rates, and other indicators across regions, avoiding additional costs from targeted modifications.

2.Strengthen hierarchical supply chain control, building a defense line for core components: Establish a hierarchical supplier access system for key components such as bottle warmer kettles and sterilizer inner liners. Assessment indicators include material testing capabilities, traceability qualifications, and new regulation adaptation experience. Unqualified suppliers are directly included in the blacklist. Sign special agreements with silicone and stainless steel suppliers, specifying that the BPA content of bottle warmer kettles ≤ 0.05mg/kg and that sterilizer gaskets contain no phthalates, while meeting Japan's Ministry of Health, Labour and Welfare Notification No. 370 and Australia's AS/NZS 4029 standard. Each batch of materials is accompanied by a third-party test report (focusing on newly added controlled substances). Build a material traceability system to achieve one-to-one correspondence of "batch - supplier - test results" for core components such as sterilizer UVC lamps and bottle warmer temperature sensors, meeting multi-region traceability requirements.

3.Build a digital compliance system to adapt to filing and traceability: Invest in a compliance management system, connect to the CPSC electronic filing platform, GCC GCTS QR code system, and Japan's product safety traceability system to realize automatic collection, synchronization, and retention of compliance data, including production batches, test reports, import customs declarations, and other information, avoiding manual filing errors. Simultaneously access the National Key Industrial Product Quality and Safety Traceability Platform (Source: General Administration of Market Supervision Official Website ), adopt the Internet of Things identification code (Ecode) as the unique product traceability code to ensure data is traceable and tamper-proof. Retention periods meet regional requirements (CPSC: 5 years, GCC/Australia: 3 years, Japan: until 2 years after product withdrawal). In addition, conduct regular system debugging, simulate filing processes and data connections, and identify technical issues in advance.

4.Cooperate with authoritative laboratories to optimize special testing processes: Select multi-region recognized laboratories such as TÜV Rheinland, Intertek, and SAI Global to conduct pre-testing for newly added test items of the two products — focus on high-temperature cycle and temperature control accuracy calibration tests for bottle warmers to adapt to national temperature standards; supplement UVC wavelength stability, antibacterial effect, salt spray, and waterproof tests for bottle sterilizers to cover special requirements of all regions. Adopt a "synchronous multi-standard testing" model, where the same batch of products completes CPSC electronic filing data verification, EU EN 12586:2025 full-item testing, GCC high-temperature sand and dust testing, Japan PSE testing, and Australia SAA/RCM full-item testing simultaneously, reducing repeated testing costs, shortening the certification cycle, and ensuring a one-time pass rate.

5.Improve internal training and emergency mechanisms, focusing on practical implementation: Conduct special training for all employees. Production positions focus on explaining bottle warmer temperature calibration processes, sterilizer UVC lamp installation specifications, and waterproof structure assembly requirements; Quality inspection positions strengthen testing capabilities for newly added controlled substances, pull tests, sterilization rates, and heavy metal migration; Foreign trade positions familiarize themselves with CPSC electronic filing, GCC GCTS QR code marking, Japanese Authorized Representative connection, and Australian importer registration processes. Establish a compliance emergency team and formulate response plans for common risks of the two products: For example, activate a backup sensor replacement plan when the bottle warmer's temperature control deviation exceeds the limit; quickly replace the inner liner material when the sterilizer's antibacterial test fails; simultaneously prepare emergency contact mechanisms with Japanese Authorized Representatives and Australian importers to minimize recall risks and losses (Source: China Economic Net Bottle Warmer Evaluation Report）

Future Trends of Maternal and Infant Appliance Compliance

The 2026 regulation updates reflect the global trend of stricter safety standards for maternal and infant products, driven by consumers' demand for transparency and governments' emphasis on risk prevention and control. For exporters, compliance is no longer a cost center — but a competitive advantage. Data shows that in 2025, export orders of brands holding the latest international certifications increased by 71% year-on-year, far exceeding non-compliant brands (Source: Kunming Information Port Maternal and Infant Industry Report). The 2025 Annual Report of the Japan Electrical Safety & Environment Technology Laboratories (JET) reveals that the customs detention rate of global maternal and infant small appliances due to non-compliance increased by 12% year-on-year, among which bottle sterilizers with excessive UV leakage and bottle warmers with insufficient temperature control accuracy accounted for over 60% (Source: JET Official Website ), further confirming the importance of compliance adaptation.

"When parents buy bottle sterilizers and warmers, their core demand is safety and peace of mind. The 2026 global new regulations essentially force brands to improve product capabilities and compliance levels," said Li Yi, Deputy Director of the Health Appliance Testing Center at China Household Electrical Appliances Research Institute (CHEARI) Testing & Certification Co., Ltd., at the 2024 Annual Maternal and Infant Appliance Technology Forum. Compliance upgrades must take quantitative technical parameters as hard indicators and convert regional new regulation requirements into product design standards. For example, the dual temperature control of bottle warmers and the antibacterial and sand-dust protection transformation of sterilizers are not only compliance bottom lines but also core competitiveness for obtaining CHCT certification and seizing the high-end market. With the full implementation of new regulations, enterprises that complete full-chain compliance adaptation in advance will be able to gain a firm foothold in the global maternal and infant appliance market.