Global Market Access Regulatory Newsletter – Q2 2025

U.S. EPA Delays PFAS Reporting Requirements

On May 13, 2025, the U.S. Environmental Protection Agency (EPA) released an interim final rule extending the reporting requirements for per- and polyfluoroalkyl substances (PFAS) under Section 8(a)(7) of the Toxic Substances Control Act (TSCA) (40 CFR Part 705). 

Under the PFAS reporting rule, anyone who has produced, imported, or been involved in the manufacturing of PFAS or PFAS-containing products at any point since January 1, 2011, through the end of the last calendar year prior to November 13, 2023, is required by the EPA to submit electronic reports detailing their PFAS use, production quantities, disposal methods, exposure risks, and associated hazards. 

The PFAS reporting period was initially scheduled to begin on November 12, 2024, as per the rule published in October 2023, but was later delayed to July 11, 2025, due to budgetary constraints.   

The EPA is now further delaying the reporting start date from July 11, 2025, to April 13, 2026, with the following reporting due dates: 

• October 13, 2026, for most manufacturers 
• April 13, 2027, for small manufacturers only reporting as PFAS article importers 

Additional resources can be found at this link:

https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-8a7-reporting-and-recordkeeping

https://www.federalregister.gov/documents/2025/05/13/2025-08168/perfluoroalkyl-and-polyfluoroalkyl-substances-pfas-data-reporting-and-recordkeeping-under-the-toxic

Taiwan MOEA Amends BSMI Requirements

Following an increase in reports of explosion incidents, the Ministry of Economic Affairs (MOEA) amended its legal inspection requirements for household electrical appliances to include the Bureau of Standards, Metrology and Inspection’s (BSMI’s) requirement for seven regulated products with secondary cells or batteries on April 24, 2025.

I. The main changes for the regulation: 

1. Secondary lithium cells or batteries used in electric insect killers (including insect swatters) and six other appliances must comply with CNS 13564: 2013 and Sections 7.3.8.1 “vibration” and 7.3.8.2 “mechanical shock” of CNS 62133-2: 2018.  
2. For electric insect killers, the description also changed to add “including insect swatters” to clarify the scope of BSMI certification for this product. 
3. Regarding the certification mode, C.C.C. code and applicable standards for these seven household electrical appliances, there are no changes. 

II. Current product standards that remain unchanged (see the amendment for more details) include:

Safety standards:

III. Implementation requirements and timeline:

For certified products:

• The existing certificates can be used until their expiration date if the product is certified before June 30, 2026. During the validity period, it is possible to add a series of products according to the original inspection requirements. 
• From July 1, 2026, applicants must provide additional application documents to meet the requirement for secondary lithium batteries for the seven regulated products when applying for renewal.  

For new applicants: 

• For products already in the BSMI scope, new applications submitted before June 30, 2026, should comply with the old regulation. The validity period of the certificate is three years. However, as of July 1, 2026, additional documentation for secondary lithium batteries will be required when applying for the BSMI certificate. 
• For products newly added to the BSMI scope, applicants shall provide application documents based on the amendment of the regulation. The validity period of the certificate is three years if the certificate is obtained after the implementation of the amendment. However, if the certificate is issued on or prior to the implementation date, its validity will be from July 1, 2026, to June 30, 2029.  

From the announcement date of April 24, 2025, the technical requirements mentioned in notes 1, 2, 3 and 4 of the amendment regulation will be implemented. However, as of July 1, 2026, the relevant old applicable standards will no longer apply to BSMI application. 

This amendment went into effect on April 24, 2025.

https://gazette.nat.gov.tw/egFront/detail.do?metaid=156808&log=detailLog 

https://www.bsmi.gov.tw/wSite/public/Data/f1745829886011.pdf

Australia Security Standards for Smart Devices

On February 27, 2025, the Australian Department of Home Affairs published the “Cyber Security (Security Standards for Smart Devices) Rules 2025.”  

This document is applicable to all relevant connectable products that are intended by the manufacturer to be used for personal, domestic or household use or consumption and:

Are not any of the following products:

Will be acquired in Australia by a consumer

Relevant connectable products are defined by the Cyber Security Act 2024 as internet‑connectable products or network‑connectable products. 

The three main requirements outlined in Part 1 of Schedule 1 of the new rules are as follows: 

1. Requirements in relation to passwords – Passwords must be unique per product or defined by the user of the product. 
2. Requirements relating to reports of security issues – During security issues, manufacturers of relevant connectable products are required to publish accessible and clear information regarding the issue as a report.  
3. Requirements relating to defined support periods and security updates – The manufacturer of a relevant connectable product must publish the defined support period for security updates for the product.  

The new requirements will become mandatory on March 4, 2026. Starting on that date, manufacturers of relevant connectable products must provide a statement of compliance with the security standard. The statement of compliance must contain the information specified in Part 2 - Division 3 - Section 9(3) of legislation. 

The authority may request a product sample, its statement of compliance or both in writing for examination or audit. The retention period for the statement of compliance is five years.

Cyber Security (Security Standards for Smart Devices) Rules 2025 - Federal Register of Legislation 

Cyber Security Act 2024 - Federal Register of Legislation

EU, New Energy Efficiency Standards Harmonized

The European Commission published Implementing Decisions on harmonized standards for ecodesign and energy labelling of commercial refrigerators, household washing machines and washer-dryers. 

The standards were published in the Official Journal of the European Union as harmonized standards. 

The Implementing Decisions included: 

• EN 16838:2024 - Refrigerated display scooping cabinets and pozzetto for gelato - Classification, requirements, performance and energy consumption testing (this is the first publication and manufacturers can already start its application)
• EN 60456:2016/A12:2023 - Clothes washing machines for household use - Methods for measuring the performance (this is amendment is applicable immediately)

When used to demonstrate the conformity of the products, the standards are mentioned in the EU Declaration of Conformity.

Implementing decision - EU - 2025/533 - EN - EUR-Lex 

Implementing decision - 2025/72 - EN - EUR-Lex 

Ecodesign - European Commission