On July 17, 2025, the U.S. Environmental Protection Agency (EPA) published a final rule in the Federal Register (90 FR 33283), issuing Significant New Use Rules (SNURs) under Toxic Substances Control Act (TSCA). These rules apply to several chemical substances previously submitted through premanufacture notices (PMNs) and also subject to TSCA Orders issued by EPA.
New Use Notification Requirement
SNURs mandate that any person intending to manufacture (including import) or process the listed chemical substances for a use identified as a “significant new use” must notify EPA at least 90 days in advance. This notification gives EPA the opportunity to evaluate potential health or environmental risks and impose restrictions or mitigation measures before the activity may proceed.
Effective and Promulgation Dates
Final rule is codified under 40 CFR Part 721 and becomes effective on September 15, 2025. For judicial review purposes.
Access to Rule Documents
Stakeholders can access the full rule and supporting documents through Docket EPA-HQ-OPPT-2024-0079 on Regulations.gov. This rule was previously notified to the World Trade Organization under the symbol G/TBT/N/USA/2171.
EPA encourages all stakeholders to review the final rule carefully to ensure full compliance with the SNUR notification requirements before undertaking any new use of the listed substances.
The U.S. Environmental Protection Agency (EPA) has issued Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were subjected to Premanufacture Notices (PMNs) or a Microbial Commercial Activity Notice (MCAN) and are also subjected to an EPA issued Order under TSCA.
Notification Requirement
Companies must notify EPA at least 90 days before starting manufacture (including import) or processing of these substances for any designated significant new use. Manufacture or processing for the new use cannot begin until:
Effective Dates
Rule will be take effect on September 29, 2025 and official announcement for judicial review will be made on August 12, 2025, at 1 p.m. EST.
Corrections to SNUR final rules
EPA has also made corrections to a final rule published on June 13, 2025 (FR Doc. 2025-10812), notified as G/TBT/N/USA/2125/Add.1 and final rule that appeared in the Federal Register of 23 June 2025 (FR Doc. 2025-11489) notified as G/TBT/N/USA/2164/Add.1.
Background
Dates of corrections for June 13th notification and June 23rd will be effective on August 12, 2025 and August 22, 2025 respectively.
You can find news for both dates by clicking on the given links below-
The U.S. Environmental Protection Agency (EPA) has released draft risk evaluations under the Toxic Substances Control Act (TSCA) for two widely used chemicals:
Butyl Benzyl Phthalate (BBP, CASRN 85-68-7)
Diisobutyl Phthalate (DIBP, CASRN 84-69-5)
This evaluations part of EPA’s ongoing work to protect human health, consumer safety, and the environment by ensuring potentially harmful chemicals are properly assessed and regulated. Stakeholders are encouraged to participate in the process by reviewing the draft evaluations and submitting comments before the deadline.
Key Findings
EPA’s preliminary analysis, based on the best available evidences, both BBP and DIBP pose unreasonable risks under certain conditions of use.
Publication Details
The notice was published in the Federal Register on 6 August 2025 (90 FR 37855, Doc. No. 2025-14882).
Dockets:
EPA-HQ-OPPT-2018-0501 (BBP)
EPA-HQ-OPPT-2018-0434 (DIBP)
Call for Public Comments
EPA is seeking feedback on the draft evaluations.
Comment Deadline: 6 October 2025, 4:00 PM EST
Where to Submit: USA WTO TBT Enquiry Point
Email: usatbtep@nist.gov
All comments received by the deadline will be shared with EPA and entered into the official docket.
On 1 August, the European
Commission launched a public consultation and Call for Evidence for the
upcoming Circular Economy Act, marking a major step in its impact assessment.
Set for adoption in 2026, the Act aims to boost the EU’s circular economy by creating
a Single Market for secondary raw materials, enhancing recycled material
supply, and increasing demand. It supports EU goals on competitiveness,
resilience, decarbonisation, and aligns with initiatives like the
Competitiveness Compass and Critical Raw Materials Act. Inspired by key reports
and declarations, the Act seeks to double the EU’s circularity rate by 2030.
Circular Economy Act
The circular economy is essential for strengthening
economic security, resilience, competitiveness, and decarbonisation, and it is
widely supported by the public as a key solution to environmental challenges.
However, progress has been limited, prompting renewed calls for action from
European industry, institutions, and recent policy reports. In response, the
European Commission has committed under its 2024–2029 Political Guidelines and
related initiatives to adopt the Circular Economy Act by 2026. This Act will
aim to strengthen the single market for waste and secondary raw materials,
boost the availability and demand for high-quality recycled materials at
competitive prices, and ensure effective market conditions for circular
products.
The Circular Economy Act
aims to strengthen the EU’s economic resilience and competitiveness while
driving sustainable production, circular economy practices, and
decarbonisation. It will support the smooth trade of circular products,
secondary raw materials, and waste across the EU. Additionally, the Act seeks
to boost the availability of high-quality recycled materials and encourage
greater demand for them within the Union.
Feedback period
Stakeholders are invited to take part in the online
consultation through the Have Your Say portal. The feedback window remains open
until 6 November 2025.
On 8 August 2025, the European
Commission adopted a regulation amending Annex XVII to REACH (Regulation (EC)
No 1907/2006) concerning carcinogens, germ cell mutagens and reproductive
toxicants (CMRs). This update reflects recent changes to the EU’s harmonised
classification and labelling of chemicals.
New Substances Added to Annex
XVII
The amendment incorporates
substances newly classified as CMR category 1B under Commission Delegated
Regulation (EU) 2024/1973. These substances are now listed in Appendices 2, 4,
and 6 of Annex XVII, meaning that they cannot be supplied to the general public
above the set concentration limits.
Among the substances included
are:
Derogation for Cumene in
Aviation Fuels
The Commission also clarified the
status of cumene (CAS 98-82-8). Although cumene had already been included in
Annex XVII in 2023, the restriction had created practical issues for aviation
fuels used by non-professional pilots. The new regulation introduces a
derogation permitting the use of cumene in kerosene and gasoline for aviation
that meet recognised international standards (e.g. Jet-A, Jet-A1, JP-x, DEF
STAN, ASTM, EN 228).
Entry into Force and
Application
The Regulation will enter into
force 20 days after publication in the Official Journal of the EU. The
restrictions related to the newly classified CMRs will apply from 1 September
2025, in line with the implementation of the updated CLP classifications. The
full text of the Regulation and the Annex can be downloaded here.
On 6 August 2025, the UK Health
and Safety Executive (HSE) issued a bulletin reminding companies exporting
chemicals listed under the GB Prior Informed Consent (PIC) Regulation that they
must submit export notifications at least 35 days before the first shipment in
2026. This requirement applies to exports to all countries, including Northern
Ireland.
Submission Requirements
Export notifications must be sent
to ukdna@hse.gov.uk using the GB
PIC export notification form. Each email should cover a single chemical or
mixture and include a Safety Data Sheet (SDS) in English and, where available,
in the official language of the importing country. Where no SDS is provided,
sections 4 and 5 of the notification form must be completed. The intended use
should be clearly stated to facilitate processing by the importing authority.
Mixtures with the same
classification, labelling, and use can be covered by one notification, provided
concentration changes do not affect labelling.
Special RIN Applications
For exports intended solely for
research or analysis, and for quantities up to 10 kg per year per importing
country, companies may apply for a Special Reference Identification Number
(Special RIN). This also applies when an importing country has waived the
notification requirement under the Rotterdam Convention. Requests should be
submitted to HSE using the Special RIN form or the bulk RIN option.
Further details and forms are
available in the bulletin here.
On August 1, 2025, the
Eurasian Economic Commission (EEC) Council approved two essential
“second-level” documents under the EAEU Technical Regulation “On Safety of
Chemical Products” (TR EAEU 041/2017):
These procedures were developed by the EEC in collaboration with all EAEU Member States — Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia—to standardize chemical product management across the EAEU.
Purpose of the Procedures
The EEC Council’s decision aims
to implement the provisions of TR EAEU 041/2017, ensuring:
Implementation through the EAEU Integrated Information System
The Unified Register will
be maintained using the EAEU integrated information system, enabling a
common and streamlined process across all EAEU member states. This digital
system ensures accurate and timely updates for companies and regulatory
authorities.
Importance for TR EAEU 041/2017
Approval of these procedures is a
key condition for enacting the EAEU Technical Regulation “On Safety of Chemical
Products” (TR EAEU 041/2017). Once fully implemented, the regulation will
strengthen chemical safety standards across the EAEU, providing legal certainty
and harmonized rules for all companies operating in the union.
The Ministry of Environment, Urbanization and Climate Change has announced via its official website that the long-awaited procedures and principles under the Registration, Evaluation, Authorization and Restriction of Chemicals (KKDİK) regulation have been finalized.
Draft versions of the communiqué had previously been shared with the public, and feedback from industry stakeholders was collected. It was known that the document had reached its final stage and was awaiting signature. The communiqué is expected to be published on the Official Gazette in the coming days.
The highlights of the circular can be listed as below:
Selection of Lead Registrants:
Responsibilities of Lead Companies:
Temporary Registration Dossier:
Pre-SIEF (Pre-registration) Deadlines:
New Working Groups:
The Government of India has officially notified the Cosmetics (Amendment) Rules, 2025, amending the Cosmetics Rules, 2020. The new rules aim to improve regulatory clarity, streamline procedures, and strengthen the oversight of cosmetic products in India. These amendments are effective immediately from the date of publication in the Official Gazette.
Highlights of Key Amendments
Clarification of “Use before” and “Expiry Date”
Revised Terminology
The term “controlling officer” has been replaced by “Controlling Authority” across relevant rules for consistency.
Appointment of Government Analyst
Only a Government Analyst appointed under section 20 of the Act will be recognized as the Government Analyst under the rules.
Central Cosmetics Laboratory Functions
The Central Drugs Laboratory will now function as the Central Cosmetics Laboratory for:
Licensing Amendments
License Cancellation or Suspension
Labelling for Export
Other Notable Changes
These amendments bring enhanced clarity and reinforce regulatory frameworks within the cosmetics industry. All stakeholders are hereby advised to ensure strict compliance with the revised provisions, especially those pertaining to record retention, licensing procedures, labelling standards, and definitions of competent authorities.
Update: As per scheduled information, mandatory standard GB 30000.1-2024 becomes effective on 1 August 2025. Now from 1 August 2025 onwards, classification and labelling of chemicals must be applicable as per GB 30000.1-2024 (GHS Rev.8) only. More information can be found here.
Original Text:
On 24 July 2024, GB 30000.1-2024 "Specification for Classification and Labelling of Chemicals—Part 1: General Rules" was officially published on the National Public Service Platform for Standards Information. This updated standard, which aligns with the eighth revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 8), will come into force on 1 August 2025 and will replace the existing GB 13690-2009 "General Rules for the Classification and Hazard Communication of Chemicals."
Draft Release and Public Consultation
On 12 March 2024, China's Ministry of Industry and Information Technology (MIIT) released a draft of the revised standard GB 30000.1. This update aims to align China's chemical classification and labelling standards with the UN's GHS 8. Public comments on this draft were invited until 12 April 2024.
Key updates to GB 30000.1
The revised GB 30000.1 introduces significant updates and new categories:
Exemptions
Certain products, such as pharmaceuticals, food additives, cosmetics, and pesticide residues in food intended for ingestion, are exempt from these labeling requirements unless workers are likely to be exposed during transport.
Implementation and Compliance
The revised GB 30000.1 will replace the existing GB 13690-2009 standard. Once adopted, it will better align China's chemical safety standards with international practices, improve hazard communication and ensure safer handling and transportation of chemicals within China and in international trade.
The adoption of GB 30000.1 is a significant step in enhancing chemical safety and regulatory compliance in China. By aligning with the UN GHS 8, China is demonstrating its commitment to global safety standards, facilitating smoother international trade and improving overall chemical safety management.
Update: On 13 August 2025, China’s Ministry of Industry and Information Technology (MIIT) releases draft standard for GB 15258 and reopened public consultation on 14 August 2025 which remain valid till 12 October 2025. China published the notice on MIIT portal. The key revisions include the introduction of a Safety Information QR Code, new rules for small packages and folding labels, reordering of hazard statements, updated simplified label rules, and examples for kit packaging. This time revised GB 15258 standard aligned with the tenth revised edition of the Globally Harmonized System for Classification and Labelling of Chemicals (GHS 10). Prior to enforcement, GB 15258-XXXX permits a one-year transition period from the final draft publication date. More details can be found here.
Original Text:
On 14 September 2024, China’s Ministry of Industry and Information Technology (MIIT) announced a consultation to revise the national standard on "Regulations on the Preparation of Chemical Safety Labels" to align with the ninth revised edition of the Globally Harmonized System for Classification and Labelling of Chemicals (GHS 9). The Ministry released this announcement on the portal of the National Standards Administration and invited stakeholders to comment on it by 14 October 2024.
After the official publication of the National Standard on the Provisions on the Preparation of Chemical Safety Labels, the National Technical Committee for Standardization of Hazardous Chemicals Management will work on its implementation.
Insights of New Labelling Standard
This new labelling standard will have the following revised information:
Alignment with the technical content of the ninth edition of the United Nations GHS, including hazard classification and precautionary statements.
Implementation of the "one enterprise, one product, one code" regulation to meet the needs of national safety supervision of hazardous chemicals. Additionally, the means of transmitting hazardous chemical hazard information needed to be strengthened, and the last mile of hazardous chemical hazard information transmission needed to be opened.
Previous Update
Previously China’s National Standards Administration revised the Provisions on the Preparation of Chemical Safety Labels in 2009. However, this 2009 version followed GHS 2 while the Ministry has now proposed to align with the provisions of GHS 9.
Comment Period and Enforcement Date
Stakeholders are invited to comment on this draft announcement till 14 October 2024. The Ministry has not yet officially announced the enforcement date of the same.
On July 29, the South Korean approved amendments to the enforcement decrees of the Act on the Registration and Evaluation of Chemical Substances (K-REACH) and the Chemical Control Act (CCA), set to take effect on August 7, 2025. These regulatory changes, overseen by the Ministry of Environment, aim to enhance public safety while streamlining chemical management systems.
Key Updates under the K-REACH Amendment:
Hazardous substances will now be categorized into three distinct types: acute human toxicity, chronic human toxicity, and ecotoxicity, replacing the previous single classification system.
The definition of acute toxic substances is being expanded to include criteria such as skin corrosion (Categories 1B & 1C) and specific target organ toxicity from single exposure (STOT-SE).
Chemical data disclosure will be broadened for materials not related to business confidentiality, promoting transparency and safe usage.
Key Updates under the CCA Amendment:
Consumer-use exemptions: Individuals using hazardous chemicals for personal consumption, or selling them directly to consumers, will no longer be subject to strict handling requirements like wearing protective gear.
Delegation of responsibilities: Foreign manufacturers can now assign local agents to handle mandatory chemical verification procedures, reducing administrative burdens for importers.
Regulatory Impact:
These amendments aim to balance public health and industry efficiency by applying risk-based management standards and reducing unnecessary compliance burdens. Greater transparency in chemical information is also expected to foster safer chemical use without compromising business trade secrets.
On 5 August 2025, Taiwan's Environmental Protection Administration (EPA) announced a draft plan to regulate 269 (per- and polyfluoroalkyl substances (PFAS) as Concerned Chemical Substances. These chemicals are widely used and can persist in the environment, posing potential risks to human health. Taiwan is following global trends to strengthen chemical safety management.
What are PFAS?
PFAS are a group of over 10,000 man-made chemicals used in various industries. Well-known examples include PFOS, PFOA, and PFHxS. The substances are already banned or restricted in Taiwan under the Stockholm Convention, due to their persistence and potential harm to people and the environment.
Why new controls?
Besides the already -regulated PFAS, many others remain in use in Taiwan. To prevent future risks, EPA reviewed which types of PFAS are used and how they are handled in Taiwan. The draft regulation aims to better control these chemicals using a tiered management system based on their risk level.
Proposed Regulatory Measures
The 269 PFAS substances will be grouped into 3 types:
Perfluoroalkyl acids (PFAAs), their precursors, and other PFAS
Polymers
Gases
For PFAAs and related compounds:
If the PFAA content is 0.1% or more, companies must :
apply for approval.
Keep monthly records and report quarterly.
Label the container and provide a safety data sheet (SDS).
For PFAS polymers or gases:
If the content is between 0.1% and 30% :
only labeling is required (no approval or reporting)
If the content is 30% or more :
approval, reporting, and labeling are all required (same as for PFAAs above)
Exceptions:
The regulation does not apply to PFAS used for testing, education, research, or analysis.
What’s next?
EPA will continue discussions with industry to support smooth implementation.
Companies will have a 2-year transition period after the regulation is officially announced.
Public comments are welcome within 30 days from the draft’s publication in the government gazette.
For more details, visit:
EPA News Website
Official Gazette (searchable after 3 days)
Send feedback to: yiting.chao@moenv.gov.tw
On 5 June 2025,the Ministry of Industry issued the Announcement on Hazardous Substances List (No. 8) B.E. 2568 (2025) under Section 5 and Section 18 of the Hazardous Substances Act B.E. 2535 (1992), with the approval of the Hazardous Substances Committee.
Clause 1 – Revocations
The following items from the Hazardous Substances List B.E. 2556 (2013) (dated 28 August 2013) are revoked:
Clause 2 – Revisions
The following items in the 2013
list are revoked and replaced:
2.1 Department of Agriculture
2.2 Food and Drug Administration
List 5.1 – Sequence No. 223: Hydrogen peroxide.
List 5.2 – Sequence No. 22: Chlorine and chlorine-releasing substances.
2.3 Department of Industrial Works
List 5.1 – Sequence Nos. 1, 32, 3, 55, 88, 95, 122, 153, 283, 289:
Clause 3 – Additions
The following are added to List
1.1 (Department of Agriculture):
Clause 4 – Transitional
Provisions
Clause 5 –
Effective Date
Effective the day after
publication in the Government Gazette.
Announced: 5
June B.E. 2568 (2025)
Signed: Ekanat Prompan, Minister of Industry
List 1.1, Controlled Substances – Department of Agriculture
Sequence
No. |
Hazardous
Substance Name |
CAS No. |
Type of
Hazardous Substance |
194 |
Dicofol |
115-32-2 |
4 |
687 |
Pentachlorobenzene |
608-93-5 |
4 |
688 |
Hexachlorobutadiene |
87-68-3 |
4 |
List 1.2, Controlled Substances – Department of Agriculture
Sequence
No. |
Hazardous
Substance Name |
CAS No. |
Type |
Conditions |
9 |
Active
ingredients, microorganisms, or products containing such, prepared for
regulating plant growth (stimulating, inhibiting, or retarding), e.g.,
flowering, fruiting, color change, rooting, etc. |
- |
2 |
Except for
plant parts with natural characteristics processed by drying, chopping,
grinding, boiling, or fermenting with water without adding other substances. |
10 |
Active
ingredients, microorganisms, or products containing such, prepared for
preventing, eliminating, destroying, repelling, attracting, or controlling
insects or animals that are plant pests. |
- |
2 |
- |
11 |
Active
ingredients, microorganisms, or products containing such, prepared for
preventing, eliminating, destroying, or controlling plant diseases. |
- |
2 |
- |
12 |
Active
ingredients, microorganisms, or products containing such, prepared for
preventing, eliminating, destroying, or controlling weeds or undesirable
plants. |
- |
2 |
- |
List 5, Controlled Substances – Food and Drug Administration
Sequence
No. |
Hazardous
Substance Name |
CAS No. |
Type |
Conditions |
223 |
Hydrogen
peroxide |
7722-84-1 |
3 |
In products
used in households or public health for bleaching clothes, disinfecting,
cleaning floors, walls, sanitary ware, and other materials. |
List 5.1, Controlled Substances – Department of Industrial
Works (Type 3)
Sequence No. |
Hazardous Substance Name |
CAS No. |
Type |
Conditions |
71 |
Gold (I) cyanide |
506-65-0 |
3 |
- |
72 |
Gold sodium cyanide |
15280-09-8 |
3 |
- |
73 |
Gold potassium cyanide |
13967-50-5 |
3 |
- |
85 |
Copper (I) cyanide |
544-92-3 |
3 |
- |
88 |
Copper (II) cyanide |
14763-77-0 |
3 |
- |
95 |
Cadmium cyanide |
542-83-6 |
3 |
- |
122 |
Zinc cyanide |
557-21-1 |
3 |
- |
147 |
Sodium cyanide |
143-33-9 |
3 |
Except for the part under FDA
responsibility |
283 |
Potassium cyanide |
151-50-8 |
3 |
Except for the part under FDA
responsibility |
289 |
Propionitrile (Ethyl cyanide) |
107-12-0 |
3 |
- |
On 25 July 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) published draft ordinance for amending the Poisonous and Deleterious Substances List on the country’s e-Gov Public Comment Portal. Fenazaquin has been proposed to get added, whereas formulations containing sodium chlorate or sodium bicarbonate scheduled to get removed from the list. Furthermore, Japan notified the World Trade Organization (WTO) on August 1, 2025, of a draft designating fenazaquin as a deleterious substance.
Poisonous and Deleterious Substances List
The Poisonous and Deleterious Substances List under Japan's Poisonous and Deleterious Substances Control Act (PDSCA) classifies chemicals based on their toxicity and health risks, categorizing them as "poisonous" or "deleterious." These substances are regulated for safe handling, storage, and transportation to prevent accidents and ensure public safety. Updated regularly by Japan's MHLW, new substances are added based on scientific evidence. The regulations include safety procedures such as labelling, record-keeping, and reporting to minimize health and environmental risks. Currently there are 587 entries present on the list.
Key Insights from the Draft Ordinance
Draft ordinance proposes the following amendments to the list of Deleterious Substances:
It was determined that fenazaquin posed a significant risk of acute toxicity upon exposure, supporting its designation as a deleterious substance. On the other hand, it was found that the sodium chlorate/sodium bicarbonate formulation had far lower toxicity, which justified its removal from the list.
Obligations for the Stakeholders
Manufacturers, importers, and distributors of the Poisonous and Deleterious Substances must register their substances with the MHLW and comply with Safety Data Sheets (SDS) and Labelling regulations.
Comment Period and Enforcement Dates
Stakeholders are requested to comment on the draft till 24 August 2025. While as per WTO notification, members can comment on the WTO draft till 30 September 2025. Final ordinance will be published in late October 2025. Enforcement is scheduled to be from 1 November 2025 (Except for delisting of entries which will come into effect on the same day of ordinance publication).
On 31 July 2025, Japan's Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW), and Ministry of Environment (MOE) jointly announced the addition of 157 new substances to the General Chemical Substance List under the Chemical Substance Control Law (CSCL). It has been determined that six of these substances pose major risks to both human health and the environment.
Previous update in July 2024
Earlier on 31 July 2024, Japan added 164 chemicals to the general chemical substance list & identified 3 chemicals with high toxicity profile. More details can be found here.
Classification of General Chemical Substances
Chemicals that are first submitted to the government for assessment and then monitored for five years are considered new substances, according to the CSCL. Chemicals that do not pose a significant risk are added to the list as "newly announced substances" and given the designation of general chemical substances following this evaluation period.
Notification Obligations for Manufacturers and Importers
Businesses must notify METI if they produce or import general chemicals in amounts of one tonne or more throughout the year. Even after these chemicals are included to the list of general chemical substances, this requirement guarantees that they are continuously reviewed.
Addition of Highly Toxic Chemicals
Six of the recently added chemicals have been identified as extremely toxic:
Assessment results published
Additionally METI released the assessment results of these chemicals for bioaccumulation and degradability on the same day they were added to the list. The list of added chemicals can be found here.
On 5 August 2025, Japan’s Ministry of Economy, Trade and Industry (METI) published the draft amendments to notification quantities for Manufacture or Import of chemicals under Chemical Substances Control Law (CSCL). METI released the draft on the Japan’s e-GOV Public Comment Portal. Chemicals covered in this draft are:
Key Insights from the Draft
METI has included following revisions in the draft and are given below:
I. Amendment to the Ministerial Ordinance
1. Cleanup of Regulations (Articles 18 & 19)
2. Changes to Electronic Notification Requirements (Articles 20–21)
i. General chemical substances (Art. 9-2)
ii. Priority assessment substances (Art. 9-3)
iii. Monitoring chemical substances (Art. 10)
iv. Class II specified chemical substances (Art. 15)
The notifier code requirement will be abolished and replaced by the passcode system, so Article 21 will be repealed.
3. New Article 19 will clarify name/identity declaration requirements in line with Article 6(4) of the Act on Advancement of Utilizing Information and Communication Technology in Administrative Procedures (Law No. 151 of 2002).
4. Other related and formatting amendments will be made to:
II. Amendment to METI Notification Related to Technical Standards
Comment Period and Enforcement Dates
Stakeholders are invited to comment on the draft by 3 September 2025. Japan will publish the final draft in October 2025, while enforcement is scheduled to commence from 1 April 2026.
Brazilian Regulatory Authority Seeks Public Contributions
The Brazilian Health Regulatory Agency (ANVISA) has opened a consultation period for a proposal to update its regulations concerning food additives and technological aids. The new guidelines will alter the existing rules under Instrução Normativa - IN nº 211, dated March 1, 2023. The regulatory updates focus on food additives and technological aids' technological functions, maximum usage limits, and conditions of use in food products.
The proposal, published in the Official Federal Gazette (DOU) on July 8, 2025, invites public feedback between July 15 and August 28, 2025, with a potential deadline extension depending on the volume of contributions. The initiative aims to ensure that food safety regulations align with technological advancements and global standards, keeping the regulatory framework in line with evolving industry needs.
ANVISA's decision to propose updates stems from the continuous need for adjustments to the lists of authorized additives and technological aids. These updates help ensure that technological innovations remain consistent with the foundational principles governing the safe use of these substances. Additionally, the changes are driven by issues raised by industry stakeholders, including food manufacturers, public agencies, and regulatory experts, highlighting the importance of aligning with international best practices.
Food additives are substances added intentionally to foods to modify their physical, chemical, biological, or sensory properties during production, processing, or packaging. Technological aids, on the other hand, are materials that aid in food production but are not consumed directly, and their use may result in trace residues in the final product.
The proposed updates include several changes, such as:
Key Dates and Consultation Process
The regulatory body has emphasized that updates are essential to maintaining safe food production practices and promoting innovation in the food sector. With new food trends like plant-based diets growing in popularity, regulatory flexibility is crucial to enabling food manufacturers to adapt to market demands while ensuring public safety.
The updates aim to provide clarity for food manufacturers on the substances that can be used in food products, ensuring that they are safe, effective, and aligned with the best available science. The regulatory changes will also aid in reducing trade barriers, as the Brazilian framework will increasingly reflect international norms.
Contributions from stakeholders are crucial for shaping the final regulatory outcome, ensuring that it meets the needs of the food industry while safeguarding public health. ANVISA has committed to transparency throughout the process, with all relevant documents available for public review during the consultation period.
This marks the third regulatory update attempt by ANVISA, following previous initiatives in August 2023 and November 2024. For further details you can consult the regulation (in Portughese) here.
A groundbreaking law passed by the Brazilian government on July 30, 2025, now prohibits the use of animals in testing products such as cosmetics, personal care items, and perfumes, as well as their ingredients. The new legislation, signed by President Luiz Inácio Lula da Silva, marks a significant step forward in the nation's animal welfare efforts.
The law amends two critical pieces of legislation—Law No. 11,794 (2008) and Law No. 6,360 (1976)—to explicitly ban the testing of products and ingredients on vertebrate animals, including those used for safety, efficacy, or danger assessments. The amendment also enforces stricter labeling regulations on products that may have been tested on animals before the law's enforcement.
Key Provisions
Under the revised Law No. 11,794, the following points stand out:
Prohibition on Animal Testing: Sections 11 and 12 of the amended law clearly state that testing on vertebrate animals is prohibited for both finished products and ingredients used in personal care, cosmetics, and perfumes. This includes any testing aimed at evaluating the safety, efficacy, or potential harm of the substances.
Restrictions on Animal-Test Data: Data from animal testing carried out after the law’s enforcement will no longer be admissible for the approval or commercialization of personal care products. This extends to any animal test data used to support the safety claims of the ingredients.
Labeling Prohibition: Manufacturers whose products' safety has been certified through post-enforcement animal testing will not be allowed to label or advertise their products as "cruelty-free" or "not tested on animals." This aims to uphold transparency and prevent misleading claims.
Alternative Testing Methods: The law prioritizes the use of internationally recognized and validated alternative testing methods. It mandates that the Brazilian authorities expedite the recognition and adoption of these methods, ensuring they become widespread throughout the nation.
Exemptions in Exceptional Circumstances: There is a provision for exemption in rare instances where a cosmetic ingredient poses a significant health risk, and no viable alternative testing method exists. These exceptions will be handled by the National Commission for the Control of Animal Experimentation.
Implementation and Enforcement
The law mandates that the health authorities have a maximum of two years to implement and regulate these new rules. Specifically, the authorities are required to:
Promote Alternative Testing: Create a strategic plan for the adoption of alternative testing methods across Brazil.
Monitor Compliance: Establish measures to ensure companies do not use post-enforcement animal testing data for regulatory purposes.
Ensure Accurate Labeling: Enforce regulations around the labeling of cruelty-free claims and ensure they align with the new legislation.
The amendment also adds a specific clause to Law No. 6,360 (1976), making compliance with the animal testing ban a requirement for product registration under Brazil’s health authority.
A Step Toward Global Change
Brazil’s landmark move positions the country as a global leader in ethical treatment of animals, aligning with international trends where more nations are adopting similar bans on animal testing for cosmetics. While some have already implemented these restrictions, Brazil is one of the largest emerging markets to take such decisive action.
This shift is expected to inspire many companies to embrace innovative, cruelty-free methods in their production processes, which could lead to broader changes across the global beauty and cosmetics industry. It is also seen as a major victory for animal rights groups, who have long advocated for such bans in the fight for humane testing practices.
The law goes into effect immediately following its publication, marking a historic day for Brazil and animal welfare advocates alike. For further details you can check the Law (in Portughese) here.
On 30 July 2025, Indonesia’s National Agency of Drug and Food Control (BPOM) released a draft five-year strategic plan (2025–2029) to enhance regulatory compliance in product safety and labelling, with a particular focus on the cosmetics sector and small and medium-sized enterprises (SMEs). The initiative seeks to transition from reactive enforcement to a proactive, risk-based oversight model supported by artificial intelligence and intersectoral collaboration.
Addressing Root Causes of Non-Compliance in Cosmetics
The strategy builds on BPOM’s analysis of widespread labelling violations observed during the 2020–2024 period, especially among SMEs in the cosmetics sector. Investigations revealed that inaccurate or misleading labelling—largely due to the absence of pre-market label evaluations—was a leading cause of non-compliance. This regulatory gap had a negative impact on national compliance metrics, as cosmetics are monitored within the same framework as pharmaceutical products.
Microbial contamination, particularly in traditional and herbal cosmetic lines, was another recurring issue. In response, BPOM expanded its post-market surveillance, conducting over 188,000 inspections and increasing product sampling from 27,000 units in 2020 to more than 43,000 in 2024.
Improved Compliance Among SMEs
BPOM reported significant progress in SME compliance rates, which rose from 73.11% in 2022 to 93.26% by 2024. The agency attributes this improvement to increased self-reliance in sourcing cosmetic raw materials and intensified outreach efforts, including regulatory education, technical assistance, and incentives aimed at elevating production standards.
Strategic Focus Areas for 2025–2029
The new strategic plan outlines several core priorities to sustain and build on recent gains:
a. Expanded technical support and training for SMEs in the cosmetics sector.
b. Development of digital platforms to facilitate regulatory updates and industry guidance.
c. Standardisation of facilitator competencies to improve local advisory services.
d. Promotion of raw material independence, particularly for locally sourced cosmetic ingredients.
These measures are designed to support a more consistent and scalable compliance culture, particularly among smaller manufacturers navigating regulatory complexities.
A Shift Toward Proactive, Technology-Driven Oversight
Central to BPOM’s strategy is the deployment of a proactive, AI-enabled risk-based monitoring system, which aims to identify potential violations before products reach consumers. This forward-looking approach will be supported by greater coordination between government agencies, industry stakeholders, and academic institutions.
Implications for Industry Stakeholders
Cosmetics producers—especially SMEs—are advised to prepare for more sophisticated compliance expectations and closer integration with digital regulatory systems. Firms should consider:
a. Investing in regulatory training for staff.
b. Reviewing labelling processes in light of upcoming pre-market evaluation requirements.
c. Engaging with BPOM’s digital platforms and public-private initiatives.
Public consultation on the draft strategic plan closed on 5 July 2025, with final adoption anticipated later this year. The plan signals a continued commitment to strengthening Indonesia’s product safety framework while supporting the sustainable growth of its domestic cosmetics industry.
Argentina has unveiled a comprehensive regulatory framework for managing the import, export, and transit of recycled non-hazardous waste. The new measures, outlined in Resolution 393/2025, are aimed at protecting the environment, ensuring compliance with international waste management treaties, and advancing the country’s circular economy.
The resolution is built on the foundation of Decree 1/2025, which establishes guidelines for the handling of non-hazardous waste, specifically materials that have undergone a recovery process to be used as inputs for industrial processes or as direct-use products. These materials must meet strict environmental standards, and the resolution creates clear procedures to regulate their movement across Argentina’s borders.
The four annexes of the resolution are closely interconnected, establishing a unified system for the import, export, and transit of non-hazardous recycled materials. Annex IV lays out the types of materials eligible for trade, while Annexes I–III set the procedural framework for how these materials can be imported, exported, or transited through the country. All applications for permits must be processed through the Trámites a Distancia (TAD) platform, where they will undergo technical evaluations, customs validation, and compliance checks.
The Basel Convention plays a central role in this framework, ensuring that materials moving across borders meet international environmental standards. In addition, all documents will be validated through Argentina's Single Window for Foreign Trade (VUCEA) and Malvina system to streamline processing and ensure robust oversight.
Annex I - Import Procedures (365 Day Authorisation)
To import non-hazardous waste, businesses must submit a sworn declaration through the TAD platform, detailing the material’s origin, composition, recovery process, intended use, and confirmation of its non-hazardous status. The Dirección Nacional de Residuos (National Waste Directorate) will assess whether the waste matches the list in Annex IV and complies with both national and international regulations. If approved, the Subsecretary of Environment will issue an authorisation valid for 365 days.
Annex II - Transit Procedures (90-Day Authorisation per Shipment)
For materials transiting Argentina en route to a third country, exporters must file a similar declaration outlining the shipment's route, estimated quantities, transport companies, and insurance details. Proof that the destination country permits the importation is also required. Transit permits are valid for 90 days, and each shipment must be treated individually.
Annex III - Export Procedures (365-Day Authorization)
Exporters must provide detailed documentation on the waste's origin, recovery process, and destination. They must also demonstrate that the material is not classified as hazardous under the Basel Convention or is recognised as raw material by the importing country. If no objections are raised within 10 working days, the export is automatically authorised, and the permit remains valid for 365 days.
Annex IV - List of Non-Hazardous Wastes
This annex defines what types of materials are considered non-hazardous. These include:
Scrap metals (iron, steel, etc.)
Certain glass waste (excluding hazardous or radioactive glass)
Paper and cardboard waste
Animal and vegetable oils
Uncontaminated metal or non-plastic containers
Selected textiles and untreated wood
Plant residues and agro-food industry waste
Human hair and clean refractory brick
Processed non-halogenated plastics (PE, PP, PET, etc.)
The annex excludes materials such as fluorinated plastics, e-waste, and any contaminated materials or waste treated with hazardous chemicals. It also provides flexibility for updating the list based on new scientific evidence or regulations.
The Subsecretary of Environment has been tasked with overseeing the compliance process. Should discrepancies arise—such as a mismatch between declared and actual materials—the goods must be returned to their country of origin within 30 days at the importer's expense. In case of repeated violations, businesses may face bans on applying for new permits for up to one year.
The TAD platform and VUCEA system ensure that all trade movements are tracked electronically, improving the efficiency of processing and reducing administrative delays. The new regulations aim to streamline operations while ensuring that waste management practices meet both Argentina's environmental standards and international obligations.
The resolution also enhances international collaboration in the management of cross-border waste. Argentina has committed to upholding its responsibilities under the Basel Convention and other international agreements, ensuring that non-hazardous waste is handled according to environmentally sound practices.
The government has stated that the new rules will foster Argentina’s circular economy, enabling the country to better manage recovered materials while minimizing environmental impact. For further details, you can consult the Resolution 393 (in Spanish) here.
The East African Community (EAC) comprising Burundi, Kenya, Rwanda, Tanzania, and Uganda has officially adopted six new East African Standards (DEAS) covering various skincare, hair dye, and mosquito repellent products. According to a notification circulated by the WTO Committee on Technical Barriers to Trade on 29 July 2025, these measures were endorsed by the EAC Council of Ministers on 2 July 2025. The updated standards aim to harmonize product specifications across the region, ensuring improved consumer safety, quality assurance, and market consistency.
Summary of Newly Adopted Standards:
Standard Code & Year | Title | Part / Edition | Brief Description |
DEAS 1205-2:2024 | Skincare special purpose product: Specification-Sunscreen | Part 2, First Edition | Sets requirements for sunscreen products, focusing on formulation, safety, and labelling to ensure adequate sun protection. |
DEAS 1205-1:2024 | Skincare special purpose product: Specification-Anti-aging | Part 1, First Edition | Defines specifications for anti-aging skincare products, ensuring efficacy claims are supported and products are safe for use. |
DEAS 461-2:2023 | Hair dye: Specification-Aryl di-amine-based liquid oxidation | Part 2, First Edition | Establishes standards for liquid oxidation hair dyes using aryl di-amines, addressing quality, safety, and permissible ingredient limits. |
DEAS 461-1:2023 | Hair dye: Specification-Aryl diamine-based formulated powder | Part 1, Third Edition | Updates the standard for powdered hair dyes using aryl diamines, ensuring safe formulation and consistent product quality. |
DEAS 1119-3:2023 | Skin applied mosquito repellents: Specification-Wipes | Part 3, First Edition | Specifies safety and performance requirements for mosquito repellent wipes, including active ingredient levels and skin compatibility. |
DEAS 1119-4:2023 | Skin applied mosquito repellent: Specification-Bathing soap | Part 4, First Edition | Details formulation and quality criteria for mosquito repellent bathing soaps to ensure effective protection and safe skin application. |
Implications for Stakeholders :
Manufacturers & Importers: Must align product formulations, labelling, and safety testing with the new standards before market entry in EAC countries.
Regulators: Will have a unified reference point for market surveillance and enforcement, reducing cross-border compliance issues.
Consumers: Benefit from improved product safety, performance reliability, and clearer labelling information.
These measures form part of the EAC’s ongoing efforts to strengthen regional trade harmonization while safeguarding public health, as reflected in the WTO notification.
The Kingdom of Saudi Arabia has announced significant updates to its Technical Regulation for Packaging, aligning the provisions with the recently issued Product Safety Law. The updated regulation, notified to the World Trade Organization (WTO) under reference G/TBT/N/SAU/1286/Add.1, aims to strengthen health, safety, and environmental protection while ensuring fair market practices for both domestic and imported packaging products.
The revised regulation sets out mandatory requirements for all packaging products placed on the Saudi market, whether manufactured locally or imported. It applies to packaging used for containing, protecting, handling, and presenting goods, with specific exclusions for packaging related to food, pharmaceuticals, cosmetics, and medical devices, which are regulated under separate technical rules.
Key updates include:
Economic operators must ensure compliance within the transition period set by the regulation. Products failing to meet the requirements may be subject to withdrawal from the market, fines, or other enforcement measures.
The Saudi Standards, Metrology and Quality Organization (SASO) has invited WTO members and stakeholders to submit comments within 30 days from the notification date.
The Kingdom of Saudi Arabia has submitted an addendum to the World Trade Organization (WTO) regarding changes to its Technical Regulation on the Restriction of Hazardous Substances in Electrical and Electronic Equipment. The update, notified under document symbol G/TBT/N/SAU/1166/Corr.1/Add.1, aligns the regulation’s provisions with the country’s recently issued Product Safety Law.
According to the WTO notification, the revised text is intended to strengthen safety, health, and environmental protection by harmonizing technical requirements for electrical and electronic equipment with current Saudi legislation. The update introduces clearer compliance obligations for manufacturers, importers, and distributors, including technical documentation, Arabic-language safety instructions, and mandatory conformity assessment procedures.
The regulation covers a broad range of products from household appliances and IT equipment to lighting devices, tools, toys, and monitoring instruments while exempting certain categories such as medical devices, military equipment, and large-scale industrial machinery.
Key provisions set maximum concentration limits for hazardous substances in homogeneous materials, including: lead (0.1%), mercury (0.1%), cadmium (0.01%), hexavalent chromium (0.1%), polybrominated biphenyls (0.1%), polybrominated diphenyl ethers (0.1%), and selected phthalates (0.1%).
Economic operators are required to maintain records, conduct risk assessments, and cooperate with market surveillance authorities. Non-compliant products may be subject to recalls, withdrawal from the market, or other corrective measures.
The updated regulation and its associated list of standards are available via the WTO and SASO platforms. Interested stakeholders have 30 days from the date of notification to submit comments.
On August 1,
2025, the Eurasian Economic Commission (EEC) Council approved two essential
“second-level” documents under the EAEU Technical Regulation “On Safety of
Chemical Products” (TR EAEU 041/2017):
These procedures
were developed by the EEC in collaboration with all EAEU Member States —
Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia—to standardize chemical
product management across the EAEU.
Purpose of the Procedures
The EEC
Council’s decision aims to implement the provisions of TR EAEU 041/2017,
ensuring:
Implementation through the EAEU
Integrated Information System
The Unified
Register will be maintained using the EAEU integrated information system,
enabling a common and streamlined process across all EAEU member states. This
digital system ensures accurate and timely updates for companies and regulatory
authorities.
Importance for TR EAEU 041/2017
Approval of
these procedures is a key condition for enacting the EAEU Technical Regulation
“On Safety of Chemical Products” (TR EAEU 041/2017). Once fully implemented,
the regulation will strengthen chemical safety standards across the EAEU,
providing legal certainty and harmonized rules for all companies operating in
the union.