GPC Newsletter Sep-2025

The U.S. Environmental Protection Agency (EPA) has released draft risk evaluations for two widely used chemicals under the Toxic Substances Control Act (TSCA) :

• Butyl Benzyl Phthalate (BBP, CASRN 85-68-7)
• Diisobutyl Phthalate (DIBP, CASRN 84-69-5)

These evaluations form part of EPA’s ongoing efforts 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 draft evaluations, prepared using the best available science, preliminarily conclude that both BBP and DIBP pose unreasonable risks to health and the environment under certain conditions of use.

• Risks extend to potentially exposed or susceptible groups, such as workers or children.
• Economic or other non-risk factors were not considered in accordance with TSCA.

Publication and Comment 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)

Comment Deadline: 6 October 2025, 4:00 PM EST

Submit via: USA WTO TBT Enquiry Point Email: usatbtep@nist.gov

Next Steps

EPA will review all comments received and finalize the risk evaluations. If the final assessments confirm unreasonable risk, the Agency will proceed to risk management actions under TSCA §6(a) to reduce or eliminate those risks.

On 1 August 2025, the European Commission launched a public consultation and Call for Evidence for the upcoming Circular Economy Act, marking a key step in its impact assessment. The initiative is planned for adoption in 2026, and aims to strengthen the EU’s circular economy by improving market conditions for secondary raw materials, enhancing recycled material supply, and increasing demand for high-quality recyclates. The Act also supports broader EU objectives on competitiven.

Purpose and Focus of the Circular Economy Act

The Commission highlights that circularity is essential for 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.

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.

The initiative aligns with existing EU strategies, including the Competitiveness Compass and Critical Raw Materials Act, and is part of the Commission’s commitment to doubling the EU circularity rate by 2030.

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:

• Diuron (CAS 330-54-1)
• Tetrabromobisphenol-A (CAS 79-94-7)
• N,N-dimethyl-p-toluidine (CAS 99-97-8)
• 4-nitrosomorpholine (CAS 59-89-2)
• 4-methylimidazole (CAS 822-36-6)
• Several phosphonium salts and diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide
• Dibutyltin compounds, including dibutyltin maleate and dibutyltin oxide

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):

• Procedure for forming and maintaining the EAEU register of chemical substances and mixtures
• Procedure for notification of new chemical substances

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:

• A unified register of chemical substances and mixtures circulating in the EAEU
• Standardized notification procedures for new chemical substances
• Up-to-date information for market participants on chemical products
• Reduced financial and time costs for preparing documents, including safety data sheets and conformity assessment

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 Turkish Ministry of Environment, Urbanization and Climate Change has announced through 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.

Key Points Shared by the Ministry

The highlights of the circular can be listed as below:

Selection of Lead Registrants (LRs):

• Lead companies will be determined by the end of 2025.
• If no volunteer LR is found, an appointment will be made under the guidance of TOBB  (Turkish Union of Chambers & Commodity Exchange).
• SIEF members will have 30 days to respond, and decisions will be based on a simple majority.

Responsibilities of Lead Companies:

• For substances without a submitted registration dossier, the lead company must share data gap analysis, tonnage bands, and contractual details with SIEF and seek renewed approval.
• If approval is not obtained, the lead company will lose its status, and a new lead will be appointed.

Temporary Registration Dossier:

• If the LR cannot access existing data, it must submit a temporary registration dossier by March 31, 2026.
• Member companies must submit their temporary dossiers by September 30, 2026.

Pre-SIEF (Pre-registration) Deadlines:

• For substances already placed on the market, the pre-registration deadline is October 31, 2025.
• For substances placed on the market after this date, a 30-day pre-MBDF window will apply.

New Working Groups:

• Two main groups will be established within the Ministry: Chemicals Advisory Group and Chemicals Science Group, to ensure scientific and strategic process management.

On 29 July 2025, the Government of India notified the Cosmetics (Amendment) Rules, 2025, through publication in the Official Gazette. The amendments, which revise select provisions of the Cosmetics Rules, 2020, entered into force immediately on the same date. The updated rules aim to enhace regulatory clarity, streamline procedures, and strengthen oversight of cosmetic products in India.

Highlights of Key Amendments

Clarification of “Use before” and “Expiry Date”

• “Use before” now means the cosmetic must be used before the first day of the month indicated on the label.
• “Date of expiry” means the product expires on the last day of the month mentioned.

Revised Terminology

• The term “controlling officer” has been replaced with “Controlling Authority” for consistency across the rules.

Appointment of Government Analyst

• Only a Government Analyst appointed under Section 20 of the Drugs and Cosmetics Act will now be recognized as the Government Analyst for cosmetics-related assessments.

Central Cosmetics Laboratory Functions

The Central Drugs Laboratory will now function as the Central Cosmetics Laboratory for:

• Product testing and analysis.
• Appellate laboratory functions.
• Any additional roles assigned by the Central Government.

Licensing Amendments

• All mentions of the “Central Licensing Authority” in specific sub-clauses have been changed to “State Licensing Authority” for clarity.
• Records and batch data can now be maintained electronically or in hardcopy and must be retained for three years or six months after expiry, whichever is later.
• Requirements for testing and documentation do not apply to the manufacture of soap. Soap manufacturers follow procedures approved by the Licensing Authority.

License Cancellation or Suspension

• The State Licensing Authority can suspend or cancel a license for non-compliance after giving the licensee a chance to be heard.
• An appeal against suspension or cancellation must be made within 90 days to the State Government. The State Government’s decision shall be final.

Labelling Requirements for Export

• Labels on cosmetics intended for export must comply with the importing country's laws.
• If the consignee requests, the manufacturer’s name and address may be omitted on the label, replaced by an approved code number.

Other Notable Changes

• References to “courier” in relation to sample transportation have been omitted.
• Definitions for spurious and adulterated cosmetics are now aligned with Section 17D of the Act.
• The terms “license” and “licensed premises” are changed to “approval” and “approved premises” in licensing and quality control related rules.

These amendments provide greater clarity for industry, streamline regulatory procedures and reinforce consumer protection within the cosmetics sector. 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 scheduled, GB 30000.1-2024 entered into force on 1 August 2025. From this date onward, chemical classification and labelling in China must comply exclusively with GB 30000.1-2024 which implements GHS Revision 8. 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:

• Terminology and Definitions: Consistency with GHS 8 ensures clear, internationally recognized terminology.
• Hazard Classification: Adds a new category for desensitized explosives, bringing the total number of hazard classes in China to 29.
• Labeling Requirements: Special provisions are made for labeling, particularly for metals and alloys in non-dispersible forms. GHS labels must be used in workplaces, with alternative methods like area-specific labels allowed.
• Safety Data Sheets (SDS): Updated SDS requirements include detailed hazard communication guidelines and cut-off values for different hazard 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) released a new draft standard of the national standard GB 15258 and reopened the public consultation on 14 August 2025. The consultation will remain open till 12 October 2025 as announced on the MIIT portal.

The draft introduces sevel significant updates, inluding:

• The addition of a Safety Information QR Code 
• New rules for small packages and folding labels
• A reordering of hazard statements
• Updated simplified label rules 
• Examples for kit packaging.

The revised GB 15258 standard is now aligned with the tenth revised edition of the Globally Harmonized System for Classification and Labelling of Chemicals (GHS 10). Prior to enforcement, a one-year transition period will apply from the date of the final publication. 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, 2025, the South Korean Government 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). These updated decrees, overseen by the Ministry of Environment (MoE), will enter into force on August 7, 2025. The revisions aim to strengthen public safety while improving the efficiency of national 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 expanded for substances not related to business confidentiality, promoting transparency and safe usage.

Key Updates under the CCA Amendment:

• Exemption for consumer-use scenarios: Individuals handling hazardous chemicals for their own personal use, or selling them directly to consumers, will no longer be subject to certain occupational safety requirements such as mandatory protective equipment.
• Delegation of responsibilities: Foreign manufacturers can now appoint local agents to carry out 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. 

On 7 July 2025, Thailand's Ministry of Industry published the Notification on Hazardous Substances List (No. 8) B.E. 2568 (2025) in the Royal Gazette. The notification was signed on 5 June 2025 under Section 5 and Section 18 of the Hazardous Substances Act B.E. 2535 (1992), with the approval of the Hazardous Substances Committee. The new list entered into force on 8 July 2025.

Clause 1 – Revocations

The following items in the Hazardous Substances List B.E. 2556 (2013) (dated 28 August 2013) are revoked:

Department of Agriculture (List 1.2)

• Sequence No. 5: Plant extracts used for preventing/eliminating agricultural pests (e.g., neem, galangal, lemongrass).

Food and Drug Administration (List 5.1)

• Sequence No. 13: Citronella oil.

Clause 2 – Revisions

The following entries in the 2013 list are revoked and replaced by updated definitions or specifications.

Department of Agriculture

List 1.1

• Sequence No. 155: Dicofol

List 1.2

• Sequence No. 5 – Active ingredients/microorganisms/products for regulating plant growth (stimulating, inhibiting, or retarding), including flowering, fruiting, color change, rooting, etc.
• Sequence No. 10 – Active ingredients/microorganisms/products for preventing, eliminating, destroying, or controlling insects or animals that are plant pests.
• Sequence No. 11 – Active ingredients/microorganisms/products for preventing, eliminating, destroying, or controlling plant diseases.
• SequenceNo. 12 – Active ingredients/microorganisms/products for preventing, eliminating, destroying, or controlling weeds or undesirable plants.

Food and Drug Administration

List 5.1

• Sequence No. 223: Hydrogen peroxide (CAS 7722-84-1)

List 5.2

• Sequence No. 22: Chlorine and chlorine-releasing substances.

Department of Industrial Works

List 5.1

• Gold (I) cyanide
• Gold sodium cyanide
• Gold potassium cyanide
• Copper (I) cyanide
• Copper (II) cyanide
• Cadmium cyanide
• Zinc cyanide
• Sodium cyanide (except parts under FDA responsibility)
• Potassium cyanide (except parts under FDA responsibility)
• Propionitrile (ethyl cyanide)

Clause 3 – Additions

The following substances are added to List 1.1 (Department of Agriculture):

• Sequence No. 253: Pentachlorobenzene
• Sequence No. 255: Hexachlorobutadiene

Clause 4 – Transitional Provisions

• Type 3 hazardous substances – Operators in business before the effective date must apply for permission within 30 days. If registration is required, it must be submitted within the same period.
• Type 4 hazardous substances – Operators in business before the effective date must comply with competent official orders within 180 days.

Clause 5 – Effective Date

Effective 8 July 2025, the day after publication in the Government Gazette.

List 1.1 Controlled Substances – Department of Agriculture

List 1.2 Controlled Substances – Department of Agriculture

List 5 Controlled Substances – Food and Drug Administration

List 5.1 Controlled Substances – Department of Industrial Works (Type 3)

Update 29 October 2025:

On 29 October 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) released the final promulgated order on the country’s e-GOV Public Comment Portal. The delisting of entries took effect on the same day.

Original News:

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:

• 4-[2-(4-tert-Butylphenyl)ethoxy]quinazoline (Fenazaquin) (CAS: 120928-09-8) and its preparations (except from those with a concentration ≤19.4%) have been designated as a new deleterious substance.
• Taking a formulation off the list: Made with sodium bicarbonate (27–37%) (CAS: 144-55-8) and sodium chlorate (47.5–52.5%) (CAS: 7775-09–9), except powdered versions.

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).

Of these, six substances have been identified as posing significant risks to both human health and the environment.

Previous update (July 2024)

On 31 July 2024, Japan added 164 chemicals to the General Chemical Substance List and identified 3 substances with high toxicity profile. More details are available here.

Classification of General Chemical Substances

Under CSCL, chemical substances submitted for evaluation are monitored for five years. Substances that do not present significant concern following this period are added to the General Chemical Substances List as "newly announced substances".

Notification Obligations for Manufacturers and Importers

Manufacturers and importers must notify METI if they produce or import general chemicals in amounts of one tonne or more per the year.

This obligation remains in force even after substances are added to the General Chemical Substance List, ensuring ongoing oversight.

Addition of Highly Toxic Chemicals

Six of the newly added chemicals have been determined to exhibit high toxicity. These are:

• Mixture of (1-)ammonium diaquabis(oxalato-kappa(2)O,O') oxidoniobate and (1-)ammonium diaquabis(oxalato-kappa(2)O,O') oxidoniobate-water(1/n)
• Disilver ethynediide
• Bis[4-({6-[(prop-2-enoyl)oxy]hexyl}oxy)phenyl] 2-{[(1,3-benzothiazol-2-yl)(6-{[(naphthalen-1-yl)acetyl]oxy}hexyl)hydrazinylidene]methyl}-1,4-phenylene bis[(1r,4r)-cyclohexane-1,4-dicarboxylate]
• 5,11,14,17-Tetrakis[(dimethylsilyl)oxy]-1,3,5,7,9,11,14,17-octaphenyltricyclo[7.3.3.3(3,7)]octasiloxane
• 4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole
• Copolymer of 2-(dimethylamino)ethyl 2-methylprop-2-enoate / N-benzyl-N,N-dimethyl-2-[(2-methylprop-2-enoyl)oxy]ethan-1-aminium chloride (It is limited that the content of the components having molecular weight less than 1,000 is 1% or less.)

Publication of Assessment Results

On the same day, METI also released the bioaccumulation and degradability assessment for these substnaces. The complete list of newly added substances can be found here.

On 5 August 2025, Japan’s Ministry of Economy, Trade and Industry (METI) published draft amendments to notification provisions for the manufacture or import of chemicals under Chemical Substances Control Law (CSCL). The draft was released on Japan’s e-GOV Public Comment Portal. The changes apply to: 

• General chemical substances
• Priority assessment substances
• Monitoring chemical substances
• Class II specified chemical substances  

Key Insights from the Draft

METI has proposed the following revisions in the draft: 

I. Amendment to the Ministerial Ordinance

1. Cleanup of Regulations (Articles 18 & 19)

• Article 18 and 19 (previously marked for deletion) will now be formally removed.

2. Changes to Electronic Notification Requirements (Articles 20–21)

• In addition to electronic signatures, user-set passcodes (such as G Biz ID) become acceptable authentication methods.
• This applies to notifications for:
  • General chemical substances (Article 9-2)
  • Priority assessment substances (Article 9-3)
  • Monitoring chemical substances (Article 10)
  • Class II specified chemical substances (Article 15)

The notifier code requirement will be abolished and replaced with the new passcode system. As a result, Article 21 will be repealed.

3. Revision of Article 19

A 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:

Additional revisions will be made to: Articles 5-2, 9-2, 9-3(2), 10(2), 15(2), and Article 22 (renumbered as Article 20),as well as to the Supplementary Provisions on transitional measures.

II. Amendment to METI Notification Related to Technical Standards

The notification specifying the technical standards for computers and electronic certificates under Articles 20 and 20-2 will be updated to reflect the regulatory changes mentioned above .

Comment Period and Enforcement Dates 

Stakeholders are invited to comment on the draft by 3 September 2025. METI plans to publish the final draft in October 2025, while enforcement is scheduled to begin on 1 April 2026.

The Brazilian Health Regulatory Agency (ANVISA) has opened a public consultation on proposed updates to the lists of food additives and technological aids. The measure aims to amend Instrução Normativa - IN nº 211, of March 1, 2023, which currently regulates the technological functions, maximum usage limits, and conditions of use for such substances in food products.

The proposal, published in the Diário Oficial da União (DOU) on July 8, 2025. The consultation period runs from July 15 to August 28, 2025, with the possibility of extension depending on the number of contributions received. The initiative seeks to ensure that Brazilian food safety regulations remain consistent 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 ongoing need to adjust the lists of authorized additives and technological aids. These revisions help ensure that technological innovations remain consistent with the fundamental principles governing the safe use of these substances. Additionally, the proposed changes respond to 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 used to facilitate food production but are not intended for consumption, although their use may result in trace residues in the final product.

• Revision of Existing Categories: Adjustments will be made to existing food product categories under the current regulation. For example, the category "Other Dairy Products" will be removed, and the substances previously listed under it will be redistributed into newly proposed categories, better reflecting current market trends.
• New Categories and Functions: The consultation proposes to introduce specific provisions for the use of additives and technological aids in "plant-based" foods, a growing segment in the global food market. This update aims to address existing regulatory gaps as the current list does not adequately cover this rapidly expanding category.
•  International Convergence: The updates seeks to harmonize Brazilian regulations with international standards, particularly those established by the Codex Alimentarius, the global food safety standards body. This is part of an ongoing effort to ensure that Brazilian food safety regulations meet global expectations and are consistent with international trade agreements.

Key Dates and Consultation Process

• Public Consultation Period: July 15 to August 28, 2025.
• Status: The proposal is currently open for public comments, and stakeholders are encouraged to submit their contributions.
• Regulatory Impact: The proposal is classified as low-impact, meaning the proposed updates are not expected to cause significant disruption to industry operations but still require consultation to ensure that stakeholders' concerns are addressed.

The proposed updates aim to provide clarity for food manufacturers regarding which 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, helping ensure 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 initiative marks the third attempt by ANVISA to update the lists of food additives and technological aids, following previous initiatives in August 2023 and November 2024. For further details, the full draft regulation (in Portuguese) is available here.

A groundbreaking law passed by the Brazilian government on July 30, 2025, now prohibits the use of animals in testing cosmetics, personal care products, 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 efforts to strengthen animal welfare protection.

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. It also introduces stricter labeling rules for products that may have been tested on animals before the law's entry into force.

Key Provisions

Under the revised Law No. 11,794, the following provisions stand out:

1. Prohibition on Animal Testing: Sections 11 and 12 of the amended law clearly prohibit testing on vertebrate animals is prohibited for both finished products and ingredients used in personal care, cosmetics, and perfumes. This includes any testing conducted to evaluate the safety, efficacy, or potential harm of the substances.

2. 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 also applies to any animal test data used to substantiate safety claims for the ingredients.

3. 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 ensure transparency and prevent misleading claims.

4. Alternative Testing Methods: The law prioritizes the use of internationally recognized and validated alternative testing methods. It requires the competent authorities to promote and expedite the recognition and adoption of these methods, ensuring they become widespread throughout the nation.

5. Exemptions in Exceptional Circumstances: In rare cases where a cosmetic ingredient poses a significant health risk, and no viable alternative testing method exists, an exemption my be granted by the National Commission for the Control of Animal Experimentation.

Implementation and Enforcement

Health authorities have a maximum of two years to implement and regulate these new rules. Specifically, the they 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 that companies do rely on post-enforcement animal testing data for regulatory purposes.

• Ensure Accurate Labeling: Enforce regulations on 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 prerequisite for product registration under Brazil’s health authority, Anvisa.

A Step Toward Global Change

Brazil’s landmark decision positions the country as a global leader in ethical treatment of animals, aligning with international trends as more nations move to prohibit animal testing for cosmetics. While several countries have already implemented similar restrictions, Brazil stands out as one of the largest emerging markets to take such decisive action.

This shift is expected to encourage 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 that have long advocated for such bans in the fight for humane testing practices.

The law took effect immediately following its publication, marking a historic day for Brazil and animal welfare advocates alike. For further details, see the full text of the Law (in Portuguese) here.

Argentina has introduced a new 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 based on 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.

Structure of the Regulation

Resolution 393/2025 includes four annexes. Annex IV defines the eligible non-hazardous recovered materials, while Annexes I, II and III outline the procedures for import, transit and export. All applications must be submitted through the Trámites a Distancia (TAD) platform and undergo technical evaluations, customs checks and compliance reviews.

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.

Compliance and Oversight

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 notifications 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, and strengthen consumer safety, quality assurance, and market consistency.

Summary of Newly Adopted Standards:

Implications for Stakeholders :

Manufacturers and Importers: Must align product formulations, labelling, and safety testing with the new standards before placing products on the market in EAC countries.

Regulators: Will have a unified reference point for market surveillance and enforcement, helping minimize cross-border compliance issues.

Consumers: Benefit from clearer labelling requirements, improved safety safeguards and more consistent product performance.

These measures contribute to ongoing EAC efforts to strengthen regulatory harmonization in support of regional trade, as reflected in the WTO notification.

On 22 July 2025, the Kingdom of Saudi Arabia notified the World Trade Organization (WTO) of changes to its Technical Regulation for Packaging. The update, circulated under G/TBT/N/SAU/1286/Add.1, confirms that the provisions of the regulation have been aligned with the recently issued Product Safety Law. The notification includes the revised regulation and the updated list of standards.

Scope and General Requirements

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 Regulatory Updates

Key updates include:

• Alignment with the Product Safety Law ensuring packaging meets safety, environmental, and consumer protection standards without discrimination between local and foreign products.
• Detailed compliance obligations for manufacturers, authorized representatives, importers, and distributors, including requirements for technical documentation, conformity assessment, labelling in Arabic, and product traceability.
• Enhanced basic requirements for design, materials, reusability, recycling, and the prohibition of hazardous substances, including limits on heavy metals such as lead, cadmium, mercury, and hexavalent chromium.
• Clear conformity assessment procedures and recognition of both Saudi and internationally harmonized standards.
• A comprehensive list of 43 national, regional, and international standards, covering environmental optimization, material recycling, barcoding, accessible design, and packaging performance criteria.

Transition and Comments

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, circulated under d G/TBT/N/SAU/1166/Corr.1/Add.1 on 23 July 2025, aligns the regulation with the country’s recently issued Product Safety Law. The WTO notification includes the revised regulatory text and the updated list of applicable standards.

Scope and Key Compliance Requirements

According to the WTO notification, the updated regulation strengthens the safety, health, and environmental compliance of electrical and electronic equipment placed on the Saudi market. It introduces clearer compliance obligations for manufacturers, importers, and distributors, including the preparation of technical documentation, Arabic-language safety instructions, and the application of mandatory conformity assessment procedures.

The regulation applies to a broad range of products, including household appliances, IT equipment, lighting devices, tools, toys, and monitoring instruments. Exemptions include medical devices, military equipment, and certain large-scale industrial machinery.

The technical limits for hazardous substances remain unchanged, setting maximum concentrations in homogeneous materials for:

• lead (0.1%)
• mercury (0.1%)
• cadmium (0.01%)
• hexavalent chromium (0.1%)
• polybrominated biphenyls (0.1%)
• polybrominated diphenyl ethers (0.1%)
• selected phthalates (0.1%)

Implementation, Enforcement and Consultation

Economic operators are required to maintain records, conduct risk assessments, ensure continued conformity of serial production, 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):

• Procedure for forming and maintaining the EAEU register of chemical substances and mixtures
• Procedure for notification of new chemical substances

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:

• A unified register of chemical substances and mixtures circulating in the EAEU
• Standardized notification procedures for new chemical substances
• Up-to-date information for market participants on chemical products
• Reduced financial and time costs for preparing documents, including safety data sheets and conformity assessment

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.