GPC Newsletter Jun-2025

On March 26, 2025, Canada amended the Domestic Substances List to apply Significant New Activity (SNAc) provisions to trixylyl phosphate (CAS RN 25155-23-1). This requires prior notification before undertaking any new use that could significantly increase human or environmental exposure to the substance.

Precautionary Action Under CEPA

Based on the suspicion that information about new activities involving trixylyl phosphate could help determine its potential toxicity under Section 64 of the Canadian Environmental Protection Act (CEPA), the Environment Minister, Steven Guilbeault, and the Health Minister jointly made the decision.

The order, issued under subsection 87(3) of CEPA, serves as a preventive measure to guarantee that any future applications of the substance are thoroughly evaluated to limit risks to the environment and public health.

Further details can be found in the Canada Gazette, Part II, Volume 159, Number 7 (here), which includes the precise substance impacted and outlines the necessary regulatory requirements.

SNAc provisions to trixylyl phosphate

Order 2024-87-24-01 amends the Domestic Substances List to apply CEPA's SNAc provisions to trixylyl phosphate, also known as phenol, dimethyl-, phosphate (3:1). This action seeks to manage potential risks associated with increased exposure in Canada and the environment due to significant new activities.

Although current use levels do not pose an immediate risk, the substance is used in flame retardants, hydraulic fluids, lubricants, plastics, and possibly food packaging. It has been identified as having potential reproductive toxicity and environmental persistence.

Notification Requirements for New Activities

Under the new requirements, any individual or company proposing a significant new activity involving trixylyl phosphate, particularly in cosmetics or consumer products, must submit a Significant New Activity Notification (SNAN) containing detailed information on the proposed use, exposure levels, and safety measures, at least 90 days prior to the activity.

The regulatory amendment follows assessments under Canada’s Chemicals Management Plan (CMP) and aims to proactively protect public health and the environment from future risks associated with the increased or altered use of this substance.

Introduced in the 2025–2026 legislative session, California Senate Bill 682 (SB 682) aims to address environmental and public health concerns associated with perfluoroalkyl and polyfluoroalkyl substances (PFAS). These substances are often referred to as "forever chemicals" due to their persistence in the environment and human body. 

Key Highlights of SB 682: 

1. Timeline for PFAS Restrictions: 

• January 1, 2027: Prohibition on distributing, selling, or offering for sale covered products containing intentionally added PFAS. There are exceptions for previously used products and instances where federal law preempts state regulation. 

• January 1, 2033: Broader restrictions on additional PFAS-containing products, unless deemed unavoidable by the Department of Toxic Substances Control (DTSC). 

• January 1, 2040: Further prohibitions on specific products, including refrigerants and solvents, unless exempted. 

2. Definition of Covered Products: 

The bill defines "covered products" to include a range of items such as cleaning products, cookware, dental floss, juvenile products, food packaging, and ski wax. 

3. Regulatory Framework: 

The Department of Toxic Substances Control (DTSC) must adopt regulations by January 1, 2027, to enforce these provisions. This includes establishing application fees. Once the regulations are in place, it will be illegal to distribute, sell, or offer for sale non-exempt products that contain more than allowed levels of PFAS. 

4. Compliance and Enforcement: 

Manufacturers will need to register with the DTSC and certify their compliance with PFAS prohibitions. The department will have the authority to test products, issue violations, and impose penalties for non-compliance. 

5. Transparency and Public Access: 

The DTSC will maintain a publicly available list of products deemed to have a currently unavoidable use of PFAS. This ensures transparency and enables consumers and businesses alike to make informed decisions. 

What This Means for You: 

As a business owner or stakeholder in the consumer products industry, it’s crucial to stay informed about these upcoming changes. Compliance with these regulations will not only be necessary to avoid penalties but also to align with growing consumer demand for PFAS-free and environmentally safer products. 

Next Steps: 

• Review Your Products: Assess your current product lines for PFAS content and begin planning for compliance with the new regulations. 

• Stay Informed: Keep an eye on updates from the DTSC regarding the development of the regulations and the compliance application process. 

• Engage with Stakeholders: Consider discussing these changes with your supply chain partners to ensure a smooth transition and compliance strategy. 

On 4 April 2025, the United States notified the World Trade Organization (WTO) of a proposed rule to establish Significant New Use Rules (SNURs) for 37 chemical substances under the Toxic Substances Control Act (TSCA). The proposal was published by the U.S. Environmental Protection Agency (EPA) in the Federal Register under docket number EPA-HQ-OPPT-2024-0332. 

Scope and Regulatory Background 

The SNURs aim to require manufacturers, importers, and processors to submit a Significant New Use Notification (SNUN) at least 90 days before engaging in any activity identified as a significant new use. This enables EPA to evaluate any potential health or environmental risks before such uses begin. 

The affected substances, which were previously reviewed under Premanufacture Notices (PMNs), are used in various applications, including polymers, coatings, adhesives, surfactants, perfumes, UV-curable resins, and catalysts. The proposed SNURs seek to limit uses that deviate from original risk assessments. 

What’s Next? 

The public comment period ended on 6 May 2025. EPA will now review the submitted feedback and may revise the proposal before publishing a final rule. Once finalized, the rule will be incorporated into 40 CFR Part 721 and compliance will be legally binding. 

Stakeholders, particularly those in the chemical manufacturing and import sectors, are advised to monitor for updates and prepare for potential regulatory obligations once the final rule is issued. 

On May 12, 2025, the U.S. Environmental Protection Agency (EPA) issued an interim final rule delaying the start of the PFAS reporting period under the Toxic Substances Control Act (TSCA) Section 8(a)(7). Originally set to begin on July 11, 2025, the reporting window will now open April 13, 2026. This extension allows the Agency more time to finalize and test the data collection system. 

New Deadlines

General manufacturers and importers: October 13, 2026 

Small manufacturers (article importers only): April 13, 2027 

The submission delay takes effect immediately, but EPA will accept public comments on it for 30 days. The Agency may also revisit other parts of the PFAS reporting rule and will review all comments together. Feedback can be submitted at www.regulations.gov (Docket: EPA-HQ-OPPT-2020-0549). 

The agency may also propose changes to other parts of the rule in the near future. 
For more information about the rule, please visit US EPA finalises rule requiring reporting of PFAS data. 

On 29 April 2025, the European Chemicals Agency (ECHA) announced a proposal for an EU-wide restriction on certain hexavalent chromium (Cr(VI)) substances. This initiative aims to mitigate the harmful effects of these carcinogenic chemicals on workers and the general public.

Background: Expansion of the Restriction Scope

In September 2023, the European Commission requested that ECHA prepare a REACH restriction proposal on certain chromium(VI) substances currently on the Authorisation List, specifically targeting chromium trioxide (entry 16) and chromic acids (entry 17). Recognizing the potential risks of substituting these substances with other hazardous chromium(VI) compounds, the Commission expanded the mandate in April 2024.

Scope of the Proposed Restriction

The restriction proposal targets Cr(VI) substances listed in entries 16 to 22 and 28 to 31 of the REACH Authorisation List. It also considers other Cr(VI) substances not currently on the Authorisation List, such as barium chromate, in order to prevent potential risks if these substances are used as substitutes.

The proposal suggests banning the use of these substances, except in specific applications where defined limits for worker exposure and environmental emissions are met. The exempted use categories include:

• Formulation of mixtures

• Electroplating on plastic substrates

• Electroplating on metal substrates

• Use of primers and other slurries

• Other surface treatments

• Functional additives/process aids

Risks Associated with Cr(VI) Exposure

Hexavalent chromium compounds are recognised as some of the most potent carcinogens in the workplace. Workers exposed to Cr(VI) are at an increased risk of developing serious health issues, particularly lung and intestinal cancers. Additionally, communities residing near industrial sites that emit these substances may also be at increased risk due to environmental contamination.

Health and Environmental Impact

The proposed EU-wide restriction on certain hexavalent chromium (Cr(VI)) substances aims to significantly reduce environmental emissions and protect public health. By limiting the use of these carcinogenic chemicals, the initiative could prevent up to 17 tonnes of Cr(VI) from being released into the environment each year. This reduction is projected to avert approximately 195 cancer cases each year. Over a 20-year period, the monetised benefits of the restriction are estimated to range between €331 million and €1.07 billion, depending on the specific measures implemented.

Next Steps

The European Chemicals Agency (ECHA) is set to initiate a six-month public consultation on the proposed restriction of certain chromium(VI) substances on 18 June 2025. This consultation period offers stakeholders an opportunity to submit detailed information and evidence pertinent to the proposal. To facilitate active participation and provide clarity on the restriction process, ECHA is planning to host an online information session. This session will provide guidance on how interested parties can contribute effectively to the consultation.

ECHA’s scientific Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) will evaluate the restriction proposal, based on the scientific evidence received during the consultation period. The European Commission, in collaboration with the 27 EU Member States, will make the final decision on the restriction and its conditions based on the proposal from ECHA and the committees’ opinions.

The full text of the Annex XV Restriction Report can be found here.

The European Commission has published a draft amendment to Regulation (EC) No 340/2008, proposing a 19.5% increase in standard fees and charges payable to the European Chemicals Agency (ECHA) under the REACH Regulation. The adjustment reflects cumulative inflation from 2021 to 2023.

To safeguard small and medium-sized enterprises (SMEs), the proposed inflation-linked increase will not apply to SMEs, in line with the EU’s SME Relief Package and the 2024–2029 Political Guidelines.

New Pre-Submission SME Verification Required

A major change concerns the SME status verification process. Under the draft regulation:

• Companies must apply for SME recognition at least two months before any fee-related submission.

• ECHA must decide on SME status within two months of receiving complete documentation.

• Recognised SME status will be valid for three years and apply to all relevant EU submissions during that period.

ECHA May Charge for SME Verification Workload

To improve efficiency, ECHA may introduce an administrative charge for SME verification, which will be waived if SME status is confirmed. The new SME provisions will take effect 15 months after the regulation enters into force. Submissions pending at the time of entry into force will not be affected.

This draft amendment forms part of the EU’s broader efforts to enhance the financial sustainability of ECHA, following a drop in fee revenue after the 2018 REACH registration deadline.

On 5 May 2025, the European Commission launched a public consultation on the evaluation of Regulation (EC) No 1223/2009 on cosmetic products. This regulation governs the safety, labelling and marketing of cosmetics in the EU. The consultation is open until 28 July 2025 and invites feedback from consumers, industry representatives, NGOs, public authorities and other stakeholders.

What the Consultation Covers

The questionnaire seeks input on a broad range of topics to support the ongoing evaluation of the Cosmetics Regulation. These include:

• Whether the Regulation continues to ensure a high level of protection for human health.

• Views on labelling requirements, including clarity, usefulness, and digital solutions.

• Safety assessments, including the role of ingredients and traceability.

• Alignment with other EU chemicals legislation (e.g. REACH and CLP).

• The effectiveness of animal testing bans and their impact on innovation.

• Market surveillance and enforcement at Member State level.

• Whether the current framework supports technological and scientific developments.

Stakeholders can respond to targeted multiple-choice questions, submit written comments, and suggest areas where improvements or clarifications may be needed.

Background: Why the Regulation Is Being Evaluated

This consultation follows the call for evidence published earlier this year and forms part of the European Commission’s broader evaluation of the Cosmetics Regulation, which was launched in early 2025 under the Better Regulation framework. The evaluation aims to determine whether the Regulation remains effective, efficient, coherent, and relevant in light of emerging challenges, such as digital labelling, animal welfare, and its interface with chemicals legislation.

Access the Consultation

Stakeholders can participate here and more information on the evaluation can be found here.
 

In May 2025, the European Commission adopted two Delegated Regulations introducing new restrictions under Regulation (EU) 2019/1021 on Persistent Organic Pollutants (POPs). These measures implement decisions from the Stockholm Convention and target two hazardous substances: UV-328 and Dechlorane Plus.

UV-328 Added to POPs Regulation – Adopted 5 May 2025

On 5 May 2025, the Commission adopted a Delegated Regulation adding UV-328 (CAS No. 25973-55-1) to Annex I of the POPs Regulation. This follows the decision taken at the 11th Conference of the Parties to the Stockholm Convention to list UV-328 for global elimination due to its persistence, bioaccumulation, and toxicity.

Key Provisions:

• Manufacture, use, and placing on the market of UV-328 is prohibited.

• A maximum concentration limit of 1 mg/kg is set for UV-328 when present as an unintentional trace contaminant in substances, mixtures, or articles.

• Time-limited exemptions (5 years) apply for specific uses such as:

  • Triacetyl cellulose film in polarizers for LCDs.

  • Photographic paper and imaging products.

  • Mechanical separators in blood collection tubes.

  • Certain articles used in land-based motor vehicles.

• Articles containing UV-328 that were already in use in the Union before or on the date of expiry of the relevant exemption may continue to be used.

Dechlorane Plus Restricted Under POPs Regulation – Adopted 15 May 2025

On 15 May 2025, the Commission adopted a second Delegated Regulation to include Dechlorane Plus (CAS No.13560-89-9) in Annex I of the POPs Regulation. This amendment aligns with Decision SC-11/10 of the Stockholm Convention, which recognises Dechlorane Plus as a persistent organic pollutant with harmful environmental and health effects.

Key Provisions:

• Manufacture, use, and placing on the market of Dechlorane Plus is prohibited.

• A temporary higher limit of 1000 mg/kg is permitted for trace contamination, to, be reduced to 1 mg/kg after 30 months to allow laboratories to adapt.

• Exemptions (5 years with possible 5-year extension) apply to:

  • Spare parts for land-based motor vehicles and outdoor power equipment.

  • Medical devices and in-vitro diagnostic devices.

  • Analytical instruments used in testing, monitoring, and production.

• Articles containing dechlorane plus that were already in use in the Union before or on the date of expiry of the relevant exemption may continue to be used.

Next Steps

Both regulations will enter into force following their publication in the Official Journal of the European Union. Companies using these substances must review their supply chains and ensure compliance within the timelines set out in the respective regulations.

On 14 May 2025, the European Chemicals Agency (ECHA) published a new guideline outlining standardized procedures for measuring formaldehyde emissions from consumer products and vehicle interiors. The document supports the implementation of Regulation (EU) 2023/1464, which introduces strict limits on formaldehyde emissions in order to protect public health.

Emission Limits and Compliance Deadlines

Regulation (EU) 2023/1464 stipulates that, as of 6 August 2026, furniture and wood-based articles must not emit more than 0.062 mg/m³ of formaldehyde. For other articles, the limit is 0.080 mg/m³. The maximum concentration inside road vehicles is also set at 0.062 mg/m³, with compliance required by 6 August 2027.

Standardized Testing Methods

The new guideline outlines detailed procedures for testing formaldehyde emissions, to ensure consistent and reliable measurements across the EU. These procedures are crucial for manufacturers and importers to verify that their products meet the new limits.

Exemptions and Regulatory Scope

The regulation includes exemptions for second-hand articles, products intended solely for outdoor use, and products that are already covered by specific EU legislation. These exemptions are designed to ensure that the regulation is both protective and proportionate.

Public Health Impact

By standardizing measurement practices and enforcing emission limits, ECHA aims to significantly reduce exposure to formaldehyde in indoor environments, thereby lowering the associated health risks, such as respiratory conditions and cancer. Stakeholders are encouraged to familiarize themselves with the guidelines ahead of the upcoming deadlines.

The guidelines can be accessed here.

On 15 May 2025, the European Commission published Regulation (EU) 2025/877, which updates Annex II of the EU Cosmetics Regulation (Regulation (EC) No 1223/2009). This amendment adds 21 substances to the list of those prohibited in cosmetic products due to their classification as carcinogenic, mutagenic, or toxic to reproduction (CMR) under Delegated Regulation (EU) 2024/197. The new bans will apply from 1 September 2025 across all EU Member States.

Affected Substances

The new entries include substances used across industrial sectors, such as:

• Tetrabromobisphenol A and Bisphenol AF, which are often used for flame retardancy and plastic stabilisation.

• Transfluthrin and clothianidin, which are known for their pesticidal properties.

• Dibutyltin maleate and dibutyltin oxide, which are used as catalysts and stabilisers in polymers.

• Aromatic amines such as N,N-dimethyl-p-toluidine.

• Several reaction mass mixtures involving bisphenol and phosphonium compounds.

Also impacted is trimethylbenzoyl diphenylphosphine oxide (CAS 75980-60-8). Previously permitted for professional nail products, it has now been fully banned due to its classification as toxic for reproduction.

List of Newly Banned Substances in Cosmetics (Annex II)

Clarification of Cymoxanil Entry in Annex II

The regulation replaces entry 1580 for cymoxanil in Annex II to include a second chemical name and corresponding CAS number (166900-80-7). This change ensures coverage of the chemical identity for both forms of the substance and improves legal clarity. Additionally, entry 311 in Annex III has been deleted.

Compliance Reminder

From 1 September 2025, all cosmetic products containing these substances must be removed from the EU market. Manufacturers, importers, and distributors should carefully review their formulations and update their compliance documentation accordingly.

The full text of the Regulation can be accessed here.

On 20 May 2025, the European Chemicals Agency (ECHA) announced that it has officially launched its redesigned Classification and Labelling (C&L) Inventory, which is now integrated into the Agency’s ECHA CHEM platform. This update provides clearer access to both harmonised EU-level classifications and company-notified entries under REACH.

Key Enhancements

• Comprehensive Data: The updated inventory includes over 4,400 EU-harmonised classifications and around 7 million classifications submitted through REACH registrations, covering approximately 350,000 substances.

• Visual Interface: Classification information for each substance is presented in a visual format, improving navigation and usability.

• Improved Transparency: Users can more easily identify the classification with the highest level of agreement and determine its source.

• Regulatory Updates Incorporated: The inventory reflects recent developments, including the introduction of new CLP hazard classes.

• Future Features: Additional functionalities such as application programming interfaces (APIs) are being explored to further enhance data accessibility.

ECHA CHEM

This update follows the initial launch of ECHA CHEM in January 2024, which gave th public access to over 100,000 REACH registrations. The revamped C&L Inventory is part of ECHA’s efforts to create a stable and scalable database that centralises EU chemical data.

Next Steps

Future releases of ECHA CHEM will include overviews of regulatory decisions and activities, such as REACH restrictions, thereby enhancing public access to EU chemicals regulation.

The UK Health and Safety Executive (HSE) has published its 2022 report on the official monitoring of plant protection products (PPPs), revealing significant compliance issues in the food and agriculture sectors. Issued under Article 68 of the retained EU Regulation 1107/2009, the report provides insights into national control measures for placing PPPs on the market and monitoring their use.

Summary of Official Controls and Enforcement

• 1,631 inspections were carried out by the HSE across Great Britain in 2022, targeting storage sites, online sales, and agricultural use.

• 65 product samples were collected for laboratory testing. Of these, 28 failed to meet legal requirements due to the presence of unauthorised co-formulants, unapproved use conditions, and labelling deficiencies.

• Follow-up actions included improvement notices, voluntary withdrawals, product recalls. In a few cases, there were enforcement notices and prosecutions.

• The focus of several campaigns was on high-risk products, such as triazole fungicides and copper compounds, and increased scrutiny of online marketplaces.

Residue Monitoring and Food Chain Risk

In collaboration with the Food Standards Agency (FSA), Food Standards Scotland (FSS), and DAERA in Northern Ireland, the UK’s pesticide residue surveillance programme tested 3,304 food samples across a wide range of commodities. Overall compliance with maximum residue levels (MRLs) was over 98%, but 60 samples exceeded the legal thresholds.

One area of concern was the detection of tri-allate residues in kale and broccoli, likely due to volatilisation and drift after application. Risk management discussions have been initiated with authorisation holders.

Northern Ireland: Online Sales and Compliance

The Department of Agriculture, Environment and Rural Affairs (DAERA) investigated six cases of non-compliance relating to unauthorised online pesticide sales. All cases were voluntarily resolved, underscoring the growing attention that enforcement is paying to digital platforms.

Industry Implications

The 2022 findings underscore the importance of:

• Maintaining robust supply chain controls to prevent contamination.

• Verifying authorisations for products marketed online and in stores.

• Ensuring that correct labelling and formulation details are upheld throughout the manufacturing and distribution process.

Looking Ahead

The HSE has indicated that future monitoring will continue to target high-risk products, unapproved imports, and digital sales channels. Retailers, manufacturers, and users of PPPs are encouraged to carefully review their compliance obligations.

Access the full 2022 report here.

The Department of Chemicals and Petrochemicals has extended the enforcement dates for Quality Control Orders (QCOs) for six chemicals. The updated dates were announced in a notification published in the Gazette of India on 25 April 2025, in consultation with Bureau of Indian Standards (BIS). The QCOs were originally published on 27 April 2022. 

Chemicals and revised enforcement dates   

The Quality Control Order mandates that the concerned substances carry the certification mark of the Bureau of Indian Standards, ensuring that the existing rules remain in force until the implementation of the new QCOs.  

India’s Ministry of Mines has issued a set of new Quality Control Orders (QCOs) that will make Bureau of Indian Standards (BIS) certification a compulsory prerequisite for the import and sale of certain non-ferrous metals. Effective from October 17, 2025, the regulation aims to improve product quality, safety, and standardization in the Indian metals market. 

Metals Affected and ISI Mark Requirements 

The metals impacted include refined nickel, tin ingots, primary lead, and refined zinc. These metals must carry the ISI mark as proof of BIS certification. Without this certification, imports will be barred from the Indian market. 

Certification Process 

The BIS certification process includes factory inspections, product testing, and document verification. Since this process may take several months, exporters should start early to avoid delays or disruptions. 

Metals Covered Under the New BIS Certification Requirement 

The affected non-ferrous metals and their applicable Indian Standards are listed below:  

• Refined Nickel – IS 2782:2023 

• Tin Ingot – IS 26:2024 

• Primary Lead – IS 27:2023 

• Refined Zinc – IS 209:2024 

Final Thoughts 

The introduction of mandatory BIS certification for these metals underscores the importance of compliance in global trade and supply chain management. Exporters to India must carefully review their product lines and certification status to ensure uninterrupted market access. 

On 11May 2025, the Bureau of Indian Standards (BIS) issued several draft Indian Standards and amendments for public consultation. This presents an important opportunity for stakeholders to provide feedback and ensure that the standards are aligned with current industry needs and practices. Participation is essential to ensuring these standards effectively meet the industry’s evolving needs. 

Draft Standards and Amendments Open for Comment 

The following documents are open for public comment: 

How to Submit Comments 

Interested parties are encouraged to review the draft standards and submit their comments by the respective deadlines, especially if any provisions may affect their business or professional activities once adopted.  

Feedback can be submitted directly via the BIS portal here, using the prescribed template.  

China’s National Medical Products Administration (NMPA) has introduced new rules the ‘Administrative Measures for Monitoring and Evaluation of Cosmetic Safety Risks‘, which are set to take effect on 1 August 2025. The purpose of the new measures  is to to strengthen supervision of cosmetics and standardize safety risk monitoring and assessment.

Key Points: 

Start Date: The rules will take effect on 1 August , 2025. 

What’s Covered:

• Checks on ingredients, finished products, and how they are made and sold.
• Monitoring for any side effects or safety issues when people use them. 

Who’s Responsible:

• Cosmetic companies (brands, manufacturers, and sellers) must track and report safety risks.

What Will Happen

• Safety Checks: The government will collect data from tests, customer complaints, and inspections. 
• Risk Levels: Products with high risks levels may be recalled or banned.
• Public Updates: Safety reports will be shared to help consumers make informed choices. 

What Companies Must Do 

• Follow quality control rules and report any safety problems. 
• For new ingredients or special claims (such as "anti-aging"), extra safety tests are needed. 
• If companies don’t comply, they could face warnings, fines, or other penalties. 

Why This Matters 
These rules aim to prevent problems before they happen, making cosmetics safer for everyone. Companies should prepare now to comply with the new system. 
The official announcement can be accessed on the NMPA website here. 

Taiwan’s Ministry of Environment has announced stricter controls on several high- risk chemicals, including PFOS, PFOA, nonylphenol (NP), nonylphenol ethoxylates (NPEO), and cycloterpenes. Starting June 1, 2025, these substances will be listed as toxic or of concern，with new concentration limits and use restrictions. 

PFAS Under Tighter Control 

Perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) are, part of the broader group of per- and polyfluoroalkyl substances (PFAS) , They are known for their persistence in the environment and their ability to accumulate in living organisms., This poses risks to ecosystems and human health. Following international conventions likeIn line with the Stockholm Convention, Taiwan is now regulating over 350 related PFAS compounds. 

Stricter Limits on NP and NPEO 

NP and NPEO, which are classified as endocrine disruptors, have been banned in household cleaning products in Taiwan since 2007. Now, stricter rules will cap their use at 0.1% in cleaning products and high-risk applications, and ban the import of such products. 

Cycloterpenes Ban in Specific Applications 

Due to their toxicity and risk of bioaccumulation, cycloterpenes,  will be banned in antifouling paints, systems, and biocides.

Grace Period and Industry Guidance 

To help businesses transition, the ministry will offer a grace period of one and a half to two years. Officials also encourage industries to find safer alternatives to protect health and the environment. More details are available on the Ministry of Environment’s website or in the Executive Yuan Gazette. 

On May 6, 2025, China’s Ministry of Ecology and Environment (MEE) published an official notice announcing updates to the Inventory of Existing Chemical Substances in China (IECSC). 

New and Registered Substances Added to IECSC 

• 44 new substances were added to the IECSC. These are chemicals that are now officially recognized as existing substances in China. This update is listed as the 2025 First Batch (Total Batch 13). 

• 37 substances, which were previously registered as new chemical substances, have now been officially added to the IECSC. This means they are no longer considered “new” and can be managed under existing substance rules. This is the 2025 First Batch (Total Batch 15). 

Revised Use Conditions for Two Substances 

• The allowed uses for 2 existing substances have been changed. This is important for companies who use or import these chemicals, as they must follow the new use conditions. This update is listed as the 2025 First Batch for Use Changes (Total Batch 1). 

These updates where made under China’s chemical management rules under MEE Order No. 12. Companies should check the updated listingss and ensure compliance with any changes. 

For more details, companies can visit the MEE website or contact their local environmental authority.  

On March 27, 2025, South Korea’s Ministry of Employment and Labor (MOEL) released a list of 72 new chemical substances that were manufactured or imported into the country during the first quarter (Q1) of 2025. The announcement is part of Korea’s continued effort to ensure chemical safety in workplaces under the Korea Occupational Safety and Health Act (KOSHA). Consequently, employers are urged to review the published list, implement the recommended safety measures, and educate all workers, especially foreign employees, on the proper chemical handling practices. 

Key Contents 

• Total Substances Announced: 72 new chemical substances registered in Q1 2025. 

• Hazardous Substances Identified: 32 substances, including 2-methylpiperazine, found to pose risks such as: 

• Acute toxicity 

• Reproductive toxicity 

• Skin corrosion/irritation 

 Compliance Requirements for Manufacturers and Importers 

• Pre-Notification Obligation: Manufacturers and importers must submit a hazard and risk assessment report to the MOEL 30 days before production/import. 

• Safety Measures for Employers: 

• Provide personal protective equipment (PPE) 

• Install local exhaust ventilation 

• Maintain and display Material Safety Data Sheets (MSDS) 

• Use proper hazard warning labels 

Foreign Worker Safety 

• To improve chemical safety for foreign employees, MOEL has published MSDS and label training materials in 17 languages, including English, Vietnamese, Chinese, and more. These materials help workers recognize hazard symbols and understand key safety instructions. 

On May 9, 2025, South Korea notified the World Trade Organization (WTO) of proposed amendments to the "Regulation on the Permission, Notification, Review, etc of Medical Devices”. The revision aims to clarify cybersecurity documentation requirements for medical devices that use wired or wireless communication. It also aligns clinical trial data requirements with international standards and addresses administrative inefficiencies identified during prior regulatory operations. 

Key Contents  

1. Procedures for Deferral of New Health Technology Assessment 

The regulations now establish clear steps for applying for approval or certification to defer new health technology evaluations. This includes adding clinical evaluation data as a new type of clinical trial documentation and providing detailed guidance on how to prepare each section. 

2. Unified Oversight for Class II Medical Device Certification 

Applicants seeking confirmation for products equivalent to already-certified Class II devices must now submit documentation to the Ministry of Food and Drug Safety (MFDS) which centralizes the process. 

3. Clarification of Manufacturing and Import Filing Procedures 

Following the amendment to the Medical Device Act Enforcement Rules, the procedure for reviewing manufacturing and import reports has been clearly defined to enhance transparency. 

4. Cybersecurity Requirements for Medical Devices 

The amendment introduces a formal definition of cybersecurity for medical devices and requires that detailed cybersecurity information be included in approval applications. Multiple related provisions and documentation templates have been updated accordingly. 

5. Support Measures for Innovative Medical Devices 

Newly developed medical devices are now eligible for expedited review. However, the exemption from submitting clinical trial data based on equivalence during post-market surveillance is restricted to ensure safety. 

6. Expanded Scope for Technical Documentation 

Examples of situations requiring the submission of clinical data are now included to help clarify when such data is necessary, thereby improving predictability and compliance. 

Public comments 

Individuals or organizations with feedback on the draft amendment may submit written comments by May 20, 2025. 

On May 16, 2025, South Korea launched the construction of the nation’s first dedicated animal-free testing facility, with the aim of promoting ethical scientific practices and improving chemical safety assessments. The facility is being built at the headquarters of the Korea Environment Corporation (K-ECO) in Incheon and is scheduled for completion in October 2026. 

This project supports the global shift towards alternatives to animal testing, aligning with similar moves by the EU and the United States. It will also contribute to South Korea’s national goal of replacing over 60% of toxicity testing with alternative methods by 2030. 

Key Contents  

1. Facility Overview: 

• Size: 7,499㎡, with 4 floors above ground and 1 basement level. 

• Budget: ₩33.4 billion (approximately $24 million). 

• Focus: Testing using human cells, artificial organs, 3D models, and AI simulations. 

2. Functions and Services: 

• Perform non-animal toxicity assessments. 

• Operate a training center for researchers. 

• Host international conferences and workshops. 

• Support certification and provide technical guidance for private testing labs. 

 3. Legal and Policy Support: 

• Based on Korea’s Chemical Substances Control Act. 

• Government policy promotes animal alternatives as a first option. 

Awareness and Engagement Activities  

To coincide with the launch, the Ministry designated May 16–23 as "Animal-Free Testing Awareness Week". Activities include: 

• May 16: Government–industry roundtable on alternative testing. 

• May 20: Expert workshop in Seoul covering: 

• Current government strategies. 

• Case studies from private labs. 

• Research updates and mental health support for animal researchers. 

This facility is expected to reduce dependence on animal testing, lower costs, and improve the accuracy and speed of testing. South Korea aims to become a global leader in ethical, science-driven toxicology and chemical safety. 

On May 19, 2025, South Korea notified the World Trade Organization (WTO) of proposed amendments to the “Special Act on Imported Food Safety Control” aimed at strengthening consumer safety by regulating the use of recycled materials in imported food-contact items such as utensils and packaging. Although Korea’s Food Sanitation Act already regulates the use of recycled materials in domestically produced food-contact items, there are currently no safety standards for recycled materials used in imported items. This gap poses a potential health risk torec consumers. The proposed amendment introduces a system to ensure that recycled materials used in imported utensils, containers, and packaging comply with Korean food safety standards. 

Key Provisions 

1. Mandatory Safety Certification for Recycled Materials (Article 10-3) 

• Importers of food-contact products made with recycled materials must obtain prior approval from the Ministry of Food and Drug Safety (MFDS) to verify that the materials meet the safety criteria under the Food Sanitation Act. 

• Importers must submit the required documentation and may be asked to provide additional safety data. 

• If approved, the MFDS will issue an official certification. 

• Certifications obtained through false or misleading means will be revoked. 

2. Ban on Non-Certified Recycled Material Imports (Article 10-4) 

• It is strictly prohibited to import or sell any food-contact articles made with recycled materials that have not received official MFDS approval. 

3. Enforcement and Penalties (Article 42 Amendment) 

• Violators who import or distribute non-certified recycled products will be subject to regulatory penalties under the revised Article 42. 

On 25 April 2025, Taiwan completed its transition to the eighth revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 8). Full implementation was achieved through the publication of updated Chinese National Standards (CNS) under the CNS 15030 series. 

The Bureau of Standards, Metrology and Inspection (BSMI), under the Ministry of Economic Affairs (MOEA), led the adoption process, releasing the revised standards in three phases: 

• 24 October 2024: Ten standards covering physical hazards were published. 

• 24 February 2025: Ten standards on health hazards were issued, including the new hazard class for desensitized explosives. 

• 25 April 2025: Two standards addressing environmental hazards and the general rules for classification and labelling were finalized. 

This phased approach aligns Taiwan’s chemical classification and labelling framework with UN GHS 8 and marks a significant upgrade from the previously adopted GHS 4, which had been in force since December 2014. 

Key Updates to the CNS 15030 Standards 

The updated standards introduce several critical changes, including: 

• New Hazard Class: Desensitized explosives (CNS 15030-29) added. 

• Flammable Gases: Category 1 is now subdivided into 1A and 1B, distinguishing pyrophoric and chemically unstable gases. 

• Aerosols: Category 3 introduced along with and a new class name – Aerosol and Chemicals under Pressure. 

• Revised Criteria: Updates to the definitions, classification criteria, and testing guidelines for acute toxicity, skin corrosion/irritation, and serious eye damage/irritation. 

Background 

Taiwan initiated the revision process in 2024, with the draft CNS 15030 standards undergoing public consultation in June of that year. In total, 23 of the 29 CNS 15030 series standards were revised to reflect GHS 8 provisions. The full list of updated standards is now accessible via the CNS Online Portal. 

Previous Implementation 

Taiwan previously implemented GHS 4 through notices issued by the Ministry of Labour and the Environmental Protection Administration in 2014. That version served as the basis for CNS 15030-1 to CNS 15030-28. 

Update: On 1 April 2025, Japan’s MHLW, METI and MOE jointly published the revised manual for the methods, procedures, and documents to be submitted for notification and application procedures for new chemical substances. The ministries shared the manual for preparing and submitting notification documents on the METI portal. 

Original Text: 

On 17 March 2025, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW), and Ministry of Environment (MOE) jointly published the amended process for the notification procedure for new chemical substances under the Chemical Substances Control Law (CSCL). The ministries also shared the manual for preparation and submission of documents for notification on the National Institute of Technology and Evaluation (NITE) portal. 

New Chemical Substances Covered by the 2025 Notification 

The following categories of new chemical substances are covered by this notification process:    

• New chemical substances: Chemicals not listed in the Existing Chemical Substances Inventory and imported or manufactured in Japan in quantities > 1 t/y. 

• Low-volume new chemical substances: This category applies to chemicals manufactured or imported in quantities ≤ 10 t/y.  

For background on the timeline leading up to the revision, see our previous GPC news here.  

On 14 May 2025, Japan’s Consumer Affairs Agency (CAA) published safety review procedures for new substances used in food contact materials (FCMs) on the portal. These procedures primarily focus on newly approved and applied substances, which are usually listed publicly. A specific application procedure has also been developed to protect the intellectual property (IP) for businesses that are concerned that revealing the names and usage of substances could harm their ability to compete. 

Key insights from the Safety Procedures 

• Added provisions for the safety assessment of new substances and the re-assessment of already approved substances. 

• A specific procedure has been added to protect intellectual property (IP). 

Positive List for Food Contact Materials (FCM) 

The Positive List is currently in a five-year transitional phase that ends on 1 June 2025.  Only substances on the list will be allowed in food contact applications after the transition period.  New materials must be evaluated before being added to the list,.  

Guidance for Stakeholders   

In Japan, FCMs are governed by the Food Sanitation Act, and the CAA regularly updates its portal to reflect the latest modifications to standards and specifications for foods and food additives. This document aims to assist manufacturers, importers, and suppliers comply with the safety review process for new substances. Following the procedure helps to prevent non-compliance with FCM supply, import, and manufacturing regulations. 

Update: On 14 May 2025, Japan’s Consumer Affairs Agency (CAA) published a revised Q&A document on its portal to further clarify the provisions of a Positive List for Food Contact Materials (FCMs). The CAA has also added a comparison of the previous and newly updated Q&A provisions. 

Original Text: 

On 6 February 2025, Japan’s Consumer Affairs Agency (CAA) published a Q&A document on its portal to clarify the provisions of a Positive List for Food Contact Materials (FCMs). The Positive List is currently in a 5-year transition period ending on 1 June 2025. At the end of the transition period, only entries on the list will be permitted in food contact applications. New materials must undergo assessment before they can be added to the list. 

Key Insights from the Q&A Document  

The main focus of the Q&A document is the Positive List of FCMs, which is governed by the Food Sanitation Act and overseen by the CAA. In general, this Act provides the basis for establishing standards for FCMs.   

The Q&A document covers topics which include following:  

• Scope and definition of the Positive List.  

• Exclusions from the list. 

• Specific product categories. 

• Provisions for polymeric substances. 

• Limits for additives. 

• Implementation guideline. 

Guidance for Stakeholders  

The Food Sanitation Act regulates FCMs in Japan, and the CAA frequently updates its portal to reflect the most recent changes to the requirements and criteria for foods and food additives. The purpose of this Q&A document is to help suppliers, importers, and manufacturers in making efficient use of the Positive List. Adhering to the list helps to prevent non-compliance in the manufacture, import and supply of FCMs. 

On 16 May 2025, Japan’s Ministry of Health, Labour, and Welfare (MHLW) published the revised list of compounds and mixtures that required labelling and safety data sheets (SDS). The list is available on the country’s Workplace Safety Portal, managed by the Ministry. According to the Industrial Safety and Health Act (ISHA), the Globally Harmonized System (GHS) for labelling must be followed.  

List of Labelling & SDS Delivery 

According to Article 57 and 57-2 of the ISHA, it is mandatory to provide a label and SDS for the listed chemicals to safeguard workers’ health and the environment. A total of 2316 chemicals are now listed, with requirements coming into effect in phases from April 2025 and April 2026. 

Previous Update in March 2025 

In March 2025, the MHLW released a list of 7 chemicals subject to labelling and SDS delivery. 

Insights from the Amended List 

From the revised list, the following must have label and SDSs: 

• 1530 chemicals applicable from 1 April 2025 

• 779 chemicals applicable from 1 April 2026 

Obligations for Stakeholders 

Manufacturers, importers, suppliers, and employers are subject to labelling and Safety Data Sheet (SDS) delivery obligations under Japan's Industrial Safety and Health Act (ISHA).  

Australia’s Department of Climate Change, Energy, the Environment and Water (DCCEEW) is moving forward with reforming packaging regulations after reviewing extensive feedback from the public and industry. A recent consultation summary revealed strong support for a nationally coordinated regulatory approach to packaging and momentum is now building towards the next phase of policy development. 

The consultation received 426 responses, including widespread public support for stronger national regulation. Over 80% favoured Commonwealth oversight, and 65% supported Option 3 - an Extended Producer Responsibility (EPR) scheme with mandatory requirements.  

Respondents emphasized the need for close industry consultation during the design of the scheme, reinvestment of EPR funds into the supply chain, and national consistency in recycling efforts. There was also strong backing for bans on problematic packaging materials, mandatory recycled content thresholds, eco-modulated fees, and recyclability labelling. The reform aims to reduce environmental impact and support a circular economy, with further policy development and stakeholder engagement planned. 

Sustainable Shift 

The vast majority (95%) of survey respondents supported the proposed goal of the packaging reform to reduce environmental impacts and promote a circular economy in Australia. Many called for stronger measures to avoid, reduce, and reuse packaging waste, especially plastic packaging. There was clear backing for targeting problematic materials first and banning harmful packaging materials such as carbon black, oxo-degradables, and PFAS.  

Respondents favoured eco-modulated financial incentives to encourage sustainable packaging design, along with mandatory national thresholds for recycled content. There was also strong support for compulsory recyclability labelling and for nationally consistent approaches across recycling systems. Some participants recommended expanding the scope of the reform to include broader environmental outcomes, such as reducing emissions. 

Further steps 

Following extensive public consultation, the Australian government is now moving into the next phase of packaging regulatory reform. Authorities will conduct further analysis of stakeholder feedback to guide the development of a new regulatory framework. Targeted consultations will continue to refine specific elements of the reform, and consideration will be given to the preferred model for a reformed packaging regulation system. 

On May 13, the Ministry of the Environment and Climate Change (MMA) officially launched a public consultation on the draft Decree intended to implement Law No. 15.022 of November 13, 2024. The law establishes the National Inventory of Chemical Substances and outlines procedures for the assessment and management of risks posed by chemicals produced, imported, or used within Brazil.

The consultation, led by the Secretariat for Urban Environment and Environmental Quality, will remain open until June 13, 2025. Interested parties must log in to the government’s platform to participate. 

Objective: Minimizing Risks to Health and the Environment

The proposed Decree provides a comprehensive regulatory framework aimed at systematically managing chemical substances and their potential risks. It establishes mechanisms to:

• Register chemical substances used, produced, or imported in Brazil;

• Prioritize substances for risk assessment;

• Assess risks to human health and the environment; and

• Implement risk management measures.

Key Provisions in the Draft Decree

• Thresholds for Registration: Chemicals that exceed 1 tonne/year of production or import (average over the past three years) must be registered.

• Committee Structure: The Technical Committee for Chemical Substances Assessment and a Deliberative Committee will oversee evaluation and decision-making processes.

• Use of Alternative Methods: The decree strictly regulates the use of animal testing, requiring it only as a last resort.

• Confidential Business Information (CBI): Provisions are included to protect trade secrets, with a clear process for requesting confidentiality.

• Fees and Enforcement: The decree introduces a Chemical Substance Registration, Evaluation, and Inspection Fee (TCAFSQ) and details the responsibilities of various regulatory bodies such as IBAMA, ANVISA, INMETRO, and the Ministry of Labor and Employment.

Call for Public Participation

Stakeholders from industry, academia, civil society, and government are encouraged to contribute comments and suggestions. The decree represents a critical milestone in the development of Brazil’s chemical regulatory infrastructure, offering a strategic tool to improve risk management, public health, and environmental safety. For more information and access to the draft decree, you can find it here (in Portughese).

A bill aiming to establish a national policy for the control of PFAS per- and polyfluoroalkyl substances, often referred to as "forever chemicals" (PFAS) is gaining momentum in the Brazilian Chamber of Deputies.

Introduced by Deputy Juninho do Pneu (UNIÃO-RJ) on May 22, 2023, Bill PL 2726/2023 seeks to regulate the use, monitoring, and elimination of PFAS across Brazil. These synthetic chemicals, found in a wide range of consumer products from non-stick cookware to firefighting foams, are known for their persistence in the environment and links to serious health issues, including cancer and hormonal disruption.

The bill is currently ready to be placed on the agenda of the Committee on Environment and Sustainable Development (CMADS) after a series of deliberations. Most recently, on April 8, 2025, CMADS issued a favorable report recommending the approval of the bill with a substitute text proposed by Deputy Duda Salabert (PDT-MG). Two amendments to the substitute text were rejected during this process.

Despite progress, the bill faced a temporary setback when it was removed from the committee’s agenda on April 9, 2025, due to an agreement among members. Meanwhile, requests have been filed by other lawmakers to expand the bill's analysis to include the Committee on Economic Development and the Committee on Industry, Commerce and Services, suggesting broader implications for national economic and industrial policy.

The legislative journey of PL 2726/2023 reflects growing concern in Brazil about the environmental and public health risks posed by PFAS, and aligns with international trends seeking stricter controls over these hazardous substances.

If passed, the bill will mark a significant step in Brazilian environmental legislation and reinforce the country’s commitment to safeguarding public health and ecological integrity. For more information, you can find the proposal (in Portughese) here. 

The Vietnamese Ministry of Health has released a new draft decree on cosmetics management. The proposed decree aims to improve the safety of cosmetics and how products are controlled in the market. It also aligns Vietnam’s requirements with ASEAN regional standards.

Key Highlights

1. Scope and Definitions

• The decree governs the classification, declaration, production, import/export, labeling, advertising, quality control, and recalls of cosmetic products.

• Defines terms such as “cosmetics,” “responsible entity,” and “product owner.”

• Declaration forms certify eligibility for market circulation but are not proof of safety or efficacy.

2. Safety and Quality Standards

• Products must be safe for normal use.

• Ingredients must comply with ASEAN limits on heavy metals, microbes, and banned substances.

• The Ministry of Health will maintain and update lists of restricted substances.

3. Classification and Product Declarations

• Cosmetics are classified by ingredients, purpose, and application method.

• Products intended for internal use or for permanently altering body functions are not considered cosmetics.

• Declaration forms are valid for 3 years and businesses must be legally registered.

• Import declarations are handled by the Ministry of Health and domestic declarations by Provincial Committees.

4. Certificates and Facility Requirements

• Certificate of Free Sale (CFS): Required for imports unless exempted for CPTPP or ASEAN countries with proper proof.

• Good Manufacturing Practice (GMP): Foreign manufacturers must have valid GMP certificates.

• Cosmetic production facilities must meet stringent standards for hygiene, personnel qualifications, equipment, and quality control.

• Existing facilities certified under previous decrees have a transition period until mid-2028.

5. Labeling and Advertising

• Labels must be clear, truthful, in Vietnamese, and display mandatory information such as ingredients, batch numbers, and expiry dates.

• Advertising must avoid misleading claims or phrases such as ‘miracle cure’ or ‘instant whitening’.

• No references to medical professionals or endangered species are allowed.

6. Product Sampling, Testing and Recall

• Random sampling by authorities ensures compliance.

• Recall procedures are clearly defined, including mandatory and voluntary recall processes.

• Non-compliant products must be recalled and destroyed, and the responsible parties must bear the costs.

7. Enforcement and Penalties

• Suspension of declaration dossiers is possible for violations such as smuggling or the use of banned ingredients.

• Penalties include revocation of certificates, product withdrawal, and fines.

• Authorities will conduct regular inspections and enforce compliance.

8. Import and Export Regulations

• Export of Vietnamese cosmetics is encouraged with proper CFS documentation.

• Imports must have valid declarations; restricted use applies to imports for research/testing.

• Customs rules apply to gifts, personal luggage, and diplomatic consignments.

9. Organizational Responsibilities

• The Ministry of Health is responsible for state management, policy issuance, training, and inspection.

• Provincial Committees handle local inspections and enforcement.

• Other ministries, including Industry and Trade, Culture and Tourism, Science and Technology, and Finance), support relevant oversight roles.

• Marketers, manufacturers, and importers must ensure product compliance, maintain records, and cooperate with authorities.

10. Implementation Timeline

• Decree effective July 1, 2026.

• Existing certificates remain valid until June 30, 2028.

• Post-2028, all manufacturers must comply with the updated requirements and reapply.

On 23 April 2025, the Department of Environment (DOE), acting as Malaysia’s Competent Authority under the Stockholm Convention, issued a reminder to industries involved in the export and import of chemicals classified as Persistent Organic Pollutants (POPs). 

Requirements for Export to Non-Party States 

Exports of POPs to countries that are not Parties to the Stockholm Convention are only permitted if the DOE issues an Annual Certification. This certification serves two essential purposes: 

• It must clearly outline the intended use of the chemical; and 

• It must confirm Malaysia’s commitment to protecting human health and the environment, in line with the Convention’s provisions. 

 
Requirements for Importing Industries  

To initiate the process, the importing industry is required to submit thorough documentation to the Department of Environment (DOE) before applying for import approval. This documentation must include: 

• A complete Safety Data Sheet (SDS) for the chemical; 

• Details on the safe handling, storage, and transportation of the substance; 

• Environmentally responsible disposal plans; 

• Compliance monitoring strategies; and 

• Worker protection measures and any public awareness efforts, if applicable. 

Following the DOE’s review and approval of these documents, the Annual Certification will be granted to the importing industry. The importing industry must then forward the certification and relevant documents to the exporting country. 

Exporting Party's Obligations 

The exporter must submit the certification to their National Authority at least 60 days before starting the export process. At present, all procedures must be carried out manually and not through the MyEHS system (Malaysia’s online environmental management portal). 

This process upholds global standards for the safe and transparent handling of hazardous substances and underscores Malaysia’s commitment to the principles of the Stockholm Convention.

In a move welcomed by the healthcare and medical technology sectors, Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has issued a new Disposition that reduces the minimum shelf life required for imported medical devices from one year to six months, effective immediately.

The change was made official through the Disposition 2565/2025 issued on April 15, 2025, which replaces Disposición N° 1655/1999, a long-standing rule that prohibited the import of medical devices with less than 12 months before expiration. The updated regulation aims to align ANMAT’s oversight with technological advances in medical devices, and to ease restrictions that stakeholders argued were limiting access to innovative products.

According to ANMAT, the review process was initiated following requests from industry representatives involved in the manufacturing, importation, and distribution of medical devices. These groups expressed concern that the original one-year requirement restricted imports and delayed the arrival of critical healthcare technologies.

Under the new framework:

• Medical devices and their accessories must now have at least six (6) months of shelf life remaining at the time of importation.

• Devices with a total approved shelf life of six months or less are exempted, provided they are not expired upon entry.

• Single-use sterile products—whether imported or locally manufactured—may not be re-sterilized, reused, or have their original packaging altered, unless specifically authorized by regulatory resolution.

• Falsifying expiration dates on packaging is explicitly prohibited and may lead to sanctions under Law No. 16.463 and possible criminal charges.

The revised policy reflects ANMAT’s intention to improve regulatory efficiency without compromising safety. The agency emphasized that shorter shelf lives should not translate into lower standards, and all products must still comply with the established quality and safety benchmarks. This update is expected to enhance the flexibility of Argentina’s healthcare supply chain, enabling hospitals and clinics to access a wider range of medical technologies while maintaining oversight to ensure patient safety. For further details, you can consult the Disposition (in Spanish) here.

In a significant regulatory update, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has announced a modification to the Official Mexican Standard NOM-059-SSA1-2015, which governs the Good Manufacturing Practices (GMP) for medicines. This update aims to facilitate the entry of innovative and essential biotechnological drugs into the Mexican market, particularly those for conditions like cancer and diabetes mellitus.

Background

NOM-059-SSA1-2015 was originally published on February 5, 2016, to establish minimum requirements for the manufacturing of medicines intended for human use. However the regulation has now been revised to align with international best practices, especially those recommended by the World Health Organization (WHO). The change follows the recognition that a large proportion of biotechnological medicines consumed in Mexico are manufactured abroad, and the existing requirement of obtaining a local GMP Certificate from COFEPRIS created unnecessary regulatory hurdles. 

Key Modifications

The revised NOM-059-SSA1-2015 introduces both additions and changes to existing sections:

New Definitions and Additions

• Point 3.128 defines biotechnological medicines and distinguishes between innovative and non-innovative (biosimilar or “biocomparable”) products.

• Point 3.129 introduces the concept of an Equivalence Agreement, which allows Mexico to recognize foreign technical regulations, sanitary measures, or conformity assessment results from trusted international authorities.

• Point 12.7 outlines that for imported biotechnological medicines (excluding vaccines), each lot must be approved by the responsible health authority before commercialization, either through document review or laboratory testing.

Modifications to Existing Provisions

• References to related standards such as NOM-073-SSA1-2015 (stability), NOM-164-SSA1-2015 (manufacturing for active ingredients), and NOM-220-SSA1-2017 (pharmacovigilance) were updated.

• Testing procedures now accept certificates of GMP or equivalent documents issued by recognized foreign regulators, including members of PIC/S and those listed under the WHO “List of Transitional WHO-Listed Authorities (WLAs)”.

• If a manufacturer already has valid GMP certification from recognized foreign authorities, only the manufacturer's analytical certificate needs to be submitted.

Purpose and Benefits

The modification establishes a formal Reliance Framework for imported biotechnological medicines, designed to:

• Accelerate market entry of high-quality therapies.

• Reduce duplication of regulatory efforts.

• Expand access to advanced treatments for Mexican patients.

• Support national health systems in acquiring timely and effective medicines.

By integrating international trust-based mechanisms, COFEPRIS aims to shift focus towards high-value national regulatory activities, including surveillance, distribution oversight, and pharmacovigilance.

Implementation Timeline

The updated regulation will enter into force on November 24, 2025 in the Diario Oficial de la Federación (DOF), setting a transition period for manufacturers and health institutions to adapt to the new framework. 

For more details, you can find the regulation (in Spanish) here. 

On 11 April 2025, Kenya notified the World Trade Organization (WTO) that several previously circulated standards covering 12 fertilizers have now been officially adopted. Published in the Kenya Gazette Notice No. 16886 on 20 December 2024, the adoption marks the formal transition of the draft texts into national standards, contributing to harmonized regulatory practices across the East African Community (EAC). 

Adoption of East African Standards 

In 2023, five East African Community countries (Burundi, Kenya, Rwanda, Tanzania and Uganda), notified the WTO of draft standards concerning various fertilizers. The majority of these drafts have now been adopted and include detailed provisions on product sampling, packaging, labelling, and allowable levels of heavy metals. The aim is to enhance environmental safety and public health. 

Background on East African Standards 

The development of harmonized East African Standards is driven by the need to unify quality benchmarks for goods and services across EAC member states. This harmonization is intended to eliminate technical barriers to trade and facilitate the seamless exchange of goods and services within the region. 

To achieve this, the East African Standards Committee was established. The committee comprises representatives from national standards bodies, private sector entities, and consumer organizations. Draft standards are circulated for public comment via national standards bodies, after which stakeholder feedback is reviewed and incorporated before final adoption. 

These standards are dynamic and subject to periodic review to reflect advancements in technology and emerging regulatory needs. Stakeholders are advised to ensure they always refer to the latest version when implementing these standards. 

Focus on Fertilizers Standards 

The newly adopted draft standards cover various types of fertilizers, including organic, foliar, urea, and phosphate-based fertilizers as well as guidelines for their safe handling and storage. The intent is to ensure uniform quality, safe usage, and environmental protection. 

The adopted standards include: 

Conclusion

The adoption of these standards marks a significant milestone in regional integration efforts, by aligning regulatory practices across East African countries. By standardizing the chemical composition, labeling, and handling of key agricultural and public health products, the region is moving closer to achieving a safer, more efficient, and more environmentally sustainable trading environment. These efforts not only strengthen internal trade within the EAC but also enhance the region’s competitiveness in global markets. 

Kenya has officially adopted both parts of the East African Standard for skin-applied mosquito repellents, marking a key step in the regional effort to harmonize safety and quality requirements for such products. The adoption was published via Gazette Notice No. 206 on 29 November 2024 and was formally notified to the World Trade Organization (WTO) on 14 April 2025. 

Developed under the framework of the East African Community (EAC) he standards (EAS 1119-1 and EAS 1119-2) aim to enhance public health by regulating skin-applied mosquito repellents. The initiative seeks to ensure the safety, efficacy, and quality of mosquito repellent products within the region. 

Objective of the Standard 

The development of these standards is driven by the need to harmonize product quality requirements across EAC member states. By establishing a unified framework, the EAC aims to eliminate trade barriers and promote the free exchange of goods and services within the community. 

Role of the East African Standards Committee  

The East African Standards Committee (EASC) is tasked with developing and issuing East African Standards. Comprising representatives from the National Standards Bodies of Partner States, as well as public and private sector organizations, the committee ensures that the standards reflect the interests of all stakeholders. The standardization process involves: 

• Formation of Technical Committees representing key sectors. 

• Circulating draft standards to stakeholders for feedback. 

• Incorporation of comments before finalization, adhering to established principles and procedures. 

Key Features of the Standard 

• Scope: The standard applies to skin-applied mosquito repellents in two product categories:  

• Part 1 (EAS 1119-1:2024) – Lotions, creams, gels and ointments 

• Part 2 (EAS 1119-2:2024) - Sprays and roll-ons. 

• Specifications: Each part outlines technical, chemical, and safety specifications to ensure product quality and consumer protection. 

• Sampling and Testing: The standard provides guidelines for sampling methods and testing protocols to assess product performance. 

• Labelling and Packaging: It sets out requirements for product labelling and packaging to inform consumers and ensure safe usage. 

Adoption in Kenya 

Kenya has officially adopted both parts of the standard as national standards: 

• KS EAS 1119-1:2024 – Skin applied mosquito repellent — Specification — Part 1: Lotions, creams, gels and ointments, First Edition 

• KS EAS 1119-2:2024 – Skin applied mosquito repellent — Specification — Part 2: Sprays and roll-ons, First Edition 

These adoptions were notified to the World Trade Organization (WTO) on 14 April 2025. 

Conclusion 

The introduction and adoption of these standards represent a significant step towards harmonizing the safety and quality of mosquito repellents in East Africa. By emphasizing consumer safety, product efficacy, and environmental responsibility, the EAC aims to promote public health and regulatory consistency throughout the region. Stakeholders are encouraged to review and align their manufacturing practices with the standards to contribute to the overarching goals of the community. 

On 28 April 2025, Singapore’s National Environment Agency (NEA) notified the World Trade Organization (WTO) of plans to tighten regulatory controls on two major agrochemicals: chlorpyrifos and paraquat (including all their salts and preparations). The proposed changes will be implemented through amendments to the Environmental Protection and Management Act 1999 (EPMA) and related hazardous substances regulations. They are scheduled to enter into force by October 2025, in alignment with the relevant international conventions. 

This regulatory update is expected to impact importers, manufacturers, distributors, and users of these chemicals both within and beyond Singapore’s borders, signaling a shift in the region’s chemical governance that aligns with global environmental frameworks. 

New Hazardous Substances Classification under EPMA 

Under the forthcoming amendments, chlorpyrifos and paraquat (along with their associated salts) will officially be designated as hazardous substances under Singapore law. The chemicals will be added to the Second Schedule of the EPMA and to the Schedule of the Environmental Protection and Management (Hazardous Substances) Regulations. These changes will apply to the chemicals at all concentrations and in all preparation forms. 

Once in effect, companies engaging in the import, export, manufacture, sale, transport, storage, or use of these substances will be required to obtain a Hazardous Substances (HS) License or Permit from NEA. 

Alignment with International Conventions 

The move comes as Singapore prepares to fulfill its anticipated obligations under the Rotterdam and Stockholm Conventions: 

• The Rotterdam Convention's Chemical Review Committee (CRC) has recommended listing chlorpyrifos and paraquat in Annex III, subjecting them to the Prior Informed Consent (PIC) procedure due to their classification as hazardous pesticides. 

• The Stockholm Convention's Persistent Organic Pollutants Review Committee (POPRC) has also found chlorpyrifos to be a persistent organic pollutant (POP), citing its high toxicity to aquatic invertebrates and potential harm to mammals. The POPRC recommends listing chlorpyrifos in Annex A of the Convention, targeting global elimination of its production and use, with limited exemptions. 

These developments are expected to be deliberated at the 12th Conferences of the Parties (COPs) for both conventions, which will take place between 28 April and 9 May 2025. 

Environmental and Health Risk Mitigation 

The proposed licensing requirements aim to mitigate the public health and environmental risks associated with these high-impact agrochemicals. Once enforced, the NEA will be able to: 

• Monitor the full life cycle of the chemicals—from import to end use. 

• Impose restrictions or eliminate use when needed. 

• Implement PIC obligations should the chemicals be formally listed in international treaties. 

Implications for Industry Stakeholders 

The regulatory changes will have significant implications for the agricultural, industrial, and chemical sectors operating in or trading with Singapore. Businesses dealing in chlorpyrifos or paraquat are urged to: 

• Review inventory and supply chains for compliance risks. 

• Begin preparing license applications. 

• Stay informed about international decisions at the upcoming COPs. 

Stakeholders have until 27 June 2025 (60 days from the date of notification) to submit comments on the proposal. The proposal  is expected to be officially adopted via government gazette in June 2025, with full enforcement planned for October 2025. 

New Zealand’s Environmental Protection Authority (EPA) has confirmed that the transition period for fluorotelomer-based firefighting foams will end on 3 December 2025. After this date, C6 fluorotelomer foams can only be used with EPA’s explicit approval and must meet strict purity and usage standards outlined in the Fire Fighting Chemicals Group Standard 2021 (HSR002573).

Key Changes

• C6 fluorotelomer foams will require prior permission for continued use in firefighting systems. Import and manufacture will remain permitted if they comply with group standards and purity requirements.

• All applications for continued use must be submitted to the EPA as soon as possible.

No Extension for Legacy PFAS Foams

There will be no extension for legacy PFAS foams which are classified as persistent organic pollutants (POPs). Their use in any system ends completely on 3 December 2025, following the earlier phase-out of uncontained uses in December 2022.

Background

Since 2020, New Zealand has been phasing out firefighting foams containing PFAS due to their persistence in the environment and potential health risks. The 2021 Fire Fighting Chemicals Group Standard regulates both legacy and C6-based foams by setting requirements for labelling, disposal, and transitioning to safer alternatives.

For more information, see the official group standard here.

At the 2025 Conferences of the Parties (COPs) to the Basel, Rotterdam, and Stockholm Conventions, held from April 28 to May 9 in Geneva, significant strides were made in global chemical safety. Notably, the Stockholm Convention introduced stringent measures targeting hazardous substances, while the Basel and Rotterdam Conventions advanced efforts in waste management and chemical trade regulations.

Stockholm Convention: Key Chemical Bans and Restrictions

At the 12th Conference of the Parties (COP-12) of the Stockholm Convention, the parties agreed to list the following substances in Annex A (elimination):

• Chlorpyrifos – A widely used organophosphate pesticide associated with neurodevelopmental harm. Although it will be banned globally, 22 specific exemptions were granted for continued use in certain applications.

• Long-chain perfluorocarboxylic acids (LC-PFCAs) – A group of PFAS substances known for their persistence and potential health impacts. Exemptions were approved for certain uses, such as in semiconductors, electronics, and textiles.

• Medium-chain chlorinated paraffins (MCCPs) – Used as flame retardants and plasticizers. MCCPs were added due to concerns over persistence, bioaccumulation, and toxicity. Exemptions apply to defined industrial uses.

In addition, exemptions for UV-328, a UV stabilizer listed in Annex A in 2023, were reopened and extended. These new exemptions cover specific uses in aviation and industrial settings, which is a rare instance of amending a previously agreed-upon elimination decision post-adoption.

Basel and Rotterdam Conventions: Complementary Advances

While the Stockholm Convention focused on POPs, the Basel and Rotterdam Conventions addressed related challenges.

• Rotterdam Convention (COP-11): Parties agreed to list several additional chemicals in Annex III, which requires prior informed consent (PIC) for international trade. However, the listing of acetochlor and carbosulfan was blocked by a few parties, continuing a trend of stalled listings due to lack of consensus.

• Basel Convention (COP-16): Parties adopted new technical guidelines to improve the management of e-waste, including devices containing POPs. Progress was also made on guidance addressing plastic waste and chemicals of concern in waste streams.

Implications and Next Steps

These decisions mark a significant advancement in global efforts to protect human health and the environment from hazardous chemicals. However, the expanded exemptions, particularly for chlorpyrifos and UV-328, have raised concerns among health and environmental advocates. Continuous monitoring and future negotiations will be crucial to ensure that these measures effectively mitigate risks associated with these substances.

The Ministry of Environmental Protection and Natural Resources of Ukraine (MEPR) has officially released the pre-registration template for chemical substances under the Ukraine REACH Technical Regulation. This is a significant step in the implementation of the national REACH framework, enabling businesses to start pre-registering substances placed on the Ukrainian market.

Who Must Pre-Register?

As outlined in the transitional provisions of Ukraine REACH, the following actors must pre-register substances manufactured or imported at ≥1 tonne per year, unless they are specifically exempted:

• Manufacturers

• Importers

• Only Representatives (ORs) acting on behalf of non-Ukrainian entities.

Pre-registration is mandatory in order to benefit from the staggered registration deadlines and ensure continued access to the Ukrainian market.

Pre-Registration Timeline

• Start Date: 26 January 2025

• Deadline: 26 January 2026

Registration Deadlines

• 26 January 2026: CMR substances (Category 1A and 1B) above 1 tonne per year, and substances very toxic to aquatic organisms (acute or chronic) above100 tonnes per year.

• 1 October 2026: Substances above 1,000 tonnes per year.

• 1 June 2028: Substances from 100 to 1,000 tonnes per year.

• 1 March 2030: Substances from 1 to 100 tonnes per year.

Pre-Registration Template and Submission Instructions

To streamline the compliance process, the MEPR has introduced a standardized Excel-based pre-registration form, which is only available in Ukrainian.

The form must be:

• Completed per substance

• Filled out in Ukrainian

• Electronically signed using a Qualified Electronic Signature (QES)

• Submitted along with supporting documents, and (if applicable) an Only Representative appointment letter

Completed forms should be submitted to reach@mepr.gov.ua

The official template and instructions can be found on the MEPR website.