GPC Newsletter Jul-2025

On May 31, 2025, Canada’s Biocides Regulations under the Food and Drugs Act officially entered into force, establishing a single regulatory framework for surface disinfectants and sanitizers—collectively referred to as biocides. These new rules replace previous authorizations granted under either the Food and Drug Regulations (FDR) or the Pest Control Products Act (PCPA).

Pre-Market Authorisation Now Mandatory

Under the new framework, all biocides must undergo a pre-market assessment by Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) to obtain a market authorization. Only then can they be sold, imported, or advertised in Canada. Authorized products will carry a unique 8-digit identification number, signaling that they meet stringent standards for safety, efficacy, and quality.

Stronger Oversight for Public and Occupational Safety

This regulatory shift ensures greater consistency, improved transparency, and enhanced public and occupational safety, particularly for products used in healthcare facilities, food premises, households, schools, and veterinary settings.

Transition Deadlines for Existing Products

• Products previously authorized under the FDR or PCPA must transition to the new framework by May 31, 2029.

• Surface sanitizers used in food premises must obtain market authorization by May 31, 2031.

Post-Market Surveillance to Continue

Health Canada will continue post-market monitoring and enforcement through its Regulatory Operations and Enforcement Branch (ROEB) and Marketed Health Products Directorate (MHPD) to ensure ongoing compliance and risk management.

The U.S. Environmental Protection Agency (EPA) has released new guidance materials to help companies meet updated requirements for submitting new chemical information under the Toxic Substances Control Act (TSCA). These requirements were introduced in a final rule published in December 2024. 

Interim Submission Process While CDX Updates Are Pending 

The final rule now requires companies to include more detailed information in their new chemical submissions—if that information is known or can reasonably be found by the company. 

While EPA is working to update its Central Data Exchange (CDX) system to handle the new requirements, those system changes are not yet complete. In the meantime, companies must use the current CDX system. To help with this, EPA has issued clear, temporary instructions on how to include the required information using the existing submission process. 

Future Implementation and Stakeholder Training 

Once the updated CDX system is ready, EPA will inform and train stakeholders on how to use the system. At that point, the temporary instructions will no longer apply. 

For more details, visit the final rule docket and EPA’s technical support page for PMN submissions. 

The Environmental Protection Agency (EPA) has proposed extending the compliance deadlines under the Toxic Substances Control Act (TSCA) for certain entities regulated for their use of methylene chloride. The 18-month extension specifically applies to non-federal laboratories that are not owned or operated by federal agencies or contractors working on behalf of the federal government, under the Workplace Chemical Protection Program (WCPP) and related record keeping requirements. 

Harmonizing Compliance Deadlines 

EPA has proposed this extension to standardize the compliance deadlines for all laboratories, —both federal and non-federal, so that they follow the timeline currently applied to federal agencies and their contractors. The change is intended to prevent interruptions to essential work performed by laboratories, such as monitoring environmental conditions at cleanup sites, supporting wastewater treatment processes, and conducting academic research. These activities, especially those handled by non-federal labs, play a crucial role in helping EPA fulfill its goal of safeguarding air and water quality and ensuring responsible waste management.  

Public Consultation and Further Information 

For more information, see the FEDERAL REGISTER notice announcing the proposed rule here.  

Earlier actions associated with reference G/TBT/N/USA/1988 are filed under Docket Number EPA-HQ-OPPT-2020-0465. This docket can be accessed on Regulations.gov at https://www.regulations.gov/docket/EPA-HQ-OPPT-2020-0465/document, where all key documents, supporting materials, and public comments are available. WTO Members and their stakeholders are encouraged to submit comments to the U.S. TBT Enquiry Point. Any comments received by 4:00 p.m. Eastern Time on 26 June 2025 will be forwarded to the EPA and included in the public docket, provided they fall within the official comment period. 

Update (24 June 2025):
The European Commission has clarified that the upcoming Delegated Regulation will also partially implement GHS Revision 11, covering aerosols and skin sensitisers in mixtures, in addition to aligning CLP with GHS Revisions 8 to 10.

Original text: 

The European Commission is preparing a Delegated Regulation to update the Classification, Labelling and Packaging (CLP) Regulation in line with technical progress and the latest updates to the UN Globally Harmonised System (GHS), specifically revisions 8 to 10.

No Public Consultation Planned

As this will be a Delegated Regulation, no public consultation will be held. The regulation is expected to be published by the end of 2025 after which there will probably be a two-year implementation period.

Technical Updates Expected

The update is expected to include technical changes such as revised criteria for aerosols and desensitized explosives, updated precautionary statements, and clarificationon labelling small containers, aligning the CLP with GHS revisions 8 to 10. However, the actual draft of the Delegated Regulation has not yet been published.

The European Commission has adopted the 23rd Adaptation to Technical Progress (ATP) to the Classification, Labelling and Packaging (CLP9 Regulation (EC) No 1272/2008 through Delegated Regulation (EU) 2025/1222. This update concerns the harmonised classification and labelling of several chemical substances.

This amendment, based on opinions from the European Chemicals Agency’s Risk Assessment Committee (RAC), was adopted on 2 April 2025 and published in the Official Journal of the EU on 20 June 2025. It will enter into force on 10 July 2025, 20 days after publication, and become mandatory on 1 February 2027. Suppliers may apply the updated classifications voluntarily from the date of entry into force.

New Substance Entries

The following substances have been added to Table 3 of Annex VI with harmonised classifications.

Updated Substance Classifications

The following entries replace existing classifications in Annex VI and reflect updated hazard information for substances already listed under the CLP Regulation.

Next Steps

Stakeholders, particularly manufacturers, importers, and downstream users, should review the updated classifications and begin preparing to update safety data sheets, product labels, and internal documentation. The new rules can be applied early from 10 July 2025, but compliance will become mandatory from 1 February 2027.

The full text of Delegated Regulation (EU) 2025/1222 is available here.

On 25 June 2025, the European Chemicals Agency (ECHA) announced the addition of three hazardous chemicals to the Candidate List of Substances of Very High Concern (SVHCs) under the REACH Regulation. This latest update brings the total number of SVHC entries to 250.

Substances Added in June 2025

The newly listed substances include two siloxanes and one azo dye component:

• 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane (CAS 17928-28-8): Classified as very persistent and very bioaccumulative (vPvB) under REACH Article 57(e), this substance is used in laboratory reagents, cosmetics, personal care products, and fragrances.

• Decamethyltetrasiloxane (CAS 141-62-8): Also meeting the vPvB criteria (Article 57(e)), this chemical is found in cosmetics, personal care products, lubricants, greases, and automotive care products.

• Tetra(sodium/potassium) 7-[(E)-{2-acetamido-4-[(E)-(4-{[4-chloro-6-({2-[(4-fluoro-6-{[4-(vinylsulfonyl)phenyl]amino}-1,3,5-triazine-2-yl)amino]propyl}amino)-1,3,5-triazine-2-yl]amino}-5-sulfonato-1-naphthyl)diazenyl]-5-methoxyphenyl}diazenyl]-1,3,6-naphthalenetrisulfonate (Reactive Brown 51) (EC 466-490-7): ​​​​​​​Listed due to its classification as toxic for reproduction (Article 57(c)). This substance is primarily used in textile treatment products and dyes.

Regulatory Implications for Industry

With the inclusion of these substances, companies supplying them, whether on their own, in mixtures, or in articles, now face specific legal obligations under REACH.

• Information Duty: Suppliers must provide customers and consumers with information on safe use if an article contains more than 0.1% w/w of any SVHC.

• Notification Requirement: Importers and producers of articles containing any of the new SVHCs must notify ECHA within six months (by 25 December 2025).

• Safety Data Sheet Updates: EU and EEA suppliers must update their Safety Data Sheets (SDS) to reflect the inclusion of these substances in the Candidate List.

• SCIP Database Notification: Under the Waste Framework Directive, producers are also required to notify ECHA if their articles contain SVHCs above the 0.1% threshold. This ensures that the substances are included in ECHA’s SCIP database of substances of concern in products.

• EU Ecolabel Impact: Products containing substances on the Candidate List cannot qualify for the EU Ecolabel.

Potential Future Authorisation

ECHA notes that inclusion on the Candidate List is often the first step towards further regulatory control. The newly listed substances may, in future, be placed on the Authorisation List (REACH Annex XIV). Once listed, their use would require formal authorisation from the European Commission.

On 4 June 2025, the UK Government published an interim position statement detailing how the concepts of persistent, mobile and toxic (PMT), and very persistent and very mobile (vPvM) substances will be used to support risk management under UK REACH. This new approach aims to enhance the regulatory control of per- and polyfluoroalkyl substances (PFAS), as these substances pose significant environmental challenges due to their extreme persistence and mobility in the environment.

The interim position statement was published by the Department for Environment, Food & Rural Affairs (Defra) and applies to England, Scotland and Wales.  It marks a significant step in aligning UK chemical policy with emerging international practices. Although PMT and vPvM are not yet recognised as formal hazard classes under UK REACH or UK CLP, the government intends to leverage these concepts to support restriction proposals and risk management measures, particularly with regard to PFAS.

PFAS as a Regulatory Priority

PFAS are often referred to as “forever chemicals” due to their resistance to environmental breakdown and capacity to spread widely through water systems. UK environmental monitoring data has revealed widespread PFAS contamination in rivers, groundwater, and organisms, including fish, suggesting that their mobility and persistence result in diffuse and long-term pollution.

Due to these characteristics, PFAS do not easily fit into traditional risk assessment models that rely on thresholds or predicted no-effect concentrations. The government is therefore adopting a precautionary approach based on the PMT/vPvM concept to guide early regulatory intervention and prevent irreversible environmental harm.

Key Features of the Interim Approach

• Non-threshold regulatory principle: Rather than identifying safe exposure levels, the UK approach focuses on minimising emissions of PMT/vPvM substances throughout their lifecycle.

• Basis for restriction proposals: The interim concept will support the development of restriction dossiers under UK REACH, including the anticipated restriction on PFAS, by identifying substances of concern based on their PMT/vPvM properties.

• Use of Article 57(f): Substances identified as PMT or vPvM may be considered substances of very high concern (SVHCs) under UK REACH, using the provision for substances with equivalent levels of concern.

Next Steps and Broader Implications

While the interim approach currently targets PFAS, the government notes that the methodology may later be expanded to cover other PMT/vPvM substances. The Environment Agency has been tasked with advancing the scientific and technical tools needed to support this strategy, including:

• Improved methods for identifying mobility beyond traditional partition coefficients (e.g. Kₒc),

• Enhanced tools for screening and prioritising PMT/vPvM substances, and

• National monitoring programmes to track their presence in the environment.

In parallel, the UK will continue to engage with international forums, such as the UN Globally Harmonized System (GHS), and monitor developments in the EU’s Classification, Labelling and Packaging (CLP) Regulation, which recently introduced PMT/vPvM as new hazard classes.

A Step Toward Future Integration

Although PMT and vPvM are not yet part of the UK’s formal hazard classification system, this interim position enables the government to address substances with properties that pose serious long-term environmental risks. By incorporating the PMT/vPvM concept into restriction proposals, the UK intends to prevent irreversible contamination and enhance chemical safety in a scientifically robust and precautionary manner.

The full text of the interim position statement can be found here.

On 25 April 2025, the Indian Ministry of Health and Family Welfare published the official gazette of Drugs and Cosmetics (Compounding of Offences) Rules, 2024, introducing a structured framework for resolving specific offences under the Drugs and Cosmetics Act, 1940, through compounding.

Objective and Scope

These new regulations enable offenders to reach settlements without going through drawn-out legal proceedings. To supervise the compounding process, the Central Government will designate officers at the level of the Central Licensing Authority, Central License Approving Authority, or Central License Approving Authority. State Governments will designate officials at lower levels for the same purpose.

Application and Process

According to the regulations that specify the application procedure, companies or individuals engaged in the production, importation, sale, or distribution of pharmaceuticals and cosmetics may apply for compounding before or following the institution of prosecution. After receiving an application, the compounding authority may request a report from the reporting authority; this report must be submitted within a month, though the compounding authority may extend this deadline.

Payment and Immunity

The applicant must provide proof of payment and pay the compounding amount within 30 days of the offense being compounded. However, if the court denies immunity from prosecution the money paid will not be reimbursed. The regulations also make it clear that the authority has discretion over whether to grant immunity, so compounding does not guarantee immunity.

These clauses seek to ensure compliance with the regulations while expediting their enforcement.

Further details can be found in the official notification here.

The Department of Chemicals and Petrochemicals has extended the enforcement dates for Quality Control Orders (QCOs) for three chemicals: H Acid (CAS No: 90-20-0), K Acid (Cas No: 118-03-6), and Vinyl Sulphone (CAS No: 16071-86-6). The updated dates were announced in a notification published in the Gazette of India on 14 May 2025, in consultation with the Bureau of Indian Standards (BIS). The QCOs were originally published on 14 November 2024.  

Chemicals and Revised Enforcement Dates:    

The Quality Control Order mandates that the substances in questioncarry 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 Department of Chemicals and Petrochemicals (DCPC) has issued the Polyethylene Material for Moulding and Extrusion (Quality Control) Amendment Order, 2025, further amending the original 2022 Quality Control Order. The latest amendment was published in the Official Gazette on 11 June 2025 and came into force on that date.

Key Changes Introduced by the 2025 Amendment

The 2025 amendment introduces two modifications to the exemption list introduced by the 2024 amendment:

• Deletion of Item (c): The previous exemption for Linear Low Density Polyethylene (LLDPE) Butene Grades has now been removed, meaning this material will become subject to the mandatory BIS certification requirements under the Quality Control Order.

• Addition of a New Exemption: A new exemption has been introduced for high-density polyethylene (HDPE) for pharmaceutical moulding (EP/USP grade, CAS No. 25087-34-7), specifically for the manufacture of disposable hypodermic syringe plungers and IV catheter/cannula components.

These changes continue the government’s phased tightening of quality control requirements for polyethylene materials, while maintaining targeted exemptions for critical medical and industrial applications.

The full text of the amendment is available here.

On May 28, 2025, South Korea notified the World Trade Organization (WTO) of a proposed amendment to the designation and safety/labeling standards for daily use consumer chemical products under the Chemical Products Safety Act. The revision aims to strengthen mandatory safety standards and streamline regulatory measures based on updated risk assessments. 

Key Changes: 

• Product Category Removal: Tattoo ink products will be removed from the list, as they will be transferred to the Ministry of Food and Drug Safety as of June 14, 2025. 

• Labeling Improvements for Reusable Products: Moisture absorbers with refillable containers will require clearer labeling and updated precautionary wording. 

• New Safety Warnings for Combustible Items: Products such as scented candles and air fresheners that involve combustion must include specific usage warnings. 

• Child-Resistant Packaging Notices: Liquid products that may qualify for child-resistant packaging due to pH changes during use must include recommended warnings. 

• Clearer Substance Management and Labeling: The chemical names of substances subject to regulation and analysis will be standardized for improved clarity and compliance. 

Public Feedback: 

WTO opens public feedback period of 20 days since the notification date. Individuals and organizations are encouraged to submit their opinions on the proposed changes by June 17, 2025. 

On June 11, 2025, South Korea published a draft regulation under the Chemical Substances Control Act (K-CCA) concerning the chemical safety framework. This action follows the restructuring of the toxic substance classification system, which now differentiates regulatory levels based on hazard type—particularly between chronic human toxicity and physical hazards. 

Previously, certain chemicals were excluded from strict control if they only posed chronic health risks. However, despite not being classified as "hazardous chemicals", some of these substances still carry significant physical risks that could lead to chemical accidents or exacerbate their impact. 

Key Changes 

• Regulatory Authority Transfer: The authority for designating "Accident Preparedness Substances" will shift from the Ministry of Environment to the National Institute of Chemical Safety (NICS) via formal notice. 

• New Substance Additions:  Three substances will be added to the list of accident preparedness substances due to their physical hazard profiles: 

  • Xylene 
  • Styrene 
  • 1,3-Butadiene 

These chemicals are currently managed as toxic substances for their chronic human health effects, but the revision addresses their potential to cause or worsen chemical accidents. 

Public Comments: 

NICS is accepting public feedback on this proposal. Stakeholders can submit opinions either online or offline by June 28, 2025. 

On June 18, 2025, South Korea issued an official notice outlining a complete revision of the national regulation titled, “Notification on the Installation and Management of Facilities for the Manufacture, Use, and Storage of Hazardous Chemicals”. This comprehensive amendment is part of an ongoing effort to enhance chemical safety and modernize risk management practices in line with recent legislative changes under the Chemical Substances Control Act (K-CCA). 

The purpose of the regulatory update is to subordinate newly introduced categorization of toxic substances (those with acute or chronic human toxicity, and ecotoxic substances) and specify the standards for each category. The key aspects of the amendment include:  

• Consolidation of existing notifications. 

• Establishment of differentiated facility standards based on categories. 

• Improvement of weakness and operational deficiencies in the current standards.  

Key Amendments 

This legislative revision aims to improve safety and regulatory efficiency in several critical areas: 

1. Integration of Related Notifications 

• The revised notification consolidates and restructures safety standards, shifting the focus from manufacturing and usage facilities to storage facilities.  

• This integration provides a clearer regulatory framework by aligning the rules with specific facility types and hazard classifications, ensuring consistency across different stages of chemical handling. 

2. Differentiated Facility Standards Based on Categories 

• The revised standards introduce tailored technical requirements according to the types of chemical hazards: human acute toxicity, human chronic toxicity, and ecological toxicity.  

• Facility criteria are now categorized into three detailed annexes (Annexes 1–3), each corresponding to a specific hazard class. This differentiation allows for more precise risk management and facility design based on the chemical properties involved. 

3. Improved Safety and Operational Guidelines for Chemical Handling Facilities 

• New safety protocols focus on storage-specific risks, including enhanced requirements for leakage detection, emergency response systems, spill containment, ventilation, labeling, and access control.  

• Operational guidelines have been updated to include detailed procedures for receiving, storing, and tracking chemicals.  

• A transitional grace period has been introduced for certain high-risk substances, allowing facilities time to comply with newly mandated emission control systems. 

Public Comments 

Stakeholders, including businesses, industry associations, academic institutions, and individuals, are encouraged to review the proposed amendment and provide feedback. Comments must be submitted in writing to the National Institute of Chemical Safety by July 7, 2025.  

The Thailand Industrial Standards Institute (TISI) has notified the World Trade Organization (WTO) of a draft Ministerial Regulation mandating that stainless steel utensils for food must conform to Thai Industrial Standard TIS 3206-2567 (2024): Stainless Steel Utensils for Food – Safety Requirement.  

Objective and Rationale 

The primary objective of this regulation is to protect human health and safety. With increasing concerns over the potential release of harmful substances from food-contact materials, it ensures that all stainless-steel utensils on the Thai market adhere to a unified national safety standard, thereby reducing risks associated with food contamination. 

Responsible Authority 

The Thai Industrial Standards Institute (TISI), under the Ministry of Industry, will be responsible for overseeing the implementation and enforcement of the proposed regulation. As the relevant regulatory body, TISI plays a crucial role in ensuring compliance with industrial standards to protect public health and environmental integrity. 

Description of content  

The draft Ministerial Regulation requires that stainless steel utensils used in contact with food and beverages conform to the safety requirements defined in TIS 3206-2567 (2024). The regulation applies to a wide range of products, including but not limited to: 

1. Pots – containers for heating liquids 

2. Pans – containers used for various cooking methods 

3. Plates – flat containers for serving food 

4. Bowls – curved containers for holding food 

5. Food Trays – including compartment, warming, or dessert trays 

6. Food Containers – with or without lids, stackable or not 

7. Beverage Containers – glasses, tumblers, bottles, flasks 

8. Spoons – for scooping food 

9. Forks – for piercing food 

10. Chopsticks – utensils used for picking up food 

11. Spatulas – for flipping or scooping food during cooking 

12. Ladles – large utensils for scooping liquids 

13. Dippers – handled containers for scooping liquids 

These utensils come into contact with food and beverages that are consumed orally or by other means, in any form. 

Timeline: 
The proposed adoption date is yet to be determined. The regulation will enter into force 270 days after its publication in the Government Gazette.

On 30 June 2025, Japan’s Ministry of Economy, Trade and Industry (METI) published its Implementation Report on the Chemical Substances Control Law (CSCL)  for Fiscal Year 2024 (FY2024) on its portal. METI releases this report annually to provide an update on the current status. The previous report, covering FY 2023, was released by METI on 21 June 2024. 

Key Insights from the Implementation Report 

1. Overview of the CSCL 

The CSCL aims to prevent environmental pollution caused by chemical substances that may harm human health or ecosystems. It mandates: 

• Pre-market evaluation of new chemical substances. 

• Post-market control through reporting on production/import volumes and toxicity information. 

• Regulatory designation of substances based on characteristics such as persistence, bioaccumulation, and toxicity. 

Substance categories include: 

• Class I Specified Chemical Substances: Most strictly regulated. 

• Class II Specified Chemical Substances: Pose long-term risks. 

• Monitored Chemical Substances: Persistent and bioaccumulative but with unknown toxicity. 

• Priority Assessment Chemical Substances and General Substances: Subject to reporting and potential future regulation. 

2. Notifications and Preliminary Evaluations (FY2024) 

• 319 new chemical notifications were assessed, with most classified as low-risk. 

• Breakdown: 34 substances showed concern for both human and environmental health. 115 were classified as low risk. 

• 1,825 low-volume (≤10 tons/year) new chemical confirmations were submitted.  

• Over 37,000 small-volume (≤1 ton/year) notifications were submitted. 

• Main uses include: Intermediates, electronic materials, paints/coatings, cleaning agents, adhesives and fragrances. 

3. Post-Market Risk Management 

• Annual reporting is required for general and priority chemicals produced or imported at ≥1 ton/year. 

• Risk evaluations are conducted using usage volume, hazard data, and monitoring results. 

• 48 substances have undergone Tier II (advanced) evaluations to date. 

• Based on these assessments, some substances may be designated as Class II Specified Chemicals. 

4. Regulatory Measures Based on Chemical Characteristics 

• Substances such as PFHxS, chlorpyrifos, MCCP, and LC-PFCA are under discussion for designation as Class I Specified Chemicals, in line with international obligations (e.g., Stockholm Convention). 

• The public consultation and regulatory updates are scheduled through FY2025 and early FY2026. 

5. Monitoring and Control Data 

• Production and import data for Monitored Chemicals and Class II Specified Chemicals are tracked annually. 

• Notable reductions have been observed for high-risk substances such as trichloroethylene and tetrachloroethylene. 

• Reported hazards from companies include biodegradability, bioaccumulation, and human/ecotoxicity findings (over 200 reports in FY2024). 

The full report can be found here. 

The Brazilian Association of Technical Standards (ABNT) released on July 3 of 2023, a significant update to the ABNT NBR14725 Standard, which governs the classification and labeling of chemicals. This update marks the most substantial revision of the standard in over a decade, bringing important changes that align Brazil's regulations with international standards, particularly the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). 

Key Changes and Enhancements: The updated ABNT NBR14725 Standard introduces several notable changes, aimed at improving chemical classification, labeling, and hazard communication. Let's explore some of the key updates: 

• Structural Reorganization: One of the prominent modifications is the reorganization of the standard's structure. Previously divided into four parts, the new version consolidates all the content into a single, more extensive and comprehensive section, making it easier for users to navigate and understand the requirements. 

• Alignment with GHS: The updated ABNT NBR14725 Standard is based on the seventh revision of the GHS Purple Book. By adopting this GHS version, Brazil's regulations now closely align with international standards, promoting consistency and harmonization in chemical classification and labeling practices. 

• New Hazard Classes: Two new hazard classes have been included in the classification system. The first is "Desensitized Explosives," which addresses substances that have been treated to reduce their explosive properties. The second is "Ozone Depleting," which focuses on chemicals that pose a risk to the ozone layer. 

• Modified Labeling Elements: The labeling requirements have been revised, with changes in hazard statements (H phrases) and precautionary statements (P phrases). New H and P phrases have been added, providing more specific information about potential hazards and necessary precautions. Existing phrases have also undergone modifications to enhance clarity and accuracy. 

• Communication of Hazard: The updated standard introduces new rules for labeling small packaging. These regulations ensure that even the smallest containers carry essential information about the hazardous nature of the contained substances, enhancing safety measures and risk awareness. 

• Revised Safety Data Sheet (SDS): The standard introduces a change in the terminology used for Safety Data Sheets (SDS). Formerly known as Material Safety Data Sheets (MSDS), they will now be referred to as SDS, aligning the Brazilian naming convention with international standards. The content and structure of SDS remain largely unchanged, maintaining the requirement of 16 sections, each providing crucial information about chemical properties, handling, and safety measures. 

Impact and Compliance: The update to ABNT NBR14725 has significant implications for companies handling chemicals in Brazil. Here are some key considerations: 

• Mandatory Updates: All companies are required to update their existing Safety Data Sheets (SDSs) to comply with the new standard. The change in document nomenclature necessitates revisions to ensure consistency and alignment with the updated requirements. Additionally, labels may need to be revised and updated to reflect the modified hazard statements and precautionary phrases. 

• Time and Cost Implications: Achieving compliance with the updated regulations may require additional investments in resources and expertise. Companies might need to allocate time and funds for training employees, acquiring specialized technologies, and reviewing and updating their SDSs and labels. The magnitude of these tasks will depend on the size of the company and the number of products in its portfolio. 

• Revised Classification: Due to changes in concentration limits, some products previously classified may no longer require classification under the updated standard. However, it's important to note that this change does not apply universally, except for the inclusion of the new hazard class "Desensitized Explosives." 

The updated ABNT NBR14725 Standard brings significant changes to the classification and labeling of chemicals in Brazil. By aligning with the 7th GHS revision and incorporating new hazard classes, the standard enhances hazard communication and harmonizes Brazil's regulations with international practices. Companies should promptly assess the impact of these changes, ensuring timely compliance with the updated requirements by reviewing and updating their Safety Data Sheets and labels. Organizations handling chemicals in Brazil are granted a two-year transition period to comply with the new standard. Full compliance is mandatory by July 4, 2025.

Access to the NBR 14725 standard is via the ABNT Catalog website, through the link: ABNT Catálogo (abntcatalogo.com.br)

Price to aquire the new regulation is R$ 244.10 reais (50 US$) and is available only in Portuguese.

On June 2, 2025, the Indonesian Food and Drug Supervisory Agency (BPOM) introduced a new draft aimed at strengthening the safety and quality oversight of imported cosmetic products. This important update outlines the mandatory test parameters that must be included in Certificates of Analysis (CoA) submitted during the import certification process.

Key Update:

The new guidelines have been issued in accordance with Article 16(6) of BPOM Regulation No. 27/2022 (amended by No. 28/2023) and supported by Presidential and BPOM regulations issued between 2017 and 2025.

Key Requirements for Importers:

1. Border Import Certificate (SKI):

All cosmetic imports must obtain an SKI prior to entering Indonesia.

2. Certificate of Analysis (CoA):

The CoA must be issued by either:

• The product manufacturer, or

• An accredited laboratory.

3. Mandatory Test Parameters in the CoA:

The CoA must include testing results for:

• Heavy metals (including lead (Pb), mercury (Hg), arsenic (As), and other specified metals)

• Microbial contamination.

4. Batch-Specific Information:

For multiple batches of the same product, the CoA must also specify:

• Dosage form

• Organoleptic properties such as appearance, smell, and texture.

5. Cosmetic Categories & Test Parameters:

6. Certificate Validity:

Each Certificate of Analysis is valid for one year from the date of issue.

7. Purpose of the Regulation

This decision is intended to:

• Provide legal clarity and compliance certainty to business actors

• Ensure consumer safety

• Enhance BPOM's ability to supervise cosmetic imports effectively.

Effective Date: The decision comes into force on the date of enactment.

On June 24, 2025, Peru’s Ministry of Health (MINSA) enacted Decreto Supremo N° 007 2025 SA, establishing the Reglamento de la Ley N° 31182. The regulation sets a maximum lead content of 90 parts per million (ppm) in paints and other coating materials, with the aim of protecting public health from lead exposure.

Why It Matters

Lead exposure, especially harmful to children, pregnant women, and other vulnerable groups, leading to developmental delays, neurological damage, and a range of health issues. The new regulation aligns Peru’s standards with international benchmarks used in the EU and the US.

This decree mandates that all paint products manufactured, imported, or sold in Peru comply with new lead concentration thresholds, ensuring safer paints across the market. The regulation also sets requirements for labeling and mandates that manufacturers and importers adjust their formulations to meet the new standard.

Over the coming months, regulatory bodies will begin compliance inspections, and manufacturers and importers must adjust formulas to meet the legal standards.

Next Steps and Enforcement

The decree will enter into force six months after its publication in the official gazette, MINSA, through Digesa (the National Directorate of Environmental Health), will oversee implementation, inspections, and sanctioning of noncompliant paint products. Consumers should soon start seeing labels marking “low lead” or “lead free” paints, offering greater confidence in safety.

Broader Context

This decree operationalizes Law N° 31182, part of ongoing efforts to reduce lead poisoning risks, a public health priority in Peru. Similar regulations exist worldwide, such as in the EU and US, where lead in paints has been restricted for decades. Peru’s move aligns the country with global health and safety standards.

Public Impact

Families and daycare centers can expect safer indoor environments. Construction and paint industries will need to update supply chains and production practices, likely increasing costs short term but improving health outcomes long term. Environmental health professionals can leverage this as a foundation for further monitoring and outreach on lead hazards.

Summary

Peru’s Decreto Supremo N° 007 2025 SA, published today, officially establishes lead content limits in paints through the Reglamento de la Ley 31182. Starting now, paints in Peru must meet new safety standards, with inspections and enforcement mechanisms to follow. It is a positive public health stride toward reducing lead poisoning and follows international best practices.

On 25 June 2025, the Organisation for Economic Co-operation and Development (OECD) published 56 new, updated, and corrected Test Guidelines for the testing of chemicals. These guidelines, available in both English and French, aim to ensure that chemical safety testing remains aligned with scientific progress and best practices. The update also strengthens the application of the Replacement, Reduction and Refinement (3Rs) principles on animal testing, ensuring that the resulting data remains covered by the OECD Mutual Acceptance of Data (MAD) framework in all member and adhering countries.

Key Highlights of the 2025 Update

• New Test Guideline on Mason Bees:

The update introduces Test No. 254: Mason bees (Osmia sp.), Acute Contact Toxicity Test, marking the first OECD test guideline dedicated to solitary bee species. This test complements existing honeybee assessments and supports pollinator protection efforts.

• Omics Data Collection Integrated into Several Tests:

Seven existing guidelines have been updated to permit the collection of tissue samples for omics analysis, thereby supporting molecular-level toxicity assessments. The affected tests include:

• • Test No. 203 (Fish, Acute Toxicity Test)

  • Test No. 210 (Fish, Early-life Stage Toxicity Test)

  • Test No. 236 (Fish Embryo Acute Toxicity Test)

  • Test Nos. 407, 408, 421, and 422 (Various rodent toxicity and reproductive screening tests)

• New Defined Approach for Eye Irritation from Surfactants:
  Test No. 467 has been updated to include a defined approach tailored for surfactant chemicals. Test No. 491 now features the new STE 0.5 method as part of this approach.

• Enhanced Skin Sensitisation Assessments:
  Test No. 497 now allows in vitro and in chemico methods (TG 442C, 442D, and 442E) as alternative sources of information and introduces a new defined approach for determining points of departure in skin sensitisation studies.

• Additional Notable Updates and Corrections:

  • Analytical clarifications (Test No. 239)

  • Removal of the EpiSkin™ model from Test Nos. 431 and 439

  • Addition of a new IL-2Luc LTT assay (Test No. 444A)

  • Further guidance on eye histopathology (Test No. 437)

  • Sub-categorisation in skin sensitisation assays (Test No. 442B)

  • Expanded endpoints in reproductive toxicity studies (Test No. 443)

  • Borderline ranges introduced in Test No. 442C

  • Data interpretation improvements for Test No. 456

  • Clarifications on the usage of historical control data (Test Nos. 470 and 488)

  • Refinements in pesticide residue stability testing (Test No. 506)

  • Corrections related to radioactive labelling (Test Nos. 111, 307, 308, and 316)

  • A correction to Test No. 492 on eye irritation classification

Broader Context and Purpose

The OECD Test Guidelines are internationally recognized as standard methods for assessing the safety of chemicals in relation to both human health and the environment. Used by government, industries, and academic institutions, they form part of the OECD Council Decision on Mutual Acceptance of Data (MAD). The guidelines cover areas including physical-chemical properties, effects on biotic systems, environmental fate and behaviour, health effects, and other specialized test methods.

These updates reflect the OECD’s ongoing efforts to ensure that testing methods remain scientifically relevant, internationally harmonized, and responsive to evolving regulatory needs.

The full list of Test Guidelines and details of the 2025 updates are available on the OECD website here.

On 28 May 2025, Ukraine officially notified the World Trade Organization (WTO) of the adoption of Cabinet of Ministers Resolution No. 588, titled “On Approval of the Procedure for State Registration of Hazardous Factors”, dated 21 May 2025. This important legislative act establishes a clear and structured process for the registration of chemical and biological hazardous factors, including both standalone substances and those contained within chemical products, that are manufactured, used, or imported into Ukraine.

What Does the Regulation Cover?

The Resolution defines the procedure for:

• Registration of chemical substances and biological agents classified as hazardous factors.

• Hazardous components within chemical products if intentionally released during use or present at concentrations of 10% or more.

• Substances manufactured, used, or imported into Ukraine, except those excluded under Part 4, Article 47 of the Law of Ukraine "On the Public Health System".

Key Elements of the Registration Procedure

1. Application Submission

Manufacturers, importers, or their authorized representatives may submit applications in person, by mail, or electronically.

2. Required Documentation

Applications must include:

2. • Identification data (IUPAC name, CAS number, EINECS).

   • Intended use and hazard classification.

   • A Safety Data Sheet (SDS) in Ukrainian.

   • List of confidential business information (if applicable).

3. Expert Review

Expert institutions have 30 calendar days to evaluate the submitted materials. An official contract between the applicant and the expert institution sets the evaluation fee, which is standardized for all applicants.

4. Decision and Entry into the Register

Based on the expert's recommendation, the Ministry of Health (MOH) will issue a registration decision within 10 calendar days and record the hazardous factor in the State Register. If approved, the entry must be made within 5 days of the decision.

Registration Characteristics

• Cost and Validity: Registration is free of charge and valid indefinitely, except in cases of temporary registration. It may be revoked if new hazardous properties are identified that pose risks to human health or the environment.

• Digital Access: The State Register of Hazardous Factors, an electronic information and communication system, will officially begin operation on 1 July 2025. 

• Transparency: The State Register will be maintained by the Ministry of Health and administered technically by the state enterprise “Electronic Health”.

WTO Notification and International Alignment

Ukraine’s notification to the WTO demonstrates its commitment to transparent regulatory practices and compliance with international trade obligations under the Technical Barriers to Trade (TBT) Agreement. This step aligns with Ukraine’s broader objectives under the EU-Ukraine Association Agreement, which aim to harmonize Ukrainian legislation with EU standards and promote trade integration with the European Single Market.

Implications for Businesses

Businesses handling chemical substances and products in Ukraine should:

• Comply with the new registration requirements.

• Update internal compliance processes to support electronic submissions.

• Prepare for mandatory expert reviews and possible requests for additional data.

Legal Framework

The Resolution was published and came into force on 28 May 2025 and will remain effective until 1 March 2030.

On 16 June 2025, Ukraine officially notified the World Trade Organization (WTO) of a draft resolution of the titled "On Approval of the Rules for Joint Submission of Information in Applications for State Registration of Identical Chemical Substance”, which was issed by the Cabinet of Ministers. The draft resolution, developed by the Ministry of Environmental Protection and Natural Resources, outlines procedural requirements for joint submissions under Ukraine’s chemical registration framework, UA-REACH.  

Who Will Be Affected 

The proposed rules apply to all business entities involved in registering identical chemical substances. The rules cover substances, mixtures, and explosive or pyrotechnic articles classified under HS codes 28–38, (excluding Chapter 30 – Pharmaceuticals), and are closely aligned with the structure and principles of the EU REACH Regulation (EC) No. 1907/2006.   

Key Requirements of the Draft Rules 

To jointly submit information for the registration of an identical chemical substance, registrants must: 

• Form or join a data-sharing consortium (Information Exchange Consortium). 

• Designate a lead registrant, authorized to act on behalf of all participants.  

• Submit a joint notification to the Ministry of Environmental Protection and Natural Resources regarding the establishment of the consortium. 

What Is a Joint Notification 

A joint notification is a formal submission made by the lead registrant. It must include:   

• Contact details of all registrants and the lead registrant. 

• The chemical name and identifiers of the substance. 

The joint notification must be submitted within 10 working days of the consortium’s formation and may be submit in paper or electronic format via Ukraine’s Unified State Web Portal of Electronic Services or integrated government systems (including the EcoSystem digital platform) using a Qualified Electronic Signature or Seal, based on a qualified public key certificate, in compliance with national law. 

Supporting Documentation Required 

Each joint notification must be accompanied by documents that comply with the requirements set out in the Technical Regulation on the Safety of Chemical Products (UA-REACH), specifically:  

• Hazard classification data for the substance. 

• Summaries of hazard studies, including objectives, methods, results, and conclusions. 

• A chemical safety report or exposure information (where full assessment is not required). 

• Proposals for new tests, where necessary to complete the safety assessment. 

If any of the submitted information changes, the lead registrant must provide updated documentation within 10 calendar days.  

Legislative Context 

This draft regulation complements and operationalizes provisions of the following Ukrainian legal acts:   

• The Law of Ukraine “On Ensuring Chemical Safety and Management of Chemical Products”. 

• The Technical Regulation on Hazard Classification, Labelling and Packaging of Chemical Products (Cabinet Resolution No. 539 of 10 May 2024). 

• The Technical Regulation on the Safety of Chemical Products (Cabinet Resolution No. 847, 23 July 2024). 

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WTO Notification and International Alignment 

By notifying the WTO, Ukraine demonstrates its commitment to transparency and to aligning its chemical safety regulations with international best practices. This draft is an important step towards aligning national legislation with the EU REACH framework, in line with Ukraine’s WTO obligations and its Association Agreement with the EU. 

Implementation Timeline and Comment Period  

The adoption date of the Resolution is yet to be determined. The regulation will enter into force upon its official publication. Stakeholders have 60 days from the notification date to review the draft and provide feedback to the Ministry of Economy of Ukraine.