Global Regulatory Developments for October 2025

Register Now For “Phthalate Risk Evaluation under TSCA and the Potential Impacts to the Plastics Industry,” October 30, 2025, 11:00 a.m. – 12:00 p.m. (EDT): The Acta Group (Acta^®), Bergeson & Campbell, P.C. (B&C^®), and B&C^® Consortia Management, L.L.C. (BCCM) are pleased to present “Phthalate Risk Evaluation under TSCA and the Potential Impacts to the Plastics Industry,” a complimentary webinar exploring the background and current status of the U.S. Environmental Protection Agency’s (EPA) precedent-setting review of seven phthalates under Toxic Substances Control Act (TSCA) Section 6. During this webinar, Heather J. Blankinship, Lara A. Hall, MS, RQAP-GLP, Lindsay A. Holden, Ph.D., DABT^®, and Lynn L. Bergeson will discuss the changing priorities of EPA’s Office of Pollution Prevention and Toxics (OPPT) industrial stakeholder expectations, key scientific aspects of the TSCA risk evaluations, paths to address claimed data gaps, and how these issues influence domestic plastic production and global efforts to regulate plastics. Register now.

TSCA Fundamentals, October 28-29, 2025, via webinar: B&C and Chemical Watch are pleased to present TSCA Fundamentals, a two-day course taught by Richard E. Engler, Ph.D. Dr. Engler will provide in-depth training on the very latest TSCA regulatory and policy developments, their impact, and how to anticipate their requirements, comply with the law, and remain commercially competitive. Firm clients and friends may contact events@chemicalwatch.com and share code BC-TSCA15 to receive 15% off the cost of registration.

AUSTRALIA

SWA Begins Review Of Model WHS Laws: Safe Work Australia (SWA) announced on September 4, 2025, that it is reviewing the model Work Health and Safety (WHS) Act and model WHS Regulations to strengthen and maintain harmonization. SWA will consider jurisdictional differences from the model WHS framework and recommendations from recent reviews and inquiries. SWA has published a discussion paper to encourage feedback to inform the review. SWA seeks comment on how it can maintain best practice WHS laws within the context of strengthening and maintaining harmonization. The formal consultation process, including written submissions, will close at 5:00 p.m. on November 3, 2025 (ADST). The review team will continue to meet with interested parties and feedback can be left via bestpracticereview@swa.gov.au until the end of March 2026. SWA will provide a final report of its findings with recommendations from the Best Practice Review to WHS ministers in mid-2026.

CANADA

Canada Releases Final Documents Implementing Modernized CEPA: On July 23, 2025, Canada announced the release of the following documents implementing the 2023 amendments to the Canadian Environmental Protection Act, 1999 (CEPA):

• Implementation Framework for the Right to a Healthy Environment under CEPA: The 2023 legislation, Strengthening Environmental Protection for a Healthier Canada Act (Bill S-5), requires that decisions made under CEPA respect the right to a healthy environment. The Implementation Framework sets out the meaning of the right to a healthy environment and provides guidance on how the Canadian government considers this right in the administration of CEPA. The Framework “provides a new lens for decision-making to support and encourage strong protection of both the environment and people who may be disproportionally impacted by pollution, now and in the future.”

• Plan of Priorities: The Plan of Priorities outlines upcoming initiatives to address chemical substances in Canada. It includes a list of more than 30 chemical substances and substance groups prioritized for assessment and includes new or expanded activities to help assess, control, and manage risks posed by substances. In selecting and prioritizing the substances, Canada took into account the following key considerations:
  
  
  • Substances that are hazardous to human health and/or the environment, including carcinogens, mutagens, and reproductive toxicants, as well as endocrine disrupting substances;
    
    
  • Substances impacting populations or environments that may be at increased risk, due to either greater exposure or greater susceptibility;
    
    
  • Substances with the potential to contribute to cumulative risks;
    
    
  • Very hazardous substances that are capable of long-range transport;
    
    
  • Substances with known hazardous properties that are used in products available to consumers; and
    
    
  • Potential substitutes for substances with known toxicity.

• Strategy to Replace, Reduce or Refine Vertebrate Animal Testing under CEPA: Health Canada (HC) and Environment and Climate Change Canada (ECCC) developed the Strategy to guide efforts toward the replacement, reduction, or refinement of vertebrate animal testing under CEPA.

Canada Begins Public Consultation On Actions To Address All Known Remaining Uses Of PFAS In Firefighting Foams: On September 26, 2025, Canada announced the publication of the consultation document for Phase 1 of the proposed risk management for the class of per- and polyfluoroalkyl substances (PFAS), excluding fluoropolymers. Canada proposes to prohibit the manufacture, use, sale, and import of PFAS, excluding fluoropolymers, in firefighting foams not currently regulated under CEPA through new regulations. The consultation document states that time-limited exemptions to the prohibition “are being considered only in exceptional circumstances — specifically to accommodate critical applications that cannot be immediately phased out.” Canada is also considering disclosure and labeling requirements regarding the presence of PFAS and concentration thresholds for the incidental presence of PFAS in Class B firefighting foams being sold and those contaminated by PFAS that originate from and are present in firefighting systems that have undergone decontamination. Comments are due November 25, 2025. Canada will consider comments when developing proposed regulations.

Fall WHPP Multi-Stakeholder Workshop Will Be Held November 20, 2025: According to an item in the September 2025 issue of HC’s Workplace Hazardous Products Program (WHPP) newsletter, the 2025 WHPP multi-stakeholder workshop will take place virtually on November 20, 2025, from 12:30-3:30 p.m. (EST). Topics to be discussed include the Hazardous Products Regulations (HPR) in the context of the United Nations (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and regulatory cooperation with the United States and compliance and enforcement. Registration is due by November 12, 2025.

Hazardous Products Must Comply With Amended HPR Beginning December 15, 2025: As reported in our January 9, 2023, memorandum, on January 4, 2023, HC amended the HPR to align with the seventh and eighth revised editions of the GHS. The September 2025 WHPP newsletter includes an item on the end of the three-year transition period for updating product classifications, safety data sheets (SDS), and labels to meet the amended HPR. Starting December 15, 2025, all hazardous products must have hazard classifications, SDSs, and labels (if applicable) that fully comply with the amended HPR. Any SDSs or labels submitted with claims for exemption under the Hazardous Materials Information Review Act on or after December 15, 2025, must comply with the amended HPR. The item states that claimants who submitted SDSs and labels based on the former HPR prior to the end of the transition period may be required, at HC’s request, to provide a revised SDS and/or label based on the amended HPR following the end of the transition period. According to the item, HC remains committed to the objectives of the Canada-U.S. Regulatory Cooperation Council, including mutual alignment of GHS implementation in both countries. HC therefore plans to take the following approach to compliance and enforcement of the amended HPR requirements:

• Until July 19, 2027 (the U.S. implementation deadline for mixtures), HC will focus on compliance promotion with regulated parties; and

• From July 19, 2027, onward, compliance and enforcement will follow a risk-based approach as per standard Departmental and program guidance.

Throughout this period, HC may take measures to induce or compel compliance with the HPR, if warranted.

CHINA

China Holds Public Consultation On Draft Law On Safety Of Hazardous Chemicals: The draft Law on Safety of Hazardous Chemicals (LSHC) underwent a first reading in December 2024 by the National People’s Congress (NPC) Standing Committee, and was submitted on September 8, 2025, for a second reading by the Committee. A public consultation on the draft LSHC began on September 16, 2025, with comments due October 11, 2025. The draft LSHC focuses on national security and enhanced hazard reporting, improved management systems, lifecycle management, stricter supervision, and stricter penalties. Following the public consultation, the Standing Committee will review the draft LSHC and advance it for final review in a future NPC session. Once final, the LSHC will replace Decree 591, which establishes a hazardous chemicals information management system, implements electronic identification, and initiates whole lifecycle information management of hazardous chemicals.

EUROPEAN UNION (EU)

EC Action Plan For The Chemicals Industry Includes Measures To Strengthen The Sector: The European Commission (EC) released on July 7, 2025, a Chemicals Industry Action Plan (Action Plan) to strengthen the competitiveness and modernization of the EU’s chemical sector. According to the EC, the Action Plan addresses key challenges, “namely high energy costs, unfair global competition, and weak demand, while promoting investment in innovation and sustainability.” The EC also released a simplification omnibus on chemicals to streamline and simplify further key EU chemicals legislation, as well as a proposed regulation to strengthen the governance and financial sustainability of the European Chemicals Agency (ECHA).

The Action Plan proposes the following measures:

• Resilience and level playing field: The EC will work with EU member states and stakeholders to establish a Critical Chemical Alliance to address the risks of capacity closures in the sector.

• Affordable energy and decarbonization: The EC will implement “at full speed” the Affordable Energy Action Plan to help reduce high energy and feedstock costs.

• Lead markets and innovation: The Action Plan highlights fiscal incentives and tax measures to boost demand for clean chemicals.

• Taking action on PFAS: The Action Plan reaffirms the EC’s commitment to minimize PFAS emissions “through a robust, science-based restriction, while ensuring continued use in critical applications under strict conditions where no alternatives are available which will be proposed swiftly after ECHA’s opinion.”

As part of its ongoing efforts to boost the EU’s competitiveness, the EC states that it adopted “a sixth simplification omnibus to reduce compliance costs and administrative burden for the chemical industry while ensuring strong protection of human health and the environment.” This includes simplifying hazardous chemical labeling rules, clarifying EU cosmetics regulations, and easing registration for EU fertilizing products by aligning information requirements with standard Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) rules for chemicals. According to the EC, it expects these measures “to save at least €363 million annually for the industry.” The EC’s fact sheet states that the omnibus will simplify the following areas:

• Classification, labeling, and packaging of products;

• Cosmetics; and

• Fertilizers.

More information is available in our August 7, 2025, memorandum.

The Council of the EU announced on September 24, 2025, that it approved one of the EC’s omnibus proposals to postpone to January 1, 2028, the date of entry into application of the revised Classification, Labelling, and Packaging (CLP) Regulation. The proposal also amends the timelines for relabeling, mandatory formatting requirements, advertisements, distance sales, and labeling of fuel pumps. The President of the Council of the EU will now negotiate with the European Parliament to reach a final agreement.

EC Begins Public Consultation On Draft Act To Improve Chemical Recycling: The EC began a public consultation on July 8, 2025, on a draft act that will establish rules for calculating, verifying, and reporting on recycled plastic content in single-use plastic beverage bottles. According to the EC, this will provide legal clarity to EU member states “so they can properly implement EU rules on single-use plastics,” helping to increase the use of recycled material in the EU economy and reduce plastic waste incineration and landfill. The draft act would repeal Commission Implementing Decision (EU) 2023/2683, which laid down the methodology for the calculation and verification of the recycled plastic content targets and the format for reporting data on recycled plastic content in beverage bottles. Comments were due August 19, 2025. More information is available in our July 31, 2025, blog item.

European Court Of Justice Upholds Decision Annulling Harmonized Classification And Labeling Of Titanium Dioxide: On August 1, 2025, the European Court of Justice (ECJ) issued a judgment upholding the 2022 decision of the General Court annulling the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. In its judgment, the ECJ notes that although the lower court erred in finding that “it was for it to assess the appropriateness of the choice of the standard density value of titanium dioxide particles used by the [Committee for Risk Assessment (RAC)] for the purposes of applying the Morrow calculation, it did not err in law in holding that the RAC had failed to take into account all the relevant factors in order to calculate the lung overload for the purposes of the assessment of the Heinrich study by means of that calculation.” The press release states that according to the ECJ, “even though the General Court exceeded the limits of its judicial review, the annulment of the contested classification and labelling is nevertheless justified.” The lower court “was fully entitled to hold that the RAC had failed to take into account all the relevant factors for the purposes of assessing the scientific study in question.” More information is available in our August 8, 2025, blog item.

ECHA Publishes Updated REACH Restriction Proposal For PFAS: ECHA announced on August 20, 2025, that it published an updated proposal to restrict PFAS under REACH. The authorities from Denmark, Germany, the Netherlands, Norway, and Sweden (Dossier Submitters) submitted the initial proposal in January 2023 and have now completed their evaluation of more than 5,600 scientific and technical comments and prepared an updated restriction proposal (Draft Background Document). According to ECHA, the Draft Background Document will form the basis for the opinions of ECHA’s RAC and Socio-Economic Analysis Committee (SEAC).

The Dossier Submitters have, among other things, identified and carried out assessments for eight sectors not specifically named in the 2023 proposal. These sectors are: printing applications; sealing applications; machinery applications; other medical applications, such as immediate packaging and excipients for pharmaceuticals; military applications; explosives; technical textiles; and broader industrial uses, such as solvents and catalysts.

In addition to adding sectors to the Draft Background Document, the Dossier Submitters have considered alternative restriction options, beyond a full ban restriction option 1 (RO1) or a ban with time-limited derogations for certain applications (RO2). The Draft Background Document now includes a third restriction option (RO3) that would allow continued use under strict conditions that minimize emissions over the full lifecycle, i.e., “regulatory options potentially allowing for adequate control of risks through means other than a ban.” The Dossier Submitters assessed alternative options for PFAS manufacturing; transport; electronics and semiconductors; energy; sealing applications; machinery applications; and technical textiles. According to the Draft Background Document, while the Dossier Submitters “propose RO2 (ban with use-specific transitional periods) for the draft Annex XVII entry text [], the appropriateness of all assessed restriction options should be evaluated by [ECHA’s] RAC and SEAC and considered by decision-makers.”

On August 27, 2025, ECHA announced a timeline for the restriction evaluation. In the August 27, 2025, note, ECHA states that including the eight sectors added to the Draft Background Document to the RAC and SEAC evaluations now “would require significant time beyond 2026 to finalise the opinion with these sectors.” Instead, while RAC and SEAC will not carry out a sector-specific evaluation of these eight sectors, the evaluation of horizontal issues will include “the hazard assessment and risk management measures of general applicability that are able to monitor and limit emissions of PFAS to the environment (e.g. reporting requirements, PFAS management plan).” RAC and SEAC plan to conclude their discussions on the 14 sectors covered by the 2023 restriction proposal plus PFAS manufacturing and horizontal issues by the end of 2025. ECHA announced on September 15, 2025, that it plans to begin a public consultation on the draft SEAC opinion “shortly after” SEAC’s meeting provisionally scheduled for the first half of March 2026. ECHA intends to confirm the exact starting date of the consultation in March 2026. To support interested parties in preparing for the consultation, ECHA will hold an online information session on October 30, 2025.

ECHA Calls For Evidence For Substances In Packaging And Packaging Waste: ECHA launched a call for evidence on September 17, 2025, to support the preparation of a study report under the Packaging and Packaging Waste Regulation (PPWR). ECHA seeks information on packaging, substances used in packaging and packaging waste, waste management, and recycling technologies related to packaging. ECHA notes that the PPWR, which came into force on February 11, 2025, replaced the Packaging and Packaging Waste Directive. It aims to minimize the quantities of packaging used and packaging waste generated while lowering the use of primary raw materials and fostering the transition to a circular, sustainable, and competitive economy. Under the PPWR, the EC, assisted by ECHA, must prepare a study report identifying substances of concern in packaging. The report will also consider appropriate follow-up measures, such as restrictions of substances of concern in packaging. Responses are due October 28, 2025.

EU Adopts Plastic Pellets Rules: On September 22, 2025, the Council of the EU adopted a regulation on preventing plastic pellet losses to reduce microplastic pollution. The European Parliament is expected to hold a final vote in October 2025. The rules will become effective 20 days after publication in the official journal and will begin to apply two years after the rule’s effective date. The rules aim to prevent plastic pellets from entering the environment during manufacturing and transport through requirements including:

• Implementation of risk management plans by regulated companies;

• Establishment of clean-up obligations in the event of losses to the environment;

• Designation of representatives for non-EU carriers to ensure fairness;

• Certification of companies handling more than 1,500 tons of pellets annually; and

• Introduction of requirements specific to maritime transport of pellets.

This regulation was adopted as part of the EC’s broader initiatives targeting plastic waste, such as the EU plastics strategy and circular economy action plan. According to EU findings, plastic pellets, which are key materials in the plastics manufacturing industry, are the third-largest source of unintentional microplastic releases to the environment. 

ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT (OECD)

OECD Publishes Best Practice Guide On Chemical Data Sharing Between Companies: On September 25, 2025, OECD released a Best Practice Guide on Chemical Data Sharing Between Companies. According to OECD, the report “sets out clear scenarios and recommendations to improve access, ensure fair compensation and support cooperation between companies.” OECD states that by promoting consistent practices, the report “aims to reduce administrative burdens, enhance regulatory harmonisation and strengthen trust among stakeholders.”

UNITED KINGDOM (UK)

HSE Holds Public Consultation On CLP Reform Proposal: The UK’s Health & Safety Executive (HSE) held a public consultation on a legislative proposal to reform the Great Britain (GB) CLP. HSE notes that GB CLP Article 37 links mandatory classification and labeling (MCL) in GB to evaluation activity in the EU’s harmonized classification and labeling (CLH) system by creating a statutory obligation to consider ECHA’s RAC opinions on harmonized classification proposals made under the EU CLP. According to HSE, the current timelines restrict its ability to prioritize its GB MCL evaluation work appropriately and to provide regulatory clarity to a timescale dictated by relevance to the GB market.

HSE proposes to consolidate GB CLP Articles 37 and 37A into one procedure under which MCL proposals would be evaluated, thereby simplifying the process for substance and mixture classification in GB. HSE notes that the consolidated procedure would include a fast-track evaluation pathway for assessing classification proposals from territories that adopt the UN GHS. and have a transparent classification process. Classification proposals from jurisdictions that do not adopt the UN GHS and do not have a transparent classification process would be evaluated under a full process, similar to that currently described in Article 37A. Comments were due August 18, 2025. More information is available in our June 27, 2025, blog item.

Defra Begins Public Consultation On Extending UK REACH Transitional Registration Submission Deadlines: The UK’s Department for Environment, Food and Rural Affairs (Defra) began a public consultation on July 14, 2025, on its proposals to extend the UK REACH transitional registration submission deadlines. UK REACH requires businesses to register with HSE chemicals that are placed on the market in GB. According to Defra, when the UK left the EU, “information on substances on the GB market which had been registered with UK REACH was not passed to the HSE.” The substances in question have remained on the GB market, but this information still needs to be registered with UK REACH. As reported in our July 12, 2023, blog item, UK REACH was amended in 2023 to extend the deadlines three years to October 2026, October 2028, and October 2030. Since it is no longer possible to deliver the legislative changes to implement the Alternative Transitional Registration model (ATRm) before the current first submission deadline in October 2026 with a “suitable” transition period, Defra is consulting on revised transitional submission deadlines that would provide sufficient time for the government to complete the ATRm and for industry to prepare to comply. The proposed new deadlines under consultation are:

• Option 1: October 2029, October 2030, and October 2031;

• Option 2: April 2029, April 2031, and April 2033; and

• Option 3: April 2029, April 2030, and April 2031.

Defra states that it prefers Option 1 “as it allows time to finalise the design and implementation of the ATRm and provides industry with a transition period of approximately two years.” According to Defra, moving from a two-year gap to a one-year gap between deadlines would provide sufficient time for industry to gather and submit information, “while managing down the overall period before the regulators are in receipt of complete registration data.” Comments were due September 8, 2025. More information is available in our July 17, 2025, blog item.

UN

UN Publishes GHS Rev 11: The UN published an electronic version of the eleventh revision (Rev 11) of the GHS on September 12, 2025. The UN states that Rev 11 takes into account the amendments to the tenth revised edition adopted by the Committee in December 2024, including provisions further clarifying the classification criteria for aerosols and chemicals under pressure (Chapter 2.3); new guidance for classification for skin sensitization using non-animal methods (Chapter 3.4); classification for substances and mixtures that are hazardous by contributing to global warming (Chapter 4.2); further rationalization of precautionary statements to improve users’ comprehensibility while taking into account usability for labeling practitioners; and a new section in Annex 11 with guidance addressing identification of simple asphyxiants.

UN Publishes Amended Model Regulations On The Transport Of Dangerous Goods: On September 15, 2025, the UN published an electronic version of the 24th revised edition of the Model Regulations on the Transport of Dangerous Goods. According to the UN, the amendments include:

• Revised provisions for cells and batteries to take into account hybrid batteries containing both lithium ion cells and sodium ion cells and to provide new entries to cover the different cases of batteries contained in equipment and of batteries installed in cargo transport unit;

• Updates of references to International Organization for Standardization (ISO) standards;

• Provisions for the use of recycled plastics material for flexible intermediate bulk containers;

• Clarification of the provisions for the packaging of solid substances that are liable to become liquid during transport;

• Provisions for transport of liquid organic hydrogen carriers (LOHC);

• Provisions for salvage pressure receptacles based on a limit of the maximum pressure volume product (pV-product);

• Provisions for the classification of energetic samples;

• Exemptions for the packaging of small quantities of liquid substances classified as environmentally hazardous; and

• Provisions for the design, construction, inspection, and testing of fiber reinforced plastics service equipment for portable tanks.

VIETNAM

Vietnam Notifies WTO Of Draft Decree On Management Of Cosmetics: On September 4, 2025, the Ministry of Health notified the World Trade Organization (WTO) of a draft decree on the management of cosmetics. The notification states that the draft decree establishes a comprehensive regulatory framework for the management of cosmetics. It provides provisions on the export and import of cosmetic products, the issuance of certificates of free sale, and requirements for product information files, labeling, and advertising in line with the Association of Southeast Asian Nations’ (ASEAN) guidelines and the Law on Advertising. The decree also introduces online procedures for product notification and dossier archiving; regulates the inspection and supervision of cosmetic safety and quality, including dossier reviews, product sampling, and testing; and stipulates the circumstances under which cosmetics may be suspended, recalled, or destroyed. Finally, the draft decree assigns responsibilities to ministries, agencies, organizations, and individuals involved in its implementation, while also setting forth transitional provisions, the effective date, and enforcement mechanisms. According to the notification, Vietnam intends to adopt the decree on November 4, 2025, and it will enter into force on July 1, 2026.

Vietnam Notifies WTO Of Draft Decrees Implementing The Law On Chemicals: On October 2, 2025, the Ministry of Industry and Trade (MOIT) notified WTO of the following draft decrees to implement the Law on Chemicals passed by the National Assembly in June 2025:

• Draft decree to organize and guide the implementation of provisions concerning the development of the chemical industry and chemical safety and security. The draft provides a comprehensive regulatory framework covering development of chemical industry, project management, specialized consultancy, chemical safety-security management, chemical safety training, and incident response.

• Draft decree establishing a comprehensive regulatory framework for the management of chemical activities and hazardous chemicals contained in products and goods. This draft decree aims to operationalize and strengthen the legal framework established under the Law on Chemicals. It introduces mechanisms for classifying, listing, and managing chemical substances, including licensing, declaration, specialized database, inspection procedures, and response capacity to minimize risks; protect public health, the environment, and national security; prevent loss and misuse (including use in criminal activity, production of chemical weapons, or manufacture of narcotics); and address regulatory gaps arising from the transition from previous regulations to the new Law in the context of increasingly complex chemical production and trade.

• Draft decree promulgating the lists of chemicals subject to management under the Law on Chemicals. These lists are provided in five Annexes: Annex I — list of basic chemicals in prioritized chemical industry sectors; Annex II — list of chemicals subject to conditional production and trading; Annex III — list of chemicals subject to special control in production and trading; Annex IV — list of chemicals required to prepare a Chemical Accident Prevention and Response Plan; and Annex V — list of training disciplines eligible to conduct chemical safety activities. This draft decree applies to domestic agencies, organizations, and individuals and foreign organizations and individuals conducting activities related to chemicals in the territory of Vietnam.

MOIT intends to adopt the decrees on December 1, 2025, to enter into force on July 1, 2026.