GPC Newsletter Nov-2025

Established under the Canadian Environmental Protection Act, 1999 (CEPA), the Federal Plastics Registry (FPR), is a central element in Canada’s efforts to reduce plastic waste and promote a circular economy. Administered by Environment and Climate Change Canada (ECCC), the Registry collects standardized national data on plastics placed on the Canadian market and how they are managed at the end of their life cycle.

The FPR is designed to improve transparency and accountability across the plastics value chain as well as harmonizing reporting across jurisdictions. Unlike existing provincial extended producer responsibility (EPR) programs, which differ in scope and definitions, the FPR establishes consistent national reporting requirements. It aims to capture plastics throughout their entire lifecycle, from manufacture and import to reuse, recycling, and disposal, providing a clear picture of how plastics circulate within the Canadian economy.

Phase 1: Initial Reporting Cycle for Producers

The first phase of the FPR applies to producers (including manufacturers, importers, and sellers) of plastic packaging and selected plastic products. Reporting covers data for the 2024 calendar year, with submissions due by 29 September 2025.

The ECCC’s detailed Phase 1 reporting guidance helped companies determine their obligations, identify applicable data categories, and calculate quantities based on resin and product types.

Producers and service providers must report on all plastics placed on the market, as well as those that are collected, reused, repaired, remanufactured, refurbished, recycled, composted, incinerated, or landfilled. They must also disclose the amount of plastic waste generated on their industrial, commercial, and institutional (ICI) premises.

Reporting under the FPR is mandatory under CEPA, and non-compliance may result in enforcement measures.

Extension Possibility under CEPA 46(6)

Under subsection 46(6) of CEPA, the Minister of the Environment may extend the reporting date set out in a Section 46 Notice, provided that a written request is submitted before the applicable deadline. While this option is no longer available for the 2024 reporting cycle, similar provisions may apply in future phases of the Federal Plastics Registry.

Future Phases and Ongoing Compliance

The Registry is being implemented gradually to expand its scope.

• Phase 2 (reporting in 2026) will extend obligations to resin manufacturers and importers, as well as to producers of additional plastic categories not covered in Phase 1. These include construction materials, textiles, and agricultural plastics.
• Phase 3 (planned for after 2026) is expected to incorporate recyclers, waste management operators, and other service providers, capturing the movement of plastics from production to recovery and final disposal.

Each new phase builds on previously collected data, enabling the ECCC to develop a comprehensive national dataset covering the full lifecycle of plastics.

By standardizing data collection across Canada, the Registry will also help to align federal and provincial EPR programs, closing existing information gaps and supporting evidence-based policy decisions.

The ECCC encourages businesses to review the current guidance and prepare for future annual submissions as Canada advances towards its zero plastic waste target by 2030.

Update 23 October 2025: 

The European Parliament has today approved the postponement of the revised CLP Regulation’s application date to 1 January 2028, confirming the text previously endorsed by the Council on 24 September 2025. The file was handled under the urgent procedure to speed up adoption, and the vote passed with 441 in favour, 108 against and 11 abstentions.

To enter into force, the draft law now requires formal approval by the Council, after which it will be published in the Official Journal of the European Union. The postponement covers obligations related to re-labelling, label formatting, advertising, distance sales, and fuel-pump labelling, easing the transition for companies.

Original News:

On 24 September 2025, the European Council approved the introduction of a “stop-the-clock” mechanism for the revised Classification, Labelling and Packaging (CLP) Regulation. The measure, part of the Commission’s Omnibus VI simplification package, delays the entry into application of the new rules to 1 January 2028.

Purpose: Legal Certainty and Simplification

The mechanism is designed to provide legal certainty for businesses and to avoid a fragmented regulatory framework. Without the postponement, different provisions of the revised CLP would have applied on different dates, creating additional compliance challenges for companies.

The alignment of deadlines covers obligations on:

• Relabelling of substances and mixtures
• Formatting requirements for labels
• Advertisements and distance sales
• Labelling at fuel pumps

By postponing these obligations, the European Council aims to give companies, particularly SMEs, more time to adapt to the new requirements while ensuring continued protection of health and the environment.

Background: Original Deadlines

The revised CLP Regulation entered into force on 10 December 2024, with the majority of obligations initially scheduled to apply from 1 July 2026, and some provisions from 2027 (see more details here). The “stop-the-clock” mechanism shifts all these dates to 1 January 2028, creating a single, harmonised starting point for compliance.

Next Steps in the Legislative Process

Following the European Council’s approval, negotiations will continue with the European Parliament to finalise the regulation. The measure forms part of the broader Omnibus VI package, which seeks to simplify EU chemicals legislation while maintaining high levels of health and environmental protection.

In a decisive move to protect human health and the environment, the European Commission has announced the final adoption of a regulation under REACH (Regulation (EC) No 1907/2006) to prohibit the use of per- and polyfluoroalkyl substances (PFAS) in firefighting foams across the EU.

The new Commission Regulation (EU) 2025/1988, published in the Official Journal of the European Union on 3 October, amends Annex XVII of REACH. This restricts the placing on the market and use of PFAS in firefighting foams from 23 October 2030 onwards. There will be phased transitional periods for specific applications.

Scope and Timeline

From 23 October 2030, firefighting foams containing PFAS in concentrations equal to or above 1 mg/l (sum of all PFAS) will no longer be permitted for sale or use, except in limited cases where substitution is not yet technically feasible. Transitional provisions apply to:

• High-risk and industrial installations under the Seveso III Directive, offshore platforms, certain ships, and military uses, where continued use is permitted until 23 October 2035 under strict conditions.
• Portable fire extinguishers and alcohol-resistant formulations may be used until 23 April 2027.
• Training, testing, and public fire services may use existing stocks with containment measures until 23 April 2027.

During these periods, operators must minimise releases to the environment, label PFAS-containing stocks, and ensure that waste is treated and destroyed properly, typically by incineration at temperatures above 1100 °C. Equipment that has contained PFAS foams must be thoroughly cleaned before being refilled with fluorine-free alternatives. A special derogation allows cleaned equipment (excluding portable extinguishers) to temporarily emit up to 50 mg/l of PFAS, subject to review by 2030.

Definition and Impact

The restriction applies to PFAS as defined by the OECD criteria; substances containing a fully fluorinated methyl (-CF₃) or methylene (-CF₂-) carbon atom without attached hydrogen or halogen atoms. According to the Commission’s assessment, firefighting foams are a major source of PFAS emissions, releasing around 470 tonnes annually across the EU.

The new restriction is expected to prevent around 13,000 tonnes of PFAS emissions over the next 30 years. The Commission highlights that the measure will also drive innovation in the development and deployment of fluorine-free alternatives.

The full text of Commission Regulation (EU) 2025/1988 can be accessed here. 

On 15 October 2025, the European Commission adopted Implementing Regulation (EU) 2025/2067, amending Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency (ECHA) under REACH. The regulation was published in the Official Journal of the European Union the following day. It introduces two major reforms: an inflation-based adjustment to standard REACH fees and a new system for verifying Small and Medium-sized Enterprise (SME) status.

Fee Adjustments

The amendment introduces a 19.5 % increase in standard REACH fees, reflecting the cumulative inflation recorded since 2021. This update ensures that the fees paid to ECHA continue to cover the costs of registration, evaluation, and other administrative processes under REACH.
However, in line with the European Commission’s SME Relief Package and the 2024–2029 Political Guidelines, small and medium-sized enterprises (SMEs) are excluded from this adjustment. The exemption is intended to maintain a fair balance between administrative sustainability and the financial capacity of smaller companies.

The revised fee structure will apply from 5 November 2025, the date the regulation enters into force. The exact fee amounts for each registration type and company size can be found in Implementing Regulation (EU) 2025/2067 which is available here.

New Approach to SME Status Verification

The amendment introduces a change to how ECHA verifies SME eligibility. Rather than reviewing SME claims after submission (the current ex post approach), ECHA will now verify SME status in advance (ex ante).

Under the revised system, companies wishing to benefit from reduced fees must obtain SME recognition before submitting their dossiers. This request must be submitted no later than two months before the intended submission date. Once granted, SME status will remain valid for three years and will cover all applications made during that period.
ECHA may charge an administrative fee to process SME recognition requests, but this fee will be waived if the company’s SME status is confirmed. 

The new SME verification system will apply from 5 February 2027, providing a 15-month transition period for companies to align their internal procedures. 

On 21 October 2025, the European Parliament adopted three legislative resolutions forming the core of the One Substance, One Assessment (OSOA) initiative. The package aims to simplify and harmonise the evaluation of chemicals across the EU by improving data accessibility, strengthening coordination among EU agencies, and transferring certain scientific and technical tasks to the European Chemicals Agency (ECHA).

Common Data Platform on Chemicals

The first regulation (P10_TA(2025)0235) establishes a common data platform on chemicals to consolidate information on hazard properties, uses, emissions, presence in the environment, and human exposure. The platform will also include data on safer alternatives and will apply the FAIR principles (findable, accessible, interoperable, and reusable) to ensure consistency and transparency in chemical data. It also establishes a monitoring and outlook framework to support the early identification of emerging chemical risks.

Re-attribution of Tasks to ECHA

The second act (P10_TA(2025)0236) reallocates specific scientific and technical tasks from the European Commission and other bodies to ECHA. These include assessing exemption requests under the Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU, coordinating technical reviews, and publishing non-confidential application information. A twenty-month transition period is foreseen to enable the transfer of responsibilities and resources.

Strengthened Inter-Agency Cooperation

The third text (P10_TA(2025)0237) amends several existing EU regulations to strengthen cooperation among EU agencies involved in chemical safety, food safety, environmental protection, and product regulation. These include:

• Regulation (EC) No 178/2002 (General Food Law Regulation)
• Regulation (EC) No 401/2009 (European Environment Agency Regulation)
• Regulation (EU) 2017/745 (Medical Devices Regulation)
• Regulation (EU) 2019/1021 (Persistent Organic Pollutants Regulation)

The amendments introduce mechanisms for data exchange, coordinated scientific assessments, and the resolution of divergent scientific opinions.

Next Steps

These measures aim to eliminate the duplication of chemical assessments, improve regulatory efficiency, and enhance the scientific coherence of EU chemicals legislation. This is in line with the objectives of the Chemicals Strategy for Sustainability and the zero-pollution ambition of the European Green Deal.

Following Parliament’s approval, the package awaits formal adoption by the Council of the European Union before entering into force. Each act will enter into force following publication in the Official Journal of the European Union, typically twenty days after publication, unless otherwise specified.

The national authorities of Denmark, Germany, the Netherlands, Norway and Sweden have released a 20-page summary explaining the updates to their proposal to restrict per- and polyfluoroalkyl substances (PFAS) under the REACH Regulation in the EU/EEA.

Purpose and Key Updates

The document, titled “What You Need to Know About the Updated PFAS Restriction Dossier,” provides an overview of the key changes made since the original proposal was submitted to ECHA in January 2023. It aims to help stakeholders navigate the broad and technically complex proposal and to clarify how consultation feedback and scientific evaluations have been incorporated.

Scope and Derogations

The updated dossier refines the definition of PFAS, includes revised or new derogations for specific uses where alternatives are not yet available, and outlines transitional periods. It also updates the socio-economic analysis and clarifies analytical and reporting requirements.

Next Steps

ECHA’s expert committees, the Committee for Risk Assessment (RAC) and the Committee for Socio‑Economic Analysis (SEAC), are expected to issue their draft opinions in spring 2026, followed by a formal public consultation (more details here).

The dossier submitters emphasise that the summary is not a substitute for the full updated restriction dossier but serves as guidance to support industry and other stakeholders in understanding the forthcoming decision-making process.

The full summary can be accessed here.

On 16 September 2025, the UK Health and Safety Executive (HSE) released the seventh edition of the Great Britain (GB) Mandatory Classification and Labelling (MCL) list. This latest update introduces new and revised mandatory classifications for 30 hazardous substances, based on the fifth GB CLP Agency recommendation formally agreed by Ministers in September 2025.

The changes were first notified to the World Trade Organization (WTO) under reference G/TBT/N/GBR/101 on 7 April 2025, giving stakeholders the opportunity to review and comment on the proposal.

Background on the GB MCL

The GB MCL list is a legally binding register of classifications maintained by HSE under the GB CLP Regulation. It provides a consistent framework for the classification and labelling of substances and mixtures across Great Britain (England, Scotland, and Wales). The list underpins regulatory obligations for manufacturers, importers, downstream users, and distributors, ensuring accurate hazard communication and supporting the protection of human health and the environment.

The GB MCL is updated on a regular basis to reflect scientific advances, regulatory decisions, and international developments. Updates may involve the addition of new substances, changes to existing classifications, and editorial improvements to ensure clarity and accuracy.

Key Highlights of the 7th Edition

• New Classifications: The update introduces new classifications for 30 hazardous chemical substances, including substances such as perboric acid (sodium salt), disodium peroxoborate and ozone. Furthermore, Pigment Red 122 and Solvent Violet 13 have been added, both of which are commonly used in tattoo inks and cosmetics and have been the subject of regulatory scrutiny in Europe.
• These classifications were evaluated by the HSE and recommended by the GB CLP Agency. The full list of substances is available in the WTO notification here  and on the HSE website here.
• Compliance Timeline: The Secretary of State’s Decision was issued on 12 September 2025, with the new and revised classifications entering into legal effect on 23 September 2025. Stakeholders must ensure compliance by the final deadline of 23 March 2027.
• Corrections and Clarifications: The 7th edition also corrects a number of editorial errors and typos from earlier versions of the GB MCL and removes duplicate entries to improve consistency.

Next Steps for Stakeholders

Stakeholders should review the updated list and prepare for the transition period ahead of the 2028 compliance deadline. The GB MCL list and the HSE GB CLP Publication Table here provide detailed information on the updated entries, including the Agency Opinions supporting each classification.

On 6 October 2025, the Food Safety and Standards Authority of India (FSSAI) released a draft notification proposing amendments to the Food Safety and Standards (Packaging) Regulations, 2018. The draft aims to prohibit the use of per- and polyfluoroalkyl substances (PFAS) and bisphenol A (BPA) in food contact materials, thereby strengthening India’s food packaging safety framework further.

First notified in December 2018, the packaging regulations set out clear standards to ensure that packaging materials used for food are safe and suitable, and do not contaminate the food product. The regulations cover aspects such as the type of packaging materials used, migration limits, and labeling requirements, with periodic updates to reflect new scientific evidence and global best practices.

Key Highlights of the Draft Notification

The FSSAI has proposed the following amendments to the Food Safety and Standards (Packaging) Regulations, 2018:

Ban on PFAS in Food Contact Materials:

• New sub-regulation (15) under General Requirements states that per- and polyfluoroalkyl substances (PFAS) shall not be used in the manufacture of food contact materials.
• PFAS are persistent chemicals associated with potential health risks and environmental concerns.

Elimination of BPA in Packaging:

• New sub-regulation (16) mandates that packaging made from polycarbonate and epoxy resins must be free from Bisphenol A (BPA) and its derivatives.
• BPA is widely recognized as an endocrine disruptor, and its restriction aligns India’s standards with international best practices. 

Significance of the Amendment

• Enhanced Consumer Protection: It minimizes exposure to harmful chemicals through food packaging.
• Global Alignment: Brings Indian standards closer to those in developed markets, thereby supporting exports and compliance.
• Sustainability Focus: Encourages the use of safer and more environmentally friendly packaging materials.

Public Consultation Period

Objections or suggestions may be submitted within 60 days of the Gazette notification being made public. Stakeholders, including food businesses, packaging manufacturers, and consumer groups, are encouraged to review the draft notification carefully and submit their inputs within the consultation period.

Background

On 15 October 2025, India’s Directorate General of Foreign Trade (DGFT) issued a notification revising the import policy conditions for certain chemicals and pesticides listed under Chapters 29 and 38 of the Indian Trade Classification (Harmonised System) [ITC (HS), 2022 – Schedule I]. The changes were made under the Foreign Trade (Development & Regulation) Act, 1992 and align with the Foreign Trade Policy (FTP) 2023.

The amendments update the import requirements for several chemical substances, introducing new permit obligations and clarifying existing rules for specific ITC (HS) codes related to organic chemicals and miscellaneous chemical products.

Key Amendments:

Introduction of Import Permit Requirement

• For certain chemicals and pesticides such as Bifenthrin (ISO), Prallethrin, and other specified insecticides and herbicides, import will now be subject to an Import Permit issued by the Central Insecticide Board & Registration Committee (CIB&RC) under the Ministry of Agriculture & Farmers Welfare.

Revised Policy Conditions for Select ITC (HS) Codes

• ITC HS 29162020 (Bifenthrin, Prallethrin):
  • Import now subject to Policy Condition No. 07 of the chapter.
• ITC HS 29314930 (Glyphosate, Fosetyl-al, Glufosinate Ammonium, Glyphosate Potassium Salt):
  • Import requires a CIB&RC import permit as per Policy Condition No. 04.
• ITC HS 38089361 (Goods under Supplementary Note 7):
  • Import subject to an import permit from CIB&RC under Ministry of Agriculture as per Policy Condition No. 04.

Special Conditions for Import of Glufosinate and Its Salts

• Import allowed only with a valid Certificate of Registration from CIB&RC and confirmation of non-prohibition under the Insecticides Act, 1968.
• Restricted: For Cost, Insurance and Frieght (CIF) value below ($14.61) per kg.
• Free: For CIF value ($14.61) per kg or above.
• The policy condition will be reviewed after one year from the date of publication of Notification No. 54/2024.

Clarification for Other Chemical and Pesticide Entries

• Multiple other HS codes under Chapters 29 and 38 have been aligned to ensure consistency with the Insecticides Act, 1968 and the CIB&RC regulatory framework.
• Import of registered and non-prohibited formulations remains free, subject to compliance with the above conditions.
• Effective Date: Immediate upon publication in the Gazette of India (Extraordinary)

Key Takeaways for Importers:

• Verify CIB&RC Registration and Import Permit before import.
• Ensure compliance with updated Import Policy Conditions for relevant HS codes.
• Note pricing restrictions for Glufosinate and its salts.
• Review contracts and documentation for conformity with new regulations.

Effect of the Notification:

The import policy conditions for several specific ITC (HS) codes under Chapters 29 and 38 have been amended with immediate effect to ensure regulatory oversight and alignment with domestic agricultural safety laws.

On September 8, 2025, the 17th session of the Standing Committee of the 14th National People’s Congress (NPC) conducted the second reading of the draft Hazardous Chemicals Safety Law. The revised draft clarifies that China will establish and improve a national management system for hazardous chemicals catalogues.

According to the draft, the catalogue of hazardous chemicals will be determined and published by the Emergency Management Department of the State Council  together with other relevant ministries. These include the ministries responsible for industry and information technology, public security, ecology and environment, transport, agriculture, health, customs, market regulation, railways, and civil aviation. The catalogue will be based on established standards for the identification and classification of chemical hazards and will be updated when necessary.

Whistleblower Protections and Incentives

The second draft also enhances provisions for public reporting and accountability mechanisms. It affirms that any organization or individual has the right to report violations or hidden safety risks related to hazardous chemicals to the competent authorities. Local governments at county level or above are required to reward those who make significant contributions in reporting and to keep whistleblower information strictly confidential.

Road Transport Safety Requirements

New requirements for the transport of hazardous chemicals are also included in the draft:

• Vehicles transporting hazardous chemicals must not obscure or remove warning signs.

• Vehicles must be equipped with satellite positioning and monitoring systems that meet national and industry standards, and these devices must remain functional without tampering or signal shielding.

• Drivers must strictly comply with road traffic safety laws, with limits set on night driving: no more than two consecutive hours without a break, and each rest stop must last at least 20 minutes.

Strengthening Oversight and Accountability

The second draft underscores China’s commitment to strengthening oversight of hazardous chemicals, with an emphasis on preventing transport-related risks and reinforcing the accountability system.

On October 14, 2025, the Environmental Protection Administration (EPA) of Taiwan proposed an amendment to the List of Prohibited Ingredients and Testing Methods for Environmental Pesticides, adding Methoxychlor (CAS No. 72-43-5) as a newly banned substance.

Alignment with Global Bans and POPs Listing

Methoxychlor, an organochlorine insecticide, has been banned in most developed countries due to its bioaccumulative properties and harmful effects on the nervous, endocrine, and reproductive systems. In May 2023, the 11th Conference of the Parties (COP-11) to the UN Stockholm Convention officially listed Methoxychlor as a Persistent Organic Pollutant (POP).

National Action to Protect Health and Environment

To align with international management trends and safeguard public health and the environment, Taiwan’s EPA has drafted this revision to explicitly prohibit Methoxychlor from being manufactured, processed, imported, exported, sold, or used in any environmental pesticide products.

This is the fourth revision to the regulation since it was first established on June 5, 2006. The most recent version, updated in July 2022, included 82 prohibited substances. Methoxychlor will become the 83rd entry once the amendment is finalized. Other provisions and microbial restrictions in the annex remain unchanged.

On 14 October 2025, the Australian Industrial Chemicals Introduction Scheme (AICIS) announced a major update to its Rolling Action Plan (RAP), initiating a national evaluation of per- and polyfluoroalkyl substances (PFAS) listed on the Australian Inventory of Industrial Chemicals (AIIC).

Conducted under section 74 of the Industrial Chemicals Act 2019, the evaluation will determine whether these PFAS are currently being imported or manufactured in Australia, and if so, for what purposes and in what quantities. This initiative aims to strengthen oversight of PFAS use and identify substances that may require further regulatory scrutiny.

A full list of the 522 PFAS currently subject to evaluation can be found in the RAP here.

Information Required from Industry

To support the evaluation, the AICIS will issue notices under section 76 of the Industrial Chemicals Act 2019 to all registrants whose registration period spans 1 September 2023 to 31 August 2025. These registrants will be legally required to provide data for the 2023–24 and 2024–25 registration years, including:

• Whether they have imported or manufactured any of the 522 listed PFAS in Australia.
• For each such substance, the CAS number and chemical name; how it was introduced (import or manufacture); the total quantity; and its intended end use.
• If certain information cannot be provided, the reason(s) must be given.

Registrants must submit the required information within 40 working days of receiving the notice, using the unique online form provided by AICIS. They are also encouraged to voluntarily report data from earlier years to assist the evaluation.

Strengthening PFAS Oversight

This initiative is part of the AICIS’s broader strategy to enhance the transparency of, and management of PFAS, a group of highly persistent chemicals that are linked to long-term environmental and health risks. The information collected will help inform future risk management and regulatory actions within Australia.

On 4 September 2025, Viet Nam notified the WTO (G/TBT/N/VNM/357) of a Draft Decree on the Management of Cosmetics introducing an updated regulatory framework for cosmetic products. The draft sets detailed requirements for  product notification, manufacturing conditions, labeling/advertising, market surveillance, and recalls—harmonized with the ASEAN Cosmetics framework.

The Ministry of Health (Drug Administration of Viet Nam) aims to adopt the Decree  on 4 November 2025 with entry into force on 1 July 2026. Stakeholders have until 3 November 2025 (60 days from notification) to submit comments.

This proposed Decree signals a shift to a unified, electronic, risk-based regime covering import/export, Certificates of Free Sale (CFS), Product Information Files (PIF), inspection/testing, and enforcement. The draft text spans 10 chapters and 60 articles, assigning responsibilities across central and provincial authorities and including detailed transitional arrangements.

Scope and ASEAN Alignment

The Decree expressly implements the ASEAN Harmonized Cosmetic Regulatory Scheme, adopting the latest ASEAN annexes for ingredient restrictions and safety assessment, and anchoring labeling and claims to ASEAN guidance and the Law on Advertising.

Key Regulatory Pillars

1) Product Notification & PIF

• Mandatory pre-market notification for both domestically produced and imported cosmetics; validity 5 years with renewal pathway.
• PIF content and accessibility to authorities are prescribed; safety must be assessed per ASEAN guidance.

2) Import/Export and CFS

• Import allowed once the product is notified on the national portals; customs verifies notification status electronically.
• CFS exemptions for products produced in, or exported from, Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) or ASEAN member countries, subject to specified documentary alternatives (e.g., proof of legal sale or ASEAN notification).

3) Manufacturing Controls (CGMP/ISO 22716)

• Production sites must meet personnel, facility, and quality-system requirements consistent with Current Good Manufacturing Practice CGMP.
• Provincial Health Departments will issue/adjust/revoke manufacturing licenses and may also issue CGMP certificates.
• Reassessments may be periodic or cause-based.

4) Labeling and Claims

• Mandatory label fields include product name, responsible company (in Vietnamese), origin, function/use, INCI ingredient list, manufacturer, batch/production date and expiry/use-after-opening rules, warnings where ASEAN annexes require, notification number, and product standard.
• Electronic labeling is permitted with conditions.
• Advertising must reflect notified information and substantiated claims.

5) Post-Market Controls, Testing, and Recalls

• Risk-based oversight: dossier review, targeted sampling/testing (GLP/ISO 17025), required independent testing for higher-risk categories (e.g., whitening, baby/toddler, sunscreen).
• Serious adverse events trigger expedited reporting and potential market actions.
• Detailed mandatory recall processes (voluntary or ordered) and suspension/blackout rules are specified.

Safety/Quality Benchmarks (Annexed Limits)

Appendix 1 sets maximum limits for heavy metals (Hg 1 ppm; As 5 ppm; Pb 20 ppm; Cd 5 ppm), microbiological limits (stricter for products for children under 3 years or for ocular or mucosal use), and a 10 ppm cap for 1,4-dioxane as a trace impurity (mirroring ASEAN parameters).

Digital Administration

The draft enables full online procedures for notification, renewals, licensing, and archiving; electronic outcomes have equal legal effect to paper. Authorities will publish notified products and licensed manufacturers on official portals to support customs clearance and market surveillance.

Phased Transition

• Adoption: 4 November 2025 (proposed). Entry into force: 1 July 2026. Comment deadline: 3 November 2025.
• From 1 January 2027, renewal procedures begin under the new Decree. Handling of notifications moved to provincial Health Departments for all products; legacy procedures before this date follow interim rules in Article 56.
• Manufacturing certificates issued under Decree 93/2016 remain valid until 31 December 2027. From 1 January 2028, facilities must meet the new CGMP-based conditions and obtain certificates under the new Decree.
• By 1 July 2026: Provincial Health Departments must ensure notified product information is published on the national e-government portal per the digitalization mandate.

Implications for Industry Stakeholders

• For importers/brand owners: Map all SKUs to ASEAN annex limits; ensure PIF completeness and claim substantiation. Prepare for CFS alternatives where CPTPP/ASEAN exemptions apply. Verify electronic notification visibility for customs.
• For manufacturers/contract manufacturers: Gap-assess facilities and QMS against CGMP/ISO 22716; plan re-certification before 1 Jan 2028. Align batch control, retention samples, and adverse-event escalation procedures with the Decree’s post-market obligations.
• For distributors/retailers and e-commerce: Sell only notified cosmetics; maintain traceability docs; be prepared to cooperate with sampling/recalls and to halt distribution upon notices.

Next Steps

Submit written comments by 3 November 2025 to the Viet Nam TBT Enquiry Point and the Drug Administration of Viet Nam using the contact details provided in the WTO notice. Monitor the finalization for any changes to adoption/entry dates and annex alignments.

On 2 October 2025, the Ministry of Industry and Trade (Vietnam Chemicals Agency) notified to the World Trade Organization (WTO) three coordinated draft decrees to implement the Law on Chemicals No. 69/2025/QH15. Together they establish: (1) policy and planning for chemical-industry development and chemical safety–security; (2) operational rules for chemical activities and for hazardous chemicals in products and goods; and (3) consolidated annexed lists of managed chemicals that trigger licensing, declarations, training, and emergency-planning duties.

Decree 1: Chemical-Industry Development and Chemical Safety–Security

Scope and structure. Spanning eight chapters and 44 articles, this decree translates high-level policy into practical levers for planning, approving, and supervising chemical projects. It defines national strategy processes, assigns roles across central ministries and provincial authorities, and sets expectations for professional consultancy, training, emergency preparedness, and security.

Core policy mechanisms

• Planning and siting: Project approvals tied to safety-distance and spatial-risk criteria; layouts that fail separation standards must be redesigned.
• Green-chemistry integration: Technology selection, feedstocks, and process design must evidence pollution prevention, safer alternatives where feasible, and energy/resource efficiency.
• Data and oversight: Periodic reporting into a national chemicals database to support supervision, benchmarking, and policy review.

Decree 2: Management of Chemical Activities and Hazardous Chemicals in Products/Goods

Scope and structure. Organized into five chapters and 32 articles, this decree governs lifecycle controls for production, trade, storage, and use, and extends explicit oversight to hazardous chemicals contained in finished goods—aligning industrial regulation with market surveillance.

Operational mechanics

• Licensing and declarations: Risk-proportionate conditions (fit-and-proper, facility controls, competence, recordkeeping) tied to the national lists.
• Digital administration: Applications, renewals, declarations, and incident reporting handled via a centralized platform with standardized identifiers (e.g., CAS/HS) and supply-chain traceability.
• Inspections and enforcement: Risk-based scheduling prioritizing higher-hazard processes and operators with adverse histories; measures aimed at preventing loss/misuse or diversion (including to narcotics or weapons).
• Incident prevention and response: Formal accident-prevention and emergency-response plans required where listed chemicals and thresholds apply.
• Products and goods: Importers, manufacturers, and distributors must maintain evidence files (composition, safety data, conformity evidence) and cooperate with targeted checks and corrective actions.

Decree 3: Consolidated Lists of Chemicals (Annex System)

Purpose of the annexes. The companion decree publishes five annexes that anchor obligations across the regime:

• Annex I: Basic chemicals in prioritized sectors (strategic planning focus).
• Annex II: Chemicals under conditional production and trading (licensing and competence triggers).
• Annex III: Special-control chemicals (heightened security, handling, and reporting).
• Annex IV: Chemicals requiring a Chemical Accident Prevention and Response Plan (threshold-based emergency-planning duties).
• Annex V: Recognized training disciplines (qualification standards for chemical-safety roles).

Timeline and Outlook

Public comments to the WTO are open until 16 November 2025 and authorities are moving on an accelerated but synchronized schedule. The three decrees are expected to be adopted together on 1 December 2025 and to take effect on 1 July 2026, ensuring that policy, operational controls, and annexed lists align from day one.

For industry, this means a predictable transition to a lifecycle-based system that links spatial risk, licensing and declarations, product oversight, and digital reporting, while setting clearer expectations for competence and emergency readiness.

The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan, BPOM) has held a public consultation on the Draft Regulation on Certification of Good Manufacturing Practices for Cosmetics (CPKB), as part of ongoing efforts to modernize and strengthen regulatory oversight of the cosmetics sector. Stakeholders were invited to submit written comments until 26 September 2025.

The draft regulation seeks to replace BPOM Regulation No. 33/2021, introducing a risk-based supervision system, streamlining certification procedures, and codifying service-level timelines for verification, inspections, and decisions.

What the Draft Changes

Two certification tracks.

• CPKB Certificate - Required for manufacturers (including contract manufacturers), issued per dosage form, and valid for five years.
• Certificate of Compliance with CPKB Aspects - Intended for non-contract manufacturers, offered as Gradual Type A (covering 10 quality-system aspects) or Type B (covering baseline aspects). This certificate may cover multiple dosage forms and is also valid for five years.

Applications must be submitted online. BPOM will verify documentation within seven working days. Following payment, inspections are coordinated within 20 days, and decisions are issued within 35 days for cases that do not require inspection. The process follows a “clock on/off” principle, allowing up to three data-request cycles of 20 days each.

Administrative changes, such as name or address change without relocation, can be approved without inspection. Certain technical changes and renewals may trigger inspection depending on risk level and recent oversight history. Late renewals must re-apply as new.

Existing CPKB or Aspect certificates and joint-use approvals remain valid until their expiry date. Floor-plan pre-approvals submitted before the new rule takes effect will be processed under Regulation 33/2021, signalling the elimination of this requirement in the new framework. Upon entry into force, Regulation 33/2021 will be repealed.

Why It Matters for Industry

• Predictable timelines via codified milestones of seven-, twenty-, and thirty-five-days reduce uncertainty and idle time during processing.
• Scalable pathways for SMEs through Aspect-Compliance options (Type A/B) provide staged on-ramps toward full CPKB.
• Risk-based renewals/changes target inspections where they add value, limiting disruption for compliant sites.
• Integrated operations enabled by formalized joint-use approvals across cosmetics, Obat Kuasi, and PKRT.

What Companies Should Do Next

1. Map your certification path (full CPKB vs Aspect Compliance A/B) and confirm dosage forms requiring certification.
2. Align dossiers and QMS with the draft’s annexed checklists; prepare for electronic submissions and clock on/off interactions.
3. Plan for renewals and changes using risk triggers to avoid unnecessary inspections and downtime.
4. Evaluate joint-use feasibility (Obat Kuasi/PKRT) and assemble validation evidence if pursuing shared lines.

Context and Next Steps

Grounded in Government Regulation No. 28/2024 under the 2023 Health Law, the draft modernizes CPKB governance by emphasizing risk management, digital administration, and enforceable service levels. With consultation closed, stakeholders should monitor BPOM for the consolidated final text and effective date.

The Peruvian government has issued a sweeping new regulation aimed at eliminating one of the world’s most dangerous industrial pollutants: polychlorinated biphenyls (PCBs). The measure, published under Decreto Supremo Nº 018-2025-SA, sets out strict rules for the identification, handling, and eventual destruction of PCB-contaminated equipment and waste.

What Are PCBs?

Polychlorinated biphenyls are a group of toxic, non-biodegradable chemicals once widely used in electrical transformers, capacitors, and other equipment for their insulating properties. Persistent in the environment, they accumulate in human and animal tissue, causing cancer, immune system damage, and neurological disorders. PCBs were banned globally under the Stockholm Convention on Persistent Organic Pollutants, but many countries, including Peru, still grapple with legacy contamination.

Key Provisions of the Decree

The new Peruvian regulation establishes a framework for sanitary and environmentally sound management of all equipment and waste containing PCBs:

• Inventories Required by 2025: All PCB holders, from power companies to mining firms, must complete inventories of their contaminated equipment and waste by 31 December 2025. These inventories will be reported to the Ministry of Environment and the Environmental Oversight Agency (OEFA)

• Elimination Deadline 2028: PCBs must be fully removed and safely disposed of by 31 December 2028. After 2025, any equipment containing PCBs will automatically be considered hazardous waste and subject to strict controls

• Treatment Standards: The regulation allows for two routes of elimination:

  • With recovery (e.g., chemical dechlorination), where oil and equipment can be reused if PCB concentrations fall below the safe threshold.

  • Without recovery (e.g., high-temperature incineration), ensuring irreversible destruction of the pollutants.

• Bans on Dilution and Trade: PCB-contaminated oils cannot be diluted with clean oils to reduce concentrations. Likewise, the transfer of PCB-containing equipment or waste to third parties is strictly prohibited

• Import and Export Rules: Import of PCB-containing goods is banned. Export of PCB waste will only be permitted when local destruction technologies are unavailable, in line with the Basel Convention on hazardous waste

Enforcement and Penalties

The Ministry of Health, through its environmental health directorate (DIGESA), will oversee occupational health standards related to PCB exposure. Meanwhile, the Ministry of Environment will manage the national PCB database and report progress internationally. Sanctions for violations range from warnings to fines of up to 100 tax units (equivalent to tens of thousands of dollars), as well as the cancellation of operating licenses in severe cases.

Public Health Measures

The decree also mandates that PCBs be added to the official list of occupational diseases within 30 days. Authorities must launch public awareness campaigns to inform communities about the dangers of PCB exposure and the government’s cleanup strategy. For futher details, please refer to the Decree here (in Spanish). 

Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has unveiled sweeping reforms to how cosmetic, personal care and hygiene product manufacturers are authorised. Under Disposición 7939/2025, published in the Boletín Oficial de la República Argentina on the 23rd of October 2025, companies will no longer need to undergo lengthy approval procedures to begin operations. Instead, they will be able to register through a digital sworn declaration system (Declaración Jurada), which confirms compliance with sanitary and manufacturing standards.

Simplified Authorisation

The new system applies to companies producing or importing cosmetics, perfumes, personal hygiene products, oral hygiene items for dental use, external disposable hygienic products, intravaginal hygienic products, and household cleaning goods (domisanitarios), except those considered high-risk.

Firms will be authorised to operate once their sworn declaration is filed online, with ANMAT assigning a registration number. The declaration has no expiry date but remains subject to inspections and compliance checks.

New Good Manufacturing Rules

The reform introduces updated Good Manufacturing Practices (GMP) for disposable and intravaginal hygiene products, published as Annex II to the decree. The standards set out detailed requirements for infrastructure, hygiene, staff training, and record-keeping, covering every stage of production and storage. Manufacturers must ensure facilities are designed to minimise contamination, maintain strict environmental controls, and train staff in hygiene and safety protocols. Each product batch must undergo testing for microbiological safety, irritation, sensitisation and, where applicable, cytotoxicity.

Packaging must preserve product quality and include labelling in Spanish in line with national health rules. Claims of special product properties must be supported by scientific evidence. Companies outsourcing manufacturing processes must also formalise contracts detailing responsibilities and quality obligations, with both parties remaining subject to inspection.

Accountability and Oversight

While the new framework shifts Argentina towards self-declaration and digital compliance, ANMAT retains full authority to carry out audits and impose sanctions. Any false or incomplete declaration may result in suspension, fines, or legal penalties under Argentina’s public health laws. Existing companies must re-register under the new system within 180 business days, though they can continue using current packaging materials for up to three years. Activities involving higher-risk household chemical products will remain regulated under previous legislation.

Regulatory Renewal

The measure also repeals several earlier resolutions dating back to 1999, unifying rules that had become fragmented across multiple decrees. Industry associations, including the Chamber of the Argentine Cosmetics and Perfume Industry (CAPA) and the Industrial Association of Personal and Household Care Products (ALPHA), were officially notified of the change.

ANMAT said the overhaul forms part of a broader government drive to modernise the public sector and align national standards with international best practice. The new regulation takes effect 60 working days after publication. For further details, you can consult the Decree here (in Spanish).

Importers and exporters in New Zealand are reminded that from 25 July 2025, permits are required not only for hazardous but also for non-hazardous e-waste shipments. This expansion of New Zealand’s existing hazardous waste controls under the Hazardous Substances and New Organisms (HSNO) framework aligns with changes to the Basel Convention.

Aligning with Basel Convention Changes

The measure implements an amendment to the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal, which introduces new waste codes for electronic waste: A1181 for hazardous e-waste under Annex VIII, and Y49 for non-hazardous e-waste under Annex II. These updates aim to strengthen global oversight of the e-waste trade and ensure proper treatment and recycling.

Permit Process and Obligations

The application process for non-hazardous e-waste permits follows the same procedure as that for controlled waste. Businesses involved in e-waste recycling, refurbishment, or export must hold a valid EPA permit before shipment, in order to comply with the Basel Convention’s prior informed consent requirements.

Clarifying the Scope

Hazardous e-waste usually comprises discarded electronic products containing or contaminated by substances such as heavy metals, PCBs, or brominated flame retardants. Non-hazardous e-waste refers to electrical or electronic equipment and components that do not contain such hazardous constituents in concentrations that would trigger classification as hazardous waste.

Further information, including guidance and application forms for import and export permits, is available on EPA’s e-waste permits webpage here.

On 22 October 2025, the Ministry of Economy, Environment and Agriculture of Ukraine published a draft resolution introducing extended deadlines and key updates to Ukraine’s chemical safety framework, UA REACH and UA CLP. The proposal aims to align national regulations more closely with EU REACH and CLP, while allowing companies additional time to meet compliance obligations.

Main Updates Proposed

1. Extended Compliance Deadlines

The draft resolution proposes the following extension of key deadlines under UA REACH and UA CLP, giving businesses more time to prepare:

• UA CLP notification: 15 November 2025 → 15 May 2026
• UA Labelling and Packaging compliance: 15 November 2025 → 1 July 2028
• UA REACH Pre-registration: 26 January 2026 → 26 January 2027

UA REACH Registration Deadlines – Proposed Extentions:

2. Institutional Update

Following a government restructuring in July 2025, the Ministry of Environmental Protection and Natural Resources (MEPR) was dissolved and merged with two other ministries. Its functions and responsibilities were transferred to the newly established Ministry of Economy, Environment and Agriculture of Ukraine (MEEA).

As a result, all references to MEPR in both UA REACH and UA CLP regulations are being updated to MEEA, ensuring that the new ministry assumes full authority over chemical safety oversight. All regulatory functions continue uninterrupted under MEEA, providing continuity in implementation.

Business Impact

The proposed amendments provide greater predictability and additional time for compliance planning. Companies will have additional time to:

• Prepare registration dossiers with improved data quality.
• Align classification, labelling, and packaging with updated UA CLP requirements.
• Manage inventory transitions smoothly thanks to extended grace periods.

Implementation Timeline and Consultation

The adoption date of the regulation has not yet been determined. The public consultation period will remain open for one month from publication, and stakeholders are encouraged to review the draft and submit their feedback to the Ministry of Economy, Environment and Agriculture of Ukraine and the State Regulatory Service of Ukraine.