GPC Newsletter Dec-2025

On 30 October 2025, Health Canada released a centralized online index of Product Safety Laboratory (PSL) test methods, which helps industry assess the safety and compliance of consumer products and cosmetics. Although the use of PSL methods is not mandatory, regulated parties remain fully responsible for ensuring that their products meet all requirements under the Canada Consumer Product Safety Act, the Food and Drugs Act, and their respective Regulations.

Purpose of the PSL Test Methods

The PSL develops and validates analytical and performance-based methods used to verify compliance with mandatory safety requirements. These methods are shared publicly to support manufacturers, importers, and distributors-particularly where a relevant standardized method is not referenced in regulation or has not yet been developed.

Where regulations do not prescribe a specific test method or testing parameters, companies may select validated procedures or equipment of their choice, provided they are appropriate for determining compliance.

How Industry Can Access These Methods

Test methods can be requested directly from Health Canada by completing the CPS Enquiry Form:

• Under Program, select Consumer Product Safety
• Under Enquiry Type, select Test Method Request

Each method includes an effective date used for version control, ensuring regulated parties reference the most current edition.

List of PSL Test Methods

Below is the full list of available PSL test methods currently published by Health Canada, including their effective dates:

Metals and Chemical Contaminants:

• Total Lead in Surface Coatings by ICP-OES (C02.2.2) - Effective 2024-11-27
• Total Lead & Cadmium in Plastic Products by ICP-OES (C02.3.1) - Effective 2021-02-22
• Total Lead & Cadmium in Metallic Products by ICP-OES (C02.4.1) - Effective 2019-03-15
• Total Metals in Cosmetics by Microwave Digestion & ICP-MS (C05) - Effective 2022-06-08
• Total Mercury in Coatings & Cosmetics by DMA 80 WR (C07) - Effective 2023-07-19
• Migratable Heavy Metals in Surface Coatings by ICP-OES (C08.1) - Effective 2022-10-18
• Leachable Lead in Kettles by ICP-MS (C09) - Effective 2024-09-27
• Migratable Lead & Cadmium from Glazed Ceramics/Glassware (C10.1) - Effective 2024-01-04
• α-Pinene, D-Limonene, α-Terpineol in Products by GC-MS (C11.1) - Effective 2020-07-08
• Ethylene Glycol & Di-Ethylene Glycol by GC-MS (C11.2) - Effective 2020-08-10

Product Formulation and Chemical Properties:

• pH of Cosmetics using PC-Titrate (C13.1) - Effective 2021-05-05
• Acid/Alkali Reserve by Titration (C14.2) - Effective 2020-06-29
• Kinematic Viscosity by Automatic Viscometer (C27) - Effective 2021-04-22
• Boric Acid in Toys by ICP-MS (C30) - Effective 2019-12-13
• Phthalates in PVC Products by GC/EI-MS (C34.3) - Effective 2025-01-24
• TCEP in Children's Products by ASE & GC-MS (C38.1) - Effective 2024-06-28
• para-Phenylenediamine in Cosmetics by GC-MS (C42) - Effective 2023-03-16

Flammability Testing:

• Flammability of Toys (F02) - Effective 2024-11-22
• Loose-Fitting Children's Sleepwear (F17) - Effective 2025-06-10
• Test Method for Lighters (F19) - Effective 2025-04-11
• Flame Projection & Flashback - Pressurized Containers (C23) - Effective 2021-05-13
• Flame Projection - Pump-Spray Containers (C23.1) - Effective 2021-05-13
• Flame Projection - Cosmetic Products (C23.2) - Effective 2021-05-13

Mechanical & Physical Hazards:

• Small Components (M00.1) - Effective 2024-02-26
• Sharp Edges (M00.2) - Effective 2025-01-24
• Sharp Points (M00.3) - Effective 2024-02-29
• Eye/Nose Security for Dolls & Plush Toys (M00.4) - Effective 2025-04-03
• Reasonably Foreseeable Use - Toys (M01.1) - Effective 2024-03-11
• Flexible Film Bags (M03) - Effective 2025-01-15
• Sound Level of Toys (M04) - Effective 2025-07-25
• Rattles (M05) - Effective 2024-04-29

Infant and Child Care Products:

• Playpens (M08) - Effective 2022-01-12
• Pacifiers & Similar Products (M09) - Effective 2025-07-11
• Cribs (M12.1) - Effective 2024-09-11
• Cradles (M12.2) - Effective 2023-12-28
• Bassinets (M12.3) - Effective 2023-12-28
• Accessories & Stands (M12.4) - Effective 2023-12-28

Other Consumer Product Categories

• Corded Window Coverings (M22) - Effective 2023-10-25

Key Takeaway for Industry

Manufacturers and importers should regularly review PSL updates to ensure that their testing programs align with the most current validated methodologies, especially for high-risk areas such as heavy metals, flammability, child safety, and cosmetic ingredients. Although PSL methods are optional, they offer a reliable benchmark for demonstrating due diligence and regulatory compliance in Canada.

On November 10, 2025, the U.S. Environmental Protection Agency (EPA) proposed revisions to the perfluoroalkyl and polyfluoroalkyl substances (PFAS) reporting requirements under the Toxic Substances Control Act (TSCA). These changes aim to make reporting more practical and implementable while reducing unnecessary or duplicative burdens on businesses, particularly small manufacturers and importers.

Background: One-Time PFAS Reporting Rule Finalized in 2023

In October 2023, EPA finalized a one-time PFAS reporting rule under TSCA section 8(a)(7). This rule required manufacturers (including importers) to report data on PFAS use, exposure, and health effects for any year between 2011 and 2022. However, the rule was criticized for imposing nearly $1 billion in compliance costs without clear implementation standards or demonstrated environmental benefits.

Key Proposed Exemptions

The new proposal seeks to maintain essential reporting requirements while exempting activities for which manufacturers are least likely to have information or be able to make reasonable determinations. Key proposed exemptions include:

• PFAS in mixtures or products at concentrations of 0.1% or lower
• Imported articles
• Certain byproducts and impurities
• Research and development chemicals
• Non-isolated intermediates

EPA also plans to make technical corrections to clarify reporting fields and adjust the data submission period.

The agency will accept public comments for 45 days following publication of the proposal in the Federal Register. Comments should be submitted to docket EPA-HQ-OPPT-2020-0549 at https://www.regulations.gov.

On 5 November 2025, the European Chemicals Agency (ECHA) added 1,1'-(ethane-1,2-diyl)bis[pentabromobenzene] (DBDPE) (CAS No. 84852-53-9) to the Candidate List of substances of very high concern (SVHCs) under the REACH Regulation (EC) No 1907/2006. The addition brings the total number of entries on the list to 251, some of which cover groups of chemicals.

The decision follows the agreement of the Member State Committee (MSC) at its October 2025 meeting, confirming the identification of DBDPE as very persistent and very bioaccumulative (vPvB) under Article 57(e) of REACH. The Swedish competent authority prepared the Annex XV dossier supporting this identification.

Reason for Inclusion and Background

DBDPE is a brominated flame retardant used in a variety of industrial applications including plastics, textiles, and electronic equipment. Its identification as an SVHC is based on a weight-of-evidence assessment demonstrating its persistence in the environment and its potential to bioaccumulate in living organisms.

ECHA noted that, beyond the usual obligations following Candidate List inclusion, the identification of DBDPE as an SVHC supports ongoing work toward a potential restriction on brominated flame retardants.

Regulatory Implications

The inclusion of DBDPE on the Candidate List triggers multiple legal obligations for companies under REACH and related EU legislation:

• Information duty: Suppliers of articles containing DBDPE in concentrations above 0.1 % w/w must inform recipients and consumers about its safe use. Consumers may request this information and must receive a response within 45 days.
• Notification to ECHA: Importers and producers of articles must notify ECHA within six months of the inclusion date (i.e. by 5 May 2026) if their articles contain DBDPE above the 0.1 % threshold and exceed one tonne per year, unless exposure can be excluded.
• Safety data sheets: Suppliers of substances or mixtures containing DBDPE must update their SDSs to reflect its Candidate List status.
• SCIP notification under the Waste Framework Directive:
  Companies producing or importing articles containing DBDPE above the 0.1 % threshold must also submit a notification to ECHA’s SCIP database of substances of concern in products.
• Restrictions on ecolabels: Products containing SVHCs cannot be awarded the EU Ecolabel under the EU Ecolabel Regulation.

ECHA notes that DBDPE may be considered for future inclusion in the Authorisation List (Annex XIV), which would prohibit its use without prior authorisation by the European Commission.

On 5 November 2025, the Council of the European Union agreed on its negotiating position for the remainder of the ‘Omnibus VI’ package, which aims to simplify the requirements for chemical products while maintaining a high level of protection for human health and the environment. The proposal introduces amendments to three core EU laws: the Classification, Labelling and Packaging (CLP) Regulation, the Cosmetics Regulation, and the Fertilising Products Regulation.

Changes to the CLP Regulation

The Council’s position builds on the 2024 revision of the CLP Regulation and maintains the “digital-by-default” labelling approach to reduce administrative burden. It introduces clearer rules on label readability, including minimum font size requirements, and harmonises labelling obligations for online and distance sales. The obligation to include a telephone contact on labels is reinstated, while digital alternatives remain possible.

As part of the package, the ‘stop-the-clock’ mechanism, already agreed under an urgent procedure by the European Parliament and the Council, will delay the entry into force of several provisions of the revised CLP Regulation until 1 January 2028. This will give industry additional time to adapt. More details on this measure are available here.

Amendments to the Cosmetics Regulation

For cosmetic products, the Council reintroduces the obligation to notify nanomaterials prior to placing them on the market, replacing the current six-month advance notification. Transition periods for the phase-out of carcinogenic, mutagenic or reprotoxic (CMR) substances will also be extended compared with current provisions to ensure practical and balanced implementation.

Updates to the Fertilising Products Regulation

The Council clarifies the role of accredited notified bodies and provides for scientific input from the European Food Safety Authority (EFSA) and the Joint Research Centre (JRC) in assessment procedures. The requirement for REACH registration of substances with harmonised classifications is also reinstated and registration obligations are introduced for micro-organisms used in fertilising products exceeding 10 tonnes per year.

Next Steps

Following the adoption of its mandate, the Council will begin negotiations with the European Parliament. This initiative supports the EU’s broader efforts to streamline legislation, reduce administrative burdens, and strengthen competitiveness, in line with the European Council’s 2024 call for regulatory simplification.

The long-awaited revision of the EU REACH Regulation (EC) No 1907/2006 has been delayed again. The European Commission’s internal planning document (SEC(2025) 2543 final, 3 November 2025), outlining possible agenda items for meetings between 12 November 2025 and 28 January 2026, does not list the REACH revision among the key legislative proposals. This confirms that the proposal will not be tabled in 2025 and is now expected in 2026, depending on progress with the revised impact assessment and inter-service consultation.

RSB Rejection Causes Further Delay

The delay also follows reports that the Regulatory Scrutiny Board (RSB) issued a negative opinion on the Commission’s impact assessment supporting the REACH revision in September 2025. The RSB reportedly requested further analysis from the Directorate-General for Environment before the proposal could proceed, contributing to the postponement of the legislative process.

Background and Objectives

Originally announced under the EU Chemicals Strategy for Sustainability, the REACH revision aims to strengthen data requirements, improve risk management for hazardous substances, and streamline administrative procedures.

On 18 November 2025, the European Chemicals Agency (ECHA) made its 12th recommendation to the European Commission, that four additional substances be added to the Authorisation List (Annex XIV of the REACH Regulation (EC No 1907/2006)). If the Commission proceeds with this recommendation, manufacturers, importers and downstream users of these substances will need to apply for authorisation if they wish to continue using them beyond the set transition deadlines.

The authorisation process is intended to manage chemicals that have already been identified as Substances of Very High Concern (SVHCs), by imposing strict requirements on their use and promoting the use of safer alternatives. The four substances targeted in this recommendation are already listed on the Candidate List of SVHCs and their proposed inclusion in Annex XIV signals heightened regulatory scrutiny.

Substances Proposed for Authorisation

Below is a summary of the proposed entries and key use/volume data.

ECHA notes that the volumes and uses of barium diboron tetraoxide within the scope of authorisation are limited. Nevertheless, the substance is recommended based on grouping considerations, as it could otherwise be used to replace other boron compounds that are already recommended, which would risk regrettable substitution.

The document also notes that the draft entry for bis(2-ethylhexyl) tetrabromophthalate, covering all isomers and combinations, was not included in the final recommendation. This substance is being addressed in a parallel restriction initiative under the Restrictions Roadmap.

Implications and next steps

The recommendation will now be considered by the European Commission and EU Member States. If the substances are added to Annex XIV, the latest application dates and sunset dates will be set out in the authorisation list.

Companies that manufacture, import or use these substances in the European Economic Area will need to check whether their uses fall within the scope of the entries. Where relevant, they will also need to prepare for authorisation applications or consider alternatives in view of the future sunset dates.

On 25 November 2025, the European Parliament adopted a new Toy Safety Regulation aimed at strengthening child health protection and updating safety requirements for all toys placed on the EU market.

Expanded Restrictions on Hazardous Chemicals

The updated regulation broadens the existing bans on dangerous substances. In addition to carcinogenic, mutagenic and reproductive toxic chemicals, the rules now prohibit endocrine disruptors, substances that are harmful to the respiratory system, skin or other organs, per- and polyfluoroalkyl substance (PFAS) and the most hazardous bisphenols. Allergenic fragrances will no longer be permitted in toys intended for children under three years of age or in toys that children may put in their mouths.

Strengthened Safety Assessments and Digital Product Passports

Manufacturers will be required to carry out comprehensive safety assessments before placing toys on the market. These assessments must consider chemical, physical, mechanical and electrical risks, as well as flammability, hygiene and radioactivity. The rules also require manufacturers of connected or digital toys to assess potential risks to children’s mental health.

All toys will require a digital product passport (DPP), which is designed to support customs and market surveillance as well as giving consumers easy access to safety information via a QR code for example. Importers, distributors and online marketplaces will face stricter obligations, and toys that do not comply with the regulation will be treated as illegal.

Next Steps

The Toy Safety Regulation will apply 20 days after its publication in the Official Journal of the European Union. A transitional period of four and a half years will allow authorities and industry to adapt to the new requirements.

On 31 October, the United Kingdom notified the World Trade Organization (WTO) of a new draft measure titled The Cosmetic Products (Restriction of Chemical Substances) Regulations 2026. Issued by the Department for Business and Trade’s Office for Product Safety and Standards (OPSS), the draft would amend Regulation (EC) No 1223/2009, as retained in Great Britain, introducing stricter controls on several cosmetic ingredients to enhance consumer safety.

Key Proposed Amendments

The draft regulation introduces three main updates:

• Formaldehyde-releasing preservatives: The labelling threshold would be lowered, requiring clearer disclosure for products releasing even small quantities of formaldehyde.
• Ban on 3-(4-Methylbenzylidene)-d1 camphor (4-MBC / Enzacamene): The UV filter would be prohibited in cosmetic products due to potential endocrine and reproductive toxicity concerns.
• Addition of 16 new CMR substances to Annex II: These substances have been classified under the GB CLP Regulation as carcinogenic, mutagenic, or reprotoxic (Category 1B or 2) and will therefore be banned for use in cosmetics.

These additions align Great Britain’s cosmetics framework more closely with recent GB CLP classification updates and reflect ongoing convergence with EU scientific risk assessments where appropriate.

Scientific Basis

The Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS) advised the government on the health risks associated with 4-MBC and formaldehyde-releasing preservatives. SAG-CS concluded that continued use of these ingredients may pose unacceptable risks to consumers, prompting the OPSS to initiate this regulatory update.

Implementation Timeline

The draft regulation is expected to be adopted in January 2026. Most provisions, including the ban on 4-MBC and the revised labelling requirements for formaldehyde-releasing substances, are scheduled to enter into force on 15 July 2026. The amendment introducing the 16 newly classified CMR substances to Annex II of the Cosmetic Regulation will follow one month later, becoming effective on 15 August 2026.

Transitional Provisions

• Products containing 4-MBC or formaldehyde-releasing preservatives placed on the market before 15 July 2026 to remain available until 15 January 2027.
• Products containing any of the newly listed CMR substances placed on the market before 15 August 2026 to remain available until 15 February 2027.

These provisions are intended to give manufacturers time to reformulate affected products and update compliance documentation.

Public Consultation

Comments are invited until 30 December 2025 and should be submitted to the UK TBT Enquiry Point via tbtenquiriesuk@businessandtrade.gov.uk.

The full draft text of The Cosmetic Products (Restriction of Chemical Substances) Regulations 2026 is available here.

On 4 November 2025, the UK Health and Safety Executive (HSE) launched a public consultation on its draft recommendation to include three substances in Annex 14 (the Authorisation List) of UK REACH. This is the first time that substances have been proposed for inclusion in the Authorisation List since the UK’s withdrawal from the European Union.

Three Substances Proposed for Inclusion

The three substances prosed for inclusion are:

• 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) (CAS No. 15571-58-1)
• *Reaction mass of DOTE and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (MOTE)
• Tetraethyl lead (TEL) (CAS No. 78-00-2)

All three substances are classified as toxic to reproduction under Article 57(c) of UK REACH and are already listed in Annex 14 of the EU REACH Regulation.

Consultation Open Until 4 February 2026

Stakeholders are invited to submit comments by 4 February 2026, providing information specific to Great Britain on current uses, exposure scenarios, possible exemptions, and the availability of safer alternatives. Following the consultation, the HSE will finalise its recommendation and submit it to the UK Secretary of State, and the Scottish and Welsh Ministers for a final decision.

Implications for Industry

Once adopted, authorisation will be required for the use or placing on the market of these substances in Great Britain after the applicable sunset dates, which are expected to be 18 to 24 months after inclusion in Annex 14.

Additional Substances for Future Prioritisation

In parallel, the HSE is inviting interested parties to submit GB-specific information on two further substances to support future prioritisation work:

• Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol (branched and linear), with ≥ 0.1 % w/w 4-heptylphenol (branched and linear) (several CAS numbers including 1471311-26-8 and 93925-00-9)
• 4,4′-bis(dimethylamino)-4″-(methylamino)trityl alcohol, with ≥ 0.1 % of Michler’s ketone or Michler’s base (CAS No. 561-41-1)

This information will help the HSE prepare future recommendations for inclusion in the Authorisation List.

Access to Consultations and Supporting Documents

All related consultation documents, including the draft recommendation, technical rationale, and background information for both the proposed and future substances, are available on the HSE consultation portal here.

On October 1, 2025, the Indian Ministry of Chemicals and Fertilizers, in accordance with the Bureau of Indian Standards Act, 2016, issued an amendment related to the quality control order (QCO) for Ethylene Vinyl Acetate Copolymers.

The amendment revises the enforcement date of the original Ethylene Vinyl Acetate Copolymers (Quality Control) Order, 2022.

Revised Implementation Timeline

The new order, titled Ethylene Vinyl Acetate Copolymers (Quality Control) Amendment Order, 2025, specifies that the QCO will now come into force on October 3, 2026, replacing the earlier enforcement date. The amendment itself took effect on the date of its publication in the Official Gazette.

This extension aims to provide stakeholders with sufficient time to comply with the updated quality standards and reflects the government’s ongoing commitment to ensuring product safety and quality control.

On 12 November 2025, the Government of India, Ministry of Chemicals and Fertilizers (Department of Chemicals & Petrochemicals) issued a series of orders rescinding fourteen previously notified BIS Quality Control Orders (QCOs) across the chemicals, petrochemicals, and polymer sectors.

These rescissions were made under Section 16 of the Bureau of Indian Standards Act, 2016 and took immediate effect, except for actions already taken or omitted before the rescissions were issued.

Key Notifications Rescinded

Implications for Industry

• These substances are no longer subject to mandatory BIS certification requirements under the rescinded QCOs.
• Manufacturers, importers, and traders dealing in these chemicals and polymers may now operate without the compliance requirements imposed by the rescinded QCOs.
• Any compliance actions already taken under earlier orders remain valid for past conduct.

These orders were issued after consultation with the Bureau of Indian Standards (BIS) and are based on the opinion that rescinding these QCOs is in the public interest.

In its Second Report (October 2025), the High-Level Committee on Non-Financial Regulatory Reforms (HLC-NFRR) called for a major overhaul of India’s Quality Control Order (QCO) framework. The number of products covered by QCOs has increased from fewer than 70 products in 2016 to nearly 790 in 2025. This has resulted in growing compliance burdens, supply-chain disruptions, and increased costs especially for MSMEs and sectors that rely on imported raw materials. The Committee recommends a nationwide rationalisation of the regime to focus on areas critical to public safety while easing unnecessary controls on raw materials and intermediate goods.

Key Recommendations

• Synthetic Fibres & Yarns
  • Revoke QCOs on PTA, MEG, PSF, VSF, FDY, POY, IDY, PSY. These are upstream inputs with a low safety risk, and mandatory BIS certification inflates costs and affects export competitiveness.
• Plastics & Polymers
  • Withdraw mandatory BIS certification for PE (LDPE/LLDPE/HDPE), PP, PVC, ABS, EVA, PU, and polycarbonate. Current QCOs restrict access to specialty grades, increase resin prices, and slow supply chains.
• Base Metals
  • Revoke QCOs for upstream metals such as copper, aluminium, tin, lead, nickel powder, and precision/intermediate grades. These are industrial inputs and downstream product standards already ensure quality.
• Steel
  • Retain QCOs for construction-grade and pressure-vessel steels (critical for public safety).
  • Suspend QCOs for engineered/alloy/auto-grade steel, electrical steel, wires, ropes, and other raw/intermediate products.
  • Subject the suspended categories to Inter-Ministerial Group (IMG) review due to import dependence.
  • Revoke the Steel Import Monitoring System (SIMS) and abolish No Objection Certificate (NOC) requirements for non-QCO steel to reduce import barriers.
• Footwear & Electronics Components
  • Roll back QCOs on input materials such as engineering copper wires, solder wires, and adhesive tapes. These are not consumer-facing items, and certification limits supplier options and raises costs.
• Upcoming / Proposed QCOs
  • Defer all new QCOs, especially for raw materials, machinery, and capital goods.
  • Require routing through an IMG for risk-based assessment.

Reform Impact

• Reduced Regulatory Burden: Easing unnecessary QCO obligations will simplify compliance for businesses across India, especially MSMEs.
• Greater Supply Chain Efficiency: Flexible access to key raw materials will enable faster production cycles, reduced delays, and reduced dependency on limited suppliers.
• Enhanced Global Competitiveness: Lower costs and fewer import barriers will help Indian manufacturers become more price-competitive in international markets.
• Shift toward Smart, Risk-Based Regulation: The reforms signal a move away from volume-driven regulation toward a more quality- and safety-driven model, focusing resources where public risk is genuinely high.

On 4 November 2025, Taiwan's Ministry of Environment (MOENV) released a draft amendment to the List of Toxic Chemical Substances and Its Management Measures.
The proposal adds the following substances as toxic chemical substances:

• Methoxychlor (CAS No. 72-43-5)
• Chlordene (Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[cd]pentalen-2-one; CAS No. 143-50-0)
• 2-(2H-benzotriazol-2-yl)-4,6-di-tert-pentylphenol (UV-328; CAS No. 25973-55-1)

The draft also specifies control concentrations and operational management measures for these substances. In addition, it strengthens management regulations for mercury and tetrachloroethylene, reinforcing Taiwan’s toxic chemical management framework.

Alignment with International Conventions

According to the MOENV, these substances are Persistent Organic Pollutants (POPs) known for their resistance to degradation, potential for long-range transport, and bioaccumulative nature, posing significant risks to human health and the environment.

The proposed amendment aligns Taiwan’s regulatory scope with the Stockholm Convention’s recent inclusion of Methoxychlor, Chlordene, and UV-328.

Classification details:

• Methoxychlor will be listed as a Class 1, Class 3, and Class 4 toxic chemical substance due to its bioaccumulation potential, persistence, and acute ecological toxicity.
• Chlordene will be listed as Class 1 and Class 4 due to its bioaccumulative and persistent nature (both with a control concentration of 0.1%).
• UV-328, which also exhibits bioaccumulation and persistence, will be classified as Class 1 and Class 4 toxic chemical substances, with a control concentration of 100%. Permitted uses are clearly defined, and threshold limits have been established in line with the EU’s POPs Regulation to ensure international consistency.

Both Methoxychlor and Chlordene will be prohibited from use, except for research, testing, and educational purposes, consistent with the Stockholm Convention.

Strengthened Controls on Mercury and Tetrachloroethylene

Mercury has been listed as a Class 1 toxic chemical substance since 1991. In line with the Minamata Convention on Mercury. The new amendment revises prohibited operations and allowable uses of mercury.

Tetrachloroethylene, listed as a Class 1 and Class 2 toxic chemical substance since 1997, will now be prohibited for use in cleaning agents. However, existing approved users may continue using it until their registered dry-cleaning equipment cycles are completed.

Traditional Measures and Industry Responsibilities

The MOENV emphasized that while new substances are being added to the list, the amendment also considers current domestic practices. Requirements include updated application procedures for permits and approvals, labeling, transportation, alarm and detection equipment, and the appointment of qualified technical and emergency response personnel. To facilitate adjustment, existing operators will be granted a transition period of one to one and a half years. The MOENV also encourages industries to identify safer substitute substances to reduce potential impacts on public health and the environment.

Public Consultation

For details of the draft amendment, please refer to the MOENV News Section (https://enews.moenv.gov.tw/) or visit the Executive Yuan Gazette Online (https://gazette.nat.gov.tw/egFront/) three days after the announcement. Comments or suggested revisions may be submitted to the Ministry of Environment within 30 days from the day following the public notice (Email: yilin.yu@moenv.gov.tw).

On 30 October 2025, Taiwan's Ministry of Environment (MOENV) announced draft amendments to the “Classification and Water Quality Standards for Surface Water Bodies”, introducing new measures to protect public health and the environment. The amendments is the first inclusion of per- and polyfluoroalkyl substances (PFAS) as a regulated parameters in Taiwan’s surface water standards.

PFAS Included as New Regulated Pollutant

The proposed amendments set a combined concentration limit for of 50 ng/L for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), aligning with Taiwan’s existing drinking water quality standards. This inclusion aims to prevent PFAS contamination of water bodies and mitigate risks to human health and aquatic ecosystems.

PFAS, commonly referred to as “forever chemicals,” are widely used in industrial and consumer products such as non-stick cookware, firefighting foams, and water-repellent materials. Due to their extreme persistence, these substances do not easily break down in the environment and can accumulate in living organisms, leading to potential health risks including hormonal disruption, immune effects, and increased cancer risk.

By setting PFAS limits in the surface water quality framework, Taiwan joins the growing number of countries tightening PFAS controls in response to international regulatory trends. The move underscores MOENV’s commitment to align national standards with global environmental and public health priorities, following similar efforts seen in the EU, US, Japan, and South Korea.

Other Key Amendments

In addition to PFAS regulation, the draft amendment also updates several key parameters to enhance monitoring effectiveness. These include:

• Replacing “coliform group” with “E. coli” for more accurate detection of fecal contamination
• Revision of ammonia nitrogen standards for Class C and adding new standards for Class D waters
• Introduction of “recreational water use” as a defined water body purpose to support growing public demand for clean, safe water recreation.

The MOENV emphasized that these revisions are part of a continuous, adaptive review of water quality standards to ensure relevance and scientific soundness. The updated standards will guide future management by both the central and local environmental authorities.

The draft documents will be available through the Executive Yuan Gazette Online (http://gazette.nat.gov.tw/egFront/) three days after the announcement.

On 27 October 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of Environment (MOE), acting as a joint council, published the consultation schedule for toxicity assessments of new chemical substances. The schedule was released on the National Institute of Technology and Evaluation (NITE) portal. New chemical substances are those not yet listed in the Existing and New Chemical Substances inventory (ENCS).

Purpose

The consultation schedule is intended to assist companies plan requests for expert consultation to verify the scientific validity of their non-standard methods (such as analogue methods and QSAR) used to assess degradability, accumulation, and toxicity before notifying a new chemical substance under the Chemical Substances Control Law (CSCL). 

Schedule

Obligations for the Stakeholders

Under the CSCL, manufacturers and importers must notify new chemical substances which are not yet listed on the ENCS to the MHLW, METI and MoE. Companies must apply for consultation using the analogy table template and consultation summary form available on the website of the National Institute of Technology and Evaluation (NITE) before the deadline, so that their assessment can be validated before the notification process.

On 5 November 2025, the Department of Climate Change, Energy, the Environment and Water (DCCEEW) launched a public consultation on proposed environmental management standards for ten groups of industrial chemicals under the Industrial Chemicals Environmental Management Standard (IChEMS). The draft decisions set out proposed schedule assignments, which determine the level of environmental control that would apply. The consultation is open until 8 December 2025. The chemical groups included in this consultation are proposed for listing in Schedules 3, 4, and 5 of IChEMS.

Chemical Groups Included in the Consultation

The proposal covers the following groups of industrial chemicals:

• Dibutylphthalate, di(2-ethylhexyl)phthalate and diisooctylphthalate
• Short-chain alkyl- and aryl-phthalates
• Lead(2+) salts of long-chain carboxylic acids
• Lead(2+) salts of medium-chain carboxylic acids
• Parabens
• Ethoxylated alcohols (Group A)
• Ethoxylated alcohols (Group B)
• Medium and long-chain alkyl sulfonates
• 1,3-Propanediamine, N-[3-(C11–14-isoalkyloxy)propyl] derivatives, C13-rich, acetates (Lilaflot 817M)
• Carbonodithioic acid, O-(2-methylbutyl) ester, sodium salt (1:1) and carbonodithioic acid, O-(3-methylbutyl) ester, sodium salt (1:1)

The two groups of ethoxylated alcohols are evaluated separately due to differences in their hazard profiles under the AICIS assessment.

• Ethoxylated alcohols (Group A) are proposed for Schedule 4, based on their classification as Aquatic Chronic 2.
• Ethoxylated alcohols (Group B) are proposed for Schedule 3, with classifications of Aquatic Chronic 3 or no chronic GHS classification.

These distinctions reflect differing levels of anticipated environmental concern and result in different proposed management requirements under IChEMS.

Background on IChEMS

IChEMS is Australia’s national framework for managing the environmental risks of industrial chemicals. The system assigns chemicals to one of seven schedules. Schedule 1 contains chemicals of minimal environmental concern that require only basic stewardship, while Schedule 7 contains chemicals of the highest concern, which may not be used, imported or manufactured without explicit authorisation. Schedules 3, 4 and 5 fall between these two extremes and impose increasing levels of environmental control depending on the assessed risk.

• Schedule 3 applies to chemicals that have the potential to cause harm to the environment.
• Schedule 4 applies to chemicals that may cause harm to the environment and therefore require tighter management measures.
• Schedule 5 applies to chemicals that are likely to cause harm to the environment and may be subject to more stringent conditions, restrictions or prohibitions.

The substances included in this consultation fall within Schedules 3, 4 and 5, reflecting varying levels of environmental concern.

Next Steps

After the consultation period ends, the DCCEEW will review stakeholder input before finalising the schedule assignments. Once adopted, the schedules will determine the environmental management obligations for importers, manufacturers, and industrial users of these chemicals.

The consultation documents, proposed scheduling decisions, chemical profiles and the survey can be found here.

On 13 November 2025, the Australian Industrial Chemicals Introduction Scheme (AICIS) opened a public consultation on proposed revisions to the Categorisation Guidelines. This annual update provides a consolidated overview of all the planned amendments to be included the September 2026 edition, bringing together technical corrections, hazard-based updates, and regulatory clarifications. Two of the proposed changes are open for public comment, while the remainder are provided for information purposes only.

Overview of Proposed Changes

The consultation package covers four categories of updates that will shape the 2026 Categorisation Guidelines.

1. Updates to the List of Chemicals with High Hazards for Categorisation (Information Only)

The AICIS is proposing extensive changes to the high-hazard list that is used to determine introducers’ obligations. The draft update includes:

• 249 new chemicals to be added
• 121 existing entries to be updated
• Two chemicals to be removed
• One CAS number correction

These changes will ensure that the hazard listings continue to reflect the latest scientific understanding, supporting more accurate categorisation outcomes. While this part of the update is not open for comment, the AICIS is providing the full list so introducers can assess the potential impact on their future introductions.

2. High Hazard Salts and Esters (Open for Comment)

The AICIS is proposing to include the following five chemicals in part 6.5.2 of the Categorisation Guidelines, based on an evaluation indicating the need to demonstrate the absence of the developmental toxicity hazard characteristic. Introducers may need to verify that their introductions are not salts or esters of these specified chemicals during the categorisation process.

Chemicals proposed for inclusion:

• 1H-Benzotriazole, 6-chloro- (CAS 94-97-3)
• 1H-Benzotriazole (CAS 95-14-7)
• 1H-Benzotriazole, 6-methyl- (CAS 136-85-6)
• 1H-Benzotriazole, 6 (or 7)-methyl- (CAS 29385-43-1)
• 1H-Benzotriazole, 7-methyl- (CAS 29878-31-7)

The exception criteria remain the same as for other chemicals in this section. A salt or ester would not fall under this hazard requirement if:

• it is a high-molecular-weight polymer with low levels of low molecular weight species, or
• its molecular weight is greater than or equal to 1,000 g/mol.

Stakeholders are invited to comment on the proposed additions and to nominate other salts or esters that may need to be assessed for developmental toxicity concerns.

3. Single Definition for “Chemical Identity Holder” (Open for Comment)

The AICIS proposes replacing the current two definitions of ‘chemical identity holder’ with a single, consolidated definition. This is intended is to clarify how the term is used throughout the Categorisation Guidelines. Stakeholders are invited to comment on the revised definition.

4. Updated Links and Minor Editorial Amendments (Information Only)

The consultation also includes several smaller updates aimed at improving usability. These involve updated links and cross-references, structural refinements, and minor editorial changes that do not alter regulatory obligations, but will improve the clarity of the Guidelines ahead of their release in 2026.

Next Steps

Comments on the two open proposals are invited until 28 January 2026. AICIS will review the feedback before finalising the September 2026 Categorisation Guidelines.

Manila, November 2025. The Philippine Food and Drug Administration (FDA) has released a draft Circular that standardizes how human medicines are classified and reclassified nationwide. The proposal replaces legacy “ethical/OTC” labels with a risk-based framework comprising prescription products and two non-prescription tiers: pharmacist-only and general-sales (which includes household remedies). The draft implements the FDA Act of 2009 and the Philippine Pharmacy Act and aligns with Department of Health Administrative Order 2024-0013 on registration rules.

Scope and policy basis

The Circular applies to all FDA-licensed pharmaceutical establishments handling medicines for human use. It links classification to product risk and intended patient access, and sets operational rules for both initial classification and subsequent reclassification.

The three access categories

a. Prescription pharmaceutical products

Assigned where medical supervision is necessary due to risks such as misuse or dependency, the need for additional safety monitoring, parenteral administration, or radiation-emitting characteristics. Dispensing requires a valid prescription and a licensed pharmacist.

b. Pharmacist-only non-prescription products

Covers medicines that do not meet prescription criteria but still require professional oversight. Supply is restricted to licensed retail pharmaceutical establishments under a pharmacist’s direct supervision.

c. General-sales non-prescription products (including household remedies)

Intended for self-selection when warnings are readily understood and the risk of misuse or misdiagnosis is minimal. A subset may be designated household remedies if they contain common actives used for minor ailments.

Classification at registration

Applications must indicate the correct class at submission; filings under the wrong class are not accepted because documentation differs. New actives not yet on FDA’s list are assigned a class during pre-assessment. Fixed-dose combinations are classified conservatively based on the most stringent active, and drug kits/combination packs follow the most stringent item they contain.

Reclassification rules

Movement to a less stringent class proceeds stepwise. FDA may up-classify without a company request where safety evidence warrants it, considering international classifications, post-marketing safety data, and the risk of inappropriate use without supervision. Following any reclassification, Market Authorization Holders must file a post-approval change (PAC) so labels and records reflect the new class; a new Certificate of Product Registration (CPR) is issued. Stockpiling in anticipation of changes is prohibited.

Active-ingredient master list

FDA will publish and update a list of active ingredients with their assigned classes. Where an active spans multiple classes, the applicable class is distinguished by dosage strength, dosage form, indication, and related criteria. Updates occur annually or when reclassification decisions are finalized.

Labelling, storage, and advertising

Pharmacist-only products must display “PHARMACIST-ONLY” prominently on the principal display panel. All non-prescription products require a Patient Information Leaflet (PIL); if no PIL is provided, equivalent information must appear on the inner panel of the outer carton when dispensed with such packaging.

Placement rules mirror access tiers: prescription and pharmacist-only medicines are stored out of direct public reach (e.g., behind the counter), while general-sales items are displayed in a segregated section. Only non-prescription medicines may be advertised to the public; prescription products are limited to professional channels.

Transition and enforcement

For products affected by reclassification, PAC submissions follow staged timelines, and a one-year manufacturing-level exhaustion period applies to labelling updates after approval. Stickering is permitted when moving to a more stringent class, subject to FDA approval. Non-compliance can result in disapproval, suspension or cancellation of registrations, findings of misbranding/adulteration, and penalties under the Consumer Act for stockpiling.

Colombia has officially completed and published its first National Inventory of Industrial Chemical Substances. Under Decree 1630/2021, all hazardous substances imported or manufactured in quantities equal to or exceeding 100 kg per year during 2021–2023 had to be registered by May 2025, while substances produced or imported in 2024 had to be registered by September 2025.

Inventory Released Through Interactive Dashboards

To promote transparency and accessibility, the government has made the inventory available through a dashboard visualization system available on the INSQUI website. The system features four interactive dashboards:

• Principal and Secondary Uses of Registered Substances
• Headquarters of Registrants
• Reported Hazards
• Registered Users

These dashboards allow users to explore and filter data across 4,473 registered substances. The tool helps determine which substances are already registered. Substances not listed in the inventory are considered “new.”

Definition of New Substances and Associated Requirements

With the publication of this national inventory, companies can now verify whether their substances are classified as new. According to Decree 1630/2021, a new chemical substance is defined as one imported or manufactured in Colombia after the May 2025 registration deadline that does not appear in the National Inventory of Chemical Substances for Industrial Use.

For such new substances, the decree requires importers or manufacturers to conduct an environmental or health risk assessment to evaluate the potential risks associated with their intended uses in Colombia. Substances that meet prioritization criteria will require an additional risk assessment before commercialization.

Access to the Inventory

The interactive dashboards can be accessed on the INSQUI website here (in Spanish).

Singapore, November 2025. Singapore has finalized amendments to the Environmental Protection and Management Act 1999 (EPMA), updating the Second Schedule (Part I) to bring chlorpyrifos expressly under hazardous-substance control, refresh the entry for paraquat and its salts, and substantially expand the category for “phosphorus compounds used as pesticides.” The measure was adopted on 12 August 2025, published on 27 August 2025, and enters into force on 27 February 2026. Once effective, importers, manufacturers, and distributors of the listed chemicals, and products containing them, must obtain the relevant hazardous substance (HS) licence/permit for import, export, sale, storage, use, and transport.

What Changes in the Second Schedule

• New explicit listing for chlorpyrifos. “Chlorpyrifos” is added as a standalone hazardous substance entry following “Chlorosulphonic acid.”
• Updated paraquat entry. The previous line is replaced to maintain coverage of “Paraquat; its salts.”
• Expanded organophosphate category. The generic line “Phosphorus compounds used as pesticides” is replaced by a detailed, illustrative list of insecticidal/acaricidal organophosphates, including (but not limited to): Chlorpyrifos, Methamidophos, Methyl-parathion, Monocrotophos, Parathion, Phosphamidon, Trichlorfon, Acephate, Bromophos, Iodofenphos, Malathion, Pirimiphos-methyl, Temephos, Tetrachlorvinphos. The amendment also codifies specific exceptions:
  • Preparations containing ≤ 0.5% w/w dichlorvos and not containing any other phosphorus pesticide;
  • Materials impregnated with dichlorvos (no other phosphorus pesticide) for slow release;
  • Preparations containing ≤ 1% w/w azamethiphos and not containing any other phosphorus pesticide.

Implementation and Compliance

NEA’s WTO TBT addendum confirms the adoption, publication, and commencement dates and reiterates that affected operators must secure HS licences/permits once the regulations take effect on 27 February 2026. The final texts are available via Singapore’s legislation portal and will appear in the Second Schedule of the EPMA.

Outlook for Industry

The update tightens Singapore’s oversight of organophosphate pesticides, aligning controls with current risk profiles and market practice. Companies handling chlorpyrifos, paraquat (and salts), or the specified organophosphates, including their preparations and impregnated materials, should map inventories against the revised Second Schedule, confirm HS-licensing needs across import/export, storage, use, and transport, and adjust supply and labelling documentation ahead of the February 2026 commencement.

The sixth meeting of the Conference of the Parties to the Minamata Convention on Mercury (COP-6) concluded in Geneva on 7 November 2025, with over 1,000 in-person participants and nearly 4,000 online viewers. The Parties adopted 22 decisions, including the landmark global phase-out of dental amalgam by 2034 as well as strengthened measures against mercury-added skin-lightening products. Delegates also advanced efforts to reduce mercury use in artisanal and small-scale gold mining (ASGM), promote supply-chain transparency, and combat the illegal mercury trade. Financial support through the Global Environment Facility’s next funding cycle (GEF-9) and preparations for the Convention’s first effectiveness evaluation were emphasized, while engagement from women, young people and Indigenous Peoples reached new levels.

New Mercury Phase-Out Measures

The COP-6 decisions included amendments to Annex A to eliminate dental amalgam, enhanced cooperation with the World Health Organization on skin-lightening products, and limited extensions for countries still transitioning from certain mercury-added items. The Parties reinforced actions relating to ASGM by supporting alternative livelihoods, accountability across the gold supply chain, and collaboration with the Global Mercury Partnership. Guidance on mercury stocks, illegal trade strategies and harmonized customs codes was updated, and an expert group on mercury compounds was established. Delegates also encouraged the alignment of mercury-reduction measures with biodiversity strategies and supported digital knowledge tools, including possible AI applications.

Highlights and Activities

Throughout the week, COP-6 hosted activities with the Geneva Environment Network and partners. The included events on mercury pollution in the Amazon, the launch of the Minamata Women’s Caucus, and discussions on planetGOLD. The Global Mercury Partnership organized exhibitions and film screenings addressing harmful beauty practices, while 19 Knowledge Labs facilitated technical exchange. COP-7 will take place in Geneva from 14 to 18 June 2027 under the presidency of Marie-Claire L'Henry.

On 19 November 2025, the Cabinet of Ministers of Ukraine adopted Resolution No. 1497 entitled “On Approval of the Rules for the Joint Submission of Information in Applications for the Registration of an Identical Chemical Substance.” The Resolution introduces procedures for the joint submission of information under Ukraine’s chemical registration framework (UA REACH), supporting data sharing and the harmonization of hazard classification while preventing duplicate testing.

Who Will Be Affected?

The rules apply to all business entities involved in registering identical chemical substances in Ukraine. This includes manufacturers, importers, and their Only Representatives and covers substances, mixtures, and other relevant chemical products.

The framework closely aligns with the principles of the EU REACH Regulation ((EC) No. 1907/2006) by promoting proportional cost-sharing, transparent communication, and efficient chemical safety assessment.

Key Requirements for Joint Submission

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

• Form an Information Exchange Consortium or join an existing consortium.
• Designate a lead registrant authorized to act on behalf of all other participants.
• Notify the Ministry of Economy, Environment and Agriculture of Ukraine within 10 calendar days of forming the consortium, providing the contact details of all participants and the designated lead registrant.

Submission of a Joint Notification

Within 60 working days of forming the consortium, the lead registrant must submit a joint notification to the Ministry of Economy, Environment and Agriculture of Ukraine.

The joint notification may be submitted in paper or electronic form via the Unified State Web Portal of Electronic Services or through the EcoSystem digital platform (where technically available), and must be signed using a Qualified Electronic Signature or Seal, in accordance with national legislation.

Supporting Documentation Required

Each joint notification must be accompanied by the following supporting information:

• Hazard classification data for the substance.
• Summaries of hazard studies, including objectives, methods, results, and conclusions.
• A Chemical Safety Report or exposure information where a full safety assessment is not required.
• Proposals for new testing if additional data is necessary to complete the safety assessment.

Other documents required under the applicable Technical Regulation on the Safety of Chemical Products (UA REACH) may also be included.

If any submitted information changes, the lead registrant must provide updated documentation within 30 calendar days of the change.

Legislative Context

Resolution No. 1497 complements and implements the following legal acts of Ukraine:

• The Law of Ukraine “On Ensuring Chemical Safety and Management of Chemical Products”.
• The Technical Regulation on the Safety of Chemical Products (Cabinet of Ministers Resolution No. 847 of 23 July 2024).
• The Technical Regulation on Hazard Classification, Labelling and Packaging of Chemical Products (Cabinet of Ministers Resolution No. 539 of 10 May 2024).

Entry Into Force and Practical Impact

The Resolution entered into force on 25 November 2025 following its official publication. From that date, all companies intending to register identical chemical substances under UA REACH must comply with the joint submission procedure set out in the Resolution.