GPC Newsletter Mar-2025

On January 25, 2025, the Government of Canada published regulatory updates in the Canada Gazette, Part I, Volume 159, Number 4, regarding the management of chemical substances, specifically addressing trisiloxane and a group of terpene and terpenoid substances.

Significant New Activity Notice for Trisiloxane

The Department of the Environment has issued a Significant New Activity (SNAc) Notice under the Canadian Environmental Protection Act, 1999 (CEPA) for trisiloxane, 3-ethyl-1,1,1,3,5,5,5-heptamethyl- (CAS RN 17861-60-8). This notice requires that any significant new activities involving this substance, particularly in cosmetic applications, require prior notification to the Minister of the Environment.

Key Restrictions

• Cosmetics Use Limits: The substance cannot be used in cosmetics beyond prescribed limits, such as 5% in hair dyes and 10% in rinse-off cosmetics.

• Advance Notification: New significant activities involving the substance must be notified 90 days in advance.

• Exemptions: Use of the substance in manufacturing for export only is exempt from these regulations.

These measures are intended to prevent potential environmental and health risks associated with excessive use of trisiloxane in consumer products.

Assessment of Terpene and Terpenoid Substances

The Department of the Environment and the Department of Health have conducted a draft assessment of 14 terpene and terpenoid substances and proposed 12 of them be added to Part 2 of Schedule 1 of CEPA due to health risks.

Key Findings

• Substances of concern include cade oil, verbena officinalis extract, ginkgo biloba extract, and sage oil.

• Potential health risks: Identified concerns include carcinogenicity, reproductive toxicity, and effects on the nervous system.

• Public consultation period: A 60-day public comment period is open from January 25, 2025, to March 26, 2025, during which stakeholders are invited to submit comments and scientific data to support further assessments.

These findings reinforce the Canadian Government’s commitment to consumer safety and regulatory oversight in the management of chemical substances.

For detailed information and to participate in the consultation process, stakeholders are encouraged to consult the official publications in the Canada Gazette here.

On January 3, 2025, the U.S. Environmental Protection Agency (EPA) released its final risk evaluation for diisodecyl phthalate (DIDP), concluding that it poses an unreasonable risk to human health, particularly to unprotected female workers of reproductive age who use spray products such as adhesives, paints, and coatings. The main concern is DIDP's potential to cause developmental toxicity, along with liver damage.  

DIDP is commonly used as a plasticizer in PVC, building materials, and automotive products, but EPA did not assess risks for uses exempted from TSCA, such as cosmetics, medical devices, and food contact materials (FCMs). 

DIDP Uses and Associated Risks  

EPA conducted a risk evaluation of DIDP at the manufacturer’s request under TSCA and approved it in 2019. During manufacture or used, DIDP can be released into water, settling in sediment or into the air where it attaches to dust particles. Indoors, DIDP can be released from products over time and adhere to dust, posing risks if inhaled or ingested. 

The evaluation found that DIDP poses a risk of developmental toxicity and liver damage, but did not find sufficient evidence of a cancer risk or male reproductive system harm, known as "phthalate syndrome.". Therefore, DIDP is excluded from the cumulative risk analysis for other phthalates linked to phthalate syndrome. 

Workers at Risk from Spray-Applied DIDP Products 

EPA identified an unreasonable risk of injury to female workers of reproductive age exposed to DIDP in six conditions of use, particularly from spray-applied products such as adhesives, sealants, paints, and coatings, which can create high concentrations of DIDP mist. This exposure represents about 1% of U.S. DIDP production. However, EPA found no unreasonable risks to consumers, the general population, or the environment. 

Regulatory Scope and Next Steps 

Uses not covered by TSCA, such as in food additives and cosmetics, were not evaluated by the EPA. Although past assessments suggest that dietary exposure is the primary risk from DIDP for certain groups, EPA's findings cannot be applied to uses of DIDP not covered by TSCA. 

Additional Information  

The list of conditions that contribute significantly to unreasonable risk are available here: 

EPA Finalizes TSCA Risk Evaluation for Diisodecyl Phthalate (DIDP) | US EPA 

On 3 February 2025, the European Chemicals Agency (ECHA) published its Single Programming Document for 2025–2027, outlining its strategic objectives and regulatory actions for the next three years. The plan reinforces ECHA’s role in ensuring chemical safety, supporting regulatory compliance, and advancing the EU’s Chemicals Strategy for Sustainability and Green Deal objectives.

Accelerating Regulatory Action on Chemicals of Concern

ECHA is strengthening its Integrated Regulatory Strategy (IRS) to accelerate the identification and management of hazardous substances. The Agency will focus on streamlining hazard assessments, prioritizing high risk chemicals and ensuring timely regulatory action to protect human health and the environment.

Enhancing the Biocidal Products Regulation Process

The Agency aims to reduce delays in the evaluation of active substances under the Biocidal Products Regulation (BPR) by improving the quality of dossiers, enhancing coordination with Member States, and optimizing assessment processes. This includes faster approvals of biocidal product families and better allocation of resources to support industry compliance.

Strengthening Non-Animal Testing Approaches

In line with EU policy objectives, ECHA will increase its efforts to promote alternative testing methods to reduce reliance on animal testing while ensuring regulatory robustness. This includes working with stakeholders to develop and integrate New Approach Methodologies (NAMs) into chemical safety assessments.

Driving Digital Transformation in Chemical Management

A strong focus on IT development will improve the efficiency and accessibility of regulatory processes. ECHA is working to modernize digital tools, improve data integration across different regulatory frameworks, and ensure that industry stakeholders have seamless access to compliance information.

Supporting Industry and Member States with Compliance

To help companies and authorities meet regulatory requirements, ECHA will expand its training, guidance, and technical support initiatives. This will include workshops, online resources, and tailor-made compliance tools for regulations such as REACH, CLP, and BPR.

Promoting Sustainability in Chemical Management

ECHA will continue to support the Safe and Sustainable by Design (SSbD) initiative, encouraging industry to move towards greener chemicals and circular economy principles. The Agency will work closely with stakeholders to ensure that sustainability considerations are embedded in chemical safety decisions.

Expected Results and Regulatory Impact

• More efficient regulatory action, leading to a higher number of restriction dossiers and harmonized classification proposals.

• Reduced delays in the assessment of biocidal products, ensuring timely market access while maintaining safety standards.

• Increased adoption of non-animal testing approaches, in line with ethical and scientific advances.

• Improved digital regulatory tools, making compliance processes more user-friendly and transparent.

ECHA’s Single Programming Document for 2025-2027 sets a clear roadmap for strengthening chemical safety while promoting innovation and sustainability across the EU. The full document is available here.

On 20 February 2025, the French National Assembly adopted a new law aimed at reducing public exposure to per- and polyfluoroalkyl substances (PFAS), often referred to as "forever chemicals" due to their persistence in the environment and the human body.

Ban on PFAS in Key Consumer Products

Beginning in 2026, the legislation will prohibit the manufacture, import, and sale of PFAS-containing products as follows:

• 1 January 2026: Prohibition on the manufacture, import, export, and sale of products containing PFAS in the following categories:

  • Cosmetics: All beauty and personal care products.

  • Textiles: Clothing items, except protective gear for military personnel and firefighters.

  • Ski Waxes: Products used to maintain and enhance the performance of skis.

• 1 January 2030: Expansion of the ban to include all textiles containing PFAS, including a broader range of fabric-based products.

These measures aim to reduce public exposure to PFAS, which are used for their waterproofing and non-stick properties, but have raised health and environmental concerns due to their persistence.

Exemptions and Industry Implications

Notably, the legislation exempts certain items from the ban:

• Protective Clothing: Gear designed for security forces and emergency responders is exempt to ensure their safety and operational effectiveness.

• Cookware: Kitchen utensils, such as nonstick pans, are exempt from the law, giving manufacturers additional time to develop suitable PFAS-free alternatives.

The phased implementation provides industries with a clear timeline to transition to safer alternatives, reflecting a balance between public health priorities and economic considerations.

This legislative move positions France at the forefront of global efforts to regulate and reduce the use of PFAS and sets a precedent for comprehensive chemical safety standards.

France’s PFAS Ban and the EU-Wide Restriction Proposal

France’s national restrictions on PFAS are being introduced alongside the EU-wide restriction proposal currently under review by the European Chemicals Agency (ECHA). The proposal, which was submitted in January 2023, seeks to ban the production, use, and sale of around 10,000 PFAS across the EU. Public consultations ended in September 2023, and a final decision is expected following a review by the European Commission and EU member states.

France is not the first EU country to take independent action on PFAS ahead of the EU-wide restriction. Denmark has already banned PFAS in paper and board food packaging from 2020 and recently announced plans to extend this ban to consumer clothing, footwear, and waterproofing agents from July 2026 (read more here). Denmark, along with Germany, the Netherlands, Norway, and Sweden, has also been a key proponent of the EU’s broader restriction proposal.

By moving forward with national legislation, France is taking a leading role in addressing PFAS pollution while supporting the broader European regulatory framework. If adopted, the EU-wide restriction could further strengthen measures to phase out PFAS in industrial and consumer applications in all member states.

On 21 February 2025, the European Commission launched a comprehensive evaluation of the Cosmetic Products Regulation (Regulation (EC) No 1223/2009) to assess its effectiveness in protecting human health, ensuring a harmonized EU market, and supporting innovation in the cosmetics industry. This is the first full review of the Regulation since its full implementation in 2013, covering all 50 amendments to its annexes, as well as broader regulatory developments.

One-Month Call for Evidence Open Until 21 March 2025

As a first step in the evaluation process, the Commission has opened a one-month Call for Evidence from 21 February to 21 March 2025. This will allow stakeholders to submit their views on the functioning, strengths, and potential gaps of the Regulation. Feedback can be provided here.

Scope of the Evaluation

The Cosmetic Products Regulation (CPR) sets strict safety and compliance requirements for cosmetic products in the European Union (EU) and European Economic Area (EEA) markets, ensuring consumer protection and fair competition. However, evolving challenges such as the growth of e-commerce, digital labelling, sustainability trends, and international regulatory alignment have prompted the Commission to assess whether the Regulation remains fit for purpose.

Key Areas under Review

The evaluation will examine the impact, effectiveness, and potential gaps of the Regulation in a number of areas, including:

• Consumer Safety and Ingredient Risk Assessment – Reviewing the generic risk approach to ensure that high-risk ingredients are properly regulated.

• Labelling and Digitalization – Examining digital labelling and whether current information requirements remain relevant.

• Market Surveillance and Online Sales – Addressing the challenges posed by e-commerce, bulk sales, and cross-border trade.

• Environmental Considerations – Assessing whether the Regulation should be extended to cover the environmental impacts of chemicals in cosmetics.

• International Competitiveness and Trade – Analyzing how the EU regulation is aligned with global cosmetics regulations to facilitate trade.

• Administrative Burden & Regulatory Simplification – Identifying opportunities to reduce compliance costs, in particular for small and medium-sized enterprises (SMEs).

The review will also evaluate consistency with other EU legislation, including the REACH Regulation, CLP Regulation, Biocidal Products Regulation (BPR), and Medical Devices Regulation.

Timeline for Stakeholder Engagement and Consultation

Following the call for evidence, the Commission will launch a 12-week public consultation to allow stakeholders to provide further feedback through surveys and interviews. The whole evaluation process will run from Q2 2025 to Q2 2026.

The Commission will be seeking feedback from:

• Industry representatives (manufacturers, suppliers, SMEs)

• Regulators and customs authorities

• Consumer and environmental organizations

• Scientific researchers and academia

• General public and end-users

On 15 February 2025, the UK Health and Safety Executive (HSE) published the 6th edition of the Great Britain (GB) Mandatory Classification and Labelling (MCL) list. This update includes new and revised classifications for 46 substances, following the fourth GB CLP Agency recommendation approved by Ministers in January 2025.

Background on the GB MCL

The GB MCL list is a legally binding list managed by the HSE, serving as a cornerstone for the classification and labelling of substances and mixtures in Great Britain (England, Scotland, and Wales). It ensures that manufacturers, importers, downstream users, and distributors adhere to consistent standards, protecting public health and the environment. The list is regularly updated to reflect new scientific data, regulatory decisions, and to align with international standards. These updates may include the addition of new substances, revisions to existing classifications, and editorial changes for clarity. Stakeholders are encouraged to stay informed about these changes to maintain compliance and safety protocols.

Key Highlights of the 6th Edition:

• New Substance Classifications: The update includes substances such as nonylphenol ethoxylates, hydrogen sulfide, diuron, and 1-phenylethylidene hydrazone. These substances have an entry into force date of 15 February 2025, with a compliance deadline of 15 August 2026. The full list, along with specific classifications and hazard information can be downloaded from the HSE website.

• Corrections and Clarifications: This update also includes a number of editorial corrections, correcting previously reported errors such as typographical mistakes. Full details of the Agency’s recommendations and updated classifications can be found in the HSE GB CLP Publication Table.

Stakeholders are encouraged to review the updated GB MCL list to ensure compliance with the new classifications by the specified deadlines.

On 25 February 2025, the UK Health and Safety Executive (HSE) published two reports detailing its 2024 evaluation activities under UK REACH, covering dossier evaluation and substance evaluation. This annual report, required by Article 54 of UK REACH, provides insight into the compliance and safety of chemical substances in the UK market.

Dossier Evaluation: Compliance Checks for Novel Substances

The HSE dossier evaluation focuses on the review of registration dossiers to assess compliance with UK REACH requirements. It involves two main activities: assessing testing proposals submitted by registrants and conducting compliance checks on registration dossiers. Between 1 January 2021 and 31 December 2024, the HSE received 82 registration dossiers for novel substances - chemicals that were not previously registered under EU REACH before 1 January 2021.

Key findings from the 38 compliance checks completed in 2024:

• 32 dossiers met the compliance standards without further requirements.

• 6 dossiers required additional data, resulting in 36 requests covering:

  • 16 requests for physicochemical data

  • 10 requests for toxicological data

  • 10 requests for ecotoxicological data

While no additional vertebrate animal testing was requested, the HSE emphasized alternative methods for data generation in line with the 3Rs principle (Replacement, Reduction, and Refinement of animal testing).

Substance Evaluation: Persistent and Bioaccumulative concerns

The HSE did not initiate any new substance evaluations in 2024, but continued to review the following chemicals under assessment:

• N-Butylbenzenesulphonamide (EC 222-823-6, CAS 3622-84-2)

  • Classified as very persistent (vP) in the environment.

  • Potential for widespread environmental distribution.

  • HSE intends to propose mandatory classification under GB CLP in 2025 to assess potential reproductive toxicity.

• Paraffin Waxes and Hydrocarbon Waxes, Chloro (LCCPs)

  • Registrants submitted additional data in 2024 to clarify substance identity.

  • HSE will assess whether LCCPs meet the criteria for bioaccumulation (B/vB) and toxicity (T) under UK REACH Annex 13, with regulatory decisions expected in 2025.

These evaluations underline the HSE's commitment to ensuring chemical safety and compliance in the UK, reflecting its proactive approach to protecting the environment and public health.

Implications for Industry

The HSE's dossier compliance checks highlight the importance of robust data submission under UK REACH. The evaluations of N-Butylbenzenesulphonamide and LCCPs signal potential future regulatory action, including classification updates and restrictions.

Companies registering chemicals in the UK should closely monitor these developments to ensure their registration dossiers meet evolving regulatory expectations.

The full reports are available here and here.

The Bureau of Indian Standards (BIS) has issued the draft Indian Standard for Phosphorus Oxychloride, Technical - Specification (Second Revision of IS 11657) for public review and comments. This draft document is open for comments until February 28, 2025. 

Background of IS 11657

The Phosphorus Oxychloride, Technical – Specification standard, first published in 1986 and revised in 2020, aims to ensure that phosphorus oxychloride produced for industrial applications meets specific technical requirements, including the quality and safety parameters essential for its use in industries such as pharmaceuticals, dyestuffs, and pesticides. The draft also incorporates instrumental test methods for the determination of iron and arsenic levels, serving as alternatives to previous methods. 

The second revision of the standard introduces important updates to improve the safety and reliability of the chemical. It includes new test methods, editorial corrections, and an updated reference list. However, the specification does not apply to pharmaceutical or electronic-grade phosphorus oxychloride. 

Key Updates in the Draft Standard

Phosphorus oxychloride (CAS No 10025-87-3) is a critical substance used in the production of phosphoric acid and various esters, and in the manufacture of plasticizers, additives for fuels, and lubricants. The new standards also emphasize handling precautions, noting that phosphorus oxychloride is highly corrosive and reacts violently with water, producing heat and toxic fumes. 

Key Updates

• Incorporation of New Test Methods: Instrumental test methods for arsenic and iron content have been added, offering more accurate alternatives to chemical testing. 

• Revised Quality Standards: The draft lays out clear requirements for the product, including: 

• Boiling range (104-108°C) 

• Relative density at 27°C (1.64-1.67) 

• Minimum assay as POC13 (98%) 

• Maximum allowable arsenic (0.0002%) and iron (0.0005%) 

• Phosphorus trichloride (max 0.3%) 

• Packaging and Labeling Requirements: The draft specifies packaging in polyethylene-lined drums or glass carboys and mandates clear, indelible markings on the containers. Labels must highlight the corrosive nature of the material with appropriate warnings and safety symbols. The label must also contain the caution: "CAUTION – phosphorus oxychloride is highly corrosive. When mixed with water, it decomposes with evolution of heat." 

This draft standard will be instrumental in regulating the use of phosphorus oxychloride and ensuring the safety of industries that rely on this chemical. The Bureau of Indian Standards encourages all stakeholders to submit their feedback and comments by the deadline of February 28, 2025. 

For further details, please refer to the official draft here. 

On January 21, 2025, South Korea's Ministry of Food and Drug Safety (MFDS) released updated regulations for advertising and labelling of cosmetics to prevent false or exaggerated claims and guide the industry.

Objective of the amendment

The Ministry has found cases of misleading advertisements that give false or exaggerated advertising After analysing the violations, the MFDS has expanded the list of prohibited expressions. These changes aim to protect consumers and ensure cosmetics businesses follow proper advertising standards.

Key prohibited expressions:

• Prohibition on expression of designation/recommendation (e.g. for hospital use)
• Prohibition on expression of human-derived ingredients (e.g. exosomes)
• Prohibition on misleading product usage methods (e.g. microneedles)
• Prohibition on claims about reducing skin age (e.g. reduces skin age by n years)

The Ministry of Food and Drug Safety plans to provide specific guidance on cosmetics matters of concern and prohibited expressions, assisting cosmetics salespeople in labeling and advertising.

On January 27, 2025, Taiwan’s Food and Drug Administration and Ministry of Health and Welfare proposed new labelling requirements for specific essence and spice ingredients.  The purpose of this order is to ensure consumers receive accurate information.

Proposed amendments

The amendment focuses on changing Article 7 of the Labeling Requirements for Cosmetic Packaging, Containers, Labels, or Directions. Key changes include:

• Essences and spices may be labelled as fragrance, Flavor, Fragrance, Parfum, Perfume, or Aroma, except when specific fragrance or flavor ingredients are required to be labelled in cosmetics.
• When the concentration of any of the essences or spice ingredient listed in the Annex exceeds the following levels, the specific ingredient must be disclosed on the label. It may not be labelled as simply "Flavor," "Fragrance," "Parfum," "Perfume," or "Aroma":

• For rinse-off products: concentration greater than 0.01%.
• Products not classified as 'rinse-off products': usage concentration greater than 0.001%.

Comments

The proposed draft was notified to the World Trade Organization (WTO) on January 27, 2025, and is open for comments for 60 days from the date of publication. Comments can be submitted to the WTO at tbtenq@bsmi.gov.tw .

The Department of Industrial Works (DIW) has released an evaluation of Thailand’s Hazardous Substances Act, following an extensive public consultation held between August and September 2024. The review assessed enforcement of the Act from 1992 to 2023 and incorporates feedback from businesses, regulators, and industry experts to address concerns and propose regulatory improvements. The goal is to enhance compliance efficiency, maintain industry competitiveness, and strengthen public safety. 

Key Issues Identified in the Consultation 

1. Licensing and Permit Regulations 

A major point of debate was the suspension and revocation of licenses for hazardous substances. Under the current law, a revoked license cannot be reapplied for until five years have passed. While some stakeholders supported this measure as a deterrent for non-compliance, others argued that it could disproportionately impact businesses. Additionally, there was strong opposition to permitting Type 4 hazardous substances for laboratory analysis under any circumstances. 

2. Clarity in Hazardous Substance Classification 

Stakeholders emphasized the need for a clearer definition of "hazardous substances" under Section 4 of the Act. The existing definition includes terms such as explosive, toxic, corrosive, and irritative, but businesses argued that it is too broad, leading to inconsistent enforcement. A revised classification system was proposed to improve regulatory certainty. 

3. Coordination Among Regulatory Agencies 

The Hazardous Substance Committee, composed of representatives from nine ministries—including Defence, Industry, Public Health, and Environment—was widely seen as a source of bureaucratic delays. Participants suggested including private sector representatives in the decision-making process to enhance efficiency. Businesses also proposed the creation of a centralized Hazardous Substance Information Centre within the Ministry of Industry to improve regulatory coordination and database management. 

4. Compliance Costs and Business Impact 

Companies raised concerns about high compliance costs associated with permits, labelling, storage, and disposal. These expenses increased product prices and operational burdens, prompting some businesses to seek alternatives. Additionally, mandatory insurance requirements were met with opposition, as stakeholders argued they would place unnecessary financial pressure on businesses handling hazardous substances. 

5. Advertising, Labelling, and Enforcement Mechanisms 

A major concern was advertising restrictions. While stakeholders supported bans on misleading claims, many opposed pre-approval requirements for advertisements, suggesting that regulatory agencies should bear the costs of approval rather than businesses. Regarding labelling compliance, some industry representatives expressed concerns about administrative burdens and suggested clearer documentation requirements for corrections. 

6. Enforcement, Penalties, and Exemptions 

Opinions were divided on increasing penalties for non-compliance. While some stakeholders were in favour of stricter penalties, others called for clearer enforcement criteria to prevent arbitrary fines. There was broad agreement for the creation of a subcommittee to handle minor offenses and to ensure consistent enforcement across agencies. Businesses also requested research and analysis exemptions for hazardous substances in transit or possession. Additionally, industry representatives argued that authorities should not impose extra fees for requesting official regulatory opinions before advertising hazardous substances. 

Proposed Amendments to the Hazardous Substances Act 

Based on stakeholder feedback, the following reforms have been proposed: 

• Improved coordination between regulatory agencies to streamline enforcement. 

• Clearer classification of hazardous substances under Section 4. 

• A unified import guarantee letter across agencies to simplify approval processes. 

• Bilingual guidelines (Thai & English) to enhance accessibility for businesses. 

• Updated storage and transport criteria reflecting modern industry standards. 

• Practical transition periods for new regulations to allow businesses to adapt. 

• Incentives for compliant businesses, including expedited approvals and dedicated application channels. 

Next Steps 

The DIW has acknowledged these concerns and has assured stakeholders that future amendments will incorporate these recommendations while aligning with international standards. As Thailand moves forward with regulatory updates, businesses and policymakers anticipate a more balanced, efficient, and fair hazardous substance management system. Draft amendments are expected to be released in the coming months for further public consultation before implementation. 

The full text of the evaluation can be found here. 

On 12 February 2025, Japan’s Ministry of Environment (MoE), together with the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Economy, Trade and Industry (METI) released a joint draft notice on its portal to amend the Priority Assessment Chemical Substances (PACS) list. This update will add 3 newly designated PACS and remove 7 PACS from the list. Following assessment of the chemicals, the three ministries have opened a public consultation on the same. In Japan, the Chemical Substances Control Law (CSCL) governs Priority Assessment Chemical Substances (PACS).

Background on PACS 

PACS are chemicals whose long-term effects on humans or the plants and animals that live in human habitats are not well understood. Therefore, in order to ensure compliance with METI laws and to encourage safety and responsibility in handling of chemicals, companies that manufacture or import these chemicals in quantities greater than 1 Tonne Per Annum (TPA) are required to file annual reports in order to protect living beings.     

Key Insights from the draft notice 

The draft notice lists the following chemicals that are proposed for addition to the PACS list because of their potential for causing long-term harm to humans or to plants and animals in the human environment is not fully understood: 

List of Newly Designated PACS 

The draft notice also lists the following chemicals whose PACS designation will be revoked due to: 

• Manufactured/imported volumes of less than 10 TPA reported for 3 consecutive years.  

• Indicated released volumes of less than 1 TPA to the environment. 

• Indication that they no longer pose a risk to living organisms. 

List of PACS to be delisted from the PACS list 

Comment Period  

Stakeholders are invited to comment on this joint draft notice till 13 March 2025. After receiving the comments, the three ministries will publicly announce further updates. 

On 17 February 2025, Japan released a document entitled "J4CE 2024 Noteworthy Cases", which highlights key circular economy initiatives, led by businesses and local governments under the Japan Circular Economy Partnership (J4CE).  

Background: Japan Partnership for Circular Economy (J4CE) 

In March 2021, the Ministry of the Environment, the Ministry of Economy, Trade, and Industry, and the Japan Business Federation (Keidanren) launched the Japan Circular Economy Partnership (J4CE), a public-private project in Japan. It aims to advance the principles of circular economy by encouraging cooperation between companies, governmental bodies, and trade associations. In order to promote sustainable resource management, waste reduction, and recycling innovations in Japan, J4CE facilitates policy discussions, business networking, and knowledge exchange. This collaboration is critical to coordinating Japan's activities with international circular economy projects, such as those outlined by the G7.  

Key Highlights from the “J4CE 2024 Noteworthy Cases” Report 

The report highlights a wide range of initiatives across multiple sectors: 

• Plastic Recycling and Repurposing: In order to produce new goods, creative projects focus on collecting and recycling used domestic plastics, industrial plastic waste, and plastic packaging (e.g. Aeon Co., Ltd). 

• Construction Waste Management: Initiatives include recycling glass and plastic waste from construction sites, reusing construction materials, and implementing digital tracking systems (e.g. Taisei Corporation). 

• Household Waste and Consumer Engagement: Programs encourage the recycling of consumer goods and used packaging, including small gadgets and diapers often use digital platforms to provide incentives for participation (e.g. Mercari Co Ltd.).  

• Automotive and Industrial Recycling: To reduce landfill waste and carbon emissions, programs concentrate on recovering and recycling plastic materials from end-of-life automobiles and industrial by-products (e.g. Mitsui and Co., Ltd.).  

• Technological Innovation: To maximize resource recovery and boost recycling effectiveness, businesses are using digital technologies and AI-driven analytics.  

Other Initiatives Supporting Japan’s Circular Economy 

With an emphasis on resource efficiency, waste reduction, and sustainable business models, Japan has created a number of frameworks to move towards a circular economy. Among the crucial frameworks are: 

1. Basic Act for Establishing a Sound Material-Cycle Society (2000) 

2. Plastic Resource Circulation Act (2022) 

3. Circular Economy Roadmap (2021) 

4. Japan Circular Economy Partnership (J4CE, 2021) 

5. Extended Producer Responsibility (EPR) Policies 

These frameworks, along with the efforts of J4CE, highlight Japan's commitment to sustainable resource management and its proactive approach to addressing environmental challenges through collaborative and innovative solutions. 

On January 22, 2025, the Department of Environment and Natural Resources (DENR) released a significant update to the Philippine Inventory of Chemicals and Chemical Substances (PICCS), adding 161 new chemicals to the official list. This update, detailed in DENR Administrative Order (DAO) 2025-09, reflects ongoing efforts to regulate and monitor chemical substances used, imported, or manufactured in the country. 

Annual Revisions and Additions to the PICCS 

Under Section 5 of the Order, the PICCS is updated annually to include newly registered chemicals that meet the Pre-Manufacture and Pre-Importation Notification (PMPIN) requirements. The latest revision includes 96 new chemicals added in Calendar Year (CY) 2022 and 65 more in CY 2023, increasing the total number of listed substances from 22,277 to 22,438. Substances not listed in the PICCS require prior approval before they can be imported, processed, or distributed in the Philippines. Entities that submitted a Notice of Commencement before December 31 of the previous year will have their chemicals included in the following year’s update. 

Effective Date and Compliance Requirements 

The updated PICCS list is available on the website of the Environmental Management Bureau (EMB) and the Online Permitting and Monitoring System (OPMS), allowing access to the latest regulatory information. As stated in Section 6, the new updates take effect 15 days after publication in a newspaper of general circulation and upon acknowledgment by the Office of the National Administrative Register (ONAR). 

With increasing attention to environmental and safety regulations, keeping track of updates such as these remains essential to ensure compliance and responsible chemical management. More information can be found on the EMB Chemical Management Division website here. 

The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has issued Circular No. 3/2024, detailing significant updates to the "Guidelines for Control of Cosmetic Products in Malaysia". These revisions, effective from December 30, 2024, introduce new bans and restrictions on certain substances used in cosmetic products.

Newly Prohibited Substances

Effective November 19, 2026, the NPRA has added several substances to the list of prohibited ingredients in cosmetic products. These include:

• Benzophenone (CAS No. 119-61-9): Previously used as a UV blocker in various cosmetic formulations.

• N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid) (Pentetic acid) (CAS No. 67-43-6): Widely used for its chelating properties.

In total, 26 substances have been newly prohibited under these Directives.

Restricted Substances with Implementation Deadlines

The NPRA has also imposed specific restrictions on certain substances, with defined implementation deadlines:

• Butylated Hydroxytoluene (BHT) (CAS No. 128-37-0):

  • Mouthwash: Maximum concentration of 0.001%.

  • Toothpaste: Maximum concentration of 0.1%.

  • Leave-on and Rinse-off Products: Maximum concentration of 1%.

  • Restrictions will be enforced starting November 19, 2026.

• Homosalate (UV Filter) (CAS No. 118-56-9):

  • Facial Products (excluding propellant sprays): Maximum concentration of 7.34%.

  • Restriction will take effect on November 19, 2027.

Compliance and Enforcement

The NPRA emphasizes that all entities involved in the manufacture, sale, supply, import, or possession of cosmetic products must adhere to these updated guidelines. Non-compliance may result in regulatory action, including product recalls or penalties.

These regulatory changes are in line with decisions made at the 40th ASEAN Cosmetic Committee Meeting in November 2024, and reflect Malaysia's commitment to regional harmonization and consumer safety.

For detailed information and the complete list of affected substances, stakeholders are encouraged to consult the official NPRA directive here.

The Indonesian Cosmetics Notification System 3.0 officially launched on January 2, 2025, bringing with it a number of significant updates designed to enhance the product notification process. With a primary focus on improving regulatory compliance, this updated system introduces several new features and requirements aimed at streamlining the way cosmetic companies manage their product notifications. 

Below is a detailed overview of the key features and new requirements within the Indonesian Cosmetics Notification System 3.0. This guide will help to navigate the system more efficiently and ensure that products comply with the latest regulations.  

Key Features of the Cosmetics Notification System 3.0: 

1. Improvements of the Cosmetic Distribution Permit  

       The updated system introduces improvements to the distribution permit process, now covering: 

• New Products: Enterprises can submit new products for notification. 

• Export-Only Products: The system now includes provisions for products intended for export only. 

• Product Clustering: Businesses can now cluster products for streamlined notification and approval. 

2. Cosmetic Notification Updates: 

       The system now allows notifications for the following: 

• Product Updates: Notify any changes or updates to existing products. 

• Cosmetic Kit Updates: Provide updates for cosmetic kits. 

• Export-Only Product Updates: Submit notifications for products intended exclusively for export. 

3. Company and Manufacturer Changes Notifications: 

       Notifications can be made for changes such as: 

• Company Changes: Notify when there are changes within the company structure. 

• Factory Changes: Report all changes related to factories. 

• Multi-Factory Changes: Manage updates for businesses operating multiple factories. 

4. Packaging Changes/Variations Notifications: 

      Now, it is possible to notify about changes to: 

• Packaging Variations for Cosmetic Products: Notify variations in product packaging. 

• Packaging Variations for Cosmetic Kits: Notify packaging changes for cosmetic kits. 

5. Cosmetic Kit Notifications:  

       The new system now accommodates notifications for cosmetic product kits, improving the management of kit-related products. 

New Requirements for Product Submission: 

In order to ensure smoother processing and regulatory compliance, the following steps and requirements must be observed when submitting product notifications: 

• Intended Use of the Cosmetic Product: Ensure that the intended application site for each product is clearly specified based on its intended use. 

• Product Information File (PIF) Link:  Notifiers can now provide a direct link to the Product Information File (PIF) for products being notified. 

• OSS Permit ID: If the newly created PB UMKU OSS permit ID is not visible, go to the Administrator menu, select "OSS permit ID," and click the "inquire permit ID" button. 

• Notification Letter Access: If the notification letter is not accessible, go to the Administrator menu, enter the product license ID, click "Show," and then click "Query File DS" in the product list. 

Important Points to Remember When Entering Ingredient Information: 

The updated system now includes the International Nomenclature of Cosmetic Ingredients (INCI) for each ingredient. Please follow these guidelines when entering ingredient data: 

• Ingredient Identification: Ingredients must be listed by either their INCI name or CAS number. 

• Ingredient Percentage: The "Percentage" column must be completed accurately. Ensure that ingredients listed in Appendices I-IV of the Technical Requirements for Cosmetic Ingredients are not marked with a. 

• Formula Consistency: When updating product information, ensure that the updated ingredient names and concentrations are consistent with previously submitted data. 

• Non-Listed Ingredients: If an ingredient is not listed in the system, businesses should consult the Directorate of Standardization of Traditional Medicines, Health Supplements, and Cosmetics for further guidance. 

For complete details and official guidance, visit the Notifikos 3.0 system here.  

The Chilean Ministry of Environment has announced the notification requirements for new industrial chemicals under Supreme Decree No. 57/19, the regulation governing classification, labeling, and notification of hazardous substances and mixtures.

Following the notification process conducted in 2024, which covered industrial-use substances manufactured or imported in 2023 and 2024, the Ministry issued Resolution No. 7595 on December 30, 2024. This resolution approved a list of  over 850 notified industrial-use substances. According to Articles 295 and 296 of Supreme Decree No. 57/19, any chemical substance imported or manufactured after the notification deadline will be considered a new substance and must be notified prior to importation, production, or commercialization.

Key Definitions 

Industrial-use substances those whose intended use and application is carried out in manufacturing activity and productive processes. (D.S. 57/19, article 3)

Notification Details

For 2025, any new industrial-use substance not listed in Resolution No. 7595/2024 must be notified via an Excel form submitted to notificacion.sqi@mma.gob.cl before its importation or production.

In the case of importatition of a substance for industrial use, the notification must be made only the first time the substance is imported in 2025, regardless of the quantity imported and the estimated amount that will be imported throughout 2025.

In the case of manufacturing a substance, report will be needed whether it has been been manufactured it and placed on the market previously (but not notified) or before commencing use or marketing.

Entities must provide:

• Chemical name and common name (if applicable)
• CAS number (if available)
• Physical state
• Hazard classification and categories
• Estimated manufactured quantity or actual and estimated imported quantity for 2025
• Industrial-use purpose

For further details, visit the Ministry of Environment’s official notification platform.

The Government of Paraguay, through the Ministry of Public Health and Social Welfare, has issued Decree No. 2942, which establishes regulations for personal hygiene, cosmetic, and perfume products. This decree replaces Decree No. 3636/2020 and aligns national legislation with international health and safety standards.

Background and Legal Framework

Decree No. 2942 is enacted under Article 39 of Law No. 1119/1997 on health products and Article 5 of Law No. 6788/2021, as amended by Law No. 7361/2024. These laws mandate the National Directorate of Health Surveillance (DINAVISA) to regulate, inspect, and ensure the quality and safety of health-related products, including cosmetics and hygiene items.

Key Provisions of the Decree

1. Regulatory Authority and Oversight

DINAVISA is designated as the primary regulatory body responsible for enforcing compliance with hygiene and cosmetic product regulations. The agency has the power to:

• Oversee registration, licensing, and monitoring of manufacturers, importers, and distributors.

• Implement sanitary control measures to ensure product safety.

• Enforce penalties for non-compliance.

2. National Registry for Hygiene and Cosmetic Products

The decree mandates the continuation of the National Registry of Hygiene, Cosmetic, and Perfume Products, which records all authorized products. This database will be publicly accessible, ensuring transparency and regulatory oversight.

3. Product Classification and Registration Requirements

Products are classified into two categories:

• Grade 1: Basic hygiene and cosmetic products with minimal safety concerns, requiring a simplified notification process (Notificación Sanitaria Obligatoria - NSO).

• Grade 2: Products with specific safety and efficacy requirements, requiring a more stringent sanitary registration process.

Both categories must comply with Good Manufacturing Practices (GMP) and submit safety documentation to obtain regulatory approval.

4. Prohibited and Restricted Substances

The decree strictly regulates ingredients in hygiene and cosmetic products. It prohibits:

• Substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) according to International Agency for Research on Cancer (IARC) standards.

• Ingredients banned under the EU Regulation No. 1223/2009 and MERCOSUR regulations.

5. Labeling and Packaging Regulations

DINAVISA will establish guidelines for labeling, packaging, and advertising, ensuring that product information is clear, accurate, and does not mislead consumers.

6. Inspection, Market Surveillance, and Penalties

To maintain quality control, DINAVISA is empowered to:

• Conduct random inspections and collect product samples for testing.

• Revoke or suspend registrations if safety risks are identified.

• Impose sanctions and penalties for regulatory violations.

Implications for Businesses

Manufacturers, importers, and distributors operating in Paraguay’s hygiene and cosmetics sector must comply with the new regulations by:

• Ensuring product registration with DINAVISA.

• Adhering to approved formulations and safety standards.

• Complying with labeling and marketing regulations.

Implementation and Enforcement

Decree No. 2942 will take effect on the 2nd of January 2025. Businesses must align their operations with the new requirements to avoid penalties and ensure continued market access.

This regulatory update reinforces Paraguay’s commitment to consumer safety and international regulatory harmonization, ensuring that hygiene and cosmetic products sold in the country meet high-quality standards. For more details, Decree 2942 can be found here (in Spanish)

In a significant move to enhance environmental safety, Singapore's National Environment Agency (NEA) has announced amendments to the Environmental Protection and Management Act 1999, specifically targeting hazardous substances. These amendments, which were published in the Government Gazette on January 31, 2025, will take effect from August 1, 2025.

New Restrictions on Stockholm Convention-listed Substances

The NEA has extended the list of hazardous substances to include:

• Long-Chain Perfluorocarboxylic Acids (LC-PFCAs): These synthetic chemicals (C9-C21) are highly persistent in the environment and pose potential health risks. LC-PFCAs were added to the Stockholm Convention’s list of persistent organic pollutants (POPs) in 2023, requiring global action to eliminate their production and use.

• Medium-chain chlorinated paraffins (MCCPs): With chain lengths between C14 and C17, MCCPs are widely used in industrial applications, but have been classified as POPs under the Stockholm Convention due to their bioaccumulative and toxic properties.

Singapore’s decision to regulate these substances is in line with its commitment to international chemical safety standards and environmental protection. These amendments follow a public consultation held in 2023, during which stakeholders were invited to provide feedback on the proposed regulatory changes. More details on the consultation can be found here.

Revised Mercury Regulations

In a concerted effort to reduce mercury pollution, the NEA has updated the regulations on mercury and its compounds:

• Controlled Electrical and Electronic Equipment (EEE): Mercury content is now restricted to a maximum of 0.1% by weight in homogeneous materials within EEE.

• Batteries: The permitted mercury content is limited to 0.0005% by weight per cell, including button cells.

• Fluorescent Lamps: Specific limits have been set for mercury content of different types of lamps, such as circular and linear fluorescent lamps, in order to promote safer alternatives.

• Measuring Devices: Certain high-precision instruments containing mercury are exempted only if no suitable mercury-free alternatives are available.

These strong measures reflect Singapore's commitment to meeting international environmental standards and protecting public health.

Timeline for Implementation

All stakeholders, including manufacturers, importers, and users of the specified substances and products, are required to comply with the new regulations by August 1, 2025. This transition period will allow industry sufficient time to adapt to the updated standards and implement any necessary changes.

Detailed information can be found in the official publications here and here.

These proactive steps underscore Singapore's commitment to promoting a safer and more sustainable environment for all.

New Zealand’s Environmental Protection Authority (EPA) has set 30 April 2025 as the final deadline for importers, manufacturers, and suppliers to comply with updated labelling, Safety Data Sheet (SDS), and packaging notices. These updates align with the seventh revised edition of the Globally Harmonised System for Classification and Labelling of Chemicals (GHS 7) and introduce new regulatory requirements for hazardous substances under the Hazardous Substances Notices. When the transition period ends, full compliance with the new standards will be mandatory.

Background

In April 2021, EPA updated the regulations for:

• Labelling of hazardous substances

• Safety Data Sheets (SDSs)

• Packaging compliance

A four-year transition period was provided for industry stakeholders to adopt the updated requirements. The transition ends on 30 April 2025, when full compliance becomes mandatory.

Who Must Comply

Importers and Manufacturers

As of 30 April 2025, all hazardous substances must meet the following updated compliance standards:

• Hazardous Substances (Labelling Notice) 2017 – Updated 30 April 2021

• Hazardous Substances (Safety Data Sheets Notice) 2017 – Updated 30 April 2021

• Hazardous Substances (Packaging Notice) 2017 – Updated 30 April 2021

Suppliers

• All hazardous substances in the supply chain must comply with the updated GHS 7 standards.

• There will be no additional grace period beyond 30 April 2025 for stock-in-trade.

Compliance Requirements

Labelling and SDS Compliance

• Labels and SDSs that are already compliant with GHS 5 are likely to meet GHS 7 standards.

• Reclassification will be required for substances with desensitised explosive and flammable gas classifications due to classification framework changes.

• Minor updates to precautionary statements may be needed.

If a label or SDS does not comply with GHS 5, updates will be needed before the deadline.

Packaging Compliance

• Full compliance with the 2021 Packaging Notice is required by 30 April 2025,.

• The updated regulations align with international packaging standards for:

  • Transport of dangerous goods

  • Child-resistant packaging

Alternative Compliance Provisions

The updated notices allow for alternative compliance using standards from Australia, the U.S., Canada, or the EU, if they meet the following conditions:

• New Zealand-specific labelling and SDS details are added.

• Packaging meets the child-resistant and permanent identification standards of international jurisdictions.

Record Keeping Requirements

Importers and manufacturers using alternative compliance provisions must:

• Document their compliance strategy and the jurisdiction they are following.

• Maintain records for at least two years after the substance is no longer supplied.

Next Steps

• Review your hazardous substance compliance with GHS 7.

• Update labels, SDSs, and packaging before 30 April 2025.

• Consult EPA notices for complete regulatory details.

On 13 February 2025, Ukraine officially notified the World Trade Organization (WTO) of its Draft Law "On Making Available on the Market and Use of Biocidal Products", developed (issued) by the Ministry of Health.  This law aims to regulate the approval, production, market placement, circulation, and safe use of biocidal products and processed products, while ensuring compliance with standards for the protection of human and animal health  and the environment .

Key Objectives of the Draft Law

• Approval of Active Substances: Establishes legal provisions for the approval, renewal, or revision of active substances in biocidal products.

• State Registration: Implements procedures for state registration of biocidal products, including a simplified process.

• Market Supervision: Defines the legal framework for the safe use and circulation of biocidal products.

• Compliance with EU Regulations: Aligns with Regulation (EU) No. 528/2012 on biocidal products (BPR).

Authorized Body for Biocidal Product Evaluation

The draft law proposes the designation of an authorized state enterprise or institution under the central executive authority responsible for state healthcare policy. This body will:

• Evaluate applications for approval, renewal, or revision of active substances.

• Prepare expert opinions on state registration or refusal of registration of biocidal products.

• Provide evaluation services for a fee, as per agreements between applicants and the authorized body.

Fee Structure and Implementation

The law stipulates that:

• Fees for registration services will be calculated based on the minimum living wage for working-age individuals.

• The central executive authority will regulate the fee-setting process for evaluation services.

• The Cabinet of Ministers of Ukraine will approve the criteria and procedures for authorizing bodies.

Establishment of the State Register of Biocidal Products

In order to streamline market regulation, the law provides for:

• The establishment of the State Register of Biocidal Products by 1 January 2029.

• The modernization of the existing State Register of Disinfectants into the new registry.

Legislative Context

The draft aligns with key Ukrainian laws, including:

• “On Public Health System”

• “On Ensuring Chemical Safety and Management of Chemical Products”

• “On Veterinary Medicine”

• “On State Control Over Compliance with Legislation on Food, Feed, Animal By-products, Animal Health and Welfare”

Implementation Timeline and Comment Period

The date of adoption of the Law is yet to be determined. The Law will enter into force on the day following the day of its publication and will be enacted 36 months after its entry into force, except for specific provisions which will apply from 1 January 2029. Stakeholders have a 60-day window from the date of notification to review the draft and provide feedback to the Ministry of Economy of Ukraine.

Impact of the Draft Law

The adoption of this legislation will enhance the domestic market for biocidal products while ensuring high standards for human, animal, and environmental health. By aligning with EU regulations, Ukraine will strengthen its regulatory framework and market oversight, promoting safer and more transparent distribution of biocidal products.