GPC Newsletter Jan-2025

Earlier this year, Congress tasked EPA chemists with developing a process to prioritize per- and polyfluoroalkyl substances (PFAS) for research based on exposure risks, toxicity, and existing data. Under the Toxic Substances Control Act (TSCA), reporting, record-keeping, testing, and restrictions apply to chemicals of concern, including PFAS.

To address these requirements, EPA researchers created a category-based framework, grouping 128 PFAS into categories for streamlined data collection. This method, building on an earlier approach used for the National PFAS Testing Strategy, allows related PFAS to be assessed together rather than individually, with a model for classifying new substances.

The project results support EPA’s efforts to gather data on PFAS use via reporting rules and to issue TSCA test orders to generate toxicity data on specific chemicals within this large, under-researched group.

PFAS:

Per- and polyfluoroalkyl substances (PFAS) are synthetic chemicals, widely used since the 1940s, that persist in water, air, and soil worldwide. Due to their durability and extensive use, PFAS are commonly detected in the blood of humans and animals. These chemicals are prevalent in:

• Drinking Water and contaminated waste sites.
• Consumer Products such as non-stick cookware, stain-resistant fabrics, paints, and cosmetics.
• Food Packaging including microwave popcorn bags and grease-resistant wrappers.
• Industrial Settings such as chrome plating, electronics, and textile manufacturing.
• Firefighting Foam used at airports and training facilities.

The EPA's PFAS Strategic Roadmap has prioritized action since October 2021, allocating $10 billion under the Bipartisan Infrastructure Law to combat emerging contaminants such as PFAS.

While studies link certain PFAS to harmful health and environmental effects, the toxicity of most remains unexamined. Ongoing research is crucial to understanding and mitigating these "forever chemicals".

CHEMICAL CATEGORY-BASED APPROACH:

EPA researchers developed a detailed categorization approach for PFAS using the following steps:

1. Initial PFAS List: The researchers applied the PFAS definition from the Toxic Substances Control Act (TSCA) to the Distributed Structure-Searchable Toxicity (DSSTox) database, retrieving a list of 13,054 PFAS. They also included 2,484 predicted PFAS degradation products from the non-confidential TSCA inventory, expanding the list to 15,538 PFAS.
2. Category Assignment: Using OECD structure-based classifications, each PFAS was assigned to a primary category. The primary categories were further divided into secondary categories based on chain length thresholds (≥7 vs <7).
3. Subcategorization by Chemical Fingerprints: Secondary categories were subdivided using chemical fingerprints to balance structural categories and similarity within each category, as measured by the Jaccard index.
4. Identification of Representative PFAS: From the 128 terminal structural categories created, a subset of representative PFAS was selected for data collection. Factors such as the availability of toxicity data, environmental monitoring, and the potential to identify responsible manufacturers/importers guided this selection.
5. Future Refinements: The approach includes potential updates using mechanistic data and physicochemical properties, aiming to improve hazard assessments and QSAR development. This categorization method helps identify high-priority PFAS for further research and regulatory action.

This systematic approach helps to prioritize PFAS for further analysis and supports efforts in environmental monitoring and risk assessment.

From December 9, 2024, the U.S. Environmental Protection Agency (EPA) will be implementing a ban on trichloroethylene (TCE, CAS No: 79-01-6) and a phase-out of perchloroethylene (PCE, CAS No: 127-18-4) under the bipartisan these long-awaited measures target two highly toxic chemicals linked to serious health risks, including cancer, and address years of inadequate protection. The rules aim to eliminate harmful exposures,promote safer alternatives, and protect public health, workers, and the environment.

Trichloroethylene (TCE): A Complete Ban on Use

TCE is a nonflammable chlorinated solvent that is a recognized carcinogen. It is known to cause liver cancer, kidney cancer, and non-Hodgkin’s lymphoma, as well as damage to the central nervous system, liver, kidneys, immune system, and reproductive organs. Even at low concentrations, TCE poses significant health risks.

Under the new rule, EPA will prohibit all consumer and most commercial uses of TCE within one year, as safer alternatives are available for most applications. Certain industrial uses of TCE will be phased out over a longer period of time with stringent worker protections, including a revised inhalation exposure limit designed to reduce long-term exposure by 97%. These uses, such as cleaning aircraft parts and manufacturing refrigerants, will eventually be banned, although exemptions allow for a gradual transition to avoid impacts on national security and critical infrastructure. Additionally, the use of TCE in the cleanup efforts at contaminated sites, such as Superfund locations, will be allowed for 50 years with necessary safeguards.

Perchloroethylene (PCE): Gradual Phase-Out and Strict Controls

PCE, another chlorinated solvent, is associated with liver, kidney, brain, and testicular cancer, as well as neurotoxicity and reproductive harm. PCE can degrade into TCE and may contain trace amounts of TCE impurities. While TCE is being banned entirely, some analogous uses of PCE will continue safely under strict workplace controls, including vapor degreasing and refrigerant production.

EPA has set a 10-year phase-out for PCE use in dry cleaning, with the transition beginning sooner for older machines. Many dry cleaners have already started this process. PCE use in consumer and commercial products will be largely phased out within three years. EPA’s rule also establishes strict controls for essential uses of PCE in critical sectors such as national security and aviation under the Workplace Chemical Protection Program.

These regulations prioritize safer, cost-effective alternatives to PCE and TCE, aligning with climate goalsand ensure the protection of workers, public health, and the environment under the Workplace Chemical Protection Program.

Protecting Health, Workers, and the Environment

These new regulations represent a major step forward in protecting public health, workers, and the environment while supporting climate goals. By prioritizing sustainable alternatives and ensuring workplace protections, EPA is addressing decades of advocacy and ensuring a safer future.

The European Union has notified the World Trade Organization (WTO) of a draft Commission Regulation proposing amendments to the REACH Regulation (Regulation (EC) No 1907/2006). The amendment aims to include recently classified carcinogens, germ cell mutagens, and reproductive toxicants (CMRs) in category 1A and 1B of the EU’s Classification, Labelling, and Packaging (CLP) Regulation (Regulation (EC) No 1272/2008). The amendments will extend the scope of Annex XVII of REACH and impose new restrictions on the placing on the market or use of these substances, in particular for supply to the general public. The amendments are in line with the recent harmonised classification of these substances under the CLP Regulation, ensuring stricter control of their use in consumer products.

Key Provisions of the Proposed Regulation

• Extended Restrictions for CMR Substances: The draft Regulation introduces new amendments to Entries 28, 29 and 30 of Annex XVII to REACH, which will impose restrictions on substances classified as CMR category 1A or 1B. These restrictions will apply to substances when sold as such, in mixtures or as constituents of other substances.

• Labelling Requirements: To further ensure safety, packaging containing these newly classified substances will have to be labelled with the warning "restricted to professional users", effectively restricting consumer access to products containing these substances.

• Derogation for Cumene in Aviation Fuels: An important derogation is introduced for cumene, allowing its presence in certain aviation fuels (kerosene and aviation gasoline) used in small aircraft flown by non-professional pilots. This derogation takes into account the limited use of aviation fuels by non-professional pilots compared to motor fuels used by non-professional car drivers.

Objectives and Rationale for the Regulation

The regulation is motivated by the recent harmonised classification of certain substances as CMR category 1A or 1B under the CLP Regulation. In response, the European Commission is using its powers under Article 68(2) of REACH to propose these restrictions which aim to protect human health and safety by reducing exposure to these dangerous substances.

Timeline and Next Steps

• Adoption Date: The Regulation is expected to be adopted in the second quarter of 2025.

• Effective Date: The restrictions on CMR substances classified as category 1B will apply from 1 September 2025. Operators will be able to apply the restrictions earlier if they wish.

• Entry into Force: The Regulation will enter into force 20 days after its publication in the Official Journal of the EU, with the derogation for cumene in aviation fuels applying immediately.

• Final Date for Comments: Stakeholders have 60 days from the date of notification to submit comments on the draft Regulation. The notification was sent to the WTO on 22 November 2024, so the final date for comments is 21 January 2025.

Conclusion

The EU’s proposed amendments to REACH aim to strengthen protection against hazardous CMR substances, particularly those newly classified as category 1A and 1B. The regulation introduces important restrictions, including enhanced labelling and an exemption for cumene in aviation fuels. Industry stakeholders are encouraged to review the draft regulation and participate in the public comment period to help shape the final text of the regulation.

The full text of the draft regulation can be accessed here.

The European Commission has announced plans to approve three active substances - 2,2-Dibromo-2-cyanoacetamide (DBNPA), 1,2-Benzisothiazol-3(2H)-one (BIT) and formic acid - for specific uses in biocidal products. These proposals, detailed in WTO notifications G/TBT/N/EU/1099, G/TBT/N/EU/1100 and G/TBT/N/EU/1101 of 2 December 2024, aim to harmonise the EU market for biocidal products while ensuring the protection of human health and the environment.

DBNPA Approval for Product Type 6

The EU intends to approve DBNPA (CAS No 10222-01-2) as an active substance for use in product type 6 biocidal products, which are in-can preservatives. DBNPA is recognised for its rapid antimicrobial action, making it effective in preserving products susceptible to microbial contamination. However, due to its endocrine disrupting properties, it meets the exclusion criteria set out in Article 5(1) of the Biocidal Products Regulation (BPR; Regulation (EU) No 528/2012). Nevertheless, a derogation under Article 5(2)(c) of the BPR allows for its approval for specific uses where there are no suitable alternatives and the benefits outweigh the risks.

BIT Approval for Product Types 6 and 13

Similarly, the EU is proposing the approval of BIT (CAS No 2634-33-5) for use in product types 6 and 13. Product type 13 refers to metalworking fluid preservatives. BIT is widely used for its efficacy against bacteria and fungi, making it valuable in the preservation of various products. Its approval is intended to provide manufacturers with an effective means of ensuring product longevity and safety.

Formic Acid Approval for Product Type 6

The EU is also planning to approve formic acid (CAS No 64-18-6) for use in product-type 6 biocidal products. Formic acid is known for its effectiveness in controlling microbial growth and is widely used in industrial applications.

Stakeholder Involvement and Implementation Date

These approvals are part of the EU's ongoing efforts to regulate biocidal products under the Biocidal Products Regulation, which aims to improve the functioning of the biocidal products market while ensuring a high level of protection for human health and the environment. Stakeholders are invited to comment on these proposals within 60 days from the date of notification. The proposed date of adoption for the approvals is February 2025, with entry into force 20 days after publication in the Official Journal of the EU.

These developments underline the EU's commitment to maintaining high standards for biocidal products, balancing the need for effective preservation solutions with the need to protect public health and the environment.

On 27 November 2024, Denmark notified the European Commission of a draft Order to ban per- and polyfluoroalkyl substances (PFAS) in consumer products. The proposed measure targets clothing, footwear, and waterproofing agents containing PFAS in order to reduce their environmental and health impacts. The notification, submitted under Directive 2015/1535, outlines a framework for national restrictions to complement the anticipated EU-wide PFAS legislation.

Scope and Application of the Draft Order

The draft Order introduces a ban on the import and sale of clothing, footwear and waterproofing agents containing PFAS at concentrations above 50 mg F/kg. The restriction applies only to consumer products for private use, including online purchases by individuals. Key dates outlined in the Order include:

• 1 July 2025: The Order is set to enter into force.

• 1 July 2026: The ban on import and sale begins.

• 1 January 2027: Sale of pre-imported stock is permitted until this date.

Production and export activities are exempted, ensuring the measure is focused solely on domestic consumer markets.

Key Exemptions and Considerations

Certain products and scenarios are excluded from the scope of the draft Order:

• Personal Protective Equipment (PPE): Items that re critical to user safety, as defined in Regulation (EU) 2016/425, are exempt due to the lack of suitable alternatives.

• Medical Devices: Products covered by the EU Medical Devices Regulation are excluded.

• Existing EU Regulated Products: Products already covered by EU-REACH and the Persistent Organic Pollutants (POPs) Regulation are not subject to the national ban.

Textiles such as curtains and home furnishings, which contribute less to PFAS emissions, are also excluded, as are reused and recycled materials due to compliance challenges.

Environmental Justification

The draft Order is in line with Denmark’s broader environmental objectives. A mass flow analysis published in February 2024 showed that textiles account for a significant portion of PFAS emissions, with clothing and footwear alone contributing 2.3 tonnes per year. Waste treatment of these articles results in additional discharges of approximately 380 tonnes per year. By implementing this restriction, Denmark expects to reduce PFAS emissions by 200-300 tonnes per year, which represents 35-50% of the country's total emissions from these sources.

The Order's threshold of 50 mg F/kg is designed to capture the intentional use of PFAS while excluding trace contaminants from manufacturing processes. This level reflects the thresholds proposed in the draft EU restrictions.

Implementation and Enforcement

To facilitate compliance by industry, the Order includes transitional measures such as a one-year grace period and permission to sell pre-imported stock until the beginning of 2027. Enforcement will be overseen by the Danish Environmental Protection Agency, with penalties for non-compliance ranging from fines to imprisonment.

Importers and downstream users will be able to provide documentary evidence to prove that fluorine content above the threshold originates from non-PFAS substances. This approach reduces the regulatory burden while ensuring effective control.

Denmark’s Commitment to PFAS Regulation

Denmark’s draft Order reflects its proactive stance on PFAS pollution. The measure is in line with the Organization for Economic Cooperation and Development (OECD) definition of PFAS and supports ongoing efforts to establish EU-wide regulations. The notification also stems from national concerns, including contamination incidents and the results of a 2024 PFAS action plan supported by all Danish parliamentary parties.

Next Steps

The European Commission’s standstill period for feedback ends on 28 February 2025. Pending approval, the Order will enter into force in mid-2025, setting a precedent for other Member States to address PFAS through national measures. By acting decisively, Denmark underlines its commitment to protecting public health and the environment, while contributing to broader EU initiatives.

The full text of the notification is accessible here.

The updated EU Classification, Labelling, and Packaging (CLP) Regulation (Regulation (EU) 2024/2865) officially entered into force on 10 December 2024. The updated CLP Regulation was adopted by the Council of the European Union on 14 October 2024 and published in the Official Journal of the European Union on 20 November 2024. This update aims to improve the identification and communication of chemical hazards, while ensuring greater protection for consumers and the environment.

Key Changes Under the Updated CLP Regulation

The updated CLP Regulation introduces several improvements to better protect public health and the environment. Notable updates include

• Improved Classification Rules: Clarification on how to classify mixtures and substances with multiple constituents.

• New Hazard Classes: Endocrine disruptors (ED), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), and very persistent and very mobile (vPvM) substances are now considered to be hazards of very high concern.

• Focus on Grouping and Harmonization: Enhanced emphasis on grouping substances for harmonised classifications.

• Clearer Labelling Requirements: Introducing of rules for clearer labelling for hazardous chemicals.

• Online Hazard Communication: Mandatory inclusion of chemical hazard information in online sales and advertisements to effectively inform consumers.

• Flexible Labelling Options: Introduces fold-out and digital labelling options to improve legibility and accessibility for users.

• Distributor Responsibilities: Distributors now play an important role in poison centre notifications. They are required to submit information for certain chemicals to ensure appropriate emergency response.

• Regulations for Refill Stations: New rules regulate the sale of chemicals at refill stations to enhance consumer safety.

• ECHA and EFSA Proposals: The European Commission may request harmonized classification proposals from the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA).

• User-Friendly Substance Inventory: Development of an inventory system that improves access to information for SMEs and increases transparency for all stakeholders.

The Role of Distributors under the Updated CLP Regulation

One of the key changes introduced by the updated CLP Regulation is the clarification of the responsibility of distributors in poison centre notifications. Distributors are now required to notify poison centres of certain hazardous mixtures they place on the market, ensuring that emergency responders have accurate information in the event of an incident. This change underscores the growing importance of transparency and preparedness in chemical safety management.

Different Application Dates for Specific Measures

While the regulation entered into force on 10 December 2024, the applicability of certain provisions varies, giving industry time to adapt:

• General Obligations: Most of the new rules will apply from 1 July 2026, giving companies time to align their operations with the updated requirements.

• Label Formatting Rules: The new label formatting requirements, including fold-out and digital labels, will apply from 1 January 2027.

• Exemptions for Existing Products: Substances and mixtures already placed on the market before 1 January 2027 will not need to be re-labelled or re-packaged under the updated rules.

  • Substances: These can remain in the supply chain until 1 July 2028 without having to update to their labels or packaging.

  • Mixtures: These can remain in the supply chain until 1 January 2029 without having to comply with the new labelling and packaging rules.

These staggered deadlines provide industry with flexibility to ensure compliance while minimizing disruption to existing supply chains.

Compliance Guidance and Resources

To assist companies with these new requirements, ECHA has published resources, including

• Detailed guidance on the new hazard classes, such as ED and PBT substances.

• Guidance on the implementation of mixture classification using bridging principles.

Upcoming resources in 2025 will provide additional guidance on labelling, Annex VIII (poison centres), and practical methods for grouping and read-across approaches.

Industry Action Required

ECHA urges companies to review their chemical portfolios and update classifications to comply with the revised regulation. This includes revising REACH registration dossiers and CLP notifications.

The full text of the updated CLP Regulation is available here.

From 29 November 2024, the European Union enforces a strict ban on lead in polyvinyl chloride (PVC) products, targeting concentrations of 0.1% or more by weight. This measure aims to further reduce exposure to the toxic substance, thereby protecting both human health and the environment.

Key Provisions of the Restriction

• Scope: The regulation applies to all PVC products, including imported goods and recycled materials.

• Transition Periods for Recovered PVC Applications

Recognising the challenges in eliminating lead from recycled materials, the EU has introduced transition periods for certain applications:

• PVC Articles Containing Recovered PVC: A 15-year derogation is granted, allowing higher lead content limits - up to 2% by weight for rigid PVC and 1% for flexible PVC. This period allows for the gradual reduction of lead in recycled PVC and supports recycling initiatives.

• Review Timeline: The derogation will be reassessed within 7.5 years of the entry into force of the restriction to evaluate progress in reducing lead content in recycled PVC.

Health and Environmental Concerns

Lead is known to cause serious damage to the nervous system, particularly in children, and is associated with chronic kidney disease and high blood pressure. It is also highly toxic to aquatic life, underlining the importance of minimising its use.

EU's Industry Initiative and Regulatory Impact

The PVC industry in the European Union has already voluntarily phased out the use of lead stabilisers. This regulation goes further by addressing imported products and materials containing recycled PVC, ensuring comprehensive protection.

Detailed information can be found in the official EU regulation here.

The General Product Safety Regulation (EU) 2023/988 (GPSR) applies from 13 December 2024, replacing the General Product Safety Directive (2001/95/EC) and Council Directive 87/357/EEC. This modernized regulation ensures consumer protection in the EU by addressing new challenges posed by digitalization, global supply chains and technological advances. It acts as the default safety framework for non-food consumer products not covered by harmonized product-specific legislation, such as cosmetics and food.

Key Updates under the General Product Safety Regulation

The GPSR introduces significant updates to the safety of consumer products:

• Extended Scope to Cover Online Sales:

  • Online marketplaces must take greater responsibility for removing unsafe products and protecting consumers in digital transactions.

• Accident Reporting Through the Product Safety Gateway:

  • Economic operators are now required to report all individual accidents involving products to the authorities, not just those that pose a "risk."

• Improved Product Recall Mechanisms:

  • Mandatory templates for recall notices and direct communication with consumers improve the efficiency of recalls. Consumers are also entitled to a remedy (e.g., repair, replacement, or refund) for recalled products.

• New Rules on the Responsible Person in the Supply Chain:

  • A designated "Responsible Person" must be based in the EU and ensure compliance with technical documentation, labelling, and safety requirements.

  • The Responsible Person must liaise with market surveillance authorities and verify ongoing product compliance.

• Labelling and Contact Information Requirements:

  • Products must now include an "electronic address" in addition to the name and postal address of the manufacturer or importer.

• Importer Responsibilities:

  • If no other relevant EU-based party can be identified, the importer is considered the Responsible Person and must ensure that all regulatory obligations are met. Importers must work with non-EU suppliers to obtain the necessary documentation.

Harmonized Market Surveillance for Safer Products

The GPSR strengthens the enforcement powers of national authorities to ensure compliance across the EU. Improved cooperation between Member States will enable rapid responses to safety issues, including the recall of unsafe products.

With 31% of product safety alerts stemming from online sales, the GPSR addresses risks in the digital marketplace and ensures that all products sold in the EU meet stringent safety standards.

A Major Step in EU Consumer Protection

Adopted on 10 May 2023, the GPSR is part of the EU's New Consumer Agenda and replaces outdated rules to adapt to a rapidly changing market. By strengthening oversight, enhancing safety measures, and addressing the complexities of digital and globalized supply chains, the GPSR reaffirms the EU’s position as a global leader in consumer product safety.

The official text of the GPSR can be found here.

On October 23, 2024, India’s Ministry of Textiles issued the Medical Textiles (Quality Control) Order, 2024, under the Bureau of Indian Standards Act, 2016, replacing the previous order from 2023. This new Order, which came into effect following its publication in the Official Gazette, mandates stringent quality standards for various medical textiles, including products such as sanitary napkins, baby diapers, and medical bedding. 

Scope and Exemptions 

The Order applies to specific medical textiles listed in the Schedules, but excludes products intended for export and those produced by self-help groups, as listed in Schedule-A. Self-help groups are informal groups of 10 to 20 individuals who come together voluntarily for collective savings, resource management and mutual benefit. In rural or tribal areas, smaller groups of at least five members are also considered self-help groups. 

Mandatory Compliance and Certification 

Standard Mark: The items listed in column (2) of the Schedules must comply with the relevant Indian Standard outlined in column (3) and bear the Standard Mark. The mark must be obtained through a license issued by the Bureau of Indian Standards in accordance with the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. 

Certification:  The Bureau of Indian Standards and the Textiles Committee, under the Ministry of Textiles, will be responsible for certifying and enforcing compliance for the goods or articles listed in column (2) of the Schedules. 

Schedules and Implementation Deadlines 

The Order sets out compliance requirements for a range of medical textiles in Schedule A (consumer-oriented products) and Schedule B (industrial and healthcare products), specifying Indian Standards and timelines for implementation: 

SCHEDULE A 

SCHEDULE B 

Significance of the Order 

This Order enforces compliance with Indian Standards for medical textiles, ensuring quality manufacturing and improving public health and consumer safety. Domestic manufacturers must ensure compliance to access the Indian market, while exporters and self-help groups are exempted. 

For more details, see the full gazette notification here. 

India’s Department of Chemicals and Petrochemicals (DCPC) has extended the enforcement date of the Quality Control Orders (QCOs) for three polymer products to 6 June 2025. The notifications were published in the Gazette of India on 6 December 2024, in consultation with the Bureau of Indian Standards (BIS) extending enforcement dates. 

The QCOs were first issued on 6 December2023 and were originally scheduled to take effect on 3 June 2024. These orders were later amended on 4 June 2024, with the enforcement date scheduled for 6 September2024. 

Revised Implementation Dates for Polymer Products 

The revised implementation dates and corresponding standards for the polymer products are as follows. 

The Quality Control Order mandates that the affected materials must carry the Bureau of Indian Standards (BIS) certification mark to ensure compliance with the specified standards until the implementation of the new QCOs.   

The Central Government of India has issued the Acrylonitrile-Butadiene Styrene (ABS) (Quality Control) Amendment Order, 2024, which amends the Acrylonitrile-Butadiene Styrene (ABS) (Quality Control) Order, 2021. This amendment came effect upon publication in the Official Gazette on 20 November 2024. It introduces a significant change in the regulation of ABS materials.

Exemption for Toco Transducer Materials

The most significant change in the new order is the addition of a provision that exempts ABS Moulding and Extrusion Materials specifically used in the production of toco transducers from the requirements of the initial Quality Control Order. This means that ABS materials intended for use in the manufacture of toco transducers, a device typically used for monitoring fetal well-being, will no longer be subject to the same regulatory controls.

Streamlined Regulations for Specialized Applications

This amendment follows consultations with the Bureau of Indian Standards (BIS) and is seen as a step towards streamlining regulations in sectors where certain ABS materials are required for specialized applications.

Implications for Industry

This move is expected to have implications for manufacturers of toco transducers, as they will no longer have to comply with the broader scope of the Quality Control Order, potentially reducing compliance burdens for companies in this specific segment.

The Ministry of Industry and Information Technology (MIIT) has announced a public consultation on eight mandatory national standards, including “Requirements for Restricted Use of Hazardous Substances in Electrical and Electronic Products”, a key technical standard supporting the China RoHS 2 regulatory framework. China RoHS 2, implemented in July 2016, restricts the use of hazardous substances in electrical and electronic products to reduce environmental and health risks, similar to the EU RoHS 2 Directive. The draft standard is consistent with these principles, including restrictions on substances such as lead, mercury and newly added phthalates.

The consultation opened on 19 November 2024 and will close on 18 January 2025. Stakeholders are invited to provide feedback by emailing to KJBZ@miit.gov.cn.

The draft standards aim to improve safety, align with global regulations, and reduce environmental and health risks from hazardous substances. The finalstandards are expected to take effect 12 months after publication.

Key Focus: Expanded Restrictions on Phthalates in Electrical and Electronic Products

The new draft standard updates and integrates two existing standards:

• GB/T 26572-2011: Requirements on Concentration Limits for Certain Hazardous Substances in Electrical and Electronic Products.

• SJ/T 11364-2014: Marking for the Restricted Use of Hazardous Substances in Electrical and Electronic Products.

A significant update is the addition of four new phthalates to the list of restricted substances:

• DBP: Dibutyl phthalate (CAS No 84-74-2)

• DIBP: Diisobutyl phthalate (CAS No 84-69-5)

• BBP: Butyl benzyl phthalate (CAS No 85-68-7)

• DEHP: Di(2-ethylhexyl) phthalate (CAS No 117-81-7)

These phthalates are widely used as plasticizers in electrical and electronic products, but are associated with environmental and health risks, including endocrine disruption. The draft standard aligns their restriction limits with the EU RoHS Directive, setting maximum concentrations of ≤1000 mg/kg for each.

Highlights of the Draft Standard

• Expanded Scope: Covers the manufacture, sale and import of electrical and electronic products in China.

• Updated Limits for Hazardous Substances: Expands the number of restricted substances from 6 to 10, ensuring compliance with global standards.

• New Labeling Options: Introduces QR codes and digital formats for hazard information, reducing compliance costs.

• Conformity Documentation: Requires test reports for high-risk components to improve the reliability of compliance declarations.

Development Process and Industry Collaboration

The standard was developed by the China Electronics Standardization Institute, in collaboration with manufacturers, industry associations, and research institutions. Key steps in its development include

• Research on phthalate restrictions in global RoHS regulations.

• Industry surveys showing that over 90% of products already meet the proposed phthalate limits, ensuring feasibility.

• Collaboration with international standards such as IEC 62321 for test methods.

The one-year transition period after publication will allow industry to adapt to the stricter requirements.

Implementation and Future Impact

Once in effect, this standard will replace

• GB/T 26572-2011: Previously defined limits for hazardous substances.

• SJ/T 11364-2014: Covered marking requirements for restricted substances.

The inclusion of phthalates reflects China’s commitment to stricter environmental controls and is in line with global practices. This update will significantly reduce the risks associated with these substances, promote green production, and support the goals of the 14th Five-Year Plan for Industrial Green Development.

The revised standard will improve compliance, simplify regulatory oversight, and position China as a leader in sustainable electronic product manufacturing.

Other Standards under Consultation

In addition to the RoHS 2-related standard, the consultation includes revisions to standards on:

• Limits of Hazardous Metal Elements Leachable from Wall Materials: Defines content limits and test methods for hazardous metals in wall materials used in industrial and residential buildings.

• Limits of Hazardous Elements in Graphite and Fluorite: Establishes limits for hazardous elements in graphite and fluorite materials.

• Limits for Heavy Metals in Ink: Establishes maximum allowable concentrations for heavy metals, including lead, cadmium, and mercury, in ink products.

• Limits of Hazardous Metal Elements Leachable from Wall Materials: Establishes content limits and test methods for hazardous metals in wall materials used in industrial and residential buildings.

These updates reflect China's commitment to modernizing safety, environmental, and technical regulations across multiple sectors.

On November 12, 2024, the Ministry of Environment announced an amendment to the "Regulations on the Specified Quantities of Toxic Substances, Restricted Substances, Prohibited Substances, and Permitted Substances." The purpose of this amendment is to inform the public of the reasons and main contents of the amendment and to gather public opinions in accordance with Article 46 of the Administrative Procedures Act. 

1. Reason for Amendment 

Following the amendment of the "Designation Notice of Toxic Substances" (Chemical Safety Agency Notice No. 2024-34) on August 30, 2024, it is necessary to establish the specified quantities for newly designated toxic substances in order to distinguish the submission targets for chemical accident prevention management plans. 

2. Main Contents of the Amendment 

• Designation of Specified Quantities for New Toxic Substances: Specified quantities will be set for 10 newly designated toxic substances, including upper and lower limits. 

• Reflecting Changes in Existing Toxic Substances: Changes to the names and CAS numbers of 2 existing toxic substances will be reflected. 

• Resetting the Review Period: The review period for the regulations will be reset. 

3. Submission of Opinions 

Institutions, organizations, or individuals with opinions on this amendment are requested to review the amendment on the website of the Ministry of Environment (www.me.go.kr) and submit their opinions to the Minister of Environment (Director of Chemical Safety Division) by December 2, 2024. 

The Korean Ministry of Environment has announced that the safety information for raw materials in 76 household chemical products will be made available on the Green Nuri Living Environment Safety Information System (https://ecolife.me.go.kr/ecolife/systemInfo ) starting December 12, 2024. This initiative aims to help consumers easily verify the safety of products through an intuitive leaf grading system. 

Key Highlights: 

• Leaf Grading System: The safety of each product is indicated by the number of leaves, ranging from one to four. Four leaves signify no safety concerns, while one leaf indicates that safer alternatives are recommended. 

• Voluntary Participation: Fifteen companies have voluntarily disclosed safety information for ingredients in 11 categories, including detergents and laundry detergents, covering a total of 76 products. 

• Safety Grades: None of the disclosed products received the lowest grade, which recommends substitution with safer ingredients. The majority of products fell into the three-leaf category, representing 55.8% of the total. 

• Consumer Trust: Park Yeon-jae, Director of the Environmental Health Bureau, emphasized that this transparency will help consumers easily understand safety information and build trust in the companies involved. 

Looking ahead, the Ministry plans to launch a next-generation chemical product management system in the first half of 2025, which will provide even more detailed safety information to ensure consumer safety. 

On November 8, 2024, the Taiwan Food and Drug Administration (FDA) announced revised guidelines for Risk Assessment for Cosmetics Containing Nanomaterials. The updates aim to strengthen regulations, ensure product safety, and align with international standards. These guidelines provide guidance to manufacturers and importers in evaluating the safety and properties of nanomaterial-containing cosmetics.

Key Highlights of the Revised Guidelines

1. Definition of Nanomaterial-Containing Cosmetics

Nanomaterial-containing cosmetics are products formulated with intentionally manufactured nanomaterials that are insoluble or non-biodegradable. These materials have dimensions or internal structures in the nanoscale range (1-100 nanometers) and may have unique properties and risks compared to conventional ingredients.

2. Alignment with International Standards

The revised guidelines follow the definitions and practices of global organizations such as the International Cooperation on Cosmetics Regulation (ICCR) and the International Organization for Standardization (ISO). According to ISO/TS 80004-1:2023, nanomaterials are materials with at least one external or internal dimension in the nanoscale range.

3. Comprehensive Risk Assessment

The guidelines provide a two-step framework for assessing the physicochemical properties of nanomaterials (e.g., particle size, shape, surface chemistry) and conducting safety evaluations (e.g., exposure analysis, toxicological studies) to ensure the safety of cosmetics before market approval.

4. Product Information File (PIF)

Manufacturers are required to prepare a PIF to document the quality and safety of their products. This includes detailed data on the physicochemical and toxicological properties of nanomaterials, which must be reviewed by qualified personnel to confirm the safety of the product.

5. Industry Reference

The guidelines provide detailed risk assessment criteria and an appendix outlining key evaluation parameters. These resources are intended to assist manufacturers conduct thorough reviews during product development and ensure compliance.

Access to the Guidelines

The revised Guidelines for Risk Assessment of Cosmetics Containing Nanomaterials are available on the official website of the Taiwan FDA. Interested parties can find the document under the "Announcements" section and the "Cosmetics Business Area > Cosmetics Regulations Area > Guidelines" page.

For more details, visit the Taiwan FDA website here.

On 21 November 2024, the two-year grace period for cosmetic products to comply with the updated ASEAN Cosmetic Directive (ACD) ended. The updates were introduced during the 36th ASEAN Cosmetic Committee (ACC) meeting and its related sessions in November 2022. Products that do not meet the updated standards must be withdrawn immediately. The amendments reflect the ASEAN region’s approach to aligning with global safety standards and protecting the health of consumers in its 10 member states. 

Key Updates to the ACD  

• Annex II – List of substances which must not form part of the composition of cosmetic products 

A consolidated list of 37 substances previously banned in the EU, has been added to Annex II of the ACD. These include entries from EU regulations (2019/831, 2019/1966, 2021/850, 2021/1902) that are not currently used in ASEAN countries. Specific compounds such as perboric acid, sodium perborate, boron compounds, octamethylcyclotetrasiloxane (D4), and p-BMHCA have also been included in Annex II. 

• Titanium Dioxide Regulation 

Revised safety criteria for the use of titanium dioxide as a colouring agent (Annex IV) and as a UV filter (Annex VII) have been adopted as per EU standards. 

• Salicylic Acid Regulation 

New limits have been introduced for salicylic acid in the Restricted Substance List (Annexes III) and in the Preservatives list (Annex VI), used in body creams, lotions, and other specific applications. 

Implications for Industry 

Cosmetic manufacturers, traders, and distributors were granted a two-year grace period to reformulate, test and phase out non-compliant products. With the end of this period concluded, compliance is now mandatory, ensuring that products meet updated safety requirements. 

Detailed guidelines for compliance can be found here. 

On 5 December 2024, Australia updated the Industrial Chemicals Environmental Management Standard (IChEMS) Register under the Industrial Chemicals Environmental Management (Register) Amendment (2024 Measures No. 2) Instrument 2024, with changes to take effect from 1 July 2025. These updates introduce new chemicals and amendments to ensure that industrial chemicals are managed in accordance with national environmental safety objectives.

Background on IChEMS

The Industrial Chemicals Environmental Management Standard (IChEMS) provides a consistent, national framework for managing industrial chemicals based on their environmental risks. The system categorizes chemicals into Schedules 1–7, with higher Schedules reflecting stricter controls or bans. IChEMS aligns state, territorial, and federal efforts to reduce environmental harm from hazardous chemicals.

New Substances Added to the IChEMS Register

The Industrial Chemicals Environmental Management (Register) Amendment (2024 Measures No. 2) Instrument 2024 introduces the following substances:

Effective 1 July 2025:

• Lauryl (dodecyl) sulfates (CAS 151-41-7, 151-21-3, and others) – Added to Schedule 3 (controlled use).

• Linear alkylbenzene sulfonates (CAS 27176-87-0, 25155-30-0, and others) – added to Schedule 3 (controlled use).

• Polychlorinated biphenyls (PCBs) (CAS 1336-36-3) – Added to Schedule 7 (use banned).

• Hexachlorobenzene (CAS 118-74-1) – Added to Schedule 7 (use banned).

• Polychlorinated terphenyls (PCTs) (CAS 61788-33-8) – Added to Schedule 7 (use banned).

Amendments to Existing Substances in Schedule 7

Key updates include:

• 1,2,3,4,5-pentachlorobenzene – Expanded allowable use for research and laboratory purposes.

• Perfluorooctanoic acid (PFOA) and related compounds – Adjustments to contamination thresholds and allowable uses for existing firefighting foams.

• Perfluorooctane sulfonic acid (PFOS) – Minor wording update.

• Short chain chlorinated paraffins (C10–13) – Typographical correction.

Compliance Requirements

Industries must:

• Review updated Schedules 3 and 7 for newly listed chemicals and amendments.

• Ensure compliance with minimum environmental management standards.

• Adjust operational practices, particularly for substances that are now banned or restricted.

Strengthening Environmental Protection

By updating the IChEMS Register with substances such as PCBs, hexachlorobenzene and PCTs, Australia continues its commitment to managing chemicals that pose significant risks to ecosystems. These changes support national efforts to reduce pollution and align chemical management practices with global standards.

The Brazilian Senate will review Projeto de Lei Nº 3.428/2023, which seeks to reduce the maximum allowable lead content in paints and similar surface coatings from 600 parts per million (ppm) to 90 ppm. The proposal was approved by the House of Representatives on October 16, 2024, and now moves to the Senate for consideration.

Key Provisions of PL 3428/2023

The bill applies to paints and related materials used for surface protection, decoration, and preparation. Exceptions include industrial and maritime paints, which may contain up to 600 ppm due to technical requirements. Paints that exceed 90 ppm but fall within the 600 ppm exception must display a warning label (in Portuguese):

“Perigo: contém chumbo. Não aplicar em superfícies acessíveis a crianças e/ou mulheres grávidas." ("Warning: Contains Lead. Not for use on surfaces accessible to children or pregnant women.")

Compliance and Penalties

Manufacturers and importers will have 365 days to meet the new requirements. Non-compliance will lead to penalties, including product seizure and fines. Regulatory authorities will oversee enforcement, ensuring adherence to the regulation and protect public safety and the environment.

Advancing Paint Technology

This initiative reflects advances in paint technology that allow for safer, lead-free alternatives without compromising performance. If enacted, the proposal would repeal Law 11.762/2008, which currently regulates limits in paints in Brazil. The law is part of Brazil’s commitment to reduce toxic substances, protect health and promote sustainable development. For more details, see the proposal (in Portuguese) here.

On October 10, 2024, the Minister of Industry and Trade (MOIT) officially issued Amendment 1:2024 QCVN 05A:2020/BCT, which amends the National Technical Regulation on Safety in Production, Commerce, Use, Storage, and Transportation of Hazardous Chemicals (QCVN 05A: 2020/BCT), through Circular No. 19/2024/TT-BCT. The amendment, developed by the Drafting Team to address practical challenges in hazardous chemical management, was evaluated by the Ministry of Science and Technology and approved by the Vietnam Chemicals Agency. 

Background on QCVN 05A: 2020/BCT and Amendment Process 

The management of chemical activities in Vietnam has generally improved since December 21, 2020, when Circular No.48/2020/TT-BCT promulgated QCVN 05A: 2020/BCT. However, the practical implementation has shown that some of the provisions are incorrect or impractical, thus necessitating the amendment. 

After consulting on a proposed amendment to the National Technical Regulation, MOIT submitted it to the Vietnam Chemicals Agency for approval on March 22, 2024. Only a few of the provisions of QCVN 05A:2020/BCT were amended in Amendment 1:2024. The remaining elements of QCVN 05A:2020/BCT, which was issued in conjunction with the Minister of Industry and Trade's Circular No. 48/2020/TT-BCT on December 21, 2020, are retained. 

Key Provisions and Compliance Deadlines 

This Circular comes into force on April 15, 2025. All factories and warehouses containing hazardous chemicals that are put into operation before April 15, 2025, must meet the requirements laid down in Amendment 1:2024 QCVN 05A:2020/BCT by April 15, 2026, at the latest. 

Appropriate leak and spill warning devices must be installed in factories and warehouses handling hazardous chemicals in liquid and gaseous form. Surveillance cameras are required for solid poisons. Hazardous gas collection and treatment equipment or automatic sprinklers must be installed to respond to accidents involving hazardous substances that can be released into the environment in gas form. 

Chemical collecting systems are required in factories and warehouses containing liquid corrosive chemicals. The minimum capacity of the collecting system must be at least 110% of the capacity of the largest container. Water-reactive chemicals must be placed on pedestals or racks at least 0.3 m above the ground. The storage capacity of the dike system must be at least 110% of the capacity of the largest container. 

Safety Measures for Incident Response 

Every individual in the vicinity of a fire or explosion incident is required to wear personal protective equipment (PPE) in order to assist in victim rescue and incident response. Participation in incident response is prohibited for those without personal protective equipment to ensure safety. Additionally, the amendment requires the use of personal protective equipment (PPE) in the event of a fire or explosion. 

For more details, see Circular No. 19/2024/TT-BCT here. 

The Malaysian Ministry of Health has proposed amendments to the Sixteenth Schedule of the Food Regulations 1985, specifically concerning pesticide residue limits in food products.

Key Highlights of the Proposal

The main changes include:

1. Introduction of New Maximum Residue Limits (MRLs):  The proposal adds MRLs for new pesticides such as famoxadone, isocycloseram, isoprothiolane, propanil, quinclorac, and others. These MRLs are designed to regulate the levels of these pesticides in various food products.

2. Expansion of Existing MRLs: The amendments also update the MRLs for existing pesticides, adding new limits for additional commodities. Pesticides such as abamectin, ametoctradin, thiamethoxam, and tebuconazole will now have MRLs for a wider range of food items.

Deviation from International Standards

The proposed MRLs are not always consistent with international standards, particularly the Codex Alimentarius, which provides globally recognized guidelines for food safety, including pesticide residue levels. Some MRLs proposed by Malaysia deviate from Codex standards or are not available internationally. For example, the MRLs for famoxadone in tomatoes, quinclorac in milled rice, and tebuconazole in mangoes differ from Codex due to differences in agricultural practices and local residue trials conducted in Malaysia and other regions.

Compliance and Prohibited Practices

The proposed amendments also clarify the definition of "pesticide" and reinforce that no food should be exposed to pesticide residue levels that exceed the limits set out in the Sixteenth Schedule. Additionally, it is prohibited to import, prepare, or sell food containing pesticide residues as follows:

• Pesticide residues exceeding the limits specified in the Sixteenth Schedule.

• Pesticide residues higher than those recommended in the Codex Alimentarius, where the pesticide is not listed in the Sixteenth Schedule.

• Pesticide residues greater than 0.01 mg/kg of if the pesticide is not specified in either the Sixteenth Schedule or Codex Alimentarius.

The President of Costa Rica, Rodrigo Chaves Robles, and the Minister of Economy, Industry, and Commerce (MEIC), Francisco Gamboa Soto, have issued a new Executive Decree that establishes a modernized framework for product conformity evaluation. This framework introduces the Supplier’s Declaration of Conformity (SDoC) as an efficient and cost-effective mechanism to ensure compliance with technical regulations, in accordance with international standards.

In line with Costa Rica’s commitment to transparency in international trade, the Decree was formally notified to the World Trade Organization (WTO) on the 3rd of December 2024, under the Agreement on Technical Barriers to Trade. The purpose of this notification is to inform trading partners of the new regulation and to promote dialogue within the global trading system.

Key Features of the Decree

1. Supplier’s Declaration of Conformity (SDoC): The SDoC allows manufacturers, producers, and suppliers to declare under oath that their products comply with applicable technical regulations. This self-declaration approach reduces administrative costs, enhances traceability, and applies primarily to low-risk products or those manufactured at the customer’s request.

2. Alignment with International Standards: The regulation is based on principles outlined in the WTO Agreement on Technical Barriers to Trade, as well as standards such as ISO/IEC 17050 and OECD guidelines. This ensures that the framework is proportional, non-discriminatory, and consistent with Costa Rica’s international commitments.

3. Market Surveillance:  The decree empowers authorities to conduct random market inspections and ensure compliance with technical regulations. Cases of non-compliance will be sanctioned by the National Consumer Commission (CNC), in accordance with Law No. 7472.

Commitment to Transparency and Global Trade Facilitation

The notification to the WTO underscores Costa Rica’s dedication to meeting international trade obligations and maintaining an open, transparent regulatory environment. This step also promotes cooperation with trading partners and ensures that the decree is in line with global best practices. For more details, the Supreme Decree is available in Spanish here.