GPC Newsletter Dec-2024

On October 31, 2024, the U.S. Environmental Protection Agency (EPA) released updated Toxics Release Inventory (TRI) data detailing toxic chemical waste management, including releases and pollution prevention activities from 2023. The data covers over 20,000 industrial and federal facilities nationwide, providing essential insights for communities, agencies, and companies.

Established under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), TRI requires annual reporting from facilities in specific industry sectors that manufacture, import, process, or use a listed chemical in an amount that exceeds the given threshold for that chemical and activity (e.g., 25,000 lbs., 10,000 lbs. 100 lbs. etc.). TRI reports, known as "Form R" or "EPCRA 313," are due each year on July 1.

Updates from the 2023 Report:

The 2023 data report is submitted by facilities in sectors such as metal mining, electric power generation, chemical manufacturing, and hazardous waste treatment. This updated dataset is based on preliminary 2023 data from July 2024 and incorporates revised and late submissions received by EPA as of October 23, 2024.

With EPA's enhanced TRI Toxics Tracker, communities can now map TRI-reporting facilities and explore data on chemical releases, waste management practices, and pollution prevention efforts. A comprehensive analysis of the 2023 data will be available in next year’s TRI National Analysis, which will assess trends, industry-specific waste management, and pollution reduction activities.

The current report suggests that zinc and lead compounds topped the list of chemical releases, with 415 million and 354 million pounds, respectively. Inorganic lead compounds, classified by EPA as probable carcinogens, pose cardiovascular, developmental, neurological, and reproductive risks. Other carcinogens released by facilities include arsenic (5.6 million pounds) and chromium compounds (4.7 million pounds).

The environmental and health impacts of mining these metals are significant. High doses of ingested zinc can cause gastrointestinal distress, and long-term exposure may lead to anemia and reduced levels of good cholesterol. Chronic manganese exposure harms multiple organs, potentially causing neurotoxic effects such as cognitive impairment, Parkinson's-like symptoms, and movement disorders such as dystonia.

The TRI data highlights the threat mining poses to drinking water sources, fish habitats, and wildlife. Toxic runoff from mine waste often leaches heavy metals such as lead and cadmium, along with arsenic, into ground and surface water. This report serves as a critical resource for communities near mines, especially Indigenous populations, who are disproportionately impacted by metal pollution.

PFAS-Related Updates: 

For the fourth consecutive year, Toxics Release Inventory (TRI) data includes reporting on per- and polyfluoroalkyl substances (PFAS), as mandated by the 2020 National Defense Authorization Act (NDAA). In 2023, facilities reported managing over 1.5 million pounds of PFAS-related waste, with 61 facilities submitting a total of 168 TRI forms covering 46 distinct PFAS compounds. In October 2023, EPA finalized a rule to enhance PFAS reporting by removing an exemption that previously allowed facilities to bypass reporting on PFAS when present in low concentrations. EPA expects expanded PFAS reporting in the 2024 TRI data.

On October 31, 2024, the U.S. Environmental Protection Agency (EPA) finalized revisions to existing regulations under the Toxic Substances Control Act (TSCA) for two persistent, bioaccumulative, and toxic (PBT) chemicals—Decabromodiphenyl Ether (decaBDE) and Phenol, Isopropylated Phosphate (PIP (3:1)). This new rule aims to address implementation challenges and reduce potential human and environmental exposure to these hazardous substances.

Background

These revisions build on the final rules originally established in January 2021, which targeted five PBT chemicals identified for expedited action under TSCA Section 6(h). Following feedback from stakeholders and further analysis, EPA determined that additional measures were necessary for decaBDE and PIP (3:1). The revisions are designed to clarify compliance requirements, extend certain compliance deadlines, and provide more robust protections particularly in sectors such as agriculture, construction, life sciences, and mining.

Key Changes to the DecaBDE Regulations

DecaBDE (CAS 1163-19-5) is widely used as a flame retardant in a variety of industries, particularly in textiles, electronics, and automotive parts. The updated rule introduces several significant changes:

• Personal Protective Equipment (PPE) Requirements: Companies involved in manufacturing, processing, or distributing decaBDE must now ensure the use of PPE to limit worker exposure.
• Prohibition on Water Releases: The release of decaBDE into water during its manufacture and processing is now banned, reflecting heightened concerns over its environmental impact.
• Extended Compliance for Specific Uses: EPA has extended the compliance deadline for the use of decaBDE in wire and cable insulation for nuclear power facilities, recognizing the critical nature of this application. Similarly, companies must notify authorities when exporting decaBDE-containing materials for nuclear power uses.
• Threshold for Unintentional Presence: The rule allows a minimal presence of decaBDE (less than 0.1% by weight) in products, recognizing the challenges of completely eliminating trace amounts from complex supply chains.

Updates to PIP (3:1) Regulations

PIP (3:1) (CAS 68937-41-7) is commonly used as a flame retardant and plasticizer in hydraulic fluids, lubricants, and electronic components. The revised regulations include:

• Expanded PPE Requirements: Similar to decaBDE, EPA is mandating the use of PPE for handling PIP (3:1) during its domestic manufacturing and processing.
• Phase-Out of Certain Uses: The rule imposes a gradual phase-out of PIP (3:1) for specified applications while allowing exemptions for critical uses, such as wire harnesses and circuit boards, until suitable alternatives are found.
• Exemptions for Replacement Parts: The regulation introduces provisions for the continued use of PIP (3:1) in replacement parts for existing equipment, thereby minimizing disruptions in industries such as aerospace and automotive manufacturing.
• 10-year grace period to phase out the use of PIP (3:1) in parts for new equipment: The extended timeline applies to manufacturing and industrial machinery, commercial electronic equipment, refrigeration, water-heating systems, power-generating equipment, etc.

This allowance is intended to give industries sufficient time to transition to alternatives while maintaining compliance with the new safety standards.

The Agency highlighted the importance of reducing exposure to these toxic substances, which have been linked to adverse health effects, including developmental and neurological harm, as well as environmental damage.

Additional requirements 

The Final rule introduces new workplace safety measures to minimize dermal and respiratory exposure, although certain import and processing applications are exempt. Recordkeeping requirements have been extended from three to five years, with companies now required to have compliance records "readily available" for prompt review, eliminating the previous 30-day grace period.

For continued use of PIP (3:1), companies must update safety data sheets (SDSs) within three months and product labels within 18 months. The rule does not change existing requirements for the other three PBT chemicals regulated under the January 2021 rule: 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP), hexachlorobutadiene (HCBD), and pentachlorothiophenol (PCTP).

The rule is set to take effect 60 days after its publication in the Federal Register, with extended compliance dates for certain sectors.

The European Union is set to revise its REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation in 2025, with the aim of streamlining chemical safety protocols and strengthening environmental protection. Insights into the forthcoming changes were highlighted in recent responses by Commissioner-designate Stéphane Séjourné (candidate for the Prosperity and Industrial Strategy portfolio) and Jessika Roswall (candidate for the Environment, Water Resilience and a Competitive Circular Economy portfolio) to questionnaires for their confirmation hearings in the European Parliament. These questionnaires, designed to detail each Commissioner’s priorities and strategies, outlined key features of the expected REACH revision, such as stricter regulations on hazardous chemicals, a greater emphasis on sustainability and simplified compliance processes for industry.

Emphasis on Broader Chemical Restrictions

A key aspect of the upcoming REACH revision is the move from individual chemical authorisations to broader category-wide restrictions. This strategy is designed to speed-up the removal of high-risk substances from the market and make compliance easier for companies, particularly small and medium-sized enterprises (SMEs). Commissioner-designate Séjourné underlined the need for a more efficient regulatory framework that will rapidly eliminate harmful substances while providing long-term investment certainty for Europe's chemical industry.

Tighter PFAS Regulations with Essential Use Criteria

The revision will also target per- and polyfluoroalkyl substances (PFAS), which are known for their persistence in the environment. The EU plans a complete ban on PFAS in consumer products such as cosmetics, food packaging and outdoor equipment. However, essential use criteria will allow PFAS applications in critical industrial sectors where no viable alternatives exist. Commissioner-designate Roswall emphasised the importance of balancing environmental protection with industrial needs and supported the continued use of PFAS in essential applications under strictly controlled conditions until suitable substitutes are developed.

Tackling Information Gaps in Chemical Safety

The forthcoming revision of REACH aims to address existing information gaps on chemical safety. Enhanced data requirements in particular for substances identified as endocrine disruptors or those with high environmental persistence, will allow for more informed regulatory decisions. This approach aims to improve risk control and ensure that both human health and the environment are adequately protected.

Advancing Circular Economy Goals through Sustainable Chemical Practices

In line with the EU's Clean Industrial Deal and Circular Economy goals, the 2025 REACH revision promotes the sustainable use of chemicals and resource efficiency. By encouraging the adoption of safer alternatives and reducing dependence on virgin materials, the EU aims to foster a more sustainable and competitive chemical industry. Commissioner-designate Séjourné underlined the need to create an enabling framework for investments that drive the transition to green and digital solutions, including clean energy sources and sustainable chemicals.

As the 2025 revision of REACH approaches, the EU is ready to implement a streamlined regulatory framework that enhances chemical safety, supports sustainable industrial practices and protects public health and the environment.

The full text of the questionnaires can be found here and here.

The European Chemicals Agency (ECHA) has published the updated Guidance on the Application of the CLP Criteria to reflect the latest regulatory developments and scientific advances. The revised guidance is now presented as a series of five separate documents to enhance usability and support compliance with Regulation (EC) No 1272/2008 (CLP Regulation).

Key Features of the Updated Guidance

Comprehensive Scope

The guidance provides detailed technical and scientific advice on the application of the classification, labelling, and packaging (CLP) criteria for physical, health and environmental hazards. It supports manufacturers, importers and downstream users in meeting their obligations under the CLP Regulation.

New Structure for Improved Usability

To improve accessibility, the guidance has been reorganised into five distinct parts:

1. Overview Document: An introduction to the guidance series.

2. Part 1: General Principles for Classification and Labelling: This basic part contains practical examples and must be consulted before using other parts.

3. Part 2: Physical Hazards: Updated to reflect recent advances, including criteria for desensitised explosives.

4. Part 3: Health Hazards: Includes new guidance on endocrine disruptors affecting human health.

5. Part 4/5: Environmental Hazards and Additional Hazards: Includes new sections on environmental endocrine disruptors, Persistent, Bioaccumulative, and Toxic (PBT), very Persistent and very Bioaccumulative (vPvB), Persistent, Mobile, and Toxic (PMT) and very Persistent and very Mobile (vPvM) criteria.

Guidance on the New Hazard Classes

The updated guidance introduces key sections addressing emerging safety concerns, with detailed information available in specific parts of the guidance series:

• Endocrine Disruption (Human Health): This section, found in Part 3: Health Hazards, Section 3.11, provides criteria for identifying substances with endocrine disrupting properties that affect human health.

• Endocrine Disruption (Environmental): Addressed in Part 4/5: Environmental Hazards and Additional Hazards, Section 4.2, this section provides guidance on the identification and classification of environmental endocrine disruptors.

• PBT, vPvB, PMT and vPvM: Covered in Part 4/5, Section 4.3, where criteria for the assessment of substances with PBT, vPvB, PMT or vPvM properties are detailed.

Each part provides comprehensive guidance on these hazard classes to ensure that stakeholders have the necessary tools for accurate classification and labelling under the CLP Regulation.

Background and Legal Notice

The guidance is based on the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) and builds on the EU’s long-standing expertise in chemical safety. ECHA emphasises that the CLP Regulation itself remains the only legally binding reference, and this guidance is intended to support its application.

The updated guidance incorporates input from experts from Member States, industry stakeholders and organisations such as the European Food Safety Authority (EFSA) to ensure a robust and science-based framework.

Recent Adoption of the New CLP Regulation

On 14 October 2024, the Council of the European Union adopted the new Regulation on the Classification, Labelling and Packaging of Chemical Substances (CLP), marking a significant step forward in chemical safety. This update modernises the 2008 CLP Regulation to better reflect evolving hazards, consumer protection trends, and sustainable practices.

The new regulation introduces voluntary digital labelling, rules for chemical refill stations and a five-year grace period for non-modified substances of botanical origin with multiple constituents (MOCS). Key changes include faster identification and classification of hazards, including endocrine disruptors, updated labelling requirements for both traditional and digital formats, and adaptations to modern trading practices such as online sales and bulk purchasing. These updates aim to enhance consumer and environmental protection while supporting the circular economy.

The Regulation was published in the Official Journal of the European Union on 20 November 2024 and will enter into force 20 days later.

Access the Updated Guidance

Stakeholders are invited to consult the new guidance documents, which are available on ECHA’s website here. The updated structure and content reflect the EU’s commitment to chemical safety and effective hazard communication.

On 20 November 2024, the European Chemicals Agency (ECHA), in collaboration with authorities from Denmark, Germany, the Netherlands, Norway and Sweden, provided a progress update on the restriction proposal for per- and polyfluoroalkyl substances (PFAS).  The update outlines the current status and future plans of ECHA's Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) as they assess the potential impact of the proposed restriction on different sectors using PFAS.

Submitted in January 2023, the PFAS restriction proposal under REACH aims to reduce the environmental and health risks associated with these persistent chemicals. PFAS are a group of thousands of man-made chemicals known for their persistence, bioaccumulation and potential toxic effects. The proposed restriction aims to ban the manufacture, use and sale of these substances in the EU in order to reduce their environmental and health impacts.

Extensive Consultation and Sector-Specific Insights

More than 5,600 scientific and technical comments were received during the six-month consultation in 2023, providing valuable insights into PFAS uses and alternatives across Europe. Newly identified uses include:

• Sealing applications: Fluoropolymer uses in seals, gaskets, and pipe linings.

• Technical textiles: High performance membranes and technical fabrics for outdoor use.

• Medical applications: Pharmaceutical packaging and excipients.

• Printing: Permanent parts and consumables.

Fluoropolymers, a subgroup of PFAS, have emerged as a key area of interest during the consultation process. Stakeholder input has provided critical insights into the availability of alternatives for certain fluoropolymer applications and the measures needed to minimise their environmental emissions. The socio-economic implications of restricting their manufacture, market placement, and use are being carefully evaluated. Due to their significance, fluoropolymers are receiving focused attention from all actors involved in the opinion development process.

Exploring Alternative Restriction Options

In addition to the initial proposals for a total ban or a ban with time-limited derogations, alternative options are being assessed to balance risk reduction with socio-economic impacts. These may include conditional authorisations for specific uses, such as:

• Batteries, fuel cells, and electrolysers

• Medical devices and semiconductors

The European Commission, with input from ECHA’s Risk Assessment and Socio-Economic Analysis Committees (RAC and SEAC), will evaluate these options and take final decisions.

Next Steps

ECHA and the dossier submitters will continue to refine their evaluation throughout 2025, leading to a consolidated opinion. Stakeholders will have further opportunities to provide input on socio-economic aspects before final decisions are taken.

The UK Department for Environment, Food and Rural Affairs (DEFRA) has recently published a report setting out a new set of recommendations for the integration of New Approach Methodologies (NAMs) into UK chemical regulations. These methodologies support a transition away from traditional animal testing by relying on advanced scientific approaches, including in vitro and in silico methods. The new recommendations mark an important step in improving the reliability of chemical safety testing, while aligning with the UK’s post-Brexit regulatory landscape.

Key Recommendations for NAM Integration

The report sets out DEFRA's strategy for the progressive adoption of NAMs, detailing a framework to enhance chemical safety through:

• Technology Agnostic NAMs: DEFRA proposes a broad definition of NAMs, focusing utility of the data in assessing the mode of action of chemicals.

• Progressive Regulatory Framework: Phased implementation would allow NAMs to progressively replace animal testing as scientific certainty increases.

• Investment in UK Centres of Excellence: The establishment of dedicated NAMs research centres is recommended to ensure regulatory alignment and technological advancement within the UK.

Benefits of Early Adoption of NAMs

By adopting NAMs, the UK will gain ethical and economic benefits and position itself as a global leader in chemical safety. Early adoption is also in line with the “3Rs” principle (Reduce, Refine and Replace animal testing), further strengthening public trust in the UK’s regulatory framework. The report highlights that NAMs enable high confidence safety evaluations and support group-based testing and prioritization, reducing the need for traditional methods.

Challenges and Future Outlook

While the integration of NAMs holds great promise, DEFRA notes the need for robust acceptance criteria to ensure scientific reliability. As NAMs continue to develop, the UK is encouraged to take a lead in establishing reporting standards, drawing on international research and collaboration. With the progressive framework, NAMs are expected to play a greater role in chemical safety assessments, promising a safer and more sustainable future for the industry.

DEFRA’s latest recommendations underline the UK’s commitment to scientific innovation in chemical regulation and highlight a strategic shift towards a safer and more ethical approach to chemical safety assessment.

On 14 November 2024, the Department of Chemicals and Petrochemicals (DCPC), in consultation with the Bureau of Indian Standards (BIS), issued a notification to implement Quality Control Orders (QCOs) for three critical chemicals: H Acid (CAS No: 90-20-0), K Acid (Cas No: 118-03-6), and Vinyl Sulphone (CAS No: 16071-86-6). These orders aim to enhance safety and quality in the industrial chemicals sector and are based on drafts published on 26 July 2024. 

Key Requirements under the New QCOs 

These chemicals must conform to Indian Standards and must bear the standard mark under a license from the Bureau of Indian Standards as per Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The Bureau of Indian Standards Act, 2016 governs the use of Standard Marks, with the Bureau of Indian Standards as the certifying and enforcing authority. Chemicals intended for export are exempted from this order. 

Standards for the notified chemicals 

Date of Enforcement 

The QCOs will come into force on 13 May 2025 (180 days after publication). The full text of the Gazette Notification can be found here. 

India’s Bureau of Indian Standards (BIS) is currently seeking feedback on several revised standards for key chemicals used across industries, including metallic zinc powder, potassium iodate and barium chloride. ThesBIS is seeking feedback on updated standards for key chemicals like zinc powder, potassium iodate, and barium chloride.e revisions aim to improve quality control, packaging, and labeling requirements, while addressing safety concerns related to heavy metals and impurities. The following are the most important updates for the 3 substances: 

1. Revised Standard for Metallic Zinc Powder (Zinc Dust) 

Consultation Deadline: 9 December 2024 

BIS has released a third revision of the standard for metallic zinc powder, a critical substance in the chemical industry used in protective coatings, organic reactions, and the production of synthetic dyes. Key revisions include: 

• New Test Methods: Includes testing for chlorides, iron, lead, and copper. 

• Grade Classification: The standard defines two grades: 

• Grade 1: Used in the manufacture of hydrosulphites and related products. 

• Grade 2: For chemical and protective coatings. 

• Packaging and Labeling: The substance should be packaged in air-tight metal drums or double polyethylene-lined bags. Packaging must include specific information such as the material’s grade, source of manufacture, and batch traceability. 

Specifications for Zinc Powder: 

2. Revised Standard for Potassium Iodate 

Consultation Deadline: 9 December 2024 

BIS is revising the standard for potassium iodate, which is widely used in the iodization of table salt and in iodometry. The new revision introduces three grades: Analytical Reagent (AR), Food Grade (FD), and Technical Grade (TECH). The revised standard also specifies maximum permissible limits for heavy metals and modifies packaging requirements. Key updates include: 

• Grade Specifications: 

• AR grade: Strict limits on impurities such as bromate, chlorides and iron. 

• FD grade: Used in food products with lower limits on contaminants. 

• TECH grade: More lenient limits suitable for industrial use. 

• Packaging: The substance must be packaged in airtight bottles or for bulk in steel or fiber drums. 

Key Specifications for Potassium Iodate: 

3. Revised Standard for Barium Chloride 

Consultation Deadline: 25 December 2024 

BIS is revising the standard for barium chloride, a substance used in the manufacture of pigments and dyes and the removal of sulphate ions from brine. The revision introduces alternative test methods for determining copper, iron, and lead content, as well as updated packaging and labeling requirements. Key updates include:  

• Two Grades: The standard proposes two grades—Technical (TECH) and Analytical Reagent (AR). 

• Packaging: The TECH grade must be packaged in clean jute bags lined with polyethylene, while the AR grade must be packaged in glass bottles. 

• Heavy Metals Limits: The revision includes limits for heavy metals and impurities such as calcium and strontium salts. 

Key Specifications for Barium Chloride: 

Packaging and Labeling Requirements for All Chemicals 

For all three substances, BIS has updated the packaging and labeling requirements, which now require clear identification of: 

• Name and grade of the material 

• Source of manufacture 

• Net weight of the material 

• Lot or batch number 

• Date of manufacture 

Conclusion 

Bis’s revised standards aim to enhance the safety, quality, and traceability of these chemicals which are used in a wide range of industries. Stakeholders are invited to provide feedback, with the consultation deadlines approaching in December 2024. The updates are expected to improve quality control, reduce contamination risks, and ensure greater transparency in the chemical industry. 

In a significant move to enhance food safety, India’s Bureau of Indian Standards (BIS) has launched a public consultation on the country’s first-ever standard for paper-based materials used in the delivery and serving of food and drink. The consultation, which is open until December 30, 2024, aims to establish clear guidelines to ensure that food packaging and materials that come into direct or indirect contact with food are safe for human consumption. 

Purpose of the Standard 

The standard focuses on setting limits for the migration of substances from packaging into food and beverages. It defines the "overall migration limit," which measures the maximum allowed amount of non-volatile substances, such as monomers, additives and pigments, that can leach from paper-based materials into food. This measure aims to protect consumers from exposure to harmful chemicals. 

Testing Requirements 

Under the proposed guidelines, paper-based materials intended for food contact must pass an overall migration test, as outlined in Indian Standard (IS) 9845. This applies to conditions where the food contact time is less than 24 hours. The migration of non-volatile substances from the material layer must not exceed 60 mg/kg and there must be no visible color migration during the test. 

Proposed Migration Limits for Substances  

The proposed standard sets specific migration limits for various heavy metals and chemicals, including:

Scope of the Proposed Standard 

The migration limits will apply to both direct and indirect food contact materials (FCMs), including items such as wraps, bags, pouches, carton boxes, plates, trays, cups, and bowls used for serving or delivery. However, the new standard does not cover materials intended for long-term food storage. 

Material Requirements 

The proposed standard has strict material requirements for paper-based products. Only virgin pulp is allowed in the manufacturing process, and materials must be free from optical brightening agents. Coating materials used on the paper must be derived from bio-based polymers such as PLA, PBS or PHA, or be made from water/solvent-based emulsions. 

Labelling Requirements 

Any paper-based material intended for food or beverage should be clearly labelled with essential information, including the source of manufacture, batch number, and the date of manufacture. Furthermore, any claims of compostability must be substantiated by a registration number from the Central Pollution Control Board (CPCB), along with an approved QR code. 

Towards Safer Food Contact Materials 

This initiative by BIS is an important step towards ensuring the safety and quality of food contact materials in India, with the aim of protecting consumers from potential health risks associated with harmful chemicals in food packaging. During the consultation period, stakeholders are encouraged to provide feedback to help finalize this important standard, which aims to ensure that food contact materials are safe, effective and environmentally responsible. 

For more details, the proposed standard can be accessed here.

On November 4, 2024, the China National Medical Products Administration (NMPA) approved a new cosmetic ingredient, isobutylamido thiazolyl resorcinol (CAS No 1428450-95-6), submitted by Beiersdorf AG, Germany. This ingredient is chemically synthesized and has been tested for safety and efficacy. It can be used as a whitening agent in leave-on cosmetics, except in products that may cause inhalation exposure. This approval offers a new option for the development of whitening cosmetics in China. 

China’s Cosmetic Regulatory Framework for New Ingredients

Under China's cosmetic regulatory framework, all cosmetics sold in the country must use ingredients listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC). Ingredients outside the IECIC are classified as new cosmetic ingredients. To promote innovation, the Cosmetics Supervision and Administration Regulation (CSAR), implemented in 2021, replaced the previous approval system with a dual-track system of registration and notification based on the risk level of the ingredient. 

New cosmetic ingredients with functions such as preservation, sun protection, coloring, hair dyeing or whitening must undergo a registration process. Other new ingredients are subject to notification. In all cases, new cosmetic ingredients must be registered or notified with the NMPA before being used in cosmetic products. 

Encouraging Innovation in Whitening Products

The approval of isobutylamido thiazolyl resorcinol demonstrates China's commitment to promoting innovation in the cosmetics industry while ensuring consumer safety. It is a significant step forward in expanding the options available for the development of spot removal and whitening products in compliance with China's stringent regulatory standards. 

For more information, please refer to the official announcement here.

On November 14, 2024, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of the new designation of lead compounds and methylene Chloride as restricted substances. The purpose of the amendment is to newly designate substances that are of high concern for hazards in certain uses as restricted substances. 

Key Changes 

1, Expansion of Lead Restrictions 

The lead identification number 06-5-8 is expanded to include lead and its compounds.  

• Prohibited uses: The manufacture, import, sale, and use of lead and its compounds for painting purposes.  

• Exemptions: Aerospace, and defense applications (e.g., maintenance and repair of aircraft or weapons). 

2, New Restriction on Methylene Chloride 

Methylene chloride and mixtures containing more than 0.1% of it are newly designated as restricted substances. The new identification number is 06-05-15. 

• Prohibited uses: Methylene chloride and mixtures containing more than 0.1% cannot be used for paint removal for household, construction, and furniture purposes.  

Public Consultation and Enforcement Timeline 

The amendment will be open for comments for 60 days from the date of notification. The proposed date for adaptation and enforcement of the amendment is January 2026.  

On November 20, 2024, South Korea’s National Institute of Chemical Safety (NICS) announced updates to its toxic substance regulations with the publication of the administrative notice of Partial Revision of the Designated Notice of Toxic Substances. The revision is in accordance with the "Act on the Registration and Evaluation of Chemical Substances (K-REACH).  

Reason for Revision 

In accordance with the Act on the Registration and Evaluation of Chemical Substances (K-REACH), substances that have been assessed as high hazard are to be designated as new toxic substances. 

Key Updates in the Revision 

1. Hazard Assessments: 

• Conducted on new and existing chemical substances per Article 18 of K-REACH. 

• Criteria have been established for the designation of 26 new toxic substances, with unique numbers ranging from "2024-1-1223" to "2024-1-1248". 

• Aquatic Environment Hazards: 2024-1-1223 to 2024-1-1247. 

• Strong Toxicity from Repeated Exposure: 2024-1-1248. 

2. Revised Data: 

• The unique number "97-1-91" has been updated to reflect the name of the chemical substance. 

• "Zinc carbonate" (97-1-91) has been excluded due to its high hazard to water, but it meets the criteria for designation as a toxic substance. 

3. Interim Measures: 

• Deadlines for compliance with the Chemicals Control Act for those handling newly designated toxic substances, including import declarations, business licenses, and labeling standards. 

Opportunity for Stakeholder Input 

Stakeholders are invited to submit their opinions on the announcement by December 10, 2024. Submissions should include: 

• Specific opinions on the notice (whether it should be revised and why). 

• Name, address, and telephone number (for organizations, include the name and representative). 

Contact Information: 

• Chemical Registration and Evaluation Team 

• Tel: 032-560-7218 

• Fax: 032-568-2038 

For detailed results, refer to the "Notification of Hazard Assessment Results of Chemical Substances" on the Chemical Safety Agency website: www.kreach.me.go.kr. 

The Ministry of Public Health and the Ministry of Industry in Thailand have jointly issued a new Ministerial Regulation under the Narcotics Code Act B.E. 2564, which establishes new labelling requirements for containers and packages containing volatile substances. Published in the Government Gazette on August 23, 2024, the regulation will take effect 120 days later and is a significant step in controlling the use and distribution of volatile substances.  

Key Updates on Volatile Substances Classification 

Earlier in January 2024, the authorities published an announcement detailing the identification and classification of chemicals and products as volatile substances. 

These include: 

1. Aliphatic and Aromatic Hydrocarbons: Such as toluene (methylbenzene). 

2. Ketones: Including acetone, methyl ethyl ketone (MEK), and methyl isobutyl ketone (MIBK). 

3. Esters: Such as ethyl acetate, methyl acetate, and butyl acetate. 

4. Volatile Alkyl Nitrites: Including amyl nitrite, isopropyl nitrite, and others. 

5. Ethers: Examples are ethylene glycol derivatives such as 2-butoxyethanol. 

Additionally, products containing these chemicals, such as thinners, lacquers, adhesives, and scientific balloons were categorized under volatile substances. This announcement reflects the government’s initiative to address the risks associated with volatile substances by clearly identifying these chemicals and their derivatives.  

New Labelling Requirements for Volatile Substances 

The Ministerial Regulation on Labelling of Volatile Substances Containers or Packages B.E. 2567 requires mandatory labelling information, including:   

• The phrase "Volatile Substance" 

• Manufacturer/importer details 

• Contents (in metric units) 

• Chemical composition 

• Instructions for use and storage 

• A bold red warning: "Do not inhale; it may be life-threatening" 

• Warning symbol featuring a black skull and crossbones within a red circle with the warning text. 

Products above 550 ml or 550 g that meet alternative legal standards are exempt from the labelling requirements. 

Regulatory Updates to Mitigate Health Risks 

The two announcements released in 2024 are designed to address the health risks associated with volatile substances, particularly inhalation abuse. By ensuring clear labelling and a comprehensive chemical classification system, the government aims to promote responsible use and protect public health. The coordinated approach by the Ministries of Public Health and Industry highlights the importance of interagency collaboration in regulatory oversight. These regulatory updates mark a significant step toward addressing the hazards posed by volatile substances, while establishing a robust legal framework for future enforcement. 

On 7 November 2024, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW) and Ministry of Environment (MoE) released a draft amendment to the Chemical Substances Control Law (CSCL) to add three chemicals to the list of Class I Specified Chemical Substances. The CSCL regulates these Class I Specified Chemical Substances and will be amended to include methoxychlor, dechlorane Plus and UV-328.  

Public Consultation in September 2024 

On 19 September 2024, Japan’s MHLW, METI and MoE jointly notified the World Trade Organization (WTO) of a draft proposal to designate three chemicals as Class I Specified Chemical Substances. The consultation ended on 18 November 2024. 

Class I Specified Chemical Substances List  

Class I Specific Chemical Substances are compounds with a high potential for bioaccumulation, persistence, and long-term toxicity to humans or higher trophic level predator animals. There are currently 35 chemicals on the list.  

 
Exemptions  

The draft includes exemptions for the use of Dechlorane Plus in certain applications, such as defence uses for insulation materials which are allowed until 26 February 2030.  

Comment Period and Enforcement Dates  

Stakeholders are invited to comment on the draft amendment until 6 December 2024. The enforcement order will be promulgated in December 2024 and come into force in February 2025. From June 2025, Japan will ban the import of products containing Dechlorane Plus and UV-328 as listed in the table below.  

The Australian Industrial Chemicals Introduction Scheme (AICIS) is seeking feedback on proposed updates to the list of chemicals with high hazards for categorisation and categorization guidelines for 2025. Key changes include the addition of 116 new chemicals and four AICIS-assessed substances, streamlined guidelines and an annual update schedule. Stakeholders are encouraged to share their input by 5 December 2024.

Key Updates to the High Hazard Chemical List

• New Additions

The AICIS will add 116 new chemicals to the list of chemicals with high hazards for categorisation, reflecting updates from external sources since the last revision. These chemicals exhibit hazard characteristics classified as human health hazard band C or environment hazard band C or D. As a result, their introduction may not qualify as exempted or reported under Steps 4 and 5 of the categorisation process.

While these changes will only affect a small number of importers or manufacturers based on current pre-introduction reports and post-introduction declarations, the AICIS will proactively contact affected companies prior to before implementing these updates.

• Adding AICIS-Assessed Chemicals to the List

Four chemicals that have been directly assessed by AICIS under the Industrial Chemicals Act 2019 are also proposed for inclusion. These substances meet the criteria for inclusion based on their human health hazard band C or environment hazard band C or D classifications. The AICIS will reach out to affected stakeholders before these chemicals are officially added.

How Chemicals Are Added to the List

AICIS has streamlined the process for adding chemicals to the list of chemicals with high hazards for categorisation. As outlined in the April 2024 Guidelines update, the executive director has discretionary authority to include chemicals identified as hazardous through assessments conducted under the Industrial Chemicals Act 2019 or the Industrial Chemicals (Notification and Assessment) Act 1989.

Proposed Revisions to the Categorization Guidelines

AICIS is seeking feedback on proposed revisions to the Industrial Chemicals Categorisation Guidelines, including editorial and structural updates. Key revisions include:

• Annual Updates: The AICIS plans to update the Guidelines and list of chemicals with high hazards for categorisation annually, beginning in September 2025, coinciding with the registration year.

• Clarified Information: Simplified descriptions in Appendix 8.1 will remove unnecessary text and ensure clear identification of listed chemicals.

• Text and Formatting Enhancements: Formatting changes will improve document accessibility and remove outdated references, including redundant footnotes.

Additional Highlights

• Text Corrections: Updates to source descriptions in Appendix 8.1 will clarify the basis for inclusion of chemicals without changing their categorisation status.

• Removed References: Sources removed in previous updates, such as the "Government of Canada Toxic Substances List," will no longer appear in the downloadable spreadsheet, streamlining the list.

• Editorial Adjustments: Non-substantive changes, such as naming conventions and link updates, are intended to improve the user experience without altering the content.

Opportunities for Stakeholder Feedback

The AICIS welcomes stakeholder perspectives on the following:

• Annual update schedule and fixed consultation timelines.

• Inclusion of AICIS-Assessed Chemicals on list of chemicals with high hazards for categorisation.

• Whether additional salts or esters of high hazard chemicals should be included in the guidelines.

The consultation will close on 5 December 2024. Feedback can be submitted through the AICIS consultation page here.

Brazil has achieved a milestone in sustainable development and public safety. On 13 November 2024, President Lula officially sanctioned Law 15.022/24, previously known as PL6120/19, creating the National Inventory of Chemical Substances. This groundbreaking legislation establishes a robust framework for the evaluation, control, and management of chemical substances produced, imported, or used in Brazil.

Development: Filling a Critical Gap in Chemical Safety

Until now, Brazil lacked a systematic mechanism to monitor chemicals entering its market. This gap created challenges in assessing risks to human health and the environment. With the implementation of Law 15.022/24, Brazil now joins a select group of countries with advanced regulatory systems, aligning itself with global best practices.

The centerpiece of the law is the National Inventory of Chemical Substances, a comprehensive tool for effective risk assessment and management. This positions Brazil as a leader in Latin America in the responsible management of chemicals and strengthens its commitment to sustainable development.

A Collaborative Effort: Key Stakeholders in the New Law

The success of this initiative is the result of years of collaboration among various stakeholders, including:

• Ministério do Meio Ambiente e Mudança do Clima (Ministry of the Environment and Climate Change)

• Abiquim (Brazilian Chemical Industry Association)

• Conasq (National Chemical Safety Commission)

These organizations, along with countless other contributors, have worked tirelessly to ensure that the law meets the needs of industry while protecting public and environmental health.

Looking Ahead: Ensuring Compliance and Sustainable Practises

At GPC, we are closely monitoring the implementation of Law 15.022/24 and will provide updates as it develops. Companies operating in Brazil must prepare to adapt to the requirements of the new legislation. We are committed to supporting companies effectively navigate these changes and ensure compliance with the National Inventory of Chemical Substances.

The sanctioning of Law 15.022/24 is a milestone for Brazil, reflecting its dedication to sustainable development and environmental responsibility. By adopting this legislation, the country sets a strong example for others in the region and reaffirms its alignment with international standards.

Costa Rica has issued the Regulation for the Prevention, Preparation, and Response to Chemical Accidents (Decree No. 44741-S-MAG), a comprehensive regulatory framework designed to minimize risks associated with the handling of hazardous chemicals. Published in the Official Gazette, this regulation reflects Costa Rica’s commitment to protecting public health and environmental sustainability while meeting its obligations as a member of the Organization for Economic Cooperation and Development (OECD).

Main Objectives and Scope

The regulation aims to establish guidelines for preventing, preparing for and responding to chemical accidents in facilities that handle hazardous substances. It addresses critical aspects such as safe handling practices, emergency preparedness, and post-accident response to protect human health, reduce economic losses and mitigate environmental impacts. The regulation applies to facilities involved in the import, manufacture, storage, distribution, and processing hazardous chemicals. However, certain activities, such as transportation and mining operations, are excluded from its scope.

Key Elements of the Regulation:

1. Risk Classification

Facilities must classify their risk level using a methodology provided in the Regulation. Facilities with higher quantities of hazardous chemicals or increased exposure risks are categorized as high-risk facilities and are subject to stricter controls, including mandatory emergency plans.

2. Emergency Response Plans

High-risk facilities are required to submit and implement a Prevention, Preparation, and Response Plan for Chemical Accidents. This plan must include:

• Risk reduction measures.

• Coordination with local communities and emergency services.

• Detailed procedures for handling emergencies, including spills, fires, and explosions.

3. Community Engagement

Facilities must educate surrounding communities about potential risks and emergency protocols. This includes conducting simulations, sharing information about hazardous substances on site, and establishing clear emergency communication channels.

4. Regulatory Oversight

The Ministry of Health and the National Animal Health Service (SENASA) will oversee compliance. The Benemérito Cuerpo de Bomberos de Costa Rica (BCBCR) will prioritize inspections based on risk levels and ensure that facilities meet safety standards.

5. Post-Accident Reporting

In the event of a chemical accident, facilities must submit a detailed report within 20 business days, that includes:

• Causes and timeline of the accident.

• Health and environmental impacts.

• Measures taken to reduce risks and prevent recurrence.

6. Penalties for Non-Compliance

Non-compliance may result in fines, suspension of operating permits, or closure of the facility. Persistent violations may result in criminal charges. Additionally, abandoned hazardous chemicals may be donated to government institutions or universities for safe disposal.

Compliance Deadline

The regulation will take effect six months after publication, on 5 May 2025.  High-risk facilities must develop and submit their emergency plans within this timeframe. This regulation imposes new responsibilities on companies that handle hazardous chemicals while providing a framework to enhance public safety and environmental protection. By fostering collaboration between businesses, communities and authorities, the country aims to create a safer, more sustainable environment for all.

For more details, stakeholders are encouraged to review the full text of Decree No. 44741-S-MAG, which is available in the Official Gazette (In Spanish) .

On 1 November 2024, the South African Minister of Health published the Regulations Relating to the Use of Food Additives in Foodstuffs, 2024. The regulations, which were developed under the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972), are set to come into force in 2025. These updated regulations introduce new guidelines for the use of additives in foodstuffs, including preservatives, antioxidants, sweeteners, colorants, and emulsifiers. These substances, which are used in food processing and production, must meet strict purity and identity specifications to ensure they do not pose a risk to public health. The aim is to ensure the safe use of food additives in accordance with internationally recognized standards. 

Key points of the Regulations of Food Additives in Foodstuffs 

Scope: This regulation is a significant step towards improving food safety and quality; the South African government has announced the implementation of new regulations. 

Application: This document provides regulations concerning the use of food additives in foodstuffs. It includes definitions, requirements for use, categories of food additives and the conditions for their use in food products. 

Requirements for the Use of Food Additives:  

• Specifications and Purity: Food additives should be manufactured, stored, and handled in accordance with Good Manufacturing Practice (GMP) standards. The quantity used should be limited to the minimum required for the intended effect. 

• Maximum Use Levels (ML): Foodstuffs containing additives must not exceed the maximum levels set by the Codex General Standard for Food Additives (GSFA). 

• Food Categories: Different food categories may have specific rules regarding food additives, e.g. infant formula may not allow certain additives. 

• Carry-over: Food additives can be carried over from raw ingredients into the final product, but must not exceed the allowed limits. 

 Extended Use of Food Additives: 

• Raw Materials: If a food additive is present in raw materials or ingredients, it must comply with the regulations and the amount carried over into the final product must not exceed the limits.  

• Infant Food: Food additives are not allowed to be carried over into foods intended for infants or young children.  

Application to Specific Food Categories: The document specifies how food additives such as color and sweeteners should be used in different food categories, including: 

• Infant foods: Strict limitations on additives like color and sweeteners. 

• Plain bread: No color or sweeteners allowed. 

• Fruit juices: May contain color additives but no sweeteners unless specified. 

• Other unflavored foodstuffs: No color or sweeteners allowed. 

• Other unprocessed foodstuffs: No color or sweeteners allowed. 

• Non-energy-reduced foodstuffs or non- sugar-reduced foodstuffs: No sweeteners are allowed 

Repeal of Previous Regulations: The new regulations repeal several earlier rules regarding colorants, sweeteners, antioxidants, and preservatives that were issued in previous government notices, such as R.733, R.1008 and R.1426. 

Public Consultation 

The Minister of Health has called for public input on the proposed regulations. Interested individuals and organizations are encouraged to submit any substantiated comments or representations to the Director-General of Health within three months of the date of publication of the Notice (i.e. 1 February 2025). 

Implementation Timeline 

• The regulations will come into force 12 months after publication. 

• Food items manufactured before the effective date are not subject to the new regulations. 

Conclusion  

In summary, South Africa’s new regulations aim to enhance food safety by setting strict standards for food additives, including preservatives, sweeteners and colorants. These regulations, which will come into effect in 2025, are in line with international guidelines and ensure the protection of public health. With specific rules for different food categories, such as infant foods and fruit juices, they offer clear guidelines for manufacturers. The public consultation process allows stakeholders to provide input to ensure that the regulations are well-informed and comprehensive. 

On 12 November 2024, Singapore’s National Environment Agency (NEA) announced regulatory updates for Dechlorane Plus and UV-328, in line with the Stockholm Convention on Persistent Organic Pollutants (POPs). The manufacture, import, and export of these substances, as well as products containing them will be prohibited from 26 February 2025, except for certain exempted uses. 

In a previous circular issued on 6 May 2024, the NEA informed stakeholders about the elimination of Dechlorane Plus, Methoxychlor and UV-328 under the Stockholm Convention. The circular outlined the phase-out schedule and urged stakeholders to prepare for the phase-out of these substances by the specified deadline.

Exemptions to Meet Critical Industry Needs

In recognition of industry feedback regarding the critical role of Dechlorane Plus and UV-328 in certain specific applications, the NEA has approved exemptions for applications in medical devices, aerospace, defence, motor vehicles and industrial machinery, among others. These exemptions which are detailed in Annex I of the update, will continue to be reviewed on a regular basis on the availability of viable alternatives, with stakeholder consultations taking place during the reviews. 

Trade Requirements for Controlled Substances

To ensure smooth implementation and compliance with the forthcoming regulations, the NEA has specified clear trade requirements for the import and export of Dechlorane Plus and UV-328. These measures are designed to enhance monitoring and facilitate proper reporting of controlled substances. The following applies:

- Specific Harmonized System (HS) and Product Codes listed in Annex II of the update must be used for all TradeNet® permit applications. 

- Permits will require approval from NEA’s Chemical Control and Management Department (CCMD). 

Additional Resources and Support

For detailed information on the management of hazardous substances in Singapore, please visit NEA’s hazardous substances page here. 

This regulatory update reflects Singapore’s commitment to international environmental standards while meeting the needs  of industry. 

New Zealand’s Environmental Protection Authority (EPA) has launched a full reassessment of chlorpyrifos (CAS No 2921-88-2), an organophosphate insecticide widely used by professionals to control pests on crops and plants. This reassessment comes after new data showed that the risks to human health and the environment in New Zealand outweigh the benefits of using chlorpyrifos. EPA is now proposing to revoke all approvals for chlorpyrifos, effectively banning its import, manufacture and use in the country.

Key Findings Supporting the Proposed Ban

1. Increased Human Health Risks:

   • Updated assessments show that the toxicological threshold for adverse effects is now 10 times lower than previously established.

   • Many uses of chlorpyrifos pose significant health risks to spray operators, workers in treated areas, and bystanders.

2. Environmental Concerns:

   • Chlorpyrifos poses severe risks to birds, bees, and aquatic ecosystems, making widespread use dangerous.

3. International Regulatory Trends:

   • Chlorpyrifos has been banned in Canada and the European Union. Australia has prohibited most uses, while the United States continues its review. These global actions reflect the declining acceptance of the chlorpyrifos in agriculture.

4. Diminished Practical Benefits:

   • With increasing international restrictions, the economic and practical benefits of chlorpyrifos are increasingly limited.

Public Consultation Open Until February 2025

EPA is seeking feedback on its proposal to ban chlorpyrifos. Comments will be accepted until 12 February 2025 (11:59 PM NZDT). Stakeholders are encouraged to submit quantitative data on risks, benefits, and potential costs of alternatives.

How to Submit Feedback:

• Online: Complete the secure submission form

• Email: Send submissions to reassessments@epa.govt.nz

• Mail: Environmental Protection Authority, Private Bag 63002, Wellington 6140

Next Steps in the Reassessment Process

After submission period closes, EPA will compile a decision-making report that incorporates public feedback. If requested, a public hearing will be organized before the EPA committee finalizes its decision. Updates and the final outcome will be published on the EPA website.

Potential Impacts of the Ban

If the ban is implemented:

• Chlorpyrifos will no longer be legally imported, manufactured or used in New Zealand.

• The decision aligns with the ongoing review of chlorpyrifos as a persistent organic pollutant (POP) under the Stockholm Convention, which could result in a global restriction.

On 15 November 2024, the Ukrainian Technical Regulation for the Classification of Hazards, Labeling and Packaging of Chemical Products, adopted in May 2024, will enter into force. Certain provisions, specifically Section 3 and clauses 130-133 of Section 6,  will enter into force on 1 January 2025.

Alignment with EU and UN Standards

With this regulation, Ukraine integrates the standards of the EU Regulation 1272/2008 on Classification, Labelling and Packaging of Chemicals and Mixtures (CLP Regulation), which incorporates the UN Globally Harmonized System (GHS) for Classification and Labeling of Chemicals.

The Technical Regulation establishes the procedure for the submission of hazard  classification data and hazard information by companies, and establishes the procedure for the approval of national hazard classifications and hazard information.

New Classification, Labeling and Packaging Requirements

The Technical Regulation in Ukraine introduces:

• European rules and criteria for the hazard classification of chemical substances and products – according to 33 hazard classes.

• Requirements for labeling and packaging  of chemical products.

Market Obligations for Compliance

This regulation increases the responsibility of market participants. Before placing chemical products on the market, manufacturers, importers, suppliers and other operators must gather all available information on the hazardous properties, assess the validity of this information and classify the chemical according to the technical regulation.

In addition, companies must ensure that:

• The chemical products they produce, import or place on the Ukrainian market are classified for hazard according to the criteria of the Globally Harmonized System (GHS).

• Such chemical products are appropriately packaged and labelled with hazard information.

Access to the Full Text

The full text of the Regulation, including Annex VIII which compares the provisions of the EU CLP Regulation and the Ukrainian Technical Regulation, is available here in Ukrainian.