GPC Newsletter Jun-2024

On 11 May 2024, the Canadian Department of Environment published a notice proposing amendments to the Domestic Substance List (DSL) and introducing significant new activity (SNAC) notification requirements for certain consumer and cosmetic uses of piperazine.

Amendments to be considered following the implementation of the draft:

• Significant New Activity Notification (SNAN): The Order amending the DSL proposes that individuals or corporations undertaking significant new activities with a substance must submit a Significant New Activity Notification (SNAN) at least 90 days before the activity begins.
• Human Health Concerns: The Order aims to address human health concerns by targeting the use of the substance in consumer products and cosmetics, as these are potential sources of direct exposure.
• Notification Requirements: SNAC notification is required for the use of piperazine in the manufacture of consumer products and cosmetics if the concentration of the substance is equal to or greater than 0.1% by weight, and for the import of the substance in consumer products if the total quantity is greater than 10 kg per year.
• Exemptions: An activity is not a SNAC if the substance is a R&D substance, a site-limited intermediate or if the substance or the product containing the substance is only intended for export.

Assessment report

Along with the notice the Department of Environment and the Department of Health have published the piperazine assessment study, which concludes that piperazine has a low risk of environmental impact.

Piperazine does not meet the criteria outlined in paragraphs 64(a) and (b) of CEPA because it does not enter the environment in a quantity or concentrations or under conditions, that have or may have an immediate or long-term harmful effect on the environment or its biological diversity, or that constitute or may constitute a danger to the environment on which life depends.

Comment deadline

The draft Notice draft is open for public comment for the next 60 days, until 10 July 2024.

On April 30, 2024, the U.S. Environmental Protection Agency (EPA) implemented a ban on most uses of methylene chloride, a hazardous substance linked to several cancers, neurotoxicity, liver damage, and even death. This action, taken under the Toxic Substances Control Act (TSCA), aims to protect public health while permitting essential uses by enhancing worker protection measures.

Methylene Chloride:

Methylene chloride is widely used by consumers for products such as aerosol degreasing and paint and coating brush cleaners, as well as in commercial and industrial applications, including the production of environmentally friendly refrigerants. Despite an EPA ban on one consumer use in 2019, methylene chloride remains prevalent and has led to numerous deaths, particularly among workers in the paint stripping and refinishing industries, even when equipped with protective gear.

EPA’s Final Rule:

EPA's final risk management rule mandates a swift reduction in the production, processing, and distribution of methylene chloride for consumer, industrial, and commercial uses, including its use in home renovations. Consumer uses will be phased out within one year, while most industrial and commercial uses will be banned within two years. Additionally, the rule establishes comprehensive worker protections through a Workplace Chemical Protection Program that ensures strict exposure limits, monitoring, and training to protect against health hazards such as cancer from exposure to methylene chloride.

The uses that will continue under the Workplace Chemical Protection Program are highly industrialized and important to national security and the economy. These activities, backed by data and evidence, demonstrate that workplace safety measures can effectively mitigate any unreasonable risks. They include:

1. Use in the production of other chemicals, including refrigerant chemicals that are important in efforts to phase down climate-damaging hydrofluorocarbons under the bipartisan American Innovation and Manufacturing Act.
2. Production of battery separators for electric vehicles.
3. Use as a processing aid in a closed system.
4. Use as a laboratory chemical.
5. Use in plastic and rubber manufacturing, including polycarbonate production.
6. Use in solvent welding.

In highly specialized settings such as those mandated by the National Aeronautics and Space Administration (NASA), the Department of Defense, and the Federal Aviation Administration, strict workplace controls will continue for specific applications of methylene chloride.

Under the Workplace Chemical Protection Program, workplaces that continue to use methylene chloride will have 18 months after the risk management rule is finalized to align with the program's guidelines. They will need to conduct regular monitoring of their premises to guarantee that workers aren't exposed to levels of methylene chloride that pose unreasonable risks.

For more information, please refer to the Risk Management for Methylene Chloride page.

The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has announced a final rule to update the Hazard Communication Standard (HCS). This update aligns the HCS primarily with the seventh revised edit of the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS 7). Published on May 20, 2024, the rule will take effect on July 19, 2024.

This final rule aims to address issues that have arisen since the implementation of the 2012 standard, as well as improve alignment with other federal agencies and Canada.

History:

The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) has been adopted worldwide to standardize the handling and labeling of hazardous chemicals. In 2012, the Occupational Safety and Health Administration (OSHA) revised its Hazard Communication Standard (HCS), 29 CFR 1910.1200, to align with the third revision of the GHS (GHS 3) (77 FR 17574). The GHS is updated every two years to incorporate improvements and clarifications. Since OSHA adopted GHS 3, there have been seven updates, the most recent being Revision 10, published in 2023. The current rulemaking primarily aligns the HCS with GHS 7, which waspublished in 2017.

Established in 1983, the HCS aims to standardize the communication of workplace hazards associated with hazardous chemicals. It mandates chemical manufacturers and importers to classify the hazards of the chemicals they produce or import. The latest amendments do not alter the basic structure of the HCS.

OSHA has determined that these updates will improve the effectiveness of the HCS, ensuring that employees are better informed about the chemical hazards they may encounter. This, in turn, is expected to reduce the incidence of chemical-related occupational illnesses and injuries. The revisions include updated criteria for classifying certain health and physical hazards, new provisions for updating labels and labeling small containers, changes related to trade secrets, technical amendments concerning the contents of safety data sheets (SDSs), and updates to definitions used in the standard.

Major changes to the Hazard Communication Standard:

• Hazard Classification: Provides specific criteria for classifying health and physical hazards and classifying of mixtures.

• Labeling: Chemical manufacturers and importers must now include a harmonized signal word, pictogram and hazard statement for each hazard class and category on their labels. Precautionary statements are also mandatory. Additionally, labels on shipped containers must display the date the chemical is released for shipment. There are new, detailed labeling requirements for small containers, specifically those with a capacity of 100 ml or less.

• Safety Data Sheets: The format for Safety Data Sheets (SDS) is now standardized to a specified 16-section layout.

• Information and Training: Employers are required to train their workers on the new label elements andupdated Safety Data Sheets format to facilitate recognition and understanding.

• Trade Secrets: When claiming a specific concentration of a substance as a trade secret, prescribed concentration ranges must now be used, adding a layer of transparency and safety.

Manufacturers, importers and distributors must comply with the new requirements by January 19, 2026, for substances and by July 19, 2027, for mixtures. Employers have until July 20, 2026, for substances and January 19, 2028, for mixtures tocomply with the new standards.

Please see the Federal Register Notice for more information.

On May 16, 2024, following an announcement in January 2024, the U.S. Environmental Protection Agency (EPA) issued a final rule to update the chemicals listed in the Toxics Release Inventory (TRI) to include seven new per- and polyfluoroalkyl substances (PFAS) for the 2024 reporting year. 

Background on the Toxics Release Inventory 

The Environmental Protection Agency (EPA) collects annual data on TRI-listed chemicals from facilities in designated industries and federal facilities that manufacture, process, or use these chemicals above certain thresholds. This data helps communities understand how these facilities handle these chemicals; facilitates informed decision-making for companies, government agencies, and the public; and aligns with the Administration's commitment to environmental justice by increasing accountability, transparency, and the well-being of families, workers, and communities. The data collected is easily accessible online. 

Mandate for PFAS Inclusion 

The Fiscal Year 2020 National Defense Authorization Act (NDAA) mandated the inclusion of seven PFAS into the Toxics Release Inventory (TRI). The latest rule includes reporting guidelines for these seven PFAS in the Code of Federal Regulations, increasing the total count of PFAS under TRI reporting to 196. The seven newly added PFAS, along with the previous 189 PFAS listed in the TRI, are affected by EPA’s decision in October 2023 to classify all PFAS under TRI reporting as chemicals of special concern. This designation eliminates the reporting exemption that previously allowed facilities to avoid reporting information on PFAS when used in small concentrations. This move demonstrates EPA's commitment to mitigating the effects of persistent chemicals and is consistent with its PFAS Strategic Roadmap, which aims to address the serious risks these chemicals pose to both human health and the environment. 

Addition of PFAS with final toxicity values 

The 2020 NDAA contains a provision requiring the automatic inclusion of PFAS to TRI once the Agency establishes a toxicity value. Six PFAS were added to the list for the 2024 Reporting Year after EPA finalized a toxicity value in 2023. Only the specified salt forms of the acids are included in this list. 

• Ammonium perfluorohexanoate; Chemical Abstracts Service Registration Number (CASRN) 21615-47-4 

• Lithium bis[(trifluoromethyl)sulfonyl] azanide; CASRN 90076-65-6 

• Perfluorohexanoic acid (PFHxA); CASRN 307-24-4 

• Perfluoropropanoic acid (PFPrA); CASRN 422-64-0 

• Sodium perfluorohexanoate; CASRN 2923-26-4 

• 1,1,1-Trifluoro-N-[(trifluoromethyl)sulfonyl] methanesulfonamide; CASRN 82113-65-3 

Removal of Confidentiality Claims 

EPA is no longer treating PFAS as confidential business information (CBI) under NDAA section 7321(e). EPA must assess CBI claims before incorporating a PFAS chemical in the Toxic Release Inventory (TRI). Betaines, dimethyl(γ-ω-perfluoro-γ-hydro-C8-18-alkyl); CASRN 2816091-53-7, was previously identified for inclusion but was not included due to CBI claims. In February 2023, the identity of the chemical was declassified and is no longer confidential. As a result, it has now been added to the TRI. 

Reporting Deadline and Compliance 

Starting January 1, 2024, facilities must report on the seven PFAS chemicals added to the TRI, under Section 313 of the Emergency Planning and Community Right-to-Know Act and submit reporting forms by July 1, 2025. 

In an effort to strengthen environmental and public health protection, the European Commission has requested the European Chemicals Agency (ECHA) to expand the scope of the REACH restriction proposal for chromium (VI) substances. The mandate, received by ECHA on 29 April 2024, now covers a wider range of chromium (VI) substances in order to reduce the potential risks associated with their use.

Previous Mandate

Previously, the Commission's request in September 2023 focused on initiating restrictions on chromium trioxide and chromic acids (entries 16 and 17 in the REACH Authorisation List). However, recognising the possibility of "regrettable substitution" with other chromium (VI) substances not subject to restrictions, the Commission has now expanded the mandate.

Inclusion of Additional Chromium (VI) Substances

The updated mandate now includes the chromium (VI) substances specified in entries 16 to 22 and 28 to 31 of the REACH Authorisation List. In addition, ECHA is mandated to  consider other chromium (VI) substances, such as barium chromate, which could pose risks if used as substitutes.

To support the preparation of the proposal, ECHA will launch a second call for evidence in June, focusing on alternatives to chromium (VI) substances and their different applications. Stakeholder input from the first call for evidence will be taken into account.

Extended Timeline and Regulatory Commitment

Due to the expanded scope, ECHA will submit the restriction proposal by 11 April 2025 instead of the previously planned date of 4 October 2024. The preparation and evaluation of the proposal will follow to the standard REACH restrictions process. including evaluation by the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC).

The Commission's decision reflects its commitment to stringent regulatory measures to protect human health and the environment from the harmful effects of chromium (VI) substances.

On 17 May 2024, the European Commission published Regulation (EU) 2024/1328, which significantly amends Annex XVII (the list of restricted substances) of the REACH Regulation. This new regulation imposes restrictions on the use and placing on the market of octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) due to their recognised harmful effects on the environment.

The regulation targets the presence of the three substances in various consumer and professional products, including leave-on cosmetic products, medical devices, and dry cleaning solvents, which contribute to the release of these hazardous substances into the environment.

D4, D5 and D6 Classification

The European Chemicals Agency (ECHA) classifies D4, D5 and D6 as Substances of Very High Concern (SVHC) due to their very persistent and very bioaccumulative (vPvB) properties. D4 has also been identified as persistent, bioaccumulative and toxic (PBT). In addition, D5 and D6 are classified as PBT if they contain 0.1 % or more by weight of D4.

Phased Implementation and Specific Exemptions

The restriction will apply from 6 June 2026 and will prohibit the use or placing on the market of D4, D5 and D6 as substances on their own, as constituents of other substances or in mixtures in a concentration equal to or greater than 0.1% by weight of the respective substance. 

However, the Regulation provides for a phased approach to the restrictions, with different deferral periods for certain uses to give industry time to adapt. For example, the use of these substances in leave-on cosmetic products will be prohibited from 6 June 2027, while medical devices and veterinary products will be deferred until 6 June 2031. The regulation also includes exemptions for certain professional uses, such as the cleaning or restoration of art and antiques, and for products such silicone insoles for horses and high-performance 3D printing applications. These exemptions are carefully defined to balance environmental protection with practical industrial needs.

The use of D4 and D5 in wash-off cosmetic products have already been restricted since 31 January 2020.

Full details of the restrictions can be found in Regulation 2024/1328 here.

Aiming for Environmental Protection

ECHA and its Committees have made extensive assessments and recommendations to ensure that the proposed restrictions effectively minimise the environmental risks associated with D4, D5 and D6. The Regulation emphasises that controlling the emissions of these substances is essential to reduce their long-term impact on both aquatic and atmospheric compartments. By implementing these measures, the European Commission aims to achieve a higher level of environmental protection, reflecting a commitment to the sustainable and safe use of chemicals within the EU.

The UK Department for Environment, Food and Rural Affairs (DEFRA) published a consultation on 6 May 2024 on proposals to amend the current transitional provisions under UK REACH by introducing an Alternative Transitional Registration model (ATRm). This initiative aims to reduce costs for companies transitioning from the EU REACH system to the UK REACH system, while maintaining existing protections for human health and the environment. The consultation will run for 8 weeks and will close on 11 July 2024.

Proposals for the Alternative Transitional Registration Model

DEFRA, in collaboration with the Health and Safety Executive (HSE) and the Environment Agency (EA), has developed the Alternative Transitional Registration model (ATRm) for UK REACH. This model aims to maintain current health and environmental protections by improving the quality of information on substance use and exposure in Great Britain. The ATRm aims to reduce business costs through a number of specific measures as follows:

Hazard requirements:

• Significantly reduce the hazard information required in registrations for transitional substances.

• Apply these revised hazard requirements to substances on the market before the end of the Exit Implementation Period.

• Maintain full hazard information requirements for new substances placed on the market after this date.

Use and exposure information:

• Improve the level of detail required on the use and exposure of substances in Great Britain.

Chemical Safety Reports:

• Propose reduced hazard requirements in Chemical Safety Reports (CSRs) for substances manufactured or imported in quantities above 10 tonnes per year.

Transitional evaluations:

• Allow the regulatory agency (HSE) to request and receive data from registrants for regulatory or risk prioritization purposes to respond to new or emerging risks.

Compliance checks:

• Conduct compliance checks on at least 20% of registrations.

• Focus on specific uses, exposures or other parameters to ensure compliance with hazard and new use and exposure information requirements.

Publication of data:

• Review and revise the “hazard data” included in the Public Register for substances under the ATRm.

Substance groups, data sharing, and joint data submission:

• Organize registrants of the same substance into Substance Groups for data sharing and joint submission of intrinsic properties, including hazard classifications.

• Formalize practical arrangements already in place under the EU-REACH registration process.

Stakeholder feedback on these detailed proposals is being sought in order to refine and implement these changes effectively. Further details of the ATRm policy proposals and the corresponding consultation questions can be found in the consultation document.

Improving UK-REACH restriction and reporting processes and protection against animal testing

In addition to the ATRm, the consultation also addresses potential improvements to the UK-REACH restriction and reporting processes. Proposals include streamlining the statutory consultation requirements to speed up decision-making and reducing the administrative burden on the regulatory agency. Specific measures are also proposed to further protect against unnecessary animal testing, either through legislation or supporting guidance. These measures will reinforce the principle of animal testing as a last resort, ensuring that such tests are only used when absolutely necessary.

Consultation and Legislative Process

This consultation provides an opportunity for stakeholders to express their views on significant policy changes. The feedback will be used to develop the legislative changes needed to implement these proposals. This initial consultation, will be followed by a second round, supported by a Statutory Instrument and a comprehensive impact assessment. This process is part of a wider effort to ensure that UK-REACH remains effective and aligned with the objectives set out in the Environment Act 2021. Before or alongside the second consultation, the Government will publish an explanation of why the proposed regulations are consistent with Article 1 of UK REACH, ensuring transparency and alignment with legislative standards.

Background and context

Since leaving the EU, the UK has established its own independent chemicals management system, including UK-REACH. This system retains the basic approach and key principles of the EU-REACH Regulation and aims to ensure a high level of protection for human health and the environment. Companies have been given a transitional period to submit their data to the HSE, but the high cost of purchasing or accessing EU hazard data has raised concerns about the potential impact on the availability of substances on the Great Britain market. The Government’s proposals, including the ATRm, aim to address these issues by reducing costs and maintaining regulatory protection.

More information is available in the consultation document: UK REACH Consultation 2024.

On 1 May 2024, the UK Department for Environment, Food and Rural Affairs (DEFRA) notified the World Trade Organization (WTO) of the draft Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024, which aims to improve recycling and waste reduction efforts in the UK. Stakeholders and interested parties are invited to submit comments on the draft regulations within 60 days of the date of notification.

Some Background

The regulations heave been developed following extensive consultations, which took place in May 2019, March 2021, and July 2023. These consultations incorporated feedback from a range of stakeholders and focused on reforming the UK's packaging producer responsibility system and aligning it with wider environmental objectives.

Objectives

The UK Government's primary objective is to protect the environment by encouraging better use of resources and reducing waste. The introduction of a single, widely recognised recycling label, will make it easier for consumers to recycle correctly, ultimately supporting the country's environmental objectives.

Scope and Requirements

The new regulations will require businesses to label packaging with either "Recycle" or "Do Not Recycle" next to a specified logo. This requirement will apply to certain categories of businesses, including importers and manufacturers of packaged products in the UK. The intention is to provide clear and consistent recycling information to consumers, thereby improving recycling rates and reducing environmental impact.

• Products covered: The Regulation covers a wide range of packaging materials including plastics, paper, glass, textiles, ceramics, and metals.

• Primary and shipment packaging: The labelling requirement applies to both primary packaging (packaging that constitutes a sales unit to consumers) and shipment packaging (additional packaging used for online and mail order sales).

• Recyclability information: Manufacturers and importers of unfilled packaging for supply to another business must inform the businesses about the recyclability of their packaging to ensure accurate labelling.

Implementation Timeline

The adoption date for this regulation is set for 1 January 2025. The regulation will come into force on 1 April 2027. However, businesses will have the option to comply earlier if they wish. This phased timeline is designed to give businesses sufficient time to adapt to the new requirements and ensure a smooth transition.

The Bureau of Indian Standards is seeking comments until 24 June on the second revision of the standard for magnesium sulphate, commonly known as Epsom salts (Second Revision of IS 2730).  

First standard for Epsom salts 

This standard was first published in 1964 and subsequently revised in 1977. Initially, two Indian Standard specifications were published for magnesium sulphate, IS 257 focusing on technical grade and IS 377 on pharmaceutical grade. These specifications were subsequently merged into IS 2730. 

 In the first revision, changes were made to the magnesium sulphate content limit and the chloride and iron were limits for the technical grade of the material for use in the leather industry. Furthermore, the criteria for pharmaceutical grade were deleted. 

Changes in the second revision of the standard 

• The revised standard proposes that there are two grades of material: pure and technical. 

• The pure grade of the material is used in cosmetics, mineral water, explosives and silk weighting. The technical grade of the material is used in the textile and leather industries where it is used as a tan precipitant for the purpose of fixing tan. It is also used as a micronutrient in fertilizers to meet magnesium deficiency in plants. 

• The material shall be in the form of colourless crystals, soluble in water and sparingly soluble in ethyl alcohol (90 percent v/v). 

• The crystals are liable to become powdery on efflorescence and, unless otherwise agreed to between the purchaser and the supplier, this condition shall not render the material unacceptable. 

• The material shall be packed in airtight containers as agreed between the purchaser and the supplier. The containers used for packing the pure grade shall be lined with polyethylene. 

Additional requirements for Epsom salts are given in the table below. 

Further details of the requirements, methods, marking and sampling and BIS certification marking can be found here: WCCHD17025380_24042024_2.pdf (bis.gov.in) 

On May 15, 2024, the Directorate General of Health Services under the Ministry of Health and Family Welfare in India issued a new circular for medical devices through the Central Drugs Standard Control Organization. 

The circular states that all medical devices, including in vitro diagnostic medical devices, will now be regulated under the Drugs and Cosmetics Act of 1940 and the Medical Devices Rules of 2017. A license/approval is required for the import/manufacture and marketing of devices in India. 

Ensuring Quality and Safety 

Licenses are issued under the aforementioned rules, subject to certain restrictions, to ensure the quality, safety and performance of medical devices on the market, as well as compliance with the Quality Management System. It is also essential that all medical device license holders have strong systems and processes in place for the timely identification, documentation, and reporting of adverse events related to medical devices.  

Importance of Post-Market Surveillance 

Post-market surveillance (PMS) of medical devices is a critical part of ensuring their safety and performance. PMS helps to identify and resolve any potential risks or adverse events associated with the medical device.  

Timely reporting of adverse events enables the identification of unrecognized dangers, analysis of the frequency of previously identified risks, and the implementation of necessary actions by manufacturers and regulatory agencies to mitigate these risks and protect public health. 

Materiovigilance Programme of India 

The Materiovigilance Programme of India (MvPI), initiated by the Ministry of Health and Family Welfare, aims to improve patient safety in India by monitoring, recording and analyzing the root causes of adverse events or risks associated with the use of medical devices. This includes in vitro diagnosis by healthcare professionals or patients/users and providing appropriate resources to regulatory authorities with the sole purpose of improving patient safety.  

The Indian Pharmacopoeia Commission (IPC) has been appointed as the National Coordinating Center (MvPI) for the Material Monitoring Programme of India. In addition to healthcare professionals/public/users/patients, one of the most important stakeholders in MvPI is the medical device industry, and their participation needs to be encouraged to have a significant impact on the outcome. 

As MVPI is an important program for adverse event reporting and coordinated analysis of medical devices, including in vitro diagnostic devices, it is proposed that all licensees use the MVPI platform to also report potential adverse events/serious events. Device-related adverse events to improve processes for identifying risks associated with medical devices. 

Reporting of Adverse Events 

In view of the above, stakeholders are urged to promptly report any adverse events related to medical devices to the MvPI. Guidance documents to facilitate the effective use of MvPI resources are available on the website of the Indian Pharmacopoeia Commission (IPC) (https://www.ipc.gov.in), to help streamline reporting processes and ensure the continued safety and efficacy of medical devices in India. 

On 19 April 2024, China’s Centre for Drug Re-evaluation (NMPA) and the National Centre for Adverse Drug Reaction Monitoring issued final guidelines on the collection and reporting of adverse reactions to cosmetics for registrants and filers.  

The guidelines provide guidance on how to go through each step of the procedure, which includes the following:

• Collection of adverse reactions to cosmetics.

• Recording and communication of adverse reactions to cosmetics.

• Confirmation of cosmetic adverse reaction reports.

• Analysis and evaluation of adverse reactions of cosmetics.

• Submission of Cosmetic Adverse Reaction Reports.

• Quality control of Cosmetic Adverse Reaction Reports

• Cosmetic adverse reaction record management.

Categorization and Reporting Procedures

Reactions are categorized into 3 groups according to how severe they are as follows:

• General cosmetic adverse reactions

• Serious cosmetic adverse reactions

• Cosmetic adverse reactions that may cause greater social impact.

Registrants and recorders must report cosmetic adverse reactions within a specified time frame, starting from the first discovery of the reaction, which is recorded as Day 0. General adverse reactions should be reported within 30 days, serious reactions within 15 days, and reactions with social impact within 3 days.

Record-Keeping and Administration

Monitoring records should as a minimum include reporter information, information about adverse reactions, symptoms or signs, the severity of the adverse reaction, date of occurrence of adverse reactions, date of discovery or knowledge of the adverse reaction, date of reporting of the adverse reaction, name of the cosmetics used, etc.

Records, whether paper or electronic, should be kept properly to prevent loss or damage, be clear, legible, and easy to understand and have  a retention period of at least three years.

South Korea’s Ministry of Environment (MoE) has announced a reorganization that will take effect from April 30, 2024, transferring certain functions from the National Institute of Environmental Research (NIER) to the National Institute of Chemical Safety (NICS). The move, which was approved on April 23, 2024, aims to streamline chemical management by consolidating tasks under the Chemical Substances Control Act, the Act on Registration and Evaluation of Chemical Substances, and the Chemical Products Safety Act.

Streamlining Chemical Management

The NICS will be expanded to include more teams to manage hazardous substances and evaluate chemical registrations. This restructuring will address previous limitations in integrated management and policy support under the three chemical laws.

The National Institute of Chemical Safety will now oversee the entire lifecycle of chemical safety management, from registration to production and use. Meanwhile, the NIER will focus on strengthening its research capabilities in risk assessment and developing alternative testing methods.

Until now, companies have had to navigate separate processes for chemical registration and accident prevention plans. The unification of these functions is expected to simplify procedures for companies and improve the efficiency of chemical safety management and facility handling.

Integration for Improved Safety

Furthermore, the integration of information systems under the three chemical laws will enable the use of big data for personalized stakeholder information and improve the designation and management of hazardous chemicals and facilities. This reorganization promises a more cohesive approach to chemical safety in South Korea.

On March 28, 2024, the South Korean Ministry of Employment and Labor (MOEL) announced the names of 71 new chemical substances, their hazards and risks, annual production and import volumes, and measures to be taken under Article 108(3) of the Occupational Safety and Health Act and Article 153 of the Enforcement Rules of the same Act.

Hazards and Risk Assessment

The hazards and risks associated with these 71 chemical substances are determined on the basis of toxicity data submitted by employers. Classification is based on the "Standards for Classification, Labeling, and Material Safety Data Sheets of Chemicals" (Ministry of Employment and Labor Notification No. 2023-9), using both domestic and foreign chemical information databases.

Continuous Risk Evaluation

New hazard/risk information may be identified through additional studies, such as toxicity tests.

Worker Protection Measures

The announcement provides basic measures that employers should take in case of short- and long-term exposure of workers handling new chemicals, even if specific hazards are not listed in the hazard and risk information section.

In a significant step to improve public health and safety, the Therapeutic Goods Administration (TGA) has announced the adoption of the new Australian/New Zealand Sunscreen Standard: AS/NZS 2604:2021 on 11 April 2024. This update aims to align sunscreen regulations in both countries, ensuring higher standards of safety and efficacy for consumers.

Key Highlights of the Proposed Sunscreen Standard AS/NZS 2604:2021

The proposed standard introduces several key changes:

1. Improved UV Protection: The new standard emphasizes improved protection against both UVA and UVB radiation. This change is designed to provide better protection against skin cancer and premature ageing caused by sun exposure.

2. Stricter Testing Requirements: Sunscreen products will undergo more rigorous testing to verify their efficacy and safety. This includes mandatory broad spectrum testing to ensure comprehensive UV protection.

3. Updated Labelling Guidelines: The new standard requires  clearer and more informative labelling. Consumers will benefit from easy-to-understand information on the level of protection offered, water resistance and proper use instructions.

4. Regulatory Harmonization: By adopting AS/NZS 2604:2021, Australia and New Zealand aim to streamline sunscreen regulations to facilitate smoother cross-border trade and reduce confusion for manufacturers and consumers.

Public Health Benefits

The adoption of this updated standard is expected to bring significant public health benefits. The stricter regulations will ensure that only high quality sunscreen products are available on the market, increasing consumer trust and promoting better skin health. Improved UV protection and clearer labelling will help consumers make more informed choices, ultimately reducing the incidence of skin cancer and other UV-related health problems.

Industry Implications

For manufacturers, the new standard presents both a challenge and an opportunity. While the increased requirements may require adjustments to formulation and testing processes, they also offer a chance to demonstrate a commitment to quality and safety. Compliance with AS/NZS 2604:2021 is likely to become a mark of excellence in the sunscreen industry, distinguishing high quality products in a competitive market.

Transitional Arrangements

The following transitional arrangements will apply:

• From 1 July 2024, all new sunscreen products registered on the Australian Register of Therapeutic Goods (ARTG) must comply with the 2021 Sunscreen Standard.

• Existing aerosols and spray pump packs listed on the ARTG before 1 July 2024 will be given a 1-year transition period to comply with the updated labelling requirements of the 2021 Sunscreen Standard.

• All sunscreen products (both aerosols and non-aerosols) already listed in the ARTG before 1 July 2024 will have a 5-year transition period during which they may comply with the testing requirements of either the 2021 Sunscreen Standard or the previous standard (2604:2012).

After the transition period, all existing sunscreen products listed on the ARTG, and all new products released for supply must comply with the 2021 Sunscreen Standard.

Conclusion

The adoption of the new Australian/New Zealand Sunscreen Standard: AS/NZS 2604:2021 is a significant step forward for public health and safety. By setting higher standards for sunscreen efficacy and safety, Australia and New Zealand are leading the way in protecting their populations from the harmful effects of sun exposure.

On March 27, 2024, the Vietnamese Ministry of Industry and Trade (MoIT) released Decree 33/2024/ND-CP implementing the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction. This new Decree which entered into force on May 19, 2024, replaces the previous Decree 38/2014/ND-CP. 

Scope and Application 

The Decree applies to entities and individuals involved in or associated with the implementation of the Chemical Weapons Convention (CWC) within the territory of the Socialist Republic of Vietnam. 

Implementation Requirements: The CWC must be implemented in accordance with this Decree and other relevant legal provisions.  

Prohibited and Permitted Activities: Prohibited behaviors and non-prohibited goals must be in accordance with Clause 1, Article 1 and Clause 9, Article 2 of the CWC. 

Key Definitions in the Decree 

"Schedule Chemicals" means toxic chemicals and precursors that are controlled under the CWC and are classified as Category 1, 2, 3 chemicals in accordance with the criteria of the Chemical Annex of the CWC. Schedule chemicals include listed chemicals and mixtures containing listed chemicals. 

A "Discrete Organic Chemical" (DOC) is defined in the CWC as any carbon compound, other than oxides, sulfides, and metal carbonates. These compounds are identifiable by their chemical name, structural formula (if known), and Chemical Abstracts Service (CAS) registry number (if assigned). A "DOC-PSF chemical" is a DOC containing one or more of the elements phosphorus, sulfur, or fluorine. 

“Storage" of a Schedule Chemical as defined in the CWC, means the storage, preservation of unused or undiminished Schedule Chemicals in special storage facilities, tanks and containers at a chemical facility. 

A "Chemical Facility" is a place where chemicals governed by the CWC are produced, processed, consumed, and stored. A Chemical Facility may consist of one or more factories or stand-alone production lines.  

Chemical Facilities are classified as follows: DOC, DOC-PSF chemical facilities; Schedule 1, Schedule 2, and Schedule 3 facilities. 

Classification of Chemical Facilities 

• Schedule 1 Facilities: Capable of producing, processing, consuming, or storing substances classified as Schedule 1. These facilities are further subdivided into various facilities and individual small-scale facilities. 

• Schedule 2 Facilities: Support activities using Schedule 2 chemicals in their manufacturing, processing, or consumption. 

• Schedule 3 Facilities: Capable of producing chemicals under Schedule 3. 

• DOC and DOC-PSF Facilities: Allow for the manufacture of DOC and DOC-PSF compounds. 

Main Revision to the Decree   

These are the main changes to the Decree:  

• The definition of schedule chemicals has been clarified. 

• Schedule chemicals subject to the Decree have been added or removed. 

• Provisions on the production of chemicals regulated under the Chemical Weapons Convention have been amended. 

• New provisions on exemptions from obtaining trade licences and import/export permits based on concentration thresholds have been introduced. Import and export licenses for Schedule 2 and Schedule 3 chemicals are exempted if the content of these chemicals is below 1%. 

• New provisions on the processing and use of regulated chemicals have been introduced. 

• Deadlines for the submission of various reports have been harmonized. Regulations concerning reports on Schedule Chemicals, DOC, DOC-PSF chemicals under Point c Clause 2 of Articles 23, 24, 25, and 26 hereof submitted via National Chemical Database will enter into force on February 15, 2025. 

The Council of the Organization for Economic Co-operation and Development (OECD) decided on February 20, 2024, to open accession talks with Indonesia, recognising the country's progress toward meeting the requirements outlined in the Framework for Consideration of Prospective Members [C(2023)176/FINAL], as well as the criteria of like-mindedness, significant player, mutual benefit, and global considerations. 

Accession Talks Begin 

OECD Secretary- General Mathias Cormann formally presented the OECD Accession Roadmap to Indonesia's Coordinating Minister for Economic Affairs, Mr. Airlangga Hartarto, during a brief ceremony at the opening session of the OECD Ministerial Conference. Both emphasized the historic nature of the OECD's accession talks with Indonesia are, given that Indonesia is the first country in South-East Asia to make such a request. 

Accession Roadmaps and Membership Commitments 

The OECD member countries have designated priority areas for accession to the Organization, and these areas are reflected in the Accession Roadmaps, which outline the conditions, and approval procedure. As part of the subsequent accession process, Indonesia's compliance with OECD standards, rules, and practices will be subject to a thorough and meticulous assessment by 26 technical committees. One such committees is the Chemicals and Biotechnology Committee, which oversees the OECD’s work on chemical safety and biosafety. The Committee helps countries work on cost-effective ways to protect human health and the environment from chemical risks. 

The Importance of Chemical Safety 

Chemicals are an essential part of human life. They are found in many items we use on a daily basis, such as sunscreen, computers, insect repellents, and insulating materials that increase energy efficiency. While chemicals have advantages, they can also harm the environment and public health. Governments must therefore have an important role to play in ensuring the safe production and use of chemicals, and in requiring chemical companies to carry out a range of tests prior to allowing chemicals onto the market. Testing chemicals is necessary, but it can be time- and resource -consuming. 

Benefits of the OECD MAD System 

The OECD's Mutual Acceptance of Data (MAD) system, guidelines for chemical testing, and other tools have increased savings for society. Countries can minimize redundant testing and remove non-tariff barriers to trade by working together on common substances. This ensures the development of chemicals that are safer for humans and the environment, as well as more effective and sustainable.  

Objectives and Obligations 

The main objective of the accession process is to bring Indonesia closer to OECD best practices, policies, and standards. This will benefit Indonesia and its people as well as OECD members. The OECD and Indonesia will work closely together throughout the accession process to facilitate the implementation of long-term reforms that will bring Indonesia line with OECD best practices, best policies, and standards. 

In joining the OECD, Indonesia will commit to: 

1. Accept the goals and objectives of the Organization as set out in the Convention. 

2. Comply with the OECD Convention and fulfil all obligations and commitments contained therein. 

3. Adopt additional protocols to the OECD Convention. 

4. Approve decisions, resolutions, rules and regulations previously adopted by the organization. 

5. Approve the financial statements and working methods of the Organization. 

6. Ratify all relevant legal documents of the Organization. 

7. Sign a privileges and immunities agreement to ensure the independence and proper functioning of the Organization. 

Conclusion 

There is no deadline for completing the accession procedures. The final result and schedule will dend upon how quickly each candidate country makes the necessary modifications to bring itself even closer to the Organization's best practices and standards. To issue an invitation for membership, the member countries of the OECD Council must reach a final, unanimous decision after all the technical committees have completed their reviews.

On December 2, 2023, the Peruvian government published Supreme Decree No. 031-2023-SA, approving the "Regulation for the Regulation and Oversight of Hazardous Substances for Domestic, Industrial, and Public Health Use." According to its final complementary provision this regulation will come into force on June 1, 2024,  six months after its publication in the Official Gazette "El Peruano."

Key Aspects of the New Regulation

The new regulation introduces strict requirements for the authorization of disinfectants and pesticides used in domestic, industrial and public health settings. Additionally, it covers industrial chemicals and substances subject to the Prior Informed Consent (PIC) procedure.

The implementation of this regulation is a significant step in improving public safety and environmental protection in Peru. By establishing clear guidelines and oversight mechanisms, the government aims to ensure that hazardous substances are handled, used, and disposed of in a manner that minimizes risks to health and the environment.

Key aspects of the regulation include:

1. Authorization Requirements: All products classified as disinfectants and pesticides for domestic, industrial or public health use must obtain proper authorization. This ensures that only products that meet safety and efficacy standards are available on the market.

2. Industrial Chemicals: The Regulation also applies to chemicals used in industrial processes, ensuring that these substances are managed safely to prevent harm to workers, communities, and the environment.

3. PIC Procedure: For certain hazardous chemicals, the Regulation enforces the Prior Informed Consent (PIC) procedure. This international mechanism ensures that countries are informed about the import and export of hazardous chemicals and can consent or deny their entry, thus preventing unwanted and potentially harmful substances from entering the country.

Preparing for Compliance

As the June 1, 2024, implementation date approaches, companies and stakeholders involved in the production, distribution and use of these substances are advised to familiarize themselves with the new requirements and ensure compliance. The Peruvian government is expected to provide further guidance and support to facilitate the transition to this new regulatory framework.

In a move aimed at enhancing environmental protection and regulating the import and export of hazardous substances, Mexico has amended its regulatory framework for the Control of Pesticides, Fertilizers, and Toxic Substances (CICOPLAFEST). These amendments, published in the Official Gazette of the Federation on March 14, 2024, came into effect 30 days after the publication and represent a significant change in Mexico's environmental regulatory landscape.

The revised agreement introduces several modifications and additions to various articles and annexes, notably impacting the classification, verification, and exportation procedures for substances falling under CICOPLAFEST. Below are the key highlights of the amendments:

1. Updated Definitions:

• The inclusion of the acronym for PROFEPA (Federal Attorney for Environmental Protection) broadens the range of regulatory entities involved in overseeing environmental compliance.

• The refinement of the "Regulation" description now includes references to the "Verification Registry," in addition to existing authorization and permit requirements, reflecting a more comprehensive regulatory approach.

2. Enhanced Verification Requirements:

• Addition of the mandate for verification and compliance with the PROFEPA verification registry for goods listed in Annex I underscores the government's commitment to ensuring adherence to environmental standards at entry and exit points.

• The requirement for attaching digital or electronic documentation to customs declarations streamlines verification processes and enhances transparency in regulatory compliance.

3. Goods Subject to Compliance with CICOPLAFEST:

• Annex I now incorporates a new homoclave system, introducing a standardized method for identifying substances subject to regulatory oversight.

• The classification of goods into distinct categories, including pesticides, toxic substances, and fertilizers, facilitates targeted regulatory measures tailored to specific environmental risks associated with each category.

4. Clarified Exportation Procedures

• Export procedures for substances outlined in Article Four, Annex II are clearly outlined, ensuring exporters are aware of their compliance obligations, minimizing regulatory ambiguities.

• Specific mention of goods not covered in Annex I underscores the necessity for export authorization, eliminating potential loopholes in oversight mechanisms.

These regulatory amendments represent a significant step forward in Mexico's efforts to strengthen environmental protection measures and promote sustainable development practices.

Stakeholders across affected industries are urged to familiarize themselves with the amended regulations and take proactive steps to ensure compliance within the stipulated timeframe.

On 9 April 2024, five East African countries (Burundi, Kenya, Rwanda, Tanzania, and Uganda) notified the World Trade Organization (WTO) of Draft East African standards for special purposes (anti-aging and sunscreen) skincare products. The notifications are open for comments for 60 days from the date of notification.

East African Standards

East African Standards (EAS) are developed by the East African Standards Committee (EASC) with the aim of harmonising quality requirements for products and services in the East African Community. The aim is to remove barriers to trade within the Community through harmonised standardisation.

East African Standards are developed by technical committees representative of key stakeholders including government, academia, consumer groups, the private sector and other interested parties. The standards are periodically reviewed to incorporate technological advances. Users of the East African Standards should therefore ensure that they have the latest versions of the standards they are using.

The EAS for skincare products have been prepared by the Technical Committee on Cosmetics and Related Products.

Draft Standard for Special Purpose Skincare

In an effort to ensure consumer safety and quality control, the draft East African Draft Standard (DEAS 1205:2024) has been introduced to provide detailed specifications for anti-aging, anti-wrinkle and sunscreen skincare products. It, however, excludes skincare products regulated under EAS 786, as well as anti-wrinkle and anti-aging products, aromatherapy substances, and hair creams, lotions, and gels.

Key points of the Anti-Aging Draft Standard

• Scope: Specifies requirements, sampling, and test methods for anti-aging/anti-wrinkle products.

• Normative References: Refers to other standards that are requirements of the EAS, including standards for labelling, cosmetics, and microbiology.

• Terms and Definitions: Defines terms used in the document relating to skincare products such as creams, lotions, gels and various skincare formulations.

• Requirements: Details the ingredients, general requirements, specific requirements, microbiological limits, and heavy metal contaminants for anti-aging products.

• Packaging and Labelling: Specifies packaging and labelling requirements, including product name, indication of whether it's anti-aging or anti-wrinkle, and other labeling requirements.

• Sampling: Describes the sampling procedure in accordance with ISO standards.

• Annexes: Includes detailed procedures for determining total fatty substance content, hydroquinone content, and antioxidant activity.

Specific details can be found in the Draft Standard here.

Key points of the Sunscreen Draft Standard

• Scope: Specifies requirements, sampling, and test methods for sunscreen products intended to protect against ultraviolet (UV) radiation.

• Normative References: Refers to other standards that are essential to the application of the EAS, including standards for labelling, cosmetics, and methods for testing sunscreen efficacy.

• Terms and Definitions: Provides definitions for terms used in the document, such as sunscreen, sun protection factor (SPF), broad-spectrum protection, water resistance and other relevant terms.

• Requirements: Details the general requirements, specific requirements, labelling requirements, microbiological limits, and heavy metal contaminants for sunscreen products.

• Packaging and Labelling: Specifies packaging and labelling requirements, including product name, SPF value, PA rating (for UVA protection), directions for use, and other required labelling information.

• Sampling: Describes the sampling procedure in accordance with ISO standards to ensure that representative samples are obtained for testing purposes.

• Annexes: Provides detailed procedures for determining SPF, UVA protection (PA rating), water resistance and other relevant tests to assess the efficacy and safety of sunscreen products.

Specific details can be found in the Draft Standard here.

Conclusion

In conclusion, the notification of the draft East African Standards for skincare products is an important step towards ensuring consumer safety and quality control in the East African region. By harmonising standards for anti-aging and sunscreen products, East African countries aim to facilitate trade while prioritising the well-being of consumers. Stakeholders now have the opportunity to provide feedback on the draft standards, ultimately contributing to the development of robust regulations that will benefit businesses and consumers alike.

WorkSafe New Zealand has announced the final deadline for submissions on proposed changes to the Workplace Exposure Standards (WES) and Biological Exposure Indices (BEI) for 2024. Stakeholders have until 30 August 2024, to submit their feedback using the online consultation form only.

What are WES, BEI and PES?

WES (Workplace Exposure Standards): These are guideline values that indicate the airborne concentration of a substance to which almost all workers can be exposed repeatedly without harm. Provided by WorkSafe, WES serve as risk management tools for health risk assessment.

BEI (Biological Exposure Indices): These are guideline values used to assess the results of biological exposure monitoring to help manage the health and safety risks associated with hazardous substances in the workplace.

PES (Prescribed Exposure Standards): These are mandatory standards designed to protect the health of workers. Unlike WESs and BEIs, which are guideline values, PESs are mandatory and are set by regulations or specific acts. Currently, ethanedinitrile (EDN) is the only substance in New Zealand with a mandatory PES.

Background to the Consultation

The consultation document supports proposed changes to WorkSafe New Zealand’s special guidance on WES and BEI for 2024. It includes reviews of 58 substances and provides comprehensive recommendations to adopt, maintain or remove specific WES and BEI values.

It’s important to note that unlike prescribed exposure standards (PES), most WES and BEI values are health-based guidelines for risk assessment rather than definitive safe/unsafe thresholds. Therefore, feedback to the consultation should focus on the health aspects of the proposed changes, without considering socio-economic impacts or feasibility.

In a move to align with EU standards, the Ukrainian government adopted the Technical Regulation for the Classification of Hazards, Labeling and Packaging of Chemical Products on 10 May 2024. This decision is a significant step as Ukraine adopts the standards set out in the EU Regulation 1272/2008 on Classification, Labelling and Packaging of Chemicals and Mixtures (CLP Regulation), which implements the Globally Harmonized System of Classification and Labelling of Chemical Substances (GHS) established by the United Nations.

The Technical Regulation will enter into force on 15 November 2024, except for some parts which will enter into force on 1 January 2025 (Section 3 and clauses 130-133 of Section 6).

Key Provisions of the Technical Regulation

Key provisions of the Technical Regulation include the introduction of EU rules and criteria for the classification of chemical substances and products according to the 33 hazard classes. It also introduces strict requirements for the labelling and packaging of chemical products.

The responsibility of market participants increases. Before placing a chemical product on the market, manufacturers, importers, suppliers and other operators are required to gather all available information on its hazardous properties, assess the validity of this information, and classify the hazards of the chemical substance in accordance with the Technical Regulation.

In addition, companies must ensure that the chemical products they manufacture, import or provide on the Ukrainian market are classified for hazard according to the criteria of the GHS. Such products must be packaged appropriately and bear the necessary hazard labels.

The full text of the Regulation can be found here in Ukrainian including Annex VIII which compares the provisions of the EU CLP Regulation and the Technical Regulation.

Law on Chemical Safety and Chemical Product Management

The adoption of the Technical Regulation follows the adoption of the Law "On Ensuring Chemical Safety and Chemical Product Management" in December 2022, which will enter into force on 29 June 2024. This framework legislation, an integral part of Ukraine's EU-integration commitments, underlines the country's commitment to protecting its citizens and environment.

According to Minister Ruslan Striltsa, the law will serve as a basis for establishing a national chemicals management system in line with European standards. It lays the foundation for further steps in this area, including the implementation of EU technical regulations such as CLP and REACH. With regard to the implementation of the REACH regulation, the Ministry of Environmental Protection and Natural Resources of Ukraine has already developed a Technical Regulation on the Safety of Chemical Products, which will be submitted to the Government for consideration in the near future.