GPC Newsletter Apr-2025

On February 5, 2025, the Government of Canada registered SOR/2025-17, officially amending the Domestic Substances List (DSL) under subsection 87(3) of the Canadian Environmental Protection Act, 1999 (CEPA). This amendment, entitled Order 2024-87-21-01, applies the Significant New Activity (SNAc) provisions of CEPA to the substance ethanol, 2-[(2-aminoethyl)amino]- (CAS RN 111-41-1), commonly known as AEEA.

Why Was This Order Issued?

The amendment results from Canada’s ongoing efforts under the Chemicals Management Plan (CMP), a federal initiative to assess and manage the risks posed by chemicals to human health and the environment. While AEEA was not found to be “toxic” under CEPA’s section 64 criteria during its 2016 screening assessment, it was identified as a substance of concern due to properties that could pose risks if its use increases in new applications.

To ensure that future uses of AEEA do not result in unanticipated environmental or health effects, the SNAc provisions will now be triggered if the substance is used in ways that are significantly different from those previously assessed.

What Is AEEA and How Is It Used?

AEEA does not occur naturally in the environment and is used in various industrial and commercial applications, including:

• Food packaging adhesives and inks (non-direct food contact)

• Paper manufacturing agents

• Closed-loop cooling systems

• Epoxy adhesives and corrosion inhibitors

• Asphalt paving and patching materials

• Pigments for fibers such as carpets

The substance is primarily used as a chemical intermediate and curing agent in the production of resins and sealants. In previous surveys, it was reported that over 500,000 kg of AEEA was imported into Canada, although domestic production was negligible or non-existent.

Internationally, AEEA is used in epoxy hardeners, personal care products, and industrial chemicals, particularly in the United States, Europe, Japan, and Switzerland.

What Are the New Requirements?

The SNAc provisions of CEPA require that any person (individual or corporation) who plans to engage in a significant new activity involving AEEA must submit a Significant New Activity Notification (SNAN) to the Minister of the Environment at least 90 days prior to the proposed activity.

Activities That Trigger Notification:

1. Manufacture or import of AEEA in concentrations ≥0.1% by weight in:

   • Consumer products (under the Canada Consumer Product Safety Act) sold in containers >250 ml

   • Cosmetics (as defined in the Food and Drugs Act)

2. Importing any of the above products containing AEEA if the total annual import exceeds 10 kg.

Activities Exempt from Notification:

• Use in research and development or as a site-limited intermediate

• Products intended solely for export

• Uses regulated under other Acts such as the Pest Control Products Act, Fertilizers Act, or Feeds Act

• Incidental presence in products, or substances formed as impurities or contaminants

Required Information for SNAN Submission:

Notifiers must provide detailed information about the activity and product, including:

• Description and function of the product

• Anticipated annual quantity

• Method of application and use

• Toxicological and environmental data

• Previous notifications to other government agencies

• Contact information and certification of accuracy

Once received, the Minister has 90 days to assess the submission before the activity may proceed.

Impact on Stakeholders and Industry

This Order does not affect currently authorized uses of AEEA in Canada. It only applies to new or modified uses that may increase the risk of exposure. Businesses using AEEA in previously assessed activities are not subject to any new regulatory obligations under this amendment.

For new uses, the SNAN process ensures pre-market review to prevent environmental or public health risks. This requirement is consistent with similar policies in international jurisdictions and supports Canada's alignment with global chemical management practices, including cooperation with the U.S. EPA and the European Chemicals Agency (ECHA).

Regulatory Context and Consultation Process

This regulatory change follows previous Notices of Intent published in the Canada Gazette, Part I in 2016 and 2020, which allowed for public and industry consultation. A stakeholder submission in 2016 resulted in refinements in the scope of what constitutes a significant new activity. No objections were received during the second public consultation.

Compliance, Enforcement, and Guidance

The Order is effective from the day of registration (February 15, 2025). Compliance promotion efforts will include direct outreach, guidance materials, and the availability of pre-notification consultations (PNCs) to help notifiers understand and meet their obligations.

Enforcement of this Order falls under the Compliance and Enforcement Policy for CEPA, which allows for a range of measures from warnings to legal action, depending on the severity and nature of the violation.

Broader Impacts and Benefits

This regulatory action is designed to prevent potential environmental and health risks from new uses of AEEA without disrupting current, low-risk uses. The application of the SNAc provisions reflects Canada's precautionary approach to chemical safety, allowing for proactive intervention before risks arise.

A Strategic Environmental and Economic Assessment concluded that this initiative supports the objectives of the CMP and will have a positive impact on human health and the environment. No adverse impacts were identified under Gender-based Analysis Plus (GBA+) or modern treaty obligations.

The U.S. Environmental Protection Agency (EPA) has extended the public comment period for its draft TSCA risk evaluation for 1,3-butadiene. Originally set to close on February 3, 2025, the deadline is now extended to March 5, 2025, to allow additional time for stakeholders to provide feedback.   

Key Findings of the Draft TSCA Risk Evaluation 

On December 2, 2024, the U.S. EPA released a draft risk evaluation for 1,3-butadiene (CAS No. 106-99-0) under the Toxic Substances Control Act (TSCA) for public comment and peer review by the Science Advisory Committee on Chemicals (SACC). EPA in its risk evaluation determined that 1,3-butadiene poses an unreasonable risk of injury to human health from inhalation exposure to workers and to the general population (including fenceline communities) which is associated with several health effects.   

1,3-Butadiene 

1,3-butadiene is a colorless, highly flammable gas with a mild odor similar to gasoline. It is used primarily in the manufacture of plastics, synthetic rubber (including tires), adhesives, fuels, lubricants, paints, and coatings. The chemical is commonly released into the air during its production and use, with minimal releases to land or water. Beyond industrial exposure, people may also encounter 1,3-butadiene in vehicle exhaust, tobacco smoke, and burning wood. 

Identified Health Risks  

Workers and Occupational Exposure:  

• Workers in manufacturing and processing facilities face significant health risks from inhaling 1,3-butadiene and maintenance and laboratory technicians are particularly vulnerable due to non-routine handling. Health effects include reduced birth weight, blood and immune system diseases, and leukemia. 

Fenceline Communities and the General Population:  

• For people living near industrial facilities long-term exposure from air emissions can lead to serious chronic health effects over time through inhalation. 

Minimal Consumer and Environmental Risk:  

• Consumer exposure is low since only trace amounts of 1,3-butadiene are found in products. The draft evaluation also concludes that there is no unreasonable environmental risk, as 1,3-butadiene does not have a significant impact on land or water. 

Uses of 1,3-Butadiene 

1,3-butadiene uses that pose a significant risk: 

• Manufacturing and processing in industries such as rubber, plastics, adhesives, fuels, and coatings. 

• Handling, repackaging, and disposal of 1,3-butadiene. 

• Recycling and laboratory use. 

Uses that pose low or no risk: 

• Consumer and industrial use in fuels 

• Automotive products 

• Lubricants 

• Packaging 

• Furniture 

• Toys  

• Distribution in commerce 

Public and Peer Review Comments 

EPA was previously accepting public comments for 60 days after the draft evaluation but has extended the comment period from February 3, 2025, to March 5, 2025. Public comments can be submitted to docket EPA-HQ-OPPT-2024-0425 on www.regulations.gov until the new deadline. 

A preparatory public meeting to discuss the scope of the evaluation scheduled for February 4 and the virtual SACC peer review meeting to review public comments and finalize recommendations was scheduled for February 25-28, 2025, but EPA is now rescheduling the February peer review meetings to review additional comments and will announce new dates soon. 

The European Commission adopted Regulation (EU) 2025/351 on 19 February 2025, which introduces significant amendments to Regulation (EU) No 10/2011 on plastic materials and articles intended as food contact materials (FCMs). The updated rules were published on 24 February 2025 and will enter into force on 16 March 2025. Companies need to ensure compliance within the transition period, which ends on 16 September 2026, to avoid potential market restrictions.

Key Amendments in Regulation (EU) 2025/351

The newly adopted Regulation now explicitly extends compositional requirements to all plastic materials and articles, removing previous ambiguities. It also refines definitions to improve the clarity of the legislation.

• Extended Scope: The compositional requirements now apply to all plastic materials and articles, not just 'plastic layers'. This change removes ambiguity, particularly for single homogeneous materials with complex shapes and ensures consistent safety standards for all plastic products. ​

• Clearer Definition of Additives: The definition of 'additives' has been clarified to distinguish them from starting substances. In particular, solid materials that are chemically bonded to polymers are now categorized as additives, even if their surfaces react with the polymers. This clarification will ensure proper classification and regulatory oversight of substances used in the manufacture of plastics.

Alignment with Biocidal Product Regulations

To ensure that food contact materials do not introduce harmful substances, the amended Regulation strengthens alignment with existing biocidal product legislation. The amendments include a reference to the Biocidal Products Regulation (Regulation (EU) No 528/2012), ensuring that only approved biocidal active substances are used in food contact materials. This alignment strengthens consumer protection by preventing the use of unauthorised biocidal substances in FCMs. ​

Stricter Migration Limits for Plastic Food Contact Materials

The Regulation introduces updated specific migration limits (SMLs) to ensure that hazardous substances are not transferred from plastic materials into food at levels that could pose a health risk. These stricter limits apply to a wider range of substances, strengthening the safety standards for food packaging.

• Compliance for multi-layer plastic materials:

Manufacturers using adhesives, coatings, or printing inks in food packaging must ensure compliance with migration testing requirements. The updated regulations emphasise the need for reliable testing methods to verify that no harmful chemicals exceed the new SML thresholds.

• Requirement for migration test data at each production stage:

Companies involved in food contact plastics, including polymer resin producers, additive suppliers, and coating manufacturers, must now provide migration test data at each stage of the production process. This will ensure that materials comply with SMLs before reaching the final product, strengthening accountability throughout the supply chain.

These measures enhance consumer protection and regulatory oversight, ensuring that plastic food contact materials meet the highest safety standards.

High Purity Standards and Sustainability Measures

The revised regulation strengthens purity requirements and introduces stricter risk assessments to ensure safer food contact materials. Key updates include:

• Stricter purity criteria:

  • Additives and UVCB substances (substances of unknown or variable composition) must meet higher purity standards.

  • Only substances with well-defined chemical identities and minimal impurities will be allowed.

  • This is particularly important for manufacturers using recycled or naturally derived materials that may contain residual contaminants.

• More comprehensive risk assessment for NIAS:

  • Non-intentionally added substances (NIAS) will have to undergo detailed risk assessments if migration exceeds 0.00015 mg/kg of food.

  • This measure aligns food contact legislation with EU-REACH (Regulation (EC) No 1907/2006) and the latest risk evaluation framework of the European Food Safety Authority (EFSA).

  • The approach will strengthen safety assessments and ensure better control of potential contaminants in food packaging and materials.

These updates reflect the EU’s commitment to higher safety standards and greater regulatory consistency in the management of FCMs.

Recycling and Reprocessing Provisions

Regulation 2025/351 introduces measures to promote sustainability and ensure the safety of recycled materials:

• Definition of 'reprocessing of plastic': A clear definition for ‘reprocessing of plastic’ has been introduced to distinguish it from recycling. This clarification ensures that by-products from plastic manufacturing, such as off-cuts and scraps, are properly managed and reused, supporting sustainability goals.

• Alignment with the Recycled Plastics Regulation (EU) 2022/1616: The amendments ensure that recycled plastics used in food contact applications meet stringent safety criteria. This alignment requires recycled plastic materials to undergo rigorous decontamination processes and reinforces the requirement that plastic materials derived from waste maintain high purity standards to prevent contamination. ​

Transitional Measures for Compliance

To facilitate a smooth transition, the Regulation provides a grace period for products already on the market and sets clear labelling requirements for non-compliant substances.

• Plastic materials and articles that comply with previous regulations and are placed on the market before 16 September 2025 may remain available until stocks are exhausted.

• Intermediates and substances that do not comply with the new regulation may still be used until 16 September 2026 but must be clearly labelled to indicate their restricted use after the transition date.

The full text of the regulation can be accessed here.

On 28 February 2024, the European Chemicals Agency (ECHA) launched a public consultation on the classification of three substances as Substances of Very High Concern (SVHC) under the REACH Regulation. This step aims to enhance the protection of human health and the environment from potential risks associated with these chemicals.

Details of the Proposed Substances

1. 1,1,1,3,5,5,5-Heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane (EC 241-867-7, CAS 17928-28-8)

   • Uses: Widely used in cosmetics, personal care products, perfumes, fragrances, and as a binder in paints, coatings, and adhesives.

   • Reason for Inclusion: Identified as very Persistent and very Bioaccumulative (vPvB) under Article 57(e) of REACH.

2. Decamethyltetrasiloxane (EC 205-491-7, CAS 141-62-8)

   • Uses: Used in cosmetics, personal care items, detergents, car care products, lubricants, and greases.

   • Reason for Inclusion: Classified as vPvB under Article 57(e) of REACH

3. Reactive Brown 51 (Tetra(sodium/potassium) 7-[(E)-{2-acetamido-4-[(E)-(4-{[4-chloro-6-({2-[(4-fluoro-6-{[4-(vinylsulfonyl)phenyl]amino}-1,3,5-triazine-2-yl)amino]propyl}amino)-1,3,5-triazine-2-yl]amino}-5-sulfonato-1-naphthyl)diazenyl]-5-methoxyphenyl}diazenyl]-1,3,6-naphthalenetrisulfonate); (EC 466-490-7, CAS -)

   • Uses: Used in textile treatment products and dyes.

   • Reason for Inclusion: Identified as toxic for reproduction under Article 57(c) of REACH.

Public Consultation Process

Stakeholders and interested parties are invited to submit their comments and feedback on these proposals by 14 April 2025. Comments can be submitted here. This consultation will allow for the collection of scientific information and perspectives that will inform the regulatory process. The feedback will be reviewed by the Member State Committee (MSC) before a final decision the classification of the substances as SVHCs is made.

Potential Impact on Industry

If these substances are officially recognized as SVHCs, they will be added to the Candidate List, which currently contains 247 entries. This listing could lead to further regulatory actions, including possible restrictions or authorizations, affecting industries that use these chemicals.

Conclusion

ECHA's proposal to identify these three substances as SVHCs underlines the Agency's commitment to protecting health and the environment. Stakeholders are encouraged to actively participate in the consultation process to ensure comprehensive evaluation and informed decision-making.

On 25 February 2025, the European Chemicals Agency (ECHA) launched a public consultation on the possible designation of ethanol as a candidate for substitution under the Biocidal Products Regulation (BPR). The consultation is open until 28 April 2025 and invites stakeholders to provide input on alternative substances.

Ethanol Biocidal Products

Ethanol is widely used in biocidal products, including:

• Product type 1 – Human hygiene products.

• Product type 2 – Disinfectants and algaecides not for direct human or animal use.

• Product type 4 – Food and feed area disinfectants.

Ethanol has been identified as a substance of very high concern (SVHC) due to its hazardous properties. Under the BPR, substances that meet substitution criteria will be reviewed for potential phase-out if safer alternatives are available.

Rules for Candidates for Substitution under the BPR

Under the Biocidal Products Regulation (BPR) (Regulation (EU) 528/2012), substances are identified as Candidates for Substitution if they meet specific hazard criteria, such as being carcinogenic, mutagenic or toxic for reproduction (CMR), endocrine disrupting, or persistent, bioaccumulative, and toxic (PBT/vPvB). These substances are subject to stricter approval conditions, and their use is only permitted if no suitable alternatives exist. If an active substance is listed as a candidate for substitution, all biocidal products containing it must be evaluated against possible safer alternatives, with the aim of phasing out the substance where feasible.

Stakeholder Participation

ECHA encourages industry representatives, non-governmental organizations (NGOs), and other stakeholders to submit data on alternatives to ethanol, its safety, and efficacy in biocidal applications. The feedback will contribute to regulatory decisions on the approval of possible restrictions of ethanol.

How to Participate

Stakeholders can access details of the consultation and submit comments via ECHA’s website here. Participation in the consultation will ensure a comprehensive evaluation of the future use of ethanol in biocidal products and help shape EU regulatory decisions.

On 25 March 2025, the European Chemicals Agency (ECHA) published the updated Community Rolling Action Plan (CoRAP) for the years 2025–2027, listing 28 substances to be evaluated under REACH. The plan includes 13 new substances, while 15 are carried over from previous plans. In addition, three substances have been withdrawn following a reassessment of their priority or the availability of new information.

Evaluation Timeline and Focus

Of the 28 substances, 14 are scheduled for evaluation in 2025, followed by 9 in 2026 and 5 in 2027. The evaluations aim to clarify potential concerns related to human health and environmental risks, including persistent, bioaccumulative and toxic (PBT) properties, endocrine disruption, carcinogenicity, and reproductive toxicity.

The selected substances are used in a wide range of applications, including consumer products, industrial processes, and professional use, increasing the likelihood of widespread exposure.

Evaluation Tasks Distributed Among 11 EU Member States

The selected substances will be assessed by 11 Member States, including Germany, France, the Netherlands, Sweden, and Poland. Each substance is assigned to a specific country, which will carry out the evaluation over the next three years.

Substance evaluation under REACH can lead to follow-up actions such as requests for additional information, proposals for harmonised classification and labelling, restriction, or identification as a substance of very high concern (SVHC). The aim is to ensure that any risks are properly assessed and managed.

Industry Encouraged to Review Dossiers

ECHA encourages companies that manufacture, import or use any of the listed substances to review and, if necessary, update their REACH registration dossiers. Up-to-date data will assist the evaluation process and may help reduce the likelihood of further information requests or compliance issues.

Full List Available Online

The full list of substances, together with the evaluation justifications and the names of the evaluating Member States, is available here.

On 10 March 2025, UK Government laid before Parliament the REACH Fees and Charges (Amendment of Commission Regulation (EC) No 340/2008) Regulations 2025, which will apply from 1 April 2025. This statutory instrument revises the fees and charges associated with the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regime to align them more closely with the actual costs incurred by the Health and Safety Executive (HSE) in administering these regulatory activities.

Key Changes

• Standard Registration Fees: A flat standard fee of £2,222 will apply to large companies for both full and intermediate registrations. This adjustment is intended to better align fees with the costs of processing registrations and maintaining the REACH IT system.

• Authorisation Fees: The base authorisation fee will increase by £10,460, bringing the standard fee from £47,229 to £57,689. Additional fees per substance and per use will continue to be calculated as a percentage of the base fee, specifically 20% and 90% respectively.

• Fees for Product and Process Oriented Research and Development (PPORD): The standard fee for a PPORD notification will increase from £475 to £751 to reflect previously unrecovered costs associated with the Environment Agency's involvement in PPORD applications.

• Updates to Registrations: A flat standard fee of £2,222 will be implemented for large companies updating their tonnage bands reflecting the actual costs of processing these updates and maintaining the REACH IT infrastructure.

• Change of Identity/Legal Personality: The fee for processing changes of identity or legal personality will be significantly reduced from £1,424 to £290, reflecting the actual costs associated with these administrative updates.

Discounts for Small and Medium-Sized Enterprises

Small and medium-sized enterprises (SMEs) will continue to benefit from reduced fees. For all fee types except applications for authorisations, SMEs will either retain their current fee if it is lower than the new standard fee, or receive a discount of 10%, 20%, or 30% for medium, small, and micro enterprises, respectively. For authorisations, the existing SME discounts of 25%, 55%, and 90% for medium, small, and micro enterprises respectively will be maintained to avoid a disproportionate burden on smaller companies.

Consultation and Implementation

An informal consultation was held from 14 August to 16 September 2024, involving the main industry trade associations and non-governmental organisations. While industry broadly welcomed the changes, concerns were raised about the increased registration fees for large companies submitting joint registrations for substances in the 1-10 tonne range. The Government took these concerns into account but emphasised the need to align fees with the actual costs of regulatory activities, as required by HM Treasury's Managing Public Money guidelines.

The revised fees and charges are designed to ensure that the HSE recovers the full economic costs of providing regulatory services under UK-REACH, thereby maintaining the sustainability and effectiveness of the UK's chemicals regulatory framework.

Further details can be found in the official legislation here and the Explanatory Memorandum here.

On 17 March 2025, the UK Health and Safety Executive (HSE) announced an important update to its guidance on health surveillance for workers exposed to respirable crystalline silica (RCS) - a hazardous substance linked to serious lung diseases, including silicosis, chronic obstructive pulmonary disease (COPD), and lung cancer.

The revised guidance aims to help employers understand when health surveillance is legally required and how to implement effective surveillance programs in accordance with the Control of Substances Hazardous to Health (COSHH) Regulations 2002.

What’s New in the Updated Guidance?

• Clearer Requirements: The guidance now provides improved explanations of when health surveillance is required for workers exposed to RCS and how employers should assess the risk.

• Structured Approach: HSE outlines a step-by-step process for setting up a health surveillance scheme, including:

  • Identifying the risk of exposure.

  • Arranging for appropriate health checks.

  • Keeping appropriate records.

  • Acting on the results to protect workers’ health.

• Emphasis on Legal Obligations: Employers are reminded that health surveillance is not optional where there is a reasonable probability that RCS exposure is causing harm. The updated guidance helps to clarify these obligations.

• Alignment with HSE’s Inspection Focus: The update comes as the HSE continues to prioritise workplace inspections in sectors such as construction, manufacturing, and stonework, where exposure to RCS is more common. Poor management of RCS risks can lead to enforcement action.

Why Health Surveillance for RCS Is Important

Respirable crystalline silica is a fine dust generated by cutting, grinding, drilling, or sanding materials such as concrete, brick, stone, or mortar. Prolonged or repeated inhalation of RCS can lead to irreversible lung damage. Early detection through health surveillance is essential to prevent long-term disease and ensure timely intervention.

Access the Updated Guidance

The revised guidance on RCS health surveillance is available here on the HSE website as part of the G series of publications. Employers, occupational health providers, and safety professionals are encouraged to review the material and update their policies and procedures as necessary.

On 20 March 2025, the United Kingdom notified the World Trade Organization (WTO) of a draft regulation proposing to update the maximum levels for certain contaminants and pesticide residues in food. The measure aims to better protect public health and reflects the latest scientific assessments.

Proposed Amendments to Contaminants and MRLs

The draft legislation introduces new and revised maximum levels (MLs) for various chemical contaminants in food and updates to the Maximum Residue Levels (MRLs) for certain pesticides. Key changes include:

• Mycotoxins: Introduction of new MLs for deoxynivalenol (DON), zearalenone, and T-2/HT-2 toxins in cereals and cereal-based foods, especially those intended for infants and young children.

• Tropane alkaloids: New MLs for atropine and scopolamine in cereal-based products.

• Nitrate: Updates of the permitted levels in spinach and lettuce, including adjustments for seasonal variations.

• Pesticide residues: Adoption of 58 new or revised MRLs for active substances such as:

  • Abamectin, cyazofamid, fludioxonil, mandestrobin, and spinetoram.

  • Affected foods include a wide range of foods, including fruits, vegetables, herbs, and spices.

Implementation Timeline

• Deadline for comments: Stakeholders are encouraged to review the proposed changes and submit comments via the WTO ePing portal by 5 May 2025

• Planned adoption and entry into force: 30 June 2025

The proposed regulation will apply in England, with corresponding legislation to follow in Scotland, Wales, and Northern Ireland to ensure UK-wide alignment.

A detailed list of the proposed MRLs can be found here.

The United Kingdom and the European Union have launched public consultations on draft risk profiles for polybrominated dibenzo-p-dioxins and dibenzofurans (PBDD/Fs), including mixed polybrominated/chlorinated dibenzo-p-dioxins and dibenzofurans (PBCDD/Fs). These consultations are part of the process under the Stockholm Convention on Persistent Organic Pollutants (POPs) to evaluate and possibly regulate these substances due to their persistence in the environment and potential health risks.

Background on PBDD/Fs and PBCDD/Fs

PBDD/Fs and PBCDD/Fs are unintentional by-products of various industrial processes, including the combustion of materials containing brominated flame retardants and certain metallurgical processes. Due to their persistence in the environment and their potential to bioaccumulate, these substances are of concern for both the environment and human health.

UK Consultation Details

The UK Department for Environment, Food & Rural Affairs (DEFRA) has published a draft risk profile for PBDD/Fs and PBCDD/Fs and is inviting stakeholders to comment. The consultation period is open from 17 March to 19 May 2025. Stakeholders are encouraged to review the draft risk profile and provide feedback by email to POPs@defra.gov.uk within the specified timeframe.

EU Consultation Details

The European Chemicals Agency (ECHA) has also published a draft risk profile for the same group of substances and is seeking input from interested parties. The EU consultation is open until 20 May 2025 and comments can be submitted here.

Next Steps in the Stockholm Convention Process

Feedback from these consultations will contribute to discussions at the upcoming 20th meeting of the Stockholm Convention POPs Review Committee (POPRC-20), scheduled for 29 September to 3 October 2025. The Committee will review the draft risk profiles and stakeholder comments to determine the need for global regulatory actions on these substances.

The UK Health and Safety Executive (HSE) has published its annual UK REACH Article 83 Report (2023–2024) and Work Programme for 2024–2025, highlighting ongoing regulatory work and outlining upcoming priorities under the UK REACH framework.

PFAS and Lead Under Regulatory Focus

HSE continues to assess the risks of per- and polyfluoroalkyl substances (PFAS), with work ongoing to investigate their use as processing aids in the manufacture of fluoropolymers. In parallel, the Agency is preparing a restriction dossier on PFAS in firefighting foams, which is expected to be submitted for public consultation in 2024/25.

The HSE is also finalising its restriction opinion on lead in ammunition used in outdoor shooting, covering both human health and environmental risks. This follows a public consultation completed in 2023.

Upcoming Work in 2024–2025

The Work Programme outlines the continuation of nine Regulatory Management Options Analyses (RMOAs), including substances such as:

• Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (trimellitic anhydride) – investigated for respiratory sensitisation risks.

• Bisphenol S (BPS) and Bisphenol F (BPF) – evaluated for endocrine disrupting properties.

• Octamethylcyclotetrasiloxane (D4) and Decamethylcyclopentasiloxane (D5) – investigated for persistence and potential environmental concerns.

No new RMOAs are planned for 2024/25.

Additionally, the HSE will assess up to six substances proposed as Substances of Very High Concern (SVHCs) under EU REACH for their relevance to the UK market. One such substance that has already been evaluated in 2023/24 was melamine, due to concerns over reproductive toxicity and widespread use.

Key Activities in 2023-2024

During 2023/24, the HSE:

• Processed all new UK REACH registrations and Article 26 inquiries within the statutory three-week timeframe.

• Carried out compliance checks on at least 20% of registration dossiers.

• Evaluated all submitted testing proposals to avoid unnecessary animal testing.

• Issued authorisation opinions on time, including assessments of trichloroethylene uses.

• Published the UK REACH evaluation report under Article 54 by the February 2024 deadline.

For 2024/25, the HSE will maintain these operational targets and continue to invest in IT systems and stakeholder engagement efforts to support future evaluations and restrictions.

The work programme was developed in collaboration with the Environment Agency and the Appropriate Authorities (Defra, the Scottish Government, and the Welsh Government) and reflects previously established regulatory priorities.

Access the full 2023-2024 Annual Report here and the 2024-2025 Work Programme here.

On 6 January 2025, India’s Ministry of Environment, Forest and Climate Change (MOEFCC) published the Environment Protection (End-of-Life Vehicles) Rules, 2025, under the powers granted by the Environment (Protection) Act, 1986. These rules apply to entities involved in the production, ownership, testing, and scrapping of vehicles, including electric and battery powered vehicles. However, the rules do not apply to waste batteries, plastic packaging, waste tyres, used oil, and e-waste, which are covered by other regulations. The rules also do not apply to agricultural machinery such as tractors, trailers, harvesters, and power tillers as defined in the Motor Vehicles Act, 1988. 

Centralised Online Portal 

The Central Pollution Control Board (CPCB) is required to establish a centralized online portal within six months of the publication of the rules. This portal will:  

• Handle registration and return filing of End-of-Life Vehicles (ELVs) for producers, bulk consumers, and Registered Vehicle Scrapping Facilities (RVSF).  

• Track the receipt of ELVs and waste materials generated by RVSFs, ensuring real-time data availability.  

• Enable the exchange of Extended Producer Responsibility (EPR) certificates between producers and RVSFs to meet EPR obligations.  

The State Board will use this portal to register RVSFs and bulk consumers, as well as for return filing. It will serve as a centralized data repository for all related activities, including issued orders. Producers may assist in the development of the portal. 

Implementation  

The Central Government may form a committee, chaired by the Chairman of the Central Board, to ensure effective implementation of specific rules. The committee will monitor implementation, take necessary actions, and guide the development and operation of a centralized online portal. It must meet at least once every six months and report to the Central Government. The Committee will consist of representatives from the Ministry of Road Transport and Highways, the Ministry of Steel, the Bureau of Indian Standards, State Boards, the National Environmental Engineering Research Institute, and stakeholders such as producers, recyclers, and scrapping facilities, along with any other nominated individuals or organizations. The Committee chairperson can invite additional individuals or organizations to attend meetings if their input is deemed valuable to the discussions. 

Extended Producer Responsibility Targets for ELVs 

The new EPR framework sets out specific obligations for vehicle manufacturers: 

1. EPR targets apply to vehicles based on their category and average lifespan. 

2. Targets include scrapping of steel from End-of-Life vehicles. 

3. EPR for batteries follows the Battery Waste Management Rules, 2022. 

4. EPR for waste tyres and used oil follows the Hazardous Waste Rules, 2016. 

5. EPR targets are specific to the type of vehicle (transport or non-transport). 

6. Producers fulfil their EPR obligations through certificates from Registered Vehicle Scrapping Facilities through a centralized portal. 

7. If certificates are unavailable, producers are responsible for the collection of vehicles. 

Entry into Force 

The Environment Protection (End-of-Life Vehicles) Rules, 2025 will come into force on 1 April 2025. 

The Bureau of Indian Standards (BIS) has released a draft of the updated Indian Standard for Sulphuric Acid - Specification (Fifth Revision) for public comments. This draft standard, identified as CHD 01 (27028) WC, December 2024, aims to update the existing guidelines for quality and testing requirements of sulphuric acid in India. The revised standard was open for review and feedback from all relevant stakeholders, including manufacturers, suppliers, and industry experts until 1 February 2025. 

Key Features of the Draft Standard: 

1. Scope: The new draft standard provides comprehensive requirements for sulphuric acid, including methods of sampling and testing to ensure product quality and safety. 

2. Grades of Sulphuric Acid: Four distinct grades are outlined in the draft: 

• Technical grade (Tech) 

• Battery grade (further divided into two sub-grades: concentrated and diluted) 

• Chemically Pure (CP) grade 

• Analytical Reagent (AR) grade  

3.  Grade-Specific Requirements:  Each grade has specific requirements regarding appearance, composition, and impurities. For instance: 

• Technical grade: The acid should be a brownish liquid. 

• Battery grade: Must be a colorless liquid, free of visible impurities. 

• CP and AR grades: These must be clear, colorless, and free from suspended matter. 

4. Optional Requirements: The draft also includes provisions for optional variation of certain chemical properties, such as total acidity and impurities, subject to mutual agreement between suppliers and purchasers. 

5. Packaging and Marking: The draft details packaging guidelines, with specific requirements for containers based on the grade of sulphuric acid. These include the use of polyethylene containers, glass bottles, and steel drums, all fitted with leak-tight stoppers. 

The containers must also bear detailed marking, including information on the material’s grade, manufacturer, expiry date, and handling instructions. In the case of Analytical Reagent grade, the chemical analysis details will be clearly marked. 

6. BIS Certification Mark: Products conforming to the final standard may be eligible for certification under the provisions of the Bureau of Indian Standards Act, 2016 and may carry the BIS certification mark. 

7. Sampling Method: The draft specifies the method for drawing representative samples for testing to ensure accurate and consistent quality control. 

Feedback and Review Process:  

This draft standard was open for public comments and review until 1 February 2025. Industry participants, including chemical manufacturers, regulatory bodies, and quality assurance experts, were encouraged to submit feedback and suggestions. This collaborative review will ensure that the standard is comprehensive, accurate, and reflective of industry needs. After the review process, the final version of the standard will be released. 

Requirements for Sulphuric Acid: 

Conclusion:  

This update to the Sulphuric Acid - Specification standard reflects ongoing efforts to ensure that the production, handling, and use of sulphuric acid in India meets the highest standards of quality and safety. By opening the draft for public review, BIS aims to incorporate industry insights and improve the document before finalization. 

The full text of the draft Standard can be accessed here- 

The South Korean Ministry of Environment (MoE), in collaboration with the Ministry of Justice (MoJ), has launched an 8-month voluntary reporting period, starting from February 28, 2025. This initiative is aimed at companies that have failed to meet the registration, change registration, or prior notification requirements under K-REACH. 

Purpose 

• The purpose of this voluntary reporting period is to collect data on chemical safety and enhance regulatory compliance, ensuring that companies align with K-REACH laws.  

• The ultimate goal is to protect public health and the environment from exposure to harmful chemicals. 

Key requirements 

• Companies that have manufactured or imported chemicals before February 27, 2025, without complying with K-REACH, are subject to the voluntary reporting. 

• To voluntarily report, companies must submit relevant documents (including manufacturing and import details) via the Chemical Substance Information Management System (kreach.me.go.kr). 

Benefits of voluntary reporting and future inspection 

• Companies that voluntarily report violations and take corrective actions will be exempt from severe penalties such as imprisonment of up to 5 years or a fine of up to 100 million KRW.  

• They will also not face surcharges based on sales, and ongoing investigations or prosecutions will be considered with more leniency. 

• The MoE will conduct thorough on-site inspections after the voluntary reporting period ends, and any violations found will be dealt with strictly in accordance with the regulations. 

On February 12, 2025, South Korea’s National Institute of Chemical Safety (NICS) announced a partial revision of the classification and labelling of certain chemical substances. The revision includes reclassification of specific restricted substances and some regulatory changes. The purpose of this partial revision is to comply with the recent amendment of Article 27 of K-REACH regarding restricted substances.  

Key Updates 

1. Substance Reclassification 

• Chrysotile will be reclassified from a restricted substance to a banned substance in accordance with the Ministry of Environment’s announcement (no. 2024-253). 

        2. Regulatory Changes 

• The entry for for Chrysotile as a restricted substance (no. 06-5-7) will be removed and it will be listed as a banned substance (no. 06-4-27). 

• Only the designation of the substance will change - no further changes to hazard classification or labeling requirements. 

Public Feedback 

A public consultation was held on this revision allowing stakeholders to submit  comments on the amendments and any suggested revisions to NICS until March 4, 2025.  

The Ministry of Public Health and the Cosmetics Committee of Thailand have introduced significant regulatory updates affecting the cosmetics industry. The latest announcements, published in the Royal Gazette in January 2025, mandate warning labels for cosmetics containing the preservative Climbazole and expand the list of substances prohibited in cosmetic formulations. These updates aim to enhance consumer safety and ensure compliance with international standards. Businesses involved in the manufacture, import, and sale of cosmetics must adhere to these new regulations within the specified transition period. 

Mandatory Labelling / Warnings for Cosmetics Containing Climbazole 

On January 31, 2025, the Cosmetics Committee published a announcement regarding the labelling of cosmetics containing preservatives (No. 5). This update, issued under the authority of the Cosmetics Act B.E. 2558, was decided during the 4/2567 Committee meeting held on August 26, 2024. 

Under this announcement, the warning label requirements for Climbazole (CAS Number: 38083-17-9) have been revised. Cosmetics containing this preservative must now include the following warning on their labels: 

“Contains Climbazole. Be careful not to get in your eyes. If irritation occurs, stop using the product and consult a doctor or pharmacist.” 

Manufacturers, importers, and contract manufacturers who have prepared labels prior to the enforcement date must comply with this new labelling requirement within 180 days of the effective date of the announcement. 

Expanded List of Prohibited Cosmetic Ingredients 

In a separate announcement, the Ministry of Public Health introduced new restrictions on prohibited substances used in cosmetics. The regulation, published on January 31, 2025, under the authority of the Cosmetics Act B.E. 2015, were enacted following recommendations from the Cosmetics Committee at its 4/2024 meeting on August 26, 2024. 

This update expands the list of prohibited cosmetic ingredients by adding 56 newly prohibited substances. Manufacturers, importers, and contract manufacturers who have received notification certificates for cosmetics containing these newly prohibited ingredients must ensure compliance within 180 days of the effective date of this announcement. 

The expanded prohibited list can be accessed here 

Implementation and Compliance 

Both announcements are now in effect following their publication in the Royal Gazette. The Thai authorities have emphasized that non-compliance will lead to regulatory actions, reinforcing their commitment to consumer safety in the cosmetics industry. Industry stakeholders are urged to review their formulations and labelling practices to ensure alignment with these updated regulations. 

On 18 March 2025, Thailand’s Ministry of Industry has issued a major update to its List of Hazardous Substances (No. 8), which will come into effect the day after its publication in the Royal Gazette. This revision introduces significant changes to the classification and management of hazardous chemicals. These changes will affect manufacturers, importers, exporters, and stakeholders throughout the global chemical industry. The changes aim to enhance public safety, environmental protection, and regulatory compliance. 

Revocations: Key Substances Removed 

In the latest revision, two hazardous substances have been officially removed from the hazardous substances list. These substances were previously classified as hazardous but will no longer be subject to regulatory control. 

The first revocation involves plant extracts used for pest control, including substances such as neem, galangal, and citronella, which were previously listed under List 1.2 and controlled by the Department of Agriculture. The second revocation affects citronella oil, a substance previously listed under List 4.1 under the jurisdiction of the Food and Drug Administration (FDA). With these revocations, the Ministry of Industry has reclassified these substances, removing them from the list of regulated hazardous substances. 

Revised Control Measures for 17 Hazardous Substances 

In addition to the revocations, the announcement also includes extensive revisions to the control measures for 17 other hazardous substances. These revisions affect substances listed under the control of several government agencies. Notably, 10 substances under the Department of Industrial Works (List 5.1) have had their control measures updated, along with several substances under the Department of Agriculture (Lists 1.1 and 1.2) and the Food and Drug Administration (Lists 4.1 and 4.2). These changes reflect ongoing efforts to align Thailand’s regulatory framework with international safety standards and to address evolving concerns regarding chemical safety and environmental risks. 

New Hazardous Substances Added to the List 

Two new substances have been added to the hazardous substances list. Both pentachlorobenzene (CAS No. 608-93-5) and hexachlorobutadiene (CAS No. 87-68-3) are now classified under List 1.1 and are under the regulatory control of the Department of Agriculture. The inclusion of these substances signals Thailand's proactive approach to managing emerging chemical risks and ensuring that potentially harmful substances are adequately regulated. 

Implications for Global Chemical Industry Stakeholders 

The changes to Thailand’s hazardous substances list have important implications for the global chemical industry. Manufacturers, importers, exporters, and anyone involved in the trade or handling of hazardous chemicals must ensure compliance with the updated regulations. In particular, businesses dealing with substances that have been revoked or added to the list must take immediate action. For substances that have been added to the list, businesses will need to apply for permits and registrations within 30 days from the date of publication in the Royal Gazette. Companies managing previously listed chemicals should also ensure that they comply with the revised control measures. 

On 3 March 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) notified the World Trade Organization (WTO) of draft revisions to the Industrial Safety and Health Act (ISHA) aimed at enhancing the delivery of safety data sheets (SDSs). The MHLW has made significant changes to the Safety Data Sheets content aiming to improve the safety of employees when handling hazardous chemicals.  

Background on ISHA: Delivery of Documents 

Under Article 57-2 of ISHA, the delivery of documents such as labels or safety data sheets is crucial for hazardous chemicals. Exposure to these chemicals might cause harm or side effects to employees working on-site. Transferors and suppliers are obliged to provide updated SDSs to the personnel working there. 

Key Provisions in the Draft Revision  

The MHLW has made the following three provisions in the draft notice for SDS delivery: 

1. Establishment of a punitive clause for non-compliance with hazard statement notifications for transferors/providers of chemical substances. 

2. Changes to the notification provisions for transferors and providers will become the new obligatory regulations.  

3. Allows notification using alternative names for confidential business information. Obligations to record and maintain information on ingredients, provide information to doctors, and report to labour standards inspection agencies. 

Comment Period and Enforcement Dates 

Stakeholders are invited to submit comments on this draft notice till 2 May 2025. The Ministry has not yet confirmed the adoption date of these provisions, but has released the scheduled enforcement dates. 

On 6 March 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) released the final enforcement notice for the Revised Criteria for Poisonous and Deleterious Substances and related provisions. The MHLW published the notice via Pharmaceuticals and Medical Devices Agency Notification No. 0306-6 on the notification portal of Japan’s National Institute of Health Sciences (NIHS). This enforcement took effect on the same day that the MHLW published the notice. 

For background on the draft criteria and consultation process, see the original news here. 

Brazil’s National Health Surveillance Agency (Anvisa) has opened Public Consultation No. 1,313, seeking public input on a proposed Normative Instruction that defines how companies must transmit and manage data under the Unique Device Identification (UDI) system for medical devices. Contributions can be submitted until May 26, 2025.

Background: What Is RDC No. 591/2021?

The consultation stems from Collegiate Board Resolution (RDC) No. 591, issued in December 2021, which introduced Brazil’s UDI framework for medical devices. The regulation aims to enhance the traceability, safety, and post-market surveillance of medical products by requiring that each device be assigned a unique identifier.

RDC 591/2021 mandated that UDI data must be transmitted to a centralized Anvisa database, but the obligation would only begin once Anvisa officially confirmed that its system was ready to receive such data.

Why This Public Consultation?

Public Consultation No. 1,313 fulfills that requirement. It:

• Announces that Anvisa’s UDI database (SIUD) is now operational and capable of receiving UDI data.

• Presents a draft Normative Instruction detailing the technical and procedural requirements for transmitting this data.

• Invites stakeholders—such as manufacturers, importers, and healthcare entities—to review and comment on the proposed framework before it is finalized.

Key Elements of the Draft Normative 

The Normative Instruction establishes:

• Two methods for UDI data transmission: individual or bulk submission.

• Company responsibilities, including the option to authorize third-party users to submit data on their behalf.

• Rules for data modification, publication, and device discontinuation.

• A timeline for mandatory compliance, based on the risk classification of each medical device as outlined in RDC 591/2021.

Devices already on the market may have their UDI data submitted voluntarily, even before mandatory deadlines apply.

How to Participate

Comments can be submitted via Anvisa Portal: Contribution Form

Submissions are public and will be available for review after the consultation closes.  Once the consultation period ends, Anvisa will analyze the input and publish the final version of the Normative Instruction, which is expected to take effect on July 1, 2025. The agency also plans to release detailed implementation guides and a user manual for the SIUD system.

This marks a significant step toward strengthening Brazil’s regulatory infrastructure for medical devices and aligning with international best practices for UDI implementation.

The Government of El Salvador has officially adopted the sixth revised edition of the Globally Harmonized System (GHS) of classification and labelling of chemicals (GHS 6), marking a significant step toward enhanced chemical safety and regulatory alignment with international standards.

"Decree No. 1, issued by the Ministry of Environment and Natural Resources (MARN), was published on 29 January 2025 in El Salvador’s Diario Oficial, enacting the Reglas Técnicas para la Introducción, Distribución y Almacenamiento de Sustancias Conforme al Sistema Globalmente Armonizado de Clasificación y Etiquetado de Productos Químicos (Technical Rules for the Introduction, Distribution, and Storage of Substances in Accordance with the Globally Harmonized System of Classification and Labeling of Chemicals)."

These technical rules establish the mandatory framework for classifying chemical substances and mixtures, as well as requirements for labelling and safety data sheets. The regulation will come into force one year after its publication, on 29 January 2026, improving the protection of public health and the environment, and facilitate trade of chemical products. This measure aligns El Salvador with global chemical safety practices as outlined by the United Nations' GHS framework. 

On January 21, 2025, the African Development Bank (AfDB) approved a new initiative, to address the problem of waste and hazardous chemicals in 11 African nations. The project focuses on the management of hazardous substances that are harmful to both humans and the environment, such as mercury and persistent organic pollutants (POPs). 

About the African Development Bank (AfDB) 

Established in 1964, the AfDB works to promote economic growth and reduce poverty throughout Africa. It provides financial and technical support to help improve infrastructure, fight climate change, strengthen food security, and integrate African economies. 

Increasing Investment for Chemicals and Waste Management in Africa: AFLDC-2 Project Overview 

The new initiative, entitled “Scaling-up Investment and Technology Transfer to Facilitate Capacity Strengthening and Technical Assistance for the Implementation of the Stockholm and Minamata Conventions in African LDCs – Phase 2” (AFLDC-2) will focus on improving chemicals and waste management in Angola, Ethiopia, Gambia, Guinea, Liberia, Mauritania, Senegal, Sierra Leone, Togo, Uganda, and Zambia. 

The project, the first of its kind by the African Development Bank, aims to strengthen national capacities, reduce toxic emissions, and eliminate stockpiles of obsolete chemicals. The project will also support compliance with international environmental agreements such as the Stockholm and Minamata Conventions, which set rules for the management of harmful chemicals. 

The Global Environment Facility (GEF) is providing a $21.3 million grant to help fund the project, with additional support coming from various AfDB-backed initiatives in urban development, agriculture, and agro-industries. 

Gareth Phillips, the AfDB’s Manager for Climate and Environment Finance, expressed his excitement about the approval, calling it a significant step in Africa's efforts to build a cleaner, healthier, and more resilient Africa. 

Conclusion 

The African Development Bank's approval of the AFLDC-2 project represents an important step forward in tackling the escalating issue of hazardous chemicals and waste management in Africa's least developed countries. By prioritizing capacity building, minimizing toxic emissions, and facilitating adherence to international environmental conventions, the project is set to yield enduring advantages for public health and the ecosystem. With financial support from the GEF and various initiatives from the AfDB, the project is well positioned to achieve substantial progress toward a cleaner, healthier, and more sustainable future for the involved nations. The AfDB's leadership in this transformative initiative underscores its dedication to promoting environmental and economic resilience across Africa. 

The National Environment Agency (NEA) of Singapore has launched a public consultation to seek feedback on the proposed regulation of Chlorpyrifos, Paraquat, and Paraquat salts in all concentrations and all preparation forms as hazardous substances under the Environmental Protection and Management Act (EPMA) and its related regulations. This consultation, open from February 27 to March 27, 2025, invites stakeholders to share their views on these proposed controls.

Background on Chlorpyrifos and Paraquat

Chlorpyrifos (CAS No 2921-88-2) is an organophosphate pesticide that is widely used to control various insect pests in agriculture. However, concerns have been raised about its persistence in the environment and potential adverse effects on human health. Similarly, Paraquat (CAS No 1910-42-5) is a herbicide known for its efficacy in weed control but poses significant toxicity risks if mishandled.

International Assessments and Recommendations

In September 2024, the Rotterdam Convention’s Chemical Review Committee (CRC) evaluated both Chlorpyrifos and Paraquat and determined that they met the criteria for inclusion in Annex III of the Convention under the pesticide category. This inclusion would subject these chemicals to the Prior Informed Consent (PIC) procedure, thereby promoting shared responsibility for their international trade. Proposals to list these substances will be discussed at the 12th Conference of the Parties (COP-12) to the Rotterdam Convention, which will take place from April 28 to May 9, 2025.

In addition, the Stockholm Convention’s Persistent Organic Pollutants Review Committee (POPRC) identified Chlorpyrifos as a persistent organic pollutant (POP) in September 2024. The committee noted its high toxicity to aquatic invertebrates and potential adverse effects on mammals. As a result, the POPRC will recommend to the COP-12 of the Stockholm Convention that Chlorpyrifos be listed in Annex A with the aim of eliminating of its production and use, with specific exemptions for certain pest and crop control applications.

Proposed Regulatory Changes in Singapore

In line with these international developments, NEA proposes to regulate Chlorpyrifos, Paraquat, and Paraquat salts at all concentration levels and in all preparation forms as hazardous substances under the EPMA and the Environmental Protection and Management (Hazardous Substances) Regulations. Currently, these chemicals are regulated with certain exemptions based on concentration and preparation forms. The proposed amendments aim to remove these exclusions and list Chlorpyrifos separately as a specific hazardous substance, rather than grouping it under phosphorus compounds.

Under these proposed controls, activities involving these chemicals - including manufacture, import, export, purchase, sale, use, transport, and storage - would require a Hazardous Substances Licence or Permit from NEA. NEA plans to gazette these regulatory changes by May 2025, followed by a six-month transition period before they come into force in October 2025.

Call for Public Feedback

NEA is seeking feedback on the potential impacts of these proposed controls, the requirement for Prior Informed Consent for transboundary movements of these chemicals, and a potential future ban on Chlorpyrifos if adopted by the Stockholm Convention. Stakeholders and interested parties are encouraged to submit their feedback by March 27, 2025.

This consultation underscores Singapore's commitment to protecting the environment and public health by aligning its regulatory framework with international standards on hazardous substances.