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GHS Report

GPC Newsletter Feb-2025



Regulatory News

Environment and Climate Change Canada (ECCC) has launched a public consultation on proposed amendments to the Export of Substances on the Export Control List Regulations. The consultation will runs from December 16, 2024, to March 1, 2025, and seeks feedback on changes to improve regulatory clarity, reduce administrative burdens, and enhance Canada’s compliance with international agreements.

 

Background and Regulatory Evolution

First introduced in 2013 under the Canadian Environmental Protection Act, 1999 (CEPA), the regulations were designed to fulfill obligations under international conventions such as the Rotterdam Convention, the Stockholm Convention, and the Minamata Convention. Incremental amendments were made in 2017 to incorporate mercury controls and in 2018 to regulate asbestos exports. However, a comprehensive review in 2024 revealed areas for improvement, prompting the current proposed amendments.

 

Key Objectives of the Proposed Amendments

The proposed amendments aim to address three primary issues identified during the review process: a lack of clarity and readability in the regulations, the administrative burden associated with export notifications, and challenges in effectively implementing Canada’s obligations under international conventions. To address these issues, ECCC has published a consultation document to gather feedback from stakeholders and the public on how to effectively modernize and streamline the regulatory framework.

 

Structure and Scope of the Export Control List

The Export Control List (ECL), which forms the basis of the regulations, categorizes substances into three parts.

  • Part 1 substances are prohibited for use in Canada and may only be exported for destruction or under specific ministerial direction.

  • Part 2 substances require notification or consent from importing countries under agreements such as the Rotterdam Convention.

  • Part 3 substances are subject to domestic restrictions but may still be exported under certain conditions.

The regulations aim to ensure that exports comply with Canada’s domestic and international commitments.

 

Proposed Changes to Improve Clarity and Readability

One significant focus of the amendments is to improve the clarity and readability of the regulations. This includes reorganizing the text to group similar provisions together, simplifying the language, and ensuring that exporters can easily identify prohibited activities. For instance, provisions related to the Minamata Convention, which currently appear later in the regulations, would be moved earlier for better visibility. The proposed changes also include standardizing terminology across provisions, such as those related to laboratory use exemptions.

 

Simplifying the Export Notification Process

Another key area of reform is the simplification of the notification process for exporting substances. The current system requires exporters to submit detailed notices of proposed export, including estimated quantities, which can be burdensome, especially for substances found in multiple products. The ECCC proposes to allow exporters to submit a single notice for multiple shipments within a calendar year and to remove the requirement to estimate quantities for certain scenarios. These changes are intended to reduce the administrative burden while maintaining the necessary oversight to meet regulatory objectives.

 

Modernization Efforts

Modernization is also a priority in the proposed amendments. The ECCC seeks to integrate electronic submission systems and update definitions to align with other federal regulations. These efforts are designed to make compliance more efficient and user-friendly for stakeholders.

 

Strengthening Compliance with International Conventions

The amendments also focus on strengthening Canada’s compliance with international conventions. Under the Stockholm Convention, for example, the proposals include the collection of additional information for exports of persistent organic pollutants (POPs) intended for destruction, such as details about the disposal facility and method. For the Rotterdam Convention, the ECCC suggests streamlining the permitting process to ensure that all exports requiring prior informed consent are adequately monitored. Similarly, the amendments propose stricter controls on mercury-containing products under the Minamata Convention to align with domestic regulations and international obligations.

 

How to Submit Feedback

The ECCC is inviting stakeholders to provide feedback on these proposals, including suggestions for further improvements. Specific questions have been raised regarding the clarity of the regulatory language, the challenges faced in submitting notices, and additional scenarios where regulatory requirements could be streamlined. The input gathered during this consultation will be used to inform the final amendments, which are expected to be published in the Canada Gazette after March 2025.

Submissions can be made via email or phone, and stakeholders are encouraged to review the accompanying guidance documents for detailed information. This consultation is an important opportunity to shape the future of Canada’s export control regulations to ensure they remain effective, efficient, and aligned with international best practices.

The Canadian Environmental Protection Act, 1999 (CEPA) governs the assessment and management of substances that may pose a risk to human health or the environment. On December 7, 2024, the Minister of the Environment and the Minister of Health issued Significant New Activity (SNAc) Notice No. 21862, under Section 85 of CEPA for phosphoric acid, mixed decyl and octyl esters, potassium salts (CAS no: 70879-47-9). The Notice outlines specific conditions of use to ensure that potential risks are effectively managed.

 

Key Highlights of the SNAc Notice

Substance Details

The substance regulated under this Notice is:

  • Name: Phosphoric acid, mixed decyl and octyl esters, potassium salts

  • CAS RN: 70879-47-9

This substance is not currently listed on the Domestic Substances List (DSL) and significant new activities involving it may result in risks to the environment or human health as defined in Section 64 of CEPA.

Purpose of the Notice

The purpose of this Notice is to:

  • Identify activities that may require further risk assessment before proceeding.

  • Outline mandatory information requirements for proposed new uses.

  • Ensure compliance with CEPA’s precautionary approach to chemical safety.

 

Significant New Activities Defined

Activities Requiring Notification

The Notice specifies that a Significant New Activity (SNA) includes:

  1. Manufacture or Distribution of Cosmetics:

    • Use of the substance in cosmetics in concentrations greater than 1% by weight.

    • Quantities of 10 kg or more per calendar year in products intended for sale.

  2. Excluded Uses:

    • Research and development or use as a site-limited intermediate.

    • Manufacture of products intended solely for export.

Information Requirements

Individuals or organizations intending to conduct a significant new activity must submit a Significant New Activity Notification (SNAN) to the Minister of the Environment. Required information includes:

  • Description of the Proposed Activity: A detailed outline of the significant new activity involving the substance.

  • Anticipated Annual Quantities: Estimated volume of the substance to be used or distributed.

  • Toxicological Data: Information on eye and skin irritation, dermal penetration, and any other relevant toxicity assessments.

  • Environmental and Human Health Impact: Documentation identifying potential adverse effects and assessing exposure risks.

  • Contact Details: Name, address, and contact information of the notifier and its Canadian representative (if applicable).

  • Certification Statement: A signed declaration confirming the accuracy and completeness of the information provided.

Review Process

The SNAN will be reviewed by the Department of the Environment and the Department of Health within 90 days of a complete submission.

 

Transitional Provisions

To facilitate compliance, transitional provisions are in place until December 7, 2025. During this period, significant new activity thresholds are as follows:

  • Manufacturing or Distribution Threshold: Quantities of up to 100 kg per year may be used in cosmetics in concentrations greater than 1% by weight.

From December 8, 2025, the threshold will revert to 10 kg per year for similar activities.

 

Compliance and Enforcement

Reporting Obligations

Entities engaging in activities involving the substance must comply with reporting requirements, including:

  • Submitting timely and accurate SNANs.

  • Reporting new information that indicates the substance is toxic or may become toxic under Section 70 of CEPA.

Transfers of Possession Obligations

Those who transfer physical possession or control of the substance must inform recipients of compliance requirements, including obligations under the SNAc Notice.

Pre-Notification Consultation (PNC)

Organizations or individuals are encouraged to consult with the regulatory authorities during the planning phase of their activities to clarify data requirements and regulatory expectations.

On January 2, 2025, the U.S. Environmental Protection Agency (EPA) finalized it's risk evaluation for formaldehyde under the Toxic Substances Control Act (TSCA). The Agency concluded that formaldehyde poses an unreasonable risk of harm to human health under various conditions of use. Widely present in everyday products and the environment, formaldehyde has been linked to significant health risks, especially for workers and consumers exposed over time. 

Understanding Formaldehyde Exposure 

Formaldehyde (CAS No 50-00-0) is a common industrial chemical found in products such as adhesives, paints, textiles, and construction materials. It is also a byproduct of combustion processes such as car emissions and stove operations and is naturally released during the decomposition of organic materials. 

Due to its widespread presence, most people are exposed to formaldehyde in both indoor and outdoor environments, primarily through inhalation or skin contact. Common sources include composite wood furniture, adhesives, and various household products. Workers in manufacturing and processing environments are at the greatest risks, particularly without adequate protective equipment. Additionally, consumers who use products such as crafting supplies, automotive care products, or new leather goods may encounter health hazards, particularly when the products are new and emit higher concentrations of formaldehyde. 

Health Impacts Identified by EPA 

EPA's evaluation highlighted both short-term and long-term health risks: 

  • Short-term (acute) exposure can cause sensory irritation, including inflammation of the eyes and respiratory tract, which typically resolves after exposure ends. 

  • Long-term (chronic) exposure is linked to reduced lung function, increased risk of asthma and allergies, and cancer. Formaldehyde is a known carcinogen, with prolonged inhalation posing significant cancer risks, especially for workers. Skin contact with materials containing formaldehyde can also trigger allergic reactions. 

Conditions of Use and Findings 

EPA examined 68 conditions of use (COU) for formaldehyde and found that 50 occupational and 8 consumer COUs contribute significantly to unreasonable risks. While some risks were identified from chronic exposure to air near industrial facilities, they were deemed minimal due to natural degradation, modeling uncertainties, and upcoming regulations. Additionally, formaldehyde poses no significant environmental risks as it breaks down quickly in water, soil, and sediment, minimizing its impact on plants, animals, and ecosystems. 

What’s next? 

EPA will now initiate the risk management process under TSCA Section 6 to address the risk of formaldehyde. This will include proposing new rules to protect workers and consumers and ensure safer chemical management across industries. 

 

On January 3, 2025, the U.S. Environmental Protection Agency (EPA) expanded the Toxics Release Inventory (TRI) by adding nine per- and polyfluoroalkyl substances (PFAS). The nine PFAS were added to the TRI list as part of the Fiscal Year 2020 National Defense Authorization Act (NDAA), which mandates annual updates based on specified EPA activities. For the 2025 reporting year, facilities are required to track and submit reports on their use, release, or waste management of these PFAS by July 1, 2026, bringing the total number of PFAS subject to TRI reporting to 205. 

TRI data helps communities, organizations, and agencies track local chemical management, supporting transparency, accountability, and informed decision-making for families, workers, and communities nationwide. 

New additions 

The 2020 NDAA provision automatically adds PFAS to the TRI list after the agency finalizes their toxicity values.  

The nine PFAS which were added for 2025 after EPA finalized toxicity values in 2024, with identities not marked as confidential are: 

  • Ammonium perfluorodecanoate (PFDA NH4) (CAS no. 3108-42-7) 

  • Sodium perfluorodecanoate (PFDA-Na) (CAS no. 3830-45-3) 

  • Perfluoro-3-methoxypropanoic acid (CAS no. 377-73-1) 

  • 6:2 Fluorotelomer sulfonate acid (CAS no. 27619-97-2) 

  • 6:2 Fluorotelomer sulfonate anion (CAS no. 425670-75-3) 

  • 6:2 Fluorotelomer sulfonate potassium salt (CAS no. 59587-38-1) 

  • 6:2 Fluorotelomer sulfonate ammonium salt (CAS no. 59587-39-2) 

  • 6:2 Fluorotelomer sulfonate sodium salt (CAS no. 27619-94-9) 

  • Acetic acid, [(γ-ω-perfluoro-C8-10-alkyl)thio] derivatives., Bu esters (CAS no. 3030471-22-5) 

Review of confidential business information 

Under NDAA Section 7321(e), EPA must review Confidential Business Information (CBI) claims before adding a PFAS to the TRI list if its identity is protected under 5 U.S.C. 552(a). Starting January 1, 2025, facilities must track activities involving these PFAS, with reports due by July 1, 2026. All PFAS on the TRI list, now 205 in total, are classified as chemicals of special concern, removing small concentration reporting exemptions.

On 21 January 2025, the European Chemicals Agency (ECHA) updated the Candidate List of Substances of Very High Concern (SVHC) to a total of 247 substances. The latest update includes five newly identified chemicals with potential risks to human health and the environment and a revision of one existing entry.

 

New Additions to the Candidate List

ECHA has identified the following substances on the basis of their hazardous properties:

  • 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid (EC: 701-118-1, CAS: 2156592-54-8)

    • Classified as toxic for reproduction under Article 57(c) of REACH.

    • Used in lubricants, greases, release products, and metalworking fluids.

  • O,O,O-triphenyl phosphorothioate (EC: 209-909-9, CAS: 597-82-0)

    • Classified as persistent, bioaccumulative, and toxic (PBT) under Article 57(d) of REACH.

    • Used in lubricants and greases.

  • Octamethyltrisiloxane (EC: 203-497-4, CAS: 107-51-7)

    • Classified as very persistent and very bioaccumulative (vPvB) under Article 57(e) of REACH.

    • Found in cosmetics, personal/health care products, pharmaceuticals, washing and cleaning products, and sealants.

  • Perfluamine (EC: 206-420-2, CAS: 338-83-0)

    • Identified as vPvB under Article 57(e) of REACH

    • Used in the manufacture of electrical, electronic, and optical equipment.

  • Reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives (EC: 421-820-9, CAS: 192268-65-8)

    • Classified as PBT under Article 57(d) of REACH.

    • No active registrations under REACH.

 

Updated Entry

  • Tris(4-nonylphenyl, branched and linear) phosphite

    • Now recognized for endocrine disrupting properties impacting the environment.

    • Used in polymers, adhesives, sealants, and coatings.

 

Implications for Companies

The inclusion of these substances give rise to a number of obligations under REACH, including:

  • Information Requirements: Suppliers must provide safety information to customers and consumers if a substance is present in an article above 0.1% w/w.

  • Notification Obligations: Importers and manufacturers of articles containing these substances must notify ECHA within six months of the listing date (by 21 July 2025).

  • Safety Data Sheet Updates: EU and EEA suppliers must revise safety data sheets to reflect the inclusion.

  • Waste Framework Directive Compliance: Companies must report the presence of SVHCs to ECHA’s SCIP database.

  • EU Ecolabel Restrictions: Products containing SVHCs are not eligible for Ecolabel certification.

 

Next Steps

Substances on the Candidate List may be considered for inclusion in the Authorisation List, requiring companies to seek approval for continued use.

For more details, visit the Candidate List of SVHCs here.

On 21 January 2025, the European Chemicals Agency (ECHA) published a new infographic to help companies manage their Unique Formula Identifiers (UFIs) effectively. The infographic provides guidance on how to ensure that UFIs included in Poison Centre Notifications (PCNs) are accurate and comply with the 'one UFI – one composition' principle.

 

Understanding the 'One UFI – One Composition' Principle

The 'one UFI – one composition' principle requires that each UFI corresponds to a single, specific mixture composition. Recent reports from Member States have identified cases where the same UFI was assigned to different mixture compositions, a practice that is prohibited. Such mismanagement can prevent poison centre operators from providing accurate information in emergencies and can lead to regulatory non-compliance and enforcement actions.

 

Guidelines for Proper UFI Management

To avoid problems related to UFI mismanagement, ECHA recommends that companies:

  • Establish Clear Internal Processes: Implement structured procedures within the organisation to systematically manage UFIs.

  • Maintain Good Practices with Third Parties: Ensure effective communication and collaboration with suppliers, distributors, and other stakeholders in the supply chain.

  • Use Available Tools and Support: Use the resources provided by ECHA, such as the UFI Generator tool and guidance documents, to facilitate the correct assignment and management of UFIs.

 

Upcoming Enforcement Actions

Starting in January 2025, EU inspectors have launched a six-month pilot project to verify notifications for hazardous mixtures. The inspections will include checks of mixture labels and, where necessary, Safety Data Sheets, to ensure compliance with UFI regulations.

 

Access the UFI Management Infographic

For a visual guide and more detailed advice on proper UFI management, companies can access ECHA’s newly published infographic here.

By following these guidelines and using the resources available, companies can ensure compliance with UFI regulations, thereby facilitating accurate and efficient emergency responses by poison centres.

On 16 January 2025, the UK notified the World Trade Organization (WTO) of its draft Cosmetic Products (Restriction of Chemical Substances) Regulations 2025. The regulation, which is expected to be adopted on 31 March 2025 and come into force on 30 September 2025, will restrict the use of methyl salicylate in cosmetic products in Great Britain (England, Scotland and Wales). A transitional period will allow products placed on the market before 30 September 2025 to remain available until 31 March 2026.

 

Methyl Salicylate: Uses and Regulatory Status

Methyl salicylate (CAS No. 119-36-8), also known as wintergreen oil, is widely used in topical analgesics, cosmetics, and personal care products for its soothing and aromatic properties. It is commonly found in pain relieving creams, mouthwashes, deodorants, and food flavouring agents. However, methyl salicylate is classified as a Category 2 CMR (Carcinogenic, Mutagenic, or Reproductive Toxicant) under the EU’s Classification, Labelling and Packaging (CLP) Regulation (Regulation (EC) No 1272/2008), leading to regulatory restrictions to ensure consumer safety. Appropriate use and concentration limits are essential to prevent potential health risks associated with overexposure.

 

Scope and Regulatory Amendments

The Regulation will amend Annex 3 of the Cosmetics Regulation (Regulation (EC) No 1223/2009) by adding new restrictions on methyl salicylate in various cosmetic products, including:

  • Rinse-off products (except hand wash products): Maximum concentration of 0.02% for children aged 0.5 to 1 year and 0.06% for older children and adults.

  • Hand wash products: 0.02% for children aged 0.5 to 1 year and 0.6% for older children and adults.

  • Leave-on skin products: 0.02% for children aged 0.5 to 1 year and 0.06% for older children and adults.

  • Lipsticks and lip balms: 0.02% for children aged 0.5 to 1 year and 0.03% for older children and adults.

  • Face makeup products: Maximum concentration of 0.05%.

  • Eye makeup products and makeup removers: Maximum concentration of 0.002%.

  • Toothpaste: Maximum concentration of 2.5%.

  • Mouthwash: 0.1% for children aged 6 to 10 years and 0.4% for older children and adults.

  • Deodorant spray/aerosol products: Maximum concentration of 0.003%.

  • Hair products: Maximum concentration of 0.009%.

 

Scientific Basis and Justification

The restrictions follow the recommendations of the Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS), which considered methyl salicylate to be safe for use in cosmetics at certain concentration limits, despite its classification as a Category 2 CMR substance under Regulation (EC) No 1272/2008.

 

Comment Period and Availability of Documents

Stakeholders have 60 days from the date of notification to submit comments. For further details, visit the official WTO notification page here.

The Revolving Fund Directorate of the Ministry of Environment, Urbanization, and Climate Change has published the KKDIK registration fees for 2025. The fees show significant increase of up to 60 % compared to 2024. On average, the fees have increased by 44%, with a maximum increase of 60% in Turkish Lira (TL).

 

Current Fee Ranges

Fees are determined by company size, tonnage band, and whether the submission is joint or individual. The pricing strongly incentivizes companies to opt for joint registration in order to minimize costs.

  • Small and Medium Enterprises (SMEs) jointly registering substances in the 1-10 tonnage band will pay fees starting from 260 TL/€ 7.

  • Large enterprises registering substances in the 1000+ tonnage band will face fees up to 61,890 TL/€ 1,684.

 

Joint Submission Fees for 2025 (in Euros): 

Tonnage Band (TPA)

Large

Medium

Small

Micro

1-10

€106

€ 43

€ 22

€ 7

10-100

€ 245

€ 127

€ 65

€ 14

100-1000

€ 705

€ 278

€139

€ 22

1000+

€ 1,684

€ 705

€ 396

€ 70

 

Equivalent Fees in Turkish Lira (₺):

Tonnage Band (TPA)

Large

Medium

Small

Micro

1-10

3,890 ₺

1,580 ₺

790 ₺

260 ₺

10-100

9,000 ₺

4,680 ₺

2,370 ₺

500 ₺

100-1000

25,910 ₺

10,220 ₺

5,110 ₺

790 ₺

1000+

61,890 ₺

25,910 ₺

14,540 ₺

2,590 ₺

 

Important Reminder

If you haven't yet completed the pre-registration of your substances, it is crucial that you do so in order to join the Substance Information Exchange Forum (SIEF) and benefit from joint registration opportunities.

For more details on the updated KKDIK registration fees for 2025 and revised deadlines, please contact GPC.

India’s Department of Chemicals and Petrochemicals (DCPC) has extended the enforcement date of the Quality Control Orders (QCOs) for three chemical products: Toluene, Poly Vinyl Chloride (PVC) Homopolymers and Polypropylene (PP) materials for moulding and extrusion.  

The notifications were published in the Gazette of India on 23 December 2024 for Toluene and on 24 December 2024 for Poly Vinyl Chloride (PVC) Homopolymers and Polypropylene (PP) Materials for Moulding and Extrusion, in consultation with the Bureau of Indian Standards (BIS).  

 

Background on QCOs 

The QCOs for Poly Vinyl Chloride (PVC) Homopolymers and Polypropylene (PP) materials were first issued on 26 February 2024 and were originally scheduled to take effect on 8 August 2024. These orders were later amended on 23 August 2024, with the enforcement date scheduled for 24 December 2024.  

The QCO for Toluene was first issued on 24 December 2021 and were originally scheduled to take effect on 22 June 2022. This order has been amended several times, most recently on 19 December 2023, with an enforcement date of 22 December 2024. 

  

Revised Implementation Dates for the Chemical Products. 

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

Products  

Indian Standards  

Revised Implementation Date  

Poly Vinyl Chloride (PVC) Homopolymers 

IS 17658: 2021 Polyvinyl Chloride (PVC) Homopolymers- Specification 

24 June 2025  

Polypropylene (PP) Materials for Moulding and Extrusion 

IS 10951 : 2020 Specification for Polypropylene (PP) Materials for Moulding and Extrusion 

24 June 2025  

Toluene 

IS 537: 2011 Toluene Specification 

22 December 2025  

  

 

Compliance Requirements 

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

On December 13, 2024, China’s Department of Food Safety Standards and Risk Monitoring and Assessment announced that two substances, have passed the safety assessment for use in food contact materials (FCMs) as new varieties. The safety evaluation was conducted by an expert review organized by the relevant regulatory body in accordance with the requirements of the Food Safety Law of the People's Republic of China.

 

Background Information

Under China’s Food Safety Law, any substance intended for use in food contact materials and articles must undergo a rigorous safety evaluation before approval. This ensures that materials meet strict standards for safety and suitability for contact with food.

 

Newly Approved Substances

The safety evaluations resulted in the approval of the following two substances:

  1. 1,3,5-Trimethyl-2,4,6-Tris(3,5-Di-tert-butyl-4-hydroxybenzyl)benzene (CAS No 1709-70-2): Approved as an additive for use in carbon monoxide-ethylene-propylene terpolymer plastic materials and products.

  2. Poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) (CAS No 147398-31-0): Approved for use in polyhydroxyalkanoate (PHA) plastic materials and products intended to come into contact with food. However, its use is subject to the following conditions:

  • It cannot be used in applications where the temperature exceeds 100°C.

  • It must not be used in the manufacture of food contact materials and products intended for infants.

  • The material must comply with GB 4806.6-2016, China's national food safety standard.

 

For further information, please refer to the complete announcement and attached documentation here.

 

On November 28, 2024, China’s State Administration for Market Regulation published GB/T 45091-2024, a national standard outlining restricted substances in recycled plastics. Effective from June 1, 2025, the standard provides guidelines for classification, requirements, and testing to ensure material safety.

 

Development and Scope

The standard, titled "Plastics – Requirements for Restricted Substances in Recycled Plastics," was developed by the Plastic Recycling Branch of the China Synthetic Resin Association (CPRRA).  The drafting process progressed rapidly from its initiation in April 2024 with a public consultation on the draft completed by August 2024.

The standard covers recycled plastic pellets and finished products made from waste plastics through processes such as screening, sorting, crushing, washing, and extrusion or modification. It also covers recycled polyethylene terephthalate (PET) bottle flakes. However, it excludes recycled plastics derived from hazardous waste sources such as medical waste, pesticide packaging, and radioactive materials, as well as recycled plastics intended for food contact or pharmaceutical packaging applications.

 

Key Provisions

The standard defines "restricted substances" as materials that are prohibited or restricted by law, regulation, or standard in recycled plastics . These substances are not necessarily classified as hazardous or harmful chemicals, but are restricted to ensure the safety, environmental sustainability, and performance of recycled plastics.

Restricted substances are divided into two categories:

  1. Voluntarily Declared Substances:

    • Manufacturers or importers are required to declare that recycled plastics, whether domestically produced or imported, do not contain certain restricted substances.

  2. Regulated Substances with Specific Limits:

    • The standard mandates monitoring and adherence to specific limits for substances classified as restricted under regulatory oversight.

For more details, visit the National Public Service Platform here.

Since January 1, 2025, South Korea has been enforcing updated registration standards for new chemical substances under K-REACH. This update aligns with National Policy Task 68 (Safe Food, Healthy Living Environment), which focuses on differentiated management based on the risk level and quantity of hazardous chemicals. 

 

Key Changes: 

  • Registration Threshold: The threshold for manufacturing and importing these substances will increase from 0.1 to 1 tonne per year. 

  • Hazard Categorization: The current definition of 'toxic substance' will be removed. Instead, substances will be categorized according to their hazardous characteristics, leading to a risk-based management system. Categories include: 

         - Acutely hazardous substances for humans 

         - Chronically hazardous substances for humans 

         - Substances harmful to ecology 

  • Safety Enhancements:  

         - Expand disclosure of information on registered and reported chemical substances. 

         - Strengthen the reporting system. 

These changes aim to reduce the registration burden on companies while enhancing public safety and transparency. 

 

Policy Overview Highlights: 

  • Revised registration standards for new chemical substances (from 0.1 tonne to 1 tonne per year). 

  • New procedures for disclosure, reporting data adjustment, and adequacy review. 

  • Defined management principles for substances with unidentified hazards. 

 

Effective Dates: 

January 1, 2025, and August 7, 2025. 

On 2 January 2025, the Korean Cosmetic Association (KCA) announced that customized cosmetics must be reported before 28 February 2025. 

 

Reporting of customized cosmetics material 

The KCA has issued a reminder of the annual reporting obligations for personalized cosmetics outlined in Article 5, Paragraph 6 of the Cosmetics Act, and Article 13 of its Enforcement Regulations.  

The Regulations on Reporting Import Performance and Ingredient List require companies to report a list of ingredients used in customized cosmetics sold in the previous year by the end of February each year.  

Companies must report the raw components used in their personalized cosmetics by 28 February 2025. The KCA recommends that companies follow the appropriate standards and submit their reports via the association's raw material list reporting system by the deadline.  

 

How to report

Companies can apply to report raw materials in cosmetics on the KCA website (www.kcia.or.kr) by submitting the raw material list at the end.  

Key Guidelines for Submission 

The KCA has issued specific instructions for companies submitting ingredient lists for personalized cosmetics, highlighting the need for standardized methods and timely reporting. These include: 

  • Standardized Ingredient Names. 
  • When filling out the "Ingredient Name" form, companies must use normal Korean names for their ingredients. 

  • For combined materials, the constituent components must be identified. 

  • The KCA's online cosmetic ingredient dictionary is provided as a source of standardized nomenclature. 

Marking Products for Export 

  • Products intended for export should be labelled "EXP" in the "usage purpose" section. 

  • If the product is not intended for export, leave this column blank. 

Product Name or Category Reporting Options 

  • Companies can report components using individual product names or categories.  

  • Customized cosmetics with identical ingredients may be grouped into one category, avoiding the need for recurrent reporting. 

Failure to meet this criterion may result in penalties or disruptions to business operations. Companies should move quickly to ensure correct and timely submissions.  

On December 20, 2024, the South Korean Ministry of Environment (MoE) announced the approval of the first 15 biocidal products under the Consumer Chemical Products and Biocides Safety Act (K-BPR). 

 

Background on the approval of biocidal substances and products

  • The K-BPR requires all biocidal substances and products to be tested for safety, and effectiveness, before being placed on the Korean market.  

  • To date, 56 biocidal substances have been approved and 15 biocidal products using these approved substances were approved for the first time, on December 20, 2024.  

 

Approval requirements for relevant products 

  • In addition to these 15 biocidal products, products containing fungicides, pesticides, acaricides, and acaricide types must be approved as biocidal products by December 2025. 

  • If they are not approved, they will be banned from distribution and sale from July 1, 2026. 

 

Sequential evaluation plans

  • The MoE and National Institute of Chemical Safety (NICS) plan to sequentially evaluate the safety and efficacy of 10 types of biocidal substances and products based on the deadlines under the K-BPR Act. 

On January 6, 2025, the Department of Industrial Works (DIW) issued a formal reminder to Category 3 factory operators to comply with the Ministry of Industry’s updated Safety Measures for Chemical Management in Industrial Plants (No. 2), under the B.E. 2566 regulations. This compliance mandate requires factories to report their hazardous chemical use and storage data annually.  

 

What are Category 3 Factories? 

Category 3 factories are industrial facilities with machinery over 50 horsepower, more than 50 workers, or significant pollution generation regardless of workforce size or machinery horsepower. 

 

Reporting Requirements and Deadlines 

Factory operators must submit their hazardous chemical reports to the Ministry of Industry's central data reporting system by April 30, 2025. Reporting is required for all hazardous chemicals in quantities of one tonne or more per year per type. Even facilities that use smaller quantities or no hazardous chemicals are required to report.  

Failure to comply with the reporting requirements may lead to penalties for non-compliance under Section 46 of the Factory Act B.E. 2535, carrying fines of up to 20,000 baht or potential administrative orders, including suspension or closure of the factory. 

 

Guidelines for Reporting to the Ministry of Industry’s Central Data System 

In order to comply with the reporting requirements, operators are required to: 

  • Register with the Ministry of Industry’s i-Industry system, providing their 13-digit business number or national ID/juristic person registration number. 

  1. Add their business and factory details. 

  1. Submit chemical information via the iSingleForm system. 

A user manual and detailed guidance on hazard classification (GHS codes) and storage classification are available via the Ministry's platform. For further assistance, factory operators can access a FAQ section provided by the Department in the user manual. 

 

Promoting Compliance Throughout Thailand’ Industrial Sector 

The Department of Industrial Works urges all factory operators to complete the process within the stipulated time to avoid legal or administrative action. Compliance will help maintain safety and legal compliance throughout Thailand's industrial sector. Businesses that have already fulfilled their obligations were thanked for their cooperation. 

On 10 January 2025, Japan’s National Institute of Technology and Evaluation (NITE) added ingredients used in cosmetics to the country’s Chemical Risk Information Platform (NITE-CHRIP). As a government agency, NITE has been designated to provide chemical management information. NITE added cosmetic ingredients to the CHRIP for the first time in collaboration with the Japan Cosmetic Industry Association (JCIA).   

 

NITE-CHRIP Database 

NITE-CHRIP is a publicly available, free database that allows users or businesses to search for national and international legislation related to chemical substances. The database also provides summaries of compliance procedures along with chemical hazard or risk assessment information. NITE-CHRIP lists more than 250,000 entries, most of which include CAS data available in both Japanese and English.   

 

Regulatory Classification of Cosmetic Ingredients 

Standards for the use of cosmetic ingredients are regulated under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act). 

Cosmetic ingredients are classified into two lists: 

  • Negative List (Appendix 1): Includes substances that are prohibited in cosmetics (excluding Class I and Class II Specified Chemical Substances under the Chemical Substances Control Law (CSCL)). 

  • Positive List: Includes Appendices 2-4 with restricted ingredients, restricted ingredients of preservatives, and restricted ingredients of UV absorbers respectively. 

 

Obligations for Companies 

Companies dealing with such cosmetic ingredients in Japan are required to comply with the standards for cosmetics under the PMD Act. 

The Australian Government has launched the National Circular Economy Framework (NCEF), a landmark initiative designed to double the circularity of Australia’s economy by 2035. This ambitious strategy aims to redefine how resources are used, reused, and regenerated across all industries, promoting environmental sustainability and economic resilience.

 

A Vision for Circularity

The framework envisions a future where economic growth and environmental protection go hand in hand. It outlines plans to transition from a linear “take, make, dispose” model to a circular economy where waste is minimized, and materials are kept in continuous use. With a current circularity rate of 4.6%, below the global average of 7.2%, Australia’s target to double circularity underlines the Government’s commitment to systemic change.

 

Key Objectives and Targets

The NCEF has set three overarching targets:

  1. Reduce the Material Footprint by 10%: By emphasizing sustainable design and longer-lasting materials, Australia aims to reduce its per capita material consumption, which is currently the highest among G20 nations.

  2. Increase Material Productivity by 30%: This will involve optimizing the use of raw materials in production processes, promoting innovation in recycling and manufacturing, and improving supply chain efficiency.

  3. Recover 80% of Resources Safely: By increasing resource recovery rates from the current 63% to 80%, the Framework aims to minimize landfill waste and increase the recycling of critical materials.

 

Addressing Chemicals of Concern

A critical aspect of the Framework is to address chemicals that hinder safe recycling and reuse. The government plans to implement advanced detection technologies and green chemistry to design safer products and ensure confidence in recycled goods. These measures align with the broader vision of creating a toxin-free circular economy.

 

Economic and Environmental Benefits

According to modelling by the Commonwealth Scientific and Industrial Research Organisation (CSIRO), meeting the targets could:

  • Add $26 billion annually to Australia’s GDP by 2035.

  • Reduce greenhouse gas emissions by 14%.

  • Divert 26 million tonnes of material from landfill each year.

By promoting a circular economy, the framework is expected to increase Australia’s competitiveness in global markets for sustainable goods, reduce dependence on virgin materials, and mitigate environmental challenges.

 

Sectoral Focus Areas

The NCEF prioritizes four key sectors:

  • Industry: Promoting the use of recycled materials in manufacturing and investing in durable, reusable goods.

  • Built Environment: Promote the use of sustainable construction materials and refurbish existing structures to reduce waste.

  • Food and Agriculture: Reducing food waste and valorizing agricultural residues for biofuels and other products.

  • Resources: Improving the recovery of critical minerals from mining tailings and end-of-life products.

 

Collaborative Implementation

The framework emphasizes collaboration across governments, businesses, investors, researchers, and individuals. Key initiatives include:

  • Embedding circular principles in public procurement.

  • Investing in advanced recycling technologies and shared infrastructure.

  • Educating consumers about sustainable practices and promoting behavior change.

 

Commitment to Indigenous Knowledge

Recognizing the longstanding stewardship of Aboriginal and Torres Strait Islander peoples, the Framework integrates traditional ecological knowledge into its strategies. This approach ensures that the transition to a circular economy also advances equity and inclusion.

 

A Pathway to Sustainability

The NCEF is Australia’s first comprehensive commitment to a national transition to a circular economy. With its targets, sectoral priorities, and collaborative approach, the framework provides a blueprint for aligning economic progress with environmental stewardship, paving the way for a sustainable future.

On December 27, 2024, ANVISA announced two critical public consultations—No. 1,304 and No. 1,305—aimed at revising regulations for substances used in personal hygiene products, cosmetics, and perfumes. These updates are set to improve consumer safety, align with international standards, and strengthen Brazil’s position in the global cosmetics market.

 

Key Updates in Public Consultations No. 1,304 and 1,305

  • Public Consultation No. 1,304: Focuses on the Restrictive List (Lista Restritiva), which identifies substances permitted for use under specific conditions and limitations. These include preservatives, colorants, filters, and straighteners.

  • Public Consultation No. 1,305: Addresses the Negative List (Lista Negativa), which bans substances that are considered unsafe for use due to their toxicity. Examples include Lilial, Lyral, and selenium disulfide.

 

Why Are These Updates Important?

These revisions aim to incorporate the latest scientific research on ingredient safety, reducing health risks while promoting global competitiveness of Brazilian cosmetics. By aligning with international regulatory benchmarks, ANVISA ensures that Brazilian products meet global standards for safety and quality.

  

Key Regulatory Highlights

  1. Restrictive List (Consultation No. 1,304):

    • Updates substances that are permitted with restrictions based on safe use levels.

    • Focuses on refining conditions for preservatives, filters, and other cosmetic components.

  2. Negative List (Consultation No. 1,305):

    • Expands the list of banned substances to improve consumer protection.

    • Includes substances that have been identified by the latest toxicological studies as posing a risk to human health.

 

Supporting Documentation

ANVISA has provided detailed resources, including:

  • Scientific assessments of key substances.

  • Meeting agendas outlining  regulatory discussions.

  • International benchmarks to support the proposed updates.

 

Why These Changes Matter

Updating the restrictive and negative lists:

  • Protects consumer health by addressing the risks of toxic substances.

  • Strengthens Brazil’s competitiveness in the global cosmetics market by aligning with international safety standards.

  • Promotes innovation and transparency in regulatory practices.

 

How to Participate

  • Contribution Period: January 7, 2025, to March 7, 2025

  • Stakeholders can submit their input through ANVISA’s official forms, with detailed guidance available on the consultation page. This process invites contributions from industry experts, public health advocates, and other stakeholders.

 

Next Steps

After the consultation period ends, ANVISA will analyze the contributions and finalize the regulatory updates. These changes will ensure Brazilian that personal care and cosmetic products meet evolving safety standards while maintaining global market relevance.

For more information and to participate, you can access Consultation No. 1,304 here (in Portuguese) and Consultation No. 1,305 here (in Portuguese). 

 

On December 31, 2024, Indonesia’s Halal Product Assurance Agency (BPJPH) officially rolled out Regulation No. 80 of 2024, which introduces updated guidelines for Halal certification, specifically tailored to Micro and Small Enterprises (MSEs). This new regulation, which supersedes Regulation No. 67 of 2022, brings significant improvements aimed at simplifying the Halal certification process and enhancing accessibility for MSEs.

 

Key Decisions and Guidelines under Regulation No. 80 of 2024

The new regulation establishes standardized guidelines to help MSEs navigate the Halal certification process. The main points of the regulation include:

1. Standard Operating Procedures (SOP)

A set of clear and standardized procedures for Halal certification applications has been laid out to ensure consistency and transparency. These guidelines are outlined in Appendix I, Appendix II, and Appendix III of the regulation, which detail the service flow, certification process, and facilitation methods for MSEs.

2. Reference for Service Officers and Recipients

The regulation specifies that these procedures will serve as the primary reference for both service officers and service recipients involved in Halal certification services at BPJPH to ensure smooth and efficient operations.

3. Facilitation for Micro and Small Business Actors

New guidelines specifically support facilitators working with MSEs to help them obtain Halal certification. This will ensure that MSEs, which may lack experience with the certification process, receive the necessary support to navigate the requirements.

4. Revocation of Previous Regulation

With the enactment of Regulation No. 80 of 2024, the previous decision of the Head of the Halal Product Assurance Organizing Agency Number 61 of 2022 regarding SOPs for Halal certification is officially revoked and no longer valid.

5. Immediate Enforcement

The regulation is now in full effect, and MSEs are encouraged to use the updated guidelines to begin their Halal certification process immediately.

 

Key Features of Regulation No. 80 of 2024

1. Clear and Standardized Guidelines

The regulation provides precise and uniform guidance to ensure that MSEs can apply for Halal certification in a consistent and transparent manner. This is a significant step toward streamlining the certification process and building trust within the Halal industry.

2. Simplified Application Methods

The updated regulation outlines four distinct methods for MSEs to apply for Halal certification through the online system (Sihalal). A key aspect of these methods is flexibility in the funding of certification fees, providing more options for businesses depending on their financial capabilities.

3. Enhanced Accessibility

The aim of the new regulation is to reduce the administrative burdens and increase the accessibility of Halal certification. This is part of a broader initiative to encourage MSE participation in Indonesia’s rapidly growing Halal market, both domestically and internationally.

 

Encouraging MSEs to Join the Halal Market

Regulation No. 80 of 2024 reflects Indonesia’s commitment to fostering the growth of its Halal industry and creating opportunities for MSEs to tap into the global Halal market. By simplifying the Halal certification process, the government is actively supporting the integration of more businesses into the Halal supply chain.

MSEs interested in starting the certification process can now access the Sihalal online system or contact the BPJPH directly for guidance and support.

With the implementation of Regulation No. 80 of 2024, Indonesia continues to develop its Halal certification infrastructure to ensure that even the smallest enterprises can compete in the burgeoning Halal market. These updated procedures provide the clarity, support, and flexibility needed for MSEs to achieve Halal certification with greater ease and accessibility.

 

For more information, MSEs are encouraged to visit the Sihalal system or contact BPJPH directly to begin the certification process. Please visit official website https://bpjph.halal.go.id/en

The Chilean Ministry of the Environment has issued Resolution No. 7595, of December 17, 2024, which officially approves the list of hazardous substances for industrial use notified in 2024. This resolution, which is in line with Supreme Decree No. 57 of 2019, ensures compliance with regulations on the classification, labeling, and notification of hazardous substances and mixtures.

 

Key Highlights of Resolution No. 7595

  • Promulgation Date: December 17, 2024

  • Publication Date: December 30, 2024

  • Public Access: The full list of notified hazardous substances is available on the Ministry of the Environment’s official platform: https://plataformasqi.mma.gob.cl.

 

Background to Supreme Decree No. 57

Supreme Decree No. 57, published on February 9, 2021,  establishes the regulatory framework for the classification, labeling, and notification of hazardous substances and mixtures. According to the decree:

  • Manufacturers or importers of hazardous substances, or substances in mixtures exceeding 1 tonne per year, are required to notify the Ministry of the Environment.

  • The notification must include relevant safety and classification information in accordance with Title III of the Regulation.

 

Notification Challenges and Timeline Adjustments

The initial notification deadline for industrial hazardous substances was August 30, 2024. However, due to challenges with the electronic system, Resolution No. 4141 extended the deadline to September 30, 2024 and provided temporary procedures for manufacturers and importers to fulfil their obligations.

 

Publication of the 2024 Hazardous Substances List

As stipulated by the regulation, the Ministry of the Environment must issue a resolution listing all notified substances by December 31, 2024. Resolution No. 7595 fulfils this requirement by publishing the approved list, ensuring transparency and public access to this important information.

Importance of Compliance

This resolution reinforces Chile’s commitment to chemical safety and ensures the responsible use of hazardous substances in industrial applications. 

 

Singapore’s National Environment Agency (NEA) announced on 20 December 2024, that formaldehyde in paints will be banned under the Environmental Protection and Management Act (EPMA) from 1 January 2026. The measure aims to protect public health by limiting exposure to formaldehyde, a known carcinogen and respiratory irritant.

 

Key Restrictions

  • Interior Paints: The import, manufacture, and sale of interior paints containing ≥ 0.01% w/w formaldehyde will be prohibited.

  • Outdoor/Industrial Paints: Outdoor or industrial use paints containing ≥ 0.01% w/w formaldehyde must comply with mandatory labelling requirements.

  • Export Exemption: Paints manufactured or imported for re-export are exempt but require a Hazardous Substance Licence.

 

Compliance and Enforcement

Manufacturers, importers, and suppliers must ensure compliance by 1 January 2026 to avoid penalties under the Environmental Protection and Management Act. Companies are advised to transition to formaldehyde-free alternatives and update product formulations accordingly. Importers and manufacturers must provide test reports on request to demonstrate formaldehyde content below 0.01% w/w. These reports should be from accredited laboratories recognized under the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC MRA).

 

HS Codes and TradeNet Applications

From 1 January 2026, traders will be required to use designated HS and product codes when submitting import and export permit applications via TradeNet. All applications will be subject to the NEA approval process.

 

Next Steps for Companies

To comply with the upcoming regulation, industry stakeholders should:

  • Reformulate products to meet the new limits.

  • Ensure proper labelling of applicable products.

  • Work with accredited laboratories to verify compliance.

For more details, including labelling requirements (Annex A), accepted test methods (Annex B), and relevant HS and product codes (Annex C), please refer to the official NEA document.

The Ministry of Environmental Protection and Natural Resources of Ukraine is driving forward the adoption of key European Union regulations on ozone-depleting substances and fluorinated greenhouse gases. This strategic initiative is an integral part of preparations for the upcoming bilateral meeting with the European Commission under Chapter 27 on Environment and Climate Change.

 

New EU Regulations on Ozone-Depleting Substances and F-Gases

On 7 February 2024, the European Union introduced updated legislation with Regulation (EU) 2024/590 on substances that deplete the ozone layer and Regulation (EU) 2024/573 on fluorinated greenhouse gases, superseding previous frameworks and amending Directive (EU) 2019/1937. Ukraine is modernizing its legal and terminological framework to align with these changes.

 

Why This Matters?

  • Alignment with EU Standards: Enables Ukraine to meet European environmental requirements, advancing its integration into the EU framework.

  • International Cooperation: Reduces the risk of misunderstandings and legal contradictions in global and regional partnerships.

  • Environmental Protection: Strengthens the ability to control substances harmful to the ozone layer and the climate.

 

Call for Stakeholder Participation

The Ministry is committed to transparency and collaboration and is now seeking input from businesses, public organizations, and individuals with expertise in environmental protection. Comments and suggestions can be submitted through the Ministry’s official website until 31 January 2025.

Looking ahead, the Ministry plans to actively engage all stakeholders in shaping and discussing these regulations to ensure broad consensus and effective outcomes.

 

New Labelling Rules Introduced

In addition to regulatory alignment, Ukraine has introduced new labelling rules for ozone-depleting substances and fluorinated greenhouse gases. On 9 September 2024, Ukraine notified the WTO of the adoption of Order No. 661, titled "On Approval of the Procedure for Labelling of Controlled Substances, Goods, and Equipment". The Order, issued by the Ministry of Environmental Protection and Natural Resources on 10 June 2024, will take effect on 1 March 2025.

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