GPC Newsletter May-2025

In response to stakeholder requests, the U.S. Environmental Protection Agency (EPA) has announced an extension of the reporting deadlines under the Toxic Substances Control Act (TSCA) Health and Safety Data Reporting Rule. The rule mandates manufacturers and importers of 16 specified chemical substances to submit lists and copies of unpublished health and safety studies to EPA. 

Extended Reporting Deadline 

The original reporting deadline for all 16 chemical substances was March 13, 2025. However, EPA has now extended the deadlines as follows: 

• Vinyl chloride – New deadline: June 11, 2025 

• Remaining 15 chemical substances – New deadline: September 9, 2025 

These extensions are intended to provide manufacturers and importers with additional time to gather and submit the required data to ensure compliance with the rule. 

For background on EPA’s health and safety data reporting for the 16 chemicals under TSCA, see the original news here. 

On 1 April 2025, the European Parliament adopted the 'one substance, one assessment' chemicals package, a comprehensive initiative to improve the efficiency and transparency of chemical safety assessments in the European Union. The package includes three key legislative proposals aimed at streamlining the assessment processes and improving the accessibility of data on chemical substances.

Towards Simplified and Coherent Chemical Assessments

The initiative aims to streamline the assessment of chemical risks by consolidating scientific and technical assessments under the most appropriate EU agencies. This “one substance, one assessment” approach is expected to reduce duplication, improve consistency, and speed up regulatory decisions under different pieces of EU chemicals legislation.

1. Establishment of a Common Data Platform on Chemicals

A central component of the package is the creation of a common data platform on chemicals. This platform will serve as a “one-stop shop” for accessing information compiled under different EU legislation, including data on:

• Hazard classifications

• Physico-chemical properties

• Chemical presence in the environment

• Emissions and uses

• Environmental sustainability

By consolidating this information, the platform aims to improve the availability and accessibility of chemical data, thereby facilitating more informed decision-making and regulatory processes. The platform will follow the FAIR principles, meaning that the data it contains will be Findable, Accessible, Interoperable, and Reusable. This approach is expected to support higher quality scientific assessments and more efficient regulatory decision-making.

2. Reallocation of Scientific and Technical Tasks Among EU Agencies

The second proposal focuses on optimizing the allocation of scientific and technical tasks related to chemical assessments among EU agencies. By reallocating specific responsibilities, the initiative aims to capitalize the unique expertise of each agency, thereby improving the efficiency and coherence of safety assessment across different legislative frameworks.

3. Amendments to the Restriction of Hazardous Substances in Electrical Equipment (RoHS Directive)

The third proposal involves amending the Directive on the Restriction of Hazardous Substances in Electrical and Electronic Equipment - commonly referred to as the RoHS Directive. This amendment aims at transferring specific scientific and technical tasks to the European Chemicals Agency (ECHA). The objective is to improve the consistency, transparency, and quality of assessments related to hazardous substances covered by this legislation

Next Steps in the Legislative Process

Now that the European Parliament has adopted its position, the 'one substance, one assessment' package will move to negotiations with the Council of the EU. The Council adopted its mandate for these negotiations on 14 June 2024. The final regulation will be agreed upon following these discussions and will form part of the EU’s broader Chemicals Strategy for Sustainability under the European Green Deal.

This new framework aims to strengthen the protection of public health and the environment while promoting innovation and the safer use of chemicals in the European Union.

At the CARACAL-54 meeting on 3 April 2025, the European Commission outlined its latest proposals to revise the REACH Regulation. These updates, forming part of the broader Chemicals Industry Package, are now open for public consultation until 25 April 2025. Adoption of the final legislative package is targeted for the fourth quarter of 2025.

The revision aims to simplify registration requirements, improve enforcement through new auditing tools, accelerate digitalisation of supply chain communication and modernise risk management procedures. Together, the proposals represent the most significant update to REACH since its inception

Key changes under the REACH revision package include:

1. Overhaul of the Registration System

• Registration validity will be limited to 10 years. ECHA may revoke registration numbers in several cases, including expiry of the validity period, failure to submit a required update after an evaluation decision, lack of a complete dataset for previously notified substances (NONS), or incompleteness identified during an ad-hoc completeness check.

• New dossier update requirements if a substance is identified as substance of very high concern (SVHCs).

• Removal of reduced requirements for substances notified under previous legislation (NONS).

• New obligations for polymers, including:

  • Notification for all polymers above 1 tonne per year.

  • Registration for polymers requiring registration (PRRs), based on hazard-related criteria.

• Stronger provisions to encourage data sharing between registrants and reduce duplication of studies. Data access mechanisms will apply to studies on structurally similar substances, especially after the expiry of data protection periods.

• Reinforced commitment to reduce animal testing, in line with Directive 2010/63/EU. Testing on vertebrate animals must be avoided whenever possible, and testing proposals will be required even for some lower-tier endpoints (Annex VII and VIII).

2. Reinforced Evaluation and Compliance Checks

The REACH revision introduces several changes aimed at improving the effectiveness, transparency, and impact of both dossier and substance evaluation.

• ECHA will be empowered to revoke registration numbers following persistent non-compliance with evaluation decisions. This applies to both dossier and substance evaluations when registrants fail to act on required updates or decisions issued by ECHA.

• The compliance check process will be clarified, particularly regarding the use of available information that is not currently part of the dossier. This aims to make ECHA’s decisions more predictable and legally sound.

• ECHA will gain stronger powers to require specific adaptations, such as read-across or derivation of Derived No-Effect Levels (DNELs) or Predicted No-Effect Concentrations (PNECs), rather than defaulting to animal testing.

• The substance evaluation procedure will explicitly allow selection based on hazard concerns, in addition to potential risks. Substances may also be selected based on similarity to other chemicals, including degradation products or constituents.

3. Streamlined Authorisation Process

The REACH revision introduces greater flexibility and clearer prioritisation in the authorisation system.

• The Candidate List will become a general tool for risk management prioritisation, not just a step toward authorisation.

• New substance prioritisation criteria will focus on high-volume chemicals, those with limited uses, or potential substitutes for existing Annex XIV substances.

• The revised approach allows uses to be included or excluded from Annex XIV, enabling tailored combinations of authorisation and restriction where appropriate.

• Greater use of Regulatory Management Option Analyses (RMOAs) will help identify the best regulatory path earlier in the process.

• The essential use concept and Derived Minimal Effect Levels (DMELs) are being considered to simplify decision-making.

4. More Targeted and Efficient Restriction Procedure

Changes to the restriction process aim to reduce delays and improve enforceability.

• Restriction proposals will be better prioritised and scoped upfront, avoiding overload and unnecessary complexity.

• The generic risk management approach will be expanded to more hazard classes, particularly for consumer uses.

• Early information on use, exposure, and alternatives will support more targeted proposals.

• Forum advice will be integrated directly into the restriction process to improve enforceability.

• The essential use concept will also play a role in simplifying restriction decisions.

5. Enhanced Enforcement and Market Surveillance

To level the playing field across the EU, the Commission proposes stronger enforcement mechanisms:

• A new European Audit Capacity will allow the Commission to assess Member States' enforcement systems.

• Customs controls will be improved via:

  • Mandatory provision of safety data sheets (SDS) at import.

  • Automated verification of registration and authorisation numbers.

  • Potential integration with the EU Single Window Environment for Customs.

• The European Anti-Fraud Office (OLAF) will be empowered to investigate serious cross-border REACH violations.

5. Tackling Distance Sales and Enabling Public Participation

• Distance sales into the EU will require a designated EU-based economic operator to ensure REACH compliance.

• Individuals and organisations will be allowed to submit substantiated concerns about non-compliance.

• Member States will be required to implement whistle-blower protections and follow Aarhus Convention principles on access to justice.

6. Digitalisation of Supply Chain Communication

 Digital transformation is central to the proposals, especially for Safety Data Sheets and product traceability:

• Introduction of harmonised electronic formats for SDS to support digital exchange across the supply chain.

• Gradual integration of Digital Product Passports (DPPs) for articles, initially covering batteries and later expanding to toys, detergents, textiles, and furniture.

• The aim is to reduce the administrative burden while increasing transparency on the presence of substances of concern.

7. Clarification of Nanomaterials Requirements

• The REACH revision will align with the EU’s 2022 definition of nanomaterials.

• Clarified registration and reporting rules will improve predictability and transparency, particularly for downstream users and nanoform characterisation.

REACH Revision Set to Modernise EU Chemicals Law by End of 2025

These proposed updates represent the most comprehensive revision of REACH in nearly two decades. They respond to long-standing challenges related to complexity, inefficiency, and uneven enforcement while also positioning the EU chemicals legislation to support the goals of the Green Deal and the circular economy.

The Commission is expected to finalise the legislative proposal following public feedback, CARACAL consultation, and internal legal drafting. Adoption is targeted for late 2025.

Stakeholders are encouraged to engage with the Commission’s consultation process, which remains open until 25 April 2025. Feedback will help shape the final legislative proposal, expected for adoption by the end of the year as part of the EU Chemicals Industry Package.

On 11 April 2025, the European Commission welcomed the provisional political agreement reached between the European Parliament and the Council on the new Regulation on the Safety of Toys. The new Regulation aims to strengthen protections for children's health while ensuring the proper functioning of the Single Market. It will replace the current Toy Safety Directive 2009/48/EC.

Key Features of the Agreed Toy Safety Regulation

• Stricter Limits on Hazardous Chemicals:

The new rules will extend existing bans to include additional harmful substances in toys, such as endocrine disruptors and reprotoxic chemicals. This goes beyond the current protections against carcinogenic and mutagenic substances. The Regulation also enables the Commission to impose future restrictions on groups of substances, such as per- and polyfluoroalkyl substances (PFAS), through implementing acts based on scientific assessments.

• Introduction of a Digital Product Passport:

All toys sold in the EU will be required to carry a Digital Product Passport (DPP), accessible via a QR code, containing detailed safety and compliance information for authorities and consumers.

• Enhanced Control of Online Sales:

Online marketplaces will be required to verify that toys offered on their platforms meet EU safety requirements, thereby addressing safety risks associated with e-commerce.

• Clearer Duties for Economic Operators:

Manufacturers, importers, and distributors will have strengthened obligations to ensure that only compliant toys are placed on the market, thereby improving traceability and enforcement.

Transition Periods

Once the Regulation is formally adopted by the European Parliament and the Council, it will enter into force 20 days after its publication in the Official Journal of the European Union. Most of its obligations will begin to apply 30 months after the entry into force. However, the requirements related to the Digital Product Passport will apply 48 months after entry into force.

Next Steps

The provisional agreement must now be formally approved by both the European Parliament and the Council. Once adopted, the new Regulation will replace Directive 2009/48/EC on the Safety of Toys, updating EU toy safety rules to address emerging risks, including chemical hazards such as PFAS, and ensuring higher standards across the Single Market.

The UK has introduced the Cosmetic Products (Restriction of Chemical Substances) Regulations 2025 (SI 2025 No. 413), which will come into force on 30 September 2025. This regulation amends Annex 3 of the UK Cosmetics Regulation (retained from Regulation (EC) No 1223/2009), following the consultation launched earlier this year. The new rules set specific concentration limits, particularly for products intended for young children.

Key Details:

• Substance Affected: Methyl salicylate (CAS No. 119-36-8)

• Regulatory Changes: The amendment introduces concentration limits for methyl salicylate across various product categories, particularly those intended for children aged between 0.5 to 1 year.

• Transitional Provisions: Cosmetic products containing methyl salicylate that are placed on the market on or before 30 September 2025 may continue to be sold until 31 March 2026.

The amendment aligns with the scientific advice provided by the UK’s Scientific Advisory Group on Chemical Safety.

For full details, the official legislation is available here.

On 10 April 2025, the Environmental Audit Committee (EAC) of the UK Parliament launched a new inquiry to investigate the environmental and health risks posed by per- and polyfluoroalkyl substances (PFAS), often referred to as “forever chemicals”. The inquiry will also assess the robustness of the UK’s current regulatory approach to managing these substances.

Why PFAS Are a Concern

PFAS are widely used in consumer products such as waterproof clothing, non-stick cookware, cosmetics, and food packaging due to their resistance to heat, water, and grease. However, these substances are highly persistent in the environment and in the human body. Scientific studies have linked PFAS exposure to:

• Reduced fertility and developmental issues.

• Certain cancers.

• Hormone disruption.

• Immune system suppression.

Their widespread use and long-lasting nature have led to growing public and political concern in the UK and around the world.

Objectives of the Inquiry

The EAC inquiry will examine:

• The extent and sources of PFAS contamination in the UK.

• The current capabilities of UK regulators to detect, monitor, and manage PFAS risks.

• The adequacy of existing laws and guidance on the manufacture, use, and disposal of PFAS.

• How the UK’s regulatory approach compares with that of other jurisdictions, particularly the EU and the US.

Call for Evidence: What Submissions Should Cover

The Committee invites written submissions from stakeholders, including scientists, regulators, industry representatives, environmental groups, and members of the public. Submissions may address:

• The extent of PFAS use in the UK and in specific sectors.

• Known or potential environmental and health impacts of PFAS.

• The effectiveness of the current UK regulatory controls (including REACH under UK law).

• Challenges in monitoring PFAS in the environment and in consumer products.

• The role of alternatives and opportunities for phase-out or substitution.

• International best practice that could inform UK regulation.

• Public awareness and risk communication of PFAS exposure.

Deadline for Submissions

Written submissions must be received by 17:00 BST on Monday, 26 May 2025. Full details and the submission portal are available on the UK Parliament website here.

On 11 April 2025, the Directorate General of Foreign Trade (DGFT) under the Ministry of Commerce and Industry, launched the 'Global Tariff and Trade Helpdesk'. This initiative aims to assist Indian exporters and importers in navigating the complexities of international trade, including identifying and addressing key challenges and opportunities.

The helpdesk offers guidance on a wide range of issues, including global tariffs, import surges, export-related hurdles, and other trade challenges crucial for the business community.

As global trade continues to evolve, with changes in tariffs and the introduction of counter-tariff measures, the helpdesk will facilitate the resolution of trade-related issues for stakeholders. The initiative focuses on tackling import surges, dumping, EXIM clearance delays, logistics and supply chain challenges, and regulatory and compliance concerns.

Key Areas of Focus

The 'Global Tariff and Trade Helpdesk' will provide assistance on a broad spectrum of trade-related concerns, including:

• Import and export challenges

• Import surges and dumping

• EXIM clearance issues

• Logistics and supply chain challenges

• Financial or banking issues

• Regulatory and compliance issues

• General trade suggestions and concerns

The helpdesk will also coordinate with relevant ministries, departments, and government agencies at the central and state levels to resolve issues requiring multi-stakeholder involvement.

How to Use the Helpdesk

Exporters, importers, and other stakeholders facing trade-related challenges can access the helpdesk through the DGFT website:

1. Visit the DGFT website at www.dgft.gov.in

2. Navigate to the 'DGFT Helpdesk' section under 'Services.'

3. Create a new request by selecting 'Global Tariff and Trade Issues' and specifying the appropriate sub-category (such as Import Challenges, Export Challenges, etc.).

4. Enter the relevant details and submit the request.

Alternatively, issues can be emailed to dgftedi@nic.in with the subject line ‘Global Tariff and Trade Helpdesk’, or stakeholders can call the Toll-Free number at 1800-111-550 for assistance.

Tracking and Resolution

Users can track the status of their issues via the status tracker under DGFT Helpdesk Services. Users will receive updates via email and SMS.

These measures aim to empower the Indian trade community by providing them with a platform to proactively manage challenges in a dynamic global trading environment. The DGFT encourages all stakeholders to take full advantage of these resources to streamline trade operations and resolve critical issues.

For more information, stakeholders should visit the official DGFT website or contact the helpdesk with any queries.

The Food Safety and Standards Authority of India (FSSAI) has introduced significant amendments to the Food Safety and Standards (Packaging) Regulations, 2025 to allow the use of specific categories of recycled plastics in food packaging. The amendments were published in the Official Gazette on 28 March 2025 and came into effect from the date of publication. They support the move towards sustainable packaging while ensuring consumer safety. 

Key Highlights of the Amendment 

• Use of Recycled Plastics: Certain categories of recycled plastics are now permitted in food packaging, subject to strict quality and safety standards. 

• Safety Compliance: All recycled plastics must meet specific migration limits to prevent contamination and ensure food safety. 

• Approved Recycling Methods: Only plastics processed through FSSAI-approved recycling technologies can be used. 

• Traceability and Labeling: Packaging must be clearly labeled to indicate the use of recycled materials and ensure traceability. 

Stakeholder Impacts 

For Manufacturers: 

• Compliance with new testing and certification requirements is mandatory. 

• Recycled plastics must be sourced from authorized suppliers using approved recycling processes. 

For Food Businesses and Brands: 

• Packaging materials must be sourced from FSSAI-compliant suppliers. 

• Internal quality checks must be updated to align with the new material standards. 

For Consumers: 

• The amendment ensures safer food packaging with greater transparency. 

• Consumers will have access to more sustainable packaging options. 

Compliance Requirements and Next Steps 

• Testing and Certification: Businesses must get their packaging materials certified under FSSAI guidelines. 

• Implementation Timeline: The regulation is already in force as of 28 March 2025. 

• Regulatory Audits: Regular inspections will be conducted to ensure compliance with the revised standards. 

Call to Action 

To avoid penalties and ensure regulatory compliance, businesses need to review their packaging materials and align with the new FSSAI standards. Detailed guidelines can be found in the official FSSAI document here. 

On March 21, 2025, the Ministry of Micro, Small, and Medium Enterprises (MSME) of the Government of India, issued a notification announcing amendments to an earlier notification published on June 26, 2020, under the Micro, Small, and Medium Enterprises Development Act, 2006.  

The updated guidelines, which came into force on April 1, 2025, introduce significant changes to the investment and turnover criteria for classifying Micro, Small and Medium Enterprises (MSMEs).  

Key Changes:  

1. Increased Threshold for Classification:  

• The maximum investment limits for different categories have been substantially increased:  

• Micro Enterprises: The investment limit has been raised from ₹1 crore to ₹2.5 crore.  

• Small Enterprises: The investment limit has been raised from ₹10 crore to ₹25 crore.  

• Medium Enterprises: The investment limit has been revised from ₹50 crore to ₹125 crore.  

2. Turnover Limits Revised:  

• The turnover limits for these enterprises have also been adjusted:  

• Micro Enterprises: From ₹5 crore to ₹10 crore.  

• Small Enterprises: From ₹50 crore to ₹100 crore.  

• Medium Enterprises: From ₹250 crore to ₹500 crore.  

3. Overall Growth Potential  

• The updated notification is expected to provide MSMEs with greater opportunities to expand, access more benefits and receive more government support. This will boost the overall growth of the sector.  

Impact of MSME Sector Growth  

The new thresholds align with the evolving economic landscape and the government's commitment to strengthening the MSME sector. This change is anticipated to allow more businesses to qualify as MSMEs, thereby increasing their access to various schemes and financial support.  

Implementation and Further Information  

The notification follows the recommendations of the Advisory Committee and took effect on April 1, 2025. For further details, the full notification is available here.  

China’s Ministry of Ecology and Environment (MEE) is seeking public feedback on draft indicative lists of long-chain perfluorocarboxylic acids (PFCAs), their salts, and related compounds. These substances are widely used in industrial applications, such as the production of non-stick cookware, stain-resistant fabrics, and firefighting foams. They are known for their environmental persistence, bioaccumulation potential, and suspected adverse health effects.

The proposed lists were developed in cooperation with the Stockholm Convention Secretariat and are part of China’s efforts to implement control measures for persistent organic pollutants (POPs) under the Convention.

Draft Chemical Lists Linked to the Stockholm Convention

The MEE has prepared a draft list of these long-chain PFCAs and related substances. The list is part of the MEE’s work under the Stockholm Convention on Persistent Organic Pollutants, to which China has been a party since 2004. This international agreement aims to eliminate or restrict the production and use of harmful chemicals. The government is encouraging businesses and experts to provide feedback on the draft list before 19 May 2025.

Potential Impact on Industry

If these chemicals are added to China’s control list, manufacturers may need to adapt their processes. This could affect how companies source materials or produce goods that rely on these chemicals.

What Companies Should Do

• Check whether their products use these chemicals, especially C9–C21 PFCAs.

• Review how the proposed rules might affect them.

• Send written feedback to the Environmental Convention Implementation Centre.

• Visit the official MEE website here for full details.

The Lists in the Consultation Include:

1. An indicative list of long-chain perfluorocarboxylic acids (PFCAs), their salts and related compounds.

2. A updated list of perfluorooctanoic acid (PFOA) its salts and related compounds.

3. A updated list of perfluorohexane sulfonic acid (PFHxS), its salts and related compounds.

Next Steps for Companies

Stakeholders are encouraged to provide input early on. Early participation may help shape the final rules, request exceptions, or suggest a longer transition periods. Companies should also monitor updates from the upcoming global meeting of the Conference of the Parties to the Stockholm Convention, scheduled for late April to early May 2025.

On February 5, 2025, a group of 13 congressmen in South Korea proposed amendments to the Act on Registration and Evaluation of Chemical Substances (also known as K-REACH). The purpose of this new proposal is, first, to improve the transparency of the chemical registration process, especially in the process of joint submission and its cost sharing. Secondly, it aims to enhance the efficiency of the Only Representative (OR) appointment system by addressing gaps related to the transfer of responsibilities when the OR is changed.  

Key Amendments and Changes 

1. Fair and Transparent Cost Allocation for Joint Registration: 

• The amendments propose a clear and fair framework for cost sharing for joint registrations of chemicals. 

• Costs will be allocated based on objective criteria, taking into account the interests of each party and the specific manufacturing or import volumes. 

• The proposal ensures transparency by requiring clear and verifiable evidence for all cost allocations. 

2. Dispute Resolution for Registration Conflicts: 

• If disputes arise during the joint registration process the parties will be able to seek mediation from the Ministry of Environment. 

• This will ensure that disputes over shared registration materials or costs are resolved in a fair and transparent manner. 

3. Protection for Latecomer Registrants: 

• To protect the interests of latecomer registrants, the amendments propose a formal process to resolve issues that cannot be settled through negotiation. 

• This protection will ensure that latecomer registrants who joined the joint submission at a late stage are not unfairly burdened with excessive fees or delays in the registration process. 

4. Clarification of the OR System for Foreign Manufacturers: 

• The amendments will address gaps in the law by providing clarity regarding the transfer of responsibilities when a foreign manufacturer changes their Only Representative. 

• The responsibilities of the previous OR, including completed registrations, will be transferred to the new OR to ensure continuity in the registration process. 

• Foreign manufacturers must report the change to the Ministry within one month. 

Public Feedback and Status of the Proposal  

• Public feedback was accepted from  February 7 to February 21, 2025.  

• The proposal is still under committee review. When there are further updates regarding this amendment, GPC will continue to update the news.  

On April 8, 2025, South Korea issued a notice of administrative announcement on a partial revision on the result of chemical hazard evaluation. This revision is based on the completion of toxicity evaluations for existing chemicals under the K-REACH Act. The revised notice includes details on the chemical substance names, hazard information, whether substances are hazardous, and other relevant results. Additionally, the notice includes the publication of the names of newly evaluated chemical substances after the expiration of their data protection periods. 

Key Changes 

1. Expiration of Data Protection: 

• Following the expiration of the data protection (2023), chemical substance names that were previously protected will now be made public. This includes four substances, with corrections to one item. 

2. Hazard Evaluation of Existing Substances: 

• The hazard evaluation results for 29 substances, conducted between February and June 2024, will be included in Annex 2.  

3. Additional Data for Previously Announced Chemicals: 

• Four additional substances will have their data updated, and 20 substances will be assigned unique identifiers based on toxicity status. 

4. Chemical Substance Details: 

• The notice will include comprehensive details such as CAS numbers, hazard status, and key hazard characteristics for substances that have been evaluated. 

Submission of Comments 

Interested individuals, institutions, and associations are invited to submit their feedback on the proposed changes by April 28, 2025. Comments should be addressed to NICS and should include details such as the subject of the feedback, contact information, and the reasons for any suggested revisions. 

On March 7, 2025, Taiwan’s Ministry of Labor (MoL) announced proposed changes to the regulations for the registration of new chemical substances. A draft version of the updated regulation is now open for public comment. The deadline for submitting comments is 60 days from March 7, 2025.

Current Regulatory Framework

Currently, there are two separate regulatory systems for registering new chemicals: one under the Ministry of Labor (MoL) and another under the Ministry of Environment (MoEnv). Since much of the required data overlaps, the MoL plans to revise its regulation to reduce duplication and make the process more efficient.

Key Proposed Changes

• Mutual Recognition of Registrations: If a company has already registered a new chemical with the MoEnv, it will no longer need to re-register the same substance with the MoL.
• Updated Legal Terminology: The name of the law has been updated from Toxic Chemical Substances Control Act to Toxic and Concerned Chemical Substances Control Act.
• Removal of Obsolete Transitional Provisions: Two transitional provisions related to older substances are being removed, as their deadlines have already passed.

Companies will still be required to submit core information, including:

• Identification of the chemical
• Details on how it is manufactured and used
• Hazard and safety data
• Toxicological information
• Environmental impact data

On 4 April 2025, Thailand’s Food and Drug Administration (Thai FDA) issued a draft notification proposing significant amendments to the labelling requirements for fluoride-containing cosmetics, including toothpaste and mouthwash. The proposed regulation will take effect the day after its publication in the Royal Gazette. These changes aim to strengthen consumer protection, particularly for young children, by enhancing product safety and information. 

Revocations: Previous Warning Statements Repealed 

Under the new draft notification, Thailand will revoke several previous labelling requirements related to fluoride compounds used in cosmetic products. Specifically, entries 23–40, 44, and 52 of the 2018 Notification on Cosmetic Labelling will be repealed. These entries previously mandated specific warnings for various fluoride-containing substances, such as ammonium monofluorophosphate, sodium fluoride, and calcium fluoride. The revocation of these entries paves the way for new, standardized warning statements to ensure consistency across product categories. 

Revised Warning Requirements for Fluoride-Containing Products 

The new regulation introduces standardized labelling requirements for products containing fluoride substances. Key updates include: 

• For children under the age of three: The recommended amount of toothpaste should be the size of a grain of rice. 

• For children aged three to under six years: An amount the size of a pea or corn kernel should be used. 

• Supervision by adults: Children in both age groups should be supervised while brushing their teeth. 

• Additional medical advice: If children are exposed to fluoride from other sources, parents or guardians should consult a doctor or dentist. 

Furthermore, mouthwash products containing fluoride should not be used by children under the age of six, and appropriate warnings must be displayed on the product label. 

Transition Period for Industry Compliance 

Manufacturers, importers, and contractors producing fluoride-containing cosmetics will be required to update their product labelling in accordance with the new regulation within one year from the effective date. This transition period will provide businesses with sufficient time to adapt their processes and ensure full compliance. 

Implications for Global Cosmetic Industry Stakeholders 

The revised labelling requirements will have significant implications for the global cosmetic industry. Companies that manufacture, import, or distribute fluoride-containing products in Thailand will need to review and update their product labels to align with the new standards. Failure to comply within the specified timeline may result in regulatory penalties. Businesses are encouraged to take immediate steps to ensure that their products meet the new labelling guidelines and to consult the full draft text for detailed requirements. 

On 10 April 2025, Japan’s Ministry of Health, Labour, and Welfare (MHLW) updated its list of chemicals identified as strong mutagens on the Workplace Safety Site. With this update, MHLW added 17 newly notified chemicals. Mutagenic chemicals are regulated under the country’s Industrial Safety and Health Law (ISHL). With this addition, the list now contains a total of 1363 chemicals including 244 existing and 1119 newly notified mutagens. 

Understanding Strong Mutagens 

Mutagens are substances or agents that can cause genetic mutations, leading to changes in an organism’s DNA. Mutagenic effects can result in serious health problems such as cancer, birth defects, and genetic disorders. Strong mutagens are chemicals or physical agents with a high potential to cause significant genetic mutations. 

Previous Update in November 2023 

On 30 November 2023, the MHLW added 18 newly notified chemicals to the list of strong mutagens, bringing the total to 1346 at that time. 

Obligations for Stakeholders 

Under Notification No. 312 (published on 17 May 1993), entities involved in the manufacturing and handling of strong mutagens are required to: 

• Measure the work environment  

• Implement exposure prevention strategies 

• Provide occupational health education 

• Prepare labelling and Safety Data Sheets (SDS) 

• Maintain records for up to 30 years 

Australia’s Department of Climate Change, Energy, the Environment and Water (DCCEEW) has proposed new environmental standards for industrial chemicals under the Industrial Chemicals Environmental Management Standard (IChEMS). These proposals aim to regulate chemicals that pose significant or irreversible harm to the environment. If adopted, these measures will impact the manufacturing, import, export, use, and disposal of several industrial chemicals starting from 2026 and 2027.

This summary provides a detailed overview of the proposed standards for the following chemicals: decabromodiphenyl ethane (DBDPE), mercury and mercury compounds, 1,2-dibromoethane, methylcyclopentadienyl manganese Tricarbonyl (MMT), 1,2-dichloroethane, and aryl sulfonate hydrotropes.

Decabromodiphenyl Ethane (DBDPE): Strict Management Measures Proposed

Chemical Identity:

• Name: Benzene, 1,1'-(1,2-ethanediyl)bis[2,3,4,5,6-pentabromo-]

• Common name: Decabromodiphenyl ethane (DBDPE)

• CAS Numbers: 84852-53-9, 1092834-40-6

• Proposed effective date: 1 January 2027

Proposed Regulations:

• Use Prohibitions: Ban on manufacturing, import, and usage unless specifically exempted for essential applications.

• Essential Use Exemptions: Allowed for critical sectors such as aerospace, automotive, defence, electronic equipment, and building industries, with a phase-out planned by 1 July 2033.

• Trace Contamination Allowance: Permitted up to 10 mg/kg in substances or mixtures and 500 mg/kg in articles.

• Waste Management: Disposal must either destroy or irreversibly transform the chemical to prevent environmental release.

Background:
DBDPE is used as a flame retardant but is persistent and toxic to the environment. Australia’s proposed actions align with international efforts to phase out such substances.

Mercury and Mercury Compounds: Tightened Controls in Line with Minamata Convention

Chemical Identity:

• Name: Mercury and mercury compounds

• CAS Number: 7439-97-6 and related compounds

• Proposed effective date: 1 July 2026

Proposed Regulations:

• Ban on Manufacture, Import, and Use: Mercury and its compounds will be strictly prohibited except for a few essential uses.

• Permitted Essential Uses: Military, civil protection, certain measuring devices, cold cathode fluorescent lamps (CCFLs), and situations where no mercury-free alternatives exist.

• Waste Management: Mercury waste containing more than 15 mg/kg must be treated according to the Basel Convention guidelines.

• Stockpile Notification: Entities holding mercury stockpiles must report and manage them responsibly.

Background:
Australia’s regulatory action aligns with commitments under the Minamata Convention on Mercury, aiming to minimize mercury releases and protect public and environmental health.

1,2-Dibromoethane: New Handling Requirements to Minimize Environmental Risks

Chemical Identity:

• Name: Ethane, 1,2-dibromo-

• CAS Number: 106-93-4

• Proposed effective date: 1 January 2026

Key Measures:

• Primary Use: As a fuel additive in leaded aviation gasoline (AvGas), with some use as a solvent and chemical intermediate.

• Environmental Management: Must be handled according to IChEMS Minimum Standards, including risk management plans and environmentally safe storage practices.

Background:
Despite its usefulness in aviation, 1,2-dibromoethane is persistent and toxic, posing environmental and human health risks.

Methylcyclopentadienyl Manganese Tricarbonyl (MMT): Fuel Additive under Scrutiny

Chemical Identity:

• Name: Manganese, tricarbonyl[(1,2,3,4,5-η)-1-methyl-2,4-cyclopentadien-1-yl]-

• Common Names: MMT, Methylcyclopentadienyl manganese tricarbonyl

• CAS Number: 12108-13-3

• Proposed effective date: 1 January 2026

Key Measures:

• Use Restriction: Limited to use as a fuel additive for anti-valve seat recession and as an octane booster.

• Management Compliance: Companies must comply with IChEMS Minimum Standards covering handling, storage, incident management, and waste disposal.

Background:
MMT is widely used to enhance fuel performance but poses risks due to the release of manganese into the environment.

1,2-Dichloroethane: New Environmental Controls Proposed

Chemical Identity:

• Name: Ethane, 1,2-dichloro-

• CAS Number: 107-06-2

• Proposed effective date: 1 January 2026

Key Measures:

• Primary Use: As a feedstock for manufacturing polyvinyl chloride (PVC) and as an industrial solvent.

• Mandatory Compliance: Management through robust risk plans and environmentally safe disposal practices as per IChEMS standards.

Background:
1,2-Dichloroethane is a high-production-volume chemical with significant environmental risks, especially through its volatilization and potential to contaminate groundwater.

Aryl Sulfonate Hydrotropes: Low-Risk Chemicals, Still Under Monitoring

Chemical Identity:

• Chemical Group: Aryl sulfonate hydrotropes

• CAS Numbers: Includes a wide range such as 98-11-3, 515-42-4, and others

• Proposed effective date: 1 January 2026

Key Measures:

• Application Areas: Extensively used in domestic products including paints, personal care items, detergents, and textiles.

• Environmental Risk Level: Classified as unlikely to cause environmental harm, but still subject to IChEMS compliance for information sharing, safe handling, and responsible waste management.

Background:
These chemicals are important emulsifiers and stabilizers used across many industries, but due diligence is still necessary to prevent environmental harm from improper disposal.

What Are the IChEMS Minimum Standards?

All chemicals addressed by the proposed decisions must comply with the IChEMS Minimum Standards, which include:

• Information and Awareness: Inform the supply chain about environmental risks.

• Risk Management Planning: Identify, evaluate, and control environmental risks.

• Harm Minimization Controls: Prioritize elimination or reduction of chemical hazards.

• Environmentally Safe Storage: Ensure secure and compliant chemical storage.

• Effective Incident Response: Prepare for and manage chemical spills and accidents.

• Environmentally Responsible Waste Management: Apply the waste hierarchy principles, ensuring proper recycling, treatment, or disposal.

Conclusion

Australia is taking significant steps to tighten the management of industrial chemicals through the IChEMS framework. By aligning domestic regulations with international conventions such as the Minamata Convention and the Basel Convention, the country aims to enhance environmental safety and sustainability. Manufacturers, importers, distributors, and of the affected chemicals should  start preparations now to ensure full compliance when the new standards enter into force.

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.

On 14 April 2025, Switzerland notified the World Trade Organization (WTO) of two proposed amendments to its chemical safety regulations. These amendments aim to enhance public health protection by restricting the availability of certain hazardous substances to the general public and aligning Swiss regulations more closely with the European REACH and CLP frameworks.

Key Provisions of the Amendments

Restriction on CMR Substances for Consumer Use

The draft amendment to the Ordinance on the Reduction of Risks Related to the Use of Particularly Dangerous Substances, Preparations, and Articles (ORRChim) prohibits the supply of substances classified as carcinogenic, mutagenic, or toxic to reproduction (CMR) to the general public. This applies to substances listed in Annex 1 to 6 of Annex XVII of the EU REACH Regulation, as well as mixtures containing these substances when their mass concentration exceeds the threshold defined in the EU CLP Regulation.

These substances may no longer be supplied to the general public in Switzerland after 31 August 2025.

Updates to Classification, Labelling and Testing Requirements

The amendment to the Ordinance on the Protection against Dangerous Substances and Preparations (OChim) updates Annexes 2 and 3 to reflect the latest EU regulations. This includes:

• Incorporation of the 22nd and 23rd Adaptations to Technical Progress (ATPs) under the EU CLP Regulation.

• Updated references to testing methods under Regulation (EC) No 440/2008, OECD Test Guidelines (as of June 2025), and the UN Manual of Tests and Criteria, 8th revised edition with the 2025 amendment.

• Transitional periods allowing the continued supply of noncompliant substances until 30 April 2026 (for the 22nd ATP) and until a future date to be determined for the 23rd ATP.

Expanded Candidate List of Substances of Very High Concern

Following developments at EU level, seven new entries are being added to Annex 3 of ChemO, Switzerland’s list of substances of very high concern (SVHCs). In addition, one existing entry is being updated. The revised list will contain 247 substances and groups of substances, effective 1 August 2025.

Effective Date

Both amended ordinances are scheduled to enter into force on 1 August 2025.

These changes reflect Switzerland's commitment to aligning its chemical safety regulations with the EU's REACH and CLP frameworks to enhance protection for the general public against particularly hazardous substances.

For more detailed information, you can access the full notifications here and here.

On March 5, 2025, the National Assembly of Vietnam published the second draft of the amended Law on Chemicals, scheduled to take effect on January 1, 2026. This revision amends the 2007 Law on Chemicals and introduces sweeping changes to strengthen the regulatory framework, enhance public safety, and bring it into line with global chemical safety standards.

The updated law simplifies the structure into 8 chapters and 50 articles, significantly broadening its scope to include hazardous chemicals in consumer products, chemical usage across industries, and newly regulated areas such as chemical consulting and risk prevention. Key provisions also address environmental sustainability, public transparency, and emergency response requirements.

Key Legislative Changes:

Expanded Scope and Modern Definitions

• Includes hazardous chemicals in products, not just pure substances.

• Introduces new definitions, including green chemistry, chemical security, industrial chemical zones, and chemical databases.

• Formally defines and regulates activities such as consulting, risk prevention, and emergency planning.

 Prohibited Activities

• Bans unauthorized use, production, or storage of dangerous chemicals.

• Prohibits concealing hazards, illicit chemical trade, and use in unapproved sectors (e.g., food, pharmaceuticals).

National Strategy for Industrial Development

• A national strategy will be developed for chemical industry growth with 10-year planning cycles and a 30-year vision.

• Focus areas include basic chemicals, petrochemicals, pharmaceuticals, and renewable-based materials.

• Emphasizes alignment with green chemistry and national defense priorities.

Mandatory Compliance Requirements

• Projects must comply with laws on environmental protection, construction, fire safety, and chemical security.

• Reports must include details on technology selection, chemical safety, and compliance with green chemistry principles.

• Chemical facilities must maintain minimum safe distances from sensitive zones.

New Licensing and Compliance Controls

• Chemicals are categorized as follows:

  • Controlled chemicals

  • Special control chemicals

  • Prohibited chemicals

• Licensing is required for production, use, import/export, and even consulting services.

• Certification and competence requirements are introduced for individuals and organizations involved in specialized chemical consulting.

Management of Chemicals in Consumer Products

• Manufacturers must disclose hazardous substances in end products.

• Additional obligations for:

  • Product labelling according to the Globally Harmonized System (GHS)

  • Laboratory testing

  • Risk management

Integration with Global Standards

• Adopts GHS for labelling and classification.

• Aligns with relevant international treaties and chemical trade agreements.

Transitional Provisions

• Companies with existing permits for chemical manufacturing, trading, or import/export can continue operations until their permits expire.

• Businesses certified for conditional chemical manufacturing or trading may operate until December 31, 2027.

• Chemical storage operators must prepare accident prevention and response plans by December 31, 2027.

In a significant move to address its growing plastic waste crisis, the Philippines has launched the National Plastic Action Partnership (NPAP) - a multi-sectoral initiative aimed at promoting a circular economy. Led by the Department of Environment and Natural Resources (DENR), NPAP brings together government agencies, private enterprises, and civil society to develop sustainable solutions. Backed by the United Kingdom, Canada, and the World Economic Forum, the partnership focuses on reducing marine plastic pollution and aligning with national policies. Hosted by the United Nations Development Programme (UNDP), NPAP will create a strategic roadmap, drive innovation, and ensure inclusivity, paving the way for sustainable development. 

About NPAP Philippines 

The National Plastic Action Partnership (NPAP) Philippines was established as a collaborative platform to address plastic pollution and move the country towards a circular economy. The NPAP aims to unite stakeholders across various sectors to foster innovation, implement practical solutions, and accelerate the Philippines’ transition to a circular economy. Through collaborative action, the initiative strives aims to significantly reduce plastic pollution and pave the way for inclusive and sustainable development nationwide.  

NPAP to Develop National Roadmap with Inclusive Strategy 

As part of its commitment to address plastic pollution, the NPAP will focus on conducting a comprehensive plastics baseline analysis and formulating a National Plastic Action Roadmap. This roadmap will serve as a foundation for evidence-based strategies aligned with the Philippines' national development priorities. Importantly, it will incorporate a gender and social inclusion framework to ensure that marginalized communities, including informal waste pickers, play an active role in the country’s transition to a circular economy. 

Plastic Waste Crisis in the Philippines 

Plastic pollution continues to pose a major environmental challenge for the Philippines, which produces an estimated 2.7 million metric tons of plastic waste each year. A considerable portion of this ends up in the ocean, placing the country among the world’s leading contributors to marine plastic pollution. 

NPAP Drives Circular Economy Shift Through Multi-Sector Collaboration 

The NPAP is spearheading efforts to move the Philippines away from the traditional “take-make-waste” economic model toward a circular economy that promotes resource efficiency, waste reduction, and material reuse. By promoting sustainable consumption and production, the initiative aims to cut emissions, foster innovation, generate green jobs, and promote social equity.  

NPAP operates under the World Economic Forum’s Global Plastic Action Partnership (GPAP) and is backed by the governments of the United Kingdom and Canada and the Coca-Cola Foundation. The platform brings together stakeholders from government, private industry, civil society, academia, and development partners and aligns its goals with key national strategies such as the Philippine Development Plan, the Extended Producer Responsibility (EPR) Act, and the country’s climate commitments. 

Malaysia’s Department of Environment (DOE) recently published a notice on the portal of the Malaysia Environmentally Hazardous Substances System (MyEHS) outlining the country’s regulatory position on two persistent organic pollutants (POPs): Dechlorane Plus and UV-328.  

Stockholm Convention Signed but Not Yet Ratified
While Malaysia has signed the Stockholm Convention but has not yet ratified it. Under the Convention, both substances are subject to strict control measures that prohibit their production, use, import, and export, except under certain exemptions. These exemptions must meet the technical and procedural conditions specified in Article 4 of the Convention, including registration with the Stockholm Convention’s Secretariat and a five-year validity period from the Convention’s entry into force for the listed chemicals. 

No Plans to Register Exemptions 
However, since Malaysia has not yet ratified the Convention, the country is not eligible to register any exemptions and currently has no plans to do so. The DOE encourages stakeholders to consult the official Stockholm Convention web portal for further information on allowable exemptions. For local regulatory guidance on the production or use of these chemicals, stakeholders should contact the Chemical Management Division of the Department of Occupational Safety and Health (DOSH). 

On 31 March 2025, the South African government officially introduced the Regulations for the Management of Mercury, 2024, published by the Department of Forestry, Fisheries and he Environment (DFFE). Finalized in 2024, these new rules represent a significant change in the nation's approach to controlling hazardous compounds marking a significant step toward environmental protection and public health. In addition to strictly regulating the use, storage, trading, and disposal of mercury, these new rules set strict phase-out deadlines for mercury-added items beginning on 1 April 2025. 

Department of Forestry, Fisheries and the Environment (DFFE) 

The DFFE is committed to upholding every South African's right to a clean and healthy environment. With a strong focus on sustainability and conservation, the department is at the forefront of initiatives in responsible environmental stewardship, safeguarding natural resources for current and future generations. Its work not only enhances community well-being but also supports international efforts to protect the planet. 

National Environmental Management Act, 1998 (South Africa) 

The National Environmental Management Act (NEMA), 1998 is a key South African law that provides the framework for environmental protection and sustainable development. It promotes responsible resource use, public participation, and the precautionary principle to ensure that economic development does not harm the environment. 

Key Highlights: New Mercury Regulations in South Africa (2024) 

South Africa has introduced the Regulations for the Management of Mercury, 2024 to control and reduce the use, trade, and storage of mercury and mercury-added products. 

Purpose of the regulations 

The purpose of the regulations is to: 

• Promote environmentally sound mercury management. 

• Phase out mercury-added products (MAPs). 

• Regulate mercury use in manufacturing. 

• Control of mercury trade and storage. 

Scope of Application 
The regulation applies to: 

• Importers, exporters, sellers, and users of mercury or MAPs. 

• Manufacturers using mercury in products or processes. 

The regulations  do not apply to mercury emissions or mercury waste. 

Phase-Out of Mercury-Added Products 

Mercury-added products will be banned after set dates (starting 1 April 2025), including: 

• Fluorescent lamps 

• Thermometers and pressure-measuring devices 

• Mercury-containing batteries 

• Cosmetics with mercury >1ppm 

• Dental amalgam in certain cases 

Entities must submit Mercury Phase-out Plans within 1 year. 

Phasing Down of Dental Amalgam 

• Use is restricted to pre-dosed capsules (max 0.58 ml). 

• Ban the use of bulk mercury by dental professionals. 

• Use is not allowed for children under 15, or for pregnant or breastfeeding women (except where necessary). 

• Dental facilities must install amalgam separators (95% efficiency) by 1 April 2026. 

• Importers/exporters must submit Mercury Phase-down Plans. 

Trade and Import/Export Controls 

• The import/export of mercury and MAPs is banned, except for limited dental, research, or storage use. 

• Notification to the DFFE is required for any approved import/export. 

Restrictions on Mercury in Manufacturing 

• Mercury use is banned in listed manufacturing processes after the phase-out dates. 

• New mercury-using processes are not allowed without written Ministerial approval. 

• Mercury releases to land or water must be prevented. 

Storage and Reporting Requirements 

• Interim storage must meet hazardous chemical laws. 

• Mercury stockpiles must be declared to the DFFE within 2 months. 

• Annual compliance reports are due by 31 March every year. 

Conclusion 

The Regulations for the Management of Mercury, 2024 mark a critical step forward in South Africa’s commitment to environmental sustainability and public health. By phasing out harmful mercury-added products, tightening controls on trade and manufacturing, and promoting safer alternatives, especially in dental care, these regulations align the country with global best practices under the Minamata Convention. As industries, healthcare providers, and government departments work together to implement these measures, South Africa is moving closer to achieving a safer, cleaner, and more sustainable future for all. 

The full text of the regulations can be found here. 

On 16 April 2025, seven Gulf countries (United Arab Emirates, Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and Yemen) submitted a joint addendum to the World Trade Organization (WTO) regarding their draft Technical Regulation on maximum limits for pesticide residues in agricultural and food products.

Key Updates

• The update, coordinated by the Saudi Food and Drug Authority (SFDA) representing the Gulf Cooperation Council (GCC), amends several Maximum Residue Limits (MRLs) in the Gulf Standard Organization’s (GSO) 2019 draft standard.

• The revised limits apply to a wide range of commodities, including fruits (e.g. apples, mangoes, and citrus), vegetables (e.g. cucumbers, tomatoes, and leafy greens), grains (e.g. barley, sorghum, and wheat), and animal products (e.g. meat, milk, and eggs).

• Notable affected pesticide substances include chlorpyrifos, fenpyroximate, imazalil, and metalaxyl, among others.

• The changes aim to align with updated scientific assessments and regional safety priorities.

Stakeholder Engagement

• WTO members and stakeholders have 60 days until 15 June 2025, to submit comments.

• The updated draft is accessible here.

• Comments should be directed to the SFDA.

This move reflects the GCC's continued effort to harmonize food safety regulations with international standards, considering regional consumption patterns and risk assessments.

On 9 April 2025, the Ministry of Environmental Protection and Natural Resources of Ukraine announced the development of an official CLP notification form to standardize the submission process for hazard classification and safety information of chemical products. This initiative aims to unify the approach for companies in Ukraine and ensure consistent and efficient compliance with the Technical Regulation on Classification, Labelling, and Packaging of Chemical Products (UA-CLP).

On 15 November 2024, Ukraine officially enforced the UA-CLP, implementing the Globally Harmonized System (GHS) into national law and aligning Ukraine’s chemical safety framework with international and EU standards.

Highlights of the UA-CLP Regulation:

• Implementation of EU-aligned criteria for classification of hazardous chemicals - covering 33 hazard classes.

• Mandatory labelling and packaging requirements for hazardous substances placed on the market in Ukraine.   

Obligation to Notify Hazard Classification

Under the UA-CLP Regulation, manufacturers, importers, suppliers, and other market operators must classify their chemical products before placing them on the market. The classification must follow GHS criteria. In addition, operators are required to submit a notification to the Ministry of Environmental Protection and Natural Resources of Ukraine (Ministry of Environment) with detailed information on:

• The hazard classification

• Associated safety information for each chemical substance

Introduction of Unified CLP Notification Form

To streamline compliance, the Ministry of Environment has introduced an official CLP notification form. This form ensures a consistent approach to preparing and submitting hazard classification notifications, simplifying compliance for companies across Ukraine.

Important:

• Only Ukrainian manufacturers and importers are obligated to submit the CLP notification.

• Only Representatives under Ukraine REACH may submit the notification voluntarily.

• The notification must be completed and submitted in Ukrainian and must be signed using a qualified digital signature.

How to Submit the Notification

1. Download the official form from the Ministry of Environment website (link here).

2. Complete the form with accurate classification and safety details and sign the document electronically.

3. Submit it via email to clp@mepr.gov.ua.

CLP Notification Deadlines

• For substances placed on the Ukrainian market before 15 November 2024: notification due by 15 November 2025

• For substances introduced after 15 November 2024: notification due within 30 days of first placing on the Ukrainian market.

By complying with the UA-CLP requirements and submitting timely notifications, companies will contribute to improved chemical safety and demonstrate alignment with global regulatory practices.