Industrial Chemical

Navigating 2025 Global Chemical Regulatory Landscape: A Strategic Insight

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Introduction

During the Chemical Materials Japan 2025, one of Japan’s leading exhibitions for the chemical materials sector, REACH24H was invited to deliver a presentation on global REACH-like regulatory trends and emerging-market developments. Building on the insights shared at the event, this article further consolidates the key changes expected across the EU, UK, Turkey, Korea, China, and emerging regions, helping companies stay ahead of regulatory shifts and plan effective compliance strategies for global operations.

EU REACH: Continuous Optimization and Forward-Looking Reform

Since its entry into force in 2007, EU REACH has remained the global benchmark for chemicals management. Chemical substances on their own or in mixtures, manufactured or imported to the EU in quantities of 1 tonne or more per year, must be registered with the European Chemicals Agency (ECHA). Certain substances also require evaluation, notification/authorisation, or restriction. Recent developments include:

Administrative Fee Adjustment

Effective November 5, 2025, EU REACH registration fees will increase by 19.5%. Fees for Small and Medium-sized Enterprises (SMEs) will remain unchanged, but the related management rules for SMEs will be adjusted.

Revision Proposals to the EU REACH Regulation

The European Commission proposed a comprehensive revision of the EU REACH Regulation in April 2025. Key areas include updates to registration requirements, the definition of nanomaterials, digitalization of the supply chain communication, simplification of authorization and restriction processes, and stronger customs enforcement.

The most notable proposal is the planned introduction of a uniform 10-year validity period for registrations. ECHA will have the authority to revoke registration numbers if dossiers are not updated or found to be non-compliant.

UK REACH: An Independent System with Flexible Adjustments Post-Brexit

Following its departure from the EU, the UK established the independent UK REACH regulatory framework, implemented on January 1, 2021.

This regulation requires manufacturers or importers of a substance, either on its own or in one or more mixture(s), in quantities of one tonne or more per year, shall submit a registration.

Focus Areas and Recent Regulatory Updates:

  • Transitional Mechanisms: To minimize disruption to trade, UK REACH includes transitional provisions such as the "Grandfathering Clause," Downstream User Import Notification (DUIN), and New Registration of an Existing Substance (NRES).

  • "Alternative Transitional Registration Model" (ATRm): The UK government is actively developing a new, lower-cost registration system designed to maintain high health and environmental standards while significantly reducing compliance costs for businesses.

  • First Deadline Likely to be Postponed: The initial submission deadline, previously set for October 2026, may be further extended due to pending details on the ATRm.

Turkey KKDIK: Entering the Operational Phase

Turkey's KKDIK Regulation, in force since 2017, closely mirrors the EU REACH framework, requiring manufacturers or importers of chemical substances to register their substances by submitting a technical dossier and a Chemical Safety Report. Unregistered substances are prohibited from sale or use in the Turkish market.

The Turkish Ministry of Environment, Urbanisation and Climate Change (MoEUCC) has announced the activation of the KKDIK registration system module, allowing the submission of "temporary (provisional) registrations" and marking the regulation's entry into a substantial operational phase:

  • Pre-registration Deadline: Substances already on the Turkish market must complete pre-registration by October 31, 2025. Substances produced or imported for the first time after this date must be pre-registered within 30 days of market placement.

  • Temporary Registration: If the Lead Registrant cannot complete the formal registration in time, a temporary registration must be submitted by March 31, 2026. Joint registrants must complete their joint submission by September 30, 2026. Temporary registration only requires the submission of physicochemical data without the need to submit ecological and toxicological data for the time being.

  • Formal Registration Extension: Companies may apply for an extension of the formal registration deadline for a maximum of two years.

K-REACH: Adjusted Tonnage and Reporting System

The Act on Registration and Evaluation, etc. of Chemical Substances (K-REACH) mandates the registration of new chemical substances and existing Priority Existing Chemicals (PECs), requiring safety data submission and risk assessment. Unregistered substances cannot circulate in Korea, and violations may result in penalties and product recalls.

Key Recent Updates:

  • New Substance Tonnage Threshold Adjustment: Effective January 1, 2025, the annual tonnage threshold for new substance notification/registration will increase from 0.1 tonnes to 1 tonne.

  • New Toxic Substance Classifications: Starting from August 7, 2025, the original concept of "toxic substances" was officially subdivided by three groups: Acute hazardous Substances to Humans, Chronic hazardous Substances to Humans, and Ecologically Hazardous Substances (collectively referred to as "Hazardous Substances Affecting Humans and the Environment").

China REACH: New Chemical Substance Management Enters a New Legal Stage

The Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12) requires companies producing or importing new chemical substances in China to complete registration according to the regulation. Unregistered substances are prohibited from production or import. The Ministry of Ecology and Environment (MEE) continues to refine this system:

  • Extension Application for Chemical Substance Identification Information Disclosure: For chemical substances that obtained a Registration Certificate under the Measures on Environmental Management of New Chemical Substances (State Environmental Protection Administration Order No. 7) before December 31, 2020, and for chemical substances listed in the Inventory of Existing Chemical Substances in China (IECSC) with identification information protection prior to the Measures taking effect, the identification information protection period is valid until December 31, 2025; Applicants may apply for an extension of disclosure, with a maximum extension of up to 5 years.

  • Elevated Regulatory Hierarchy: The pending Ecological and Environmental Code will establish the Environmental Management Registration System for New Chemical Substances, significantly increasing penalties for violations and strengthening "evidence-driven" management.

Ukraine REACH

The Technical Regulations on the Safety of Chemical Products (Ukraine REACH) introduces a "no data, no market" principle, meaning that chemical substances produced or imported into Ukraine in quantities of 1 ton/year or more must be registered. The regulation applies to substances on their own, in mixtures, or in articles, and introduces new requirements for registration, hazard classification, risk assessment, and more.

On October 22, 2025, the Cabinet of Ministers of Ukraine issued a draft proposal, outlining a one-year extension for the UA REACH pre-registration deadline. Moreover, the formal registration deadlines have been significantly postponed, with adjustments based on the tonnage and hazard of substances

Brazil REACH

Brazil’s REACH regulation (Law 15.022) officially came into force on November 15, 2024. A Supplementary Regulation Draft released in May 2025 specified details such as tonnage-tiered fees, a maximum five-year application period for CBI protection, and substance risk assessment.

Colombia REACH

In November 2021, Colombia enacted Decree No. 1630, Comprehensive Management Regulation for Industrial Chemicals, establishing a National Inventory of Chemical Substances and a registration catalog. It introduced an Integrated Management Mechanism for industrial chemicals classified under the GHS.

The first National Industrial Chemicals Inventory was published on November 11, 2025. This inventory is accessible via an interactive platform. Substances not included in this inventory are classified as "New Substances" (or "nueva" in Spanish), requiring enterprises to submit a New Substance Notification within six months of exceeding the 100 kg production or import threshold. 

What Should Corporations Do?

Given the continuous evolution and regional divergence of global chemical regulatory systems, companies are advised to establish a systematic compliance strategy, shifting from passive reaction to proactive management:

Define Clear Compliance Pathways and Timelines

For target export or operational markets, systematically review national regulatory obligations and critical deadlines to establish an internal compliance calendar.

Pay close attention to recently updated or postponed registration deadlines in countries like Turkey, Ukraine, and the UK to prevent market access disruption due to missed submissions.

Dynamically Track Regulations and Leverage Tools for Cost-Efficiency

Establish a regulatory monitoring mechanism to timely acquire the latest policies on data sharing, alternative testing methods, and simplified registration procedures in various countries.

Flexibly utilize data sharing mechanisms and transitional registration schemes to significantly reduce testing costs and timelines.

Engage Early with Drafts and Transitional Policies

Maintain close attention to regulations still in the draft or review stage, and conduct preliminary impact assessments.

For markets with transitional arrangements, seize the policy window (e.g., Turkey's temporary registration, UK's ATRm) to start compliance preparations early, avoiding the full registration burden immediately after the transition period ends.

Establish Expert Support and Internal Synergy

Engage with professional compliance consulting firms for regulatory interpretation and operational guidance.

Internally, strengthen collaboration among R&D, Marketing, and Compliance departments to ensure a smooth end-to-end process—from substance evaluation and data preparation to registration submission—synchronizing compliance with business objectives.


For more information and inquiries on global chemical regulatory compliance, please feel free to contact us at customer@reach24h.com.

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