What's Changing in Chemical Compliance: TSCA, REACH 2.0, UK REACH and APAC

TSCA PFAS Reporting Rule — Section 8(a)(7)

The EPA's final rule under TSCA Section 8(a)(7) requires manufacturers and importers of PFAS-containing substances and articles to report data covering the period 2011–2022. Reportable information includes substance identity, volumes manufactured or imported, categories of use, worker exposure, environmental releases, and disposal methods. The reporting window runs from 13 April to 13 October 2026 for most manufacturers, with a later window for small businesses and article importers. Over 1,400 individual PFAS substances fall within scope of the rule — including many fluoropolymers, surfactants, and processing aids not previously subject to specific US reporting obligations. Civil penalties for non-reporting reach $48,500 per day per violation under TSCA.

Many businesses conducting pre-reporting substance inventories are discovering PFAS in supply chain inputs — raw material coatings, equipment lubricants, processing aids, and packaging treatments — that were not previously tracked. A systematic supply chain disclosure programme, including requests to raw material suppliers and article manufacturers for PFAS confirmation, should be completed before the reporting window to avoid rushed submissions based on incomplete data.

TSCA TCE Risk Management Rule — Trichloroethylene Phaseout

The EPA's final risk management rule for trichloroethylene (TCE) under TSCA Section 6(a) prohibits manufacture, processing, distribution in commerce, and use of TCE across the vast majority of industrial and commercial applications from 18 May 2026. TCE has been widely used as a degreaser, industrial cleaning solvent, and intermediate in the manufacture of hydrofluorocarbons and other chemicals. The rule reflects the EPA's determination that TCE presents an unreasonable risk to human health under TSCA's updated risk evaluation framework.

Affected businesses must identify all current uses of TCE across their operations and supply chains, evaluate alternative chemistries or processes, and implement substitution before the compliance date. The EPA has granted limited transition periods for some categories — a 12-month extension for certain industrial uses, and a 24-month extension for critical or essential uses where alternatives are not yet available. Businesses seeking these extensions must act now, as applications require documentation of alternative assessment efforts and implementation timelines.

TSCA Import Enforcement — Expanded Scope

The EPA has expanded its TSCA import enforcement programme from December 2025, deploying Customs and Border Protection coordination to intercept shipments of chemical substances and articles that do not comply with applicable TSCA requirements. The expanded programme targets: articles containing substances on the significant new use rule (SNUR) list; PFAS-containing articles where reporting obligations have not been met; and chemical substances imported without the required TSCA certification (positive or negative). Importers should ensure that their customs filings include accurate TSCA certifications and that compliance documentation is available for inspection at the border.

EU REACH 2.0 Revision — Commission Proposal Published

The European Commission published its proposal for a revised REACH regulation in April 2025 — the first fundamental reform of the framework since REACH came into force in 2007. The proposal introduces generic risk assessment approaches for groups of structurally similar substances (reducing the need for individual substance evaluations), expands the criteria for SVHC identification and Authorisation List inclusion, proposes a restructured Registration dossier format, and introduces new requirements for digital product passport integration for certain substances. The Regulatory Scrutiny Board issued a negative opinion on the Commission's impact assessment in September 2025, citing insufficient analysis of compliance costs for small and medium enterprises — requiring revision before the legislative process can advance.

The co-legislative timeline for REACH 2.0 adoption is expected to run through 2026 or 2027, with transitional periods before the new requirements apply. Existing REACH obligations are not paused during the revision process — SVHC Candidate List additions continue, Authorisation List deadlines remain active, and substance evaluation commitments under the Community Rolling Action Plan (CoRAP) proceed on their existing schedules.

EU PFAS Universal Restriction — Annex XVII Process

ECHA's universal PFAS restriction proposal under REACH Annex XVII covers approximately 10,000 PFAS substances and was submitted for RAC and SEAC scientific committee review in 2023. Final committee opinions are expected in 2026, after which the Commission must adopt the restriction through the regulatory procedure. Implementation — if the restriction is adopted — is not expected before 2028–2029, with derogations for essential or critical uses likely extending to 2030 and beyond for some sectors. The restriction proposal, if adopted in the form submitted, would prohibit the manufacture, use, and placement on the EU market of PFAS across virtually all industrial sectors including textiles, construction, food packaging, and chemical processing.

PFAS alternative assessment and substitution programmes in sectors with long product development cycles — including aerospace, medical devices, and industrial coatings — need to begin now to have a realistic chance of completing qualification before formal restriction deadlines. ECHA's SVHC Candidate List already includes a growing number of individual PFAS substances, creating notification obligations to EU customers and SCIP database entries independent of the broader restriction timeline.

SVHC Candidate List — Active Notification Obligations

ECHA's Candidate List of Substances of Very High Concern now includes over 251 substances. Any supplier of articles containing a Candidate List substance above 0.1% by weight must notify customers and consumers upon request — with no grace period from the date of listing. Any importer or manufacturer of a substance or mixture above 1 tonne per year that contains an SVHC must submit a SCIP database notification. New additions to the Candidate List are made twice per year — businesses must monitor updates and assess their portfolios within weeks of each addition, not months. Failure to notify customers of SVHC presence in articles is directly enforceable by EU member state authorities, and supply chain disclosure expectations from customers under extended producer responsibility frameworks are increasing independent of regulatory enforcement.

UK REACH Registration — Independent from EU REACH

UK REACH — the post-Brexit chemical registration regime administered by the HSE and DEFRA — requires manufacturers and importers of chemical substances into Great Britain to submit full registration dossiers independent of any EU REACH registration. The original grandfathering mechanism (Transitional Registration — downstream user import notifications) expires in phases: Phase 1 for high-volume and hazardous substances closes in 2026, Phase 2 for medium-volume substances in 2028, and Phase 3 for lower-volume substances in 2030. After each deadline, substances without valid UK REACH registrations may not legally be placed on the Great Britain market.

Critically, UK REACH does not allow downstream users to rely on their supplier's registration — the obligation sits with the GB-market entity. Non-GB manufacturers must appoint a UK Only Representative to fulfil the registration obligation, or require their GB importer to register directly. Many businesses that relied on EU Only Representative arrangements for REACH compliance cannot transfer that arrangement to UK REACH — a separate UK OR appointment and dossier is required. The SVHC Candidate List for UK REACH has been diverging from the EU list since 2021, and must be monitored independently.

K-REACH Korea — GHS SDS Format Change and 2025 Structural Amendments

South Korea's Chemical Substances Control Act and K-REACH framework require that Safety Data Sheets be prepared in Korea's specific GHS SDS format. From 1 July 2026, the legacy MSDS format — which was still accepted under transitional provisions — is no longer valid. All SDS for chemical substances and mixtures supplied into Korea, whether domestically manufactured or imported, must comply with the revised GHS SDS structure aligned with the 9th Revised Edition of the UN GHS. This includes specific Korean-language content requirements, prescribed section ordering, and hazard classification aligned with Korea's designated substance lists under K-REACH and the CSCA.

K-REACH's 2025 structural amendments also introduced mandatory electronic transmission of SDS to downstream users — paper-based SDS delivery no longer satisfies the communication obligation for most supply chain scenarios. New substance registration requirements under the amended K-REACH framework now include expanded pre-registration consultation requirements with the National Institute of Chemical Safety (NICS) for substances above threshold tonnage. Korean enforcement authorities have increased inspection activity at ports for imported chemical products since 2024.

Japan ISHL — GHS SDS and Labelling Amendments Now in Effect

Japan's Industrial Safety and Health Law (ISHL) amendments that took effect in April 2025 expanded mandatory GHS-compliant Safety Data Sheet and labelling requirements to a significantly larger list of designated chemical substances. The amendments narrowed the concentration thresholds below which substances in mixtures were previously exempt from mandatory SDS provision. For importers supplying chemical substances and mixtures into Japan, the obligation to provide a GHS-format SDS sits with the entity placing the product on the Japanese market.

Legacy MSDS documents, EU-format SDS not adapted to Japan's ISHL classification criteria, or SDS covering only the substances previously designated under the older ISHL list do not satisfy the obligation under the amended framework. The Ministry of Health, Labour and Welfare has issued compliance guidance making clear that translation of a EU SDS into Japanese is not, by itself, sufficient — the classification must follow Japan's ISHL GHS implementation, which differs from EU CLP in several substance-specific classifications.

China MEE Order 12 — New Chemical Substance Registration

China's Measures for Environmental Management Registration of New Chemical Substances (MEE Order 12) require manufacturers and importers to register new chemical substances with the Ministry of Ecology and Environment before their first import or manufacture. A new chemical substance for China's purposes is any substance not appearing in the China Existing Chemical Substances Inventory (IECSC). Registration pathways are tiered by volume and risk — simplified registration for low-volume or low-risk substances, and standard registration for substances above 1 tonne per year or with specific hazard profiles. The MEE conducted its first enforcement inspections under Order 12 in 2024, issuing administrative penalties to importers found to have supplied substances not appearing on the IECSC without completing the required registration. The enforcement signals an end to the informal compliance culture that previously characterised new substance registration in China.