📋 Report Overview
| Item | Content |
|---|---|
| Review Date | September 3, 2026 (Thursday) |
| Key Areas | EU REACH SVHC Candidate List · US EPA TSCA · China GB Standards |
| Same-Day Major Change | Yes — GB 4806.10/16-2025 two mandatory FCM standards take effect today |
| Overall Risk Level | Medium |
1. EU REACH SVHC Candidate List (Baseline Monitoring)
Current status: The Candidate List contains 253 substances. The latest update (February 4, 2026) added n-hexane (CAS 110-54-3) and Bisphenol AF (BPAF) group substances.
Critical: Art. 7(2) Notification Deadline — Passed
For articles containing the newly listed SVHCs (≥0.1% w/w), the ECHA notification deadline was August 4, 2026. Companies that have not yet submitted notifications are now in non-compliance, facing Member State enforcement, product recalls, and market exclusion risks.
Active Obligations
- Supply-chain communication (Art. 33): Articles with SVHC ≥0.1% require safe-use information to downstream recipients/consumers; consumer written requests must be answered free of charge within 45 days.
- SCIP database notification: Under the Waste Framework Directive, articles with SVHC ≥0.1% must be reported to ECHA’s SCIP database.
- Authorisation risk: SVHCs may later move to Annex XIV, after which use requires authorisation.
Recommended Actions
- Immediately (within 7 days) screen EU-bound articles for n-hexane and BPAF (focus: fluoroelastomer seals/O-rings, cleaning agents, coatings, cross-linking agents)
- For articles ≥1 tonne/year containing the above substances, submit the overdue ECHA notification and complete SCIP notification in parallel
- Establish a semi-annual SVHC review mechanism (ECHA typically updates twice yearly; H2 2026 update expected ~October)
2. US EPA TSCA (Significant New Use Rules)
Latest Developments
- July 24, 2026 (Final Rule): Multi-walled carbon nanotube (MWCNT) SNUR final rule published; effective September 22, 2026.
- July 30, 2026 (Proposed Rule): EPA proposed SNURs for 14 chemical substances (Batch 26-4), covering few-layer graphene (3-9 layers/~32 layers, for batteries, electronics, construction materials), lithography sulfonates, tert-butylalanine (semiconductor manufacturing), and more; public comment period closed August 31, 2026.
- August 26, 2026 (Final Rule, Batch 24-5.5e): SNUR final rule published; effective October 26, 2026.
14 Regulated Substances — Batch 26-4 Summary
| PMN No. | Substance/Use | Key Restrictions |
|---|---|---|
| P-21-7/8 | Alumina-zirconia reaction products (catalyst) | — |
| P-21-36 | 5-hexen-2-one derivatives (domestic fragrance) | ≤50,000 kg/year; ≤1% concentration |
| P-21-59 | Ytterbium triflate (stabilizer) | Liquid formulations only |
| P-21-185 | Ethyl cyclohexylpropionate (fragrance ingredient) | — |
| P-24-27 | Fatty acid pyranosyl mannose esters (industrial cleaner) | ≤5% concentration |
| P-24-86/87 | Few-layer graphene (3-9 layers & ~32 layers) | Batteries, electronics, construction materials |
| P-24-196 | 2-pyrrolidinone polymer (construction coating additive) | ≤10,000 kg/year |
| P-25-15 | Modified tall oil fatty acid polyamine condensate (paving additive) | — |
| P-25-25 | Carbon monocyclic alcohol compound (lithography use) | — |
| P-25-77 | Tert-butylalanine (semiconductor manufacturing) | — |
| P-25-126/127 | Photoresist sulfonate compounds | Import only |
Recommended Actions
- Graphene/nanomaterials exporters: confirm SNUR effective date (September 22), establish a 90-day advance-notification workflow
- Semiconductor/electronic chemical exporters: assess whether any “significant new use” conditions are triggered; submit comments if comment period was still open
- Build a TSCA new chemicals tracking mechanism; continuously monitor Batch 26-3 and 26-4 rulemaking progress
3. China GB Standards (Today’s Major Change)
⭐ Effective Today: GB 4806.10/16-2025 Food Contact Materials Standards
Effective date: September 3, 2026 (mandatory enforcement from today)
On September 25, 2025, China’s National Health Commission (NHC) and State Administration for Market Regulation (SAMR) jointly issued two national food safety standards, effective September 2, 2026, now mandatorily enforced from today:
GB 4806.10-2025 — Coatings and Coatings for Food Contact Materials
- Expanded scope: Paper coatings explicitly included (governed by GB 9685)
- Refined raw material management: New polymers assessed for safety and with proven process necessity now permitted (MW >1,000 Da), opening compliance space for new materials
- New primary aromatic amine (PAA) migration limit: Coatings containing isocyanates or azo colorants must test final product for total PAA migration
- Optimised metal can test method: Where coating detachment/foaming occurs, inert substrate sampling or 10% ethanol substitution for 4% acetic acid is permitted
GB 4806.16-2025 — Silicone Rubber Materials for Food Contact
- Replaces silicone rubber requirements from GB 4806.11-2016
- New volatile substance testing indicator added (Appendix B)
- Sensory requirements: Normal colour, no odours or foreign matter
- Migration test temperature refined: Specific total migration conditions for articles with contact temperature ≤40°C and contact time ≤24h
Related Test Method Standards (Already in Force)
- GB 31604.21-2025 (effective March 2, 2026): Benzoic acid and phthalic acid migration measurement
- GB 31604.64-2025 (effective March 2, 2026): Citrate and sebacate migration measurement
Recommended Actions
- Act now: Food contact coating/silicone rubber manufacturers and exporters must ensure products comply with the new standards effective today
- Priority review: PAA migration compliance, volatile substance testing, raw material list updates
- Update Declaration of Conformity (DoC) and technical documentation
- FCM coating exporters to the EU must simultaneously comply with EU (EU)2025/351 “high purity” requirements and China’s new GB standards
4. Risk Summary
| Policy Area | Risk Level | Affected Parties | Trigger |
|---|---|---|---|
| EU REACH SVHC (n-Hexane/BPAF) | Medium-High | Fluoroelastomer, coatings, cleaners, electronic component exporters to EU | Notification deadline (Aug 4) passed; SCIP not filed |
| US EPA TSCA (MWCNT/Graphene SNUR) | Medium | Nanomaterials, electronic chemicals, semiconductor material exporters to US | SNUR effective Sep 22; 14-substance proposal under comment |
| China GB (GB 4806.10/16-2025) | Medium-High | Food contact coating/silicone rubber manufacturers and exporters | Today (Sep 3) mandatory enforcement begins |
5. Action Checklist
| Priority | Action Item | Deadline |
|---|---|---|
| 🔴 Urgent | Submit overdue ECHA Art.7(2) notification for n-hexane/BPAF articles (if not yet done) | ASAP |
| 🔴 Urgent | Complete GB 4806.10/16-2025 compliance assessment for food contact coating/silicone rubber products | Effective immediately |
| 🟡 Important | File or update SCIP database notifications (n-hexane/BPAF articles) | This week |
| 🟡 Important | Assess TSCA SNUR compliance for graphene/nanomaterials exporters | Before Sep 22 |
| 🔵 Ongoing | Establish semi-annual SVHC review; monitor H2 2026 SVHC update pipeline | Long-term |
📅 Report generated: September 3, 2026 · LiiFoo Market Intelligence
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