2025 Global Compliance Checklist for Specialty Chemical Exports
1. European Union (EU)
Regulatory Framework
REACH Regulation (EC No 1907/2006):
Substances of Very High Concern (SVHC) must be declared if present above 0.1% in products.
Compliance with CLP Regulation (classification, labeling, and packaging).
Registration fees increased by 19.5% effective November 5, 2025 .
SMEs must apply for SME status certification at least 2 months before submitting registrations, valid for 3 years .
Key Changes in 2025:
Critical Requirements:
EU Sanctions on Russia:
Ban on Russian liquefied natural gas (LNG) and oil imports from Rosneft/Gazprom Neft .
Export restrictions on dual-use chemicals and equipment linked to Russia’s military-industrial complex.
Tariff Adjustments:
No new tariffs on specialty chemicals, but regional supply chains (e.g., EU Critical Chemicals Alliance) prioritize domestic sourcing .
2. United States (US)
Regulatory Framework
FDA Drug Master Files (DMFs):
Model Master Files (MMFs) under Type V DMF now accepted for generic drug submissions using modeling/simulation .
Type II DMF required for APIs and intermediates. Applications must use eCTD format via the Electronic Submissions Gateway (ESG) .
Key Changes:
Tariff Policies:
Section 232 Tariffs: 25% duty on steel/aluminum imports, impacting chemical equipment .
Reciprocal Tariffs: Up to 245% on Chinese chemical products (e.g., ethylene derivatives) .
Exemptions: Semiconductor equipment and critical minerals from EU partners .
TSCA Inventory:
New chemical substances must be notified to EPA 90 days before manufacture/import. Fees vary by substance type .
3. India
Regulatory Framework
BIS Certification:
Scheme X (Effective August 28, 2025): New certification for machinery and high-risk equipment (e.g., pumps, valves) .
FMCS Scheme: Foreign manufacturers must appoint an Indian Authorized Representative (AIR) and undergo factory audits .
Mandatory for 679+ Products:
Key Chemicals: Caustic soda, acetic acid, methanol, and pharmaceutical intermediates require BIS compliance .
Tariff Policies:
15% import duty on Chinese pharmaceutical intermediates to protect domestic industry .
Simplified duty-free imports under SIONs for triethyl phosphate and methyl ethyl ketone peroxide .
4. Japan
Regulatory Framework
Positive List System (PL) for Food Contact Materials (FCMs):
Only synthetic resins listed in Table 1 (base materials) and Table 2 (additives) are permitted .
Exemptions apply to non-resin materials (e.g., glass, rubber) and substances with migration <0.01 ppm .
Effective June 1, 2025:
Tariff Adjustments:
No major tariff changes, but FTA preferences (e.g., with ASEAN) reduce duties on specialty chemicals.
5. China
Regulatory Framework
Export Controls:
Lithium-ion batteries (≥300 Wh/kg) and graphite负极材料 require dual-use export licenses .
Tungsten,碲,铋,钼,铟-related chemicals now subject to strict export controls .
New Restrictions (2025):
Tariff Rebates:
Refined oil products, batteries, and non-metallic minerals: 13% → 9% .
Canceled Rebates: Chemically modified oils/fats .
Reduced Rates (Effective December 1, 2025):
Green Policies:
Tax incentives for bio-based chemicals and high-purity semiconductor materials (e.g., cycloolefin polymers) .
6. Southeast Asia (ASEAN)
Regulatory Framework
RCEP Benefits:
Duty-free access for specialty chemicals under cumulative rules of origin (e.g., Chinese PTA exports to Vietnam) .
Country-Specific Requirements:
Vietnam: BIS-like certifications for construction chemicals (e.g., paints, adhesives).
Indonesia: 5% import duty on Chinese polypropylene, favoring ASEAN/Korean suppliers .
Key Action Items for Exporters
EU:
Submit REACH registrations before November 5, 2025, to avoid fee hikes.
Verify compliance with EU sanctions on Russia-linked transactions.
US:
Leverage Type V DMF for MMF submissions to accelerate generic drug approvals.
Use FTZ strategies to defer tariff payments on intermediate chemicals .
India:
Appoint AIR and initiate BIS audits 6–8 months before export.
Utilize SIONs for duty-free raw material imports.
Japan:
Test FCMs against PL criteria and maintain compliance records.
Opt for third-party certifications (e.g., NSF International) for complex formulations.
China:
Obtain dual-use licenses for high-capacity batteries and rare earth chemicals.
Adjust pricing strategies to reflect reduced tariff rebates.
Southeast Asia:
Establish regional hubs (e.g., Singapore) to streamline RCEP compliance.
Monitor local standards (e.g., Indonesia’s SNI) for niche chemicals.