EU 80+ Allergen Rules & US MoCRA: The 2026 Regulatory Roadmap for Fragrance Importers

1. European Union: Regulation (EU) 2023/1545 (80+ Allergens)

As of July 31, 2026, the European Commission's expanded fragrance allergen labeling rules enter full enforcement:

• Expanded Allergen List: Increased from the original 26 fragrance substances to over 80 individually labeled allergens (including specific natural extracts, linalool derivatives, and geraniol isomers).
• Labeling Thresholds: Mandatory individual disclosure on product ingredient labels when present at concentrations exceeding 0.001% (10 ppm) for leave-on perfumery products.
• Product Information File (PIF): Every formulation imported into the EU must have a comprehensive PIF lodged with a designated EU Responsible Person (RP) and notified on the Cosmetic Products Notification Portal (CPNP).

2. United States: FDA MoCRA Compliance

The Modernization of Cosmetics Regulation Act (MoCRA) establishes rigorous oversight for the US fragrance market:

• Facility Registration: Manufacturing and processing facilities exporting to the US must register with the FDA and renew biennially.
• Product Listing: Every cosmetic fragrance SKU must be formally listed through FDA's Cosmetics Direct portal with full ingredient breakdowns.
• Safety Substantiation: Importers and brand owners must maintain technical documentation demonstrating adequate safety evidence for each formulation.
• Adverse Event Reporting: Mandatory recording and reporting of serious adverse events to the FDA within 15 business days.

Arabesque Perfumes Compliance Guarantee

All export allocations shipped through Arabesque Perfumes include: - IFRA 51st Amendment Certificate of Conformity. - 16-Section Safety Data Sheet (SDS / MSDS) compliant with GHS and OSHA standards. - Certificate of Analysis (CoA) detailing batch-specific chromatography, density, and refractive index. - Complete Allergen Breakdown Sheets enabling instant CPNP registration and MoCRA submission.