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EU 2026 Compliance Guide

EU Fragrance Allergen Disclosure 2026 — Regulation 2023/1545 Compliance Guide

EU Commission Regulation 2023/1545 amends Regulation 1223/2009 (the EU Cosmetics Regulation), expanding the fragrance allergen disclosure list from 26 to 81 substances. For cosmetic brands selling in the EU, this creates a July 2026 compliance cliff. No self-serve compliance tool currently surfaces this deadline in a searchable, structured format. Here is what you need to know.

What is Regulation 2023/1545?

Expanded Allergen Disclosure Requirements

Regulation 2023/1545 was published on July 26, 2023, and entered into force on August 15, 2023. It expands Annex III of the EU Cosmetics Regulation to include 81 fragrance allergens (up from 26). From July 30, 2026, all cosmetic products sold in the EU must disclose these allergens by name on the product label when present above specified concentration thresholds.

  • 26 existing allergens — Already required to be disclosed on labels (e.g., Limonene, Linalool, Citronellol).
  • 55 new allergens — Added by 2023/1545, including natural extracts and synthetic fragrance components.
  • Total: 81 substances — All must appear by INCI name when thresholds are exceeded.
  • Mandatory INCI format — Commission Implementing Decision 2025/1175 confirms that only official INCI names are accepted on EU cosmetic labels.
Key Deadlines

Compliance Timeline

The compliance deadline is fixed. There is no grace period for new products placed on the EU market after July 30, 2026.

  • July 30, 2026 — All new cosmetic products must comply with the expanded allergen disclosure list.
  • Existing stock — Products manufactured before July 30, 2026 may continue to be sold until stock is depleted (no fixed sell-through deadline announced as of May 2026).
  • Label updates — Brands must verify that all 81 allergens are checked in their formulations and that any exceeding threshold concentrations are listed by INCI name.
Concentration Thresholds

When Must an Allergen Be Disclosed?

Disclosure is required only when the allergen concentration exceeds the threshold. The thresholds differ by product type:

  • Leave-on products — 0.001% (0.01 g/kg) or higher.
  • Rinse-off products — 0.01% (0.1 g/kg) or higher.
  • Individual listing — Each allergen must be listed separately by INCI name. Group terms like "fragrance" or "parfum" are not sufficient when thresholds are exceeded.
Canada Parallel

Canada SOR/2024-63: Similar Requirements

Canada is implementing similar allergen disclosure requirements through SOR/2024-63. The initial compliance deadline is April 2026. Brands selling in both the EU and Canada should prepare for dual compliance.

  • April 2026 — Initial compliance deadline for Canada fragrance allergen disclosure.
  • Thresholds TBD — Canada has not yet published final concentration thresholds; expect alignment with EU standards.
  • INCI naming — Canada also requires INCI-compliant ingredient naming for cosmetics.
How to Check Your Formula

Use the IngredientCompliance Checker

Our database already flags EU Annex III ingredients, including the 81 fragrance allergens covered by Regulation 2023/1545. Run a check on your formula to identify which ingredients require disclosure.

Check Your Formula Now →

For food and supplement brands, see our EU Food Additive vs GRAS guide for crossover compliance issues.

Checklist

Is Your Formula Ready for EU 2026?

  • I have checked all fragrance ingredients in my formula against the 81-allergen list.
  • I know which allergens exceed 0.001% (leave-on) or 0.01% (rinse-off).
  • My labels list each allergen by its official INCI name.
  • I have updated label artwork for all EU-bound SKUs.
  • I have verified Canada SOR/2024-63 requirements if selling in Canada.
  • I have documented allergen concentrations in my PIF (Product Information File).

Legal Disclaimer

This service is provided "AS IS" without warranties of any kind. Regulatory data is for reference only and does not constitute legal or regulatory advice. Always consult a qualified attorney or regulatory consultant before making compliance decisions. Not affiliated with the U.S. Food and Drug Administration (FDA) or any government agency. IngredientCompliance is an independent tool operated by Gerim-Sterling LLC. © 2026 Gerim-Sterling LLC.

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