The European Union cosmetic industry is currently undergoing its most extensive regulatory update in nearly a decade. Starting July 31, 2026, all cosmetics being placed on the market in the EU must disclose an additional 56 fragrance allergens on their labels, where applicable.
This mandate implies critical updates for almost all products containing fragrances or plant essential oils, including:
- Product labels
- Product Information Files (PIF)
- Cosmetic Product Safety Reports (CPSR)
- CPNP notifications
1. Why is the EU Adding 56 New Fragrance Allergens?
In 1999, the Scientific Committee confirmed 26 fragrance allergens required label disclosure to assist consumers in avoiding allergic reactions. Following updated clinical and experimental data from the SCCS in 2011 indicating further sensitizing potentials, the EU released Regulation (EU) 2023/1545 on July 26, 2023. This regulation officially added 56 allergens, bringing the total number of required disclosures to 82 items.
2. What are Fragrance Allergens?
Fragrance substances are organic compounds with characteristic odors found in perfumes, skincare, detergents, and other daily chemical products. Because repeated skin contact with certain components can induce contact dermatitis, the EU requires disclosure so sensitized individuals can actively avoid these substances.
3. Key Documents Required for Compliance
In addition to standard raw material specifications, SDS, and CoA, fragrance-related materials must include:
- IFRA Certificate: Proving the fragrance meets International Fragrance Association standards.
- Allergen Declaration / Allergen List: This must cover all 82 allergens listed in Annex III of the EU regulation to determine if label disclosure is necessary.
- Finished Product Testing (if necessary): To verify actual allergen levels and ensure accurate labeling.
4. What are the Disclosure Thresholds?
Allergens must be listed individually on the label if they exceed the following concentrations:
| Product Type | Disclosure Threshold |
| Leave-on | > 0.001% |
| Rinse-off | > 0.01% |
5. Defining “Placing on the Market”
The deadline applies to products placed on the market for the first time after July 31, 2026. Key distinctions include:
- Placing on the market: The initial supply to a distributor or consumer.
- Making available: Subsequent circulation (e.g., a distributor selling to a consumer); this does not constitute “placing”.
- Individual basis: This status is calculated for every individual unit, not just the product model.
Deadlines and Exceptions:
Non-applicable scenarios: “Placing on the market” does not include products for personal use, samples for testing, exhibition displays, products intended solely for export, or goods still in a factory/importer warehouse not yet supplied for distribution.
New batches produced after July 31, 2026, must be fully compliant.
Old batches already placed on the market before the deadline may be sold until July 31, 2028.
