Compliance Countdown for Companies! EU Fragrance Allergens Expanded to 81 Substances

The EU list of fragrance allergens has been expanded to 81 substances, and companies must complete compliance labeling of new products by July 31, 2026. With the compliance countdown underway, CIRS Group systematically reviews the successive revisions — including the transitional arrangements and the three categories of changes — to help companies respond efficiently.

Fragrances are widely used in cosmetics; however, certain fragrance ingredients may cause skin allergic reactions and pose potential health risks to sensitive individuals. On July 26, 2023, the EU published Regulation (EU) 2023/1545, amending Annex III (list of restricted substances) of the EU Cosmetics Regulation (EC) No 1223/2009, replacing and deleting certain existing entries, and thereby expanding the EU fragrance-allergen labeling list to 81 substances.

For all cosmetics placed on the EU market, when the concentration of a fragrance allergen exceeds 0.001% in leave-on products or 0.01% in rinse-off products, it must be individually disclosed in the ingredients list on the label. Under the transitional arrangements, companies must complete compliance labeling of new products by July 31, 2026, and existing products must be brought into compliance by July 31, 2028 at the latest.

EU Regulatory History of Fragrance Allergens

The main basis for EU regulation of fragrances in cosmetics is the EU Cosmetics Regulation (EC) No 1223/2009 and its Annex III (list of restricted substances). The Regulation requires all cosmetics placed on the EU market to disclose fragrance allergens on the label to ensure product safety and compliance.

Since this framework was established in 2009, it has undergone multiple revisions and updates, reflecting the EU's continuously strengthening consumer-safety protection.

Details of the Successive Revisions

Calculation: 26 − 2 + 12 + 45 = 81 fragrance allergens in total that must be declared on cosmetic labels.

Analysis of the Three Transitional-Period Categories

A. Adjustments to Existing Entries

CIRS Interpretation: The original entries Nos. 67–92 of (EC) 1223/2009 contained 26 substances; former No. 79 (HICC/Lyral) and No. 83 (BMHCA/Lilial) have been moved to the prohibited-substances list. In addition, 4 existing entries were updated: No. 70 Citral and No. 88 Limonene now require labeling of multiple isomers. These adjustments are intended to make allergen labeling more precise and refined, helping consumers more accurately identify potential sensitizing substances.

Transitional period: Cosmetic products containing substances that do not meet the restriction requirements may be placed on the EU market before July 31, 2026, and remain on sale in the EU market until July 31, 2028.

B. Replacements and Updates

CIRS Interpretation: Existing entries were replaced and merged. Former entries No. 45 and No. 68 were merged and replaced by the new entry No. 46. In addition, the substances corresponding to entries Nos. 109, 114, 122, 124, 131, 133, 154, 157, 175, 196, and 324 were updated, and 12 new substances were added.

Transitional period: Cosmetic products containing substances that do not meet the restriction requirements, where they meet the restriction conditions applicable on August 15, 2023, may be placed on the EU market before July 31, 2026, and remain on sale in the EU market until July 31, 2028.

C. Entirely New Additions

CIRS Interpretation: New entries Nos. 327–371 add 45 fragrance allergens. These 45 new allergens cover single-chemical substances and plant-extract groups, among other types. Some of the newly added substances (e.g., Menthol, Camphor) are extremely widely used in cosmetics.

Transitional period: Cosmetic products containing substances that do not meet the restriction requirements may be placed on the EU market before July 31, 2026, and remain on sale in the EU market until July 31, 2028.

Global Regulatory Trends

It is worth noting that Health Canada, referencing EU standards, has required the labeling of 24 fragrance allergens in cosmetics from April 12, 2026, and plans to expand the labeling scope to 81 substances from August 1, 2026, aligning with the EU. South Korea has also recently proposed amendments to the regulations on precautions for use and allergen labeling for cosmetics. This means that major cosmetics markets worldwide are strengthening the regulation of fragrance allergens, and export-oriented companies need to monitor compliance requirements across multiple target markets simultaneously.

The List Has Been Fully Updated

CIRS Group's independently developed Global CosIng is designed to provide cosmetic companies and ingredient suppliers with a convenient and efficient channel for accessing ingredient and regulatory information. Companies can quickly obtain the latest regulatory updates on more than 40,000 ingredients across major markets including China (including Taiwan, China), the EU, the US, Canada, ASEAN countries, South Korea, and Japan. With advanced ingredient-search and real-time update features, Global CosIng precisely presents regulatory requirements such as prohibited/restricted status and safety limits for each ingredient.

The EU fragrance-allergen list — EU list of fragrance allergens in cosmetic products — has now been fully updated. It contains the 81 fragrance allergens mentioned above and covers the corresponding INCI names, CAS numbers, and specific use restrictions and requirements.

CIRS Reminder

Faced with the significant expansion of the EU fragrance-allergen list and the imminent compliance countdown, cosmetics companies should prepare in the following areas:

• Comprehensive formula review: promptly conduct a full review of all product formulas exported to the EU, cross-checking them one by one against the 81-substance fragrance-allergen list to confirm whether the products contain any allergen components that must be labeled;
• Update product labels: products containing allergens above the threshold must individually disclose each allergen on the packaging label. Companies should assess existing packaging inventory and arrange a packaging-update plan to avoid non-compliant labels preventing products from being placed on the market;
• Watch the transitional-period milestones: July 31, 2026 is the key deadline for compliant placement of new products on the market, and existing products must be brought into compliance by July 31, 2028 at the latest. Companies should develop a detailed compliance schedule to ensure all compliance work is completed before the deadlines.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

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