Regulatory update · 4 min read
On July 27, 2023, the European Commission published Regulation (EU) 2023/1545, which amends the EU Cosmetics Regulation (EC) No 1223/2009 by expanding the list of fragrance allergens that must be individually declared on cosmetic product labels. With the compliance deadline approaching fast, brands selling in the EU need to act now.
Two key deadlines:
• ⚠️ July 31, 2026 — placing on the market: Any new units supplied for the first time (to distributors or end users) must comply with the updated labelling requirements.
• 🛑 July 31, 2028 — making available on the market: Products already placed on the EU market before the 2026 deadline may continue to be sold until this date.
While Canada has also taken a similar approach with slightly different deadlines, the UK has not yet adopted equivalent labelling requirements, but will accept labels with extended allergens listed.
Background: from 26 to 82 declared allergens
The EU has required disclosure of fragrance allergens on cosmetic labels since 2005, when 26 substances were first added to Annex III of the Cosmetics Regulation. Since then, ongoing scientific reviews have identified many additional fragrance substances capable of causing allergic sensitisation.
Based on a 2011 Scientific Committee on Consumer Safety (SCCS) opinion, Regulation (EU) 2023/1545 adds 56 new allergens to the list — bringing the total to 82 substances subject to individual labelling requirements.
The regulation also updates substance names to align with the latest Common Ingredients Glossary, revises CAS and EC numbers where needed, and groups certain similar substances under a single entry.
Annex III fragrance allergens — original 24 vs. 56 newly added, totalling 80, as two have since been prohibited
| Original 24 allergens | 56 newly added allergens |
|---|---|
| 1. Alpha-Isomethyl Ionone | 1. Pinus Mugo |
| 2. Amyl Cinnamal | 2. Pinus Pumila |
| 3. Amyl Cinnamyl Alcohol | 3. Cedrus Atlantica Oil/Extract |
| 4. Anise Alcohol | 4. Turpentine |
| 5. Benzyl Alcohol | 5. Alpha-Terpinene |
| 6. Benzyl Benzoate | 6. Terpinolene |
| 7. Benzyl Cinnamate | 7. Myroxylon Pereirae Oil/Extract |
| 8. Benzyl Salicylate | 8. Rose Ketones |
| 9. Cinnamal | 9. 3-Propylidenephthalide |
| 10. Cinnamyl Alcohol | 10. Lippia Citriodora Absolute |
| 11. Citral | 11. Methyl Salicylate |
| 12. Citronellol | 12. Acetyl Cedrene |
| 13. Coumarin | 13. Amyl Salicylate |
| 14. Eugenol | 14. Anethole |
| 15. Evernia Prunastri Extract | 15. Benzaldehyde |
| 16. Evernia Furfuracea Extract | 16. Camphor |
| 17. Farnesol | 17. Beta-Caryophyllene |
| 18. Geraniol | 18. Carvone |
| 19. Hexyl Cinnamal | 19. Dimethyl Phenethyl Acetate |
| 20. Hydroxycitronellal | 20. Hexadecanolactone |
| 21. Isoeugenol | 21. Hexamethylindanopyran |
| 22. Limonene | 22. Linalyl Acetate |
| 23. Linalool | 23. Menthol |
| 24. Methyl 2-Octynoate | 24. Trimethylcyclopentenyl Methylisopentenol |
| 25. Salicylaldehyde | |
| 26. Santalol | |
| 27. Sclareol | |
| 28. Terpineol | |
| 29. Tetramethyl acetyloctahydronaphthalenes | |
| 30. Trimethylbenzenepropanol | |
| 31. Vanillin | |
| 32. Cananga Odorata Oil/Extract | |
| 33. Cinnamomum Cassia Leaf Oil | |
| 34. Cinnamomum Zeylanicum Bark Oil | |
| 35. Citrus Aurantium Flower Oil | |
| 36. Citrus Aurantium Peel Oil | |
| 37. Citrus Aurantium Bergamia Peel Oil | |
| 38. Citrus Limon Peel Oil | |
| 39. Lemongrass Oil | |
| 40. Eucalyptus Globulus Oil | |
| 41. Eugenia Caryophyllus Oil | |
| 42. Jasmine Oil/Extract | |
| 43. Juniperus Virginiana Oil | |
| 44. Laurus Nobilis Leaf Oil | |
| 45. Lavandula Oil/Extract | |
| 46. Mentha Piperita Oil | |
| 47. Mentha Viridis Leaf Oil | |
| 48. Narcissus Extract | |
| 49. Pelargonium Graveolens Flower Oil | |
| 50. Pogostemon Cablin Oil | |
| 51. Rose Flower Oil/Extract | |
| 52. Santalum Album Oil | |
| 53. Eugenyl Acetate | |
| 54. Geranyl Acetate | |
| 55. Isoeugenyl Acetate | |
| 56. Pinene |
Disclosure thresholds
Allergens must be listed on the product label if their concentration in the finished product exceeds:
• 0.001% in leave-on products (e.g. creams, serums, perfumes)
• 0.01% in rinse-off products (e.g. shampoos, shower gels)
Note on natural ingredients 🌿
Fragrance allergens are not limited to synthetic compounds. Essential oils and botanical extracts can also contain regulated allergens and are subject to the same labelling requirements.
Grouped allergen entries
Certain fragrance allergen entries in Annex III are composed of multiple substances and are treated as a grouped allergen. When a product contains substances that fall under a grouped entry, the group name — as indicated in Annex III — must be used in the list of ingredients.
The disclosure threshold for a grouped allergen is triggered when the sum of the concentrations of all substances within that group exceeds 0.001% in leave-on products or 0.01% in rinse-off products.
It is permitted to also list the individual substance names as additional information in the ingredient list, but this is not mandatory.
Example
A leave-on product contains 0.0008% Rosa Damascena Flower Oil and 0.002% Rosa Damascena Flower Extract. Their combined concentration exceeds the 0.001% threshold, so the grouped name “Rose Flower Oil/Extract” must appear in the ingredient list. Listing the individual names alongside it is acceptable but optional.
🍁 Did you know — Canada too
Canada also requires labelling of the new fragrance allergens on cosmetic products, with a phased timeline:
• April 12, 2026 — all new and existing cosmetics must disclose the first 24 fragrance allergens in the ingredient list, when present above 0.001% in leave-on products or 0.01% in rinse-off products.
• August 1, 2026 — new cosmetics must also disclose the expanded list of additional allergens (List 2) at the same concentration thresholds.
• August 1, 2028 — existing cosmetics must also disclose the List 2 allergens.
In addition to updating product labels, brands selling in Canada must include the new fragrance allergens in the Cosmetic Notification Form (CNF) submitted to Health Canada.
What brands need to do
Here is a practical checklist to ensure your products are compliant before the July 2026 deadline:
1. Obtain updated allergen documentation from suppliers
Request updated raw material specifications, IFRA certificates (where applicable), and allergen declarations covering all 82 Annex III allergens. This applies to both synthetic fragrance compounds and botanical ingredients such as essential oils.
2. Check and update your Product Information Files (PIFs)
Review the allergen declarations in your PIFs against the expanded list. If the documentation was prepared before the updated regulation, it will need to be replaced with declarations covering all 82 regulated allergens.
3. Review your Cosmetic Product Safety Report (CPSR)
Verify that the CPSR was prepared using the latest allergen declarations and IFRA statements. If not, it should be updated to incorporate the new allergen data and allow the safety assessor to evaluate the product based on current information.
4. Assess allergen concentrations in finished products
Using the updated supplier documentation, evaluate whether any of the 56 new allergens — including grouped entries — are present above the relevant thresholds. For products containing high concentrations of natural ingredients, analytical testing of the finished product is strongly advisable.
5. Update product labels and CPNP notifications
Where any new allergens are present above threshold, amend the ingredient list on the label accordingly — using the correct group name where applicable. Update the corresponding product notification on the Cosmetic Products Notification Portal (CPNP) to reflect the revised labelling.
6. Selling in Canada? Update your Cosmetic Notification Form
Canada requires the same allergen labelling updates on product packaging. The new fragrance allergens must also be reflected in the CNF filed with Health Canada. If your CNF was submitted before the expanded allergen list was adopted, an updated notification is needed.
Need help with compliance? If you have questions about allergen documentation, PIF updates, or CPSR review, get in touch with our regulatory team.


