New allergens

For a long time, the cosmetic law has not changed at such a dizzying pace. On July 26th, the long-awaited regulation introducing the need to label 56 new fragrance allergens appeared. This is a real revolution that the industry has been waiting for for a long time and about which we have already written on the blog:

What will change?

The aforementioned changes are introduced by the EU Commission Regulation 2023/1545 of 26 July 2023 amending Regulation (EC) No. 1223/2009 of the European Parliament and of the Council as regards the labeling of fragrance allergens in cosmetic products. So far, it was necessary to mark in the INCI composition on the cosmetic label 24 allergens listed in items 45 and 67-92 of Annex III to Regulation No. 1223/2009, i.e.:

  • Alpha-Isomethyl Ionone,
  • Amyl Cinnamal,
  • Amyl Cinnamyl Alcohol,
  • Anise Alcohol,
  • Benzyl Alcohol,
  • Benzyl Benzoate,
  • Benzyl Cinnamate,
  • Benzyl Salicylate,
  • Cinnamal,
  • Cinnamyl Alcohol,
  • Citral,
  • Citronellol,
  • Coumarin,
  • Eugenol,
  • Evernia Prunastri Extract,
  • Evernia Furfuracea Extract,
  • Farnesol,
  • Geraniol,
  • Hexyl Cinnamal,
  • Hydroxycitronellal,
  • Isoeugenol,
  • Limonene,
  • Linalool,
  • Methyl 2-Octynoate,

if they exceeded the concentration:

  • 0.01% in rinse-off products (e.g. soaps, shampoos),
  • 0.001% in leave-on products (e.g. creams).

The new regulation introduces the obligation to label additional – 56 new fragrance allergens, in addition to those listed above. Annex III will therefore be extended to these allergens, including:

  1. Pinus Mugo,
  2. Pinus Pumila,
  3. Cedrus Atlantica Oil/Extract,
  4. Turpentine,
  5. Alpha-Terpinene,
  6. Terpinolene, 
  7. Myroxylon Pereirae Oil/Extract,
  8. Rose Ketones, 
  9.  3-Propylidenephthalide,
  10. Lippia Citriodora Absolute, 
  11. Methyl Salicylate, 
  12. Acetyl Cedrene,
  13. Amyl Salicylate,
  14. Anethole,
  15. Benzaldehyde,
  16. Camphor,
  17. Beta-Caryophyllene,
  18. Carvone,
  19. Dimethyl Phenethyl Acetate,
  20. Hexadecanolactone,
  21. Hexamethylindanopyran,
  22. Linalyl Acetate,
  23. Menthol,
  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.

After these changes, there will be 371 entries in Annex III.

And one more important information – allergens will be marked in two ways: individually or by grouping. Individual labeling is already known to us and it is simply about one name for one specific substance, e.g. Limonene will be labeled as Limonene. What is new will be group tagging, where several similar allergens will be grouped into one item. An example would be position 70 where Citral, Geranial and Neral will be labeled as Citral. So if in a given fragrance composition there will be e.g. Geranial and Citral in the proper concentration, then in the INCI we have to enter only Citral.

Link to the full text of the new regulation:

Change dates

Fortunately, the transitional periods proposed by the European Commission are quite long. We have time to adapt to the new changes until:

  • July 31, 2026 – for placing cosmetics that do not meet the new requirements on the market,
  • July 31, 2028 – to be made available on the market.

After these dates, it will be necessary to update the labels and documentation (including safety assessment) of cosmetics with new allergens.

Undoubtedly, there is a lot of work ahead of the manufacturers of fragrances and cosmetics. The former will have to update e.g. lists of allergens, the latter – INCI compositions on labels. Fingers crossed that the proposed transitional periods will be sufficient to introduce such major changes.

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