EU Cosmetic Regulations

Labelling of additional fragrance allergens

New EU allergens labeling regulation: 

The European Commission published on the 27th of July 2023 Regulation (EU) 2023/1545 introducing news rules for allergens labeling and 56 new ingredients to label.

This Regulation introduces several changes to Annex III of Cosmetic Regulation (EC) No 1223/2009:

  • The 24 existing fragrance allergens remain valid, although some minor changes (mainly addition of CAS number) for some of them
  • The 56 additional ingredients will have to respect the same labeling rules as existing so called “fragrance allergens”
  • For reasons of consistency and clarity, similar substances are grouped in one entry. One common grouping name should be used for labelling to be more consumer-friendly.   For example, Geranial and Neral will be labeled under the name “Citral”
  • For reasons of clarity and consistency, some existing entries for fragrance allergens in Annex III will be updated to align their common names with those of the latest version of the Common Ingredient Glossary or by adding isomers, completing and amending the respective CAS and EC numbers (e.g. “Pinus Pumila Needle Extract, “Pinus Pumila Twig Leaf Extract”, and “Pinus Pumila Twig Leaf Oil” will be grouped under the name “Pinus Pumila”)

How to label allergens?

The allergens listed in annex I must be disclosed if their concentration exceeds:

  • 0.001 % (10 ppm) in leave-on products
  • 0.01 % (100 ppm) in rinse-off products

When the substance is concerned by a grouping name, the grouping name must be labelled.

When to label new allergens?

The Regulation will enter into force on the 16th of August 2023. Transition periods are granted for the industry to comply with these new restrictions as below:

  • 3 years to place on the EU market compliant labels: deadline 31st July 2026
  • 5 years to make available on the EU market compliant labels: deadline 31st July 2028

We hope that this will be of help and stay at your disposal for any questions related to this topic. Should you have any question, please, feel free to contact your CRM (Customer Relationship Manager) or contact us directly:


Thanks to Stéphanie Annet for writing this article.


To assist us in enhancing our regulatory articles and news, we kindly encourage you to provide your thoughts by utilizing the thumbs-up/thumbs-down buttons located below the article. Your feedback will remain anonymous.

Get in Touch

Need a piece of advice, a quotation or answers to your questions? Contact us…

Fill in this form or contact us directly: We will answer as soon as possible!


  • Frédéric Lebreux

    Dr. Frédéric Lebreux is Biorius's Chief Executive Officer and has worked in the cosmetic industry for more than 13 years. He is regularly invited as a speaker or Professor to cosmetic events.

    View all posts