The EU Regulation 2023/1545 amends EC Regulation 1223/2009 on the labelling of Fragrance Allergens in Cosmetic Products.
The EC Regulation 1223/2009 on Cosmetic Products contains a list of substances (Annex III) which Cosmetic Products must not contain except subject to restrictions.
The adding of 56 allergens to the original list 24 allergens (initially 26, but two are now banned) to now make 80.
What are Fragrance Allergens?
Some chemicals which are used to create fragrance in cosmetic products are crafted blends of natural and/or synthetic compounds. These allergenic substances are known as fragrance allergens.
An allergenic chemical can occur from some synthetic aromatic materials which are also natural within essential oils. Allergenic chemicals have the potential to cause an allergen reaction.
What were the labelling requirements for fragrance allergens before the new amendment?
Before this amendment, cosmetic products with fragrance, required to list any of the 26 specific fragrance allergens on the ingredient labels. This is mandatory if the allergen exceeded certain concentrations thresholds of 0.001% for leave-on products and 0.01% for rinse-off products.
Where should fragrance allergens be listed on the label?
All ingredients used in the cosmetic product must be listed in the ingredients list by their INCI name, and the fragrance mixtures are generally labelling as ‘Parfum’ or ‘Aroma’. Those identified as ‘fragrance allergens’ must be listed individually. Ingredients should be listed in descending order of weight when they are added to the cosmetic product. Ingredients in concentrations of less than 1% can be listed in any order after those exceeding 1%. You can list fragrance allergens based on concentration and place them at the end of the ingredient list within the labelling, if they are not intentional cosmetic ingredients.
What are the labelling requirements for fragrance allergens with the new amendment?
The new amendment introduces changes to the labelling requirements for fragrance allergens. A further 56 substances are now recognised as fragrance allergens and require individual labelling. The amended Annex III to the EC Cosmetic Regulation includes these newly identified allergens.
Allergens will be marked in two ways: individually or by grouping.
Individual labelling is already known to us, and it is simply about one name for one specific substance, e.g. Limonene will be labelled as Limonene.
What is new will be group tagging, where several similar allergens will be grouped into one item.
An example would be: Citral, Geranial and Neral will be labelled as Citral. So, if in each fragrance composition there will be e.g. Geranial and Citral in the proper concentrations, then in the INCI listing it must enter only Citral.
Possible Challenges
With the expansion to the list of allergens introducing new Regulatory and implementation requirements, some challenges may arise:
– Many complex names to be memorized by allergic consumers for the same type of allergen.
– Issue of space on labels due to the very long list of ingredients. To address these issues, a new annex III regulatory approach had to be developed in the new regulation, allowing substances with the same cross-sensitising properties to be listed under a common group name rather than the individual substance name.
When do the amended allergen labelling requirements come into force?
The Regulation (EU) 2023/1545 was implemented 16th August 2023 and applies to all EU Member States. There is a transitional compliance period to accommodate the adjustments, such as revising product formulations and Cosmetic Product Safety Reports (CPSRs) and issuing new labels.
They are:
31st July 2026 – for placing cosmetics that do not meet the new requirements on the market
31st July 2028 – to be made available on the market
Conclusion
In conclusion, with all the updates to the additional fragrance allergens, there are many considerations posed to cosmetic manufacturers by the revising of product formulations, considerations to Safety Reports and solutions to product labelling.
Contact Us
For further information and personalised guidance, please feel free to reach out to Advena via either our website contact page, www.advenamedical.com, email (info@advena.com) or phone (01926 800153) to start a conversation today.
