Fragrance Allergen Extended List - One Year On

I'm sure you've all heard the EU has expanded the list of fragrance allergens on Annex III from the original 26 to 82, but why has this happened?

Fragrances can induce contact allergy and sensitization for an individual so the new regulation aims to protect allergic individuals by giving them labelling information that allows them to make a suitable choice when buying products. 

The extended list was published in July 2023 under EU Commission Regulation 2023/1545 with an  additional 56 new fragrance allergens compared to the original 26 allergens. The EU Commission requested the Scientific Committee on Consumer Safety (SCCS) to research fragrance allergens where it was identified that 56 additional substances can cause allergies to humans. At the time, these substances had no individual labelling requirement but following on from the SCCS recommendation and after many years of discussion, thishas led to the amendment of the Cosmetics Regulation.

How should you label your products?

Labelling will continue to be mandatory if the substance is present in the cosmetic product above specific threshold concentrations; 0.01% for leave-on products and 0.001% rinse-off products. The new regulation has 2 different approaches to the allergens: Standalone and Grouped. What is the difference?

A standalone entry in Annex III is the same approach we have always used for allergen labelling, using the name of the common ingredient when labelling the allergens in an ingredient list.

A grouped allergen entry groups certain substances (with the same cross-sensitising properties) under one common name. This helps with simplifying the information for consumers and with labelling for companies as the names of allergens can be long and complex. You will find the group name in column H of annex III (Restrictions - Other) of the cosmetic regulation. How does this work?

 Example

The annex III entry above shows that Pinus Mugo Leaf Oil; Pinus Mugo Twig Leaf Extract; Pinus Mugo Twig Oil all have the grouped INCI name Pinus Mugo that should be used for allergen labelling.

Here are some common questions you may have:

Q: I only have one of the three allergens in my fragrance and it is over the threshold, how should I list it?

A: The allergen should be listed under the group name. The regulation does not require you to label with the common name but if you wish to add the common name (in addition to the group name), that could be provided as additional information.

Q: But what happens if I have 2 out of 3 substances in my fragrance for my moisturiser, how should I list them?

A: You will have to add the concentrations of fragrance allergens together and if they exceed 0.01 then the group name will need to be listed instead of the 2 substances

How will this impact your business?

One year has already passed since the Regulation was published! So it is important that you start checking your fragrance allergens and updating your ingredients lists where necessary. Please keep in mind that your formula does not need to be changed. You will not be required to remove these substances so there is no need to consider reformulating your products as most consumers will not experience any allergic response associated with the presence of these substances. As always the Cosmetic Regulation is there for the safety of consumers and it is only highlighting the allergens to those who need them.

What is the deadline?

The date of the entry into force of the new regulation was 16 August 2023. However, a transition period has been applied. You will have until 31 July 2026 for placing new products on the market to ensure they comply with the new extended list of allergens. For products already placed on the market you will have until 31 July 2028 to ensure they are compliant with the new regulation or they will need to be withdrawn from the market by this date.

We have started to see the new extended allergen lists come through from suppliers when we are creating ingredient lists for our customers. At Bloom, we understand that this can be a lot of work if you have any products containing fragrances. If you require any support to ensure you are complying with the new regulation please contact us and we will be happy to help update your ingredient lists and to devise a strategy for ensuring all product labels are updated appropriate

Sofia Nuzzo