Stay Compliant: EU Expands Fragrance Allergen Rules
Important details
The European Union has expanded the list of fragrance allergens from 24 to 80+. If your Cosmetic Product Safety Report (CPSR) isn’t updated, your products risk falling out of compliance.
Read the Delphic HSE Statement
Contact allergy is a life-long, altered specific reactivity in the human immune system. Upon re-exposure to a sufficient amount of an allergen, eczema (allergic contact dermatitis) may develop. When a person has already been sensitised to an allergen, a much lower concentration of it is sufficient to trigger symptoms of an allergy. Different measures aim to protect the whole population from acquiring fragrance allergies (primary prevention) and to protect sensitised individuals from developing allergy symptoms (secondary prevention). For the purposes of primary prevention, a restriction of fragrance allergens may be sufficient. However, sensitised persons may develop symptoms when they are exposed to lower concentrations of an allergen than the maximum permitted levels. Therefore, as a measure of secondary prevention, it is important to provide information on the presence of individual fragrance allergens in cosmetic products so that sensitised persons can avoid contact with the substance to which they are allergic.
On 26th July 2023, the European Union (EU) adopted Regulation (EU) 2023/1545 to update labelling of fragrance allergens under Annex III to Regulation (EC) 1223/2009 on cosmetic products. This amendment contains 3 important changes for allergen entries: 1) Replaces 17 entries; 2) Deletes 10 entries; 3) Adds 45 entries. Among the 17 replaced entries, 12 substances have been updated as allergens with newly added fragrance allergen label restrictions. Together with the 45 new entries, there are 57 EU Extended Allergens added in as compared to the previous 24 fragrance allergens controlled under EU cosmetic regulation. A transition period of 3 years (for new cosmetics ) or 5 years (for existing cosmetics) is given to the industry to adapt the new requirements in response to Regulation (EU) 2023/1545.
Key compliance deadlines you can’t miss
31st July 2026 for products to be ‘placed on the market’.
This refers to new products which have previously not been sold on the EU market. After this date, the presence of any of the 80+ allergens above the declaration limits must be included on the product ingredient list.
31st July 2028 for products to be ‘made available on the market’.
This refers to products which were placed on the market before 31st July 2026, and contain any of the 80+ allergens above the declaration limit, but do not include the name of those allergens on the ingredient list. Such products must not be sold on the EU market after this date. After 31st July 2028 all products which contain any of the 80+ allergens above the declaration limit, must bear the name of those allergens on the label.
Declaration limits
The declaration limits (depending on the different product types) are:
- 0.01% for Rinse-Off cosmetic products.
- 0.001% for Leave-On cosmetic products.
What you need to do
Already hold a CPSR with Delphic HSE? Update now at a discounted rate.
No CPSR yet? We’ll prepare a new one in line with the extended requirements.
Don’t leave compliance to the last minute.
Complete the form and our team will contact you to discuss updating your CPSR or preparing a new one.