A new era in the EU regulation on fragrance allergens in cosmetics
The European Union is constantly updating its regulations to improve consumer safety regarding cosmetic products. In this context , fragrance allergens are subject to particular scrutiny, as they can trigger allergic reactions in sensitive individuals.
The latest regulations have expanded the list of fragrance allergens that must be labeled on cosmetic products and introduced more detailed reporting requirements for manufacturers.
Why are fragrance allergens subject to regulation?
Fragrances can be either synthetic or natural and consist of a mixture of numerous chemical compounds. Some of these ingredients may:
- Sensitive skin
- Allergic contact dermatitis
- May cause irritation to the eyes and respiratory tract.
Since even very low concentrations can trigger reactions, particularly in sensitive individuals, EU legislation requires more transparent labeling of these substances.
What has changed with Regulation 2023/1545?
With the update published by the European Commission, the list of fragrance allergens that must be listed on cosmetic products has been significantly expanded.
This regulation:
- The existing list of fragrance allergens has been expanded
- New scientific assessments have been added to the list
- the labeling requirements have been tightened
The aim is to enable consumers to make more informed decisions about product ingredients.
How is the labeling requirement implemented?
The labeling of fragrance allergens is mandatory if certain thresholds are exceeded.
Non-rinse products (leave-on)
- Cream
- Perfume
- Serum
- Lotion
For these products, the threshold is very low, and certain allergens must be labeled even at very low concentrations.
Rinse-off products
- Shampoo
- Shower gel
- Cleaning products
For these products, allergens that exceed a certain threshold must be labeled.
Even natural ingredients can pose a risk
A common misconception is that fragrance allergens consist exclusively of synthetic ingredients. However:
- Essential oils
- Plant extracts
- Natural fragrances
may also contain a high proportion of allergenic ingredients.
For example, derivatives of lavender, lemon, or rose, even though they are natural, may contain potent allergenic molecules.
What does this mean for cosmetics manufacturers?
For cosmetics manufacturers, this regulation means more than just a change in labeling. It also requires:
1. Reformulation: All fragrances in the product must be re-evaluated.
2. Supplier documentation:Detailed information on allergens must be requested atthe raw material level.
3. Analytical verification: Theallergen concentrations in the final product must be confirmed by laboratory analysis.
4. Updating the technical documentation: PIFs and safety assessment reports must be revised in accordance with the new list.