Allergens in cosmetic products: What are the requirements for the European Market?
What is an allergen?
An allergen is commonly defined as “any substance, often a protein, that induces an allergy”. Allergens usually are contained in fragrances, which can be used in perfumes, scented cosmetics, and other household products such as detergents, candles, and fabric softeners. The Scientific Committee on Consumer Safety (SCCS) has published a factsheet where they explain that 1 to 3% of the European population have an allergy due to fragrance ingredients.
Due to their widespread use and allergenic potential, the SCCS recommended updating the regulatory framework to better inform and protect consumers. The amendment 2023/1545 was published in July 2023 to request the labeling of fragrance allergens.
In the EU Cosmetic Regulation, the word “allergen” does not appear, but 24 substances known for their allergenic potential and listed in the Annex III of the Regulation. The amendment 2023/1545 is adding 57 substances to the 24 existing, requiring the same thresholds and labelling restrictions.
What is the purpose of allergen labelling?
The main goal is to protect consumers from products that may trigger allergic reactions, by providing enough information at the time of purchase. The consumer should know right away if the cosmetic does contain allergens in order to avoid intolerance symptoms.
The information should be clear and easily accessible to the consumer and to the medical profession. Labeling must be used (mandatory requirements), but some dematerialized digital means can also be used, i.e. providing allergen information online, on the website where the products are sold.
Means of communication to the consumer must be practical, easily manageable by the industry and able to absorb and adapt to additional regulatory requirements on the long-run.
What is the aim of the restriction of certain fragrance?
The objective is to protect consumers that are subject to allergies by providing enough information at the time of purchase of the product. The consumer should know right away if the cosmetic does contain allergens in order to avoid intolerance symptoms.
The information should be clear and easily accessible to the consumer and to the medical profession. Labeling must be used (mandatory requirements), but some dematerialized digital means should also be used, i.e. providing allergen information to your website.
Means of communication to the consumer must be practical, easily manageable by the industry and able to absorb and adapt to additional regulatory requirements on the long-run
COSMED, the French trade association, offers a hybrid approach:
- Labeling of the current 26 allergens on the product
- Pictogram on the label to refer to a web link which includes the exhaustive information: presence of other allergens, condition of use and prevention.
What if my product contains allergenic substances?
If one of the 81 substances is present in your finished formula, you have to comply with the restriction in Annex III of the European Regulation including labeling requirements. You must comply with the following rules:
The allergenic substances must appear on the label if:
- The concentration is higher than 0.01% in a rinse-off product, e.g. a shampoo.
- The concentration is higher than 0.001% in a leave-on product, e.g. a night cream.
Note: If an allergen is contained in different ingredient of your product, you have to add up all the concentration to verify the threshold and label your product in accordance with the rule above. There is now the possibility to label the allergens using grouping names. See our article dedicated to this news (link).
Finally, for the “new” additional allergens (from the amendment 2023/1545), the labels must be adapted by the following dates:
- 31 July 2026 for new cosmetic products to enter the EU market;
- 31 July 2028 for cosmetic products already on the EU market.
For more info you can take a look at our Expert Advice on cosmetic claims.
Discover our European Cosmetics Regulation services
Last updated May 19, 2025
What is an allergen?
An allergen is commonly defined as “any substance, often a protein, that induces an allergy”. Allergens usually are contained in fragrances, which can be used in perfumes, scented cosmetics, and other household products such as detergents, candles, and fabric softeners. The Scientific Committee on Consumer Safety (SCCS) has published a factsheet where they explain that 1 to 3% of the European population have an allergy due to fragrance ingredients.
Due to their widespread use and allergenic potential, the SCCS recommended updating the regulatory framework to better inform and protect consumers. The amendment 2023/1545 was published in July 2023 to request the labeling of fragrance allergens.
In the EU Cosmetic Regulation, the word “allergen” does not appear, but 24 substances known for their allergenic potential and listed in the Annex III of the Regulation. The amendment 2023/1545 is adding 57 substances to the 24 existing, requiring the same thresholds and labelling restrictions.
What is the purpose of allergen labelling?
The main goal is to protect consumers from products that may trigger allergic reactions, by providing enough information at the time of purchase. The consumer should know right away if the cosmetic does contain allergens in order to avoid intolerance symptoms.
The information should be clear and easily accessible to the consumer and to the medical profession. Labeling must be used (mandatory requirements), but some dematerialized digital means can also be used, i.e. providing allergen information online, on the website where the products are sold.
Means of communication to the consumer must be practical, easily manageable by the industry and able to absorb and adapt to additional regulatory requirements on the long-run.
What is the aim of the restriction of certain fragrance?
The objective is to protect consumers that are subject to allergies by providing enough information at the time of purchase of the product. The consumer should know right away if the cosmetic does contain allergens in order to avoid intolerance symptoms.
The information should be clear and easily accessible to the consumer and to the medical profession. Labeling must be used (mandatory requirements), but some dematerialized digital means should also be used, i.e. providing allergen information to your website.
Means of communication to the consumer must be practical, easily manageable by the industry and able to absorb and adapt to additional regulatory requirements on the long-run
COSMED, the French trade association, offers a hybrid approach:
- Labeling of the current 26 allergens on the product
- Pictogram on the label to refer to a web link which includes the exhaustive information: presence of other allergens, condition of use and prevention.
What if my product contains allergenic substances?
If one of the 81 substances is present in your finished formula, you have to comply with the restriction in Annex III of the European Regulation including labeling requirements. You must comply with the following rules:
The allergenic substances must appear on the label if:
- The concentration is higher than 0.01% in a rinse-off product, e.g. a shampoo.
- The concentration is higher than 0.001% in a leave-on product, e.g. a night cream.
Note: If an allergen is contained in different ingredient of your product, you have to add up all the concentration to verify the threshold and label your product in accordance with the rule above. There is now the possibility to label the allergens using grouping names. See our article dedicated to this news (link).
Finally, for the “new” additional allergens (from the amendment 2023/1545), the labels must be adapted by the following dates:
- 31 July 2026 for new cosmetic products to enter the EU market;
- 31 July 2028 for cosmetic products already on the EU market.
For more info you can take a look at our Expert Advice on cosmetic claims.
Discover our European Cosmetics Regulation services
Last updated May 19, 2025
