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Fragrance allergen labelling of cosmetics

With innovation shaping the beauty industry, more cosmetic products are entering the marketplace. This requires strict regulations, as cosmetic goods may contain allergens which are harmful to those susceptible to allergies.

The two most common causes of allergens in cosmetic goods are found in preservatives and fragrances. An example of allergen substances are thiazolinones. These preservatives, when applied to the skin, may cause itchy skin, rashes, dermatitis, and hives.

In 2012, the Scientific Committee on Consumer Safety (SCCS) released its scientific opinion on fragrance allergens. The findings deduced that 16% of eczema patients were sensitized to ingredients found in fragrances. From the everyday population, 1-3% of Europeans shows allergic reactions to common fragrance ingredients.

Annex I and V of Regulation (EC) No 1223/2009 mentions that substances which are likely to cause allergic reactions must be mentioned in the ingredient list, in a manner which draws the attention of the customer. The amount of the allergen causing substances must also be limited. Substances which are likely to cause allergies for a significant portion of the population may result in a ban or further restrictions if deemed necessary.



The aforementioned Cosmetic Regulation states that any of the 26 allergens mentioned in Annex III should be mentioned in the ingredients, but only if:

  • Leave-on products (e.g. body lotion, make-up), exceed 0.001% of the total concentration
  • Rinse-off products (e.g. shower gel, shampoo) exceed 0.01% of the total concentration

Annex II of the regulation states that over 1300 different substances are prohibited in cosmetic goods. As of 23 August, 2019, Lyral, atranol, and chloroatranol have been added to this list. Of all these substances, the ban of Lyral is causing a stir, as many fragrances contain this chemical. Products with these substances currently on the market may be sold until 23 August, 2021.


BAV Institut – A Tentamus Company tests cosmetic goods to ensure that all they comply with the European Cosmetics Regulation (EC) No. 1223/2009, and the cosmetics labelling criteria stated in Regulation (EU) 655/2013. The services offered include:

  • Compliance with the applicable legal requirements
  • Meeting desired product quality
  • Correct labelling of products

BAV Institut also offers an audit report if all the requirements listed above are met. This is used to increase the product’s marketability, as the product’s safety and integrity is stressed to the customer.


Do you have any questions about this?

Contact our expert Bernhard Fellenberg at bernhard.fellenberg@bav-institut.de or via phone under +49 781 969 47 194

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