The US Food and Drug Administration (FDA) website lists a wide variety of allergenic reactions that people can experience when using cosmetics, ranging from hives to anaphylaxis.1 The problem is everyone reacts differently and what may cause a life-threatening reaction in one person, will have no effect on another. Consumers need to be able to look on the ingredients list and see if there is an allergen that could accidentally harm them.
This problem is made worse by incorrect label information. A study published by the Council of Europe and its European Directorate for the Quality of Medicines & Healthcare (EDQM) in December 2020 found that 7.7% of cosmetic products did not comply with current regulations governing the use of allergenic fragrance compounds. Of the 932 samples that were evaluated, 544 were marked ‘perfume-free’ and yet 3.1% of these were found to be non-compliant.2 If a consumer bought one of these products with the understanding that it did not contain a substance they were allergic to, but then found the labeling was incorrect, the result could be very serious.
26 allergenic fragrances
Cosmetic products supplied to European Union (EU) markets must comply with EU Regulation 1223/2009. This requires the presence of any of 26 substances to be indicated on the list of ingredients, in addition to use of the terms ‘parfum’ or ‘aroma’.
These 26 substances are recognized as allergenic and so their inclusion in a cosmetic product must be clearly signaled to consumers. They are derived from synthetic fragrances or natural essential oils/extracts and include substances like amyl cinnamal, benzyl alcohol, citronellol, farnesol, geraniol, limonene and methyl 2-octynoate.
In practice, manufacturers and suppliers of cosmetic products to EU markets are required to list the presence of these substances on the container or packaging when they are present at the following levels or greater:
- 0.01% in a rinse-off cosmetic (e.g., soap, shower gel, shampoo)
- 0.001% in a leave-on cosmetic (e.g., cream, lotion, tonic)
The EU’s Scientific Committee on Consumer Safety (SCCS) adopted SCCS/1459/11 – “Opinion on fragrance allergens in cosmetic products” – in December 2011.3 Through clinical and experimental analysis, they concluded that humans were sensitive to a greater number of substances than the 26 already listed in Regulation 1223/2009. Plans were then made to include around 56 additional substances to the scope of Regulation 1223/2009.
Among the substances that are being proposed for inclusion in Annex III of Regulation 1223/2009 are:
- Pure substances: e.g., menthol, terpineol, linalyl acetate, camphor, vanillin, and geraniol derivatives (geranial and geranyl acetate)
- Natural extracts: e.g., ylang-ylang oil (Cananga odorata flower oil), cinnamon oil (Cinnamomum zeylanicum bark oil), and lavender oil (Lavandula officinalis flower oil)4
Several factors, including the COVID-19 pandemic, have meant the adoption of this expansion has been delayed. The original plan was to introduce the expansion in 2020 but that date has now passed and, without a clear indication of when/if the expansion in scope will be adopted, manufacturers and consumers are left in a state of confusion.
The expectation is that the expansion of Annex III of Regulation 1223/2009 will eventually come into force. Manufacturers looking to gain competitive advantage should therefore prepare themselves by making sure their cosmetic products are properly tested and the results clearly listed on relevant packaging.
Expanding the scope of inquiry to cover all 82 substances will have benefits for both consumers and manufacturers. For consumers, they will have access to better information to help them avoid an allergic reaction. For manufacturers, consumers will have greater trust in their products, thereby helping to build a brand’s reputation.
We offer a comprehensive range of analytical testing solutions covering all pure allergenic fragrance substances listed in Regulation 1223/2009 and SCCS/1459/1. We are also currently working on a methodology to cover the new natural extracts. Utilizing our unique global network of state-of-the-art laboratories, we help manufacturers to ensure their products are safe and comply with relevant legislation, whatever global markets they wish to target.
Learn more through here.
For more information, please contact:
Health & Nutrition/Cosmetics & Hygiene – Customer Service Consultant
t: +49 6128 744 383
Health & Nutrition/Cosmetics & Hygiene – Sales Manager & Business Development Manager New Projects
t: +49 172 27 45 950
1 Allergens in Cosmetics | FDA
2 Allergenic fragrances found in EU ‘perfume-free’ cosmetics: Council of Europe surveillance study
3 SCCS OPINION on Fragrance allergens in cosmetic products
4 Public consultation on fragrance allergens in the framework of Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on cosmetic products – Annex