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EU Changes to Cosmetic Allergen Rules

Manufacturers should be aware of European plans to expand the list of allergenic fragrances that must be reported on cosmetic product packaging.

When using cosmetics, consumers can develop allergic reactions, ranging in severity from hives to life-threatening anaphylaxis. The US Food and Drug Administration (FDA) website provides a list of common allergens in cosmetics and an overview of the wide range of possible reactions of allergenic reactions that people can experience when using them1. As everyone reacts differently, with some having potentially fatal reactions and others having no reaction at all, consumers must be able to tell from the ingredients list if the product contains an allergen that could harm them.

Importance of Accurate Labeling

Incorrect labeling puts consumers at increased risk for serious harm. In December 2020, the Council of Europe and its European Directorate for the Quality of Medicines & Healthcare (EDQM) published a study which found that 7.7% of cosmetic products did not comply with current regulations governing the use of allergenic fragrance compounds. Of 932 samples that were evaluated, 3.1% of the 544 marked “perfume-free” were found to be non-compliant.2

EU Regulation 1223/2009 – Current Rules

EU Regulation 1223/2009, which applies to cosmetics products supplied to European Union (EU) markets, requires the presence of any of 26 substances recognized as allergenic to be indicated on the ingredients list, in addition to the use of the terms “parfum” or “aroma”. These substances must be listed on the container or packaging when present at the following or greater levels:

  • 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 26 substances, derived from synthetic fragrances or natural essential oils/extracts, include amyl cinnamal, benzyl alcohol, citronellol, farnesol, geraniol, limonene, methyl 2-octynoate and others.

Updated List of Allergens

In December 2011, The EU’s Scientific Committee on Consumer Safety (SCCS) adopted SCCS/1459/11 – “Opinion on fragrance allergens in cosmetic products”3 , which concluded that humans were sensitive to more substances than the 26 already listed in Regulation 1223/2009. Plans were made to add around 56 more substances to the regulation’s scope.

Additional substances proposed for inclusion in Annex III include:

  • 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

Why You Need to Prepare

Although the adoption of the expansion of Annex III Regulation 1223/2009 was originally expected to occur in 2020, this his been postponed due to several factors, including the COVID-19 pandemic. Currently, there is no clear indication of when or if this will take place. However, the expansion is expected to eventually come into force, so manufacturers should make sure that their cosmetic products are properly tested, with results clearly listed on relevant packaging.

Ultimately, the expansion to cover all 82 substances will benefit consumers, who will have access to better information, and manufacturers, as they will be able to build a brand’s reputation by enabling consumers to have greater trust in the safety of their products.

How SGS Can Help

With a unique global network of state-of-the-art laboratories, we have the resources to help manufacturers ensure their products are safe and compliant with relevant legislation. Our comprehensive range of analytical testing solutions covers all pure allergenic fragrance substances listed in Regulation 1223/2009 and SCCS/1459/1. Additionally, we are currently working on a methodology to cover the new natural extracts.

For further information, please contact:

Annika Kauschat
Health & Nutrition/Cosmetics & Hygiene – Customer Service Consultant
t: +49 6128 744 383


  1. Allergens in Cosmetics
  2. Allergenic fragrances found in EU ‘perfume-free’ cosmetics: Council of Europe surveillance study
  3. Scientific Committee on Consumer Safety: 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

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