European Commission regulates the labelling of fragrance allergens in cosmetic products

On 26 July 2023, the European Commission published Regulation (EU) 2023/1545 in the Official Journal of the European Union, amending Regulation (EC) No 1223/2009 (the Cosmetics Regulation) concerning the labelling of fragrance allergens in cosmetic products. The Regulation will come into force on 15 August 2023.

So far 26 fragrance allergens listed in Annex III of the Cosmetics Regulation must be mentioned in the list of ingredients (individual labelling). However, in an opinion published by the Scientific Committee on Consumer Safety (SCCS) in 2012 identified a further 56 additional fragrance ingredients in cosmetic products that clearly caused allergies in humans and that did not have any requirement of individual labelling.

Regulation 2023/1545 introduces new obligations to individually label the 56 additional fragrance allergens listed by the SCCS. These allergens must be labelled individually if their concentration surpasses 0.001% in leave-on products and 0.01% in rinse-off products. The introduction of these new obligations is accomplished by generating new entries in Annex III to Regulation (EC) No 1223/2009. Under the new regulation, there is a strong emphasis on maintaining consistency and clarity. To achieve this, certain existing entries for fragrance allergens in Annex III to Regulation (EC) No 1223/2009 are being updated. The aim is to align the common names of substances with the most recent version of the Common Ingredients Glossary, as referenced in Article 33 of the Regulation. Moreover, similar substances will be grouped together, streamlining the labeling process and minimizing any potential confusion.

The list of affected fragrance allergens can be found here. There will be a transition period of 3 years for adapting product formulations and containers so that only cosmetic products complying with the new requirements are placed on the market. A 5-year transition period is given to withdraw cosmetic products from the market which do not comply with the new requirements and were placed on the market before the new labelling provisions become applicable.