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EU Amends the Restricted Ingredients List Regarding the Labelling of Fragrance Allergens

The EU has recently amended the restricted ingredients list of the Cosmetics Regulation by adding 45 new entries, revising 17 existing entries, and deleting 10 entries. The amendments will take effect on August 16, 2023, with a transitional period of three to five years.

In September 2022, EU notified WTO of a draft regulation aimed at extending the individual labelling requirements for 56 newly identified fragrance allergens. On July 27, EU released the finalized regulation in its official journal. It will enter into force on August 16, 2023, with a transitional period of three to five years.1

Under Regulation (EC) No 1223/2009 (Cosmetics Regulation), identified fragrance allergens shall be individually labelled on the package of cosmetics when their concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products. Currently, 24 fragrance allergens in the restricted ingredients list annexed to the Cosmetics Regulation are subject to this individual labelling requirement.

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In response to the request of the European Commission for an update of the fragrance allergens list, the Scientific Committee on Consumer Safety (SCCS) adopted an opinion at its plenary meeting in 2012. This opinion identified 56 additional fragrance allergens that had clearly caused allergies in humans with no labelling requirements. Following the SCCS's opinion, the finalized regulation introduces an obligation to individually label the newly identified fragrance allergens in the restricted ingredients list, which extends the list of fragrance allergens to a total of 80

Additionally, the finalized regulation aligns the common names of annexed fragrance allergens in accordance with the updated Glossary of Common Ingredient Names, as well as complements and amends their respective CAS and EU numbers. As a result, the restricted ingredients list includes 45 new entries, revises 17 existing entries, and deletes 10 entries

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* The detailed amendments to the restricted ingredients list can be found here

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