Reg. 2023/1545: A new update of EU Cosmetic Products Regulation has been published

The Cosmetic Products Regulation

The Cosmetic Products Regulation (Regulation 2009/1223) is the main regulatory framework for finished cosmetic products placed on the EU market. It lays down the rules applicable to all cosmetic products to ensure a well-functioning internal market and to provide a high level of public health protection by regulating the labeling criteria for Cosmetics products containing specific fragrance ingredients above 0.001% in leave-on products, 0.01% in rinse-off products or as otherwise reported in Annex III to Reg. 2009/1223.

Following the draft published in October 2022, Reg. 2023/1545 was finally published on July 27th 2023, focusing on the addition of allergenic substances in Annex III of the Cosmetics Regulation.

Reg. 2023/1545: what’s new?

With the publication of Reg. 2023/1545, 56 new fragrance allergens have been identified and added to Annex III to Reg. 2009/1223. Among the newly added allergens, we report:

• Vanilin (CAS 121-33-5)
• Benzaldehyde (CAS 100-52-7)
• Menthol and its stereoisomers (CAS 89-78-1, 1490-04-6, 2216-51-5 and 15356-60-2)

Furthermore, various modification to the identifiers of pre-existing entries and the addition of various common names of isomers have been noted, among which we report:

• Benzyl Alcohol (CAS 100-51-6)
• Limonene and its stereoisomers (CAS 138-86-3, 7705-14-8, 5989-27-5 and 5989-54-8)
• Methyl Salicylate (CAS 119-36-8)

Moreover, in order for the labelling to be streamlined and more consumer-friendly, in case there are multiple common ingredient names for a substance, the labelling requirement set out for the allergens will set out which name is to be used in the list of the ingredients referred to in Article 19(1), point (g).

In order to improve usability and readability of labels for the consumer, similar substances have been grouped under the same heading: in such occurrence, a single common name must be used in the list of ingredients referred to in Article 19, paragraph 1, letter (g ).

Finally, where there is more than one common name for a substance, the established labeling requirement for allergens will indicate which name should be used.

Reg. 2023/1545: when?

In order to provide a reasonable amount of time to adapt to the updated labelling requirements, the European Commission foresees a transition period of 3 year to place on the EU market new products compliant with the updated provisions and 5 years to sell the products labelled with the current criteria already on the market or, ultimately, to withdraw them.

Trace One (previously known as Trace One) has already prepared the analysis of this update and will keep you updated on any news regarding the implementation in our solutions.

For more information, please consult the following links:

• 2023/1545