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Commission Regulation (EU) 2023/1545 on allergens.

On July 26, 2023 the annex III fragrance adaptation was published. The Annex III amendment increases the fragrance allergen list to 82 substances in total (adding 56 to the previously listed allergens)

Commission Regulation (EU) 2023/1545 increases the fragrance allergen list to 82 substances in total (adding 56 to the previously listed allergens)


All the allergens meeting the treshold, will have to be declared on your artwork. 

The treshold remains the same:
* 0.001% in leave-on products
* 0.01% in rinse-off products
 
In addition, for certain allergens, it is necessary to indicate the presence of the substance using a specific name listed in column 'h' of the Annex entry. For example, Eucalyptus Globulus Leaf/Twig Oil' has to be indicated on the product label as ‘Eucalyptus Globulus Oil’ (Entry 355). The full list of all substances that need to be declared and substances names that need to be used can be found here.
 
Impact & timeline
Cosmetic products containing substance(s) that do not comply with the new restriction(s) may be placed on the market until 31 July 2026 and made available on the Union market until 31 July 2028.
New products need to comply after 31 July 2026 and existing cosmetic products placed on the market before 31 July 2026, need to comply after 31 July 2028 or be taken off the market if not compliant by then.

To comply, updated raw material documentation is needed for perfumes and essential oils. Part of this documentation is an allergen statement that has information on all 82 (Annex II and III) perfume substances, to ensure safety of the product and to create new INCI declaration so the product label can be adjusted accordingly (and thus CPNP). 
This new regulation can result in a significant increase in the length of the ingredients' list on your product label.
 
We hope to have informed you of fragrance annex III, what it entails and how to comply with EU legislation. If you have other questions about fragrance allergens or annex III, please contact: office@skinconsult.com.

Remember, safety first!