Currently, the EU Cosmetics Regulation 1223/2009 requires the presence of 24 allergens to be included on a cosmetic product’s list of ingredients. On July 27, 2023, the European Commission (EC) published a new amendment to this Regulation adding 45 entries to the Annex, with new allergens such as vanillin, terpineol, menthol, mentha piperita oil and lippia citriodora absolute.
In total, 80 ingredients and groups of ingredients are recognized as allergenic and need to be labeled on cosmetic products. Other fragrance compounds are also limited or banned such as Lilial, Atranol and Chloratranol.
All these ingredients, derived from synthetic fragrances or natural essential oils, must be listed on the product container or packaging, in addition to the use of the term “parfum” or “aroma” when present above the following 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 new Regulation 2023/1545, amending Annex III of Regulation 1223/2009 also amends 17 entries to align common names of the substances to those in the latest version of the Common Ingredients Glossary, to add isomers and to complement and amend the respective Chemical Abstracts Service (CAS) and EC numbers.
Economic operators will need to make adjustments to product formulations and containers to ensure that only cosmetic products complying with the new requirements are placed on the market.
Considering the large number of new fragrance allergens to be individually labeled and the significant number of cosmetic products concerned, a reasonable transition period has been agreed by the Commission. Cosmetic products not complying with the new label requirements may be placed on the Union market until July 31, 2026 and made available on the Union market until July 31, 2028.
With a unique global network of state-of-the-art laboratories, SGS has 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.