56 new allergens – Amendment to the EU Cosmetics Regulation

Guest contribution by Mag. Dr. Doris Plank

On July 26, 2023, the Official Journal of the European Union published Regulation (EU) 2023/1545 amending Regulation (EC) No 1223/2009 as regards the labeling of fragrance allergens in cosmetic products.

 

What has changed?

56 additional fragrance allergens

The new regulation introduces 56 additional fragrance allergens. This is being implemented via new/amended entries in Annex III of the Cosmetic Regulation. These must be labeled if their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products. Labeling is carried out via the ingredients list, analogous to existing labeling requirements.

The expanded labeling requirement also affects many essential oils (natural extracts), for example: Atlas cedar, neroli, cinnamon, bergamot, sweet orange, lemongrass, eucalyptus, clove, lemon, lavender, peppermint, rose geranium, patchouli, rose, sandalwood, ylang-ylang, and others.

INNOMETICS tip: Switch to allergen-reduced perfume oils. What does allergen-reduced mean? 

 

Amendment of existing entries in Annex III

Certain existing entries in Annex III have also been amended. This includes adapting common ingredient names to the latest version of the Common Ingredients Glossary (CosIng). Similar substances have also been grouped together, which streamlines and simplifies the labeling process.

 

What you as a cosmetics manufacturer need to consider now:

However, transition periods of 3 and 5 years respectively have been provided for implementation.

For products, the following applies:

From July 31, 2026, only cosmetic products that comply with the new labeling requirements may be placed on the market.

From July 31, 2028, only compliant cosmetic products may be made available on the Union market. This allows companies to withdraw from the market any cosmetic products that do not comply with the new requirements and were placed on the market before the new labeling rules entered into force.

PLEASE NOTE: For products marked with ** in Annex III, the following prerequisite applies for the transition period: the restrictions applicable as of August 15, 2023, must be met.

Link to the regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R1545

 

Please note that other documents (keyword: PIF, safety report) will likely need to be adjusted as well. If you have any questions about this, please feel free to get in touch.

 

Mag. Dr. Doris Plank | + 43 650 311 38 33 | www.cosmetic-consulting.at | doris@cosmetic-consulting.at
As a chemist with a doctorate and an authorized safety assessor in accordance with § 73 LMSVG, Doris works intensively on the composition and (toxicological) effects of modern natural cosmetics and prepares, among other things, Product Information Files (PIF) including safety reports for cosmetic products for her clients in accordance with the EU Cosmetics Regulation (EC) No 1223/2009 and its supplementary provisions.