Fragrance Allergen Labeling Rules | Why the EU Added 56 Substances

In Japan’s full ingredient labeling, ingredients added to give fragrance are usually listed together as “fragrance.” In the EU as well, fragrances can be listed collectively as “parfum,” but certain fragrance ingredients are exceptions: if they exceed a specified concentration, they must be named individually. In 2023, the scope of those ingredients expanded significantly.

The original framework: Names listed separately from “fragrance”

Article 19 of the EU Cosmetics Regulation (Regulation (EC) No 1223/2009) provides that fragrances may be listed collectively as “parfum” or “aroma,” while also requiring substances specified in Annex III to be listed additionally in the ingredient declaration. The concentration thresholds requiring listing are more than 0.001% for leave-on products and more than 0.01% for rinse-off products. In the text as enacted in 2009, 26 substances, including amyl cinnamal, benzyl alcohol, and citronellol, were subject to this treatment.

What changed under Regulation (EU) 2023/1545

Commission Regulation (EU) 2023/1545, adopted on July 26, 2023, amended Annex III and newly added 56 substances as fragrance allergens requiring individual labeling. The amendment is described as being based on the assessment of the European Commission’s Scientific Committee on Consumer Safety (SCCS). The transition period has two stages: from July 31, 2026, products that do not comply with the new rules can no longer be newly placed on the EU market. From July 31, 2028, non-compliant products already on the market can no longer be sold.

Individual labeling of fragrance allergens is a framework in which only specified substances among the ingredients included under the single term “fragrance” must be named. The thresholds are more than 0.001% for leave-on products and more than 0.01% for rinse-off products. With 56 substances added to the original 26, products newly shipped in the EU from July 31, 2026 are required to be labeled according to the expanded list.

Developments in other regions

In the United States, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires the FDA to establish rules on fragrance allergen labeling (Explanation of MoCRA). The specific substances and thresholds are still at the stage of being determined through future rules. Ingredient labeling simply communicates the fact of formulation, and whether a product suits the skin varies by individual. For how ingredient lists are arranged and read, see How to Read the Full Ingredient List as well.

References: European Commission, Official Journal of the European Union (Regulation (EC) No 1223/2009, Regulation (EU) 2023/1545), U.S. Food and Drug Administration (FDA)

—The Value Village Editorial Team