Fragrance Allergen Labelling Amendment (EU) 2023/1545

On 26 July 2023, the European Commission published Commission Regulation (EU) 2023/1545, amending Regulation (EC) No 1223/2009 on the labelling of fragrance allergenic substances in cosmetic products. The amendment aims to provide consumers with better information on fragrance allergenic substances present in cosmetics and to protect individuals who are sensitive to allergic reactions.

Rationale for the allergen labelling amendment

Fragrance substances are commonly used not only in perfumes and fragranced cosmetic products, but also in other household items such as detergents, candles, and fabric softeners. However, these substances may cause contact allergies in certain individuals, leading to eczema or allergic contact dermatitis. It is estimated that approximately 1–3% of the EU population is allergic to fragrance allergens.

Under the current rules, 24 fragrance allergenic substances listed in entries 67–92 of Annex III to Regulation (EC) No 1223/2009 must be indicated in the ingredients list of cosmetic products. However, following a Commission request for an update in 2012, the Scientific Committee on Consumer Safety (SCCS) identified an additional 57 fragrance allergens, expanding the list of substances subject to labelling to a total of 81. Previously, these newly identified allergens were not subject to individual labelling requirements.

‍
Where can I find the complete list of fragrance allergens?

The Ecomundo website provides a complete and updated list of currently regulated fragrance allergens, and ingredients requiring verification can be searched by INCI name or CAS number.

🌐 Check the European fragrance allergen list

Outcomes of the fragrance allergen amendment

Based on the SCCS opinion, the European Commission acknowledged potential risks to human health associated with the use of these additional fragrance allergenic substances. It therefore concluded that individual labelling should be required when the concentration of these allergens exceeds 0.001% in leave-on products or 0.01% in rinse-off products.

In addition, fragrance substances that can be transformed into known contact allergens through air oxidation or bioactivation are treated as equivalent to fragrance allergens, and the same restrictions and regulatory requirements apply.

The amendment also aims to improve consistency and clarity by updating the common names of substances in Annex III to align with the latest version of the common ingredients glossary. Similar substances are grouped together under a single entry, and where a substance has multiple common ingredient names, the specific name to be used in the ingredients list is designated. These updates are expected to streamline the labelling process, making it more consumer-friendly and facilitating the work of economic operators and authorities.

💡 Note: Beyond allergen labelling, ingredient restrictions, bans, and regulatory changes

In the EU, allergen labelling is only one layer of requirements. Separate restrictions may be introduced or tightened over time—and in some cases, an ingredient may ultimately be banned—based on new scientific assessments and regulatory developments. This may include conditions targeting specific product types or vulnerable populations (e.g., children).

Deadlines and transition periods

To ensure a smooth transition, economic operators are granted a reasonable transition period to adapt to the new requirements under the updated list of fragrance allergens. Compliance may require changes to product formulations and packaging text.

🚩 Transition periods

• All products placing on the market after 31st of July, 2026 will have to be compliant to the new rule.  

• For all products already on the market, you have until the 31st of July 2028 to make it compliant.

The European Commission considers that these measures, based on the SCCS opinion, will significantly strengthen consumer protection and improve consumers’ ability to make informed choices when selecting cosmetic products.

‍