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2025-03-03

Navigating Allergen80 (EU) 2023/1545 as a cosmetic brand

On July 26, 2023, the EU adopted Regulation (EU) 2023/1545, revising the guidelines for allergen labeling on cosmetic products to ensure greater transparency and compliance. This article outlines what the regulation entails for businesses in the cosmetics industry.

Cosmetic products may contain allergens—substances that can cause allergic reactions, discomfort, or irritation in sensitive individuals, particularly those with fragrance allergies. Before 2023, the law required 24 specific allergens to be listed on cosmetic product packaging. With the new regulation, an additional 56 allergens have been identified, increasing the total to 80 substances that must be declared on product labels if their concentrations exceed certain thresholds.*

 

What does Allergen80 mean for the cosmetics Industry?

The regulation mandates that brand-owning companies, referred to as the Responsible Person, thoroughly review their cosmetic products to ensure compliance with the updated labeling requirements. These companies must:

• Determine whether their products contain any of the 80 listed allergens: Commission Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards labelling of fragrance allergens in cosmetic products.
• *Update ingredient lists to include any of the listed allergens when it’s concentration exceeds:
  • 0.001% in leave-on products.
  • 0.01% in rinse-off products.
• Modify product packaging and labels to align with the new regulations.
• Plan the transition for existing products before July 31, 2028, to maintain their market availability.

The regulation applies to products sold in the European market. Companies exporting outside the EU must verify the applicable regulations in their target markets. Businesses operating across multiple regions may need to adjust labeling and ingredient lists to maintain consistent product packaging globally.

 

Key compliance deadlines

Brand-owning companies must adhere to the new requirements according to the following timeline:

• Starting July 31, 2026, all products placed on the EU market must comply with the updated labeling requirements.
• Products already on the market before July 31, 2026, may continue to be sold until July 31, 2028.
• After July 31, 2028, all products must fully comply with the revised regulations.
   

Why has this regulation been introduced?

Repeated or prolonged exposure to certain substances, particularly fragrance ingredients, may develop fragrance allergies and/or contact allergies. By requiring clearer allergen labeling on cosmetic products, Regulation (EU) 2023/1545 enables consumers with known allergies to make informed choices and avoid potential reactions. Additionally, the law enhances market transparency and ensures greater consumer protection.

 

Sources

Fragrance allergens labelling - European Commission
Guidelines on the ‘fragrance allergens’ requirements

 

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