EU Cosmetic Regulation Update: Enhanced Labeling from 24 to 80 Allergens

As a leading consulting firm in the cosmetic industry, we understand the importance of staying up-to-date with the latest regulatory changes. The EU has introduced a crucial amendment to its Cosmetic Regulation that focuses on the labeling of fragrance allergens in cosmetic products. Commission Regulation (EU) 2023/1545, which was introduced on July 26, 2023, amends Regulation (EC) No 1223/2009 of the European Parliament and of the Council. This article helps to provide a concise overview of the key points within this regulatory update.

The SCCS Opinion

In response to the Commission's request for an update of the list of individually labeled fragrance allergens, the Scientific Committee on Consumer Safety (SCCS) conducted an extensive review. At its plenary meeting in June 2012, the SCCS confirmed the continued relevance of fragrance allergens listed in entries 45 and 67–92 of Annex III to Regulation (EC) No 1223/2009. Additionally, the committee identified 56 new fragrance allergens, which have been known to cause allergies in humans but currently lack individual labeling requirements.

Addressing Potential Health Risks

Considering the SCCS opinion and the potential risk to human health associated with these additional fragrance allergens, the EU deemed it necessary to inform consumers about their presence in cosmetic products. Consequently, Commission Regulation (EU) 2023/1545 introduces an obligation to individually label these fragrance allergens when their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products .

Furthermore, the regulation recognizes the potential of certain fragrance substances, such as prehaptens and prohaptens, to transform into known contact allergens through air oxidation or bioactivation. To ensure consumer safety, these substances are treated as equivalent to fragrance allergens, subject to the same restrictions and other regulatory requirements.

Consistency and Clarity in Labeling

To achieve consistency and clarity in product labeling, the amendment mandates updates to certain existing entries for fragrance allergens in Annex III to Regulation (EC) No 1223/2009 . This includes aligning the common names of substances with the latest version of the Common Ingredients Glossary, as referred to in Article 33 of the Regulation. Additionally, similar substances are grouped under a single entry to streamline labeling.

Moreover, when a substance has multiple common ingredient names, the regulation specifies the name to be used in the list of ingredients (referred to in Article 19(1), point (g)) to enhance consumer-friendliness. This measure also facilitates the work of economic operators and national authorities, promoting efficient compliance with the updated labeling requirements.

The Transition Period

Acknowledging the challenges faced by economic operators in adapting to the new restrictions, the EU grants a reasonable transition period. This period allows businesses to make necessary adjustments to product formulations and containers to ensure that only cosmetic products complying with the new requirements are placed on the market.

During the transition period, economic operators are also permitted to withdraw from the market, cosmetic products that do not comply with the new labeling provisions. This applies to products that were placed on the market before the new requirements became applicable. Considering factors such as the relatively low percentage of consumers developing allergic contact dermatitis, the significant number of new fragrance allergens, and the wide range of cosmetic products affected, the transition period is set at three and five years, respectively.

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Author

Yasmine Boulanouar, Senior Regulatory Toxicologist in CIRS Europe

Yasmine has an MS in Toxicology, risk assessment and vigilance from the Farmacy University of Paris - Saclay. She has more than ten years of experience in the cosmetics and consumer products industries, working for companies such as L'Oréal, J&J, and Bic. She specializes in toxicology and risk assessment, as well as regulatory affairs. She is based in Paris and covers the UK and European markets.