Publication of the Amendment of the Cosmetic Regulation regarding Fragrance Allergens labeling

August 8, 2023

Intention of the amendment

Fragrance substances are commonly used in perfumes, perfumed cosmetic products, as well as other household products such as detergents, candles and fabric softeners. However, these substances can cause contact allergies in certain individuals, leading to eczema or allergic contact dermatitis. It is estimated that approximately 1-9% of the population in the European Union is allergic to fragrance allergens.

Under the current regulations, 24 fragrance allergens listed in entries 67 to 92 of Annex III to Regulation (EC) No 1223/2009 must be individually labeled in the list of ingredients of cosmetic products. However, in 2012, in response to the Commission's request for an update, the Scientific Committee on Consumer Safety (SCCS) identified an additional 56 fragrance allergens that have caused allergies in humans, for a total of 81 entries of labelable allergens (57 new substances concerned). These additional allergens were not subjected to individual labeling requirements.

Consequences of the fragrance allergens’ amendment

Based on the SCCS's opinion, the European Commission acknowledges the potential risk to human health associated with the use of these additional fragrance allergens. Therefore, it is deemed necessary to introduce an obligation to individually label these allergens when their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.

Additionally, fragrance substances that can be transformed to known contact allergens via air oxidation or bioactivation, will be treated as equivalent to fragrance allergens, subject to the same restrictions and regulatory requirements.

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 will be grouped together in one entry, and in cases where a substance has multiple common ingredient names, the specific name to be used in the list of ingredients will be specified. These updates will streamline the labeling process, making it more consumer-friendly and facilitating the work of economic operators and national authorities.

💡 Restrictions on methyl salicylate:

Methyl salicylate is an allergenic substance already included in Omnibus V as of December 2022. These restrictions have now been incorporated into the new regulation. Methyl salicylate is therefore banned in preparations intended for children under 6, with the exception of toothpastes.

Deadline and Transition Period

To ensure a smooth transition, economic operators will be given a reasonable period to adapt to the new restrictions imposed by the updated list of fragrance allergens. They will need to make adjustments to product formulations and containers to comply with the new requirements. Additionally, they will be allowed sufficient time to withdraw non-compliant cosmetic products from the market that were placed before the new labeling provisions become applicable.                                                                                                                                                                    

Transition period: from 3 years for new products (July 31st, 2026), to 5 years for existing products (July 31st, 2028).

The European Commission believes that these measures, based on the opinion of the Scientific Committee on Consumer Safety (SCCS), will significantly improve the protection of consumers and enhance their ability to make informed choices when selecting cosmetic products.

Practical Limitations of Allergens’ labeling

While the amendment to fragrance allergen labeling is a step in the right direction, traditional physical labeling methods have practical limitations.

Digital labeling solutions provide an opportunity to overcome these challenges by utilizing scannable codes and smartphone technology. Consumers can access detailed information about fragrance allergens, helping them make informed choices.

However, ensuring accessibility and establishing standardized guidelines for digital labeling will be essential to maximize its benefits and ensure consistency across cosmetic products and brands. Collaboration between regulatory bodies, industry stakeholders, and technology providers is key to implementing effective digital labeling systems in the future.

For more information, don't hesitate to contact us!

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