September 20, 2023 | Reading time: 4 minutes

EU Amends Cosmetics Regulation Regarding Fragrance Allergens

Hidden within cosmetics are ingredients that may trigger uncomfortable allergic reactions for some. The recent updates (Annex III) to the EU Cosmetics Regulation (EC) 1223/2009 acknowledge this risk, compelling cosmetics manufacturers to disclose an expanded list of allergens on product labels. This is a significant stride toward safeguarding consumer health and well-being. In this blog, we will explore the amendments in the EU Cosmetics Regulation and explain why these changes in fragrance allergen labelling matter to manufacturers and consumers.

What are fragrance allergens?

In cosmetics and fragranced products, fragrances enhance the sensory experience. These fragrances are carefully crafted blends of natural and synthetic compounds and are often labelled generically as ‘parfum’ or ‘aroma’ on product packaging.

Recent regulatory changes in the EU Cosmetics Regulation highlight a crucial aspect of these fragrances – the presence of specific substances known as fragrance allergens. These substances can potentially induce contact allergies and sensitisation in susceptible individuals. In response to this health concern, the updated regulation now mandates individual labelling of fragrance allergens if they surpass defined concentration thresholds.

For professionals in the cosmetics industry, comprehending what fragrance allergens are and why their identification on labels is crucial for consumer well-being is imperative. This article explores this essential topic.

What were the labelling requirements for fragrance allergens before the new amendment?

Before this amendment, cosmetic and fragranced products containing 24 specific fragrance allergens had to list them on their ingredient labels. This was mandatory if the allergen exceeded certain concentration thresholds (0.001% for leave-on products and 0.01% for rinse-off products). With the recent regulatory changes, this list of mandatory allergen labelling has expanded to encompass over 80 allergen entries, significantly broadening the requirements.

What are the labelling requirements for fragrance allergens with the new amendment?

The new amendment introduces critical changes to the labelling requirements for fragrance allergens. An additional 56 substances are now recognised as fragrance allergens and require individual labelling. The amended Annex III to the Cosmetics Regulation includes these newly identified allergens. Moreover, certain substances known as Prehaptens and Prohaptens, which can transform into allergic substances through chemical reactions, are now treated as equivalent to fragrance allergens, subject to the same labelling requirements. To enhance clarity and consumer-friendliness, some existing entries have been updated to include individual isomers and align common names with the latest version of the Common Ingredients Glossary, a reference for ingredient names on product labels.

It is crucial to note that these fragrance allergens must be listed on the ingredients label, regardless of their source. Even though they bear the label ‘fragrance allergens’, these substances must be disclosed on the label, whether they originate from the fragrance component or are intentionally added as specific cosmetic ingredients. This comprehensive approach ensures that consumers have access to vital information about allergenic substances, promoting safety and transparency in the cosmetics and fragrance industry.

When do the amended allergen labelling requirements come into force?

The Regulation (EU) 2023/1545 officially takes effect on August 16, 2023, and applies to all Member States. There is a transitional compliance period to accommodate substantial adjustments, such as revising product formulations, and containers, removing non-compliant items, and issuing new labels.

Have a look at the image below to see how this transition extends for new and existing products.

EU Cosmetics Regulation (EC) 2023/1545 timeline

Where should fragrance allergens be listed on the label?

Ingredient labelling in cosmetics empowers consumers to make informed choices, especially if they have diagnosed or suspected allergies to specific ingredients. An ingredient is any substance or mixture intentionally used in a cosmetic product during manufacturing. All ingredients used in the product must be listed in the ingredients list, aiding those with allergies or skin sensitivities in avoiding problematic ingredients. While fragrance mixtures are generally labelled as ‘parfum’, those identified as ‘fragrance allergens’ must be listed individually.

A common naming system called the International Nomenclature for Cosmetic Ingredients (INCI) is employed to make ingredient identification easy for the public. This ensures consistency in ingredient names across the EU, GB, and most countries worldwide. Ingredients should be listed in descending order of weight when they are added to the cosmetic product. Ingredients in concentrations of less than 1% can be listed in any order after those exceeding 1%. You can list fragrance allergens based on concentration or place them at the end if they are not intentional cosmetic ingredients.

Challenges and adaptations of expanded allergen listings

The expansion of allergen listings has presented fresh challenges in regulations and implementation:

The challenge of allergic consumers memorising many complex allergen names within the same category.
Label space constraints due to extensive ingredient lists.
Implications for globally compatible labelling practices.

To mitigate the complexity of fragrance allergen names and label space constraints, a novel system has been devised. It involves categorising substances with similar allergenic properties under shared group names rather than listing individual substance names. Additionally, to ensure the global effectiveness of these new group names, some substances and the newly introduced group names have received approval for INCI names – International Nomenclature for Cosmetic Ingredients, internationally recognised systematic names for identifying cosmetic ingredients.

Consumer awareness and safety

Understanding the significance of allergen labelling in cosmetic products is crucial for consumer well-being. Informed consumers can make choices that protect their health and prevent allergic reactions. To navigate the world of fragrances and allergens, consumers should scrutinise product labels, where allergens are now more clearly designated. Familiarising oneself with common allergen group names and referring to accessible online resources for detailed information can significantly aid identification.

Consumer advocacy groups and organisations play a vital role in promoting safety by advocating for stricter regulations, raising awareness, and offering guidance to those with allergies. By staying informed and advocating for their rights, consumers contribute to a safer and more transparent cosmetics market, ensuring that their choices align with their sensitivities and preferences.

Conclusion

In conclusion, the recent updates to fragrance allergen labelling are a significant step toward enhancing consumer safety and transparency in the cosmetic industry. With an expanded list of allergens and precise labelling requirements, consumers can make informed choices, safeguarding their health and well-being.

While these changes may initially pose challenges for cosmetic manufacturers, innovative labelling solutions and a commitment to consumer safety ensure that a diverse range of products remains accessible.