Two cosmetic products can have varying fragrance compositions and still display the same allergen name on their ingredient lists.
How is that possible?
Under Commission Regulation (EU) 2023/1545, the EU expanded its fragrance allergen labelling requirements. The regulation introduced an important distinction in how certain substances are being assessed.
While some allergens are declared individually, others are assessed together under a common name. On top of the labelling requirements, another discussion on whether certain fragrance ingredients should also be subject to additional concentration limits or conditions of use.
What happens when several allergens share one name?
One of the less obvious changes introduced by Regulation (EU) 2023/1545 concerns how fragrance allergens are organised under Annex III of the EU Cosmetics Regulation.
There are two types of entries worth understanding: standalone entries and grouped entities.
Standalone entries occur when a specific fragrance allergen is identified individually, and its designated name must appear in the ingredient list when the applicable declaration threshold is exceeded.
Group entries, on the other hand, uses the designated group name when the relevant labelling requirement is triggered instead of declaring each substance separately.
Why exactly? With the number of fragrance allergens requiring individual labelling increasing, ingredient lists are becoming longer raising concerns that labels may become more difficult for consumers to understand. Potentially making it harder to identify the information that they deem the most relevant to them. Group entries allow that information to become more manageable.
Several Concentrations to Calculate for One Name
For grouped entries, manufacturers must calculate the combined concentration of all substances covered by the same Annex III entry, instead of assessing each one separately.
This means that even when individual substances are present at low concentrations, their combined amount may exceed the applicable declaration threshold, making it necessary for the group name to appear on the label.
Emphasising how imperative it is for supplier information to be accurate, especially for complex fragrance mixtures. If there is insufficient documentation, additional assessment or testing could be recommended to establish the allergen content of the finished product.
Getting the declaration right means you are on the right track. Knowing when an allergen needs to appear on a label is different from understanding how much of that ingredient can safely be used.
Allergen labelling helps consumers identify substances that may trigger a reaction, and certain fragrance ingredients may also be subject to concentration limits or other conditions of use under the EU Cosmetics Regulation.
For manufacturers, this means checking what needs to be declared and if the formulation complies with any applicable restrictions.
QRA2: How much of a fragrance ingredient is too much?
Quantitative Risk Assessment 2 is a methodology developed within the fragrance industry’s scientific framework to assess the risk of skin sensitisation that is associated with fragrance ingredients.
In simpler terms, QRA2 aims to estimate exposure levels where a fragrance ingredient is unlikely to induce skin sensitisation. However, the SCCS has identified scientific uncertainties in the methodology, meaning its suitability must still be assessed on a case-by-case basis.
A substance’s likelihood to cause skin sensitisation is a safety topic often discussed; another is understanding how exposure influences that risk.
In the EU, QRA2 data can be considered by the Scientific Committee on Consumer Safety (SCCS) when it comes to navigating fragrance substances. On the other hand, QRA2 does not automatically mean that an ingredient will be restricted.
What Cosmetic Brands Should Keep an Eye On
Fragrance safety requirements are also evolving as new scientific evidence becomes available. The Scientific Committee on Consumer Safety plays a vital role in this process by assessing the safety of cosmetic ingredients and advising the European Commission.
Depending on its findings, certain fragrance substances may become subject to new concentration limits or other restrictions, although these changes must first go through the relevant regulatory process.
The expanded fragrance allergen requirements have made ingredient transparency a priority, but the work does not end with a compliant label. From grouped allergen calculations to evolving safety assessments, there is plenty happening behind the ingredient list. Obelis can support cosmetic manufacturers with formulation reviews, allergen assessments, finished-product testing and EU regulatory compliance, helping brands navigate these requirements as they evolve.
Frequently Asked Questions (FAQs)
- What is the difference between standalone and grouped fragrance allergens under EU Regulation 2023/1545?
Standalone fragrance allergens are declared individually when the applicable labelling threshold is exceeded. Grouped entries, on the other hand, cover several substances under one designated name.
- Does QRA2 determine the maximum concentration of fragrance ingredients in cosmetics?
Not directly. Quantitative Risk Assessment 2 is a scientific methodology designed to assess skin sensitisation risks associated with fragrance ingredients. The SCCS considers its suitability on a case-by-case basis, and QRA2 does not automatically establish legally binding concentration limits under the EU Cosmetics Regulation.
- What are the EU Fragrance Allergen Labelling thresholds for cosmetic products?
Under the EU Cosmetics Regulation, fragrance allergens must be individually declared when their concentration exceeds 0.001% in leave-on products, such as creams and lotions, or 0.01% in rinse-off products such as shampoos and shower gels.
References
European Commission. (2023). 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. Retrieved on 15/10/2026.
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