Fragrances are used in a wide range of cosmetic products, including creams, shampoos, and body lotions. They may give a product its desired scent or help mask odors from other ingredients.
When developing a product, brands need to decide on the desired scent while also reviewing the ingredient information for the fragrance they plan to use.
In particular, the EU’s expanded fragrance allergen labeling requirements mean that brands preparing to sell products in the EU need to review both the fragrance composition data and the finished product’s ingredient list.
This is because the required labeling may vary depending not only on which substances the fragrance contains, but also on how much fragrance is used in the finished product and whether the same substances are also present in other ingredients.
What, then, should brands review throughout the process—from fragrance selection and product development to finalizing the label?
1. What Has Changed Under the EU Fragrance Allergen Labeling Requirements?
In the EU, perfume and aromatic compositions may be listed as “parfum” or “aroma” in a cosmetic product’s list of ingredients. However, certain fragrance ingredients must be listed individually by name when their concentration in the finished product exceeds the applicable threshold.
In 2023, the EU amended its rules to add 56 additional fragrance allergens to the individual labeling requirements. The amendment also updated substance information and labeling names for existing entries and grouped certain substances under a common labeling name.
The purpose of this individual labeling is to provide information to consumers who are allergic to particular fragrance ingredients. Some fragrance ingredients may cause skin reactions in people who are sensitized to them.
Unlike listing a fragrance simply as “parfum,” listing the relevant ingredients individually allows consumers to check whether a product contains a substance they need to avoid and make an informed choice.
However, the fact that an allergen is named in the list of ingredients does not, by itself, mean that the product is unsafe. The amendment has increased the number of fragrance ingredients that must be listed individually.
Brands therefore need to determine both whether any ingredients subject to individual labeling are present and whether their concentrations in the finished product exceed the applicable thresholds.
2. Whether Labeling Is Required Depends on the Concentration in the Finished Product
Whether a fragrance allergen must be individually listed depends on its concentration in the finished product.
Different thresholds apply to leave-on and rinse-off products.
| Product Type | Threshold for Individual Ingredient Labeling |
|---|---|
| Leave-on products | Concentration above 0.001% in the finished product |
| Rinse-off products | Concentration above 0.01% in the finished product |
Even when the same fragrance is used, whether individual labeling is required must be assessed separately based on how the product is used and the amount of fragrance in the formulation.
These figures do not represent the maximum concentrations at which the substances may be used. They are thresholds for individual ingredient labeling, so whether a substance may be used and whether any other restrictions apply must be reviewed separately.
The general rules for listing cosmetic ingredients must also be considered.
For example, if a substance is added directly as an individual cosmetic ingredient rather than being present as part of a fragrance mixture, the general ingredient-listing requirements apply. In that case, the ingredient cannot be omitted from the list simply because its concentration is below the thresholds above.
It is therefore important to distinguish between the additional labeling thresholds for substances contained in a fragrance mixture and the general ingredient-listing requirements for ingredients added individually.
3. How Do the Compliance Deadlines Differ for Products Newly Placed on the Market and Existing Stock?
When preparing for the expanded EU labeling requirements, brands need to distinguish between products being placed on the EU market for the first time and existing stock that has already been placed on the market.
| Category | Deadline | Requirement |
|---|---|---|
| Products placed on the EU market for the first time | 31 July 2026 | Products first placed on the market after this date must comply with the expanded labeling requirements. |
| Continued availability of existing stock | 31 July 2028 | Products placed on the EU market by the 2026 deadline that complied with the previous requirements and other applicable conditions may continue to be made available until this date. |
As of October 2026, the first deadline has already passed. Products now being placed on the EU market for the first time must therefore comply with the expanded labeling requirements.
The transition period allowing continued availability until 2028 applies only to existing stock that meets the relevant conditions. Even for the same product, new stock placed on the EU market after the 31 July 2026 deadline is subject to the expanded labeling requirements.
An existing product that has been rebranded, repackaged, reformulated, or relabeled may, depending on the nature of the change, be considered a new product being placed on the market.
If any such changes have been made, brands should separately confirm whether the transition period for existing products also applies to the modified product.
When reviewing existing stock, it is advisable to examine both documentation showing when the relevant stock was first placed on the EU market and records of any changes made to the product.
4. Review Both Fragrance Documentation and the Composition of Other Raw Materials
Confirm That the Documentation Matches the Fragrance Actually Used
The first step is to confirm that the documentation supplied relates to the fragrance actually used in the product.
Brands should check the fragrance product code and supplier and determine whether the documentation provides composition and concentration data covering the expanded list of substances subject to individual labeling.
To determine the labeling requirements for the finished product, brands need to know not only whether a particular substance is present but also how much of it is present. This information is needed to calculate its concentration in the finished product based on the actual amount of fragrance used.
If the fragrance or supplier changes, the documentation for the new raw material should be reviewed and the updated information reflected in the labeling assessment for the finished product.
Include Contributions from Other Raw Materials
The review should not be limited to the fragrance itself.
Other raw materials, including essential oils and botanical extracts, may also contain substances subject to individual labeling. Using naturally derived ingredients therefore does not remove the need for a labeling review.
If the same substance is present in multiple raw materials, the amounts contributed by all sources must be added together to calculate its total concentration in the finished product.
For example, if a substance subject to individual labeling is present in both the fragrance and a botanical ingredient, calculating only the amount contributed by the fragrance will not provide its total concentration in the finished product.
In addition, when the regulation groups multiple substances under a single entry, brands need to confirm both the combined concentration of those substances and the prescribed labeling name. Rather than copying substance names directly from supplier documentation, brands should verify that the names match those required under the regulation.
How Is the Concentration in the Finished Product Calculated?
To illustrate the calculation, consider linalool, which was already subject to individual labeling requirements before the amendment. Assume that a fragrance containing 1% linalool is added to a finished product at 0.5%.
All figures are by weight, and the example assumes that no other raw material contributes linalool.
A 100 g finished product contains 0.5 g of fragrance. Because linalool accounts for 1% of that fragrance, the product contains 0.005 g of linalool. The linalool concentration in the finished product is therefore 0.005%.
If this hypothetical product is a leave-on product, the concentration exceeds the labeling threshold of 0.001%, so linalool must be listed individually in the list of ingredients. By contrast, it does not exceed the 0.01% threshold for a rinse-off product.
This example shows why both the concentration of each substance stated in the fragrance documentation and the actual amount of fragrance used must be considered when determining the labeling requirements for the finished product.
5. Do the Expanded Labeling Requirements Mean the Fragrance Must Be Changed?
The expansion of the labeling requirements does not mean that the fragrance in every product must be changed.
Brands should first confirm that the raw materials currently used meet the relevant conditions of use and determine whether any additional substances now need to be listed individually.
If the existing fragrance and its use level remain unchanged and only the labeling needs to be updated, the necessary changes can be reflected in the final list of ingredients, product label, and related product documentation.
However, if the type or amount of fragrance is changed, the product’s ingredient composition and proportions—in other words, its formula—will also change. The scope of the required review will therefore change as well.
EU guidance on preparing the Cosmetic Product Safety Report explains that the safety assessment should be reviewed and, where necessary, updated when the formulation changes or when the composition or quality specifications of a raw material are modified.
However, changing the fragrance does not automatically mean that every test previously conducted must be repeated.
The first step is to assess whether the existing test data remain applicable to the reformulated product. Existing stability test data, which show whether the product remains stable during storage, should also be reviewed to determine whether they are appropriate for evaluating the revised formula.
Brands can then determine whether additional testing or documentation is needed based on factors such as the composition and use level of the new fragrance.
Brands and manufacturers should document the changes and work with the safety assessor to confirm the required documentation and the scope of any additional testing.
6. What Should Be Checked Before the Label Is Finalized?
Before the label is finalized, brands need to confirm that the ingredient information reviewed in the preceding steps has been accurately reflected in the final label artwork.
The final artwork, the way the information is displayed, and the supporting documentation should be reviewed with the following points in mind:
- Completeness of the ingredient list: Confirm that all substances requiring individual labeling are included in the final list of ingredients.
- Correct labeling names: Confirm that the required ingredient names and the prescribed labeling names for grouped entries have been used.
- Print quality and legibility: Confirm that the ingredient names are legible, clearly visible, and indelible.
- Consistency with product documentation: Confirm that the final label matches the product’s actual composition and the contents of the Product Information File. The Product Information File contains relevant documentation, including the product description and safety report.
It is also advisable to review these final checks with the EU Responsible Person (RP).
Conclusion
Responding to the expanded EU fragrance allergen labeling requirements involves reviewing not only the list of substances subject to individual labeling, but also composition information for the raw materials actually used and the concentrations present in the finished product.
It is also important to account for substances that may come from raw materials other than the fragrance and to distinguish between cases that require only a labeling update and those that involve a change to the formula.
From the early stages of product development, brands need to work with their manufacturers to confirm the necessary composition information and prepare labels and product documentation in line with their planned EU supply schedule.
Neo Mirae supports brands throughout the process, from cosmetic product development and packaging to production. If you are planning a product for international markets, work with Neo Mirae to refine your product development direction.
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