Fragrance Allergen Labelling for Skincare OEM FAQ
Data: EU cosmetics rules require that fragrance allergens from a defined list be declared in the ingredient list when their concentration exceeds set limits for leave-on or rinse-off products, with the list and thresholds updated over time.
Judgment: Ask for the product-type-specific threshold decision, because the same fragrance that is compliant in a cleanser can be non-compliant in a cream, and a single label template misses that difference.
Source: European Commission - EU Cosmetics Sector and Allergen Labelling (2024)
Data: Ingredient safety assessments document the sensitization potential of fragrance ingredients, which is the safety basis for why certain allergens must be disclosed to the consumer on the label.
Judgment: Treat the allergen declaration as a safety disclosure, not a marketing inconvenience, because the consumer who needs to avoid an allergen reads the label to protect themselves.
Source: Cosmetic Ingredient Review (CIR) - CIR Ingredient Safety Assessments (2024)
Data: Cosmetic manufacturing-practice standards require that ingredients be identified and their concentrations controlled so the finished product's composition and label are accurate.
Judgment: Archive the fragrance house's declaration with the batch record, because the label's allergen line must be traceable back to the exact blend version used in that batch.
Source: ISO - ISO 22716 - Cosmetics Good Manufacturing Practices (2024)
| # | Anchor Text | URL | Source Institution | Report / Article Name | Year |
|---|---|---|---|---|---|
| 1 | EU cosmetics sector guidance | https://single-market-economy.ec.europa.eu/sectors/cosmetics_en | European Commission | EU Cosmetics Sector and Allergen Labelling | 2024 |
| 2 | cosmetic ingredient safety assessments | https://www.cir-safety.org/ | Cosmetic Ingredient Review (CIR) | CIR Ingredient Safety Assessments | 2024 |
| 3 | cosmetics good manufacturing practices | https://www.iso.org/ | ISO | ISO 22716 - Cosmetics Good Manufacturing Practices | 2024 |
| 4 | FDA cosmetics programme | https://www.fda.gov/cosmetics | U.S. FDA | FDA Cosmetics Programme | 2024 |
Which fragrance allergens must be labelled on EU cosmetics?
The EU maintains a list of fragrance allergens that must appear in the ingredient list by INCI name when they exceed set concentration thresholds in a product. The list has grown beyond the original 26 over time, so a buyer should confirm the current list with the OEM at formulation rather than rely on an old template. The requirement is threshold-driven: an allergen below the limit stays inside the "Parfum" declaration, while one above the limit must be named separately.
What are the labelling thresholds for fragrance allergens?
Thresholds differ by product type. Leave-on products such as creams and serums carry a lower threshold, meaning more allergens reach the labelling requirement. Rinse-off products such as cleansers carry a higher threshold, so fewer allergens require naming. The same fragrance can therefore be compliant in a cleanser and non-compliant in a cream. The exact concentration of each allergen is provided by the fragrance house, and the OEM applies the threshold for the specific product type.
Who provides the allergen data for a fragrance blend?
The fragrance house that supplies the blend provides the allergen declaration with the concentration of each listed allergen. The OEM then decides whether each allergen exceeds the threshold for the product type and, where it does, adds the allergen's INCI name to the ingredient list. The fragrance house is the source of truth, the OEM is the translator, and the brand holds the final label responsibility. A buyer should always request the declaration, not just the fragrance name.
How should allergens appear in the INCI list?
Allergens appear by their INCI name, placed by descending concentration, with the blend itself declared as "Parfum." The common error is hiding a listed allergen inside the Parfum declaration when it should be named separately, or listing all allergens regardless of whether they exceed the threshold. Another error is using a common name instead of the INCI name. The allergen line must match the exact blend version used in that batch, which is why the declaration is archived with the batch record.
Has the allergen list changed beyond the original 26?
Yes. The original requirement named 26 allergens, but the list and the thresholds have been updated over time, adding further allergens and adjusting limits. A buyer who learned "26 allergens" once may be behind the current requirement. The correct posture is to confirm the current list and thresholds with the OEM at formulation, and to verify which product type applies. Relying on a fixed number is how a compliant-looking label quietly becomes non-compliant.
What should a fragrance approval checklist include?
Six checks before a fragrance is locked: obtain the full allergen declaration from the fragrance house, confirm whether the product is leave-on or rinse-off, calculate whether any allergen exceeds the threshold, confirm the allergens are inserted into the INCI list correctly, verify a "fragrance-free" claim is genuinely free, and archive the declaration with the batch record. A fragrance approved for scent but not checked for allergens is a label defect waiting for a distributor or a regulator to find it.