Cosmetic Allergens: New Labelling Rules and Deadlines 2026-2028
Cosmetic allergens are one of the key aspects to be checked when preparing a cosmetic product label and managing the product’s regulatory documentation.
With Commission Regulation (EU) 2023/1545 of 26 July 2023, Annex III to Regulation (EC) No 1223/2009 was amended as regards the labelling of fragrance allergens in cosmetic products. The regulation introduces new obligations for the individual labelling of additional fragrance allergens when they exceed specific concentration thresholds.
Why Fragrance Allergens Must Be Labelled
Fragrances are widely used in cosmetic products, not only in perfumes, but also in creams, detergents, shampoos, deodorants, make-up and many other scented products.
Some fragrance substances may cause contact allergies in sensitised individuals. For this reason, EU cosmetic legislation requires certain fragrance allergens to be listed individually in the ingredients list when their concentration exceeds defined limits.
The aim is to allow allergic or sensitised consumers to identify substances that may trigger an allergic reaction and make informed choices when purchasing or using cosmetic products.
What Changes with Regulation (EU) 2023/1545
Before this update, a limited number of fragrance allergens already had to be indicated individually on cosmetic labels when present above the applicable thresholds.
Following the opinion of the SCCS – Scientific Committee on Consumer Safety, 56 additional fragrance allergens were identified as having clearly caused allergies in humans and as not yet being subject to individual labelling requirements.
Regulation (EU) 2023/1545 therefore expands the list of fragrance allergens that must be declared in the ingredients list, updating Annex III to the Cosmetics Regulation.
Thresholds for Labelling
Fragrance allergens must be indicated in the ingredients list when their concentration exceeds:
| Product type | Labelling threshold |
|---|---|
| Leave-on products | above 0.001% |
| Rinse-off products | above 0.01% |
These thresholds are confirmed in Regulation (EU) 2023/1545 and apply to the fragrance allergens covered by the updated Annex III.
Leave-On and Rinse-Off Products
The distinction between leave-on and rinse-off products is essential.
Leave-on products are intended to remain in contact with the skin, hair or mucous membranes after application. Examples include face creams, serums, perfumes, deodorants, make-up and leave-on hair products.
Rinse-off products are intended to be removed with water after use, such as shampoos, shower gels, cleansers, rinse-off conditioners and soaps.
Since leave-on products remain in contact with the skin for longer, the labelling threshold for allergens is lower.
Deadlines for Compliance
Regulation (EU) 2023/1545 provides transitional periods to allow companies to adapt formulas, labels, packaging materials and regulatory documentation.
The key deadlines are:
| Deadline | Practical meaning |
|---|---|
| 31 July 2026 | Cosmetic products that do not comply with the new allergen labelling requirements may be placed on the EU market only until this date, provided that they comply with the rules applicable on 15 August 2023. |
| 31 July 2028 | Cosmetic products that do not comply with the new requirements and have already been placed on the market may be made available on the EU market only until this date. |
After 31 July 2026, newly placed products must comply with the updated allergen labelling rules. After 31 July 2028, non-compliant products can no longer be made available on the EU market.
Which Cosmetic Products Are Affected
The update may affect any cosmetic product containing fragrances, aromas, essential oils or scented raw materials.
Products to be checked may include:
- perfumes and scented waters;
- face and body creams;
- cleansers;
- shampoos and conditioners;
- deodorants;
- make-up products;
- lip products;
- hair products;
- body oils;
- products containing essential oils or botanical extracts.
The presence of allergens is not limited to products marketed as “perfumed”. Allergens may also be present in natural extracts, essential oils, aromatic mixtures and some functional raw materials.
Fragrances, Essential Oils and Aromatic Mixtures
Many fragrance allergens may be present within complex mixtures, such as:
- parfum;
- aroma;
- essential oils;
- botanical extracts;
- fragrance compounds;
- aromatic raw materials.
For this reason, checking the finished product INCI list alone is not sufficient. Companies should also review the technical documentation supplied by fragrance houses and raw material suppliers, including updated allergen declarations and the composition of perfuming mixtures.
What Cosmetic Companies Should Do
Cosmetic companies, manufacturers, brand owners, importers, distributors and Responsible Persons should plan the update in advance.
The main activities include:
- checking the presence of parfum, aromas, essential oils and scented raw materials;
- requesting updated allergen declarations from suppliers;
- calculating allergen concentrations in the finished product;
- distinguishing between leave-on and rinse-off products;
- updating the ingredients list on the label;
- reviewing primary packaging, cartons, artwork and promotional material;
- updating the PIF and CPSR, where necessary;
- checking consistency with the CPNP notification;
- planning stock management before the relevant deadlines;
- assessing whether reformulation or fragrance replacement is needed.
Label, PIF, CPSR and CPNP
The allergen update does not concern the label only.
When the ingredients list, fragrance composition or raw material documentation changes, companies should also verify consistency with:
- qualitative and quantitative formula;
- PIF – Product Information File;
- Cosmetic Product Safety Report;
- safety assessment;
- CPNP notification;
- supplier documentation;
- claims and commercial communication.
A label updated without alignment with the PIF, CPSR or formulation may still represent a regulatory issue.
Allergen Review and Regulatory Compliance
Regulation (EU) 2023/1545 requires a targeted review of many cosmetic products already on the market or currently under development.
The expansion of the fragrance allergens to be declared in the ingredients list may affect formulas, artwork, PIF, CPSR and stock management.
A preventive review of supplier documentation and allergen concentrations in the finished product allows companies to plan the update within the applicable deadlines and maintain compliance with EU cosmetic legislation.