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EU Fragrance Allergen Labelling Deadline: What Cosmetic Companies Need to Know

Writer: Daniel Jiménez
Daniel Jiménez
Feb 2, 2024
5 min read


The deadline for complying with the European Union’s expanded fragrance allergen labelling requirements is approaching.

From 31 July 2026, cosmetic products that do not comply with the new requirements introduced by Commission Regulation (EU) 2023/1545 may no longer be placed on the EU market.

Products that were lawfully placed on the market before this deadline may continue to be made available to distributors, retailers and consumers until 31 July 2028.


EU Cosmetic Regulations: 81 Allergens Now Mandatory on Product Labels

For cosmetic brands, manufacturers, importers and Responsible Persons, this means that affected formulations, ingredient lists and product artwork should now be reviewed and updated.


What has changed?

Under the previous EU framework, 26 fragrance allergens were subject to individual declaration in the cosmetic product’s ingredient list when present above the applicable concentration thresholds.

Commission Regulation (EU) 2023/1545 introduced individual labelling requirements for 56 additional fragrance allergens and reorganised certain existing Annex III entries by grouping related substances under common labelling names.

Consequently, references to “81 allergens” are frequently used within the cosmetics industry. However, it is more accurate to refer to the expanded list of fragrance allergens subject to individual labelling, as the regulatory annex contains grouped entries and, in some cases, several chemically related substances may be declared using one common ingredient name.

The new substances are not automatically required on every cosmetic label. Individual declaration is necessary only when the concentration of the relevant fragrance allergen in the finished product exceeds:

  • 0.001% in leave-on products

  • 0.01% in rinse-off products

Below these thresholds, the substance does not need to be declared separately from the general terms “Parfum” or “Aroma”, unless another regulatory provision requires its inclusion.


Key compliance dates

The Regulation established two different transitional deadlines:


  • 31 July 2026: deadline for placing products on the market

Until this date, cosmetic products that comply with the previous fragrance allergen labelling rules may still be placed on the EU market.

From 1 August 2026, products placed on the market must comply with the expanded individual labelling requirements.

In regulatory terms, “placing on the market” means making a cosmetic product available on the EU market for the first time. It should not be confused with simply selling an existing unit to a consumer.


  • 31 July 2028: deadline for making existing products available

Products that were already placed on the EU market before 31 July 2026 under the previous labelling rules may continue to move through the distribution chain and be sold until 31 July 2028.

After that date, cosmetic products that do not comply with the new fragrance allergen labelling provisions may no longer remain available on the EU market.


Which cosmetic products may be affected?

The requirements are not limited to perfumes or products marketed primarily for their fragrance.

They may affect any cosmetic product containing perfume compositions, essential oils, botanical extracts, aromatic raw materials or other ingredients that naturally contain substances covered by the expanded allergen list.

Potentially affected categories include:

  • Perfumes and body sprays

  • Face and body creams

  • Shampoos and conditioners

  • Hair styling products

  • Shower gels and cleansers

  • Deodorants

  • Make-up products

  • Essential-oil-based cosmetics

  • Baby and sensitive-skin products

  • Professional-use cosmetic products

Even products that contain only a small amount of fragrance should be assessed, as some allergens may exceed the applicable threshold in the finished formulation.


What should cosmetic companies do?

Companies should not wait until the deadline to start reviewing their product portfolios. Updating a cosmetic label may require coordination between fragrance suppliers, formulators, safety assessors, Responsible Persons, artwork teams, packaging suppliers and distributors.


A suitable compliance review should include the following steps:


1. Obtain updated fragrance documentation

Fragrance houses and raw material suppliers should provide updated documentation identifying the allergens covered by Regulation (EU) 2023/1545 and their concentration within the supplied material.

Older fragrance allergen declarations that only cover the previous 26 substances may no longer provide sufficient information to assess the finished product.


2. Calculate the concentration in the finished cosmetic product

The allergen concentration in the fragrance mixture or raw material must be combined with the percentage at which that material is used in the finished formulation.

This calculation determines whether each substance exceeds the applicable threshold for leave-on or rinse-off products.


3. Update the ingredient list

Any allergen exceeding the relevant threshold must be individually included in the product’s ingredient list using the appropriate common ingredient name.

The order of the ingredient list should also be reviewed in accordance with Article 19 of Regulation (EC) No 1223/2009.


4. Review labels and packaging artwork

Once the revised ingredient list has been prepared, companies should confirm that all packaging versions, translations and market-specific artworks are updated.

This may include primary packaging, secondary packaging, labels, stickers, leaflets and digital artwork files.


5. Update the Product Information File

The Product Information File should reflect the current formulation, supplier documentation, allergen assessment and final approved labelling.

Where relevant, the Cosmetic Product Safety Report should also be reviewed to ensure consistency with the updated information.


6. Coordinate existing and new stock

Companies should distinguish between:

  • Products placed on the market before 31 July 2026

  • Products intended to be placed on the market from 1 August 2026

  • Remaining non-compliant stock that must no longer be made available after 31 July 2028

Clear batch, manufacturing, distribution and invoicing records may be important for demonstrating when a product was first placed on the EU market.


Is reformulation required?

The Regulation primarily introduces expanded labelling requirements. It does not generally prohibit the use of the newly listed fragrance allergens.

Therefore, reformulation is not automatically required simply because a product contains one of these substances.


In many cases, compliance can be achieved by assessing the concentration of each allergen and updating the ingredient list and product artwork.


Nevertheless, some companies may voluntarily choose to reformulate products to simplify labels, meet internal policies or reduce the presence of certain sensitising substances.


The deadline is now approaching

As 31 July 2026 approaches, cosmetic companies should already have completed—or be finalising—their fragrance documentation reviews, allergen calculations and label updates.


The transition period ending in July 2028 should not be interpreted as permission to continue manufacturing or placing newly produced non-compliant products on the EU market after the 2026 deadline. It applies only to products that were already placed on the market before 31 July 2026.


Belab Services supports cosmetic companies with:

  • Fragrance allergen assessments

  • Finished-product concentration calculations

  • Updated INCI ingredient lists

  • Cosmetic label and artwork reviews

  • Product Information File updates

  • EU Responsible Person services

  • CPNP notifications and regulatory compliance


Companies that have not yet assessed their product portfolios should act now to ensure that products placed on the EU market after July 2026 comply with Regulation (EU) 2023/1545.

For further information, visit www.belabservices.com or contact us at contact@belabservices.com.

1 Comment


Philip T. Greene
Philip T. Greene
Apr 12, 2025

This is a timely and important update! With consumer awareness growing, it's essential that regulations keep pace to ensure transparency and safety. At Made by Nature Labs, we fully support the EU’s move toward clearer labeling and incorporate these standards into all of our Cosmetici a Marchio Privato and Skin Care formulations. Transparency builds trust—and that starts with the label.

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