Labelling of cosmetic fragrance allergens 

The Commission Regulation (EU) 2023/1545 published in July 2023 updates Regulation (EC) 1223/2009 (‘the Cosmetics Regulation’) and introduces an expanded list of more than 80 fragrance allergens requiring mandatory on‑pack disclosure. The amendment to the Cosmetics Regulation aims to strengthen consumer protection by enabling individuals sensitised to specific allergens to identify and avoid triggering substances.

This page is for members of the cosmetics industry and aims to provide clarifications in response to frequently asked questions.

Can products that do not declare fragrance allergens still be placed on the market?

Products placed on the market before 31 July 2026

Cosmetic products which have been placed on the market before 31 July 2026, that contain allergens in the expanded list but do not yet declare them in the list of ingredients on product labels, may continue to be placed on the market until 31 July 2028.

Products placed on the market after 31 July 2026

Any new cosmetic products placed on the market post 31 July 2026 must comply with the updated labelling requirements set out in Regulation (EU) 2023/1545.

How do the timelines for ‘placing’ and ‘making available’ on the market differ?

The Regulation specifies two different deadlines depending on when a cosmetic product was first supplied. Consult the Regulation for full details and clarification related to the timelines listed below.

The HPRA applies the definitions of ‘placing on the market’ and ‘making available on the market’ as set out in Article 2 of the Cosmetics Regulation:

• ‘Placing on the market’ means the first making available of a cosmetic product on the Community market.
• ‘Making available on the market’ means any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge.
  

At national level, the HPRA does not apply additional definitions beyond these EU provisions.

When is a product considered ‘placed on the market’?

 Notifying a product to CPNP does not mean that the product has been placed on the market. The product must be available for sale, either via digital platforms or through physical retail channels for it to be considered as being placed on the market. Evidence of the date which a product has been placed on the market, such as invoices or batch-specific certificates of analysis, may be requested by the HPRA during our market surveillance.

Is a rebranded product considered a new product being placed on the market?

If a product is undergoing rebranding (for example, a white label formulation with new branding), repackaging, reformulation or relabelling, it may be considered as being placed on the market (i.e., a new product). As such, products placed on the market after 31 July 2026 would be expected to comply with the appropriate regulatory requirements, including extended labelling where applicable.

Next steps and actions

Obligations of the responsible person (RP)

The RP must ensure that:

• All formulations are reviewed for products made available on the market, in the context of Regulation 2023/1545.
• Necessary updates to product labelling and regulatory documentation (product information file and cosmetic product safety report) are made by 31 July 2028, for products placed on the market before 31 July 2026.
• Products placed on the market after 31 July 2026 comply with Regulation 2023/1545.
• Distributors/clients are contacted to ensure that sufficient notice is given to remove non-compliant stock from the market in advance of the regulatory deadlines.

Obligations of the distributor

The distributor must ensure that:

• They engage with their suppliers to ensure that only products compliant with Regulation 2023/1545 are available for distribution in line with the deadlines provided.
• Sufficient time is provided to allow for stock without the expanded list of allergens to be sold through/removed from the market.
• If non-compliant labelling is identified, they contact the supplier and the EU RP detailed on the product labelling to discuss CAPAs.

Staying up to date with changes to regulatory changes

We recommend monitoring the  SCCS - Opinions - Public Health - European Commission published by the European Commission, as these scientific assessments often inform future omnibus amendments to the Cosmetics Regulation and may impact cosmetic product labelling.

Manufacturers, distributors and suppliers are responsible for keeping up to date with any changes to the Cosmetics Regulation to ensure their products remain compliant.

Find more information about staying up to date by visiting Restricted and prohibited ingredients in cosmetic products.