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New Fragrance Allergens: July 2026 Deadline and CPSR Updates for Cosmetic Products

  • 4 days ago
  • 4 min read

The recent amendment to the European Cosmetic Regulation significantly expands the list of fragrance allergens that must be declared on the INCI label (Regulation (EU) No 2023/1545 updating certain entries of Annex III of the EU Cosmetic Regulation). 


In the original version of Regulation (EC) No 1223/2009, 26 allergens were subject to mandatory labelling. Two of them ,Lyral and Lilial, have since been prohibited. The new regulation adds 57 additional substances, bringing the total number of labelled allergens to 81. These include individual molecules as well as botanical extracts and essential oils that may induce skin allergy. Products already on the market containing these substances must be reviewed more closely, both to ensure correct labelling and to clarify potential risks. 


The intrinsic risk of skin sensitisation of a product does not automatically change. However, if a substance was not previously identified, it may now need to be considered, particularly if the product claims to be “hypoallergenic” or suitable for “sensitive skin.” 


Among the newly concerned substances are widely used cosmetic ingredients such as: 

  • Vanillin 

  • Benzaldehyde 

  • Lavandin oil and extracts (Lavandula Hybrida Oil) 

  • Peppermint oil (Mentha Piperita Oil) 


Labelling is required when concentrations exceed: 

  • 0.001% in leave-on products 

  • 0.01% in rinse-off products 


The regulatory deadlines are clearly defined: 

  • Products placed on the market must comply by July 31, 2026 

  • Products already on the market must comply by July 31, 2028 


This regulatory development requires companies to conduct a systematic review of fragrance compositions, supplier data, and safety documentation. 

However, labelling is only one part of the regulatory obligation. 


Beyond Labelling: Annex I Requires a Complete Safety Assessment 


Article 10 and Annex I: Mandatory Update of the Cosmetic Product Safety Report (CPSR)


Article 10 of Regulation (EC) No 1223/2009 and Annex I require a complete safety assessment based on documented toxicological profiles and the calculation of the Margin of Safety (MOS) for each ingredient. Article 10(1)(c) specifies that the Safety Report (CPSR) must be updated whenever new relevant information becomes available. 


A compliant cosmetic safety assessment requires: 

  • The use of documented toxicological profiles 

  • Evaluation of local effects (sensitisation, irritation, phototoxicity) and systemic effects, including identification of relevant concerns (critical warnings) 

  • Calculation of the Systemic Exposure Dose (SED) 

  • Determination of the Margin of Safety (MOS) 

  • Integration of conclusions into the Cosmetic Product Safety Report (CPSR) 


Margin of Safety (MOS): The Central Indicator in Cosmetic Risk Assessment


The Margin of Safety (MOS) is the core regulatory indicator used to demonstrate ingredient safety within the CPSR framework. 


It quantitatively expresses the relationship between hazard (NOAEL or relevant point of departure POD) and actual consumer exposure. 


A product may comply with labelling thresholds while still requiring an in-depth evaluation. It is important to note that the 2012 SCCS opinion focused on skin sensitisation and did not address other potential toxicological endpoints. 


Regulatory compliance therefore relies on a structured demonstration of the hazard × exposure assessment, not solely on verification of labelling thresholds. 


Tableau d’évaluation de sécurité des allergènes parfumants dans une formule cosmétique montrant Rosa Canina Flower Oil, Citral, Heliotropine et Geraniol avec indicateurs de risque toxicologique et conclusion de toxicité systémique sans risque selon les marges d’exposition.

Allergens requiring labeling (underscored) are identified based on their final concentration and the type of product. A margin of safety or margin of exposure is calculated each time it is possible. 


Operational Impact: Recalculation of Margins of Safety and Update of the PIF 


The transition from 24 to 81 labelled allergens significantly increases operational complexity: 

  • Verification of fragrance compositions and botanical extracts 

  • Recalculation of cumulative concentrations 

  • Verification of the need to add allergens to the ingredient list 

  • Confirmation of exposure scenarios 

  • Reassessment of risks and recalculation of Margins of Safety 

  • Update of the safety assessment through the CPSR and the Product Information File (PIF) 


Any modification in concentration or formulation may directly impact the SED and consequently the MOS. 


Traceability and reproducibility of calculations therefore become essential. 


Toxicological Database and Digital Cosmetic Risk Assessment Tool


In this context, the use of a structured toxicological database combined with a digital cosmetic risk assessment tool facilitates: 

  • Harmonised access to toxicological profiles 

  • Consistent calculation of SED and Margin of Safety 

  • Generation of documentation compliant with Annex I 

  • Consideration of the SCCS assessment methods and other international frameworks. 


July 2026: A Regulatory Trigger for Systematic Risk Reassessment


Therefore, Regulation (EU) No 2023/1545 updates the list of labelled allergens under Annex III of the EU Cosmetic Regulation and requires an update of the regulatory dossier. 


The July 2026 deadline should be considered a regulatory trigger to: 

  • To re-examine fragrance compositions and botanical extracts with regard to labelling requirements 

  • To verify the Margins of Safety and confirm warnings or the absence of risk, and to update the CPSR accordingly The expansion of allergen labelling aims to enhance transparency. 


However, consumer protection ultimately depends on the robustness of the cosmetic risk assessment and the scientific justification of safety through the Margin of Safety. 


In regulatory practice, compliance does not merely consist of updating the INCI list. 


It requires a continuously documented, traceable and scientifically substantiated assessment framework. These updates are therefore not simply an administrative revision of the ingredient list; they require regulatory and scientific expertise which, at least for Part B of the CPSR — covering the safety assessment — must be validated by a qualified safety assessor (toxicologist, pharmacist, etc.), as defined in Article 10 of the EU Cosmetic Regulation. 


Would you like to ensure the safe assessment of allergens in your cosmetic formulas?


Our experts can assist you in identifying allergens, conducting toxicological assessments, and ensuring your products comply with European and international requirements.


To learn more about COSMETICK and our approach to cosmetic risk assessment, please contact:

  • Clarisse Bavoux : Toxicologist, Deputy Chief Executive Officer in charge of digital solutions

  • Florian Gautier : Cosmetics Market Leader



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