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    Topic

    EU 2023/1545, the expanded fragrance allergen disclosure rules.

    Regulation (EU) 2023/1545 amends Annex III of the EU Cosmetics Regulation 1223/2009 and expands the list of fragrance allergens that must be named on the ingredient list from 24 to around 80 substances. New cosmetic products must comply from 31 July 2026 and existing stock must be withdrawn from 31 July 2028. Health Canada is finalising a parallel disclosure regime.

    Quick answer

    Regulation (EU) 2023/1545, published in July 2023, amends Annex III of Regulation (EC) 1223/2009 and extends fragrance allergen labelling to roughly 80 substances. Each listed allergen must be declared by its INCI name in the ingredient list when present above 0.001% in leave-on products or 0.01% in rinse-off products. Products placed on the EU market from 31 July 2026 must comply; products already on the market may be sold until 31 July 2028. Health Canada published a parallel proposal in 2023 requiring disclosure of a similar set of fragrance allergens on cosmetic labels.

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    • Amends Annex III of EU Regulation 1223/2009
    • Expands declarable fragrance allergens from 24 to around 80
    • Thresholds: 0.001% leave-on, 0.01% rinse-off
    • Compliance for new products from 31 July 2026
    • Sell-through of non-compliant stock until 31 July 2028
    • Health Canada finalising a parallel disclosure regime

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    What Regulation (EU) 2023/1545 changes

    The old Annex III list required 24 fragrance allergens to be named on cosmetic labels above the standard thresholds. Regulation (EU) 2023/1545, adopted on 26 July 2023, extends that list to roughly 80 substances, including additional natural extracts and isomers identified by the Scientific Committee on Consumer Safety (SCCS) as relevant skin sensitisers. Once present above 0.001% in a leave-on product or 0.01% in a rinse-off product, each allergen must appear in the ingredient list by its INCI name, in line with Article 19(1)(g) of Regulation (EC) 1223/2009.

    Transition timelines that matter

    Two dates govern the transition. From 31 July 2026, cosmetic products placed on the EU market must declare the full expanded list of fragrance allergens on the label. From 31 July 2028, products that do not meet the new labelling rules can no longer be made available, even if they were placed on the market before the first deadline. Brands typically need to repaper labels, refresh CPNP and SCPN notifications and re-issue the PIF and CPSR ahead of the 2026 cut-off.

    Health Canada's parallel rule

    Health Canada published a notice of intent in 2023 proposing fragrance allergen disclosure on cosmetic labels, broadly aligned with the EU's expanded list. The Canadian proposal uses similar concentration thresholds and INCI naming, with disclosure either on the label or via a digital link. Brands selling into both markets benefit from treating the EU list as the working master and mapping Canadian-specific differences as exceptions.

    Worldover for this

    Be ready for 31 July 2026 without a relabelling fire drill

    Worldover screens every formula against the expanded Annex III allergen list, regenerates the ingredient declaration, and re-issues PIF, CPSR, CPNP and SCPN as a byproduct. Health Canada disclosures are handled from the same record.

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    Running 80 allergens across hundreds of SKUs

    For one product line, this is a manual relabelling exercise. For a brand with hundreds of SKUs across multiple fragrances, contract manufacturers and markets, it is a data problem: every formulation must be re-screened against the new Annex III, every label artwork updated, every CPNP, SCPN and (where relevant) MoCRA submission re-issued, and every PIF and CPSR re-signed. Worldover holds the formulation once, screens it against the live Annex III list and Health Canada's published list, generates the updated ingredient declaration and pushes refreshed labels and notifications downstream.

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