New Fragrance Allergen Rules Will Reshape Cosmetic Labelling
Introduction
Fragrance ingredients represent one of the most common causes of allergic contact dermatitis from cosmetic products, with an estimated 1-3% of the general population sensitized to one or more fragrance allergens [1]. Regulation (EC) No 1223/2009 addresses fragrance allergens through Annex III, which lists 26 substances that must be indicated in the list of ingredients when their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products [2]. However, by February 2023, scientific evidence accumulated by the Scientific Committee on Consumer Safety (SCCS) indicated that these thresholds were insufficient to protect sensitized individuals, and that additional fragrance substances should be subject to labelling requirements or restrictions [3]. The SCCS opinion on fragrance allergens (SCCS/1459/11, updated in subsequent opinions) recommended lowering labelling thresholds, prohibiting certain highly sensitizing substances, and expanding the list of regulated fragrance allergens [4].
The anticipated regulatory changes created significant compliance challenges for the cosmetic industry, as fragrance formulations are complex mixtures containing dozens to hundreds of individual components, many of which are present at low concentrations [5]. Reformulation to eliminate or reduce fragrance allergens while maintaining olfactory profile and consumer acceptance required extensive collaboration between perfumers, toxicologists, and regulatory affairs professionals [6]. Article 19 labelling requirements would necessitate artwork changes for thousands of products, and Article 13 CPNP notifications would require updates to reflect revised formulations [7]. The fragrance allergen case exemplified the ongoing evolution of cosmetic regulation toward enhanced consumer protection and transparency, driven by advancing scientific understanding of sensitization mechanisms and exposure-response relationships [8].
Regulatory Framework and Legal Analysis
Annex III of Regulation (EC) No 1223/2009 lists substances subject to restrictions, including the 26 fragrance allergens that must be indicated in the list of ingredients when present above specified thresholds [9]. These substances include well-known allergens such as limonene, linalool, geraniol, citronellol, and coumarin, as well as more potent sensitizers such as hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC, also known as Lyral) and tree moss and oak moss extracts [10]. The labelling thresholds—0.001% in leave-on products and 0.01% in rinse-off products—were established based on scientific advice available at the time of the regulation’s adoption, reflecting a balance between consumer protection and practical feasibility [11].
However, subsequent SCCS opinions concluded that these thresholds do not adequately protect sensitized individuals from elicitation reactions [12]. SCCS/1459/11 on fragrance allergens recommended that labelling thresholds be lowered to 0.0001% for leave-on products and 0.001% for rinse-off products for several substances, including HICC, farnesol, and alpha-hexylcinnamaldehyde [13]. The SCCS also recommended that HICC be prohibited due to its high sensitization rate and potency, and that several other substances be subject to concentration limits or use restrictions [14].
Article 14 of Regulation (EC) No 1223/2009 establishes the procedure for amending Annexes II and III, requiring the Commission to take into account technical and scientific progress and adopt implementing acts [15]. The Commission initiated a regulatory process to implement the SCCS recommendations, including public consultations and impact assessments to evaluate the feasibility and proportionality of the proposed changes [16]. By February 2023, draft amendments to Annex III were under consideration, with anticipated adoption in 2023-2024 and transition periods of 12-24 months to allow industry reformulation and labelling updates [17].
The proposed amendments included several categories of changes. First, lowering of labelling thresholds for specific fragrance allergens, requiring that these substances be indicated in the ingredient list at lower concentrations than currently required [18]. Second, prohibition of HICC and potentially other highly sensitizing substances, requiring their removal from all cosmetic formulations [19]. Third, expansion of the list of regulated fragrance allergens to include additional substances identified by the SCCS as significant sensitizers, such as oxidized linalool and oxidized limonene [20]. Fourth, potential introduction of concentration limits for certain fragrance allergens, restricting their maximum use levels in cosmetic products [21].
Article 19(1)(g) requires that the list of ingredients be indicated on cosmetic products, and Article 19(2) specifies that ingredients must be listed in descending order of weight, using INCI nomenclature [22]. For fragrance allergens subject to Annex III labelling requirements, the specific substance name must appear in the ingredient list, even if it is a component of a fragrance mixture [23]. This creates complexity for fragrance formulations, as perfumers must disclose individual allergen components while maintaining confidentiality of the overall fragrance composition [24].
Article 20 claims substantiation becomes relevant for products marketed as “hypoallergenic,” “fragrance-free,” or “suitable for sensitive skin” [25]. Commission Regulation (EU) No 655/2013 requires that such claims be supported by adequate and verifiable evidence, and the Technical Document on Cosmetic Claims specifies that “hypoallergenic” claims should be based on appropriate testing, such as repeat insult patch testing (RIPT) or human patch testing demonstrating low sensitization potential [26]. Products marketed with these claims must carefully manage fragrance allergen content, as the presence of known sensitizers may contradict the claim and constitute misleading advertising [27].
Toxicological and Safety Science Considerations
Allergic contact dermatitis (ACD) is a Type IV delayed-type hypersensitivity reaction mediated by T lymphocytes [28]. Sensitization occurs when a chemical (hapten) penetrates the skin, binds to proteins, and is processed by antigen-presenting cells (Langerhans cells), which migrate to lymph nodes and activate T cells [29]. Upon re-exposure, sensitized T cells recognize the hapten-protein complex and trigger an inflammatory response, resulting in erythema, edema, vesiculation, and pruritus [30]. Fragrance allergens are typically low-molecular-weight lipophilic substances that readily penetrate the stratum corneum and form protein adducts, making them potent sensitizers [31].
The SCCS Notes of Guidance (10th Revision, SCCS/1602/18) require that skin sensitization be assessed for all cosmetic ingredients, using validated methods such as the local lymph node assay (LLNA) in mice or, preferably, in vitro alternatives such as the Direct Peptide Reactivity Assay (DPRA), KeratinoSens™, or h-CLAT [32]. These assays identify substances with sensitization potential, but do not predict the threshold concentration below which sensitization or elicitation will not occur [33]. Quantitative risk assessment for skin sensitizers requires determination of the No Expected Sensitization Induction Level (NESIL) and the Acceptable Exposure Level (AEL), which are compared to consumer exposure to calculate a margin of safety [34].
For fragrance allergens, the SCCS has applied a point-of-departure approach based on human data, using the Quantitative Risk Assessment (QRA) methodology developed by the Research Institute for Fragrance Materials (RIFM) [35]. This methodology derives a NESIL from human repeat insult patch test (HRIPT) data, applies uncertainty factors to account for inter-individual variability and exposure conditions, and calculates an AEL [36]. The AEL is compared to consumer exposure, estimated from product use data and fragrance concentration, to determine whether the ingredient can be used safely [37].
The SCCS has concluded that several fragrance allergens cannot be used safely at any concentration due to their high sensitization potency and prevalence of sensitization in the population [38]. HICC (Lyral) is the most notable example, with sensitization rates exceeding 3% in some populations and elicitation thresholds below 0.0001% [39]. The SCCS recommended prohibition of HICC in SCCS/1564/15, and this recommendation was implemented through amendment of Annex II in 2019, with a transition period ending in August 2021 [40].
Other fragrance allergens, such as farnesol, alpha-hexylcinnamaldehyde, and citral, have been evaluated by the SCCS and found to require lower labelling thresholds or concentration limits to protect sensitized individuals [41]. The SCCS opinions consider the prevalence of sensitization (determined from patch test data in dermatology clinics), the elicitation threshold (the concentration at which sensitized individuals experience reactions), and consumer exposure (estimated from product use surveys and fragrance concentration data) [42]. If the margin between the elicitation threshold and consumer exposure is insufficient (typically <10), the SCCS recommends restrictions [43].
Oxidation of fragrance allergens during storage or upon exposure to air can generate more potent sensitizers [44]. Linalool and limonene, which are weak sensitizers in their pure form, oxidize to form hydroperoxides and epoxides that are significantly more sensitizing [45]. The SCCS has recommended that oxidized linalool and oxidized limonene be added to the list of regulated fragrance allergens, requiring labelling when present above specified thresholds [46]. This creates challenges for manufacturers, as oxidation occurs over time and the concentration of oxidation products may increase during product shelf life [47].
Practical Compliance Guidance
For Responsible Persons, compliance with anticipated fragrance allergen regulations requires a multi-faceted approach addressing formulation, labelling, safety assessment, and supply chain management. First, comprehensive fragrance allergen screening must be conducted for all products containing fragrance, identifying all regulated allergens and their concentrations [48]. Fragrance suppliers should provide detailed compositional data, including concentrations of all 26 currently regulated allergens and any additional substances likely to be added to Annex III [49]. If oxidation products (e.g., oxidized linalool, oxidized limonene) are anticipated to be regulated, stability studies should assess their formation during product shelf life [50].
Second, reformulation strategies should prioritize elimination or reduction of highly sensitizing substances, particularly those subject to prohibition or very low concentration limits [51]. Perfumers should be engaged early in the reformulation process to identify alternative fragrance compositions that maintain olfactory profile while reducing allergen content [52]. The IFRA (International Fragrance Association) Standards provide guidance on safe use levels for fragrance ingredients, and compliance with IFRA Standards is often considered best practice, even though IFRA Standards are not legally binding under Regulation (EC) No 1223/2009 [53].
Third, safety assessment under Article 10 must address skin sensitization for all fragrance ingredients, including individual allergen components and the fragrance mixture as a whole [54]. Part A of the CPSR should include skin sensitization data for each fragrance allergen, including LLNA or in vitro sensitization assay results, HRIPT data if available, and QRA calculations demonstrating that the AEL is not exceeded [55]. Part B should evaluate the overall sensitization risk from the product, considering aggregate exposure from multiple allergens and the potential for cross-reactivity [56].
Fourth, Article 19 labelling must accurately list all fragrance allergens present above the applicable thresholds [57]. If labelling thresholds are lowered, many products will require artwork updates to include additional allergen declarations [58]. Responsible Persons should implement labelling management systems that track allergen concentrations and automatically flag products requiring labelling updates when regulatory thresholds change [59]. For products marketed in multiple jurisdictions, labelling must comply with the most stringent requirements, as some countries (e.g., Switzerland) have adopted lower thresholds than the EU [60].
Fifth, CPNP notification under Article 13 must be updated for reformulated products, including revised ingredient lists and updated safety assessments [61]. The notification should include detailed information on fragrance allergen content, enabling poison centers to provide appropriate medical advice in case of adverse reactions [62]. Article 23 requires reporting of serious undesirable effects, and Responsible Persons should implement post-market surveillance systems to monitor and investigate reports of allergic reactions potentially related to fragrance allergens [63].
Sixth, claims substantiation under Article 20 must be carefully managed for products marketed as “hypoallergenic,” “fragrance-free,” or “suitable for sensitive skin” [64]. “Fragrance-free” claims should only be used if the product contains no fragrance ingredients, including essential oils and fragrance allergens [65]. “Hypoallergenic” claims should be supported by HRIPT or clinical testing demonstrating low sensitization potential, and the presence of known fragrance allergens should be minimized or eliminated [66]. The Technical Document on Cosmetic Claims emphasizes that “hypoallergenic” does not mean “will not cause allergic reactions,” and claims should not create unrealistic expectations [67].
Conclusion
The anticipated regulatory changes to fragrance allergen requirements during 2023 reflected the SCCS’s ongoing scientific evaluation of sensitization risks and the Commission’s commitment to enhancing consumer protection. Lowering of labelling thresholds, prohibition of highly sensitizing substances, and expansion of the list of regulated allergens created significant compliance obligations for the cosmetic industry, requiring reformulation, labelling updates, and enhanced safety assessment. Responsible Persons must implement systematic fragrance allergen management programs, including comprehensive screening, reformulation strategies, robust safety assessment, accurate labelling, and proactive monitoring of regulatory developments. As scientific understanding of sensitization mechanisms and exposure-response relationships continues to advance, the regulatory framework for fragrance allergens will likely continue to evolve, and the industry must maintain flexibility and commitment to consumer safety while preserving the sensory experience that fragrance provides.
References
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