‘Preservative-Free’ Marketing Claims Attract Greater Scrutiny

Introduction

Preservatives—ingredients that inhibit microbial growth and ensure microbiological safety of cosmetic products—are essential for multi-use products containing water, particularly those packaged in jars or tubes that facilitate microbial contamination during use [1]. However, consumer concerns regarding preservative safety, driven by reports of skin sensitization and endocrine disruption, fueled demand for “preservative-free” cosmetic products during the 2020s [2]. By September 2024, enforcement authorities across the EU intensified scrutiny of “preservative-free” claims, questioning whether such claims were substantiated, misleading, or compromised product safety [3]. The regulatory framework governing preservative use and claims, established by Annex V of Regulation (EC) No 1223/2009 (list of authorized preservatives), Article 20 (claims), and Commission Regulation (EU) No 655/2013 (claims criteria), required that “preservative-free” claims be truthful, evidenced, and not misleading [4].

The “preservative-free” phenomenon presented unique regulatory and safety challenges because the term “preservative” has both a regulatory definition (substances listed in Annex V) and a functional definition (substances that inhibit microbial growth) [5]. Some brands marketed products as “preservative-free” while using ingredients with antimicrobial properties that were not listed in Annex V, such as certain essential oils, organic acids, or multifunctional ingredients [6]. This practice raised questions regarding whether such claims were misleading and whether products lacking Annex V preservatives were adequately preserved and microbiologically safe [7].

Regulatory Framework and Legal Analysis

Annex V of Regulation (EC) No 1223/2009 lists preservatives authorized for use in cosmetic products, specifying maximum concentrations, authorized uses, and any required warnings or conditions [8]. Article 14(1)(b) prohibits the use of preservatives except those listed in Annex V, creating a positive list system where only explicitly authorized substances may be used as preservatives [9]. The definition of “preservative” in Article 2(1)(i) is functional: “substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product” [10].

This functional definition creates ambiguity for multifunctional ingredients that provide antimicrobial activity alongside other functions (e.g., pH adjustment, chelation, emulsification) [11]. The SCCS has addressed this issue in several opinions, concluding that substances used primarily for non-preservative functions but which incidentally provide antimicrobial activity are not considered preservatives under Annex V, provided their primary function is clearly established and their antimicrobial contribution is secondary [12]. However, if a substance is used primarily or exclusively for its antimicrobial properties, it must be listed in Annex V regardless of its other functions [13].

Article 20 of Regulation (EC) No 1223/2009 prohibits misleading claims, and Commission Regulation (EU) No 655/2013 establishes six common criteria that all claims must satisfy: legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making [14]. The Technical Document on Cosmetic Claims, published by the Commission in July 2017, addresses “free-from” claims, stating that such claims should only be used when the absence of the substance provides a real benefit or when the substance is widely expected to be present [15]. The guidance cautions that “free-from” claims may be misleading if they imply that the presence of the substance would be harmful or illegal, or if they create unjustified concerns about the safety of products containing the substance [16].

For “preservative-free” claims, the Technical Document specifies that such claims should only be used if the product contains no Annex V preservatives and no other substances used primarily for antimicrobial purposes [17]. If the product contains multifunctional ingredients with antimicrobial properties, the claim may be misleading unless it is clarified that the product is “free from Annex V preservatives” or “free from traditional preservatives” [18]. Additionally, “preservative-free” claims must not imply that the product is inherently safer than preserved products, as this would violate the fairness and honesty criteria [19].

Microbiological safety is a critical consideration for “preservative-free” products. Article 3 requires that cosmetic products be safe for human health, and microbiological contamination can cause skin and eye infections, particularly in products applied to mucous membranes or compromised skin [20]. The SCCS Notes of Guidance (10th Revision, SCCS/1602/18) require that the CPSR address microbiological quality, including preservative efficacy testing (challenge testing) demonstrating that the product resists microbial contamination under normal use conditions [21]. ISO 11930:2019 specifies the method for challenge testing, requiring that the product be inoculated with specified microorganisms and demonstrating adequate reduction in microbial counts over time [22].

For “preservative-free” products, challenge testing is particularly important to demonstrate that the product’s formulation (e.g., low water activity, low pH, high alcohol content) or packaging (e.g., airless pump, single-use sachets) provides adequate microbiological protection [23]. If challenge testing demonstrates inadequate preservation, the product does not comply with Article 3 and must not be placed on the market [24].

Toxicological and Safety Science Considerations

The toxicological profile of preservatives varies widely, reflecting the structural diversity of this ingredient class [25]. Some preservatives, such as parabens (methyl- and ethylparaben), have favorable safety profiles with low sensitization rates and minimal systemic toxicity [26]. Others, such as methylisothiazolinone (MI) and methylchloroisothiazolinone (MCI), are potent skin sensitizers and have been restricted to rinse-off products at very low concentrations [27]. The SCCS has issued numerous opinions on preservatives, frequently recommending restrictions or prohibitions based on sensitization data from dermatology clinics and human patch testing [28].

Skin sensitization is the primary safety concern for preservatives, as these ingredients are present in leave-on products at concentrations sufficient to induce sensitization in susceptible individuals [29]. The SCCS evaluates sensitization risk using the Quantitative Risk Assessment (QRA) methodology, which derives a No Expected Sensitization Induction Level (NESIL) from human repeat insult patch test (HRIPT) data and compares it to consumer exposure [30]. If the margin between NESIL and exposure is insufficient (typically <10), the SCCS recommends restrictions [31].

For example, methylisothiazolinone (MI) was initially authorized in Annex V at concentrations up to 0.01% in rinse-off products and 0.0015% in leave-on products [32]. However, increasing sensitization rates in the population, driven by widespread use of MI in cosmetics and household products, prompted the SCCS to recommend prohibition of MI in leave-on products (SCCS/1557/15) [33]. This recommendation was implemented through amendment of Annex V in 2016, with a transition period ending in 2017 [34].

Multifunctional ingredients with antimicrobial properties present unique safety assessment challenges because their antimicrobial activity may not be fully characterized, and their contribution to overall product preservation may be uncertain [35]. Common multifunctional ingredients include organic acids (e.g., benzoic acid, salicylic acid), alcohols (e.g., ethanol, phenoxyethanol), and certain essential oils (e.g., tea tree oil, lavender oil) [36]. These ingredients may provide antimicrobial activity through pH reduction, membrane disruption, or other mechanisms, but their efficacy depends on formulation context (e.g., pH, water activity, presence of other ingredients) [37].

The SCCS has emphasized that safety assessment of multifunctional ingredients must consider their total concentration and all functions, including antimicrobial activity [38]. If an ingredient is used at concentrations higher than necessary for its primary function, and the excess concentration provides antimicrobial activity, it may be considered a preservative and must be listed in Annex V [39]. This determination requires case-by-case evaluation based on formulation data and challenge testing results [40].

Microbiological safety risks from inadequately preserved products include bacterial contamination (e.g., Pseudomonas aeruginosa, Staphylococcus aureus), fungal contamination (e.g., Candida albicans, Aspergillus species), and production of microbial toxins [41]. Contaminated products can cause skin infections, eye infections (particularly from contaminated mascara or eyeliner), and, in severe cases, systemic infections in immunocompromised individuals [42]. The SCCS Notes of Guidance require that the CPSR address microbiological safety, and Article 23 requires reporting of serious undesirable effects, including infections resulting from contaminated products [43].

Practical Compliance Guidance

For Responsible Persons, ensuring compliance with “preservative-free” claims requires rigorous substantiation, comprehensive microbiological testing, and careful claim wording. First, the formulation must be evaluated to determine whether it contains any Annex V preservatives or other substances used primarily for antimicrobial purposes [44]. If the product contains multifunctional ingredients with antimicrobial properties, the primary function of each ingredient must be clearly established and documented [45]. Supplier declarations and formulation rationale should be maintained in the PIF to support the claim [46].

Second, challenge testing must be conducted according to ISO 11930:2019 to demonstrate that the product resists microbial contamination under normal use conditions [47]. The testing should inoculate the product with specified microorganisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Aspergillus brasiliensis, and optionally Escherichia coli) and demonstrate adequate reduction in microbial counts (typically ≥3 log reduction for bacteria and ≥1 log reduction for fungi within specified timeframes) [48]. If challenge testing demonstrates inadequate preservation, the formulation must be modified (e.g., by reducing water activity, lowering pH, adding antimicrobial ingredients, or changing packaging) or the product must not be placed on the market [49].

Third, the CPSR must address microbiological safety, including challenge testing results and justification for the absence of Annex V preservatives [50]. Part A should include microbiological quality data, including challenge testing reports and stability data demonstrating that microbiological quality is maintained throughout the product’s shelf life [51]. Part B should assess whether the product is adequately preserved and whether microbiological contamination poses a risk to consumer safety [52].

Fourth, “preservative-free” claims must be carefully worded to avoid misleading consumers [53]. Acceptable claim wording includes “free from Annex V preservatives,” “free from traditional preservatives,” or “preserved through formulation design” (if the product relies on low water activity, low pH, or other formulation characteristics) [54]. Unacceptable claim wording includes “preservative-free” without qualification if the product contains multifunctional ingredients with antimicrobial properties, or claims that imply the product is inherently safer than preserved products [55]. The Technical Document on Cosmetic Claims provides guidance on acceptable claim types and substantiation requirements [56].

Fifth, packaging design is critical for “preservative-free” products, as packaging that minimizes microbial contamination during use can reduce the need for preservatives [57]. Airless pump dispensers, single-use sachets, and tubes with one-way valves prevent introduction of microorganisms during use and may enable “preservative-free” formulations [58]. The CPSR should address packaging design and its contribution to microbiological safety [59].

Sixth, post-market surveillance is particularly important for “preservative-free” products, as microbiological contamination may not be detected until products are in consumer use [60]. Responsible Persons should implement systems to monitor consumer complaints regarding product odor, appearance changes, or adverse reactions potentially related to microbial contamination [61]. Article 23 requires reporting of serious undesirable effects, and infections resulting from contaminated products must be reported to competent authorities [62]. If microbiological safety concerns emerge, Article 25 empowers authorities to require withdrawal or recall [63].

Conclusion

The intensifying scrutiny of “preservative-free” marketing claims during 2024 reflected enforcement authorities’ concerns that such claims may mislead consumers and compromise product safety. Annex V of Regulation (EC) No 1223/2009 establishes a positive list of authorized preservatives, and Article 20 requires that claims be truthful, evidenced, and not misleading. “Preservative-free” claims must be substantiated through comprehensive microbiological testing, careful evaluation of multifunctional ingredients, and clear claim wording that does not imply inherent safety superiority. Responsible Persons must balance consumer demand for preservative-free products with the fundamental safety requirement in Article 3, ensuring that products are adequately preserved and microbiologically safe throughout their shelf life and under normal use conditions. As the regulatory framework continues to evolve and enforcement authorities intensify scrutiny, the cosmetic industry must maintain rigorous microbiological quality standards and transparent communication regarding preservation strategies.

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