‘Clean Beauty’ Claims Face Growing Regulatory Scrutiny

Introduction

The proliferation of “clean beauty” marketing claims during the early 2020s reflected growing consumer demand for cosmetic products perceived as safer, more natural, and environmentally sustainable [1]. Terms such as “clean,” “non-toxic,” “free from harmful chemicals,” and “safe” became ubiquitous in cosmetic marketing, often accompanied by exclusion lists highlighting ingredients that brands had voluntarily removed from formulations [2]. However, by October 2022, these claims faced intensifying regulatory scrutiny from enforcement authorities across the EU, who questioned whether such claims were substantiated, misleading, or implied that competing products were unsafe [3]. The regulatory framework governing cosmetic claims, established by Article 20 of Regulation (EC) No 1223/2009 and elaborated in Commission Regulation (EU) No 655/2013, requires that all claims be truthful, evidenced, honest, fair, and allow consumers to make informed choices [4].

The “clean beauty” phenomenon presented unique regulatory challenges because the term “clean” lacks a standardized definition, and brands applied the concept inconsistently, creating consumer confusion and competitive disadvantage for companies adhering to evidence-based formulation practices [5]. Some brands defined “clean” as excluding specific ingredients (e.g., parabens, sulfates, phthalates), while others emphasized natural or organic sourcing, and still others focused on sustainability or ethical considerations [6]. This definitional ambiguity, coupled with implicit suggestions that excluded ingredients were harmful despite regulatory approval, raised concerns that “clean beauty” claims could undermine consumer confidence in the safety of cosmetic products generally and contradict the science-based regulatory framework established by Regulation (EC) No 1223/2009 [7].

Regulatory Framework and Legal Analysis

Article 20 of Regulation (EC) No 1223/2009 establishes the legal framework for cosmetic claims, stating that “the labelling, making available on the market and advertising of cosmetic products shall not be misleading” [8]. Article 20(2) specifies that claims must comply with common criteria, and Article 20(3) empowers the Commission to adopt measures establishing those criteria [9]. Commission Regulation (EU) No 655/2013, adopted pursuant to Article 20(3), establishes six common criteria that all cosmetic claims must satisfy: (a) legal compliance; (b) truthfulness; (c) evidential support; (d) honesty; (e) fairness; and (f) informed decision-making [10].

The legal compliance criterion requires that claims comply with all relevant EU legislation, including Regulation (EC) No 1223/2009 and sector-specific rules such as Regulation (EC) No 1924/2006 on nutrition and health claims [11]. The truthfulness criterion requires that claims be accurate and not misleading, considering the overall presentation and the reasonable expectations of the average consumer [12]. The evidential support criterion requires that claims be supported by adequate and verifiable evidence, with the level of evidence proportionate to the type of claim [123]. The honesty criterion requires that claims present information objectively and not exaggerate or create unrealistic expectations [14]. The fairness criterion requires that claims be fair and not denigrate competitors or their products [15]. The informed decision-making criterion requires that claims enable consumers to make informed choices and not exploit their lack of knowledge [16].

The Technical Document on Cosmetic Claims, published by the Commission in July 2017, provides detailed guidance on applying these criteria to specific claim types [17]. The document addresses “free-from” claims, which are prevalent in “clean beauty” marketing, stating that such claims should only be used when the absence of the substance provides a real benefit to the consumer or when the substance is widely expected to be present [18]. 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 [19].

For example, a claim such as “paraben-free” may be misleading if it implies that parabens are unsafe, given that the SCCS has concluded that certain parabens are safe at specified concentrations and they remain permitted under Regulation (EC) No 1223/2009 [20]. Similarly, claims such as “free from harmful chemicals” or “non-toxic” may be misleading because they suggest that competing products contain harmful or toxic substances, which would contradict the Article 3 requirement that all cosmetic products placed on the market be safe for human health [21]. Such claims may also violate the fairness criterion by denigrating competitors and the honesty criterion by creating unrealistic expectations that the product is inherently safer than alternatives [22].

Article 25 of Regulation (EC) No 1223/2009 empowers competent authorities to take measures to prohibit or restrict the making available on the market of products that do not comply with the regulation, including products bearing non-compliant claims [23]. National enforcement authorities increasingly scrutinized “clean beauty” claims during 2022, with several Member States issuing guidance or taking enforcement action against brands making unsubstantiated or misleading claims [24]. The Administrative Cooperation (AdCo) group facilitated information exchange regarding non-compliant claims, and coordinated enforcement actions were undertaken in some cases [25].

Toxicological and Safety Science Considerations

From a toxicological perspective, “clean beauty” claims often reflect a fundamental misunderstanding of the hazard-versus-risk paradigm that underpins modern safety assessment [26]. The presence of a substance with inherent hazard properties (e.g., skin sensitization potential, endocrine activity) does not automatically render a product unsafe; rather, safety depends on the exposure level and the margin of safety between the exposure level and the threshold for adverse effects [27]. The SCCS Notes of Guidance (10th Revision, SCCS/1602/18) emphasize that “the safety assessment should be based on the risk, not the hazard” and that “the presence of a hazardous substance in a cosmetic product does not necessarily mean that the product is unsafe” [28].

Many ingredients commonly excluded from “clean beauty” formulations have been extensively evaluated by the SCCS and found to be safe at specified concentrations [29]. For example, parabens (methyl- and ethylparaben) are safe at concentrations up to 0.4% (as acid) for individual esters and 0.8% for mixtures, based on comprehensive toxicological data including dermal absorption, repeated-dose toxicity, reproductive toxicity, and endocrine activity studies [30]. Sulfates (sodium lauryl sulfate, sodium laureth sulfate) are safe as cleansing agents at concentrations typically used in cosmetics, despite their potential to cause mild skin irritation at high concentrations or with prolonged exposure [31]. Phthalates, which are often cited in “clean beauty” exclusion lists, are already prohibited in cosmetics under Annex II of Regulation (EC) No 1223/2009, rendering “phthalate-free” claims redundant and potentially misleading [32].

Conversely, “natural” or “botanical” ingredients, which are often favored in “clean beauty” formulations, are not inherently safer than synthetic ingredients and may present unique safety challenges [33]. Natural ingredients are complex mixtures containing multiple chemical constituents, some of which may be allergens, irritants, or phototoxins [34]. Essential oils, for example, contain numerous fragrance allergens regulated under Annex III of Regulation (EC) No 1223/2009, and their use in cosmetics requires careful safety assessment and labelling [35]. Plant extracts may contain pesticide residues, heavy metals, or microbial contaminants, necessitating rigorous quality control and safety testing [36].

The SCCS has issued several opinions highlighting safety concerns with natural ingredients. For example, SCCS/1459/11 on Methylisothiazolinone (MI) noted that this preservative, often used in “natural” formulations as an alternative to parabens, is a potent skin sensitizer and should be restricted to rinse-off products at concentrations not exceeding 0.0015% [37]. SCCS/1564/15 on hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC), a fragrance ingredient, concluded that it should be prohibited due to high sensitization rates, despite its natural occurrence in some essential oils [38].

The toxicological principle of “dose makes the poison,” articulated by Paracelsus in the 16th century, remains fundamental to modern safety assessment [39]. All substances, whether natural or synthetic, can cause adverse effects at sufficiently high doses, and safety depends on ensuring that exposure levels remain below thresholds for toxicity [40]. “Clean beauty” claims that imply categorical safety based on ingredient origin (natural vs. synthetic) or presence/absence of specific substances misrepresent this fundamental principle and may mislead consumers into believing that “clean” products are inherently safer, regardless of formulation or exposure [41].

Practical Compliance Guidance

For Responsible Persons, ensuring compliance with Article 20 and Commission Regulation (EU) No 655/2013 when using “clean beauty” or related claims requires rigorous substantiation and careful claim wording. First, brands should establish clear, science-based definitions of “clean” or similar terms used in marketing, and ensure that these definitions are consistently applied across all products and communications [42]. The definition should be based on objective criteria (e.g., specific ingredient exclusions, sourcing standards, sustainability metrics) rather than subjective or aspirational concepts [43].

Second, “free-from” claims should be used judiciously and only when the absence of the substance provides a genuine benefit or addresses a legitimate consumer concern [44]. Claims should not imply that the presence of the substance would be harmful, illegal, or inconsistent with safety [45]. For example, “paraben-free” claims should be accompanied by context explaining that the product uses alternative preservation systems, rather than implying that parabens are unsafe [46]. Claims such as “free from harmful chemicals” or “non-toxic” should be avoided, as they are inherently misleading and violate the fairness and honesty criteria [47].

Third, all claims must be supported by adequate and verifiable evidence, as required by the evidential support criterion [48]. For safety-related claims (e.g., “gentle,” “hypoallergenic,” “dermatologically tested”), the Technical Document on Cosmetic Claims specifies that evidence should include appropriate testing, such as patch testing, repeat insult patch testing (RIPT), or clinical studies demonstrating tolerability [49]. For environmental or sustainability claims (e.g., “eco-friendly,” “sustainable,” “carbon-neutral”), evidence should include life-cycle assessment data, third-party certifications, or other objective metrics [50].

Fourth, Responsible Persons should ensure that marketing materials, including websites, social media, and product packaging, present claims in a balanced and objective manner that does not denigrate competitors or create unjustified concerns about the safety of other products [51]. Article 20 and the fairness criterion prohibit comparative claims that disparage competitors, and enforcement authorities may take action against brands whose marketing implies that competing products are unsafe or inferior [52].

Fifth, internal compliance review processes should include evaluation of all claims against the six common criteria established in Commission Regulation (EU) No 655/2013 [53]. This review should be documented in the Product Information File under Article 11, demonstrating that the Responsible Person has assessed claim compliance and possesses substantiating evidence [54]. If enforcement authorities request information under Article 21, the Responsible Person must be able to provide documentation supporting all claims [55].

Sixth, Responsible Persons should monitor enforcement trends and guidance issued by national competent authorities and the AdCo group [56]. Several Member States, including France, Germany, and the Netherlands, have issued guidance on “free-from” and “clean beauty” claims, and enforcement priorities may vary across jurisdictions [57]. Proactive engagement with enforcement authorities, including pre-market consultation where available, can reduce compliance risk and provide clarity regarding acceptable claim wording [58].

Conclusion

The growing regulatory scrutiny of “clean beauty” claims during 2022 reflected enforcement authorities’ concerns that such claims may mislead consumers, undermine confidence in the safety of cosmetic products, and contradict the science-based regulatory framework established by Regulation (EC) No 1223/2009. Article 20 and Commission Regulation (EU) No 655/2013 require that all claims be truthful, evidenced, honest, fair, and enable informed decision-making. “Free-from” claims and safety-related claims must be carefully substantiated and worded to avoid implying that the presence of excluded substances would be harmful or that “clean” products are inherently safer than alternatives. Responsible Persons must implement rigorous claims review processes, maintain comprehensive substantiation documentation, and monitor enforcement trends to ensure compliance and reduce regulatory risk. As consumer demand for transparency and sustainability continues to grow, the cosmetic industry must balance marketing innovation with adherence to evidence-based safety principles and regulatory requirements.

References

[1] Commission Regulation (EU) No 655/2013.

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[4] Commission Regulation (EU) No 655/2013.

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