CBD Cosmetics Continue to Present Regulatory Uncertainty

Introduction

Cannabidiol (CBD)—a non-psychoactive cannabinoid derived from Cannabis sativa—emerged as a popular cosmetic ingredient during the early 2020s, marketed for purported anti-inflammatory, antioxidant, and skin-soothing properties [1]. However, the regulatory status of CBD in cosmetics remained uncertain throughout 2024, creating significant compliance challenges for manufacturers and Responsible Persons [2]. The primary source of uncertainty stemmed from the classification of CBD under EU novel food regulations (Regulation (EU) 2015/2283), which required pre-market authorization for CBD intended for ingestion, and the question of whether this classification extended to topical cosmetic applications [3]. Additionally, the source of CBD (hemp vs. marijuana), the presence of other cannabinoids (particularly THC), and the potential for psychoactive effects or drug interactions complicated the regulatory analysis [4].

Article 2(1)(a) of Regulation (EC) No 1223/2009 defines a cosmetic product as “any substance or mixture intended to be placed in contact with the external parts of the human body or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours” [5]. This definition excludes products intended to treat or prevent disease, which would be classified as medicinal products under Directive 2001/83/EC [6]. CBD cosmetics marketed with therapeutic claims (e.g., “treats eczema,” “relieves pain,” “reduces inflammation”) risked classification as medicinal products, triggering entirely different regulatory requirements including pre-market authorization and clinical trials [7].

Regulatory Framework and Legal Analysis

The regulatory uncertainty surrounding CBD cosmetics arose from the intersection of multiple legal frameworks. First, Regulation (EU) 2015/2283 on novel foods requires pre-market authorization for foods that were not consumed to a significant degree within the EU before 15 May 1997 [8]. The European Commission’s Novel Food Catalogue listed CBD extracts and isolates as novel foods, requiring authorization before use in food or food supplements [9]. However, the Novel Food Regulation applies only to foods, defined as products intended for ingestion, and does not directly regulate cosmetic products [10].

The question of whether CBD’s novel food status affects its use in cosmetics remained subject to debate [11]. Some Member States took the position that CBD’s novel food classification indicated insufficient safety data for any consumer use, including topical application, and therefore CBD cosmetics should not be permitted until comprehensive safety data were submitted and evaluated [12]. Other Member States distinguished between ingestion and topical use, arguing that the novel food classification was irrelevant to cosmetics and that CBD could be used in cosmetics provided it satisfied the general safety requirement in Article 3 of Regulation (EC) No 1223/2009 [13].

Article 3 requires that cosmetic products be safe for human health when used under normal or reasonably foreseeable conditions of use [14]. Article 10 requires a safety assessment addressing all relevant toxicological endpoints, and the SCCS Notes of Guidance (10th Revision, SCCS/1602/18) specify the data requirements for demonstrating safety [15]. For CBD, the safety assessment must address dermal absorption, systemic exposure, acute and repeated-dose toxicity, skin sensitization, mutagenicity, reproductive toxicity, and potential for drug interactions [16].

The source of CBD is legally significant because Cannabis sativa is subject to drug control regulations [17]. EU law distinguishes between hemp (Cannabis sativa varieties with THC content ≤0.2% or ≤0.3% depending on Member State) and marijuana (Cannabis sativa varieties with higher THC content) [18]. Hemp cultivation is permitted under EU agricultural regulations, and hemp-derived ingredients may be used in cosmetics provided they comply with Regulation (EC) No 1223/2009 [19]. Marijuana cultivation and use remain prohibited under drug control laws, and marijuana-derived ingredients cannot be used in cosmetics [20].

THC (tetrahydrocannabinol), the psychoactive cannabinoid in Cannabis sativa, is listed in Annex II of Regulation (EC) No 1223/2009 as a prohibited substance [21]. Cosmetic products must not contain THC, and CBD extracts must be purified to remove THC to below detectable levels [22]. Analytical verification using gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS) is necessary to confirm THC absence [23].

The cosmetic-medicinal product borderline is particularly relevant for CBD cosmetics because CBD has demonstrated pharmacological activity in preclinical and clinical studies, including anti-inflammatory, analgesic, and anxiolytic effects [24]. Article 2(1)(a) of Regulation (EC) No 1223/2009 specifies that cosmetic products are intended “exclusively or mainly” for cosmetic purposes, and products with significant pharmacological effects may be classified as medicinal products [25]. The European Court of Justice has held that classification depends on the product’s function and presentation, and that products marketed with therapeutic claims are presumed to be medicinal products [26].

Article 20 of Regulation (EC) No 1223/2009 prohibits misleading claims, and Article 20(2) requires that claims comply with common criteria established in Commission Regulation (EU) No 655/2013 [27]. CBD cosmetics marketed with therapeutic claims (e.g., “treats acne,” “relieves pain,” “reduces anxiety”) violate Article 20 and may trigger classification as medicinal products [28]. The Technical Document on Cosmetic Claims emphasizes that cosmetic claims must be limited to cosmetic functions (cleaning, perfuming, changing appearance, protecting, keeping in good condition) and must not suggest treatment or prevention of disease [29].

Toxicological and Safety Science Considerations

The toxicological profile of CBD has been evaluated in several preclinical and clinical studies, primarily in the context of oral administration for therapeutic applications [30]. CBD demonstrates low acute toxicity, with LD50 values in rodents exceeding 1,000 mg/kg body weight [31]. Repeated-dose toxicity studies in rodents and dogs have identified liver enzyme elevations and hepatotoxicity at high doses (≥10 mg/kg/day), but these effects are observed at systemic exposures far exceeding those expected from topical cosmetic use [32].

Dermal absorption is the critical determinant of systemic exposure from cosmetic products [33]. In vitro dermal absorption studies using Franz diffusion cells and human skin demonstrate that CBD, which is lipophilic (log P ≈6) and has a molecular weight of 314 Da, can penetrate the stratum corneum and reach viable epidermis [34]. However, systemic absorption (penetration through the full thickness of skin into the receptor fluid) is limited, typically <5% of the applied dose [35]. The SCCS Notes of Guidance recommend that dermal absorption be measured using validated methods and that the highest value from multiple studies be used for SED calculation [36].

Systemic exposure dosage (SED) calculation for CBD in cosmetics depends on the product type, application area, and CBD concentration [37]. For a leave-on product (e.g., facial serum) containing 1% CBD, applied to the face (approximately 500 cm²) at 2 mg/cm², with 5% dermal absorption, the SED would be approximately 0.008 mg/kg bw/day for a 60 kg adult [38]. For a body lotion containing 0.5% CBD, applied to the whole body (approximately 18,000 cm²) at 2 mg/cm², with 5% dermal absorption, the SED would be approximately 0.3 mg/kg bw/day [39].

Margin of safety (MoS) calculation requires a NOAEL from repeated-dose toxicity studies [40]. The most sensitive endpoint for CBD is hepatotoxicity, with a NOAEL of approximately 10 mg/kg/day in rodent studies [41]. For the facial serum example above (SED = 0.008 mg/kg bw/day), the MoS would be 10 / 0.008 = 1,250, well above the acceptable threshold of 100 [42]. For the body lotion example (SED = 0.3 mg/kg bw/day), the MoS would be 10 / 0.3 = 33, below the acceptable threshold, indicating that the concentration or application area should be reduced [43].

Skin sensitization is an important endpoint for cosmetic ingredients, and CBD has been evaluated in the local lymph node assay (LLNA) and in vitro sensitization assays [44]. Results have been mixed, with some studies reporting negative results and others reporting weak sensitization potential [45]. The SCCS Notes of Guidance recommend a weight-of-evidence approach, integrating results from multiple assays and considering structural alerts and human experience [46]. Human patch testing and repeat insult patch testing (RIPT) provide the most relevant data for assessing sensitization risk under realistic use conditions [47].

Drug interactions are a potential concern for CBD because it inhibits several cytochrome P450 enzymes (particularly CYP3A4 and CYP2C19) involved in drug metabolism [48]. However, these interactions are primarily relevant for oral CBD administration at therapeutic doses (≥100 mg/day), and the low systemic exposure from topical cosmetic use is unlikely to result in clinically significant drug interactions [49]. Nevertheless, the CPSR should address this potential risk, particularly for products intended for use on large body surface areas or by individuals taking medications metabolized by CYP enzymes [50].

Practical Compliance Guidance

For Responsible Persons developing CBD cosmetics, navigating the regulatory uncertainty requires a cautious, evidence-based approach. First, the source of CBD must be verified to ensure it is derived from hemp (Cannabis sativa with THC ≤0.2% or ≤0.3%) and not from marijuana [51]. Suppliers should provide certificates of analysis confirming CBD content and THC absence, and Responsible Persons should conduct independent analytical verification using validated methods [52]. Article 11 requires that the PIF contain information on the source and quality of ingredients, and comprehensive documentation of CBD sourcing and purity is essential [53].

Second, safety assessment under Article 10 must address all relevant toxicological endpoints, with particular emphasis on dermal absorption, systemic exposure, and hepatotoxicity [54]. Part A of the CPSR should include dermal absorption data generated using validated methods (e.g., OECD TG 428), repeated-dose toxicity data from oral studies (recognizing that dermal exposure will be lower), and skin sensitization data from LLNA or in vitro assays [55]. Part B should calculate SED and MoS, ensuring that the MoS exceeds 100 [56]. If the MoS is below 100, the CBD concentration should be reduced, the application area should be limited, or additional safety data should be generated to support a higher NOAEL [57].

Third, claims substantiation under Article 20 and Commission Regulation (EU) No 655/2013 must be carefully managed to avoid therapeutic claims that could trigger medicinal product classification [58]. Acceptable cosmetic claims for CBD include “moisturizing,” “soothing,” “antioxidant,” and “skin-conditioning,” provided these claims are supported by appropriate evidence such as in vitro antioxidant assays or clinical studies demonstrating moisturization or skin barrier improvement [59]. Unacceptable claims include “treats acne,” “relieves pain,” “reduces inflammation,” “treats eczema,” or any claim suggesting treatment or prevention of disease [60]. The Technical Document on Cosmetic Claims provides guidance on acceptable claim types and substantiation requirements [61].

Fourth, CPNP notification under Article 13 must accurately identify CBD in the formulation, using the INCI name “Cannabidiol” [62]. Article 19 labelling must include CBD in the ingredient list, and the Responsible Person’s contact information must be provided to enable consumer inquiries under Article 21 [63]. Given the regulatory uncertainty surrounding CBD, Responsible Persons should be prepared to provide detailed information to consumers and enforcement authorities regarding CBD sourcing, safety assessment, and claims substantiation [64].

Fifth, Responsible Persons should monitor regulatory developments in Member States, as enforcement approaches to CBD cosmetics vary across jurisdictions [65]. Some Member States (e.g., France, Germany) have issued guidance or taken enforcement action against CBD cosmetics, while others have adopted a more permissive approach [66]. The AdCo group has discussed CBD cosmetics, but no EU-wide harmonized position has been established [67]. Proactive engagement with national competent authorities, including pre-market consultation where available, can provide clarity regarding acceptable use and reduce enforcement risk [68].

Sixth, post-market surveillance under Article 4(4) is particularly important for CBD cosmetics given the limited human experience with topical CBD use [69]. Responsible Persons should implement systems to monitor and investigate consumer complaints and adverse event reports, and Article 23 requires reporting of serious undesirable effects to competent authorities [70]. If safety concerns emerge, Article 25 empowers authorities to require withdrawal or recall, and proactive monitoring enables early detection and mitigation of risks [71].

Conclusion

CBD cosmetics continued to present regulatory uncertainty during 2024, arising from the intersection of novel food regulations, drug control laws, and the cosmetic-medicinal product borderline. While CBD can be used in cosmetics provided it satisfies the general safety requirement in Article 3 of Regulation (EC) No 1223/2009, Responsible Persons must navigate complex sourcing requirements, comprehensive safety assessment obligations, and careful claims management to avoid medicinal product classification. The absence of EU-wide harmonized guidance and the variation in Member State enforcement approaches create compliance challenges that necessitate cautious, evidence-based strategies and proactive engagement with regulatory authorities. As scientific understanding of CBD’s safety and efficacy continues to evolve, and as regulatory frameworks adapt to address this novel ingredient, the cosmetic industry must maintain flexibility and commitment to consumer safety while exploring the potential benefits of cannabinoid-based formulations.

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