September 15, 2023. There is an ongoing call for data on the safety of Cannabidiol (CBD) in cosmetic products. On June 1, 2023, the European Commission invited all interested parties to submit any scientific information about the use of CBD in cosmetics. The consultation will remain open until September 30, 2024. The data collected will be the basis for mandating the Scientific Committee on Consumer Safety (SCCS) to assess the safety of CBD in cosmetics as well as the safe trace level of Tetrahydrocannabinol (THC).
This process aims at harmonising the rules at the EU level on the use of CBD in cosmetic products. Indeed, in recent years, several EU Member States have raised concerns about the potential risk of CBD for consumers’ health and, at the moment, there are some national discrepancies.
CBD vs THC
Cannabidiol (CBD) is a non-psychoactive cannabinoid (compound of the Cannabis plant), and it can be extracted from different parts of the plant or synthetically manufactured. Its use in cosmetic products has increased in recent years due to its popularity and properties. CBD is found to have the following functions: sebum controlling, antioxidant and anti-inflammatory.
Conversely, Tetrahydrocannabinol (THC) is a compound of Cannabis with psychotropic effects. In the European Union, Regulation (EU) 2021/2115 establishes that the maximum allowed content of THC in hemp is 0.3%.
The regulatory framework and latest development
Annex II to the EU Cosmetics Regulation lists the substances prohibited in cosmetic products. Entry 306 bans “narcotics, natural and synthetic: all substances listed in Tables I and II of the Single Convention on Narcotic Drugs of 1961”. The United Nations Single Convention on Narcotic Drugs of 1961 is an international drug control convention regulating the production, trade, and use of narcotics. In November 2020, the Court of Justice of the European Union provided her interpretation on this point in the Kanavape judgement (ECJ C-663/18). The ECJ concluded that CBD cannot be classified as a narcotic according to the criteria and the spirit of the UN Single Convention. Therefore, natural and synthetic CBD can be used in cosmetic products if it meets the THC limit.
However, national legislation may apply. For example, the Portuguese authority clarifies that only substances obtained from seeds of the Cannabis plant with THC content ≤ 0.2% are allowed in cosmetics.
Furthermore, the Swiss authority found many CBD oils sold as oral care products. In a guide dated December 2022, the Swiss authority noted that these products do not comply with the definition of cosmetic products and there is considerable potential for misuse. Additionally, the authorities did not find a sufficient demonstration of dermal absorption safety in the documentation of the products investigated.
Key concepts for compliance
Do you want to sell cosmetic products containing CBD in the European Union? Below is a list of key concepts you should consider:
- The THC in the CBD must be ≤3% in the raw material. Your supplier shall provide you with a Certificate of Analysis (CoA) with such information.
- Additional national laws might apply: you should investigate those before deciding in where to market your products.
- Your product must fulfil all regulatory requirements for cosmetic products, including having a Responsible Person, a complete Product Information File (PIF), a safety assessment report and a notification to the CPNP.
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References:
- European Commission. (2023). Call for data on ingredients used in cosmetic products. Retrieved on 28/08/2023
- EUR-Lex. (2020). Judgment of the Court in case C-663/18. Retrieved on 28/08/2023
- Infarmed. (2022). Circular Informativa No. 014/CD/100.20.200: Utilização de canábis e seus derivados em produtos cosméticos. Retrieved on 28/08/2023
- MDPI. (2021). Topical Use of Cannabis sativa L. Biochemicals. Retrieved on 28/08/2023
- Swissmedic. (2022). Products containing CBD — Overview and implementation guide. Retrieved on 28/08/2023
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