- June 20, 2023
- Posted by: MDSS Cosmetics
- Category: Uncategorized
Call for data on the safety Cannabidiol (CBD) used in cosmetic products
The European Commission published a call for data on the safety Cannabidiol (CBD) in the framework of Regulation (EC) No 1223/2009 with the purpose of obtaining scientific information relevant to the safety assessment of CBD in pure form and as extracts with the particular focus on potential contaminants, including Tetrahydrocannabinol (THC).[1]
The consultation period for submitting data started on 1st June 2023 and will be due until 30th September 2024. The main recipients for this call include academic and other research institutes, EU countries’ authorities, manufacturers of cosmetic products, producers of CBD and consumer associations.
This pro-active approach by the Commission stems on a judgment passed by the Court of Justice of the EU (CJEU) on 19th November 2020 (Case C663/18[2]), concluding that Member States may not prohibit the marketing of CBD lawfully produced in another Member State when it is extracted from the full Cannabis plant and not only from certain parts.
Furthermore, CBD as single substance, unlike THC not appearing to have any psychotropic effect, shall not be considered as a drug under the UN Single Convention on Narcotic Drugs of 1961, mentioning the Cannabis plant in its entirety and not CBD[3]. This Convention is referenced in entry no. 306 of Annex II of the Regulation 1223/2009, indicating that all substances listed in this Convention shall be prohibited for cosmetics.
The CJEU however does not provide in its judgment any specific information on purity levels for CBD – especially regarding THC residues, but also concerning other relevant substances. The Commission explicitly highlights that the judgement refers to CBD in pure while THC and its variants are classified as narcotic drugs in their own right according to the 1971 Convention on Psychotropic Substances[4].
Due to the limited availability of reliable information regarding the safety of CBD in cosmetic products, EU Member States and other organisations expressed their concern about potential risks to human health. The Scientific Committee on Consumer Safety (SCCS) will be therefore requested by the Commission to perform a comprehensive safety assessment on CBD used in cosmetic products, also considering the possible presence of other substances, and a content of THC residue that could be considered safe in cosmetic products.
For preparing the SCCS mandate, interested parties are invited by the Commission to submit scientific information, including physicochemical properties, toxicological endpoints, assessments of exposure through consumer products and indications of the suggested maximum concentration levels for CBD, and maximum trace levels of THC, or any other cannabinoid that might be present as a contaminant.
To ensure compliance, data submissions should follow the 12th revision with the SCCS Notes of Guidance[5].
Overall, this call for data aims to enhance the scientific understanding of CBD used in cosmetic products and to establish appropriate safety standards.
[1] https://single-market-economy.ec.europa.eu/consultations/call-data-ingredients-used-cosmetic-products-0_en
[3] https://www.who.int/medicines/access/controlled-substances/UNSG_letter_ECDD41_recommendations_cannabis_24Jan19.pdf?ua=1
[4] https://polis.osce.org/convention-psychotropic-substances