European Commission consultation on safety of
CBD in Cosmetics

The European Commission opened a public consultation on the 1st June 2023 as a call for data on the safety of Cannabidiol (CBD) in cosmetic products, within the framework of legislation 1223/2009. The consultation is aimed at CBD in its pure form when used in cosmetics and as an extract that may contain contaminants other than cannabinoids, such as THC (Tetrahydrocannabinol) in trace amounts.

It comes with the Commission’s intention to request the EU Scientific Committee on Consumer Safety (SCCS) perform a safety assessment on CBD in the aforementioned forms.

CBD has been a very popular ingredient in cosmetic products, but since its explosion onto the market, it caused several regulatory issues and debates, from products being marketed for sleep issues and pain relief, both of which are medicinal claims, issues related to the amounts of impurities such as THC or delta-9-THC which are capped across the Union at 0.2% or 0.3% and normally captured within national narcotics laws, and even an attempt in France to ban altogether the use of CBD extracted from the Cannabis sativa plant in its entirety.

The latter was revoked on 19 November 2020, when the Court of Justice of the EU (CJEU) delivered a judgment in Case C663/181 in response to the request for a preliminary ruling questioning the conformity with EU law as CBD was not mentioned in Convention on Psychotropic Substances and did not appear to have any psychotropic effect or any harmful effect on human health.

However, due to the lack of data, member states and various organisations have brought into question the potential risk to consumer health when used long-term.

The invitation to submit data refers to:

  • physicochemical properties
  • toxicokinetics and toxicological endpoints
  • assessment of exposure through consumer products
  • an indication of the suggested safe concentration levels for CBD and safe trace levels of THC, or any other cannabinoid that might be present as a contaminant is such preparations.

As the SCCS will undertake this assessment, CBD and traces of THC could either further be restricted and subsequently listed in Annex III of regulation 1223/2009 or would provide clarity on its safety within specific applications as a cosmetic ingredient.

Currently, the CosIng database lists CBD ingredients (both synthetically produced and extract/tincture/resin from Cannabis – CAS # 13956-29-1) without restrictions of use with the cosmetic functions: antioxidant, anti-sebum, skin conditioning and skin protecting.

The deadline for the public consultation to be finalised is October 1st, 2024 and all parties are invited to submit data with the reference “Call for Data – CBD” to to GROW-COSMETICS-CALLS-FOR-DATA@ec.europa.eu by September 30th 2024 at the latest.

References:

  1. European Commission (Call for data on ingredients used in cosmetic products): https://single-market-economy.ec.europa.eu/consultations/call-data-ingredients-used-cosmetic-products-0_en
  2. HPRA:https://www.hpra.ie/homepage/cosmetics/news-events/item?t=/european-commission-consultation-on-cannabidiol-(cbd)-used-in-cosmetic-products&id=b79b1526-9782-6eee-9b55-ff00008c97d0
Mihai Inceu
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