Details
- Status
- Open
- Opening date
- Deadline
Target audience
Any interested parties, including
- academic and other research institutes
- EU countries’ authorities
- manufacturers of cosmetic products
- producers of the ingredient concerned
- relevant industry and consumers associations
Policy fields
Internal market and industry, public health.
Consultation period
From 1 June 2023 to 30 September 2024 (15 months)
Request
The European Commission would like to invite any interested parties, including academic and other research institutes, EU countries’ authorities, manufacturers of cosmetic products, producers of Cannabidiol (CBD) and consumers associations, to submit any scientific information relevant to the safety of Cannabidiol (CBD) (CAS No. 13956-29-1, EC No. 689-176-3) in pure form, as well as an extract that my contain contaminants of other cannabinoids, including trans-Δ⁹- tetrahydrocannabinol (THC or delta-9-THC) (CAS No. 1972-08-3, EC No. 625-153-6), at trace levels.
Action proposed by the Commission
On 19 November 2020, the Court of Justice of the EU (CJEU) delivered a judgment in Case C663/181 in response to the request for preliminary ruling questioning the conformity with EU law of the French legislation prohibiting the marketing of CBD extracted from the Cannabis sativa plant in its entirety. In the judgement, the CJEU concluded that CBD at stake in the main proceedings, should not be considered as a drug under the UN Single Convention on Narcotic Drugs of 1961.
The Court considered that CBD is not mentioned in Convention on Psychotropic Substances and such classification would be contrary to the general spirit of that convention and to its objective of protecting ‘the health and welfare of mankind’. In addition, the Court stated that 1 Case C-663/18, B S and C A, ECLI:EU:C:2020:938 according to the current state of scientific knowledge, unlike THC, the CBD at issue does not appear to have any psychotropic effect or any harmful effect on human health.
However, it is not possible to derive from the judgement the purity level of CBD, or the THC content or the level of other relevant substances. In this respect, it is worth highlighting THC and its stereochemical variants are drugs in their own right according to the 1971 Convention on Psychotropic Substances. The Court in the ruling refers to CBD in general, without any other substances included in it, except for impurities. Since the CBD substance is defined and, according to the current state of scientific knowledge, considered as not having psychotropic effect, the presence of THC in CBD may only be residual.
EU Member States and civil society organisations have raised questions about the use of CBD in cosmetic products and the potential risk to consumer’s health due to the very limited available information concerning its safety in such products. The Commission intends, therefore, to request the EU Scientific Committee on Consumer Safety (SCCS) to perform a safety assessment on CBD when used in cosmetic products, as well as on the THC content that could be deemed safe at trace levels in finished cosmetic products that contain CBD or other hemp and cannabis-derived ingredients.
In order to prepare a mandate to the SCCS, interested parties are invited to submit, in accordance with the requirements described below, any scientific information relevant for the safety assessment of CBD and the possible non-intended presence at trace levels of other cannabinoids, including THC.
Requirements
We invite you to submit data on all
- physicochemical properties
- toxicokinetics and toxicological endpoints
- assessment of exposure through consumer products
and/or
- 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.
Please provide your input with
a) The attached template-checklist
b) A table of contents
c) Numbered references
Data submitted should be in line with the SCCS Notes of Guidance (testing of cosmetic ingredients and their safety evaluation - 12th revision).
How to submit your contribution
Any information should be emailed with the reference: "Call for data – CBD" to GROW-COSMETICS-CALLS-FOR-DATA
ec [dot] europa [dot] eu (GROW-COSMETICS-CALLS-FOR-DATA[at]ec[dot]europa[dot]eu) by 30 September 2024 at the latest.