GRS News

On 1st June 2023, the European Commission opened a consultation call for data on the safety of Cannabidiol (CBD) in the framework of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30th November 2009 on cosmetic products.

 

Until 30th September 2024 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

are invited 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 may 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.

The Commission has classified the type of data required by them where you can submit data on all 

• 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.

Please provide your input with

• a) The attached template checklist – [Click here to get an email of Extracted checklist from the main document]
• 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).

 

Any information should be emailed with the reference: "Call for data – CBD" to GROW-COSMETICS-CALLS-FOR-DATA@ec.europa.eu  by 30th September 2024 at the latest.

 

Our experts and specialists are here to provide complete guidance on launching CBD and CBD-infused cosmetic products. Reach out to our team by sending an email – creme@creme.uk.com or by submitting a web form - https://www.creme.uk.com/contact-us

 

Why is the European Commission looking for this data?

On 19th 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.

 

Find out more details on the

European Commission's website - https://single-market-economy.ec.europa.eu/consultations/call-data-ingredients-used-cosmetic-products-0_en

 

While the EU explores the use of CBD and trials with uncertain regulations, Our team of experts and specialists are here to provide you with complete guidance on launching CBD and CBD-infused products.

Reach out to our team by sending an email – grs@globalregulatoryservices.com or by submitting a web form - https://globalregulatoryservices.com/global-regulatory-services-contact-details