CBD beauty regulated in the EU
Use of cannabidiol (CBD) - an active compound found in several species of Cannabis sativa L. - in cosmetics is harmonised within the European Cosmetic Regulation 1223/2009, under entry 306 ‘Narcotics, natural and synthetic’ of Annex II, and has been for some time. The regulation prohibits use of cannabis and cannabis extracts in cosmetics, as they are banned substances in Schedule I of the Single Convention on Narcotic Drugs, signed in New York in 1961.
However, cannabidiol (CBD) specifically is not referenced in this convention. And so, amid rising confusion on the matter, at the beginning of this year the European Commission (EC) added two entries to its database of cosmetics ingredients for cannabidiol (CBD) to differentiate between: CBD ‘derived from extract or tincture or resin of cannabis’ and CBD ‘synthetically produced’.
Both entries contain the same text: Cannabidiol (CBD) as such, irrespective of its source, is not listed in the Schedules of the 1961 Single Convention on Narcotic Drugs. However, it shall be prohibited from use in cosmetic products (II/306), if it is prepared as an extract or tincture or resin of Cannabis in accordance with the Single Convention. Please note that national legislations on controlled substances may also apply.
Essentially, use of naturally-derived CBD from cannabis plants is prohibited in the EU but use of hemp-derived or synthetically-produced CBD is allowed. However, the Single Convention’s banned ingredients list does not include cannabis seeds or leaves without tops, meaning use of CBD derived from these parts of the cannabis plant is not currently prohibited.
Hélène Sevestre, regulatory expert at EcoMundo – an international regulatory compliance specialist, said further clarification on the status of CBD products could happen in the coming months, should the Single Convention be updated.
“Cannabis extracts are still under discussion by the WHO Expert Committee on Drug Dependence, which recommended in January 2019 to add a footnote in the Single Convention in order to put cannabidiol preparations out of the scope of the cannabis and cannabis resins entry,” Sevestre told CosmeticsDesign-Europe.
Added complexity: Member States also have national CBD laws
While CBD was technically harmonised under EU regulation and applicable to all Member States, Sevestre said national texts also regulated use of cannabis and its derivatives – creating a more complex regulatory landscape in the region.
For instance, in France CBD preparations had to meet three cumulative conditions: only some varieties of Cannabis sativa L. were allowed; preparations could only be derived from the seed and fibres (use of flowers was banned); and there could be no trace of THC in finished cosmetic products.
By comparison, Sweden only allowed derivatives to come from the seed and subterranean parts of the cannabis plant and THC levels of 0.3% were currently allowed in cosmetics and food supplements.
Switzerland had aligned its regulation with EU rules for CBD in cosmetics – authorising derivatives of seeds and leaves of cannabis without the tops.
“In this way, without a strict regulatory watch or a regulatory accompany, it may be complicated for foreign companies to broach the European market,” Sevestre said.
A closer watch: CBD beauty inspections will increase
As interest in CBD products garnered pace, she said it was also “reasonably predictable” that competent authorities would increase the number of inspections.
Companies, therefore, had to remain aware of regulations in place, and any updates, to avoid legal trouble or products being withdrawn from the market. It would be especially important cosmetic firms ensured raw materials and final THC levels were compliant, she said.
Asked what strategies cosmetics companies could take with CBD use, Sevestre said: “The first milestone is a strict selection of the suppliers and the raw materials” – particularly THC content and what part of the plant extracts came from.
“Then, it’s recommended to make a precise map of the expected markets in order to focus on the national regulations applicable,” she said.
Finally, Sevestre said it was crucial Responsible Persons payed close attention to finished product claims. “CBD-containing cosmetic products must not claim a therapeutic effect. Furthermore, the product must not bring confusion between cannabis and CBD within consumer minds.”
There were numerous experts on the market that could assist with product development and market-entry, she said, which was particularly important should industry have any doubts in the area.
The future of CBD beauty?
Sister site CosmeticsDesign recently covered the regulatory landscape for CBD beauty in the US, speaking to Ronie Schmelz, counsel at Tucker Ellis LLP.
Ellis is one of the speakers at our upcoming free online webinar‘How to Tap into the CBD Trend the Right Way’ - register to secure your place!