It is well known that Cannabis and its derivatives are widely used in both drugs and food supplements, but the past decade has witnessed a steep spike in its use in cosmetics products especially in skin care products like serums, creams etc. Also, for products like mascaras made with beeswax, cannabis oil seems to be the best vegan alternative available. Let us take a quick look at how different health authorities worldwide regulate its use in cosmetics.
On December 20, 2018, the US Department of Agriculture enforced the Farm Bill which regulates the product of Hemp for commercial purposes. This act removed hemp from the list of controlled substances if THC (Tetrahydrocannabinol) concentration of its derivatives is less than 0.3%. This led to an increased use of CBD in cosmetics thereby claiming therapeutic benefit. US FDA has shared over 50 warnings letters between the duration of 2019-2020 to cosmetic companies manufacturing cosmetics with CBD and labeling therapeutic benefits. According to US FDA, these types of cosmetics can be treated as adulterated or misbranded if cosmetics claim to pose therapeutic effects. The 2018 Farm Bill defined Hemp as “plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3% on a dry weight basis”. Hence, all the derivates of Cannabis, including CBD can be used in cosmetics products provided that their THC concentration is less than 0.3% and the derivatives fall under the definition of Hemp in 2018 Farm Bill.
Labeling of cosmetics containing Cannabis and its derivatives remain as a grey area and hence all cosmetic products must comply with cosmetics labeling guide of the US FDA for labeling of cosmetic products.
Cannabis Act passed by government of Canada defined Cannabis as “any part of a cannabis plant, including the phytocannabinoids produced by, or found in, such a plant, regardless of whether that part has been processed or not, other than a part of plant that includes non-viable seed, mature stalk - without any leaf, flower, seed or branch, fibre derived from a stalk, root or any part of the root of Cannabis plant. Based on this definition, the Health Canada has listed the below mentioned ingredients in the Cosmetic Ingredient Hotlist under the list of ingredients that are prohibited for use in cosmetics.
Cannabis Sativa Flower Extract
Cannabis Sativa Flower/Leaf/Stem Extract
On the other hand, ingredients such as Cannabis sativa seed oil, Hemp seed oil, Hydrolyzed Hemp seed protein are permitted for use in cosmetics with restrictions as “can be used in cosmetics with concentrations less than 10 μg/g THC (delta-9-tetrahydrocannabinol), as per the Industrial Hemp Regulations and must not contain an isolated or concentrated phytocannabinoid or a synthetic duplicate of that phytocannabinoid”.
Like the regulations in Canada, the European Commission also prohibited the use of certain derivatives of Cannabis in cosmetics and legalized use of Industrial Hemp derivatives such as hemp fibre and oil, provided that THC levels are less than 0.2%.
On February 4, 2021, the European Union’s Directorate General has added Cannabidiol (CBD) that is derived from extract or tincture or resin of Cannabis and also the natural derivative of Cannabis to the CosIng database legalizing its use in cosmetic products. Cannabis Sativa Flower Extract and Cannabis Sativa Flower /Leaf/Stem Extract are still listed in Annex II prohibiting its use in cosmetics. However, various derivates of Cannabis Sativa seed, stem, sprout, and leaf are permitted for use in cosmetics.
If you are a manufacturer or importer of cosmetic products containing Cannabis and its derivates, you must know the plant source of the extract, type of extract and the levels of THC. With this information, you can ensure the compliance of your cosmetic formulation before launching your product in the market for commercial purposes. Our skilled team of cosmetic industry experts can help you understand the region-specific regulatory legalities involved and assist in smooth market entry in a timely, compliant, and cost-effective manner.
The author of this blog Dr. Sravya is one of our in-house cosmetic regulatory experts. With hands-on experience in consulting for cosmetic manufacturing companies worldwide, her sharp eye for detail speaks for itself. You can find her on Linkedin.
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