From now on, not only leaf extracts are allowed to be used in cosmetics in the EU, but also natural CBD, the European Industrial Hemp Association (EIHA) informed in their media alert today.
Following the ruling of the European Court of Justice on the Kanavape case in November 2020, which established that CBD, extracted from the entire hemp plant (including leaves and flowers), should not be classified as a drug, the European Industrial Hemp Association (EIHA) kindly asked DG Grow to update the Cosmetic ingredient database (CosIng) accordingly.
More specifically, EIHA requested to lift all bans on Cannabis Sativa L. (restricted under ref. II/306: narcotic) and to integrate new INCI entries. They are pleased to inform you that this request has been granted by including a brand-new entry dedicated to Cannabidiol (CBD) (CANNABIDIOL – derived from extract or tincture or resin of cannabis).
CosIng is the database created by the European Commission to provide information on cosmetics substances and ingredients. The Catalogue serves an informative purpose and has no legal value; however, it serves as a guideline for the Member States and operators, its ultimate purpose being to harmonize the marketing of cosmetic products across Europe.
So far, only the use of synthetic CBD was envisaged in the database.
“These are the types of news that make my day. Thanks to the intensive, yet very rewarding, work of our team and the trust our members put in us, pure CBD (i.e., naturally-derived) and extracts from leaves containing CBD have been secured and can be now marketed in the EU as cosmetic products”, says Ms. Lorenza Romanese, EIHA Managing Director.
“I feel like the legal clarity we are meticulously asking for is about to come. Of course, there is still a long way to go, but it is a good thing that our constant efforts can be measured by tangible results”.
EIHA proposes a three-tier approach
On the 1st of February 2021, the EIHA updated its position paper on CBD, with a summary of the most recent regulatory framework. They are proposing a three-tier approach to regulate different doses and application of CBD.
As they emphasized in their position paper, the various biological and physiological effects of CBD mainly depend on the dose that is taken daily. A pharmacological effect with the consequence of the classification as a functional drug and a correspondingly required approval according to pharmaceutical law is only to be assumed with a recommended daily dose of considerably more than 175 mg CBD.
For different doses and applications of CBD, EIHA proposes a three-tier regulation:
• At high doses, CBD-containing products are considered medicinal products and should be regulated as such.
• At low to medium doses up to 70 mg/d for an adult, irrespective of delivery mechanism (capsules, tinctures, etc.), CBD for oral intake should be regarded as a food supplement. This dual approach is already applied for many substances, such as valerian, glucosamine, products to improve the bacterial flora of the intestine, essential oils, chondroitin (sulfate), Ginkgo Biloba, silymarin, some vitamins, and iron products.
• Low CBD concentrations should be allowed in food products insofar as the recommended daily dose that is far enough from exerting pharmaceutical effects, is not exceeded.
Medium doses without a prescription
EIHA proposes that the products with a high concentration of CBD, for example, a product recommending more than 175 mg orally/day for the average adult may be treated as a medicinal product requiring a prescription. This would apply only to products making the stated dosage recommendations, including any product containing high levels of isolated, pure CBD, and extracts containing high levels of CBD, with a corresponding daily intake.
On the other hand, CBD in medium doses should be available without a prescription. Products with a low to medium CBD concentration and a recommended intake of 10 to 70 mg orally /day for the average adult should be available in retail, drugstores, and pharmacies as food supplements. This would apply only to products making the stated dose recommendations, including any product containing isolated, pure CBD and extracts containing lower levels of CBD. The FSA has pointed out a certain remaining risk for 70 mg/d of CBD4 and advising against its use by young children and pregnant or breastfeeding women and those taking medication (which could interfere with liver metabolism of substances).
As EIHA points out, this is a reference dose, based on the assumptions and current toxicological and pharmacological knowledge, both rapidly evolving. This approach, as proposed, is already in common practice.
Extracts and tinctures should be an exemption
Products – hemp extracts rich in naturally occurring cannabinoids, and tinctures in particular – should preferably be standardized to a certain CBD-concentration. EIHA concludes that these extracts and tinctures should not fall under the novel food framework if not containing higher levels of cannabinoids than in the plant material. This is due to the fact that CBD and other phytocannabinoids are indigenous constituents in hemp food which have been extensively consumed across Europe for over 2,000 years. Numerous clinical studies demonstrate that CBD does not have significant pharmacological activity below 100 mg oral/day for an average adult. These references also highlight, that starting from ca. 20 mg CBD per day to ca. 100 mg CBD exerts physiological effects in the meaning of the European Food Supplement Directive.
EIHA proposes that the THC level in CBD products should be regulated, but not as strictly as for food, because of the much lower daily intake amount of food supplements compared to other food categories. EIHA also urges the industry to not make any unwarranted health claims when advertising and marketing CBD-rich extracts or tinctures as food supplements. Low CBD concentrations (intake 1-10 mg/day for the average adult) should be allowed in food products without any restrictions.