By Joerg Gruenwald, Co-Founder, analyze & realize GmbH09.08.22
In the EU, cannabis products (i.e., products containing extracts of Cannabis sativa), in general are considered to be narcotics as long as they contain THC (tetrahydrocannabinol)—a psychotropic substance found naturally in most varieties of Cannabis sativa—in amounts exceeding 0.2%. As such, they cannot be marketed as food.
Products made from a varietal of C. sativa, industrial hemp on the other hand, which naturally contains little-to-no THC, can in general be marketed as food products, as long as the THC content is below 0.2%.
As it turned out, the isolated substance CBD came to be considered as a novel food because it was not consumed in the EU before May 1997. This means that it will need to receive a novel food authorization before it can be marketed as food. Currently, more than 150 applications have been received, of which 19 are under risk assessment at the European Food Safety Authority (EFSA). Most applications were submitted for hemp-derived CBD, and some for chemically synthesized CBD.
EFSA has collected the existing literature and, while assessing the applications, it has become clear that data is neither sufficient for any individual product nor for the overall picture. There are gaps in knowledge that need to be addressed before a conclusion on the safety of CBD as a food ingredient can be drawn.
Some of the significant data gaps EFSA pointed out relate to the effects of CBD on human metabolism. Since CBD has a certain bioavailability depending on the matrix used to deliver the CBD, further studies on toxicokinetics are required. Although there is clear evidence of liver toxicity, and no NOAEL (no-observed-adverse-effect level) can be derived from available studies, no further investigations were sought to date. The indications of reproductive toxicity have also not been adequately investigated. Furthermore, the potential interactions with other drugs need to be clarified because of the common metabolic pathway.
As an important point, EFSA emphasized the need for long-term human data and studies with healthy people, rather than patients suffering from epilepsy. EFSA will only be able to conclude on the safety of CBD as a novel food ingredient after the applicants have filled the data gaps. Thus, the situation continues to be in limbo for CBD products.
The novel food catalog specifically states that "some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour, defatted hemp seed have a history of consumption in the EU and therefore are not novel.”
This is the EU level.
In a statement published in July 2021, the German food safety authority BfR concluded that Cannabis itself is psychoactive and thus not allowed in food products. However, seeds from industrial hemp, with its naturally low THC content, are not psychoactive and thus have food status. This is in line with the EU view.
But CBD is regarded as a drug substance in Germany and thus not allowed in food products anyway, regardless of its novel food status.
The fact that national legislation in the various EU member states take precedence while no overarching decisions are made by the EU Commission means that food business operators need to be aware of these differing takes by national authorities before marketing their Cannabis products in the EU.
Views do vary wildly, so food business operators are well-advised to seek the expertise of experienced consultants such as analyze & realize GmbH.
About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100, Fax: +49-30-40008500; e-mail: jgruenwald@a-r.com, www.analyze-realize.com.
Products made from a varietal of C. sativa, industrial hemp on the other hand, which naturally contains little-to-no THC, can in general be marketed as food products, as long as the THC content is below 0.2%.
What About CBD?
So far so good. So, what about one of the main constituents, CBD (cannabidiol)? In November 2020, the European Court of Justice did not classify CBD as a narcotic drug because it has no psychotropic effect. Consequently, it first looked like CBD could be qualified as food, and that products containing the substance could be marketed freely as food in the EU.As it turned out, the isolated substance CBD came to be considered as a novel food because it was not consumed in the EU before May 1997. This means that it will need to receive a novel food authorization before it can be marketed as food. Currently, more than 150 applications have been received, of which 19 are under risk assessment at the European Food Safety Authority (EFSA). Most applications were submitted for hemp-derived CBD, and some for chemically synthesized CBD.
EFSA has collected the existing literature and, while assessing the applications, it has become clear that data is neither sufficient for any individual product nor for the overall picture. There are gaps in knowledge that need to be addressed before a conclusion on the safety of CBD as a food ingredient can be drawn.
EFSA: More Research Needed
In a statement, EFSA outlined several data gaps and uncertainties regarding the safety assessment of CBD. The studies submitted were often not conducted with the specific product, but were carried out with Epidyolex (Epidiolex in the U.S.), a CBD drug authorized to treat epilepsy.Some of the significant data gaps EFSA pointed out relate to the effects of CBD on human metabolism. Since CBD has a certain bioavailability depending on the matrix used to deliver the CBD, further studies on toxicokinetics are required. Although there is clear evidence of liver toxicity, and no NOAEL (no-observed-adverse-effect level) can be derived from available studies, no further investigations were sought to date. The indications of reproductive toxicity have also not been adequately investigated. Furthermore, the potential interactions with other drugs need to be clarified because of the common metabolic pathway.
As an important point, EFSA emphasized the need for long-term human data and studies with healthy people, rather than patients suffering from epilepsy. EFSA will only be able to conclude on the safety of CBD as a novel food ingredient after the applicants have filled the data gaps. Thus, the situation continues to be in limbo for CBD products.
Hemp Seeds and Flour Are Not Novel Foods
It is important to note that hemp seed oils and flour derived from hemp seeds do not encounter any novel food issue, as they were consumed in the EU before 1997. They are therefore free to use in food products, provided they do not contain critical amounts of THC (0.2 %), e.g. from contamination by leaves or flowers.The novel food catalog specifically states that "some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour, defatted hemp seed have a history of consumption in the EU and therefore are not novel.”
This is the EU level.
Member States Weigh In
Then there are the individual member states, which have enough authority in the matter to make things even more confusing.In a statement published in July 2021, the German food safety authority BfR concluded that Cannabis itself is psychoactive and thus not allowed in food products. However, seeds from industrial hemp, with its naturally low THC content, are not psychoactive and thus have food status. This is in line with the EU view.
But CBD is regarded as a drug substance in Germany and thus not allowed in food products anyway, regardless of its novel food status.
The fact that national legislation in the various EU member states take precedence while no overarching decisions are made by the EU Commission means that food business operators need to be aware of these differing takes by national authorities before marketing their Cannabis products in the EU.
Views do vary wildly, so food business operators are well-advised to seek the expertise of experienced consultants such as analyze & realize GmbH.
About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100, Fax: +49-30-40008500; e-mail: jgruenwald@a-r.com, www.analyze-realize.com.
