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CBD Where regulations collide!

Cannabidiol (CBD)...It's the new kid on the block when it comes to functional ingredients but its existence in nature is not new. For over 5000 years we have had one of its most used source materials in our diet and life - that of the plant Cannabis. This dioecious species a member of the Cannabidaeceae family has been found in Chinese burial clothing from as far back as 1200BC and thus it's of no surprise it may be one of the most important botanicals to grace the functional ingredient market place.

Fast forwarding to the modern day, we see that there is huge potential for a bioactive that exists in nature (within Cannabis) but its isolation (natural or synthetic) may now tread the line between food, medicine, drug and safety and free movement laws. These issues are not simply European in perspective but cross the Atlantic with the USA having its own battle to determine what can lawfully be sold. However, for now, let's keep this tied to the European market place (it is only a short blog after all).

With the form of Cannabis as a source material impacting issue around cultivation and legality, we will leave varieties such as indica, ruderalis and vulgaris to one side and focus on the most used source of industrial hemp, that of Cannabis sativa L.

FOOD or MEDICINE?

Hemp cultivation as a food source can be dated to the philosophers Discorides and Galen where fried hemp seeds. Even in the UK we have evidence dating back to 2000BP, based on pollen, shell fragments and microfossil evidence of achanes (Fruit/Seeds). There is also evidence of Hemp oil production in Yorkshire from the 16th Century.

In the EU there is evidence of Hempseed soup, Porridge, Beer, and Desserts that have been consumed well before the 1900s. As such the use of Cannabis as a food source cannot be ignored by regulators. However, the understanding of the bioactive composition of such foods is raising question over safety and classifications as borderline medicines or drugs. The main concerns are with compounds such as Tetrahydrocannabinol (THC) which are psychoactive. There are also specific situations that can result in the conversion of other cannabidiols into THC.

Ignoring traditional history of use for Cannabis sativa, real food use is accepted for hemp in the EU, but in modern day legislation, food must be safe and not a drug or medicine. The result has been a fragmentation of the rules for the legal sale of Cannabis and its derivatives (including CBD).

WHAT IS REQUIRED FOR LEGAL SALE?

Because the rules on cannabis and its extract outside of cultivation have not been harmonised across the EU, then each member state may have its own view on when Cannabis sativa or its derivatives are food legal. They also may state when they believe it may not be food (borderline medicine or drug or psychoactive substance), when its unsafe even as food or novel as no history of consumption (amongst other criteria for such a classification).

As such it is incumbent for every food business to do its due diligence over the source material (plant variety), part of plant used, form of derivative (cold pressed, alcohol extraction, co2 extraction), dose of THC, CBD and other cannabidiol, and its marketing before taking a view its legal for sale as a food.

Whilst there are views from competent authorities on what is a legal food, whats novel and what is medicine or drug but these are conservative view and not based on a case by case basis. Therefore, any proposed ban unless written into law are not effective.

NEXT STEPS

One of the initial challenges to novel foods classification has been a true misunderstanding of the regulation by trade organisation and industry publications. Secondly, its lack of understanding of what makes a product fall into the category of medicine and/or drug (these are not always the same). Most believe this is just down to the level of THC (it's not). Finally, is the incoherence across the industry to put forward an effective defence early in the history of the CDB market. The result could be a possible restriction of the sale of Cannabis derived products.

Whilst the challenges of making for sale legal foods for the European market continue the push for innovation and delivering health benefits have to be weighed together. How much is to much risk for food businesses, consumers and competent authorities only time will tell.