Importing Ingestible’s Products Into The EU

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Depending on the ingredients in your ingestible’s, the products will either be considered/registered as a herbal supplement or a Novel food.  Novel foods are those that do not have a history of consumption before May 1997 and the register largely lists botanical names – see registration link below. So, whether a particular herbal tea or food tincture is a novel food will depend on its botanical origin. Otherwise, herbal teas are to be regulated under food regulations.

 Additionally, Tinctures are herbal ingredients and can be supplied freely to herbal practitioners for example, and used by them. These are advertised as a food supplement. See this link for an example - https://www.baldwins.co.uk/a-vogel-aesculus-horse-chestnut-50ml-tincture 

 My understanding is that you have to treat each case on its merits depending on the ingredients and the claims made for it along these lines https://www.gov.uk/guidance/classifying-herbal-medicines-supplements-tonics

 CBD is listed on the register because it was being sold on the market before 1997. It is not a novel food, therefore, it has to comply with the HFMA regulations.

You can seek specific advice from a specialist organization like HFMA https://www.hfma.co.uk/

Novel foods regulation https://www.food.gov.uk/business-guidance/novel-foods  makes reference to the EU novel foods register and CBD is on it.  


More detail

As I understand it before 15 May 1997 Cannabis sativa was typically supplied as an ingredient made from the whole plant (leaves, flowers, stem) and the CBD content would be that present in the whole plant. Currently, CBD is added to supplements as a CBD extract and the content of CBD in the extract may be higher than the CBD content in the original plant material depending on how much it has been concentrated by removing the solvent used to extract the CBD.  Consequently, there is no history of consuming CBD in ingredients with levels higher than in the whole plant and so these ingredients have to be assessed for safety and registered under the Novel Foods Regulation.

 So, if the CBD content of an extract of CBD to be used as an ingredient in a food product is the same or less than that present in the whole plant used to make the CBD extract then it has a history of consumption and is not regulated under the Novel Foods regulations. If it is higher than it is subject to the Novel Foods Regulation.

 The problem is that you have to know the CBD content of the plant material used to make the extract before you can decide whether the extract is regulated under the Novel Foods Regulations or not. This was discussed at the recent herbal Forum meeting I attended and one of the members has asked the Food Standards Agency (FSA) if they actually have a view on what the CBD level in Cannabis sativa plants is, or if there is a typical concentration of CBD that can be used to decide whether a CBD containing ingredient is a novel food or not. The FSA does not have one. In practice, there are so many Cannabis sativa varieties and they all have different CBD contents that it would be difficult to provide a typical value. So, it looks like each CBD extract has to be taken as an individual case and the manufacturer of the extract will have to determine the CBD content of the original plant material used to extract the CBD for each extract they sell as well as the CBD content of the extract. 

 So, what seems like a simple statement ‘Extracts of Cannabis sativa L in which cannabidiol (CBD) levels are higher than the CBD levels in the source Cannabis sativa L are novel in food.’ Is in practice quite complicated and the information on CBD levels in the plant material used to make the CBD extract may not be routinely available.  For this reason, I recommend you seek legal guidance and guidance from your EU responsible person.




Further reading if interested

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See links below for the laws on all aspects and guidance.

https://www.bromley.gov.uk/leaflet/168221/5/681/d 

http://ec.europa.eu/food/safety/novel_food/catalogue/search/public/index.cfm# 

https://www.baldwins.co.uk/salus-house-organic-anise-fennel-caraway-tea-bags-15-bags.