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New ‘novel food’ regulations could impact the availability of CBD products

It was announced yesterday at the Novel Food Commission meeting in Brussels that the European Food Safety Association (EFSA) is reviewing its decision to classify CBD as a novel food. It is thought that a final decision will be made imminently.

In 2015, the first cannabidiol (CBD) product, a CBD vaping device called Kanavape, became easily obtainable online by UK consumers. However, within a year there was a problem. The Medicines and Healthcare Products Regulatory Agency (MHRA) said CBD products, if advertised for medical purposes such as relieving spasms or spasticity, needed to be licensed.

As a result of this ruling CBD oil is now marketed as a ‘food supplement’ rather than a medical product and for the past few years CBD ‘food supplements’ have been available at small specialist health shops, as well as a few major high street retailers.

However, selling CBD as a food supplement recently hit a whole new regulatory problem when in a series of tweets issued at the end of January the UK’s Food Standards Agency (FSA), the government body which makes sure food is safe and is what it says it is, made the following announcement: “There has been a recent change to the EU Novel Food Catalogue which affects some CBD products. Food businesses have not been able to show there was a significant history of consumption of these products in food and food supplements prior to May 1997 in the EU. Under the Novel Food Regulations, foods or food ingredients which do not have a history of consumption need to be evaluated and authorised before they are permitted to be placed on the market.

“We are considering the way forward in light of this clarification at EU level. We are meeting with relevant industry representative bodies, local authorities and other stakeholders to clarify how to achieve compliance in the marketplace in a proportionate manner.”

A product is defined as a novel food if it cannot be shown to have been in long term and safe use before 1997.

Currently, the European Commission’s Working Group of Novel Foods catalogues the term ‘Cannabinoids’ as “…extracts of Cannabis Sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated.”

However, evidence presented at the meeting by the European Industrial Hemp Association (EIHA) shows evidence of hemp and hemp extracts being used as early as 1220 – well before May 1997, ruling out its ‘novel food’ status.

Evidence presented by EIHA indicates that CBD Oils are not novel and should therefore be allowed to remain on shelves. The decision on whether or not to label CBD as ‘novel food’, will go some way to deciding how best to ensure compliance and safety in the marketplace.

EIHA was asked by the European Commission to advise on traditional or novel food status of hemp extracts and said, “Hemp extracts were indeed made and sold in products, which would nowadays be called supplements. We are requesting the European Commission to recognise hemp extracts with naturally occurring CBD levels as traditional in food.”

A spokesperson at CannabiGold, a CBD oil producer and manufacturer added, “Collected evidence clearly demonstrate that hemp leaves, flowers and whole plant hemp extract have a history of use prior to 1997 in Europe and there should be no doubt over their novel status. Allowing the use of hemp extract in food products is perfectly safe and is in the interest of European consumer.”

The safety profile of CBD is well documented and widely accepted. Cannabidiol has been proven safe by The World Health Organisation (WHO) experts on drug dependence in their final Critical review in 2018 acknowledging, “The Committee recommended that preparations considered to be pure CBD should not be scheduled within the international drug control conventions".

"There are no case reports of abuse or dependence relating to the use of pure CBD. No public health problems have been associated with CBD use.”

The World Health Organisation concluded last summer that CBD is “generally well tolerated with a good safety profile,” the spokesperson added.

Nutritionist Fiona Lawson, working in collaboration with CannabiGold says, “We’re living in an age of wellness awareness. People are both interested in maintaining health, and more inclined to choose a natural approach – so the popularity of CBD will no doubt increase”.

Source: MS-UK 13/03/19

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