Updated EC ruling for CBD classes supplement ingredient as Novel Food

By Will Chu

- Last updated on GMT

©iStock
©iStock
The European Commission (EC) has reclassified cannabidiol (CBD) as a Novel Food in a change that may mean CBD and hemp-derived food supplements cannot be legally sold within Europe.

Whilst not an official ruling the recently-added submission​,​ specifically by the European Commission's Working Group of Novel Foods, to the Novel Foods catalogue for the term ‘Cannabinoids’ now states, “…extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated.

“This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel.”

The amendment comes as media reports identified the UK, France, Germany, Italy and the Netherlands as the countries asking for an update to the catalogue, citing ambiguity concerning regulation of CBD and other hemp-derived products.

Further news reports suggested the UK’s Food Standards Agency (FSA) now want CBD food products removed from commercial sale while the application to permit its use is finalised.

If successful, producers would be unable to sell products for up to 18 months cutting off supply to consumers.

“We are considering the way forward in light of this clarification at EU level,”​ said the FSA.

“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.”

Final opinion in March

EFSA are currently considering a novel food application for CBD for use in food supplements in adults with a daily intake of up to 130 milligrams (mg).  A final opinion is expected from March 2019.

If EFSA's opinion is positive, the EC will draft an implementing act permitting the use of the product within seven months.

The European Industrial Hemp Association (EIHA), which only last October were asked by the European Commission to advise on traditional or novel food status of hemp extracts, reiterated its position by saying, “Hemp extracts and tinctures were indeed made and sold in products, which would nowadays be “supplements” up to 80 years ago.

“Other evidence shows the use of hemp green parts (flowers, leaves) in applications such as "hemp-beer" brewing and herbal infusions/tea making.

“Hemp flowers used for the production of beer-like beverages have been recognised as food ingredients by the European commission since 1998.”

The Association went on to request that European Union institutions rapidly adopt a policy strategy that would allow Europe to compete on the world stage that shows increasing competitive approaches from Asia, Canada and the US.

“For all these reasons EIHA requests the European Commission to recognise hemp extracts with naturally occurring CBD levels as traditional in food.”

WHO opinion

A World Health Organisation (WHO) report​ published back in June 2018 quoted WHO experts, who stated CBD is generally well tolerated with a good safety profile.

Dr Sarah Brewer, medical nutritionist and health journalist believed the new classification by EFSA was for regulatory/technicality reasons and not for safety reasons.

“Given that there is some uncertainty on the future free availability of CBD supplement, I'd recommend that people who find it beneficial for well-being continue as previously by ordering from a trusted supplier and continuing to take their CBD Oil."

"With all the change taking place there is still a great deal of misunderstanding and misleading information about CBD Oil on the market.

Approved Novel Food Status

Rollo de Sausmarez, director of new product marketing and development at Healthspan, a UK-based mail-order supplier of vitamins, minerals and health supplements said the next steps were to get CBD an Approved Novel Food Status.

“Many things have been deemed safe by passing a safety assessment under the Novel Food Regulation – e.g. Chia seeds, Krill Oil, Vitamin K,”​ he said.

“This process takes about a year, and CBD manufacturers and brands will be pursuing this approach. All over Europe the local food safety authorities will be considering their approach, in each member state and in time will publish their stance. 

"Healthspan will continue to work with relevant bodies such as EFSA, FSA and the CTA (Cannabis Trade Association)."

The EU novel foods legislation refers to any food or ingredient not in widespread use prior to 1997 now needs to undergo an authorisation procedure that demonstrates evidence of its widespread use before 1997 and/or that it is safe for consumption.

Each country has a legal right to have changes made to the Novel Food Register if they can get a majority to agree. In this case, the five initial petitioners, Germany, Italy, France, UK and The Netherlands managed to gain support from 17 member states.

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4 comments

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Please provide factually correct journalism

Posted by Nigel Baldwin,

EFSA does not rule on the regulatory status. The Commission does. Neither does the Agency have a novel food catalogue. For simple understanding to readers. The Commission and Member States regulate, EFSA provides scientific opinions in support of the Commission and member states. Member States enforce locally, with the support of the Commission and EFSA guidance tools etc.

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Dr John Wilkinson Regulatory Consultancy

Posted by Dr John Wilkinson,

We have helped many companies over the years with obtaining history of consumption (HoC) data throughout the EU to support both novel foods approval (e.g Baobab fruit from Africa) and to achieve not novel food status for food ingredients and supplements. But it needs to be done properly, for example, to "weed out" false HoC claims. Failing that there are other ways to regulatory compliance providing safety and consistent quality criteria can be met. The regulators want to see that it is safe and of consistent quality and intake levels properly described. HoC is one way to support the safety requirements of a food. Such data is also used to support both efficacy and safety in the EU for herbal medicine registrations. There are many consumers that are stating that CBD oil is safe, however, the regulators want to see the proof and that is what the industry needs to now come up with.

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cannabinoids and CBD

Posted by Martin,

Its is good that there come proper rules for production but not a novell food rule the way it is described. We manufacture (www.optimacbd.com) according and in a GMP certified factory as one of the view. And not in a warehouse or so like some do. That is the big difference. CBD is prooven safe and has health benefits and is a body own compound. Look also to the studies on www.pubmed.com Hope the EFSA releases it for everybody otherwise it come a illigeal substance. In the mean time the half world wants to legalize cannabis and hemp.

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