Updated EFSA ruling for CBD classes supplement ingredient as Novel Food

The European Food Safety Authority (EFSA) 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 to the Agency’s 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 is successful, the European Commission 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

Approved Novel Food Status.

Rollo de Sausmarez, director of new product marketing and development at Healthspan, a UK-based mailorder 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.