MAKERS and sellers of CBD (cannabidiol) products should conform to the European Union Novel Food regulations introduced in January 2019.
Under European Union law, food that has not been consumed to a significant degree by humans in the EU before May 15, 1997 – when the first Novel Food classification was introduced – is considered a Novel Food.
There are three routes by which a Novel Food can be approved:
-By showing significant history of use in the EU prior to 1997
-A full application based on submission of a dossier for a Novel Food authorisation.
-Demonstrating the food is a ‘traditional’ one from a third country, where a history of safe food use for at least 25 years can be demonstrated. Examples here include; haskap berries and fonio seeds, traditionally eaten in Japan and West Africa, respectively.
CBD Is ‘Not’ A Novel Food
Wholesale enforcement of the CBD Novel Food rules has barely started, while authorities in the 27 member EU states consider how best to proceed.
But, the Novel Food ruling has opened a wide chasm in the industry.
On one-side are those who say hemp, cannabis and CBD extracts have an established history of use, and on the other, those who contend adhering to the Novel Food benchmark will allow for the creation of well-regulated and compliant CBD market-place.
Three trade groups namely; The Cannabis Trades Association, The European Industrial hemp Association and CannaPro say CBD is not novel.
Some are challenging its designation using an Article 4 route which permits an opportunity to demonstrate the food in question has been used prior to May 1997.
A second challenge is being considered under an Article 5 route which says the ‘EC may decide, on its own initiative or upon a request by a Member State…whether or not a particular food falls within the definition of Novel Food’.
Novel Food Pathway
In the UK the Food Standards Agency (FSA) says it expects all companies wanting to sell CBD products after March 31, 2020, to have an application for a Novel Food authorisation validated by either itself or the European Union.
The FSA has chosen to maintain this alignment with the Novel Food standard as the UK leaves the European Union in January 2021.
Czech Republic firm Cannabis Pharma was one of the first to submit a Novel Food application and it was recently been reported that dozens more have been submitted to the European Union.
Once lodged it could take a further two years for an application to be approved, say industry experts.
Completing a submission to regulators to secure a Novel Food authorisation is also expensive business – with some saying it will cost at least £200,000.
ACI Supports A Well-Regulated Industry
The UK-based Association of the Cannabinoid Industry (ACI) believes the rigorous standards required for a Novel Food authorisation will boost public confidence in the existence of a safe CBD industry.
A Novel Food authorisation will ensure the CBD product in question is safe and stable and capable of being produced in the same manner – batch after batch, after batch.
This could prove to be a significant challenge as whole plant extracts can contain over 100 cannabinoids and ensuring that such a complex combination of compounds are replicated over time could prove an Herculean – and expensive – challenge.
As a result, CBD isolates may well come to dominate the market in the years to come.