NOVEL FOOD GUIDELINES AND CBD (CANNABIDIOL)
Novel Food regulations are probably the least understood rules that influence the CBD market.
In this article we will share the most relevant information as far as it relates to the CBD industry and selling CBD as a food supplement in the EU and United Kingdom.
In the EU the European Food Safety Authority (EFSA) is the governing body in relation to novel food. In the UK it is the Food Standards Agency (FSA)
Why do novel food guidelines exist?
To protect European consumers against foodstuffs that are not (yet) proven safe.
How do novel food guidelines protect consumers?
In principle, every food that was not consumed as a food in significant quantities inside the EU before 1996, is considered a ‘novel food’. To place a novel food on the EU market, pre-market authorisation must be obtained. An application must be made, this application must be validated by the European Commission, and processed by the EFSA. Part of the application is proving that the product is safe for human consumption.
Historical Perspective
Hemp products containing CBD were not a novel food before 2017, as long as the ‘cannabinoid levels do not exceed that of the source, Cannabis Sativa L’.
In January 2019, a new entry was placed in the Novel Food Catalog, suggesting that all products containing CBD could be novel foods. This listing contradicted the earlier listing in a way that was not possible by the definitions of the guidelines itself.
This left the market with a lot of worry and doubt: what is a novel food and what isn’t? Member states started to act without much harmony on a European level, as the new entry was so poorly written that it was open to wide interpretation. Most member states chose to ignore the new listing completely.
Germany interpreted the rules literally, although it’s regions differed significantly in their approach. Several large CBD companies had products seized and court cases ensued.
Are Full Spectrum Extracts Novel Food – German Government BVL & BMEL (March 2020)
TOXICOLOGY STUDIES
The most important part of a novel food application is the toxicology study. This is the study that proves the product is safe for human consumption.
Are there any successful novel food applications for CBD to date?
As we write this article, only novel food applications for synthetic CBD have been accepted.
https://open.efsa.europa.eu/questions/
IS CBD SAFE FOR HUMAN CONSUMPTION?
Scientifically, it has been clear for quite some time now that CBD is safe for human consumption (as stated for instance by the WHO).
https://www.who.int/medicines/access/controlled-substances/5.2_CBD.pdf
According to the WHO, “CBD is generally well tolerated with a good safety profile. Reported adverse effects may be as a result of drug-drug interactions between CBD and patients’ existing medications.”
THE EUROPEAN COMMISSION
The resistance to a normal treatment of CBD products can be found to originate mostly from the European Commission. This European body is where lobby groups focus most of their efforts. Until now, the Commission has proven less than willing to engage with the CBD industry in a productive way.
This has resulted in a strange sequence of events, where first (before 2017) hemp products were not a novel food as long as they did not exceed the CBD levels of the plant.
Then, suddenly, all CBD products could be deemed as novel in food.
EFSA has not yet developed Guidance for CBD supplements. In order to sell a product on the EU market, an application dossier must be first authorised by the European Commission, as set out by Regulation EU 2015/2283.
IS CBD A NARCOTIC?
After this, with yet another sudden and scientifically incomprehensible move, the commission communicated the opinion that CBD, if produced from hemp, is to be considered a narcotic and therefore can never be (novel) food. This was based on an obvious misinterpretation of the 1961 single convention on narcotic drugs.
EUROPEAN COURT OF JUSTICE RULING
This nonsensical argument was struck down, quite unexpectedly in November 2020, by the ECJ in Case C-663/18, with the words ‘CBD (…) cannot be regarded as a narcotic drug’.
In light of the comments received from applicants and of the recent Court’s judgment in case C-663/184, the Commission has reviewed its preliminary assessment and concludes that cannabidiol should not be considered as drug within the meaning of the United Nations Single Convention on Narcotic Drugs of 1961 in so far as it does not have psychotropic effect. As a consequence, cannabidiol can be qualified as food, provided that also the other conditions of Article 2 of Regulation (EC) No178/2002 are met.
Later in this ruling, the ECJ goes even further to state that: ‘CBD at issue does not appear to have any psychotropic effect or any harmful effect on human health’.
Court Ruling
Court Ruling Documents
Press release
Press Release
With this strong statement, the ECJ has overruled the European Commission, and provided some much needed clarity regarding the classification of CBD products on the EU market.
NOVEL FOOD APPLICATIONS
Currently we expect the European Commission to start validation applications again, for the EFSA to process.
While writing this on 4 January, this has not happened yet.
What about Brexit and Novel Food Applications?
Brexit has a consequence for novel food applications in the UK. Since January 1st 2021, the FSA has gained competence, and the EFSA no longer decides on related matters inside the UK.
The FSA (the UK counterpart of the EFSA) has always maintained that CBD can not be regarded as a narcotic, and therefore they will start accepting novel food applications.
The FSA has indicated they will clarify the requirements around toxicology, and are expected to communicate these requirements before the end of January 2021.
HOW CAN YOUR BUSINESS CONTINUE TO SELL CBD LEGALLY?
CBD products will soon split into those that are considered novel foods, and those that are not. Traditional products (where no purification / isolation has been performed) do not fall under the scope of the novel food guidelines.
For instance, a freeze dried hemp powder containing CBD is not a novel food, because it has not been purified or isolated. On the other hand, any product made with CBD isolate will be considered a novel food.
Where exactly the dividing line is, will become clear in the courts of the EU, with at least one hopeful fact being that the ECJ seems to take a clear, scientifically accurate line of reasoning, protecting honest operators in this nascent industry.
All in all, 2021 is expected to be another booming year for the sector as a whole.
EIHA – NOVEL FOOD CONSORTIUM
How do we protect our clients against novel food regulations?
We are part of the EIHA consortium that is paying a total of €3,5 million Europe’s to conduct toxicity studies. These studies will form the basis of our consortium’s novel food application, that will be submitted both with the EFSA and with the FSA.
Our clients will be able to get covered by this application via a licensing system that we have developed with EIHA projects GmbH (the consortium).
You can read older articles on Novel food below:
Novel Foods – Cannabidiol, Cannabinoids & Hemp Extracts Debate
