As the market grows both in Europe and the UK for CBD food based products it has become increasingly important for producers to understand the complexities of the law and regulations governing the production and processing of hemp based CBD food commodities and the Novel food status of CBD in the EU

Novel Food regulations are probably the least understood rules that currently influence the CBD market  throughout the region.

In the EU the European Food Safety Authority (EFSA) is the governing body in relation to novel food and in the  UK it is the Food Standards Agency (FSA)

 

What Does Novel Food Mean ?

All products not consumed as a food in significant quantities inside the EU before 1996 are considered a ‘novel food’. To place a novel food on the EU market for consumption, pre-market authorisation must be obtained from the relevant authority.

 

 

An application must be made and then be validated by the European Commission, and processed by the EFSA. Part of the application by the producer is to prove that the product is safe for human consumption.

Post Brexit the same applies in the UK with the Food Standards Agency

Historical Perspective For Hemp & Hemp Based CBD Products

Hemp products containing CBD were not  considered a novel food before 2017, as long as the ‘cannabinoid levels did not exceed that of the source.

In January 2019, a new entry was placed in the Novel Food Catalogue, 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.

 

Lists products of plant and animal origin and other substances subject to the Novel Food Regulation, after EU countries and the Commission agree in the Novel Food Working Group. It is non-exhaustive, and serves as orientation on whether a product will need authorisation under the Novel Food Regulation.

 

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 with little harmony on a European level, as the new ruling was so poorly written many saw  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  subsequently court cases ensued.

 

Is It Proven that CBD Is 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). In the following document

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

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.

The UK

The FSA has given a March 31 2021 deadline for all applications relating to all CBD products including food based commodities and write in their latest guidance dated 11 March 2021 about Novel food status of CBD in the UK

 

 

 

 

The content of any application for CBD products should follow the usual application for novel foods.

An important part of any application will be a consideration of the product’s safety. Applicants will need to include details of the toxicological studies they have undertaken, or propose to undertake with clear details of the reasoning for these particular tests. Where all information isn’t available at the time of submission, a justification for the delay and when results will be available must also be included. Without such information it is unlikely we will be able to validate an application.

Meeting the validation standard does not mean the product will necessarily be authorised. Each application will be considered on its own merits, but with so little publicly available information on the safety of CBD we anticipate that directly relevant studies will be needed. Applications will be progressed and potentially authorised only if this directly relevant safety information is included.

Deadline for businesses to submit CBD applications to continue to sell existing products in the UK

Businesses need to submit novel food authorisation applications by 31 March 2021.

After this date, only products which were on the market at the time of our announcement on CBD (13 February 2020) and for which the FSA has received an application which is subsequently validated will be allowed to remain on the market.

We have advised local authorities that businesses can continue to sell their existing CBD products during this time, provided they:

  • are not incorrectly labelled
  • are not unsafe
  • do not contain substances that fall under drugs legislation

However, no new CBD extracts or isolates, including new brands, should be sold until they have the necessary authorisation. A validated application is not sufficient to put new products on the market.

The deadline applies in England and Wales. Novel foods regulations in Scotland are covered by Food Standards Scotland.  

 

European Court of Justice Rulings

The ECJ has recently ruled on a number of CBD cases brought before it

In November 2020, by the ECJ in Case C-663/18, with the words the court ruled  ‘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
http://curia.europa.eu/juris/document/document.jsf?text=&docid=233925&pageIndex=0&doclang=EN&mode=req&dir=&occ=first&part=1&cid=14674252

Press release
https://curia.europa.eu/jcms/upload/docs/application/pdf/2020-11/cp200141en.pdf

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

It  is expected the European Commission to start validation applications again, for the EFSA to process.

 

Can Business Continue To Sell Food Product 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.

The EIHA – Novel Food Consortium

Protecting clients against novel food regulations?

The EIHA consortium  is paying a total of €3,5 million Europe’s to conduct toxicity studies. These studies will form the basis of the  consortium’s novel food application, that will be submitted both with the EFSA and with the FSA.

Clients will be able to get covered by this application via a licensing system that we have been developed with EIHA projects GmbH (the consortium).