Novel food status of CBD in the EU

Everyone involved in the CBD business is probably aware that CBD and other cannabinoids are classified as a novel food in EU. This was announced by the EU in its so-called “Novel food catalogue”:

But is this really the current situation in the EU? Continue reading and you will see how complex the situation is now. 

Let us start with the basics – what exactly does the term “novel food” mean? 

Novel foods are those which, according to Regulation (EU) 2015/2283, have not been widely consumed by people in the EU prior to May 1997. In other words, foods that do not have a history of consumption. In addition, these foods cannot be placed on the market before authorisation by the European Commission (EC). 

Thus, before placing a CBD product on the EU market, a business operator must submit an application to the EC the product’s authorisation. The application must be prepared in line with the regulatory requirements. The processing of the application is relatively complex and consists of the following steps: 

• The EC usually requests the European Food Safety Authority (EFSA) to carry out a risk assessment.
• The EFSA expresses its opinion on the novel food within 9 months.
• Within 7 months of the EFSA’s opinion, the EC submits a draft implementing act, authorising the placement of the novel food on the market.
• Once the act receives a favourable vote from the Standing Committee and is adopted by the EC, the novel food can be lawfully placed on the EU market.

This sounds complex? Well, it can get even more when CBD is involved. 

In July 2020, the EC gave the following new, and rather unexpected, official preliminary opinion on CBD:

“Although cannabidiols that can be obtained from the Cannabis sativa L plant are not explicitly mentioned in the schedules of the International Drug Control Conventions, they are, in the Commission’s preliminary view, covered by the description of the production method laid out in Schedule I of the Narcotics Convention (i.e., ‘extracts and tinctures of cannabis’). It follows that cannabidiol, when extracted from ‘cannabis’, has to be considered as a substance … that is qualified as ‘drug’ thereunder. Therefore, the Commission has come to the preliminary conclusion that such cannabidiol cannot be regarded as food.”

In other words, the EC’s opinion is that CBD might be classified as a drug and therefore cannot be used in foodstuffs. This is rather odd, as CBD is not psychoactive. Moreover, even the World Health Organisation (WHO) is considering the re-scheduling on cannabis and cannabis-related substances. The WHO recommends that “Preparations containing predominantly cannabidiol and not more than 0.2 per cent of delta-9-tetrahydrocannabinol are not under international control”.   

The Member States will vote on the WHO recommendations given below during the 63rd reconvened session in December 2020: 

 

The positive outcomes of this vote will most probably affect the EC and the preliminary opinion on CBD classification (as a controlled substance) will change. Hence, CBD and other cannabinoids remain classified as novel foods. 

The whole CBD industry, including Pharmahemp, is waiting for the vote in December as we began with the process of novel food authorisation for CBD products over a year ago.  

If you want to get the latest updates on the outcomes of the WHO vote and the status of CBD in the EU and individual countries, follow us and check the forthcoming blogs.