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EFSA stalls CBD novel food evaluation citing ‘several hazards’

Data gaps and uncertainties surrounding the potential risks associated with the consumption of cannabidiol (CBD) have stalled EFSA’s certification of CBD as a novel food. “We have identified several hazards related to CBD intake,” says one EFSA scientist.

Sourced from Cannabis sativa L. plants, CBD has recorded phenomenal growth in popularity over recent years, hailed for its anti-inflammatory properties and ability to ease sensations of pain, anxiety, and insomnia.

Boasting a projected compound annual growth rate (CAGR) of almost 37%, the global CBD market will soar to a value of over $56.2 billion in 2028, a report by Global Market Insights predicts.

EFSA: Data on CBD effects on human health is ‘insufficient’

However, as a relatively nascent product on the global food market, there is currently limited and insufficient data available regarding the impacts of CBD on human health and wellbeing. According to the European Food Safety Authority (EFSA), the effects of CBD consumption on the liver, gastrointestinal tract, endocrine system, nervous system and on people’s psychological well-being are yet to be fully determined.

Additionally, following animal trials, questions have been raised concerning the potential adverse effects of CBD intake on reproduction, EFSA said. It is yet to be determined whether these same effects are observed in humans. Therefore, it decided to pause evaluations on the product’s safety, pending new data.

“We have identified several hazards related to CBD intake and determined that the many data gaps on these health effects need filling before these evaluations can go ahead. It is important to stress at this point that we have not concluded that CBD is unsafe as food,” chair of the NDA Panel, Professor Dominique Turck said.

EFSA’s recent decision could hinder CBD market growth

Despite its growing popularity in food and drink products, CBD is yet to be certified as safe for human consumption by a handful of the world’s leading food regulators, including EFSA and the US Food & Drug Administration (FDA).

The latest decision from EFSA’s expert Panel on Nutrition, Novel Foods and Food Allergens (NDA) to halt evaluations of CBD as a novel food may put a spanner in the works when it comes to achieving the sector’s projected levels of market capitalisation.

In order to qualify as a novel food in Europe, CBD must meet the European Commission’s (EC) conditions of EU legislation on novel foods. The panel has until now received 19 applications for CBD as a novel food, and currently awaits a final ruling from EFSA as to whether the product is safe for human consumption.

What are the next steps for applicants?  

While not uncommon, halting the assessment of novel foods can be frustrating and can cause significant setbacks to those who are awaiting decisions on application submissions.

In cases where information is seen to be missing, EFSA communicates with applicants in order to aid them in identifying what is needed and addressing these additional requirements, Ana Afonso, head of nutrition and food innovation at EFSA said.

In addition, EFSA has announced that it will be hosting an info-session for those who are keen to learn more about novel food regulations later this month. Special attention will be given to the NDA Panel’s statement on the uses of cannabidiol (CBD) as a novel food, and applicant and stakeholder queries will be addressed.

The session will take place on 28 June and is accessible online via the EFSA registration link.

To place a novel food on the EU market, food manufacturers must undergo a three-step authorisation process, spearheaded by the EC. First, an application for the authorisation of the novel food should be processed, followed by the adoption of an implementing act that authorises its placing on the market, and concluding with the updating of the EU list of novel foods.