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EFSA puts CBD novel food approval on hold due to data gaps: ‘We have identified several hazards’

The European food safety body cited ‘data gaps’ and ‘uncertainties’ about potential hazards related to CBD intake.

Cannabidiol is a substance that can be obtained from Cannabis sativa L. plants or produced via chemical synthesis.

The European Commission considers that CBD qualifies as a novel food, provided it meets the conditions of EU legislation on novel foods. Following the submission of ‘numerous applications’ for CBD under the novel food regulation, the Commission asked EFSA to give its opinion on whether CBD consumption is safe for humans.

EFSA’s expert Panel on Nutrition, Novel Foods and Food Allergens (NDA) has received 19 applications for CBD as a novel food, with more in the pipeline. However, the panel revealed today that data gaps need to be addressed before further evaluations can be completed.

“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,”​ said Chair of the NDA Panel, Prof. Dominique Turck.

Insufficient data doesn’t mean its dangerous 

However, Prof. Turck stressed, EFSA has not come to the conclusion that CBD consumption is dangerous. “It is important to stress at this point that we have not concluded that CBD is unsafe as food,”​ the food safety expert stressed.

EU food law requires decision makers to apply the precautionary principle where available supporting information and data are not sufficiently complete to enable a comprehensive risk assessment to be made.

According to EFSA, what were the limitations of the currently available data?

EFSA experts noted insufficient data on the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and on people’s psychological well-being.

“Studies in animals show significant adverse effects especially in relation to reproduction. It is important to determine if these effects are also seen in humans,”​ EFSA said.

Other data gaps identified were that animal studies were performed with non-chemically pure CBD, which may misrepresent or obscure the true effects of CBD. Several human studies were performed with patients that were, at the same time, receiving treatment with other medications and with high therapeutic doses that may have affected the data. And no observed adverse effect level (NOAEL) for CBD could be identified from the reviewed studies.

‘This is very good news’: UK Cannabidiol group 

Responding to the news, the Association for the Cannabinoid Industry (ACI) – the UK’s CBD sector trade body – said the announcement was actually a positive for the CBD sector.

“We are very excited, we think it’s very good news,”​ ACI founder Steve Moore told FoodNavigator.

Regulation has been a grey area for European CBD companies since the sector was given a deadline of 31 March 2021 to submit Novel Food applications for CBD products on the market. This meant CBD products already on sale needed to apply for novel foods authorisation, while a patchwork of national approaches to enforcement meant that manufacturers who haven’t submitted their dossiers can still be found on some European shelves.

Post-Brexit, the UK has taken a different approach, raising hopes it will be at the vanguard of CBD innovation and investment after the country’s Foods Standards Agency created a list of more than 3,500 food products permitted for sale to consumers. These products will now go on to be assessed by the FSA for safety before being placed on the market, expected in 2023.

The latest EFSA announcement could actually signal that the approach taken by European regulators is starting to align with the UK’s food safety authorities, ACI Regulatory and Compliance Lead Parveen Bhatarah told us.

“They are finally coming around to agreeing with us on the data that is needed to establish the safety [of CBD],”​ she said. Bhatarah pointed to the necessity to have safe dosage data in particular. “We have an answer to that,” ​she said pointing to the work the ACI has done preparing its application to the FSA. 

“This will open a path to regulatory compliance.”

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