The European Commission has suspended so-called novel food applications for non-synthetic CBD products as it considers whether to label the ingredient as narcotic-related.
Some 50 applications have been paused by the European Commission (EC) as it invites feedback from applicants on its proposal by September. The directive only applies to food items containing naturally-occurring CBD and not synthetically-produced products.
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Novel foods are described by the European Union, and consequently, at present, the UK too, as products that were not widely consumed before 1997 and so have a limited history with regard to safety. Producers are therefore required to submit applications for authorisation under the Novel Foods regulations.
A spokesperson for the EC said its main concerns relate to “CBD extracted from the flowering and fruiting tops of the hemp plant (Cannabis sativa)”. The Commission has “informed the applicants of its preliminary views and invited them to provide comments”, the spokesperson added.
“The Commission must verify whether the individual applications fall within the scope of the Novel Foods Regulation and whether the data requirements are fulfilled. This includes a verification of whether the specific products falls within the definition of food. The Commission will take a decision on the validity of the concerned applications afterwards.”
Meanwhile, a spokesperson for the European Industrial Hemp Association told just-food the “EIHA is currently under intensive lobbying actions” and the organisation has been “extremely busy since this bomb dropped last week”. It will provide an official response next week.
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By GlobalDataCannabidiol, or CBD – a non-high compound that is increasingly being used in food products – has been linked with health benefits such as relieving pain and treating stress and anxiety. But concerns over its use still remain.
The EC spokesperson continued: “Applications for synthetic CBD (not extracted from the plant) can be considered valid and some have already been sent to the European Food Safety Authority for risk assessment. This verification is ongoing as regards to CBD extracted from the hemp plant.”
In the UK, authorities have no plans to label non-synthetic CBD products as narcotics, according to the regulatory body, the Food Standards Agency (FSA). However, until the UK’s departure from the European Union becomes officially binding at the end of the 12-month transition period on 31 December, novel food applications still come under the purview of the EU and the EC.
“Narcotics are overseen by national legislation and the FSA’s view is consistent with the Home Office in that CBD extracts themselves are not considered narcotics,” a spokesperson told just-food. “If a product is classified as a narcotic it would not be subject to novel food regulations.”
The FSA will be formally accepting novel food applications from January 2021, after the transition period ends, the spokesperson said.
However, food products containing THC – the psychoactive compound tetra-hydro cannabinol found in marijuana that gets you ‘high’ – will be restricted.
“Novel food authorisation applications will need to demonstrate that CBD products are not subject to control under the Misuse of Drugs Act 1971. If a CBD product contained THC (or other controlled cannabinoids), then it is highly likely that the product would be controlled,” the FSA spokesperson added.
The EC spokesperson clarified the classifications of the products involved. “The 50 applications correspond to the total number for hemp-derived products, including extractions from the flowering parts but also from other plant parts. The Commission’s preliminary view is that CBD extracted from the flowering and fruiting tops of the hemp plant should be considered as a narcotic falling under the United Nations Single Convention on Narcotic Drugs, 1961.”
The FSA has also provided guidance on its website, and says novel food applications need to be submitted and authorised by 31 March.
“After this date, only products for which the FSA has a valid application will be allowed to remain on the market,” it noted. “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 and do not contain substances that fall under drugs legislation. However, no new CBD extracts or isolates should be sold until they have the necessary authorisation.”
Meanwhile, the UK-based Association for the Cannabinoid Industry (ACI) said the EC proposal would have an effect on the EU market but the FSA’s stance will allow the UK market to thrive.
The ACI projects the UK market could grow to more than GBP1bn (US$1.2bn) after 2025, “which gives any serious players in the CBD industry an opportunity to build a strong and successful business”, according to a spokesperson for the organisation.
“The UK already has a burgeoning CBD industry which shows little sign of slowing down in its growth,” the spokesperson said. “The main concern for UK regulators is proving the safety of products with the work the ACI is doing with our members around toxicology studies and support with novel foods. We believe it is the professional companies in the UK showing a real endeavour to ensure compliance and foster a safe and well-regulated CBD industry which gives our FSA the confidence in this industry.”
