Following our previous article on this topic and the recently heightened profile of cannabis food products in the UK, we take a look at the current and expected future regulation of such products, including recent regulatory developments.
Hemp
Food products derived from the hemp plant (Cannabis sativa L.) do not require authorisation under Regulation (EU) 2015/2283 (“Novel Food Regulation”) to be placed on the market in the EU, provided the plant variety is registered in the EU Catalogue of Varieties of Agricultural Plant Species and the tetrahydrocannabinol (“THC”) content does not exceed 0.2% w/w.
Hemp food products can be imported and sold in the UK legally, provided (1) the above EU criteria is met; and (2) the product does not contain more than 1mg of THC, in accordance with the restrictions under the UK Misuse of Drugs legislation.
CBD
However, the position differs where the food product contains cannabinoids such as cannabidiol (“CBD”). Cannabinoids are still considered novel and cannot be placed on the market in the EU without prior authorisation.
Industry finally received a long-awaited response from the Food Standards Authority (“FSA”) on 13 February 2020,[1] following the European Commission’s decision to classify CBD as a novel food over a year ago. Previously, the enforcement approach was unclear, as the FSA simply stated that it “accepts the clarification from the EU that CBD extracts are considered novel foods” and that it is “committed to finding a proportionate way forward by working with local authorities, businesses and consumers to clarify how to achieve compliance in the marketplace in a proportionate manner.”
It seems that a proportionate way forward has now been found.
The FSA has now given the CBD industry a deadline of 31 March 2021 to submit valid novel food authorisation applications. Businesses should be able to continue to sell their existing CBD products during this time provided they are not incorrectly labelled or unsafe to eat and do not contain substances that fall under Misuse of Drugs legislation (i.e. THC). After this deadline, only products which have submitted a valid application will be allowed to remain on the market.[2] It appears that there is be no requirement for the application to have been approved, only that such application has been validly made by the deadline.
Novel food applications
As set out in the Novel Food Regulation, to obtain approval, an applicant would need to either:
- demonstrate a significant history of use of the ingredient as a traditional foodstuff that has been in common usage since before 1997;
- submit a notification for a traditional food from third countries (provided a history of safe use in a third country for at least 25 years can be demonstrated); or
- submit a dossier for the registration of a novel food.
Whilst a new streamlined novel foods application process was implemented in January 2018, an approval is still expected to take at least 9 months.
Recommended intake levels
The FSA has also advised that those who are pregnant, breastfeeding or taking any medication should not to consume CBD products. Healthy adults are advised to “think carefully” before taking CBD, and the FSA recommends no more than 70mg a day (about 28 drops of 5% CBD) unless under medical direction. This new precautionary advice is based on recent findings by the UK Government’s Committee on Toxicity.[3]
Comment
The FSA has taken a strong stance. Industry will now be forced to supply information through novel food applications to reassure the regulator that its CBD products are safe. Whilst it may slow the pace of growth in the market and result in a significant amount of products being taken off shelves, this could also be an opportunity for committed food businesses to demonstrate compliance, position themselves as leaders in the market and drive forward the evidence of product safety that is increasingly in demand from both the industry and the consumer.
[1]https://www.food.gov.uk/news-alerts/news/food-standards-agency-sets-deadline-for-the-cbd-industry-and-provides-safety-advice-to-consumers.
[2]The statement by the FSA applies in England, Wales and Northern Ireland only. Novel food regulation in Scotland is covered by Food Standards Scotland.
[3]https://cot.food.gov.uk/sites/default/files/tox2019-32.pdf.
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