The Food Standards Agency is reiterating its advice to the CBD industry to submit their novel food applications and move towards compliance with novel food regulations. Companies with suitably validated applications should then be able to continue selling their products in England and Wales until they have been considered by independent scientific committees and a decision on authorisation has been made.
The criteria for products which can remain on sale from 1 April 2021 has been updated. Previously, only products which were on sale at the time of the FSA’s announcement (13 February 2020) and were linked to an application which had been validated by 31 March 2021 were to be included. To maximise the opportunity to pass validation, this now includes all products on sale on 13 February 2020 and linked to an application submitted before 31 March 2021 that is subsequently validated.
Emily Miles, Chief Executive of the Food Standards Agency, said:
‘Applying for novel food authorisation is the only way CBD products can remain on sale here. For the past year, we’ve been encouraging all businesses to submit good quality applications as a matter of urgency.
‘However, we have received a large number of applications close to the deadline. This means that, in order to process these properly, we are adapting the criteria of products allowed to remain on sale from 1 April.
‘For some time now we’ve been supporting a pragmatic and proportionate approach to CBD regulation. Our commitment to ensuring that consumers know these products are being checked for safety remains firm.’
Applications are subject to an 8-day admin check, and it can then take up to 30 working days for an application to be validated. These validated applications will then continue through an authorisation process that undertakes checks on safety to determine whether products can be authorised for sale.
A list of products linked to validated applications will be published on the FSA’s website in April and regularly updated.
The FSA will also publish a list of products associated with applications which have not yet fully met the legal requirements to be validated but have set out sufficiently robust plans to prove they are fully committed to delivering the remaining information required. This will include evidence of plans to complete the risk assessment process, with a clear deadline for submission of the outstanding information.
Validation is not the same as authorisation, and there is no guarantee that a validated application will eventually be authorised – each application must follow the comprehensive risk analysis process.
Local authorities will continue to enforce novel food legislation. We have advised them that only products which were on sale at the time of the FSA’s announcement and are linked to a suitable novel food application submitted before 31 March 2021 should remain on sale from 1 April 2021.
What is CBD?
CBD is a chemical found naturally within the cannabis plant, it has only very recently been removed and sold as a separate CBD extract. CBD extracts can be found in a range of products such as oils, confectionery, bakery products and drinks. At present no CBD products are authorised for food sales.
CBD was confirmed as a novel food product in January 2019. Under the novel food regulations, foods or food ingredients which do not have a history of consumption before May 1997 must be evaluated and authorised by the food safety regulator before they can be placed on the market.
The FSA is responsible for regulating CBD as a novel food. This does not include cosmetics, vapes, products making medicinal claims or products which are regarded as narcotics due to containing controlled substances.
Based on recommendations from the Committee on Toxicity, the FSA advises that, as a precaution, those who are pregnant, breastfeeding or taking any medication do not to consume CBD products. Healthy adults are also 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.
Novel food authorisation
Businesses wishing to sell their products in Britain should submit their novel food applications via the new Regulated Products system which is jointly operated by the Food Standards Agency and Food Standards Scotland.
The Northern Ireland Protocol outlines the EU law that applies in Northern Ireland. This includes novel foods regulations and businesses wishing to sell CBD products in Northern Ireland should continue to submit novel food authorisation applications to the European Commission.
The FSA is the government department with the policy responsibility for food safety in England, Wales and Northern Ireland, however local authorities are responsible for the day to day enforcement of novel food regulations. The FSA issues guidance to support consistency in approach, but ultimately it is for local authorities to make specific enforcement decisions based on the facts of individual cases and circumstances.