The newest legislation for Novel Foods was laid out in January of 2018 and CBD was classified as novel (meaning that it wasn’t consumed to a significant degree in humans before the 15th of May 1997) in January of 2019. Any CBD product which was on the market before the announcement must have a ‘validated’ application by the 31st of March to remain trading legally, and products sold after must have an approved application to remain on the market. From the 1st of April, any product that fails to meet these criteria is subject to removal by the local trading authority. Since a validated application can take between 1-3 months and an approved application can take anything up to 2 years, it is critical for business that wish to continue trading to begin their application as soon as possible, or to ensure that their chosen supplier is making an application that covers their product.
A dossier of evidence supporting the safety of the proposed foodstuff must be compiled for a Novel Foods application, which includes such things as the production process, product specifications and toxicology information. Some of this will be immediately available, but things like subchronic toxicity (for example) will require specialised testing to be carried out. Once the dossier has been completed and submitted to the European Commission (or FSA in the UK after the 1st January 2021) there will be a 2-3 month period in which they will determine if the application is suitable to be validated. Once validated, the application will be passed to the EFSA who will have 9 months to perform a risk assessment if no further information is required. If the EFSA approves, it is then passed to the European Commission who have a further 7 months in which to decide whether to add the foodstuff to the list of Novel Foods.
There are clearly many steps and a lot of time required for a Novel Foods Application. For applicants, the earlier an application can be submitted, the better. However, only high-quality applications will make it past the verification step, so there is a definite trade-off to be made.