For those who are familiar with Novel Food Regulations, they will know that the success of an application depends on as much on the supplier of the material as the work that is done to satisfy the scientific rigour. The best foundation for any application is a fully audited and open supply chain which instantly gives the application the kudos of a full bank of data. This along with Good Agricultural Practice (GAP) means you know everything that has happened to that crop from before it was planted, throughout the growth and harvest and ultimately through to the final processing and delivery.
As a leader in the testing of CBD products, ADACT Medical has already put together a process to conduct testing on cannabidiol (CBD) as a novel food from our own ISO 17025 certified laboratory. We will conduct the analytical work and stability studies needed to support your novel food application which will be supported by a full exposure related safety and toxicology assessment, ADME, genotoxicology assessments and allergen assessments.
In order to establish your strategy for successful novel food application, we will provide a full strategy review. While there will be a charge for this service, this will be credited back to you against a full application cost where applicable. The initial review is available for £250 plus VAT for a telephone assessment and £750 plus VAT for an onsite feasibility assessment. This will be followed by a detailed audit and stage one document preparation at an additional £3,500 plus VAT. This approach doesn’t commit you to the full cost of a novel food application should there be any issues with your products which don’t lend themselves to a successful application.
The cost of a complete novel food application is dependant on your specific circumstances and the number of individual products in the programme which will include testing on raw materials, intermediaries and final products. In a situation where companies share a supply chain, they can come together which would lower the costs dramatically and similar discounts could be achieved where existing data can be used to support the application.
Read more about business guidance on cannabidiol (CBD) as a novel food from the Food Standards Agency at: https://www.food.gov.uk/business-guidance/cannabidiol-cbd To discuss your testing requirements in detail please contact ADACT’s Chief Regulatory Officer, Damien Bové, on +44 (0)1302 98 60 88 or firstname.lastname@example.org