UK Novel foods application
(Excludes required 12 month stability study and toxicology data.)
UK Novel foods application
At ADACT Medical, we provide a full end-to-end service package to help companies apply for their products to be registered as a UK Novel foods application with the Foods Standards Agency (FSA) in the UK.
We compile full novel foods dossiers from seed-to-shelf for CBD products and submit it to the FSA for evaluation. Throughout the process, we support clients with technical advice and guidance.
If you are currently in the process of an application to the FSA or have novel food status, we can help you with additional testing or submit an extension to the FSA for new product developments.
As a leader of testing CBD products, ADACT has created a process to conduct testing in our ISO/IEC 17025:2017 accredited laboratory here in the UK. We conduct analytical work and stability studies needed to support novel food applications. Through every step of the process, we support applications with a full exposure related safety and toxicology assessment, ADME, genotoxicity and allergen assessments.
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The first part is a feasibility assessment to assess the readiness for an application. We review the CBD raw material from ‘seed-to-shelf’ and look at its supply chain. Does it meet Good Agricultural Practice (GAP)? Next, we audit the manufacturing and quality processes, and finished product specifications. By going through a detailed questionnaire, we can highlight any areas of potential weakness for improvement to ensure we have all the elements needed for a successful novel foods application.
The second part of the process, is the collation of the required data within the specific FSA framework, and the completion of the application. As the data required for applications is very similar, with specific components relating to ex. CBD toxicology, there is a opportunity to share the high costs of putting together background data. Hence, not only can we guide clients through the complex regulatory process, we can help keep costs down by sharing some otherwise costly data.
Further information and guidance is available from food.gov.uk/business-guidance/regulated-products/novel-foods-guidance.
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In January 2019, the status of CBD as a novel food was confirmed and added to the Novel Foods Catalogue by the Foods Standard Agency (FSA). CBD products may only be sold legally as a novel food, and food businesses must apply for authorisations of their CBD extracts and isolates.
Our other CBD services include:
What our quality service offers:
a full end-to-end service package
ISO/IEC 17025:2017 accredited laboratory
state-of-the-art instruments
analysis by scientists in the UK.
Phone our friendly team on +44(0)1302986088 or email hello@adactmedical.com.
We look forward to speaking with you soon.