We help businesses prepare for CBD novel food application
As of 13th February 2020, manufacturers are required to submit a CBD novel food application in the UK prior to sale. A CBD food is yet to be approved and new rules are emerging.
We offer a number of services to help manufacturers prepare and submit a novel food application for a CBD product. Please note that if you are a finished product-only manufacturer or marketing-only company and not the CBD raw material manufacturer it may be difficult to make a novel food application.
A CBD Novel Food Application is a term used to describe the process by which manufacturers can market CBD foods in the EU. Under EU Regulation 2015/2283, manufacturers and importers of CBD food, drink and supplements are required to submit an application to the European Commission as part of a premarket authorisation process.
Novel food regulations require manufacturers to submit manufacturing and product information to the European Commission for review and approval. It is important to note that while the UK is no longer a member of the EU the Food Standards Agency still requires a novel food application for CBD products on the UK market. Read the latest from the FSA in our blog post here.
Timeframe from preparation to approval: approx 24 months
Cost: £30K – £100K
IMPORTANT: The timeframe depends on a number of factors including quality of dossier and the scope of submission e.g. intended uses. The wider the scope, the higher the cost.
Gather analytical lab data, safety and exposure data, manufacturing process, composition, purity, intended use information.
Duration: 6 months approx
Complete application form (online portal)
Duration: 2/3 days
Evaluation by EFSA
EFSA evaluate submitted information
Duration: 9 months
Questions from EFSA
Receive questions by EFSA. Company prepares response to questions.
Duration: Depends on number and nature of questions and company response time.
When EFSA are satisfied the application is deemed complete the product details are uploaded to Union list of permitted novel foods and the CBD novel food can be marketed in the EU.
Duration: 3-6 months
Whether you manufacture raw CBD extract for CBD oils, CBD infused drinks or CBD food we can help you to prepare and submit a novel food application.
In order to provide a quote for a novel food application we require some information about you and your product.
Please read the information below and use the contact form to send an enquiry. Please note that we can only provide a quote if you are the raw material manufacturer (CBD extract). Unfortunately, we cannot provide quotes if you are marketing-only company or finished product-only manufacturer. More information is provided below.
An application for a CBD novel food requires confidential information about how the CBD raw material is manufactured. Some of this confidential manufacturing information is also required to provide an accurate quote. This means that if you do not have access to this information (e.g. you are a marketing/branding-only company or finished product-only manufacturers) we cannot offer an accurate quote.
To take it to the next step and formalise a quote the following information shall be required:
Note: The Quality Manager of the manufacturer would be the best person to complete this stage of the quote process.
We recommend that you request information on the novel food application status and type of application from your CBD raw material manufacturers. If they have not made an application yet, we advise that you source a manufacturer that has already done so.
In addition to the video guides (above), to help CBD businesses navigate the emerging regulations we provide free information on CBD regulations and laws in the UK here.
We are a London-based regulatory affairs consultancy providing services to the biocide, CBD, e-cigarette, cosmetic and pharmaceutical industry. We help e-cigarette companies comply with the Tobacco Products Directive and pharmaceutical companies obtain and maintain medical product licences. We also offer UKAS accredited biocide and CBD analytical testing services.
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