As CBD has become increasingly popular and seen a huge increase in demand over the last few years, regulation has been introduced by the European Commission in order to ensure that products containing CBD are safe and do what they say they will.
As of January 2019, CBD products are now regulated as Novel Food Products in the EU, meaning that CBD manufacturers must submit a Novel Food Application for each of their products by 31st March 2021 in order to place their products on the market legally.
We offer a full Novel Foods Application Service which is split into three parts for simplicity. Here‘s an overview of the CBD Novel Foods Application and our tips for successful submission.
1. Strategy development
Every business will need to approach the Novel Food Application differently depending on the type of products they sell, how many products they wish to place on the market and their individual needs. Therefore, it is crucial to develop an effective strategy ahead of your application.
We collaborate with our clients to plan every aspect of their application, in order to ensure that the submission process is as smooth as possible. This includes reviewing data held by the company, strategy generation and engaging with the relevant regulatory authorities.
2. Testing and data generation
A dossier containing data about the products, generated from laboratory testing and compliance, will be included to support your Novel Food Application.
At a minimum, this dossier should include a stability study, toxicological review, CMC data and risk assessments. At Inter Scientific, our fully equipped laboratory and dedicated lab technicians conduct all of the testing and analysis required to support your application.
3. Submission
Finally, once testing and data generation has been completed, Inter Scientific will compile and prepare the data generated into a dossier, which will be submitted to the European Commission via an electronic portal.
Once submitted, the authority may have queries to be answered before approving the products, which Inter Scientific will respond to accordingly.
How long does the Novel Food Application take?
Understandably, the length of time for each application varies depending on the number of products submitted and the strategy employed, however, below is a guide for how long the process takes on average.
- Strategy development – 1-2 months
- Testing and data generation – from 12 months (this is due to the required length of the stability study, however, the application can be submitted before the stability study ends)
- Submission – up to 14 days
We offer a full service for clients wishing to submit for authorisation under the Novel Foods Regulations (EU 2015/2283) for CBD containing products. We have developed our integrated services to provide our clients with peace of mind and to ensure product compliance.
To learn more and get a quote, email info@inter-scientific.com.
The post How to submit a successful Novel Food Application for your CBD products appeared first on Inter Scientific.
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