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English Cymraeg

Information on invalidated CBD applications

England and Wales

Information for applicants who submitted novel food authorisation applications for existing CBD products before 31 March 2021 and whose applications have been invalidated.

Last updated: 31 March 2022

Why your application has been invalidated

Your application has been invalidated because the submission was missing the information needed to assess if it meets the requirement under the novel food regulations. A novel food authorisation application for a CBD product cannot be taken forward in the authorisation process if this is the case.

To be validated, applications should have been submitted with a full set of data and with all relevant studies.

Literature review only toxicology submissions

We cannot accept a literature only approach to evidence the toxicological safety of a CBD novel ingredient. If an application is missing toxicological data it cannot be taken forward in the novel food application process. 

The Committee on Toxicology (COT) notes in its Position paper on the potential risk of CBD in CBD food products that there is a gap in the available toxicological information from literature, especially in the areas of reproduction and immunology (point 8). It reached the conclusion that even with the data on Epidiolex in the data set it was not possible to identify a safe upper intake level of CBD. It was consequently agreed that the topic of toxicology would be reviewed, once more data became available (point 9). Therefore, a literature only approach cannot be accepted, unless significant further evidence, not considered by the COT, can be presented to support the dose at which CBD is safe, in relation to the CBD novel ingredient covered by an application.  
 
While the FSA is open to applicants working collaboratively to gather data, it has maintained its position that data is required to support a CBD novel food application and cannot accept literature only to evidence safety of a novel ingredient. 

Withdrawing your products from the market

CBD products or ingredients linked to invalidated applications will have to be removed from the market as they are not linked to progressing applications.

We expect such products to be voluntarily withdrawn from the market. Local authorities are responsible for enforcement and may remove these products from the market. 

Reapplying for authorisation

You can re-submit your application to us with a revised dossier including any information highlighted to you as missing in the original assessment. We expect any future applications to be submitted as a standalone dossier which integrates the missing data, and not presented as additions to the original application.

Toxicological testing

The Committee on Toxicity’s view is that there are several data gaps for CBD in the literature. These gaps and any indications from the literature, such as with repro-toxicology where there may be areas of concern, would provide a useful basis to further development of your testing plans.

For developing toxicological testing of CBD products, we recommend considering the EFSA guidelines on novel food applications. The guidelines suggest a repeated dose 90-day oral toxicity study following the OECD TG 408 protocol. The protocol should be modified to include assessment of additional parameters. These parameters are described in the more recent guideline on repeated-dose 28-day oral toxicity studies in rodents (OECD TG 407). The EFSA guidance also recommends genotoxicity bacterial reverse mutation test (OECD TG 471), and an in vitro mammalian cell micronucleus test (OECD TG 487). 

We suggest the test items used to generate studies are carefully chosen to ensure all novel ingredients being applied for are covered. If safety is not demonstrated in the tests, further studies may be required to explore specific issues identified. We encourage applicants to provide all studies at submission to allow for a  risk assessment.

We are committed to minimising animal testing as much as possible. We encourage business to act as consortiums or work collaboratively and share information on novel ingredients in products for which they seek authorisation. This would minimise the need for animal studies. We support the use of alternative methodologies if the method has been evidenced as being as good as an animal study and as robust in testing safety parameters.

Appealing decision to invalidate application

There is no appeal process for the decisions made on whether a dossier is valid and can progress through the assessment process. There is a core set of information needed to review a dossier and assess if it meets the requirement under the regulation, as outlined in the guidance for applicants. For the dossiers considered invalid it has been identified that there is insufficient information for the assessment. We have provided detailed feedback, so that if applicants would like to reapply it is clear what additional information is needed to pass validation.