APO Pipette EMAIL CAMPAIGN 2 APO Pipette EMAIL CAMPAIGN 2

Novel Foods Application With Always Pure Organics

APO Pipette EMAIL CAMPAIGN 2 APO Pipette EMAIL CAMPAIGN 2 APO Pipette EMAIL CAMPAIGN 2

The CBD world is set to change following the introduction of the new Novel Foods legislation in the UK. Always Pure Organics are working tirelessly to ensure we have a top-quality application to guarantee the best chance of verification. Here we share our experience with the process so far, our progress and what comes next with our application.

Overview:

Always Pure Organics’ Novel Foods application will consist of several major components and a larger number of smaller segments that support them. Listed below are the major components, their current status, and how we are proceeding. There will be more to the final submission, but the purpose of this document is to provide an overview of our current situation, not to exhaustively detail each aspect of the application in full. The main areas to be completed are the Production Processes, Compositional Data, Toxicological data and Secondary Application status.

Production Process:

We are performing a thorough overview of how the Isolate is produced; this covers growing conditions, extraction, purification and GMP status/other relevant accreditation (such as HACCP). We have already had some feedback from the regulators themselves, meaning that once we implement the changes they have requested, hopefully nothing else will be required on this section.

Compositional Analysis:

Compositional analysis has been agreed with the Food and Environment Research Agency (FERA). They will analyse 5 distinct batches of our Swiss and Colombian Isolated CBD, using a combination of qNMR and LC-MS:MS for a full suite of pesticide, residual solvent, heavy metal, and cannabinoid analysis. This comprehensive testing will show exactly what our Isolate is composed of to determine if it is safe for human consumption as a foodstuff. All batches are at FERA at the time of writing and are undergoing this process.

Toxicological Data:

APO has engaged the services of DevelRx – experts in toxicology who have produced a 67-page report on the toxicological profile of CBD Isolate and have prior experience with cannabinoids from working on the dossier for Epidiolex. DevelRx normally work on drug formulations but have agreed to compile our Novel Foods dossier. This will bring down the price of the necessary toxicology studies (which at this moment is Reproductive and Immunotoxicity, and Carcinogenicity) and is more ethical as it will require fewer animal tests to be carried out. Important to note is that toxicological testing is not required for validation but will be required for full authorisation. This means that we can submit our dossier without the full data, provided we can prove that we are organising proper testing and have it in our pipeline.

Secondary Applications:

Still a somewhat complicated topic. Most of the products our clients produce should be covered under our application, though there will obviously be some outliers such as for things like CBD coffee, cakes, or chocolates. These complicated products will require ADME/nutritional data at some point, whereas simpler products such as Isolate in MCT will likely be covered by the raw material application’s desk-based approach. Currently, it seems that the FSA is more focused on the toxicology data than any other aspect of the dossier, so ADME and nutritional data aren’t a priority at this time. Another interesting thing to note is that a product of high strength – if approved – will allow for production of the same product at a lower strength without needing additional data, assuming the product is otherwise identical.

To conclude, APO expects to have both applications ready for an informal submission to the FSA by the end of November. This will allow the FSA to provide feedback and make both organisations’ jobs easier come the submission date in January.

Read more about the Food Standards Agency CBD Guidance here: https://www.food.gov.uk/business-guidance/cannabidiol-cbd

The CBD world is set to change following the introduction of the new Novel Foods legislation in the UK. Always Pure Organics are working tirelessly to ensure we have a top-quality application to guarantee the best chance of verification. Here we share our experience with the process so far, our progress and what comes next with our application.

Overview:

Always Pure Organics’ Novel Foods application will consist of several major components and a larger number of smaller segments that support them. Listed below are the major components, their current status, and how we are proceeding. There will be more to the final submission, but the purpose of this document is to provide an overview of our current situation, not to exhaustively detail each aspect of the application in full. The main areas to be completed are the Production Processes, Compositional Data, Toxicological data and Secondary Application status.

Production Process:

We are performing a thorough overview of how the Isolate is produced; this covers growing conditions, extraction, purification and GMP status/other relevant accreditation (such as HACCP). We have already had some feedback from the regulators themselves, meaning that once we implement the changes they have requested, hopefully nothing else will be required on this section.

Compositional Analysis:

Compositional analysis has been agreed with the Food and Environment Research Agency (FERA). They will analyse 5 distinct batches of our Swiss and Colombian Isolated CBD, using a combination of qNMR and LC-MS:MS for a full suite of pesticide, residual solvent, heavy metal, and cannabinoid analysis. This comprehensive testing will show exactly what our Isolate is composed of to determine if it is safe for human consumption as a foodstuff. All batches are at FERA at the time of writing and are undergoing this process.

Toxicological Data:

APO has engaged the services of DevelRx – experts in toxicology who have produced a 67-page report on the toxicological profile of CBD Isolate and have prior experience with cannabinoids from working on the dossier for Epidiolex. DevelRx normally work on drug formulations but have agreed to compile our Novel Foods dossier. This will bring down the price of the necessary toxicology studies (which at this moment is Reproductive and Immunotoxicity, and Carcinogenicity) and is more ethical as it will require fewer animal tests to be carried out. Important to note is that toxicological testing is not required for validation but will be required for full authorisation. This means that we can submit our dossier without the full data, provided we can prove that we are organising proper testing and have it in our pipeline.

Secondary Applications:

Still a somewhat complicated topic. Most of the products our clients produce should be covered under our application, though there will obviously be some outliers such as for things like CBD coffee, cakes, or chocolates. These complicated products will require ADME/nutritional data at some point, whereas simpler products such as Isolate in MCT will likely be covered by the raw material application’s desk-based approach. Currently, it seems that the FSA is more focused on the toxicology data than any other aspect of the dossier, so ADME and nutritional data aren’t a priority at this time. Another interesting thing to note is that a product of high strength – if approved – will allow for production of the same product at a lower strength without needing additional data, assuming the product is otherwise identical.

To conclude, APO expects to have both applications ready for an informal submission to the FSA by the end of November. This will allow the FSA to provide feedback and make both organisations’ jobs easier come the submission date in January.

Read more about the Food Standards Agency CBD Guidance here: https://www.food.gov.uk/business-guidance/cannabidiol-cbd

Andrew Megahy1

Andrew Megahy

Lead Scientific Officer Linkedin