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The Association for the Cannabinoid Industry (ACI) says it has initiated the first steps towards processing applications from its raw-product manufacturing members for ‘novel foods’ authorisation.

Required by the European Food Safety Agency (EFSA) as a safety assessment, the authorisation involves proving that manufacturers have a controlled and consistent process to produce an ingredient which is fully characterised and safe.

The toxicity of the ingredient needs to be thoroughly explored through testing and literature reviews, which, as a dossier of information, is submitted to EFSA to demonstrate the safety to go into the food chain.

The ACI – an industry body committed to nurturing a safe, legal and well-regulated CBD market in the UK – has conducted detailed assessments of multiple testing laboratories with tests launched by its regulatory head with vital support from a specialist from Global Regulatory Services (GRS) – experts for regulatory strategy and license submission well-versed in the ‘novel foods’ application process.

Dr Sarah Gaunt from GRS said: “Through a thorough analysis of world-class testing laboratories we were able to identify the ideal partners to assist ACI, ensuring we compile watertight ‘novel foods’ applications for our members. This enables us to create a solid foundation for building a responsible and safe industry in Europe and beyond.”

The evaluation of the testing authorities included a review of the technology used for testing as well as their analytical laboratory standards and regulatory compliance to international standards.

The ACI said it was important to also clearly understand the laboratories’ current CBD and controlled substance method validation status.

Dr Parveen Bhatarah, Regulatory and Compliance lead, ACI, said: “As more European countries enforce regulations based on EFSA’s ‘novel foods’ classification of CBD, it is essential the ACI take this important first step to demonstrate we have a clear plan to ensure legal compliance for the industry within the UK and EU.”

The initial tests on the raw materials themselves will be the analysis for cannabinoids, terpenes, pyrrolizidine alkaloids, microbiology, mycotoxins, pesticides, residual solvents, heavy metals and genotoxicity.

The ACI said it would also be working with a UK University – one of the world-leaders in food safety studies – to perform a ‘gap’ analysis to review the guidance from EFSA and the literature in the public domain to show where gaps might be such as genotoxcity of CBD, so the initial dossier passes the first phase of the submission seamlessly.

This will give ACI a clear indication of the final requirements for each submission.

The industry body have notified their members that this process will begin and those within the company responsible for regulatory affairs are in the process of finalising the details and providing samples for their respective application.

With deadline for acknowledgement of engagement from members set for 20th of December, testing is expected to commence in the new year with actual applications being submitted to the EFSA within 3 to 6 months, depending on the results of the gap analysis.

Wendi Young, Regulatory and Compliance vice president of Mile High Labs, a member of ACI, said: “We have been preparing for our novel foods application over the last few months. As a company which has led calls for better regulation across the industry, we support the novel foods process and encourage all those involved in the sector to do everything possible to bolster consumer confidence by ensuring that they are compliant with the process.”

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