Our regulatory approach

The ACI partnered with The Cannabis Conversation to produce this panel discussion and explainer with Dr Parveen Bhatarah the CMC/ACI Regulatory Lead, Dr Sarah Gaunt from Global Regulatory Services our regulation partners and Shomi Malik our Development Director.

WATCH THE VIDEO

In January 2019, EFSA found that, with no clear history of human consumption in the EU or elsewhere prior to 1997, Cannabis L. Sativa and its extracts are Novel Foods, under Regulation (EU) 2015/2283 ("the Novel Food Regulation").

All extracts of hemp and derived products containing cannabinoids, including CBD, are now regarded by the European Commission as novel.

The FSA, the UK regulators for food standards, accepts the EFSA clarification, and all UK CBD businesses trading consumed products will need to ensure their products have undergone the necessary safety assessment to gain Novel Foods approval.

The ACI have partnered with Global Regulatory Services, an award-winning life-science consultancy firm, to ensure ACI members are in the process of making Novel Foods applications and are doing so in a correct and timely manner.

Greer Deal, Director GRS

“Full compliance with the relevant regulatory bodies is the only way that the future cannabis industry can exist. It’s time that those operating within this sector wake up to this reality and embark on the journey to becoming serious and sustainable participants. This is the opportunity for the cannabis industry to shine in Europe. GRS look forward to working with CMC to achieve this.”

The application process is lengthy and must contain extensive safety data and toxicological studies supporting the safety of the product. Included in the required content of the application, submitted via online portal, are the following key elements:

  • Administrative data
  • Characterisation of the novel food, technical and scientific data
    • Identity of the novel food
    • Production process
    • Compositional data
    • Specifications
    • History of use of the novel food and/or of its source
    • Proposed uses and use levels and anticipated intake
    • Absorption, distribution, metabolism and excretion
    • Nutritional information
    • Toxicological information
    • Allergenicity
  • Annexes to the dossier
    • The glossary or abbreviations of terms quoted throughout the dossier
    • The certificates (on the accreditation of laboratories, certificates of analyses)
    • Full copies/reprints of all pertinent scientific data (published and unpublished)
    • Full study reports
    • Scientific opinions of national/international regulatory bodies

In accordance with Article 10 of the Novel Foods Regulation, the process for approval follows these steps:

ACI Application Infographic

Once the act is approved by the Standing Committee on Plants, Animals, Food and Feed Committee, and is adopted and published by the EC, the novel food can be placed on the EU market.

The ACI will assist with applications and will work collectively with our members in syndicating the required safety assessments, substantially reducing individual costs and ensuring that all reporting meets the necessary standards for approval.