Securing regulatory compliance for our members
On March 31st 2022 the UK Food Standards Agency updated their list of CBD products that are allowed to remain on the market. All the applications submitted by our members made it on to that list. This represents a staggering 69% of all successful applications.
- Technical and scientific guidance to attain UK and EU regulatory compliance
- Bespoke novel foods application consultancy
- Access to licensed toxicological data
Bespoke consultancy service
Our consultancy team is experienced in cannabinoid chemistry (including CBD and other plant derived cannabinoids), manufacturing, regulatory and related analytical methodology. They support our members with their critical business requirements.
- Technical and scientific advice to achieve UK and EU regulatory compliance
- End-to-end novel foods application consultancy. Writing full application, pre-submission application review and follow-up advice to meet requests for further information
- Business to Business marketing and communication services
ACI technical consultancy includes
Introduction to novel foods dossier requirements
Customer checklist reviewed and signed off by ACI
Gap analysis based on checklist results
Definition of project timeline and approval
Full review of each section on completion
Advice on identifying partners for stability testing and advice on identifying partners for product testing
Formulation-specific risk assessment guidance
Guidance on:
Stability data protocols
Specification controls
Supply chain visibility HACCP, GACP and other critical control points
Guidance on data generation, such as toxicological data or ADME studies
Overall risk assessment & risk mitigation plan guidance
Toxicological data
- Access to licensed toxicological data from OECD 471, 487 and 408 studies
- Cost-efficient access to toxicological data for FSA and EFSA novel foods authorisation for representative isolate and/or distillate CBD extracts
- Standardised methodology and accredited laboratory partners
In February 2020 the UK Food Standards Agency set out a new deadline for the CBD industry to apply for European Union safety evaluations known as a “novel foods authorisation” and also provided consumption guidelines to consumers. They set a deadline for all products on the market prior to 13 February 2020 to submit a novel foods application to them by 31 March 2021.
Products that were not on the market prior to 13 February 2021 require a full novel foods authorisation from the FSA to be sold in the UK.
To assist our members in producing the necessary scientific dossiers for their novel foods applications ACI launched a CBD safety study to generate the required data. The novel foods dossiers linked to this study were submitted on 16 February 2021.
The data generated through this study can help your company enter the lucrative UK and European markets.
Reports and papers
White Paper: Cannabis in the UK
The UK’s market for consumer CBD products will be worth nearly £690 million ($1 billion) in 2021. This makes the UK the world’s second largest market for consumer CBD after the US. In this free white paper you’ll learn the requirements to enter this lucrative market.
Market Sizing: Demand for CBD Soars During Lockdown As UK Market Now Estimated at £690 Million
ACI and Centre for Medicinal Cannabis (CMC) today launch the report Green Shoots – Sowing The Seeds Of The New UK Cannabinoid Market with a new assessment of the size of the UK consumer cannabidiol (CBD) sector.
Research Paper: ACI and CMC Recommend Home Office Clarifies THC Limits for CBD Products
Experts from the Association for the Cannabinoid Industry (ACI) and Centre for Medicinal Cannabis (CMC) have put together a detailed safety review paper of THC – Health Guidance Levels for THC in CBD products: Safety Assessment & Regulatory Recommendations. The paper recommends further research and makes policy recommendations.
