Posted on Tuesday March 24, 2020
The leading Cannabis Law department at Mackrell.Solicitors has recently received clarification from the Food Standards Agency (“FSA”) in relation to the FSA’s recent announcement, concerning novel CBD food products and applications.
On 13 February 2020 the FSA announced that businesses will need to submit, and have fully validated, novel food authorisation applications by 31 March 2021, and that after this date, only products for which the FSA has received a valid application will be allowed to remain on the market. The FSA’s business guidance on CBD as a novel food was then updated on 19 March 2020.
Shortly after the FSA’s announcement, the Cannabis Law team at Mackrell.Solicitors wrote to the FSA seeking further guidance and clarification, in particular in relation to the European Commission’s own stance and guidance on the application process regarding novel foods, in that the EC state quite clearly that:
“The authorisations of novel foods under the former novel food regulation were addressed specifically to the applicant and gave the applicant exclusive rights to the novel food. With the current novel food regulation, although the specific authorisations, the conditions of use, the specifications and the labelling contained in them remain valid, they are no longer applicant-specific but have become generic following their inclusion in the Union list. This enables any food business operator to place the authorised novel foods in the European Union market.”
In response to Mackrell’s letter, the FSA have confirmed the following points:
- Whereas marketing authorisations are not applicant specific, it should be noted that any subsequently authorised novel product (such as CBD isolates, synthetics, extracts, etc.) is specific to that product only and will not generally encompass any other CBD product. The authorisation would only apply to any other products if they were made in exactly the same way using the same production specifics, and for the exact same uses as described within the authorisation, using the same safety evidence base.
- Furthermore, where the applicant requests and is granted confidentiality in respect of their application, this substantially limits the ability of third parties to be able to replicate production, research and use data.
- After five years confidentiality is lifted, which means that information will be more widely available.
- Any marketing authorisations issued by the European Commission during the Brexit implementation period (which ends on 31 December 2020) will continue to be valid for the UK market thereafter;
- Any marketing authorisations issued by the European Commission after the implementation period ends will not automatically apply within the UK;
- If a business wishes to market CBD extracts in the UK after the FSA’s 31 March 2021 deadline, the business (or its source manufacturer) will need to submit a marketing authorisation application to the FSA in the good time.
We have now considered the FSA amended announcement and their letter clarifying their announcement and we feel that:
- More clarification is required from the FSA in relation to secondary products (i.e. products that do not have their own specific marketing authorisation, but may be marketed lawfully, because they fall within the scope of another existing marketing authorisation that has already been approved). Marketing authorisation applications are extensive and detailed, and so in order to benefit from the new “non applicant specific” rules, the industry will need a clear and comprehensive guide in relation to the criteria that secondary products must meet (i.e. which precise elements of an approved product’s authorisation will a secondary product need to match to be considered lawful?).
- When attempting to market a secondary product, it will be important to consider whether an original applicant’s intellectual property rights are being infringed (for example by copying a production process).
For more information regarding this matter and to discuss how it may affect your business, please contact us.