IN Brief:
- The FSA is asking its Board to support recommendations to authorise three high-purity CBD novel foods.
- Proposed conditions include a 10mg daily intake, vulnerable-group warnings, and limits for THC and other controlled cannabinoids.
- Ministers will make the final authorisation decisions; the September Board paper does not itself legalise the products.
The Food Standards Agency is preparing to recommend authorisation of three high-purity cannabidiol novel foods, moving the first applications of their kind towards ministerial decisions after completing safety assessment and public consultation.
The applications cover synthetic CBD under reference RP 7 and two CBD isolates, RP 350 and RP 427. Each product contains at least 98% CBD and has received a positive safety opinion from the FSA and Food Standards Scotland under its proposed conditions of use.
The September paper does not itself authorise the ingredients. The FSA Board is being asked to agree that officials’ risk-management recommendations are suitable for submission to ministers in England and Wales, who will make the final decisions on whether the novel foods may be placed on the market and under what conditions.
That distinction matters because the CBD food market has operated for several years under an interim arrangement. Thousands of products remain linked to applications on the FSA’s Public List, but inclusion on that list has never amounted to full novel-food authorisation.
The first three applications would begin replacing that transitional position with defined legal specifications. The proposed conditions cover permitted uses, labelling, maximum intake, controlled cannabinoids and other requirements intended to give manufacturers, retailers and enforcement bodies clearer rules.
The FSA is maintaining a provisional acceptable daily intake of 10mg of CBD per day for adults. Product labelling would have to communicate that limit and carry warnings for people under 18, those who are pregnant, breastfeeding or trying to conceive, people taking medication and those who are immunosuppressed.
The applications are not identical in scope. All three seek use in food supplements, while RP 350 also covers certain beverage and confectionery applications. Any eventual authorisation would apply only to the specified novel food and the conditions attached to it rather than creating a general approval for CBD across food and drink.
Manufacturing specifications are another significant part of the proposals. Authorised ingredients would have to comply with defined limits for delta-9-tetrahydrocannabinol and other controlled cannabinoids, creating measurable parameters for quality control and enforcement.
The FSA has revised one aspect of that approach following consultation. For RP 427, officials are proposing a different delta-9-THC specification after considering additional production evidence from the applicant, balancing consumer protection with a level that can be achieved and verified consistently in commercial manufacture.
That is an important regulatory detail for ingredient producers. A theoretical purity requirement has limited value if normal production cannot meet it repeatably or analytical laboratories cannot determine compliance with sufficient reliability. Specifications have to function in routine manufacturing and enforcement rather than only on paper.
The agency received 46 responses during its 12-week consultation, with 68% supporting the overall risk-management proposals. The consultation also led to changes in the presentation of the daily intake and clearer treatment of warnings for vulnerable groups.
The scale of the existing market gives the decisions broader significance. The FSA says around 3,000 individual CBD products on its Public List are linked to these first three applications, although those products remain unauthorised novel foods until ministers complete the statutory process.
Authorisation would therefore start moving part of the market from interim enforcement discretion into a conventional compliance framework. Manufacturers using the authorised ingredients would have clearer requirements around composition, dosage and labelling, while products outside the approved terms would remain subject to enforcement.
The FSA is also preparing further guidance for local authorities. That will be necessary because a new authorisation does not remove the need to establish whether individual finished products actually contain the authorised novel food, remain within its permitted uses and comply with the associated conditions.
More CBD applications are progressing behind the first three. The agency says it has now published 14 positive safety assessments for novel foods containing more than 97% CBD, although each application will continue to require its own regulatory consideration.
The wider UK-EU regulatory position remains unsettled. Negotiations over a sanitary and phytosanitary agreement include proposals for dynamic alignment that could ultimately require EU novel-food authorisations to apply in Great Britain unless an exception is agreed.
That creates an unusual situation in which the FSA is completing applications under the current domestic regime while the future shape of that regime is still being negotiated. The agency’s position is that the statutory process continues to apply until any new arrangement takes effect.
There is also a substantive difference between the FSA and European Food Safety Authority positions on intake. The September paper notes that EFSA’s current provisional safe level is lower than the FSA’s 10mg daily figure, reflecting different datasets and risk assessments.
For manufacturers, that divergence reinforces the need to treat authorisation as market-specific rather than assuming one CBD specification will automatically support sales across Britain and the EU.
The immediate milestone is the FSA Board meeting on 16 September. If the Board supports the recommendations, officials can finalise advice for ministers. Only after those ministerial decisions will the first three applications move from assessed and consulted-upon ingredients into formally authorised novel foods.
