The Food Standards Agency (FSA), which regulates foods and food businesses in England, Wales and Northern Ireland, yesterday issued its long awaited statement on CBD in foods.
In January 2019, the European Commission updated the Novel Food Catalogue to state that extracts of Cannabis sativa L. and derived products containing cannabinoids are considered as novel foods, as a history of consumption has not been demonstrated. As a result, all extracts of hemp and derived products containing cannabinoids (including CBD) are now regarded by the European Commission as novel. The FSA responded by stating that it accepted the conclusion of the Commission and was “committed to finding a proportionate way forward…to clarify how to achieve compliance in the marketplace in a proportionate manner”.
Following the UK’s departure from the European Union, the current rules on novel foods will continue to apply until 1 January 2021, when the transition period under the UK’s withdrawal agreement from the EU comes to an end. The FSA has now however confirmed its position on enforcement and prescribed actions which it considers “are a pragmatic and proportionate step in balancing the protection of public health with consumer choice”.
The main actions are:
- the FSA has set a deadline of 31 March 2021 for companies to submit novel food authorisation applications;
- after 31 March 2021, only CBD food products where a “valid novel food authorisation application” has been submitted will be allowed to remain on the market – all other CBD food products will need to be removed from sale;
- the FSA has also issued safety advice to consumers based on the conclusions of the Government’s Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT). This recommends that vulnerable groups (such as pregnant or breast feeding mothers and people on medication) should not consume CBD products and healthy adults should consume no more than 70mg/day.
Importantly, the statement by the FSA provides reassurance that no enforcement action will be taken in relation to CBD foods prior to 31 March 2021 if these are correctly labelled, are not unsafe to eat and do not contain substances that fall under the Misuse of Drugs Act and associated legislation and as long as no new safety concerns arise.
Any novel food authorisation application for a CBD food made before 31 December 2020 will need to be submitted to the European Commission (although the FSA recommends that applications are also sent to them). The application will need to include:
- details of the ingredients and production process;
- the composition of the food and stability data;
- history of use, proposed uses, use levels and anticipated intake;
- details of absorption, distribution, metabolism and excretion;
- nutritional information;
- toxicological and clinical data; and
Once received the Commission will either validate the application or reject it on the basis that the application does not contain all the necessary elements. Once validated, the application is risk-assessed. From 1 January 2021, any application for a novel food authorisation for the UK will need to be submitted to the FSA, in accordance with the UK authorisation process established at the expiry of the transition period.