In partnership with Advanced Development and Safety Laboratory (ADSL) and a consortium of CBD companies, the study aims to provide the data required by the novel foods application process.
More specifically, the study will look to address data gaps identified by the Government Committee on Toxicity (COT) that includes CBD’s role in causing drowsiness, liver toxicity or drug interactions.
“We are satisfied that any company that does not have such original derived data will not have their novel foods dossier validated by the FSA,” the ACI says in a statement. “Only products with this validation will be allowed on the market after 31 March 2021.”
The announcement comes a day after the UK Food and Safety Agency (FSA) updated its advice to businesses looking to achieve a novel food approval for any CBD-based product it has produced or is selling.
In reference to CBD’s safety the FSA states that applicants would need to include details of the toxicological studies undertaken or propose to undertake with detailed reasoning for these tests.
Little publicly available info
“Meeting the validation standard does not mean the product will necessarily be authorised,” the FSA warns.
“Each application will be considered on its own merits, but with so little publicly available information on the safety of CBD we anticipate that directly relevant studies will be needed.
“Only by including this directly relevant safety information will applications be able to progress and potentially be authorised.”
Changes to the application process has been a common theme in the FSA’s guidance, which the industry claiming has added to the confusion and upped costs in satisfying approval criteria.
In its statement, the FSA says, “We have discussed CBD with various trade bodies and many other organisations involved in the novel food and CBD industry. We will continue to do so.
“While it is important that we understand their views, we have not in any way endorsed any specific trade body’s approach to the route to compliance for CBD extract products.
“There are no specific agreements with individual trade bodies and all businesses marketing novel CBD products are treated the same.”
31 March 2021 deadline
In February this year the Agency set the new deadline of 31 March 2021 for firms to apply for European Union safety evaluations as a novel food as well as providing consumption guidelines to consumers.
The advice is primarily aimed at healthy adults and vulnerable groups and includes recommended doses as well as potential risks to those who are pregnant, breast-feeding or taking medication.
More changes were afoot in July as the European Commission postponed the application process of non-synthetic CBD products with news that it could reclassify non-synthetic CBD as a narcotic.
In commenting about the new study’s significance, the ACI adds that this consortia approach follows the path of one OECD 408 rodent study where data is usable by all participating members.
“[The study] is consequently more ethically aligned with minimising animal usage than the scenario of many products each undertaking their own study,” the ACI says as it adds that the safety information generated would respond to future demands of regulatory authorities in the US and EU.