Linnea, the expert manufacturer of botanical extracts for the pharmaceutical industry, has had its novel foods application reinstated by the Food Standards Agency, following its removal from the list earlier this year.
Cannabinoid Insight understands the company was originally told its application had been validated, only for the FSA to later rule Linnea out due to insufficient toxicology plans.
This week, the FSA has written to advise that upon reflection, it will reverse this decision, permitting Linnea to move to the ‘awaiting evidence’ section of the CBD list.
This means Linnea’s cannabinoid extracts will now join the list of more than five thousand CBD products permitted for sale in England and Wales, pending full market authorisation.
The news follows a recent policy change made by the national body for food safety, which gives CBD companies until 26 May to supply evidence for their products.
Linnea joined the Association for the Cannabinoid Industry in April 2022, and in doing so joined the ACI’s Novel Foods Consortium. This allowed Linnea to benefit from the consortium’s toxicology data, commissioned in line with the FSA’s standard requirements. These studies are OECD/GLP compliant and the live phase of the OECD 408 study is complete.
In a press release circulated on 29 April to announce a major update to the CBD list, FSA’s directory of policy, Rebecca Sudworth, said:
“Businesses that wish to supply evidence for their products for possible inclusion on the public list can also provide evidence of studies they have commissioned, for example toxicological studies.
“These can have been commissioned either before or after the deadline for applications in March 2021, and the evidence of commissioning must be submitted before 26 May.”
Based in Switzerland, Linnea has specialised in providing natural ingredients to Europe’s pharmaceutical sector for 40 years. Many of its botanicals are used to make over-the-counter remedies which are widely available in UK pharmacies and supermarkets.
One such extract, Butylscopolamine, is a key ingredient in Buscopan, commonly provided to soothe abdominal pain.
In recent years, the company has become increasingly focused on supplying quality cannabinoids, and now offers tailor-made CBD and CBG extracts.
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