EDITOR'S SPOTLIGHT: SCIENCE & REGULATION
CBDepot files Novel Food application for synthetic CBD form
The application follows Cannabis Pharma’s back in 2016, in which the firm put forward a cannabis plant-derived CBD form for scrutiny. However, the EU Commission has not declared this dossier as valid.
“We can only assume the reasons for this may be similar with what European hemp industry has been experiencing in the cosmetics sector since March 2019,” says CBDepot.
“Synthetically produced” CBD is allowed for cosmetics use without specific restrictions while CBD derived from extract or tincture or resin of cannabis is restricted.”
EFSA hold back
Hesitancy by the EU Commission in advancing this application forward has had a knock-on effect with the European Food Safety Application (EFSA) delaying its risk assessment to evaluate this application.
CBDepot’s application, made on 27 November 2019 refers to a “trans-cannabidiol” form of the phytocannabinoid, chemically synthesised as a novel food ingredient for use in supplements.
The firm’s application has been registered in the Register of Questions (reference: EFSA-Q-2019-00750). CBDepot’s dossier NF 2019/1371 was filed on October 24, 2019.
“We believe the source of chemical substance does not matter in its assessment of legality, provided it was manufactured according to legal requirements in the country of origin,” CBDepot says.
“By filling application for authorisation on synthesised Cannabidiol, we hope to lift the legal prejudices on this molecule based on its source.”
The Czech Republic-based firm adds that with Cannabis Pharma’s application on hemp-derived CBD filed through the Czech Ministry of Agriculture, and re-filed in early 2018, the two companies “now cover both versions of Cannabidiol to be approved as NF ingredient for food supplement use.”
Cannabis Pharma application
Cannabis Pharma’s dossier mentions the firm’s method of CBD extraction, obtained via a series of purification steps from Cannabis sativa L. plants.
Hemp seed oil has been traditionally consumed as food containing high concentrations of poly-unsaturated fatty acids and rare omega 3 and omega 6 acids present such as gamma-linolenic and stearidonic acid, and certain phytosterols.
Hemp seed oil is also a high source of vitamin E with the hemp seed and seed cake high in vitamins and minerals: thiamin, vitamin B6, folate, iron, phosphorus, magnesium, zinc, copper and manganese.
The application describes the safety of CBD for use in food supplements for adults with a daily intake of up to 130 milligrams (mg) or 1.86 mg/kilogram (kg) body weight.
As an additional precautionary measure, the food supplements containing CBD will be limited to the adult population, excluding pregnant and lactating women.