After extensive review, the European Food Safety Authority (EFSA) has positively assessed the patented mushroom powder ingredient, which delivers 40,000 International Units (IU) of Vitamin D per gram, from a non-GMO, clean-label, natural source.
The ingredient's high concentration of Vitamin D allows producers to offer ‘Good’, ‘Excellent’ and ‘High Potency’ source label claims with only a few milligrams of the ingredient plus it is minimally processed, therefore enabling a clean label positioning.
The EU approval covers Earthlight's use in a broad range of food, food supplement and beverage products, ranging from breakfast cereals and bakery products to juices, dairy products and and meat replacements.
The positive opinion by EFSA provides PLT a five-year exclusivity on European sales of the powder, made by Oakshire Naturals, LP.
According to Devin Stagg, Chief Operating Officer at PLT, the approval is timely considering rapidly growing interest in Vitamin D supplementation.
"Earthlight is the right ingredient at the right time for food and beverage producers in Europe and multinationals seeking to create global formulations. Adequate levels of Vitamin D have always been important, but today, people are more tuned into D than ever."
The debate continues as to the link between the vitamin and COVID-19 severity but a number of research reports have linked low vitamin D status to more severe COVID-19 symptoms and higher risk of death.
Earthlight is produced from mushrooms via a patented process, by exposing these mushrooms to light, as they produce Vitamin D when exposed to UV light.
"As a whole food, plant-based, clean label ingredient, Earthlight supports virtually every major food and beverage market trend and can really help product developers differentiate their offerings if they choose to fortify with Vitamin D," added Stagg.
The ingredient also received approval of its Food Additive Petition from the U.S. Food & Drug Administration in July of this year.
According to Barbara A. Davis, PhD, RD, Head of Clinical & Regulatory Sciences for PLT, Novel Foods approval of Earthlight is the culmination of years of work on the safety of the ingredient.
"In April of this year, Public Health England expanded its recommendation on Vitamin D supplementation beyond at-risk groups, suggesting that all citizens 'consider taking 10 micrograms of vitamin D a day to keep your bones and muscles healthy,'" she said. "With the achievement of Novel Foods and our recent successful FAP petition in the USA, and other pending regulatory applications, Earthlight can be considered a global ingredient today."