Earthlight® Whole Food Vitamin D Receives Novel Foods Approval for the European Market

Clean Label, Plant-Based Ingredient Permitted as Fortification in a Dozen Food Categories as Health Authorities Recommend Higher Vitamin D Supplementation Levels

News provided by

PLT Health Solutions

Sep 02, 2020, 08:42 ET

MORRISTOWN, N.J., Sept. 2, 2020 /PRNewswire/ -- PLT Health Solutions, Inc. today announced that Earthlight^® Whole Food Vitamin D has received Novel Foods Approval in the EU, paving the way for this unique dietary ingredient to be used in food and beverages produced and sold in Europe. After extensive review of this mushroom-based ingredient, the European Food Safety Authority (EFSA) has positively assessed the safety of Earthlight Whole Food Vitamin D as a novel food pursuant to Regulation (EU) 2020/1163. The 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 soups and broths. The approval also covers use in dairy analogues and meat replacement – ideal applications for Earthlight since it is plant-based and considered acceptable for use by vegans. The positive opinion by EFSA provides PLT a 5-year exclusivity on sales of mushroom powder Vitamin D in Europe.

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.

According to Devin Stagg, Chief Operating Officer at PLT Health Solutions, Novel Foods approval of Earthlight 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. 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," he said. Stagg went on to point out that Earthlight received approval of its Food Additive Petition from the U.S. Food & Drug Administration in July of this year.

Plant-based, Whole Food Vitamin D

Earthlight is produced from mushrooms via a patented (EU Patent EP2900089B1) process, by exposing these mushrooms to light. Much like the human body, mushrooms produce Vitamin D when exposed to UV light. Earthlight is a whole food ingredient that is minimally processed without any extract solvents. It offers consumer-friendly labeling. This non-GMO ingredient delivers 1,000 micrograms (40,000 IU) of Vitamin D per gram of ingredient. Earthlight's high concentration of Vitamin D means low use levels and excellent economics. Low use levels mean that it won't affect the organoleptics of a food or beverage product. Earthlight is available in both conventional and organic grades.

Approved Use in a Broad Range of Food & Beverage Products

Earthlight is approved for use in many food, food supplement & beverage products that have traditionally featured Vitamin D fortification, like breakfast cereals and bread products. But it is also approved for up and coming food and beverage types – particularly in the plant-based category. Table 1 reviews the food groups in which Earthlight may be used in the EU.

Table 1: Novel Foods Approved Uses for Earthlight^® Whole Food Vitamin D

Food Category	Maximum Level of Vitamin D2
Breakfast cereals	2.25 μg of vitamin D2/100 g
Yeast-leavened bread & pastries	2.25 μg of vitamin D2/100 g
Grain products & pastas	2.25 μg of vitamin D2/100 g
Fruit juice and fruit/vegetable blend beverages	1.125 μg of vitamin D2/100 mL
Milk & dairy products (excluding fluid milks)	2.25 μg of vitamin D2/100 g/1.125 μg of vitamin D2/100 mL (beverages)
Cheese (excluding cottage cheese. ricotta cheese and hard-grating cheeses)	2.25 μg of vitamin D2/100 g
Meal replacement bars & beverages	2.25 μg of vitamin D2/100 g/1.125 μg of vitamin D2/100 mL (beverages)
Dairy analogues	2.25 μg of vitamin D2/100 g/1.125 μg of vitamin D2/100 mL (beverages)
Meat analogues	2.25 μg of vitamin D2/100 g
Soups & broths	2.25 μg of vitamin D2/100 g
Extruded vegetable snacks	2.25 μg of vitamin D2/100 g
Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 excluding those intended for infants	15 μg/day
Food supplements as defined in Directive 2002/46/EC intended for the general population excluding infants	15 μg/day

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," she added.

For more information, visit www.plthealth.com/earthlight.

Media Contact:
Mark Falconer
Sciencewerks
Voice: 407-412-9705
E-mail: [email protected]

Company Contact:
Steve Fink
PLT Health Solutions, Inc.
Voice: 973-984-0900 x214
E-mail: [email protected]

SOURCE PLT Health Solutions