Regulatory round up: Mushroom powder and boron supplement source added to EC register
Detailing the decision-making process in its official journal, the EC responded to Ireland-based MBio, Monaghan Mushrooms’ application to place its vitamin D2 mushroom powder on the Union market as a novel food.
The application requested the Vitamin D2 mushroom powder be approved for use in food supplements (15 micrograms (μg) of vitamin D2/day) excluding food supplements intended for infants and young children.
Other relevant food categories include meal replacement foods for weight control (2.1 micrograms per 100 grams (μg/100g)) and dairy products and analogues other than beverages (2.1 μg/100 g (marketed as such or reconstituted as instructed by the manufacturer)
“The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘UV-treated mushroom powder containing vitamin D2,” the application details.
“The labelling of food supplements containing vitamin D2 mushroom powder shall bear a statement that they should not be consumed by infants and children under 3 years of age.”
Calcium fructoborate green light
Earlier this month, the EC also notified its intentions to approve the placing on the market of calcium fructoborate as a novel food.
The applicant, US-based VDF FutureCeuticals, had requested calcium fructoborate to be used in food supplements for the adult population, excluding pregnant and lactating women.
The EC has allowed the use of the natural sugar-borate ester as a rich source of soluble boron in supplements at a maximum level of 220 milligrams per day.
Produced by combining fructose with boric acid in water, calcium carbonate is then added to produce a solution containing the calcium salt of fructoborate (tetrahydrate).
The solution is then freeze-dried, ground to produce the final powdered product, and then packaged and stored under representative storage conditions (22 ± 1°C RH 55-60 %)
The ingredient has been implicated in relieving symptoms of physiological response to stress, including inflammation of the mucous membranes, and discomfort associated with osteoarthritis disorders.
Further research has suggested a role in reducing bone loss, supporting cardiovascular health and as an anti-inflammatory agent.
Additional specific labelling requirements requested by the EC include the designation of the novel food on the labelling of the foodstuffs containing it shall be ‘calcium fructoborate.’
EFSA iron source opinion
Finally, European Food Safety Authority (EFSA) has given its backing for the use of iron hydroxide adipate tartrate as a source of iron for use in supplements up to a maximum dose of 100mg per day.
According to EFSA’s Scientific Opinion this amount corresponds to a maximum daily intake of iron of 36mg.
“The target population proposed by the applicant is the general population above 3 years of age,” the opinion continues.
“The Panel considers that the NF, iron hydroxide adipate tartrate, is a source from which iron is bioavailable and concludes is safe under the proposed conditions of use.”
Iron hydroxide adipate tartrate is an engineered nanomaterial having primary particles, of almost spherical morphology, with a diameter typically smaller than five nanometres (nm).
Supporting studies provided by the applicant Nemysis Limited, indicates that iron from the NF is bioavailable, and once taken up into the epithelial cells of the gut, is subject to the same mechanisms of regulation and absorption as that of other forms of iron.
Further studies provided in the context of the toxicological assessment indicate that the NF does not lead to iron bioaccumulation in tissues and organs at the doses tested.