TY - JOUR
T1 - Safety of vitamin D2 mushroom powder as a Novel food pursuant to Regulation (EU) 2015/2283 (NF 2019/1471).
AU - Turck, Dominique
AU - Bohn, Torsten
AU - Castenmiller, Jacqueline
AU - De Henauw, Stefaan
AU - Hirsch-Ernst, Karen Ildico
AU - Maciuk, Alexandre
AU - Mangelsdorf, Inge
AU - McArdle, Harry J
AU - Naska, Androniki
AU - Pelaez, Carmen
AU - Pentieva, Kristina
AU - Siani, Alfonso
AU - Thies, Frank
AU - Tsabouri, Sophia
AU - Vinceti, Marco
AU - Cubadda, Francesco
AU - Frenzel, Thomas
AU - Heinonen, Marina
AU - Marchelli, Rosangela
AU - Neuhäuser-Berthold, Monika
AU - Poulsen, Morten
AU - Prieto Maradona, Miguel
AU - Schlatter, Josef Rudolf
AU - van Loveren, Henk
AU - Gerazova-Efremova, Katerina
AU - Roldán-Torres, Ruth
AU - Knutsen, Helle Katrine
AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
N1 - Funding Information:
The Panel wishes to thank Petra Gergelová for the support provided to this scientific opinion.
Publisher Copyright:
© 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.
PY - 2022/6/10
Y1 - 2022/6/10
N2 - Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on vitamin D2 mushroom powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced from Agaricus bisporus mushroom that has been exposed to ultraviolet (UV) irradiation to induce the conversion of provitamin D2 (ergosterol) to vitamin D2 (ergocalciferol). The NF contains levels of vitamin D in the form of vitamin D2 in the range of 125–375 µg/g. The information provided on the production process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF as an ingredient in a variety of foods and beverages in amounts that result in either 1.125 or 2.25 µg vitamin D2 per 100 g or 100 mL of the food as consumed. The applicant also intends to add the NF in food supplements, for infants from 7 to 11 months at a maximum of 10 µg vitamin D2/day and of 15 µg vitamin D2/day for individuals aged 1 year or older, as well as in foods for special medical purposes (FSMPs) and total and meal diet replacement for weight control. For the adult population, the maximum intended use level in FSMPs is 15 µg vitamin D2/day and 5 µg vitamin D2/meal in total and meal diet replacement for weight control. The Panel concludes that the NF is safe under the proposed conditions of use. The Panel notes uncertainty regarding the calculated combined exposures to vitamin D for the general population, given the fact that the range of foods fortified with vitamin D has increased over the years, as well as the marketing of high-dose vitamin D supplements.
AB - Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on vitamin D2 mushroom powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced from Agaricus bisporus mushroom that has been exposed to ultraviolet (UV) irradiation to induce the conversion of provitamin D2 (ergosterol) to vitamin D2 (ergocalciferol). The NF contains levels of vitamin D in the form of vitamin D2 in the range of 125–375 µg/g. The information provided on the production process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF as an ingredient in a variety of foods and beverages in amounts that result in either 1.125 or 2.25 µg vitamin D2 per 100 g or 100 mL of the food as consumed. The applicant also intends to add the NF in food supplements, for infants from 7 to 11 months at a maximum of 10 µg vitamin D2/day and of 15 µg vitamin D2/day for individuals aged 1 year or older, as well as in foods for special medical purposes (FSMPs) and total and meal diet replacement for weight control. For the adult population, the maximum intended use level in FSMPs is 15 µg vitamin D2/day and 5 µg vitamin D2/meal in total and meal diet replacement for weight control. The Panel concludes that the NF is safe under the proposed conditions of use. The Panel notes uncertainty regarding the calculated combined exposures to vitamin D for the general population, given the fact that the range of foods fortified with vitamin D has increased over the years, as well as the marketing of high-dose vitamin D supplements.
KW - Agaricus bisporus
KW - food supplement
KW - mushroom powder
KW - Novel Foods
KW - safety
KW - UV treatment
KW - vitamin D
UR - http://www.scopus.com/inward/record.url?scp=85133249307&partnerID=8YFLogxK
UR - https://pubmed.ncbi.nlm.nih.gov/35706680
U2 - 10.2903/j.efsa.2022.7326
DO - 10.2903/j.efsa.2022.7326
M3 - Article
C2 - 35706680
SN - 1831-4732
VL - 20
JO - EFSA Journal
JF - EFSA Journal
IS - 6
M1 - e07326
ER -