TY - JOUR
T1 - Safety of mineral salt containing potassium and magnesium as a novel food pursuant to Regulation (EU) 2015/2283
AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
AU - Turck, Dominique
AU - Bohn, Torsten
AU - Cámara, Montaña
AU - Castenmiller, Jacqueline
AU - De Henauw, Stefaan
AU - Jos, Ángeles
AU - Knutsen, Helle Katrine
AU - Maciuk, Alexandre
AU - Mangelsdorf, Inge
AU - McNulty, Breige
AU - McArdle, Harry J.
AU - Naska, Androniki
AU - Pentieva, Kristina
AU - Siani, Alfonso
AU - Thies, Frank
AU - Aguilera-Gómez, Margarita
AU - Cubadda, Francesco
AU - Frenzel, Thomas
AU - Heinonen, Marina
AU - Neuhäuser-Berthold, Monika
AU - Poulsen, Morten
AU - Prieto Maradona, Miguel
AU - Schlatter, Josef Rudolf
AU - Siskos, Alexandros
AU - van Loveren, Henk
AU - Turla, Emanuela
AU - Hirsch-Ernst, Karen Ildico
N1 - Publisher Copyright:
© 2025 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.
PY - 2025
Y1 - 2025
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 a mineral salt, containing potassium and magnesium, as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a mineral salt that consists mainly of magnesium potassium trichloride hexahydrate. The information provided on the composition is sufficient for characterising the NF and does not raise safety concerns. The production process is sufficiently described and does not raise safety concerns. The NF is intended to be added to meat, sausages and dishes based on pasta, rice and other cereals. Taking into account the composition of the NF and the proposed use and use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. Regarding the presence of bromide in the NF, the Panel notes that the combined daily intake of bromide from the NF and the background diet does not exceed the tolerable daily intake of bromide of 0.4 mg/kg body weight (bw) per day. Based on its physicochemical characteristics and solubility data, the NF is expected to be dissociated in the gastrointestinal tract. Taking into account the composition and the nature of the NF, the Panel considers that no toxicological studies with the NF are required. The Panel concludes that the NF (i.e. a mineral salt containing potassium and magnesium) is safe under the proposed conditions of use.
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 a mineral salt, containing potassium and magnesium, as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a mineral salt that consists mainly of magnesium potassium trichloride hexahydrate. The information provided on the composition is sufficient for characterising the NF and does not raise safety concerns. The production process is sufficiently described and does not raise safety concerns. The NF is intended to be added to meat, sausages and dishes based on pasta, rice and other cereals. Taking into account the composition of the NF and the proposed use and use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. Regarding the presence of bromide in the NF, the Panel notes that the combined daily intake of bromide from the NF and the background diet does not exceed the tolerable daily intake of bromide of 0.4 mg/kg body weight (bw) per day. Based on its physicochemical characteristics and solubility data, the NF is expected to be dissociated in the gastrointestinal tract. Taking into account the composition and the nature of the NF, the Panel considers that no toxicological studies with the NF are required. The Panel concludes that the NF (i.e. a mineral salt containing potassium and magnesium) is safe under the proposed conditions of use.
KW - Magnesium
KW - Mineral salt
KW - Novel food
KW - Potassium
KW - Safety
U2 - 10.2903/j.efsa.2025.9205
DO - 10.2903/j.efsa.2025.9205
M3 - Journal article
C2 - 39816961
AN - SCOPUS:85215533039
SN - 1831-4732
VL - 23
JO - EFSA Journal
JF - EFSA Journal
IS - 1
M1 - e9205
ER -