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Safety of mineral salt containing potassium and magnesium as a novel food pursuant to Regulation (EU) 2015/2283.

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Title: Safety of mineral salt containing potassium and magnesium as a novel food pursuant to Regulation (EU) 2015/2283.
Authors: Turck, Dominique, Bohn, Torsten, Cámara, Montaña, Castenmiller, Jacqueline, De Henauw, Stefaan, Jos, Ángeles, Knutsen, Helle Katrine, Maciuk, Alexandre, Mangelsdorf, Inge, McNulty, Breige, McArdle, Harry J., Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Neuhäuser‐Berthold, Monika
Source: EFSA Supporting Publications; Jan2025, Vol. 22 Issue 1, p1-15, 15p
Subject Terms: POTASSIUM, MAGNESIUM, SALTS, NUTRITION policy, FOOD safety, BROMIDES, SAFETY
Company/Entity: EUROPEAN Commission
Abstract: 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. [ABSTRACT FROM AUTHOR]
Copyright of EFSA Supporting Publications is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Complementary Index
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  Data: Safety of mineral salt containing potassium and magnesium as a novel food pursuant to Regulation (EU) 2015/2283.
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  Data: <searchLink fieldCode="AR" term="%22Turck%2C+Dominique%22">Turck, Dominique</searchLink><br /><searchLink fieldCode="AR" term="%22Bohn%2C+Torsten%22">Bohn, Torsten</searchLink><br /><searchLink fieldCode="AR" term="%22Cámara%2C+Montaña%22">Cámara, Montaña</searchLink><br /><searchLink fieldCode="AR" term="%22Castenmiller%2C+Jacqueline%22">Castenmiller, Jacqueline</searchLink><br /><searchLink fieldCode="AR" term="%22De+Henauw%2C+Stefaan%22">De Henauw, Stefaan</searchLink><br /><searchLink fieldCode="AR" term="%22Jos%2C+Ángeles%22">Jos, Ángeles</searchLink><br /><searchLink fieldCode="AR" term="%22Knutsen%2C+Helle+Katrine%22">Knutsen, Helle Katrine</searchLink><br /><searchLink fieldCode="AR" term="%22Maciuk%2C+Alexandre%22">Maciuk, Alexandre</searchLink><br /><searchLink fieldCode="AR" term="%22Mangelsdorf%2C+Inge%22">Mangelsdorf, Inge</searchLink><br /><searchLink fieldCode="AR" term="%22McNulty%2C+Breige%22">McNulty, Breige</searchLink><br /><searchLink fieldCode="AR" term="%22McArdle%2C+Harry+J%2E%22">McArdle, Harry J.</searchLink><br /><searchLink fieldCode="AR" term="%22Naska%2C+Androniki%22">Naska, Androniki</searchLink><br /><searchLink fieldCode="AR" term="%22Pentieva%2C+Kristina%22">Pentieva, Kristina</searchLink><br /><searchLink fieldCode="AR" term="%22Siani%2C+Alfonso%22">Siani, Alfonso</searchLink><br /><searchLink fieldCode="AR" term="%22Thies%2C+Frank%22">Thies, Frank</searchLink><br /><searchLink fieldCode="AR" term="%22Aguilera‐Gómez%2C+Margarita%22">Aguilera‐Gómez, Margarita</searchLink><br /><searchLink fieldCode="AR" term="%22Cubadda%2C+Francesco%22">Cubadda, Francesco</searchLink><br /><searchLink fieldCode="AR" term="%22Frenzel%2C+Thomas%22">Frenzel, Thomas</searchLink><br /><searchLink fieldCode="AR" term="%22Heinonen%2C+Marina%22">Heinonen, Marina</searchLink><br /><searchLink fieldCode="AR" term="%22Neuhäuser‐Berthold%2C+Monika%22">Neuhäuser‐Berthold, Monika</searchLink>
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  Data: EFSA Supporting Publications; Jan2025, Vol. 22 Issue 1, p1-15, 15p
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  Data: <searchLink fieldCode="DE" term="%22POTASSIUM%22">POTASSIUM</searchLink><br /><searchLink fieldCode="DE" term="%22MAGNESIUM%22">MAGNESIUM</searchLink><br /><searchLink fieldCode="DE" term="%22SALTS%22">SALTS</searchLink><br /><searchLink fieldCode="DE" term="%22NUTRITION+policy%22">NUTRITION policy</searchLink><br /><searchLink fieldCode="DE" term="%22FOOD+safety%22">FOOD safety</searchLink><br /><searchLink fieldCode="DE" term="%22BROMIDES%22">BROMIDES</searchLink><br /><searchLink fieldCode="DE" term="%22SAFETY%22">SAFETY</searchLink>
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– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: 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. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label:
  Group: Ab
  Data: <i>Copyright of EFSA Supporting Publications is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.2903/j.efsa.2025.9205
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      – Code: eng
        Text: English
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      – SubjectFull: POTASSIUM
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      – SubjectFull: SAFETY
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              Text: Jan2025
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