Safety of mineral salt containing

EFSA Journal. 2025;23:e9205. | 1 of 15 https://doi.org/10.2903/j.efsa.2025.9205 efsa.onlinelibrary.wiley.com/journal/1831-4732 SCIENTIFIC OPINION Safety of mineral salt containing potassium and magnesium as a novel food pursuant to Regulation (EU) 2015/2283 EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) | Dominique Turck | Torsten Bohn | Montaña Cámara | Jacqueline Castenmiller | Stefaan DeHenauw | Ángeles Jos | Helle Katrine Knutsen | Alexandre Maciuk | Inge Mangelsdorf | Breige McNulty | Harry J. McArdle | Androniki Naska | Kristina Pentieva | Alfonso Siani | Frank Thies | Margarita AguileraGómez | Francesco Cubadda | Thomas Frenzel | Marina Heinonen | Monika NeuhäuserBerthold | Morten Poulsen | Miguel Prieto Maradona | Josef Rudolf Schlatter | Alexandros Siskos | Henk van Loveren | Emanuela Turla | Karen Ildico HirschErnst Adopted: 17 December 2024 DOI: 10.2903/j.efsa.2025.9205 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. KEYWORDS magnesium, mineral salt, novel food, potassium, safety The declarations of interest of all scientific experts active in EFSA's work are available at https:// open. efsa. europa. eu/ experts This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. © 2025 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority. Correspondence: [email protected] 2 of 15 | SAFETY OF A MINERAL SALT CONTAINING POTASSIUM AND MAGNESIUM AS NOVEL FOOD CONTENTS Abstract................................................................................................................................................................................................................................1 1. Introduction ..............................................................................................................................................................................................................3 1.1. Background and Terms of Reference as provided by the requestor .........................................................................................3 2. Data and Methodologies ......................................................................................................................................................................................3 2.1. Data ...................................................................................................................................................................................................................3 2.2. Methodologies..............................................................................................................................................................................................3 3. Assessment ................................................................................................................................................................................................................3 3.1. Introduction ...................................................................................................................................................................................................3 3.2. Identity of the NF .........................................................................................................................................................................................3 3.3. Production process .....................................................................................................................................................................................4 3.4. Compositional data .....................................................................................................................................................................................4 3.4.1. Stability ............................................................................................................................................................................................6 3.5. Specifications ................................................................................................................................................................................................6 3.6. History of use of the NF .............................................................................................................................................................................8 3.7. Proposed uses and use levels and anticipated intake ....................................................................................................................8 3.7.1. Target population .........................................................................................................................................................................8 3.7.2. Proposed uses and use levels ..................................................................................................................................................8 3.7.3. Anticipated daily intake of the NF ..........................................................................................................................................8 3.7.4. Estimate of exposure to undesirable substances .............................................................................................................9 3.8. Absorption, distribution, metabolism and excretion (ADME) .....................................................................................................9 3.9. Nutritional information ...........................................................................................................................................................................10 3.10. Toxicological information .......................................................................................................................................................................11 3.10.1. Human data ..................................................................................................................................................................................11 3.11. Allergenicity .................................................................................................................................................................................................11 4. Discussion.................................................................................................................................................................................................................11 5. Conclusions ............................................................................................................................................................................................................. 12 5.1. Protection of proprietary data in accordance with Article 26 of Regulation (EU) 2015/2283........................................ 12 6. Steps taken by EFSA ............................................................................................................................................................................................. 12 Abbreviations ................................................................................................................................................................................................................. 12 Requestor ......................................................................................................................................................................................................................... 12 Question number .......................................................................................................................................................................................................... 12 Amendment .................................................................................................................................................................................................................... 13 Copyright for nonEFSA content.............................................................................................................................................................................. 13 Panel members .............................................................................................................................................................................................................. 13 References........................................................................................................................................................................................................................ 13 Appendix A ...................................................................................................................................................................................................................... 14 Annex A ............................................................................................................................................................................................................................ 15 18314732, 2025, 1, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9205 by Readcube (Labtiva Inc.), Wiley Online Library on [13/05/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License | 3 of 15 SAFETY OF A MINERAL SALT CONTAINING POTASSIUM AND MAGNESIUM AS NOVEL FOOD 1 | INTRODUCTION 1.1 | Background and Terms of Reference as provided by the requestor On 21 December 2018, the company BK Guilini GmbH (member of the ICL group) submitted a request to the European Commission in accordance with Article 10 of Regulation (EU) 2015/22831 to authorise placing on the market a mineral salt containing potassium and magnesium as a Novel Food (NF). The applicant requests to authorise the use of a mineral salt containing potassium and magnesium in a number of foods. The target population is adults and elderly people. The applicant has not requested data protection under Article 26 of Regulation (EU) 2015/2283. In accordance with Article 10(3) of Regulation (EU) 2015/2283, the European Commission asks the European Food Safety Authority (EFSA) to provide a scientific opinion on the safety of a mineral salt containing potassium and magnesium as a NF. 2 | DATA AND METHODOLOGIES 2.1 | Data The safety assessment of this NF is based on data supplied in the application and information submitted by the applicant following EFSA's requests for supplementary information. During the assessment, the Panel identified additional data which were not included in the application. Administrative and scientific requirements for NF applications referred to in Article 10 of Regulation (EU) 2015/2283 are listed in Commission Implementing Regulation (EU) 2017/2469.2 A common and structured format on the presentation of NF applications is described in the EFSA guidance on the preparation and presentation of an NF application (EFSA NDA Panel,2016). As indicated in this guidance, it is the duty of the applicant to provide all available (proprietary, confidential and published) scientific data (including both data in favour and not in favour) that are pertinent to the safety of the NF. During the assessment, the applicant requested data protection in accordance with Article 26 of Regulation (EU) 2015/2283 for information on the production process and composition. The data requested by the applicant to be protected are listed in AppendixA. 2.2 | Methodologies The assessment follows the methodology set out in the EFSA guidance on NF applications (EFSA NDA Panel,2016) and the principles described in the relevant existing guidance documents from the EFSA Scientific Committee. The legal provisions for the assessment are laid down in Article 11 of Regulation (EU) 2015/2283 and in Article 7 of Commission Implementing Regulation (EU) 2017/2469. This assessment concerns only the risks that might be associated with consumption of the NF under the proposed conditions of use and is not an assessment of the efficacy of the NF with regard to any claimed benefit. 3 | ASSESSMENT 3.1 | Introduction The NF which is the subject of this application is a mineral salt, which mainly consists of magnesium potassium trichloride hexahydrate. The NF falls under the category of ‘food consisting of, isolated from or produced from material of mineral origin’ (Art. 3 (2) (a) (iii)). The NF is produced by a multistep crystallisation process of seawater from the Dead Sea by solar evaporation. The NF is intended to be added to meat, sausages, pastabased dishes, ricebased dishes and other cereal baseddishes. 3.2 | Identity of the NF The NF is a natural mixture of mineral salts, which mainly consists of magnesium potassium trichloride hexahydrate (CAS No. 1318270; chemical formula: KMgCl3·6H2O or KCl.MgCl2·6H2O; molecular weight: 277.85; synonyms: carnallite, magnesium potassium trichloride hydrate). In order to characterise the saline structure of the NF, infrared spectra were performed on three batches of the NF. Xray diffraction spectroscopy was applied to six batches of the NF to determine the composition of the crystals of the NF. These 1Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 concerning novel foods. OJ L 327, 11.12.2015, pp. 1–22. 2Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. OJ L 351, 30.12.2017, pp. 64–71. 18314732, 2025, 1, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9205 by Readcube (Labtiva Inc.), Wiley Online Library on [13/05/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License 4 of 15 | SAFETY OF A MINERAL SALT CONTAINING POTASSIUM AND MAGNESIUM AS NOVEL FOOD analyses showed that magnesium potassium trichloride hexahydrate (KMgCl3.6H2O) amounted to 80%–93% in the batches tested. The other salts identified in these batches were magnesium chloride hexahydrate (MgCl2.6H2O) (3%–16%), sodium chloride (NaCl) (2%–5%) and magnesium chloride (MgCl2), which was detected only in one batch (1%). 3.3 | Production process The NF is produced by solar evaporation of water exclusively originating from the Dead Sea in Israel through a series of evaporation ponds. The process is based on precipitation of minerals, dredging the minerals by large, augerstyle dredges, and processing them into the final product. The NF is produced in a discontinuous process about four to six times a year, each process lasting about 5 days. Dead Sea brines are pumped into the first of a series of socalled ‘salt ponds’, where solar evaporation results in the precipitation of NaCl. Subsequently, the resulting brine is pumped into a series of ponds called ‘carnallite ponds’. In these ponds, the solution is further concentrated via solar evaporation, and carnallite crystallises and precipitates. Carnallite is mechanically ‘harvested’ from the bottom of the ponds and transferred to the food grade salt plant where the damp crystals are sieved. The final material is stored in silos and packed in polyethylene (PE) bags. According to the information provided, the NF is produced in line with good manufacturing practice and hazard analysis critical control points principles. The Panel considers that the production process is sufficiently described and does not raise safety concerns. 3.4 | Compositional data The NF mainly consists of magnesium potassium trichloride hexahydrate. In order to confirm that the manufacturing process is reproducible and adequate to produce the NF on a commercial scale, the applicant provided analytical information for up to six batches of the NF (Tables1 and 2). The applicant also tested up to six batches of the NF for several metals and other elements, which may be present in the seawater of the Dead Sea (Table3). Upon EFSA's request for additional information, the applicant investigated the possible formation of bromate (BrO3 −) in the NF which may be formed by reaction of bromide and ozone. The analysis provided by the applicant showed that bromate was below the limit of quantification (LOQ < 1 mg/kg) in all three analysed batches of the NF. The batches were also tested for pesticides, polycyclic aromatic hydrocarbons, dioxins and dioxinlike polychlorinated biphenyls, which were all found to be below LOQs. The applicant provided information on the accreditation of the laboratories which conducted the analyses presented in this application. TABLE 1 Batch to batch analysis of the NF. Parameter Batch 1 Batch 2 Batch 3 Batch 7 Batch 8 Batch 9 Method of analysis Potassium (g/100 g) 11.3 11.5 11.7 11.8 12.1 12.5 Batches 1, 2, 3: ICPOES (according to DIN EN ISO 11885:2009–09) Batches 7, 8, 9: ICPMS (according to DIN EN ISO 172942) Magnesium (g/100 g) 8.0 8.2 8.5 9.2b9.2b8.9 Calcium (g/100 g) 0.068 0.070 0.076 0.110 0.116 0.064 Sodium (g/100 g) 2.00 1.76 2.09 2.37 1.91 2.25 Chloride (g/100 g) 41.3 41.3 40.2 (−) (−) (−) § 64 LFGB L 17.00–6: 1988–12 (potentiometric titration) Bromine (total) (g/100 g) 0.43 0.42 0.42 0.416c 0.381d0.415c 0.418d0.431c 0.397dBatches 1, 2, 3: ICPMS Batches 7, 8, 9c,d Bromide (Br−) (g/100 g) (−) (−) (−) 0.40 0.35 0.39 Ionchromatography (according to DIN EN ISO 103041:2009–07) Total water at 180°C (water of crystallisation plus moisture) (g/100 g) 36.2e36.3e36.4e(−) (−) (−) Gravimetric method Carnallite (g/100 g) 94.13 94.94 91.73 (−) (−) (−) Calculateda Note: (−) not tested or not calculated. Abbreviations: DIN, Deutsches Institut für Normung (German Institute for Standardization); EN, Europäische Norm (European Standard); ICPMS, Inductively Coupled Plasma Mass Spectrometry; ICPOES, Inductively Coupled Plasma Optical Emission Spectrometry; ISO, International Organization for Standardization; LFGB, Lebensmittel- , Bedarfsgegenständeund Futtermittelgesetzbuch (German Food, Articles of Daily Use and Feed Code). aCarnallite calculated from ion analysis and gravimetry only = 100 – (%NaCl + %CaCl2 + SO4 2− + Br− + %insoluble). bThis value exceeds the limit listed in the specifications (Table4). cResults obtained with X-ray (according to DIN 51418-2). dResults obtained with ICP-MS (according to DIN EN ISO 17294-2). eTotal water at 180°C was measured in three other batches. 18314732, 2025, 1, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9205 by Readcube (Labtiva Inc.), Wiley Online Library on [13/05/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License | 5 of 15 SAFETY OF A MINERAL SALT CONTAINING POTASSIUM AND MAGNESIUM AS NOVEL FOOD TABLE 2 Physicochemical and microbiological parameters of the NF. Appearance and smell Batch 1 Batch 2 Batch 3 Method of analysis White dry granules without a specific smell Moisture (g/100 g) 1.5 3.2 0.8 64 LFGB L 17.00–1: 1982–05 Ash (g/100 g) 60.5 60.2 58.7 64 LFGB L 17.00–3: 1982–05 Ash, HClinsoluble (g/100 g) 1.7 2.3 2.2 64 LFGB L 53.00–4: 1996–02 Insoluble parts (cold water) (g/100 g) < 1.0 < 1.0 < 1.0 HHMAM 10–004: 2016–10 Insoluble parts (boiling water) (g/100 g) 0.25 0.35 0.33 ISO 2479: 1972–12 Acid insoluble parts (g/100 g) < 0.05 < 0.05 < 0.05 ISO 2479: 1972–12 Water activity (awvalue) (25°C) 0.024 ± 0.001a0.026 ± 0.001a0.027 ± 0.001aISO 18787 Relative density 1.662 1.665 1.666 2011–033520204D Melting point, onset°C 151.9 152.7 151.9 2011–035350203D – Ph.Eur. 9.5 Protein, N x F: 6.25 (g/100 g) < 0.1 < 0.1 < 0.1 § 64 LFGB L 17.00–15: 2013–08 Total organic carbon (%) < 0.10 < 0.10 < 0.10 ISO 10694: 1995–03 Extractable organic halides (mg/kg) < 1.0 < 1.0 < 1.0 DIN 38409–8 (H8): 1984–09 Total Plate Count (CFU/g) < 10 < 10 < 10 DIN EN ISO 48331: 2013–12 Coliforms (CFU/g) < 10 < 10 < 10 ISO 4832: 2006–02 E. coli (in 1 gram) Not detected Not detected Not detected Ph. Eur. 2.6.13: 2010–04 Staphylococci. coag. positive (CFU/g) < 10 < 10 < 10 DIN EN ISO 68881: 2003–12 Salmonella (in 25 gram) Not detected Not detected Not detected 64 LFGB L 00.00–20: 2008–12 Halotolerant bacteria (CFU/g) < 100 < 100 < 100 MB Bd. VI 7.22.2, 7. Erg. 2010 Abbreviations: CFU, colony forming units; DIN, Deutsches Institut für Normung; DIN EN ISO, Deutsches Institut für Normung, Europäische Norm, International Organization for Standardization; F, factor; HH, Headspace Analysis; LFGB, LebensmittelBedarfsgegenständeund Futtermittelgesetzbuch (German Food, Articles of Daily Use and Feed Code); MA, Mass Spectrometry Analysis; N, nitrogen; Ph. Eur., Pharmacopoeia Europaea (European Pharmacopoeia). aWater activity was measured in three other batches. TABLE 3 Batchto batch analyses for metals and other elements in the NF. Parameter Batch 1 Batch 2 Batch 3Batch 7 Batch 8 Batch 9 Method of analysis Aluminium (mg/kg) < 1.0 < 1.0 < 1.0 < 1.0 < 1.0 < 1.0 DIN EN15763, mod., ICPMS: 2010–04 Ammonium (% w/w) < 0.02 < 0.02 < 0.02 (−) (−) (−) 2011–058970100D (ion selective electrode) Antimony (mg/kg) < 0.050 < 0.050 < 0.050 (−) (−) (−) DIN EN 15763, mod., ICPMS: 2010–04 Arsenic (mg/kg) < 0.040 < 0.040 < 0.040 (−) (−) (−) DIN EN ISO 15763, ICPMS: 2010–04 Barium (mg/kg) 0.22 0.22 0.26 0.27 0.24 0.15 DIN EN 15763, mod., ICPMS: 2010–04 Bismuth (mg/kg) < 0.50 < 0.50 < 0.50 (−) (−) (−) DIN EN ISO 172942 (E29), ICPMS:2017–01 Boron (mg/kg) < 10 < 10 < 10 (−) (−) (−) DIN EN ISO 11885, ICPOES: 2009–09 Bromate (mg/kg) (−) (−) (−) < 1 < 1 < 1 DIN EN ISO ion chromatography 10,304–1: 2009–07 Cadmium (mg/kg) < 0.010 < 0.010 < 0.010 (−) (−) (−) DIN EN 15763, ICPMS: 2010–04 Carbonate (wt.- %) 0.039 0.036 0.040 (−) (−) (−) Calculated from solids (carbon, inorganic) Chlorate (mg/kg) 0.15 0.16 0.17 (−) (−) (−) HHMAM 02–151, LC–MS/MS: 2018–03 Chromium (mg/kg) < 0.080 < 0.080 < 0.080 (−) (−) (−) DIN EN 15763, mod., ICPMS: 2010–04 Cobalt (mg/kg) < 0.050 < 0.050 < 0.050 (−) (−) (−) DIN EN 15763, mod., ICPMS: 2010–04 Copper (mg/kg) 0.046 0.060 < 0.040 0.03 0.03 0.10 DIN EN 15763, mod., ICPMS: 2010–04 Fluoride (mg/kg) < 5 < 5 < 5 < 40*< 40*< 40*Batches 1,2, 3: selective electrode DIN EN ISO 16279: 2012–09 Batches 7, 8, 9: ion chromatography DIN EN ISO 103041: 2009–07 Iodine (mg/kg) < 0.1 < 0.1 < 0.1 (−) (−) (−) DIN EN 15111: 2007–06 ICP/MS Iron (mg/kg) 2.1 2.0 1.8 3.6 3.4 2.5 DIN EN ISO 11885, ICPOES: 2009–09 Lead (mg/kg) < 0.020 < 0.020 < 0.020 (−) (−) (−) DIN EN 15763, ICPMS: 2010–04 18314732, 2025, 1, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9205 by Readcube (Labtiva Inc.), Wiley Online Library on [13/05/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License 6 of 15 | SAFETY OF A MINERAL SALT CONTAINING POTASSIUM AND MAGNESIUM AS NOVEL FOOD Sieve analyses of three batches of the NF resulted in 55%–60% of the particles sized 180–450 μm with only less than 0.5% of the particles with a particle size below 180 μm. A laser diffraction analysis indicated that the particle size distribution ranged from 52.33 to 1184 μm with a mean value of 556.4 μm. During the assessment, the applicant was requested to perform solubility tests in accordance with the EFSA Guidance on the technical requirements to establish the presence of small particles, including nanoparticles (EFSA Scientific Committee, 2021). Considering the high solubility of the NF (≥ 33.3 g/L), there are no concerns regarding the presence of particles in the nanoscale range. The Panel considers that the information provided on the composition of the NF is sufficient and does not raise safety concerns. 3.4.1 | Stability The applicant proposed a shelflife of 60 months for the NF, to be stored in a dry covered area at humidity below 75%. The NF is packed in PE bags to prevent absorption of water. The water activity of the NF is lower than the water activity of KCl and NaCl. Taking into account the nature of the NF, the Panel considers that no undesirable degradation products are expected to occur under the proposed storage conditions. 3.5 | Specifications The specifications of the NF are presented in Table4. The Panel considers that the information provided on the specifications of the NF is sufficient and does not raise safety concerns. Parameter Batch 1 Batch 2 Batch 3Batch 7 Batch 8 Batch 9 Method of analysis Lithium (mg/kg) 1.0 1.1 0.77 1.0 0.95 0.65 DIN EN ISO 11885, ICPOES: 2009–09 Manganese (mg/kg) 2.1 2.1 2.8 2.5 1.9 1.9 DIN EN ISO 11885, ICPOES: 2009–09 Mercury (mg/kg) < 0.010 < 0.010 < 0.010 (−) (−) (−) DIN EN 15763, ICPMS: 2010–04 Nickel (mg/kg) < 0.040 < 0.040 < 0.040 (−) (−) (−) DIN EN 15763, mod., ICPMS: 2010–04 Nitrate (mg/kg) < 100 < 100 < 100 < 400 < 400 < 400 Batches 1,2, 3: 2011–057250199D (ion chromatography) Batches 7, 8, 9: DIN EN ISO 103041: 2009–07 Nitrite (mg/kg) < 100*< 100*< 100*< 10 < 10 < 10 Batches 1,2, 3: 2011–057250199D (ion chromatography) Batches 7, 8, 9: DIN EN ISO 103041: 2009–07 Perchlorate (mg/kg) < 0.050 < 0.050 < 0.050 (−) (−) (−) HHMAM 02–151, LC–MS/MS: 2018–03 Phosphate (mg/kg) < 100 < 100 < 100 (−) (−) (−) 2011–057250199D (ion chromatography) Phosphorus (total) (mg/kg) < 5.0 < 5.0 < 5.0 (−) (−) (−) DIN EN ISO 11885, ICPOES: 2009–09 Selenium (mg/kg) < 0.10 < 0.10 < 0.10 (−) (−) (−) DIN EN 15763, mod., ICPMS: 2010–04 Silicon (mg/kg) (−) (−) (−) < 10 < 10 < 10 DIN EN ISO 17294-2, ICP-MS: 01/2017 Silver (mg/kg) < 0.050 < 0.050 < 0.050 (−) (−) (−) DIN EN 15763, mod., ICPMS: 2010–04 Strontium (mg/kg) 14 14 20 21 19 12 DIN EN ISO 11885, ICPOES: 2009–09 Sulfate (mg/kg) 100 100 100 < 400 < 400 < 400 Batches 1, 2, 3: ion chromatography (according to 2011–057250199D) Batches 7, 8, 9: ion chromatography (according to DIN EN ISO 103041: 2009–07) Sulfur (mg/kg) 51 < 50.0 54.9 < 1000 < 1000 < 1000 Batches 1, 2 and 3: ICPMS Batches 7, 8, 9: DIN EN ISO 11885, ICPOES: 2009–09 Tin (mg/kg) < 0.040 < 0.040 < 0.040 (−) (−) (−) DIN EN 15763, ICPMS: 2010–04 Zinc (mg/kg) < 0.50 0.54 0.58 (−) (−) (−) DIN EN 15763, ICPMS: 2010–04 Note: (−) not analysed. Abbreviations: DIN EN, Deutsches Institut für Normung, Europäische Norm; DIN EN ISO, Deutsches Institut für Normung, Europäische Norm, International Organization for Standardization; HH, Headspace Analysis; ICPMS, Inductively Coupled Plasma Mass Spectrometry; ICPOES, Inductively Coupled Plasma Optical Emission Spectrometry; ISO, International Organization for Standardization; LC–MS/MS, Liquid Chromatography Tandem Mass Spectrometry; MA, Mass Spectrometry Analysis; Ph. Eur., Pharmacopoeia Europaea (European Pharmacopoeia); w/w, weight per weight. *Value above the proposed limit in the specifications. TABLE 3 (Continued) 18314732, 2025, 1, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9205 by Readcube (Labtiva Inc.), Wiley Online Library on [13/05/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License | 7 of 15 SAFETY OF A MINERAL SALT CONTAINING POTASSIUM AND MAGNESIUM AS NOVEL FOOD TABLE 4 Specifications of the NF. Description of the NF, Mineral salt containing potassium and magnesium. White, offwhite crystalline, fine granular, slightly hygroscopic product with a characteristic saline taste. Exclusively originating from water of the Dead Sea, Israel, produced by fractional precipitation. Synonyms Potassium magnesium chloride hydrate Identity Positive by Xray diffraction Parameter Specification (unit) Melting point (range) 149.6–160.2°C Solubility pH 1.94; 4.13 and 6.80 Freely soluble pH 8.06 Slightly soluble Insoluble parts ≤ 0.3% (w/w) Water at 180°C (water of crystallisation plus moisture) 32%–40% Main constituents Chloride 40%–42% (w/w) Potassium 11.0%–13.6% (w/w) Magnesium 7.9%–8.9% (w/w) Calcium ≤ 0.2% (w/w) Sodium ≤ 2.75% (w/w) Heavy metals Arsenic < 0.1 mg/kg Cadmium < 0.1 mg/kg Mercury < 0.05 mg/kg Lead < 0.1 mg/kg Trace elements Bromide (Br−)≤ 0.40% (w/w) Strontium ≤ 25 mg/kg Manganese ≤ 3.0 mg/kg Iron ≤ 4.0 mg/kg Copper ≤ 0.5 mg/kg Boron ≤ 10 mg/kg Aluminium ≤ 1.0 mg/kg Total phosphorous ≤ 5 mg/kg Sulfate < 500 mg/kg Nitrite < 10 mg/kg Nitrate < 400 mg/kg Chlorate < 0.2 mg/kg Bromate < 1 mg/kg Fluoride ≤ 5 mg/kg Iodine < 0.1 mg/kg Microbiological parameters Total plate count < 100 CFU/g E. coli Not detected in 1 g Salmonella Not detected in 25 g Salttolerant microorganisms < 100 CFU/g Sum parameters TOC < 0.10% (w/w) Abbreviations: CFU, colony forming units; TOC, total organic carbon; w/w, weight per weight. 18314732, 2025, 1, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9205 by Readcube (Labtiva Inc.), Wiley Online Library on [13/05/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License 8 of 15 | SAFETY OF A MINERAL SALT CONTAINING POTASSIUM AND MAGNESIUM AS NOVEL FOOD 3.6 | History of use of the NF In 2012, a GRAS (generally recognised as safe) status of the NF was granted by the FDA (GRN n. 4033). 3.7 | Proposed uses and use levels and anticipated intake 3.7.1 | Target population The target population proposed by the applicant is adults (individuals aged 18 years and above). However, as the NF is intended to be used as an ingredient in standard foods, it cannot be excluded that the NF would be also consumed by other groups of the population. Therefore, the safety data and the exposure assessment shall cover all population groups (Article 5(6) of Commission Implementing Regulation (EU) 2017/2469). 3.7.2 | Proposed uses and use levels During the assessment, EFSA requested the applicant to revise the initially proposed uses and use levels of the NF taking into account the recently established tolerable daily intake (TDI) of bromide (see Section3.7.4). Table5 presents the new intended uses proposed by the applicant with the maximum use levels. The applicant clarified that the NF is intended to partially replace salt, and it is to be sold exclusively to food manufacturers and not to final consumers. 3.7.3 | Anticipated daily intake of the NF The applicant performed an intake assessment of the anticipated daily intake of the NF, which was confirmed by EFSA, based on the applicant's proposed uses and maximum use levels (Table5), using the EFSA Dietary Exposure (DietEx) Tool4 which is based on individual data from the EFSA Comprehensive European Food Consumption Database (EFSA,2011). The lowest and highest mean and 95th percentile anticipated daily intakes of the NF for each population group, among the EU dietary surveys, are presented in Tables6 and 7 (expressed as mg/kg bw per day and mg/day, respectively). The estimated daily intake of the NF for each population group from each EU dietary survey is available in the Excel file annexed to this scientific opinion (under supporting information). 3https:// www. cfsan appse xtern al. fda. gov/ scrip ts/ fdcc/? set= GRASN otice s& id= 403& sort= GRN_ No& order= DESC& start row= 1& type= basic & search= 403. 4https:// www. efsa. europa. eu/ it/ scien ce/ toolsandresou rces/ dietex. TABLE 6 Ranges (lowest and highest) among EU dietary surveys of the estimated daily intake of the NF (mg/kg bw per day) as an ingredient in the intended food categories at the maximum proposed use levels. Population groups (age) Mean intake (mg/kg bw per day) P95 intake (mg/kg bw per day) LowestaHighestaLowestbHighestb Infants (up to 11 months) 0.01 8.69 0.00 44.72 Young children (12–35 months)c1.80 21.19 9.84 67.04 Other children (3–9 years) 4.26 20.77 14.30 59.14 Adolescents (10–17 years) 2.24 13.63 7.40 36.77 Adults (18 years and above)d0.62 10.23 3.09 31.28 Abbreviations: bw, body weight; P95, 95th percentile. aIntakes are assessed for all EU dietary surveys available in the food comprehensive database on 16 July 2024. The lowest and the highest averages observed among all EU surveys are reported in these columns. bIntakes are assessed for all EU dietary surveys available in the food comprehensive database on 16 July 2024. The lowest and the highest P95 observed among all EU surveys are reported in these columns (P95 based on less than 60 individuals are not considered). cReferred to as ‘toddlers’ in the EFSA food consumption comprehensive database (EFSA,2011). dIncludes population groups of elderly, very elderly, pregnant women and lactating women. TABLE 5 Food categories (defined using the FoodEx2a hierarchy) and maximum use levels of the NF. FoodEx2 codes FoodEx2 level Food category Maximum use level of the NF A022R L3 Raw cured (or seasoned) meat 1050 mg/100 g A023G L3 Cooked cured (or seasoned) meat 700 mg/100 g A040M L3 Pastas and rice (or other cereal)- based dishes 600 mg/100 g A0EYP L3 Preserved or partly preserved sausage 1050 mg/100 g aEFSA food classification system https:// www. efsa. europa. eu/ en/ data/ datastand ardis ation . 18314732, 2025, 1, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9205 by Readcube (Labtiva Inc.), Wiley Online Library on [13/05/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License | 9 of 15 SAFETY OF A MINERAL SALT CONTAINING POTASSIUM AND MAGNESIUM AS NOVEL FOOD 3.7.4 | Estimate of exposure to undesirable substances Considering the maximum amounts of lithium and barium observed in the NF and the maximum limits of strontium and chlorate set in the specifications of the NF and the intended use of the NF, the Panel considers that the contribution of these substances to the background diet is small and of no concern. The exposure to bromide and bromate from the NF has been addressed in the following subsections. Bromide The EFSA Scientific Committee conducted an assessment to establish toxicological reference values for bromide.5 On 20 November 2024, during the open plenary of the EFSA Scientific Committee, the opinion on bromide was discussed and adopted (EFSA Scientific Committee,2025). The adopted opinion sets a TDI for bromide of 0.4 mg/kg bw per day. Based on this recently established TDI and considering an exposure to bromide from the background diet of 0.1 mg/kg bw per day, as indicated in the opinion on bromide, the applicant was requested to revise the intended uses and use levels of the NF, which are presented in Table5. Based on the highest 95th percentile anticipated daily intake of the NF (67.04 mg/kg bw per day), which occurred in the population group of young children, and the maximum level of bromide proposed in the specifications (0.4%), the highest 95th percentile exposure to bromide from the NF was estimated to be 0.27 mg/kg bw per day. The Panel notes that the highest 95th percentile exposure to bromide from the NF (0.27 mg/kg bw per day) in combination with the chronic exposure to bromide from the diet (0.1 mg/kg bw per day) does not exceed the TDI of bromide of 0.4 mg/kg bw per day. Bromate Considering the production process, which occurs via solar irradiation of ponds covering large areas, the Panel requested the applicant to investigate the possible presence of bromate (BrO3- ) in the NF which could be formed by reaction of bromide (Br- ) and ozone (O3). Bromate was below the LOQ (LOQ: 1 mg/kg) in all three batches of the NF tested (Table3). In a worstcase scenario in which bromate from the NF would be present in amounts close to the LOQ of 1 mg/kg, the exposure to bromate from the NF would range from 0.031 to 0.067 μg/kg bw per day. Considering the TDI reported by WHO, (2005 – publication retrieved by EFSA) (1 μg/kg bw per day), the Panel considers that the potential presence of bromate in the NF does not raise safety concerns. 3.8 | Absorption, distribution, metabolism and excretion (ADME) Based on its physicochemical characteristics and solubility data, the NF is expected to dissociate in the gastrointestinal tract. Taking into account the nature of the NF, ADME information on the main constituents of the NF (i.e. chloride, potassium, magnesium) as well as bromide are described in this section. 5https:// open. efsa. europa. eu/ quest ions/ EFSA-Q202200329 . TABLE 7 Ranges (lowest and highest) among EU dietary surveys of the estimated daily intake of the NF (mg/day) as an ingredient in the intended food categories at the maximum proposed use levels. Population groups (age) Mean intake (mg/day) P95 intake (mg/day) LowestaHighestaLowestbHighestb Infants (up to 11 months) 0.13 66.89 0.00 399.00 Young children (12–35 months)c21.49 261.75 118.13 866.25 Other children (3–9 years) 100.51 515.56 336.00 1320.63 Adolescents (10–17 years) 124.72 676.96 386.61 1785.00 Adults (18 years and above)d51.09 799.25 262.50 2464.87 Abbreviation: P95, 95th percentile. aIntakes are assessed for all EU dietary surveys available in the food comprehensive database on 16 July 2024. The lowest and the highest averages observed among all EU surveys are reported in these columns. bIntakes are assessed for all EU dietary surveys available in the food comprehensive database on 16 July 2024. The lowest and the highest P95 observed among all EU surveys are reported in these columns (P95 based on less than 60 individuals are not considered). cReferred to as ‘toddlers’ in the EFSA food consumption comprehensive database (EFSA,2011). dIncludes population groups of elderly, very elderly, pregnant women and lactating women. 18314732, 2025, 1, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9205 by Readcube (Labtiva Inc.), Wiley Online Library on [13/05/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License