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 an extension of use for the Novel Food (NF) ‘oleoresin from Haematococcus (H.) pluvialis containing astaxanthin (ATX)’ pursuant to Regulation (EU) 2015/2283. The NF is already authorised under Regulation (EU) 2015/2283 as an ingredient for use in food supplements (FS) as defined in Directive 2002/46/EC. The NF is produced by supercritical CO2 extraction of the homogenised and dried biomass of cultivated H. pluvialis and contains approximately 10% w/w ATX With the present dossier, the applicant seeks authorisation for an extension of use of the NF for the use in dairy analogues, including beverage whiteners and fruit juices as defined by Directive 2001/112/EC. The applicant performed an intake assessment for ATX which covered combined exposure from the background diet with the consumption of fish and crustacea plus intakes of the NF from the intended new uses. In such a scenario the exposure for all population groups is below or at the acceptable daily intake (ADI) of 0.2 mg/kg bw per day. When adding also potential intake of ATX from the authorised use of the NF in FS, for children of 3 years of age and older and adolescents, the combined exposure from all three sources exceeds the ADI. For adults, the combined estimated intake is at the level of the ADI. The Panel concludes that the NF is safe at the intended new uses (dairy analogues, including beverage whiteners and fruit juices), provided that FS containing ATX are not consumed on the same day by children and adolescents.

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 UV‐treated oil from yellow mealworm (Tenebrio molitor larvae) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced from farmed T. molitor larvae and consists mainly of fat (~99%). It is obtained by mechanical separation and is subsequently exposed to UVB radiation to enhance vitamin D3 content. UV‐treatment substantially increased vitamin D3 levels. Under the proposed use levels, the NF represents a significant contributor to vitamin D intake from foods (including the background diet and fortified foods), accounting for up to half of the intake in older children, adolescents, and adults. Combined intakes from foods and the NF remained below the tolerable upper intake level (UL) for all age groups. Analytical data showed that contaminant levels were below regulatory limits established for other foods, and intake estimates indicated that consumption of the NF would not substantially increase overall dietary exposure to undesirable substances. The Panel further notes that there are no safety concerns regarding the stability of the NF. The NF is intended for use as an ingredient in a range of food products, including bakery products, sauces, dairy desserts, and fats. The target population is the general population. Toxicological studies, including newly submitted in vitro genotoxicity tests, did not raise safety concerns. Animal studies indicated that vitamin D3 from the NF is bioavailable. The intake of the NF is not nutritionally disadvantageous. The Panel notes that allergic reactions may occur upon consumption, due to primary sensitisation or cross‐reactivity with other allergens. The Panel concludes that the NF is safe under the proposed uses and use levels.

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 synthetic cannabidiol as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF which is subject of the application is the (−)‐cannabidiol (CBD) produced by chemical synthesis and proposed to be used in food supplements at a maximum use level of 150 mg/day. The target population is the general population above 6 years of age, excluding pregnant and lactating women. During the risk assessment, the Panel identified a number of data gaps, which needed to be addressed by the applicant. EFSA's request for additional information was sent to the applicant. The requested data concerned the identity, the production process, the compositional data, the specifications, the genotoxicity, the reproductive and developmental toxicity and the human data of the NF. The applicant did not reply or provide sufficient information on the identity (small particles and/or nanoparticles), stability, genotoxicity, reproductive and developmental toxicity and the human data for the NF. The applicant did not reply to the latest EFSA's request (in June 2022) for additional data. Based on the available data, the Panel concludes that the safety of the NF cannot be established.

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 the changes in the conditions of use and the specifications of the hydrothermally treated Jatropha curcas L. (Chuta) in form of kernels (whole or broken), flour and paste as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The extension of use pertains to the inclusion of two new forms of the already authorised NF (i.e. kernel as flour and kernel as paste, both consisting of 100% ground kernel) and to increase the maximum use levels of NF kernels from 5 g NF/100 g to 30 g NF/100 g in the previously authorised food categories. Additionally, the change in the specifications aims at increasing the fat content range (from 54%–61% to 54%–64%) in the final NF. According to the applicant, the grinding of Chuta kernels does not alter the safety and inherent characteristics of the NF. In the previous assessment, the Panel identified the potential presence of phorbol esters (PEs) as the major hazard in the consumption of the NF. Similarly to what has been done in the previous opinion, a conservative scenario for exposure to PEs from the three forms of NF was calculated based on the newly proposed uses and use levels. The lowest estimated margin of exposure (MoE) was 190. Considering the absence of genotoxicity concerns and the magnitude of the calculated MoEs, the Panel concluded that the new forms of the NF do not raise any safety concerns under the proposed conditions of use.

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 the safety of the fungal biomass from Fusarium species strain flavolapis as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF as the frozen form of the Fusarium sp. str. flavolapis (named by the applicant), which is proposed by the applicant to be used as an ingredient in several food categories, is sufficiently characterised. The information provided on the production process, composition, stability and specifications of the NF is sufficient and does not raise safety concerns. Based on the findings of a repeated dose 90‐day oral toxicity study in rats conducted with the dehydrated NF, and considering the evidence for thyroidal effects along with the lack of robustness of other findings at the low dose tested, the Panel considers the lowest dose tested as the no observed adverse effect level (NOAEL), i.e. 2744 mg/kg bw per day of the NF in a dehydrated form, corresponding to approximately 10,400 mg/kg bw per day NF. Under the proposed conditions of use, the highest intake estimates of the NF range from 189 to 556 mg/kg bw per day. Applying a default uncertainty factor of 200 to the NOAEL, the Panel considers that the margins of exposure (i.e. 55 in adolescents and 19 in infants) between the intake of the NF at the proposed use and use levels and the NOAEL from the 90‐day study are insufficient. The Panel considers that it is likely that the NF may trigger allergic reactions in allergic subjects. The Panel concludes that, based on the available data, the safety of the NF, i.e. biomass of Fusarium strain flavolapis (F. sp. strain flavolapis) fungus, cannot be established.

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 the safety of an extension of use of pasteurised Akkermansia muciniphila as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The extension pertains to the use of the NF in food supplements and Foods for Special Medical Purposes (FSMPs) for adolescents from 12 to < 18 years of age and to pregnant and lactating women. The maximum proposed daily doses of the NF correspond to about 4.8 × 108 cells/kg bodyweight per day, which was the safe dose as established for the NF by the Panel in 2021. The newly identified toxicological and human studies with A. muciniphila from various strains, including the strain to which the NF belongs, do not raise safety concerns in view of the extension of use of the NF for adolescents from 12 years of age. However, no evidence was provided for the safety of the NF in pregnant and lactating women. The Panel concludes that the NF, pasteurised A. muciniphila, is safe at doses up to 2.1 × 1010 cells/day for adolescents from 12 to < 14 years and 3.0 × 1010 cells/day for adolescents from 14 years until < 18 years. The safety of the NF in pregnant and lactating women has not been established.

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 rhamnogalacturonan‐I enriched carrot fibre (cRG‐I) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a high molecular weight polysaccharide derived from carrot pomace. The Panel considers that the production process is sufficiently described and does not raise safety concerns. The novel food is intended for use as ingredient in various food products targeting the general population, in food for special medical purposes, meal replacement for weight control and food supplements targeting the general population excluding infants, and in total diet replacement for weight control targeting the adult population. Taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. Based on the data provided the Panel considers that there are no concerns regarding genotoxicity. Results from the 90‐day study did not show effects of toxicological relevance for humans up to the highest dose tested (7753 mg/kg bw per day). The NF may retain the allergenic potential of carrots and allergic reactions to the NF may occur, but they will not be dissimilar from those triggered by the consumption of carrots. The Panel considers the margins of exposure to be sufficient considering that the source (i.e. carrots), nature, composition and production of the NF do not raise safety concerns. The Panel concludes that the NF, cRG‐I, a rhamnogalacturonan‐rich polysaccharide fraction derived from carrot pomace, is safe under the proposed conditions of use.

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 lacto‐N‐tetraose (LNT) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human‐identical milk oligosaccharide (HiMO) LNT, but it also contains lacto‐N‐triose II, d‐lactose, LNT‐fructose isomer and a small fraction of other related saccharides. The NF is produced by fermentation with a genetically modified strain (Escherichia coli K‐12 MG1655 INB_LNT_01) of E. coli K‐12 MG1655 (ATCC 700926). LNT when produced by fermentation with genetically modified strains of E. coli K‐12 DH1 or E. coli BL21 is already authorised and included in the EU list of NFs. This application refers to a change in the production process and specifications, while the target population, conditions of use and consequently the anticipated intake remain unchanged. The information provided on the identity, production process, composition and specifications of the NF does not raise safety concerns. The intake of other carbohydrate‐type compounds structurally related to LNT is also considered of no safety concern. In line with other HiMOs, the safety assessment of this NF is mainly based on the comparison between the intake of breastfed infants and the estimated intake of the NF. Given that the NF would be consumed to the same extent as the already authorised LNT, the Panel considers that the consumption of the NF at the proposed uses and use levels does not raise safety concerns. The Panel concludes that the NF is safe under the proposed conditions of use.

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 the safety of inulin‐propionate ester as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, which is the subject of the application, is a compound constituted by a natural polymer composed mainly of fructose moieties, polysaccharide inulin (65%–95% w/w), esterified with a short‐chain fatty acid (SCFA) moiety, propionic acid (5%–35% w/w). The NF is synthesised by the chemical reaction of inulin with propionic anhydride, under alkaline conditions and controlled temperature. The target population for the NF is the general population and it is intended to be used as an ingredient in cereal bars and fruit smoothie type beverages. Based on the provided studies investigating the metabolic fate of the NF, the Panel considers that the NF is not absorbed intact, but it is metabolised mainly in the large intestine to inulin and propionate which then exhibit normal metabolic fate of non‐digestible dietary fibre and SCFA, respectively. Taking into account physico‐chemical properties of the NF, the production process and metabolic fate of the NF, which do not raise safety concerns, and given that propionic acid and its salts were previously assessed by EFSA ANS Panel (2014), as well as that a large body of safety data were available on inulin, the Panel considers that no genotoxicity and subchronic toxicological studies are required on the NF. Despite the limitations of the provided human studies (primarily designed to investigate efficacy endpoints), the Panel notes that the NF, at doses up to 20 g/day for durations up to 12 months, appears to be generally well‐tolerated. The Panel concludes that the NF, inulin‐propionate ester, is safe for the general population under the proposed conditions of use.

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 the safety of magnesium orotate dihydrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of magnesium from this source in the context of Directive 2002/46/EC. The NF is produced by chemical synthesis and is proposed to be used in food supplements at a maximum intake level of 6100 mg per day by adults. This intake level corresponds to around 5000 mg/day orotic acid and 400 mg/day magnesium. The Panel notes that this would exceed the established UL for supplemental magnesium of 250 mg/day, therefore the use of the NF could be nutritionally disadvantageous. The Panel also notes the previous safety assessment of magnesium orotate dihydrate, where concerns were raised regarding the exposure to orotic acid, based on several animal studies demonstrating tumour‐promoting effects. The ANS Panel derived a no observed adverse effect level (NOAEL) for orotic acid of 50 mg/kg bw per day. The margin between the derived NOAEL for orotic acid and the exposure resulting from the proposed maximum use level of the NF is 0.7 (based on the average bw of an adult person of 70 kg) which is even lower than the margin considered by the ANS Panel of being inadequate. The applicant has not provided any toxicological data on the NF or on orotic acid that could address or mitigate these safety concerns. The Panel concludes that the safety of the NF, magnesium orotate dihydrate, cannot be established under the proposed conditions of use. The assessment of bioavailability of magnesium from the NF in comparison to natural sources was not conducted.

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 synthetic cannabidiol as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF which is subject of the application is trans-cannabidiol (CBD), produced by chemical synthesis and proposed to be used in food supplements at a level of 30 mg/day. The target population is the general population, excluding pregnant and lactating women. During the risk assessment, the Panel identified a number of data gaps, which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data concerned the identity, the production process, the compositional data, the specifications, the genotoxicity, the reproductive and developmental toxicity and the human data of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. Based on the available data, the Panel concludes that the safety of the NF, i.e. synthetic cannabidiol, cannot be established.

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 grain and flour from perennial intermediate wheatgrass (IWG) (Thinopyrum intermedium) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, composed primarily of carbohydrates, proteins and water, is produced by cultivating the IWG plant and subsequently processing it to yield either grains or flour. The target population proposed by the applicant is the general population and the NF is proposed as a food ingredient in several food products. Considering the nutritional profile of the NF and the proposed conditions of use, its consumption is considered not nutritionally disadvantageous, and the Panel considers that no toxicological studies are required on this NF. The microbiological analyses for several batches of the NF revealed high microbial counts regarding total aerobic microbial count, Enterobacteriaceae, yeasts and moulds, highlighting excessive variability in the hygiene conditions along the production process. The NF has the same potential as wheat, barley and rye to trigger IgE‐mediated allergic reactions in cereal‐allergic individuals and/or adverse reactions in individuals with coeliac disease under the proposed conditions of use. The Panel notes that, due to the high microbial loads observed in both IWG grain and flour batches, the microbiological quality of the NF is compromised. The potential presence of Enterobacteriaceae and opportunistic pathogen Pantoea species, such as P. agglomerans, and further released compounds could pose safety concerns. Moreover, the provided stability data do not support a 12‐month shelf‐life for the NF. Based on the available data, the Panel concludes that the safety of the NF, grain and flour from perennial intermediate wheatgrass (Thinopyrum intermedium) cannot be established.

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 D-allulose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps, which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data concerned the identity, the production process, proposed uses and use levels, genotoxicity and human data of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. Based on the available data, the Panel concludes that the safety of the NF, i.e. D-allulose, cannot be established.

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 yellow tomato extract used as a novel food (NF) pursuant to Regulation (EU) 2283/2015. The NF which is the subject of the application is a carotenoid-rich extract from the yellow tomato containing predominantly phytoene plus phytofluene (PE/PF) at up to 10% of the NF, as well as a lesser amount of zeta-carotene (≤ 5%), beta-carotene (≤ 0.5%) and lycopene (≤ 0.4%). The NF is produced from the tomato pulp using supercritical CO2 extraction. The applicant proposes to use the NF in food supplements (FS) for adults only at a maximum daily dose of 100 mg. The intake of lycopene from such FS would correspond to 0.4 mg/day which corresponds to 5.7 μg/kg body weight and day for an adult weighing 70 kg. This is approximately 1.1% of the acceptable daily intake (ADI) for lycopene established by EFSA (i.e. 0.5 mg/kg body weight), which does not raise safety concerns. According to the exposure assessment performed by EFSA, which included all population age groups, the highest mean and highest P95 intakes/kg bw estimates for PE/PF from the background diet of infants and toddlers are higher than the combined exposure of adults from the background diet and the NF under its proposed use and use levels in food supplements. Noting that the main sources for PE/PF are commonly and regularly consumed also by the youngest age groups and that PE/PF exposure from the background diet does not raise safety concern, the Panel considers that the NF is nutritionally not disadvantageous at the proposed intake of the NF of up to 100 mg/day used in FS in adults. The Panel concludes that the NF, yellow tomato extract, is safe under the proposed conditions of use.

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 Clostridium butyricum TO-A as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, which is proposed by the applicant to be used as a food supplement, is sufficiently characterised. The information provided on the production process, composition, stability and specifications of the NF is sufficient and does not raise safety concerns. Based on the findings of a repeated dose 90-day oral toxicity study in rats, and considering an uncertainty factor of 200, the Panel estimated a safe dose in humans of 4.5 × 106 colony forming unit (CFU)/kg body weight (bw) per day. However, considering that appropriate initial bacteria colonisation of the gastrointestinal tract in humans, in particular during the first 3 years of life, profoundly affects health during infancy and childhood, that disruptions to the microbiota early in life can have lasting health effects into adulthood, and taking into account that the 90-day oral toxicity study was conducted in adult rats, the Panel considers that the target population for the NF should be restricted to children above 3 years of age, adolescents and adults, excluding pregnant and lactating women. The Panel concludes that the NF, C. butyricum TO-A, is safe at 1.0 × 108 CFU/day for other children (3 to < 10 years), 2.0 × 108 CFU/day for adolescents from 10 to < 14 years, 2.8 × 108 CFU/day for adolescents from 14 to < 18 years and 3.2 × 108 CFU/day for adults, excluding pregnant and lactating women.

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 dried biomass powder of Chlamydomonas reinhardtii THN 6 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data pertained to the identity, the production process, composition, specifications, history of use, proposed uses and use levels, nutritional information, genotoxicity and allergenicity of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. The Panel concludes that, based on the available data, the safety of the NF, i.e. dried biomass powder of C. reinhardtii THN 6, cannot be established.

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 the safety of the extension of use of 3-fucosyllactose (3-FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, produced with a genetically modified strain (Escherichia coli BL21 (DE3) JBT-3FL) of E. coli BL21 (DE3), is already authorised as ingredient in several food categories, including infant formula (IF) and follow-on formula (FOF). The applicant proposed to increase the maximum use levels of the NF in IF, FOF, food for special medical purposes (FSMP) and food supplements (FS). EFSA estimated the anticipated daily intake of the NF from the proposed extension of use in the relevant food categories. Additionally, a new intake estimate including the already authorised conditions of use in other food categories was carried out. The estimated daily intake of the NF from high consumption of IF alone at the proposed maximum use level in infants < 16 weeks of age is lower than the estimated natural highest mean daily intake of 3-FL from human milk in breastfed infants. The estimated highest 95th percentile daily intake in infants from the combined exposure from the maximum authorised and proposed uses of 3-FL, is somewhat higher than the estimated intake from the already authorised uses and below the estimated highest natural mean daily intake of 3-FL from human milk in breastfed infants. The same applies to the use of the NF in FSMP and FS. Therefore, the Panel considers that the proposed extension of use does not affect the safety of the NF and concludes that the NF, 3-FL, is safe under the proposed conditions of use.

Novel food (NF) approvals in the European Union between 2018 and 2023 (n=117) were retrieved and analysed. They consist of new NF (52.1%), modification (38.5%), and traditional food (9.4%). The average time taken for new NF applications to be approved was 38 months in 2023, with clock-stops occurring in all approvals since 2020. For new NFs, only 21.3% and 9.8% performed tests by bioinformatics homology and immunological analyses respectively, suggesting that allergenicity assessments remain a challenge. Allergenicity risks were regarded as possible for 47.5% of the new NF approvals, while 52.5% were expected to be low, very low, or unlikely. However, it was not always clear what the decision was based on. While protein intake levels were rarely mentioned in the allergenicity conclusions of approvals, new NFs with allergenicity risks typically had protein intake exceeding 1mg/day. Establishing a dose that represents a Threshold of Allergological Concern below which a protein is unlikely to cause sensitisation in consumers, could make de novo allergenicity assessment of NFs more feasible. This approach might exempt certain proteins from testing, instead focusing on proteins of possible allergenic relevance.

Abstract The Novel Foods Risk Assessment Data Modelling and Extraction (NORA) project, commissioned by the European Food Safety Authority (EFSA) and implemented by EcoMole s.r.o., aimed to develop a structured database to support the risk assessment process for novel foods (NF). The project encompassed three key objectives: (1) designing a comprehensive data model for NF opinions, leveraging and extending existing frameworks like OpenFoodTox 2.0; (2) extracting and integrating data from published NF opinions into the database; and (3) creating a guideline for systematic data entry to support future use. The resulting data model successfully captured administrative, compositional, toxicological, and allergenic properties of NFs with approximately 35% of the data model adopted from OpenFoodTox 2.0 and 65% representing new or refined elements specific to NF assessment. Relevant data from 196 NF opinions published by June 2024 were extracted and integrated into the database. The database supports advanced querying, filtering, and exporting functionalities, while a user interface facilitates efficient data entry and visualisation.

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.