All fetuses were examined grossly for sex distribution and for external abnormalities (one‐third detailed visceral examination and two‐third stained and examined for skeletal defects). no adequate specific studies addressing the safety of use of guar gum (E 412) in this population under certain medical conditions were available. The food consumption data gathered by EFSA were collected by different methodologies and thus direct country‐to‐country comparisons should be interpreted with caution. This Guidance states, that in carrying out its risk assessments, the Panel sought to define a health‐based guidance value, e.g. The effects on serum lipids of minipigs after addition of guar gum (15 and 30 g) to diets containing either with cornstarch or sucrose were studied (Ahrens et al., 1991). Dosages mentioned in these publications were between 5 and 9 g/day, no information on dosage was available in two of those studies. Guar gum was tested in vitro in bacterial test with Salmonella Typhimurium strains G46 and TA1530 (Stanford Research Inst., 1972). The EFSA NDA Panel (2010) reviewed the health claims on guar gum and found no cause and effect relationship between the consumption of guar gum and health claims such as glucose maintenance, satiety or maintenance of cholesterol blood concentrations. infants and young children consuming foods belonging to these food categories may show a higher susceptibility to the gastrointestinal effects of guar gum than their healthy counterparts due to their underlying medical condition. The Panel noted that this assay did not receive further validation and it is not currently employed for genotoxicity testing. The Panel considered that this hypersensitivity might be due to the guar gum proteins and therefore their content should be reduced as much as possible. Based on the available information, the Panel considers that guar gum is unable to elicit genotoxic effects at the gene and chromosomal level. Therefore, the Panel considered that the uncertainties identified would, in general, result in an overestimation of the exposure to guar gum (E 412) as a food additive according to Annex II in European countries for all scenarios. The Panel considered the abdominal discomfort as undesirable but not adverse. was used to measure calcium, iron and zinc availability from casein‐based and whey‐based infant formulas supplemented with soluble fibre fractions, among them guar gum (Bosscher et al., 2001). Positive skin prick test but no specific IgE were reported towards the meal substitute. The AFC Panel concluded that any of these gel‐forming additives or of any other type that gave rise to a confectionery product of a similar size, with similar physical and/or physicochemical properties and that could be ingested in the same way as the jelly mini‐cups, would give rise to a risk for choking (EFSA AFC Panel, 2004). The effects on the fetuses of the highest dose such as sex ratio cannot be used for the safety evaluation as only nine litters were available for examination at necropsy. No specific information on reaction and fate in foods was identified. To reduce these adverse effects, it is advised to take only half the dosage/intake (or to start only with 1 intake/day) at the beginning of consumption and to increase the dosage within a week to the recommended therapeutic dosage. After removal of the hull by sifting or by sieving, the pure endosperm is obtained with a galactomannan content of 85–95% based on dry matter. Available online: http://www.efsa.europa.eu/en/food-consumption/comprehensive-database Very few cases were reported after consumption of foods containing guar gum. However, information provided by the industry on analysis of lead, cadmium, arsenic and mercury in batches of guar gum ranged from < 0.02 to 0.21 mg/kg, < 0.01 to < 0.1 mg/kg, < 0.005 to < 0.1 mg/kg and < 0.01 to < 0.1 mg/kg, respectively (Document provided to EFSA n. 7; Document provided to EFSA n. 5). Guar gum is one of the food additives that composed jelly mini‐cups which were suspended in 2004 by the European Commission to be placed on the market and import (Commission Decision 2004/37/EC, EC 2004), following the measures taken and information provided by different Member States. The Panel considers that these uses would require a specific risk assessment in line with the recommendations given by JECFA and the SCF and endorsed by the Panel in its current Guidance for submission for food additives evaluations (EFSA ANS Panel, 2012). From a dietary combined fertility and developmental 13‐weeks toxicity study on female and male Osborne–Mendel rats (Collins et al., 1987), the Panel could identify a NOAEL for general toxicity of 2,700 mg/kg bw per day (based on decreased body weight on GD 0), a NOAEL of 5,200 mg/kg bw per day for fertility effects based on decreased number of corpora lutea and a NOAEL for developmental toxicity of 11,800 mg/kg bw per day the highest dose tested. Overall, data on in vitro degradation by human gastrointestinal fluids and on in vivo digestibility of guar gum in animals demonstrated that this compound would not be absorbed intact or hydrolysed by digestive enzymes. Available from: http://www.efsa.europa.eu/en/dataclosed/call/ans091123 The substrates fermented by the largest number of species were d‐galactosamine, d‐glucosamine, amylose and amylopectin.
The 1% dispersion shows a pH of 5.5–6.1. In all assays performed, the treatment regime used consisted of three dose levels 30, 2,500 and 5,000 mg/kg bw administered acutely by oral gavage, as single dose or subacutely using the same dosages as those in the acute study, each day for five consecutive days, 24 h apart (Stanford Research Inst., 1972). No other tissue examined was reported having consistent histopathological alterations that could be attributed to exposure to guar gum. During gestation, feed consumption was reduced in all treated groups compared to control animals, but this reduction was only statistically significant at the 2,700 and 5,200 mg/kg bw per day doses and was not dose‐related. delayed gastric emptying, decreased small bowel motility, decreased glucose absorption resulting from increased viscosity of the contents of the gastrointestinal tract and/or inhibition of gastrointestinal hormones (Gruenwald et al., 2007; Martindale, 2014). Commission Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. The weight gain of male rats in this group was decreased by 16% as compared to controls. Females were sacrificed at 15 days after separation from males, and at necropsy, the uterus were analysed for early deaths, late fetal deaths and total implantations. Commercial food‐grade guar gum is reported to contain usually about 80% guaran, 5–6% crude protein, 8–15% moisture, 2.5% crude fibre, 0.5–0.8% ash, and small amounts of lipids composed mainly of free and esterified plant fatty acids. EUROGUM A/S, 2014. Serum total cholesterol decreased in guar gum diet and HDL cholesterol was not affected. The Panel noted that most of the reported cases of allergic reaction to guar gum were after inhalation in occupational settings. Results obtained indicated that tester strains S. Typhimurium TA1530, G‐46 and S. cerevisiae D3 did not show any increase in revertants and mitotic recombination, respectively, both in the acute and subacute treatments. Ingestion of 5 g guar gum granules led to a complete obstruction of the distal oesophagus in a 63‐year‐old diabetic patient without predisposing oesophageal disease. Table 4 summarises the estimated exposure to guar gum (E 412) from its use as a food additive in six population groups (Table 3) according to the different exposure scenario's. Rep. Ser. An in vitro continuous flow dialysis model with a preliminary intraluminal digestive phase2121 The Panel agreed with these conclusions.
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