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Younes Maged - One of the best experts on this subject based on the ideXlab platform.
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Safety assessment of titanium dioxide (E171) as a Food Additive
'Wiley', 2021Co-Authors: Younes Maged, Aquilina Gabriele, Castle Laurence, Fowler Paul, Frutos Fernandez, Maria Jose, Engel Karl\u2010heinz, F\ufcrst Peter, G\ufcrtler Rainer, Gundert\u2010remy Ursula, Hus\uf8y TrineAbstract:The present opinion deals with an updated safety assessment of the Food Additive titanium dioxide(E 171) based on new relevant scientific evidence considered by the Panel to be reliable, includingdata obtained with TiO2nanoparticles (NPs) and data from an extended one-generation reproductivetoxicity (EOGRT) study. Less than 50% of constituent particles by number in E 171 have a minimumexternal dimension30 nm) up to the highest dose tested of100 mg/kg bw per day. No effects on reproductive and developmental toxicity were observed up to adose of 1,000 mg E 171/kg bw per day, the highest dose tested in the EOGRT study. However,observations of potential immunotoxicity and inflammation with E 171 and potential neurotoxicity withTiO2NPs, together with the potential induction of aberrant crypt foci with E 171, may indicate adverseeffects. With respect to genotoxicity, the Panel concluded that TiO2particles have the potential toinduce DNA strand breaks and chromosomal damage, but not gene mutations. No clear correlationwas observed between the physico-chemical properties of TiO2particles and the outcome of eitherin vitroorin vivogenotoxicity assays. A concern for genotoxicity of TiO2particles that may be presentin E 171 could therefore not be ruled out. Several modes of action for the genotoxicity may operate inparallel and the relative contributions of different molecular mechanisms elicited by TiO2particles arenot known. There was uncertainty as to whether a threshold mode of action could be assumed. Inaddition, a cut-off value for TiO2particle size with respect to genotoxicity could not be identified. Noappropriately designed study was available to investigate the potential carcinogenic effects of TiO2NPs. Based on all the evidence available, a concern for genotoxicity could not be ruled out, and giventhe many uncertainties, the Panel concluded that E 171 can no longer be considered as safe whenused as a Food Additive.\ua92021 European Food Safety Authority. EFSA Journalpublished by John Wiley and Sons Ltd on behalfof European Food Safety Authority.Keywords:Titanium dioxide, E 171, CAS No 13463-67-7EFSA Journal 2021;19(5):6585www.efsa.europa.eu/efsajourna
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Re\u2010evaluation of polydextrose (E 1200) as a Food Additive
'Wiley', 2021Co-Authors: Younes Maged, Aquilina Gabriele, Castle Laurence, Fowler Paul, Engel Karl\u2010heinz, F\ufcrst Peter, G\ufcrtler Rainer, Gundert\u2010remy Ursula, Hus\uf8y Trine, Manco MelaniaAbstract:This opinion deals with the re-evaluation of polydextrose (E 1200) when used as a Food Additive. The Panel followed the conceptual framework for the risk assessment of certain Additives and considered that: adequate exposure estimates were available; the margin of safety (MOS)/margin of exposure (MOE) for arsenic was between 0.5-14 and 8.5 for lead; the exhaustions of the tolerable weekly intake (TWI) for cadmium would be 165%, 10% for mercury, whereas the exhaustion of the tolerable daily intake (TDI) for nickel would be 9%; the absorption is limited and part of polydextrose is fermented in the large intestine into short-chain fatty acids (SCFA); adequate toxicity data were available; there is no concern with respect to genotoxicity; no adverse effects were reported in subchronic studies in rats, dogs or monkeys nor in chronic or carcinogenicity studies in mice and rats at the highest doses tested of up 12,500 mg/kg body weight (bw) per day and 15,000 mg/kg bw per day, respectively; the nephrocalcinosis in dogs given high doses of polydextrose was considered to be a treatment-related but a secondary effect related to diarrhoea, and hence not relevant for the risk assessment; no adverse effects were reported in reproductive or developmental toxicity studies in rats administered up to 10,000 mg polydextrose/kg bw per day, or in a developmental toxicity study in rabbits up to 1,818 mg/kg bw per day (the highest dose tested). Therefore, the Panel concluded that there is no need for numerical acceptable daily intake (ADI) for polydextrose (E 1200), and that there is no safety concern for the reported uses and use levels of polydextrose as a Food Additive. The Panel recommended that European Commission considers to lower the maximum limit for lead and to introduce limits for arsenic, cadmium and mercury in the EU specifications for polydextrose (E 1200), and to verify that polydextrose-N as a Food Additive (E 1200) is no longer marketed in the EU
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Safety assessment of titanium dioxide (E171) as a Food Additive.
'Wiley', 2021Co-Authors: Efsa Panel on Food Additives And Flavourings, Younes Maged, A. Gabriele, C. Laurence, E. Karl-heinz, F. Paul, F.fernandez Jose, F. Peter, G.r. Ursula, G. RainerAbstract:The present opinion deals with an updated safety assessment of the Food Additive titanium dioxide (E 171) based on new relevant scientific evidence considered by the Panel to be reliable, including data obtained with TiO nanoparticles (NPs) and data from an extended one-generation reproductive toxicity (EOGRT) study. Less than 50% of constituent particles by number in E 171 have a minimum external dimension < 100 nm. In addition, the Panel noted that constituent particles < 30 nm amounted to less than 1% of particles by number. The Panel therefore considered that studies with TiO NPs < 30 nm were of limited relevance to the safety assessment of E 171. The Panel concluded that although gastrointestinal absorption of TiO particles is low, they may accumulate in the body. Studies on general and organ toxicity did not indicate adverse effects with either E 171 up to a dose of 1,000 mg/kg body weight (bw) per day or with TiO NPs (> 30 nm) up to the highest dose tested of 100 mg/kg bw per day. No effects on reproductive and developmental toxicity were observed up to a dose of 1,000 mg E 171/kg bw per day, the highest dose tested in the EOGRT study. However, observations of potential immunotoxicity and inflammation with E 171 and potential neurotoxicity with TiO NPs, together with the potential induction of aberrant crypt foci with E 171, may indicate adverse effects. With respect to genotoxicity, the Panel concluded that TiO particles have the potential to induce DNA strand breaks and chromosomal damage, but not gene mutations. No clear correlation was observed between the physico-chemical properties of TiO particles and the outcome of either or genotoxicity assays. A concern for genotoxicity of TiO particles that may be present in E 171 could therefore not be ruled out. Several modes of action for the genotoxicity may operate in parallel and the relative contributions of different molecular mechanisms elicited by TiO particles are not known. There was uncertainty as to whether a threshold mode of action could be assumed. In addition, a cut-off value for TiO particle size with respect to genotoxicity could not be identified. No appropriately designed study was available to investigate the potential carcinogenic effects of TiO NPs. Based on all the evidence available, a concern for genotoxicity could not be ruled out, and given the many uncertainties, the Panel concluded that E 171 can no longer be considered as safe when used as a Food Additive.
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Opinion on the re‐evaluation of ascorbyl palmitate (E 304i) as a Food Additive in Foods for infants below 16 weeks of age and the follow‐up of its re‐evaluation as a Food Additive for uses in Foods for all population groups
'Wiley', 2020Co-Authors: Younes Maged, Aquilina Gabriele, Castle Laurence, Engel Karl‐, Fowler Paul, Frutos Fernandez, Maria Jose, Manco MelaniaAbstract:Ascorbyl palmitate (E 304(i)) was re\u2010evaluated in 2015 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS ). As a follow\u2010up to this assessment, the Panel on Food Additives and Flavourings (FAF ) was requested to assess the safety of ascorbyl palmitate (E 304(i)) for its uses as Food Additive in Food for infants below 16 weeks of age belonging to Food categories 13.1.1 (Infant formulae) and 13.1.5.1 (Dietary Foods for infants for special medical purposes and special formulae for infants) and as carry over in line with Annex III , Part 5 Section B to Regulation (EC ) No 1333/2008. In addition, the FAF Panel was requested to address the issues already identified during the re\u2010evaluation of the Food Additive when used in Food for the general population. The process involved the publication of a call for data to allow the interested business operators to provide the requested information to complete the risk assessment. On the basis of the data submitted by interested business operators and the considerations from the Panel, a revision of the existing EU specifications for ascorbyl palmitate (E 304 (i)) has been recommended. Based on in vitro data, the FAF Panel assumed that ascorbyl palmitate fully hydrolyses pre\u2010systemically to ascorbic acid and palmitate. The Panel concluded that the intake of both metabolites, at the MPL s for ascorbyl palmitate as a Food Additive in infant formula belonging to FC 13.1.1 or in Food for special medical purposes belonging to FC 13.1.5.1, does not raise health concerns
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Safety of a proposed amendment of the specifications for steviol glycosides (E 960) as a Food Additive: to expand the list of steviol glycosides to all those identified in the leaves of Stevia Rebaudiana Bertoni
'Wiley', 2020Co-Authors: Younes Maged, Aquilina Gabriele, Engel Karl‐, Fowler Paul, Frutos Fernandez, Maria Jose, Manco MelaniaAbstract:The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of the proposed amendment of the specifications for steviol glycosides (E 960) as a Food Additive, in particular to expand the list of steviol glycosides to 60 steviol glycosides identified in the leaves of Stevia Rebaudiana Bertoni. With the existing specifications, the Food Additive must be comprised of not less than 95% of the 11 named steviol glycosides. The proposed change is to include all 60 steviol glycosides in the same limit value of 95% and this would allow the presence of up to 5% of impurities. FAF Panel considered that all steviol glycosides share the same metabolic fate, and therefore, the safety of 60 identified steviol glycosides can be based on read\u2010across from toxicological data previously evaluated by EFSA and the acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day will apply to all those steviol glycosides. However, according to the proposed change in specifications, there remains a small but not insignificant fraction of the Additive that would be undefined and therefore cannot be evaluated by the Panel. The Panel concluded that the inclusion of the 60 steviol glycosides in the proposed specifications for steviol glycoside (E960) would not be of safety concern. However, the Panel cannot conclude on the safety of the proposed amendment to the specifications of steviol glycosides (E 960) as Food Additive if the purity assay value of not less than 95% for the total content of steviol glycosides is maintained
A J Alnughamish - One of the best experts on this subject based on the ideXlab platform.
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hepatotoxicity induced by the anti oxidant Food Additive butylated hydroxytoluene bht in rats an electron microscopical study
Histology and Histopathology, 1999Co-Authors: A M Safer, A J AlnughamishAbstract:The anti-oxidant Food Additive, butylated hydroxytoluene (BHT), was fed to Sprague-Dawley rats at three concentrations: 0.2%, 0.4% and 0.8% for periods of 6, 12, 18 and 24 weeks, and the results were compared with corresponding groups treated with a potent carcinogen, 7,12-dimethylbenz[a]anthracene (DMBA) groups, with olive oil, and with untreated control groups. BHT resulted in a significant increase in liver weight. The liver cells presented gradual vacuolization, cytoplasmic disintegration, "moth-eaten" appearance, ballooning degeneration, hepatocellular necrosis, aggregation of chromatin material around the periphery of the nuclear envelope, SER proliferation, RER clumping with broken cisternae, withered and autolyzed mitochondria, augmentation of lipid droplets and glycogen depletion. On the other hand, there was no sign of tumorigenicity. Whether or not BHT acts as a carcinogen in long-term administration may depend not only upon the organ system examined, but also on the strain of the animal used.
Kalipada Pahan - One of the best experts on this subject based on the ideXlab platform.
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sodium benzoate a metabolite of cinnamon and a Food Additive upregulates ciliary neurotrophic factor in astrocytes and oligodendrocytes
Neurochemical Research, 2015Co-Authors: Khushbu K Modi, Malabendu Jana, Susanta Mondal, Kalipada PahanAbstract:Ciliary neurotrophic factor (CNTF) is a promyelinating trophic factor that plays an important role in multiple sclerosis (MS). However, mechanisms by which CNTF expression could be increased in the brain are poorly understood. Recently we have discovered anti-inflammatory and immunomodulatory activities of sodium benzoate (NaB), a metabolite of cinnamon and a widely-used Food Additive. Here, we delineate that NaB is also capable of increasing the mRNA and protein expression of CNTF in primary mouse astrocytes and oligodendrocytes and primary human astrocytes. Accordingly, oral administration of NaB and cinnamon led to the upregulation of astroglial and oligodendroglial CNTF in vivo in mouse brain. Induction of experimental allergic encephalomyelitis, an animal model of MS, reduced the level of CNTF in the brain, which was restored by oral administration of cinnamon. While investigating underlying mechanisms, we observed that NaB induced the activation of protein kinase A (PKA) and H-89, an inhibitor of PKA, abrogated NaB-induced expression of CNTF. The activation of cAMP response element binding (CREB) protein by NaB, the recruitment of CREB and CREB-binding protein to the CNTF promoter by NaB and the abrogation of NaB-induced expression of CNTF in astrocytes by siRNA knockdown of CREB suggest that NaB increases the expression of CNTF via the activation of CREB. These results highlight a novel myelinogenic property of NaB and cinnamon, which may be of benefit for MS and other demyelinating disorders.
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sodium benzoate a metabolite of cinnamon and a Food Additive upregulates neuroprotective parkinson disease protein dj 1 in astrocytes and neurons
Journal of Neuroimmune Pharmacology, 2012Co-Authors: Saurabh Khasnavis, Kalipada PahanAbstract:DJ-1 (PARK7) is a neuroprotective protein that protects cells from oxidative stress. Accordingly, loss-of-function DJ-1 mutations have been linked with a familial form of early onset Parkinson disease. Mechanisms by which DJ-1 level could be enriched in the CNS are poorly understood. Recently we have discovered anti-inflammatory activity of sodium benzoate (NaB), a metabolite of cinnamon and a widely-used Food Additive. Here we delineate that NaB is also capable of increasing the level of DJ-1 in primary mouse and human astrocytes and human neurons highlighting another novel neuroprotective effect of this compound. Reversal of DJ-1-inducing effect of NaB by mevalonate, farnesyl phosphate, but not cholesterol and ubiquinone, suggests that depletion of intermediates, but not end products, of the mevalonate pathway is involved in the induction of DJ-1 by NaB. Accordingly, either an inhibitor of p21ras farnesyl protein transferase (FPTI) or a dominant-negative mutant of p21ras alone was also able to increase the expression of DJ-1 in astrocytes suggesting an involvement of p21ras in DJ-1 expression. However, an inhibitor of geranyl geranyl transferase (GGTI) and a dominant-negative mutant of p21rac had no effect on the expression of DJ-1, indicating the specificity of the effect. Similarly lipopolysaccharide (LPS), an activator of small G proteins, also inhibited the expression of DJ-1, and NaB and FPTI, but not GGTI, abrogated LPS-mediated inhibition. Together, these results suggest that NaB upregulates DJ-1 via modulation of mevalonate metabolites and that p21ras, but not p21rac, is involved in the regulation of DJ-1.
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sodium benzoate a Food Additive and a metabolite of cinnamon modifies t cells at multiple steps and inhibits adoptive transfer of experimental allergic encephalomyelitis
Journal of Immunology, 2007Co-Authors: Saurav Brahmachari, Kalipada PahanAbstract:Experimental allergic encephalomyelitis (EAE) is the animal model for multiple sclerosis. This study explores a novel use of sodium benzoate (NaB), a commonly used Food Additive and a Food and Drug Administration-approved nontoxic drug for urea cycle disorders, in treating the disease process of relapsing-remitting EAE in female SJL/J mice. NaB, administered through drinking water at physiologically tolerable doses, ameliorated clinical symptoms and disease progression of EAE in recipient mice and suppressed the generation of encephalitogenic T cells in donor mice. Histological studies reveal that NaB effectively inhibited infiltration of mononuclear cells and demyelination in the spinal cord of EAE mice. Consequently, NaB also suppressed the expression of proinflammatory molecules and normalized myelin gene expression in the CNS of EAE mice. Furthermore, we observed that NaB switched the differentiation of myelin basic protein-primed T cells from Th1 to Th2 mode, enriched regulatory T cell population, and down-regulated the expression of various contact molecules in T cells. Taken together, our results suggest that NaB modifies encephalitogenic T cells at multiple steps and that NaB may have therapeutic importance in multiple sclerosis.
A M Safer - One of the best experts on this subject based on the ideXlab platform.
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hepatotoxicity induced by the anti oxidant Food Additive butylated hydroxytoluene bht in rats an electron microscopical study
Histology and Histopathology, 1999Co-Authors: A M Safer, A J AlnughamishAbstract:The anti-oxidant Food Additive, butylated hydroxytoluene (BHT), was fed to Sprague-Dawley rats at three concentrations: 0.2%, 0.4% and 0.8% for periods of 6, 12, 18 and 24 weeks, and the results were compared with corresponding groups treated with a potent carcinogen, 7,12-dimethylbenz[a]anthracene (DMBA) groups, with olive oil, and with untreated control groups. BHT resulted in a significant increase in liver weight. The liver cells presented gradual vacuolization, cytoplasmic disintegration, "moth-eaten" appearance, ballooning degeneration, hepatocellular necrosis, aggregation of chromatin material around the periphery of the nuclear envelope, SER proliferation, RER clumping with broken cisternae, withered and autolyzed mitochondria, augmentation of lipid droplets and glycogen depletion. On the other hand, there was no sign of tumorigenicity. Whether or not BHT acts as a carcinogen in long-term administration may depend not only upon the organ system examined, but also on the strain of the animal used.
Monis Bilal Shamsi - One of the best experts on this subject based on the ideXlab platform.
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exploring the mode of binding between Food Additive butylated hydroxytoluene bht and human serum albumin spectroscopic as well as molecular docking study
Journal of Molecular Liquids, 2017Co-Authors: Nasser Abdulatif Alshabib, Javed Masood Khan, Mohd Sajid Ali, Hamad A Allohedan, Mohd Shahnawaz Khan, Abdulrahman M Alsenaidy, Fohad Mabood Husain, Monis Bilal ShamsiAbstract:Abstract Butylated hydroxytoluene (BHT) is a Food Additive and used as an antioxidant in Food products. BHT also concerning several health risks such as cancer, asthma and behavioral disorder in children. Human serum albumin (HSA) is the main constituents of blood plasma and known as a carrier protein because it has a very strong ability to bind a variety of ligands. The binding of a drug or small molecules to serum albumin is a crucial determinant of its pharmacokinetic and pharmacodynamic profile. This study investigates the interaction between BHT and HSA at pH 7.4 using various spectroscopic techniques such as UV–visible absorption spectrophotometry, fluorescence quenching, circular dichroism (CD) and molecular docking. The interactions of BHT with human serum albumin in the UV–visible range of spectrum exhibits increased absorption peak at 280 nm that elevates with increasing concentrations of BHT. BHT was also found to quench the fluorescence of human serum albumin (HSA). However, the fluorescence quenching constant was decreased with increasing the temperature, indicating that the interaction between BHT and HSA takes place via the static quenching mechanism. The thermodynamic measurements indicated that both hydrogen and hydrophobic forces involved in the binding of BHT with HSA. Moreover, the negative ∆ G value showed that the binding process was spontaneous. Far-UV CD data suggested the marginal conformational changes in HSA due to BHT interactions. Furthermore, molecular docking study suggested that BHT interacted with HSA at domain III via hydrophobic interaction. Conclusively, spectroscopies, as well as computational analysis extend our understanding of BHT interaction with serum albumin, which has far reaching applications in the Food industry.