Reconsideration of the temporary ADI and refined exposure assessment for Sunset Yellow FCF (E 110)

Panel, Efsa Ans

doi:10.2903/j.efsa.2014.3765

Cited by 67 publications

(26 citation statements)

References 11 publications

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“…Sunset yellow represents one of the most frequently artificial dyes applied into food products. Undoubtedly, the use is controlled by regulations, for instance, an accepted daily intake (ADI) of 4 mg/kg body/day has been established by the European Food Safety Authority (EFSA) [7]. Some European countries (Finland, Sweden) have even banned its use.…”

Section: Introductionmentioning

confidence: 99%

Highly sensitive and rapid determination of sunset yellow in drinks using a low-cost carbon material-based electrochemical sensor

et al. 2019

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Starting from simple graphite flakes, an electrochemical sensor for sunset yellow monitoring is developed by using a very simple and effective strategy. The direct electrochemical reduction of a suspension of exfoliated graphene oxide (GO) onto a glassy carbon electrode (GCE) surface leads to the electrodeposition of electrochemically reduced oxide at the surface, obtaining GCE/ERGO-modified electrodes. They are characterized by cyclic voltammetry measurements (CV) and field emission scanning electron spectroscopy (FE-SEM). The GCE/ERGO electrode has a high electrochemically active surface allowing efficient adsorption of SY. Using differential pulse voltammetry (DPV) technique with only 2 min accumulation, the GCE/ERGO sensor exhibits good performance to SY detection with a good linear calibration for concentration range varying 50-1000 nM (R 2 = 0.996) and limit of detection (LOD) estimated to 19.2 nM (equivalent to 8.9 µg.L-1). The developed sensor possesses a very high sensitivity of 9 µA/µM while fabricated with only one component. This electrochemical sensor also displays a good reliability with RSD value of 2.13% (n = 7) and excellent reusability (signal response change < 3.5% after 6 measuring/cleaning cycles). The GCE/ERGO demonstrates a successful practical application for determination of sunset yellow in commercial soft drinks.

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Section: Introductionmentioning

confidence: 99%

Highly sensitive and rapid determination of sunset yellow in drinks using a low-cost carbon material-based electrochemical sensor

et al. 2019

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“…For example, the concentrations calculated for Allura Red AC are 113-fold and 45-fold higher than the Ki values obtained at pH 7.4 (DBF) and pH 5.5 (estrone sulfate). a Data from EFSA (European Food Safety Authority) exposure assessments (References [38][39][40][41][42][43][44] ). Data for maximum reported use level or brand-loyal scenario in adults, if not otherwise stated b 95 th or 97th percentile c [I] Estimated intestinal concentration calculated according to EMA guidance (0.1-fold the maximum dose on one occasion/250 ml).…”

Section: Discussionmentioning

confidence: 99%

Food Additives as Inhibitors of Intestinal Drug Transporter OATP2B1

et al. 2020

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Food additives are compounds that are added to food and beverage to improve taste, color, preservation or composition. Generally, food additives are considered safe for human use due to safety evaluation conducted by food safety authorities and high safety margins applied to permitted usage levels. However, the interaction potential of food additives with simultaneously administered medication has not received much attention. Even though many food additives are poorly absorbed into systemic circulation, high concentrations could exist in the intestinal lumen making intestinal drug transporters, such as the uptake transporter organic anion transporting polypeptide 2B1 (OATP2B1), a possible site of food additive-drug interaction. In the present work, we aimed to characterize the interaction of a selection of 25 food additives including colorants, preservatives and sweeteners with OATP2B1 in vitro. In HEK293 cells transiently overexpressing OATP2B1 or control, uptake of dibromofluorescein was studied with and without 50 µM food additive at pH 7.4. As OATP2B1 displays substrateand pH-dependent transport function and the intraluminal pH varies along the gastrointestinal tract, we performed the studies also at pH 5.5 using estrone sulfate as OATP2B1 substrate. Food additives that inhibited OATP2B1mediated substrate transport with ≥50% were subjected to dose-response studies. Six colorants were identified and validated as OATP2B1 inhibitors at pH 5.5, but only three of these were categorized as inhibitors at pH 7.4. One sweetener was validated as an inhibitor at both assay conditions whereas none of the preservatives exhibited ≥50% inhibition of OATP2B1-mediated transport. Extrapolation of computed inhibitory constants (Ki values) to estimations of intestinal food additive concentrations imply that selected colorants could inhibit intestinal OATP2B1 also in vivo. These results suggest that food additives, especially colorants, could alter the pharmacokinetics of orally administered OATP2B1 substrate drugs, although further in vivo studies are warranted to understand the overall clinical consequences of the findings.

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“…Four different azodyes, commonly used as food colorants and that proved to have no adverse cytotoxic, carcinogenic or mutagenic effects 38–41 were used as substrates for subsequent analyses. BHIS medium was chosen to simulate the nutrient-rich environment of the gastrointestinal tract.…”

Section: Discussionmentioning

confidence: 99%

Azoreductase activity of dye-decolorizing bacteria isolated from the human gut microbiota

Zahran

Ali-Tammam

Hashem

et al. 2019

Sci Rep

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The gut microbiota enriches the human gene pool and contributes to xenobiotic metabolism. Microbial azoreductases modulate the reduction of azo-bonds, activating produgs and azo polymer-coated dosage forms, or degrading food additives. Here, we aimed to screen the healthy human gut microbiota for food colorant-reducing activity and to characterize factors modulating it. Four representative isolates from screened fecal samples were identified as E. coli (AZO-Ec), E. faecalis (AZO-Ef), E. avium (AZO-Ev) and B. cereus (AZO-Bc). Both AZO-Ef and AZO-Ev decolorized amaranth aerobically and microaerophilically while AZO-Ec and AZO-Bc had higher aerobic reduction rates. The isolates varied in their activities against different dyes, and the azo-reduction activity mostly followed zero-order reaction kinetics, with a few exceptions. Additionally, the isolates had different pH dependence, e.g., AZO-Ec was not affected by pH variation while AZO-Bc exhibited variable degradation kinetics at different pH levels. Cell-free extracts showed NADH-dependent enzymatic activities 14–19 times higher than extracellular fractions. FMN did not affect the reducing activity of AZO-Ef cell-free extract, whereas AZO-Ec, AZO-Ev and AZO-Bc had significantly higher reduction rates in its presence ( P values = 0.02, 0.0001 and 0.02, respectively). Using Degenerate primers allowed the amplification of azoreductase genes, whose sequences were 98–99% similar to genes encoding FMN-dependent-NADH azoreductases.

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Reconsideration of the temporary ADI and refined exposure assessment for Sunset Yellow FCF (E 110)

Cited by 67 publications

References 11 publications

Highly sensitive and rapid determination of sunset yellow in drinks using a low-cost carbon material-based electrochemical sensor

Highly sensitive and rapid determination of sunset yellow in drinks using a low-cost carbon material-based electrochemical sensor

Food Additives as Inhibitors of Intestinal Drug Transporter OATP2B1

Azoreductase activity of dye-decolorizing bacteria isolated from the human gut microbiota

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