802 results on '"Degen, Gisela"'
Search Results
2. Integrated data from intravital imaging and HPLC–MS/MS analysis reveal large interspecies differences in AFB1 metabolism in mice and rats
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Hassan, Reham, Gerdemann, Andrea, Cramer, Benedikt, Hobloss, Zaynab, Myllys, Maiju, González, Daniela, Albrecht, Wiebke, Veerkamp, Jannik, Friebel, Adrian, Hoehme, Stefan, Esselen, Melanie, Degen, Gisela H., Humpf, Hans-Ulrich, Hengstler, Jan G., and Ghallab, Ahmed
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- 2024
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3. Occurrence of ochratoxin A in breast milk and urine samples of nursing mothers in Bangladesh
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Das Trisha, Aporajita, Hafsa, Jaasia Momtahena, Hasan, Akibul, Habib, Ahsan, Tuba, Humaira Rashid, Degen, Gisela H., and Ali, Nurshad
- Published
- 2024
- Full Text
- View/download PDF
4. Comparative metabolism of aflatoxin B1 in mouse, rat and human primary hepatocytes using HPLC–MS/MS
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Gerdemann, Andrea, Cramer, Benedikt, Degen, Gisela H., Veerkamp, Jannik, Günther, Georgia, Albrecht, Wiebke, Behrens, Matthias, Esselen, Melanie, Ghallab, Ahmed, Hengstler, Jan G., and Humpf, Hans-Ulrich
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- 2023
- Full Text
- View/download PDF
5. Inhibition of cytochrome P450 enhances the nephro- and hepatotoxicity of ochratoxin A
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Hassan, Reham, González, Daniela, Hobloss, Zaynab, Brackhagen, Lisa, Myllys, Maiju, Friebel, Adrian, Seddek, Abdel-latif, Marchan, Rosemarie, Cramer, Benedikt, Humpf, Hans-Ulrich, Hoehme, Stefan, Degen, Gisela H., Hengstler, Jan G., and Ghallab, Ahmed
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- 2022
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6. Hypoalbuminemia affects the spatio-temporal tissue distribution of ochratoxin A in liver and kidneys: consequences for organ toxicity
- Author
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Hassan, Reham, Friebel, Adrian, Brackhagen, Lisa, Hobloss, Zaynab, Myllys, Maiju, González, Daniela, Albrecht, Wiebke, Mohammed, Elsayed S. I., Seddek, Abdel-latif, Marchan, Rosemarie, Cadenas, Cristina, Cramer, Benedikt, Humpf, Hans-Ulrich, Hartl, Lukas, Simbrunner, Benedikt, Reiberger, Thomas, Trauner, Michael, Hoehme, Stefan, Degen, Gisela H., Hengstler, Jan G., and Ghallab, Ahmed
- Published
- 2022
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7. Assessment of multiple mycotoxin exposure and its association with food consumption: a human biomonitoring study in a pregnant cohort in rural Bangladesh
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Kyei, Nicholas N. A., Cramer, Benedikt, Humpf, Hans-Ulrich, Degen, Gisela H., Ali, Nurshad, and Gabrysch, Sabine
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- 2022
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8. Safety of soy leghemoglobin from genetically modified Komagataella phaffii as a food additive.
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Younes, Maged, Aquilina, Gabriele, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Passamonti, Sabina, Moldeus, Peter, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Barat Baviera, José Manuel, Gott, David, and Herman, Lieve
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FOOD additives ,MEAT alternatives ,PEPTIDES ,MEAT ,HEME - Abstract
The EFSA Panel on Food Additive and Flavourings (FAF Panel) provides a scientific opinion on the safety of soy leghemoglobin from genetically modified Komagataella phaffii as a food additive in accordance with Regulation (EC) No 1331/2008. The proposed food additive, LegH Prep, is intended to be used as a colour in meat analogue products. The yeast Komagataella phaffii strain MXY0541 has been genetically modified to produce soy leghemoglobin; the safety of the genetic modification is under assessment by the EFSA GMO Panel (EFSA‐GMO‐NL‐2019‐162). The amount of haem iron provided by soy leghemoglobin from its proposed uses in meat analogue products is comparable to that provided by similar amounts of different types of meat. The exposure to iron from the proposed food additive, both at the mean and 95th percentile exposure, will be below the 'safe levels of intake' established by the NDA Panel for all population groups. Considering that the components of the proposed food additive will be digested to small peptide, amino acids and haem B; the recipient (non GM) strain qualifies for qualified presumption of safety status; no genotoxicity concern has been identified and no adverse effects have been identified at the highest dose tested in the available toxicological studies, the Panel concluded that there was no need to set a numerical acceptable daily intake (ADI) and that the food additive does not raise a safety concern at the proposed use in food category 12.9 and maximum use level. The Panel concluded that the use of soy leghemoglobin from genetically modified Komagataella phaffii MXY0541 as a new food additive does not raise a safety concern at the proposed use and use level. This safety evaluation of the proposed food additive remains provisional subject to the ongoing safety assessment of the genetic modification of the production strain by the GMO Panel (EFSA‐GMO‐NL‐2019‐162). [ABSTRACT FROM AUTHOR]
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- 2024
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9. Flavouring Group Evaluation 413 (FGE.413): Naringenin.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul J., Frutos Fernandez, Maria José, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Benigni, Romualdo, Bolognesi, Claudia, and Chipman, Kevin
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NARINGENIN ,FOOD additives ,DRUG interactions ,BODY weight ,MANUFACTURING processes - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of naringenin [FL‐no: 16.132] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. No other substances with sufficient structural similarity have been identified in existing FGEs that could be used to support a read‐across approach. The information provided on the manufacturing process, the composition and the stability of [FL‐no: 16.132] was considered sufficient. From studies carried out with naringenin, the Panel concluded that there is no concern with respect to genotoxicity. The use of naringenin as a flavouring substance at added portions exposure technique (APET) exposure levels is unlikely to pose a risk for drug interaction. For the toxicological evaluation of naringenin, the Panel requested an extended one‐generation toxicity study on naringenin, in line with the requirements of the Procedure and to investigate the consequence of a possible endocrine‐disrupting activity. The Panel considered that changes in thymus weight, litter size, post‐implantation loss and a consistent reduced pup weight in the high‐dose F2 generation could not be dismissed and selected therefore, the mid‐dose of 1320 mg/kg body weight (bw) per day for the parental males as the no observed adverse effect level (NOAEL) of the study. The exposure estimates for [FL‐no: 16.132] (31,500 and 50,000 μg/person per day for children and adults, respectively) were above the threshold of toxicological of concern (TTC) for its structural class (III). Using the NOAEL of 1320 mg/kg bw per day at step A4 of the procedure, margins of exposure (MoE) of 1590 and 630 could be calculated for adults and children, respectively. Based on the calculated MoEs, the Panel concluded that the use of naringenin as a flavouring substance does not raise a safety concern. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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10. Flavouring group evaluation 419 (FGE.419): 2‐methyl‐1‐(2‐(5‐(p‐tolyl)‐1H‐imidazol‐2‐yl)piperidin‐1‐yl)butan‐1‐one.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul J., Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Benigni, Romualdo, Bolognesi, Claudia, and Chipman, Kevin
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BACTERIAL mutation ,CONFIDENCE intervals ,CHEWING gum ,FOOD additives ,NUCLEOLUS ,CINNAMON - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of 2‐methyl‐1‐(2‐(5‐(p‐tolyl)‐1H‐imidazol‐2‐yl)piperidin‐1‐yl)butan‐1‐one [FL‐no: 16.134] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. The substance has not been reported to occur naturally and is chemically synthesised. In food, it is intended to be used as a flavouring substance only in chewing gum. The chronic dietary exposure to [FL‐no: 16.134] was estimated to be 45 μg/person per day for a 60‐kg adult and 28.4 μg/person per day for a 15‐kg 3‐year‐old child. [FL‐no: 16.134] did not show genotoxicity in a bacterial reverse mutation test and an in vitro mammalian cell micronucleus assay. Based on the submitted toxicokinetic and metabolism data, it can be predicted that the flavouring substance is metabolised to innocuous products only. The Panel derived a lower confidence limit of the benchmark dose (BMDL) of 0.71 mg/kg bw per day for a 20% increase in the relative thyroid (including parathyroid) weight observed in a 90‐day toxicity study in rats. Based on this BMDL, adequate margins of exposure of 887 and 374 could be calculated for adults and children, respectively. The Panel concluded that there is no safety concern for [FL‐no: 16.134], when used as a flavouring substance at the estimated level of dietary exposure, based on the intended use and use levels as specified in Appendix B. The Panel further concluded that the combined exposure to [FL‐no: 16.134] from its use as a food flavouring substance and from its presence in toothpaste and mouthwash is also not of safety concern. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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11. Re‐evaluation of guar gum (E 412) as a food additive in foods for infants below 16 weeks of age and follow‐up of its re‐evaluation as food additive for uses in foods for all population groups.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Dusemund, Birgit, Mortensen, Alicja, and Turck, Dominique
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GUAR gum ,FOOD additives ,BABY foods ,INFANT formulas - Abstract
Guar gum (E 412) was re‐evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow‐up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of guar gum (E 412) 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). In addition, the FAF Panel was requested to address the issues already identified during the re‐evaluation 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. In the response to EFSA requests, one IBO stated that E 412 is not used in food categories 13.1.1 and 13.1.5.1, but it is present in products under food category 13.1.5.2. The Panel concluded that the submitted data are not sufficient to support the safe use of guar gum (E 412) in food for infants (below and above 16 weeks of age) and young children under FC 13.1.1, 13.1.5.1 and 13.1.5.2. Additionally, the Panel concluded that the technical data provided by the IBO support further amendments of the specifications for E 412 laid down in Commission Regulation (EU) No 231/2012. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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12. Occurrence of aflatoxin M1 in human breast milk in Bangladesh
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Islam, Farjana, Das Trisha, Aporajita, Hafsa, Jaasia Momtahena, Hasan, Akibul, Degen, Gisela H., and Ali, Nurshad
- Published
- 2021
- Full Text
- View/download PDF
13. Aflatoxin M1 Analysis in Urine of Mill Workers in Bangladesh: A Pilot Study
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Ali, Nurshad, primary, Habib, Ahsan, additional, Mahmud, Firoz, additional, Tuba, Humaira Rashid, additional, and Degen, Gisela H., additional
- Published
- 2024
- Full Text
- View/download PDF
14. Contribution to the ongoing discussion on fluoride toxicity
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Guth, Sabine, Hüser, Stephanie, Roth, Angelika, Degen, Gisela, Diel, Patrick, Edlund, Karolina, Eisenbrand, Gerhard, Engel, Karl-Heinz, Epe, Bernd, Grune, Tilman, Heinz, Volker, Henle, Thomas, Humpf, Hans-Ulrich, Jäger, Henry, Joost, Hans-Georg, Kulling, Sabine E., Lampen, Alfonso, Mally, Angela, Marchan, Rosemarie, Marko, Doris, Mühle, Eva, Nitsche, Michael A., Röhrdanz, Elke, Stadler, Richard, van Thriel, Christoph, Vieths, Stefan, Vogel, Rudi F., Wascher, Edmund, Watzl, Carsten, Nöthlings, Ute, and Hengstler, Jan G.
- Published
- 2021
- Full Text
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15. Subcellular spatio-temporal intravital kinetics of aflatoxin B1 and ochratoxin A in liver and kidney
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Ghallab, Ahmed, Hassan, Reham, Myllys, Maiju, Albrecht, Wiebke, Friebel, Adrian, Hoehme, Stefan, Hofmann, Ute, Seddek, Abdel-latif, Braeuning, Albert, Kuepfer, Lars, Cramer, Benedikt, Humpf, Hans-Ulrich, Boor, Peter, Degen, Gisela H., and Hengstler, Jan G.
- Published
- 2021
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16. Integrated data from intravital imaging and HPLC–MS/MS analysis reveal large interspecies differences in AFB1 metabolism in mice and rats.
- Author
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Hassan, Reham, Gerdemann, Andrea, Cramer, Benedikt, Hobloss, Zaynab, Myllys, Maiju, González, Daniela, Albrecht, Wiebke, Veerkamp, Jannik, Friebel, Adrian, Hoehme, Stefan, Esselen, Melanie, Degen, Gisela H., Humpf, Hans-Ulrich, Hengstler, Jan G., and Ghallab, Ahmed
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RATS ,MICE ,IMAGE analysis ,BILE ,LABORATORY rats ,METABOLISM ,DNA adducts ,AFLATOXINS - Abstract
Large interspecies differences between rats and mice concerning the hepatotoxicity and carcinogenicity of aflatoxin B
1 (AFB1 ) are known, with mice being more resistant. However, a comprehensive interspecies comparison including subcellular liver tissue compartments has not yet been performed. In this study, we performed spatio-temporal intravital analysis of AFB1 kinetics in the livers of anesthetized mice and rats. This was supported by time-dependent analysis of the parent compound as well as metabolites and adducts in blood, urine, and bile of both species by HPLC–MS/MS. The integrated data from intravital imaging and HPLC–MS/MS analysis revealed major interspecies differences between rats and mice: (1) AFB1 -associated fluorescence persisted much longer in the nuclei of rat than mouse hepatocytes; (2) in the sinusoidal blood, AFB1 -associated fluorescence was rapidly cleared in mice, while a time-dependent increase was observed in rats in the first three hours after injection followed by a plateau that lasted until the end of the observation period of six hours; (3) this coincided with a far stronger increase of AFB1 -lysine adducts in the blood of rats compared to mice; (4) the AFB1 -guanine adduct was detected at much higher concentrations in bile and urine of rats than mice. In both species, the AFB1 -glutathione conjugate was efficiently excreted via bile, where it reached concentrations at least three orders of magnitude higher compared to blood. In conclusion, major differences between mice and rats were observed, concerning the nuclear persistence, formation of AFB1 -lysine adducts, and the AFB1 -guanine adducts. [ABSTRACT FROM AUTHOR]- Published
- 2024
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17. Follow‐up of the re‐evaluation of quillaia extract (E 999) as a food additive and safety of the proposed extension of uses.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Cheyns, Karlien, Mirat, Manuela, and Rincon, Ana Maria
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FOOD additives ,FOOD safety ,CALCIUM oxalate ,DIETARY supplements ,BABY foods ,ENERGY consumption ,SUPPLY & demand - Abstract
Quillaia extract (E 999) was re‐evaluated in 2019 by the EFSA Panel on Food Additives and Flavourings (FAF). EFSA derived an acceptable daily intake (ADI) of 3 mg saponins/kg bw per day for E 999. Following a European Commission call for data to submit data to fill the data gaps, the present follow‐up opinion assesses data provided by interested business operators (IBOs) to support an amendment of the EU specifications for E 999. Additionally, this opinion deals with the assessment of the proposed extension of use for E 999 in food supplements supplied in a solid and liquid form, excluding food supplements for infants and young children and, as a carrier in botanical nutrients. The Panel concluded that the proposed extension of use, if authorised, could result in an exceedance of the ADI at the maximum of the ranges of the mean for children, adolescents and the elderly, and for all populations at the 95th percentile. An additional proposed extension of use for E 999 to be used as a carrier for glazing agents on entire fresh fruits and vegetables has been received. Since no information on the proposed use levels of E 999 on a saponins content basis has been provided by this applicant, the Panel was not able to evaluate the safety of this extension of use. Considering the technical data submitted, the Panel recommended some modifications of the existing EU specifications for E 999, mainly to lower the limits for lead, mercury and arsenic and to include a maximum limit for cadmium and for calcium oxalate. The Panel also recommended that the limits would be expressed on a saponins basis. The Panel proposed to revise the definition of E 999 to better describe the composition in a qualitative way. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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18. Biological monitoring for ochratoxin A and citrinin and their metabolites in urine samples of infants and children in Bangladesh
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Ali, Nurshad and Degen, Gisela H.
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- 2020
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19. Determination of aflatoxin M1 and deoxynivalenol biomarkers in infants and children urines from Bangladesh
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Ali, Nurshad, Manirujjaman, M., Rana, Sohel, and Degen, Gisela H.
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- 2020
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20. Occurrence of ochratoxin A in breast milk and urine samples of nursing mothers in Bangladesh
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Trisha, Aporajita Das, primary, Hafsa, Jaasia Momtahena, additional, Hasan, Akibul, additional, Habib, Ahsan, additional, Tuba, Humaira Rashid, additional, Degen, Gisela H., additional, and Ali, Nurshad, additional
- Published
- 2023
- Full Text
- View/download PDF
21. Toxicity of fluoride: critical evaluation of evidence for human developmental neurotoxicity in epidemiological studies, animal experiments and in vitro analyses
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Guth, Sabine, Hüser, Stephanie, Roth, Angelika, Degen, Gisela, Diel, Patrick, Edlund, Karolina, Eisenbrand, Gerhard, Engel, Karl-Heinz, Epe, Bernd, Grune, Tilman, Heinz, Volker, Henle, Thomas, Humpf, Hans-Ulrich, Jäger, Henry, Joost, Hans-Georg, Kulling, Sabine E., Lampen, Alfonso, Mally, Angela, Marchan, Rosemarie, Marko, Doris, Mühle, Eva, Nitsche, Michael A., Röhrdanz, Elke, Stadler, Richard, van Thriel, Christoph, Vieths, Stefan, Vogel, Rudi F., Wascher, Edmund, Watzl, Carsten, Nöthlings, Ute, and Hengstler, Jan G.
- Published
- 2020
- Full Text
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22. The life of Hans-Günter Neumann and his contributions to chemical carcinogenesis
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Metzler, Manfred, Bitsch, Annette, and Degen, Gisela H.
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- 2020
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23. Citrinin biomarkers: a review of recent data and application to human exposure assessment
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Ali, Nurshad and Degen, Gisela H.
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- 2019
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24. Analyses of biomarkers of exposure to nephrotoxic mycotoxins in a cohort of patients with renal tumours
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Malir, Frantisek, Louda, Miroslav, Ostry, Vladimir, Toman, Jakub, Ali, Nurshad, Grosse, Yann, Malirova, Eva, Pacovsky, Jaroslav, Pickova, Darina, Brodak, Milos, Pfohl-Leszkowicz, Annie, and Degen, Gisela H.
- Published
- 2019
- Full Text
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25. Aflatoxin M 1 Analysis in Urine of Mill Workers in Bangladesh: A Pilot Study.
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Ali, Nurshad, Habib, Ahsan, Mahmud, Firoz, Tuba, Humaira Rashid, and Degen, Gisela H.
- Subjects
AFLATOXINS ,URINALYSIS ,FOOD habits ,PILOT projects ,OCCUPATIONAL exposure - Abstract
Presence of aflatoxin B
1 (AFB1 ) in food and feed is a serious problem, especially in developing countries. Human exposure to this carcinogenic mycotoxin can occur through dietary intake, but also through inhalation or dermal contact when handling and processing AFB1 -contaminated crops. A suitable biomarker of AFB1 exposure by all routes is the occurrence of its hydroxylated metabolite aflatoxin M1 (AFM1 ) in urine. To assess mycotoxin exposure in mill workers in Bangladesh, we analyzed AFM1 levels in urine samples of this population group who may encounter both dietary and occupational AFB1 exposure. In this pilot study, a total of 76 participants (51 mill workers and 25 controls) were enrolled from the Sylhet region of Bangladesh. Urine samples were collected from people who worked in rice, wheat, maize and spice mills and from controls with no occupational contact to these materials. A questionnaire was used to collect information on basic characteristics and normal food habits of all participants. Levels of AFM1 in the urine samples were determined by a competitive enzyme linked immunosorbent assay. AFM1 was detected in 96.1% of mill workers' urine samples with a range of LOD (40) of 217.7 pg/mL and also in 92% of control subject's urine samples with a range of LOD of 307.0 pg/mL). The mean level of AFM1 in mill workers' urine (106.5 ± 35.0 pg/mL) was slightly lower than that of the control group (123.3 ± 52.4 pg/mL), whilst the mean AFM1 urinary level adjusted for creatinine was higher in mill workers (142.1 ± 126.1 pg/mg crea) than in the control group (98.5 ± 71.2 pg/mg crea). Yet, these differences in biomarker levels were not statistically significant. Slightly different mean urinary AFM1 levels were observed between maize mill, spice mill, rice mill, and wheat mill workers, yet biomarker values are based on a small number of individuals in these subgroups. No significant correlations were found between the study subjects' urine AFM1 levels and their consumption of some staple food items, except for a significant correlation observed between urinary biomarker levels and consumption of groundnuts. In conclusion, this pilot study revealed the frequent presence of AFM1 in the urine of mill workers in Bangladesh and those of concurrent controls with dietary AFB1 exposure only. The absence of a statistical difference in mean biomarker levels for workers and controls suggests that in the specific setting, no extra occupational exposure occurred. Yet, the high prevalence of non-negligible AFM1 levels in the collected urines encourage further studies in Bangladesh regarding aflatoxin exposure. [ABSTRACT FROM AUTHOR]- Published
- 2024
- Full Text
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26. Comparative metabolism of aflatoxin B1 in mouse, rat and human primary hepatocytes using HPLC–MS/MS.
- Author
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Gerdemann, Andrea, Cramer, Benedikt, Degen, Gisela H., Veerkamp, Jannik, Günther, Georgia, Albrecht, Wiebke, Behrens, Matthias, Esselen, Melanie, Ghallab, Ahmed, Hengstler, Jan G., and Humpf, Hans-Ulrich
- Subjects
DNA adducts ,AFLATOXINS ,LIVER cells ,MICE ,METABOLISM ,RATS ,DNA repair - Abstract
Aflatoxin B
1 (AFB1 ) is a highly hepatotoxic and carcinogenic mycotoxin produced by Aspergillus species. The compound is mainly metabolized in the liver and its metabolism varies between species. The present study quantified relevant AFB1 - metabolites formed by mouse, rat, and human primary hepatocytes after treatment with 1 µM and 10 µM AFB1 . The use of liquid chromatographic separation coupled with tandem mass spectrometric detection enabled the selective and sensitive determination of phase I and phase II metabolites of AFB1 over incubation times of up to 24 h. The binding of AFB1 to macromolecules was also considered. The fastest metabolism of AFB1 was observed in mouse hepatocytes which formed aflatoxin P1 as a major metabolite and also its glucuronidated form, while AFP1 occurred only in traces in the other species. Aflatoxin M1 was formed in all species and was, together with aflatoxin Q1 and aflatoxicol, the main metabolite in human cells. Effective epoxidation led to high amounts of DNA adducts already 30 min post-treatment, especially in rat hepatocytes. Lower levels of DNA adducts and fast DNA repair were found in mouse hepatocytes. Also, protein adducts arising from reactive intermediates were formed rapidly in all three species. Detoxification via glutathione conjugation and subsequent formation of the N-acetylcysteine derivative appeared to be similar in mice and in rats and strongly differed from human hepatocytes which did not form these metabolites at all. The use of qualitative reference material of a multitude of metabolites and the comparison of hepatocyte metabolism in three species using advanced methods enabled considerations on toxification and detoxification mechanisms of AFB1 . In addition to glutathione conjugation, phase I metabolism is strongly involved in the detoxification of AFB1 . [ABSTRACT FROM AUTHOR]- Published
- 2023
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27. Safety evaluation of synthesised DNA oligonucleotides as a food additive.
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Younes, Maged, Aquilina, Gabriele, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Passamonti, Sabina, Moldeus, Peter, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Barat Baviera, José Manuel, Gott, David, and Herman, Lieve
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FOOD additives ,OLIGONUCLEOTIDES ,ARTIFICIAL chromosomes ,DNA ,TECHNICAL specifications - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of synthesised DNA oligonucleotides as a new food additive, in accordance with Regulation (EC) No 1331/2008. Considering that the additional information requested by the Panel during the risk assessment was not provided by the applicant, the assessment was concluded on the basis of the sole information available in the application. The proposed food additive consists of purified synthetic DNA sequences intended to be used for traceability purposes, alone or combined with carriers. Information provided by the applicant on the identity, characterisation and production process of the proposed food additive was considered insufficient. The Panel considered that the product specifications as proposed by the applicant do not adequately define and characterise the proposed food additive. The applicant proposed for the food additive the maximum use levels of 0.001 mg/kg for a variety of food categories. The food additive was also proposed as a Group I additive at a specific maximum level of quantum satis. The applicant did not provide exposure estimates according to the EFSA ANS Panel guidance (2012). No biological or toxicological data were provided by the applicant for the proposed food additive. Considering the inadequate information available and the uncertainty introduced by the proposal at quantum satis, along with the insufficient specifications, the Panel could not conclude on the safety of the food additive as proposed and described by the applicant. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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- View/download PDF
28. Re‐evaluation of erythritol (E 968) as a food additive.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul J., Frutos Fernandez, Maria José, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Batke, Monika, and Boon, Polly
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FOOD additives ,ERYTHRITOL ,CLINICAL trials ,WARNING labels ,BODY weight - Abstract
This opinion addresses the re‐evaluation of erythritol (E 968) as food additive and an application for its exemption from the laxative warning label requirement as established under Regulation (EU) No 1169/2011. Erythritol is a polyol obtained by fermentation with Moniliella pollinis BC or Moniliella megachiliensis KW3‐6, followed by purifications and drying. Erythritol is readily and dose‐dependently absorbed in humans and can be metabolised to erythronate to a small extent. Erythritol is then excreted unchanged in the urine. It does not raise concerns regarding genotoxicity. The dataset evaluated consisted of human interventional studies. The Panel considered that erythritol has the potential to cause diarrhoea in humans, which was considered adverse because its potential association with electrolyte and water imbalance. The lower bound of the range of no observed adverse effect levels (NOAELs) for diarrhoea of 0.5 g/kg body weight (bw) was identified as reference point. The Panel considered appropriate to set a numerical acceptable daily intake (ADI) at the level of the reference point. An ADI of 0.5 g/kg bw per day was considered by the Panel to be protective for the immediate laxative effect as well as potential chronic effects, secondary to diarrhoea. The highest mean and 95th percentile chronic exposure was in children (742 mg/kg bw per day) and adolescents (1532 mg/kg bw per day). Acute exposure was maximally 3531 mg/kg bw per meal for children at the 99th percentile. Overall, the Panel considered both dietary exposure assessments an overestimation. The Panel concluded that the exposure estimates for both acute and chronic dietary exposure to erythritol (E 968) were above the ADI, indicating that individuals with high intake may be at risk of experiencing adverse effects after single and repeated exposure. Concerning the new application, the Panel concluded that the available data do not support the proposal for exemption. [ABSTRACT FROM AUTHOR]
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- 2023
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29. Safety evaluation of the food additive steviol glycosides, predominantly Rebaudioside M, produced by fermentation using Yarrowia lipolyticaVRM.
- Author
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Younes, Maged, Aquilina, Gabriele, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Passamonti, Sabina, Moldeus, Peter, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Barat Baviera, José Manuel, Gott, David, and Herman, Lieve
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FOOD additives ,GLYCOSIDES ,BACTERIAL mutation ,FERMENTATION ,FOOD safety - Abstract
The EFSA Panel on Food Additive and Flavourings (FAF Panel) provides a scientific opinion on the safety of a new process to produce steviol glycosides by fermentation of simple sugars using a genetically modified strain of Yarrowia lipolytica (named Y. lipolytica VRM). The manufacturing process may result in impurities different from those that may be present in the other steviol glycosides E 960a‐d, therefore the Panel concluded that separate specifications are required for the food additive produced as described in the current application. Viable cells and DNA from the production strain are not present in the final product. The Panel considered that the demonstration of the absence of kaurenoic acid in the proposed food additive, using a method with a limit of detection (LOD) of 0.3 mg/kg, is adequate to dispel the concerns for potential genotoxicity. Given that all steviol glycosides follow the same metabolic pathways, the Panel considered that the current steviol glycosides would fall within the same group of substances. Therefore, the Panel considered that the already existing data on rebaudioside M and structurally related steviol glycosides are sufficient, and a similar metabolic fate and toxicity is expected for the food additive. The results from the bacterial reverse mutation assay and the in vitro micronucleus assay were negative and indicated absence of genotoxicity from the food additive. The existing acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day, expressed as steviol equivalents, was considered to be applicable to the proposed food additive. The Panel concluded that there is no safety concern for steviol glycosides, predominantly Rebaudioside M, produced by fermentation using Y. lipolytica VRM, to be used as a food additive at the proposed uses and use levels. [ABSTRACT FROM AUTHOR]
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- 2023
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30. Scientific opinion on the renewal of the authorisation of SmokEz Enviro‐23 (SF‐006) as a smoke flavouring Primary Product.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Benigni, Romualdo, Boon, Polly, and Bolognesi, Claudia
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ORAL drug administration ,SMOKE ,FOOD additives ,GENETIC toxicology ,BODY weight - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product SmokEz Enviro‐23 (SF‐006), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. SmokEz Enviro‐23 is obtained by pyrolysis of oak, maple, hickory, ash, birch, beech and cherry woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.01 to 3.2 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 9.5 mg/kg bw per day at the 95th percentile. The Panel concluded that four components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity. [ABSTRACT FROM AUTHOR]
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- 2023
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31. Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) as a smoke flavouring Primary Product.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Benigni, Romualdo, Boon, Polly, and Bolognesi, Claudia
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ORAL drug administration ,SMOKE ,FOOD additives ,GENETIC toxicology ,BODY weight - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product SmoKEz C‐10 (SF‐005), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. SmoKEz C‐10 is obtained by pyrolysis of maple, oak, hickory, ash, birch, beech and cherry woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.01 to 5.1 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 18.1 mg/kg bw per day at the 95th percentile. The Panel concluded that five components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity. [ABSTRACT FROM AUTHOR]
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- 2023
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32. Scientific opinion on the renewal of the authorisation of Fumokomp (SF‐009) as a smoke flavouring Primary Product.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Benigni, Romualdo, Boon, Polly, and Bolognesi, Claudia
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GAS chromatography/Mass spectrometry (GC-MS) ,SMOKE ,FOOD additives - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product Fumokomp (SF‐009), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003 (in the renewal application the Primary Product is reported as 'Fumokomp Conc.'). This opinion refers to an assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. Fumokomp Conc. is produced by pyrolysis of beech and hornbeam woods. Gas chromatography–mass spectrometry (GC–MS) was applied for both identification and quantification of the volatile constituents of the Primary Product. Given the limitations of the method, the Panel cannot judge with confidence whether the applied method meets the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. Moreover, the Panel concluded that the absence of furan‐2(5H)‐one from the Primary Product was not convincingly demonstrated. At the maximum proposed use levels, dietary exposure estimates calculated with FAIM ranged from 0.04 to 0.9 mg/kg body weight (bw) per day at the mean and from 0.1 to 1.5 mg/kg bw per day at the 95th percentile. The information available on the 32 identified components of the Primary Product, although limited, did not indicate a concern for genotoxicity for any of these substances. However, whole mixture testing in an in vitro mouse lymphoma assay gave positive results which would require an adequate in vivo follow‐up study. In addition, the potential for aneugenicity of the Primary Product has not been adequately investigated. Accordingly, the potential safety concern for genotoxicity of the Primary Product cannot be ruled out. [ABSTRACT FROM AUTHOR]
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- 2023
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33. Scientific opinion on the renewal of the authorisation of proFagus Smoke R709 (SF‐008) as a smoke flavouring Primary Product.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Benigni, Romualdo, Boon, Polly, and Bolognesi, Claudia
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ORAL drug administration ,SMOKE ,FOOD additives ,GENETIC toxicology ,BODY weight - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product proFagus Smoke R709 (SF‐008), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. ProFagus Smoke R709 is obtained by pyrolysis of beech and oak wood as main source materials. The panel concluded that the compositional data provided on the Primary Product are adequate. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.8 to 12.2 mg/kg body weight (bw) per day at the mean and from 2.3 to 51.4 mg/kg bw per day at the 95th percentile. The Panel concluded that three components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for this component are above the TTC of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the panel concluded that the Primary Product raises concern with respect to genotoxicity. [ABSTRACT FROM AUTHOR]
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- 2023
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34. Scientific opinion on the renewal of the authorisation of Smoke Concentrate 809045 (SF‐003) as a smoke flavouring Primary Product.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Benigni, Romualdo, Boon, Polly, and Bolognesi, Claudia
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ORAL drug administration ,SMOKE ,FOOD additives ,GENETIC toxicology ,BODY weight - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product Smoke Concentrate 809045 (SF‐003), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. Product Smoke Concentrate 809045 is obtained by pyrolysis of beech wood. The Panel concluded that the compositional data provided on the Primary Product are adequate. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.1 to 1.5 mg/kg body weight (bw) per day at the mean and from 0.2 to 5.2 mg/kg bw per day at the 95th percentile. The Panel concluded that eleven components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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35. Scientific opinion on the renewal of the authorisation of Scansmoke SEF7525 (SF‐004) as a smoke flavouring Primary Product.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Benigni, Romualdo, Boon, Polly, and Bolognesi, Claudia
- Subjects
FOOD additives ,SMOKE ,WHITE oak ,MOLE fraction ,GENETIC toxicology - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product Scansmoke SEF7525 (SF‐004), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. Scansmoke SEF7525 is obtained from a tar produced from a mixture of red oak, white oak, maple, beech and hickory. Based on the compositional data, the Panel noted that the identified and quantified proportion of the solvent‐free fraction amounts to 32.6 weight (wt)%, thus the applied method does not meet the legal quality criterion that at least 50% of the solvent‐free fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with Food Additive Intake Model (FAIM) ranged from 0.6 to 3.8 mg/kg body weight (bw) per day at the mean and from 1.1 to 10.1 mg/kg bw per day at the 95th percentile. Based on the available information on genotoxicity on 44 identified components, the Panel concluded that two substances in the Primary Product, styrene and benzofuran, raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. Considering that the exposure estimates for styrene and benzofuran are above the threshold of toxicological concern (TTC) value of 0.0025 kg/kg bw per day for DNA‐reactive mutagens and/or carcinogens and since further data are needed to clarify their potential genotoxicity, the Panel concluded that the potential safety concern for genotoxicity of the Primary Product cannot be ruled out. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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36. Scientific opinion on the renewal of the authorisation of Zesti Smoke Code 10 (SF‐002) as a smoke flavouring Primary Product.
- Author
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Benigni, Romualdo, Boon, Polly, and Bolognesi, Claudia
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SMOKE ,ORAL drug administration ,FOOD additives ,GENETIC toxicology ,BODY weight - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product Zesti Smoke Code 10 (SF‐002), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. Zesti Smoke Code 10 is obtained by pyrolysis of hickory and oak woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.02 to 4.6 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 13.0 mg/kg bw per day at the 95th percentile. The Panel concluded that four components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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37. Correction: Degen et al. Citrinin Exposure in Germany: Urine Biomarker Analysis in Children and Adults. Toxins 2023, 15, 26
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Degen, Gisela H., primary, Reinders, Jörg, additional, Kraft, Martin, additional, Völkel, Wolfgang, additional, Gerull, Felicia, additional, Burghardt, Rafael, additional, Sievering, Silvia, additional, Engelmann, Jennifer, additional, Chovolou, Yvonni, additional, Hengstler, Jan G., additional, and Fromme, Hermann, additional
- Published
- 2023
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38. Preliminary data on citrinin kinetics in humans and their use to estimate citrinin exposure based on biomarkers
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Degen, Gisela H., Ali, Nurshad, and Gundert-Remy, Ursula
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- 2018
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39. Urinary biomarkers of exposure to the mycoestrogen zearalenone and its modified forms in German adults
- Author
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Ali, Nurshad and Degen, Gisela H.
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- 2018
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40. Re-evaluation of locust bean gum (E 410) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as a food additive for uses in foods for all population groups
- Author
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl-Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Wright, Matthew, Wölfle, Detlef, Dusemund, Birgit, Mortensen, Alicja, Turck, Dominique, Barmaz, Stefania, Mech, Agnieszka, Rincon, Ana Maria, Tard, Alexandra, Vianello, Giorgia, Gundert-Remy, Ursula, Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl-Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Wright, Matthew, Wölfle, Detlef, Dusemund, Birgit, Mortensen, Alicja, Turck, Dominique, Barmaz, Stefania, Mech, Agnieszka, Rincon, Ana Maria, Tard, Alexandra, Vianello, Giorgia, and Gundert-Remy, Ursula
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food additive ,infants ,locust bean gum ,E 410 ,infant - Abstract
Locust bean gum (E 410) was re-evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow-up to that assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of locust bean gum (E 410) for its uses as a food additive in food for infants below 16 weeks of age belonging to food category 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants). In addition, the FAF Panel was requested to address the issues already identified during the re-evaluation of the food additive when used in food for the general population, including the safety assessment for FC 13.1.5.1 and 13.1.5.2 (Dietary foods for babies and young children for special medical purposes as defined in directive 1999/21/EC). The process involved the publication of a call for data. Based on the received data, the Panel concluded that the technical data provided by the interested business operators support an amendment of the specifications for locust bean gum (E 410) laid down in Commission Regulation (EU) No 231/2012. The Panel identified a reference point of 1,400 mg/kg bw per day based on reduced blood zinc levels in a piglet study. It applied the margin of exposure (MoE) for the safety assessment of locust bean gum (E 410) when used as a food additive in FC 13.1.5.1 and 13.1.5.2. The Panel concluded that a MoE above 1 would not raise a safety concern. A MoE above 1 was obtained for some of the scenarios and exposure levels for infants. For toddlers (consumers only of food for special medical purposes), the MoE was above 1 for all exposure levels.
- Published
- 2023
41. Opinion on the re-evaluation of sodium carboxy methyl cellulose (E 466) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as food additive for uses in foods for all population groups
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl-Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Wright, Matthew, Dusemund, Birgit, Mortensen, Alicja, Turck, Dominique, Wölfle, Detlef, Barmaz, Stefania, Mech, Agnieszka, Rincon, Ana Maria, Tard, Alexandra, Vianello, Giorgia, Gundert-Remy, Ursula, Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl-Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Wright, Matthew, Dusemund, Birgit, Mortensen, Alicja, Turck, Dominique, Wölfle, Detlef, Barmaz, Stefania, Mech, Agnieszka, Rincon, Ana Maria, Tard, Alexandra, Vianello, Giorgia, and Gundert-Remy, Ursula
- Subjects
food additive ,E 466 ,infants ,sodium carboxy methyl cellulose ,infant - Abstract
Sodium carboxy methyl cellulose (E 466) was re-evaluated in 2018 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow-up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of E 466 for its uses as a food additive in food for infants below 16 weeks of age belonging to food categories (FC) 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) in line with Regulation (EC) No 1333/2008. In addition, the FAF Panel was requested to address the issues already identified during the re-evaluation of the food additive when used in food for the general population, including the safety assessment for FC 13.1.5.1 and 13.1.5.2 (Dietary foods for babies and young children for special medical purposes as defined in directive 1999/21/EC). The process involved the publication of a call for data. Based on the received data, the Panel concluded that the technical data provided by the interested business operator support an amendment of the specifications for sodium carboxy methyl cellulose (E 466) laid down in Commission Regulation (EU) No 231/2012. The interested business operators declared that E 466 is not used in food for infants below 16 weeks of age and in FC 13.1.5.1. Due to the lack of data, an assessment has not been performed for this FC and age group. The interested business operators did not provide biological and toxicological data to support the uses of E 466 in FC 13.1.5.2. Due to the almost unchanged database compared to the situation before the call for data, the FAF Panel confirmed the previous EFSA ANS Panel conclusion according to which the available data did not allow for an adequate assessment of the safety of use of sodium carboxy methyl cellulose (E 466) in infants and young children consuming foods belonging to the FC 13.1.5.2. (c) 2022 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
- Published
- 2022
42. Re-evaluation of neohesperidine dihydrochalcone (E 959) as a food additive
- Author
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl-Heinz, Fowler, Paul J, Frutos Fernandez, Maria José, Fürst, Peter, Gundert-Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Wright, Matthew, Batke, Monika, Boon, Polly, Bruzell, Ellen, Chipman, James, Crebelli, Riccardo, FitzGerald, Rex, Fortes, Cristina, Halldorsson, Thorhallur, LeBlanc, Jean-Charles, Lindtner, Oliver, Mortensen, Alicja, Ntzani, Evangelia, Wallace, Heather, Cascio, Claudia, Civitella, Consuelo, Horvath, Zsuzsanna, Lodi, Federica, Mech, Agnieszka, Tard, Alexandra, Vianello, Giorgia, Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl-Heinz, Fowler, Paul J, Frutos Fernandez, Maria José, Fürst, Peter, Gundert-Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Wright, Matthew, Batke, Monika, Boon, Polly, Bruzell, Ellen, Chipman, Jame, Crebelli, Riccardo, Fitzgerald, Rex, Fortes, Cristina, Halldorsson, Thorhallur, Leblanc, Jean-Charle, Lindtner, Oliver, Mortensen, Alicja, Ntzani, Evangelia, Wallace, Heather, Cascio, Claudia, Civitella, Consuelo, Horvath, Zsuzsanna, Lodi, Federica, Mech, Agnieszka, Tard, Alexandra, and Vianello, Giorgia
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E 959 ,food additive ,neohesperidine dihydrochalcone ,sweetener - Abstract
The present opinion deals with the re-evaluation of neohesperidine dihydrochalcone (E 959) when used as a food additive. It is obtained by catalytic hydrogenation of a flavanone - neohesperidine - which is naturally occurring and thus isolated by alcohol extraction in bitter oranges (Citrus aurantium). Based on in vivo data in rat, neohesperidine dihydrochalcone is likely to be absorbed, also in humans, and to become systemically available. It does not raise a concern regarding genotoxicity. The toxicity data set consisted of studies on subchronic and prenatal developmental toxicity. No human studies were available. The data set was considered sufficient to derive a new acceptable daily intake (ADI). Based on the weight of evidence (WoE) analysis, the Panel considered unlikely that neohesperidine dihydrochalcone would lead to adverse effects on health in animals in the dose ranges tested. The Panel also considered that a carcinogenicity study was not warranted and that the lack of human data did not affect the overall confidence in the body of evidence. The Panel derived an ADI of 20 mg/kg bodyweight (bw) per day based on a no observed adverse effect level (NOAEL) of 4,000 mg/kg bw per day from a 13-week study in rat, applying the standard default factors of 100 for inter- and intraspecies differences and of 2 for extrapolation from subchronic to chronic exposure. For the refined brand-loyal exposure assessment scenario, considered to be the most appropriate for the risk assessment, the exposure estimates at the mean ranged from
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- 2022
43. Ochratoxin A and its metabolites in urines of German adults—An assessment of variables in biomarker analysis
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Ali, Nurshad, Muñoz, Katherine, and Degen, Gisela H.
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- 2017
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44. Blood plasma biomarkers of citrinin and ochratoxin A exposure in young adults in Bangladesh
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Ali, Nurshad, Hossain, Khaled, and Degen, Gisela H.
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- 2018
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45. Citrinin Exposure in Germany: Urine Biomarker Analysis in Children and Adults
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Degen, Gisela H., primary, Reinders, Jörg, additional, Kraft, Martin, additional, Völkel, Wolfgang, additional, Gerull, Felicia, additional, Burghardt, Rafael, additional, Sievering, Silvia, additional, Engelmann, Jennifer, additional, Chovolou, Yvonni, additional, Hengstler, Jan G., additional, and Fromme, Hermann, additional
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- 2022
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46. Scientific Opinion on Flavouring Group Evaluation 7, Revision 6 (FGE.07Rev6): saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids from chemical group 5
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl-Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert-Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Benigni, Romualdo, Bolognesi, Claudia, Chipman, Kevin, Cordelli, Eugenia, Degen, Gisela, Marzin, Daniel, Nørby, Karin Kristiane, Svendsen, Camilla, Vianello, Giorgia, Mennes, Wim, Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl-Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert-Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Benigni, Romualdo, Bolognesi, Claudia, Chipman, Kevin, Cordelli, Eugenia, Degen, Gisela, Marzin, Daniel, Nørby, Karin Kristiane, Svendsen, Camilla, Vianello, Giorgia, and Mennes, Wim
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FGE.63 ,Flavourings ,JECFA ,α,β‐unsaturated carbonyls and precursors ,α ,Flavouring ,β‐unsaturated carbonyls and precursors - Abstract
The EFSA Panel on Food Additives and Flavourings was requested to evaluate 55 flavouring substances assigned to the Flavouring Group Evaluation 07 (FGE.07), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Fifty-three substances have already been considered in FGE.07 and its revisions. This revision 6 includes two additional substances which have been cleared with respect to genotoxicity in FGE.201Rev2 (4-methyl-3-hepten-5-one [FL-no: 07.261]) and FGE.204Rev1 (non-2-en-4-one, [FL-no: 07.187]). The substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern (TTC) and available data on metabolism and toxicity. The Panel concluded that none of the 55 substances gives rise to safety concerns at their levels of dietary intake, when estimated on the basis of the 'Maximised Survey-derived Daily Intake' (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate. Normal and maximum use levels were available for all flavouring substances. For 52 substances, including the newly included substances [FL-no: 07.187 and 07.261], their 'modified Theoretical Added Maximum Daily Intakes' (mTAMDIs) estimates were above the TTC for their structural classes (I and II). Therefore, for these 52 flavouring substances, more detailed data on uses and use levels should be provided to finalise their safety evaluations.
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- 2022
47. Scientific Opinion on Flavouring Group Evaluation 63, Revision 4 (FGE.63Rev4): consideration of aliphatic secondary saturated and unsaturated alcohols, ketones and related esters evaluated by JECFA (59th and 69th meetings) structurally related to flavouring substances evaluated by EFSA in FGE.07Rev6
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl-Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert-Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Benigni, Romualdo, Bolognesi, Claudia, Chipman, Kevin, Cordelli, Eugenia, Degen, Gisela, Marzin, Daniel, Nørby, Karin Kristiane, Svendsen, Camilla, Vianello, Giorgia, Mennes, Wim, Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl-Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert-Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Benigni, Romualdo, Bolognesi, Claudia, Chipman, Kevin, Cordelli, Eugenia, Degen, Gisela, Marzin, Daniel, Nørby, Karin Kristiane, Svendsen, Camilla, Vianello, Giorgia, and Mennes, Wim
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FGE.07Rev6 ,Flavourings ,JECFA ,α,β‐unsaturated carbonyls and precursors ,α ,Flavouring ,β‐unsaturated carbonyls and precursors - Abstract
The EFSA Panel on Food Additives and Flavourings was requested to evaluate 43 flavouring substances assigned to the Flavouring Group Evaluation 63 (FGE.63), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Twenty-nine substances have already been considered in FGE.63 and its revisions ([FL-no: 02.023, 02.099, 02.104, 02.136, 02.155, 02.252, 07.015, 07.069, 07.081, 07.099, 07.100, 07.101, 07.102, 07.114, 07.123, 07.151, 07.190, 07.240, 07.247, 07.249, 07.256, 09.281, 09.282, 09.657, 09.658, 09.923, 09.924, 09.925 and 09.936]). The remaining 14 flavouring substances have been cleared with respect to genotoxicity in FGE.204Rev1 ([FL-no: 02.102, 02.193, 07.044, 07.048, 07.082, 07.104, 07.105, 07.106, 07.107, 07.121, 07.139, 07.177, 07.188 and 07.244]) and they are considered in this revision 4 of FGE.63. The substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern (TTC) and available data on metabolism and toxicity. The Panel concluded that none of these 43 substances gives rise to safety concerns at their levels of dietary intake, when estimated on the basis of the 'Maximised Survey-derived Daily Intake' (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate for 43 flavouring substances. However, for 14 of these flavouring substances in the present revision and for 10 of the substances in the previous revision (FGE.63Rev3), the 'modified Theoretical Added Maximum Daily Intakes' (mTAMDIs) values are equal to or above the TTCs for their structural classes (I and II). For 15 substances previously evaluated in FGE.63Rev3, use levels are still needed to calculate the mTAMDI estimates. Therefore, in total for 39 flavouring substances, more data on uses and use levels should be provided to finalise their safety evaluations.
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- 2022
48. Follow‐up of the re‐evaluation of glycerol esters of wood rosins (E 445) as a food additive.
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Younes, Maged, Aquilina, Gabriele, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Passamonti, Sabina, Moldeus, Peter, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Cheyns, Karlien, Fitzgerald, Reginald, Mirat, Manuela, and Mortensen, Alicja
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FOOD additives ,GUMS & resins ,TOXICITY testing ,ESTERS ,SLASH pine - Abstract
Glycerol esters of wood rosin (GEWR) (E 445) were re‐evaluated in 2018. On the toxicity database and given the absence of reproductive and developmental toxicity data, the acceptable daily intake (ADI) of 12.5 mg/kg body weight (bw) per day for GEWR (E 445) established by the Scientific Committee on Food (SCF) in 1994 was considered temporary. The conclusions of the assessment were restricted to GEWR derived from Pinus palustris and Pinus elliottii and with a chemical composition in compliance with GEWR used in the toxicological testing. Following a European Commission call for data to submit data to fill the data gaps, the present follow‐up opinion assesses data provided by interested business operators (IBOs). Considering the technical data submitted by IBOs, the EFSA Panel on Food Additives and Flavourings (FAF Panel) recommended some modifications of the existing EU specifications for E 445, mainly a revision of the definition of the food additive and lowering the limits for toxic elements. Considering the available toxicological database evaluated during the re‐evaluation of E 445 by the ANS Panel in 2018, and the toxicological studies submitted by the IBOs, the Panel established an ADI of 10 mg/kg bw per day based on the no observed adverse effect level (NOAEL) of 976 mg/kg bw per day from the newly available dietary reproduction/developmental toxicity screening study in rats and applying an uncertainty factor of 100. Since GEWR from P. palustris and P. elliottii were tested in the toxicity studies considered to establish the ADI and in the absence of detailed information on the chemical composition (major constituents) in GEWR generated from other Pinus species, thus not allowing read across, the ADI is restricted to the GEWR (E 445) manufactured from P. palustris and P. elliottii. The Panel concluded that there was no safety concern for the use of GEWR (E 445), at either the maximum permitted levels or at the reported uses and use levels. [ABSTRACT FROM AUTHOR]
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- 2023
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49. Re‐evaluation of calcium carbonate (E 170) as a food additive in foods for infants below 16 weeks of age and follow‐up of its re‐evaluation as food additive for uses in foods for all population groups.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Wölfle, Detlef, Dusemund, Birgit, and Mortensen, Alicja
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FOOD additives ,CALCIUM carbonate ,BABY foods ,DIETARY calcium ,AGE groups - Abstract
Calcium carbonate (E 170) was re‐evaluated in 2011 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow‐up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of calcium carbonate (E 170) for its uses as a food additive in food for infants below 16 weeks of age belonging to food category 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‐evaluation 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 (IBOs) to provide the requested information to complete the risk assessment. The Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for calcium carbonate and that, in principle, there are no safety concern with respect to the exposure to calcium carbonate per se at the currently reported uses and use levels in all age groups of the population, including infants below 16 weeks of age. With respect to the calcium intake resulting from the use of E 170 in food for the general population and infants < 16 weeks of age, the Panel concluded that it contributes only to a small part to the overall calcium dietary exposure. However, the unavoidable presence of aluminium in E 170 is of concern and should be addressed. In addition, the Panel concluded that the technical data provided by the IBO support further amendments of the specifications for E 170 laid down in Commission Regulation (EU) No 231/2012. [ABSTRACT FROM AUTHOR]
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- 2023
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50. Follow‐up of the re‐evaluation of indigo carmine (E 132) as a food additive.
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Younes, Maged, Aquilina, Gabriele, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Passamonti, Sabina, Moldeus, Peter, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Cheyns, Karlien, FitzGerald, Reginald, Mirat, Manuela, and Mortensen, Alicja
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FOOD additives ,SODIUM dichromate ,BODY weight ,MANUFACTURING processes ,TESTIS - Abstract
Indigo carmine (E 312) was re‐evaluated in 2014 by the EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). The ANS Panel confirmed the acceptable daily intake (ADI) of 5 mg/kg body weight (bw) per day for indigo carmine allocated by JECFA (1975). The ANS Panel indicated that the ADI was applicable to a material with a purity of 93% pure colouring and manufactured using processes resulting in comparable residuals as material used in the Borzelleca et al. studies (1985, 1986) and Borzelleca and Hogan (1985) which were the basis for deriving the ADI. The ANS Panel considered that any extension of the ADI to indigo carmine of lower purity and/or manufactured using a different process would require new data to address the adverse effects on the testes observed in the Dixit and Goyal (2013) study. Following a European Commission call for data to submit data to fill the data gaps, an IBO submitted technical and toxicological data. Considering the technical data, the EFSA Panel on Food Additives and Flavourings (FAF Panel) recommended some modifications of the existing EU specifications for E 132, mainly to lower the limits for toxic elements. Considering the toxicological data, an IBO has submitted a 56‐day dietary study to address the adverse effects on testes using a material with 88% purity. The results of this study submitted did not confirm the severe adverse effects observed in the Dixit and Goyal study. Considering all the available information, the Panel confirmed the ADI of 5 mg/kg bw per day for indigo carmine (E 132) disodium salts, meeting the proposed revisions of the specifications (85% minimum for the colouring matter). The Panel concluded that there is no safety concern for the use of indigo carmine (E 132) disodium salts at the reported use levels and submitted analytical data. [ABSTRACT FROM AUTHOR]
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- 2023
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