1,374 results on '"Engel, Karl-Heinz"'
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2. Stellungnahme zu Acetaldehyd als Aromastoff: Aspekte der Risikobewertung
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Hengstler, Jan G., Baum, Matthias, Cartus, Alexander T., Diel, Patrick, Eisenbrand, Gerhard, Engel, Karl-Heinz, Engeli, Barbara, Epe, Bernd, Grune, Tilman, Guth, Sabine, Haller, Dirk, Heinz, Volker, Hellwig, Michael, Henle, Thomas, Humpf, Hans-Ulrich, Jäger, Henry, Joost, Hans-Georg, Kulling, Sabine E., Lachenmeier, Dirk W., Lampen, Alfonso, Leist, Marcel, Mally, Angela, Marko, Doris, Nöthlings, Ute, Röhrdanz, Elke, Roth, Angelika, Spranger, Joachim, Stadler, Richard, Steinberg, Pablo, Vieths, Stefan, and Wätjen, Wim
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- 2022
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3. Salivary nitrate/nitrite and acetaldehyde in humans: potential combination effects in the upper gastrointestinal tract and possible consequences for the in vivo formation of N-nitroso compounds—a hypothesis
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Eisenbrand, Gerhard, Baum, Matthias, Cartus, Alexander T., Diel, Patrick, Engel, Karl-Heinz, Engeli, Barbara, Epe, Bernd, Grune, Tilman, Guth, Sabine, Haller, Dirk, Heinz, Volker, Hellwig, Michael, Hengstler, Jan G., Henle, Thomas, Humpf, Hans-Ulrich, Jäger, Henry, Joost, Hans-Georg, Kulling, Sabine, Lachenmeier, Dirk W., Lampen, Alfonso, Leist, Marcel, Mally, Angela, Marko, Doris, Nöthlings, Ute, Röhrdanz, Elke, Roth, Angelika, Spranger, Joachim, Stadler, Richard, Vieths, Stefan, Wätjen, Wim, and Steinberg, Pablo
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- 2022
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4. Re‐evaluation of silicon dioxide (E 551) 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.
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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, Andreoli, Cristina, Bastos, Maria, and Benford, Diane
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FOOD additives ,BABY foods ,SILICA ,AGE groups ,RISK assessment - Abstract
The present opinion is the follow‐up of the conclusions and recommendations of the Scientific Opinion on the re‐evaluation of silicon dioxide (E 551) as a food additive relevant to the safety assessment for all age groups. In addition, the risk assessment of silicon dioxide (E 551) for its use in food for infants below 16 weeks of age is performed. Based on the newly available information on the characterisation of the SAS used as E 551 and following the principles of the 2021 EFSA Guidance on Particle‐TR, the conventional safety assessment has been complemented with nano‐specific considerations. Given the uncertainties resulting from the limitations of the database and in the absence of genotoxicity concern, the Panel considered that it is not appropriate to derive an acceptable daily intake (ADI) but applied the margin of exposure (MOE) approach for the risk assessment. The Panel concluded that the MOE should be at least 36 for not raising a safety concern. The calculated MOEs considering the dietary exposure estimates for all population groups using the refined non‐brand loyal scenario, estimated at the time of the 2018 re‐evaluation, were all above 36. The Panel concluded that E 551 does not raise a safety concern in all population groups at the reported uses and use levels. The use of E 551 in food for infants below 16 weeks of age in FC 13.1.1 and FC 13.1.5.1 does not raise a safety concern at the current exposure levels. The Panel also concluded that the technical data provided support an amendment of the specifications for E 551 laid down in Commission Regulation (EU) No 231/2012. The paucity of toxicological studies with proper dispersion protocol (with the exception of the genotoxicity studies) creates uncertainty in the present assessment of the potential toxicological effects related to the exposure to E 551 nanosize aggregates. [ABSTRACT FROM AUTHOR]
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- 2024
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5. 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.
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- 2021
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6. Impact of cross-breeding on the metabolites of the low phytic acid rice mutant Os-lpa -MH86-1.
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Zhou, Chen-guang, primary, Tan, Yuan-yuan, additional, Gossner, Sophia, additional, Li, You-fa, additional, Shu, Qing-yao, additional, and Engel, Karl-Heinz, additional
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- 2021
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7. Guidance on the scientific requirements for a notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283.
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, de Henauw, Stefaan, Engel, Karl‐heinz, Hirsch‐Ernst, Karen Ildico, Kearney, John, Knutsen, Helle Katrine, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Peláez, Carmen, van Loveren, Henk, and Gelbmann, Wolfgang
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FOOD consumption ,FOOD safety ,FOOD production ,HAZARDS ,ADVICE - Abstract
The European Commission requested EFSA to update the scientific guidance for the preparation of notifications for authorisation of traditional foods, previously developed following the adoption of Regulation (EU) 2015/2283 on novel foods. This guidance document provides advice on the scientific information needed to be submitted by applicants when submitting traditional food notifications pursuant to Article 14 and traditional food applications pursuant to Article 16 of Regulation (EU) 2015/2283. The safety of a traditional food should be substantiated by data on its composition, its experience of continued use and its proposed conditions of use. Its normal consumption should not be nutritionally disadvantageous. The applicant should integrate the information on the composition and the experience of continued use and provide a concise overall consideration on how this substantiates the history of safe use of the traditional food and how this relates to the proposed conditions of use for the EU. Potential health hazards identified on the basis of compositional data and/or data from the experience of continued use should be discussed. On the basis of the information provided, EFSA will assess the safety related to the consumption of the traditional food under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
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- 2024
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8. Flavouring Group Evaluation 80, Revision 2 (FGE.80Rev2): Consideration of alicyclic, alicyclic‐fused and aromatic‐fused ring lactones evaluated by the JECFA (61st and 82nd meetings) structurally related to an aromatic lactone evaluated in FGE.27
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Castle, Laurence, Andreassen, Monica, Aquilina, Gabriele, Bastos, Maria, Boon, Polly, Fallico, Biagio, Fitzgerald, Reginald, Frutos Fernandez, Maria Jose, Grasl‐Kraupp, Bettina, Gundert‐Remy, Ursula, Gürtler, Rainer, Houdeau, Eric, Kurek, Marcin, Louro, Henriqueta, Morales, Patricia, Passamonti, Sabina, Benigni, Romualdo, Degen, Gisela, Engel, Karl‐Heinz, and Fowler, Paul
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FOOD additives ,FOOD consumption ,GENETIC toxicology ,LACTONES ,METABOLISM - Abstract
The EFSA Panel on Food Additives and Flavourings was requested to evaluate 14 flavouring substances assigned to the Flavouring Group Evaluation 80 (FGE.80), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Thirteen substances have already been considered in FGE.80 and its revision and in FGE.96 [FL‐no: 10.005, 10.024, 10.025, 10.050, 10.061, 10.069, 10.070, 10.072, 10.169, 13.009, 13.012, 13.161 and 16.055]. The remaining flavouring substance 3a,4,5,7a‐tetrahydro‐3,6‐dimethylbenzofuran‐2(3H)‐one [FL‐no: 10.057] has been cleared with respect to genotoxicity in FGE.217Rev3 and it is considered in this revision 2 of FGE.80. The substance [FL‐no: 10.057] was evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, threshold of toxicological concern (TTC) and available data on metabolism and toxicity. The Panel concluded that [FL‐no: 10.057] does not give rise to safety concerns at its 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 substance, the specifications for the material of commerce have also been considered and the information provided was complete for [FL‐no: 10.057]. However, for the flavouring substance [FL‐no: 10.057] in the present revision and for eight substances evaluated in previous revisions, the 'modified Theoretical Added Maximum Daily Intakes' (mTAMDIs) values are above the TTC for their structural class (III). For four substances previously evaluated in FGE.80Rev1 and in FGE.96, use levels are still needed to calculate the mTAMDI estimates. Therefore, in total for 13 flavouring substances, data on uses and use levels should be provided to finalise their safety evaluations. For [FL‐no: 10.050, 10.069 and 13.161], information on the composition of stereoisomeric mixtures is needed. [ABSTRACT FROM AUTHOR]
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- 2024
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9. Re‐evaluation of shellac (E 904) as a food additive and a new application on the extension of use of shellac (E 904) in dietary foods for special medical purposes.
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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, Gundert‐Remy, Ursula, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Boon, Polly, and Crebelli, Riccardo
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FOOD additives ,LEAD ,MANUFACTURING processes ,AGE groups ,BODY weight - Abstract
The present opinion deals with the re‐evaluation of shellac (E 904) when used as a food additive and with the new application on the extension of use of shellac (E 904) in dietary foods for special medical purposes. The Panel derived an acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day for wax‐free shellac (E 904) produced by physical decolouring, based on a NOAEL of 400 mg/kg bw per day and applying an uncertainty factor of 100. The Panel concluded that the ADI of 4 mg/kg bw per day should be considered temporary for wax‐free shellac (E 904) produced by chemical bleaching, while new data are generated on the identity and levels of the organochlorine impurities in E 904. This ADI is not applicable for wax‐containing shellac as a food additive. For several age groups, the ADI was exceeded at the 95th percentile in the non‐brand‐loyal exposure assessment scenario and maximum level exposure assessment scenario. Considering the low exceedance and the fact that both the exposure estimation and the toxicological evaluation of shellac were conservative, the panel concluded that the calculated exceedance of the ADI does not indicate a safety concern. The Panel recommended to the European Commission separating specifications for E 904 depending on the manufacturing process, chemical bleaching and physical decolouring, because they result in different impurities; revising the definition of the food additive to include a description of each manufacturing process; deleting information on wax‐containing shellac from the EU specifications; revising the acid value for wax‐free shellac produced by chemical bleaching; lowering the maximum limit for lead; to consider introducing limits for other toxic elements potentially present in shellac; including a maximum limit for chloroform and total inorganic chloride in the EU specification for shellac produced by chemical bleaching. [ABSTRACT FROM AUTHOR]
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- 2024
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10. 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.
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- 2020
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11. Analytical and sensory characterization of the stereoisomers of 2-mercapto-4-alkanols and related substituted 1,3-oxathianes
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Engel, Karl-Heinz (Prof. Dr.), Engel, Karl-Heinz (Prof. Dr.);Schwab, Wilfried (Prof. Dr.), Riegel, Anja Devenie, Engel, Karl-Heinz (Prof. Dr.), Engel, Karl-Heinz (Prof. Dr.);Schwab, Wilfried (Prof. Dr.), and Riegel, Anja Devenie
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Structure-odor correlations were investigated for a homologous series (C6-C10) of 2-mercapto-4-alkanols and for 2,4-dimethyl-6-propyl-1,3-oxathiane and 2,6-dimethyl-4-propyl-1,3-oxathiane. The stereoisomers were separated via capillary gas chromatography using chiral stationary phases, their configurations were assigned, and their odor thresholds and odor properties were determined. The data demonstrate the impact of the stereochemistry of these sulfur-containing flavor compounds on their sensory properties., Struktur-Geruchs-Korrelationen wurden untersucht für eine homologe Reihe (C6-C10) von 2-Mercapto-4-alkanolen und für 2,4-Dimethyl-6-propyl-1,3-oxathian and 2,6-Dimethyl-4-propyl-1,3-oxathian. Die Stereoisomere wurden mittels Kapillargaschromatographie unter Verwendung chiraler stationärer Phasen getrennt, ihre Konfigurationen wurden bestimmt und Geruchsschwellenwerte sowie Geruchseigenschaften ermittelt. Die Daten belegen die Bedeutung der Stereochemie dieser chiralen flüchtigen Aromastoffe für ihre sensorischen Eigenschaften.
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- 2023
12. 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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13. 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]
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- 2024
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14. 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]
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- 2024
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15. 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]
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- 2024
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16. Impact of cross-breeding of low phytic acid rice (Oryza sativa L.) mutants with commercial cultivars on the phytic acid contents
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Zhou, Chenguang, Tan, Yuanyuan, Goßner, Sophia, Li, Youfa, Shu, Qingyao, and Engel, Karl-Heinz
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- 2019
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17. Sensory active piperine analogues from Macropiper excelsum and their effects on intestinal nutrient uptake in Caco-2 cells
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Obst, Katja, Lieder, Barbara, Reichelt, Katharina V., Backes, Michael, Paetz, Susanne, Geißler, Katrin, Krammer, Gerhard, Somoza, Veronika, Ley, Jakob P., and Engel, Karl-Heinz
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- 2017
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18. 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]
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- 2024
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19. 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
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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.
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- 2023
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20. 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, Mortensen, Alicja, Turck, Dominique, Cheyns, Karlien, Gaffet, Eric, Loeschner, Katrin, Mast, Jan, Mirat, Manuela, Undas, Anna, Barmaz, Stefania, Mech, Agnieszka, Rincon, Ana Maria, Smeraldi, Camilla, Tard, Alexandra, 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, Cheyns, Karlien, Gaffet, Eric, Loeschner, Katrin, Mast, Jan, Mirat, Manuela, Undas, Anna, Barmaz, Stefania, Mech, Agnieszka, Rincon, Ana Maria, Smeraldi, Camilla, Tard, Alexandra, and Gundert-Remy, Ursula
- 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.
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- 2023
21. Dietary fat and gut microbiota interactions determine diet-induced obesity in mice
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Kübeck, Raphaela, Bonet-Ripoll, Catalina, Hoffmann, Christina, Walker, Alesia, Müller, Veronika Maria, Schüppel, Valentina Luise, Lagkouvardos, Ilias, Scholz, Birgit, Engel, Karl-Heinz, Daniel, Hannelore, Schmitt-Kopplin, Philippe, Haller, Dirk, Clavel, Thomas, and Klingenspor, Martin
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- 2016
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22. An approach based on ultrahigh performance liquid chromatography-atmospheric pressure chemical ionization-mass spectrometry allowing the quantification of both individual phytosteryl and phytostanyl fatty acid esters in complex mixtures
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Scholz, Birgit, Menzel, Nicole, Lander, Vera, and Engel, Karl-Heinz
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- 2016
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23. 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
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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.
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- 2022
24. Re-evaluation of neohesperidine dihydrochalcone (E 959) 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, 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
25. 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]
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- 2023
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26. 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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27. Safety evaluation of the food additive steviol glycosides, predominantly Rebaudioside M, produced by fermentation using Yarrowia lipolyticaVRM.
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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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28. 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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29. 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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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
- Subjects
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]
- Published
- 2023
- Full Text
- View/download PDF
31. Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) 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
- Subjects
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]
- Published
- 2023
- Full Text
- View/download PDF
32. 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]
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- 2023
- Full Text
- View/download PDF
33. 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]
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- 2023
- Full Text
- View/download PDF
34. 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
- Subjects
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]
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- 2023
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35. On-line liquid chromatography–gas chromatography: A novel approach for the analysis of phytosterol oxidation products in enriched foods
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Scholz, Birgit, Wocheslander, Stefan, Lander, Vera, and Engel, Karl-Heinz
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- 2015
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36. Regulatorische Rahmenbedingungen und Prinzipien der Sicherheitsbewertung funktioneller Lebensmittel
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Engel, Karl-Heinz, Haller, Dirk, editor, Rimbach, Gerald, editor, and Grune, Tilman, editor
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- 2013
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37. Regulatory Oversight and Safety Assessment of Flavorings
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Engel, Karl-Heinz and Buettner, Andrea, editor
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- 2017
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- View/download PDF
38. 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
- Author
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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
39. 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
- Author
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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
40. Scientific opinion on Prosmoke BW 01
- Author
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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, Cordelli, Eugenia, Chipman, Kevin, Degen, Gisela, Nørby, Karin, Svendsen, Camilla, Carfì, Maria, Martino, Carla, Tard, Alexandra, 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, Cordelli, Eugenia, Chipman, Kevin, Degen, Gisela, Nørby, Karin, Svendsen, Camilla, Carfì, Maria, Martino, Carla, Tard, Alexandra, Vianello, Giorgia, and Mennes, Wim
- Subjects
Prosmoke BW 01 ,furan‐2(5H)‐one ,genotoxicity ,smoke flavouring primary product - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of Prosmoke BW 01 as a new smoke flavouring primary product, in accordance with Regulation (EC) No 2065/2003. Prosmoke BW01 is produced by pyrolysis of beechwood (Fagus sylvatica L.) sawdust. Its water content is estimated at 56 wt%, the total identified volatile fraction accounts for 28 wt% of the primary product, corresponding to 64% of the solvent-free mass, while the unidentified fraction amounts to 16 wt% of the primary product. Analytical data provided for three batches demonstrated that their batch-to-batch-variability was sufficiently low. However, for the batch used for the toxicological studies, there were substantial deviations in the concentration of nearly all the constituents compared to the other three batches. The dietary exposure of Prosmoke BW 01 was estimated to be between 6.2 and 9.2 mg/kg body weight (bw) per day, respectively, using SMK-EPIC and SMK-TAMDI. Using the FAIM tool, the 95th percentile exposure estimates ranged from 3.2 mg/kg bw per day for the elderly to 17.9 mg/kg bw per day for children. The Panel noted that furan-2(5H)-one is present in all batches of the primary product at an average concentration of 0.88 wt%. This substance was evaluated by the FAF Panel as genotoxic in vivo after oral exposure. The Panel considered that the (geno)toxicity studies available on the whole mixture were not adequate to support the safety assessment, due to limitations in these studies and because they were performed with a batch which may not be representative for the material of commerce. Considering that the exposure estimates for furan-2(5H)-one are above the TTC value of 0.0025 mu g/kg bw per day (or 0.15 mu g/person per day) for DNA-reactive mutagens and/or carcinogens, the Panel concluded that Prosmoke BW 01 raises a concern with respect to genotoxicity.
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- 2022
41. Scientific opinion on flavouring group evaluation 415 (FGE.415): (E)-3-benzo[1,3]dioxol-5-yl-N,N-diphenyl-2-propenamide
- 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, Bolognesi, Claudia, Chipman, Kevin, Cordelli, Eugenia, Nørby, Karin, Svendsen, Camilla, Carfí, Maria, Vianello, Giorgia, Mennes, Wim, 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, Chipman, Kevin, Cordelli, Eugenia, Nørby, Karin, Svendsen, Camilla, Carfí, Maria, Vianello, Giorgia, and Mennes, Wim
- Subjects
(E)‐3‐benzo[1 ,flavouring ,FGE.415 ,(E)‐3‐benzo[1,3]dioxol‐5‐yl‐N,N‐diphenyl‐2‐propenamide ,FL‐no: 16.135 ,N‐diphenyl‐2‐propenamide ,16.135 [FL‐no] ,3]dioxol‐5‐yl‐N - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the substance (E)-3-benzo[1,3]dioxol-5-yl-N,N-diphenyl-2-propenamide [FL-no: 16.135] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. The substance has not been reported to occur naturally and it is chemically synthesised. It is intended to be used as a flavouring substance in specific categories of food, but not intended to be used in beverages. The chronic dietary exposure to [FL-no: 16.135] estimated using the added portions exposure technique (APET), is calculated to be 780 mu g/person per day for a 60-kg adult and 480 mu g/person per day for a 15-kg 3-year-old child. [FL-no: 16.135] did not show genotoxic effects in bacterial mutagenicity and mammalian cell micronucleus assays in vitro. Developmental toxicity was not observed in a study in rats at the dose levels up to 1,000 mg/kg body weight (bw) per day. The Panel derived a BMDL of 101 mg/kg bw per day from a 90-day toxicity study. Based on this BMDL, adequate margins of exposure of 7,800 and 3,200 could be calculated for adults and children, respectively. The Panel concluded that there is no safety concern for [FL-no: 16.135], when used as a flavouring substance at the estimated level of dietary exposure calculated using the APET approach, based on the intended uses and use levels as specified in Appendix B. The Panel further concluded that the combined exposure to [FL-no: 16.135] from its use as a food flavouring substance and from its presence in toothpaste is also not of safety concern. (C) 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.
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- 2022
42. Follow-up of the re-evaluation of sulfur dioxide (E 220), sodium sulfite (E 221), sodium bisulfite (E 222), sodium metabisulfite (E 223), potassium metabisulfite (E 224), calcium sulfite (E 226), calcium bisulfite (E 227) and potassium bisulfite (E 228)
- Author
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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, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Boon, Polly, Cheyns, Karlien, Crebelli, Riccardo, FitzGerald, Rex, Lambré, Claude, Mirat, Manuela, Ulbrich, Beate, Vleminckx, Christiane, Mech, Agnieszka, Rincon, Ana Maria, Tard, Alexandra, Horvath, Zsuzsanna, Wright, Matthew, 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, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Boon, Polly, Cheyns, Karlien, Crebelli, Riccardo, Fitzgerald, Rex, Lambré, Claude, Mirat, Manuela, Ulbrich, Beate, Vleminckx, Christiane, Mech, Agnieszka, Rincon, Ana Maria, Tard, Alexandra, Horvath, Zsuzsanna, and Wright, Matthew
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potassium metabisulfite ,CAS 16731‐55‐8 ,CAS 13780‐03‐5 ,CAS 7631‐90‐5 ,CAS 10257‐55‐3 ,CAS 7446‐09‐5 ,sodium metabisulfite ,potassium bisulfite ,sulfur dioxide ,sodium bisulfite ,CAS 7773‐03‐7 ,CAS 7757‐83‐7 ,calcium bisulfite ,food additive ,E 221 ,sodium sulfite ,E 220 ,E 223 ,CAS 7681‐57‐4 ,E 222 ,E 224 ,E 226 ,E 227 ,E 228 ,calcium sulfite - Abstract
Sulfur dioxide-sulfites (E 220-228) were re-evaluated in 2016, resulting in the setting of a temporary ADI of 0.7 mg SO2 equivalents/kg bw per day. Following a European Commission call for data, the present follow-up opinion assesses data provided by interested business operators (IBOs) and additional evidence identified in the publicly available literature. No new biological or toxicological data addressing the data gaps described in the re-evaluation were submitted by IBOs. Taking into account data identified from the literature search, the Panel concluded that there was no substantial reduction in the uncertainties previously identified in the re-evaluation. Therefore, the Panel considered that the available toxicity database was inadequate to derive an ADI and withdrew the current temporary group acceptable daily intake (ADI). A margin of exposure (MOE) approach was considered appropriate to assess the risk for these food additives. A lower confidence limit of the benchmark dose of 38 mg SO2 equivalents/kg bw per day, which is lower than the previous reference point of 70 mg SO2 equivalents/kg bw per day, was estimated based on prolonged visual evoked potential latency. An assessment factor of 80 was applied for the assessment of the MoE. At the estimated dietary exposures, when using a refined exposure scenario (Data set D), MOEs at the maximum of 95th percentile ranges were below 80 for all population groups except for adolescents. The dietary exposures estimated using the maximum permitted levels would result in MOEs below 80 in all population groups at the maximum of the ranges of the mean, and for most of the population groups at both minimum and maximum of the ranges at the 95th percentile. The Panel concluded that this raises a safety concern for both dietary exposure scenarios. The Panel also performed a risk assessment for toxic elements present in sulfur dioxide-sulfites (E 220-228), based on data submitted by IBOs, and concluded that the maximum limits in the EU specifications for arsenic, lead and mercury should be lowered and a maximum limit for cadmium should be introduced.
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- 2022
43. Follow-up of the re-evaluation of polyglycerol polyricinoleate (E 476) as a food additive
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, 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, Wölfle, Detlef, Wright, Matthew, Cheyns, Karlien, Mirat, Manuela, Rincon, Ana Maria, Tard, Alexandra, Fürst, Peter, Younes, Maged, Aquilina, Gabriele, Castle, Laurence, 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, Wölfle, Detlef, Wright, Matthew, Cheyns, Karlien, Mirat, Manuela, Rincon, Ana Maria, Tard, Alexandra, and Fürst, Peter
- Subjects
food additive ,polyglycerol polyricinoleate ,CAS Registry Number 68936‐89‐0 ,PGPR ,emulsifier ,E 476 - Abstract
Polyglycerol polyricinoleate (PGPR, E 476) 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, in this opinion, the Panel on Food Additives and Flavouring (FAF) addresses the data gaps identified to support an amendment of the EU specifications for E 476. Additionally, this opinion deals with the assessment of the proposed extension of use for E 476 in edible ices and a revision of the maximum permitted level in emulsified sauces. The Panel concluded that the proposed extension of use, if authorised, would not give rise to a safety concern. Additionally, the Panel performed a risk assessment of undesirable impurities potentially present in E 476. The Panel concluded that the maximum limits in the EU specifications for the four toxic elements (arsenic, lead, mercury, cadmium) should be lowered based on actual levels in the commercial food additive E 476. The Panel also concluded that maximum limits for glycidyl esters and 3-monochloropropanediol should be included in the EU specifications for E 476. Alternatively, the Panel recommends an amendment of the definition of E 476 to include a requirement that the fats and oils used in the manufacturing of E 476 comply with the respective EU legislation regarding suitability for human consumption. Further, the Panel recommends a modification of the definition of E 476 indicating that polyglycerol used for the manufacturing of E 476 should be produced from glycerol meeting the specifications for E 422 (Commission Regulation (EU) No 231/2012). In this case, respective specification limits for epichlorohydrin, acrolein and butanetriol would not be needed for E 476. Finally, the Panel concluded that the proposed method based on the determination of ricinoleic acid is suitable for the determination of E 476 content in food.
- Published
- 2022
- Full Text
- View/download PDF
44. Safety of the proposed amendment of the specifications for enzymatically produced steviol glycosides (E 960c): Rebaudioside D produced via enzymatic bioconversion of purified stevia leaf extract
- Author
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Younes, Maged, Aquilina, Gabriele, Engel, Karl-Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Gundert-Remy, Ursula, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Wright, Matthew, Barat Baviera, José Manuel, Degen, Gisela, Herman, Lieve, Leblanc, Jean-Charles, Wölfle, Detlef, Aguilera, Jaime, Giarola, Alessandra, Smeraldi, Camilla, Vianello, Giorgia, Castle, Laurence, Younes, Maged, Aquilina, Gabriele, Engel, Karl-Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Gundert-Remy, Ursula, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Wright, Matthew, Barat Baviera, José Manuel, Degen, Gisela, Herman, Lieve, Leblanc, Jean-Charle, Wölfle, Detlef, Aguilera, Jaime, Giarola, Alessandra, Smeraldi, Camilla, Vianello, Giorgia, and Castle, Laurence
- Subjects
steviol glycoside preparation ,steviol glycoside preparations ,enzymatic bioconversion ,rebaudioside D ,yeast K. phaffii ,Veterinary (miscellaneous) ,Animal Science and Zoology ,Parasitology ,Plant Science ,Microbiology ,Food Science - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of a proposed amendment of the specifications of enzymatically produced steviol glycosides (E 960c) with respect to the inclusion of rebaudioside D produced via enzyme-catalysed bioconversion of purified stevia leaf extract. Rebaudioside D (95% on dry basis) is produced via enzymatic bioconversion of purified stevia leaf extract using uridine diphosphate (UDP)-glucosyltransferase (UGT) and sucrose synthase enzymes produced by the genetically modified yeast K. phaffii UGT-A, that facilitates the transfer of glucose to purified stevia leaf extract via glycosidic bonds. The same enzymes from K. phaffii UGT-A may be used in the manufacturing process of the food additive, rebaudioside M produced via enzyme modification of steviol glycosides from stevia (E 960c(i)). The Panel considered that separate specifications would be needed for this food additive produced via the manufacturing process described in the current application, aligned with those already established for E 960c(i). The Panel concluded that there is no toxicological concern for Rebaudioside D produced via enzymatic bioconversion of purified stevia leaf extract using UDP-glucosyltransferase and sucrose synthase produced by a genetically modified strain of the yeast K. phaffii. However, based on the available data, the Panel could not exclude the possibility that some residual amount of DNA coding for the kanamycin resistance gene could remain in the final product. Should this gene propagate in microbiota due to the presence of recombinant DNA in the final product, this would be of concern. Therefore, the Panel concluded that the safety of Rebaudioside D produced via this enzymatic bioconversion was not sufficiently demonstrated with the available data given that the absence of recombinant DNA was not shown.
- Published
- 2022
45. Follow‐up of the re‐evaluation of glycerol esters of wood rosins (E 445) as a food additive.
- Author
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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
- Subjects
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]
- Published
- 2023
- Full Text
- View/download PDF
46. Follow‐up of the re‐evaluation of indigo carmine (E 132) as a food additive.
- Author
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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]
- Published
- 2023
- Full Text
- View/download PDF
47. Modelling framework for assessment of dietary exposure to added flavouring substances within the FACET (Flavours, Additives, and Food Contact Material Exposure Task) project
- Author
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Mistura, Lorenza, Sette, Stefania, O’Mahony, Cian, Engel, Karl-Heinz, Mehegan, John, and Leclercq, Catherine
- Published
- 2013
- Full Text
- View/download PDF
48. DNA-based quantification of food allergens: Comparative assessment of quantification methods and application of the standard addition
- Author
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Engel, Karl-Heinz (Prof. Dr.), Engel, Karl-Heinz (Prof. Dr.);Schwab, Wilfried (Prof. Dr.), Luber, Florian, Engel, Karl-Heinz (Prof. Dr.), Engel, Karl-Heinz (Prof. Dr.);Schwab, Wilfried (Prof. Dr.), and Luber, Florian
- Abstract
The performance of different DNA-based methods for the quantification of food allergens (i) with matrix-adapted calibration, (ii) using an internal standard, and (iii) by standard addition was compared on the basis of pre-defined framework conditions and uniform criteria. The standard addition emerged as the most appropriate approach and was combined with a tetraplex real-time PCR. The established method was validated and tested for its suitability using commercially available food samples., Die Leistungsfähigkeit DNA-basierter Methoden zur Quantifizierung von allergenen Lebensmitteln mittels matrix-adaptierter Kalibrierung, unter Verwendung eines internen Standards und mit Hilfe einer Standardaddition wurde unter vordefinierten Rahmenbedingungen auf Basis einheitlicher Kriterien verglichen. Die Standardaddition erwies sich als die geeignetste und wurde mit einer tetraplex real-time PCR kombiniert. Die etablierte Methode wurde validiert und ihre Eignung an kommerziellen Proben gezeigt.
- Published
- 2020
49. Re‐evaluation of xanthan gum (E 415) 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, and Mortensen, Alicja
- Subjects
XANTHAN gum ,FOOD additives ,BABY foods ,INFANTS ,PREMATURE infants ,INFANT formulas - Abstract
Xanthan gum (E 415) was re‐evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food. As a follow‐up to that assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of xanthan gum (E 415) for its uses as a food additive in food for infants below 16 weeks of age belonging to food category (FC) 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. The Panel concluded that the technical data provided by the interested business operators support an amendment of the specifications for E 415 laid down in Commission Regulation (EU) No 231/2012. Due to the low validity of the available clinical studies, the Panel concluded that a reference point could not be derived from them but the results of the available studies on neonatal piglets could serve to derive a reference point. The Panel calculated the margin of exposure for infants below 16 weeks of age consuming food for special medical purposes (FC 13.1.5.1) for the highest xanthan gum exposure and concluded that there are no safety concerns for the use of xanthan gum (E 415) as a food additive in FC 13.1.5.1. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
50. Flavouring Group Evaluation 217 Revision 3 (FGE.217Rev3): consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones.
- 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, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Benigni, Romualdo, Bolognesi, Claudia, and Chipman, Kevin
- Subjects
CHEMICAL precursors ,LACTONES ,CHROMOSOME abnormalities ,FOOD additives ,KETONES - Abstract
The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of four flavouring substances [FL‐no: 10.023, 10.030, 10.057 and 13.012] from subgroup 4.1 of FGE.19. For three of these substances [FL‐no: 10.023, 10.030 and 13.012], the concern for genotoxicity has been ruled out in previous revisions of Flavouring Group Evaluation 217 (FGE.217). However, in FGE.217Rev2, a concern for genotoxicity could not be ruled out for 3a,4,5,7a‐tetrahydro‐3,6‐dimethylbenzofuran‐2(3H)‐one [FL‐no: 10.057]. After publication of FGE.217Rev2, industry provided additional genotoxicity studies for [FL‐no: 10.057], which are evaluated in the present opinion FGE.217Rev3. The flavouring substance [FL‐no: 10.057] did not induce gene mutations or numerical or structural chromosomal aberrations in vitro. Based on these data, the Panel concluded that the concern for genotoxicity is ruled out for [FL‐no: 10.057]. Consequently, it can be evaluated through the Procedure. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
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