146 results on '"Gundert-Remy, Ursula"'
Search Results
2. Quality of reporting animal studies
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Batke, Monika, Corsini, Emanuela, Fitzgerald, Rex, Scanziani, Eugenio, Schroeder, Henri, Steffensen, Inger-Lise, Ulbrich, Beate C., van Loveren, Henk, Waalkens-Berendsen, Dina, Woelfle, Detlef, and Gundert-Remy, Ursula
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- 2023
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3. 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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4. 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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5. 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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6. 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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7. 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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8. 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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9. 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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10. Scientific opinion on the renewal of the authorisation of SmokEz Enviro‐23 (SF‐006) as a smoke flavouring Primary Product.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Benigni, Romualdo, Boon, Polly, and Bolognesi, Claudia
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ORAL drug administration ,SMOKE ,FOOD additives ,GENETIC toxicology ,BODY weight - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product SmokEz Enviro‐23 (SF‐006), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. SmokEz Enviro‐23 is obtained by pyrolysis of oak, maple, hickory, ash, birch, beech and cherry woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.01 to 3.2 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 9.5 mg/kg bw per day at the 95th percentile. The Panel concluded that four components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity. [ABSTRACT FROM AUTHOR]
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- 2023
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11. Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) as a smoke flavouring Primary Product.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Benigni, Romualdo, Boon, Polly, and Bolognesi, Claudia
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ORAL drug administration ,SMOKE ,FOOD additives ,GENETIC toxicology ,BODY weight - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product SmoKEz C‐10 (SF‐005), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. SmoKEz C‐10 is obtained by pyrolysis of maple, oak, hickory, ash, birch, beech and cherry woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.01 to 5.1 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 18.1 mg/kg bw per day at the 95th percentile. The Panel concluded that five components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one and benzene‐1,2‐diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity. [ABSTRACT FROM AUTHOR]
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- 2023
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12. 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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13. 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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14. 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
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15. 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
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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
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16. Scientific opinion on the renewal of the authorisation of Zesti Smoke Code 10 (SF‐002) 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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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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17. 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
18. Scientific opinion on flavouring group evaluation 415 (FGE.415): (E)-3-benzo[1,3]dioxol-5-yl-N,N-diphenyl-2-propenamide
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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
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(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
19. Scientific opinion on Prosmoke BW 01
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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
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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
20. 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)
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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
21. 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
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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.
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- 2022
22. 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
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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
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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.
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- 2022
23. Infant Exposure to Antituberculosis Drugs via Breast Milk and Assessment of Potential Adverse Effects in Breastfed Infants: Critical Review of Data.
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Algharably, Engi Abdelhady, Kreutz, Reinhold, and Gundert-Remy, Ursula
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BREASTFEEDING ,ANTITUBERCULAR agents ,BREAST milk ,INFANTS ,CYCLOSERINE - Abstract
Infants of mothers treated for tuberculosis might be exposed to drugs via breast milk. The existing information on the exposure of breastfed infants lacks a critical review of the published data. We aimed to evaluate the quality of the existing data on antituberculosis (anti-TB) drug concentrations in the plasma and milk as a methodologically sound basis for the potential risk of breastfeeding under therapy. We performed a systematic search in PubMed for bedaquiline, clofazimine, cycloserine/terizidone, levofloxacin, linezolid, pretomanid/pa824, pyrazinamide, streptomycin, ethambutol, rifampicin and isoniazid, supplemented with update references found in LactMed
® . We calculated the external infant exposure (EID) for each drug and compared it with the recommended WHO dose for infants (relative external infant dose) and assessed their potential to elicit adverse effects in the breastfed infant. Breast milk concentration data were mainly not satisfactory to properly estimate the EID. Most of the studies suffer from limitations in the sample collection, quantity, timing and study design. Infant plasma concentrations are extremely scarce and very little data exist documenting the clinical outcome in exposed infants. Concerns for potential adverse effects in breastfed infants could be ruled out for bedaquiline, cycloserine/terizidone, linezolid and pyrazinamide. Adequate studies should be performed covering the scenario in treated mothers, breast milk and infants. [ABSTRACT FROM AUTHOR]- Published
- 2023
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24. 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.
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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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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]
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- 2023
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25. Prediction of in vivo prenatal chlorpyrifos exposure leading to developmental neurotoxicity in humans based on in vitro toxicity data by quantitative in vitro--in vivo extrapolation.
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Algharably, Engi Abdelhady, Di Consiglio, Emma, Testai, Emanuela, Pistollato, Francesca, Bal-Price, Anna, Najjar, Abdulkarim, Kreutz, Reinhold, and Gundert-Remy, Ursula
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NEURAL stem cells ,PRENATAL exposure ,FETAL brain ,FETUS ,CHOLINERGIC mechanisms ,EXTRAPOLATION ,NEUROTOXICOLOGY ,CELL differentiation - Abstract
Introduction: Epidemiological studies in children suggested that in utero exposure to chlorpyrifos (CPF), an organophosphate insecticide, may cause developmental neurotoxicity (DNT). We applied quantitative in vitro--in vivo extrapolation (QIVIVE) based on in vitro concentration and non-choline esterase-dependent effects data combined with Benchmark dose (BMD) modelling to predict oral maternal CPF exposure during pregnancy leading to fetal brain effect concentration. By comparing the results with data from epidemiological studies, we evaluated the contribution of the in vitro endpoints to the mode of action (MoA) for CPF-induced DNT. Methods: A maternal-fetal PBK model built in PK-Sim® was used to perform QIVIVE predicting CPF concentrations in a pregnant women population at 15 weeks of gestation from cell lysate concentrations obtained in human induced pluripotent stem cell-derived neural stem cells undergoing differentiation towards neurons and glia exposed to CPF for 14 days. The in vitro concentration and effect data were used to perform BMD modelling. Results: The upper BMD was converted into maternal doses which ranged from 3.21 to 271 mg/kg bw/day. Maternal CPF blood levels from epidemiological studies reporting DNT findings in their children were used to estimate oral CPF exposure during pregnancy using the PBK model. It ranged from 0.11 to 140 μg/kg bw/day. Discussion: The effective daily intake doses predicted from the in vitro model were several orders of magnitude higher than exposures estimated from epidemiological studies to induce developmental non-cholinergic neurotoxic responses, which were captured by the analyzed in vitro test battery. These were also higher than the in vivo LOEC for cholinergic effects. Therefore, the quantitative predictive value of the investigated non-choline esterase-dependent effects, although possibly relevant for other chemicals, may not adequately represent potential key events in the MoA for CPF-associated DNT. [ABSTRACT FROM AUTHOR]
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- 2023
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26. Flavouring Group Evaluation 76 Revision 2 (FGE.76Rev2): Consideration of sulfur‐containing heterocyclic compounds, evaluated by JECFA, structurally related to thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical group 29 and miscellaneous substances from chemical group 30 evaluated by EFSA in FGE.21Rev5
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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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HETEROCYCLIC compounds ,THIOPHENES ,CHEMICAL derivatives ,THIAZOLES ,FOOD additives ,CHEMICAL laws - Abstract
The Panel on Food Additives and Flavourings (FAF) was requested to consider the JECFA evaluations of 28 flavouring substances in the Flavouring Group Evaluation 76 (FGE.76Rev2). Twenty‐one of these substances have been considered in FGE.76Rev1. Seven substances could not be evaluated, because of concerns with respect to genotoxicity. New genotoxicity data have been provided for 4‐methyl‐5‐vinylthiazole [FL‐no: 15.018] and 4,5‐dimethyl‐2‐isobutyl‐3‐thiazoline [FL‐no: 15.032], which are representative substances of [FL‐no: 15.005] and [FL‐no: 15.029, 15.030, 15.130 and 15.131], respectively. The Panel concluded that the concern for genotoxicity is ruled out for [FL‐no: 15.018 and 15.005]. The concerns for gene mutations and clastogenicity are ruled out for [FL‐no: 15.032, 15.029, 15.030, 15.130 and 15.131]. In vitro, [FL‐no: 15.032] induced micronuclei through an aneugenic mode of action. The available in vivo micronucleus study was not adequate to rule out the concern for potential aneugenicity in vivo. The Panel compared the lowest concentration resulting in aneugenicity in vitro with the use levels reported for [FL‐no: 15.032]. Based on this comparison, the Panel concluded that the use of [FL‐no: 15.032] at the maximum reported use levels does not raise a concern for aneugenicity. Based on structural similarity, for the remaining four substances [FL‐no: 15.029, 15.030, 15.130 and 15.131], an aneugenic potential may also be anticipated. Individual genotoxicity data are needed to establish whether they have aneugenic potential. The Panel agrees with JECFA conclusions for 24 flavouring substances 'No safety concern at estimated levels of intake as flavouring substances' when based on the MSDI approach. For six substances, more reliable information on uses and use levels are needed to refine the mTAMDI estimates. For 15 substances, use levels are needed to calculate the mTAMDIs. For [FL‐no: 15.109 and 15.113], information on the actual stereochemical composition is inadequate and the conclusion reached for the named substances cannot be applied to the materials of commerce. [ABSTRACT FROM AUTHOR]
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- 2023
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27. Flavouring Group Evaluation 21 Revision 6 (FGE.21Rev6): thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30.
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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, Passamonti, Sabina, Moldeus, Peter, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Benigni, Romualdo, Bolognesi, Claudia, and Chipman, Kevin
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THIOPHENES ,CHEMICAL derivatives ,THIAZOLES ,FOOD additives ,GENETIC mutation - Abstract
The Panel on Food additives and Flavourings (FAF) was requested to evaluate the flavouring substances 2,4‐dimethyl‐3‐thiazoline [FL‐no: 15.060] and 2‐isobutyl‐3‐thiazoline [FL‐no: 15.119] in Flavouring Group Evaluation 21 revision 6 (FGE.21Rev6). FGE.21Rev6 deals with 41 flavouring substances of which 39 have been already evaluated to be of no safety concern when based on the MSDI approach. For [FL‐no: 15.060 and 15.119], a concern for genotoxicity was raised in FGE.21. Genotoxicity data have been submitted for the supporting substance 4,5‐dimethyl‐2‐isobutyl‐3‐thiazoline [FL‐no: 15.032] evaluated in FGE.76Rev2. The concerns for gene mutations and clastogenicity are ruled out for [FL‐no: 15.032] and for the structurally related substances [FL‐no: 15.060 and 15.119], but not for aneugenicity. Therefore, the aneugenic potential of [FL‐no: 15.060 and 15.119] should be investigated in studies with the individual substances. For [FL‐no: 15.054, 15.055, 15.057, 15.079 and 15.135], (more reliable) information on uses and use levels is needed to (re)calculate the mTAMDIs in order to finalise their evaluation. Provided that information is submitted for [FL‐no: 15.060 and 15.119] with respect to potential aneugenicity, that would allow evaluation of these substances through the Procedure, also for these two substances, more reliable data on uses and use levels would be required. Upon submission of such data, additional data on toxicity may become necessary for all seven substances. For [FL‐no: 15.054, 15.057, 15.079 and 15.135], information on the actual percentages of stereoisomers in the material of commerce based on analytical data should be provided. [ABSTRACT FROM AUTHOR]
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- 2023
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28. Scientific opinion on the safety evaluation of the food enzyme containing trypsin, chymotrypsin, α-amylase and triacylglycerol lipase from porcine pancreas
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger-Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Glandorf, Boet, Gundert-Remy, Ursula, Herman, Lieve, Turck, Dominique, Andryszkiewicz, Magdalena, Kovalkovičová, Natália, Maia, Joaquim, Liu, Yi, Rainieri, Sandra, and Chesson, Andrew
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- 2022
29. Scientific Guidance on the data required for the risk assessment of flavourings to be used in or on foods.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Fowler, Paul J, Fernandez, Maria Jose Frutos, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Benigni, Romualdo, and Bolognesi, Claudia
- Abstract
Following a request from the European Commission, EFSA developed a new scientific guidance to assist applicants in the preparation of applications for the authorisation of flavourings to be used in or on foods. This guidance applies to applications for a new authorisation as well as for a modification of an existing authorisation of a food flavouring, submitted under Regulation (EC) No 1331/2008. It defines the scientific data required for the evaluation of those food flavourings for which an evaluation and approval is required according to Article 9 of Regulation (EC) No 1334/2008. This applies to flavouring substances, flavouring preparations, thermal process flavourings, flavour precursors, other flavourings and source materials, as defined in Article 3 of Regulation (EC) No 1334/2008. Information to be provided in all applications relates to: (a) the characterisation of the food flavouring, including the description of its identity, manufacturing process, chemical composition, specifications, stability and reaction and fate in foods; (b) the proposed uses and use levels and the assessment of the dietary exposure and (c) the safety data, including information on the genotoxic potential of the food flavouring, toxicological data other than genotoxicity and information on the safety for the environment. For the toxicological studies, a tiered approach is applied, for which the testing requirements, key issues and triggers are described. Applicants should generate the data requested in each section to support the safety assessment of the food flavouring. Based on the submitted data, EFSA will assess the safety of the food flavouring and conclude whether or not it presents risks to human health and to the environment, if applicable, under the proposed conditions of use.This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2022.EN-7669/full [ABSTRACT FROM AUTHOR]
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- 2022
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30. 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, and Boon, Polly
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FOOD additives ,CATALYTIC hydrogenation ,ANIMAL health ,AGE groups ,REFERENCE values - 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 < 0.01 to 0.09 mg/kg bw per day and at the 95th percentile (P95) from 0.01 to 0.24 mg/kg bw per day. Considering the derived ADI of 20 mg/kg bw per day, the exposure estimates were below the reference value in all age groups. Therefore, the Panel concluded that dietary exposure to the food additive neohesperidine dihydrochalcone (E 959) at the reported uses and use levels would not raise a safety concern. [ABSTRACT FROM AUTHOR]
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- 2022
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31. Scientific opinion on Flavouring group evaluation 216 revision 2 (FGE.216Rev2): consideration of the genotoxicity potential of α,β‐unsaturated 2‐phenyl‐2‐alkenals from subgroup 3.3 of FGE.19.
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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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GENETIC toxicology ,GENETIC mutation ,FOOD additives ,NUCLEOLUS ,IN vivo studies - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the genotoxic potential of five flavouring substances from subgroup 3.3 of FGE.19, in the Flavouring Group Evaluation 216 (FGE.216). In FGE.216 and in FGE.216Rev1, the CEF Panel requested additional genotoxicity data on 2‐phenylcrotonaldehyde [FL‐no: 05.062], the representative for these five substances. New experimental data on [FL‐no: 05.062] were provided and are evaluated in the present revision of FGE.216 (FGE.216Rev2). Based on the new data, the Panel concluded that, for all the five substances, the concerns for gene mutations and clastogenicity are ruled out by the negative results observed in an in vivo gene mutation assay and in an in vivo comet assay, respectively. In vitro, [FL‐no: 05.062] induced micronuclei through an aneugenic mode of action. The available in vivo micronucleus studies were inconclusive and cannot be used to rule out potential aneugenicity of [FL‐no: 05.062] in vivo. Therefore, the Panel compared the lowest concentration resulting in aneugenicity in vitro with the use levels reported for this substance. Based on this comparison, the Panel concluded that the use of the flavouring substance [FL‐no: 05.062] at the reported use levels in several food categories would raise a concern for aneugenicity. Based on structural similarity, for the remaining four substances in this FGE [FL‐no: 05.099, 05.100, 05.175 and 05.222], an aneugenic potential may also be anticipated. For these four substances, individual data are needed to establish whether they have aneugenic potential. Accordingly, it is currently not appropriate to assess any of these five substances through the Procedure for the evaluation of flavouring substances. [ABSTRACT FROM AUTHOR]
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- 2022
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32. Follow‐up of the re‐evaluation of glycerol (E 422) 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, and Rincon, Ana Maria
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FOOD additives ,GLYCERIN ,FATS & oils ,VEGETABLE oils ,ACROLEIN - Abstract
Glycerol (E 422) 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, in this opinion, the Panel on Food Additives and Flavourings (FAF) addresses the data gaps identified to support an amendment of the EU specifications for E 422 in Commission Regulation (EU) No 231/2012. The Panel performed a risk assessment of undesirable impurities present in E 422. The Panel concluded that the maximum limits in the EU specifications for the four toxic elements (arsenic, lead, mercury and cadmium) should be lowered based on actual levels in the commercial food additive E 422. The Panel recommended setting a numerical limit value for acrolein in the specifications for E 422. The potential exposure to free 3‐monochloropropanediol at the maximum limit of 0.1 mg/kg, as laid out in the specifications for E 422, does not give rise to a health concern. The Panel recommended to consider modifying the definition of E 422 in Commission Regulation (EU) No 231/2012 indicating that E 422 is obtained only from vegetable oils and fats and undergoes purification processes that involve distillation, and other clean up steps to obtain refined glycerol. Overall, the Panel concluded that the technical data provided support an amendment of the specifications for glycerol (E 422). [ABSTRACT FROM AUTHOR]
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- 2022
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33. Follow‐up of the re‐evaluation of polyglycerol esters of fatty acids (E 475) 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, and Rincon, Ana Maria
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FOOD additives ,FATTY acid esters ,TRANS fatty acids ,FATS & oils ,VEGETABLE oils ,POISONS ,COMMERCIAL products - Abstract
Polyglycerol esters of fatty acids (PEFA, E 475) 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 475. The Panel performed a risk assessment of undesirable impurities and constituents potentially present in E 475. The Panel concluded that the maximum limits in the EU specifications for the 4 toxic elements (arsenic, lead, mercury and cadmium) should be lowered based on actual levels in the commercial food additive E 475. The Panel also concluded that maximum limits for erucic acid, 3‐monochloropropanediol and glycidyl esters should be included in the EU specifications for E 475. Alternatively, the Panel recommends an amendment of the definition of E 475 to include a requirement that the fats and oils used in the manufacturing of E 475 comply with the respective EU legislation regarding suitability for human consumption. Further, the Panel concluded that there is no need for setting a specification limit for the content of trans‐fatty acids in E 475 as a limit is established in the Regulation (EU) No 2019/649, i.e. 2 g of trans‐fat per 100 g fat in food for the final consumer. Finally, the Panel recommends a modification of the definition of E 475 indicating that polyglycerol used for the manufacturing of E 475 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 475. [ABSTRACT FROM AUTHOR]
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- 2022
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34. Safety evaluation of the food enzyme containing trypsin, chymotrypsin, α‐amylase and triacylglycerol lipase from porcine pancreas.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Glandorf, Boet, Gundert‐Remy, Ursula, Herman, Lieve, and Turck, Dominique
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MULTIENZYME complexes ,CHYMOTRYPSIN ,TRYPSIN ,LIPASES ,MILK proteins ,SOYBEAN meal ,COMMERCIAL products - Abstract
The food enzyme complex, containing trypsin (EC 3.4.21.4), chymotrypsin (EC 3.4.21.1), α‐amylase (1,4‐α‐d‐glucan glucanohydrolase, EC 3.2.1.1) and triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3), is obtained from porcine pancreas by American Laboratories, Inc., USA. The food enzyme is intended primarily for the hydrolysis of milk proteins to be used in foods for special medical or nutritional dietary management. ■■■■■ is extensively used in the manufacturing process, and residual amounts of the solvent remain in the food enzyme. The applicant estimates a typical range of ■■■■■ in the food enzyme to be 10,000–13,000 mg/kg. Directive 2009/32/EC sets a maximum residue level of 10 mg/kg for foods and food ingredients produced in the EU or imported into the EU. The use of ■■■■■ for the production of a food enzyme falls within the scope of Directive 2009/32/EC. Consequently, the food enzyme does not comply with the existing requirements within the EU governing residual amount of solvent. [ABSTRACT FROM AUTHOR]
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- 2022
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35. Scientific Opinion on Flavouring Group Evaluation 63, Revision 4 (FGE.63Rev4): consideration of aliphatic secondary saturated and unsaturated alcohols, ketones and related esters evaluated by JECFA (59th and 69th meetings) structurally related to flavouring substances evaluated by EFSA in FGE.07Rev6
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl‐Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Benigni, Romualdo, Bolognesi, Claudia, and Chipman, Kevin
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KETONES ,STRUCTURE-activity relationships ,FOOD additives ,FOOD consumption ,ESTERS - 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. [ABSTRACT FROM AUTHOR]
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- 2022
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36. Scientific Opinion on Flavouring Group Evaluation 7, Revision 6 (FGE.07Rev6): saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched‐chain carboxylic acids from chemical group 5
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl‐Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Benigni, Romualdo, Bolognesi, Claudia, and Chipman, Kevin
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ALIPHATIC alcohols ,CARBOXYLIC acids ,KETONES ,FOOD additives ,ESTERS ,SCIENCE publishing - 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. [ABSTRACT FROM AUTHOR]
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- 2022
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37. Safety evaluation of glucosylated steviol glycosides as a food additive in different food categories.
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Younes, Maged, Aquilina, Gabriele, Engel, Karl‐Heinz, J 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, Wölfle, Detlef, Wright, Matthew, Barat, Jose Manuel, Degen, Gisela, and Herman, Lieve
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FOOD additives ,GLYCOSIDES ,STEVIA rebaudiana ,BODY weight ,BIOCONVERSION - Abstract
The EFSA Panel on Food Additive and Flavourings (FAF) assessed the safety of glucosylated steviol glycosides proposed for use as a new food additive in different food categories. Glucosylated steviol glycosides consist of a mixture of glucosylated steviol glycosides, containing 1–20 additional glucose units bound to the parent steviol glycosides. Glucosylated steviol glycosides consist of not less than 95% (on dry, dextrin‐free, basis) of total steviol glycosides, comprised of glucosylated and parent steviol glycosides. Glucosylated steviol glycosides are produced via enzymatic bioconversion using cyclomaltodextrin glucanotransferase (CGTase) (EC 2.4.1.19), derived from a non‐genetically modified strain of Anoxybacillus caldiproteolyticus, that catalyses the transfer of glucose from starch to steviol glycosides mixtures isolated from the dried leaves of Stevia Rebaudiana. The Panel considered that the metabolism of glucosylated steviol glycosides is sufficiently similar to the already authorised steviol glycosides, and thus, the toxicological data previously assessed by the ANS Panel for steviol glycosides (E 960) were considered to support their safety as food additive. The existing acceptable daily intake (ADI) for steviol glycosides (E 960) of 4 mg/kg body weight (bw) per day expressed as steviol can also be applied to glucosylated steviol glycosides. The Panel concluded that there is no safety concern for the use of glucosylated steviol glycosides as a new food additive at the proposed use and use levels. The Panel recommended some modifications to the specifications proposed by the applicant for glucosylated steviol glycosides with respect to the assay, the definition of the proposed new food additive and the proposed maximum limits for arsenic. [ABSTRACT FROM AUTHOR]
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- 2022
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38. Scientific Opinion of the Scientific Panel on Plant Protection Products and their Residues (PPR Panel) on testing and interpretation of comparative in vitro metabolism studies.
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Hernandez‐Jerez, Antonio F, Adriaanse, Paulien, Aldrich, Annette, Berny, Philippe, Coja, Tamara, Duquesne, Sabine, Focks, Andreas, Marinovich, Marina, Millet, Maurice, Pelkonen, Olavi, Pieper, Silvia, Tiktak, Aaldrik, Topping, Christopher J, Widenfalk, Anneli, Wilks, Martin, Wolterink, Gerrit, Gundert‐Remy, Ursula, Louisse, Jochem, Rudaz, Serge, and Testai, Emanuela
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PLANT products ,PLANT protection ,TEST interpretation ,IN vitro studies ,HAZARDOUS substances - Abstract
EFSA asked the Panel on Plant Protection Products and their residues to deliver a Scientific Opinion on testing and interpretation of comparative in vitro metabolism studies for both new active substances and existing ones. The main aim of comparative in vitro metabolism studies of pesticide active substances is to evaluate whether all significant metabolites formed in the human in vitro test system, as a surrogate of the in vivo situation, are also present at comparable level in animal species tested in toxicological studies and, therefore, if their potential toxicity has been appropriately covered by animal studies. The studies may also help to decide which animal model, with regard to a particular compound, is the most relevant for humans. In the experimental strategy, primary hepatocytes in suspension or culture are recommended since hepatocytes are considered the most representative in vitro system for prediction of in vivo metabolites. The experimental design of 3 × 3 × 3 (concentrations, time points, technical replicates, on pooled hepatocytes) will maximise the chance to identify unique (UHM) and disproportionate (DHM) human metabolites. When DHM and UHM are being assessed, test item‐related radioactivity recovery and metabolite profile are the most important parameters. Subsequently, structural characterisation of the assigned metabolites is performed with appropriate analytical techniques. In toxicological assessment of metabolites, the uncertainty factor approach is the first alternative to testing option, followed by new approach methodologies (QSAR, read‐across, in vitro methods), and only if these fail, in vivo animal toxicity studies may be performed. Knowledge of in vitro metabolites in human and animal hepatocytes would enable toxicological evaluation of all metabolites of concern, and, furthermore, add useful pieces of information for detection and evaluation of metabolites in different matrices (crops, livestock, environment), improve biomonitoring efforts via better toxicokinetic understanding, and ultimately, develop regulatory schemes employing physiologically based or physiology‐mimicking in silico and/or in vitro test systems to anticipate the exposure of humans to potentially hazardous substances in plant protection products. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6989/full [ABSTRACT FROM AUTHOR]
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- 2021
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39. Re‐evaluation of thaumatin (E 957) as food additive.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl‐Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Gundert‐Remy, Ursula, Husøy, Trine, Manco, Melania, Mennes, Wim, Passamonti, Sabina, Moldeus, Peter, Shah, Romina, Waalkens‐Berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Batke, Monika, and Boon, Polly
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THAUMATINS ,FOOD additives - Abstract
The present opinion deals with the re‐evaluation of thaumatin (E 957) when used as a food additive. Thaumatin is a natural plant protein, consisting of thaumatin I and thaumatin II proteins together with minor amounts of plant constituents, obtained by acidic aqueous extraction of the arils of the fruit of Thaumatococcus daniellii plant. The Panel followed the conceptual framework for the risk assessment of certain food additives and considered that thaumatin is a digestible protein; adequate exposure estimates were available; there was no concern with respect to the genotoxicity; no conclusion on oral allergenicity could be drawn from the available human data; no adverse effects were observed in sub‐chronic toxicity studies in rats and dogs at the highest dose tested of up 5,200 and 1,476 mg/kg bodyweight (bw) per day, respectively, and in a prenatal developmental toxicity study up to 2,000 mg/kg bw per day; moderate confidence in the body of evidence supported the absence of association between exposure to thaumatin and adverse health outcomes. Therefore, the Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for thaumatin (E 957) and, based on a margin of safety (MOS) of 5,417, considered to be an underestimate and derived using the highest 95th percentile (P95) exposure of 0.48 mg/kg bw per day in consumers only, there is no safety concern for thaumatin (E 957) at the regulatory maximum level exposure assessment scenario, which was considered the most appropriate. The Panel recommended that European Commission considers introducing in the EU specifications for thaumatin (E 957) a new specification limit for the minimum combined content of thaumatin I and II proteins in E 957, a specification limit for yeast, mould counts and Salmonella spp and lowering the existing maximum limit for arsenic along with the inclusion of maximum limits for mercury and cadmium.This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6918/full [ABSTRACT FROM AUTHOR]
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- 2021
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40. Scientific opinion on flavouring group evaluation 414 (FGE.414): 2-hydroxy-4-methoxybenzaldehyde.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl-Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Gundert-Remy, Ursula, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Benigni, Romualdo, Chipman, Kevin, and Cordelli, Eugenia
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SUBSTANCE abuse ,FOOD additives ,STRUCTURAL panels ,MANUFACTURING processes ,BODY weight ,SCIENCE publishing - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the substance 2-hydroxy-4-methoxybenzaldehyde [FL-no: 05.229] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. 2-Hydroxy-4-methoxybenzaldehyde belongs to chemical group 23 (Commission Regulation (EC) No 1565/2000) and is structurally related to the hydroxy- and alkoxy-ring substituted benzyl derivatives evaluated in FGE.52 and in FGE.20Rev4. The Panel considered the structural/metabolic similarity sufficient to evaluate the candidate substance following a group-based approach according to the EFSA Guidance on the data required for the risk assessment of flavourings to be used in or on foods. The information provided on the manufacturing process, the composition and the stability of [FL-no: 05.229] was considered sufficient. From studies carried out with this substance, the Panel concluded that there is no concern with respect to genotoxicity. Based on QSAR evaluation of possible metabolism, and based on information from structurally related substances, various metabolic routes can be anticipated, which only result in the formation of innocuous metabolites. The exposure estimates for [FL-no: 05.229] (24 and 60 μg/person per day for children and adults, respectively) were below the Threshold of Toxicological Concern (TTC) for its structural class (I). Accordingly, toxicity studies are not required and the Panel concluded at step A3 of the Procedure that 2-hydroxy-4-methoxybenzaldehyde is not of safety concern when used as a flavouring substance at the intended uses and use levels. Cumulative exposure estimates for 2-hydroxy-4-methoxybenzaldehyde and three structurally related substances (2.4 and 6.2 mg/kg body weight (bw) per day for adults and children, respectively) are above the TTC for structural class I, but below the ADI (acceptable daily intake) of 0-10 mg/kg bw per day for vanillin, which is one of these structurally related substances. Therefore, the cumulative exposure to these four substances [FL-no: 05.015, 05.018, 05.229 and 09.749] also does not raise a safety concern. [ABSTRACT FROM AUTHOR]
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- 2021
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41. Safety evaluation of steviol glycoside preparations, including rebaudioside AM, obtained by enzymatic bioconversion of highly purified stevioside and/or rebaudioside A stevia leaf extracts.
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl-Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Gundert-Remy, Ursula, Husøy, Trine, Manco, Melania, Mennes, Wim, Passamonti, Sabina, Moldeus, Peter, Shah, Romina, Waalkens-Berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Barat Baviera, José Manuel, and Degen, Gisela
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STEVIOSIDE ,FOOD additives ,STEVIA ,BIOCONVERSION ,COMMERCIAL products ,SAFETY ,NATURAL products - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of steviol glycoside preparations, including rebaudioside AM, obtained by enzymatic bioconversion of highly purified stevioside and/or rebaudioside A stevia leaf extracts. These steviol glycoside preparations are produced via enzymatic bioconversion of highly purified stevioside and/or rebaudioside A extracts obtained from stevia plant using two UDP-glucosyltransferases and one sucrose synthase enzymes produced by the genetically modified strains of E. coli K-12 that facilitate the transfer of glucose to purified stevia leaf extracts via glycosidic bonds. The Panel considered that the parental strain is a derivative of E. coli K-12 which is well characterised and its safety has been documented; therefore, it is considered to be safe for production purposes. The Panel concluded that there is no safety concern for steviol glycoside preparations, including rebaudioside AM, obtained by enzymatic bioconversion of highly purified stevioside and/or rebaudioside A stevia leaf extracts using UDP-glucosyltransferases and sucrose synthase enzymes produced by the genetically modified strains of E. coli K-12, to be used as a food additive. The Panel recommends the European Commission to consider the proposal of establishing separate specifications for steviol glycoside preparations, including rebaudioside AM, obtained by enzymatic bioconversion of highly purified stevioside and/or rebaudioside A stevia leaf extracts in Commission Regulation (EU) No 231/2012. [ABSTRACT FROM AUTHOR]
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- 2021
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42. Safety evaluation of crosslinked polyacrylic acid polymers (carbomer) as a new food additive.
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Younes, Maged, Aquilina, Gabriele, Engel, Karl-Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Gundert-Remy, Ursula, Husøy, Trine, Manco, Melania, Mennes, Wim, Passamonti, Sabina, Moldeus, Peter, Shah, Romina, Waalkens-Berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Barat Baviera, José Manuel, Degen, Gisela, and Leblanc, Jean-Charles
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FOOD additives ,POLYACRYLIC acid ,POLYMERS ,ACRYLIC acid ,FLUID foods - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of crosslinked polyacrylic acid polymers (carbomer) proposed for use as food additive in solid and liquid food supplements. Carbomer is formed from the monomer, acrylic acid, which is polymerised and crosslinked with allyl pentaerythritol (APE). The polymers are synthesised in ethyl acetate using as free-radical polymerisation initiator. In vivo data showed no evidence for systemic availability or biotransformation of carbomer. Carbomer does not raise a concern regarding genotoxicity. Considering the available data set, the Panel derived an acceptable daily intake (ADI) of 190 mg/kg body weight (bw) per day based on a no observed adverse effect level (NOAEL) of 1,500 mg/kg bw per day from a sub-chronic 13-week study in rat, applying a compound specific uncertainty factor (UF) of 8. At the proposed maximum use levels, the exposure estimates ranged at the mean from 1.1 to 90.2 mg/kg bw per day and at the p95 from 12.5 to 237.4 mg/kg bw per day. At the proposed typical use level, the exposure estimates ranged at the mean from 0.7 to 60.2 mg/kg bw per day and at the p95 from 10.3 to 159.5 mg/kg bw per day. The Panel noted that the maximum proposed use levels would result in exposure estimates close to or above the ADI. The Panel also noted that level of exposure to carbomer from its proposed use is likely to be an overestimation. Taking a conservative approach, the Panel considered that exposure to carbomer would not give rise to a safety concern if the proposed maximum use level for solid food supplements is lowered to the typical use level reported by the applicant. [ABSTRACT FROM AUTHOR]
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- 2021
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43. Follow-up of the re-evaluation of glycerol (E 422) as a food additive
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Maged, Younes, Gabriele, Aquilina, Laurence, Castle, Karl-Heinz, Engel, Paul, Fowler, Maria Jose, Frutos Fernandez, Ursula, Gundert-Remy, Rainer, Gürtler, Trine, Husøy, Melania, Manco, Wim, Mennes, Peter, Moldeus, Sabina, Passamonti, Romina, Shah, Ine, Waalkens-Berendsen, Detlef, Wölfle, Matthew, Wright, Karlien, Cheyns, Manuela, Mirat, Ana Maria, Rincon, Peter, Fürst, 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, and Fürst, Peter
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food additive ,glycerin ,CAS Registry Number 56‐85‐1 ,E 422 ,glycerine ,glycerol - Abstract
Glycerol (E 422) 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, in this opinion, the Panel on Food Additives and Flavourings (FAF) addresses the data gaps identified to support an amendment of the EU specifications for E 422 in Commission Regulation (EU) No 231/2012. The Panel performed a risk assessment of undesirable impurities present in E 422. The Panel concluded that the maximum limits in the EU specifications for the four toxic elements (arsenic, lead, mercury and cadmium) should be lowered based on actual levels in the commercial food additive E 422. The Panel recommended setting a numerical limit value for acrolein in the specifications for E 422. The potential exposure to free 3-monochloropropanediol at the maximum limit of 0.1 mg/kg, as laid out in the specifications for E 422, does not give rise to a health concern. The Panel recommended to consider modifying the definition of E 422 in Commission Regulation (EU) No 231/2012 indicating that E 422 is obtained only from vegetable oils and fats and undergoes purification processes that involve distillation, and other clean up steps to obtain refined glycerol. Overall, the Panel concluded that the technical data provided support an amendment of the specifications for glycerol (E 422).
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- 2022
44. Scientific opinion on Flavouring group evaluation 216 revision 2 (FGE.216Rev2): consideration of the genotoxicity potential of α,β‐unsaturated 2‐phenyl‐2‐alkenals from subgroup 3.3 of FGE.19
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Maged, Younes, Gabriele, Aquilina, Laurence, Castle, Gisela, Degen, Karl-Heinz, Engel, Paul J, Fowler, Maria Jose, Frutos Fernandez, Peter, Fürst, Ursula, Gundert-Remy, Rainer, Gürtler, Trine, Husøy, Melania, Manco, Peter, Moldeus, Sabina, Passamonti, Romina, Shah, Ine, Waalkens-Berendsen, Matthew, Wright, Romualdo, Benigni, Claudia, Bolognesi, Kevin, Chipman, Eugenia, Cordelli, Karin, Nørby, Camilla, Svendsen, Maria, Carfì, Carla, Martino, Wim, Mennes, 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, Carfì, Maria, Martino, Carla, and Mennes, Wim
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subgroup 3.3, FGE.19 ,FGE.216 ,flavouring substance ,safety evaluation ,a,b-unsaturated 2-phenyl-2-alkenal - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the genotoxic potential of five flavouring substances from subgroup 3.3 of FGE.19, in the Flavouring Group Evaluation 216 (FGE.216). In FGE.216 and in FGE.216Rev1, the CEF Panel requested additional genotoxicity data on 2-phenylcrotonaldehyde [FL-no: 05.062], the representative for these five substances. New experimental data on [FL-no: 05.062] were provided and are evaluated in the present revision of FGE.216 (FGE.216Rev2). Based on the new data, the Panel concluded that, for all the five substances, the concerns for gene mutations and clastogenicity are ruled out by the negative results observed in an in vivo gene mutation assay and in an in vivo comet assay, respectively. In vitro, [FL-no: 05.062] induced micronuclei through an aneugenic mode of action. The available in vivo micronucleus studies were inconclusive and cannot be used to rule out potential aneugenicity of [FL-no: 05.062] in vivo. Therefore, the Panel compared the lowest concentration resulting in aneugenicity in vitro with the use levels reported for this substance. Based on this comparison, the Panel concluded that the use of the flavouring substance [FL-no: 05.062] at the reported use levels in several food categories would raise a concern for aneugenicity. Based on structural similarity, for the remaining four substances in this FGE [FL-no: 05.099, 05.100, 05.175 and 05.222], an aneugenic potential may also be anticipated. For these four substances, individual data are needed to establish whether they have aneugenic potential. Accordingly, it is currently not appropriate to assess any of these five substances through the Procedure for the evaluation of flavouring substances.
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- 2022
45. Scientific Guidance on the data required for the risk assessment of flavourings to be used in or on foods
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Maged, Younes, Gabriele, Aquilina, Laurence, Castle, Gisela, Degen, Paul J, Fowler, Maria Jose Frutos, Fernandez, Peter, Fürst, Ursula, Gundert-Remy, Rainer, Gürtler, Trine, Husøy, Melania, Manco, Wim, Mennes, Peter, Moldeus, Sabina, Passamonti, Romina, Shah, Ine, Waalkens-Berendsen, Detlef, Wölfle, Matthew, Wright, Romualdo, Benigni, Claudia, Bolognesi, Polly, Boon, Kevin, Chipman, Joop, De Knecht, Karin, Nørby, Davide, Arcella, Stefania, Barmaz, Maria, Carfì, Marcello, Laganaro, Carla, Martino, Alexandra, Tard, Giorgia, Vianello, Karl-Heinz, Engel, Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Fowler, Paul J, Fernandez, Maria Jose Fruto, Fürst, Peter, Gundert-Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Benigni, Romualdo, Bolognesi, Claudia, Boon, Polly, Chipman, Kevin, De Knecht, Joop, Nørby, Karin, Arcella, Davide, Barmaz, Stefania, Carfì, Maria, Laganaro, Marcello, Martino, Carla, Tard, Alexandra, Vianello, Giorgia, and Engel, Karl-Heinz
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thermal process flavourings ,source material ,flavouring preparation ,flavouring substance ,other flavouring ,flavour precursor ,Food flavouring - Abstract
Following a request from the European Commission, EFSA developed a new scientific guidance to assist applicants in the preparation of applications for the authorisation of flavourings to be used in or on foods. This guidance applies to applications for a new authorisation as well as for a modification of an existing authorisation of a food flavouring, submitted under Regulation (EC) No 1331/2008. It defines the scientific data required for the evaluation of those food flavourings for which an evaluation and approval is required according to Article 9 of Regulation (EC) No 1334/2008. This applies to flavouring substances, flavouring preparations, thermal process flavourings, flavour precursors, other flavourings and source materials, as defined in Article 3 of Regulation (EC) No 1334/2008. Information to be provided in all applications relates to: (a) the characterisation of the food flavouring, including the description of its identity, manufacturing process, chemical composition, specifications, stability and reaction and fate in foods; (b) the proposed uses and use levels and the assessment of the dietary exposure and (c) the safety data, including information on the genotoxic potential of the food flavouring, toxicological data other than genotoxicity and information on the safety for the environment. For the toxicological studies, a tiered approach is applied, for which the testing requirements, key issues and triggers are described. Applicants should generate the data requested in each section to support the safety assessment of the food flavouring. Based on the submitted data, EFSA will assess the safety of the food flavouring and conclude whether or not it presents risks to human health and to the environment, if applicable, under the proposed conditions of use.
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- 2022
46. Scientific opinion on flavouring group evaluation 414 (FGE.414): 2‐hydroxy‐4‐methoxybenzaldehyde
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EFSA Panel on Food Additives and Flavourings (FAF), Maged Younes, Gabriele Aquilina, Laurence Castle, Karl‐Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Ursula Gundert‐Remy, Trine Husøy, Melania Manco, Peter Moldeus, Sabina Passamonti, Romina Shah, Ine Waalkens‐Berendsen, Detlef Wölfle, Matthew Wright, Romualdo Benigni, Kevin Chipman, Eugenia Cordelli, Gisela Degen, Maria Carfí, Giorgia Vianello, Wim Mennes, Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl‐heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Gundert‐remy, Ursula, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Benigni, Romualdo, Chipman, Kevin, Cordelli, Eugenia, Degen, Gisela, Carfí, Maria, Vianello, Giorgia, and Mennes, Wim
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Acceptable daily intake ,food.ingredient ,Veterinary (miscellaneous) ,FL-no: 05.229 ,Group evaluation ,Cumulative Exposure ,Plant Science ,TP1-1185 ,Body weight ,medicine.disease_cause ,2-hydroxy-4-methoxybenzaldehyde ,Microbiology ,05.229 [FGE.414, FL-no] ,Anim2953 ,chemistry.chemical_compound ,food ,2-Hydroxy-4-methoxybenzaldehyde ,medicine ,TX341-641 ,Food science ,FGE.414, FL-no: 05.229 ,business.industry ,Nutrition. Foods and food supply ,Food additive ,Chemical technology ,Scientific Opinion ,chemistry ,FGE.414 ,2‐hydroxy‐4-methoxybenzaldehyde ,Toxicity ,Animal Science and Zoology ,Parasitology ,FL‐no: 05.229 ,business ,Genotoxicity ,Food Science - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the substance 2‐hydroxy‐4‐methoxybenzaldehyde [FL‐no: 05.229] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. 2‐Hydroxy‐4‐methoxybenzaldehyde belongs to chemical group 23 (Commission Regulation (EC) No 1565/2000) and is structurally related to the hydroxy‐ and alkoxy‐ring substituted benzyl derivatives evaluated in FGE.52 and in FGE.20Rev4. The Panel considered the structural/metabolic similarity sufficient to evaluate the candidate substance following a group‐based approach according to the EFSA Guidance on the data required for the risk assessment of flavourings to be used in or on foods. The information provided on the manufacturing process, the composition and the stability of [FL‐no: 05.229] was considered sufficient. From studies carried out with this substance, the Panel concluded that there is no concern with respect to genotoxicity. Based on QSAR evaluation of possible metabolism, and based on information from structurally related substances, various metabolic routes can be anticipated, which only result in the formation of innocuous metabolites. The exposure estimates for [FL‐no: 05.229] (24 and 60 μg/person per day for children and adults, respectively) were below the Threshold of Toxicological Concern (TTC) for its structural class (I). Accordingly, toxicity studies are not required and the Panel concluded at step A3 of the Procedure that 2‐hydroxy‐4‐methoxybenzaldehyde is not of safety concern when used as a flavouring substance at the intended uses and use levels. Cumulative exposure estimates for 2‐hydroxy‐4‐methoxybenzaldehyde and three structurally related substances (2.4 and 6.2 mg/kg body weight (bw) per day for adults and children, respectively) are above the TTC for structural class I, but below the ADI (acceptable daily intake) of 0‐10 mg/kg bw per day for vanillin, which is one of these structurally related substances. Therefore, the cumulative exposure to these four substances [FL‐no: 05.015, 05.018, 05.229 and 09.749] also does not raise a safety concern.
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- 2021
47. Safety evaluation of crosslinked polyacrylic acid polymers (carbomer) as a new food additive
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Camilla Smeraldi, Consuelo Civitella, Maria Jose Frutos Fernandez, Giorgia Vianello, Gisela H. Degen, Ursula Gundert-Remy, Trine Husøy, Karl-Heinz Engel, Ine Waalkens-Berendsen, Rainer Gürtler, Alexandra Tard, Jean-Charles Leblanc, Gabriele Aquilina, Wim Mennes, Melania Manco, Sabina Passamonti, Detlef Wölfle, Laurence Castle, José Manuel Barat Baviera, Alessandra Giarola, Paul Fowler, Peter Moldeus, Matthew Wright, Romina Shah, Maged Younes, Lieve Herman, Peter Fürst, Flavourings (Faf), Younes, Maged, Aquilina, Gabriele, Engel, Karl‐heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Gundert‐remy, Ursula, Husøy, Trine, Manco, Melania, Mennes, Wim, Passamonti, Sabina, Moldeus, Peter, Shah, Romina, Waalkens‐berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Barat Baviera, José Manuel, Degen, Gisela, Leblanc, Jean‐charle, Herman, Lieve, Civitella, Consuelo, Giarola, Alessandra, Smeraldi, Camilla, Tard, Alexandra, Vianello, Giorgia, and Castle, Laurence
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carbomer ,No-observed-adverse-effect level ,Acceptable daily intake ,food.ingredient ,TECNOLOGIA DE ALIMENTOS ,crosslinked polyacrylic acid polymers ,food additive ,Veterinary (miscellaneous) ,Ethyl acetate ,TP1-1185 ,Plant Science ,medicine.disease_cause ,Microbiology ,chemistry.chemical_compound ,food ,medicine ,Crosslinked polyacrylic acid polymers ,TX341-641 ,Food science ,Food8822 ,Acrylic acid ,chemistry.chemical_classification ,Nutrition. Foods and food supply ,Chemical technology ,Food additive ,Polyacrylic acid ,Polymer ,Scientific Opinion ,chemistry ,crosslinked polyacrylic acid polymer ,Animal Science and Zoology ,Parasitology ,Genotoxicity ,Food Science - Abstract
[EN] The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of crosslinked polyacrylic acid polymers (carbomer) proposed for use as food additive in solid and liquid food supplements. Carbomer is formed from the monomer, acrylic acid, which is polymerised and crosslinked with allyl pentaerythritol (APE). The polymers are synthesised in ethyl acetate using as free-radical polymerisation initiator. In vivo data showed no evidence for systemic availability or biotransformation of carbomer. Carbomer does not raise a concern regarding genotoxicity. Considering the available data set, the Panel derived an acceptable daily intake (ADI) of 190 mg/kg body weight (bw) per day based on a no observed adverse effect level (NOAEL) of 1,500 mg/kg bw per day from a sub-chronic 13-week study in rat, applying a compound specific uncertainty factor (UF) of 8. At the proposed maximum use levels, the exposure estimates ranged at the mean from 1.1 to 90.2 mg/kg bw per day and at the p95 from 12.5 to 237.4 mg/kg bw per day. At the proposed typical use level, the exposure estimates ranged at the mean from 0.7 to 60.2 mg/kg bw per day and at the p95 from 10.3 to 159.5 mg/kg bw per day. The Panel noted that the maximum proposed use levels would result in exposure estimates close to or above the ADI. The Panel also noted that level of exposure to carbomer from its proposed use is likely to be an overestimation. Taking a conservative approach, the Panel considered that exposure to carbomer would not give rise to a safety concern if the proposed maximum use level for solid food supplements is lowered to the typical use level reported by the applicant. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
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- 2021
48. 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 M, Aquilina G, Castle L, Degen G, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gürtler R, Husøy T, Manco M, Mennes W, Moldeus P, Passamonti S, Shah R, Waalkens-Berendsen I, Wright M, Dusemund B, Mortensen A, Turck D, Wölfle D, Barmaz S, Mech A, Tard A, and Gundert-Remy U
- 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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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49. Metabolites in the regulatory risk assessment of pesticides in the EU.
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Pelkonen O, Abass K, Parra Morte JM, Panzarea M, Testai E, Rudaz S, Louisse J, Gundert-Remy U, Wolterink G, Jean-Lou Cm D, Coecke S, and Bernasconi C
- Abstract
A large majority of chemicals is converted into metabolites through xenobiotic-metabolising enzymes. Metabolites may present a spectrum of characteristics varying from similar to vastly different compared with the parent compound in terms of both toxicokinetics and toxicodynamics. In the pesticide arena, the role of metabolism and metabolites is increasingly recognised as a significant factor particularly for the design and interpretation of mammalian toxicological studies and in the toxicity assessment of pesticide/metabolite-associated issues for hazard characterization and risk assessment purposes, including the role of metabolites as parts in various residues in ecotoxicological adversities. This is of particular relevance to pesticide metabolites that are unique to humans in comparison with metabolites found in in vitro or in vivo animal studies, but also to disproportionate metabolites (quantitative differences) between humans and mammalian species. Presence of unique or disproportionate metabolites may underlie potential toxicological concerns. This review aims to present the current state-of-the-art of comparative metabolism and metabolites in pesticide research for hazard and risk assessment, including One Health perspectives, and future research needs based on the experiences gained at the European Food Safety Authority., Competing Interests: JoL, JeL, MP and JP were employed by the European Food Safety Authority (EFSA). SC and CB were employed by the European Commission Joint Research Centre (JRC). The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2023 Pelkonen, Abass, Parra Morte, Panzarea, Testai, Rudaz, Louisse, Gundert-Remy, Wolterink, Jean-Lou CM, Coecke and Bernasconi.)
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- 2023
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50. 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.
- Author
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Younes M, Aquilina G, Castle L, Degen G, Engel KH, Fowler PJ, Frutos Fernandez MJ, Fürst P, Gürtler R, Husøy T, Manco M, Mennes W, Moldeus P, Passamonti S, Shah R, Waalkens-Berendsen I, Wright M, Wölfle D, Dusemund B, Mortensen A, Turck D, Cheyns K, Gaffet E, Loeschner K, Mast J, Mirat M, Undas A, Barmaz S, Mech A, Rincon AM, Smeraldi C, Tard A, and Gundert-Remy U
- 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
- Full Text
- View/download PDF
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