Scientific Opinion of Flavouring Group Evaluation 410 (FGE.410): 4’,5,7-trihydroxyflavanone from chemical group 25 (phenol derivatives containing ring-alkyl, ring-alkoxy, and side-chains with an oxygenated functional group)

Flavourings and Processing Aids (CEF) EFSA Panel on Food Contact Materials Enzymes, Vittorio Silano, Claudia Bolognesi, Laurence Castle, Kevin Chipman, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Maria Rosaria Milana, Karla Pfaff, Gilles Riviere, Jannavi Srinivasan, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle & 14 others Holger Zorn, Ulla Beckman Sundh, Romualdo Benigni, Mona-Lise Binderup, Leon Brimer, Francesca Marcon, Daniel Marzin, Pasquale Mosesso, Gerard Mulder, Agneta Oskarsson, Camilla Svendsen, Maria Anastassiadou, Maria Carfì, Wim Mennes

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Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 4′,5,7-trihydroxyflavanone or naringenin [FL-no: 16.132], in the Flavouring Group Evaluation 410 (FGE.410), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance occurs naturally in grapefruits, oranges and tomatoes. It is intended to be used as a flavouring substance with flavour-modifying properties in specific categories of food. Information on specifications and manufacturing of [FL-no: 16.132] were considered adequate; however, data on stability in food are incomplete. The Panel noted that the available genotoxicity studies have significant shortcomings and are insufficient to conclude on the genotoxic potential of naringenin. Therefore, [FL-no: 16.132] cannot be evaluated through the Procedure. Additionally, the Panel noted that inhibition of CYP 450 by [FL-no: 16.132] has been clearly demonstrated in animal species in vivo which implies that the substance may interact with the metabolism and elimination of medicines and no convincing information is available that this does not pose a risk to humans at the estimated levels of exposure. To continue with the safety assessment of [FL-no: 16.132], a bacterial gene mutation assay and an in vitro micronucleus assay (according to OECD guidelines 471, 487 and GLP) are required. Even if these studies do not indicate a genotoxic potential, additional toxicological data are needed to finalise the evaluation.
Original languageEnglish
Pagese05011
Volume15
No.11
Specialist publicationEFSA Journal
PublisherEuropean Food Safety Authority (EFSA)
DOIs
Publication statusPublished - Nov 2017

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Phenol
Food
Citrus paradisi
Bacterial Genes
Micronucleus Tests
Lycopersicon esculentum
Toxicology
Guidelines
Safety
Mutation
Health
Enzymes
alkoxyl radical
naringenin

Keywords

  • flavouring
  • 4′,5,7-trihydroxyflavanone
  • naringenin
  • FGE.410
  • [FL-no: 16.132]

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Scientific Opinion of Flavouring Group Evaluation 410 (FGE.410): 4’,5,7-trihydroxyflavanone from chemical group 25 (phenol derivatives containing ring-alkyl, ring-alkoxy, and side-chains with an oxygenated functional group). / EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF); Silano, Vittorio; Bolognesi, Claudia; Castle, Laurence; Chipman, Kevin; Cravedi, Jean-Pierre; Engel, Karl-Heinz; Fowler, Paul; Franz, Roland; Grob, Konrad; Gürtler, Rainer; Husøy, Trine; Kärenlampi, Sirpa; Milana, Maria Rosaria; Pfaff, Karla; Riviere, Gilles; Srinivasan, Jannavi; Tavares Poças, Maria de Fátima; Tlustos, Christina; Wölfle, Detlef; Zorn, Holger; Beckman Sundh, Ulla; Benigni, Romualdo; Binderup, Mona-Lise; Brimer, Leon; Marcon, Francesca; Marzin, Daniel; Mosesso, Pasquale; Mulder, Gerard; Oskarsson, Agneta; Svendsen, Camilla; Anastassiadou, Maria; Carfì, Maria; Mennes, Wim.

In: EFSA Journal, Vol. 15, No. 11, 11.2017, p. e05011.

Research output: Contribution to specialist publicationArticle

EFSA Panel on Food Contact Materials Enzymes, FAPACEF, Silano, V, Bolognesi, C, Castle, L, Chipman, K, Cravedi, J-P, Engel, K-H, Fowler, P, Franz, R, Grob, K, Gürtler, R, Husøy, T, Kärenlampi, S, Milana, MR, Pfaff, K, Riviere, G, Srinivasan, J, Tavares Poças, MDF, Tlustos, C, Wölfle, D, Zorn, H, Beckman Sundh, U, Benigni, R, Binderup, M-L, Brimer, L, Marcon, F, Marzin, D, Mosesso, P, Mulder, G, Oskarsson, A, Svendsen, C, Anastassiadou, M, Carfì, M & Mennes, W 2017, 'Scientific Opinion of Flavouring Group Evaluation 410 (FGE.410): 4’,5,7-trihydroxyflavanone from chemical group 25 (phenol derivatives containing ring-alkyl, ring-alkoxy, and side-chains with an oxygenated functional group)' EFSA Journal, vol. 15, no. 11, pp. e05011. https://doi.org/10.2903/j.efsa.2017.5011
EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF) ; Silano, Vittorio ; Bolognesi, Claudia ; Castle, Laurence ; Chipman, Kevin ; Cravedi, Jean-Pierre ; Engel, Karl-Heinz ; Fowler, Paul ; Franz, Roland ; Grob, Konrad ; Gürtler, Rainer ; Husøy, Trine ; Kärenlampi, Sirpa ; Milana, Maria Rosaria ; Pfaff, Karla ; Riviere, Gilles ; Srinivasan, Jannavi ; Tavares Poças, Maria de Fátima ; Tlustos, Christina ; Wölfle, Detlef ; Zorn, Holger ; Beckman Sundh, Ulla ; Benigni, Romualdo ; Binderup, Mona-Lise ; Brimer, Leon ; Marcon, Francesca ; Marzin, Daniel ; Mosesso, Pasquale ; Mulder, Gerard ; Oskarsson, Agneta ; Svendsen, Camilla ; Anastassiadou, Maria ; Carfì, Maria ; Mennes, Wim. / Scientific Opinion of Flavouring Group Evaluation 410 (FGE.410): 4’,5,7-trihydroxyflavanone from chemical group 25 (phenol derivatives containing ring-alkyl, ring-alkoxy, and side-chains with an oxygenated functional group). In: EFSA Journal. 2017 ; Vol. 15, No. 11. pp. e05011.
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abstract = "The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 4′,5,7-trihydroxyflavanone or naringenin [FL-no: 16.132], in the Flavouring Group Evaluation 410 (FGE.410), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance occurs naturally in grapefruits, oranges and tomatoes. It is intended to be used as a flavouring substance with flavour-modifying properties in specific categories of food. Information on specifications and manufacturing of [FL-no: 16.132] were considered adequate; however, data on stability in food are incomplete. The Panel noted that the available genotoxicity studies have significant shortcomings and are insufficient to conclude on the genotoxic potential of naringenin. Therefore, [FL-no: 16.132] cannot be evaluated through the Procedure. Additionally, the Panel noted that inhibition of CYP 450 by [FL-no: 16.132] has been clearly demonstrated in animal species in vivo which implies that the substance may interact with the metabolism and elimination of medicines and no convincing information is available that this does not pose a risk to humans at the estimated levels of exposure. To continue with the safety assessment of [FL-no: 16.132], a bacterial gene mutation assay and an in vitro micronucleus assay (according to OECD guidelines 471, 487 and GLP) are required. Even if these studies do not indicate a genotoxic potential, additional toxicological data are needed to finalise the evaluation.",
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AU - Silano, Vittorio

AU - Bolognesi, Claudia

AU - Castle, Laurence

AU - Chipman, Kevin

AU - Cravedi, Jean-Pierre

AU - Engel, Karl-Heinz

AU - Fowler, Paul

AU - Franz, Roland

AU - Grob, Konrad

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AU - Tavares Poças, Maria de Fátima

AU - Tlustos, Christina

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AU - Beckman Sundh, Ulla

AU - Benigni, Romualdo

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AU - Marcon, Francesca

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AU - Mosesso, Pasquale

AU - Mulder, Gerard

AU - Oskarsson, Agneta

AU - Svendsen, Camilla

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N2 - The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 4′,5,7-trihydroxyflavanone or naringenin [FL-no: 16.132], in the Flavouring Group Evaluation 410 (FGE.410), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance occurs naturally in grapefruits, oranges and tomatoes. It is intended to be used as a flavouring substance with flavour-modifying properties in specific categories of food. Information on specifications and manufacturing of [FL-no: 16.132] were considered adequate; however, data on stability in food are incomplete. The Panel noted that the available genotoxicity studies have significant shortcomings and are insufficient to conclude on the genotoxic potential of naringenin. Therefore, [FL-no: 16.132] cannot be evaluated through the Procedure. Additionally, the Panel noted that inhibition of CYP 450 by [FL-no: 16.132] has been clearly demonstrated in animal species in vivo which implies that the substance may interact with the metabolism and elimination of medicines and no convincing information is available that this does not pose a risk to humans at the estimated levels of exposure. To continue with the safety assessment of [FL-no: 16.132], a bacterial gene mutation assay and an in vitro micronucleus assay (according to OECD guidelines 471, 487 and GLP) are required. Even if these studies do not indicate a genotoxic potential, additional toxicological data are needed to finalise the evaluation.

AB - The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 4′,5,7-trihydroxyflavanone or naringenin [FL-no: 16.132], in the Flavouring Group Evaluation 410 (FGE.410), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance occurs naturally in grapefruits, oranges and tomatoes. It is intended to be used as a flavouring substance with flavour-modifying properties in specific categories of food. Information on specifications and manufacturing of [FL-no: 16.132] were considered adequate; however, data on stability in food are incomplete. The Panel noted that the available genotoxicity studies have significant shortcomings and are insufficient to conclude on the genotoxic potential of naringenin. Therefore, [FL-no: 16.132] cannot be evaluated through the Procedure. Additionally, the Panel noted that inhibition of CYP 450 by [FL-no: 16.132] has been clearly demonstrated in animal species in vivo which implies that the substance may interact with the metabolism and elimination of medicines and no convincing information is available that this does not pose a risk to humans at the estimated levels of exposure. To continue with the safety assessment of [FL-no: 16.132], a bacterial gene mutation assay and an in vitro micronucleus assay (according to OECD guidelines 471, 487 and GLP) are required. Even if these studies do not indicate a genotoxic potential, additional toxicological data are needed to finalise the evaluation.

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KW - 4′,5,7-trihydroxyflavanone

KW - naringenin

KW - FGE.410

KW - [FL-no: 16.132]

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