Scientific Opinion of Flavouring Group Evaluation 407 (FGE.407): 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid

Vittorio Silano, Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler , Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Maria Rosaria Milana, André Penninks, Maria de Fátima Tavares Poças, Andrew Smith, Christina Tlustos, Detlef Wölfle , Holger Zorn, Corina-Aurelia Zugravu, Ulla Beckman Sundh & 5 others Leon Brimer, Gerard Mulder, Maria Anastassiadou, Wim Mennes, EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

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Abstract

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid [FL-no: 16.130], in the Flavouring Group Evaluation 407 (FGE.407), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intended to be used as both the parent compound and its hemisulfate monohydrate salt as a flavouring substance with modifying properties in specific categories of food. The chronic dietary exposure to the substance estimated using the added portions exposure technique (APET), is calculated to be 882 μg/person per day for a 60-kg adult and 547 μg/person per day for a 15-kg 3-year-old child. There is no concern with respect to genotoxicity. A 90-day dietary administration study in rats showed no adverse effects for doses up to 100 mg/kg body weight (bw) per day, providing an adequate margin of safety. Developmental toxicity was not observed in a study with rats at the dose levels up to 1,000 mg/kg bw per day. The Panel concluded that [FL-no: 16.130] and its hemisulfate monohydrate salt are not expected to be of safety concern at the estimated levels of dietary exposure calculated using the APET approach. This conclusion applies only to the use of the substance as a flavour modifier as requested and when used at the levels as specified for foods from different food categories.
Original languageEnglish
Pagese04660
Volume15
No.1
Specialist publicationEFSA Journal
PublisherEuropean Food Safety Authority (EFSA)
DOIs
Publication statusPublished - Jan 2017

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Carboxylic Acids
Food
Salts
Body Weight
Safety
2-methylquinoline
Health
Enzymes

Keywords

  • 4-amino-5-(3-(isopropylamino)-2; 2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid
  • FGE.407; [FL-no: 16.130]

Cite this

Silano, V., Bolognesi, C., Castle, L., Cravedi, J-P., Engel, K-H., Fowler , P., ... EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) (2017). Scientific Opinion of Flavouring Group Evaluation 407 (FGE.407): 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid. EFSA Journal, 15(1), e04660. https://doi.org/10.2903/j.efsa.2017.4660

Scientific Opinion of Flavouring Group Evaluation 407 (FGE.407): 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid. / Silano, Vittorio; Bolognesi, Claudia; Castle, Laurence; Cravedi, Jean-Pierre; Engel, Karl-Heinz; Fowler , Paul; Franz, Roland; Grob, Konrad; Gürtler, Rainer; Husøy, Trine; Kärenlampi, Sirpa; Rosaria Milana, Maria; Penninks, André; de Fátima Tavares Poças, Maria; Smith, Andrew; Tlustos, Christina; Wölfle , Detlef; Zorn, Holger; Zugravu, Corina-Aurelia; Sundh, Ulla Beckman; Brimer, Leon ; Mulder, Gerard ; Anastassiadou, Maria ; Mennes, Wim ; EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF).

In: EFSA Journal, Vol. 15, No. 1, 01.2017, p. e04660.

Research output: Contribution to specialist publicationArticle

Silano, V, Bolognesi, C, Castle, L, Cravedi, J-P, Engel, K-H, Fowler , P, Franz, R, Grob, K, Gürtler, R, Husøy, T, Kärenlampi, S, Rosaria Milana, M, Penninks, A, de Fátima Tavares Poças, M, Smith, A, Tlustos, C, Wölfle , D, Zorn, H, Zugravu, C-A, Sundh, UB, Brimer, L, Mulder, G, Anastassiadou, M, Mennes, W & EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2017, 'Scientific Opinion of Flavouring Group Evaluation 407 (FGE.407): 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid' EFSA Journal, vol. 15, no. 1, pp. e04660. https://doi.org/10.2903/j.efsa.2017.4660
Silano, Vittorio ; Bolognesi, Claudia ; Castle, Laurence ; Cravedi, Jean-Pierre ; Engel, Karl-Heinz ; Fowler , Paul ; Franz, Roland ; Grob, Konrad ; Gürtler, Rainer ; Husøy, Trine ; Kärenlampi, Sirpa ; Rosaria Milana, Maria ; Penninks, André ; de Fátima Tavares Poças, Maria ; Smith, Andrew ; Tlustos, Christina ; Wölfle , Detlef ; Zorn, Holger ; Zugravu, Corina-Aurelia ; Sundh, Ulla Beckman ; Brimer, Leon ; Mulder, Gerard ; Anastassiadou, Maria ; Mennes, Wim ; EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). / Scientific Opinion of Flavouring Group Evaluation 407 (FGE.407): 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid. In: EFSA Journal. 2017 ; Vol. 15, No. 1. pp. e04660.
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abstract = "The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid [FL-no: 16.130], in the Flavouring Group Evaluation 407 (FGE.407), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intended to be used as both the parent compound and its hemisulfate monohydrate salt as a flavouring substance with modifying properties in specific categories of food. The chronic dietary exposure to the substance estimated using the added portions exposure technique (APET), is calculated to be 882 μg/person per day for a 60-kg adult and 547 μg/person per day for a 15-kg 3-year-old child. There is no concern with respect to genotoxicity. A 90-day dietary administration study in rats showed no adverse effects for doses up to 100 mg/kg body weight (bw) per day, providing an adequate margin of safety. Developmental toxicity was not observed in a study with rats at the dose levels up to 1,000 mg/kg bw per day. The Panel concluded that [FL-no: 16.130] and its hemisulfate monohydrate salt are not expected to be of safety concern at the estimated levels of dietary exposure calculated using the APET approach. This conclusion applies only to the use of the substance as a flavour modifier as requested and when used at the levels as specified for foods from different food categories.",
keywords = "4-amino-5-(3-(isopropylamino)-2; 2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid, FGE.407; [FL-no: 16.130]",
author = "Vittorio Silano and Claudia Bolognesi and Laurence Castle and Jean-Pierre Cravedi and Karl-Heinz Engel and Paul Fowler and Roland Franz and Konrad Grob and Rainer G{\"u}rtler and Trine Hus{\o}y and Sirpa K{\"a}renlampi and {Rosaria Milana}, Maria and Andr{\'e} Penninks and {de F{\'a}tima Tavares Po{\cc}as}, Maria and Andrew Smith and Christina Tlustos and Detlef W{\"o}lfle and Holger Zorn and Corina-Aurelia Zugravu and Sundh, {Ulla Beckman} and Leon Brimer and Gerard Mulder and Maria Anastassiadou and Wim Mennes and {EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)}",
note = "Acknowledgements: The Panel wishes to thank the members of the Working Group on Flavourings: Ulla Beckman Sundh, Leon Brimer, Karl-Heinz Engel, Paul Fowler, Rainer G{\"u}rtler, Trine Hus{\o}y, Wim Mennes, Gerard Mulder and Harriet Wallin and Claudia Bolognesi from the Genotoxicity working group on flavourings for the preparatory work on this scientific opinion and the hearing experts: Vibe Beltoft and Karin N{\o}rby and EFSA staff: Maria Anastassiadou, Maria Carf{\'i}, Nat{\'a}lia Kovalkovicov{\'a}, Carla Martino and Annamaria Rossi for the support provided to this scientific opinion.",
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AU - Silano, Vittorio

AU - Bolognesi, Claudia

AU - Castle, Laurence

AU - Cravedi, Jean-Pierre

AU - Engel, Karl-Heinz

AU - Fowler , Paul

AU - Franz, Roland

AU - Grob, Konrad

AU - Gürtler, Rainer

AU - Husøy, Trine

AU - Kärenlampi, Sirpa

AU - Rosaria Milana, Maria

AU - Penninks, André

AU - de Fátima Tavares Poças, Maria

AU - Smith, Andrew

AU - Tlustos, Christina

AU - Wölfle , Detlef

AU - Zorn, Holger

AU - Zugravu, Corina-Aurelia

AU - Sundh, Ulla Beckman

AU - Brimer, Leon

AU - Mulder, Gerard

AU - Anastassiadou, Maria

AU - Mennes, Wim

AU - EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

N1 - Acknowledgements: The Panel wishes to thank the members of the Working Group on Flavourings: Ulla Beckman Sundh, Leon Brimer, Karl-Heinz Engel, Paul Fowler, Rainer Gürtler, Trine Husøy, Wim Mennes, Gerard Mulder and Harriet Wallin and Claudia Bolognesi from the Genotoxicity working group on flavourings for the preparatory work on this scientific opinion and the hearing experts: Vibe Beltoft and Karin Nørby and EFSA staff: Maria Anastassiadou, Maria Carfí, Natália Kovalkovicová, Carla Martino and Annamaria Rossi for the support provided to this scientific opinion.

PY - 2017/1

Y1 - 2017/1

N2 - The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid [FL-no: 16.130], in the Flavouring Group Evaluation 407 (FGE.407), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intended to be used as both the parent compound and its hemisulfate monohydrate salt as a flavouring substance with modifying properties in specific categories of food. The chronic dietary exposure to the substance estimated using the added portions exposure technique (APET), is calculated to be 882 μg/person per day for a 60-kg adult and 547 μg/person per day for a 15-kg 3-year-old child. There is no concern with respect to genotoxicity. A 90-day dietary administration study in rats showed no adverse effects for doses up to 100 mg/kg body weight (bw) per day, providing an adequate margin of safety. Developmental toxicity was not observed in a study with rats at the dose levels up to 1,000 mg/kg bw per day. The Panel concluded that [FL-no: 16.130] and its hemisulfate monohydrate salt are not expected to be of safety concern at the estimated levels of dietary exposure calculated using the APET approach. This conclusion applies only to the use of the substance as a flavour modifier as requested and when used at the levels as specified for foods from different food categories.

AB - The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid [FL-no: 16.130], in the Flavouring Group Evaluation 407 (FGE.407), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intended to be used as both the parent compound and its hemisulfate monohydrate salt as a flavouring substance with modifying properties in specific categories of food. The chronic dietary exposure to the substance estimated using the added portions exposure technique (APET), is calculated to be 882 μg/person per day for a 60-kg adult and 547 μg/person per day for a 15-kg 3-year-old child. There is no concern with respect to genotoxicity. A 90-day dietary administration study in rats showed no adverse effects for doses up to 100 mg/kg body weight (bw) per day, providing an adequate margin of safety. Developmental toxicity was not observed in a study with rats at the dose levels up to 1,000 mg/kg bw per day. The Panel concluded that [FL-no: 16.130] and its hemisulfate monohydrate salt are not expected to be of safety concern at the estimated levels of dietary exposure calculated using the APET approach. This conclusion applies only to the use of the substance as a flavour modifier as requested and when used at the levels as specified for foods from different food categories.

KW - 4-amino-5-(3-(isopropylamino)-2; 2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid

KW - FGE.407; [FL-no: 16.130]

U2 - 10.2903/j.efsa.2017.4660

DO - 10.2903/j.efsa.2017.4660

M3 - Article

VL - 15

SP - e04660

JO - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

PB - European Food Safety Authority (EFSA)

ER -