Scientific Opinion on Flavouring Group Evaluation 63, Revision 3 (FGE.63Rev3): aliphatic secondary alcohols, ketones and related esters evaluated by JECFA (59th and 69th meetings) structurally related to saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids evaluated by EFSA in FGE.07Rev4

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 SundhLeon Brimer, Gerard Mulder, Mona-Lise Binderup, Riccardo Crebelli, Francesca Marcon, Daniel Marzin, Pasquale Mosesso, Natália Kovalkovičová, Wim Mennes, EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

Research output: Contribution to specialist publicationArticle

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Abstract

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/20001. The present consideration concerns a group of 29 aliphatic secondary alcohols, ketones and related esters evaluated by JECFA at the 59th and 69th meetings in 2002 and 2008. This revision is made due to the inclusion of nine additional substances cleared for genotoxicity concern in FGE.205 Revision 1. The substances were evaluated through a stepwise approach that integrates information on structure–activity relationships, intake from current uses, toxicological threshold of concern and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by JECFA for all 29 substances considered in this FGE. For all substances, the Panel concludes that there is ‘no safety concern at the estimated levels of intake as flavouring substances based on the MSDI approach’. For all 29 substances, the specifications for the materials of commerce have also been considered and found adequate. Ten out of the 14 substances for which use levels became available exceed the modified theoretical added maximum daily intake (mTAMDI) and more reliable exposure data are required to finalise their evaluation. On the basis of such data, additional toxicological data might become necessary. For 15 substances, use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment to finalise the evaluation.
Original languageEnglish
Pagese04662
Volume15
No.1
Specialist publicationEFSA Journal
PublisherEuropean Food Safety Authority (EFSA)
DOIs
Publication statusPublished - Jan 2017

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Keywords

  • JECFA flavouring substances
  • FGE.07
  • FGE.63
  • FGE.204
  • FGE.205
  • FGE.206

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Scientific Opinion on Flavouring Group Evaluation 63, Revision 3 (FGE.63Rev3): aliphatic secondary alcohols, ketones and related esters evaluated by JECFA (59th and 69th meetings) structurally related to saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids evaluated by EFSA in FGE.07Rev4. / 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 ; Binderup, Mona-Lise ; Crebelli, Riccardo; Marcon, Francesca ; Marzin, Daniel ; Mosesso, Pasquale ; Kovalkovičová, Natália ; Mennes, Wim ; EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF).

In: EFSA Journal, Vol. 15, No. 1, 01.2017, p. e04662.

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, Binderup, M-L, Crebelli, R, Marcon, F, Marzin, D, Mosesso, P, Kovalkovičová, N, Mennes, W & EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2017, 'Scientific Opinion on Flavouring Group Evaluation 63, Revision 3 (FGE.63Rev3): aliphatic secondary alcohols, ketones and related esters evaluated by JECFA (59th and 69th meetings) structurally related to saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids evaluated by EFSA in FGE.07Rev4' EFSA Journal, vol. 15, no. 1, pp. e04662. https://doi.org/10.2903/j.efsa.2017.4662
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 ; Binderup, Mona-Lise ; Crebelli, Riccardo ; Marcon, Francesca ; Marzin, Daniel ; Mosesso, Pasquale ; Kovalkovičová, Natália ; Mennes, Wim ; EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). / Scientific Opinion on Flavouring Group Evaluation 63, Revision 3 (FGE.63Rev3): aliphatic secondary alcohols, ketones and related esters evaluated by JECFA (59th and 69th meetings) structurally related to saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids evaluated by EFSA in FGE.07Rev4. In: EFSA Journal. 2017 ; Vol. 15, No. 1. pp. e04662.
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abstract = "The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/20001. The present consideration concerns a group of 29 aliphatic secondary alcohols, ketones and related esters evaluated by JECFA at the 59th and 69th meetings in 2002 and 2008. This revision is made due to the inclusion of nine additional substances cleared for genotoxicity concern in FGE.205 Revision 1. The substances were evaluated through a stepwise approach that integrates information on structure–activity relationships, intake from current uses, toxicological threshold of concern and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by JECFA for all 29 substances considered in this FGE. For all substances, the Panel concludes that there is ‘no safety concern at the estimated levels of intake as flavouring substances based on the MSDI approach’. For all 29 substances, the specifications for the materials of commerce have also been considered and found adequate. Ten out of the 14 substances for which use levels became available exceed the modified theoretical added maximum daily intake (mTAMDI) and more reliable exposure data are required to finalise their evaluation. On the basis of such data, additional toxicological data might become necessary. For 15 substances, use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment to finalise the evaluation.",
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AU - Bolognesi, Claudia

AU - Castle, Laurence

AU - Cravedi, Jean-Pierre

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AU - Fowler , Paul

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KW - JECFA flavouring substances

KW - FGE.07

KW - FGE.63

KW - FGE.204

KW - FGE.205

KW - FGE.206

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