Scientific Opinion on Flavouring Group Evaluation 49, Revision 1 (FGE.49Rev1): xanthine alkaloids from the priority list

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 & 9 others Leon Brimer, Pasquale Mosesso, Gerard Mulder, Maria Anastassiadou, Davide Arcella, Maria Carfí, Silvia Valtueña Martinez, Wim Mennes, EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

Research output: Contribution to specialist publicationArticle

4 Downloads (Pure)

Abstract

Following a request from the European Commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to deliver a scientific opinion on the safety assessment of the flavouring substances caffeine [FL-no: 16.016] and theobromine [FL-no: 16.032] in the Flavouring Group Evaluation 49, Revision 1. Consequent to the 2015 scientific opinion from the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the safety of caffeine from all dietary sources, the CEF Panel considered it inappropriate to evaluate the two substances through the Procedure. For caffeine, the Panel based its assessment on the safety threshold of 5.7 mg/kg body weight (bw) per day for adults, except pregnant/lactating women, and 3 mg/kg bw per day for children, adolescents, pregnant and lactating women, as established by the NDA Panel. The safety evaluation of theobromine takes into account that approximately 11% of an oral dose of caffeine is metabolised to theobromine and that both substances have a similar pharmacological profile. For the exposure assessment, a brand loyalty model was chosen. In this model, it was assumed that a consumer is exposed on a long-term basis to a specific category of food (i.e. non-alcoholic beverages), containing caffeine or theobromine at their respective maximum use levels. For the rest of the categories, normal use levels applied. Daily dietary exposure to caffeine and theobromine (excluding systemic exposure) added as a chemically defined flavouring substance ranged 0–2.3 and 0–0.4 mg/kg bw, respectively, across all population groups. The Panel concluded that caffeine [FL-no: 16.016] and theobromine [FL-no: 16.032] would not be expected to present safety concern based on their estimated levels of intake from their use as flavouring substances.
Original languageEnglish
Pagese04729
Volume15
No.4
Specialist publicationEFSA Journal
PublisherEuropean Food Safety Authority (EFSA)
DOIs
Publication statusPublished - 25 Apr 2017

Fingerprint

Theobromine
Xanthine
Caffeine
Alkaloids
Safety
Body Weight
Pregnant Women
Food
Dietetics
Beverages
Population Groups
Hypersensitivity
Pharmacology
Enzymes

Keywords

  • flavourings
  • food safety
  • xanthine alkaloids
  • caffeine
  • theobromine
  • FGE.49

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 on Flavouring Group Evaluation 49, Revision 1 (FGE.49Rev1): xanthine alkaloids from the priority list. EFSA Journal, 15(4), e04729. https://doi.org/10.2903/j.efsa.2017.4729

Scientific Opinion on Flavouring Group Evaluation 49, Revision 1 (FGE.49Rev1): xanthine alkaloids from the priority list. / Silano, Vittorio; Bolognesi, Claudia; Castle, Laurence; Cravedi, Jean-Pierre; Engel, Karl-Heinz; Fowler, Paul; Franz, Roland; Grob, Konrad; Gürtler, Rainer; Husøy, Trine; Kärenlampi, Sirpa; Milana, Maria Rosaria; Penninks, André; Tavares Poças, Maria de Fátima; Smith, Andrew; Tlustos, Christina; Wölfle, Detlef; Zorn, Holger; Zugravu, Corina-Aurelia; Beckman Sundh, Ulla; Brimer, Leon; Mosesso, Pasquale; Mulder, Gerard; Anastassiadou, Maria; Arcella, Davide; Carfí, Maria; Valtueña Martinez, Silvia; Mennes, Wim; EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF).

In: EFSA Journal, Vol. 15, No. 4, 25.04.2017, p. e04729.

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, Milana, MR, Penninks, A, Tavares Poças, MDF, Smith, A, Tlustos, C, Wölfle, D, Zorn, H, Zugravu, C-A, Beckman Sundh, U, Brimer, L, Mosesso, P, Mulder, G, Anastassiadou, M, Arcella, D, Carfí, M, Valtueña Martinez, S, Mennes, W & EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2017, 'Scientific Opinion on Flavouring Group Evaluation 49, Revision 1 (FGE.49Rev1): xanthine alkaloids from the priority list' EFSA Journal, vol. 15, no. 4, pp. e04729. https://doi.org/10.2903/j.efsa.2017.4729
Silano, Vittorio ; Bolognesi, Claudia ; Castle, Laurence ; Cravedi, Jean-Pierre ; Engel, Karl-Heinz ; Fowler, Paul ; Franz, Roland ; Grob, Konrad ; Gürtler, Rainer ; Husøy, Trine ; Kärenlampi, Sirpa ; Milana, Maria Rosaria ; Penninks, André ; Tavares Poças, Maria de Fátima ; Smith, Andrew ; Tlustos, Christina ; Wölfle, Detlef ; Zorn, Holger ; Zugravu, Corina-Aurelia ; Beckman Sundh, Ulla ; Brimer, Leon ; Mosesso, Pasquale ; Mulder, Gerard ; Anastassiadou, Maria ; Arcella, Davide ; Carfí, Maria ; Valtueña Martinez, Silvia ; Mennes, Wim ; EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). / Scientific Opinion on Flavouring Group Evaluation 49, Revision 1 (FGE.49Rev1): xanthine alkaloids from the priority list. In: EFSA Journal. 2017 ; Vol. 15, No. 4. pp. e04729.
@misc{9fbc2bf3bc3646d4862940356c875878,
title = "Scientific Opinion on Flavouring Group Evaluation 49, Revision 1 (FGE.49Rev1): xanthine alkaloids from the priority list",
abstract = "Following a request from the European Commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to deliver a scientific opinion on the safety assessment of the flavouring substances caffeine [FL-no: 16.016] and theobromine [FL-no: 16.032] in the Flavouring Group Evaluation 49, Revision 1. Consequent to the 2015 scientific opinion from the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the safety of caffeine from all dietary sources, the CEF Panel considered it inappropriate to evaluate the two substances through the Procedure. For caffeine, the Panel based its assessment on the safety threshold of 5.7 mg/kg body weight (bw) per day for adults, except pregnant/lactating women, and 3 mg/kg bw per day for children, adolescents, pregnant and lactating women, as established by the NDA Panel. The safety evaluation of theobromine takes into account that approximately 11{\%} of an oral dose of caffeine is metabolised to theobromine and that both substances have a similar pharmacological profile. For the exposure assessment, a brand loyalty model was chosen. In this model, it was assumed that a consumer is exposed on a long-term basis to a specific category of food (i.e. non-alcoholic beverages), containing caffeine or theobromine at their respective maximum use levels. For the rest of the categories, normal use levels applied. Daily dietary exposure to caffeine and theobromine (excluding systemic exposure) added as a chemically defined flavouring substance ranged 0–2.3 and 0–0.4 mg/kg bw, respectively, across all population groups. The Panel concluded that caffeine [FL-no: 16.016] and theobromine [FL-no: 16.032] would not be expected to present safety concern based on their estimated levels of intake from their use as flavouring substances.",
keywords = "flavourings, food safety, xanthine alkaloids, caffeine, theobromine, FGE.49",
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 Milana, {Maria Rosaria} and Andr{\'e} Penninks and {Tavares Po{\cc}as}, {Maria de F{\'a}tima} and Andrew Smith and Christina Tlustos and Detlef W{\"o}lfle and Holger Zorn and Corina-Aurelia Zugravu and {Beckman Sundh}, Ulla and Leon Brimer and Pasquale Mosesso and Gerard Mulder and Maria Anastassiadou and Davide Arcella and Maria Carf{\'i} and {Valtue{\~n}a Martinez}, Silvia and Wim Mennes and {EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)}",
year = "2017",
month = "4",
day = "25",
doi = "10.2903/j.efsa.2017.4729",
language = "English",
volume = "15",
pages = "e04729",
journal = "EFSA Journal",
issn = "1831-4732",
publisher = "European Food Safety Authority (EFSA)",

}

TY - GEN

T1 - Scientific Opinion on Flavouring Group Evaluation 49, Revision 1 (FGE.49Rev1): xanthine alkaloids from the priority list

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 - Milana, Maria Rosaria

AU - Penninks, André

AU - Tavares Poças, Maria de Fátima

AU - Smith, Andrew

AU - Tlustos, Christina

AU - Wölfle, Detlef

AU - Zorn, Holger

AU - Zugravu, Corina-Aurelia

AU - Beckman Sundh, Ulla

AU - Brimer, Leon

AU - Mosesso, Pasquale

AU - Mulder, Gerard

AU - Anastassiadou, Maria

AU - Arcella, Davide

AU - Carfí, Maria

AU - Valtueña Martinez, Silvia

AU - Mennes, Wim

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

PY - 2017/4/25

Y1 - 2017/4/25

N2 - Following a request from the European Commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to deliver a scientific opinion on the safety assessment of the flavouring substances caffeine [FL-no: 16.016] and theobromine [FL-no: 16.032] in the Flavouring Group Evaluation 49, Revision 1. Consequent to the 2015 scientific opinion from the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the safety of caffeine from all dietary sources, the CEF Panel considered it inappropriate to evaluate the two substances through the Procedure. For caffeine, the Panel based its assessment on the safety threshold of 5.7 mg/kg body weight (bw) per day for adults, except pregnant/lactating women, and 3 mg/kg bw per day for children, adolescents, pregnant and lactating women, as established by the NDA Panel. The safety evaluation of theobromine takes into account that approximately 11% of an oral dose of caffeine is metabolised to theobromine and that both substances have a similar pharmacological profile. For the exposure assessment, a brand loyalty model was chosen. In this model, it was assumed that a consumer is exposed on a long-term basis to a specific category of food (i.e. non-alcoholic beverages), containing caffeine or theobromine at their respective maximum use levels. For the rest of the categories, normal use levels applied. Daily dietary exposure to caffeine and theobromine (excluding systemic exposure) added as a chemically defined flavouring substance ranged 0–2.3 and 0–0.4 mg/kg bw, respectively, across all population groups. The Panel concluded that caffeine [FL-no: 16.016] and theobromine [FL-no: 16.032] would not be expected to present safety concern based on their estimated levels of intake from their use as flavouring substances.

AB - Following a request from the European Commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to deliver a scientific opinion on the safety assessment of the flavouring substances caffeine [FL-no: 16.016] and theobromine [FL-no: 16.032] in the Flavouring Group Evaluation 49, Revision 1. Consequent to the 2015 scientific opinion from the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the safety of caffeine from all dietary sources, the CEF Panel considered it inappropriate to evaluate the two substances through the Procedure. For caffeine, the Panel based its assessment on the safety threshold of 5.7 mg/kg body weight (bw) per day for adults, except pregnant/lactating women, and 3 mg/kg bw per day for children, adolescents, pregnant and lactating women, as established by the NDA Panel. The safety evaluation of theobromine takes into account that approximately 11% of an oral dose of caffeine is metabolised to theobromine and that both substances have a similar pharmacological profile. For the exposure assessment, a brand loyalty model was chosen. In this model, it was assumed that a consumer is exposed on a long-term basis to a specific category of food (i.e. non-alcoholic beverages), containing caffeine or theobromine at their respective maximum use levels. For the rest of the categories, normal use levels applied. Daily dietary exposure to caffeine and theobromine (excluding systemic exposure) added as a chemically defined flavouring substance ranged 0–2.3 and 0–0.4 mg/kg bw, respectively, across all population groups. The Panel concluded that caffeine [FL-no: 16.016] and theobromine [FL-no: 16.032] would not be expected to present safety concern based on their estimated levels of intake from their use as flavouring substances.

KW - flavourings

KW - food safety

KW - xanthine alkaloids

KW - caffeine

KW - theobromine

KW - FGE.49

U2 - 10.2903/j.efsa.2017.4729

DO - 10.2903/j.efsa.2017.4729

M3 - Article

VL - 15

SP - e04729

JO - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

PB - European Food Safety Authority (EFSA)

ER -