Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283

Dominique Turck, J Castenmiller, S De Henauw, K Hirsch‐Ernst, J Kearney, A Maciuk, I Mangelsdorf, H McArdle, A Naska, C Pelaez, K. Pentieva, A Siani, F Thies, S Tsabouri, M Vinceti, F Cubbada, KH Engel, T Frenzel, Marina Heinonen, R Marchelli & 8 others M Neuhauser-Berthold, A Poting, M Poulsen, Y Sanz, JR Schlatter, H van Loveren, Emanuela Turla, H Knutsen

Research output: Contribution to journalArticle

Abstract

In 2017, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) concluded that betaine as a novel food (NF) is safe to be used at a maximum intake level of 6 mg/kg body weight per day in addition to the intake from the background diet. Following the present request from the European Commission, the EFSA NDA Panel was asked to deliver a scientific opinion on betaine by carrying out the assessment for the revised uses and use levels of betaine as proposed by the applicant. Thus, EFSA performed an intake assessment based on individual data from the EFSA Comprehensive European Food Consumption Database and the new proposed uses of the NF for the general population. The resulting ranges for the mean and high-level estimated intakes of betaine for the general population do not exceed the safe level of intake previously established. The Panel concludes that the NF, betaine, is safe under the new proposed conditions of use.

LanguageEnglish
Article numbere05658
Number of pages8
JournalEFSA Journal
Volume17
Issue number4
DOIs
Publication statusPublished - 5 Apr 2019

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Betaine
novel foods
betaine
Safety
Food
allergens
food consumption
Allergens
Population
nutrition
Body Weight
Databases
body weight
Diet
diet

Keywords

  • betaine
  • novel food
  • intake assessment

Cite this

Turck, D., Castenmiller, J., De Henauw, S., Hirsch‐Ernst, K., Kearney, J., Maciuk, A., ... Knutsen, H. (2019). Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 17(4), [e05658]. https://doi.org/10.2903/j.efsa.2019.5658
Turck, Dominique ; Castenmiller, J ; De Henauw, S ; Hirsch‐Ernst, K ; Kearney, J ; Maciuk, A ; Mangelsdorf, I ; McArdle, H ; Naska, A ; Pelaez, C ; Pentieva, K. ; Siani, A ; Thies, F ; Tsabouri, S ; Vinceti, M ; Cubbada, F ; Engel, KH ; Frenzel, T ; Heinonen, Marina ; Marchelli, R ; Neuhauser-Berthold, M ; Poting, A ; Poulsen, M ; Sanz, Y ; Schlatter, JR ; van Loveren, H ; Turla, Emanuela ; Knutsen, H. / Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283. In: EFSA Journal. 2019 ; Vol. 17, No. 4.
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abstract = "In 2017, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) concluded that betaine as a novel food (NF) is safe to be used at a maximum intake level of 6 mg/kg body weight per day in addition to the intake from the background diet. Following the present request from the European Commission, the EFSA NDA Panel was asked to deliver a scientific opinion on betaine by carrying out the assessment for the revised uses and use levels of betaine as proposed by the applicant. Thus, EFSA performed an intake assessment based on individual data from the EFSA Comprehensive European Food Consumption Database and the new proposed uses of the NF for the general population. The resulting ranges for the mean and high-level estimated intakes of betaine for the general population do not exceed the safe level of intake previously established. The Panel concludes that the NF, betaine, is safe under the new proposed conditions of use.",
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Turck, D, Castenmiller, J, De Henauw, S, Hirsch‐Ernst, K, Kearney, J, Maciuk, A, Mangelsdorf, I, McArdle, H, Naska, A, Pelaez, C, Pentieva, K, Siani, A, Thies, F, Tsabouri, S, Vinceti, M, Cubbada, F, Engel, KH, Frenzel, T, Heinonen, M, Marchelli, R, Neuhauser-Berthold, M, Poting, A, Poulsen, M, Sanz, Y, Schlatter, JR, van Loveren, H, Turla, E & Knutsen, H 2019, 'Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283', EFSA Journal, vol. 17, no. 4, e05658. https://doi.org/10.2903/j.efsa.2019.5658

Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283. / Turck, Dominique; Castenmiller, J; De Henauw, S; Hirsch‐Ernst, K; Kearney, J; Maciuk, A; Mangelsdorf, I; McArdle, H; Naska, A; Pelaez, C; Pentieva, K.; Siani, A; Thies, F; Tsabouri, S; Vinceti, M; Cubbada, F; Engel, KH; Frenzel, T; Heinonen, Marina; Marchelli, R; Neuhauser-Berthold, M; Poting, A; Poulsen, M; Sanz, Y; Schlatter, JR; van Loveren, H; Turla, Emanuela; Knutsen, H.

In: EFSA Journal, Vol. 17, No. 4, e05658, 05.04.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283

AU - Turck, Dominique

AU - Castenmiller, J

AU - De Henauw, S

AU - Hirsch‐Ernst, K

AU - Kearney, J

AU - Maciuk, A

AU - Mangelsdorf, I

AU - McArdle, H

AU - Naska, A

AU - Pelaez, C

AU - Pentieva, K.

AU - Siani, A

AU - Thies, F

AU - Tsabouri, S

AU - Vinceti, M

AU - Cubbada, F

AU - Engel, KH

AU - Frenzel, T

AU - Heinonen, Marina

AU - Marchelli, R

AU - Neuhauser-Berthold, M

AU - Poting, A

AU - Poulsen, M

AU - Sanz, Y

AU - Schlatter, JR

AU - van Loveren, H

AU - Turla, Emanuela

AU - Knutsen, H

N1 - The acceptance date is know as adopted date and this is listed in the author manuscript

PY - 2019/4/5

Y1 - 2019/4/5

N2 - In 2017, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) concluded that betaine as a novel food (NF) is safe to be used at a maximum intake level of 6 mg/kg body weight per day in addition to the intake from the background diet. Following the present request from the European Commission, the EFSA NDA Panel was asked to deliver a scientific opinion on betaine by carrying out the assessment for the revised uses and use levels of betaine as proposed by the applicant. Thus, EFSA performed an intake assessment based on individual data from the EFSA Comprehensive European Food Consumption Database and the new proposed uses of the NF for the general population. The resulting ranges for the mean and high-level estimated intakes of betaine for the general population do not exceed the safe level of intake previously established. The Panel concludes that the NF, betaine, is safe under the new proposed conditions of use.

AB - In 2017, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) concluded that betaine as a novel food (NF) is safe to be used at a maximum intake level of 6 mg/kg body weight per day in addition to the intake from the background diet. Following the present request from the European Commission, the EFSA NDA Panel was asked to deliver a scientific opinion on betaine by carrying out the assessment for the revised uses and use levels of betaine as proposed by the applicant. Thus, EFSA performed an intake assessment based on individual data from the EFSA Comprehensive European Food Consumption Database and the new proposed uses of the NF for the general population. The resulting ranges for the mean and high-level estimated intakes of betaine for the general population do not exceed the safe level of intake previously established. The Panel concludes that the NF, betaine, is safe under the new proposed conditions of use.

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KW - novel food

KW - intake assessment

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Turck D, Castenmiller J, De Henauw S, Hirsch‐Ernst K, Kearney J, Maciuk A et al. Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal. 2019 Apr 5;17(4). e05658. https://doi.org/10.2903/j.efsa.2019.5658