Choline and contribution to normal liver function of the foetus and exclusively breastfed infants: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Abstract Following an application from Procter & Gamble BV pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health clai...

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Main Authors: EFSA Panel on Nutrition, Novel Foods and Food allergens (NDA), Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch‐Ernst, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Kristina Pentieva, Frank Thies, Sophia Tsabouri, Marco Vinceti, Jean‐Louis Bresson, Thibault Fiolet, Alfonso Siani
Format: Article
Language:English
Published: Wiley 2023-07-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2023.8115
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author EFSA Panel on Nutrition, Novel Foods and Food allergens (NDA)
Dominique Turck
Torsten Bohn
Jacqueline Castenmiller
Stefaan De Henauw
Karen Ildico Hirsch‐Ernst
Helle Katrine Knutsen
Alexandre Maciuk
Inge Mangelsdorf
Harry J McArdle
Androniki Naska
Kristina Pentieva
Frank Thies
Sophia Tsabouri
Marco Vinceti
Jean‐Louis Bresson
Thibault Fiolet
Alfonso Siani
author_facet EFSA Panel on Nutrition, Novel Foods and Food allergens (NDA)
Dominique Turck
Torsten Bohn
Jacqueline Castenmiller
Stefaan De Henauw
Karen Ildico Hirsch‐Ernst
Helle Katrine Knutsen
Alexandre Maciuk
Inge Mangelsdorf
Harry J McArdle
Androniki Naska
Kristina Pentieva
Frank Thies
Sophia Tsabouri
Marco Vinceti
Jean‐Louis Bresson
Thibault Fiolet
Alfonso Siani
author_sort EFSA Panel on Nutrition, Novel Foods and Food allergens (NDA)
collection DOAJ
description Abstract Following an application from Procter & Gamble BV pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to choline and contribution to normal liver function of the foetus and exclusively breastfed infant. The scope of the application was proposed to fall under a health claim referring to children's development and health. The Panel considers that choline is sufficiently characterised. The claimed effect proposed by the applicant is contribution ‘to normal foetal and infant development, especially liver’. The proposed target population is ‘unborn fetuses and breastfed infants’. Choline is involved in the structure of cell membranes, cell signalling, metabolism and transport of lipids and cholesterol and neurotransmitter synthesis. Although choline can be synthesised de novo by the human body, depletion‐repletion studies in humans show that low choline intake leads to liver dysfunction and muscle damage, which are reverted by the administration of dietary choline. For these functions, de novo synthesis of choline by the human body is insufficient and choline must be obtained from dietary sources. No human studies have addressed the effect of low maternal dietary choline intake on liver function in the fetus or exclusively breastfed infants. However, the Panel considers that the biological role of choline in normal liver function and dietary choline being essential for the function applies to all ages, including fetus and infants. The Panel concludes that a cause and effect relationship has been established between the intake of choline by pregnant and lactating women and contribution to normal liver function of the fetus and exclusively breastfed infants.
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spelling doaj.art-91131297323141de93aa67703f4cbdef2023-08-04T10:16:08ZengWileyEFSA Journal1831-47322023-07-01217n/an/a10.2903/j.efsa.2023.8115Choline and contribution to normal liver function of the foetus and exclusively breastfed infants: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006EFSA Panel on Nutrition, Novel Foods and Food allergens (NDA)Dominique TurckTorsten BohnJacqueline CastenmillerStefaan De HenauwKaren Ildico Hirsch‐ErnstHelle Katrine KnutsenAlexandre MaciukInge MangelsdorfHarry J McArdleAndroniki NaskaKristina PentievaFrank ThiesSophia TsabouriMarco VincetiJean‐Louis BressonThibault FioletAlfonso SianiAbstract Following an application from Procter & Gamble BV pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to choline and contribution to normal liver function of the foetus and exclusively breastfed infant. The scope of the application was proposed to fall under a health claim referring to children's development and health. The Panel considers that choline is sufficiently characterised. The claimed effect proposed by the applicant is contribution ‘to normal foetal and infant development, especially liver’. The proposed target population is ‘unborn fetuses and breastfed infants’. Choline is involved in the structure of cell membranes, cell signalling, metabolism and transport of lipids and cholesterol and neurotransmitter synthesis. Although choline can be synthesised de novo by the human body, depletion‐repletion studies in humans show that low choline intake leads to liver dysfunction and muscle damage, which are reverted by the administration of dietary choline. For these functions, de novo synthesis of choline by the human body is insufficient and choline must be obtained from dietary sources. No human studies have addressed the effect of low maternal dietary choline intake on liver function in the fetus or exclusively breastfed infants. However, the Panel considers that the biological role of choline in normal liver function and dietary choline being essential for the function applies to all ages, including fetus and infants. The Panel concludes that a cause and effect relationship has been established between the intake of choline by pregnant and lactating women and contribution to normal liver function of the fetus and exclusively breastfed infants.https://doi.org/10.2903/j.efsa.2023.8115cholinefetal developmenthealth claimsinfantsfetus
spellingShingle EFSA Panel on Nutrition, Novel Foods and Food allergens (NDA)
Dominique Turck
Torsten Bohn
Jacqueline Castenmiller
Stefaan De Henauw
Karen Ildico Hirsch‐Ernst
Helle Katrine Knutsen
Alexandre Maciuk
Inge Mangelsdorf
Harry J McArdle
Androniki Naska
Kristina Pentieva
Frank Thies
Sophia Tsabouri
Marco Vinceti
Jean‐Louis Bresson
Thibault Fiolet
Alfonso Siani
Choline and contribution to normal liver function of the foetus and exclusively breastfed infants: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006
EFSA Journal
choline
fetal development
health claims
infants
fetus
title Choline and contribution to normal liver function of the foetus and exclusively breastfed infants: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006
title_full Choline and contribution to normal liver function of the foetus and exclusively breastfed infants: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006
title_fullStr Choline and contribution to normal liver function of the foetus and exclusively breastfed infants: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006
title_full_unstemmed Choline and contribution to normal liver function of the foetus and exclusively breastfed infants: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006
title_short Choline and contribution to normal liver function of the foetus and exclusively breastfed infants: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006
title_sort choline and contribution to normal liver function of the foetus and exclusively breastfed infants evaluation of a health claim pursuant to article 14 of regulation ec no 1924 2006
topic choline
fetal development
health claims
infants
fetus
url https://doi.org/10.2903/j.efsa.2023.8115
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