On June 22, 2023, the European Authority (EFSA) published a scientific opinion recognizing the contribution of choline to the normal hepatic function of the fetus and exclusively breastfed infants. She recognized the scientific basis of this effect on health following the request for a health claim on this subject.
Applicant:
The company Procter & Gamble BV sent a dossier through Belgium to request authorization of a health claim relating to choline and the contribution to normal liver function of the fetus and exclusively breastfed infant.
Type of health claim:
The request concerns a health claim relating to the health and development of children (Article 14.1.b) according to the European Regulation on nutritional and health claims.
Justification provided:
The dossier is based on the essentiality of this nutrient. Choline can be synthesized de novo by the human body but depletion-repletion studies in humans show that low choline intake leads to liver dysfunction and muscle damage, which is reversed by administration of dietary choline. During pregnancy, the body’s need for choline is increased by approximately 20%, and most pregnant women need more choline than they consume in their daily diet. In 2016, EFSA published a scientific opinion on the dietary reference value (DRV) of choline. DRVs have been proposed for all population groups including pregnant and lactating women as emerging evidence in humans has shown that endogenous choline synthesis may be insufficient to cover physiological needs (EFSA NDA Panel on Nutrition, Novel Foods and Food Allergens), 2016. Dietary Reference Values for choline. EFSA Journal 2016;14(8):4484, 44 pp.https://doi.org/10.2903/j.efsa.2011.4484).
Opinion of EFSA:
The EFSA believes that the biological role of choline in normal liver function and dietary choline being essential for function applies to all ages, including the fetus and infants. The committee concludes that a cause and effect relationship has been established between the intake of choline by pregnant and breastfeeding women and the contribution to normal liver function of the fetus and exclusively breastfed infants. On June 22, 2023, EFSA published a favorable scientific opinion on this application.
To find out more, you can consult the EFSA announcement.
Orchidali can help you prepare, write and submit health claim applications.
Français
Choline contributes to normal liver function in the fetus and exclusively breastfed infants
On June 22, 2023, the European Authority (EFSA) published a scientific opinion recognizing the contribution of choline to the normal hepatic function of the fetus and exclusively breastfed infants. She recognized the scientific basis of this effect on health following the request for a health claim on this subject.
Applicant:
The company Procter & Gamble BV sent a dossier through Belgium to request authorization of a health claim relating to choline and the contribution to normal liver function of the fetus and exclusively breastfed infant.
Type of health claim:
The request concerns a health claim relating to the health and development of children (Article 14.1.b) according to the European Regulation on nutritional and health claims.
Justification provided:
The dossier is based on the essentiality of this nutrient. Choline can be synthesized de novo by the human body but depletion-repletion studies in humans show that low choline intake leads to liver dysfunction and muscle damage, which is reversed by administration of dietary choline. During pregnancy, the body’s need for choline is increased by approximately 20%, and most pregnant women need more choline than they consume in their daily diet. In 2016, EFSA published a scientific opinion on the dietary reference value (DRV) of choline. DRVs have been proposed for all population groups including pregnant and lactating women as emerging evidence in humans has shown that endogenous choline synthesis may be insufficient to cover physiological needs (EFSA NDA Panel on Nutrition, Novel Foods and Food Allergens), 2016. Dietary Reference Values for choline. EFSA Journal 2016;14(8):4484, 44 pp.https://doi.org/10.2903/j.efsa.2011.4484).
Opinion of EFSA:
The EFSA believes that the biological role of choline in normal liver function and dietary choline being essential for function applies to all ages, including the fetus and infants. The committee concludes that a cause and effect relationship has been established between the intake of choline by pregnant and breastfeeding women and the contribution to normal liver function of the fetus and exclusively breastfed infants. On June 22, 2023, EFSA published a favorable scientific opinion on this application.
To find out more, you can consult the EFSA announcement.
Orchidali can help you prepare, write and submit health claim applications.
Tags: