LATEST EFSA Approval: Choline Acknowledged for the first time as Essential Nutrient for Normal Liver Function of the Foetus and Exclusively Breastfed Infants1

P&G HEALTH is thrilled to announce that the European Food Safety Authority (EFSA) has officially recognized choline as an essential nutrient contributing to the normal liver function of the foetus and exclusively breastfed infants.¹

This scientific acknowledgment comes as a result of a rigorous evaluation by the EFSA, upon P&G HEALTH claim application, and it opens new avenues for ensuring the health and well-being of our Future generation.

Choline is involved in the structure of cell membranes, cell signaling, neurotransmitter synthesis and contributes as phosphatidylcholine to a normal lipid metabolism and transport from the liver to extrahepatic tissues. Without adequate choline, fat can accumulate in the liver.^1-3 After many decades of first discovery of choline (1849) and of first time acknowledging the role of choline in normal liver function of human adults (1998), its specific importance in supporting normal liver function in the foetus and exclusively breastfed infants has now been firmly established, leading to its inclusion in EU registered list of approved health and nutritional claims.¹

Although choline can be synthesized 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.³ In fact, during pregnancy, the body’s needs for choline are 20% higher⁴ but most pregnant women require more choline than they are getting in their day-to-day diet. ⁵

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.¹

The EFSA's approval comes as a validation of the substantial evidence indicating choline's significance in supporting liver function in the foetus and exclusively breastfed infants. This recognition marks a significant milestone in the field of maternal nutrition and is expected to have a far-reaching impact on public health policies and recommendations for pregnant and lactating women.

Prof. Rima Obeid, a renowned international scientist in pregnancy nutrition commented, "The EFSA's recognition of choline as a nutrient for the healthy liver function of the foetus and exclusively breastfed infants is a major stride towards fostering a healthier future for our children. This acknowledgment reinforces the importance of choline intake during pregnancy and lactation, ensuring that both mothers and their unborn babies and infants receive the necessary nourishment for optimal development."

P&G HEALTH, as an organization committed to promoting health and well-being, commends EFSA's dedication to advancing nutritional science and ensuring evidence-based health claims. With this recognition, we are inspired to intensify our efforts to raise awareness about the significance of choline-rich diets or supplemental sources of choline for expectant mothers and the benefits of exclusive breastfeeding during the first months of an infant's life.

We encourage healthcare professionals, policymakers, and the public to take note of this milestone and integrate this crucial information into their dietary choices and recommendations. By emphasizing the inclusion of choline-rich foods or supplemental sources of choline in expectant mothers' diets and promoting exclusive breastfeeding, we can collectively foster healthier outcomes for the next generation.

Always on the Pulse of Science, Femibion® identified Choline as the next essential nutrient that could be crucial from the first moment of life in prenatal care. That’s why today our Femibion portfolio contains Choline with Femibion® Phase 1 (early pregnancy), Femibion® Phase 2 (pregnancy) and Femibion® Phase 3 (breastfeeding).

Femibion® with selected nutrients like Folic Acid Plus and DHA is tailored to each phase of the pregnancy to support healthy development of the baby*. With Folic Acid Plus** and Choline.

* Supplemental folic acid intake increases maternal folate level. Low maternal folate level is one of the risk factors in the development of neural tube defects in the developing foetus. It is therefore recommended that women take a 400μg supplemental folic acid daily for at least 1 month before and up to 3 months after conception. The association between low maternal folate status as an important risk factor for neural tube defects has been scientifically proven. There are further risk factors, therefore altering one of the factors might not in each case have a beneficial effect. Folic acid supports other pregnancy relevant functions: it contributes to blood formation, cell division and maternal tissue growth.
Docosahexaenoic acid (DHA) maternal intake contributes to the normal brain development of the foetus and breastfed infants.. pregnant and lactating women that the beneficial effect is obtained with a daily intake of 200 mg of DHA in addition to the recommended daily intake for omega-3 fatty acids for adults, i.e.: 250 mg DHA and EPA.
**Folic acid and L-Methylfolate

About P&G health
P&G Health, the healthcare division of P&G, competes in the largest and fastest growing personal care and oral care categories and markets to drive consumer-centric innovation.

The P&G healthcare portfolio includes leading brands in cold with WICK® and Nasivin®, pregnancy with Femibion® and Clearblue®, dental and oral care with Oral-B®, blend-a-dent® and blend-a-med®, vitamin - and mineral products with Bion3® and Vigantol® / Vigantolvit® as well as pain relief with Kytta®.

About Procter & Gamble
P&G serves consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always®, Ambi Pur®, Ariel®, Bounty®, Charmin®, Crest®, Dawn®, Downy®, Fairy®, Febreze®, Gain®, Gillette®, Head & Shoulders®, Lenor®, Olay®, Oral-B®, Pampers®, Pantene®, SK-II®, Tide®, Vicks®, and Whisper®. The P&G community includes operations in approximately 70 countries worldwide. Please visit https://www.pg.com for the latest news and information about P&G and its brands. For other P&G news, visit us at https://www.pg.com/news.

1 EFSA Journal 2023; 21(7):8115
2 Corbin KD, Zeisel SH. Curr Opin Gastroenterol 2012; 28(2):159-165
3 Fischer LM et al. Am J Clin Nutr 2007; 85(5):1275-1285
4 EFSA Journal 2016;14(8):4484
5 Derbyshire E et al. Nutrients 2021 ; 13(12) :4390

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Contact information

For media inquiries, interviews, or further information:
Victoria Reason at Victoria.reason@pgone.co.uk