Total Choline in Infant Formula

Introduction

Choline is an essential nutrient that plays a crucial role in brain development, liver function, and overall infant health. It is especially important for infants, as it supports cognitive development, neural tube formation, and lipid metabolism. Since infants rely on breast milk or formula for their complete nutrition during their first months of life, ensuring adequate choline intake is vital.

In this blog, we will explore the significance of total choline in infant formula, its recommended intake, sources, and the impact of choline deficiency on infant health.

What is Choline?

Choline is a water-soluble compound that is often grouped with the B-vitamin family due to its similar functions. It is a precursor to acetylcholine, a neurotransmitter essential for memory and muscle control. Additionally, choline is required for the formation of phospholipids, which are key structural components of cell membranes. Since infants have high demands for rapid brain development and growth, choline plays a fundamental role in early nutrition.

Why is Choline Important for Infants?

Function	Role of Choline
Brain Development & Cognitive Function	Essential for acetylcholine synthesis, supporting learning, memory, and muscle coordination.
Liver Function & Fat Metabolism	Aids in fat transport, preventing liver fat accumulation and reducing the risk of fatty liver disease.
Neural Tube Formation	Supports proper neural tube closure, lowering the risk of neural tube defects during fetal development.
Cell Membrane Integrity	Maintains structural integrity of cell membranes, crucial for brain and nervous system growth.
Gene Expression & DNA Methylation	Plays a role in epigenetic regulation by donating methyl groups for gene expression.

Importance of Testing for Choline in Infant Formula

Supports Infant Health – Ensures proper choline levels for brain development, memory, and metabolism.
Regulatory Compliance – Meets standards set by FDA, EFSA, WHO, and FSSAI, preventing legal issues.
Consumer Trust – Ensures safety, prevents recalls, and maintains brand reputation.
Quality & Stability – Verifies choline levels remain stable during storage and shelf life.

Impact of Choline Deficiency in Infants

Choline deficiency in infants can lead to several health concerns, including:

Delayed brain development – Insufficient choline can impair memory and cognitive function later in life.
Fatty liver disease – Without enough choline, the liver struggles to process fats properly.
Muscle damage & poor growth – Choline is essential for muscle function and energy metabolism.
Increased risk of metabolic disorders – Deficiency may contribute to long-term metabolic and cardiovascular issues.

Standards and regulations

The Food Safety and Standards Authority of India (FSSAI) regulates infant nutrition under the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. These regulations set strict compositional and labeling standards for infant formulas, follow-on formulas, and complementary foods, ensuring optimal growth and development in infants.

FSSAI Regulations on Choline

Infant Formula: Minimum 32 mg per 100 g (or 6.80 mg per 100 kcal).
Milk Cereal-Based Complementary Food: Maximum 32 mg per 100 g (or 6.80 mg per 100 kcal).
Processed Cereal-Based Complementary Food: Minimum 32 mg per 100 g (or 6.80 mg per 100 kcal).
Follow-up Formula: Minimum 32 mg per 100 g (or 6.80 mg per 100 kcal).
Preterm Infant Milk Substitute:30–50.00 mg per 100 kcal.

EFSA has set dietary reference values for choline as part of its review of scientific advice on nutrient intakes. Choline plays an important role in the human body, in particular for the maintenance of normal liver function.

The Panel on Dietetic Products, Nutrition and Allergies (NDA) defines daily adequate intakes (AIs) for choline as follows:

400 mg for adults and adolescents aged 15-17 years.
140 to 340 mg for children aged 1-14 years.
160 mg for infants aged 7-11 months.
480 mg for pregnant women and 520 mg for lactating women.

https://www.efsa.europa.eu/en/press/news/160817

US FDA

Choline Function & Adequate Intake (AI):

AI for adults: 550 mg/day for men, 425 mg/day for women.
AI based on prevention of liver damage (measured via serum alanine aminotransferase levels).

Tolerable Upper Intake Level (UL):

5 g/day for adults.
Excess intake may cause hypotension, cholinergic side effects (sweating, diarrhea), and fishy body odour.

https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/nutrient-content-claims-notification-choline-containing-foods

FSSAI

The Food Safety and Standards Authority of India (FSSAI) has issued regulations regarding the use of choline in food products, particularly in the category of Health Supplements, Nutraceuticals, Food for Special Dietary Use (FSDU), and Food for Special Medical Purpose (FSMP). According to the FSSAI notification (F. No. Stds/Nutra(27)/FSSAI-2017), choline is recognized as a permissible ingredient in these categories with specific dosage limits.

Key points regarding choline under FSSAI regulations:

Permitted Forms: Choline can be used in various forms such as choline bitartrate, choline chloride, and choline citrate.
Usage Limits: The maximum permissible limit for choline varies based on the intended category and consumer age group.

https://fssai.gov.in/upload/advisories/2022/05/627a160339d32Order_FSS_Nutra_10_05_2022.pdf

AOAC International:

AOAC International has established Standard Method Performance Requirements (SMPR) for determining total choline in infant formula and adult/pediatric nutritional formula. These SMPRs serve as a global method for dispute resolution

https://www.aoac.org/wp-content/uploads/2020/11/SMPR202012_013.pdf

Methods for Testing Total Choline in Infant Formula (Concise)

LC-MS – High accuracy, detects different choline forms, used in regulatory testing.
HPLC – Separates and quantifies choline, widely used in food testing.

Eurofins role in testing Total Choline in Infant Formula

Eurofins plays a significant role in testing total choline in infant formula. Here's a summary of their involvement:

Method Development: Expertise in vitamin and amino acid analysis; involved in choline testing method development.

Analytical Techniques: Uses LC-MS/MS with extraction and saponification; also analyzes free choline via direct extraction.

SPIFAN Participation: Key player in the Stakeholder Program on Infant Formula and Adult Nutrition (SPIFAN)—validates new methods, participates in expert review panels.

Global Initiative: Supports modernization of infant formula testing.

Standard Reference Material: Collaborates with NIST (SRM 1869) for method validation in choline and other nutrients.

Accreditation & Quality: Follows ISO IEC 17025 standards, uses daily controls, and participates in FAPAS, BIPEA, and NIST proficiency tests.

Comprehensive Testing: Ensures the quality, safety, and nutritional accuracy of infant formula products.