Bovine Lactoferrin

About

What it is and where it shows up.

Bovine lactoferrin (bLf) is an iron-binding glycoprotein naturally present in cow's milk, belonging to the transferrin protein family, with a single polypeptide chain of ~700 amino acids and 75–80 kDa. It is added to infant formulas, dairy products, and functional foods for its antimicrobial, immunomodulatory, anti-inflammatory, and antianemic properties.

Safety summary

The regulatory and scientific consensus.

Bovine lactoferrin is broadly considered safe for the general adult population, with no established ADI; major regulatory bodies (FDA, EFSA) have assessed it as safe under intended use conditions. It is a milk-derived protein, so individuals with cow's milk protein allergy should avoid it. Infants and young children are the most studied sensitive population due to high relative intake from formula; EFSA estimated maximum infant intake at 1.1 g/day at 1000 mg/L in formula, which was deemed safe.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Authorized as a novel food ingredient under Regulation (EC) No 258/97 via Commission Implementing Decision of 22 November 2012; permitted in infant and follow-on formulae at up to 1000 mg/L, dietary foods for special medical purposes, dairy products, yoghurts, and chewing gums.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Lactoferrin is permissible as an optional ingredient in infant formula and as a nutraceutical/health supplement ingredient under FSSAI's Foods for Infant Nutrition Regulations 2020 and Health Supplements & Nutraceuticals Regulations 2016; specific maximum use levels are not prominently published in a standalone lactoferrin monograph.source
FDA (Food and Drug Administration) (United States)	Approved	Cow's milk-derived lactoferrin granted GRAS status (GRN 000464) for use in infant formula and various food applications; multiple subsequent GRAS notices (e.g., GRN 000130, GRN 000465, GRN 000669) cover different manufacturers and use levels including powdered infant and toddler formulas up to 30 mg/100 g.source

Who should approach with care

Whose guidance would steer them away.

Other — Individuals with confirmed cow's milk protein allergy should avoid bovine lactoferrin, as it is a bovine milk-derived glycoprotein that may trigger allergic reactions.

Infants — While EFSA and FDA have approved lactoferrin in infant formula at defined levels, intake in infants can be relatively high (up to 1.1 g/day per EFSA estimates) and dosing should align with regulatory standards for infant formula; supplementation above formula-standard levels should be under medical guidance.

Lactation — There is limited safety data on high-dose bovine lactoferrin supplementation during lactation; caution is warranted until further clinical evidence is established.

Pregnancy — High-dose supplemental bovine lactoferrin has not been adequately studied in pregnant women; while naturally present in human milk, supplementation at elevated doses should be discussed with a healthcare provider.

Research citations

The sources behind this verdict.

1PubMed. Nutraceutical and Health-Promoting Potential of Lactoferrin, an Iron-Binding Protein in Human and Animal: Current Knowledge, 2023. pmc.ncbi.nlm.nih.gov
2other. Lactoferrin from Bovine Milk: A Protective Companion for Life, 2020. ncbi.nlm.nih.gov
3FDA. Agency Response Letter GRAS Notice No. GRN 000612 – Fractionated whey protein isolate containing lactoferrin, 2018. fda.gov
4FDA. Agency Response Letter GRAS Notice No. GRN 000464 – Cow's milk-derived lactoferrin, 2014. hfpappexternal.fda.gov
5EFSA. Scientific Opinion on Bovine Lactoferrin, 2012. efsa.europa.eu

Independently researched5 citations