EFSA deems whey protein isolate as safe for infant formula use

By Will Chu

- Last updated on GMT

Whey basic protein isolate as a novel food (NF) for use in infant formula and food supplements is safe under the proposed uses and use levels, the European Food and Safety Authority (EFSA) confirms.

The NF, a mixture of basic whey proteins obtained from skimmed cow's milk, is considered safe up to a highest estimated intake of 24.8 milligrams per kilogram body weight (mg/kg bw) per day in infants and 27.8 in toddlers.

“Taking into account the composition of the NF and the intended use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous,”​ the Authority stated.

“The information provided on composition, specifications, production process and stability of the NF does not raise safety concerns.”

Central to the decision made by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) were the results of a subchronic 13‐week study in which rats showed no observed adverse effects when subjected to 2000 mg/kg bw of the NF per day.

While the applicant, France-based Armor Protéines, did not provide human studies performed with the NF, eight human studies were included with products containing main components of the NF.

Six of these studies, however, investigated dose levels for bovine lactoferrin (bLF) and lactoperoxidase (bLP), which were considerably below the proposed maximum intake levels of this NF.

Although these studies did not raise concern with regard to bLF and bLP, the Panel noted the limitations of these studies (i.e. not performed with the NF, dose levels tested, limited number of endpoints) in relation to the safety of the NF.

Proposed target populations

In their target populations, Armor Protéines set out to focus on infants and toddlers (infant and follow‐on formulae), explaining that its use set out to achieve intake levels of transforming growth factor β2 (TGF‐β2) comparable to those of breast‐fed infants.

Other target populations included the general adult population (meal replacement beverages) and the general population (foods for special medical purposes and food supplements).

Proposed use levels of the NF through infant and follow‐on formulae could lead to a consumption of the NF of 20 and 23 mg/kg bw per day in infants and toddlers, 

Under the proposed conditions of use, for meal replacement beverages, the intake is highest in children between the age of 4 and 10 where they can account for up to 3.9 mg/kg bw per day. In the adult population, they can account for between 1 and 1.7 mg/kg bw per day.

Maximum use levels for food supplements and food for special medical purposes were estimated at 610 mg per day (and serving) for adults and 58 mg per day (and serving) for children aged 1-3 years.

For adults, this represents an intake of 8.7 mg/kg bw per day, when considering a body weight of 70 kg and 4.8 mg/kg bw per day for children 1-3 years when considering the mean body weight of 12 kg.

Whey protein history

Bovine whey, whey protein concentrates and demineralised whey powder are regularly consumed in the EU, forming the mainstay of infant and follow‐on formulae products, dietetic food for special medical purposes and sports nutrition.

In 2012, EFSA published two opinions on the safety of bLF, where the proposed maximum use of reconstituted (ready‐to‐drink) infant formulae and follow‐on formulae was of 100 mg bLF/100 mL.

The Panel considered that the estimated maximum daily intake of 3.4 g bLF for adults, and for toddlers, the 95th percentile intake of 203 mg/kg bw per day were safe.

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