The notification allows 25 milligrams per day (mg/day) of the bovine milk basic whey protein isolate in food supplements for infants up to 12 months.
“The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate,” the EC’s notification states.
“Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/ children/adolescents under the age of one/three/eighteen years (depending on the age group the food supplement is intended for).”
Writing in the Official Journal of the European Union, the EC permits 30 milligrams (mg) per 100 grams (g) of powder formula for infants during the first months of life until the introduction of appropriate complementary feeding.
A value of 3.9 mg/100 millilitres (mL) is permitted for reconstituted formula for infants also during the first months of life until the introduction of appropriate complementary feeding.
It is the same story for follow-on formulae, where guidelines allow 30mg/100 g (powder) and 4.2mg/100 mL (reconstituted) for infants until appropriate complementary feeding is introduced.
What is bovine milk whey protein?
Bovine milk basic whey protein isolate is a yellowish grey powder obtained from bovine skimmed milk via a series of isolation and purification steps.
The fractionation process used to produce the novel ingredient removes acidic proteins including casein and the two major whey proteins β-lactoglobulin and α-lactalbumin, thereby isolating the minor basic whey proteins lactoferrin (47%) and lactoperoxidase (26%).
Other proteins in the isolate (approximately 20%) are made up of polymeric immunoglobulin receptor (secretory component), complement C3, β-lactoglobulin, and α-S1-casein.
With a total protein content (w/weight of product) of over 90%, the isolate has also proved suitable for use in dietary foods for weight control (specifically meal replacement beverages) and dietary foods for special medical purposes.
Application history
On 10 October 2018, functional and nutritional dairy ingredients firm Armor Protéines made a request to the Commission for the extension of use of the bovine milk basic whey protein isolate.
On 24 January 2019, the Commission consulted the European Food Safety Authority (EFSA), asking the agency to carry out an additional assessment for the extension of its use as a novel food.
Later that year in March, the Authority adopted its scientific opinion ‘Safety of whey basic protein isolate for extended uses in foods for special medical purposes and food supplements for infants pursuant to Regulation (EU) 2015/2283.’
“Considering a combined intake of five milligrams per kilogram body weight per day (mg/kg bw per day) from food supplements plus 20 mg/kg bw per day from either Foods for special medical purposes (FSMP) formulae or from the authorised use in infant and follow‐on formula, the margin of exposure (MOE) would increase to 80 which is considered sufficient by the Panel, in line with its conclusions of its Opinion from 2018,” EFSA’s FSA Panel on Nutrition, Novel Foods and Food Allergens rules.
EFSA’s scientific opinion gave sufficient grounds to establish that bovine milk basic whey protein isolate, in the proposed extended uses and use levels in foods for special medical purposes, and in food supplements for infants up to 12 months,
“It is therefore appropriate to amend the Union list of authorised novel foods to include this extension of uses in the authorised uses of the bovine milk basic whey protein isolate,” concludes the EC.