EFSA deem protein isolates safe for extended use in infant formula and supplements

The decision refers to a request by the European Commission (EC), which asked for safety considerations of the ingredient’s use in foods for special medical purposes (FSMP) and supplements for infants.

The EC considered the application by Armor Protéines to extend its use to infant formula (powdered 30 milligrams (mg) per 100 grams (g) and reconstituted 3.9 mg/100 millilitres (mL).

The French-based dairy specialists also requested extended uses in follow on formula (powdered 30 mg/100 g and reconstituted 4.2 mg/100 mL) as well as in food supplements for infants (25 milligrams per day (mg/day)).

Does not exceed intake level​

“The applicant intends to market the use of the Novel Foods (NF) in FSMP and food supplements as alternative sources to its use in infant and follow on formula,”​ EFSA notes.

“The Panel notes that a combined unintended intake of 5 milligrams/kilogram per body weight (mg/kg bw) per day from food supplements and 20 mg/kg bw per day from either infant and follow on formulae or from FSMP formulae would not exceed the intake level which were considered safe by the EFSA Opinion of 2018.”​

The decision’s timeline stretches back to 10 October 2018, where Armor Protéines submitted a request to the EC to update the entry for bovine milk basic whey protein isolate in the Union list of authorised novel foods.

On 27 June 2018, the EFSA NDA Panel concluded its assessment that specifically concluded whey basic protein isolates obtained by ion exchange chromatography of skimmed cow's milk was safe for human consumption.

In the same year, the EC went on to grant marketing authorisation of the NF for its uses in infant formula, follow‐on formula and total diet replacement foods for weight control.

The ingredient’s use in two other categories, FSMP and food supplements, was restricted to children aged 1–3 years and children/adolescents from 3 - 18 years of age through to adults.