ARTICLE
24 February 2017

EFSA Consults On Follow-On Formulae

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The guidance document specifies what kind of information and data applicants need to submit.
European Union Food, Drugs, Healthcare, Life Sciences

EFSA has launched a public consultation on its draft scientific opinion on the safety and suitability of "follow-on formulae" with a protein content of at least 1.6 g/100 kcal, which is lower than the levels permitted under current EU legislation. Follow-on formulae are "food[s] used by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants." EFSA considered follow-on formulae made from various protein sources and concluded that follow-on formulae made from cow's milk protein or goat's milk protein with a protein content of at least 1.6 g/100 kcal, but otherwise complying with relevant EU legislation, is safe and suitable for infants living in Europe. The available data did not allow EFSA to establish the safety and suitability of follow-on formulae with a similar protein content made from soy protein isolates or protein hydrolysates.

In parallel, EFSA has also launched a public consultation on its draft guidance for the preparation and presentation of applications for authorization of infant or follow-on formulae manufactured from protein hydrolysates. The guidance document specifies what kind of information and data applicants need to submit. It covers applications for the assessment of the safety and suitability of the specific formula and applications on the formula's efficacy in reducing the risk of infants becoming allergic to milk proteins. Written comments are due March 3, 2017.

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