Open AccessGuidance on the risk assessment of substances present in food intended for infants below 16 weeks of age
Author(s) -
Hardy Anthony,
Benford Diane,
Halldorsson Thorhallur,
Jeger Michael John,
Knutsen Helle Katrine,
More Simon,
Naegeli Hanspeter,
Noteborn Hubert,
Ockleford Colin,
Ricci Antonia,
Rychen Guido,
Schlatter Josef R,
Silano Vittorio,
Solecki Roland,
Turck Dominique,
Bresson JeanLouis,
Dusemund Birgit,
GundertRemy Ursula,
Kersting Mathilde,
Lambré Claude,
Penninks André,
Tritscher Angelika,
WaalkensBerendsen Ine,
Woutersen Ruud,
Arcella Davide,
Court Marques Daniele,
Dorne JeanLou,
Kass George EN,
Mortensen Alicja
Publication year - 2017
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2017.4849
Subject(s) - infant formula , population , risk assessment , environmental health , medicine , european commission , physiology , pediatrics , european union , computer security , computer science , business , economic policy
Following a request from the European Commission to EFSA , the EFSA Scientific Committee ( SC ) prepared a guidance for the risk assessment of substances present in food intended for infants below 16 weeks of age. In its approach to develop this guidance, the EFSA SC took into account, among others, (i) an exposure assessment based on infant formula as the only source of nutrition; (ii) knowledge of organ development in human infants, including the development of the gut, metabolic and excretory capacities, the brain and brain barriers, the immune system, the endocrine and reproductive systems; (iii) the overall toxicological profile of the substance identified through the standard toxicological tests, including critical effects; (iv) the relevance for the human infant of the neonatal experimental animal models used. The EFSA SC notes that during the period from birth up to 16 weeks, infants are expected to be exclusively fed on breast milk and/or infant formula. The EFSA SC views this period as the time where health‐based guidance values for the general population do not apply without further considerations. High infant formula consumption per body weight is derived from 95th percentile consumption. The first weeks of life is the time of the highest relative consumption on a body weight basis. Therefore, when performing an exposure assessment, the EFSA SC proposes to use the high consumption value of 260 mL/kg bw per day. A decision tree approach is proposed that enables a risk assessment of substances present in food intended for infants below 16 weeks of age. The additional information needed when testing substances present in food for infants below 16 weeks of age and the approach to be taken for the risk assessment are on a case‐by‐case basis, depending on whether the substance is added intentionally to food and is systemically available.