Guidance on the risk assessment of substances present 1 in food intended for infants below 16 weeks of age 2 EFSA Scientific Committee

12 Following a request from the European Commission to the European Food Safety Authority (EFSA), 13 EFSA's Scientific Committee (SC) prepared a guidance for the risk assessment of substances present 14 in food intended for infants below 16 weeks of age. In its approach to develop this guidance, the 15 EFSA SC took into account, among others, (i) an exposure assessment based on infant formula as the 16 only source of nutrition; (ii) knowledge of organ development in human infants, including the 17 development of the gut, metabolic and excretory capacities, the brain and brain barriers, the immune 18 system, the endocrine and reproductive systems; (iii) the overall toxicological profile of the substance 19 identified through the standard toxicological tests, including critical effects; (iv) the relevance for the 20 human infant of the neonatal experimental animal models used. The EFSA SC notes that during the 21 period from birth up to 16 weeks, infants are expected to be exclusively fed on breast milk and/or 22 infant formula. The EFSA SC views this period as the time where health-based guidance values for the 23 general population do not apply without further considerations. High infant formula consumption per 24 body weight is derived from 95 percentile consumption. The first weeks of life is the time of the 25 highest relative consumption on a body weight basis. Therefore, when performing an exposure 26 assessment, the EFSA SC proposes to use the high consumption value of 260 mL/kg bw/day. A 27 decision tree approach is proposed that enables a risk assessment of substances present in food 28 intended for infants below 16 weeks of age. The additional information needed when testing 29 substances present in food for infants below 16 weeks of age and the approach to be taken for the 30 risk assessment are on a case-by-case basis, depending on whether the substance is added 31 intentionally to food and is systemically available. 32 © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on 33 behalf of European Food Safety Authority. 34