The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age. The document was prepared by a dedicated working group of the Scientific Committee and endorsed by the Scientific Committee for public consultation at its Plenary meeting of 13-14 February 2017. The written public consultation for this document was opened from 20 February to 31 March 2017. EFSA received 108 comments from nine interested parties. EFSA’s Panels and its Scientific Committee wish to thank all stakeholders for their contributions. This report presents statistics on the comments received and lists all comments together with detailed answers to them. The stakeholders’ valuable and detailed comments were taken into account by the Scientific Committee Working Group to prepare an updated version of the Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age. The Guidance was discussed and adopted at the Scientific Committee Plenary meeting on 26 April 2017, and is published in the EFSA Journal.