Literature searches were performed in Web of Science (http://wok.mimas.ac.uk/) and PubMed (http://www.ncbi.nlm.nih.gov/pubmed/) to identify publications in the public domain in the following areas relevant to the developing infant.

Toxicology

Nutritional needs

Physiological and biochemical considerations

—  Physiology of the gut

—  Metabolic and excretory capacities relevant for the elimination of chemicals

—  The nervous system, including brain and brain barriers

—  The immune system

—  The male and female reproductive systems

—  The endocrine system

Comprehensive reviews covering the above areas were identified in order to recognise recent developments since the latest comprehensive assessments of infant toxicology and development by national and international authorities and agencies. The periods covered ranged from January 2012 to February 2016 and the searches were performed in Web of Science. The search limits were document type = review and search terms in title. The search terms combined were ‘intestin*’ OR ‘gastro*’ AND ‘development*’ OR ‘infant’ OR ‘neonat*’ (retrieved 98; selected 5); ‘metabolism’ OR ‘cytochrome’ OR ‘CYP*’ OR ‘glucuronidation’ OR ‘glucuronosyl*’ OR ‘sulfation’ OR ‘sulphation’ OR ‘sulfonyl*’ OR sulphonyl*’ OR ‘acetylation’ OR ‘conjugation’ OR ‘glutathione OR ‘transporter’ or ‘clearance’ OR ‘ADME’ AND ‘development*’ OR ‘ontogeny’ OR ‘infant’ OR ‘neonat*’ (retrieved 121; selected 10); ‘brain’ AND ‘development*’ OR ‘infant’ OR ‘neonat*’ (retrieved 256; selected 21); ‘immun*’ AND ‘development*’ OR ‘infant’ OR ‘neonat*’ (retrieved 289; selected 14); ‘reproduct*’ OR ‘gonad*’ OR ‘sexua*’ OR ‘endocrin*’ AND ‘development*’ OR ‘infant’ OR ‘neonat*’ (retrieved 105; selected 25). The selection criteria included coverage of the perinatal or post‐natal period and relevance to the assessment. Additional primary references of particular relevance were identified by the working group members (up to May 2016).
In addition, publicly available guidance documents and reports produced by committees and international authorities such as the Joint FAO‐WHO Expert Committee on Food Additives (JECFA), Scientific Committee on Food (SCF), EFSA and the European Medicines Agency (EMA) that were relevant to risk assessment of substances in food intended for infants were considered.
A draft of this document Guidance underwent a public consultation from 20 February to 31 March 2017. The comments received were considered and have been incorporated where appropriate.
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