ArticleEFSA journal. European Food Safety Authority2017
Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age.
Article in EFSA journal. European Food Safety Authority, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 116 papers, 1 of them a synthesis that pooled it.
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Who cites it
116 citing papers in PubMed, 1 synthesis or guideline pooled it, 197 citations in OpenAlex.
- Evaluation of Mycotoxins in Infant Breast Milk and Infant Food, Reviewing the Literature Data.Toxins · 2021Pooled it
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- Human Milk as a Model for Next-Generation Infant Formula: Opportunities and Challenges.Advances in nutrition (Bethesda, Md.) · 2026Review
- Safety assessment of the substance 1,3-benzenedicarboxamide, 5-[[[EFSA journal. European Food Safety Authority · 2026Article
- Safety of lacto-N-triose II as a novel food pursuant to Regulation (EU) 2015/2283.EFSA journal. European Food Safety Authority · 2026Article
- Update of the risk assessment on emerging and novel brominated flame retardants in food.EFSA journal. European Food Safety Authority · 2026Article
- Safety assessment of the substance l-aspartic acid,EFSA journal. European Food Safety Authority · 2026Article
- Dietary phosphate exposure-strategies to protect vulnerable population groups.Archives of toxicology · 2026Review
- Glutamate: Safe and Adequate Intake Levels for Infants-Foods (Basel, Switzerland) · 2026Article
- Dietary exposure to lycopene from background diet, novel foods and food additive use in the European population.EFSA journal. European Food Safety Authority · 2026Article
- Safety assessment of the substance (2E,2'E)-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diylbis(2-methylpropane-2,1-diyl) bis(2-cyano-3-(3,4-dimethoxyphenyl)acrylate for use in plastic food contact materials.EFSA journal. European Food Safety Authority · 2026Article
- Rapid risk assessment on acute reference dose (ARfD) of cereulide in infants and information on acute consumption of infant formulae.EFSA journal. European Food Safety Authority · 2026Article
- Guidance on the scientific data requirements for an application for authorisation of a food additive submitted under Regulation (EC) No 1331/2008.EFSA journal. European Food Safety Authority · 2026Article
- Safety evaluation of a second extension of use of the food enzyme triacylglycerol lipase from the non-genetically modifiedEFSA journal. European Food Safety Authority · 2025Article
- Microalgal diversity, nutritional profiles, and applications in poultry nutrition: A comprehensive review.Animal nutrition (Zhongguo xu mu shou yi xue hui) · 2025Review
- Aflatoxin MToxins · 2025Article
- Updated consumer risk assessment of fluoride in food and drinking water including the contribution from other sources of oral exposure.EFSA journal. European Food Safety Authority · 2025Article
- Article
- Safety assessment of the substance N,N'-(2-(4-(2-aminobenzamido)butyl)pentane-1,5-diyl)bis(2-aminobenzamide) for use in plastic food contact materials.EFSA journal. European Food Safety Authority · 2025Article
- Safety of the extension of use of 3-fucosyllactose (3-FL) as a novel food pursuant to Regulation (EU) 2015/2283.EFSA journal. European Food Safety Authority · 2025Article
56 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
30 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Registered trials
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