On February 20, 2017 the European Food Safety Authority (EFSA) published a draft guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age. The European Commission requested EFSA to provide a scientific opinion on scientific and technical guidance for the risk assessment of substances in baby food, including food additives, pesticide residues, contaminants, and substances migrating from food contact materials (FCMs). “From birth up to 16 weeks, infants are exclusively fed on breast milk and/or infant formula and safe levels set for the general population do not apply,” EFSA explains in its news article. Therefore, EFSA’s Scientific Committee proposes “a new approach for assessing the substances found in infant formula that can better support EU decision-making on the safe use of infant formula.” In developing its approach, EFSA’s Scientific Committee considered, among others, the following: i) Exposure assessment with infant formula as the only source of nutrition; ii) 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) overall toxicological profile of substances identified through standard toxicological tests, including critical effects; and iv) relevance of neonatal experimental animal models for the human infant.

According to EU legislation, there are specific provisions for certain substances used in FCMs intended for infant food, e.g. i) a lowered specific migration limit (SML) for epoxidized soybean oil in polyvinyl chloride (PVC) gaskets used to seal glass jars containing infant formulae, follow-on formulae, processed cereal- based foods, and baby foods for infants and young children, and ii) a ban on the use of bisphenol A (BPA, CAS 80-05-7) for the manufacture of polycarbonate infant feeding bottles.

EFSA launched a public consultation on the draft guidance and comments can be submitted by March 31, 2017.

Read more

EFSA (February 20, 2017). “Draft guidance on substances in food for infants below 16 weeks, open for comments.

EFSA (February 20, 2017). “Public consultation on the draft EFSA guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age.


EFSA (February 20, 2017). “Draft: Guidance on the risk assessment of substances present 2 in food intended for infants below 16 weeks of age.(pdf)