The change will further support European Union decision-making on the safety of food for this age group, the agency has announced.
The guidance will apply from now on to EFSA assessments linked to food safety including some food additive evaluations.
The composition of food intended for infants is regulated at EU level. The rules include requirements concerning the use and/or presence of substances such as food additives, pesticide residues, contaminants and food contact materials.
The EFSA’s Scientific Committee noted 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.
“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,” according to the committee.
State-of-the-art assessment methodology
EFSA’s Scientific Committee developed guidance that provides an approach for carrying out risk assessment of these types of substances in food, whether intentionally added or not, for infants younger than 16 weeks.
EFSA scientists developed the approach following a state-of-the-art assessment of infant development before and after birth. The guidance identifies bodily processes and organ functions that might enhance an infant’s sensitivity towards substances in food. Also, new consumption values for young infants based on their intake of formula as the sole source of nutrition will help to estimate their exposure to these substances.
How the approach works
The Scientific Committee has developed a stepwise approach that allows a case-by-case risk assessment based on evidence of:
- organ development in human infants, including the gut, metabolism, the brain and brain barriers, the immune system, the endocrine and reproductive systems; and
- the toxicity of the substance based on tests in juvenile and adult animals, as well as tests in infant animals, for effects not seen in juvenile/adult animals, or for effects potentially occurring at lower doses in infant animals.
Relevant feedback from a public consultation was taken into consideration by the Scientific Committee in finalizing the Guidance and is included in an accompanying report.
Based in Parma, Italy, the European Food Safety Authority is the agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
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