Latest science further protects infants

EFSA’s approach for assessing substances found in food intended for infants below 16 weeks of age will further support EU decision-making on the safety of food for this age group. The guidance will apply from now on to EFSA assessments linked to food safety including some food additive A substance deliberately added to foods or beverages for beneficial technological reasons (e.g. to preserve, flavour, colour or ensure a particular texture). Food additives are not normally consumed by themselves nor used as typical ingredients in food. 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 Substance used to kill or control pests, including disease-carrying organisms and undesirable insects, animals and plants. residues, contaminants and food contact materials.

State-of-the-art assessment methodology

EFSA’s Scientific Committee has developed guidance that provides an approach for carrying out risk assessment  A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. of these types of substances in food (intentionally added or not) for infants below 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 The amount of a substance (e.g. nutrient or chemical) that is ingested by a person or animal via the diet. of formula as the sole source of nutrition The science of how diet relates to the body's need for sustenance. will help to estimate their exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. 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:

1. organ development in human infants, including the gut, metabolism The total sum of physical and chemical processes that occur within living organisms., the brain and brain barriers, the immune system, the endocrine and reproductive systems
2. the toxicity The potential of a substance to cause harm to a living organism. of the substance from:
   • tests in juvenile and adult animals
   • 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 finalising the Guidance and is included in an accompanying report.

• Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age
• Report: public consultation on Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age