Latest science further protects infants

The European Food Safety Authority (EFSA) published its final guidance on 31st May on the assessment needed for  food for babies under the age of 16 weeks.  Following a consultation EFSA maintains the requirement for an extended one generation reproductive toxicity study for substances added intentionally to infant formula. 

The baby food industry (Specialised Nutrition Europe)  argued, as it usually does, that wherever standards are set  a  ‘history of safe use’ is sufficient:  “We strongly feel a different risk assessment approach should be applied for additives that also have a function and a long history of use as a permitted nutritional substance in formulas for infants, including infants below 16 weeks of age.”

However such arguments were dismissed by EFSA,  saying that  “a presumption of safety based on traditional uses has been accepted under certain conditions eg for botanical preparations,  but is not suitable for the risk assessment of food for infants”

EFSA says tests are needed if substances are intentionally added and systematically available.  It argues that tests should look at the effect on the reproductive and immune system, as well as the developing nervous system. EFSA  stresses the importance of human data


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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 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.

State-of-the-art assessment methodology

EFSA’s Scientific Committee has developed guidance that provides an approach for carrying out risk assessment 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 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:

  1. organ development in human infants, including the gut, metabolism, the brain and brain barriers, the immune system, the endocrine and reproductive systems
  2. the toxicity 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.

Media contacts

EFSA Media Relations Office
Tel. +39 0521 036 149

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