A European Food Safety Authority (EFSA) panel of experts found no concerns regarding genotoxicity and toxicity, and minimal likelihood of allergenic reactions among the target group following a risk assessment of safety parameters.
The panel reviewed regulatory requirements and the relevant body of clinical evidence on current 3-FL consumption and considered the NF safe “under the proposed conditions of use”.
The scientific opinion states: “Taking into account the intrinsic nature of HMOs with their limited absorption, the absence of toxicologically relevant effects in the sub-chronic study and considering that infants are naturally exposed to these substances, the Panel considers that the consumption of the NF at the proposed uses and use levels does not raise safety concerns.”
Composition and purpose
The novel food comprises a powdered mixture produced by fermentation of a derivative GM strain of E. coli BL21, which is considered non-pathogenic and unlikely to survive in host tissues or to cause disease. The primary constituent is the non-digestible oligosaccharide 3-FL (90%), with added D-lactose, L-fucose, D-glucose and D-galactose, and a small fraction of other related saccharides.
3-FL is a natural component of mammalian milk, with the highest levels found in human milk: it is therefore commonly referred to as human milk oligosaccharide (HMO).
The panel notes that the history of 3-FL use in human is primarily limited to breastfed infants, although there is wide variability of concentrations in human milk. For the purposes of the assessment, daily intake levels were established based on European data of maximum and mean concentrations in infants aged 3-6 months.
Parameters for use
The panel’s opinion was predicated on the IF being the only food consumed by infants aged 0-16 weeks who are not breastfed and considered all intended applications.
As well as IF and FOF, these include processed cereal-based food and baby food for infants and young children, food for infants and young children for special medical purposes, and food for special medical purposes (FSMP) as defined in Regulation (EU) No 609/20132, milk-based drinks and similar products intended for young children, and food supplements (FS) as defined in Directive 2002/46/EC3 .
High levels were estimated at 260 mL/kg body weight per day. Based on the maximum proposed level of NF (0.9 g/L in IF), high intake of NF from IF alone is approximately 234 mg/kg per day and does not exceed high daily intake of 3-FL of 460 mg/kg in breastfed infants.
While 3-FL is already authorised for use in other food categories (such as drinks, flavoured and unflavoured fermented milk-based products and cereal bars), the panel was confident that combined exposure would not exceed estimated high levels of 3-FL intake (460 mg/kg body weight).
Some statistically significant physiological changes were noted in evidence supplied by Christian Hansen. A 90-day study identified reductions in spontaneous motility in treated male rats and a slight increase in body temperature in female rats.
A decrease in white blood cells (neutrophils) and proteins (albumin and globulin), and increases in albumin/globulin ratios, alanine aminotransferase, and urea in females were also noted, as well as reductions in urinalysis. Researchers also observed reductions in absolute brain weight in treated males and relative kidneys weight in female rats.
However, these changes were deemed of low magnitude and considered “not biologically relevant” by the panel.
Nevertheless, it determined that infants and young children should not consume human milk and food supplements (FS) on the same day.
Equally, the panel commented that consumption of the NF under the proposed conditions was not considered nutritionally disadvantageous.