EFSA revaluates novel synthetic oligosaccharides: ‘May cause mild gastrointestinal symptoms’

By Annie Harrison-Dunn contact

- Last updated on GMT

Safety concerns raised - but EFSA notes that intake estimates are based on 'conservative assumptions'. Photo credit: iStock.com josewsy
Safety concerns raised - but EFSA notes that intake estimates are based on 'conservative assumptions'. Photo credit: iStock.com josewsy

Related tags: Food supplements, Food

Doses of lacto-N-neotetraose and 2'‑O-fucosyllactose in foods and supplements for children aged 1-10 years could mean intakes linked to mild gastrointestinal symptoms in adults, the European Food Safety Authority (EFSA) said in a second novel food evaluation.

The opinion from EFSA’s panel​ on dietetic products, nutrition and allergies (NDA) on lacto-N-neotetraose (LNnT) and 2'‑O-fucosyllactose (2’-FL) came at the request of the European Commission.

The Commission asked EFSA to look at the novel synthetic oligosaccharides in food supplements for children, excluding infants.

The panel already concluded in July 2015​ that the ingredients were safe for infants and young children when added to infant, follow-on and young-child formulae under specific conditions of use as well as for adults from food supplements at certain levels including a maximum intended daily intake of 1.5 g for LNnT and 3 g for 2’-FL.  

The application, filed by Danish firm Glycom, also looked to include LNnT and 2’-FL in food supplements for children, with maximum daily intake levels of 0.6 g for LNnT and 1.2 g for 2’-FL for toddlers (1-3 years of age), and maximum daily intake levels of 1.5 g for LNnT and 3 g for 2’-FL for children (4-10 years of age) and teenagers (11-18 years of age).

However in its latest assessment EFSA said in children aged one to ten, the combined intakes from all foods intended to contain the ingredients could result in intake levels which have been reported to cause mild gastrointestinal symptoms in adults.

Meanwhile the panel said LNnT and 2’-FL were safe for the proposed use in food supplements at the maximum use levels proposed for toddlers (aged one to three years) of 0.6 g/day for LNnT and/or 1.2 g/day for 2’-FL and for children (four–18 years of age) of 1.5 g for LNnT and/or 3 g for 2’‑FL.

Concluding, EFSA wrote: “The panel notes that the intake estimates are based on the conservative assumptions that all proposed food items consumed by an individual actually contain the novel food ingredient at the maximum specified level of use and that in addition to such intakes these ingredients are also consumed from food supplements at the maximum proposed intake levels.”

EFSA’s latest opinion looked at two consumption scenarios whereby the maximum daily intakes from food supplements were added to the average and 95th percentile intake estimates based on body weight from all foods to which the ingredients were intended to be added.

Related topics: Policy, Labelling

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