Safety of lacto‐N‐neotetraose as a novel food ingredient pursuant to Regulation (EC) No 258/97

Products, Efsa Panel on Dietetic

doi:10.2903/j.efsa.2015.4183

Cited by 23 publications

(33 citation statements)

References 36 publications

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“…LNT is one of the most abundant HMO along with 2'-FL, 6'-SL, lacto-N-fucopentaose I and LNnT. The Panel notes that a safety assessment of its constitutional isomer (LNnT) when chemically synthesised has been carried out by EFSA (EFSA NDA Panel, 2015). The Panel also noted that LNnT when obtained by fermentation (E. coli K-12 DH1) has been included in the European novel food list.…”

Section: Discussionmentioning

confidence: 99%

“…No human intervention studies with LNT have been provided by the applicant and no reference to human data was made. The Panel noted that studies with the constitutional isomer LNnT obtained by chemical synthesis have been conducted in adults and infants, and that data were overall sufficient to conclude about the safety of its use under the proposed conditions (EFSA NDA Panel, 2015). The Panel considers the information as supportive for the assessment of LNT.…”

Section: Human Datamentioning

confidence: 99%

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Safety of lacto‐N‐tetraose (LNT) as a novel food pursuant to Regulation (EU) 2015/2283

Turck¹,

Castenmiller²,

Henauw³

et al. 2019

EFS2

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Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on lacto-N-tetraose (LNT) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a powdered mixture mainly composed by LNT, but also containing D-lactose and other oligosaccharides such as para-lacto-N-hexaose-2 (para-LNH-2), lacto-N-triose II and a small fraction of other carbohydrates. It is produced by fermentation with a genetically modified strain of Escherichia coli K-12. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods, including infant and follow-on formula, foods for infants and toddlers, foods for special medical purposes and food supplements. The target population is the general population except for food supplements, for which the target population is individuals above 1 year of age. The intake of LNT from the NF at the proposed use levels is unlikely to exceed the intake level of naturally occurring LNT in breastfed infants on a body weight basis. The intake of other carbohydratetype compounds structurally related to LNT is considered of no safety concern. The Panel concludes that the NF is safe under the proposed conditions of use for the proposed target populations.

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Section: Discussionmentioning

confidence: 99%

Section: Human Datamentioning

confidence: 99%

Safety of lacto‐N‐tetraose (LNT) as a novel food pursuant to Regulation (EU) 2015/2283

Turck¹,

Castenmiller²,

Henauw³

et al. 2019

EFS2

View full text Add to dashboard Cite

show abstract

“…Regulatory authorities have generally accepted this study design of using neonatal animals for evaluating the safety of novel IF ingredients such as HiMOs ([European Food Safety Authority (EFSA, 2015a, 2015b] and food additives (JECFA, 2014). Conducting toxicity studies in neonatal animals also follows the strategy for safety assessment of non-absorbable compounds intended for use in foods for infants proposed in the EFSA guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age (EFSA, 2017).…”

Section: Introductionmentioning

confidence: 99%

Toxicological safety assessment of the human‐identical milk oligosaccharide 3′‐sialyllactose sodium salt

Phipps

Baldwin

Lynch

et al. 2019

J of Applied Toxicology

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Human breastmilk is a mixture of nutrients, hormones and bioactive molecules that are vital for infant growth and development. Infant formula (IF) lacks many of these compounds, most notably human milk oligosaccharides (HMOs), which are abundant in breastmilk but scarce in IF. Sialyllactoses, such as 3′‐sialyllactose, constitute a large portion of the HMO fraction. To produce IF that matches breastmilk more closely, biosynthesized human‐identical milk oligosaccharides (structurally identical to HMOs) such as 3′‐sialyllactose sodium salt (3′‐SL) are proposed for use in IF and foods for the general population. The safety assessment of 3′‐SL comprised in vitro genotoxicity tests and a 90‐day oral (gavage) toxicity study. This is the first 90‐day study conducted with 3′‐SL using neonatal rats (7 days old at the start of dosing—equivalent age to newborn human infants in terms of central nervous system and reproductive development), demonstrating the safety of 3′‐SL for consumption by infants, the most sensitive age group. The neonatal rats received 3′‐SL at doses up to 5,000 mg/kg body weight (BW)/day and reference controls received 5,000 mg/kg BW/day of fructooligosaccharide (an ingredient approved for use in IF) for comparison with the high‐dose 3′‐SL group, followed by a 4‐week recovery period. There was no evidence of genotoxicity in vitro. In the absence of any test item‐related adverse effects in the 90‐day study, the high dose (5,000 mg/kg BW/day) was established as the no‐observed‐adverse‐effect level. This confirms the safety of 3′‐SL for use in IF for infants, as well as in functional foods for the general population.

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“…This approach included conduct of a 90-day oral gavage study in neonatal rats [dosed from postnatal day (PND) 7] designed to simulate human infant exposure and allow for assessment of any potential systemic toxicity following exposure covering pre-and post-weaning from growth into adulthood. This study design has been generally accepted by regulatory authorities for assessing the safety of novel infant formula ingredients such as HiMOs (EFSA, 2015a(EFSA, , 2015b and food additives (JECFA, 2014), and follows the testing strategy (for nonabsorbable compounds) proposed in the European Food Safety Authority (EFSA) guidance on the risk assessment of substances present in food intended for infants under 16 weeks of age (EFSA, 2017).…”

Section: Introductionmentioning

confidence: 99%

Toxicological safety evaluation of the human‐identical milk oligosaccharide 6′‐sialyllactose sodium salt

Phipps

Baldwin

Lynch

et al. 2019

J of Applied Toxicology

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Human milk oligosaccharides (HMOs) are abundant in breastmilk, but their presence in infant formula is negligible. Sialylated HMOs, such as 6′‐sialyllactose, constitute a significant portion of the HMO fraction of human milk and are linked to important biological functions. To produce infant formula that is more comparable with human milk, biosynthesized sialyllactoses known as human‐identical milk oligosaccharides (structurally identical counterparts to their respective naturally occurring HMOs in breastmilk) are proposed for use in infant formula and other functional foods for the general population. To support the safety of 6′‐sialyllactose sodium salt (6′‐SL), a 90‐day oral (gavage) toxicity study and in vitro genotoxicity tests were conducted. The 90‐day study is the first to be conducted with 6′‐SL using neonatal rats (day 7 of age at the start of dosing), thus addressing safety of 6′‐SL for consumption by the most sensitive age group (infants). In the 90‐day study, neonatal rats received 6′‐SL at doses up to 5000 mg/kg body weight (BW)/day and reference controls received 5000 mg/kg BW/day of fructooligosaccharide (an ingredient approved for use in infant formula) for comparison with the high‐dose 6′‐SL group, followed by a 4‐week recovery period. There was no evidence of genotoxicity in vitro. No test item‐related adverse effects were observed on any parameter in the 90‐day study, thus the high dose (5000 mg/kg BW/day) was established as the no‐observed‐adverse‐effect level. These results confirm that 6′‐SL is safe for use in formula milk for infants and in other functional foods for the general population.

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Safety of lacto‐N‐neotetraose as a novel food ingredient pursuant to Regulation (EC) No 258/97

Cited by 23 publications

References 36 publications

Safety of lacto‐N‐tetraose (LNT) as a novel food pursuant to Regulation (EU) 2015/2283

Safety of lacto‐N‐tetraose (LNT) as a novel food pursuant to Regulation (EU) 2015/2283

Toxicological safety assessment of the human‐identical milk oligosaccharide 3′‐sialyllactose sodium salt

Toxicological safety evaluation of the human‐identical milk oligosaccharide 6′‐sialyllactose sodium salt

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