TY - JOUR

T1 - Safety of 2'-O-fucosyllactose as a novel food ingredient pursuant to Regulation (EC) No 258/97

T2 - (Scientific Opinion)

AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)

AU - Tetens, Inge

AU - Sjödin, Anders Mikael

N1 - On request from the European Commission. Question No. EFSA-Q-2015-00052, adopted on 29 June 2015. European Food Safety Authority (EFSA), Parma, Italy

PY - 2015

Y1 - 2015

N2 - Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 2'-O-fucosyllactose as a novel food ingredient (NFI) submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. 2'-O-fucosyllactose (2'-FL) is a synthetic trisaccharide, which is intended to be used in infant and follow-on formulae, foods for special medical purposes for infants and young children, and other foods for infants and young children, as well as in foods or food supplements for adults. The information provided on the potential mutagenicity of 2'-FL does not raise safety concerns as regards the genotoxicity of this NFI. Based on the observations from a sub-chronic 90-day toxicity study in rats, the Panel considers that the no observed adverse effect level is 2 000 mg/kg body weight per day. The applicant provided a double-blind, randomised, controlled clinical trial on the effects of 2’-FL consumed in combination with another oligosaccharide (lacto-N-neotetraose (LNnT)) in infants. The Panel concludes that 2’-FL is safe for infants (up to one year of age) when added to infant and follow-on formulae, in combination with LNnT, at concentrations up to 1.2 g/L of 2’-FL and up to 0.6 g/L of LNnT, at a ratio of 2:1 in the reconstituted formulae; is safe for young children (older than one year of age) when added to follow-on and young-child formulae, at concentrations up to 1.2 g/L of 2’-FL (alone or in combination with LNnT, at concentrations up to 0.6 g/L, at a ratio of 2:1). The Panel also concludes that 2’-FL is safe when added to other foods at the uses and use levels proposed by the applicant.

AB - Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 2'-O-fucosyllactose as a novel food ingredient (NFI) submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. 2'-O-fucosyllactose (2'-FL) is a synthetic trisaccharide, which is intended to be used in infant and follow-on formulae, foods for special medical purposes for infants and young children, and other foods for infants and young children, as well as in foods or food supplements for adults. The information provided on the potential mutagenicity of 2'-FL does not raise safety concerns as regards the genotoxicity of this NFI. Based on the observations from a sub-chronic 90-day toxicity study in rats, the Panel considers that the no observed adverse effect level is 2 000 mg/kg body weight per day. The applicant provided a double-blind, randomised, controlled clinical trial on the effects of 2’-FL consumed in combination with another oligosaccharide (lacto-N-neotetraose (LNnT)) in infants. The Panel concludes that 2’-FL is safe for infants (up to one year of age) when added to infant and follow-on formulae, in combination with LNnT, at concentrations up to 1.2 g/L of 2’-FL and up to 0.6 g/L of LNnT, at a ratio of 2:1 in the reconstituted formulae; is safe for young children (older than one year of age) when added to follow-on and young-child formulae, at concentrations up to 1.2 g/L of 2’-FL (alone or in combination with LNnT, at concentrations up to 0.6 g/L, at a ratio of 2:1). The Panel also concludes that 2’-FL is safe when added to other foods at the uses and use levels proposed by the applicant.

KW - Faculty of Science

KW - 2'-O-fucosyllactose

KW - 2'-FL

KW - Synthetic oligosaccharide

KW - Novel food ingredient

KW - Safety

U2 - 10.2903/j.efsa.2015.4184

DO - 10.2903/j.efsa.2015.4184

M3 - Journal article

VL - 13

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 7

M1 - 4184

ER -