EFSA’s opinion deems the mixture safe stating the 2’‐FL and DFL intake at proposed levels is unlikely to exceed the naturally occurring 2’‐FL and DFL levels in breastfed infants per kilogram body weight.
“The information provided on the manufacturing process, composition and specifications of the Novel Food (NF) does not raise safety concerns,” said EFSA responding to an application from Danish biotech firm Glycom.
“Considering that 2’‐FL and DFL are naturally occurring oligosaccharides present in human milk, the history of human exposure to 2’‐FL and DFL concerns breast‐fed infants.
“The Panel notes that 2’‐FL, which is the major component of the NF, has already been assessed and authorised as a NF to be added to infant and follow‐on formulae (IF, FOF), as well as to food supplements.”
Proposed uses and maximum levels
In a document published in the EFSA journal, the NF mixture in question is described as “two oligosaccharides obtained by fermentation from a genetically modified strain of E. coli K12.”
Glycom intends to add the NF to foods for infants and young children as well as foods for special medical purposes with the general population the focus. For food supplements, the firm target all individuals above one year of age.
The proposed food uses and maximum use levels of the NF in infant formula is set at 1.6 grams per litre (g/L) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.
Follow‐on formula is given a maximum use level of 1.2 g/L in the final product ready for use, also marketed as such or reconstituted as instructed by the manufacturer.
Maximum use levels for special medical purpose foods are to be decided on a case‐by‐case basis, as Glycom did not propose maximum use levels.
“The Panel considers that the maximum use levels of the NF should be in accordance with the particular nutritional requirements of the population segment for which the products are intended,” EFSA said.
“But in any case [these maximum use levels] must not be higher than the maximum levels specified for the proposed food uses or the maximum daily intake proposed for food supplements.”
2’‐FL and DFL
Together 2’‐FL and DFL constitute on average around 70% of the total HMO fraction in human milk. 2’‐FL in particular is an ingredient tied closely to the raft of new infant formula products now available.
Already authorised as a NF last year, 2’‐FL along with DFL, bring formula manufacturers one step closer to replicating the nutritional qualities of human breast milk.
Its blending with fellow human milk oligosaccharide (HMO) DFL opens up further product benefits for long-term infant health and development.
Current infant formula players dabbling with HMOs include BASF, which recently entered an agreement with biotechnology firm Glycosyn to develop and commercialise HMOs for use in dietary supplements, functional nutrition and medical food.
In February of this year, DuPont Nutrition & Health and Lonza Consumer Health & Nutrition joined forces to manufacture and supply human milk oligosaccharide (HMO) in a deal that looked to tap into the €44bn global infant nutrition sector.
