Writing in the Official Journal of the European Union, authorities approve Glycom’s application to place onto the market its 2'-Fucosyllactose/Difucosyllactose (‘2'-FL/DFL’) blend.
The decision spells good news for Glycom, a Danish biotech firm, which now intends to make its 2'-FL/DFL’ blend GlyCare commercially available from 2020.
“GlyCare 2FL/DFL will be available as a mix of 2'FL and DFL in a ratio close to the composition naturally found in breast milk,” says the firm.
"GlyCare 2FL/DFL has been approved as a Novel Food in Europe and regulatory filings have been made in the US. Preparation is on way for other major markets.”
The notification details the amounts permitted for 2'-FL/DFL’s use in unflavoured pasteurised and unflavoured sterilised milk products flavoured and unflavoured fermented milk based products (2.0 grams per litre (g/L)).
These products extend to infant (1.6 g/L) and follow-on formula, baby food for infants and young children (1.2 g/L) and foods for special medical purposes.
Amounts permitted for total diet replacement foods for weight control are limited to 4.0 g/L (beverages) and 40 g/kg (products other than beverages).
2'-FL/DFL can also be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council intended for the general population excluding infants.
Conclusions reached by the EC follows recommendations made by the European Food Safety Authority (EFSA), which in May 2019, concluded that the mixture of 2’‐FL and DFL, was safe.
2'FL is the most abundant fucosylated HMO in human milk at around 2 grams per litre (g/L) with studies pointing to its protective role in preventing infection of the gut
The ingredient is said to also improve gut barrier and immune regulation as well as playing a key role in cognitive development.
DFL is also a highly abundant fucosylated HMO in human milk with anti-infective benefits that work by inhibiting the adhesion of pathogenic bacteria. DFL also positively supports gut health by selectively stimulating bifidobacteria.
Synthetic chili pepper extract
The Authority also takes heed of EFSA’s recommendations in its approval of the synthetic chili pepper extract phenylcapsaicin,
Here, the EC permit the applicant aXichem to use 2.5 milligrams per day (mg/day) of the extract in food supplements intended for the general population, excluding children under the age of 11 years.
The same amount is permitted for use in foods for special medical purposes excluding foods for infants, young children and children under the age of 11 years.
The decision follows EFSA’s findings indicating no safety concerns with the Novel Food (NF), which stated its use in supplements and special medical purpose foods at the stated levels do not pose a safety threat.
This level corresponds to 36 micrograms per kilogram (μg/kg) body weight (bw) per day for adults (considering an average bodyweight of 70 kg) and 58 μg/kg bw per day for adolescents aged 10–14 years (considering an average bodyweight of 43.4 kg).
The Authority wrote in its opinion: “The Panel considers that phenylcapsaicin does not have a nutritionally relevant role in the diet and that the consumption of the NF is not nutritionally disadvantageous.”