Commission implementing Regulation (EU) 2019/1979 of 26 November 2019 authorising the placing on the market of 2'-Fucosyllactose/Difucosyllactose mixture as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)
Commission implementing Regulation (EU) 2019/1979 of 26 November 2019 authorising the placing on the market of 2'-Fucosyllactose/Difucosyllactose mixture as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
1. 2'-FL/DFL as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
2. For a period of five years from the date of entry into force of this Regulation only the initial Applicant:
Company: Glycom A/S;
Address: Kogle Allé 4, DK-2970 Hørsholm, Denmark,
is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 to this Regulation or with the agreement of Glycom A/S.
3. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
4. The authorisation provided for in this Article shall be without prejudice to the provisions of Regulation (EU) No 609/2013, of Directive 2002/46/EC, and Regulation (EU) No 1308/2013.
The studies and reports contained in the application file on the basis of which 2'-FL/DFL has been assessed by the Authority, claimed by the Applicant as fulfilling the requirements laid down in Article 26(2) of Regulation (EC) 2015/2283, shall not be used for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of Glycom A/S.
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1)
in Table 1 (Authorised novel foods), the following entry is inserted in alphabetical order:
Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
Data Protection
‘ 2'-Fucosyllactose/Difucosyllactose mixture (‘2'-FL/DFL’)
(microbial source)
Specified food category
Maximum levels
The designation of the novel food on the labelling of the foodstuffs containing it shall be “2'-Fucosyllactose/Difucosyllactose mixture”.
The labelling of food supplements containing the 2'-Fucosyllactose/Difucosyllactose mixture shall bear a statement that they should not be used if breast milk or other foods containing added 2'-Fucosyllactose and/or Difucosyllactose are consumed the same day.
Authorised on 19.12.2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 2'-Fucosyllactose/Difucosyllactose mixture is authorised for placing on the market within the Union only by Glycom A/S, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S.
End date of the data protection: 19.12.2024.’
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products
2,0 g/L
Unflavoured fermented milk-based products
2,0 g/L (beverages)
20 g/kg (products other than beverages)
Flavoured fermented milk-based products including heat-treated products
2,0 g/L (beverages)
20 g/kg (products other than beverages)
Beverages (flavoured drinks)
2,0 g/L
Cereal bars
20 g/kg
Infant formula as defined under Regulation (EU) No 609/2013
1,6 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Follow-on formula as defined under Regulation (EU) No 609/2013
1,2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined under Regulation (EU) No 609/2013
1,2 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
10 g/kg for products other than beverages
Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013
4,0 g/L (beverages)
40 g/kg (products other than beverages)
Food for special medical purposes as defined under Regulation (EU) No 609/2013
In accordance with the particular nutritional requirements of the persons for whom the products are intended
Food Supplements as defined in Directive 2002/46/EC intended for the general population excluding infants
4,0 g/day
(2)
in Table 2 (Specifications), the following entry is inserted in alphabetical order:
Authorised Novel Food
Specification
‘ 2'-Fucosyllactose/Difucosyllactose mixture (‘2'-FL/DFL’)
(microbial source)
Description/Definition:
2'-Fucosyllactose/Difucosyllactose mixture is a purified, white to off-white amorphous powder that is produced by a microbial process. After purification, the 2'-Fucosyllactose/Difucosyllactose mixture is isolated by spray drying.
Source: Genetically modified strain of Escherichia coli strain K-12 DH1
Characteristics/Composition
Appearance: White to off white powder or agglomerates
Sum of 2'-Fucosyllactose, Difucosyllactose, Lactose and Fucose (% of dry matter): ≥ 92,0 % (w/w)
Sum of 2'-fucosyllactose and difucosyllactose (% of dry matter): ≥ 85,0 % (w/w)
2'-Fucosyllactose (% of dry matter): ≥ 75,0 % (w/w)
Difucosyllactose (% of dry matter): ≥ 5,0 % (w/w)
D-Lactose: ≤ 10,0 % (w/w)
L-Fucose: ≤ 1,0 % (w/w)
2'-Fucosyl-D-lactulose: ≤ 2,0 % (w/w)
Sum of other carbohydrates ( *1 ) : ≤ 6,0 % (w/w)
Moisture: ≤ 6,0 % (w/w)
Ash, sulfated: ≤ 0,8 % (w/w)
pH (20 °C, 5 % solution): 4,0-6,0
Residual protein: ≤ 0,01 % (w/w)
Microbiological criteria:
Aerobic mesophilic bacteria total plate count: ≤ 1000 CFU/g
Enterobacteriaceae : ≤ 10 CFU/g
Salmonella sp.: Negative/25 g
Yeast: ≤ 100 CFU/g
Mould: ≤ 100 CFU/g
Residual endotoxins: ≤ 10 EU/mg
CFU: Colony Forming Units; EU: Endotoxin Units
( *1 ) 3'-Fucosyllactose, 2'-Fucosyl-galactose, Glucose, Galactose, Mannitol, Sorbitol, Galactitol, Trihexose, Allo-lactose and other structurally related carbohydrates.’
