Commission Implementing Decision (EU) 2017/2201 of 27 November 2017 authorising the placing on the market of 2′-fucosyllactose produced with Escherichia coli strain BL21 as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2017) 7662) (Only the German text is authentic)
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Address https://gelex.eu/eli/EU/decision/2017/2201@2017-11-27/en
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, and in particular Article 7 thereof,
Whereas:
(1) On 4 August 2014, the company Jennewein Biotechnologie GmbH made a request to the competent authority of the Netherlands to place powder and liquid concentrate of the oligosaccharide 2′-fucosyllactose produced with a genetically modified strain of Escherichia coli BL21 on the Union market as novel food ingredient within the meaning of point (d) of Article 1(2) of Regulation (EC) No 258/97. The target population is the infant population.
(2) 2′-fucosyllactose falls outside the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as the genetically modified strain of Escherichia coli BL21 is used as a processing aid and the material derived from the genetically modified microorganism is not present in the novel food.
(3) On 3 June 2016, the competent authority of the Netherlands issued its initial assessment report. In that report it came to the conclusion that powder and liquid concentrate of the oligosaccharide 2′-fucosyllactose produced with a genetically modified strain of Escherichia coli BL21 meets the criteria for novel food ingredients set out in Article 3(1) of Regulation (EC) No 258/97.
(4) On 13 June 2016, the Commission forwarded the initial assessment report to the other Member States.
(5) Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97. In particular, objections concerning elevated intake levels of 2′-fucosyllactose were raised. In accordance with Article 7(1) of Regulation (EC) No 258/97, a decision should be adopted taking into account the objections raised. The applicant consequently modified the request concerning the maximum amount of 2′-fucosyllactose in infant formulae and follow- on formulae. That change and additional explanations provided by the applicant alleviated the concerns to the satisfaction of Member States and of the Commission.
(6) Regulation (EU) No 609/2013 of the European Parliament and of the Council lays down requirements for food intended for infants and young children. The use of 2′-fucosyllactose powder and liquid concentrate should be authorised without prejudice to that Regulation and to any other legislation that applies in parallel to Regulation (EC) No 258/97.
(7) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS DECISION:
Article 1
Without prejudice to Regulation (EU) No 609/2013, 2′-fucosyllactose powder and liquid concentrate as specified in Annex I to this Decision may be placed on the Union market as a novel food ingredient for the uses defined and at the maximum level established in Annex II to this Decision.
Article 2
The designation of 2′-fucosyllactose powder and liquid concentrate authorised by this Decision on the labelling of the foodstuffs shall be 2′-fucosyllactose for the powder and for the liquid concentrate.
Article 3
This Decision is addressed to Jennewein Biotechnologie GmbH, Maarweg 32, 53619 Rheinbreitbach, Germany.
Done at Brussels, 27 November 2017. For the Commission Vytenis Andriukaitis Member of the Commission
ANNEX
ANNEX I SPECIFICATIONS OF 2′-FUCOSYLLACTOSE
Definition: Chemical name α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranoside Chemical formula C18H32O15 Molecular mass 488,44 Da CAS No. 41263-94-9 Description: 2′-fucosyllactose powder produced with a genetically modified strain of Escherichia coli BL21 is a white to ivory powder that is derived from 2′-fucosyllactose liquid concentrate by spray drying. The 2′-fucosyllactose liquid concentrate is a colourless to slight yellow clear 45 % w/v ± 5 % w/v aqueous solution.
Specifications of 2′-fucosyllactose powder
Specification Parameter Limits Physical parameter White to ivory colour Chemical analysis 2′-fucosyllactose ≥ 90 % Lactose ≤ 5 % 3-fucosyllactose ≤ 5 % Difucosyllactose ≤ 5 % Fucosylgalactose ≤ 3 % Glucose ≤ 3 % Galactose ≤ 3 % Fucose ≤ 3 % GMO detection Negative Water content ≤ 9,0 % Protein content ≤ 100 μg/g Total Ash ≤ 0,5 % Contaminants Lead ≤ 0,02 mg/kg Arsenic ≤ 0,2 mg/kg Cadmium ≤ 0,1 mg/kg Mercury ≤ 0,5 mg/kg Aflatoxin M1 ≤ 0,025 μg/kg Microbial Parameters Total Plate Count (TPC) ≤ 104 CFU/g Enterobacteria/Coliforms absent in 11 g Yeast and Mould ≤ 100 CFU/g Salmonella spp. Negative/100 g Cronobacter spp. Negative/100 g Endotoxins ≤ 100 EU/g CFU: Colony Forming Units; EU: Endotoxin Units
Specifications of 2′-fucosyllactose liquid concentrate
Specification Parameter Limits Physical parameter Colourless to slightly yellow, clear solution Solids content 45 % w/v (+/– 5 % w/v) dry matter in water Chemical analysis 2′-fucosyllactose ≥ 90 % Lactose ≤ 5 % 3-fucosyllactose ≤ 5 % Difucosyllactose ≤ 5 % Fucosylgalactose ≤ 3 % Glucose ≤ 3 % Galactose ≤ 3 % Fucose ≤ 3 % GMO detection Negative Protein content ≤ 100 μg/g Total Ash ≤ 0,5 % Contaminants Lead ≤ 0,02 mg/kg Arsenic ≤ 0,2 mg/kg Cadmium ≤ 0,1 mg/kg Mercury ≤ 0,5 mg/kg Aflatoxin M1 ≤ 0,025 μg/kg Microbial Parameters Total Plate Count (TPC) ≤ 5000 CFU/g Enterobacteria/Coliforms absent in 11 g Yeast and Mould ≤ 50 CFU/g Salmonella spp. Negative/200 ml Cronobacter spp. Negative/200 ml Endotoxins ≤ 100 EU/ml CFU: Colony Forming Units; EU: Endotoxin Units
ANNEX II Authorised uses of 2′-fucosyllactose powder and liquid concentrate
Food category Maximum level Infant formulae and follow-on formulae 1,2 gram 2′-fucosyllactose per litre final product ready for use marketed as such or reconstituted as instructed by the manufacturer.
Versions
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