# 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), Introduction: Introductory text

Extent: E+W+S+N.I.

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)
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:

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Source: https://www.legislation.gov.uk/eudn/2017/2201/introduction (the official version)
Page: https://openlegislation.uk/eu-decision-2017-2201/introduction
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.