(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing the Union list of authorised novel foods, was adopted.

(3)

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draft implementing act authorising the placing on the Union market of a novel food and updating the Union list.

(4)

Commission Implementing Decision (EU) 2016/375 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), the placing on the market of chemically synthesized Lacto-N-neotetraose as a novel food ingredient.

(5)

Pursuant to Article 5 of Regulation (EC) No 258/97, on 1 September 2016, the company Glycom A/S informed the Commission of its intention to place on the market Lacto-N-neotetraose of microbial source produced with Escherichia coli strain K-12 as a novel food ingredient.

(6)

In the notification to the Commission, Glycom A/S also submitted a report issued by the competent authority of Ireland pursuant to Article 3(4) of Regulation (EC) No 258/97, which, on the basis of the scientific evidence submitted by that company, had concluded that Lacto-N-neotetraose produced with Escherichia coli strain K-12 is substantially equivalent to the synthetic Lacto-N-neotetraose authorised by Implementing Decision (EU) 2016/375. Therefore, Lacto-N-neotetraose of microbial source was included in the Union list of novel foods.

(7)

On 23 June 2019, the company Chr. Hansen A/S (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for the authorisation of Lacto-N-neotetraose (microbial source) produced by the combined activity of the derivative strains PS-LNnT-JBT and DS-LNnT-JBT of Escherichia coli strain BL21(DE3) as a novel food under the same conditions of use as the ones currently authorised for synthetic and microbial sourced Lacto-N-neotetraose. The applicant requested an update of the union list with regard to the new source of that novel food.

(8)

In addition, the applicant proposed updating some of the specifications of Lacto-N-neotetraose (microbial source) produced by that new source, as they differ from the specifications of the authorised microbiologically sourced Lacto-N-neotetraose produced with Escherichia coli strain K-12, as far as they concern an increase in the levels of ash from ≤ 0,4 % to ≤ 1,0 %; a higher level for the presence of yeasts and moulds from the current ≤ 10 Colony Forming Units (‘CFU’)/g of novel food for each type of microorganism to ≤ 50 CFU/g for the combination of the two; and the absence of methanol (from the current ≤ 100 mg/kg), and of Lacto-N-neotetraose fructose isomer (from the current ≤ 1,0 %).

(9)

On 17 January 2020, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of Lacto-N-neotetraose produced by the combined activity of the derivative strains PS-LNnT-JBT and DS-LNnT-JBT of Escherichia coli strain BL21(DE3) in accordance with the requirements of Article 11 of Regulation (EU) 2015/2283.

(10)

On 22 October 2020, the Authority adopted its scientific opinion ‘Safety of lacto-N-neotetraose (LNnT) produced by derivative strains of E. coli BL21 as a novel food pursuant to Regulation (EU) 2015/2283’ (5).

(11)

In its scientific opinion, the Authority concluded that Lacto-N-neotetraose (LNnT) produced by the combined activity of the derivative strains PS-LNnT-JBT and DS-LNnT-JBT of Escherichia coli strain BL21(DE3) as a novel food pursuant to Regulation (EU) 2015/2283 is safe for the currently authorised conditions of use. Therefore, that scientific opinion gives sufficient grounds to establish that Lacto-N-neotetraose (LNnT) produced by the combined activity of the derivative strains PS-LNnT-JBT and DS-LNnT-JBT of Escherichia coli strain BL21(DE3), complies with Article 12(1) of Regulation (EU) 2015/2283.

(12)

It is therefore appropriate to amend the specifications of the microbiologically produced Lacto-N-neotetraose, to include the derivative strains PS-LNnT-JBT and DS-LNnT-JBT of Escherichia coli strain BL21(DE3) as the source of the novel food in addition to the authorised Escherichia coli strain K12 and to amend the proposed levels for the presence of ash and moulds, and yeast.

(13)

The Annex to Regulation (EU) 2017/2470 should therefore be amended accordingly.

(14)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,