BAKGRUNN (fra kommisjonsforordningen)

(1)    Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods 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  has established a Union list of authorised novel foods.
 

(3)    The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes both chemically synthesised and microbiologically produced 2´-Fucosyllactose (‘2′-FL’) as an authorised novel food.  The conditions of use, maximum levels and specific labelling requirements set out in Table 1 of the Annex to that Regulation are common for both the synthetically and the microbiologically produced 2′-FL. At the same time, in in Table 2 of the Annex of that Regulation, separate specifications are set out for chemically synthesised 2′-FL (‘2´-Fucosyllactose (synthetic)’) and for microbiologically produced 2′-FL (‘2´-Fucosyllactose (microbial source)’).
 

(4)    On 30 June 2021, 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 a change in the conditions of use of 2´-FL. The applicant requested to increase in the maximum authorised levels of 2´-FL in infant formulae and follow-on formulae as defined in Article 2 of Regulation (EU) No 609/2013 of the European Parliament and of the Council , from the currently authorised 1.2 g/L in both infant formulae and follow-on formulae to 3.0 g/L in infant formulae and to 3.64 g/L in follow-on formulae.
 

(5)    In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 28 September 2022 requesting it to provide a scientific opinion on the proposed increase in the maximum authorised levels of 2´-FL in infant formulae and follow-on formulae.
 

(6)    On 26 September 2023, the Authority adopted its scientific opinion on the ‘Safety of the extension of use of 2′‐fucosyllactose (2′‐FL) as a novel food pursuant to Regulation (EU) 2015/2283’ , in accordance with Article 11 of Regulation (EU) 2015/2283.
 

(7)    In its scientific opinion, the Authority concluded that 2′-FL is safe when used in infant formulae and follow-on formulae at the proposed maximum levels of 3.0 g/L and 3.64 g/L respectively, and therefore it is appropriate to amend the conditions of use of 2′-FL.
 

(8)    The information provided in the application and the Authority’s scientific opinion give sufficient grounds to establish that the changes to the conditions of use of 2′-FL are in accordance with Article 12(1) of Regulation (EU) 2015/2283.
 

(9)    On 27 October 2023, the applicant submitted another application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change in the specifications of 2´-FL produced by fermentation using a derivative of Escherichia coli strain BL-21. The applicant requested the increase in the authorised maximum levels of residual endotoxin limits from the currently authorised ≤ 100 Endotoxin Units (‘EU’)/g (or ≤ 0,1 EU/mg) of novel food for the powder form or ≤ 100 EU/ml (or ≤ 0,1 EU/μl) of novel food for the liquid form to ≤ 10 EU/mg of novel food for the powder form or ≤ 10 EU/μl of novel food for the liquid form. 
 

(10)    The applicant requested to increase the residual endotoxin limits for 2´-FL produced by fermentation using a derivative of Escherichia coli strain BL21 to align them to that of the already authorised 2´-FL produced with a derivative of Escherichia coli strain K-12, which is authorised under the same conditions of use, and that of other authorised human identical milk oligosaccharides which are also authorised at identical or similar residual endotoxin levels in infant formulae and follow-on formulae. 
 

(11)    The Commission considers that the requested update of the Union list of novel foods to increase the residual endotoxin limits in the specifications of 2´-FL produced with a derivative of Escherichia coli strain BL-21 is not liable to have an effect on human health, and that a safety evaluation by the Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. The Authority’s opinions , ,  on other currently authorised human identical milk oligosaccharides with residual endotoxin limits ≤ 10 EU/mg of novel food and with the same or similar conditions of use as 2´-FL produced with a derivative of Escherichia coli strain BL-21, concluded that these maximum residual levels of endotoxins, are safe. 
 

(12)    The information provided in the applications and the Authority’s existing opinions give sufficient grounds to establish that the changes in the conditions of use of 2´-FL to increase its maximum use levels in infant formulae and follow-on formulae and the changes in the specifications of 2´-FL produced by fermentation using a derivative of Escherichia coli strain BL21 to modify the limits of residual endotoxins, are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.
 

(13)    The Annex to Implementing 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,