# Commission Implementing Decision (EU) 2015/1291Show full title

Commission Implementing Decision (EU) 2015/1291 of 23 July 2015 authorising the placing on the market of heat-treated milk            products fermented with Bacteroides xylanisolvens (DSM 23964) as a novel food under Regulation (EC) No 258/97 of the European            Parliament and of the Council (notified under document C(2015) 4960) (Only the German text is authentic)         

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U.K.

# Commission Implementing Decision (EU) 2015/1291                     

# of 23 July 2015

# authorising the placing on the market of heat-treated milk products fermented with *Bacteroides xylanisolvens* (DSM 23964) as a novel food under Regulation (EC) No 258/97 of the European Parliament and of the Council                     

# *(notified under document C(2015) 4960)*

# (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(1), and in particular Article 7 thereof,                        

Whereas:

(1)On 18 December 2012, the company Avitop GmbH made a request to the competent authorities of Ireland to place heat-treated                              milk products fermented with *Bacteroides xylanisolvens* (DSM 23964) on the market as a novel food.

(2)On 21 June 2013, the competent food assessment body of Ireland issued its initial assessment report. In that report it came                              to the conclusion that heat-treated milk products fermented with *Bacteroides xylanisolvens* (DSM 23964) meet the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

(3)On 4 September 2013, the Commission forwarded the initial assessment report to the other Member States.

(4)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.

(5)On 10 April 2014, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an assessment                              for heat-treated milk products fermented with *Bacteroides xylanisolvens* (DSM 23964) as novel food in accordance with Regulation (EC) No 258/97.

(6)On 10 December 2014, EFSA adopted ‘Scientific Opinion on the safety of “heat-treated milk products fermented with *Bacteroides xylanisolvens* DSM 23964” as a novel food’(2), concluding that those milk products are safe.

(7)That opinion gives sufficient grounds to establish that heat-treated milk products fermented with *Bacteroides xylanisolvens* (DSM 23964) as a novel food complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

(8)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 1U.K.

Heat-treated milk products fermented with *Bacteroides xylanisolvens* (DSM 23964) as specified in the Annex may be placed on the market in the Union as a novel food in liquid, semi-liquid and                     spray-dried powder forms.                  

# Article 2U.K.

This Decision is addressed to Avitop GmbH, Robert Rössle Str. 10, D-13125 Berlin, Germany.

Done at Brussels, 23 July 2015.

*For the Commission*                            

Vytenis Andriukaitis                            

*Member of the Commission*                            

## ANNEXU.K.**SPECIFICATION OF HEAT-TREATED MILK PRODUCTS FERMENTED WITH *BACTEROIDES XYLANISOLVENS* (DSM 23964)**

**Definition**

:

Heat-treated fermented milk products are produced with *Bacteroides xylanisolvens* (DSM 23964) as starter culture.                     

**Description**

:

Semi-skimmed milk (between 1,5 % and 1,8 % fat) or skimmed milk (0,5 % fat or less) is pasteurised or ultra-heat-treated before                        starting the fermentation with *Bacteroides xylanisolvens* (DSM 23964). The resulting fermented milk product is homogenised and then heat-treated to inactivate *Bacteroides xylanisolvens* (DSM 23964). The final product does not contain viable cells of *Bacteroides xylanisolvens* (DSM 23964)(3).                     

1

OJ L 43, 14.2.1997, p. 1.                           

2

*EFSA Journal* 2015; 13(1):3956.                           

3

Modified DIN EN ISO 21528-2.