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)
Date: 2015-07-23
Institutions: European Commission
Subjects: bioprocess, food additive, food safety, health risk, market approval, milk product








L_2015198EN.01002601.xml










28.7.2015   


EN


Official Journal of the European Union


L 198/26








            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 1
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 2
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






(1)  
            OJ L 43, 14.2.1997, p. 1.

(2)  
            EFSA Journal 2015; 13(1):3956.




ANNEX

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) (1).






(1)  Modified DIN EN ISO 21528-2.