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 R?ssle 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.
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 R?ssle 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.
