Introductory text
United Kingdom
Commission Implementing Decision (EU) 2017/1387
of 24 July 2017
authorising the placing on the market of an enzyme preparation of prolyl oligopeptidase produced with a genetically modified strain of Aspergillus niger as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
(notified under document C(2017) 4975)
(Only the English 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 ingredientsf1, and in particular Article 7(1) thereof,
Whereas:
(1)
On 13 June 2012, the company DSM Food Specialties made a request to the competent authorities of France to place an enzyme preparation of prolyl oligopeptidase produced with a genetically modified strain of Aspergillus niger, on the Union market as a novel food ingredient within the meaning of point (d) of Article 1(2) of Regulation (EC) No 258/97. The target population is the general adult population.
(2)
On 31 July 2014, the competent food assessment body of France issued its initial assessment report. In that report it came to the conclusion that an enzyme preparation of prolyl oligopeptidase produced with a genetically modified strain of Aspergillus niger meets the criteria for novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97.
(3)
On 11 November 2014, the Commission forwarded the initial assessment report to the other Member States.
(4)
Reasoned objections were raised by other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97.
(5)
On 25 November 2015, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for an enzyme preparation of prolyl oligopeptidase produced with a genetically modified strain of Aspergillus niger as a novel food ingredient in accordance with Regulation (EC) No 258/97.
(6)
On 13 December 2016, EFSA in its opinion on the safety of prolyl oligopeptidase as a novel food ingredient pursuant to Regulation (EC) No 258/97 concluded that the enzyme preparation of prolyl oligopeptidase produced with a genetically modified strain of Aspergillus niger is safe for the proposed use and use levelsf2.
(7)
That opinion gives sufficient grounds to establish that the enzyme preparation of prolyl oligopeptidase produced with a genetically modified strain of Aspergillus niger in the proposed use and use levels complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.
(8)
Enzyme preparation of prolyl oligopeptidase falls outside the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Councilf3 on genetically modified food and feed as the genetically modified strain of Aspergillus niger is used as a processing aid and the material derived from the genetically modified microorganism is not present in the novel food.
(9)
Directive 2002/46/EC of the European Parliament and of the Councilf4 lays down requirements on food supplements. The use of the enzyme preparation of prolyl oligopeptidase produced with a genetically modified strain of Aspergillus niger should be authorised without prejudice to the provisions of that Directive.
(10)
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:
Annotations
Footnotes
- f1
- f2
-
EFSA Journal 2017; 15(2): 4681.
- f3
-
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).
- f4
-
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).