(9) Considering that the proposed maximum levels of cadaverine in the novel food and the resulting intakes on the basis of the authorised conditions of use of the novel food will be at least three orders of magnitude lower than the levels of cadaverine that are ingested from a normal diet, the Commission considers that the proposed changes in the cadaverine levels in the specifications of the spermidine-rich wheat germ extract do not alter the safety considerations that supported the authorisation of this novel food, and that a safety evaluation of the current application by the Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. Therefore, it is appropriate to amend the specifications of the novel food spermidine-rich wheat germ extract at the level for cadaverine requested by the applicant.
(10) The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
(11) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
The entry in the Union list of authorised novel foods, as provided for in Article 6 of Regulation (EU) 2015/2283 and included in Implementing Regulation (EU) 2017/2470, referring to the novel food spermidine-rich wheat germ extract (
Triticum aestivum
), is amended as specified in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union
.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 March 2020.
For the Commission
The President
Ursula VON DER LEYEN
(1)
OJ L 327, 11.12.2015, p. 1
.
(2) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (
OJ L 351, 30.12.2017, p. 72
).
(3) Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients.
OJ L 43, 14.2.1997, p. 1
.
(4) EFSA Journal 2011;9(10):2393.
ANNEX
In the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘Spermidine-rich wheat germ extract (
Triticum aestivum)
’ in Table 2 (Specifications) is replaced by the following:
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