COMMISSION IMPLEMENTING DECISION (EU) 2018/2045

of 19 December 2018

renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize NK603 × MON 810 (MON-ØØ6Ø3-6 × MON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2018) 8239)

(Only the Dutch and French texts are authentic)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular to Article 11(3) and Article 23(3) thereof,

Whereas:

(1) Commission Decision 2007/701/EC (2) authorised the placing on the market of food and feed containing, consisting of, or produced from genetically modified maize NK603 × MON 810 (hereinafter ‘maize NK603 × MON 810’). The scope of that authorisation also covers the placing on the market of products, other than food and feed, containing or consisting of maize NK603 × MON 810 for the same uses as any other maize with the exception of cultivation.

(2) On 20 October 2016, Monsanto Europe N.V./S.A. submitted to the Commission an application, in accordance with Article 11 and Article 23 of Regulation (EC) No 1829/2003, for the renewal of that authorisation.

(3) On 26 February 2018, the European Food Safety Authority (‘the Authority’) issued a favourable opinion (3) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that the renewal application did not contain evidence for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize NK603 × MON 810, adopted by the Authority in 2005 (4).

(4) In its opinion of 26 February 2018, the Authority considered all the questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(5) The Authority also concluded that the monitoring plan for environmental effects, consisting of a general surveillance plan, submitted by the applicant, is in line with the intended uses of the products.

(6) Taking into account those considerations, the authorisation for the placing on the market of foods and food ingredients containing, consisting of, or produced from maize NK603 × MON 810, feed containing, consisting of, or produced from maize NK603 × MON 810 and products, other than food and feed, containing or consisting of maize NK603 × MON 810 for the same uses as any other maize with the exception of cultivation should be renewed.

(7) A unique identifier has been assigned to maize NK603 × MON 810, in accordance with Commission Regulation (EC) No 65/2004 (5), in the context of the initial authorisation of maize NK603 × MON 810. That unique identifier should continue to be used.