6.7.2017   

EN

Official Journal of the European Union

L 173/18

(1)

On 11 and 18 April 2007, Monsanto Europe SA submitted to the Commission three applications, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of the authorisation of existing foods, food ingredients and feed produced from maize MON 810, of the authorisation of feed containing and consisting of maize MON 810 and of the authorisation of maize MON 810 in products consisting of it or containing it for other uses than food and feed, as any other maize, including cultivation. After the date of the entry into force of Regulation (EC) No 1829/2003, those products were notified to the Commission pursuant to Article 8(1)(a) and (b) and Article 20(1)(b) of that Regulation and included in the Community Register of genetically modified food and feed.

(2)

On 9 March 2016, Monsanto Europe SA sent a letter to the Commission requesting that the part of the application concerning cultivation be considered separately from the rest of the application. Therefore, this Decision does not cover the use of maize MON 810 seeds for cultivation.

(3)

The placing on the market of pollen produced from maize MON 810 was authorised by Commission Implementing Decision 2013/649/EU (2) and is therefore not covered by this Decision.

(4)

On 30 June 2009, the European Food Safety Authority (‘EFSA’) issued a favourable opinion (updated on 30 July 2009) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that genetically modified maize MON 810, as described in the application, is as safe as its conventional counterpart with respect to potential adverse effects on human and animal health and is unlikely to have adverse effects on the environment taking into account its intended uses (3).

(5)

In its opinion, EFSA considered all the specific 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.

(6)

Taking into account those considerations, the authorisation should be renewed for food and food ingredients produced from maize MON 810, with the exception of pollen, for feed containing or consisting of, or produced from maize MON 810 and for maize MON 810 in products consisting of it or containing it for other uses than food or feed, with the exception of cultivation.

(7)

A unique identifier has been assigned to genetically modified maize MON 810 in accordance with Commission Regulation (EC) No 65/2004 (4), in the context of the initial authorisation of maize MON 810. That unique identifier should continue to be used.

(8)

On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for food and food ingredients produced from maize MON 810 and for feed containing, consisting of, or produced from maize MON 810.

(9)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in in this monitoring plan. Those results should be presented in accordance with Commission Decision 2009/770/EC (5).

(10)

The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or for the use and handling of the food and feed, including post-market monitoring requirements.

(11)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed referred to in Regulation (EC) No 1829/2003.

(12)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients produced from MON-ØØ81Ø-6 maize, with the exception of pollen;

(b)

feed containing, consisting of or produced from MON-ØØ81Ø-6 maize;

(c)

MON-ØØ81Ø-6 maize in products containing it or consisting of it for any other use than food or feed, with the exception of cultivation.