SCHEDULE 1Renewal of the authorisation of the placing on the market of products containing, consisting of, or produced from genetically modified maize MIR604
Genetically modified organism and unique identifierI11
For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the unique identifier SYN-IR6Ø4-5 is specified for genetically modified maize MIR604.
AuthorisationI22
The following products are authorised for the purposes of Articles 4(2) and 16(2) of Regulation (EC) 1829/2003, in accordance with the conditions set out in this schedule—
a
food and food ingredients containing, consisting of or produced from genetically modified maize SYN-IR6Ø4-5,
b
feed containing, consisting of or produced from genetically modified maize SYN-IR6Ø4-5,
c
products containing or consisting of genetically modified maize SYN-IR6Ø4-5 for uses other than those provided for in sub-paragraphs (a) and (b), with the exception of cultivation.
LabellingI33
1
For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) 1829/2003, and in Article 4(6) of Regulation (EC) 1830/2003, the “name of the organism” is “maize”.
2
The words “not for cultivation” must appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize SYN-IR6Ø4-5, with the exception of food and food ingredients.
Method of detectionI44
1
For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the method specified in sub-paragraph (2) is to be used for the detection of genetically modified maize referred to in paragraph 1.
2
The method specified in this sub-paragraph is event-specific real-time quantitative PCR based method of detection of the genetically modified maize as set out in the document entitled “Event-specific Method for the Quantification of Maize Line MIR604 using real time PCR”, reference “CRLVL04/05VP corrected version 1”.
3
The method of DNA extraction for use in the detection method specified in sub-paragraph 2 is as set out in the document entitled “Maize Seeds Sampling and DNA extraction Report on the Validation of a DNA Extraction Method from Maize Seeds”, reference “CRLVL04/05XP”.
4
For the purposes of Articles 7(3) and 19(3) of Regulation (EC) 1829/2003, the reference material ERM®-BF423 is accessible from the Joint Research Centre (JRC) of the European Commission10.
Monitoring plan for the environmental effectsI55
1
The authorisation holder must implement the monitoring plan for environmental effects, which accompanied the application for renewal of the authorisation of genetically modified maize SYN-IR6Ø4-5, reference number “RP476” submitted to the Food Safety Authority on 3 March 2021.
2
The authorisation holder must submit to the Food Safety Authority annual reports on the implementation of, and the results of the activities as set out in the monitoring plan, in accordance with the format set out in Annex 2 of Decision 2009/770/EC.
Authorisation holderI66
1
The name and address of the authorisation holder is Syngenta Crop Protection AG, Rosentalstrasse 67, CH-4058 Basel, Switzerland.
2
The authorisation holder is represented in Great Britain by Syngenta Limited, Jealott’s Hill International Research Centre, Bracknell, Berkshire, England, RG42 6EY.