Opinion of the Scientific Panel on genetically modified organisms [GMO] on an application (Reference EFSA‐GMO‐UK‐2004‐05) for the placing on the market of insect‐protected and glufosinate and glyphosate‐tolerant genetically modified maize 1507 × NK603, for food and feed uses, and import and processing under Regulation (EC) No 1829/2003 from Pioneer Hi‐Bred and Mycogen Seeds

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doi:10.2903/j.efsa.2006.355

Cited by 4 publications

(7 citation statements)

References 11 publications

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“…On 22 December 2016, the European Food Safety Authority (EFSA) received from the European Commission (DG SANTE) application EFSA-GMO-RX-008 by Pioneer Hi-Bred International, Inc. and Dow AgroSciences LLC for the renewal of authorisation of genetically modified (GM) maize 1507 9 NK603 for the placing on the market of products containing, consisting of, or produced from this GM maize for import and processing submitted within the framework of Regulation (EC) No 1829/ 2003. Before sending the application to EFSA, the European Commission confirmed whether the data submitted in the context of this renewal application were in line with the legal requirements laid down in Articles 11 and 23 (EFSA, 2006), the placing on the market of maize 1507 9 NK603 for products containing, consisting of, or produced from this GM maize for import and processing, excluding cultivation in the European Union, was authorised by Commission Decision 2007/703/EC. 3 A copy of this authorisation was provided by the applicant.…”

Section: Introductionmentioning

confidence: 80%

“…After receiving application EFSA-GMO-RX-008, and in accordance with Articles 5(2)(b) and 17 (2) Following the submission of application EFSA-GMO-UK-2004-05 and the publication of the EFSA scientific opinion (EFSA, 2006), the placing on the market of maize 1507 9 NK603 for products containing, consisting of, or produced from this GM maize for import and processing, excluding cultivation in the European Union, was authorised by Commission Decision 2007/703/EC. 3 A copy of this authorisation was provided by the applicant.…”

Section: Discussionmentioning

confidence: 99%

“…In line with the requirements listed in the renewal guidance (EFSA GMO Panel, 2015), the applicant provided an overall assessment concluding that information provided in the application for renewal of authorisation of maize 1507 9 NK603 for food and feed use and processing in the EU, does not change the outcome of the original risk assessment (EFSA, 2006).…”

Section: Overall Assessment As Provided By the Applicant 12mentioning

confidence: 99%

“…5 This single nucleotide change did not lead to a change in the amino acid sequence of the Cry1F protein. With regard to NK603, the applicant has stated that the NK603 sequence in 1507 9 NK603 is identical to that of the original event (EFSA, 2006). 6 Taking into account the above described sequence information and in accordance with the GMO Panel guidelines for renewal of applications of GM food and feed authorised under Regulation (EC) No 1829/2003 (EFSA GMO Panel, 2015), the GMO Panel evaluated the data provided in the context of this maize 1507 9 NK603 renewal application under the assumption that the event sequences in 1507 9 NK603 currently on the market are identical to the newly reported 1507 event sequence, and to the NK603 event sequence submitted in the originally assessed stack.…”

Section: Datamentioning

confidence: 99%

“…The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. In conclusion, under the assumption that the DNA sequence of the events in maize 1507 9 NK603 considered for renewal are identical to the newly reported 1507 sequence and the NK603 sequence of the originally assessed two-event stack maize, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-008 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize 1507 9 NK603 (EFSA, 2006).…”

mentioning

confidence: 94%

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Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐008)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2018

EFS2

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Following the submission of application EFSA-GMO-RX-008 under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc. and Dow AgroSciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant, herbicide-tolerant genetically modified maize 1507 9 NK603, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. In conclusion, under the assumption that the DNA sequence of the events in maize 1507 9 NK603 considered for renewal are identical to the newly reported 1507 sequence and the NK603 sequence of the originally assessed two-event stack maize, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-008 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize 1507 9 NK603 (EFSA, 2006).

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Section: Introductionmentioning

confidence: 80%

Section: Discussionmentioning

confidence: 99%

Section: Overall Assessment As Provided By the Applicant 12mentioning

confidence: 99%

Section: Datamentioning

confidence: 99%

mentioning

confidence: 94%

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Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐008)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2018

EFS2

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Assessment of genetically modified maize 1507 × 59122 × MON810 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2011‐92)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2017

EFS2

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In this opinion, the GMO Panel assessed the four‐event stack maize 1507 × 59122 × MON810 × NK603 and its ten subcombinations, independently of their origin. The GMO Panel previously assessed the four single events combined in this four‐event stack maize and five of their combinations and did not identify safety concerns. No new data on the single events or their previously assessed combinations leading to modification of the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single maize events and of the newly expressed proteins in the four‐event stack maize did not give rise to food and feed safety or nutritional issues. The GMO Panel concludes that the four‐event stack maize is as safe and as nutritious as its non‐GM comparator. In the case of accidental release of viable grains of maize 1507 × 59122 × MON810 × NK603 into the environment, this would not raise environmental safety concerns. For four of the subcombinations not previously assessed, protein expression data were provided and did not indicate an interaction affecting the levels of the newly expressed proteins in these subcombinations. The five subcombinations not previously assessed are expected to be as safe as the single maize events, the previously assessed subcombinations and the four‐event stack maize. The GMO Panel considers that post‐market monitoring of maize 1507 × 59122 ×MON810 × NK603 and its subcombinations is not necessary. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize 1507 × 59122 × MON810 ×NK603 and its subcombinations.

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Assessment of genetically modified maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing, under Regulation (EC) No 1829‐2003 (application EFSA‐GMO‐NL‐2013‐112)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2019

EFS2

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Maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON 89034, 1507, NK603 and DAS‐40278‐9. The GMO Panel previously assessed the four single events and four of their subcombinations and did not identify safety concerns. No new data on the maize single events or their four subcombinations that could lead to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicates that the combination of the single maize events and of the newly expressed proteins in the four‐event stack maize does not give rise to food/feed safety and nutritional concerns. The GMO Panel concludes that the four‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the four‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the six maize subcombinations for which no experimental data were provided, and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the four‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the four‐event stack maize. No post‐market monitoring for food/feed is necessary. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

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Cited by 4 publications

References 11 publications

Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐008)

Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐008)

Assessment of genetically modified maize 1507 × 59122 × MON810 × NK603 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2011‐92)

Assessment of genetically modified maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing, under Regulation (EC) No 1829‐2003 (application EFSA‐GMO‐NL‐2013‐112)

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