Animal dietary exposure in the risk assessment of feed derived from genetically modified plants

Mullins, Ewen; Bresson, Jean‐Louis; Dalmay, Tamás; Dewhurst, Ian Crawford; Epstein, Michelle M; Firbank, Leslie George; Guerche, Philippe; Hejátko, Jan; Moreno, F. Javier; Naegeli, Hanspeter; Nogué, Fabien; Rostoks, Nils; Serrano, Jose Juan Sánchez; Savoini, G.; Veromann, Eve; Veronesi, F.; Dumont, Antonio Fernández; Ardizzone, Michele

doi:10.2903/j.efsa.2023.7732

Cited by 2 publications

(4 citation statements)

References 61 publications

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“…Based on the information available, the GMO Panel confirms that farmed and companion animals, including herbivorous animals, e.g. ruminants and horses, but also gestating and lactating sow and laying hens (Ebertz et al., 2020 ; EFSA GMO Panel, 2023c ; OECD, 2009 , 2013 ; Steenfeldt et al., 2007 ), are naturally exposed to background levels of ZMM28 protein through consumption of rations containing maize R4 forage/silage.…”

Section: Assessmentmentioning

confidence: 99%

Assessment of genetically modified maize DP202216 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2019‐159)

Mullins,

Bresson,

Dalmay

et al. 2024

EFS2

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Genetically modified maize DP202216 was developed to confer tolerance to glufosinate-ammonium-containing herbicides and to provide an opportunity for yield enhancement under field conditions. These properties were achieved by introducing the mo-pat and zmm28 expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/ feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize DP202216 and its comparator needs further assessment, except for the levels of stearic acid (C18:0), which do not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the PAT and ZMM28 proteins as expressed in maize DP202216, and finds no evidence that the genetic modification would change the overall allergenicity of maize DP202216. In the context of this application, the consumption of food and feed from maize DP202216 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize DP202216 is as safe as the comparator and non-GM reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize DP202216 grains into the environment, this would not raise environmental safety concerns. The postmarket environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP202216. The GMO Panel concludes that maize DP202216 is as safe as its 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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Section: Assessmentmentioning

confidence: 99%

Assessment of genetically modified maize DP202216 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2019‐159)

Mullins,

Bresson,

Dalmay

et al. 2024

EFS2

Self Cite

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“…Upon EFSA request to provide further clarifications on the animal dietary exposure (ADE) originally provided in the main dossier, the applicant submitted a new ADE study which was assessed by the GMO Panel. The recommendations outlined in the GMO Panel statement on ADE, recently published (EFSA GMO Panel, 2023 ), were followed.…”

Section: Assessmentmentioning

confidence: 99%

“…Mean levels of Vip3Aa19 and APH4 proteins in cotton meal were calculated to be respectively 1.75‐fold than in seed, based on factors that take into account the protein content in these feed materials relative to cotton seed, and assuming that no protein is lost during their production/processing (EFSA GMO Panel, 2023 ).…”

Section: Assessmentmentioning

confidence: 99%

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Assessment of genetically modified cotton COT102 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2017‐141)

Mullins,

Bresson,

Dalmay

et al. 2023

EFS2

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Genetically modified cotton COT102 was developed to confer resistance against several lepidopteran species. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the differences in the agronomic-phenotypic and compositional characteristics between cotton COT102 and its non-GM comparator needs further assessment, except for levels of acid detergent fibre, which do not raise safety or nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the Vip3Aa19 and APH4 proteins as expressed in cotton COT102 and finds no evidence that the genetic modification would change the overall allergenicity of cotton COT102. In the context of this application, the consumption of food and feed from cotton COT102 does not represent a nutritional concern for humans and animals. The GMO Panel concludes that cotton COT102 is as safe as the non-GM comparator and non-GM cotton varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable cotton COT102 seeds into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton COT102. The GMO Panel concludes that cotton COT102 is as safe as its non-GM comparator and the tested non-GM cotton varieties with respect to potential effects on human and animal health and the environment.

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Animal dietary exposure in the risk assessment of feed derived from genetically modified plants

Cited by 2 publications

References 61 publications

Assessment of genetically modified maize DP202216 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2019‐159)

Assessment of genetically modified maize DP202216 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2019‐159)

Assessment of genetically modified cotton COT102 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2017‐141)

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