Repeated-dose 90-day Oral Toxicity Studies on Whole ... - Europabio
Repeated-dose 90-day Oral Toxicity Studies on Whole ... - Europabio
Repeated-dose 90-day Oral Toxicity Studies on Whole ... - Europabio
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Discussi<strong>on</strong><br />
• EuropaBio Members agree with EFSA’s Scientific<br />
Opini<strong>on</strong> (2011a) that an applicant could forego<br />
c<strong>on</strong>ducting a <str<strong>on</strong>g>90</str<strong>on</strong>g>-<str<strong>on</strong>g>day</str<strong>on</strong>g> study if data indicating the GM<br />
crop and its parental isoline:<br />
– Are Substantially Equivalent in regard to nutriti<strong>on</strong>al compositi<strong>on</strong>.<br />
– Dem<strong>on</strong>strate no indicati<strong>on</strong>s of unintended adverse effects in<br />
molecular, compositi<strong>on</strong>al, or phenotypic analyses.<br />
• EuropaBio Members request clarificati<strong>on</strong> <strong>on</strong> whether<br />
inclusi<strong>on</strong> of two (or more) <str<strong>on</strong>g>dose</str<strong>on</strong>g> levels is mandatory<br />
and, if so, how results from the low <str<strong>on</strong>g>dose</str<strong>on</strong>g> will be<br />
used.<br />
8
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