Scientific Opinion on application (EFSA‐GMO‐NL‐2009‐64) for the placing on the market of herbicide‐tolerant genetically modified soybean BPS‐CV127‐9 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from BASF Plant Science

,

doi:10.2903/j.efsa.2014.3505

Cited by 2 publications

(1 citation statement)

References 27 publications

(39 reference statements)

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“…The metabolism of imazapyr in primary crops was investigated in herbicide resistant soya bean and maize using 14 C-pyridine labelled imazapyr after foliar application. The studies were submitted under the current import tolerance application and assessed by the EMS (United Kingdom, 2013, 2014. These studies were also assessed by JMPR (FAO, 2013).…”

Section: Acceptable Daily Intake (Adi) and Acute Reference Dose (Arfd)mentioning

confidence: 99%

Reasoned opinion on the setting of MRLs for imazapyr in genetically modified soya bean and other oilseeds and in lentils

2014

EFS2

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In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, hereafter referred to as the evaluating Member State (EMS), received an import tolerance application from Exponent International Ltd., on behalf of BASF Corporation, to set MRLs for the use of the active substance imazapyr in genetically modified soya bean grown in Brazil, imidazolinone-tolerant lentils, rape and mustard plants grown in Canada and sunflowers in Argentina. The United Kingdom proposed to set MRLs of 5 mg/kg in soya bean, 0.08 mg/kg in sunflower seed, 0.05 mg/kg in rape seed and mustard seed and 0.2 mg/kg in lentils. The United Kingdom drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive MRL proposals of 5 mg/kg on soya bean, 0.08 mg/kg on sunflower seed, the limit of quantification (LOQ) of 0.05 mg/kg on rape and mustard seed and 0.3 mg/kg on lentils. In the countries of origin the MRLs are set at 3 mg/kg on soya bean, 0.05 mg/kg on sunflower, rape and mustard seed and 0.2 mg/kg on lentils. Adequate analytical enforcement methods are available to control the residues of imazapyr in the crops under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of imazapyr in soya bean, sunflower seed, rape seed, mustard seed and lentils will not result in a consumer exposure exceeding the toxicological reference value and therefore are unlikely to pose a consumer health risk. EFSA bases its assessment on the evaluation report and the response to the EFSA request for additional information, the original data (dossier) submitted by the applicant, the comments received during the Member State consultation of the draft reasoned opinion and the JMPR evaluation report. © EuropeanThe toxicological profile of imazapyr was assessed in the framework of the import tolerance application. From these data, the United Kingdom proposed an ADI of 2.5 mg/kg bw per day, whereas no ARfD was deemed necessary. The proposal was accepted by EFSA and by Member States during the consultation.The metabolism of imazapyr in primary crops was investigated in genetically modified soya bean and imidazolinone-tolerant maize labelled in the pyridine ring after foliar application. From these studies the EMS proposed to establish the residue definition for enforcement and risk assessment as imazapyr. EFSA agrees with the proposed residue definitions for the crops under consideration (group of pulses and oilseeds).EFSA concludes that the submitted supervised residue trials are sufficient to derive MRL proposals of 5 mg/kg on soya bean, 0.08 mg/kg on sunflower seed, the limit of quantification (LOQ) of 0.05 mg/kg on rape and mustard seed and 0.3 mg/kg on lentils. In the countries of origin the MRLs are set at 3 mg/kg on soya bean, 0.05 mg/kg on sunflower, rape and mustard seed and 0.2 mg/kg on lentils. The validity of the residue data on rape seeds with regard to st...

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Section: Acceptable Daily Intake (Adi) and Acute Reference Dose (Arfd)mentioning

confidence: 99%

Reasoned opinion on the setting of MRLs for imazapyr in genetically modified soya bean and other oilseeds and in lentils

2014

EFS2

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Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Papadopoulou¹,

Ramon²

2018

EFS2

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The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean BPS‐CV127‐9 and to indicate whether the previous conclusions of the GMO Panel on safety of GM soybean BPS‐CV127‐9 remain valid. The new sequencing data indicated a two nucleotide difference in the unannotated Arabidopsis genomic DNA sequence downstream of the 3′ untranslated region of the ahasl (also referred to as csr1‐2) gene as compared to the sequencing data originally provided. One of these nucleotide differences reported in the new nucleic acid sequencing data from GM soybean event BPS‐CV127‐9 was shown to be already present in the original plant material used for the risk assessment. However, for the other nucleotide difference reported, no evidence could be provided to differentiate between a sequencing error and point‐mutation. With the exception of bioinformatics analyses, the studies performed for the risk assessment of the single event soybean BPS‐CV127‐9 remain valid. The new sequencing data and the bioinformatics analyses performed on the new sequence did not give rise to safety issues. Therefore, EFSA concludes that the original risk assessment of soybean BPS‐CV127‐9 remains valid.

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Scientific Opinion on application (EFSA‐GMO‐NL‐2009‐64) for the placing on the market of herbicide‐tolerant genetically modified soybean BPS‐CV127‐9 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from BASF Plant Science

Cited by 2 publications

References 27 publications

Reasoned opinion on the setting of MRLs for imazapyr in genetically modified soya bean and other oilseeds and in lentils

Reasoned opinion on the setting of MRLs for imazapyr in genetically modified soya bean and other oilseeds and in lentils

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

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