Setting of an MRL for ethametsulfuron‐methyl in rape seed
Bibliographic record
Abstract
According to Article 6 of the Regulation (EC) No 396/2005, the United Kingdom, herewith referred as the evaluating Member State (EMS), received an application from DuPont (UK) Ltd. to set an import tolerance on rape seed for the new active substance ethametsulfuron-methyl (DPX-A7881).In order to accommodate the authorized use of ethametsulfuron-methyl on spring-sown rape seed in Canada, it is proposed to raise the existing MRL from the default value of 0.01 mg/kg to the validated LOQ of 0.02 mg/kg.The United Kingdom drafted an evaluation report according to Article 8 of that regulation, which was submitted to the European Commission and forwarded to EFSA on 12 April 2010.On 1 September 2010, some data requirements were identified, which prevented EFSA to conclude on the consumer risk assessment.The required data were submitted by the EMS on the 27 September 2010 and taken into consideration by EFSA for finalization of this reasoned opinion.EFSA Journal 2010;8(12):1959 definitions are restricted to pulses and oilseeds because of the lack of metabolism studies in other crop groups.Analytical methods are available for the determination of ethametsulfuron-methyl in high oil content commodities with the validated LOQ of 0.02 mg/kg.The number of supervised residue trials performed in accordance with the intended GAP was sufficient to propose an MRL of 0.02* mg/kg for ethametsulfuron-methyl in rape seed equivalent to the limit of quantification.The nature of the residues of ethametsulfuron-methyl formed under standard hydrolytic conditions simulating pasteurisation, boiling/cooking and sterilisation was not investigated.Although not triggered, processing studies investigating the magnitude of residues in processed commodities were provided and indicated residue levels of ethametsulfuron-methyl below the LOQ (<0.02 mg/kg) of the analytical method in all the processed products.Since all samples of whole seeds and processed fractions were found to contain residues of ethametsulfuron-methyl below the LOQ of 0.02 mg/kg, no processing factors could be derived.The occurrence of ethametsulfuron-methyl residues in rotational and/or succeeding crops was not investigated as the crop rotation is not relevant for the import tolerance applications.Since rape seed and/or its by-products can be used as livestock feed, the potential livestock exposure to ethametsulfuron-methyl residues was assessed.The calculated dietary burden did not trigger ruminants and poultry metabolism and livestock feeding studies.Consequently there is no need to set the MRLs for ethametsulfuron-methyl in food commodities of animal origin.The consumer dietary risk assessment was performed with revision 2 of the EFSA PRIMo.For the calculation of the chronic exposure EFSA used the STMR value for rape seed as derived from the supervised field trials.For the remaining crops, the default MRL of 0.01 mg/kg applicable according to Article 18(1)(b) of Regulation No 396/2005 was used as the input value for the consumer risk assessment.The acute dietary risk assessment was performed only with regard to rape seed applying the STMR value measured in the supervised residue trials.No chronic intake concerns were identified for any of the European diets and the total intake values accounted for a maximum of 0.3% of the ADI.The contribution of rape seed to the total dietary intake was insignificant (<0.006% of the ADI).No acute intake concerns were identified in relation to the MRL proposal for oilseed rape seeds (0.009% of the ARfD) EFSA concludes that the data provided are sufficient to confirm the proposed MRL of 0.02 mg/kg.The consumer risk assessment demonstrated that this MRL proposal will not pose a public health concern.Thus, the following MRL proposal is derived: Code number Commodity Existing EC MRL (mg/kg) Proposed EC MRL (mg/kg) Justification for the proposal Enforcement residue definition: Ethametsulfuron-methyl (Data were provided only for pulses and oilseeds) 0401060 Rape seed (canola) 0.01* 0.02* The MRL proposal is sufficiently supported by data and no consumer chronic and acute intake concerns were identified.(*): Indicates that the MRL is set at the limit of analytical quantification.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.011 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.002 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.004 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".