| Commodity | Region/a | Residue levels observed in the supervised residue trials (mg/kg) | Comments/Source | Calculated MRL (mg/kg) | HRb (mg/kg) | STMRc (mg/kg) | CFd |
|---|---|---|---|---|---|---|---|
| Residue definition for enforcement: Emamectin B1a and its salts, expressed as emamectin B1a (free base) Residue definition for risk assessment: Sum of emamectin B1a, emamectin B1b, 8,9‐Z‐MAB1a, plus 3 times AB1a, plus 3 times MFB1a and 3 times FAB1a, expressed as emamectin B1a | |||||||
| Pome fruits | NEU | Mo: 6 × < 0.001; 0.002; 2 × 0.003; 0.004 RA: 6 × < 0.012; 0.013; 2 × 0.014; 0.015 | Residue trials on apples (8) and pears (2) compliant with GAP (25% tolerance in application rate). Extrapolation to pome fruits possible. Emamectin B1b benzoate, AB1a, MFB1a, FAB1a (individually): 10 × < 0.001 mg/kg 8,9‐Z‐MAB1a: 9 × < 0.001; 0.001 mg/kg | 0.01 | 0.004 | 0.001 | 1.00 |
| SEU | Mo: 2 × < 0.001; 0.003; 2 × 0.004; 2 × 0.005; 2 × 0.007; 0.009; 2 × 0.010 RA: 2 × < 0.012; 0.014; 2 × 0.015; 2 × 0.016; 2 × 0.018; 0.020; 2 × 0.021 | Residue trials on apples (10) and pears (2) compliant with GAP (25% tolerance in application rate) Extrapolation to pome fruits possible. EMA B1b benzoate, AB1a, FAB1a, 8,9‐Z‐MAB1a (individually): 12 × < 0.001 mg/kg MFB1a: 11 × < 0.001; 0.001 mg/kg | 0.02 | 0.010 | 0.005 | 1.00 | |
| Apricots | SEU | Mo: 0.001; 0.005; 0.011; 0.014 0.018; 2 × 0.019; 0.021 RA: < 0.012; 0.016; 0.022; 0.025; 2 × 0.030; 0.032; 0.035 | Residue trials on peaches (4) and apricots (4) compliant (25% tolerance in application rate) with GAP and combined to derive the MRL proposal in apricots. EMA B1b benzoate, AB1a, FAB1a, 8,9‐Z‐MAB1a (individually): 8 × < 0.001 mg/kg MFB1a: 6 × < 0.001; 2 × 0.002 mg/kg Individual CFs: 1.00; 2 × 1.57; 1.66; 1.76; 1.78; 2.04; 3.08 | 0.05 | Mo: 0.021 RA: 0.035 | Mo: 0.017 RA: 0.028 | 1.71 |
| Cherries | NEU | Mo: < 0.001; 4 × < 0.001; 0.002; 0.009; 0.017 RA: 4 × < 0.012; < 0.012; 0.013; 0.020; 0.028 | Combined NEU (8) and SEU (4) residue trials on cherries compliant with GAP (25% tolerance) and slightly overdosed (underlined values, total of 5 NEU and 2 SEU trials, but only in 2 NEU trials the 3rd and last application still exceeded the 25% tolerance). Emamectin B1b benzoate, 8,9‐Z‐MAB1a, AB1a, MFB1a, FAB1a (individually): 16 × < 0.001 mg/kg MRLNEU: 0.03 mg/kg MRLSEU: 0.05 mg/kg | 0.04 | 0.022 | 0.002 | 1.00 |
| SEU | Mo: < 0.001; 0.009; 0.010; 0.022 RA: < 0.012; 0.020; 0.021; 0.033 | ||||||
| Spinaches and similar leaves | NEU | Mo: 0.004; 0.024; 2 × 0.032 RA: 0.015; 0.035; 0.043; 0.049 | Residue trials on open leaf lettuces compliant with GAP on spinaches and similar leaves. Extrapolation to the whole group of spinaches and similar leaves possible but number of trials not sufficient (minimum 6 trials per zone would be required) according to SANCO 7525/VI/95 (European Commission, 2017). Emamectin B1b benzoate, FAB1a (individually): 4 × < 0.001 mg/kg 8,9‐Z‐MAB1a: 2 × < 0.001; 2 × 0.001 mg/kg AB1a: < 0.001; 2 × 0.001; 0.002 mg/kg MFB1a: 3 × < 0.001; 0.002 mg/kg Individual CFs: 1.35; 1.46; 1.54; 4.13 | – | Mo: 0.032 RA: 0.049 | Mo: 0.028 RA: 0.039 | 1.50 |
| SEU | Mo: 0.006; 0.025; 0.026; 0.029; 0.037; 0.051; 0.092; 0.096 RA: 0.017; 0.035; 0.040; 0.044; 0.050; 0.069; 0.115; 0.119 | Residue trials on open leaf lettuces compliant with GAP on spinaches and similar leaves. Extrapolation to spinaches and similar leaves possible. FAB1a. 8 × < 0.001 mg/kg EMA B1b benzoate: 3 × < 0.001; 0.001; 0.002; 0.003; 2 × 0.004 mg/kg 8,9‐Z‐MAB1a: 5 × < 0.001; 2 × 0.001; 0.002 mg/kg AB1a: < 0.001; 6 × 0.001; 0.002 mg/kg MFB1a; 3 × < 0.001; 3 × 0.002; 2 × 0.004 mg/kg Individual CFs: 1.23; 1.25; 1.27; 1.34; 1.37; 1.51; 1.52; 2.79 | 0.2 | Mo: 0.096 RA: 0.119 | Mo: 0.033 RA: 0.047 | 1.41 | |
| NEU/SEU | Mo: 0.004; 0.006; 2 × 0.024; 0.026; 0.029; 2 × 0.032; 0.037; 0.051; 0.092; 0.096 RA: 0.015; 0.017; 2 × 0.035; 0.040; 0.043; 0.044; 0.049; 0.050; 0.069; 0.115; 0.119 | Combined data set of NEU and SEU residue trials on open leaf lettuces compliant with GAP on spinaches and similar leaves. According to SANTE/2019/12752, extrapolation to the whole group of spinaches and similar leaves possible based on a minimum of 6 residue trials equally distributed across both zones for applications under Regulation (EU) No 283/2013. Since this proposal deviates from the data requirements applicable for the assessment of this MRL application, EFSA proposes a risk management decision for this MRL proposal. | 0.15 | Mo: 0.096 RA: 0.119 | Mo: 0.030 RA: 0.044 | 1.46 | |
| Herbal infusions from leaves and herbs | NEU | Mo: see individual levels for spinaches and similar leaves RA: see individual levels for spinaches and similar leaves | Residue trials on open leaf lettuces compliant with GAP on leaves and herbs used for herbal infusions. Extrapolation possible but number of trials may not be sufficient depending on the legislative framework (see individual comments for spinaches and similar leaves). A dehydration factor of 10 is applied as MRL refers to dried products. | – | Mo: 0.32 RA: 0.49 | Mo: 0.28 RA: 0.39 | 1.50 |
| SEU | 2 | Mo: 0.96 RA: 1.19 | Mo: 0.33 RA: 0.47 | 1.41 | |||
| NEU/SEU | 1.5 | Mo: 0.96 RA: 1.19 | Mo: 0.30 RA: 0.44 | 1.46 | |||
MRL: maximum residue level; GAP: Good Agricultural Practice; Mo: monitoring; RA: risk assessment; EMA: emamectin.
NEU: Outdoor trials conducted in northern Europe, SEU: Outdoor trials conducted in southern Europe, EU: indoor EU trials or Country code: if non‐EU trials.
Highest residue. The highest residue for risk assessment refers to the whole commodity and not to the edible portion. Each individual value is paired to the value for enforcement which is reported in ascendent order.
Supervised trials median residue. The median residue for risk assessment refers to the whole commodity and not to the edible portion. Each individual value is paired to the value for enforcement which is reported in ascendent order.
Conversion factor (CF) to recalculate residues according to the residue definition for monitoring to the residue definition for risk assessment. The individual CFs were calculated applying the criteria adopted in the MRL review (EFSA, 2019c): when residues of the compounds included in the residue definition for risk assessment (emamectin B1b, 8,9‐Z‐MAB1a, FAB1a, MFB1a, AB1a) were all ≤ LOQ the CF was indicated as 1, whereas when residues were above the LOQ in at least one component, the experimental value was calculated from the results of the residue trial submitted. The mean CF is reported.
Note:Mo: individual residue values above the LOQ determined as emamectin (EMA) B1a benzoate in the residue trials (France, 2020) and calculated as EMA B1a free base by applying a molecular weight (MW) conversion factor of 0.88.
RA: Individual residues of EMA B1a benzoate and EMA B1b benzoate above the LOQ were calculated as free base using a MW CF of 0.88 and 1.12, respectively; Since the individual values of the photodegradation products were below the LOQ (FAB1a) and only occasionally above the LOQ (8,9‐ZB1a AB1a and MFB1a) in the samples from the residue trials submitted and considering that for the latter three compounds the MW CFs are close to 1, the individual levels above the LOQ were not calculated as emamectin B1a equivalents prior to be summed up. Ultimately, the risk assessment (RA) individual residue level took not account the individual Relative Potency Factor (RPF) of 3.