Modification of the existing maximum residue levels and setting of import tolerances for fluopyram in various crops

EFSA (European Food Safety Authority); Giulia Bellisai; Giovanni Bernasconi; Alba Brancato; Luis Carrasco Cabrera; Irene Castellan; Monica Del Aguila; Lucien Ferreira; German Giner Santonja; Luna Greco; Samira Jarrah; Renata Leuschner; Ileana Miron; Stefanie Nave; Ragnor Pedersen; Hermine Reich; Silvia Ruocco; Miguel Santos; Alessia Pia Scarlato; Anne Theobald; Manuela Tiramani; Alessia Verani

doi:10.2903/j.efsa.2023.8036

Commodity	Region^(a)	Residue levels observed in the supervised residue trials (mg/kg)	Comments/Source	Calculated MRL (mg/kg)	HR^(b) (mg/kg)	STMR^(c) (mg/kg)	CF^(d)
Apples	NEU	Mo: 0.07; 0.07; 0.01; 0.10; 0.11; 0.12; 0.14; 0.24; 0.40 RA: 0.08; 0.08; 0.11; 0.11; 0.12; 0.13; 0.15; 0.25; 0.41	Residue trials on apples and pears compliant with GAP were merged (Germany, 2023). Residues of benzamide‐fluopyram (M25) were below the LOQ in all the residue trials. Residue results of trials on pears are underlined.	0.6	Mo: 0.40 RA: 0.41	Mo: 0.11 RA: 0.12	1
Apples	SEU	Mo: 0.06; 0.07; 0.07; 0.08; 0.09; 0.11; 0.13; 2 × 0.16; 0.17 RA: 0.07; 0.08; 0.08; 0.09; 0.10; 0.12; 0.14; 2 × 0.17; 0.18	Residue trials on apples and pears compliant with GAP were merged (Germany, 2023). Residues of benzamide‐fluopyram (M25) were below the LOQ in all the residue trials. Residue results of trials on pears are underlined.	0.4	Mo: 0.17 RA: 0.18	Mo: 0.10 RA: 0.11	1
Pome fruits	US	Mo: 0.06; 0.06; 4 × 0.07; 0.09; 0.11^(e); 0.12; 0.13; 0.13; 0.14; 0.16; 2 × 0.17; 0.19; 0.20; 0.20; 0.21; 0.23; 0.25; 0.50 RA: –	Residue trials on apples and pears compliant with the authorised GAP were merged (Germany, 2023). Only residues of parent fluopyram were determined. To express residues in for risk assessment, a CF of 1 was used. Residue results of trials on pears are underlined. Extrapolation of residue data on apples and pears to the whole group of pome fruit is acceptable (European Commission, 2020).	0.6	Mo: 0.50 RA: 0.50	Mo: 0.14 RA: 0.14	1
Kiwi	SEU	Mo: 0.19; 0.23; 0.29; 2 × 0.33; 0.4; 0.43^(e); 0.46; 0.49; 0.52 RA: 0.20; 0.24; 0.30; 2 × 0.34; 0.41; 0.44^(e); 0.47; 0.50; 0.53	Residue trials on kiwi compliant with intended GAP (Italy, 2022). Residues of benzamide‐fluopyram (M25) were below the LOQ in all the residue trials.	1.5	Mo: 0.52 RA: 0.53	Mo: 0.33 RA: 0.34	1
Cardoon, Florence fennel, rhubarb, palm hearts, bamboo shoots	NEU	Mo: 0.047; 0.12; 0.28 RA: 0.057; 0.13; 0.29	Residue trials on celery compliant with the intended GAPs (Germany, 2022). Residues of benzamide‐fluopyram (M25) were below the LOQ in all the residue trials. The extrapolation of residue data on celery is acceptable to cardoon, Florence fennel and rhubarb. Extrapolation to palm hearts and bamboo shoots is not acceptable (European Commission, 2020).	0.7^(f)	Mo: 0.28^(f) RA: 0.29^(f)	Mo: 0.12^(f) RA: 0.13^(f)	1
	SEU	Mo: 0.046; 0.094; 0.52 RA: 0.056; 0.10; 0.53		1.5^(f)	Mo: 0.52^(f) RA: 0.53^(f)	Mo: 0.094^(f) RA: 0.10^(f)	1
Cardoon, Florence fennel, rhubarb	EU	Mo: 0.036; 0.14; 0.55; 5.6 RA: 0.046; 0.15; 0.56; 5.6	Residue trials on celery compliant with the intended GAPs (Germany, 2022). Residues of benzamide‐fluopyram (M25) were below the LOQ in all the residue trials. The extrapolation of residue data on celery is acceptable to cardoon, Florence fennel and rhubarb.	15	Mo: 5.6 RA: 5.6	Mo: 0.35 RA: 0.36	1
Peanuts/groundnuts	US	Mo: 0.012; 0.015^(e); 2 × 0.032; 0.033; 0.042; 0.043; 0.047; 0.052; 0.13 RA: 0.022; 0.025^(e); 2 × 0.042; 0.043; 0.044; 0.052; 0.053; 0.059; 0.17	Residue trials on peanuts compliant with the authorised GAP (Germany, 2023). Residues of the metabolite benzamide‐fluopyram (M25) were in a range between < 0.01 and 0.036 mg/kg.	0.2	Mo: 0.13 RA: 0.17	Mo: 0.033 RA: 0.043	1.3
Soyabean	NEU	Mo: < 0.01; 0.012; 0.015; 0.026; 0.035; 0.042; 0.054; 0.057; 0.062; 0.064; 0.091; 0.18 RA: < 0.02; 0.022; 0.025; 0.036; 0.045; 0.052; 0.064; 0.067; 0.072; 0.074; 0.1; 0.19	Residue trials on soyabean compliant with the intended GAP (Germany, 2023). Residues of benzamide‐fluopyram (M25) were below the LOQ in all the residue trials.	0.3	Mo: 0.18 RA: 0.19	Mo: 0.048 RA: 0.058	1
Seed spices (except dill)	NEU	No data	Residue trials on fennel compliant with intended GAP (Germany, 2022). Residues of benzamide‐fluopyram (M25) were below the LOQ in all the residue trials except for one trial at 0.016 mg/kg. The extrapolation of residue data in fennel seed to the whole group of seed spices is acceptable. The intended uses in France are on minor crops not clearly reattached to one zone and therefore a complete data set for either NEU or SEU are enough to set an MRL (European Commission, 2020).	40	Mo: 13.2 RA: 13.2	Mo: 6.8 RA: 6.8	1
Seed spices (except dill)	SEU	Mo: 1.8; 1.9; 11.7; 13.2 RA: 1.8; 1.9; 11.7; 13.2
Honey	EU	Mo: 4 × < 0.01 RA: 4 × < 0.02	Northern and southern Europe semi‐field trials on Phacelia tanacetifolia treated with 2 × 250 g a.s./ha with a 7‐day interval during the flowering phase via foliar application. The number of trials is sufficient to derive an MRL in honey	0.01^*	Mo: 0.01 RA: 0.02	Mo: 0.01 RA: 0.02	1

MRL: maximum residue level; GAP: Good Agricultural Practice; LOQ: limit of quantification; Mo: monitoring; RA: risk assessment.

^*Indicates that the value is proposed at the limit of quantification.

^(a)NEU: Outdoor trials conducted in northern Europe, SEU: Outdoor trials conducted in southern Europe, EU: indoor EU trials, Country code: if non‐EU trials.

^(b)Highest residue. The highest residue for risk assessment refers to the whole commodity and not to the edible portion.

^(c)Supervised trials median residue. The median residue for risk assessment refers to the whole commodity and not to the edible portion.

^(d)Conversion factor to recalculate residues according to the residue definition for monitoring to the residue definition for risk assessment.

^(e)Maximum residue value taken from two non‐independent trials.

^(f)The number of trials is below the required minimum of four independent trials for minor crop set under regulation 544/2011. MRL, HR and STMR values are only indicative.