training session product file notes and registration reports, 23 october 2006 1 product file note...
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Training Session Product File Notes and Registration Reports, 23 October 2006
Product File NotePart Ecotoxicology
Ilse PittomvilsFederal Public Service of Public Health,
Food Chain Safety and EnvironmentBelgium
23 October 2006
2
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Overview
Submitted studies LabellingExposureRisk assessmentExample
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Submitted studies
see presentation of M. Guelton two remarks:
Clearly indicate the units (e.g. 10 mg formulation/l or 10 mg active substance/l) because sometimes studies are carried out with the product but the endpoint is expressed in active substanceAlways mention the most critical endpoint, for algae this is most often the EbC50 and not the ErC50 value
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Labelling
Only labelling concerning ecotoxicology must be mentionned hereUse the most critical acute endpoints for labelling (e.g.algae: EbC50)Most critical acute endpoint < 1 mg product/ l R501 mg productl < Most critical acute endpoint < 10 mg/l R5110 mg productl < Most critical acute endpoint < 100 mg/l R52Most critical acute endpoint > 100 mg product/l no ecotox classification
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Labelling (2)
R53 is assigned by default for a product with R50, 51 or 52 unless a biodegradability study reveals that this phrase is not necessarySafety phrases
Professionals: S35-61 if R50 or 51S61 if R52
Non-professionals: S29-56 if R50, R51 or 52
If studies on non target arthropods: the product has no unacceptable effects on e.g. Typhlodromus pyri
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Exposure (of aquatic organisms) Excell sheet for cereals, maize = leafy crops, vegetables
= grassland, herbicide in orchards in case of aquatic risk evaluation
to be used for all ‘horizontal’ cultivated plants i.e. vegetables, grains, grasslandTo be used for herbicides
Excell sheet for grapevineTo be used for all ‘vertical’ cultivated crops i.e. grapes, small fruits, ornamentals, tomatoes, …
Excell sheet for orchardsTo be used for apple, pear, …
Excell sheets for hopsTo be used for hops
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Exposure (2)
PEC-calculations: By formula in the excell-sheet Input data: concentration of a.s. in the product, application rate, number of applications, interval, DT50 DT50 = 1000 unless data from water/sediment study are available known DT50 for products with more than one a.s. :
if one a.s. is clearly more toxic than the other one: take the DT50 of the most toxic a.s. if toxicity is related to both a.s., than take the worst case DT50
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Risk assessment
TER-calculationTER = EC50 / PECFish, daphnia: if TER > 100, then risk is acceptableAlgue: if TER > 10, then risk is acceptable
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Example: Risk evaluation by means of the excell sheets
Test Carried out with endpoint
results
a.s. formulation
Compar. Formul.
Acute algae
x EbC50 0,05 mg product/l
Acute daphnia
x EC50 2,5 mg product/l
Acute fish
x LC50 0,15 mg product/l
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Example (2)
Information about the exposure:Product X, 200 g/L a.s.Intended use: Apple: 2 x 1 L / ha leaf wall area 2 x 1,8 L / ha soil
applications before and after flowering Grapevine: 2 x 1 L / ha Potatoes: 2 x 1 L / ha
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
23 October 2006
12
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Orchards (application by orchard airblast sprayer)
Formulation
Input data
Information on application
Active substance name a.s.
Formulation product X
Formulation conc (g/l) 200
Appl. rate (l/ha, kg/ha) 1,8
Nb of applications 2
Interval (days) 14
Drift reduction factor 1
Crop apple
Environmental data
DT50 soil DT50 water DT50 sediment Single appl. rate (g a.s./ha)
1000,0 1000,0 1000,0 360
Ecotoxicological data (expressed as formulation)
LD50 bird LC50 bird NOEL repro. bird
LD50 mammal NOEL repr mammal
LC50 fish EC50 daphnia EC50 algae Mesocosm assessment
0,15 2,5 0,05 -
NOEC chronic fish NOEC chronic daphniaNOEC chironomus EC50 lemna
- - - -
LD50 bee oral LD50 bee contact
- -
LC50 earthworm NOEC earthworm
- -
Predicted Environmental Concentrations (mg form./kg or mg form./l - just after last application)
soil (no intercept) mg/kg water (overspray) mg/lsed (overspray) mg/kg
4,777 1,194 13,779
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Toxicity exposure ratios for aquatic organisms drift reduction factor 1
Appl. rate (kg/ha, l/ha) Organism Distance TER (early) TER (late) Annex VI trigger
1,8 LC50 fish 0 0,1 0,1 100 R R
3 0,4 0,8 100 R R
5 0,6 1,5 100 R R
10 1,1 3,5 100 R R
15 2,3 6,9 100 R R
20 4,5 11,5 100 R R
30 12,1 23,3 100 R R
40 24,2 39,3 100 R R
50 41,9 57,1 100 R R
1,8 EC50 daphnia 0 2,1 2,1 100 R R
3 7,2 13,3 100 R R
5 10,5 24,9 100 R R
10 17,7 58,2 100 R R
15 37,7 115,7 100 R
20 75,6 192,1 100 R
30 201,3 387,7 100
40 402,6 654,2 100
50 697,8 951,6 100
1,8 EC50 algae 0 0,0 0,0 10 R R
3 0,1 0,3 10 R R
5 0,2 0,5 10 R R
10 0,4 1,2 10 R R
15 0,8 2,3 10 R R
20 1,5 3,8 10 R R
30 4,0 7,8 10 R R
40 8,1 13,1 10 R
50 14,0 19,0 10
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Orchards (application by orchard airblast sprayer)
Formulation
Input data
Information on application
Active substance name a.s.
Formulation product X
Formulation conc (g/l) 200
Appl. rate (l/ha, kg/ha) 1,8
Nb of applications 2
Interval (days) 14
Drift reduction factor 0,1
Crop apple
Environmental data
DT50 soil DT50 water DT50 sediment Single appl. rate (g a.s./ha)
1000,0 1000,0 1000,0 360
Ecotoxicological data (expressed as formulation)
LD50 bird LC50 bird NOEL repro. bird
LD50 mammal NOEL repr mammal
LC50 fish EC50 daphnia EC50 algae Mesocosm assessment
0,15 2,5 0,05 -
NOEC chronic fish NOEC chronic daphniaNOEC chironomus EC50 lemna
- - - -
LD50 bee oral LD50 bee contact
- -
LC50 earthworm NOEC earthworm
- -
Predicted Environmental Concentrations (mg form./kg or mg form./l - just after last application)
soil (no intercept) mg/kg water (overspray) mg/lsed (overspray) mg/kg
4,777 1,194 13,779
23 October 2006
16
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Toxicity exposure ratios for aquatic organisms drift reduction factor 0,1
Appl. rate (kg/ha, l/ha) Organism Distance TER (early) TER (late) Annex VI trigger
1,8 LC50 fish 0 0,1 0,1 100 R R
3 4,3 8,0 100 R R
5 6,3 14,9 100 R R
10 10,6 34,9 100 R R
15 22,6 69,4 100 R R
20 45,3 115,2 100 R
30 120,8 232,6 100
40 241,6 392,5 100
50 418,7 570,9 100
1,8 EC50 daphnia 0 2,1 2,1 100 R R
3 71,7 133,1 100 R
5 105,3 248,9 100
10 177,3 581,5 100
15 377,2 1156,6 100
20 755,8 1920,6 100
30 2012,9 3876,7 100
40 4025,8 6542,0 100
50 6978,1 9515,6 100
1,8 EC50 algae 0 0,0 0,0 10 R R
3 1,4 2,7 10 R R
5 2,1 5,0 10 R R
10 3,5 11,6 10 R
15 7,5 23,1 10 R
20 15,1 38,4 10
30 40,3 77,5 10
40 80,5 130,8 10
50 139,6 190,3 10
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Grapevine, small fruit (currant,…)
Formulation
Input data
Information on application
Active substance name a.s.
Formulation Product X
Formulation conc (g/l) 200
Appl. rate (l/ha, kg/ha) 1
Nb of applications 2
Interval (days) 14
Drift reduction factor 0,5
Crop grapevine
Environmental data
DT50 soil DT50 water DT50 sediment Single appl. rate (g a.s./ha)
1000,0 1000,0 1000,0 200
Ecotoxicological data (expressed as formulation)
LD50 bird LC50 bird NOEL repro. bird
LD50 mammal NOEL repr mammal
LC50 fish EC50 daphnia EC50 algae Mesocosm assessment
0,15 2,5 0,05 10
NOEC chronic fish NOEC chronic daphniaNOEC chironomus EC50 lemna
LD50 bee oral LD50 bee contact
LC50 earthworm NOEC earthworm
Predicted Environmental Concentrations (mg form./kg or mg form./l - just after last application)
soil (no intercept) mg/kg water (overspray) mg/lsed (overspray) mg/kg
2,654 0,663 7,655
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Toxicity exposure ratios for aquatic organisms drift reduction factor 0,5
Appl. rate (kg/ha, l/ha) Organism Distance TER (early) TER (late) Annex VI trigger
1 LC50 fish 0 0,2 0,2 100 R R
3 16,7 5,6 100 R R
5 38,3 12,5 100 R R
10 115,9 36,8 100 R
15 226,1 69,6 100 R
20 347,8 107,7 100
30 646,0 205,5 100
40 1130,5 323,0 100
50 1507,3 452,2 100
1 EC50 daphnia 0 3,8 3,8 100 R R
3 279,1 94,0 100 R
5 638,7 208,2 100
10 1932,4 612,7 100
15 3768,2 1159,4 100
20 5797,2 1794,4 100
30 10766,3 3425,6 100
40 18841,0 5383,1 100
50 25121,3 7536,4 100
1 EC50 algae 0 0,1 0,1 10 R R
3 5,6 1,9 10 R R
5 12,8 4,2 10 R
10 38,6 12,3 10
15 75,4 23,2 10
20 115,9 35,9 10
30 215,3 68,5 10
40 376,8 107,7 10
50 502,4 150,7 10
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Leafy crops (sugar beets, oilseed rape,…), vegetables
Formulation
Input data
Information on application
Active substance name a.s.
Formulation product X
Formulation conc (g/l) 200
Appl. rate (l/ha, kg/ha) 1
Nb of applications 2
Interval (days) 14
Drift reduction factor 1
Crop potato
Environmental data
DT50 soil DT50 water DT50 sediment Single appl. rate (g a.s./ha)
1000,0 1000,0 1000,0 200
Ecotoxicological data (expressed as formulation)
LD50 bird LC50 bird NOEL repro. bird
LD50 mammal NOEL repr mammal
LC50 fish EC50 daphnia EC50 algae Mesocosm assessment
0,15 2,5 0,05
NOEC chronic fish NOEC chronic daphnia NOEC chironomus EC50 lemna
LD50 bee oral LD50 bee contact
LC50 earthworm NOEC earthworm
Predicted Environmental Concentrations (mg form./kg or mg form./l - just after last application)
soil (no intercept) mg/kg water (overspray) mg/l sed (overspray) mg/kg
2,654 0,663 7,655
23 October 2006
20
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Toxicity exposure ratios for aquatic organisms drift reduction factor: 1
Appl. rate (kg/ha, l/ha) Organism Distance TER Annex VI trigger
1 LC50 fish 0 0,2 100 R
1 8,4 100 R
2 14,1 100 R
3 22,6 100 R
4 25,1 100 R
5 39,7 100 R
10 78,0 100 R
20 150,7 100
30 226,1 100
1 EC50 daphnia 0 3,8 100 R
1 139,6 100
2 235,5 100
3 376,8 100
4 418,7 100
5 661,1 100
10 1299,4 100
20 2512,1 100
30 3768,2 100
1 EC50 algae 0 0,1 10 R
1 2,8 10 R
2 4,7 10 R
3 7,5 10 R
4 8,4 10 R
5 13,2 10
10 26,0 10
20 50,2 10
30 75,4 10
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Example: Results of risk evaluation Crop category
Crops applied for
Dose (L product/ha)
Nr of applications
Drift mitigation measures
Horizontal crops
potato 1 2 20 meter with classic technique
Vertical crops
grapevine
1 2 20 meter with 50% drift reduction
Orchards apple 1.8 2 30 meter with 90% drift reduction
23 October 2006
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Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Thank you for listening!
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