Product File Note Part Ecotoxicology

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Product File NotePart Ecotoxicology

• Ilse Pittomvils
• Federal Public Service of Public Health,
• Food Chain Safety and Environment
• Belgium

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Overview

• Submitted studies
• Labelling
• Exposure
• Risk assessment
• Example

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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 substance
• Always mention the most critical endpoint, for
  algae this is most often the EbC50 and not the
  ErC50 value

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Labelling

• Only labelling concerning ecotoxicology must be
  mentionned here
• Use the most critical acute endpoints for
  labelling (e.g.algae EbC50)
• Most critical acute endpoint lt 1 mg product/ l ?
  R50
• 1 mg productl lt Most critical acute endpoint lt 10
  mg/l ? R51
• 10 mg productl lt Most critical acute endpoint lt
  100 mg/l ? R52
• Most critical acute endpoint gt 100 mg product/l ?
  no ecotox classification

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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 necessary
• Safety phrases
• Professionals S35-61 if R50 or 51
• S61 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

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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, grassland
• To be used for herbicides
• Excell sheet for grapevine
• To be used for all vertical cultivated crops
  i.e. grapes, small fruits, ornamentals, tomatoes,
  
• Excell sheet for orchards
• To be used for apple, pear,
• Excell sheets for hops
• To be used for hops

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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

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Risk assessment

• TER-calculation
• TER EC50 / PEC
• Fish, daphnia if TER gt 100, then risk is
  acceptable
• Algue if TER gt 10, then risk is acceptable

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Example Risk evaluation by means of the excell
sheets
Test Carried out with Carried out with Carried out with endpoint results
Test a.s. formulation Compar. Formul. endpoint results
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
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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

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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
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• Thank you for listening!