Product File Note Part Ecotoxicology

1. Product File NotePart Ecotoxicology Ilse Pittomvils Federal Public Service of Public Health, Food Chain Safety and Environment Belgium

2. Overview • Submitted studies • Labelling • Exposure • Risk assessment • Example Training Session Product File Notes and Registration Reports

3. 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 Training Session Product File Notes and Registration Reports

4. 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 < 1 mg product/ l  R50 • 1 mg productl < Most critical acute endpoint < 10 mg/l  R51 • 10 mg productl < Most critical acute endpoint < 100 mg/l  R52 • Most critical acute endpoint > 100 mg product/l  no ecotox classification Training Session Product File Notes and Registration Reports

5. 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 Training Session Product File Notes and Registration Reports

6. 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 Training Session Product File Notes and Registration Reports

7. 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 Training Session Product File Notes and Registration Reports

8. Risk assessment • TER-calculation • TER = EC50 / PEC • Fish, daphnia: if TER > 100, then risk is acceptable • Algue: if TER > 10, then risk is acceptable Training Session Product File Notes and Registration Reports

9. Example: Risk evaluation by means of the excell sheets Training Session Product File Notes and Registration Reports

10. 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 Training Session Product File Notes and Registration Reports

11. Training Session Product File Notes and Registration Reports

12. Training Session Product File Notes and Registration Reports

13. Training Session Product File Notes and Registration Reports

14. Training Session Product File Notes and Registration Reports

15. Training Session Product File Notes and Registration Reports

16. Training Session Product File Notes and Registration Reports

17. Training Session Product File Notes and Registration Reports

18. Training Session Product File Notes and Registration Reports

19. Training Session Product File Notes and Registration Reports

20. Training Session Product File Notes and Registration Reports

21. Example: Results of risk evaluation Training Session Product File Notes and Registration Reports

22. Thank you for listening! Training Session Product File Notes and Registration Reports