1. Training Session Product File Notes and Registration Reports, 23 October 2006 1 Product File Note Part Ecotoxicology Ilse Pittomvils Federal Public Service of Public Health, Food Chain Safety and Environment Belgium

2. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 2 Training Session Product File Notes and Registration Reports Overview Submitted studies Labelling Exposure Risk assessment Example

3. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 3 Training Session Product File Notes and Registration Reports 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

4. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 4 Training Session Product File Notes and Registration Reports 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

5. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 5 Training Session Product File Notes and Registration Reports 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

6. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 6 Training Session Product File Notes and Registration Reports 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

7. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 7 Training Session Product File Notes and Registration Reports 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

8. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 8 Training Session Product File Notes and Registration Reports Risk assessment TER-calculation TER = EC50 / PEC Fish, daphnia: if TER > 100, then risk is acceptable Algue: if TER > 10, then risk is acceptable

9. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 9 Training Session Product File Notes and Registration Reports Example: Risk evaluation by means of the excell sheets TestCarried out withendpointresults a.s.formu lation Compar. Formul. Acute algae xEbC500,05 mg product/l Acute daphnia xEC502,5 mg product/l Acute fish xLC500,15 mg product/l

10. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 10 Training Session Product File Notes and Registration Reports 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

11. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 11 Training Session Product File Notes and Registration Reports

12. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 12 Training Session Product File Notes and Registration Reports

13. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 13 Training Session Product File Notes and Registration Reports

14. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 14 Training Session Product File Notes and Registration Reports

15. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 15 Training Session Product File Notes and Registration Reports

16. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 16 Training Session Product File Notes and Registration Reports

17. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 17 Training Session Product File Notes and Registration Reports

18. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 18 Training Session Product File Notes and Registration Reports

19. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 19 Training Session Product File Notes and Registration Reports

20. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 20 Training Session Product File Notes and Registration Reports

21. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 21 Training Session Product File Notes and Registration Reports Example: Results of risk evaluation Crop category Crops applied for Dose (L product /ha) Nr of applicatio ns Drift mitigation measures Horizontal crops potato1220 meter with classic technique Vertical crops grapevine1220 meter with 50% drift reduction Orchardsapple1.8230 meter with 90% drift reduction

22. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 22 Training Session Product File Notes and Registration Reports Thank you for listening!