1. Training Session Product File Notes and Registration Reports, 23 October 2006 1 Registration Report: General aspects M. Trybou 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 Drafting principles Working principle Part A Part B Part C Extra : Uses applied for

3. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 3 Training Session Product File Notes and Registration Reports Introduction - The Guidance doc Sanco/10798/2003 followed a “skeleton approach” (only titles) - The Belgian model was created by pasting examples of evaluations into the skeleton model - The Guidance doc is under revision (so suggestions are welcome)

4. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 4 Training Session Product File Notes and Registration Reports Drafting principles Drafting the RR is preparing the work as much as possible. So: - Add also conclusions, justifications,… (« acceptable ») - Avoid changes that will need to be unchanged (layout,...) After revision and evaluation, the RR is considered to be property of the Belgian Authorities. So : - No terms as « our product », « our dossier is complete… » - No company names in headings… - Preferably no company names at all (‘the applicant’) Drafting = Thinking as the (Belgian) Authorities !

5. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 5 Training Session Product File Notes and Registration Reports Working principle - First draft will be revised in ‘track changes’ and sent back to the applicant - Applicant can accept changes and make more tracked changes - Once draft is acceptable, changes are accepted and the document is sent to the experts together with the dossier - After approval RR is finalised and sent to applicant

6. Training Session Product File Notes and Registration Reports, 23 October 2006 6 Part A 1.Details of the application 2.Details of the authorisation 2.1. Product identity 2.2. Classification and labelling 2.2.1. R-S sentences

7. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 7 Training Session Product File Notes and Registration Reports Part A (2) 2.2.2. R and S phrases under Directive 2003/82/EC (Annex IV and V of Directive 91/414/EEC) See Standard phrases for special risks and safety precautions - Belgian implementation on www.phytoweb.fgov.beStandard phrases for special risks and safety precautions - Belgian implementation www.phytoweb.fgov.be e.g.: SPe3 : buffer zones for surface water SPo2 (triggered by S36) SPo(2) : personal protective equipment, …

8. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 8 Training Session Product File Notes and Registration Reports 2.2.3. Other phrases allowed according to Directive 91/414/EEC : Art 16 f : first aid Art 16 k : use conditions Art 16 l : use directions Art 16 m : safety periods Art 16 n : crop sensitivity Art 16.3 : users category Art 16.4 : non target species

9. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 9 Training Session Product File Notes and Registration Reports 3. Risk Management : also to be filled out by the applicant 3.1. Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 3.1.1 Physical and chemical properties 3.1.2 Etc… 3.2 Conclusions 3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation

10. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 10 Training Session Product File Notes and Registration Reports PART B Detailed summary of the risk assessment 1.Identity of the plant protection product 1.1Applicant 1.2Identity of the active substance 1.3Identity of the plant protection product 1.4Function 1.5Uses applied for (see further) 1.6Background to the application 1.7Packaging details

11. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 11 Training Session Product File Notes and Registration Reports Comments - Please make sure that the conclusions of part A (risk management, proposed uses, proposed labelling,…) are in line with the evaluations in part B - Please refer as much as possible to the DAR or Review Report, and indicate which data is already evaluated (in order to avoid duplicate work) - Please clearly mention the used endpoints

12. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 12 Training Session Product File Notes and Registration Reports Part C Please mention here the complete composition, and other confidential data If other formulations were tested, comparison can be made here, together with argumentations

13. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 13 Training Session Product File Notes and Registration Reports 1.5Uses applied for (2 tables) International presentation of uses : for use by other Member States National presentation of uses : for national use Information to be copied into authorization certificate Basis for evaluation Both tables should reflect the same uses !

14. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 14 Training Session Product File Notes and Registration Reports National Presentation of Uses A national guidance document will soon be available. Same principles as for Product File Note. Crops : several crops in same table cell if all use conditions are identical (otherwise : new table) Crop stage : full description + BBCH codes Crop remark : remarks valid for all uses in this crop : - secondary effects against certain pests (pest not authorised as such) - limitation of total number of applications or total amount of a.s./ha

15. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 15 Training Session Product File Notes and Registration Reports Limitation of total application number For each ennemy : dose + number of applications: Rust : 1 L/ha, 1-2 applications Alternaria : 1 L/ha, 1-2 applications If more ennemies : total number of applications has to be limited (idem for total amount of a.s./ha)

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