Registration Report: General aspects

1. Registration Report:General aspects M. Trybou Federal Public Service of Public Health, Food Chain Safety and Environment Belgium

2. Overview • Drafting principles • Working principle • Part A • Part B • Part C • Extra : Uses applied for Training Session Product File Notes and Registration Reports

3. 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) Training Session Product File Notes and Registration Reports

4. 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 ! Training Session Product File Notes and Registration Reports

5. 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 Training Session Product File Notes and Registration Reports

6. Part A Details of the application Details of the authorisation 2.1. Product identity 2.2. Classification and labelling 2.2.1. R-S sentences

7. 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.be • e.g.: • SPe3 : buffer zones for surface water • SPo2 (triggered by S36) • SPo(2) : personal protective equipment, … Training Session Product File Notes and Registration Reports

8. 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 Training Session Product File Notes and Registration Reports

9. 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 Training Session Product File Notes and Registration Reports

10. PART B Detailed summary of the risk assessment • 1. Identity of the plant protection product • 1.1 Applicant • 1.2 Identity of the active substance • 1.3 Identity of the plant protection product • 1.4 Function • 1.5 Uses applied for(see further) • 1.6 Background to the application • 1.7 Packaging details Training Session Product File Notes and Registration Reports

11. 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 Training Session Product File Notes and Registration Reports

12. 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 Training Session Product File Notes and Registration Reports

13. 1.5 Uses 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 ! Training Session Product File Notes and Registration Reports

14. 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 Training Session Product File Notes and Registration Reports

15. 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) Training Session Product File Notes and Registration Reports

16. Thank you for your attention ! Training Session Product File Notes and Registration Reports