Product File Note (PFN)

1. Product File Note (PFN) Maarten Derudder - Olivier Guelton Federal Public Service of Public Health, Food Chain Safety and Environment Service Pesticides and Fertilizers

2. Overview Product File Note • Introduction • General administrative aspects • Data protection • Overview of the standard document • Physico-chemical properties and analysis • Toxicology • Biology • Residues • Ecotoxicology • Fate and behaviour • Other information / administrative aspects / confidential info

3. Introduction • Target of Product File Note (PFN) • Diminish work load Section Pesticides and Fertilizers (no new staff, existing delay) • Leave possibility of priorisation of dossiers to firms (no more changing dossiers in waiting line, call for an ‘urgent dossier’) • PFN is the only possibility for a quicker evaluation • Pro-active: applicants more aware of completeness of dossier + more complete proposal/evaluation • Type of dossiers concerned: ‘National Dossiers’ • Only for applications for products based on old active substances which are not (all) included in annex I of directive 91/414/EEC. • authorisation of formulation containing new active substance + one or more old active substances: possible with PFN IF engagement firm to furnish Registration Reports once all active substances included in annex I • See fast track procedures document

4. General Administrative Aspects (1)Working procedures • when treating a dossier with a PFN: completeness check by administration • if not complete: PFN sent back (e-mail) to applicant for modification/ completion • if complete: product on agenda Authorisation committee • once accepted by secretary of Authorisation Committee: PFN sent back to applicant, applicant sends by post a paper copy to officialize PFN • GOAL = gain time for Pesticide Service

5. General administrative aspects (2) • Cfr. circulaire! • classical application form: still required, reference can be made to PFN • PFN has to be furnished digitally (CDRom or e-mail (for old dossiers in queue – confidentiality? – composition details in annex to file note)) • model will be placed on Phytoweb (Eng, Fr, Dutch) • dossiers with PFN treated with priority, dossiers without PFN will also be treated! • In framework Aarhus convention: reports of Authorisation committee will be placed on Phytoweb – file note as well, minus the confidential parts

6. General Administrative Aspects (3) • PFN is only a model: non-relevant parts should be removed – with TRACK CHANGES • PFN for all types of applications, not only authorisation but also renewal, prolongation, change of composition, extension • treatment of PFN: OG & MD, following date of reception

7. Data Protection Scope: at Belgian level data protection can be granted by the Service Pesticides and Fertilizers at the request of the notifier (art. 13 of the Royal Decree of 28/02/1994)

8. Data Protection: General Requirement • The following studies are always necessary to obtain a registration: • GLP analysis of 5 samples of a.s. • Analysis of physical & chemical properties of the formulation • Toxicological studies (acute oral & dermal (& inhalation), irritation skin & eyes, sensibilization potential) • Ecotoxicological studies on water organisms (algae, Daphnia & fish) • The notifier must not require the protection for these data

9. Data Protection: Particular Cases • Data protection can be granted in the case of : • 1. Additional data submitted by the authorisation holder in order to modify the current registration • For example: residue (& biological) studies for a label extension, study on the biodegradibility, … • 2. Additional data required by the Belgian Authorisation Committee and necessary to preserve the registration • For example:mesocosm study, … • The notifier must require the protection for these data (and has to fill in the table)

10. Request For Data Protection • The table has to be filled in by the applicant but only for the particular cases

11. Data Protection: Decision Making • Treatment of the request by the Service Pesticides and Fertilizers • Advice of the expert (quality of the study (GLP), …) • Proposal to the Authorisation Committee • Decision by the Authorisation Committee (Protection Yes/No) • Decision concerning data protection will be mentioned in the letter sent to the registration holder • Start: date on the letter sent by the Service Pesticides and Fertilizers

12. Data Protection: Validity Of The Protection

13. Overview of the Standard Document • Physico-chemical properties and analysis • 1. Active Substance • 2. Physchem parameters • Toxicology • Biology • Residues • Ecotoxicology • Fate and behaviour • Other information / administrative aspects

14. Overview of the Standard Document:Physico-chemical properties and analysis Active Substance 1. Data Requirement 2. Evaluation 3. Technical Equivalence Formulation Data Requirement Evaluation

15. 1. A.S.: Data Requirement • 1.1. Specifications of the a.s. • Minimum purity of a.s. • Maximum concentration of impurities • incl. CAS n°, formules, IUPAC denomination ! • 1.2. GLP analyse of 5 production batches of technical a.s. • 1.3. Manufacturing process of a.s. • Remark: Data required for a new origin (authorisation or alternative source) and renewal

16. 2. A.S.: Evaluation (1) • 2.1. Quality of the submitted documents: secretariat & expert • 2.2. Evaluation of the results: • Respect of FAO standard (if existing): • Yes: evaluation goes on • No: no authorisation (origin not acceptable)

17. 2. A.S.: Evaluation (2) • If a.s. already authorised in Belgium: • Min. purity  Min. purity reference and no new impurity: • Yes: evaluation goes on • No: demonstration of technical equivalence • New impurity or known impurity but at a concentration > concentration in the reference: • Yes: demonstration of technical equivalence • No: evaluation goes on

18. 3. A.S.: Technical Equivalence (1) • Technical equivalence according to: • Guidance document on the assessment of the equivalence of technical materials of substances regulated under council directive 91414EEC (Sanco10597/2003) • Document & instructions available on www.phytoweb.fgov.be • Technical equivalence must be demonstrated before the granting of the authorisation

19. 3. A.S.: Technical Equivalence (2) • Tier I required (Part I and Part II): analytical aspect 2 cases: • the new source is equivalent to the reference source: evaluation goes on • if the equivalence of the new source can not be established based on Tier I criteria alone: Tier II evaluation is required 2) Tier II required: tox. & ecotoxicity aspects included Studies can be necessary to assess the equivalence (case by case)

20. 3. A.S.: Technical Equivalence (3) • Conclusion of Tier II: • Technical equivalence of the new source regarding to the reference? • Yes: evaluation goes on • No: no registration (application not acceptable)

21. FORMULATION • Data requirement (1): • All parameters relevant for the formulation for which an authorisation is asked (see PFN) (and according to the right method !) • Well-argued justification in case of data gap • Data before storage and after storage 2 weeks at 54°C must be present in the application dossier (+ storage under cold conditions if required)

22. FORMULATION: Data requirement (2) • Explanation in case of unusual storage conditions (for example, 8 weeks at 40°C instead of 2 weeks at 54°C) • If new origin of calcium sulphate, clay, vermiculite, natrolite-phonolite, calcium aluminates and clinoptilotite of sedimentary origin: • - analysis of dioxin and furan content of this new origin by a GLP laboratory or a recognized laboratory • - if concentrations > norms MD June 7th 2006: risk assessment is required • Acceptable risk must be demonstrated before the granting of the registration

23. FORMULATION: Evaluation • Completeness check: Secretariat • Physico-chemical properties: Alain Dubois • Prolongation condition: analysis after storage 2 years at ambient temperature • Dioxin and furan aspect: Samira Jarrah (based on the norms published by the Ministerial Decree of June 7th 2006 concerning trade and use of products intended to be used for animal feeding) • If risk unacceptable: change of origin

24. Overview of the Standard Document • Physico-chemical properties and analysis • Toxicology • Biology • Residues • Ecotoxicology • Fate and behaviour • Other information / administrative aspects

25. Overview of the standard document: toxicology (1) • standard data package: acute oral, dermal and inhalation studies, irritation skin and eyes, sensibilisation with formulation • other studies (long term, …): also evaluated – fast evaluation, in depth will be done once annex III dossier • all furnished data must be mentioned on PFN (to be added in existing table (cfr. ecotoxicology)) • operator exposure (for new applications with new active substances)

26. Overview of the standard document: toxicology (2) • data protection: table to be filled out (see above) • MSDS: composition to be mentioned! • applicant must furnish labelling proposition • first aid dossier • Evaluation by Christiane Vleminckx

27. Overview of the Standard Document • Physico-chemical properties and analysis • Toxicology • Biology • Residues • Ecotoxicology • Fate and behaviour • Other information / administrative aspects

28. Overview of the standard document: BIOLOGY Table intended use (1) : has to be completely filled in application stage: according to BBCH code Pre-harvest interval not always required (depending on application stage) MRL: not to be filled in

29. Biological dossier: partim efficacy • Required for new intended use • Have to be demonstrated by means of GEP studies accordingly EPPO • Not required in case of copy product • With Letter of Access (LoA): no additional retribution • Without LoA: additional retribution (to be paid before the granting of the authorisation)

30. Biological dossier: partim selectivity • Required for new product, new intended use and composition change • Not required in case of copy product with LoA

31. EVALUATION • Evaluation of the biological dossier by: • François Cors: fungicides, insecticides, acaricides and rodenticides • Bernard Weickmans: herbicides and growth regulators

32. Overview of the Standard Document • Physico-chemical properties and analysis • Toxicology • Biology • Residues • Ecotoxicology • Fate and behaviour • Other information / administrative aspects

33. Overview of the standard document: Residues • only for new or changed applications (if relevant) – to be removed if not relevant • data protection • Evaluation by Frédéric Joris or Bruno Dujardin

34. Overview of the Standard Document • Physico-chemical properties and analysis • Toxicology • Biology • Residues • Ecotoxicology • Fate and behaviour • Other information / administrative aspects

35. Overview of the standard document: ECOTOXICOLOGY Requirements (1): Ecotoxicological studies of the preparation on water organisms (algae, daphnia and fish) With another preparation: composition to be provided + argumentation With a.i. : acceptable for preparation containing a.i. and inerts only

36. ECOTOXICOLOGY: Requirements (2) • Only for the products registered in orchards or intended to be used in orchards: • Effect of the preparation on Typhlodromus pyri if product registered (or application for a registration) in apple • Effect of the preparation on Anthocorisnemoralis if product registered (or application for a registration) in pear • For new application or renewal submitted before October 23rd 2006: condition for prolongation • For new application submitted after October 23rd 2006: condition for registration

37. Table - risk assessment - evaluation • If the dossier (for example Annex III dossier) contains other studies than the 3 «classic» studies on water organism: all the studies have to be mentioned (add rows to the table and fill them in like for the aquatox studies) • Proposal for labelling and risk assessment for aquatox have to be joined • Evaluation by Ilse Pittomvils

38. Overview of the Standard Document • Physico-chemical properties and analysis • Toxicology • Biology • Residues • Ecotoxicology • Fate and behaviour • Other information / administrative aspects

39. Overview of the standard document: Fate and behaviour • Only for active substances already on annex I or in case of specific problems (e.g. ground water contamination) • Of importance if an annex III dossier has been furnished while the old procedure is still possible (national dossier) • Data protection • Evaluation by Sébastien Vanhiesbecq

40. Overview of the Standard Document • Physico-chemical properties and analysis • Toxicology • Biology • Residues • Ecotoxicology • Fate and behaviour • Other information / administrative aspects / confidential info

41. Overview of the standard document: administrative aspects • retribution paid: only after reception of invoice! • instructions for first aid (see website phytoweb) • non-confidential dossier: still required (legislation) • additional retribution: cfr. part biology • label: to verify completeness of furnished label • Confidential part: separate file

42. Remarks – experience in practice?? • remove non relevant parts – track changes • mention all furnished data, e.g. toxicology: not only acute tox if also other studies have been furnished • composition of formulations used in studies!! • references to studies must be complete (title, author, year, reference number applicant, reference number lab) • On the whole: sent in PFNs fairly well done