Product File Note (PFN)

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Training Session Product File Note and Registration Reports, 23 October 2006

Product File Note (PFN)

Maarten Derudder - Olivier GueltonFederal Public Service of Public Health,

Food Chain Safety and EnvironmentService Pesticides and Fertilizers

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Federal Public Service ‘Public Health, Food Chain Safety and Environment’

Overview Product File Note

Introduction General administrative aspects Data protection Overview of the standard document

Physico-chemical properties and analysisToxicology Biology Residues EcotoxicologyFate and behaviourOther information / administrative aspects / confidential info

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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

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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

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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

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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

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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)

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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

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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)

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Request For Data Protection

The table has to be filled in by the applicant but only for the particular cases

Dossier Data Protection for

Expiry date of protecti

on

Holder of protection

Confirma-tion of the protection

Study reference (title, author, year, ref n° of applicant, ref n° of

lab) (Active substance active, ev. formulation type, N number if known)

Mesocosm study

Reduction of bufferzone

Applicant

Author, Year, Source (where different from company)Company, Report No.GLP or GEP status (where relevant)Published or Unpublished

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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 holderStart: date on the letter sent by the Service Pesticides and Fertilizers

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Data Protection: Validity Of The Protection

Annex II data Annex III data

Not included new a.s.

None None

Included new a.s. 10 years after inclusion

10 years after authorisation

Not included old a.s.

10 years after authorisation5 years after maintenance of authorisation

None

Included old a.s. 5 years after inclusion

10 years after re-registration

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Overview of the Standard Document

Physico-chemical properties and analysis1. Active Substance2. Physchem parameters

Toxicology Biology Residues EcotoxicologyFate and behaviourOther information / administrative aspects

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Overview of the Standard Document:Physico-chemical properties and analysisActive Substance1. Data Requirement2. Evaluation3. Technical Equivalence

Formulation1. Data Requirement2. Evaluation

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1. A.S.: Data Requirement

1.1. Specifications of the a.s.Minimum purity of a.s.Maximum concentration of impuritiesincl. 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

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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)

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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

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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

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1) Tier I required (Part I and Part II): analytical aspect2 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 includedStudies can be necessary to assess the equivalence (case by case)

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Conclusion of Tier II:Technical equivalence of the new source regarding to the reference?

Yes: evaluation goes onNo: no registration (application not acceptable)

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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)

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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 requiredAcceptable risk must be demonstrated before the granting of the registration

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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

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Physico-chemical properties and analysisToxicology Biology Residues EcotoxicologyFate and behaviourOther information / administrative aspects

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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)

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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

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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

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Biological dossier: partim efficacy

Required for new intended useHave to be demonstrated by means of GEP studies accordingly EPPO

Not required in case of copy productWith Letter of Access (LoA): no additional retributionWithout LoA: additional retribution (to be paid

before the granting of the authorisation)

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Biological dossier: partim selectivity

Required for new product, new intended use and composition change

Not required in case of copy product with LoA

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EVALUATION

Evaluation of the biological dossier by:

François Cors: fungicides, insecticides, acaricides and rodenticides

Bernard Weickmans: herbicides and growth regulators

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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

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Overview of the standard document: ECOTOXICOLOGYRequirements (1):

Ecotoxicological studies of the preparation on water organisms (algae, daphnia and fish)With another preparation: composition to be provided + argumentationWith a.i. : acceptable for preparation containing a.i. and inerts only

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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 appleEffect of the preparation on Anthocoris nemoralis if product registered (or application for a registration) in pear

For new application or renewal submitted before October 23rd 2006: condition for prolongationFor new application submitted after October 23rd 2006: condition for registration

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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

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Overview of the standard document: Fate and behaviourOnly 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

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Physico-chemical properties and analysisToxicology Biology Residues EcotoxicologyFate and behaviourOther information / administrative aspects / confidential info

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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

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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

Product File Note (PFN)

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