Product File Note (PFN)

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Product File Note (PFN)

• Maarten Derudder - Olivier Guelton
• Federal Public Service of Public Health,
• Food Chain Safety and Environment
• Service Pesticides and Fertilizers

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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

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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 protection 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
  holder
• Start 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 authorisation 5 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 analysis
• 1. Active Substance
• 2. Physchem parameters
• Toxicology
• Biology
• Residues
• Ecotoxicology
• Fate and behaviour
• Other information / administrative aspects

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Overview of the Standard DocumentPhysico-chemic
al properties and analysis

• Active Substance
• 1. Data Requirement
• 2. Evaluation
• 3. Technical Equivalence
• Formulation
• Data Requirement
• 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 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

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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 gt 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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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)

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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)

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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
  54C 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 40C instead of 2 weeks
  at 54C)
• 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 gt norms MD June 7th 2006
  risk assessment is required
• Acceptable 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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Overview of the Standard Document

• Physico-chemical properties and analysis
• Toxicology
• Biology
• Residues
• Ecotoxicology
• Fate and behaviour
• Other 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

• Physico-chemical properties and analysis
• Toxicology
• Biology
• Residues
• Ecotoxicology
• Fate and behaviour
• Other information / administrative aspects

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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 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)

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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

• Physico-chemical properties and analysis
• Toxicology
• Biology
• Residues
• Ecotoxicology
• Fate and behaviour
• Other information / administrative aspects

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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

• Physico-chemical properties and analysis
• Toxicology
• Biology
• Residues
• Ecotoxicology
• Fate and behaviour
• Other information / administrative aspects

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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

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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 apple
• Effect 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 prolongation
• For 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

• Physico-chemical properties and analysis
• Toxicology
• Biology
• Residues
• Ecotoxicology
• Fate and behaviour
• Other information / administrative aspects

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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

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Overview of the Standard Document

• Physico-chemical properties and analysis
• Toxicology
• Biology
• Residues
• Ecotoxicology
• Fate and behaviour
• Other 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