PIP SA Meeting Johannesburg 11062004

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PIP SA MeetingJohannesburg 11/06/2004

• New European regulation
• Implications and Perspectives
• Impact on horticultural ACP countries exports to
  Europe
• Pesticides Initiative Programme implementation
• Roland M. Levy Regulation and Residues
  Pesticides Initiative Programme

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• Table of Contents
• Situation update on EU legislation
• related mainly with Residues
• Strategy of COLEACP/PIP programme

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(No Transcript)
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Regulatory Context Higher standards regarding
consumers safety

• New facts creation of the European Food Safety
  Agency (EFSA)
• New legislative tools regarding residues of Plant
  Protection Products

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New facts creation of the European Food
Safety Authority (EFSA)

• To ensure a uniform and high level of protection
  of the consumers health and put more confidence
  in a new system following all recent EU food
  crisis.
• Impact more control, the evaluation of Plant
  Protection Products will be transferred to this
  new organisation, thus transparency ..
• Responsibility of the Food safety will be given
  to all different actors responsible of the
  production of food,
• Member States will conduct monitoring and the
  European Commission will ensure system is
  efficient through audit and control measures.

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New EU legislation related to Residues
announced by D.Byrne, March 2003 EU
Commissioner for health and Consumer protection

• 4 existing EU MRLs Directives replaced
• with one single regulation CONSOLIDATION
• New procedures are acting through
• regulations rather than directives
  SIMPLIFICATION
• Transfer Risk Assessment procedure and
• the MRL proposals to EFSA EFFICIENCY
• Problems of non harmonised substances
• (EU MRLs) should be solved through
  PRACTICAL measures

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MRLs - Definitions

• Definitions MRL
• Maximum residue levels (MRLs) reflect the use of
  minimum quantities of pesticides to achieve
  effective plant protection, applied in such a
  manner that the amount of residue is the smallest
  practicable and is toxicologically acceptable.
• MRLs are representing the maximum quantity of
  residues in the raw commodity of plant or animal
  origin (sometimes after processing) after an
  application of a pesticide according to Good
  Agricultural Practices (GAP).

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MRLs - Definitions

• In other words, MRLs are strictly based on
• Good Agricultural Practices (GAP).
• GAP are authorised agricultural practices
  related to Pest Control and are defined as
  follows (for a specific crop)
• formulation type,
• application pattern,
• applied dose,
• number of applications,
• pre-harvest Interval (PHI)
• if GAP is different, MRL may be different

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How EU MRLs are set

• 1 Definition of the relevant residues (parent
  and/or metabolites)
• 2 Compile existing residue results or conduct
  new residue studies, according to authorised
  GAPs in Europe. Basis crop grouping and
  extrapolation
• 3 Select relevant data corresponding to THE
  CRITICAL GAP
• 4 Statistical evaluation of data
• 5 Estimate potential ingestion to consumers
  and compare with toxicological end-point
  (chronic and acute when necessary). Same for
  consumer population potentially at risk, when
  necessary ie toddlers, infants..
• 6 Submit to relevant Regulatory Authority,
  National authority, RMS or European Commission
• 7 wait, wait

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EU MRLs Practical example

• Basis to set EU MRLs
• Definitions classification of crops in
  major/minor/very minor
• major crops consumption 7.5 g/jour (adult)
• gt 10000 ha
• gt 200 000 t/an
• minor/very minor by list
• Studies should be conducted in different
  geographical zones so as to representing the
  impact of potential variability in the different
  results following application Northern EU,
  Southern EU, Greenhouses when necessary.
• For MRL setting procedure, the choice of the
  crop to be tested should be optimised taken into
  account crop grouping and possibility to
  extrapolate.
• Definitions from the Document 7525/VI/95 rev 7
  of 12/06/2001 p.8

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MRLs EU Crop grouping (minor/major)
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Minor crops and exotic fruits

• DG SANCO reconsider the idea of crop grouping ?
  IR-4 of US EPA (Environment Protection Agency)
  which created 15 groups of crops and for each of
  them a working group of experts. Unfortunately,
  DG SANCO is not in a position to dedicate that
  many people to study problems related with minor
  crops
• Nevertheless, after having defined the crop
  groups, DG SANCO has decided to require IT only
  for one or maximum 2 main crops of the group and
  extrapolate the values to all the other crops

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• The suggestion is to use as often as possible the
  MRL extrapolation procedure
• The crop grouping a long lasting procedure is,
  the more so that it requires at least one
  registration per group in the application
  country.
• Pesticides manufacturers are reluctant in
  starting a registration procedure for a minor or
  very minor crop.

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MRLs Example of Extrapolation Application
close to harvest
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MRLs

• Conclusion
• MRLs are a quantitative way to ensure that the
  products are applied according to registered
  uses. It should be clear that it is considered
  illegal to import or commercialise products with
  a residue level higher than the considered MRL.
• MRLs are
• Regulatory limits with a legal basis for the
  presence of residues in the treated commodities.
• Are directly linked to GAP ie to the registered
  uses of products
• As low as possible to protect consumers

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Relationship EU - WTO

• WTO SPS working group.
• While modifying or fixing an MRL in Europe, DG
  SANCO, in charge of european MRLs, must notify
  the WTO SPS working group(Sanitary and
  Phytosanitary).
• Everybody has the possibility of reacting during
  a period of 2 months, after which, if no comment,
  the decision is implemented.(2,4-D on citrus in
  June 2003)

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Relationship EU - WTO

• 2. WTO TBT working group.
• Before withdrawing an active substance from the
  Directive 91/414 list , DG SANCO must notify it
  to the WTO TBT working group (Technical Barrier
  to Trade)
• Everybody has the possibility of reacting during
  a period of 2 months, after which, if no comment,
  the decision is implemented.
• The notification procedure applies to all
  countries of the world

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• Impact of the 91/414/EEC Directive on MRLs
• Review
• New Active Substances (AS)

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EU Review Existing Active Ingredients

• Step 1 90 active substances Regulation
  3600/92/CE
• Submission dossiers in 1994
• Step 2 149 active substances Regulation
  451/2000/CE
• Submission dossier 2002
• Step 3 399 active substances Regulation
  451/2000/CE
• Submission dossier 2003 and 2004
• Step 4 277 active substances Regulation
  1112/2002
• Submission dossier ? Modification in 2004 (100
  new products)
• TOTAL 838 active substances on the EU market
  after July 1993

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EU Review Existing Active Ingredients as per
91/414/EEC

• In 2004, where do we stand?

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Directive EU 91/414/EC Situation May.2003

• Existing A.S.
• List Nr a.s Annex 1 Withdrawn
  On-going Date of completion
• 1 90 AS 40
  26 24 2005
• 2 147 AS -
  96 51 2005
• 3 404 AS -
  238 166 2008
• 4 373 AS -
  87 286 2008
• 
  _____
• Total 40
  446
• New AS (chemicalsmicroorg)
• Annex 1 Withdrawn On-going
  Total
• 51 7 47
  98
• At present (May. 2003) Annex I 89 AS, 476
  withdrawn (incl. 19 not PPP)

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Directive EU 91/414/EC Situation May. 2003

• Status regarding MRL (w/o µorg.)
• Annex 1 likely to stay Harmonised
  Not harmonised
• Existing AS 40 417
  94 323
• New AS 51 100
  23 77
• Total 91 517 117
  ca. 400
• Withdrawn
  Harmonised Not harmonised
• Existing AS 446
  63 376
• New AS 7
  21(provis.) 0
• Other (79/117/EEC) 17
  17 0
• Total 470
  101 ca. 376
• Grand Total 218 ca. 776

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Consequences of listing on Annex 1

• Member State review of existing registrations
• 6 months given to registration holders for
  decision
• - if data protection rules not satisfied,
  withdrawal
• (example in France registration granted for
  deltamethrin to a distributor in November 2003
  now listed on Annex 1 . Due to data protection,
  this registration will be probably withdrawn in
  May 2004)
• - if data sharing accepted cost is prohibitive.

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• Although data protection is fully understandable
  for the so-called new molecules, actually already
  protected by a patent, protection for another 10
  years, for existing molecules, as foreseen in the
  new proposal becomes really surrealistic and
  leads to a non acknowledged monopoly given to the
  main manufacturers.

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Trading Issues an example

• Example of Prochloraz on Mango (post-harvest
  fungicide)
• Until 08/2003 no harmonised EU MRL for
  prochloraz.
• In France no MRL, Germany 2 mg/kg, Belgium 3
  mg/kg, Spain 5 mg/kg.
• In 1997, import in Germany followed by France was
  attracting goods consignement and penalties for
  the French import company. Nowadays MRL is
  harmonised at 5 mg/kg (EU Directive 79/2002)
  dated October, 2nd 2002 with effect in all MS by
  August, 1st 2003.

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Harmonisation difficulties

• Each member state can fix its own MRLs
• For a same couple A.S./crop MRLs could differ
  from an MS to another.
• No application of EU free circulation rules.
• Arbitrage Directive 97/41 amending Dir.90/642
  does not apply the procedure is too complicated
  and too long
• No action is really taken at Commission level by
  importers
• If no objection raised by EU Parliament to
  Sturdys report on new proposal, in the most
  optimistic case, the new regulation could be
  implemented in 2006.

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Harmonisation difficulties

• For the moment DG SANCO is setting up a data base
  gathering all national MRLs with the idea of
  harmonising them even before the implementation
  of the new regulation. The idea is to select the
   critical  MRL, actually the highest national
  one and to consider it as the temporary
  harmonised EU MRL with a validity of 4 years.
• Deadline end of 2004, realism or utopia?
• But each MS is eager to show how tough it is in
  protecting consumer health by being reluctant to
  easily modify its own MRLs.

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EU Review Existing Active Ingredients EU
Review 4th list

• Regulation 1112/2002
• 377 active substances (since April 2004, due to
  the 10 new MS)
• Notification to be submitted before 30/10/2002
  includes
• Microorganisms
• Authorised substances in feedstuffs
• Plant extracts
• Pheromones, attractants, repellants
• Industrial products (sulfuric acid)
• Rodenticides
• Others like ethanol, nicotine, rotenone
• Sulfur compounds and ethylene (COLEACP for
  banana)

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EU New Active Ingredients

• New active substances
• Active Substances first authorisation after July
  1993
• Provisional approval lead to provisional /
  temporary MRL to facilitate trading.

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EU MRLs change in Procedure Proposals
(applic. 2004?)

• When no harmonised MRL, MRLs could be set by
  Member States leading to potential trading issues
• New proposal MS will not set anymore MRLs
• EFSA will propose MRLs to European Commission
• Key dates 91/414/EEC 2003 and 2008
• Key dates Residue legislation 2004
• ca. 446 substances withdrawn
• ca. 400 on the market w/o harmonized MRLs.

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MRL change in Procedure Proposals (contd)

• MRLs will be deleted if
• no authorised uses,
• insufficient data,
• MRL not safe to consumers..surrogate zero MRL
  of 0.01 mg/kg (could be less, mostly AS with very
  low ADI). Necessary because of the review where
  no analytical method and residue data are
  available.
• Why 0.01 mg/kg? ? practical experience, consumer
  protection, detection by multi-residue methods

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MRL change in Procedure Proposals (contd)

• Proposal 2 types of MRLs
• Fixed
• collection of all harmonised MRLs irrespective
  inclusion in Annex I or not
• Temporary
• all substances not having an harmonized MRL (ca.
  770 substances). For the 446 withdrawn, default
  LOD policy will apply (probably end of 2004)
  before moving to fixed MRLs

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MRL change in Procedure Proposals (contd)

• Import tolerances is required when
• 1. A.S authorized in EU, IT requested for
  application on a non EU crop (okra)
• Crop treated with AS not authorized or withdrawn
  inEU, but registered in the country of origin.
• If residue level below 0,01mg/kg, no
  restriction
• If above 0,01mg/kg, requires a full dossier.
  
• If toxicological issue, no IT could be
  granted
• 3. Higher residues than harmonized MRLs

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Import Tolerance dossier (Content)

• The dossier comprises
• Definition of the relevant residue and Method of
  Analysis
• National certificate of registration
• GAP description and biological justification of
  the GAP
• Residue data 8 for major crop and 4 for minor in
  principle (expert judgement)
• Data related to the behaviour of the residues
  (metabolism in plant, livestock, feeding studies,
  processing, animal metabolism, industrial
  process..)

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Import Tolerance dossier (Content)

• MRL proposal
• Toxicological data to establish ADI and Acute
  reference dose when relevant
• Dietary intake estimates (WHO diet 2003 or Euro
  model in preparation)
• Other data (CODEX, registration status..)
• Additional data when necessary

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Timeline for Import Tolerance setting

• Whenever the IT request dossier is ready, the
  procedure today is as follows
• Introduction of the dossier to the DG SANCO in
  Brussels
• Completeness check
• Dossier submitted to corresponding RMS for
  assessment
• RMS makes recommendation and sends back dossier
  to DG SANCO
• DG SANCO organises meeting with working group
  residues (WGR) for indicative opinion on
  recommendations

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Timeline for Import Tolerance setting

• If agreed upon Notification to the working group
  SPS of WTO
• After the 2 months notice delay, meeting again of
  WGR for final opinion to be transferred onto the
  Commission
• Commission adopts and publishes through
   Directive 
• Best case 15 months
• Worse case 24-36 months
• EC Documents - Doc. 7196/VI/99 rev.1
• - Doc. 2734/SANCO/99

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B. Regulation and Residues

• Priorities selection pesticide/crop according
  to Directive 91/414. Reviewed with the EC,
  Manufacturers and research institutions
• Associated crop experts visiting with the
  companies and establishing basic crop
  protocols (including IPM, ICM). 8 protocols
  are ready and will be discussed in workshops.
• List pests and diseases by crop
• Crop selection
• Fruits Pineapples, mangos,
  papaya, avocados, passion fruit Vegetables
  Beanspeas, cherry tomatoes, okra
• Close Contact with the DG Health and Consumer
  and partnership agreement with Crop Life
  Intl and the pesticides manufacturers

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B. Regulation and Residues
(continued)

• Define after final selection of the priorities
  crop/pesticides a reference technical itinerary
  (RTI) taking into account all EU regulation
  requirements.
• Planning trials programmes with the crop
  experts, the manufacturers , local service
  providers and authorities for the validation of
  Reference Technical Itineraries. Started on
  10/03.
• Case studies pineapple, papaya, french beans,
  cherry tomato
• Monitoring and determination of IT requirements
• Preparing, with the manufacturers, MRL/IT
  requests through
• - experiments (pineapple, papaya, beans)
• - extrapolation (yams)
  (Doc.7525/VI/95-rev 7)

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Process of selection of AS (MRL/IT)
Kenya
Ivory Coast
Senegal
Others
Priorities (exhaustive list)
NO
Withdrawal
Alternatives?
Alternatives?
Yes
NO
NO
Retained list
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Pineapple Technical Itinerary(13 - 15 month
Cycle )

• Before plantation herbicidenematicide
• 0 to 8 months plantation / artificial
  flowering induction, no residues expected
• 8 to 12 months no pesticides used
• 13th month insecticide (1 to 3 weeks b.h.)
  degreening (1 week before
  harvesting)
• Post-harvest fungicide (triadimefon)

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Papaya Technical Itinerary (36 months Cycle)

• Before plantation herbicide
• 6 - 8 months first fruits
• 8 to 36 months weekly harvesting with in
  between fungicides and insecticides
  spraying
• what about PHI and Residues?
• Post-harvest fungicide (prochloraz)

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Beans Technical Itinerary (valid for Western
Africa)(55 to 75 days)

• Seeds treated with fungicide
  (thirame)
• Before plantation nematicides
• During growth treatement with various
  fungicides,
  insecticides
• Harvest manual harvesting
  every other day
• (potential issues with PHI and residues)
• Post-harvest no treatment

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B. Regulation and Residues (continued)

• Discussing with local authorities for approvals
  (papaya). Manufacturers starting
  registration procedure when required with the
  cooperation of ACP authorities which should
  recognize the specificity of the horticultural
  network (export)
• Controlling analytical methods for residue
  analysis
• Determining the exporters needs for residues
  control
• Suggesting alternatives organic, others
• Checking and reinforcing the local analytical
  capacities
• Helping in adjusting ACP national and
  continental regulation
• Setting up specific technical workshops.
  Kenya(09/03), Senegal (09/03), Ghana (10/03)

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Request for Import Tolerance

• Residue monitoring studies have been undertaken
  and residues measured according to analytical
  methods approved by DG SANCO or developed by the
  pesticides manufacturers specifically for  new
  molecules 
• Two possibilities
• The residue level is ? LOQ which is presently
  0,02 - 0,05mg/kg related to the combinations
  pesticide/crop and the analytical method used
• In that case, PIP will require from DG SANCO
  that the LOQ be considered as the real MRL
• .

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Request for Import Tolerance

• Because, whenever the new regulation comes into
  force, the LOQ will automatically be set at
• 0,01mg/kg below the present LOQ.
• The residue level is ? LOQ
• The pesticide manufacturer of the active
  substance will prepare and introduce the request
  for an IT dossier
• Most of the field trials, besides those for
  mango, as well as the residue monitoring should
  be completed by the end of 2004.

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Request for Import Tolerance

• By that time, the PPP manufacturers will have to
  prepare the IT dossiers to which a local
  certificate of registration should be joined. In
  many countries, this document is not available
• We shall then be needing a provisional approval
  in order to proceed with the demand. DG SANCO,
  which has approved the field trials and residue
  monotoring protocols is accepting the results
  obtained in a GLP laboratory to support the
  demand without going through the long lasting
  residue studies.
• If our dossiers are complete and introduced
  latest, in the first quarter of 2005, DG SANCO
  committed itself in promising IT to be fixed by
  the end of 2005

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CONCLUSION

• What is the future made of ?
• According to Directive 178/2002 (Art.18),
  traceability will become compulsory from January
  1st, 2005 onwards.
• Many of the supermarkets, mainly from UK or the
  Netherlands
• will require from their suppliers EUREPGAP
  certification.
• French supermarkets will set their own
  specifications integrating very strictly the new
  EU regulation requirements
• Some supermarkets will be more demanding residue
  level at
• 50 of the MRL or even less. What if the MRL is
  set at LOD?