Pesticide Residue Monitoring EU and NL

1
Pesticide Residue Monitoring EU and NL

• Henk van der Schee
• Food and Consumer Product Safety Authority
  (VWA)
• main responsibility pesticide residue official
  control program
• Hoogte Kadijk 401
• 1018BK Amsterdam
• E-mail henk.van.der.schee_at_vwa.nl

2
MRL Regulations

• History
• Current situation of MRL setting
• EU MRL Regulation 396/2005
• Scope
• Structure and requirements
• Status of work
• MRL setting under Regulation 396/2005
• Official control of MRL

3
MRL Regulations

• History
• Four directives
• 76/895 minimum MRLs preventing market problems
• 86/362, 86/363 extension to cereals and animal
  products
• 90/642 current main framework
• Main problems
• Partial harmonisation
• Complex structure
• Import tolerances not regulated
• Lack of synchronisation with 91/414
• New regulation 396/2005

4
MRL Setting and MRL Regulations

• Current situation of MRL setting
• MRL setting independent of 91/414 evaluation
• Evaluations started after accepting 90/642
• Many MRLs before Annex I inclusion (existing
  substances, from 1993)
• About 175 active substances
• About 125 with real MRLs (not all LOD)
• About 50 with only LOD-MRLs (forbidden
  pesticides, non-inclusions)
• About 50 new
• New substances MRL setting after Annex I
  inclusion
• 4 year period of provisional MRLs
• MRLs set in commission directive, prepared by RMS
  approved by SCFCAH

5
MRL Setting and MRL Regulations

• Current situation of MRL setting
• EU-MRLs obligatory for member states
• Member states can have MRLs for non-harmonised
  pesticides
• Existing pesticides, including import tolerances
• Provisional MRLs for new substances
• Main trade problem on fruit vegetable market

6
MRL Regulation 396/2005

• Regulation vs. Directive
• Regulation directly in force in member states
• Directive must be implemented in national
  legislation
• Scope
• All food
• fresh
• processed
• composite
• Feed (new)
• Products must be listed in Annex I
• Pesticides according to 91/414
• some need no MRL -gt in Annex IV

7
MRL Regulation

• MRLs
• Existing EU-MRLS (Annex II)
• Existing national MRLs, when safe (Temporary
  Annex III)
• Default MRL (0,01 mg/kg) for all other pesticides
• Products must comply with MRLs
• MRL violation is allowed
• After post harvest treatment during waiting
  period
• After authorisations as 91/414 art. 8(4)
  exceptions
• Dilution is prohibited
• MRLs for processed products are derived from
  fresh products unless defined explicitly
• Official Control is demanded

8
MRL Regulation

• EU support measures are required at Community
  level
• a consolidated database
• support to laboratory quality
• not mentioned in Regulation, but based on food
  feed control regulation Community Reference
  Laboratories
• studies of
• intake estimation
• cumulative and synergistic effects

9
MRL Regulation

• Status of work
• Filling in of Annexes
• Annex I published
• Structure like ANNEX II of 90/642
• Grouped individual commodities
• "others" in each group
• Additions spices, herbal infusions, sugar
  plants, "veterinary products"
• Not yet fishery products, feed
• To diminish ambiguity CODEX codes, biological
  Latin names
• Annex II straight forward transposing of current
  EU MRLs
• existing national MRLs for new products under
  enquiry

10
MRL Regulation

• Annex III
• Temporary MRLs from existing national MRLs
• Inventory database complete
• Safety evaluation by EFSA
• 195 pesticides with MRLs gt LOD
• More than 10.000 pesticide/product combinations gt
  LOD
• (many group tolerances, extrapolations to be
  justified)
• Country with highest value gives supporting data
• If no data (MS)/not safe (EFSA) next country

11
MRL Setting and MRL Regulations

• MRL setting under Regulation 396/2005
• Data Requirements for Residue Studies
• Guidance documents
• Role Rapporteur Member State (RMS)
• Role European Food Safety Authority (EFSA)
• Role European Commission
• Role Standing Committee of the Food Chain and
  Animal Health (SCFCAH)

12
MRL Setting

• Data Requirements for Residue Studies (91/414
  OECD)
• Residue definition (Risk assessment and
  monitoring/enforcement)
• Chronic and acute exposure risk assessment
  endpoints
• Processing factors
• MRL proposals
• Guidance documents
• Stability of residues
• Metabolism, distribution and expression of
  residues (plants, animals)
• Residue trials (plant products, livestock feeding
  studies)
• Processing studies, incl. distribution peel/pulp
• Proposed residue definition for risk-assessment
  and MRL-setting
• Proposed pre-harvest intervals
• Estimation of exposure from diet and other
  sources

13
MRL Setting

• Data Compiled in Dossier
• EU regulation 396/2005 gives procedure to set
  MRLs
• Application of authorisation in a member state
• Member state
• evaluates necessity of MRL
• requires applying for MRL
• notifies Commission and EFSA
• evaluates application (possibly done by RMS)
• reports to Commission and EFSA

14
MRL Setting

• EFSA
• assesses
• suitability proposed method of analysis for
  routine control
• anticipated LOD
• risks of exceeding ADI or ARfD
• has three months
• Commission
• Prepares Regulation
• Decision to be made in the SCFCAH
• has three months

15
MRL Official Control

• EU regulation
• Official control (monitoring enforcement)
  obligatory
• Directly linked to official controls of food and
  feed
• Official control Regulation 882/2004
• Community reference laboratories
• Requires national reference laboratories

16
MRL Official Control

• EU regulation
• Official control (monitoring enforcement)
  obligatory
• Directly linked to official controls of food and
  feed
• Samples representative for market
• Also at point of consumer supply
• Sampling in accordance 2002/63
• Requirements for laboratories
• As food feed 882/2004 additional measures
• Existence of Community and national control
  programs
• Requirements for the national program
• Requirements for the national and Community
  reporting
• MS must have rules for applying sanctions to
  infringements

17
MRL Enforcement

• Differences with current situation
• sampling at end user supply obligatory
• obligatory guidelines for national program
• current recommendations become law
• EU-coordinated program
• Analytical Quality Control guideline
• EU proficiency test for laboratories
• Reporting according to EU format

18
Summary MRL regulations

• New Regulation is necessary because of
• Trade problems because of incomplete
  harmonisation
• Poorly organised set of directives
• MRL-setting will be synchronised with 91/414 with
  clear responsibilities
• Import tolerances at EU level
• Default MRLs for all pesticides
• Temporary MRLs, based on current national MRLs,
  evaluated by EFSA
• Enforcement along lines of current practice, but
  obligatory

19
MRL-enforcement and monitoring

• EU requires monitoring
• EU Plan
• Recommendation multi annual rolling program

20
MRL-enforcement and monitoring

• EU Plan
• (Harmonised) pesticides, 2006 55 2007 70

21
MRL-enforcement and monitoring

• EU Plan
• Products in program, ca 25

22
MRL-enforcement and monitoring

• EU Results

23
MRL-enforcement and monitoring

• EU Results

24
MRL-enforcement and monitoring

• Monitoring of pesticide residues in the
  Netherlands
• Government
• Ministry of Agriculture, Nature and Food
• Private sector
• Growers organisations
• Importers

25
MRL-enforcement and monitoring

• The Netherlands
• One enforcement/monitoring laboratory
• More efficiency
• Better comparability
• Better quality
• National Plan
• Planning of 25 main products, including
  EU-coordinated program
• Less products to obtain representative results
• 3500 samples
• Explicit planning of non-Dutch production
• Sampling coordinated from surveillance unit
• Feed back during year

26

• Plan 2006

27
MRL-enforcement and monitoring

• Sampling
• Regulations
• Food Act
• implementation of 2002/63, implementation of
  CODEX guideline
• minimum sample size internal procedure, in
  accordance with CODEX
• more units than required

28
MRL-enforcement and monitoring

• Sampling points
• Importers EU
• Distribution centres Food Chains
• Auctions (Dutch produce)
• Importers 3rd country
• Proces industry

29
MRL-enforcement and monitoring

• Organisation sampling
• Communication of sampling plan to regional
  services
• plan contains
• which weeks regions do inspections
• for each month
• how many samples
• which products
• which trade channel
• NL, EU, import
• 12 times a year feed back

30
MRL-enforcement and monitoring

• Measures when non complying
• Official prosecution
• when gt MRL uncertainty 2 MRL
• Uncertainty in result 2 interlaboratory
  std.dev. (25 )
• Additional measures
• contacting AID (General Inspection service, Dutch
  products)
• contacting producers organisations
• contacting embassies
• (Seizure)

31
MRL-enforcement and monitoring

• Special cases
• Import from 3rd countries
• Sampling at customs at clearance on indicated
  profile
• 72 hour delay for analysis
• no import when not complying and hazardous
• import once with warning when not hazardous
• Sampling in distribution channel
• Rapid alerts

32
Rapid Alert System

• EU-system to react immediately on calamities
• Situated at commission
• Contact points in member states (NL VWA)
• Alerts
• require direct action
• non-Alerts
• no direct risk
• food concerned already from market (consumed)
• information only
• to set priorities in countries

33
Rapid Alert System

• Case Pesticide residues
• Laboratory detects non-compliance (Amsterdam)
• Pesticide Level high consumption is compared
  with ARfD (Amsterdam)
• When non complying application form (Amsterdam
  -gt Central Site (the Hague) -gt Brussels)

34
Rapid Alert System

• Alert/non-Alert enters central site
• Handled in the consumer complaint system
• Advice from chief inspector account
• Regional services take action in cooperation with
  surveillance units

35
Rapid Alert System

• Rapid Alerts Primary Agricultural Products
• Pesticides, mycotoxines
• on products from the Netherlands
• sampling of producer/distributor with seizure
• extra monitoring
• on products from other countries
• extra monitoring
• especially at Border Inspection Points

36
Pesticide Residues Monitoring

• Dutch results 2004

37
Pesticide Residues Monitoring

• Dutch results 2004

38
Pesticide Residues Monitoring

• Dutch results 2004

39
Pesticide Residues Monitoring

• Market developments

40
Pesticide Residues Monitoring

• Market developments

41
Analysis

• first choice multiresidue methods
• as wide a scope as possible
• simple extraction
• no clean-up
• if not possible SRM (e.g. chlormequat)

42
Analysis

• SAMPLING
• HOMOGENIZATION
• EXTRACTION (Luke)
• MRMs
• GC LC-MS/MS

43
Analysis

• GC multiresidue methods
• GC-ITD full scan
• 1 mixture of reference pesticides (76x)
• 3 mixtures of other pesticidesTotal ca.
  400x
• GC-ECD 1 mixture of reference pesticides (14x)
• dichloran, lindane, chlorothalonil, aldrin,
• captan, folpet, dicofol, endosulfan-a, b,
  sulphate,
• cypermethrin, deltamethrin

44
Analysis

• GC-ITD (ca 300)
• If pesticides are not detectable by GC-ITD use
  LC-MS/MS (150 validated)
• GC-ECD (10)
• dithiocarbamates (sum as CS2, GC-FPD/ECD,)

45
Analysis

• Scope Priorities
• EU-coordinated program
• Found in past
• New insecticides, fungicides (Authorisation
  bodies, CIRCA, PAN)
• Less priority
• herbicides
• Old substances stay in method

46
General aspects

• EU-requirements/aspects
• Accreditation scope multiresidue methods
  general fruits vegetables
• Taking part in proficiency tests (EU, FAPAS)
• Taking part in QC-workshops
• Working along the lines of the QC-documents
• AQC document for residue analysis
• Guidance Document 825/2000 for validation for
  authorisation dossier
• Cooperation with Community Reference Labs

47
Turkish products