aoac vdr sub-group community meeting - 09202016-topic 4 - aoac community...aoac vdr sub-group...

130th Annual Meeting & Exposition

September 18-21, 2016

Dallas, TX

AOAC VDR Sub-Group Community

Meeting

Tuesday, September 20, 2016

11:45am – 1:15pm

Room : San Antonio A

Sheraton Dallas Hotel

Co-Chairs: Eric Verdon & Jian Wang



Dallas, TX

Topic No 4.

Latest method performance criteria guidelines update

1) CAC/GL 71-2009 Appendix C – Performance Characteristics for

Multi-Residue Methods (MRMs) for Veterinary Drugs

2) Acceptance Criteria for Confirmation of Identity of Chemical

Residues using Exact Mass Data for the FDA FVM Program

3) Update for European Decision 2002/657/EC for VDR methods

performances

4) Guidance document on analytical quality control and method

validation procedures for pesticides residues analysis in food and

feed. SANTE/11945/2015

5) CCPR Draft Guidelines on Performance Criteria for Methods of

Analysis for the Determination of Pesticide Residues in Food



Dallas, TX

CAC / GL 71-2009

Guidelines for the Design and Implementation of National

Regulatory Food Safety Assurance Programmes Associated with

the Use of Veterinary Drugs in Food Producing Animals

• Adopted 2009. Revision 2012, 2014.

Appendix C – Performance Characteristics for Multi-Residue

Methods (MRMs) for Veterinary Drugs • C1. SCOPE

• C2. DEFINITIONS

• C3. SUMMARY OF PERFORMANCE PARAMETERS TO BE CHARACTERISED AND DEFINED FOR

MULTI-RESIDUE ANALYTICAL METHODS

• C4. PERFORMANCE CHARACTERISTICS FOR MRMS

• C5. PERFORMANCE CHARACTERISTICS OF MRMS FOR SCREENING ANALYSIS

• C6. PERFORMANCE CHARACTERISTICS OF MRMS FOR QUANTITATIVE ANALYSIS

• C7. PERFORMANCE CHARACTERISTICS FOR MRMS FOR CONFIRMATORY METHODS

• C8. VALIDATION OF THE FULLY CHARACTERIZED MRMS

http://www.fao.org/fao-who-codexalimentarius/standards/list-of-

standards/en/



Dallas, TX

Acceptance Criteria for Confirmation of Identity of Chemical Residues

using Exact Mass Data for the FDA FVM Program

http://www.fda.gov/downloads/ScienceResearch

/FieldScience/UCM491328.pdf



Dallas, TX

European Commission Decision 2002/657/EC

http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32002D0657



Dallas, TX

Process of Revision of

European Commission Decision 2002/657/EC

Agenda and Objectives of this 2016-2017 Revision

To reorganize the 3 technical documents

(657/2002 + 2726/2004 + CRLs 2010 Screening Guidance)

Confirmatory issues : identification & quantitation

– Criteria linked to Exact mass measurement in HRMS

– Ion Ratio Tolerances in LR-MS/MS and HR-MS/MS

– LC Retention Times Tolerances

– CCalpha for confirmation / LOQ and MRL

Screening issues : for biological and chemical methods

– Criteria for Validation on Screening in Multi-Class/Multi-Residue

(100+ analytes) by LC-MS/MS or LC-HRMS

– CCbeta for screening / LOD



Dallas, TX

SANTE/11945/2015

http://ec.europa.eu/food/plant/docs/plant_pesticides_mrl_guidelines_wr

kdoc_11945_en.pdf



Dallas, TX

CCPR Draft Guidelines on Performance Criteria for Methods of Analysis for

the Determination of Pesticide Residues in Food

http://www.fao.org/fao-who-codexalimentarius/meetings-reports/en/?y=2016&mf=07



Dallas, TX

CCPR Draft Guidelines on Performance Criteria for Methods of Analysis for

the Determination of Pesticide Residues in Food

aoac vdr sub-group community meeting - 09202016-topic 4 - aoac community...aoac vdr sub-group...

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