ACCREDITATION AND METHOD VALIDATION IN SWEDEN Accreditation Good

ACCREDITATION AND METHOD VALIDATION IN SWEDEN Accreditation Good Laboratory Practice Method Validation in Sweden 5 th Meeting with the Italian Pesticide Residue Laboratories National Institute of Health - ROME 26 - 27 November 2001 Arne Andersson 2001 -11 -27 NATIONAL FOOD ADMINISTRATION, Sweden 1

ACCREDITATION AND METHOD VALIDATION IN SWEDEN Accreditation Our contracted laboratory for pesticide residue analyses was accredited in 1994 according to SS-EN 45001 By 1 July 2002 the laboratory must be accredited according to EN ISO/IEC 17025 Arne Andersson 2001 -11 -27 NATIONAL FOOD ADMINISTRATION, Sweden

ACCREDITATION AND METHOD VALIDATION IN SWEDEN Accreditation SWEDAC (Swedish Board for Accreditation and Conformity Assessment) - is the official accreditation body in Sweden - laboratories which carry out examinations on samples of foods shall be accredited by SWEDAC (Food Decree § 50) Arne Andersson 2001 -11 -27 NATIONAL FOOD ADMINISTRATION, Sweden

ACCREDITATION AND METHOD VALIDATION IN SWEDEN Accreditation For official food control (since 1996) additional specific demands: Tecnicians: specific education/competence ”Responsible investigator”: university degree, at least on year practical experience (training) under a supervisor Arne Andersson 2001 -11 -27 NATIONAL FOOD ADMINISTRATION, Sweden

ACCREDITATION AND METHOD VALIDATION IN SWEDEN Accreditation On an individual method basis for specified: - analytes - matrices - determination techniques e. g. GC, GC-MS, HPLC, LC-MS The approval contains also information on - measurement uncertainty - working range / LOQ Arne Andersson 2001 -11 -27 NATIONAL FOOD ADMINISTRATION, Sweden

ACCREDITATION AND METHOD VALIDATION IN SWEDEN Accreditation Exception - if there are special reasons why the testing of such laboratories shall be carried out in another way, the NFA may though regulations decide that the laboratories shall instead be approved by the Administration Arne Andersson 2001 -11 -27 NATIONAL FOOD ADMINISTRATION, Sweden

ACCREDITATION AND METHOD VALIDATION IN SWEDEN Accreditation NFA regulation for food control (SLVFS 1996: 15) § 7 Accredited or approved laboratories - acute cases where established analytical tecnique is lacking - situations when the analytes have not previously been examined - certain very specific analyses If NFA commissions a laboratory to carry out an investigation, the laboratory is considered to be Arne Andersson 2001 -11 -27 approved for this mission NATIONAL FOOD ADMINISTRATION, Sweden

ACCREDITATION AND METHOD VALIDATION IN SWEDEN Accreditation Flexible scope accreditation Not yet for pesticide residue analyses but at NFA for determination of mycotoxins in Food by HPLC Arne Andersson 2001 -11 -27 NATIONAL FOOD ADMINISTRATION, Sweden

ACCREDITATION AND METHOD VALIDATION IN SWEDEN Good Laboratory Practice Codex guidelines on Good Laboratory Practice in Pesticide Residue Analysis NMKL* -document ”Guidelines in Quality Assurance for Chemical Food Laboratories” * Nordic Committeé on Food Analysis Arne Andersson 2001 -11 -27 NATIONAL FOOD ADMINISTRATION, Sweden

ACCREDITATION AND METHOD VALIDATION IN SWEDEN Method Validiation ” Old routine ” Recovery tests at least 2 levels: LOQ and a ”higher” level 7 tests per level and matrix, 3 matrices Additional matrices one level (LOQ), 4 tests per matrix normally at least 5 matrices Mean recovery 70 -110 % RSD < 30 % depending on the level Arne Andersson 2001 -11 -27 NATIONAL FOOD ADMINISTRATION, Sweden

ACCREDITATION AND METHOD VALIDATION IN SWEDEN Method Validiation Commodity groups (11) • Citrus fruits • Pome fruits • Stone fruits • Berries and small fruits • Miscellaneous fruits • Root and Tuber Vegetables incl. potatoes • Bulb vegetables • Cucurbits • Flowering Brassica • Lettuce and similar • Stem vegetables NATIONAL FOOD ADMINISTRATION, Sweden Arne Andersson 2001 -11 -27

ACCREDITATION AND METHOD VALIDATION IN SWEDEN Method Validiation ”New approach ” Linearity tests: 5 levels Recovery tests: 0. 01 and 0. 05 mg/kg • 4 replicates for each of 5 matrices (from different groups) and level • One recovery for each of the additional matrice at 0. 05 0. 5 mg/kg • One recovery for each of the 5 matrices Test of matrix effects Arne Andersson 2001 -11 -27 NATIONAL FOOD ADMINISTRATION, Sweden

ACCREDITATION AND METHOD VALIDATION IN SWEDEN Results from the Swedish Control of Pesticide Residues are available on our Web Site : www. slv. se - on the left side of our web site choose “in English” and there you will find The Swedish Monitoring of Pesticide Residues in Food of Plant Origin: 2000 This is a PDF-file and you need Acrobat Reader 5, which is free to download. Quarterly reports are available in Swedish and the third one, 3 -2001, will be presented within a week. Arne Andersson 2001 -11 -27 NATIONAL FOOD ADMINISTRATION, Sweden

ACCREDITATION AND METHOD VALIDATION IN SWEDEN Short-term intake Arne Andersson 2001 -11 -27 NATIONAL FOOD ADMINISTRATION, Sweden