Standard Methods versus Method Criteria

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1 Nordic Committee on Food Analysis Standard Methods versus Method Criteria AOAC Europe NMKL NordVal International Symposium, Stockholm 2015 Hilde Skår Norli NMKL Secretary General

2 Contents Specified standard methods in legislation vs stating method performance criteria that need to be fulfilled Background for method criteria Pros & Cons Established criteria

3 Standard methods Methods published by Standard Developing Organisations, SDOs: American Oil Chemists Society (AOCS) AOAC INTERNATIONAL (AOAC) AOAC Research Institute (AOAC RI) Association of American Feed Control Officials (AAFCO) European Committee for Standardization (CEN) National Food Processors Association International Association for Cereal Sciences & Technology (ICC) International Commission for Uniform Methods of Sugar Analysis (ICUMSA) International Dairy Federation (IDF) International Federation of Fruit Juice Producers (IFU) International Federation of Glucose Industries (IFG) International Office of Cocoa, Chocolate and Sugar Confectionery (IOCCC) International Organization for Standardization (ISO) International Wine and Vine Office (OIV) Nordic Committee on Food Analysis (NMKL)

4 Standard methods Scope and field of application Principles Chemicals/Diluent/Substrates/Reagents Apparatus/Equipment Sampling (secondary) Procedure Preparation Analysis Calculation and expression of the results Reliability of the method

5 Performance characteristics M P Criteria is numeric values for the Performance Characteristics

6 Background for the method criteria Administratively difficult to change a specified method in legislation Several methods provide equivalent results Better, faster and cheaper methods might be available

7 Pros & Cons for method criteria More flexible Fit for purpose Resource-saving Quality driven Easier to enforce Easier to obtain similar results

8 Application Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs. Guidance document on analytical quality control and validation procedures for pesticide residues analysis in food and feed. Document No Sanco 12571/2013. Commission regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs

9 - develops harmonized international food standards, guidelines and codes of practice to protect the health of the consumers and ensure fair practices in the food trade 186 Codex Members Codex Observers 16 commodity committees 10 general committees (CCMAS)

10 Method Criteria CCMAS 1992 (NMKL- Sweden lead the project from 2005) Reviewed methods for heavy metals Criteria included in Codex PM 2008 (working instruction 2009)

11 Elaboration of method criteria The method has to be applicable for the analyte, matrix, and specified level(s) (maximum and/or minimum) (ML). ML-a ML ML+a a = 2 s or 3 s s = standard deviation Level

12 s, at levels 0.1 mg/kg Same relation between concentration and standard deviation regardless of analyte, matrix, method principle and time. PRSD R = 2C (-0.15) (%) RSD R /PRSD R 2 HorRat Dr. William Horwitz, Photo: AOAC Int

13 s, at levels < 0.1 mg/kg More recent studies (2000) RSD took a value of 22% for levels below 0.1 mg/kg Prof. Dr. Michael Thompson, Photo: Birkbeck University, London

14 Trueness: z-score 2 proven in pt-scheme or use of crm Type in ML in mg/kg in the cells below, and the LOD The criteria are as follow: Applicability: The method has to be applicable for the specified provision, minimum applicable range and precision are calcul spesified commodity and the specified levels(s) (maximum and/or minium) (ML). The minimum applicable range of the Calculation of criteria for ML 0.1 mg/kg method depends on the specified level (ML) to be assessed, Min. applicable ra and can either be expressed in terms of the reproducibility ML 0,1 LOD LOQ From standard deviation (sr) or in terms of LOD and LOQ. in mg/kg mg/kg mg/kg mg/kg 0,1 0,01 0,02 0,032 Minimum For ML 0.1 mg/kg ; [ML - 3sR, ML+ 3sR] 1 0,1 0,2 0,520 applicable range: For ML < 0.1 mg/kg ; [ML - 2sR, ML+ 2sR] 2 0,2 0,4 1, ,606 Limit of For ML 0.1 mg/kg ; LOD ML 1/ ,003 Detection (LOD): For ML < 0.1 mg/kg ; LOD ML 1/5 0 0 #DIV/0! 0 0 #DIV/0! Limit of Quanti- For ML 0.1 mg/kg ; LOQ ML 1/5 0 0 #DIV/0! fication(loq): For ML < 0.1 mg/kg ; LOQ ML 2/5 0 0 #DIV/0! 0 0 #DIV/0! Precision: For ML 0.1 mg/kg ; HorRat value 2 For ML < 0.1 mg/kg ; RSDR <44% Calculation of criteria for ML < 0,1 mg/kg Recovery: Conc. Recovery (%) Min. applicable ra 100 g/100g ML < 0,1 LOD LOQ From 10 g/100g in mg/kg mg/kg mg/kg mg/kg 1 g/100g ,01 0,002 0,004 0,006 1 mg/g ,02 0,004 0,008 0, mg/kg ,005 0,001 0,002 0, mg/kg ,000 1 mg/kg , μg/kg , μg/kg ,000 1 μg/kg

15 These criteria are applicable to: Rational methods, GC, HPLC, AAS, ICP etc. where concentrations are measured and where Horwitz and Thompson equation applies.

16 PRINCIPLES AND GUIDELINES FOR THE ESTABLISHMENT AND APPLICATION OF MICROBIOLOGICAL CRITERIA RELATED TO FOODS CAC/GL (2013) 4.7 ANALYTICAL METHODS 33. Depending on the microbiological limit (e.g. presence/absence of a specific foodborne pathogen), an appropriate analytical method should be selected. The methods used should be fit for purpose, meaning the method has been validated for relevant performance characteristics (e.g. limit of detection, repeatability, reproducibility, inclusivity, exclusivity). The validation study should be based on internationally accepted protocols and include an interlaboratory study. If not available, a validation should be done by the laboratory applying the method, according to a standardised protocol. 34. The analytical methods specified should be reasonable with regard to complexity, availability of media, equipment, ease of interpretation, time required and costs. 35. The results of testing may be impacted by compositing (i.e. pooling) of sample units prior to analysis. Compositing will affect the final concentration in the tested sample and is not appropriate for enumeration methods of analysis or within three-class sampling plans. Compositing may be considered in the case of presence/absence testing within a two-class sampling plan, as long as it is ensured that the result of testing will not be affected when compared to testing of individual analytical units.

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