SPDS Lutein and Turmeric ERPs

G UIDELINES FOR D IETARY S UPPLEMENTS AND B OTANICALS

AOAC O FFICIAL M ETHODS OF A NALYSIS (2013)

Appendix K, p. 16

PART II AOAC Guidelines for Validation of Botanical Identification Methods

3.20 Test Portion 4 Validation Study Guidelines 4.1 SMPRs 4.2 SLV Study 4.3 Independent Validation Study 4.4 Collaborative Study Annex A: Candidate Method (or Prevalidation Study) Annex B: Understanding the POI Model Annex C: Number of Test Portions 1 Scope

Contents 1 Scope 2 Applicability 3 Terms and Definitions 3.1 Botanical 3.2 Botanical Identification Method (BIM) 3.3 Candidate Method 3.4 Exclusivity 3.5 Exclusivity Sampling Frame (ESF) 3.6 Exclusivity Panel 3.7 Identity Specification (IS) 3.8 Inclusivity 3.9 Inclusivity Sampling Frame (ISF) 3.10 Inclusivity Panel 3.11 Laboratory Sample 3.12 Nontarget Botanical Material 3.13 Physical Form 3.14 Probability of Identification (POI) 3.15 Sample

The purpose of this document is to provide comprehensive technical guidance for conducting AOAC INTERNATIONAL (AOAC) validation studies for botanical identification methods submitted for AOAC Official Methods of Analysis SM (OMA) status and/or for Performance Tested Methods SM (PTM) status. The requirements for single-laboratory validation (SLV) studies, independent validation studies, and collaborative validation studies for those methods are described. 2 Applicability These guidelines are intended to be applicable to the validation of all candidate botanical identification methods ( Annex A ) submitted to AOAC for ( 1 ) OMA status through either a collaborative study or an alternative pathway study or ( 2 ) PTM certification. 3 Terms and Definitions 3.1 Botanical Of, or relating to, plants or botany. May also include algae and fungi. May refer to the whole plant, a part of the plant (e.g., bark, woods, leaves, stems, roots, rhizomes, flowers, fruits, seeds, etc.), or an extract of the parts. 3.2 Botanical Identification Method (BIM) A method that establishes identity specifications for a botanical material and determines, within a specified statistical limit, a binary test result: YES, the test material is a true example of the target botanical material and meets the identity specifications, or NO, it is not the target botanical. Thus, a BIM answers the question, “Is the test material the same as the target material?” not “What is this material?” In most cases, the method will achieve this goal by comparison of the test material with materials from the inclusivity panel and will return a YES/NO (or, in some cases, a consistent/ nonconsistent) answer. 3.3 Candidate Method The method to be validated or submitted for validation ( Annex A ). 3.4 Exclusivity Ability of a BIM to correctly reject nontarget botanical materials. 3.5 Exclusivity Sampling Frame (ESF) A list of practically obtainable nontarget botanical materials that have taxonomic, physical, or chemical composition characteristics similar to the target botanical and must give a negative result when tested by the BIM.

3.16 Specified Inferior Test Material (SITM) 3.17 Specified Superior Test Material (SSTM) 3.18 Standard Method Performance Requirements (SMPRs) 3.19 Target Botanical Material This document provides technical protocol guidelines for the AOAC validation of botanical identification methods and/or procedures, and covers terms and their definitions associated with the Performance Tested Methods SM and Official Methods of Analysis SM programs. The guidelines working group consisted of James Harnly (Chair, USDA, ARS), Wendy Applequist (Missouri Botanical Garden), Paula Brown (British Columbia Institute of Technology), Steven Caspar (FDA/CFSAN), Peter Harrington (Ohio University), Danica Harbaugh-Reynaud (AuthenTechnologies, LLC), Norma Hill (Alcohol and Tobacco Tax and Trade Bureau Compliance Laboratory), Robert LaBudde (Least Cost Formulations and Old Dominion University), James Neal-Kababick (Flora Research Laboratories), Mark Roman (Tampa Bay Analytical Research), Shauna Roman (Schiff Nutrition International, Inc.), Darryl Sullivan (Covance Laboratories), Barry Titlow (Compound Solutions), and Paul Wehling (General Mills/Medallion Laboratories). The guidelines were approved by the AOAC Official Methods Board on October 13, 2011. This work was funded by the National Institutes of Health, Office of Dietary Supplements. Reference: J. AOAC Int . 95 , 268–272(2012); DOI: 10.5740/ jaoacint.11-447

© 2013 AOAC INTERNATIONAL