USP and the FCC Developing Standards for Food Authenticity. Wei Zhu, Ph. D. Director, Food Chemicals U.S. Pharmacopeial Convention

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1 USP and the FCC Developing Standards for Food Authenticity Wei Zhu, Ph. D. Director, Food Chemicals U.S. Pharmacopeial Convention

2 USP Mission

3 The U.S. Pharmacopeial Convention Independent, notfor-profit sciencebased public health organization 3

4 Food Chemicals Laboratory

5 USP Food Chemicals Lab 5

6 USP Organizational Structure Convention Members Policy Body Meets every five years Elects Board, COE Chairs and Adopts Resolutions Board of Trustees Strategic, Fiduciary Body Council of Experts Expert Committees Scientific Body Approve contents of the USP NF, Food Chemicals Codex, other USP Compendia USP Staff 800+ Supports volunteers, Operations, Public Support 1000 volunteers (international) ~ 600 convention members 6

7 The public standard setting process Transparent and science-based mechanism to develop new and revised quality standards Process driven by stakeholders (mostly industry) Process open to public input Approval by independent, volunteer scientific expert committee 7

8 USP Spectrum of Standards 3,000+ Reference Standards now available

9 Food Chemicals Codex (FCC) Compendium of testing standards and specifications for food ingredients Testing philosophy: Characterize what a food ingredient should be (Integrity) Exclude materials that have been economically motivated adulterated(fraud) Authenticity Can it be verified Help maintain the integrity of supply chain Aids products safety Purity /Assay Identity Is the ingredient what it purports to be Help prevent substitution Is enough of the ingredient present Help prevent dilution Compendium standard Set minimum quality specification Help prevent EMA (fraud)

10 Food Chemicals Codex (FCC) Internationally recognized standards for authenticating the quality and purity of food ingredients More than 1,200 monographs 15 appendices detailing more than 150 tests and assays Print and online formats Published every two years with three supplements published between editions Updated via the free online FCC Forum, two 90-day comment periods each year 2,000+ entries from the USP Food Fraud Database

11 Food Fraud History The First and Only Comprehensive and Public Database: Volunteers

12 Strength of Test Methods and specifications FCC Concept: Compositional complexity and variability of an ingredient must be balanced by an appropriate number and strength of analytical tests to prevent fraud

13 USP guideline:mitigate Food Fraud Focused on EMA and ingredients Structured, step-wise framework intended to guide users to develop their own system Questions to ask Information resources Illustrative examples How to use information to make informed decisions 60 pages Online on Nov.17, 2014

14 Step 1: Conceptual framework - likelihood Likelihood factor Testing Frequency Contribution to vulnerability Low Medium High Every lot Random lots Supplier approval CoA only None Audit strategy Firm audits 3 rd party audits None Supply chain Firm vertically integrated Supplier vertically integrated Supplier manufactures Upstream supplier manufacturers Open market Supplier relationship Testing susceptibility Dedicated Long term Limited Large number None None Low Medium Medium-High High Geo-politics Fraud history None Rumors Reported issues On-going incidents Potential public health impact None reasonable None known Potential identified Morbidity Mortality

15 Step 2: Consequence Contribution to Vulnerability Impact Type Low Medium High Food safety - Public health Brand Trade

16 Step 1+2: Overall Fraud Vulnerabilities Characterization

17 SMART analysis Vision for a SMART, RISK BASED assessment testing paradigm 1 4 Increasing risk / vulnerability Recommended Testing Extent Identification testing only Full FCC Monograph? Monograph + Monograph ++

18 Global Reach of FCC Outreach to geographies that recognize FCC Canada, Australia/New Zealand, Israel, Mercosur MOU with Chinese National Center for Food Safety Risk Assessment (CFSA) Translation of FCC into Chinese (FCC7 Chinese version Jan. 2014) USP participation in Codex Alimentarius USP now has observer status Participation of experts outside USA China, Canada, Israel, Europe

19 Creating an FCC Standard for Krill Oil New ingredient Little is known about it by consumers High value ingredient Theoretically high potential for adulteration Complex ingredient PUFAs, Phospholipids, Astaxanthin not just an oil Variability Production methods Testing methods NATURE (not easily controlled) Higher demand can mean more players in the game but do they all play FAIR?

20 Important characteristics for Krill Oil Fatty Acid Profile IDENTIFICATION Composed of triglycerides and phospholipids DHA and EPA Content ASSAY Sold (partially) as a source of these two Omega-3 fatty acids Phospholipid Content SPECIFIC TESTS - PHOSPHOLIPIDS Contains a relatively high concentration of phospholipids Amount and types are characteristic of krill source Astaxanthin Content SPECIFIC TESTS ASTAXANTHIN ESTERIFICATION A source of ESTERIFIED carotenoid Gives characteristic color AND adds stability

21 Krill Oil The Proposal (Dec 2010) Identification Fatty Acid Composition and UV-Vis Spectrum Assay DHA/EPA Content Impurities Arsenic (Inorganic), Lead, Mercury, Acetone Specific Tests Astaxanthin (Content and Esterification), Phospholipids (TLC, Qualitative Only), Quality Parameters Labeling Requirement DHA/EPA Content and presence of any other oils

22 Public Comments What We Heard Seasonal Variation Composition (extracted) affected by WHEN the krill are harvested. Quality Parameters Typical test methods used to determine the quality of oils (Iodine Value, Peroxide Value) rely on titrations with colorimetric endpoints which may not be appropriate for a colored oil. Methods Industry does not always use the same methods and means of declaration of Astaxanthin content and the differences are not always clear. Phospholipids Qualitative determination alone is insufficient.

23 The FCC Krill Oil AS REVISED Seasonal Variation Composition ranges include several years worth of data from multiple suppliers Quality Parameters Can also be calculated from the Fatty Acid Composition (not affected by oil color) Methods Astaxanthin content method changed to UV/vis (commonly used); Terminology for limits clarified Phospholipids QUANTITATIVE NMR method added, along with characteristic QUALITATIVE profile for phospholipids and appropriate limits

24 FCC Work in Oil Quality / Authenticity Source Specific Monographs Complete monographs specific for source of oil and contain fatty acid composition parameters Monographs for DHA Oils from Crypthecodenium and Schizochytrium Sterol Content Included when fatty acid composition is not sufficient for Identification Newly proposed monograph for High Gamma-Linolenic Safflower Oil Expert Panel Newly formed USP Olive Oil Authenticity and Quality Expert Panel

25 USP Olive Oil Authenticity and Quality Expert Panel Formed in 2014 Serves under Food Ingredients Expert Committee Membership includes industry and academic experts To address current issues Substitution/dilution with other oils Quality or grade improperly described Inadequate and inconsistent international standards Regional / seasonal variability

26 Opportunities to Work Together Collaborative Research Projects Skim milk powder adulteration methods Donation of skim milk powders Submit entries for the USP Food Fraud Database Volunteer for a USP Expert Committee or Panel New monographs, standards, tools Formal submission to USP All suggestions WELCOME! 26

27 USP food ingredient expert committee USP s Expert Panel on Food Ingredients Intentional Adulterant USP staff