2009/SOM2/SCSC/WKSP2/014

Transcription

1 2009/SOM2/SCSC/WKSP2/014 Modernizing and Harmonizing Infant Formula and Medical Foods Nutrient Methods - Risk Management Perspective: A Stakeholder Approach for Establishing International Consensus Standards Submitted by: Abbott Laboratories Examination of Hot Issues in Risk Analysis Workshop Singapore 1-2 August 2009

2 Modernizing and Harmonizing Infant Formula and Medical Foods Nutrient Methods Risk Management Perspective: A Stakeholder Approach for Establishing International Consensus Standards Dan Schmitz Laboratory Director Analytical Research and Development - Abbott Laboratories Worldwide 100+ products Marketed in 130 countries Pediatric Similac, Isomil, Gain, PediaSure Medical Foods Jevity, Prosure, Oxepa, Perative Adult Ensure, Glucerna, Nepro, Devices Performance EAS, ZonePerfect 1

3 What is Infant Formula Infant formula is often a sole source of nutrition during the first months of life Inadequate nutrient composition can result in malnutrition resulting in disease and even death The Codex Alimentarius standard for Infant Formula (recently revised) specifies 57 separate nutrient composition requirements, many of which have narrow tolerances. There are an additional 20 non-essential nutrients which, if added, are also regulated. Risk Management Background on Essential Composition Infant Formula (IF) and Medical Foods (MF) are one of the most heavily regulated and tested categories of foods because of the vulnerable populations they serve Regulations around nutrient composition are becoming more stringent (e.g. CODEX STAN Rev. 2007), placing greater demands on the nutrient methods used to establish compliance for domestic sale and international trade Analysis of nutrients in complex matrices like IF and MF has always presented a significant analytical challenge, particularly since many of the micronutrients occupy ranges in the low ppm to ppb 2

4 Multiple and Varying Nutrient Standard Test Methods There are multiple sets of national and international standard methods for determining nutrient levels AOAC* (International) ISO (International) CEN (Europe) GB (China) BIS (India) Others They encompass a range of low tech to state of the art methods and technologies. These methods are rarely equivalent across the broad range of matrices encountered with IF or MF AOAC International (Assoc. of Official Analytical Chemists) is an independent, non-profit scientific association based in Maryland, USA which is recognized internationally for its standards development process A Trade Problem Most major manufacturers of IF and MF distribute and market their products around the world and are subject to separate national regulations and methods. Disputes originating in differences in test methods are increasing and impacting trade. The complexity of these methods makes such disputes protracted and difficult to resolve Codex has assembled a list of referee methods specifically for infant formula, but member governments acknowledge that they are not sufficiently robust to resolve most disputes. Codex member governments therefore acknowledged the need to develop, upgrade and modernize the available set of methods. 3

5 A Needed Solution Protecting the Consumer Trade disputes can have more than just a market impact, as many of these specialty products are the sole source of nutrition important to get it right and to ensure vulnerable populations have access to necessary nutrition. Ensure Safety and Facilitate Trade Robust international reference methods benefit governments and manufacturers equally by having an agreed mechanism for moderating and quickly resolving disputes regarding IF and MF compositional claims. A New Way Forward Engage all international key stakeholders, public and private International dispute resolution methods Codex Type II Definitive reference methods that can also be used to verify/validate other routine methods (proprietary or compendial) Key criteria will be accuracy and precision utilizing most robust technologies this will likely entail modernization of test methodology Specifically validated and collaboratively studied across the spectrum of infant formula and medical foods matrices Revise or add methods as new matrices warrant - proactive 4

6 AOAC Stakeholder Process Advisory Panel Reps from AOAC/IFC/Select Manufacturers and Governments Planning committee including identifying principal stakeholders Stakeholders Panel Community establishing method performance requirements and Best Practices (anticipate 40-50) Key Stakeholders (subset of above 12-15) voting members overseeing project including review/approval of method performance requirements, best practices, validation and collaboration guidelines, working groups, etc. Working Groups Experts that develop method performance requirements AOAC Conformity Assessment Process 5

7 Present Status An advisory panel is being formed which will begin assembling the stakeholder community and identifying key stakeholders The first official stakeholder meeting is tentatively planned for Sept. 09 as part of the AOAC national meeting being held in Philadelphia, USA The initial objective will be to identify the top 20 nutrient priorities and assign working groups to begin developing method performance requirements. The target is to deliver 5-10 new standards by the second year and each year thereafter Appraisal of CCNFSDU/CCMAS Recommendations for Infant Formula (TYPE II Methods) Oil Soluble Vitamin Methodology Vit A AOAC Valid and Collab Milk-based infant formula / Extraction is not applicable across all matrices Vit D EN Not Valid and Collab for IF and MF / method is written as guidance / Vulnerability is with HPLC separation Vit E EN Not Valid and Collab for IF and MF / does not discriminate natural and synthetic forms commonly used Vit K AOAC /EN14148 Valid and Collab milk/whey/soy-based formulas / Extraction is not applicable across all matrices 6

8 Appraisal of CCNFSDU/CCMAS Recommendations for Infant Formula (TYPE II Methods) Water Soluble Vitamin Methodology Vit B1- EN Not Valid and Collab for IF and MF Vit B2- EN Not Valid and Collab for IF and MF Vit B6- AOAC /EN14164 Valid and Collab milk/soy based IF Niacin EN Not Valid and Collab for IF and MF Folate AOAC Valid and Collab milk-based IF EN Not Valid and Collab for IF and MF Both Micro Assays Pantothenate AOAC Valid and Collab milk-based IF / Micro Assay Biotin EN Valid and Collab Infant Formula (? Matrix) Vit B12 AOAC Valid and Collab milk-based IF / Micro Assay Vit C EN Not Valid and Collab for IF and MF Appraisal of CCNFSDU/CCMAS Recommendations for Infant Formula (TYPE II Methods) Mineral Methodology FAAS and Spectrophotometry (Type II) vs. ICP (Type III) Practicality vs. Definitive Ref. UTM s not validated with infant formula or medical foods Gaps or Concerns Phospholipids, Amino Acids, DHA/AA/EPA, Inositol, Carnitine, Nucleotides, Carotenoids, Iodine, Prebiotics 7

9 Appraisal of CCNFSDU/CCMAS Recommendations for Infant Formula (TYPE II Methods) Fatty Acids AOAC Not Valid and Collab for IF and MF / special concern with low levels of LCPUFAs General ambiguity around total forms and reporting conventions, particularly for vitamins Next Steps - Opportunities for APEC Economies The collaborative is seeking participation from interested government and other industry stakeholders Options for participation - expert participation in Stakeholder Panel - participation of laboratories in test panels - participation in Advisory Group Explore collaborative model as potential means of developing or enhancing standards for food safety in other areas, e.g., microbiological, chemical, and economic adulteration 8

10 Contact Information Project Director: E. James Bradford, Ph.D. Executive Director and CEO AOAC INTERNATIONAL 481 N. Frederick Avenue, Suite 500 Gaithersburg, MD