Ensuring the Safety of New and Existing Food Additives and GRAS Substances

1. Ensuring the Safety of New and Existing Food Additives and GRAS Substances IFT Annual Meeting July 16, 2013 Chicago, IL

2. Symposium Outline • Session Overview • Haley Stevens, IFAC • Understanding the GRAS Process • Martin Hahn, Hogan Lovells • Industry Perspectives on GRAS • Angela Lim, DuPont Nutrition & Health • How the Food Ingredient Industry has Responded to FSMA • Haley Stevens, IFAC • Priscilla Zawislak, Ashland, Inc. • Global Harmonization of Food Ingredient Specifications and the Importance of Codex • Dave Schoneker, Colorcon

3. IFAC Background The International Food Additives Council is an international association, representing companies who produce high quality substances used worldwide as food ingredients. www.foodadditives.org

4. IFAC Strives to: • Promote science-based regulation worldwide. • Increase IFAC’s involvement in international regulatory processes. • Further establish IFAC as a source of credible scientific information on food ingredients. • Organize and sponsor pertinent scientific research on food ingredients.

5. How the Food Ingredient Industry has Responded to FSMA • The food additive industry is significantly different than the food industry (e.g., production, packaging, etc.) • Food additives undergo further downstream processing by customers/manufacturers • GMPs for finished foods are not necessarily relevant to food additives • IFAC strongly supports FDA’s efforts to implement FSMA • In addition to participating in the FSMA implementation process, IFAC developed a Good Manufacturing Practices (GMP) Guide for Food Additives and GRAS Substances • Available at foodadditives.org/foodsafety

6. IFAC GMP Guide • Developed by IFAC • Food Safety Committee: • Ashland • Chr. Hansen • Colorcon • CP Kelco • Danisco (DuPont) • Decernis • FMC Corporation • ICL Food Specialties • Innophos • Kerry Ingredients & Flavours • Lubrizol Advanced Materials • Pinova • Prayon

7. IFAC GMP Guide (cont’d) • Guide development began in 2010 (completed in 2012) • Modeled after joint IPEC-PQG GMP Guide • Represents voluntary guidance for the food additive and GRAS substance industry • Provides GMP and quality assurance principles to ensure safe manufacture of food additives and GRAS substances • Incorporates FSMA requirements and may be used to supplement existing regulations in other countries • Not regulatory requirements

8. IFAC GMP Guide (cont’d) • GMP Guide Sections: • Introduction • Definitions • General Guidance • Quality Management System – Food Additive/GRAS Substance Quality Systems • Resource Management • Product Realization • Measurement, Analysis and Improvement • Appendices

9. How the Food Ingredient Industry has Responded to FSMA • Many other groups have received the Guide, including FDA, GMA, China FSMA, ETA, CCC, IACM, and others • Guide is the “go to” guide for the food ingredientindustry.

10. How the Food Ingredient Industry has Responded to FSMA • IFAC has also developed an Audit Guide to match the GMP Guide • Sections: • FOOD SAFETY & QUALITY MANAGEMENT SYSTEM-FOOD ADDITIVE GRAS SUBSTANCE QUALITY SYSTEMS • RESOURCE MANAGEMENT • PRODUCT REALIZATION • MEASUREMENT, ANALYSIS AND IMPROVEMENT • Not yet Available, but soon on foodadditives.org

11. IFAC GMP and Audit Guide Webinar • Coming in the fall 2014 • Webinar will cover details of the Guides section by section and answer any questions

12. Questions? Haley C. Stevens, Ph.D. Executive Director International Food Additives Council (404) 252-3663 hstevens@kellencompany.com