Ensuring the Safety of New and
Existing Food Additives and GRAS
Substances
IFT Annual Meeting
July 16, 2013
Chicago, IL
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
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
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.
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
IFAC GMP Guide
• Developed by IFAC
Food Safety Committee:
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Ashland
Chr. Hansen
Colorcon
CP Kelco
Danisco (DuPont)
Decernis
FMC Corporation
ICL Food
Specialties
– Innophos
– Kerry Ingredients
& Flavours
– Lubrizol Advanced
Materials
– Pinova
– Prayon
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
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
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
ingredient industry.
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 SYSTEMFOOD ADDITIVE GRAS SUBSTANCE QUALITY SYSTEMS
– RESOURCE MANAGEMENT
– PRODUCT REALIZATION
– MEASUREMENT, ANALYSIS AND IMPROVEMENT
Not yet Available, but soon on foodadditives.org
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
Questions?
Haley C. Stevens, Ph.D.
Executive Director
International Food Additives Council
(404) 252-3663
hstevens@kellencompany.com