Beyond Collaboration: Partnering with trade associations and industry groups
"Freedom to operate in this space is hugely important."
Product Stewardship & Regulatory Leader Vincent Sewalt explains how close collaboration within the regulatory community - from trade associations to competitors - is critical to ensuring product safety.
These jointly-developed safety evaluation frameworks are providing better choices and the freedom to operate for our customers, both today and into the future.
Our safety assessment framework
Nutrition & Biosciences played a key role in the development of best practices in safety evaluation for enzymes in the food and animal feed industries. These best practices have provided a best-in-class evaluation framework for both the FDA and regulatory bodies around the world to review the safety of enzymes, ensuring product safety with focus on the risk in use. The risk-focused approach enables faster decision making in the approval process, reducing time to market for new products of low risk.
The GRAS Process for Industrial Microbial Enzymes
GRAS (Generally Recognized as Safe) is a regulatory designation by the U.S. Food and Drug Administration that exempts a food substance from FDA pre-market approval as a food additive, if it is commonly known throughout the scientific community as safe under the conditions of its intended use.
Enzymes fit the GRAS designation very well, in part based on their history of safe use in food, in part due to the use of production strains that are well documented to belong to Safe Strain Lineages, a concept recognized in the safety assessment framework. Enzyme GRAS Notices thrive in the FDA review process with very high approval rating.
Regulatory Expertise for Antimicrobial Products
Our Microbial Control professionals have substantial experience in the evolving framework of laws and regulations which govern the use of antimicrobial products under FIFRA, the various EU directives, and other similar regulatory schemes across the world. Our regulatory team not only adapts to industry trends, but anticipates and applies new regulatory and scientific strategies to add value to customer product development and registration pathways.