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Product Safety and Stewardship
Product safety and freedom to operate through regulatory leadership and insight
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LEADING THE WAY IN PRODUCT SAFETY AND STEWARDSHIP

Using science responsibly is the way we operate, and we ensure we adhere to the strictest standards during development and manufacturing of our products. DuPont is a world leader in science-based, risk focused regulatory oversight, working closely with regulatory bodies globally to educate and advocate on current and future technology, its safety, and its benefits to society.

LEADING THE WAY IN PRODUCT SAFETY AND STEWARDSHIP

Delivering Innovation through Industry Advocacy

DuPont works across a wide range of industries, all over the world.  To deliver the best new technology and innovation to our customers, we share insights and information with industry associations and advocacy groups so that our scientific advances are understood and accepted.  We see these interactions as pivotal to our success, and the success of progress in the many industries we serve.  

Delivering Innovation through Industry Advocacy

Beyond Collaboration: Partnering with trade associations and industry groups

From establishing food safety evaluation methodologies to speaking at key industry events, DuPont's participation in  trade and industry associations allows us to continuously collaborate with stakeholders, and join the conversation around safe and sustainable industrial biotechnology development.

Beyond Collaboration: Partnering with trade associations and industry groups
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"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

DuPont 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.

OUR SAFETY ASSESSMENT FRAMEWORK

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.

READ THE FULL REPORT Link-externalurl
GRAS Notices processed by CFSAN from 1997 through 2015 Expand
The GRAS Process for Industrial Microbial Enzymes

SAFE ENZYME HANDLING GUIDELINES

The DuPont enzyme safety program has been designed to cover the key elements of enzyme safety, and provide resources to help our customers with sound risk management practices to work safely with our enzyme products.

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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.

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Publications & Conference Presentations

14 May 2018
Insights from MIFFI: Future Food Ingredients Present Innovation, Regulatory Challenges and Opportunities
In the past few years, cellular agriculture and synthetic biology have exploded onto the scene, opening up a new world of food and feed ingredients. Against the backdrop of this exponential growth, convening these conversations between regulators, companies and experts is very important.
Read more on LINKEDIN Link-externalurl
3 November 2017
How the global industrial biotech industry continuously improves its product safety evaluation processes
Establishing and maintaining a science-based, risk-focused regulatory oversight framework for industrial biotechnology products requires relevant data and effective dialogue with global stakeholders (expert groups, regulators and consumer groups) on the technology, its safety, and its benefits.
Read more on linkedin Link-externalurl
1 October 2017
Performance Enzymes for Food Ingredients at the BIO World Congress—Enabling Biotechnologies and Supporting Capabilities
Commmentary on the educational program at the July 2017 Biotechnology Innovation Organization’s World Congress in Montreal included several panels on the rapidly evolving tool box in support of industrial biotechnology.
Read more on INDUSTRIAL BIOTECHNOLOGY Link-externalurl
7 August 2017
DEVELOPMENT & COMMERCIALIZATION OF PERFORMANCE ENZYMES FOR FOOD
Presentation from the 2017 BIO World Congress
Read more on bio.org Link-externalurl
1 October 2016
The Generally Recognized as Safe (GRAS) Process for Industrial Microbial Enzymes
The Generally Recognized as Safe (GRAS) process is well suited for enzymes, given the general availability of scientific data supporting enzyme safety, and the generally recognized (peer-reviewed) methodology and decision trees for evaluating the safety of microbial enzymes used in food processing and in animal feed, respectively. In this paper we describe the elements of a safety evaluation of an enzyme used in food and feed and how the available published data and information related to each element can form the basis for a determination of GRAS for an intended use.
Read more on INDUSTRIAL BIOTECHNOLOGY Link-externalurl
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