GRAS Notice vs. Self-Affirmed GRAS: Which One to Choose?
If you’re exploring GRAS compliance for your product, you’ve likely come across two key pathways: GRAS Notice and Self-Affirmed GRAS. At first glance, they might seem similar, but the choice between them can significantly impact your business’s regulatory strategy. Understanding the differences is crucial to ensure your product meets FDA requirements while aligning with your […]
Can You Combine Ingredients for a GRAS Conclusion?
Learn how combining ingredients can meet GRAS conclusion standards and explore FDA requirements for multi-ingredient safety evaluations.
How to Get GRAS Status for an Enzyme
Learn how to secure GRAS status for an enzyme with this step-by-step guide. Ensure compliance, reduce delays, and build trust in your ingredients.
What Changed in the EFSA Novel Food Guidance?
Discover the key updates to EFSA Novel Food Guidance, from identity to ADME testing, and learn how these changes impact novel food applications.
GRAS Pathways: When Expert Panels Are Required
Discover how Expert Panels ensure ingredient safety in the GRAS process, from unbiased reviews to recommending safety tests for regulatory success.
Why Clinical Studies Are Crucial for Your EFSA Novel Food Application?
Learn why clinical studies are vital for an EFSA novel food application. Our step-by-step guide helps ensure your product meets EU standards.
Navigating EFSA’s Transparency Rules for Novel Foods
In the world of food innovation, novel foods offer exciting chances for companies to create new products. However, these opportunities come with the challenge of following strict rules for novel foods, especially in the European Union (EU), where clear regulations and product safety are very important. The European Food Safety Authority (EFSA) plays a central […]
7 Must-Know EFSA Novel Food Regulation Changes for 2025
Is your business ready for the updates to the EFSA Novel Food Regulation? If you’re planning to introduce novel food products to the European market in 2025, understanding these changes is crucial. The updated framework, effective February 1, 2025, will impact areas such as risk assessments, labeling, and sustainability requirements. Staying informed about these updates […]
What Are the Differences Between GRAS and NDIN?
For businesses in the food and dietary supplement industries, regulatory compliance with the U.S. Food and Drug Administration (FDA) is critical. Two key pathways to ensure the safety of ingredients are the GRAS (Generally Recognized As Safe) notification and the NDIN (New Dietary Ingredient Notification). While both serve to protect consumers, they differ in terms […]
5 Key Toxicological Studies for Fast GRAS Approval
Bringing a food ingredient or additive to the market comes with many challenges, but one critical hurdle is achieving GRAS Approval from the FDA. Without it, your product can’t hit the shelves, and consumer trust in its safety won’t be secured. So, how do you ensure your ingredient passes the necessary safety evaluations? Toxicological studies […]