Company CEO Robert Brooke also comments, "By introducing GRAS
Associates into the process, we can gain significant access to knowledgeable scientific expertise that is directly familiar with the regulatory approval process.
In the end, achieving GRAS
status is worth considering when developing a novel ingredient.
The GRAS notification process offers food manufacturers two potential routes for demonstrating the safety of their food or food ingredient.
Unlike the GRAS notification process, the information used to support the safety of a novel food can come from publicly available data and/or unpublished data.
Review Process for GRAS Notifications and Novel Food Applications
A GRAS panel is often composed of three to four independent scientific experts who rely on their area of expertise by training and their detailed analysis of available evidence to make a GRAS determination.
Furthermore, the GRAS process places the burden and cost of locating and retaining independent scientific experts on the manufacturer, rather than the FDA, eliminating the use of Agency resources required for rulemaking in the food additive petition process.
For more information on the GRAS system and how it works, visit www.
Now that GRAS has been established, we hope to develop health claims for flax.
Institute of Medicine and the National Institute of Health (NIH), as an appropriate source of omega-3 fatty acid, FDA 'official' approval of GRAS status of flax has proven elusive due to a lack of a comprehensive safety and toxicological assessment of flax.
Since 2004, Flax Canada 2015 has led the process to develop a data package to submit to the expert panel to obtain GRAS status for flax.