Benefits of GRAS self-affirmation under FSMA:
Expedited Process: GRAS self-affirmation provides a potentially faster and more streamlined pathway for establishing the safety of an ingredient compared to the formal GRAS notification process that involves FDA review.
Flexibility and Autonomy: Companies have the autonomy to conduct their own safety assessments and make determinations about the safety of their ingredients. This allows for greater flexibility in the evaluation process.
Cost Savings: Avoiding the formal GRAS notification process can result in cost savings, as companies do not need to engage in the extensive data compilation and submission required for FDA review.
Confidentiality: The GRAS self-affirmation process may allow companies to keep proprietary information and trade secrets confidential, as the information submitted to the FDA is not subject to public disclosure in the same way as a formal GRAS notification.
Customization: Companies can tailor their safety assessments and evaluation processes to their specific ingredients and intended uses, allowing for a more customized approach.
Timely Market Entry: The ability to self-affirm GRAS status can enable companies to bring new ingredients to market more quickly, as there is no waiting period for FDA review.
Innovation: The GRAS self-affirmation process encourages innovation by allowing companies to introduce new and innovative ingredients to the food supply without the need for extensive regulatory review.
Expertise Utilization: Companies can engage their own qualified experts to conduct safety assessments, ensuring that those with the most knowledge about the ingredient are involved in the determination process.
GRAS self-affirmation places the responsibility on companies to conduct thorough and credible safety assessments. It’s advisable to ensure that the safety assessment process follows established scientific principles and that the conclusions are well-supported by scientific evidence. Companies considering GRAS self-affirmation should also be prepared to provide documentation and evidence of their safety assessment if requested by regulatory authorities.