An important regulatory goal has been achieved with the conclusion reached by an independent expert panel for the self-affirmed GRAS (Generally Recognized as Safe) determination of our postbiotic CRL1505® HI. This designation acknowledges the safety of the ingredient for use in foods and dietary supplements intended for human nutrition in the United States.
GRAS status represents a key step in the development and commercialization of innovative functional ingredients. It requires a comprehensive scientific evaluation demonstrating that a substance is safe for its intended use, based on publicly available evidence and expert consensus.
The GRAS determination for heat-inactivated L. rhamnosus CRL1505 (CRL1505® HI) was supported by a thorough assessment conducted by an independent panel of experts. The evaluation included the identification of the microorganism, its phenotypic and genotypic characteristics, details of the manufacturing process and product specifications, as well as the estimated dietary exposure from the intended uses. The review also considered the published scientific literature addressing the safety profile of both the microbial species and the specific CRL1505 strain.
The ingredient can be incorporated into a wide range of food and nutrition products, including dairy products, fruit and vegetable juices, water-based beverages, confectionery, dairy alternatives, shelf-stable foods, and functional or nutritional formulations. This versatility offers new opportunities for the development of innovative products targeting immune and respiratory health.
CRL1505® HI is a science-based postbiotic ingredient supported by clinical research. Studies have demonstrated its functionality in supporting respiratory health. The ingredient has been shown to stimulate the activity and circulation of dendritic cells, which play a key role in antiviral immune responses. Through this mechanism, CRL1505® HI contributes to strengthening immune defense and has been associated with a reduction in the number of symptomatic days related to respiratory conditions.
The achievement of GRAS status represents an important step toward expanding the availability of scientifically validated postbiotic ingredients for the development of next-generation functional foods and dietary supplements.