Red Arrow New grill flavor for the EU
The company continues to demonstrate its due diligence with an extensive safety evaluation plan, initiated in 2017, to go above and beyond answering any questions that EFA had cited in their opinions of 2017 which indicated that more data was required.
According to Nancy Higley, Ph.D., Vice President Regulatory and Toxicology External Affairs, the Red Arrow program is designed to meet the global standards of food safety evaluation. The following studies are being conducted:
• Characterization of unknown fraction: Although it can be inferred from the manufacturing process that the majority of the product is derived from the starting oil material, Red Arrow has an extensive analytical program using state of the art reference libraries to further identify the unknown fractions of Grillin’ 5078 and Grillin’ CB-200SF. Preliminary unaudited results: As expected, the >400 constituents in these Grillin’ flavors are fatty acids and phospholipids typically found in the starting oil material.
• Exposure refinement: Although there is a history of safe use of Grillin’ flavors, Red Arrow has revisited the use levels and engaged an expert third party to estimate the consumption of these grill flavors. There are several acceptable methods to determine exposure to flavoring substances. Red Arrow has chosen the Added Portions Exposure Technique (APET). APET was developed by EFSA and is an adaptation of the method acceptable by the Joint Expert Committee on Food Additives (JECFA) of the World Health Organization (WHO). Preliminary unaudited results: Based on the normal and maximum use levels for adults and children, the exposure estimates continue to indicate adequate margins of safety for the current consumption of Grillin’ flavors. In addition, the results support the doses planned for the feeding study.
• Toxicology study: Reverse bacterial mutation using preincubation. Although previously the external scientists had advised that this study was not necessary, Red Arrow has since conducted this study for both Grillin’ 5078 and Grillin’ CB-200SF. Preliminary unaudited results: Confirmed results indicate no increase in revertant colonies, therefore, no demonstration of genotoxicity. The laboratory draft report is in review.
• Toxicology study: Micronucleus study. Although previously the external scientists had advised that this study was not necessary, Red Arrow is conducting this study for Grillin’ CB-200SF. Preliminary unaudited results: No preliminary data is currently available.
• Toxicology Study: Subchronic study. Although EFSA has not indicated the necessity of this study, Red Arrow is demonstrating its commitment to the safety program by conducting this study for both Grillin’ 5078 and Grillin’ CB-200SF. Preliminary unaudited results: Confirmed that a dietary route of exposure is acceptable by the animals and technically feasible. The 14-day, dose-range study on Grillin’ CB-200SF indicated no in-life adverse effects and no adverse macroscopic observations upon necropsy.
Red Arrow is proceeding to conduct the 90-day study in accordance with global standards and consideration of the completed exposure assessment.
All unaudited data and reports reviewed to date demonstrate no safety concerns. The company continues to complete this very extensive program and continues to support that Grillin’ 5078 and Grillin’ CB-200SF are safe under the conditions of intended use. Red Arrow Products will continue to keep the industry updated as more results from these studies become available.
The company has created a new grill flavor that is approved for use in the EU and is identical in flavor characteristics to the legacy grill flavors. It is named Grillin’ RA18016. The new product is a natural flavouring that brings the authentic grill impact customers have come to expect from the creators of the gold standard for grill flavors.