GEWR is the only glycerol ester of rosin approved for use in beverages by the European Food Safety Authority (EFSA). EFSA was petitioned by T&R Chemicals, Inc., in 2008 for the approval of GEGR as a beverage-weighting agent under E 445. A claim of chemical equivalence was put forth by the petitioner to justify use of the original GEWR toxicity test data. The EFSA Scientific Panel on Food Additives and Nutrient Sources Added to Food (ANS) reviewed the proposal and concluded that the available data was too limited to evaluate GEGR’s safety as a food additive. The panel couldn’t verify chemical equivalence of GEGR and GEWR due to the lack of critical information on composition, so toxicological data for GEWR could not be used for read-across to GEGR.
The EFSA issued a scientific opinion in 2018 after completing a re-evaluation of GEWR as a food additive. The EFSA noted that the toxicological studies that were the basis for E 445 and INS 445 approvals were based on GEWR produced from a mixture of the two species: P. palustris and P. elliottii. No comparable toxicological studies were available for GEWR originating from other pine species, and insufficient compositional information was available for those variations. Given this lack of information, determining chemical equivalence of GEWR from other pine species with GEWR originating from P. palustris and P. elliottii wasn’t possible, making read-across of toxicological data invalid.
The long-term success of GEWR as a beverage-weighting agent has required continued engagement with and active support of the regulatory process. This should be an expectation for any responsible food additive manufacturer, whether attempting to bring a new product to market or to support an existing product.
Merck is research and development manager at DRT. Reach him at firstname.lastname@example.org. Kennedy is senior vice president of Technology & Innovation at DRT. Reach him at email@example.com.