Scientific Opinion on the safety of glycerol esters of gum rosin for the proposed uses as a food additive

Abstract

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion evaluating the safety of glycerol esters of gum rosin (GEGR) for the proposed use as a stabilising and emulsifying food additive in certain beverages to a maximum level of 100 mg/l. The Joint FAO/WHO Expert Committee on Food Additives established a group ADI of 0-25 mg/kg bw/day for glycerol esters of wood rosin (GEWR) and GEGR and tentative specifications for GEGR pending the submission of additional data. GEGR are obtained by esterification of refined gum rosin and are described as a complex mixture of tri-and diglycerol esters of resin acids and a residual fraction of monoglycerol esters. Besides these esters, up to 4.2% free resin acids and up to 20.1% other non-acidic saponifiable and unsaponifiable substances are present in GEGR. The percentages of resin acids derived from the three fractions upon saponification of GEGR are known. However, data on the identity and quantity of individual components in the three fractions of GEGR are absent and also data on the proportions of glycerol monoesters, (1,2)-glycerol diesters, (1,3)-glycerol diesters and glycerol triesters are not provided. In view of missing toxicity studies for GEGR, analytical data were submitted to demonstrate that GEGR are chemically equivalent to GEWR which have already been authorised as a food additive by Directive 95/2/EC. Overall, the Panel concluded that the chemical and toxicological characterisation of GEGR is not adequate. The Panel also did not have sufficient information to evaluate the chemical equivalence of GEGR and GEWR on the basis of which the toxicological data obtained with GEWR could be used for read across. Therefore, the Panel concluded that the available data are too limited to conclude on the safety of GEGR as a food additive at the proposed uses and use levels. KEY WORDSGlycerol esters of gum rosin, glycerol-modified gum rosin, CAS Registry Number 8050-31-5. SUMMARYFollowing a request from the European Commission to the European Food Safety Authority (EFSA), the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to provide a scientific opinion on the safety of glycerol esters of gum rosin (GEGR) when used as a stabilising and emulsifying food additive in certain non-alcoholic flavoured cloudy drinks and certain cloudy spirit drinks to a maximum level of 100 mg/l. GEGR have been evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2009. The Committee established a group ADI of 0 -25 mg/kg bw/day for GEWR (glycerol esters of wood rosin) and GEGR. The specifications for GEGR were made tentative, pending the submission of additional data and information by the end of 2010 concerning the identity of GEGR, the resin acid composition and methods to identify the individual glycerol esters of rosins and their differentiation. Furthermore, the Committee requested the full reports of the two 90-day toxicity studies in rats performed using oral administration of GEGR, to ...

Re‐evaluation of glycerol esters of wood rosin (E 445) as a food additive

“…Therefore, the toxicological data obtained with GEWR could not be used for read across. The Panel concluded that the available data were too limited to conclude on the safety of GEGR or GETOR as food additives at the proposed uses and use levels (EFSA ANS Panel, 2010.…”

“…Analytical results on the contents of individual resin acids in GEWR measured after saponification are presented in the EFSA opinion on the safety of GEGR for the proposed use as a food additive for reasons of comparison (EFSA ANS Panel, 2010). In samples of saponificated GEWR (botanical origin not specified), the following resin acid concentrations were measured after saponification (given percentage refers to the total of each resin acid present in GEWR in bound and unbound form): abietic (19.5-26.0%), dehydroabietic (22.7-34.6%), palustric (4.29-5.90%), neoabietic (0.546-2.77%), pimaric (5.31-6.45%), isopimaric (9.35-15.0%), sandaracopimaric (5.76-6.41%) and communic (9.69-10.7%) acids (EFSA ANS panel, 2010). The given concentrations of the individual resin acids measured in GEWR samples after saponification covers the fraction of free resin acids and resin acids as hydrolysis products from esters.…”

“…Also unpublished studies conducted with GEWR and the parent compound wood rosin in the early 1960s by Industrial Bio-Test Laboratories (Documentation provided to EFSA N. 9 and 10; Documentation provided to EFSA N. 19) were available from the EFSA public call for data. The reliability of the studies is questionable since several reports conducted by Industrial Bio-Test Laboratories have been disqualified by the FDA as a result of an investigation that revealed improper practices in the conducting laboratory (Marshall, 1983;EFSA ANS Panel, 2010). Furthermore, the composition of resin acids in GEWR is expected to differ from that of the parent compound wood rosin.…”