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.

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

GRILLI, SANDRO;
2010

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.
F. Aguilar; B. Dusemund; P. Galtier; J. Gilbert; D.M. Gott; S. Grilli; R. Gürtler; J. König; C. Lambré; J-C. Larsen; J-C. Leblanc; A. Mortensen; D. Parent-Massin; I. Pratt; I.M.C.M. Rietjens; I. Stankovic; P. Tobback; T. Verguieva; R.A. Woutersen.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11585/101826
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