Re‐evaluation of glycerol (E 422) as a food additive

Abstract

The ANS Panel provides a scientific opinion re-evaluating the safety of glycerol (E 422) used as a food additive. In 1981, the Scientific Committee on Food (SCF) endorsed the conclusion from the Joint FAO/ WHO Expert Committee on Food Additives (JECFA) in 1976 of 'acceptable daily intake (ADI) for man not specified'. The Panel concluded that glycerol has low acute toxicity and that local irritating effects of glycerol in the gastrointestinal tract reported in some gavage studies was likely due to hygroscopic and osmotic effects of glycerol. Glycerol did not raise concern with respect to genotoxicity and was of no concern with regard to carcinogenicity. Reproductive and prenatal developmental studies were limited to conclude on reproductive toxicity but no dose-related adverse effects were reported. None of the animal studies available identified an adverse effect for glycerol. The Panel conservatively estimated the lowest oral dose of glycerol required for therapeutic effect to be 125 mg/kg bw per hour and noted that infants and toddlers can be exposed to that dose by drinking less than the volume of one can (330 mL) of a flavoured drink. The Panel concluded that there is no need for a numerical ADI and no safety concern regarding the use of glycerol (E 422) as a food additive at the refined exposure assessment for the reported uses. The Panel also concluded that the manufacturing process of glycerol should not allow the production of a food additive, which contains genotoxic and carcinogenic residuals at a level which would result in a margin of exposure below 10,000. The Panel recommended modification of the EU specifications for E 422. The Panel also recommended that more information on uses and use levels and analytical data should be made available to the Panel.

Re‐evaluation of mono‐ and di‐glycerides of fatty acids (E 471) as food additives

“…Glycerol is used in the manufacturing process of mono‐ and di‐glycerides of fatty acids (E 471) and, therefore, the recommendations made by the Panel for the specifications of glycerol (E 422) used as a food additive (EFSA ANS Panel, ) should apply to the EU specifications for E 471.…”

“…Accordingly, the Panel considered that it is very likely that hydrolysis of mono‐ and di‐glycerides of fatty acids by lipases in the gastrointestinal tract would occur, resulting in the release of glycerol and fatty acids. The Panel re‐evaluated glycerol (E 422) and fatty acids (E 570) as food additives and concluded that there was no safety concern regarding their use as food additives (EFSA ANS Panel, ,b).…”

“…Information on the manufacturing processes of glycerol has been considered by the ANS Panel in the re‐evaluation of glycerol (E 422) (EFSA ANS Panel, ). The Panel noted that glycerol (E 422) can be produced by a variety of methods and that many of them lead to the presence or formation of contaminants, which are of toxicological concern.…”

Re‐evaluation of polyglycerol esters of fatty acids (E 475) as a food additive

“…The Panel recommended that: the European Commission considers lowering the current limits for toxic elements (arsenic, lead, mercury and cadmium) in the EU specifications for PEFA (E 475 in order to ensure that the food additive will not be a significant source of exposure to these toxic elements in food. the European Commission considers revising the EU specifications for PEFA (E 475) including maximum limits for epichlorohydrin and glycidol, given that during the manufacturing processes of polyglycerols these genotoxic impurities could be present. the European Commission considers revising the EU specifications for PEFA (E 475) including maximum limits for trans fatty acids because PEFA (E 475) can be manufactured by glycerolysis of hydrogenated fats and/or oils, which contain significant amounts of trans fatty acids. the European Commission considers revising the EU specifications for PEFA (E 475) including maximum limits for glycidyl esters/glycidol and 3‐monochloropropane‐1,2‐diol (3‐MCPD) esters, because it is likely that residues of those substances occur in the food additive PEFA (E 475), if they were present in the raw materials used in the manufacturing of the food additive by transesterification. the European Commission considers revising the EU specifications for PEFA (E 475) including maximum limits for erucic acid since erucic acid can be present among the fatty acids in edible oils, which can be used for manufacturing of PEFA (E 475). the European Commission considers revising the EU specifications for PEFA (E 475) including maximum limits for impurities currently included in the EU specifications for glycerol (E 422) or recommended by the Panel in the re‐evaluation of glycerol (E 422) (EFSA ANS Panel, ,b,c). …”

“…Furthermore, the Panel noted that the absorption of intact PEFA before hydrolysis to polyglycerols and fatty acids in the gastrointestinal tract is extremely low. The safety of polyglycerols and specific fatty acids has recently been assessed in the opinions on the re‐evaluation of polyglycerol polyricinoleate (E 476) (EFSA ANS Panel, ) and of fatty acids (E 570) (EFSA ANS Panel, ). No adverse effects of polyglycerols or specific fatty acids were identified in studies reported in those opinions.…”