PMID 32625431 Re-evaluation of glycerol (E 422) as a food additive Agency re-evaluation opinion · EFSA Journal, 2017 No numerical intake limit needed. But infants can reach the osmotic-effect dose (125 mg/kg per hour) on under 330 mL of a flavoured drink.
Key summary
An EFSA Panel opinion re-evaluating glycerol (E 422). In 1981 the Scientific Committee for Food endorsed JECFA's 1976 conclusion of an intake limit 'not specified for man'. Acute toxicity is low, and local gastrointestinal irritation in some gavage studies was attributed to hygroscopic and osmotic effects. There was no genotoxicity or carcinogenicity concern, and while the reproductive and prenatal developmental studies were limited, no dose-related adverse effects were reported. The panel conservatively estimated the lowest oral dose producing an osmotic effect at 125 mg/kg per hour and noted that infants and toddlers can be exposed to it on less than one 330 mL can of a flavoured drink. The conclusion is no numerical intake limit and no safety concern at the refined exposure assessment, with the added condition that manufacturing must not yield genotoxic and carcinogenic residuals at a level giving a margin of exposure below 10,000.
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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. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 35770238 Follow-up of the re-evaluation of glycerol (E 422) as a food additive Agency follow-up opinion · EFSA Journal, 2022 Impurity assessment. Recommends lowering the limits for arsenic, lead, mercury, and cadmium and setting a numerical limit for acrolein.
Key summary
A follow-up to the 2017 re-evaluation addressing the data gaps identified, to support an amendment of the specifications. The panel assessed the risk from undesirable impurities present in E 422. Based on actual levels in the commercial additive it concluded that the EU maximum limits for four toxic elements (arsenic, lead, mercury, cadmium) should be lowered, and recommended setting a numerical limit for acrolein. Potential exposure to free 3-monochloropropanediol at the specification limit of 0.1 mg/kg was judged not to raise a health concern. It also recommended redefining E 422 as obtained only from vegetable oils and fats and subjected to distillation and other clean-up steps, and concluded that the technical data support amending the specifications.
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Glycerol (E 422) was re-evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow-up to that assessment, in this opinion, the Panel on Food Additives and Flavourings (FAF) addresses the data gaps identified to support an amendment of the EU specifications for E 422 in Commission Regulation (EU) No 231/2012. The Panel performed a risk assessment of undesirable impurities present in E 422. The Panel concluded that the maximum limits in the EU specifications for the four toxic elements (arsenic, lead, mercury and cadmium) should be lowered based on actual levels in the commercial food additive E 422. The Panel recommended setting a numerical limit value for acrolein in the specifications for E 422. The potential exposure to free 3-monochloropropanediol at the maximum limit of 0.1 mg/kg, as laid out in the specifications for E 422, does not give rise to a health concern. The Panel recommended to consider modifying the definition of E 422 in Commission Regulation (EU) No 231/2012 indicating that E 422 is obtained only from vegetable oils and fats and undergoes purification processes that involve distillation, and other clean up steps to obtain refined glycerol. Overall, the Panel concluded that the technical data provided support an amendment of the specifications for glycerol (E 422). ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
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