Dataset Information

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

ABSTRACT: The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of mono- and di-glycerides of fatty acids (E 471) when used as a food additive. 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. Glycerol (E 422) and fatty acids (E 570) have been re-evaluated and the Panel concluded that there was no safety concern regarding their use as food additives. Toxicological studies with mono- and di-glycerides rich in unsaturated fatty acids were considered for the re-evaluation of E 471. No evidence for adverse effects was reported in short-term, subchronic studies, chronic, reproductive and developmental toxicity studies. Neither carcinogenic potential nor a promotion effect in initiation/promotion was reported. The available studies did not raise any concern with regard to genotoxicity. The refined estimates were based on 31 out of 84 food categories in which E 471 is authorised. The Panel noted that the contribution of E 471 represented at the mean only 0.8-3.5% of the recommended daily fat intake. Based on the approach described in the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010 and taking into account the considerations mentioned above, the Panel concluded that there was no need for a numerical acceptable daily intake (ADI) and that the food additive mono- and di-glycerides of fatty acids (E 471) was of no safety concern at the reported uses and use levels. The Panel recommended some modifications of the EU specifications for E 471.

SUBMITTER: EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)

PROVIDER: S-EPMC7010209 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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

Younes Maged M Aggett Peter P Aguilar Fernando F Crebelli Riccardo R Dusemund Birgit B Filipič Metka M Frutos Maria Jose MJ Galtier Pierre P Gott David D Gundert-Remy Ursula U Kuhnle Gunter Georg GG Leblanc Jean-Charles JC Lillegaard Inger Therese IT Moldeus Peter P Mortensen Alicja A Oskarsson Agneta A Stankovic Ivan I Waalkens-Berendsen Ine I Woutersen Rudolf Antonius RA Wright Matthew M Boon Polly P Chrysafidis Dimitrios D Gürtler Rainer R Mosesso Pasquale P Tobback Paul P Rincon Ana Maria AM Horvath Zsuzsanna Z Lambré Claude C

EFSA journal. European Food Safety Authority 20171110 11

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of mono- and di-glycerides of fatty acids (E 471) when used as a food additive. 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. Glycerol (E 422) and fatty acids (E 570) have been re-evaluated and the Panel con ...[more]

PMID: 32625340

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Project description:The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was no reliable information regarding the absorption, distribution, metabolism, excretion (ADME) for TOSOM. No adverse effects have been detected in a limited subchronic toxicity study in pigs. The Panel identified a no observed adverse effect level (NOAEL) of 5,400, the highest dose tested, from a chronic and carcinogenicity study in rats. No genotoxicity data were available. No reliable studies for reproductive or developmental toxicity were available. From the chronic and carcinogenicity study, no lesions in reproductive organs were described and the lack of carcinogenic effect alleviated the concern for genotoxicity at the first site of contact. The Panel concluded that the available toxicological data were insufficient to support the current ADI, in particular, due to the lack of ADME data and absence of developmental toxicity studies TOSOM (E 479b) is only authorised in one food category and only one reported use level that equals the maximum permitted level was submitted. The estimated high (P95) exposure reached an upper value of 10.1 mg/kg bw per day for toddlers. When comparing the highest estimated exposure of 10 mg/kg bw per day in toddlers with the NOAEL of 5,400 mg/kg bw per day (the highest dose tested), the margin of safety (MoS) would be 540. Therefore, the Panel considered the use of TOSOM (E 479b) to be of no safety concern, in particular when considering the limited current use of this food additive. The Panel also recommended some modifications of the EU specifications for E 479b.

Project description:The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of propane-1,2-diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane-1,2-diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short-term studies in rats and dogs at the highest doses tested. The Panel considered that E 477 did not raise a concern for genotoxicity. No chronic toxicity, carcinogenicity, reproductive and developmental toxicity studies with propane-1,2-diol esters of fatty acids were available to the Panel. The Panel considered that any potential adverse effect of propane-1,2-diol ester of fatty acids would be due to propane-1,2-diol, previously re-evaluated as a food additive and for which an ADI of 25 mg/kg bw per day was established. Considering the overall metabolic and toxicity database, the Panel confirmed the previously established ADI for propane-1,2-diol esters of fatty acids (E 477) of 25 mg/kg bw per day expressed as propane 1,2 diol. This corresponds to an ADI for E 477 of 80 mg/kg bw per day, based on the concentration of free and bound propane-1,2-diol amounting to a maximum of 31% as laid down in the EU specification. The Panel concluded that there would not be a safety concern at the reported use levels for E 477 because exposure estimates from the refined non-brand loyal scenario did not exceed the ADI for E 477 in any of the population groups. However, the Panel aims to explore the feasibility of establishing a group ADI for those food additives that result in an exposure to propane-1,2-diol, such as E 477, E 1520 and E 405. Additionally, the Panel will also consider performing a combined exposure assessment to propane-1,2-diol resulting from the use of these food additives. The Panel also recommended some modifications of the EU specifications for E 477.

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Dataset Information

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

Publications

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

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