Re-evaluation of mono- and di-glycerides of fatty acids (E 471)

Re-evaluation of mono- and di-glycerides of fatty acids (E 471)

Mono- and di-glycerides of fatty acids (E 471) is authorised as a food additive in the European Union (EU) in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008 on food additives and specific purity criteria have been defined in the Commission Regulation (EU) No 231/2012. The Scientific Committee on Food (SCF) concluded that the use of mono- and di-glycerides of fatty acids in nutrient preparations for use in infant formulae and follow-on formulae is acceptable within the direct additive limit of 4 g/L and for use in weaning foods within the direct additive limit of 5 g/kg. The Panel noted that this food additive has not been evaluated for its other authorised uses as a food additive in EU.

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.

In rats, only traces of cottonseed oil monoglycerides were found in the faeces, indicating that after hydrolysis, the components were well absorbed (97.8 ± 0.4%). In another study, the absorption of hydrolysis products from diglycerides of fatty acids was calculated to be 58.8 ± 14.3%.

The Panel noted that the diacylglycerol (diglyceride) used in several toxicity studies described below was intended to be used for nutritional purposes (as an edible oil substitute) and that it had a composition rich in unsaturated fatty acids (> 95%). The Panel further noted that its composition made this material acceptable with regard to the specifications of E 471. The Panel considered that the results of the toxicological studies with these diacylglycerols can be used for the assessment of E 471.

No study was available to evaluate the acute toxicity of E 471. No evidence for adverse effects were reported in short-term and subchronic studies in rats and hamsters even at the highest dose tested of 2,500 mg diacylglycerol/kg body weight (bw) per day in the rats and 7,500 mg glyceryl stearate/kg bw per day in hamsters.

The Panel considered that the available studies did not raise any concern with regard to genotoxicity.

No adverse effects were reported in chronic toxicity studies at doses as high as 7,800 and 2,000 mg diacylglycerol/kg bw per day in mice and rats, respectively. In mice and rats, diacylglycerol did neither show carcinogenic potential nor a promotion effect in initiation/promotion studies.

The refined estimates were based on 31 out of 84 food categories in which mono- and di-glycerides of fatty acids (E 471) is authorised. The Panel considered that the uncertainties identified would, in general, result in an overestimation of the exposure to mono- and di-glycerides of fatty acids (E 471) as a food additive in European countries for the refined scenario as the food additive may not be used in food categories, for which no usage data have been provided.

However, the Panel noted that considering information from the Mintel’s Global New Products Database (GNPD), mono- and di-glycerides of fatty acids (E 471) is used in food categories for which no use levels have been provided to the European Food Safety Authority (EFSA). The main food categories, in terms of amount consumed, for which no use levels reported were: unripened cheese, different kinds of pasta, processed fish and fishery products including molluscs and crustaceans, processed eggs and egg products and salads and savoury-based sandwich spreads. The Panel further noted that the exposure to mono- and di-glycerides of fatty acids (E 471) from their use according the Annex III to Regulation (EC) No 1333/2008 (Parts 1, 2, 3, 4, and 5 A and B) was not considered in the exposure assessment. Therefore, the exposure to mono- and di-glycerides of fatty acids (E 471) may be underestimated in all scenarios.

The Panel noted that in Annex II of Regulation (EC) No 1333/2008, use levels of mono- and di-glycerides of fatty acids (E 471) in food for infants under the age of 12 weeks are included in category 13.1.1, 13.1.5.1 and 13.1.5.2. The Panel considered that these uses for infants under the age of 12 weeks would require a specific risk assessment in line with the recommendations given by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) (1978), the SCF (1998) and EFSA (EFSA Scientific Committee, 2017). Therefore, the current re-evaluation of mono- and di-glycerides of fatty acids (E 471) as a food additive is not applicable for infants under the age of 12 weeks.

The Panel noted that no specific clinical data addressing the safety of use of mono- and di-glycerides of fatty acids (E 471) in ‘dietary foods for infants for special medical purposes and special formulae for infants’ (food category 13.1.5.1) and in ‘dietary foods for baby and young children for special medical purposes as defined in Directive 1999/21/EC’ (food category 13.1.5.2) considering the defined maximum use levels were available to the Panel.

According to the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010 (EFSA ANS Panel, 2014) and given that:

  • in the current safety assessment carried out by the Panel, the uses and use levels reported by the food industry in 46 out of 84 food categories in which mono- and di-glycerides of fatty acids (E 471) is authorised were considered. However, only 31 food categories were taken into account for the refined exposure assessment;
  • mono- and di-glycerides of fatty acids are subjected to hydrolysis by lipases in the gastrointestinal tract to liberate glycerol and fatty acids;
  • data from the evaluation previously conducted for the food additives glycerol (E 422) and fatty acids (E 570) can be used for the evaluation of the food additive mono- and di-glycerides of fatty acids (E 471);
  • there was no indication for a genotoxic, carcinogenic or reprotoxic potential from the available data;
  • the contribution of mono- and di-glycerides of fatty acids (E 471) to the daily diet represented at the mean only 0.8–3.5% of the recommended daily fat intake;

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 that:

  • the European Commission considers lowering the current limits for toxic elements (arsenic, lead, mercury and cadmium) in the EU specifications for mono- and di-glycerides of fatty acids (E 471) 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 mono- and di-glycerides of fatty acids (E 471) 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, 2017b).
  • the European Commission considers revising the EU specifications for mono- and di-glycerides of fatty acids (E 471) including maximum limits for residual solvents which can be used when manufacturing mono- and di-glycerides of fatty acids (E 471), i.e. tert-butanol or tert-pentanol.
  • the European Commission considers revising the EU specifications for mono- and di-glycerides of fatty acids (E 471) including maximum limits for trans fatty acids because mono- and di-glycerides of fatty acids (E 471) 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 mono- and di-glycerides of fatty acids (E 471) including maximum limits for glycidyl esters because refined vegetable oil, which can be used for manufacturing of mono- and di-glycerides of fatty acids (E 471) is the only identified source of glycidyl esters of fatty acids, which are formed during deodorisation.
  • the European Commission considers revising the EU specifications for mono- and di-glycerides of fatty acids (E 471) including maximum limits for erucic acid because erucic acid can be present among the fatty acids in edible oils which can be used for manufacturing of mono- and di-glycerides of fatty acids (E 471).
  • more data should be generated to decrease uncertainty arising from the from the occurrence of compounds of toxicological concern (e.g. 3-monochloropropane-1,2-diol (3-MCPD) or glycidyl esters), which can be produced under certain processing conditions from the food additive mono- and di-glycerides of fatty acids (E 471).

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