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Summary

Following a request from the European Commission to the European Food Safety Authority (EFSA), the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the safety in use as food additive of sucrose esters of fatty acids produced from an alternative route by reacting sucrose and vinyl esters of fatty acids. In addition the applicant has requested an extension of the use of sucrose esters of fatty acids to allow the additives to be used in flavourings in order to improve solubility of the flavouring in water based beverages.

Sucrose esters of fatty acids (E 473) are authorised for use in a number of foods via Directive 95/2/EC of the European Parliament and Council on food additives other than colours and sweeteners. Sucrose esters of fatty acids were evaluated by the EC Scientific Committee for Food (SCF) in 1992. At that time the SCF established a group ADI of 0-20 mg/kg bw/day (expressed as sucrose monostearate) for sucrose esters of fatty acids and sucroglycerides derived from palm oil, lard and tallow fatty acids. In 2004, in light of new studies which had been provided, EFSA re-examined the safety of these food additives and established a group ADI of 40 mg/kg bw/day for sucrose esters of fatty acids (E 473) and sucroglycerides (E 474). However, sucrose ester of lauric acid were not considered in these evaluations.

Sucrose esters of fatty acids (and sucroglycerides) were evaluated by JECFA in 1992 and 1995. In the later evaluation JECFA allocated a temporary group ADI of 0-20 mg/kg bw/day (WHO, 1995). JECFA made the ADI temporary and requested the results of a well designed and conducted tolerance study for review in 1997 (WHO, 1995). This study was submitted and evaluated by JECFA in 1997 and a full group ADI of 0-30 mg/kg bw was established (WHO, 1998).

In 2009, JECFA established a group ADI of 0-30 mg/kg bw/day for sucrose esters of fatty acids, sucroglycerides and sucrose oligoesters type I and type II (JECFA, 2009).

The present opinion deals with the safety of sucrose esters of fatty acids (monoesters of lauric acid, myristic acid, palmitic acid, and stearic acid) produced by an alternative route by reacting sucrose and vinyl esters of fatty acids. The new manufacturing process results in residue levels of vinyl esters of fatty acid from <10-111 mg/kg, acetaldehyde (formed from the vinyl portion of the vinyl fatty acid esters) levels from 20-48 mg/kg, and not detectable (<0.1 mg/kg) levels of p-methoxyphenol (stabiliser) in the sucrose esters of fatty acids manufactured by this process.

In addition, the opinion has considered whether a requested extension of the use of sucrose esters of fatty acids in flavourings in water based beverages will increase the total intake of sucrose esters of fatty acids.

The Panel concludes that these monoesters are extensively hydrolysed in the gastrointestinal tract into the constituent fatty acids and sucrose prior to absorption. The Panel considers that there is no reason to believe that the sucrose monoesters of fatty acids per se produced by the new manufacturing process should in any way have biological or toxicological effects different from those of sucrose monoesters of fatty acids produced by the currently-used manufacturing methods.

The Panel notes that lauric acid is a natural dietary constituent found at relatively high concentrations in a number of foods, but that no specific toxicological data are available on the sucrose ester of lauric acid. The Panel considers that although the available data on the toxicological profile of lauric acid are limited, they do not give rise to specific concerns.

The maximum residual level of vinyl esters of fatty acids in sucrose esters of fatty acids, as reported by the petitioner, is around 111 mg/kg. The daily average and high level (95th percentile) exposure of Irish adults to vinyl fatty acid esters from all foodstuffs, in which sucrose esters of fatty acids are permitted, has been estimated by the Panel at 3.2 and 7.1 µg/kg bw/day. Clear soft drinks contribute insignificantly with 0.001 and 0.006 µg/kg bw/day, respectively. For children, exposure is estimated at 5.7 and 13 µg/kg bw/day for the average and high level (95th percentile) intakes, respectively. In addition, according to the petitioner the vinyl esters of the fatty acids are hydrolysed in the gastrointestinal tract, the vinyl portion of the fatty acid vinyl ester instantly tautomerises to acetaldehyde and can only be detected in food in the form of acetaldehyde. The Panel concludes that the exposure to the vinyl portion of the vinyl esters of fatty acids, if present, will be very low.

The maximum residual level of acetaldehyde in sucrose esters of fatty acids, as reported by the petitioner, is 48.3 mg/kg. The daily average and high level (95th percentile) consumer exposure for Irish adults to acetaldehyde from all foodstuffs in which sucrose esters of fatty acids are permitted has been estimated by the Panel at 1.4 and 3.1 µg/kg bw/day, respectively. For children, exposure is estimated at 2.5 and 5.7 µg/kg bw/day for the average and high level (95th percentile) consumer intakes, respectively. Clear soft drinks among adults contribute marginally with 0.0005 and 0.003 µg/kg bw, respectively. Although the International Agency for Research on Cancer (IARC) recently concluded when assessing alcohol that acetaldehyde associated with alcohol consumption is carcinogenic to humans (Group 1), the Panel noted that the evaluation by IARC was mainly based on experimental data obtained from animals after inhalation exposure and on human epidemiological data considering polymorphisms of the enzymes involved in ethanol metabolism, i.e. alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH), while in the single available carcinogenicity study in which the animals were orally exposed to acetaldehyde the effects were not dose-related and no clear conclusion could be drawn from this study. In the light that acetaldehyde occurs naturally in many fruits and vegetables and other food categories, e.g. up to 132 mg/kg in orange juice and up to 10 mg/kg in bread, and that it can occur endogenously in blood plasma resulting from metabolism of ethanol and carbohydrates, the Panel considered that an additional average exposure of 1.4 µg/kg bw/day resulting from the use of sucrose esters of fatty acids as food additive would be negligible and not of safety concern.

The Panel notes that the maximum residual level of p-methoxyphenol in sucrose esters of fatty acids as reported by the petitioner was <0.1 mg/kg and concludes that any exposure to this impurity resulting from the use of sucrose esters of fatty acids as food additive would be negligible and not of safety concern.

The Panel therefore concludes that sucrose esters of fatty acids produced by the new manufacturing method do not present any safety concern provided the exposure is within the ADI of 40 mg/kg bw/day for sucrose esters of fatty acids and sucroglycerides.

However, the Panel notes that the EC specifications for sucrose esters of fatty acids may need to be amended to include the sucrose ester of lauric acid and to permit supercritical carbon dioxide as an approved solvent to be used for their preparation.

The Panel additionally concludes that an additional use of sucrose esters of fatty acids in fruit beverages only contributes to a few percent of the group ADI of 40 mg/kg bw/day for sucrose esters of fatty acids (E 473) and sucroglycerides (E 474) established by EFSA in 2004. The Panel notes however that Tier 2 intake estimates calculated for Irish consumers give a mean dietary exposure to sucrose esters of fatty acids of 29.1 mg/kg bw/day, and of 64.2 mg/kg bw/day at the 95th percentile, the intake by high level adult consumers being above the ADI.

The Panel notes that the mean dietary exposure of Irish children aged 5-12 years was 51.6 mg/kg bw/day, and 117.3 mg/kg bw/day at the 95th percentile. For both groups (average intake and high level consumers), the estimated intakes were above the ADI.

The Panel noted that in the refined estimates the main contribution to total mean dietary exposure was from fruits (36% and 46% for adults and children, respectively), due to the use of sucrose esters of fatty acids as a surface glazing agent. For a more refined estimate, exact usage data of sucrose esters of fatty acids in fruit would have to be known, or in absence of the former, information on the exact depth of the application layer, the types of fruit which are treated with the glazing agent and the market share of the glazing agent in comparison to other glazing agents/waxes would have to be provided.

    原文报道：http://www.efsa.europa.eu/en/scdocs/scdoc/1512.htm