Following a request from the European Commission, the Panel of Food Additives and Nutrient Sources added to Food (ANS) was asked to re-evaluate the safety of sodium stearoyl-2-lactylate (E 481, SSL) and calcium stearoyl-2-lactylate (E 482, CSL) when used as food additives. SSL and CSL are used as emulsifiers and stabilizers. The Panel noted that although the additives E 481 and E 482 are both described in Commission Regulation (EU) No 231/2012 and by JECFA as ‘sodium stearoyl-2-lactylate’ and ‘calcium stearoyl-2-lactylate’ respectively, it is stated that the mono-esters of lactic acid are the major components.
The Panel considered the evaluation of SSL and CSL in one opinion and the allocation of a common ADI (either singly or in combination) justified since SSL and CSL differ only due to the cation. Both, sodium and calcium are endogenous cations without toxicological relevance for the evaluation of SSL and CSL as food additives.
The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations and reviews, and additional literature that came available since then and the data available following a public call for data. The Panel noted that not all original studies on which previous evaluations were based were available for re-evaluation.
SSL is applied as a dough conditioner/emulsifier in high fat, yeast leavened baked goods. SSL is also used as an aerating agent in both dairy and non-dairy whipped toppings and desserts. It has been used in non-dairy coffee creamers where it functions both as a surfactant and complexing agent, and in whitening powder as fat replacer. CSL is used in yeast-leavened bakery products such as bread, buns, cakes, etc., and also in their respective ready-to-use mixes. As a component of the dough, CSL acts in combination with gluten to give the dough greater tolerance to virtually all processing variables. It is also used in fine bakery wares as a fat replacer. CSL may also be used as an egg-white whipping aid. Furthermore, both SSL and CSL are used in fat spreads, dairy fat spreads and blended spreads.
Maximum levels of permitted uses for SSL and CSL (either individually or in combination) have been defined in Commission Regulation (EU) No 1129/2011.The Maximum Permitted Level (MPL) for fat spreads, dietary fat spreads and blended spreads is defined in the Codex Alimentarius to be 10 000 mg/kg.
An Acceptable Daily Intake (ADI) of 0-20 mg/kg bw for SSL and CSL (either individually or in combination) was established in 1974 by JECFA on the basis of the No Observed Adverse Effect Level (NOAEL) of 1000 mg/kg bw/day in sub-chronic feeding studies in rats and an uncertainty factor of 50. A report published in 1978 by the SCF endorsed this ADI of 20 mg/kg bw/day established by JECFA. An additional evaluation is also available from the Nordic Council of Ministers. They concluded that both additives are degraded to their basic constituents, stearic acid and lactic acid after ingestion. Both metabolites are components of natural food and also part of endogenous metabolism.
In vivo and in vitro experiments with CSL labelled with 14C at the lactate moiety (Calcium stearoyl-2-[U-14C]lactylate) ([14CY]CSL) showed a nearly complete absorption of the radiolabel and hydrolysis of CSL to lactic acid and stearic acid. The biological fate of CSL is comparable in rodent and non-rodent species. The Panel noted that the toxicokinetics of SSL and CSL would be similar.
The acute oral toxicity in rats is low. Unpublished studies in rats and dogs on subacute and subchronic oral toxicity revealed a NOAEL of 5 % in the diet (corresponding to 2500 mg/kg bw/day) for SSL or CSL.
Rats appear to tolerate large doses of sodium stearoyl-2-lactylate and calcium stearoyl-2-lactylate for one year without evidence of toxicity. Dogs seem less sensitive than the rat for oral exposure to calcium stearoyl-2-lactylate.
The data on genotoxicity in vitro gave no indication for mutagenic activity in the bacterial reverse mutation assay or in a mammalian chromosome aberration test.
The Panel concluded that neither SSL and CSL nor their breakdown products stearic and lactic acid, raise concern for genotoxicity.
From the results of a one-year oral toxicity study in rats with SSL, a NOAEL was determined to be the high dose level of 5 % in the diet corresponding to 2214 mg/kg bw/day for males and 2641 mg/kg bw/day for females.
No data are available on reproductive toxicity and carcinogenicity. However, no reproductive toxic or carcinogenic effects are expected since the products of hydrolysis, stearic acid and lactic acids are constituents of natural food and part of endogenous metabolism in mammals and therefore no additional uncertainty factor would be required.
The Panel concluded that based on the NOAEL of 2200 mg/kg bw/day from a one-year toxicity study in rats and using an uncertainty factor of 100, an ADI of 22 mg/kg bw/day for sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482), either singly or in combination, can be established.
The estimated exposure to SSL and CSL occurs mainly via the consumption of flavoured fermented milk products including heat treated products, bread and rolls and fine bakery wares and is below the ADI of 22 mg/kg bw/day for all the adult population including the elderly, but exceeds the ADI for other groups of the population at mean level and for all groups of the population at high level.