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. 2020 Mar 11;18(3):e06030.
doi: 10.2903/j.efsa.2020.6030. eCollection 2020 Mar.

Re-evaluation of l(+)-tartaric acid (E 334), sodium tartrates (E 335), potassium tartrates (E 336), potassium sodium tartrate (E 337) and calcium tartrate (E 354) as food additives

EFSA Panel on Food Additives and Flavourings (FAF); Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Ursula Gundert-Remy, Trine Husøy, Wim Mennes, Romina Shah, Ine Waalkens-Berendsen, Detlef Wölfle, Polly Boon, Paul Tobback, Matthew Wright, Jaime Aguilera, Ana Maria Rincon, Alexandra Tard, Peter Moldeus

Re-evaluation of l(+)-tartaric acid (E 334), sodium tartrates (E 335), potassium tartrates (E 336), potassium sodium tartrate (E 337) and calcium tartrate (E 354) as food additives

EFSA Panel on Food Additives and Flavourings (FAF) et al. EFSA J. .

Abstract

The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on tartaric acid-tartrates (E 334-337, 354) when used as food additives. The Scientific Committee for Food (SCF) in 1990 established an acceptable daily intake (ADI) of 30 mg/kg body weight (bw) per day, for l(+)-tartaric acid and its potassium and sodium salts. The metabolism of l(+)-tartaric acid and its potassium sodium salt was shown to be species dependent, with a greater absorption in rats than in humans. No toxic effects, including nephrotoxicity, were observed in toxicological studies in which the l(+)-form was tested. There was no indication for a genotoxic potential of tartaric acid and its sodium and potassium salts. In a chronic study in rats, no indication for carcinogenicity of monosodium l(+)-tartrate was reported at the highest dose tested (3,100 mg/kg bw per day). The available studies for maternal or developmental toxicity did not report any relevant effects; no studies for reproductive toxicity were available; however, no effects on reproductive organs were observed in the chronic toxicity study. The Panel concluded that the data on systemic availability were robust enough to derive a chemical-specific uncertainty factor instead of the usual default uncertainty factor of 100. A total uncertainty factor of 10 was derived by applying a total interspecies uncertainty factor of 1 instead of 10, based on data showing lower internal exposure in humans compared to rats. The Panel established a group ADI for l(+)-tartaric acid-tartrates (E 334-337 and E 354) of 240 mg/kg bw per day, expressed as tartaric acid, by applying the total uncertainty factor of 10 to the reference point of 3,100 mg sodium tartrate/kg bw per day, approximately to 2,440 mg tartaric acid/kg bw per day. The exposure estimates for the different population groups for the refined non-brand-loyal exposure scenario did not exceed the group ADI of 240 mg/kg bw per day, expressed as tartaric acid. Some recommendations were made by the Panel.

Keywords: E 334; E 335; E 336; E 337; E 354; calcium tartrate; potassium tartrate; sodium tartrate; tartaric acid.

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Figures

Figure 1
Figure 1
Structural formula of l(+) tartaric acid
Figure 2
Figure 2
Structural formula of monosodium tartrate (anhydrous form)
Figure 3
Figure 3
Structural formula of disodium tartrate (anhydrous form)
Figure 4
Figure 4
Structural formula of monopotassium tartrate
Figure 5
Figure 5
Structural formula of dipotassium tartrate (anhydrous form)
Figure 6
Figure 6
Structural formula of potassium sodium tartrate (anhydrous form)
Figure 7
Figure 7
Structural formula of calcium tartrate (anhydrous form)
See this image and copyright information in PMC

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