In 1990, the Scientific Committee for Food (SCF) established a group acceptable daily intake (ADI) of 30 mg/kg bw for L(+)-tartaric acid (E 334) and its potassium and sodium salts (E 335-337, 354). This was based on a chronic oral no-observed-adverse-effect level (NOAEL) in rats of 3100 mg monosodium tartrate/kg bw/day (2400 mg/kg bw/day as tartaric acid). In a new evaluation the SCF’s successor, EFSA, decided that the available data on systemic bioavailability were robust enough to increase the group ADI to 240 mg/kg bw (as tartaric acid). The point of departure was the same as that used by the SCF, but the total uncertainty factor applied by EFSA was reduced from 100 to 10. Calcium tartrate was also included in this group value.

A related opinion covers mono- and di-glycerides of tartaric acid (E 472d), diacetyltartaric acid (E 472e) and mixed acetic and tartaric acids (E 472f). EFSA determined ADIs of 480 mg/kg bw for E 472d and 600 mg/kg bw for each of E 472e and E 472f, based on the total amount of L(+)-tartaric acid released from these food additives. For other acid esters of mono- and di-glycerides of fatty acids (acetic acid E 472a, lactic acid E 472b and citric acid E 472c) there was no need for a numerical ADI.

In a third opinion, EFSA concluded that there were inadequate toxicity data on stearyl tartrate (E 483) to inform on its safety. A lack of toxicokinetic data also excluded the possibility of read-across from its constituents. As a result, the safety of stearyl tartrate could not be assessed and the ADI of 20 mg/kg bw (as tartaric acid) established by the SCF in 1978 could not be confirmed.

European Food Safety Authority (2020). Panel on Food Additives and Flavourings (FAF). 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. http://www.efsa.europa.eu/en/efsajournal/pub/6030 Acetic acid, lactic acid, citric acid, tartaric acid, mono- and diacetyltartaric acid, mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids (E 472a-f) as food additives. www.efsa.europa.eu/en/efsajournal/pub/6032 Stearyl tartrate (E 483) as a food additive. http://www.efsa.europa.eu/en/efsajournal/pub/6033

 

The above items were taken from the May 2020 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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