Author(s): EFSA, Panel on Food Additives and Nutrient Sources Added to Food | Publication Year: 2015
Following a request from the European Commission, an exposure assessment was carried out based on the maximum permitted levels (MPLs) authorised in Annex II of Regulation (EC) No 1333/2008 for thaumatin (E 957) and the proposed increase in its use level in flavoured drinks and proposed extension of use in several food categories at the levels proposed by the applicant. The safety of thaumatin as a food additive was previously evaluated by the EU Scientific Committee on Food (SCF) in 1984 and 1988 and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1989. Following these assessments, thaumatin was considered acceptable for use, and the ADI was established as ‘not specified’. In these evaluations it was, moreover, noted that thaumatin, being a protein, undergoes digestion to normal food components. In providing a scientific opinion on the safety of the proposed extensions of use and use levels, the ANS Panel has decided that a comparison of the exposure resulting from the current uses and use levels with the exposure resulting from these additional proposed uses would be sufficient to address the safety of thaumatin. The Panel calculated that a maximum daily intake of 1.03 mg/kg bw/day of thaumatin, resulting from the exposure assessment at the current proposed uses, or 1.10 mg/kg bw/day, at the proposed new Maximum Permitted Levels (MPLs), would represent 0.12 % or 0.13 %, respectively, of the total daily protein intake for an adult. These percentages would be even lower for children of all ages. The Panel concluded, based on the existing toxicological evaluations, that the proposed extension of uses and changes to use levels would result in a margin of safety of approximately 1 300 which would not represent a safety concern.
In its assessment in 2015, EFSA concluded that there is no safety concern from the extension of use of thaumatin in several food categories.
Thaumatin (E 957) is an authorised food additive in the European Union under Annex II of Regulation (EC) No 1333/2008. It is an aqueous extract obtained from the arils of the katemfe fruit (Thaumatococcus daniellii Benth) and is composed primarily of two proteins. It may be used in several food categories, either as a sweetener (thaumatin is approximately 2 000 to 3 000 times sweeter than sucrose) or as a flavour enhancer.
Following a request from the European Commission to take into account the extension of use of thaumatin in several food categories at different permitted levels, the increase in the currently approved maximum use level (from 0.5 mg/L to 5 mg/L) in Flavoured drinks, and the use as a food additive in food flavourings (Annex III, part 4, of Regulation (EC) No 1333/2008), the EFSA Panel concluded, based on the existing toxicological evaluations, that the proposed extension of uses and changes to use levels would not represent a safety concern.