Scientific Opinion on the safety of the extension of use of thaumatin (E 957)

Abstract

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.

Low-/No-Calorie Sweeteners: A Review of Global Intakes

“…A further seven studies were identified from authoritative sources [70,71,72,73,74,75,76]. These data examined exposure by various EU population groups to all seven sweeteners of interest.…”

“…These data examined exposure by various EU population groups to all seven sweeteners of interest. Most of the scientific opinions published by the EFSA examined intake in response to requests for extension of use for specific sweeteners considering the total diet [73,74] or in foods for special medical purposes (FSMPs) [75,76]. Acesulfame-K and aspartame have been the most frequently evaluated sweeteners in Europe, with intakes estimated for both sweeteners in 16 different peer-reviewed publications and in one EFSA scientific opinion.…”

“…Specifically, this involves using individual-based consumption data from national dietary surveys combined with the MPL for the respective sweeteners, in accordance with Regulation 1333/2008 [77] (Tier 2) and/or chemical concentration data (Tier 3). There were some exceptions to this approach, such as the inclusion of summary statistics derived from the EFSA Comprehensive dataset or the FAIM tool [62,68,70,73,74,78] and annual estimated per capita beverage consumption data [54,55,59]. Two assessments by the EFSA considered specific consumption scenarios based on the proposed use of sucralose and acesulfame-K in FSMPs by young children [75,76].…”

“…The high-level intake percentile has been most commonly established at the 95th percentile, which aligns with EFSA resources, such as the EFSA Comprehensive Database [79] and the FAIM Tool [4,6]. Several studies examined intakes in specific subgroups, including young children [52,53,56,60,61,62,64,70,71,72,73,74], diabetics [58,63], phenylketonurics (PKU) or subjects with severe cow’s milk protein allergy (CMPA) (who are consumers of FSMPs that are sweetened to increase palatability) [65,67]. …”

Bioproduction of the Recombinant Sweet Protein Thaumatin: Current State of the Art and Perspectives

“…The authors Higginbotham et al (1983) also denote that thaumatin does not cause any hazardous effect when used as a flavor modifier or partial sweetener within a specific level of consumption. The safety of this protein was evaluated by SCF and JECFA who concluded that thaumatin can be considered as an acceptable ingredient for use (European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources Added to Food, 2015). This sweet protein is approved within the European Union since 1984 (E957) under Annex II of Regulation (EC) No.…”