Following a request from the European Commission, the European Food Safety Authority (EFSA) asked the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) to deliver a scientific opinion to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, EFSA was requested to carry out a safety assessment of one flavouring substance (candidate substance) in the Flavouring Group Evaluation 401 (FGE.401) in accordance with Commission Regulation (EC) no. 1334/2008.
The candidate substance, γ-glutamyl-valyl-glycine [FL-no: 17.038], is a synthetic substance; however, it has been identified as a natural component in vegetable and animal materials and has been quantitated in some unprocessed and processed food.
According to the applicant, γ-glutamyl-valyl-glycine [FL-no: 17.038] is intended to be used to modify and balance the total flavour bringing out the middle to afternote and adds brothy, creamy flavours similar to that of well-cooked stew.
The dietary exposure to the candidate substance from use as a flavouring substance is calculated to be 92 μg/kg bw/day in a 60 kg adult and 231 μg/kg bw/day in a 15 kg three-year old child. The Panel is aware that the flavouring substance is not intended to be used in the food categories specifically intended for infants and young children, however, they may also consume food from the general food categories flavoured with the candidate substance. Nevertheless, as the safety assessment of the substance is based on exposure to the separate amino acids, the Panel considers this to be of no safety concern.
There was no indication of a genotoxic potential of the candidate substance in the bacteria reversion mutation assays, in an in vitro chromosome aberration assay or in an in vivo micronucleus test.
Since it can be assumed that the candidate substance γ-glutamyl-valyl-glycine [FL-no: 17.038] is rapidly hydrolysed to its individual amino acids after consumption, the Panel based its risk assessment on the hydrolysis products, the three individual amino acids, L-glutamic acid (evaluated by the JECFA, JECFA no 1420), L-valine [FL-no: 17.028] (evaluated by the EFSA in FGE.26Rev1) and glycine [FL-no: 17.034] (evaluated by the JECFA, JECFA no 1421 and considered by EFSA in FGE.79). The human exposure to these three endogenous amino acids through food is orders of magnitude higher than the anticipated levels of exposure from their use as flavouring substances. Therefore, these three substances were not taken through the Procedure and the Panel concluded that the substances were not of safety concern at their estimated levels of intake as flavouring substances.
The specifications for [FL-no: 17.038] are considered adequate according to Commission Regulation (EC) no 1334/2008.
Based on the above considerations, the candidate substance γ-glutamyl-valyl-glycine [FL-no: 17.038] is not considered to be of safety concern at its estimated level of intake as flavouring substance.