Open AccessScientific Opinion on Flavouring Group Evaluation 312 (FGE.312): 3‐[(4‐amino‐2, 2‐dioxido‐1H‐2, 1,3‐benzothiadiazin‐5‐yl)oxy]‐2, 2‐dimethyl‐N‐propylpropanamide
Author(s) -
Flavourings
Publication year - 2013
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2013.3404
Subject(s) - food contact materials , european commission , food additive , food intake , chemistry , food safety , food science , commission , psychoactive substance , food and drug administration , toxicology , food packaging , environmental health , psychology , political science , medicine , business , biology , psychiatry , law , economic policy , european union
Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate (3‐[(4‐amino‐2, 2‐dioxido‐1 H ‐2, 1,3‐benzothiadiazin‐5‐yl)oxy]‐2, 2‐dimethyl‐ N ‐propylpropanamide) [FL‐no: 16.126] in the Flavouring Group Evaluation 312, using the Procedure in Commission Regulation (EC) No 1565/2000. On the basis of the available data, it can be concluded that [FL‐no: 16.126] exhibits no genotoxic potential. The substance was evaluated through a stepwise approach (the Procedure) that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that [FL‐no: 16.126] does not give rise to safety concern at its level of dietary intake, based on the MSDI approach. Besides the safety assessment of this flavouring substance, the specifications for the material of commerce have also been considered. Adequate specifications including complete purity and identity for the material of commerce have been provided for the candidate substance.