Scientific Opinion on Flavouring Group Evaluation 501 (FGE.501): Grill flavour concentrate (vegetable)

Abstract The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to deliver a scientific opinion on the implications for human health of the product Grill flavour concentrate (vegetable) [FL‐no: 21.002] in the Flavouring Group Evaluation 501 (FGE.501), according to Regulation (EC) No 1331/2008 and Regulation (EC) No 1334/2008 of the European Parliament and of the Council. The product is derived from heat‐treated canola oil and intended to be used as a food flavouring with grilled aroma in a wide variety of food categories. Information on manufacturing and compositional data was considered adequate to show the reproducibility of the production process. The chronic dietary exposure to the substance estimated using the added portions exposure technique (APET) was calculated to be 0.402 and 0.252 mg/person per day for a 60‐kg adult and for a 15‐kg child, respectively. Based on exposure estimate and the results from the repeated‐dose toxicity studies, a sufficient margin of safety could be calculated. However, the Panel noted that for six constituents of the flavouring there is an indication for genotoxicity. Therefore, these six substances have to be further considered. Until these evaluations have been finalised the safety of Grill flavour concentrate (vegetable) cannot be fully assessed.

[1]  Flavourings.  Public consultation on the draft scientific guidance on the data required for the risk assessment of flavourings to be used in or on foods , 2010, EFSA Supporting Publications.

[2]  R. Benigni,et al.  Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones , 2019, EFSA journal. European Food Safety Authority.

[3]  Juan Manuel Parra Morte,et al.  Genotoxicity assessment of chemical mixtures , 2018, EFSA journal. European Food Safety Authority.

[4]  T. Husøy,et al.  Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19 , 2018, EFSA journal. European Food Safety Authority.

[5]  J. Cravedi,et al.  Scientific Opinion on Flavouring Group Evaluation 203, Revision 2 (FGE.203Rev2): α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double‐bonds and with or without additional non‐conjugated double‐bonds , 2018, EFSA journal. European Food Safety Authority.

[6]  José Cortiñas Abrahantes,et al.  Update: use of the benchmark dose approach in risk assessment , 2017, EFSA journal. European Food Safety Authority.

[7]  Efsa Publication.  Scientific opinion of Flavouring Group Evaluation 205 Revision 1 (FGE.205Rev1): consideration of genotoxicity data on representatives for 13 α,β-unsaturated aliphatic ketones with terminal double bonds and precursors from chemical subgroup 1.2.2 of FGE.19 , 2016 .

[8]  Flavourings.  Scientific Opinion on Flavouring Group Evaluation 212 Revision 3 (FGE.212Rev3): α,β-unsaturated alicyclic ketones and precursors from chemical subgroup 2.6 of FGE.19 , 2015 .

[9]  Flavourings.  Scientific Opinion on Flavouring Group Evaluation 204 (FGE.204): Consideration of genotoxicity data on representatives for 18 mono-unsaturated, aliphatic, α,β-unsaturated ketones and precursors from chemical subgroup 1.2.1 of FGE.19 by EFSA , 2012 .

[10]  Flavourings.  Scientific Opinion on Flavouring Group Evaluation 67, Revision 1 (FGE.67Rev.1): Consideration of 40 furan-substituted aliphatic hydrocarbons, alcohols, aldehydes, ketones, carboxylic acids and related esters, sulfides, disulfides and ethers evaluated by J: Flavouring Group Evaluation 67, Revision 1 , 2011 .

[11]  Flavourings.  EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Flavouring Group Evaluation 13, Revision 2 (FGE.13 Rev2) Furfuryl and furan derivatives with and without additional side-chain substituents and heteroatoms from chemical group 14 , 2011 .

[12]  Flavourings.  EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Flavouring Group Evaluation 212 Rev1 (FGE.212 Rev1):alpha,beta-Unsaturated alicyclic ketones and precursors from chemical subgroup 2.6 of FGE.19 , 2011 .

[13]  J A Swenberg,et al.  Alpha 2u-globulin nephropathy: review of the cellular and molecular mechanisms involved and their implications for human risk assessment. , 1993, Environmental health perspectives.

[14]  L. Valcovic,et al.  Hazard evaluation of chemicals that cause accumulation of alpha 2u-globulin, hyaline droplet nephropathy, and tubule neoplasia in the kidneys of male rats. , 1993, Environmental health perspectives.