Scientific Opinion on Flavouring Group Evaluation 78, Revision 1 (FGE.78Rev1): Consideration of aliphatic and alicyclic and aromatic hydrocarbons evaluated by JECFA (63rd meeting) structurally related to aliphatic and aromatic hydrocarbons evaluated by EF

Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 24 aliphatic, alicyclic and aromatic hydrocarbons evaluated by the JECFA (65th meeting). In the previous version of FGE.78, the Panel concluded that for 13 substances no applicable NOAEL was available for the substance itself or on a structurally related compound and therefore further data were required. Additional data (long term study of toxicity, mutagenicity studies and new tonnage figure) have now become available for beta‐myrcene [FL‐no: 01.008] and the present revision of FGE.78, FGE.78Rev1, includes the evaluation of these data. The substances were 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. Two substances [FL‐no: 01.011 and 01.013] are genotoxic in vitro and potentially carcinogenic, and are therefore not evaluated using the Procedure. The Panel concluded that the nine substance [FL‐no: 01.002, 01.005, 01.006, 01.010, 01.016, 01.019, 01.020, 01.045 and 01.077] do not give rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach. For 13 substances [FL‐no: 01.003, 01.004, 01.007, 01.008, 01.009, 01.014, 01.017, 01.018, 01.024, 01.026, 01.029, 01.040 and 01.061] additional toxicity data are requested. For one substance [FL‐no: 01.024] EU production figure is needed to finalise the evaluation. Besides the safety assessment of these substances, the specifications for the materials of commerce have been considered. For two substances [FL‐no: 01.018 and 01.061] the isomeric composition is lacking. For 14 substances [FL‐no: 01.004, 01.007, 01.008, 01.009, 01.017, 01.018, 01.019, 01.020, 01.024, 01.026, 01.029, 01.040, 01.045 and 01.061] further information on the composition of mixture is requested.

Toxicity Assessment of Refill Liquids for Electronic Cigarettes

“…The other products contained limonene in quantities below or in the range of MSDI USA. The level of alpha-pinene present in H60376 (14 mg for 3 g ingested) was 6 times above the MSDI-EU limit of 2.2 mg/pers/day cited by EFSA, calculated for a person of 60 kg [32]. Beta-pinene was detected in H60376 at levels corresponding to a daily intake more than 100 times above the MSDI USA limit of 760 µg/pers/day (MSDI EU of 1.3 mg/pers/day) [32], indicating a potential risk from oral chronic exposure.…”

“…The level of alpha-pinene present in H60376 (14 mg for 3 g ingested) was 6 times above the MSDI-EU limit of 2.2 mg/pers/day cited by EFSA, calculated for a person of 60 kg [32]. Beta-pinene was detected in H60376 at levels corresponding to a daily intake more than 100 times above the MSDI USA limit of 760 µg/pers/day (MSDI EU of 1.3 mg/pers/day) [32], indicating a potential risk from oral chronic exposure. Gamma-terpinene was also found in H60376 at levels leading to a total daily intake more than 100 times above the MSDI USA level of 321 µg/pers/day [32].…”

“…Beta-pinene was detected in H60376 at levels corresponding to a daily intake more than 100 times above the MSDI USA limit of 760 µg/pers/day (MSDI EU of 1.3 mg/pers/day) [32], indicating a potential risk from oral chronic exposure. Gamma-terpinene was also found in H60376 at levels leading to a total daily intake more than 100 times above the MSDI USA level of 321 µg/pers/day [32]. The intake of benzene 1-methyl-4-(1-methylethyl) from H60376 represented almost 35 times the MSDI USA limit of 470 µg/pers/day [32].…”

“…Gamma-terpinene was also found in H60376 at levels leading to a total daily intake more than 100 times above the MSDI USA level of 321 µg/pers/day [32]. The intake of benzene 1-methyl-4-(1-methylethyl) from H60376 represented almost 35 times the MSDI USA limit of 470 µg/pers/day [32]. Consequently, the sample H60376 ( Amaretto Stone Sour from Tasty Vapor ) revealed a potential for oral toxicity from chronic daily exposure.…”

Myrcene—What Are the Potential Health Benefits of This Flavouring and Aroma Agent?

“…In contrast, the susceptibility of different strains of rats to renal carcinogenicity varies widely (27), with Bastaki et al, finding a lack of renal toxicity to β-myrcene when using Sprague-Dawley rats. In addition, the B6C3F1 male mice included in the NTP study are recognised for having a high and variable background incidence of hepatocellular tumours; on this basis the EFSA has rejected its relevance for human health (144). Furthermore, based on this review, numerous studies have indicated the anti-mutagenic and anti-metastatic effects of β-myrcene on several different cancer cell lines (25,145), highlighting the positive effects of β-myrcene on cancer prevention.…”