Scientific Opinion on Flavouring Group Evaluation 78, Revision 2 (FGE.78Rev2): Consideration of aliphatic and alicyclic and aromatic hydrocarbons evaluated by JECFA (63rd meeting) structurally related to aliphatic hydrocarbons evaluated by EFSA in FGE.25Rev3

Abstract

] is in the process of being deleted from the Union List. This revision is owing to additional genotoxicity data on β-caryophyllene .007] and 90-day studies in rats on β-caryophyllene .007] and myrcene [FLno: 01.008]. The substances were evaluated through a stepwise approach that integrates information on structureactivity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The specifications for the materials of commerce are adequate for all substances. The Panel concluded that the 21 aromatic, aliphatic and alicyclic hydrocarbons 01.024, 01.026, 01.029, 01.040, 01.045 .029] based upon the respective MSDI for these substances and the NOAEL for ß-caryophyllene, range between 7400 and 1.1x10 7 . The Panel agrees that this provides sufficient safety margins and that these flavouring substances can be evaluated at step B4 in the Procedure as being of no safety concern.For four substances 01.018, 01.040 and 01.061] adequate margins of safety compared to the estimated levels of intake were estimated based upon a NOAEL from a 90-day study in rats, for the representative substance myrcene . The NOAEL of 44 mg/kg bw per day provides a margin of safety of 9100 for myrcene. The margins of safety for 01.040 and 01.061] based upon the respective MSDI for these substances and the NOAEL for myrcene are 4.8x10 5 , 4.4x10 6 and 1.1x10 7 , respectively. The Panel agrees that this provides sufficient safety margins and that these flavouring substances can be evaluated at step B4 in the Procedure as being of no safety concern. .026] and the mTAMDI have been considered. The mTAMDI figures calculated were above the threshold of concern for all four substances and more reliable exposure data are needed. On the basis of such additional data these flavouring substances should be reconsidered using the Procedure. For the remaining 17 substances evaluated through the Procedure use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment to finalise the evaluation.In order to determine whether the conclusion for the 21 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications.Adequate specifications including complete purity criteria and identity are available for all 21 JECFA evaluated substances.Thus, for the 21 substances 4

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

“…The EFSA stated that there are no safety concern relating to β-myrcene, including no evidence of a potential genotoxic or mutagenic activity (138). Additionally, the Expert Panel of the Flavour and Extract Manufacturers Association (FEMA) most recently evaluated the safety of 54 citrus derived natural flavour complexes.…”

Safety and efficacy of eight compounds belonging to chemical group 31 (aliphatic and aromatic hydrocarbons) when used as flavourings for all animal species and categories

“…Human exposure in the European Union (EU) to the individual compounds range from 13 to 1800 μg/person per day (EFSA CEF Panel, 2015b). Human exposure in the European Union (EU) to the individual compounds range from 13 to 1800 μg/person per day (EFSA CEF Panel, 2015b).…”

Scientific Opinion on Flavouring Group Evaluation 18, Revision 3 (FGE.18Rev3): Aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols, aromatic tertiary alcohols and their esters from chemical groups 6 and 8

“…Since the publication of FGE.18Rev2 (EFSA CEF Panel, 2011) new data on myrcene have become available (Bauter, 2013). The results are described in more detail in FGE.78Rev2 (EFSA, 2015). In this FGE a NOAEL of 44 mg/kg bw per day was derived which can be used for the evaluation of [FLno: 02.146] in the current FGE.…”