Flavouring Group Evaluation 86, (FGE.86) - Consideration of aliphatic and aromatic amines and amides evaluated by JECFA (65th meeting) - Scientific Opinion of the Panel on Food Additives - Flavourings, Processing Aids and Materials in Contact with Food

Abstract

The present consideration concerns 35 aliphatic and aromatic amines and amides evaluated by the JECFA (65 th meeting). The Panel concluded that no corresponding FGE is available.Further two substances were evaluated by the JECFA in this group, but these are not in the Register (1-amino-2-propanol and acetamide; JECFA-no: 1591 and 1592, respectively).The Panel agreed with the application of the Procedure as performed by the JECFA for 28 of the 35 substances. The JECFA concluded the five substances 14.003, 16 11.004, 11.005, 11.007, 11.014, 11.015, 11.016, 11.017, 11.018, 11.020, 11.021, 11.023, 11.025, 11.026, 14.080, 14.133, 14.141, 14.168, 16.049, 16.052, 16.091 and 16.092] the EU production figures are anticipated.For 22 substances evaluated by the JECFA through the Procedure use levels have been provided by the Industry 11.004, 11.005, 11.007, 11.014, 11.015, 11.016, 11.018, 11.020, 11.021, 11.023, 11.025, 11.026, 14.080, 14.133, 14.141, 16.049, 16. 14.141, 16.052, 16.091, 16.092, 16.093 and 16.094] the intakes, estimated on the basis of the mTAMDI approach, exceed the threshold for their structural classes. Therefore more reliable exposure data are required. On the basis of such additional data, these flavouring substances should be considered using the Procedure. Subsequently, additional data might become necessary.For the remaining 13 substances 11.003, 11.006, 11.009, 11.017, 14.003, 14.010, 14.064, 14.167, 14,168, 16.006, 16.013 and 16.053] use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.In order to determine whether the conclusion for the 35 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications:Specifications including complete purity criteria and identity tests are available for 30 of the 35 JECFA evaluated substances. For one substance .013] information on the stereoisomeric composition is lacking and for one substance .017] composition of mixture has to be specified. For two substances ] data on solubility are needed, and for three substance 14.168 and 16.094] identity tests are missing.Thus, for seven substances 11.017, 14.064, 14.168, 16.013, 16.053 and 16.094] the Panel has reservations (no European production volumes available, preventing them from being evaluated using the Procedure, and/or missing data on specifications and/or information on stereoisomerism /composition).For seven of the 35 evaluated substances the Panel did not agree with the JECFA application of the Procedure and additional toxicity data are required for five of the seven substances [FLno: 11.014, 14.003, 16.091, 16.093 and 16.094]. One substance cannot be evaluated through the Procedure due to concern with respect to genotoxicity/carcinogenicity .049] and one substance ] is evaluated along the A-side, while the JECFA evaluated it along the B-side.Overall, for the remaining 23 of the 35 JECFA evaluated aliphatic and ar...

Safety Aspects of the Use of Isolated Piperine Ingested as a Bolus

“…The European Food Safety Authority (EFSA) has evaluated the use of piperine as a flavouring substance. In its evaluations, EFSA (2008;2011;2015) disagreed with a No Observed Effect Level (NOEL) of 20 mg piperine/kg bw/day that had previously been identified by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) (2006), due to the shortcomings of the underlying animal study (lack of histopathology, study duration) and in 2015 identified a No Observed Adverse Effect Level (NOAEL) of 5 mg piperine/kg bw/day, based on a newly available 90-day rat feeding study performed according to OECD guideline 408 (endpoint: dose-dependent increase in cholesterol level in male animals) [29,32,[48][49][50] (see (2) in Section 4.2.2). In its final conclusion, EFSA (2015) agreed with the JECFA (2006) conclusion "no safety concern at estimated levels of intake as flavouring substance" based on the MSDI approach (estimated European per capita intake by the MSDI approach: 6.2 µg piperine/day) [32,50].…”

“…In its assessment of piperine as a flavouring agent, JECFA (2006) concluded regarding genotoxicity that piperine belongs to a group of aliphatic and aromatic amine and amide derivates for which negative results were reported in bacterial assays for reverse mutation and that piperine consistently gave negative results in a variety of in vivo studies [50,[52][53][54]. EFSA agreed in its assessment with JECFA that the available studies on genotoxicity did not preclude the evaluation of piperine (and some other aliphatic and arylalkyl amines and amides) as a flavouring agent [32,48,49].…”

“…(2) Subchronic Toxicity Studies In a study with groups of young male rats that received 100 mg piperine/kg feed for 56 days or 110, 220 or 440 mg pepper oleoresin/kg feed (equivalent to 50-200 mg piperine/kg feed), or 2 g pepper/kg feed, no adverse effects on growth, food efficacy, organ weights, blood count and investigated clinical chemistry parameters were observed compared to the control group [50,57]. In its evaluation of piperine as a flavouring agent, JECFA (2006) based its NOEL for piperine of 20 mg/kg bw/day on this animal study, but EFSA (2008) considered this study inadequate for NOAEL identification due to studydesign limitations [48,50]. It should be mentioned that this animal study reported increased haemoglobin values for the piperine group (242 g/L) compared to the control and to the pepper/pepper oleoresin groups (~140 g/L); however, the red blood cell count was similar to the other groups, making a typing error highly possible [57].…”