The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (the Panel) is asked to advise the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Scientific Panel is asked to evaluate 33 flavouring substances in the Flavouring Group Evaluation 24, Revision 1 (FGE. 24Rev1), using the procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 33 flavouring substances belong to chemical group 28 of Annex I of the Commission Regulation (EC) No 1565/2000. The present Flavouring Group Evaluation deals with 33 pyridine, pyrrole, indole and quinoline derivatives. None of the 33 candidate substances can exist as geometrical or optical isomers. Twenty-six of the flavouring substances are classified into structural class II and seven are classified into structural class III. Thirty of the flavouring substances in the present group have been reported to occur naturally in a wide range of food items. In its evaluation, the Panel as a default used the Maximised Survey-derived Daily Intakes (MSDIs) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Panel examined the information provided by the European Flavouring Industry on the use levels in various foods, it appeared obvious that the MSDI approach in a number of cases would grossly underestimate the intake by regular consumers of products flavoured at the use level reported by the Industry, especially in those cases where the annual production values were reported to be small. In consequence, the Panel had reservations about the data on use and use levels provided and the intake estimates obtained by the MSDI approach. In the absence of more precise information that would enable the Panel to make a more realistic estimate of the daily intakes per person using a modified Theoretical Added Maximum Daily Intake (mTAMDI) approach based on the normal use levels reported by Industry. In those cases where the mTAMDI approach indicated that the intake of a flavouring substance might exceed its corresponding threshold of concern, the Panel decided not to carry out a formal safety assessment using the Procedure. In these cases the Panel requires more precise data on use and use levels. According to the default MSDI approach, the 33 flavouring substances in this group have intakes in Europe from 0.0012 to 0.73 microgram/capita/day, which are all below the thresholds of concern for both structural class II (540 microgram/person/day) and structural class III (90 microgram/person/day) substances. Data on genotoxicity of the flavouring substances are limited and the genotoxicity could not be adequately assessed. The data available, however, give rise to some concern of a genotoxic potential of the quinoline derivatives 2-methylquinoline [FL-no: 14.138], 4-methylquinoline [FLno: 14.002] and 4-butylquinoline [FL-no: 14.094]. The Panel, therefore, concluded that the Procedure could not be applied to these three substances until adequate in vivo data become available. The genotoxicity data available for the remaining candidate substances do not preclude their evaluation through the Procedure. Two of the 30 flavouring substances, evaluated through the Procedure, ethyl nicotinate [FL-no: 14.110] and isopropyl nicotinate [FL-no: 14.120], are expected to be metabolised to innocuous products. For the remaining 28 flavouring substances it cannot be anticipated that they will be metabolised to innocuous products. It was noted that where toxicity data were available they were consistent with the conclusions in the present flavouring group evaluation using the Procedure. For seven candidate substances, 2-acetyl-1-furfurylpyrrole [FL-no: 13.100], 1-methylpyrrole [FLno: 14.023], 2-acetyl-5-methylpyrrole [FL-no: 14.085], 2,5-dimethylpyrrole [FL-no: 14.107], pyrrole-2-carbaldehyde [FL-no: 14.145], 1-methylpyrrole-2-carboxaldehyde [FL-no: 14.163] and 1ethyl- 2-pyrrolecarboxaldehyde [FL-no: 14.169], a No Observed Adverse Effect Level (NOAEL) could not be derived for the substance or a structurally related substance. Accordingly, additional data are required for these seven flavouring substances. It was considered that, on the basis of the default MSDI approach, the remaining 23 of the 30 substances, to which the Procedure could be applied, would not give rise to safety concerns at the estimated levels of intake arising from their use as flavouring substances. When the estimated intakes were based on the mTAMDI they ranged from 310 to 670 microgram/person/day for the 26 flavouring substances from structural class II. The intake was above the threshold of concern of 540 microgram/person/day for one of these candidate substances. The mTAMDI estimates of the four flavouring substances, assigned to structural class III and evaluated using the Procedure, are between 160 and 400 microgram/person/day, which are all above the threshold of concern for structural class III of 90 microgram/person/day. Thus, for five of the 30 flavouring substances evaluated through the Procedure the intakes, estimated on the basis of the mTAMDI, exceed the relevant threshold for their structural class, to which the flavouring substance has been assigned. Therefore, for these five substances [FL-no: 13.100, 14.023, 14.088 14.131 and 14.163] more reliable exposure data are required. On the basis of such additional data, these flavouring substances should be reconsidered along the steps of the Procedure. Following this procedure additional toxicological data might become necessary. In order to determine whether this evaluation could be applied to the materials of commerce, it is necessary to consider the available specifications: Adequate specifications including complete purity criteria and identity tests for the materials of commerce have been provided for all the candidate substances: Thus, the final evaluation of the materials of commerce can be performed for all substances evaluated. For seven substances 2-acetyl-1-furfurylpyrrole [FL-no: 13.100], 1-methylpyrrole [FLno: 14.023], 2-acetyl-5-methylpyrrole [FL-no: 14.085], 2,5-dimethylpyrrole [FL-no: 14.107], pyrrole-2-carbaldehyde [FL-no: 14.145], 1-methylpyrrole-2-carboxaldehyde [FL-no: 14.163] and 1ethyl- 2-pyrrolecarboxaldehyde [FL-no: 14.169], the Panel considered that additional data are required. The remaining 23 substances, evaluated through the Procedure, would present no safety concern at the levels of intake estimated on the basis of the MSDI approach.
