Résumé
The 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 Panel is requested to consider the Joint FAO/WHO Expert Committee on Food Additives (the JECFA) evaluations of flavouring substances assessed since 2000, and to decide whether no further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. These flavouring substances are listed in the Register, which was adopted by Commission Decision 1999/217 EC and its consecutive amendments.
The present consideration concerns 22 pyridine, pyrrole and quinoline derivatives evaluated by the JECFA (63rd meeting) and will be considered in relation to the European Food Safety Authority (EFSA) evaluation of pyridine, pyrrole, indole and quinoline derivatives evaluated in the Flavouring Group Evaluation 24, Revision 1 (FGE.24Rev1).
The Panel concluded that the 22 substances in the JECFA flavouring group of pyridine, pyrrole and quinoline derivatives are structurally related to the group of pyridine, pyrrole, indole and quinoline derivatives evaluated by EFSA in FGE.24Rev1.
The Panel agrees with the application of the Procedure as performed by the JECFA for five of the 22 substances: methyl nicotinate [FL-no: 14.071], indole [FL-no: 14.007] and 3-methylindole [FLno: 14.004] were evaluated on the A-side of the Procedure as they were anticipated to be metabolised to innocuous products. 1-Furfurylpyrrole [FL-no: 13.134] and 2-pyridine methanethiol [FL-no: 14.030] were the only two substances evaluated through the B-side of the Procedure as the substances were not anticipated to be metabolised to innocuous products by the JECFA.
The Panel concluded, in line with the conclusions for 2-methylquinoline, 4-methylquinoline and 4-butylquinoline [FL-no: 14.138, 14.002 and 14.094] in FGE. 24Rev1, that 6-methylquinoline [FL-no: 14.042] should not be evaluated through the Procedure due to concern with respect to genotoxicity in vitro.
For the remaining 16 substances the Panel, in contrast to the JECFA, did not anticipate that they will be metabolised to innocuous products and accordingly concluded that they should be evaluated along the B-side.
For pyrrole and the five pyrrole derivatives and for isoquinoline [FL-no: 13.134, 14.001, 14.041, 14.045, 14.046, 14.047 and 14.068] No Observed Adverse Effect Levels (NOAELs) could not be derived as such or for structurally related substances. Accordingly, additional toxicological data are required for these seven substances. For 10 substances [FL-no: 14.038, 14.039, 14.058, 14.059, 14.060, 14.061, 14.065, 14.066, 14.072 and 14.164] NOAELs could be derived to provide adequate margins of safety at the estimated level of intakes as flavouring substance.
For four substances [FL-no: 14.045, 14.058, 14.059 and 14.164] the JECFA evaluation is based on Maximised Survey-derived Daily Intake (MSDI) derived from production figures only from the USA. EU production figures are needed in order to finalise the evaluation of these substances.
For all 21 substances evaluated through the Procedure use levels are needed to calculate the modified Theoretical Added Maximum Daily Intake (mTAMDI) 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 22 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 tests are available for 16 of the 22 JECFA evaluated substances. For six substances [FL-no: 13.134, 14.007, 14.030, 14.038, 14.045, and 14.046] data on solubility in water is missing.
Thus, for 10 substances [FL-no: 13.134, 14.001, 14.041, 14.045, 14.046, 14.047, 14.058, 14.059, 14.068 and 14.164] the Panel has reservations (no European production volumes available, preventing them from being evaluated using the Procedure and/or additional toxicological data are required). For one substance, 6-methylquinoline [FL-no: 14.042], the Panel concluded that the Procedure should not be applied until adequate genotoxicity data become available. For the remaining 11 of the 22 JECFA evaluated pyridine, pyrrole and quinoline derivatives [FL-no: 14.004, 14.007, 14.030, 14.038, 14.039, 14.060, 14.061, 14.065, 14.066, 14.071 and 14.072] the Panel agrees with the JECFA conclusion "no safety concern at estimated levels of intake as flavouring substances" based on the MSDI approach.