RESUMO
The EFSA Panel on Food Additives and Flavourings was requested to evaluate 43 flavouring substances assigned to the Flavouring Group Evaluation 63 (FGE.63), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Twenty-nine substances have already been considered in FGE.63 and its revisions ([FL-no: 02.023, 02.099, 02.104, 02.136, 02.155, 02.252, 07.015, 07.069, 07.081, 07.099, 07.100, 07.101, 07.102, 07.114, 07.123, 07.151, 07.190, 07.240, 07.247, 07.249, 07.256, 09.281, 09.282, 09.657, 09.658, 09.923, 09.924, 09.925 and 09.936]). The remaining 14 flavouring substances have been cleared with respect to genotoxicity in FGE.204Rev1 ([FL-no: 02.102, 02.193, 07.044, 07.048, 07.082, 07.104, 07.105, 07.106, 07.107, 07.121, 07.139, 07.177, 07.188 and 07.244]) and they are considered in this revision 4 of FGE.63. The substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern (TTC) and available data on metabolism and toxicity. The Panel concluded that none of these 43 substances gives rise to safety concerns at their levels of dietary intake, when estimated on the basis of the 'Maximised Survey-derived Daily Intake' (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate for 43 flavouring substances. However, for 14 of these flavouring substances in the present revision and for 10 of the substances in the previous revision (FGE.63Rev3), the 'modified Theoretical Added Maximum Daily Intakes' (mTAMDIs) values are equal to or above the TTCs for their structural classes (I and II). For 15 substances previously evaluated in FGE.63Rev3, use levels are still needed to calculate the mTAMDI estimates. Therefore, in total for 39 flavouring substances, more data on uses and use levels should be provided to finalise their safety evaluations.
RESUMO
The EFSA Panel on Food Additives and Flavourings was requested to evaluate 55 flavouring substances assigned to the Flavouring Group Evaluation 07 (FGE.07), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Fifty-three substances have already been considered in FGE.07 and its revisions. This revision 6 includes two additional substances which have been cleared with respect to genotoxicity in FGE.201Rev2 (4-methyl-3-hepten-5-one [FL-no: 07.261]) and FGE.204Rev1 (non-2-en-4-one, [FL-no: 07.187]). The substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern (TTC) and available data on metabolism and toxicity. The Panel concluded that none of the 55 substances gives rise to safety concerns at their levels of dietary intake, when estimated on the basis of the 'Maximised Survey-derived Daily Intake' (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate. Normal and maximum use levels were available for all flavouring substances. For 52 substances, including the newly included substances [FL-no: 07.187 and 07.261], their 'modified Theoretical Added Maximum Daily Intakes' (mTAMDIs) estimates were above the TTC for their structural classes (I and II). Therefore, for these 52 flavouring substances, more detailed data on uses and use levels should be provided to finalise their safety evaluations.
