FGE 85: Consideration of miscellaneous nitrogen-containing substances evaluated by JECFA (65th meeting) Scientific Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (Question No EFSA-Q-2008-069) Adopted on 22 May 2008

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 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 any 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 16 miscellaneous nitrogen-containing substances evaluated by the JECFA (65th meeting). The Panel concluded that no corresponding FGE is available. The Panel agrees with the application of the Procedure as performed by the JECFA for the 16 substances considered in this FGE. For three substances [FL-no: 14.014, 14.029 and 14.070] the JECFA evaluation is only based on Maximised Survey-derived Daily Intake MSDI values derived from production figures from the USA. EU production figures are needed in order to finalise the evaluation of these three substances. For four substances [FL-no: 12.025, 12.030, 13.039 and 13.115] evaluated through the JECFA Procedure intake data are available for the EU. For the remaining nine substances [FL-no: 12.102, 12.107, 12.193, 13.091, 13.112, 13.118, 13.154, 13.169 and 13.195] the EU intake data are based on anticipated production figures. For seven substances the Industry has submitted use levels [FL-no: 12.102, 12.107, 13.112, 13.115, 13.118, 13.154 and 13.169] and the calculated modified Theoretical Added Maximum Daily Intake (mTAMDI) figures were 96 microgram/person/day for all seven substances. These intakes were below the threshold of concern for structural class II of 540 microgram/person/day. For the remaining nine substances 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 16 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications: Adequate specifications including purity criteria and identity are available for 13 of the 16 JECFA evaluated substances. For two substances [FL-no: 13.039 and 13.115] information on the stereoisomeric composition is lacking and for one substance [FL-no: 12.193] an ID-test is missing. Thus, for six substances [FL-no: 12.193, 13.039, 13.115, 14.014, 14.029 and 14.070] the Panel has reservations (no European production volumes available, preventing them from being evaluated using the Procedure and/or missing data on specification or steroisomerism). For the remaining 10 of the 16 JECFA evaluated miscellaneous nitrogen-containing substances [FL-no: 12.025, 12.030, 12.102, 12.107, 13.091, 13.112, 13.118, 13.154, 13.169 and 13.195] the Panel agrees with the JECFA conclusion "No safety concern at estimated levels of intake as flavouring substances" based on the MSDI approach.