Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC) on a request from the Commission

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 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 44 hydroxy- and alkoxy-substituted benzyl derivatives evaluated by JECFA (57th meeting) and will be considered in relation to the European Food Safety Authority (EFSA) evaluation of 35 benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters evaluated in the Flavouring Group Evaluation 20 (FGE.20). The Panel concluded that the 44 substances in the JECFA flavouring group of hydroxy-and alkoxy-substituted benzyl derivatives are structurally related to the group of benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters evaluated by EFSA in the FGE.20. Further two substances were evaluated by the JECFA in this group but are not in the Register (2methoxybenzoic acid and ethyl vanillin propylene glycol acetal) and therefore not dealt with in this consideration. The Panel agrees with the application of the Procedure as performed by the JECFA for 43 of the 44 substances considered in this FGE. For butyl 4-hydroxybenzoate [FL -no: 09.754] additional data would be required before it can be evaluated as a flavouring substance, using the Procedure. For eight substances [FL -no: 04.093, 08.071, 08.076, 08.092, 09.145, 09.754, 09.807 and 16.075] 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 substances. For all 44 substances use levels are needed to calculate the modified Theorical 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 44 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications: Adequate specifications are available for 40 of the 44 JECFA evaluated substances. For four substances [FL -no: 06.132, 09.087, 09.751 and 09.763] further information on specifications are requested. Thus, for 12 substances [FL -no: 04.093, 06.132, 08.071, 08.076, 08.092, 09.087, 09.145, 09.751, 09.754, 09.763, 09.807 and 16.075] the Panel has reservations (only USA production volumes available and/or missing data on specifications and/or isomerism/composition). For one of these 12 substances, butyl 4-hydroxybenzoate [FL -no: 09.754], the Panel concluded that additional data would be required before it can be evaluated as a flavouring substance using the Procedure. For the remaining 32 JECFA evaluated hydroxy-and alkoxy-substituted benzyl derivatives [FL -no: 02.128, 02.165, 02.213, 04.094, 05.015, 05.016, 05.017, 05.018, 05.019, 05.047, 05.055, 05.056, 05.091, 08.040, 08.043, 08.112, 09.019, 09.035, 09.058, 09.220, 09.430, 09.706, 09.713, 09.714, 09.748, 09.749, 09.750, 09.752, 09.753, 09.796, 09.811 and 09.933] the Panel agrees with the JECFA conclusion "No safety concern at estimated levels of intake as flavouring substance" based on the MSDI approach.