Flavouring Group Evaluation 47, (FGE.47) Bicyclic secondary alcohols, ketones and related esters from chemical group 8 Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food

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 Panel is asked to evaluate four flavouring substances in the Flavouring Group Evaluation 47 (FGE.47), using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. These four flavouring substances belong to chemical group 8, Annex I of the Commission Regulation (EC) No 1565/2000. The present Flavouring Group Evaluation deals with four bicyclic secondary alcohols, ketones and related esters from chemical group 8. The four flavouring substances possess one or more chiral centres. For one of the flavouring substances [FL-no: 09.888] the stereoisomeric composition has not been specified. Three of the four flavouring substances belong to structural class I and one belongs to structural class II according to decision tree approach presented by presented by Cramer et al., (1978). Only one of the flavouring substances in the present group [FL-no: 07.171] has been reported to occur naturally. In its evaluation, the Panel as a default used the Maximised Survey-derived Daily Intake (MSDI) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Panel examined the information provided by the European Flavour 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 intakes of the flavouring substances, the Panel has decided also to perform an 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 four flavouring substances in this group have intakes in Europe from 0.011 to 0.085 microgram/capita/day, which are below the threshold of concern value for structural class I (1800 microgram/person/day) and structural class II (540 microgram/person/day) substances. Genotoxicity data are available only for a limited number of substances, and the genotoxicity could not be assessed adequately. However, the data available do not preclude the evaluation of the four flavouring substances using the Procedure. The four flavouring substances are expected to 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. It is considered that on the basis of the default MSDI approach the four flavouring substances 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 approach they ranged from 1900 to 2300 microgram/person/day for the three flavouring substances from structural class I. These intakes are above the threshold of concern for structural class I of 1800 microgram/person/day. The estimated intake of the one flavouring substance [FL-no: 07.171] assigned to structural class II, based on the mTAMDI, approach is 1000 microgram/person/day, which is above the threshold of concern for structural class II of 540 microgram/person/day. Thus, for the all four flavouring substances the estimated intakes, based on the mTAMDI approach, exceed the relevant threshold for the structural class. Therefore, for all four substances more reliable exposure data are required. On the basis of such additional data, these flavouring substances should be reconsidered using the Procedure. Subsequently, additional 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. Specifications including purity criteria for the materials of commerce have been provided for all four flavouring substances. Information on chirality is missing for one substance [FL-no: 09.888] and for all four substances identity tests are missing. Thus, the final evaluation of the materials of commerce cannot be performed for the four substances [FL-no: 07.171, 09.584, 09.848 and 09.888], pending further information on specifications.