Flavouring Group Evaluation 31, (FGE. 31) One Epoxide from Chemical Group 321 Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (Question No EFSA-Q-2008-035) 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 asked to evaluate one flavouring substance in the Flavouring Group Evaluation FGE. 31 (FGE. 31), using the procedure as referred to in the Commission Regulation (EC) No 1565/2000. This one flavouring substance belongs to chemical group 32, Annex I of the Commission Regulation (EC) No 1565/2000. The present Flavouring Group Evaluation 31 (FGE. 31) deals with one epoxide, carvone-5,6-oxide [FL-no: 16.042]. Carvone-5,6-oxide possesses three chiral centres. The flavouring substance is classified by the decision tree approach into structural class III. It has been reported that the flavouring substance can occur naturally in bilberry, rosemary and gin. 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 Flavouring 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 substance has a daily per capita intake in Europe as a flavouring of 0.012 microgram/capita/day, which is below the threshold of concern of 90 microgram/person/day for a substance belonging to structural class III. On the basis of the reported annual production in Europe (MSDI approach), the total combined estimated level of intake of the candidate substance and five supporting substances is approximately 320 microgram/capita/day, which is above the threshold of concern for structural class III substances of 90 microgram/person/day. When using the mTAMDI method the intake was estimated to be 1000 microgram/person/day for the candidate substance, which is above the threshold of concern of 90 microgram/person/day for structural class III substances. The epoxide ring in the structure of this candidate substance is considered a structural alert for genotoxicity. In the absence of any data on the genotoxic potential of this candidate substance, it is not considered justified to evaluate this substance through the Procedure. In order to determine whether the conclusion for the candidate substance can be applied to the materials of commerce, it is necessary to consider the available specifications: Adequate specification including complete purity criteria for the material of commerce has been provided for the flavouring substance, except that information on identity test is missing. Thus, the final evaluation of the material of commerce cannot be performed for the substance, pending further information. Thus, in conclusion, for the flavouring substance carvone-5,6-oxide [FL-no: 16.042], the Panel concluded that there was a possible genotoxic potential, and therefore the Procedure could not be applied to the substance until adequate genotoxicity data become available.