The Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food 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 24 flavouring substances in the Flavouring Group Evaluation FGE. 05, using the procedure as referred to in the Commission Regulation EC No 1565/2000. These 24 flavouring substances belong to chemical groups 1, 2, and 5 of Annex I of the Commission Regulation EC No 1565/2000. The present Flavouring Group Evaluation deals with 24 esters with branched-and straight-chain aliphatic saturated primary alcohols (including one secondary alcohol) and branched-and straightchain unsaturated carboxylic acids. Nineteen of the 24 flavouring substances can exist as geometrical isomers. In 11 of these cases, no indication has been given that one of the possible isomers has preponderance in the commercial flavouring material. In addition, one candidate substance possesses a chiral centre. Twenty-one of them belong to structural class I while three substances were assigned to structural class II. Twenty-two of the substances in the present group of 24 substances have been reported to occur naturally in a wide range of food items. In its evaluation, the Panel as a default used the Maximised Survey-derived Daily Intakes (MSDIs) 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 24 flavouring substances in this group have intakes in Europe from 0.0012 to 1.7 microgram/capita/day which are below the threshold of concern value for both structural class I (1800 microgram/person/day) and structural class II (540 microgram/person/day) substances. All 24 flavouring substances are expected to participate in common routes of absorption, distribution and metabolism, and exhibit similar toxicological properties. Data for short and medium length linear and branched-chain alcohols and the carboxylic acids included in the present Flavouring Group Evaluation and general information for this class of chemicals indicate that they are rapidly absorbed from the intestinal tract, metabolised and excreted, and it can be expected that the 24 esters of the group will be hydrolysed to their corresponding acids and alcohols in humans within a relatively short time. There are three methacrylates in this group of 24 flavouring substances, i.e. ethyl methacrylate [FLno: 09.375], methyl methacrylate [FL-no: 09.647], and isobutyl 2-methylprop-2-enoate [FL-no: 09.586]. Ethyl methacrylate induced neurotoxicity in a 60-day drinking water study in rats at 50 mg/kg body weight/day, the lowest dose tested. Accordingly, a NOAEL could not be established. Methyl methacrylate has a neurotoxic potential likewise, as shown in an EU Risk Assessment Report. However, an adequate NOAEL from an oral study is not available for methyl methacrylate. For isobutyl 2-methylprop-2-enoate, there are neither neurotoxicity studies nor other repeated dose toxicity studies. Therefore, additional toxicity data for ethyl methacrylate [FL-no: 09.375], methyl methacrylate [FL-no: 09.647], and isobutyl 2-methylprop-2-enoate [FL-no: 09.586] are required. Genotoxicity data are limited and the genotoxicity could not be assessed adequately. However, the available data as well as the chemical structures of the candidate substances do not raise concerns about genotoxicity for the flavouring substances in this group. It is considered that on the basis of the default MSDI approach 21 of the 24 substances would not give rise to safety concerns at the estimated levels of intake arising from their use as flavouring substances. For three flavouring substances, i.e. ethyl methacrylate [FL-no: 09.375], methyl methacrylate [FL-no: 09.647], and isobutyl-2-methylprop-2-enoate [FL-no: 09.586], the evaluation has been deferred as additional toxicity data are required. When the estimated intakes were based on the mTAMDI they ranged from 3400 to 3700 microgram/person/day for the 21 candidate substances from structural class I. Thus, the intakes were above the threshold of concern for structural class I of 1800 microgram/person/day. For each of the three flavouring substances assigned to structural class II, the estimated intake based on the mTAMDI is 3700 microgram/capita/day, which is above the threshold of concern for structural class II of 540 microgram/person/day. Thus, for the 24 flavouring substances the intakes estimated on the basis of the mTAMDI exceed the threshold for the structural class, for which the flavouring has been assigned. Therefore, more reliable exposure data are required. On the basis of such additional data, these flavouring substances should be reconsidered along the steps of the procedure. Following this procedure, additional toxicological data might become necessary. In order to determine whether this evaluation could be applied to the material of commerce, it is necessary to consider the available specifications. Adequate specifications including complete purity criteria and identity tests for the materials of commerce have been provided for all 24 candidate flavouring substances, except that information on geometrical and optical isomerism is needed for 11 substances. Thus, the final evaluation of the materials of commerce cannot be performed for these 11 substances [FL-no: 09.324, 09.329, 09.330, 09.335, 09.372, 09.374, 09.379, 09.625, 09.637, 09.641, and 09.865], pending further information on specifications.
