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 substances in the Flavouring Group Evaluation 38 (FGE.38), using the procedure as referred to in the Commission Regulation (EC) No 1565/2000. This flavouring substance belongs to chemical group 30, Annex I of the Commission Regulation (EC) No 1565/2000. The flavouring substance in the present Flavouring Group Evaluation 38 (FGE.38) is 3butenyl isothiocyanate [FL-no: 12.283]. No geometrical or optical isomers exist for this flavouring substance. 3-Butenyl isothiocyanate belongs to structural class II, according to the decision tree approach presented by Cramer et al., 1978. 3-Butenyl isothiocyanate has 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 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, 3-butenyl isothiocyanate has a daily per capita intake in Europe of 110 microgram, which is below the threshold of concern for a structural class II substance of 540 microgram/capita/day. The Panel concludes that the available data on genotoxicity and carcinogenicity do not preclude the evaluation of 3-butenyl isothiocyanate through the Procedure. As 3-butenyl isothiocyanate is closely related to allyl isothiocyanate it is concluded that 3-butenyl isothiocyanate cannot be anticipated to be metabolised to innocuous products. Data from a long-term toxicity and carcinogenicity study on allyl isothiocyanate in rats provide an adequate No Observed Adverse Effect Level (NOAEL) for the evaluation of its use as a flavouring substance. The NOAEL for allyl isothiocyanate in a 2-year study in rats was 12 mg/kg body weight (bw) per day, which is more than 6000 times the estimated daily exposure to 3-butenyl isothiocyanate from its use as a flavouring substance in Europe (1.8 microgram/kg bw per day). Therefore, it is concluded that 3-butenyl isothiocyanate would not be expected to present a safety concern at the estimated level of intake based on the MSDI approach. The total combined intake of the candidate and supporting substances is approximately 1400 microgram/capita/day, which is above the threshold of concern of 540 microgram/person/day for structural class II substances. However, the major contribution (92 %) to the total combined intake of flavouring substances is provided by one supporting substance, allyl isothiocyanate [FL-no: 12.025] (1282 microgram/capita/day). The NOAEL for allyl isothiocyanate of 12 mg/kg bw/day (NTP, 1982b), which corresponds to 720 mg/person/day, provides a margin of safety of more than 500 to the total combined intake of the isothiocyanates of 1.4 mg/person/day. When the estimated intake was based on the mTAMDI approach it was 4000 microgram/person/day, which is above the threshold of concern for a structural class II substance of 540 microgram/person/day. Therefore, more reliable exposure data are required. On the basis of such additional data, the flavouring substance 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: Specifications including complete purity criteria for the materials of commerce have been provided for the flavouring substance, except that an identity test is missing for one substance. Thus, the final evaluation of the material of commerce cannot be performed for the substance, pending further information.
