Following a request from the European Commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was asked to deliver a scientific opinion on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was 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 revision of FGE.99, FGE.99Rev1, includes the assessment of one additional candidate substance, the 2,5-dimethyl-4-methoxyfuran-3(2H)-one [FL-no: 13.089], which was evaluated by the JECFA at its 63rd meeting. This substance, containing an α,β-unsaturated carbonyl, raised concern for genotoxicity. In the recently published FGE.220Rev3, new genotoxicity data on the structurally related 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] have become available. The Panel concluded that the data available rules out the concern for genotoxicity for [FL-no: 13.089] and accordingly this substance can be evaluated through the Procedure in this revision.
This consideration deals with six flavouring substances [FL-nos: 13.010, 13.084, 13.085, 13.089, 13.099 and 13.176], which belong to a group of 18 tetrahydrofuran and furanone derivatives and a group of 40 furan-substituted aliphatic hydrocarbons, alcohols, aldehydes, ketones, carboxylic acids and related esters, sulphides, disulphides and ethers evaluated by the JECFA at the 63rd, 65th and 69th meetings.
The Panel agrees with the application of the Procedure as performed by the JECFA for only one substance [FL-no: 13.010] considered in this FGE. The JECFA stated that the four substances [FL-nos: 13.084, 13.085, 13.089 and 13.099] belong to structural class II, but as data on natural occurrence indicate that these substances cannot be considered to be common components of food, the Panel disagrees with this and allocates these four substances to structural class III. In addition, for substance with [FL-no: 13.176] the JECFA concluded that the Procedure for the Safety Evaluation of Flavouring Agents could not apply because of the unresolved toxicological concerns related to the epoxidation and opening of the furan ring. The Panel disagreed with the conclusions by the JECFA and regarded this substance to be sufficiently structurally related to the other substances in this group.
The Panel concluded that there is no safety concern for the six substances [FL-nos: 13.010, 13.084, 13.085, 13.089, 13.099 and 13.176] in this FGE, based on the MSDI approach.
In order to determine whether the conclusion for the six JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications. Adequate specifications including complete purity criteria, identity tests and information on stereoisomeric composition are available for all JECFA evaluated substances.
For all six substances evaluated through the Procedure use levels are required to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.