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.67, FGE.67Rev2, which has been made due to new toxicity data provided for 3-(5-methyl-2-furyl) butanal, deals with 28 substances. Twenty-seven of these were previously considered by the JECFA in a group of 40 furan-substituted aliphatic hydrocarbons, alcohols, aldehydes, ketones, carboxylic acids and related esters, sulfides, disulfides and ethers (JECFA, 2009a). One of these 40 substances [FL-no: 13.192] appeared to be a synonym of substance [FL-no: 13.178] which has already been evaluated in FGE.13Rev2. Therefore this substance [FL-no: 13.192] will not be further considered in this FGE and should be removed from the Register. Another substance [FL-no: 13.176] will be evaluated in FGE.99 rather than in FGE.67, because of better structural similarity with candidate substances in FGE.99. Furthermore, one candidate substance [FL-no: 13.031] from FGE.66Rev1 has been included in this revision of FGE.67, because this substance has better structural similarity to a candidate flavouring substance [FL-no: 13.074] in FGE.67 than to the other candidate flavouring substances in FGE.66Rev1.
Thirteen of the 40 substances considered by JECFA are α,β-unsaturated carbonyls, which have been evaluated by EFSA in FGE.19 context with respect to a concern for a possible genotoxic potential. This concern for genotoxicity could not be alleviated for six substances [FL-nos: 13.034, 13.043, 13.044, 13.046, 13.137 and 13.150], corresponding to FGE.19 subgroup 4.6. These six substances were therefore not further considered in this FGE.
For five substances the Flavourings Industry has announced that they do no longer support their use as flavouring substances in Europe [former FL-nos: 13.029, 13.030, 13.092, 13.107 and 13.191], these substances have been withdrawn from the safety evaluation in the present FGE.
The 28 candidate substances considered in this FGE [FL-nos: 13.006, 13.021, 13.022, 13.023, 13.024, 13.031, 13.045, 13.047, 13.052, 13.054, 13.058, 13.059, 13.061, 13.066, 13.069, 13.070, 13.074, 13.083, 13.101, 13.103, 13.105, 13.106, 13.116, 13.123, 13.138, 13.148, 13.163 and 13.190] have been allocated to various subgroups, based on their chemical structures. These substances are structurally related to the group of 27 furfuryl and furan derivatives evaluated by EFSA in FGE.13Rev2. Part of the substances is also structurally related to a group of 33 sulphur-substituted furan derivatives used as flavouring agents, evaluated by EFSA in FGE.65Rev1 and another part is structurally related to 14 furfuryl derivatives evaluated in FGE.66Rev1.
The Panel agrees with the JECFA for 17 of the substances [FL-nos: 13.045, 13.052, 13.054, 13.059, 13.061, 13.066, 13.069, 13.070, 13.083, 13.101, 13.103, 13.105, 13.106, 13.123, 13.138, 13.148 and 13.163] that these substances cannot be evaluated through the Procedure, based on concerns with respect to genotoxicity.
On the basis of the new data on toxicity for 3-(5-methyl-2-furyl) butanal [FL-no: 13.058] an appropriate NOAEL of 5.9mg/kg bw per day was derived, supporting the evaluation of this candidate substance.
In line with the approaches taken in previous FGEs (FGE.13Rev2, FGE.65Rev1 and FGE.66Rev1), the Panel considers that 11 substances [FL-nos: 13.006, 13.021, 13.022, 13.023, 13.024, 13.031, 13.047, 13.058, 13.074, 13.116 and 13.190] can be evaluated using the Procedure. It was concluded for all 11 substances, that they would be of no safety concern at their estimated intake levels based on the MSDI approach.
In order to determine whether the conclusion for the evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications. Adequate specifications including complete purity criteria and identity are available for all 28 substances. Thus, for the 11 furane derivatives evaluated through the Procedure [FL-nos: 13.006, 13.021, 13.022, 13.023, 13.024, 13.031, 13.047, 13.058, 13.074, 13.116 and 13.190], the Panel considered that the materials of commerce would not present a safety concern at their estimated levels of intake based on the MSDI approach.
The mTAMDI could be calculated for 4 of the 11 substances that were evaluated through the Procedure. For three substances [FL-nos: 13.031, 13.047 and 13.074] the mTAMDI exceeds the threshold for the corresponding structural class and therefore more reliable exposure data are required.
For seven substances [FL-nos: 13.006, 13.021, 13.022, 13.023, 13.024, 13.116 and 13.190], use levels are needed in order to calculate the mTAMDIs and identify those flavouring substances that need more refined exposure assessment to finalise the evaluation. On the basis of such additional data these flavouring substances should be reconsidered along the steps of the Procedure. Then, additional toxicological data might become necessary.
For 17 substances [FL-nos: 13.045, 13.052, 13.054, 13.059, 13.061, 13.066, 13.069, 13.070, 13.083, 13.101, 13.103, 13.105, 13.106, 13.123, 13.138, 13.148 and 13.163] additional toxicity / genotoxicity data are required. The Panel noted further that for 7 of these 17 substances [FL-nos: 13.045, 13.052, 13.054, 13.059, 13.061, 13.069 and 13.083], use levels have not yet been submitted.