Résumé
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 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 consideration concerns a group of six monocyclic secondary alcohols, ketones and related esters evaluated by the JECFA (63rd meeting) and will be considered in relation to the European Food Safety Authority (EFSA) evaluation of 15 monocyclic secondary alcohols, ketones and related esters in the Flavouring Group Evaluation 9, Revision 1 (FGE. 09Rev1)
The Panel agrees with the application of the Procedure as performed by the JECFA for four out of the six monocyclic secondary alcohols, ketones and related esters [FL- no: 02.224, 02.246, 02.254 and 09.521]. However, for three substances [FL- no: 02.224, 02.246 and 02.254] no European production figures were available and consequently no European exposure estimates could be calculated. Accordingly, the safety in use could not be assessed using the Procedure for these three substances. For [FL- no: 07.110 and 07.111], the Panel concluded that in line with cyclotetradeca none [FL- no: 07.207] evaluated in FGE. 09Rev1, that the substances could not be anticipated to be metabolised to innocuous products and were therefore evaluated via the B- side of the EFSA Procedure. As no adequate No Observed Adverse Effects Level (NOAEL) were available for those substances additional data were required for [FL- no: 07.110 and 07.111].
For three substances [FL- no: 02.224, 02.246 and 02.254] the JECFA evaluation is only based on MSDI values derived from production figures from the USA. EU production figures are needed in order to finalise the evaluation of these substances.
For all six substances evaluated through the Procedure use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessments and to finalise the evaluation.
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:
Specfications are available for the five materials of commerce. Information on stereoisomerism is lacking for [FL- no: 09.521].
Thus, for the six JECFA evaluated monocyclic secondary alcohols, ketones and related esters the Panel has reservations. For [FL- no: 02.224, 02.246 and 02.254] there is no European production volume available, preventing evaluation of the substances through the Procedure. For [FL- no: 09.521] information on stereoisomerism is missing. For [FL- no: 07.110 and 07.111] additional toxicity data are required.