Commission Regulation (EU) 2019/799 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of the flavouring substance furan- 2(5H)-one (FL-no 10.066) (Text with EEA relevance). Language(s): English, French and Spanish. Number of pages: 3
The Union list of flavourings and source materials is laid down in Annex I to Regulation (EC) No 1334/3008. It was established by Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances notified in G/SPS/N/EU/13/Add.1 (12 October 2012) which is now amended by this Regulation.
This addendum concerns the removal of the flavouring substance furan-2(5H)-one (FL-no 10.066) from the European Union list of flavourings following the European Food Safety Authority opinion published at the end of January 2019 which concluded that this substance is genotoxic in vivo and therefore its use as a flavouring substance raises a safety concern.
The measure has been taken in urgency in view of this EFSA assessment indicating a serious risk (genotoxicity) of this flavouring substance FL 10.066 on the basis of new scientific data. Therefore, its addition to foods should be stopped swiftly. It has not been possible to notify the draft measure in view of the nature of the risk involved.
According to the European Association of producers of flavourings (EFFA) as reported in the opinion by EFSA, the poundage for this substance in Europe is very low (zero in 2017).
This substance furan-2(5H)-one (FL No 10.066) can also be identified with CAS No. 497-23-4, JECFA No 2000 and JECFA name "4-hydroxy-2-butenoic acid gamma lactone". The EFSA opinion is available as EFSA Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxicity potential for alpha, beta unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones; EFSA Journal 2019;17(1):5568.