Notice - Notification of WTO Members: 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 (FLno 10.066)


WTO code G/SPS/N/EU/325
Date notice 05/06/2019
Notice type Regular
Title 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 (FLno 10.066)
Summary

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 (FLno 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

Product Flavourings, food
Country European Union

File attach:
NEU325.pdf

Orther Notice:


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