COMMISSION REGUL ATION (EU) 2019/799 
of 17 May 2019 
amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the 
Council as regards the remo val from the Union list of the flavour ing subst ance furan-2(5H)-one 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regard to Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 
on flavourings and certain food ingredients with flavouri ng proper ties for use in and on foods and amending Council 
Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (1), and 
in particular Article 11(3) thereof, 
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 
establishing a common author isation procedure for food additives, food enzymes and food flavourings (2), and in 
particular Article 7(6) thereof, 
Whereas: 
(1)  Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source mater ials appro ved 
for use in and on foods and their conditions of use. 
(2)  Commission Implementing Regulation (EU) No 872/2012 (3) adopt ed a list of flavouri ng substances and 
introduced that list in Part A of Annex I to Regulation (EC) No 1334/2008. 
(3)  Annex I to Regulation (EC) No 1334/2008 may be updated in accordance with the common procedure refer red 
to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or followi ng an 
application submitte d by a Member State or by an interest ed party. 
(4)  Part A of the Union list contains both evaluated flavouring substances and flavouring substances under 
evaluation. 
(5)  The flavouring substance furan-2(5H)-one (FL No 10.066) is included in Annex I to Regulation (EC) 
No 1334/2008 as a flavouring substance under evaluation and for whic h additional scientific data was request ed 
by the European Food Safety Auth ority (hereinaf ter ‘the Author ity’). Such data was submitted by the applicant. 
(6)  The Auth ority evaluated the submitted data and concluded in its scientifi c opinion of 11 December 2018 (4) that 
furan-2(5H)-one (FL No 10.066) raises a safety concer n with respect to genoto xicity as it is genoto xic in vivo. 
(7)  The use of furan-2(5H)-one (FL No 10.066) theref ore does not compl y with the general conditions of use for 
flavourings set out in Article 4(a) of Regulation (EC) No 1334/2008. Consequently , that substance should be 
remo ved from the list without dela y in order to prote ct human health. 
(8)  As regar ds the identification details of furan-2(5H)-one (FL No 10.066) the Author ity provides in its opinion 
additional elements regarding the identity and charact erisation of this substance which are not included in its 
current entr y in Part A of Annex I of Regulation (EC) No 1334/2008. In order to ensure clarity and certainty 
regar ding the identity of the substance and to help stak eholders to properly identify this substance, it is relevant 
to note that further identification details of furan-2(5H)-one (FL No 10.066) provi ded by the Author ity in its 
Opinion are: the CAS No. is 497-23-4, its JECF A No is 2000 and the JECF A name is 4-hydro xy-2-bute noic acid 
gamma lacto ne. 20.5.2019 L 132/12 Official Jour nal of the European Union EN     
(1)OJ L 354, 31.12.2008, p. 34. 
(2)OJ L 354, 31.12.2008, p. 1. 
(3)Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by 
Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 
of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 
1999/217/EC (OJ L 267, 2.10.2012, p. 1). 
(4)EFSA FAF Panel (EFSA Panel on Food Additives and Flav ourings). Scientific Opinion on Flav ouring Group Evaluation 217 Revision 2 
(FGE.217Rev2), consideration of genotoxicity potential for alpha, beta unsaturat ed ketones and precursors from chemical subgroup 4.1 
of FGE.19: lactones; EFSA Journal 2019;17(1):5568. (9)  As the substance raises a safety concer n, The Commission should use the urgency procedure for the removal of 
furan-2(5H)-one from the Union list. Part A of Annex I to Regulation (EC) No 1334/2008 should theref ore be 
amended according ly. 
(10)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Part A of Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation. 
Article 2 
This Regulation shall enter into force on the day followi ng that of its publication in the Official Journal of the Europ ean 
Union. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 17 May 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  20.5.2019 L 132/13 Official Jour nal of the European Union EN     ANNEX 
In Section 2 of Part A of Annex I to Regulation (EC) No 1334/2008, the followi ng entr y is deleted: 
‘10.066 Furan-2(5H)-one      2 EFSA ’   20.5.2019 L 132/14 Official Jour nal of the European Union EN