COMMI SSION REGUL ATION (EU) 2016/55 
of 19 Januar y 2016 
amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the 
Council as regards certain flavour ing subst ances 
(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(5) thereof, 
Whereas: 
(1)  Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavouri ngs and source mater ials for use in 
food and their conditions of use. 
(2)  Commission Implementing Regulation (EU) No 872/2012 (3) adop ted the list of flavouring substances and 
introduced that list in Part A of Annex I to Regulation (EC) No 1334/2008. 
(3)  That list 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 following an application submitted by a Member 
State or by an interested party. 
(4)  Part A of the Union list contains both evaluated flavouri ng substances, which are assigned no footnote s, and 
flavouring substances under evaluation, whic h are identified by footnote references 1 to 4 in that list. 
(5)  The European Food Safety Author ity (EFSA) has complet ed the assessment of 5 substances which are currently 
listed as flavouri ng substances under evaluation. Those flavouring substances were assessed by EFSA in the 
following flavouring group evaluations: evaluation FGE.12rev5 (4) (substances FL-nos. 07.041 and 07.224), 
FGE.63rev2 (5) (substances FL-n os. 07.099 and 07.101), and evaluation FGE.312 (6) (substance FL-no 16.126). 
EFSA concluded that these flavouring substances do not give rise to safety concer ns at the estimated levels of 
dietar y intak e. 
(6)  As part of its evaluation, EFSA has made comments on the specifi cations of certain of those substances. The 
comments are related to names, purity or composition of the substances FL-n os: 07.041, 07.224 and 07.099. 
Those comments should be introduced in the list. 
(7)  The Union list refer red to in Regulation (EC) No 1334/2008 is intended to regulate only the use of flavouring 
substances whic h are added to food in order to impart or modify odour and/or taste. Substance FL-no 16.126 
could also be added to food for other purposes than flavouring and such uses remain subject to other rules. This 
Regulation lays down conditions of use which relate solely to its use as a flavouring substance. 20.1.2016 L 13/43 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 Octo ber 2012 adopt ing 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 Jour nal 2014; 11(12):3911. 
(5)EFSA Jour nal 2014; 11(4):3188. 
(6)EFSA Jour nal 2013; 11(10):3404. (8)  The flavouri ng substances assessed in those evaluations should be listed as evaluated substances by deleting 
footnot e references 1 and 2 in the relevant entr ies of the Union list. 
(9)  Part A of Annex I to Regulation (EC) No 1334/2008 should theref ore be amended according ly. 
(10)  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committ ee 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 twentieth day following that of its publication in the Official Journal of the 
European Union. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 19 Januar y 2016. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  20.1.2016 L 13/44 Official Jour nal of the European Union EN     ANNEX 
Part A of Annex I to Regulation (EC) No 1334/2008 is amended as follows:  
(1) The entr y concer ning FL-n o 07.041 is replaced by the following: 
‘07.041 beta-Isometh ylionone 79-89-0  650 Mixture of E/Z isomers 
(50-70 % (E) and  
30-50 % (Z))   EFSA ’   
(2) The entr y concer ning FL-n o 07.099 is replaced by the following: 
‘07.099 6-Methy lhepta-3,5-dien-2-one 1604-28-0 1134 11143 Mixture of E/Z stereo­
isomers: 60-90 % (E)   EFSA ’   
(3) The entr y concer ning FL-n o 07.101 is replaced by the following: 
‘07.101 4-Methy lpent-3-en-2-one 141-79-7 1131 11853    EFSA ’   
(4) The entr y concer ning FL-n o 07.224 is replaced by the following: 
‘07.224 trans-1-(2,6,6- Trimethyl -1-cy ­
clohexen -1-yl)but-2-en-1-one 23726-91-2   At least 90 %; second ­
ary components 2-4 % 
alpha-damascone and  
2-4 % delta-damascone   EFSA ’   
(5) The entr y concer ning FL-n o 16.126 is replaced by the following: 
‘16.126 3-[(4-amino-2,2-dio xido-1H- 
2,1,3-benzothiadiazin-5-yl) 
oxy]-2,2-dimeth yl-N-prop yl­
propanamide 1093200-92-0 2082   Restr ictions for use as a flavouring substance: 
In catego ry 1 — not more than 3 mg/kg. 
In catego ry 3 — not more than 5 mg/kg. 
In catego ry 5 — not more than 15 mg/kg. 
In catego ry 5.3 — not more than 30 mg/kg. 
In catego ry 5.4 — not more than 10 mg/kg. 
In catego ry 6.3 — not more than 15 mg/kg. 
In catego ry 7 — not more than 10 mg/kg. 
In catego ry 12 — not more than 10 mg/kg. 
In catego ry 14.1 — not more than 5 mg/kg. 
In categor y 16, excl uding products covered in 
catego ries 1, 3 and 4 — not more than 5 mg/kg.  EFSA ’   20.1.2016 L 13/45 Official Jour nal of the European Union EN