EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10070/2016 ANNEX CIS 
(POOL/E2/2016/10070/10070-EN 
ANNEX CIS) […](2016) XXX  draft 
ANNEX 1 
  
ANNEX 
to the 
COMMISSION REGULATION (EU) …/… 
amending Annex I to Regulat ion (EC) No 1334/2008 of the Eu ropean Parliament and of 
the Council as regards certain flavouring substances 
  
EN 2   EN ANNEX 
Table 1 of Section 2 of Part A of Annex I to Regulation (EC) No 1334/2008 is amended as follows: 
(a) the entry for FL No 02.139 is replaced by the following: “ 
02.139  Deca-2,4-dien-1-ol  18409-21-7  1189 11748   Restrictions of use 
as a flavouring 
substance:  
In category 2 – not 
more than 
1.5 mg/kg,  
in category 3 – not more than 5 mg/kg,
 
in category 5 – not more than 9 mg/kg,
 
in category 7 – not 
more than 
15 mg/kg,  
in category 8 – not more than 5 mg/kg,
 
in category 12 – not 
more than 3 mg/kg,  
in category 14.1 – 
not more than 
2 mg/kg,  
in category 14.2 – 
not more than 
1 mg/kg,  
in category 16 – not more than 2 mg/kg.
 1 EFSA  
“  
EN 3   EN (b) the entry for FL No 02.153 is replaced by the following: 
“ 
02.153  Hepta-2,4-dien-1-ol  33467-79-7  1784   Restrictions of use 
as a flavouring 
substance:  
In category 1 – not 
more than 
35 mg/kg,  
in category 2 – not 
more than 
25 mg/kg,  
in category 3 – not 
more than 30 mg/kg,
 
in category 4.2 – 
not more than 
50 mg/kg,  
in category 5 – not 
more than 
50 mg/kg,  
in category 6 – not 
more than 
25 mg/kg,  
in category 7 – not 
more than 
50 mg/kg,  
in category 8 – not 
more than 10 mg/kg,
 
in category 9 – not more than 
10 mg/kg,
 1 EFSA   
EN 4   EN in category 12 – not 
more than 
100 mg/kg,  
in category 14.1 – 
not more than 
25 mg/kg,  
in category 15 – not 
more than 50 mg/kg,
 
in category 16 – not 
more than 
25 mg/kg.  
“ 
(c) the entry for FL No 02.162 is replaced by the following: “ 
02.162  Hexa-2,4-dien-1-ol  111-28-4  1174   Restrictions of use 
as a flavouring 
substance:  
In category 3 – not more than 4 mg/kg,
 
in category 4.2 – 
not more than 
2 mg/kg,  
in category 5 – not more than 2 mg/kg,
 
in category 12 – not more than 4 mg/kg,
 
in category 14.1 – 
not more than 
4 mg/kg,  1 EFSA   
EN 5   EN in category 14.2 – 
not more than 
1 mg/kg,  
in category 15 – not more than 1 mg/kg,
 
in category 16 – not more than 2 mg/kg.
 
“ 
(d) the entry for FL No 02.188  is replaced by the following: 
“ 
02.188  Nona-2,4-dien-1-ol  62488-56-6  1183 11802  At least 92%; 
secondary component 3-4% 2-nonen-1-ol 
 Restrictions of use as a flavouring substance:
 
In category 1 – not more than 2 mg/kg,
 
in category 2 – not more than 5 mg/kg,
 
in category 3 – not more than 5 mg/kg,
 
in category 4.2 – not more than 
5 mg/kg,
 
in category 5 – not 
more than 
10 mg/kg,  
in category 6 – not more than 1 mg/kg,
 
in category 7 – not 
more than 
14.5 mg/kg,  1 EFSA   
EN 6   EN in category 8 – not 
more than 5 mg/kg,  
in category 12 – not 
more than 
10 mg/kg,  
in category 14.1 – 
not more than 
2 mg/kg,  
in category 14.2 – 
not more than 5 mg/kg,
 
in category 15 – not 
more than 5 mg/kg,  
in category 16 – not 
more than 
2.5 mg/kg.  
“ 
(e) the entry for FL No 05.057 is replaced by the following: “ 
05.057  Hexa-2(trans),4(trans)-dienal  142-83-6  1175 640  Restrictions of use 
as a flavouring 
substance:  
In category 1 – not 
more than 
10 mg/kg,  
in category 3 – not 
more than 10 mg/kg,
 
in category 4.2 – not more than 1
 EFSA   
EN 7   EN 15 mg/kg,
in category 5 – not 
more than 
20 mg/kg,  
in category 6 – not 
more than 
0.05 mg/kg,  
in category 7 – not 
more than 
15 mg/kg,  
in category 8 – not 
more than 
15 mg/kg,  
in category 9 – not 
more than 
20 mg/kg,  
in category 11 – not 
more than 
50 mg/kg,  
in category 12 – not more than 4 mg/kg,
 
in category 14.1 – 
not more than 
15 mg/kg,  
in category 14.2 – 
not more than 1 mg/kg,
 
in category 16 – not 
more than 
10 mg/kg.  
“ 
(f) the entry for FL No 05.064 is replaced by the following:  
EN 8   EN “ 
05.064  Trideca-2(trans),4(cis),7(cis)-trienal  13552-96-0  1198 685 At least 71%; 
secondary components 
14% 4-cis-7-cis-tridecadienol; 6% 3-cis-7-cis- tridecadienol; 5% 2-
trans-7-cis-
tridecadienal; 3% 2-trans-4-trans-7-cis-
tridecatrienal 
 Restrictions of use 
as a flavouring 
substance:  
In category 2 – not more than 1 mg/kg,
 
in category 8 – not more than 2 mg/kg,
 
in category 9 – not more than 1 mg/kg,
 
in category 12 – not more than 1 mg/kg,
 
in category 15 – not more than 1 mg/kg.
 1 EFSA  
“ 
(g) the entry for FL No 05.071 is replaced by the following: “ 
05.071  Nona-2,4-dienal  6750-03-4  1185 732 At least 89%; 
secondary components 
5-6% 2,4-nonadien-1-
ol and 1-2% 2-nonen-
1-ol  Restrictions of use 
as a flavouring 
substance:  
In category 1 – not 
more than 1.5 mg/kg,
 
in category 2 – not more than 5 mg/kg,
 
in category 3 – not more than 1 mg/kg,
 
in category 4.2 – 
not more than 
1 mg/kg,  1 EFSA   
EN 9   EN in category 5 – not 
more than 5 mg/kg,  
in category 6 – not more than 1 mg/kg,
 
in category 7 – not more than 5 mg/kg,
 
in category 8 – not more than 5 mg/kg,
 
in category 9 – not more than 5 mg/kg,
 
in category 10 – not more than 1 mg/kg,
 
in category 11 – not more than 1 mg/kg,
 
in category 12 – not 
more than 
10 mg/kg,  
in category 14.1 – 
not more than 1 mg/kg,
 
in category 14.2 – not more than 
1 mg/kg,
 
in category 15 – not more than 5 mg/kg,
 
in category 16 – not more than 1 mg/kg.
 
“ 
(h) the entry for FL No 05.081 is replaced by the following: 
“  
EN 10   EN 05.081  2,4-Decadienal  2363-88-4  3135 2120 At least 89%; 
secondary components 
mixture of the (cis, cis)-; (cis, trans)- and (trans, cis)- 2,4-decadienals (sum of all 
isomers 95%); acetone 
and isopropanol 
 Restrictions of use 
as a flavouring 
substance:  
In category 1 – not 
more than 
1.5 mg/kg,  
in category 2 – not more than 5 mg/kg,
 
in category 3 – not 
more than 
1.5 mg/kg,  
in category 4.2 – 
not more than 5 mg/kg,
 
in category 5 – not 
more than 5 mg/kg 
(except in category 5.3 – not more than 
10 mg/kg),
 
in category 6 – not more than 5 mg/kg,
 
in category 7 – not more than 5 mg/kg,
 
in category 8 – not 
more than 
10 mg/kg,  
in category 9 – not more than 3 mg/kg,
 
in category 10 – not 
more than 1 mg/kg,  
in category 11 – not 
more than 1 EFSA   
EN 11   EN 7.5 mg/kg,
in category 12 – not 
more than 
10 mg/kg,  
in category 14.1 – 
not more than 
1 mg/kg,  
in category 14.2 – 
not more than 
1 mg/kg,  
in category 15 – not 
more than 
20 mg/kg,  
in category 16 – not 
more than 
1.5 mg/kg.  
“ 
(i) the entry for FL No 05.084 is replaced by the following: “ 
05.084  Hepta-2,4-dienal  4313-03-5  1179 729 At least 92%; 
secondary components 
2-4% (E,Z)-2,4-heptadienal and 2-4% 2,4-heptadienoic acid 
 Restrictions of use 
as a flavouring 
substance:  
In category 1 – not more than 5 mg/kg,
 
in category 2 – not 
more than 
10 mg/kg,  
in category 3 – not 
more than 1 mg/kg,  
in category 4.2 – 1 EFSA   
EN 12   EN not more than 
1 mg/kg,  
in category 5 – not more than 5 mg/kg,
 
in category 6 – not 
more than 
0.5 mg/kg,  
in category 7 – not 
more than 
10 mg/kg,  
in category 8 – not 
more than 6 mg/kg,  
in category 9 – not more than 6 mg/kg,
 
in category 10 – not more than 1 mg/kg,
 
in category 11 – not more than 1 mg/kg,
 
in category 12 – not more than 2 mg/kg,
 
in category 14.1 – not more than 
1 mg/kg,
 
in category 14.2 – 
not more than 
1 mg/kg,  
in category 15 – not more than 3 mg/kg,
 
in category 16 – not more than 1 mg/kg
 
. 
“  
EN 13   EN (j) the entry for FL No 05.101 is replaced by the following: 
“ 
05.101  Penta-2,4-dienal  764-40-9  1173 11695   Restrictions of use 
as a flavouring 
substance:  
In category 1 – not more than 1 mg/kg,
 
in category 3 – not more than 1 mg/kg,
 
in category 5 – not more than 1 mg/kg,
 
in category 6 – not more than 1 mg/kg,
 
in category 7 – not more than 1 mg/kg,
 
in category 8 – not more than 1 mg/kg,
 
in category 12 – not more than 1 mg/kg,
 
in category 14.1 – 
not more than 
1 mg/kg,  
in category 14.2 – 
not more than 1 mg/kg,
 
in category 16 – not more than 1 mg/kg.
 1 EFSA  
“ 
(k) the entry for FL No 05.108 is replaced by the following: “  
EN 14   EN 05.108  Undeca-2,4-dienal  13162-46-4  1195 10385   Restrictions of use 
as a flavouring 
substance:  
In category 1 – not more than 1 mg/kg,
 
in category 2 – not more than 5 mg/kg.
 
In category 3 – not more than 1 mg/kg.
 
In category 4.2 – 
not more than 
1 mg/kg,  
in category 5 – not 
more than 1 mg/kg (except in category 
5.3 – not more than 
10 mg/kg),
 
in category 6 – not more than 1 mg/kg,
 
in category 7 – not more than 5 mg/kg,
 
in category 8 – not more than 3 mg/kg,
 
in category 9 – not more than 3 mg/kg,
 
in category 10 – not more than 1 mg/kg,
 
in category 11 – not more than 1 mg/kg,
 
in category 12 – not more than 1 mg/kg,
 
in category 14.1 – 1 EFSA   
EN 15   EN not more than 
1 mg/kg,  
in category 14.2 – 
not more than 
1 mg/kg,  
in category 15 – not more than 3 mg/kg,
 
in category 16 – not more than 1 mg/kg.
 
“ 
(l) the entry for FL No 05.125 is replaced by the following: “ 
05.125  Dodeca-2,4-dienal  21662-16-8  1196 11758  At least 85%; 
secondary component 
11- 12% 2-trans-4-cis 
isomer  Restrictions of use 
as a flavouring substance:
 
In category 1 – not more than 1 mg/kg,
 
in category 2 – not more than 5 mg/kg,
 
in category 3 – not 
more than 1 mg/kg,  
in category 4.2 – 
not more than 
1 mg/kg,  
in category 5 – not 
more than 1 mg/kg (except in category 5.3 – not more than 10 mg/kg),
 
in category 6 – not 1 EFSA   
EN 16   EN more than 1 mg/kg,
in category 7 – not 
more than 3 mg/kg,  
in category 8 – not more than 3 mg/kg,
 
in category 9 – not more than 3 mg/kg,
 
in category 10 – not more than 1 mg/kg,
 
in category 11 – not more than 1 mg/kg,
 
in category 12 – not more than 1 mg/kg,
 
in category 14.1 – 
not more than 
1 mg/kg,  
in category 14.2 – 
not more than 
1 mg/kg,  
in category 15 – not 
more than 3 mg/kg,  
in category 16 – not more than 1 mg/kg.
 
“ 
(m) the entry for FL No 05.127 is replaced by the following: “ 
05.127  Octa-2(trans),4(trans)-dienal  30361-28-5  1181 11805   Restrictions of use 
as a flavouring 
substance:  
In category 1 – not 1 EFSA   
EN 17   EN more than 1 mg/kg,
in category 3 – not 
more than 1 mg/kg,  
in category 5 – not 
more than 
10 mg/kg,  
in category 6 – not more than 5 mg/kg,
 
in category 7 – not more than 2 mg/kg,
 
in category 8 – not more than 2 mg/kg,
 
in category 12 – not more than 2 mg/kg,
 
in category 14.1 – 
not more than 
3 mg/kg,  
in category 15 – not more than 1 mg/kg,
 
in category 16 – not 
more than 2 mg/kg.  
“ 
(n) the entry for FL No 05.140 is replaced by the following: “ 
05.140  Deca-2(trans),4(trans)-dienal  25152-84-5  1190 2120 At least 89%; 
secondary components 
3-4% mixture of ( cis-cis)-; (cis-trans)- and (trans-cis)- 2,4-decadienals; 3-4% Restrictions of use 
as a flavouring 
substance:
 
In category 1 – not 
more than 
1.5 mg/kg,  1 EFSA   
EN 18   EN acetone and trace of 
isopropanol  in category 2 – not more than 5 mg/kg,
 
in category 3 – not 
more than 
1.5 mg/kg,  
in category 4.2 – 
not more than 
5 mg/kg,  
in category 5 – not 
more than 5 mg/kg, 
(except in category 
5.3 – not more than 
10 mg/kg),  
in category 6 – not more than 5 mg/kg,
 
in category 7 – not more than 5 mg/kg 
 
In category 8 – not 
more than 
10 mg/kg,  
in category 9 – not more than 3 mg/kg,
 
in category 10 – not more than 1 mg/kg,
 
in category 11 – not 
more than 7.5 mg/kg,
 
in category 12 – not 
more than 
10 mg/kg,  
in category 14.1 – 
not more than 
1 mg/kg,   
EN 19   EN in category 14.2 – 
not more than 
1 mg/kg,  
in category 15 – not 
more than 
20 mg/kg,  
in category 16 – not 
more than 1.5 mg/kg.
 
“ 
(o) the entry for FL No 05.141 is replaced by the following: “ 
05.141  Deca-2,4,7-trienal  51325-37-2  1786   Restrictions of use 
as a flavouring 
substance:  
In category 1 – not more than 1 mg/kg,
 
in category 2 – not more than 1 mg/kg,
 
in category 3 – not more than 1 mg/kg,
 
in category 4.2 – 
not more than 
1 mg/kg,  
in category 5 – not more than 1 mg/kg,
 
in category 6 – not more than 1 mg/kg,
 
in category 7 – not more than 1 mg/kg,
 1 EFSA   
EN 20   EN in category 8 – not 
more than 1 mg/kg,  
in category 9 – not more than 1 mg/kg,
 
in category 10 – not more than 1 mg/kg,
 
in category 11 – not more than 1 mg/kg,
 
in category 12 – not more than 1 mg/kg,
 
in category 14.1 – 
not more than 
1 mg/kg,  
in category 14.2 – 
not more than 1 mg/kg,
 
in category 15 – not more than 1 mg/kg,
 
in category 16 – not more than 1 mg/kg.
 
“ 
(p) the entry for FL No 05.173 is replaced by the following: “ 
05.173  Nona-2,4,6-trienal  57018-53-8  1785   Restrictions of use 
as a flavouring 
substance:  
In category 1 – not 
more than 
15 mg/kg,  
in category 2 – not 1 EFSA   
EN 21   EN more than 
10 mg/kg,  
in category 3 – not 
more than 
15 mg/kg,  
in category 4.2 – 
not more than 
15 mg/kg,  
in category 5 – not 
more than 20 mg/kg,
 
in category 6 – not more than 
10 mg/kg,
 
in category 7 – not 
more than 
25 mg/kg,  
in category 8 – not more than 5 mg/kg,
 
in category 9 – not more than 5 mg/kg,
 
in category 12 – not 
more than 
25 mg/kg,  
in category 14.1 – 
not more than 10 mg/kg,
 
in category 15 – not 
more than 
15 mg/kg,  
in category 16 – not 
more than 
15 mg/kg.   
EN 22   EN “ 
(q) the entry for FL No 05.186 is replaced by the following: “ 
05.186  2,4-Octadienal  5577-44-6   11805   Restrictions of use 
as a flavouring 
substance:  
In category 1 – not more than 1 mg/kg,
 
in category 3 – not more than 1 mg/kg,
 
in category 5 – not 
more than 
10 mg/kg,  
in category 6 – not more than 5 mg/kg,
 
in category 7 – not more than 2 mg/kg,
 
in category 8 – not more than 2 mg/kg,
 
in category 12 – not more than 2 mg/kg,
 
in category 14.1 – 
not more than 3 mg/kg,
 
in category 15 – not more than 1 mg/kg,
 
in category 16 – not more than 2 mg/kg.
 1 EFSA  
“ 
(r) the entry for FL No 05.194 is replaced by the following:  
EN 23   EN “ 
05.194  tr-2, tr-4-Nonadienal  5910-87-2   732 At least 89%; 
secondary components 
at least 5% 2,4-nonadien-1-ol and 2-nonen-1- ol and other isomers of 2,4-nonadienal 
 Restrictions of use 
as a flavouring 
substance:  
In category 1 – not 
more than 
1.5 mg/kg,  
in category 2 – not more than 5 mg/kg,
 
in category 3 – not more than 1 mg/kg,
 
in category 4.2 – 
not more than 
1 mg/kg,  
in category 5 – not more than 5 mg/kg,
 
in category 6 – not more than 1 mg/kg,
 
in category 7 – not 
more than 5 mg/kg,  
in category 8 – not more than 5 mg/kg,
 
in category 9 – not more than 5 mg/kg,
 
in category 10 – not more than 1 mg/kg,
 
in category 11 – not more than 1 mg/kg,
 
in category 12 – not more than 
10 mg/kg,
 
in category 14.1 – 1 EFSA   
EN 24   EN not more than 
1 mg/kg,  
in category 14.2 – 
not more than 
1 mg/kg,  
in category 15 – not more than 5 mg/kg,
 
in category 16 – not more than 1 mg/kg.
 
“ 
(s) the entry for FL No 05.196 is replaced by the following: “ 
05.196  tr-2, tr-4-Undecadienal  30361-29-6   10385   Restrictions of use 
as a flavouring substance:
 
In category 1 – not more than 1 mg/kg,
 
in category 2 – not more than 5 mg/kg,
 
in category 3 – not 
more than 1 mg/kg,  
in category 4.2 – 
not more than 
1 mg/kg,  
in category 5 – not 
more than 1 mg/kg (except in category 5.3 – not more than 10 mg/kg),
 
in category 6 – not 1 EFSA   
EN 25   EN more than 1 mg/kg,
in category 7 – not 
more than 5 mg/kg,  
in category 8 – not more than 3 mg/kg,
 
in category 9 – not more than 3 mg/kg,
 
in category 10 – not more than 1 mg/kg,
 
in category 11 – not more than 1 mg/kg,
 
in category 12 – not more than 1 mg/kg,
 
in category 14.1 – 
not more than 
1 mg/kg,  
in category 14.2 – 
not more than 
1 mg/kg,  
in category 15 – not 
more than 3 mg/kg,  
in category 16 – not more than 1 mg/kg.
 
“ 
(t) the entry for FL No 09.573 is replaced by the following: “ 
09.573  Hexa-2,4-dienyl acetate  1516-17-2  1780 10675   Restrictions of use 
as a flavouring 
substance:  
In category 1 – not 1 EFSA   
EN 26   EN more than 
25 mg/kg,  
in category 3 – not 
more than 
20 mg/kg,  
in category 4.2 – 
not more than 
25 mg/kg,  
in category 5 – not 
more than 25 mg/kg,
 
in category 6 – not more than 
10 mg/kg,
 
in category 7 – not 
more than 
25 mg/kg,  
in category 12 – not 
more than 
10 mg/kg,  
in category 14.1 – 
not more than 20 mg/kg,
 
in category 14.2 – 
not more than 
20 mg/kg,  
in category 15 – not 
more than 
25 mg/kg,  
in category 16 – not 
more than 
25 mg/kg.   
EN 27   EN “