EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2014) XXX  draft 
ANNEX 1 
  
ANNEX 
to the 
COMMISSION REGULATION (EU) No …/.. 
amending Regulation (EU) No 10/2011 on plastic materials a nd articles intended to come 
into contact with food 
 EN 2   EN ANNEX 
to the 
COMMISSION REGULATION (EU) No …/.. 
amending Regulation (EU) No 10/2011 on plasti c materials and articles intended to come 
into contact with food EN 3   EN ANNEX 
 
Annex I to Regulation (EU) No 10/2011 is amended as follows: 
(1) Table 1 is amended as follows: 
(a) the entries concerning FCM substances Nos. 161, 241, 344, 364, 410, 784, 799, 
880 and 881 are replaced by the following:  
'161 9216
0 000087-
69-4 L-(+)-tartaric acid yes No no'     
'241 2296
0 0000108-
95-2 phenol no yes no 3'    
'344 1381
0 
2182
1 0000505-
65-7 1,4-butanediol formal no yes no 0,05 15 
30  (22)
' 
'364 1540
4 0000652-
67-5 1,4:3,6-
dianhydrosorbitol No Yes no 5   Only to be used 
as: 
- a co-monomer in 
poly(ethylene-co-isosorbide 
terephthalate) 
- a co-monomer at 
levels of up to 40 
mole% of the diol 
component in combination with 
ethylene glycol 
and/or 1,4-bis(hydroxymethy
l)cyclohexane, for 
the production of 
polyesters 
Polyesters made 
using 
dianhydrosorbitol 
together with 1,4-bis(hydroxymethy
l)cyclohexane are 
not be used in contact with foods 
containing more 
than 15 % alcohol'  
'410 6272
0 0001332-
58-7 kaolin yes no no   particles can be 
thinner than 100 
nm only if incorporated up to 
12% w/w in an 
ethylene vinyl alcohol 
copolymer  EN 4   EN (EVOH) inner 
layer of a multi-
layer structure, in 
which the layer in direct contact 
with the food 
provides a functional barrier 
preventing 
migration of particles into the 
food' 
'713 4348
0 0064365-
11-3 
0007440-
44-0 charcoal, activated yes no no   Only for use in 
PET at maximum 
10 mg/kg of 
polymer. 
Same purity 
requirements as 
for Vegetable Carbon (E 153) 
set out by 
Commission Directive 
95/45/EC (OJ L 
226, 22.9.1995, p. 1) with exception 
of ash content 
which can be up to 10 % (w/w).'   
'784 9542
0 0745070-
61-5 1,3,5-tris (2,2-
dimethylpropanamido
) 
benzene yes no no 5'    
'799 7770
8  polyethyleneglycol 
(EO= 1-50) ethers of linear and branched 
primary (C8-C22) 
alcohols yes no no 1,8  In compliance 
with the maximum 
ethylene oxide 
content as laid down in the purity 
criteria for food 
additives in Directive 
2008/84/EC (OJ 
L. 253, 20.9.2008, p. 1)'  
'880 3134
8  acids, fatty (C8-C22 
), esters with 
pentaeryhtritol' yes no no'     
'881 2518
7 0003010-
96-6 2,2,4,4-
tetramethylcyclobuta
ne-1,3-diol no yes no 5  Only for: 
- repeated use 
articles for long 
term storage at 
room temperature 
or below and (21)
' EN 5   EN hotfill 
- for use as a co-
monomer in 
single use 
applications for long time storage 
at room 
temperature or below and hot fill 
at a maximum use 
level of 35 mol % 
of the diol 
component of polyesters in 
contact with food 
types for which table 2 of Annex 
III does not assign 
simulant D2, and which have an 
alcohol content of 
less than 20% 
If used in single 
use applications 
for foods for which table 2 of 
Annex III assigns 
simulant D1, supporting 
documentation 
shall be available 
to demonstrate 
that the production of the 
material is under 
good manufacturing 
practice and 
respects the maximum use 
level of the Diol 
component  
 
(b) the following entries are inserted in accordance with the numerical order: 
'859   (butadiene, ethyl 
acrylate, methyl methacrylate, styrene) 
copolymer crosslinked 
with divinylbenzene, in nanoform yes no no   to be used only as 
particles in non-plasticised PVC 
up to 10% w/w in 
contact with all food types at 
ambient 
temperature or 
below including 
long-term storage. 
When used 
together with the  EN 6   EN substances with 
FCM No 998, 
FCM No 1043, or 
both, the restriction of 10% 
w/w applies to the 
sum of these substances. 
The diameter of 
particles shall be > 20 nm, and for 
at least 95% by 
number it shall be 
> 40 nm.' 
'903  37486-
69-4 2H-perfluoro-
[(5,8,11,14-tetramethyl)-
tetraethyleneglycol 
ethyl propyl ether] yes no no   Only to be used as 
a polymer production aid
 in 
the 
polymerisation of fluoropolymers 
intended for: 
- repeated and 
single use 
materials and 
articles when sintered or 
processed (non-
sintered) at temperatures at or 
above 360°C for 
at least 10 
minutes or at 
higher temperatures for 
equivalent shorter 
times, 
- repeated use 
materials and 
articles when processed (non-
sintered) at 
temperatures from 300°C and up to 
360°C for at least 
10 minutes'  
'969  24937-
78-8 ethylene-vinyl acetate 
copolymer wax yes no no   Only to be used as 
a polymeric 
additive up to 2 % 
w/w in polyolefins. 
The migration of 
low molecular 
weight oligomeric 
fraction below 1000 Da shall not 
exceed 5 mg/kg  EN 7   EN food' 
'998   (butadiene, ethyl 
acrylate, methyl 
methacrylate, styrene) 
copolymer not cross-linked, in nanoform yes no no   to be used only as 
particles in non-
plasticised PVC 
up to 10% w/w in contact with all 
food types at 
ambient temperature or 
below including 
long-term storage. 
When used 
together with the substances with 
FCM No 859, 
FCM No 1043, or both, the 
restriction of 10% 
w/w applies to the sum of these 
substances. 
The diameter of 
particles shall be 
> 20 nm, and for 
at least 95% by number it shall be 
> 40 nm'  
'101
7  25618-
55-7 polyglycerol yes no no   To be processed 
under conditions preventing the 
decomposition of 
the substance up 
to a maximum 
temperature of 275 °C'  
'104
3   (butadiene, ethyl 
acrylate, methyl 
methacrylate, styrene) copolymer crosslinked 
with 1,3-butanediol 
dimethacrylate, in nanoform 
  yes no no   to be used only as 
particles in non-
plasticised PVC up to 10% w/w in 
contact with all 
food types at ambient 
temperature or 
below including long-term storage. 
When used 
together with the substances with 
FCM No 859, 
FCM No 998, or both, the 
restriction of 10% 
w/w applies to the 
sum of these 
substances.  EN 8   EN The diameter of 
particles shall be 
> 20 nm, and for 
at least 95% by number it shall be 
> 40 nm.' 
(c) the following entry is deleted: 
'72
5 7789
5 0068439 -
49-6 Polyethyleneglycol 
(EO = 2 -6) monoalkyl 
(C16-C18) ether  yes no  no  0,05   The composition 
of this mixture is 
as follows:  
- 
polyethyleneglyco
l (EO = 2 -6) 
monoalkyl (C 16-
C18) ether  
(approximately 
28%) , 
- fatty alcohols  
(C16-C18) 
(approximately 
48%),  
- ethyleneglycol 
(EO = 2 -6) 
monoalkyl (C 16-
C18) ether 
(approximately 
24%)'   
 
(2) In Table 2, the entries concerning group re striction Nos. 15 and 30 are replaced by 
the following:  
'15 98 
196 344 15 expressed as formaldehyde' 
'30 254 
344 672 5 expressed as 1,4-butanediol' 
 
(3) In Table 3, the following entries are added: 
'(21) When tested in simulant D1 a materi al containing the substance may exceed the 
migration limits. In such a case verificati on of compliance shall be on the basis o f 
supporting documentation demonstrating that  the maximum use level of the diol 
component was not exceeded during manu facturing that took place under Good 
Manufacturing Practice' 
'(22) In case of reaction with foods or simulants veri fication of compliance shall 
include verification that the migrat ion limits of the hydrolysis products, EN 9   EN formaldehyde and 1,4-butanediol, are not exceeded'