EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10747/2018 ANNEX CIS 
(POOL/E2/2018/10747/10747 -EN 
ANNEX CIS.doc)  
[…](2018) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) .../...  
amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles 
intended to come into contact with food  
   
EN 1  EN ANNEX  
Annex es I and III to Regulation (EU) No 10/2011 are amended as follows:  
(1) in Annex I,  Table 1 is amended as follows:  
(a) the entr ies concerning FCM substance s No 467, 744, 1066 , and 1068  are 
replaced by the following:   
“467  14800  3724 -65-0 crotonic acid  yes yes no  (35) ”    
45600  
“744  18888  080181 -31-
3 3-hydroxybutanoic 
acid-3- 
hydroxypentanoic 
acid, copolymer  no yes no  (35) The substance is used 
as product obtained 
by bacterial 
fermentation. In 
compliance with the 
specifications 
mentioned in the 
Table 4 of Annex I .”  
“1066   23985 -75-3 1,2,3,4 -
tetrahydronapht hale
ne-2,6-dicarboxylic 
acid, dimethyl ester  no yes no 0,05  Only to be used as a 
co-monomer in the 
manufacture of a 
polyester non -food 
contact layer in a 
plastic multilayer 
material, which is to 
be used only in 
contact with foods for 
which food simulants 
A, B, C and/or D1 are 
assigned in Table 2 of 
Annex III  to 
Regulation (EU) No 
10/2011 . The specific 
migration limit in 
column 8 refers to the 
sum of the substance 
and of its dimers 
(cyclic and open 
chain).  ”   
“1068   2530 -83-8 [3-(2,3-
epoxypropoxy) prop
yl]trimethoxy silane  no yes no   Only to be used as a 
component of a sizing 
agent to treat glass 
fibres to be embedded 
in glass -fibre -
reinforced low 
diffusivity plastics 
(polyethylene 
terephthalate (PET), 
polycarbonate (PC), 
polybutylene 
terephthalate (PBT), 
thermoset polyesters 
and epoxy bisphenol 
vinylester) in conta ct 
with all foodstuffs. In 
treated glass fibres, 
residues of the 
substance must not be 
detectable at 0,01   
EN 2  EN mg/kg for the 
substance and 0,06 
mg/kg for each of the 
reaction products 
(hydrolysed 
monomers and epoxy -
containing cyclic 
dimer, trimer and 
tetramer). ”  
(b) the following entries are inserted in numerical order of the FCM substance 
numbers:  
“1059  147398 -
31-0 Poly(( R)-3-
hydroxybutyrate -co-
(R)-3-
hydroxyhexanoate)  no yes no  (35) Only to be used alone 
or blended with other 
polymers in contact 
with foods for which 
food simulant E is 
assigned in Table 2 of 
Annex III to 
Regulation (EU) No 
10/2011. ”   
“1067   616-38-6 Dimethyl carbonate  no yes no   Only to be used:  
a) with 1,6 -
hexanediol in the 
manufacture of 
polycarbonate pre -
polymers that are 
used at up to 30% to 
manufacture 
thermoplastic 
polyurethanes with 
methylene diphenyl 
isocyanate and diols, 
such as 
polypropylene glycol 
and 1,4 -butanediol. 
The resulting material  
shall only be applied 
in repeated use 
articles intended to 
come into short –term 
contact (≤ 30 min at 
room temperature ) 
with food for which 
simulants A and/or B 
are assigned in Table 
2 of Annex III  to 
Regulation (EU) No 
10/2011 ; or  
b) for the production 
of other 
polycarbonates 
and/or other 
conditions provided 
that the migration of 
dimethyl carbonate 
does not exceed 0,05 
mg/kg food  and that 
the migration of all (27) 
”  
EN 3  EN polycarbonate 
oligomers with a 
molecular weight 
below 1 000 Da 
together does not 
exceed 0,05 mg/k g 
food.”  
“1069  75-28-5 isobutane   yes no no   Only to be used as a 
blowing agent.”   
(2) in Table 2 of Annex I, the following entry is added:  
“35 467 
744 
1059  0,05 expressed as crotonic acid”  
(3) in Table 3 of Annex I , the following entr y is added:  
“(27) When a final material or article containing this substance  and produced under conditions 
other than those described in point a) column 10 of Table 1 is placed on the market , a well 
described method to determine whether the oligomer migration complies w ith the 
restrictions specified in point b) column 10 of Table 1 shall form part of the supporting 
documentation referred to in Article 16  of Regulation (EU) No 10/2011 . This method shall 
be suitable for use by a competent authority to verify compliance. If  an adequate method is 
publicly available, reference shall be made to that method. If the method requires a 
calibration sample, a sufficient sample shall be supplied to the compe tent authority on its 
request."  
(4) in Table 4 of Annex I, the row concerning restriction of the entry concerning 
substance FCM No 744 is replaced by the following:  
“Restriction  Specific migrati on limit for crotonic acid is 0, 05 mg/kg food”  
(5) in table 3 of point 4 of Annex III, the third and fourth rows are replaced by the 
following :  
“all aqueous and alcoholic foods and milk 
products with a pH ≥ 4.5 food simulant D1  
all aqueous and alcoholic foods and milk 
products with a pH < 4.5 food simulant D1 and food simulant B”