EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
SANCO/11620/2011 (POOL/E6/2011/11620/11620-EN.doc) 
[…](2011) XXX draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX 
amending and correcting Commission Regulati on (EU) No 10/2011 on plastic materials 
and articles intended to come into contact with food 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX 
amending and correcting Commission Regulati on (EU) No 10/2011 on plastic materials 
and articles intended to come into contact with food 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the 
Council of 27 October 2004 on materials and articles intended to come into  contact with food 
and repealing Directives  80/590/EEC and 89/109/EEC
1, and in particular points (a) and (e) of 
Article 5(1), Article 11(3) and Article 12 (6) thereof, 
Whereas: (1) Commission Regulation (EU) No 10/2011of 14 January 2011 on plastic materials and 
articles intended to come into contact with food
2 establishes a Union list of monomers, 
other starting substances and additives wh ich may be used in the manufacture of 
plastic materials and articles. Recently the European Food Safety Authority (‘the Authority’) issued a favourable scientific evaluation for additional substances which 
should now be added to the current list. 
(2) For certain other substances, the restrictions and/or specifications already established 
at the European level should be amended on the basis of a new favourable scientific 
evaluation by the Authority.  
(3) The restrictions and specifications for th e use of the substance with FCM Substance 
Number 239 with the name 2,4,6-triami no-1,3,5-triazine ("Melamine") should be 
amended following the scientific opinion published on 13 April 2010 by the Authority. 
That opinion laid down a tolerable daily in take (TDI) of 0,2 mg/kg body weight for 
this substance. In its opini on the Authority concluded also that exposure in children 
due to migration from food contact materials only would be in th e range of the TDI. 
Taking into account the TDI and the exposur e from all other sources the migration 
limit for the substance 239 should be reduced. The proposed migration limit of 2,5 mg/kg food is in line with the maximum level of melamine contamination allowed 
in food laid down in the Co mmission Decision of 26 Se ptember 2008 imposing special 
                                                
 
1 OJ L 338, 13.11.2004, p. 4. 
2 OJ L 12, 15.1.2011, p. 1.  
EN 3   EN conditions governing the import of products  containing milk or milk products 
originating in or consigned from China3. 
(4) Annex I to Regulation (EU) No 10/2011 s hould therefore be amended accordingly. 
(5) The substance with FCM Substance Number 438 and the name bis (2,6-
diisopropylphenyl) carbodiimide is authorised to be used as additive in plastics 
according to Table 1 of Annex I to Regul ation (EU) No 10/2011. The Authority re-
assessed the safety of the authorised substance. The Opinion delivered by the 
Authority4 clarified that the substance is to be used as monomer instead of as additive 
in plastics. For this reason it is appropria te to correct the use and to update the 
Reference Number accordingly in the Annex I.  
(6) The substance with FCM Substance Numb er 376 and the name N-methylpyrrolidone 
is authorised to be used as additive in pl astics in Table 1 of Annex I to Regulation 
(EU) No 10/2011 without specific migrati on limit. The Opinion delivered by the 
Authority5 established a TDI of 1 mg/kg b.w. resulting in an SML of 60 mg/kg food. 
This limit coincides with the generic specific migration limit established in Article 11(2) of Regulation (EU) No 10/ 2011, however if the SML of 60 mg/kg is 
derived from a toxicological threshold such as the TDI the SML should be specifically 
mentioned in the Annex I. 
(7) The substance with FCM Substance Number  797 and the name polyester of adipic 
acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol is authorised to be 
used as additive in plastics  in Table 1 of Annex I to Regulation (EU) No 10/2011 and 
listed with the CAS No 0007328-26-5. Accord ing to the Opinion delivered by the 
Authority
6 this CAS No should read 0073018-26- 5. Therefore the CAS No for this 
substance needs to be corrected in the Annex I.  
(8) In order to limit the admini strative burden to business opera tors, plastic materials and 
articles which have been lawfully placed on the market based on the requirements set 
out in Regulation (EU) 10/ 2011 and which do not comply w ith this Regulation should 
be able to be imported and placed on the market until [ 1 January 2013 ]. They should 
be able to remain on the market until exhaustion of stocks. 
(9) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health, and neither the European 
Parliament nor the Council has opposed them. 
                                                 
3 OJ L 259, 27.9.2008, p. 10. 
4 Scientific Opinion on the safety evaluation of th e substance bis(2,6-diisopropylphenyl)carbodiimide for 
use in food contact materials. The EFSA Journal 2010; 8(12):1928. 
5 Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact 
with food (AFC) on a request from the Commission related to a 7th list of substances for food contact 
materials. The EFSA Journal (2005)201, 1-28. 
6 Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact 
with food (AFC) on a request related to a 18th list of substances for food contact materials. The EFSA 
Journal (2008) 628-633, 1-19.  
EN 4   EN HAS ADOPTED THIS REGULATION: 
Article 1 
Annex I to Regulation (EU) No 10/2011 is ame nded in accordance with the Annex to this 
Regulation. 
Article 2 
Plastic materials and articles which have be en lawfully placed on the market before 
[1 January 2012] and which do not comply with th is Regulation may continue to be placed on 
the market until [1 January 2013]. Those plastic materials and articles may remain on the market until the exhaustion of stocks. 
Article 3  
This Regulation shall enter into force on the 20th day following its publication in the Official 
Journal of the European Union . 
This Regulation shall be binding in its entirety a nd directly applicable in the Member States in 
accordance with the Treaties.  
Done at Brussels, 
 For the Commission 
 José Manuel BARROSO 
 The President  
EN 5   EN ANNEX  
Annex I to Regulation No (EU) 10/2011 is amended as follows: 
(1) In Table 1 the following lines are inserted in  numerical order of the FCM Substance numbers: 
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
FCM 
Sub-
stance 
No. Ref. 
No. CAS No. Substance Name  Use as 
additive 
or 
polymer 
producti
on aid 
(yes/no) Use as 
monomer or 
other 
starting 
substance or 
macro-
molecule 
obtained 
from 
microbial 
fermentation 
(yes/no) FRF 
applicable 
(yes/no) SML 
[mg/kg] SML(T) 
[mg/kg] 
(Group 
restriction 
No) Restrictions and specifications Notes on 
verifi-
cation of 
com-
pliance 
855  40560    (butadiene, styrene, 
methyl methacrylate) 
copolymer cross-linked 
with 1,3-butanediol 
dimethacrylate yes no no    Only to be used in rigid poly(vinyl chloride) (PVC) 
at a maximum level of 12 % at room temperature or 
below.  
856  40563    (butadiene, styrene, 
methyl methacrylate, butyl 
acrylate) copolymer cross-
linked with 
divinylbenzene or 1,3-
butanediol dimethacrylate yes no no    Only to be used in rigid poly(vinyl chloride) (PVC) 
at a maximum level of 12 % at room temperature or 
below.  
857  66765  0037953
-21-2 (methyl methacrylate, 
butyl acrylate, styrene, 
glycidyl methacrylate) 
copolymer yes no no    Only to be used in rigid poly(vinyl chloride) (PVC) 
at a maximum level of 2 % at room temperature or 
below.   
EN 6   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
863  15260  0000646
-25-3 1,10-decanediamine no yes no 0,05  Only  to be used as a co-monomer for 
manufacturing polyamide articles for repeated use 
in contact with aqueous, acidic and dairy foodstuffs 
at room temperature or for short term contact up to 
150°C.  
873  93460    titanium dioxide reacted 
with octyltriethoxysilane  yes no no    Reaction product of titanium dioxide with up to 2% 
w/w surface treatment substance 
octyltriethoxysilane, processed at high 
temperatures.  
894  93360  0016545
-54-3 thiodipropionic acid, 
ditetradecyl ester yes no no   (14)    
895  47060  0171090
-93-0 3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propanoic 
acid, esters with C13-C15 
branched and linear 
alcohols yes no no 0,05  Only to be used in polyolefins in contact with foods 
other than fatty/high-alc oholic and dairy products.  
896 71958 0958445
-44-8 3H-perfluoro-3-[(3-
methoxy-
propoxy)propanoic acid], 
ammonium salt yes no no   Only to be used in the polymerisation of 
fluoropolymers processed at temperatures higher 
than 280°C for at least 10 minutes or in the 
polymerisation of fluoropolymers processed at 
temperatures higher than 190°C for being used at 
levels up to 30% in blends with polyoxymethylene polymers intended for repeated use articles.  
923  39150  0000120
-40-1 N,N-bis(2-
hydroxyethyl)dodecanami
de yes no no 5  The residual amount of  diethanolamine in plastics, 
as an impurity and deco mposition product of the 
substance, should not resu lt in a migration of 
diethanolamine higher than 0,3 mg/kg food. (18) 
924  94987    trimethylolpropane, mixed 
triester and diesters with 
n-octanoic and n-decanoic 
acids yes no no 0,05  Only for PET in c ontact with all types of foods 
other than fatty, high-alc oholic and dairy products.   
EN 7   EN (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
926 71955 0908020
-52-0 perfluoro[(2-ethyloxy-
ethoxy)acetic acid], 
ammonium salt yes no no   Only to be used in the polymerisation of 
fluoropolymers that are processed at temperatures 
higher than 300°C for at least 10 minutes.  
971  25885  0002459
-10-1 trimethyl trimellitate no yes no    Only to  be used as a co-m onomer up to 0,35% w/w 
to produce modified polyesters intended to be used 
in contact with aqueous and dry foodstuffs 
containing no free fat at the surface. (17) 
972  45197  0012158
-74-6 copper hydroxide 
phosphate yes no no       
973  22931  0019430
-93-4 (perfluorobutyl)ethylene no yes no    Only to be used as a co-monomer up to 0,1% w/w 
in the polymerisation of fluoropolymers, sintered at 
high temperatures.  
974 74050 939402-
02-5 phosphorous acid, mixed 
2,4-bis(1,1-
dimethylpropyl)phenyl 
and 4-(1,1-
dimethylpropyl)phenyl 
triesters yes no yes 5  SML expressed as the sum of phosphite and 
phosphate form of the substance and the hydrolysis 
product 4-t-amylphenol. 
The migration of the hydrolysis product 2,4-di-t-
amylphenol should not exceed 0,05 mg/kg.  
  
EN 8   EN (2) In Table 1 for the following substance, the content of the co lumns (2), (5), (6) and (10) is replaced by the following: 
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
FCM 
Sub-
stance 
No. Ref. 
No. CAS No. Substance Name  Use as 
additive 
or 
polymer 
producti
on aid 
(yes/no) Use as 
monomer or 
other 
starting 
substance or 
macro-
molecule 
obtained 
from 
microbial 
fermentation 
(yes/no) FRF 
applicable 
(yes/no) SML 
[mg/kg] SML(T) 
[mg/kg] 
(Group 
restriction 
No) Restrictions and specifications Notes on 
verifi-
cation of 
com-
pliance 
438  13303  0002162
-74-5 bis(2,6-diisopropylphenyl) 
carbodiimide no yes no 0,05  Expressed as the sum of bis(2,6-
diisopropylphenyl)carbodiimide and its hydrolysis 
product 2,6-diisopropylaniline  
  
EN 9   EN (2) In Table 1 for the following substance, the cont ent of the column (3) is replaced by the following: 
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
FCM 
Sub-
stance 
No. Ref. 
No. CAS No. Substance Name  Use as 
additive 
or 
polymer 
producti
on aid 
(yes/no) Use as 
monomer or 
other 
starting 
substance or 
macro-
molecule 
obtained 
from 
microbial 
fermentation 
(yes/no) FRF 
applicable 
(yes/no) SML 
[mg/kg] SML(T) 
[mg/kg] 
(Group 
restriction 
No) Restrictions and specifications Notes on 
verifi-
cation of 
com-
pliance 
797 76807 0073018
-26-5 polyester of adipic acid 
with 1,3-butanediol, 1,2-
propanediol and 2-ethyl-1-
hexanol yes no yes  (31) 
(32)   
   
EN 10   EN (3) In Table 1 for the following subs tances, the content of the column (8) is replaced by the following: 
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
FCM 
Sub-
stance 
No. Ref. 
No. CAS No. Substance Name  Use as 
additive 
or 
polymer 
producti
on aid 
(yes/no) Use as 
monomer or 
other 
starting 
substance or 
macro-
molecule 
obtained 
from 
microbial 
fermentation 
(yes/no) FRF 
applicable 
(yes/no) SML 
[mg/kg] SML(T) 
[mg/kg] 
(Group 
restriction 
No) Restrictions and specifications Notes on 
verifi-
cation of 
com-
pliance 
19975 
25420  239  
93720  0000108
-78-1 2,4,6-triamino-1,3,5-
triazine yes yes no 2,5    
376  66905  0000872
-50-4 N-methylpyrrolidone yes no no 60     
  
EN 11   EN (4) In Table 1 for the following substan ces, the content of the columns (8) a nd (10) is replaced by the following: 
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
FCM 
Sub-
stance 
No. Ref. 
No. CAS No. Substance Name  Use as 
additive 
or 
polymer 
producti
on aid 
(yes/no) Use as 
monomer or 
other 
starting 
substance or 
macro-
molecule 
obtained 
from 
microbial 
fermentation 
(yes/no) FRF 
applicable 
(yes/no) SML 
[mg/kg] SML(T) 
[mg/kg] 
(Group 
restriction 
No) Restrictions and specifications Notes on 
verifi-
cation of 
com-
pliance 
452  38885  0002725
-22-6 2,4-bis(2,4-
dimethylphenyl)-6-(2-
hydroxy-4-n-
octyloxyphenyl)-1,3,5-
triazine yes no no 5     
  
EN 12   EN (5) In Table 1 for the following substances, the conten t of the column (10) is replaced by the following: 
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
FCM 
Sub-
stance 
No. Ref. 
No. CAS No. Substance Name  Use as 
additive 
or 
polymer 
producti
on aid 
(yes/no) Use as 
monomer or 
other 
starting 
substance or 
macro-
molecule 
obtained 
from 
microbial 
fermentation 
(yes/no) FRF 
applicable 
(yes/no) SML 
[mg/kg] SML(T) 
[mg/kg] 
(Group 
restriction 
No) Restrictions and specifications Notes on 
verifi-
cation of 
com-
pliance 
794  18117  0000079
-14-1 glycolic acid no yes no    Only to be used for manufacture of polyglycolic 
acid (PGA) for i) indirect food contact behind 
polyesters such as polyethylene terephthalate (PET) 
and polylactic acid (PLA) and ii) direct food 
contact of a blend of PGA up to 3% w/w in PET 
and PLA.  
812  80350  0124578
-12-7 poly(12-hydroxystearic 
acid)-polyethyleneimine 
copolymer yes no no    Only to be used in plastics up to 0,1 % w/w. 
Prepared by the reaction of poly(12-hydroxystearic 
acid) with polyethyleneimine.  
  
EN 13   EN (6) In Table 1 for the following substance, the content of the columns (10) and (11) is  replaced by the following: 
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) 
FCM 
Sub-
stance 
No. Ref. 
No. CAS No. Substance Name  Use as 
additive 
or 
polymer 
producti
on aid 
(yes/no) Use as 
monomer or 
other 
starting 
substance or 
macro-
molecule 
obtained 
from 
microbial 
fermentation 
(yes/no) FRF 
applicable 
(yes/no) SML 
[mg/kg] SML(T) 
[mg/kg] 
(Group 
restriction 
No) Restrictions and specifications Notes on 
verifi-
cation of 
com-
pliance 
862 15180 0018085
-02-4 3,4-diacetoxy-1-butene no yes no 0,05  SML including the hydrolysis product 3,4-
dihydroxy-1-butene 
Only to be used as a co-monomer for 
ethylvinylalchohol (EVOH)  and polyvinylalcohol 
(PVOH) copolymers  (17) 
(19) 
  
EN 14   EN (7) In Table 2 for the following group restric tions, the content of the columns (2) and (4) 
is replaced by the following: 
(1) (2) (3) (4) 
Group 
Restric-
tion No FCM 
substance 
No SML (T) 
[mg/kg] Group restriction specification 
14  294 
368 
894 5 expressed as the sum of the substances and their 
oxidation products 
 
(8) In Table 3 the following note on verificati on of compliance is inserted in numerical 
order: 
(1) (2) 
Note 
No Notes on verification of compliance  
(18) There is a risk that the SML coul d be exceeded from low-density polyethylene 
(LDPE) 
(19) There is a risk that the OML could be exceeded in direct contact with aqueous 
foods from ethylvinylalchohol (EVOH) and polyvinylalcohol (PVOH) 
copolymers