REGULATIONS  
COMMISSION REGULATION (EU) No 1282/2011  
of 28 November 2011  
amending and correcting Commission Regulation (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 10/2011 of 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 
which 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 spec ­
ifications already established at the EU level should be 
amended on the basis of a new favourable scientific 
evaluation by the Authority.  
(3) The restrictions and specifications for the use of the 
substance with FCM substance number 239 with the 
name 2,4,6-triamino-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 intake (TDI) of 0,2 mg/kg body 
weight (b.w.) for this substance. In its opinion the 
Authority also concluded that exposure in children due 
to migration from food contact materials would be in the 
range of the TDI. Taking into account the TDI and the 
exposure 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 Commission Regulation (EC) 
No 1135/2009 of 25 November 2009 imposing special 
conditions governing the import of products originating 
in or consigned from China, and repealing Commission 
Decision 2008/798/EC (  3 ). 
(4) Annex I to Regulation (EU) No 10/2011 should therefore 
be amended accordingly.  
(5) The substance with FCM substance number 438 and the 
name bis(2,6-diisopropylphenyl) carbodiimide is auth ­
orised to be used as an additive in plastics according 
to Table 1 of Annex I to Regulation (EU) No 10/2011. 
The Authority reassessed the safety of the authorised 
substance. The Opinion delivered by the Authority (  4 ) 
clarified that the substance is to be used as a monomer 
instead of an additive in plastics. For this reason it is 
appropriate to correct the use and to update the 
reference number accordingly in the Annex I.  
(6) The substance with FCM substance number 376 and the 
name N-methylpyrrolidone is authorised to be used as an 
additive in plastics in Table 1 of Annex I to Regulation 
(EU) No 10/2011 without a specific migration limit. The 
Opinion delivered by the Authority (  5 ) 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 an additive in plastics in Table 1 of Annex I to 
Regulation (EU) No 10/2011 and listed with the CASEN L 328/22 Official Journal of the European Union 10.12.2011  
( 1 ) OJ L 338, 13.11.2004, p. 4.  
( 2 ) OJ L 12, 15.1.2011, p. 1.  ( 3 ) OJ L 311, 26.11.2009, p. 3.  
( 4 ) Scientific Opinion on the safety evaluation of the substance bis 
(2,6-diisopropylphenyl)carbodiimide for use in food contact 
materials.  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 seventh list of substances 
for food contact materials.  EFSA Journal  (2005) 201, 1-28.No 0007328-26-5. According to the Opinion delivered 
by the Authority (  1 ) 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 administrative burden to business 
operators, plastic materials and articles which have been 
lawfully placed on the market based on the requirements 
set out in Regulation (EU) No 10/2011 and which do not 
comply with this Regulation should be able to be 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 Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health, and 
neither the European Parliament nor the Council has 
opposed them,  HAS ADOPTED THIS REGULATION:  
Article 1  
Annex I to Regulation (EU) No 10/2011 is amended in 
accordance with the Annex to this Regulation.  
Article 2  
Plastic materials and articles which have been lawfully placed on 
the market before 1 January 2012 and which do not comply 
with this 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 and directly applicable in the Member States in 
accordance with the Treaties.  
Done at Brussels, 28 November 2011.  
For the Commission  
The President  
José Manuel BARROSOEN 10.12.2011 Official Journal of the European Union L 328/23  
( 1 ) 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.  EFSA Journal  (2008) 628-633, 1-19.EN L 328/24 Official Journal of the European Union 10.12.2011
 ANNEX  
Annex I to Regulation (EU) No 10/2011 is amended as follows:  
(1) in Table 1 the following lines are inserted in numerical order of the FCM substance numbers:  
FCM 
substance 
No Ref. No  CAS No  Substance name  Use as 
additive or 
polymer 
production 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 
verification 
of 
compliance  
(1) (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9)  (10)  (11)  
855  40560  (butadiene, styrene, methyl metha ­
crylate) 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 metha ­
crylate, 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.  
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 octyl ­
triethoxysilane  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-alcoholic and dairy products.EN 10.12.2011 Official Journal of the European Union L 328/25
 (1) (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9)  (10)  (11)  
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 when: 
— processed at temperatures higher 
than 280 °C for at least 10 
minutes, 
— processed at temperatures higher 
than 190 °C up to 30 % w/w 
for use in blends with polyoxy ­
methylene polymers and intended 
for repeated use articles.  
923  39150  0000120-40-1  N,N-bis(2-hydroxyethyl)dodecanamide  yes  no  no  5  The residual amount of diethanolamine 
in plastics, as an impurity and decom ­
position product of the substance, 
should not result in a migration of 
diethanolamine higher than 0,3 mg/kg 
food.  (18)  
924  94987  trimethylolpropane, mixed triesters 
and diesters with n-octanoic and n- 
decanoic acids  yes no  no  0,05  Only for use in PET in contact with all 
types of foods other than fatty, high- 
alcoholic and dairy products.  
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-monomer 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.EN L 328/26 Official Journal of the European Union 10.12.2011
 (1) (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9)  (10)  (11)  
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.  
(2) in Table 1 for the following substance, the content of the columns (2), (5), (6) and (10) is replaced by the following:  
FCM 
substance 
No Ref. No  CAS No  Substance name  Use as 
additive or 
polymer 
production 
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 
verification 
of 
compliance  
(1) (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9)  (10)  (11)  
438  13303  0002162-74-5  bis(2,6-diisopropylphenyl) 
carbodiimide  no yes  no  0,05  Expressed as the sum of bis(2,6-diisopro ­
pylphenyl)carbodiimide and its hydrolysis 
product 2,6-diisopropylaniline  
(3) in Table 1 for the following substance, the content of the column (3) is replaced by the following:  
FCM 
substance 
No Ref. No  CAS No  Substance name  Use as 
additive or 
polymer 
production 
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 
verification 
of 
compliance  
(1) (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9)  (10)  (11)  
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 10.12.2011 Official Journal of the European Union L 328/27
 (4) in Table 1 for the following substances, the content of the column (8) is replaced by the following:  
FCM 
substance 
No Ref. No  CAS No  Substance name  Use as 
additive or 
polymer 
production 
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 
verification 
of 
compliance  
(1) (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9)  (10)  (11)  
239  19975  0000108-78-1  2,4,6-triamino-1,3,5-triazine  yes  yes  no  2,5  
25420  
93720  
376  66905  0000872-50-4  N-methylpyrrolidone  yes  no  no  60  
(5) in Table 1 for the following substance, the content of the columns (8) and (10) is replaced by the following:  
FCM 
substance 
No Ref. No  CAS No  Substance name  Use as 
additive or 
polymer 
production 
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 
verification 
of 
compliance  
(1) (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9)  (10)  (11)  
452  38885  0002725-22-6  2,4-bis(2,4-dimethylphenyl)- 
6-(2-hydroxy-4-n-octylo ­
xyphenyl)-1,3,5-triazine  yes no  no  5EN L 328/28 Official Journal of the European Union 10.12.2011
 (6) in Table 1 for the following substances, the content of the column (10) is replaced by the following:  
FCM 
substance 
No Ref. No  CAS No  Substance name  Use as 
additive or 
polymer 
production 
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 
verification 
of 
compliance  
(1) (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9)  (10)  (11)  
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) or polylactic acid (PLA); and (ii) direct 
food contact of a blend of PGA up to 3 % w/w 
in PET or 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-hydroxys ­
tearic acid) with polyethyleneimine.  
(7) in Table 1 for the following substance, the content of the columns (10) and (11) is replaced by the following:  
FCM 
substance 
No Ref. No  CAS No  Substance name  Use as 
additive or 
polymer 
production 
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 
verification 
of 
compliance  
(1) (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9)  (10)  (11)  
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 ethylviny ­
lalcohol (EVOH) and polyvinylalcohol (PVOH) 
copolymers.  (17) 
(19)(8) in Table 2 for the following group restriction, the content of the columns (2) and (4) is replaced by the following:  
Group 
restriction 
No FCM 
substance 
No SML (T) 
[mg/kg]  Group restriction specification  
(1) (2)  (3)  (4)  
14 294  5  Expressed as the sum of the substances and their oxidation products  
368  
894  
(9) in Table 3 the following notes on verification of compliance are inserted in numerical order:  
Note No  Notes on verification of compliance  
(1) (2)  
(18)  There is a risk that the SML could 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 
ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymersEN 10.12.2011 Official Journal of the European Union L 328/29