REGULATIONS  
COMMISSION REGULATION (EU) No 1183/2012  
of 30 November 2012  
amending and correcting 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), and Articles 
11(3) and 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 favourable 
scientific evaluations 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) Annex I to Regulation (EU) No 10/2011 should therefore 
be amended accordingly.  
(4) The substance with FCM Substance Number 257 and the 
name dipropyleneglycol 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 CAS No 0000110- 
98-5. In Commission Directive 2002/72/EC of 6 August 
2002 relating to plastic materials and articles intended to 
come into contact with foodstuffs (  3 ) this substance was 
referred to by CAS No 0025265-71-8. That reference 
was deleted upon the entry into force of Regulation 
(EU) No 10/2011, replacing Directive 2002/72/EC, 
because it was considered superfluous. However, taking into account that CAS No 0025265-71-8 refers to the 
commercially used mixture of isomers rather than to the 
pure substance, it should be reinserted in Regulation (EU) 
No 10/2011. CAS No 0000110-98-5 should remain in 
Table 1.  
(5) Compliance Note No (4) in Table 3 of Annex I to Regu ­
lation (EU) No 10/2011 gives an ambiguous reference to 
simulant D, where a reference to simulant D2 is 
intended. Therefore, Note No (4) should refer to 
simulant D2.  
(6) Annex I to Regulation (EU) No 10/2011 should therefore 
be corrected accordingly.  
(7) 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 one year after entry into force 
of this Regulation. They should be able to remain on the 
market until exhaustion of stocks.  
(8) 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 2013 and which do not comply 
with this Regulation may continue to be placed on the market 
until 1 January 2014. Those plastic materials and articles may 
remain on the market until the exhaustion of stocks.EN 12.12.2012 Official Journal of the European Union L 338/11  
( 1 ) OJ L 338, 13.11.2004, p. 4.  
( 2 ) OJ L 12, 15.1.2011, p. 1.  
( 3 ) OJ L 220, 15.8.2002, p. 18.Article 3  
This Regulation shall enter into force on the twentieth day following its publication in the  Official Journal of 
the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels, 30 November 2012.  
For the Commission  
The President  
José Manuel BARROSOEN L 338/12 Official Journal of the European Union 12.12.2012ANNEX  
Annex I to Regulation (EU) No 10/2011 is amended as follows:  
(1) in Table 1 for the following substance, the content of column (3) is replaced by the following:  
(1) (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9)  (10)  (11)  
257  13550  0000110-98-5  dipropyleneg ­
lycol  yes yes  no  
16660  0025265-71-8  
51760  
(2) in Table 1 for the following substance, the content of column (8) is replaced by the following:  
(1) (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9)  (10)  (11)  
449  49840  0002500-88-1  dioctadecyl 
disulphide  yes no  yes  0,05  
(3) in Table 1 for the following substance, the content of columns (8) and (9) is replaced by the following:  
(1) (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9)  (10)  (11)  
180  17160  0000097-53-0  eugenol  no  yes  no  (33)  
(4) in Table 1 for the following substances, the content of column (10) is replaced by the following:  
(1) (2)  (3)  (4)  (5)  (6)  (7)  (8)  (9)  (10)  (11)  
807  93485  —  titanium nitride, 
nanoparticles  yes no  no  No migration of 
titanium nitride nano ­
particles. 
Only to be used in 
polyethylene tereph ­
thalate (PET) up to 
20 mg/kg. 
In the PET, the agglom ­
erates have a diameter of 
100-500 nm consisting 
of primary titanium 
nitride nanoparticles; 
primary particles have a 
diameter of approxi ­
mately 20 nm.  
865  40619  0025322-99-0  (butyl acrylate, 
methyl metha ­
crylate, butyl 
methacrylate) 
copolymer  yes no  no  Only to be used in: 
(a) rigid poly(vinyl 
chloride) (PVC) at a 
maximum level of 
1 % w/w; 
(b) polylactic acid (PLA) 
at a maximum level 
of 5 % w/w.  
868  53245  0009010-88-2  (ethyl acrylate, 
methyl metha ­
crylate) 
copolymer  yes no  no  Only to be used in: 
(a) rigid poly(vinyl 
chloride) (PVC) at a 
maximum level of 
2 % w/w; 
(b) polylactic acid (PLA) 
at a maximum level 
of 5 % w/w; 
(c) polyethylene tereph ­
thalate (PET) at a 
maximum level of 
5 % w/w.EN 12.12.2012 Official Journal of the European Union L 338/13(5) 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)  
858  38565  0090498-90-1  3,9-bis[2-(3-(3- 
tert-butyl-4- 
hydroxy-5- 
methylphenyl) 
propionyloxy)- 
1,1-dimethyl ­
ethyl]-2,4,8,10- 
tetraoxaspiro 
[5,5]undecane  yes no  yes  0,05  SML expressed as the 
sum of the substance 
and its oxidation product 
3-[(3-(3-tert-butyl-4- 
hydroxy-5-methylphe ­
nyl)prop-2-enoyloxy)- 
1,1-dimethylethyl]-9-[(3- 
(3-tert-butyl-4-hydroxy- 
5-methylphenyl)pro ­
pionyloxy)-1,1-dimethyl ­
ethyl]-2,4,8,10-tetraox ­
aspiro[5,5]-undecane in 
equilibrium with its 
paragraph quinone 
methid tautomer.  (2) 
874  16265  0156065-00-8  α-dimethyl-3- 
(4’-hydroxy-3’- 
methoxyphe ­
nyl)propyls ­
ilyloxy, ω-3- 
dimethyl-3-(4’- 
hydroxy-3’- 
methoxyphenyl) 
propylsilyl 
polydimethylsil ­
oxane  no yes  no  0,05  (33)  Only to be used as 
comonomer in siloxane 
modified polycarbonate. 
The oligomeric mixture 
shall be characterised by 
the formula 
C 24 H 38 Si 2 O 5 (SiOC  2 H 6 )n 
(50 > n ≥ 26).  
902  0000128-44-9  1,2-benziso ­
thiazol-3(2H)- 
one 1,1- 
dioxide, sodium 
salt yes no  no  The substance shall 
comply with the specific 
purity criteria as set out 
in Commission Regu ­
lation (EU) No 
231/2012 (  1 ). 
979  79987  —  (polyethylene 
terephthalate, 
hydroxylated 
polybutadiene, 
pyromellitic 
anhydride) 
copolymer  yes no  no  Only to be used in 
polyethylene tereph ­
thalate (PET) at a 
maximum level of 5 % 
w/w.  
( 1 ) OJ L 83, 22.3.2012, p. 1.  
(6) in Table 2 the following line is inserted in numerical order of the group restriction numbers:  
(1) (2)  (3)  (4)  
Group Restriction 
No FCM substance No  SML (T) [mg/kg]  Group restriction specification  
33 180 
874  ND expressed as eugenolEN L 338/14 Official Journal of the European Union 12.12.2012(7) in Table 3 on verification of compliance the content of Note No (4) is replaced by the following:  
(1) (2)  
Note No  Note on verification of compliance  
(4) Compliance testing when there is a fat contact should be performed using saturated 
fatty food simulants as simulant D2.EN 12.12.2012 Official Journal of the European Union L 338/15