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12.12.2012 Official
Journal
of
the
European
Union L
338/11
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,
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)
Having regard to the Treaty on the Functioning of the European
No 10/2011. CAS No 0000110-98-5 should remain in
Union,
Table 1.
Having regard to Regulation (EC) No 1935/2004 of the
European Parliament and of the Council of 27 October 2004
(5) Compliance
Note
No
(4)
in
Table
3
of
Annex
I
to
Regu
on materials and articles intended to come into contact with
lation (EU) No 10/2011 gives an ambiguous reference to
food and repealing Directives 80/590/EEC and 89/109/EEC (
simulant D, where a reference to simulant D2 is

1 ),
and in particular points (a) and (e) of Article 5(1), and Articles
intended. Therefore, Note No (4) should refer to
11(3) and 12(6) thereof,
simulant D2.
Whereas:
(6) Annex
I
to
Regulation
(EU)
No
10/2011
should
therefore
be corrected accordingly.
(1) Commission
Regulation
(EU)
No
10/2011
of
14
January
2011 on plastic materials and articles intended to come
into contact with food (
(7) In
order
to
limit
the
administrative
burden
to
business

2 ) establishes a Union list of
monomers, other starting substances and additives
operators, plastic materials and articles which have been
which may be used in the manufacture of plastic
lawfully placed on the market based on the requirements
materials and articles. Recently the European Food
set out in Regulation (EU) No 10/2011 and which do
Safety Authority (the Authority) issued favourable
not comply with this Regulation should be able to be
scientific evaluations for additional substances which
placed on the market until one year after entry into force
should now be added to the current list.
of this Regulation. They should be able to remain on the
market until exhaustion of stocks.
(2) For
certain
other
substances,
the
restrictions
and/or
spec
ifications already established at the EU level should be
(8) The
measures
provided
for
in
this
Regulation
are
in
amended on the basis of a new favourable scientific
accordance with the opinion of the Standing
evaluation by the Authority.
Committee on the Food Chain and Animal Health, and
neither the European Parliament nor the Council has
opposed them,
(3) Annex
I
to
Regulation
(EU)
No
10/2011
should
therefore
be amended accordingly.
HAS ADOPTED THIS REGULATION:
(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
Article 1
(EU) No 10/2011 and listed with the CAS No 0000110-
98-5. In Commission Directive 2002/72/EC of 6 August
Annex I to Regulation (EU) No 10/2011 is amended in
2002 relating to plastic materials and articles intended to
accordance with the Annex to this Regulation.
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
Article 2
(EU) No 10/2011, replacing Directive 2002/72/EC,
because it was considered superfluous. However, taking
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
( 1 ) OJ L 338, 13.11.2004, p. 4.
( 2 ) OJ L 12, 15.1.2011, p. 1.
until 1 January 2014. Those plastic materials and articles may
( 3 ) OJ L 220, 15.8.2002, p. 18.
remain on the market until the exhaustion of stocks.

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L 338/12
EN
Official Journal of the European Union
12.12.2012
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 BARROSO

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EN
12.12.2012 Official
Journal
of
the
European
Union L
338/13
ANNEX
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
yes yes no
lycol
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
yes no yes 0,05
disulphide
(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,
yes no no No
migration
of
nanoparticles
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, yes no no Only
to
be
used
in:
methyl metha
(a) rigid poly(vinyl
crylate, butyl
chloride) (PVC) at a
methacrylate)
maximum level of
copolymer
1 % w/w;
(b) polylactic acid (PLA)
at a maximum level
of 5 % w/w.
868 53245 0009010-88-2 (ethyl acrylate, yes no no Only
to
be
used
in:
methyl metha
(a) rigid poly(vinyl
crylate)
chloride) (PVC) at a
copolymer
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.

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L 338/14
EN
Official Journal of the European Union
12.12.2012
(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- yes no yes 0,05 SML
expressed
as
the
(2)
tert-butyl-4-
sum of the substance
hydroxy-5-
and its oxidation product
methylphenyl)
3-[(3-(3-tert-butyl-4-
propionyloxy)-
hydroxy-5-methylphe
1,1-dimethyl
nyl)prop-2-enoyloxy)-
ethyl]-2,4,8,10-
1,1-dimethylethyl]-9-[(3-
tetraoxaspiro
(3-tert-butyl-4-hydroxy-
[5,5]undecane
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.
874 16265 0156065-00-8 α-dimethyl-3-
no yes no 0,05 (33) Only
to
be
used
as
(4’-hydroxy-3’-
comonomer in siloxane
methoxyphe
modified polycarbonate.
nyl)propyls
The oligomeric mixture
ilyloxy, ω-3-
shall be characterised by
dimethyl-3-(4’-
the formula
hydroxy-3’-
methoxyphenyl)
C 24 H 38 Si 2 O 5 (SiOC 2 H 6 )n
propylsilyl
(50 > n ≥ 26).
polydimethylsil
oxane
902 0000128-44-9 1,2-benziso
yes no no The
substance
shall
thiazol-3(2H)-
comply with the specific
one 1,1-
purity criteria as set out
dioxide, sodium
in Commission Regu
salt
lation (EU) No
231/2012 ( 1 ).
979 79987
— (polyethylene
yes no no Only
to
be
used
in
terephthalate,
polyethylene tereph
hydroxylated
thalate (PET) at a
polybutadiene,
maximum level of 5 %
pyromellitic
w/w.
anhydride)
copolymer
( 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 ND expressed
as
eugenol
874

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EN
12.12.2012 Official
Journal
of
the
European
Union L
338/15
(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.

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