HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 328/22
EN
Official Journal of the European Union
10.12.2011
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,
maximum level of melamine contamination allowed in
food laid down in the Commission Regulation (EC)
No 1135/2009 of 25 November 2009 imposing special
Having regard to the Treaty on the Functioning of the European
conditions governing the import of products originating
Union,
in or consigned from China, and repealing Commission
Decision 2008/798/EC ( 3 ).
Having regard to Regulation (EC) No 1935/2004 of the
European Parliament and of the Council of 27 October 2004
(4) Annex
I
to
Regulation
(EU)
No
10/2011
should
therefore
on materials and articles intended to come into contact with
be amended accordingly.
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,
(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
Whereas:
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 )
(1) Commission
Regulation
(EU)
No
10/2011
of
14
January
clarified that the substance is to be used as a monomer
2011 on plastic materials and articles intended to come
instead of an additive in plastics. For this reason it is
into contact with food ( 2 ) establishes a Union list of
appropriate to correct the use and to update the
monomers, other starting substances and additives
reference number accordingly in the Annex I.
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
(6) The
substance
with
FCM
substance
number
376
and
the
should now be added to the current list.
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 (
(2) For
certain
other
substances,
the
restrictions
and/or
spec

5 ) established a TDI
ifications already established at the EU level should be
of 1 mg/kg b.w. resulting in an SML of 60 mg/kg food.
amended on the basis of a new favourable scientific
This limit coincides with the generic specific migration
evaluation by the Authority.
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.
(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
(7) The
substance
with
FCM
substance
number
797
and
the
on 13 April 2010 by the Authority. That opinion laid
name polyester of adipic acid with 1,3-butanediol, 1,2-
down a tolerable daily intake (TDI) of 0,2 mg/kg body
propanediol and 2-ethyl-1-hexanol is authorised to be
weight (b.w.) for this substance. In its opinion the
used as an additive in plastics in Table 1 of Annex I to
Authority also concluded that exposure in children due
Regulation (EU) No 10/2011 and listed with the CAS
to migration from food contact materials would be in the
range of the TDI. Taking into account the TDI and the
( 3 ) OJ L 311, 26.11.2009, p. 3.
exposure from all other sources the migration limit for
( 4 ) Scientific Opinion on the safety evaluation of the substance bis
the substance 239 should be reduced. The proposed
(2,6-diisopropylphenyl)carbodiimide for use in food contact
migration limit of 2,5 mg/kg food is in line with the
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
( 1 ) OJ L 338, 13.11.2004, p. 4.
request from the Commission related to a seventh list of substances
( 2 ) OJ L 12, 15.1.2011, p. 1.
for food contact materials. EFSA Journal (2005) 201, 1-28.

---

EN
10.12.2011 Official
Journal
of
the
European
Union L
328/23
No 0007328-26-5. According to the Opinion delivered
HAS ADOPTED THIS REGULATION:
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.
Article 1
Annex I to Regulation (EU) No 10/2011 is amended in
accordance with the Annex to this Regulation.
(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
Article 2
set out in Regulation (EU) No 10/2011 and which do not
comply with this Regulation should be able to be placed
Plastic materials and articles which have been lawfully placed on
on the market until 1 January 2013. They should be able
the market before 1 January 2012 and which do not comply
to remain on the market until exhaustion of stocks.
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.
(9) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Article 3
Committee on the Food Chain and Animal Health, and
neither the European Parliament nor the Council has
This Regulation shall enter into force on the 20th day following
opposed them,
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 BARROSO
( 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.

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L 328/24
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:
EN
Use as monomer or

Use as
other starting
SML(T)
FCM
additive or
substance or
FRF
[mg/kg]
Notes on
substance Ref. No CAS
No Substance
name
polymer
macro-molecule
applicable
SML
(Group
Restrictions and specifications
verification
No
production aid
obtained from
(yes/no)
[mg/kg]
restriction
of
(yes/no)
microbial
compliance
fermentation
No)
(yes/no)
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
855 40560 (butadiene,
styrene,
methyl
metha
yes no no Only
to
be
used
in
rigid
Off
poly(vinyl
crylate) copolymer cross-linked with
chloride) (PVC) at a maximum level of
icial
1,3-butanediol dimethacrylate
12 % at room temperature or below.
Jour
856 40563 (butadiene,
styrene,
methyl
metha
yes no no Only
to
be
used
in
rigid
nal
poly(vinyl
crylate, butyl acrylate) copolymer
chloride) (PVC) at a maximum level of
cross-linked with divinylbenzene or
12 % at room temperature or below.
of
1,3-butanediol dimethacrylate
the
European
857 66765 0037953-21-2 (methyl methacrylate,
butyl acrylate,
yes no no Only
to
be
used
in
rigid
poly(vinyl
styrene, glycidyl methacrylate)
chloride) (PVC) at a maximum level of
copolymer
2 % at room temperature or below.
Union
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
yes no no Reaction
product
of
titanium
dioxide
triethoxysilane
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)
10.12.2011
895 47060 0171090-93-0 3-(3,5-di-tert-butyl-4-hydroxyphenyl)
yes no no 0,05 Only
to
be
used
in
polyolefins
in
propanoic acid, esters with C13-C15
contact with foods other than fatty/
branched and linear alcohols
high-alcoholic and dairy products.

---

10.12.2011 Off
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
896 71958 0958445-44-8 3H-perfluoro-3-[(3-methoxy-propoxy)
yes no no Only
to
be
used
in
the
polymerisation
propanoic acid], ammonium salt
of fluoropolymers when:
— processed at temperatures higher
than 280
°C for at least 10
EN
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
(18)
in plastics, as an impurity and decom
position product of the substance,
should not result in a migration of
icial
diethanolamine higher than 0,3 mg/kg
Jour
food.
nal
of
924 94987 trimethylolpropane,
mixed
triesters
yes no no 0,05 Only
for
use
in
PET
in
contact
with
all
the
and diesters with n-octanoic and n-
types of foods other than fatty, high-
decanoic acids
alcoholic and dairy products.
European
926 71955 0908020-52-0 perfluoro[(2-ethyloxy-ethoxy)acetic
yes no no Only
to
be
used
in
the
Union
polymerisation
acid], ammonium salt
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
(17)
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.
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
L
co-monomer
up
to 0,1 % w/w in the polymerisation of
328/25
fluoropolymers, sintered at high
temperatures.

---

L 328/26
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
974 74050 939402-02-5 phosphorous
acid,
mixed
2,4-bis(1,1-
yes no yes
5 SML
expressed
as
the
sum
of
phosphite
dimethylpropyl)phenyl and 4-(1,1-
and phosphate form of the substance
dimethylpropyl)phenyl triesters
and the hydrolysis product 4-t-
amylphenol.
EN

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:
Off
Use as
Use as monomer or other
additive or
starting substance or
SML(T)
Notes on
icial
FCM
FRF
[mg/kg]
substance Ref. No CAS
No Substance
name
polymer
macro-molecule obtained
SML
verification
production
from microbial
applicable [mg/kg] (Group
Restrictions and specifications
of
Jour
No
aid
fermentation
(yes/no)
restriction
compliance
(yes/no)
(yes/no)
No)
nal
of
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
the
European
438 13303 0002162-74-5 bis(2,6-diisopropylphenyl)
no yes no 0,05 Expressed
as
the
sum
of
bis(2,6-diisopro
carbodiimide
pylphenyl)carbodiimide and its hydrolysis
product 2,6-diisopropylaniline
Union
(3) in Table 1 for the following substance, the content of the column (3) is replaced by the following:
Use as
Use as monomer or other
SML(T)
FCM
additive or
starting substance or
FRF
[mg/kg]
Notes on
substance Ref. No CAS
No Substance
name
polymer
macro-molecule obtained applicable SML
(Group
Restrictions and specifications
verification
No
production
from microbial
[mg/kg]
of
aid
fermentation
(yes/no)
restriction
compliance
(yes/no)
(yes/no)
No)
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
797 76807 0073018-26-5 polyester of adipic acid
yes no yes (31)
10.12.2011
with 1,3-butanediol, 1,2-
(32)
propanediol and 2-ethyl-1-
hexanol

---

10.12.2011 Off
(4) in Table 1 for the following substances, the content of the column (8) is replaced by the following:
Use as
Use as monomer or other
SML(T)
FCM
additive or
starting substance or
FRF
[mg/kg]
Notes on
substance Ref. No CAS
No Substance
name
polymer
macro-molecule obtained applicable SML
(Group
Restrictions and specifications
verification
No
production
from microbial
[mg/kg]
of
aid
fermentation
(yes/no)
restriction
compliance
(yes/no)
(yes/no)
No)
EN

(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
icial
Jour
nal
93720
of
the
European
376 66905 0000872-50-4 N-methylpyrrolidone yes no no 60
Union
(5) in Table 1 for the following substance, the content of the columns (8) and (10) is replaced by the following:
Use as
Use as monomer or other
SML(T)
FCM
additive or
starting substance or
FRF
[mg/kg]
Notes on
substance Ref. No CAS
No Substance
name
polymer
macro-molecule obtained applicable SML
(Group
Restrictions and specifications
verification
No
production
from microbial
[mg/kg]
of
aid
fermentation
(yes/no)
restriction
compliance
(yes/no)
(yes/no)
No)
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
452 38885 0002725-22-6 2,4-bis(2,4-dimethylphenyl)-
yes no no
5
L
6-(2-hydroxy-4-n-octylo
328/27
xyphenyl)-1,3,5-triazine

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L 328/28
(6) in Table 1 for the following substances, the content of the column (10) is replaced by the following:
Use as
Use as monomer or other
SML(T)
FCM
additive or
starting substance or
FRF
[mg/kg]
Notes on
substance Ref. No CAS
No Substance
name
polymer
macro-molecule obtained applicable SML
(Group
Restrictions and specifications
verification
No
production
from microbial
[mg/kg]
of
aid
fermentation
(yes/no)
restriction
compliance
(yes/no)
(yes/no)
No)
EN

(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.
Off
icial
Jour
nal
of
812 80350 0124578-12-7 poly(12-hydroxystearic
yes no no Only
to
be
used
in
plastics
up
to
0,1
%
the
w/w.
acid)-polyethyleneimine
Prepared by the reaction of poly(12-hydroxys
copolymer
European
tearic acid) with polyethyleneimine.
Union
(7) in Table 1 for the following substance, the content of the columns (10) and (11) is replaced by the following:
Use as
Use as monomer or other
SML(T)
FCM
additive or
starting substance or
FRF
[mg/kg]
Notes on
substance Ref. No CAS
No Substance
name
polymer
macro-molecule obtained applicable SML
(Group
Restrictions and specifications
verification
No
production
from microbial
[mg/kg]
of
aid
fermentation
(yes/no)
restriction
compliance
(yes/no)
(yes/no)
No)
(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-
(17)
dihydroxy-1-butene
(19)
Only to be used as a co-monomer for ethylviny
10.12.2011
lalcohol (EVOH) and polyvinylalcohol (PVOH)
copolymers.

---

EN
10.12.2011 Official
Journal
of
the
European
Union L
328/29
(8) in Table 2 for the following group restriction, the content of the columns (2) and (4) is replaced by the following:
Group
FCM
SML (T)
restriction
substance
Group restriction specification
No
No
[mg/kg]
(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) copolymers

---