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 (5) established a TDI
(2) For certain other substances, the restrictions and/or spec­
of 1 mg/kg b.w. resulting in an SML of 60 mg/kg food.
ifications already established at the EU level should be
This limit coincides with the generic specific migration
amended on the basis of a new favourable scientific
limit established in Article 11(2) of Regulation (EU)
evaluation by the Authority.
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.
10.12.2011 EN 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.
 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:

Use as monomer or

EN
other starting
Use as SML(T)
substance or Notes on
FCM additive or FRF [mg/kg]
macro-molecule SML verification
substance Ref. No CAS No Substance name polymer applicable (Group Restrictions and specifications
obtained from [mg/kg] of
No production aid (yes/no) restriction
microbial compliance
(yes/no) No)
fermentation
(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 poly(vinyl
crylate) copolymer cross-linked with chloride) (PVC) at a maximum level of

Official Journal of the European Union

1,3-butanediol dimethacrylate 12 % at room temperature or below.

856 40563 (butadiene, styrene, methyl metha­ yes no no Only to be used in rigid poly(vinyl
crylate, butyl acrylate) copolymer chloride) (PVC) at a maximum level of
cross-linked with divinylbenzene or 12 % at room temperature or below.
1,3-butanediol dimethacrylate

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.

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
(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
minutes,

EN
— 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,

Official Journal of the European Union

should not result in a migration of
diethanolamine higher than 0,3 mg/kg
food.

924 94987 trimethylolpropane, mixed triesters yes no no 0,05 Only for use in PET in contact with all
and diesters with n-octanoic and n- types of foods other than fatty, high-
decanoic acids alcoholic and dairy products.

926 71955 0908020-52-0 perfluoro[(2-ethyloxy-ethoxy)acetic yes no no Only to be used in the 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 co-monomer up

to 0,1 % w/w in the polymerisation of

L 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:

Use as Use as monomer or other

Official Journal of the European Union

SML(T)
additive or starting substance or Notes on
FCM FRF [mg/kg]
polymer macro-molecule obtained SML verification
substance Ref. No CAS No Substance name applicable (Group Restrictions and specifications
production from microbial [mg/kg] of
No (yes/no) restriction
aid fermentation compliance
No)
(yes/no) (yes/no)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)

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

(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)
additive or starting substance or Notes on
FCM FRF [mg/kg]
polymer macro-molecule obtained SML verification
substance Ref. No CAS No Substance name applicable (Group Restrictions and specifications
production from microbial [mg/kg] of
No (yes/no) restriction
aid fermentation compliance
No)
(yes/no) (yes/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)

with 1,3-butanediol, 1,2- (32)

10.12.2011
propanediol and 2-ethyl-1-
hexanol
 10.12.2011
(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)
additive or starting substance or Notes on
FCM FRF [mg/kg]
polymer macro-molecule obtained SML verification
substance Ref. No CAS No Substance name applicable (Group Restrictions and specifications
production from microbial [mg/kg] of
No (yes/no) restriction
aid fermentation compliance
No)
(yes/no) (yes/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

Official Journal of the European Union

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:

Use as Use as monomer or other

SML(T)
additive or starting substance or Notes on
FCM FRF [mg/kg]
polymer macro-molecule obtained SML verification
substance Ref. No CAS No Substance name applicable (Group Restrictions and specifications
production from microbial [mg/kg] of
No (yes/no) restriction
aid fermentation compliance
No)
(yes/no) (yes/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

6-(2-hydroxy-4-n-octylo­

L 328/27
xyphenyl)-1,3,5-triazine
 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)
additive or starting substance or Notes on
FCM FRF [mg/kg]
polymer macro-molecule obtained SML verification
substance Ref. No CAS No Substance name applicable (Group Restrictions and specifications
production from microbial [mg/kg] of
No (yes/no) restriction
aid fermentation compliance
No)
(yes/no) (yes/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.

Official Journal of the European Union

812 80350 0124578-12-7 poly(12-hydroxystearic yes no no Only to be used in plastics up to 0,1 % w/w.
acid)-polyethyleneimine Prepared by the reaction of poly(12-hydroxys­
copolymer 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:

Use as Use as monomer or other

SML(T)
additive or starting substance or Notes on
FCM FRF [mg/kg]
polymer macro-molecule obtained SML verification
substance Ref. No CAS No Substance name applicable (Group Restrictions and specifications
production from microbial [mg/kg] of
No (yes/no) restriction
aid fermentation compliance
No)
(yes/no) (yes/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.
10.12.2011 EN 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