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

• CELEX: Regulation (EU) No 1183/2012
• Articles: 4

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.

Article 3

This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

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

dipropyleneglycol

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 nanoparticles.

Only to be used in polyethylene terephthalate (PET) up to 20 mg/kg.

In the PET, the agglomerates have a diameter of 100-500 nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm.

865

40619

0025322-99-0

(butyl acrylate, methyl methacrylate, 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 methacrylate) 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 terephthalate (PET) at a maximum level of 5 % w/w.

(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-dimethylethyl]-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-methylphenyl)prop-2-enoyloxy)-1,1-dimethylethyl]-9-[(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro[5,5]-undecane in equilibrium with its paragraph quinone methid tautomer.

(2)

874

16265

0156065-00-8

α-dimethyl-3-(4’-hydroxy-3’-methoxyphenyl)propylsilyloxy, ω-3-dimethyl-3-(4’-hydroxy-3’-methoxyphenyl)propylsilyl polydimethylsiloxane

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-benzisothiazol-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 Regulation (EU) No 231/2012  ( 1 ) .

979

79987

—

(polyethylene terephthalate, hydroxylated polybutadiene, pyromellitic anhydride) copolymer

yes

no

no

Only to be used in polyethylene terephthalate (PET) at a maximum level of 5 % w/w.

(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 eugenol

(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.

( 1 )

OJ L 83, 22.3.2012, p. 1 .