Commission Regulation (EU) No 1183/2012Show full title

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)

ANNEXU.K.

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)
257135500000110-98-5dipropyleneglycolyesyesno
166600025265-71-8
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)
449498400002500-88-1dioctadecyl disulphideyesnoyes0,05
(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)
180171600000097-53-0eugenolnoyesno(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)
80793485titanium nitride, nanoparticlesyesnono

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.

865406190025322-99-0(butyl acrylate, methyl methacrylate, butyl methacrylate) copolymeryesnono

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.

868532450009010-88-2(ethyl acrylate, methyl methacrylate) copolymeryesnono

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)
[X1858 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 para quinone methid tautomer. (2)]
874162650156065-00-8α-dimethyl-3-(4’-hydroxy-3’-methoxyphenyl)propylsilyloxy, ω-3-dimethyl-3-(4’-hydroxy-3’-methoxyphenyl)propylsilyl polydimethylsiloxanenoyesno0,05(33)

Only to be used as comonomer in siloxane modified polycarbonate.

The oligomeric mixture shall be characterised by the formula

C24H38Si2O5(SiOC2H6)n (50 > n ≥ 26).

9020000128-44-91,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium saltyesnonoThe substance shall comply with the specific purity criteria as set out in Commission Regulation (EU) No 231/2012a.
97979987(polyethylene terephthalate, hydroxylated polybutadiene, pyromellitic anhydride) copolymeryesnonoOnly 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 NoFCM substance NoSML (T) [mg/kg]Group restriction specification
33

180

874

NDexpressed as eugenol
(7)

in Table 3 on verification of compliance the content of Note No (4) is replaced by the following:

(1)(2)
Note NoNote on verification of compliance
(4)Compliance testing when there is a fat contact should be performed using saturated fatty food simulants as simulant D2.