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

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:

a OJ L 83, 22.3.2012, p. 1.
(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 C24H38Si2O5(SiOC2H6)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 231/2012a.
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.