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.
- (a)
- (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
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 231/20124.
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.