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Annex I to Regulation (EU) No 10/2011 is amended as follows:
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 |
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 |
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) |
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. |
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)] | |
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. |
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 |
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. |
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