ANNEXSupplementary provisions
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 .