ANNEX

Annotations:

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

  1. (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. (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. (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. (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:

    1. (a)

      rigid poly(vinyl chloride) (PVC) at a maximum level of 1 % w/w;

    2. (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:

    1. (a)

      rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % w/w;

    2. (b)

      polylactic acid (PLA) at a maximum level of 5 % w/w;

    3. (c)

      polyethylene terephthalate (PET) at a maximum level of 5 % w/w.

  5. (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)

    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. (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. (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.