ANNEX

  1. (1)

    in Table 1 the following lines are inserted in numerical order of the FCM substance numbers:

    FCM substance No

    Ref. No

    CAS No

    Substance name

    Use as additive or polymer production aid(yes/no)

    Use as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no)

    FRF applicable(yes/no)

    SML[mg/kg]

    SML(T)[mg/kg](Group restriction No)

    Restrictions and specifications

    Notes on verification of compliance

    (1)

    (2)

    (3)

    (4)

    (5)

    (6)

    (7)

    (8)

    (9)

    (10)

    (11)

    855

    40560

    (butadiene, styrene, methyl methacrylate) copolymer cross-linked with 1,3-butanediol dimethacrylate

    yes

    no

    no

    Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.

    856

    40563

    (butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate

    yes

    no

    no

    Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 12 % at room temperature or below.

    857

    66765

    0037953-21-2

    (methyl methacrylate, butyl acrylate, styrene, glycidyl methacrylate) copolymer

    yes

    no

    no

    Only to be used in rigid poly(vinyl chloride) (PVC) at a maximum level of 2 % at room temperature or below.

    863

    15260

    0000646-25-3

    1,10-decanediamine

    no

    yes

    no

    0,05

    Only to be used as a co-monomer for manufacturing polyamide articles for repeated use in contact with aqueous, acidic and dairy foodstuffs at room temperature or for short term contact up to 150 °C.

    873

    93460

    titanium dioxide reacted with octyltriethoxysilane

    yes

    no

    no

    Reaction product of titanium dioxide with up to 2 % w/w surface treatment substance octyltriethoxysilane, processed at high temperatures.

    894

    93360

    0016545-54-3

    thiodipropionic acid, ditetradecyl ester

    yes

    no

    no

    (14)

    895

    47060

    0171090-93-0

    3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoic acid, esters with C13-C15 branched and linear alcohols

    yes

    no

    no

    0,05

    Only to be used in polyolefins in contact with foods other than fatty/high-alcoholic and dairy products.

    896

    71958

    0958445-44-8

    3H-perfluoro-3-[(3-methoxy-propoxy)propanoic acid], ammonium salt

    yes

    no

    no

    Only to be used in the polymerisation of fluoropolymers when:

    • processed at temperatures higher than 280 °C for at least 10 minutes,

    • processed at temperatures higher than 190 °C up to 30 % w/w for use in blends with polyoxymethylene polymers and intended for repeated use articles.

    923

    39150

    0000120-40-1

    N,N-bis(2-hydroxyethyl)dodecanamide

    yes

    no

    no

    5

    The residual amount of diethanolamine in plastics, as an impurity and decomposition product of the substance, should not result in a migration of diethanolamine higher than 0,3 mg/kg food.

    (18)

    924

    94987

    trimethylolpropane, mixed triesters and diesters with n-octanoic and n-decanoic acids

    yes

    no

    no

    0,05

    Only for use in PET in contact with all types of foods other than fatty, high-alcoholic and dairy products.

    926

    71955

    0908020-52-0

    perfluoro[(2-ethyloxy-ethoxy)acetic acid], ammonium salt

    yes

    no

    no

    Only to be used in the polymerisation of fluoropolymers that are processed at temperatures higher than 300 °C for at least 10 minutes.

    971

    25885

    0002459-10-1

    trimethyl trimellitate

    no

    yes

    no

    Only to be used as a co-monomer up to 0,35 % w/w to produce modified polyesters intended to be used in contact with aqueous and dry foodstuffs containing no free fat at the surface.

    (17)

    972

    45197

    0012158-74-6

    copper hydroxide phosphate

    yes

    no

    no

    973

    22931

    0019430-93-4

    (perfluorobutyl)ethylene

    no

    yes

    no

    Only to be used as a co-monomer up to 0,1 % w/w in the polymerisation of fluoropolymers, sintered at high temperatures.

    974

    74050

    939402-02-5

    phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters

    yes

    no

    yes

    5

    SML expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis product 4-t-amylphenol.

    The migration of the hydrolysis product 2,4-di-t-amylphenol should not exceed 0,05 mg/kg.

  2. (2)

    in Table 1 for the following substance, the content of the columns (2), (5), (6) and (10) is replaced by the following:

    FCM substance No

    Ref. No

    CAS No

    Substance name

    Use as additive or polymer production aid(yes/no)

    Use as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no)

    FRF applicable(yes/no)

    SML[mg/kg]

    SML(T)[mg/kg](Group restriction No)

    Restrictions and specifications

    Notes on verification of compliance

    (1)

    (2)

    (3)

    (4)

    (5)

    (6)

    (7)

    (8)

    (9)

    (10)

    (11)

    438

    13303

    0002162-74-5

    bis(2,6-diisopropylphenyl) carbodiimide

    no

    yes

    no

    0,05

    Expressed as the sum of bis(2,6-diisopropylphenyl)carbodiimide and its hydrolysis product 2,6-diisopropylaniline

  3. (3)

    in Table 1 for the following substance, the content of the column (3) is replaced by the following:

    FCM substance No

    Ref. No

    CAS No

    Substance name

    Use as additive or polymer production aid(yes/no)

    Use as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no)

    FRF applicable(yes/no)

    SML[mg/kg]

    SML(T)[mg/kg](Group restriction No)

    Restrictions and specifications

    Notes on verification of compliance

    (1)

    (2)

    (3)

    (4)

    (5)

    (6)

    (7)

    (8)

    (9)

    (10)

    (11)

    797

    76807

    0073018-26-5

    polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol

    yes

    no

    yes

    (31)

    (32)

  4. (4)

    in Table 1 for the following substances, the content of the column (8) is replaced by the following:

    FCM substance No

    Ref. No

    CAS No

    Substance name

    Use as additive or polymer production aid(yes/no)

    Use as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no)

    FRF applicable(yes/no)

    SML[mg/kg]

    SML(T)[mg/kg](Group restriction No)

    Restrictions and specifications

    Notes on verification of compliance

    (1)

    (2)

    (3)

    (4)

    (5)

    (6)

    (7)

    (8)

    (9)

    (10)

    (11)

    239

    19975

    0000108-78-1

    2,4,6-triamino-1,3,5-triazine

    yes

    yes

    no

    2,5

    25420

    93720

    376

    66905

    0000872-50-4

    N-methylpyrrolidone

    yes

    no

    no

    60

  5. (5)

    in Table 1 for the following substance, the content of the columns (8) and (10) is replaced by the following:

    FCM substance No

    Ref. No

    CAS No

    Substance name

    Use as additive or polymer production aid(yes/no)

    Use as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no)

    FRF applicable(yes/no)

    SML[mg/kg]

    SML(T)[mg/kg](Group restriction No)

    Restrictions and specifications

    Notes on verification of compliance

    (1)

    (2)

    (3)

    (4)

    (5)

    (6)

    (7)

    (8)

    (9)

    (10)

    (11)

    452

    38885

    0002725-22-6

    2,4-bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine

    yes

    no

    no

    5

  6. (6)

    in Table 1 for the following substances, the content of the column (10) is replaced by the following:

    FCM substance No

    Ref. No

    CAS No

    Substance name

    Use as additive or polymer production aid(yes/no)

    Use as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no)

    FRF applicable(yes/no)

    SML[mg/kg]

    SML(T)[mg/kg](Group restriction No)

    Restrictions and specifications

    Notes on verification of compliance

    (1)

    (2)

    (3)

    (4)

    (5)

    (6)

    (7)

    (8)

    (9)

    (10)

    (11)

    794

    18117

    0000079-14-1

    glycolic acid

    no

    yes

    no

    Only to be used for manufacture of polyglycolic acid (PGA) for (i) indirect food contact behind polyesters such as polyethylene terephthalate (PET) or polylactic acid (PLA); and (ii) direct food contact of a blend of PGA up to 3 % w/w in PET or PLA.

    812

    80350

    0124578-12-7

    poly(12-hydroxystearic acid)-polyethyleneimine copolymer

    yes

    no

    no

    Only to be used in plastics up to 0,1 % w/w.

    Prepared by the reaction of poly(12-hydroxystearic acid) with polyethyleneimine.

  7. (7)

    in Table 1 for the following substance, the content of the columns (10) and (11) is replaced by the following:

    FCM substance No

    Ref. No

    CAS No

    Substance name

    Use as additive or polymer production aid(yes/no)

    Use as monomer or other starting substance or macro-molecule obtained from microbial fermentation(yes/no)

    FRF applicable(yes/no)

    SML[mg/kg]

    SML(T)[mg/kg](Group restriction No)

    Restrictions and specifications

    Notes on verification of compliance

    (1)

    (2)

    (3)

    (4)

    (5)

    (6)

    (7)

    (8)

    (9)

    (10)

    (11)

    862

    15180

    0018085-02-4

    3,4-diacetoxy-1-butene

    no

    yes

    no

    0,05

    SML including the hydrolysis product 3,4-dihydroxy-1-butene

    Only to be used as a co-monomer for ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers.

    (17)

    (19)

  8. (8)

    in Table 2 for the following group restriction, the content of the columns (2) and (4) is replaced by the following:

    Group restriction No

    FCM substance No

    SML (T)[mg/kg]

    Group restriction specification

    (1)

    (2)

    (3)

    (4)

    14

    294

    5

    Expressed as the sum of the substances and their oxidation products

    368

    894

  9. (9)

    in Table 3 the following notes on verification of compliance are inserted in numerical order:

    Note No

    Notes on verification of compliance

    (1)

    (2)

    (18)

    There is a risk that the SML could be exceeded from low-density polyethylene (LDPE)

    (19)

    There is a risk that the OML could be exceeded in direct contact with aqueous foods from ethylvinylalcohol (EVOH) and polyvinylalcohol (PVOH) copolymers