ANNEX I

Annex II to Directive 2002/72/EC is amended as follows:

  1. 1.

    point 2 of the general introduction is replaced by the following:

    2.The following substances are not included even if they are intentionally used and are authorised:

    1. (a)

      salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium of authorised acids, phenols or alcohols. However, names containing “… acid(s), salts” appear in the lists, if the corresponding free acid(s) is (are) not mentioned;

    2. (b)

      salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. For these salts a Group SML = 25 mg/kg (expressed as Zn) apply. The same restriction for Zn applies to:

      1. (i)

        substances whose name contains “… acid(s), salts” which appear in the lists, if the corresponding free acid(s) is (are) not mentioned,

      2. (ii)

        substances referred to in note 38 of Annex VI.

  2. 2.

    section A is amended as follows:

    1. (a)

      the following lines are inserted in the table in numerical order:

      Reference No

      CAS No

      Name

      Restrictions and/or specifications

      (1)

      (2)

      (3)

      (4)

      ‘11005

      012542-30-2

      Acrylic acid, dicyclopentenyl ester

      QMA = 0,05 mg/6 dm2

      11500

      000103-11-7

      Acrylic acid, 2-ethylhexyl ester

      SML = 0,05 mg/kg

      12786

      000919-30-2

      3-Aminopropyltriethoxysilane

      Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler. To be used only for the reactive surface treatment of inorganic fillers

      13317

      132459-54-2

      N,N′-Bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide

      SML = 0,05 mg/kg. Purity > 98,1 % (w/w). To be used only as co-monomer (max 4 %) for polyesters (PET, PBT)

      14260

      000502-44-3

      Caprolactone

      SML = 0,05 mg/kg (expressed as the sum of caprolactone and 6-hydroxyhexanoic acid)

      16955

      000096-49-1

      Ethylene carbonate

      Residual content = 5 mg/kg of hydrogel at a maximum ratio of 10 g of hydrogel to 1 kg of food. The hydrolysate contains ethyleneglycol having an SML = 30 mg/kg

      21370

      010595-80-9

      Methacrylic acid, 2-sulphoethyl ester

      QMA = ND (DL = 0,02 mg/6 dm2)

      22210

      000098-83-9

      alpha-Methylstyrene

      SML = 0,05 mg/kg

      22932

      001187-93-5

      Perfluoromethyl perfluorovinyl ether

      SML = 0,05 mg/kg. Only to be used for anti-stick coatings

      24903

      068425-17-2

      Syrups, hydrolysed starch, hydrogenated

      In compliance with the specifications laid down in Annex V

      25540

      000528-44-9

      Trimellitic acid

      SML(T) = 5 mg/kg (35)

      25550

      000552-30-7

      Trimellitic anhydride

      SML(T) = 5 mg/kg (35) (expressed as trimellitic acid)’

    2. (b)

      in the following lines the content of the columns ‘CAS No’ or ‘Restrictions and/or specifications’ is replaced by the following:

      Reference No

      CAS No

      Name

      Restrictions and/or specifications

      (1)

      (2)

      (3)

      (4)

      ‘10690

      000079-10-7

      Acrylic acid

      SML(T) = 6 mg/kg (36)

      10750

      002495-35-4

      Acrylic acid, benzyl ester

      SML(T) = 6 mg/kg (36)

      10780

      000141-32-2

      Acrylic acid, n-butyl ester

      SML(T) = 6 mg/kg (36)

      10810

      002998-08-5

      Acrylic acid, sec-butyl ester

      SML(T) = 6 mg/kg (36)

      10840

      001663-39-4

      Acrylic acid, tert-butyl ester

      SML(T) = 6 mg/kg (36)

      11470

      000140-88-5

      Acrylic acid, ethyl ester

      SML(T) = 6 mg/kg (36)

      11590

      000106-63-8

      Acrylic acid, isobutyl ester

      SML(T) = 6 mg/kg (36)

      11680

      000689-12-3

      Acrylic acid, isopropyl ester

      SML(T) = 6 mg/kg (36)

      11710

      000096-33-3

      Acrylic acid, methyl ester

      SML(T) = 6 mg/kg (36)

      11830

      000818-61-1

      Acrylic acid, monoester with ethyleneglycol

      SML(T) = 6 mg/kg (36)

      11890

      002499-59-4

      Acrylic acid, n-octyl ester

      SML(T) = 6 mg/kg (36)

      11980

      000925-60-0

      Acrylic acid, propyl ester

      SML(T) = 6 mg/kg (36)

      13720

      000110-63-4

      1,4-Butanediol

      SML(T) = 5 mg/kg (24)

      20020

      000079-41-4

      Methacrylic acid

      SML(T) = 6 mg/kg (37)

      20080

      002495-37-6

      Methacrylic acid, benzyl ester

      SML(T) = 6 mg/kg (37)

      20110

      000097-88-1

      Methacrylic acid, butyl ester

      SML(T) = 6 mg/kg (37)

      20140

      002998-18-7

      Methacrylic acid, sec-butyl ester

      SML(T) = 6 mg/kg (37)

      20170

      000585-07-9

      Methacrylic acid, tert-butyl ester

      SML(T) = 6 mg/kg (37)

      20890

      000097-63-2

      Methacrylic acid, ethyl ester

      SML(T) = 6 mg/kg (37)

      21010

      000097-86-9

      Methacrylic acid, isobutyl ester

      SML(T) = 6 mg/kg (37)

      21100

      004655-34-9

      Methacrylic acid, isopropyl ester

      SML(T) = 6 mg/kg (37)

      21130

      000080-62-6

      Methacrylic acid, methyl ester

      SML(T) = 6 mg/kg (37)

      21190

      000868-77-9

      Methacrylic acid, monoester with ethyleneglycol

      SML(T) = 6 mg/kg (37)

      21280

      002177-70-0

      Methacrylic acid, phenyl ester

      SML(T) = 6 mg/kg (37)

      21340

      002210-28-8

      Methacrylic acid, propyl ester

      SML(T) = 6 mg/kg (37)

      21460

      000760-93-0

      Methacrylic anhydride

      SML(T) = 6 mg/kg (37)

      24190

      008050-09-7

      Rosin wood

      See “Rosin” (Reference No 24100)’

    3. (c)

      the following line is deleted:

      Reference No

      CAS No

      Name

      Restrictions and/or specifications

      (1)

      (2)

      (3)

      (4)

      ‘11000

      050976-02-8

      Acrylic acid, dicyclopentadienyl ester

      QMA = 0,05 mg/6 dm2’

  3. 3.

    in section B the following lines are deleted:

    Reference No

    CAS No

    Name

    Restrictions and/or specifications

    (1)

    (2)

    (3)

    (4)

    ‘11500

    000103-11-7

    Acrylic acid, 2-ethylhexyl ester

    14260

    000502-44-3

    Caprolactone

    21370

    010595-80-9

    Methacrylic acid, 2-sulphoethyl ester

    22210

    000098-83-9

    alpha-Methylstyrene

    25540

    000528-44-9

    Trimellitic acid

    QM(T) = 5 mg/kg in FP

    25550

    000552-30-7

    Trimellitic anhydride

    QM(T) = 5 mg/kg in FP (expressed as trimellitic acid)’

ANNEX II

Annex III to Directive 2002/72/EC is amended as follows:

  1. 1.

    point 2 is replaced by the following:

    2.The following substances are not included even if they are intentionally used and are authorised:

    1. (a)

      salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium and sodium of authorised acids, phenols or alcohols. However, names containing “… acid(s), salts” appear in the lists, if the corresponding free acid(s) is (are) not mentioned;

    2. (b)

      salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. For these salts a Group SML = 25 mg/kg (expressed as Zn) apply. The same restriction for Zn applies to:

      1. (i)

        substances whose name contains “… acid(s), salts” which appear in the lists, if the corresponding free acid(s) is (are) not mentioned,

      2. (ii)

        substances referred to in note 38 of Annex VI.

  2. 2.

    section A is amended as follows:

    1. (a)

      the following lines are inserted in numerical order:

      Reference No

      CAS No

      Name

      Restrictions and/or specifications

      (1)

      (2)

      (3)

      (4)

      ‘30340

      330198-91-9

      12-(Acetoxy)stearic acid, 2,3-bis(acetoxy)propyl ester

      30401

      —

      Acetylated mono- and diglycerides of fatty acids

      31542

      174254-23-0

      Acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters

      QM = 0,5 % (w/w) in FP

      43480

      064365-11-3

      Charcoal, activated

      In compliance with the specifications laid down in Annex V, Part B

      62245

      012751-22-3

      Iron phosphide

      For PET polymers and copolymers only

      64990

      025736-61-2

      Maleic anhydride-styrene, copolymer, sodium salt

      In compliance with specifications laid down in Annex V

      66905

      000872-50-4

      N-Methylpyrrolidone

      66930

      068554-70-1

      Methylsilsesquioxane

      Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane/kg of methylsilsesquioxane

      67155

      —

      Mixture of 4-(2-Benzoxazolyl)-4′-(5-methyl-2-benzoxazolyl)stilbene, 4,4′-bis(2-benzoxazolyl) stilbene and 4,4′-bis(5-methyl-2-benzoxazolyl)stilbene)

      Not more than 0,05 % w/w (quantity of substance used/quantity of the formulation). In compliance with the specifications laid down in Annex V

      76415

      019455-79-9

      Pimelic acid, calcium salt

      76815

      —

      Polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids

      In compliance with the specifications laid down in Annex V

      76845

      031831-53-5

      Polyester of 1,4-butanediol with caprolactone

      In compliance with the specifications laid down in Annex V

      77370

      070142-34-6

      Polyethyleneglycol-30 dipolyhydroxystearate

      79600

      009046-01-9

      Polyethyleneglycol tridecyl ether phosphate

      SML = 5 mg/kg. For materials and articles intended for contact with aqueous foods only. In compliance with the specification laid down in Annex V

      80000

      009002-88-4

      Polyethylene wax

      81060

      009003-07-0

      Polypropylene wax’

    2. (b)

      in the following lines the content of the columns ‘Name’ and ‘Restrictions and/or specifications’ is replaced by the following:

      Reference No

      CAS No

      Name

      Restrictions and/or specifications

      (1)

      (2)

      (3)

      (4)

      ‘30080

      004180-12-5

      Acetic acid, copper salt

      SML(T) = 5 mg/kg (7) (expressed as Copper)

      35760

      001309-64-4

      Antimony trioxide

      SML = 0,04 mg/kg (39) (expressed as Antimony)

      40580

      000110-63-4

      1,4-Butanediol

      SML(T) = 5 mg/kg (24)

      42320

      007492-68-4

      Carbonic acid, copper salt

      SML(T) = 5 mg/kg (7) (expressed as Copper)

      45195

      007787-70-4

      Copper bromide

      SML(T) = 5 mg/kg (7) (expressed as Copper)

      45200

      001335-23-5

      Copper iodide

      SML(T) = 5 mg/kg (7) (expressed as Copper)

      53610

      054453-03-1

      Ethylenediaminetetraacetic acid, copper salt

      SML(T) = 5 mg/kg (7) (expressed as Copper)

      81515

      087189-25-1

      Poly(zinc glycerolate)

      SML(T) = 25 mg/kg (38) (as Zinc)

      81760

      —

      Powders, flakes and fibers of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and iron

      SML(T) = 5 mg/kg (7) (expressed as Copper)

      88640

      008013-07-08

      Soybean oil, epoxidised

      SML = 60 mg/kg. However in the case of PVC gaskets used to seal glass jars containing infant formulae and follow-on formulae as defined by Commission Directive 91/321/EEC or containing processed cereal-based foods and baby foods for infants and young children as defined by Directive 96/5/EC, the SML is lowered to 30 mg/kg

      89200

      007617-31-4

      Stearic acid, copper salt

      SML(T) = 5 mg/kg (7) (expressed as Copper)

      92030

      010124-44-4

      Sulphuric acid, copper salt

      SML(T) = 5 mg/kg (7) (expressed as Copper)

      96190

      020427-58-1

      Zinc hydroxide

      SML(T) = 25 mg/kg (38) (as Zinc)

      96240

      001314-13-2

      Zinc oxide

      SML(T) = 25 mg/kg (38) (as Zinc)

      96320

      001314-98-3

      Zinc sulphide

      SML(T) = 25 mg/kg (38) (as Zinc)’

    3. (c)

      the following lines are deleted:

      Reference No

      CAS No

      Name

      Restrictions and/or specifications

      (1)

      (2)

      (3)

      (4)

      ‘30400

      —

      Acetylated glycerides

      38320

      005242-49-9

      4-(2-Benzoxazolyl)-4′-(5-methyl-2-benzoxazolyl)stilbene

      In compliance with the specifications laid down in Annex V’

  3. 3.

    section B is amended as follows:

    1. (a)

      the following lines are inserted in numerical order:

      Reference No

      CAS No

      Name

      Restrictions and/or specifications

      (1)

      (2)

      (3)

      (4)

      ‘31500

      025134-51-4

      Acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer

      SML(T) = 6 mg/kg (36) (expressed as acrylic acid) and SML = 0,05 mg/kg (expressed as acrylic acid, 2-ethylhexyl ester)

      38505

      351870-33-2

      cis-endo-Bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, disodium salt

      SML = 5 mg/kg. Not to be used with polyethylene in contact with acidic foods. Purity ≥ 96 %

      38940

      110675-26-8

      2,4-Bis(dodecylthiomethyl)-6-methylphenol

      SML(T) = 5 mg/kg (40)

      49595

      057583-35-4

      Dimethyltin bis(ethylhexyl mercaptoacetate)

      SML(T) = 0,18 mg/kg (16) (expressed as Tin)

      63940

      008062-15-5

      Lignosulphonic acid

      SML = 0,24 mg/kg and to be used only as dispersant for plastics dispersions

      66350

      085209-93-4

      2,2′-Methylenebis(4,6-di-tert-butylphenyl) lithium phosphate

      SML = 5 mg/kg and SML(T) = 0,6 (8) (expressed as Lithium)

      67515

      057583-34-3

      Monomethyltin tris(ethylhexyl mercaptoacetate)

      SML(T) = 0,18 mg/kg (16) (expressed as Tin)

      69160

      014666-94-5

      Oleic acid, cobalt salt

      SML(T) = 0,05 mg/kg (14) (expressed as Cobalt)

      76681

      —

      Polycyclopentadiene, hydrogenated

      SML = 5 mg/kg (1)

      85950

      037296-97-2

      Silicic acid, magnesium-sodium-fluoride salt

      SML = 0,15 mg/kg (expressed as fluoride). Only to be used in layers of multilayers materials not coming into direct contact with food

      95265

      227099-60-7

      1,3,5-Tris(4-benzoylphenyl) benzene

      SML = 0,05 mg/kg’

    2. (b)

      in the following lines the content of the columns ‘Name’ and ‘Restrictions and/or specifications’ is replaced by the following:

      Reference No

      CAS No

      Name

      Restrictions and/or specifications

      (1)

      (2)

      (3)

      (4)

      ‘40020

      110553-27-0

      2,4-Bis(octylthiomethyl)-6-methylphenol

      SML(T) = 5 mg/kg (40)

      50160

      —

      Di-n-octyltin bis(n-alkyl(C10-C16) mercaptoacetate)

      SML(T) = 0,006 mg/kg (17) (expressed as Tin)

      50240

      010039-33-5

      Di-n-octyltin bis(2-ethylhexyl maleate)

      SML(T) = 0,006 mg/kg (17) (expressed as Tin)

      50320

      015571-58-1

      Di-n-octyltin bis(2-ethylhexyl mercaptoacetate)

      SML(T) = 0,006 mg/kg (17) (expressed as Tin)

      50360

      —

      Di-n-octyltin bis(ethyl maleate)

      SML(T) = 0,006 mg/kg (17) (expressed as Tin)

      50400

      033568-99-9

      Di-n-octyltin bis(isooctyl maleate)

      SML(T) = 0,006 mg/kg (17) (expressed as Tin)

      50480

      026401-97-8

      Di-n-octyltin bis(isooctyl mercaptoacetate)

      SML(T) = 0,006 mg/kg (17) (expressed as Tin)

      50560

      —

      Di-n-octyltin 1,4-butanediol bis(mercaptoacetate)

      SML(T) = 0,006 mg/kg (17) (expressed as Tin)

      50640

      003648-18-8

      Di-n-octyltin dilaurate

      SML(T) = 0,006 mg/kg (17) (expressed as Tin)

      50720

      015571-60-5

      Di-n-octyltin dimaleate

      SML(T) = 0,006 mg/kg (17) (expressed as Tin)

      50800

      —

      Di-n-octyltin dimaleate, esterified

      SML(T) = 0,006 mg/kg (17) (expressed as Tin)

      50880

      —

      Di-n-octyltin dimaleate, polymers (n = 2-4)

      SML(T) = 0,006 mg/kg (17) (expressed as Tin)

      50960

      069226-44-4

      Di-n-octyltin ethyleneglycol bis(mercaptoacetate)

      SML(T) = 0,006 mg/kg (17) (expressed as Tin)

      51040

      015535-79-2

      Di-n-octyltin mercaptoacetate

      SML(T) = 0,006 mg/kg (17) (expressed as Tin)

      51120

      —

      Di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetate

      SML(T) = 0,006 mg/kg (17) (expressed as Tin)

      67180

      —

      Mixture of (50 % w/w) phthalic acid n-decyl n-octyl ester, (25 % w/w) phthalic acid di-n-decyl ester, (25 % w/w) phthalic acid di-n-octyl ester

      SML = 5 mg/kg (1)’

    3. (c)

      The following line is deleted:

      Reference No

      CAS No

      Name

      Restrictions and/or specifications

      (1)

      (2)

      (3)

      (4)

      ‘76680

      068132-00-3

      Polycyclopentadiene, hydrogenated

      SML = 5 mg/kg (1)’

ANNEX III

In Part B of Annex V, the following lines are inserted in numerical order:

Reference No

OTHER SPECIFICATIONS

‘24903

Syrups, hydrolysed starch, hydrogenated

In compliance with the purity criteria for maltitol syrup E 965(ii) (Commission Directive 95/31/EC (OJ L 178, 28.7.1995, p. 1) as last amended by 2004/46/EC (OJ L 114, 21.04.2004, p. 15))

43480

Charcoal, activated

To be used only in PET at maximum 10 mg/kg of polymer. Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Directive 95/45/EC ((OJ L 226, 22.9.1995, p. 1). Directive as last amended by Directive 2004/47/EC (OJ L 113, 20.4.2004, p. 24)) with exception of ash content which can be up to 10 % (w/w).

64990

Maleic anhydride-styrene, copolymer, sodium salt

MW fraction < 1 000 is less than 0,05 % (w/w)

67155

Mixture of 4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene, 4,4'-bis(2-benzoxazolyl) stilbene and 4,4'-bis(5-methyl-2-benzoxazolyl)stilbene

Mixture obtained from the manufacturing process in the typical ratio of (58-62 %):(23-27 %): (13-17 %).

76845

Polyester of 1,4-butanediol with caprolactone

MW fraction < 1 000 is less than 0,05 % (w/w)

76815

Polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids

MW fraction < 1 000 is less than 5 % (w/w)

79600

Polyethyleneglycol tridecyl ether phosphate

Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum 10 % content of polyethyleneglycol (EO ≤ 11) tridecylether’

ANNEX IV

Annex VI is amended as follows:

  1. 1.

    the notes (8), (14) and (16) are replaced by the following:

    (8)

    SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 38000, 42400, 64320, 66350, 67896, 73040, 85760, 85840, 85920 and 95725.

    (14)

    SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 44960, 68078, 69160, 82020 and 89170.

    (16)

    SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 49595, 49600, 67520, 67515 and 83599.

  2. 2.

    the following notes are added:

    (35)

    SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 25540 and 25550.

    (36)

    SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 10690, 10750, 10780, 10810, 10840, 11470, 11590, 11680, 11710, 11830, 11890, 11980 and 31500.

    (37)

    SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 20020, 20080, 20110, 20140, 20170, 20890, 21010, 21100, 21130, 21190, 21280, 21340 and 21460.

    (38)

    SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 81515, 96190, 96240 and 96320 as well as of salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. The same restriction for Zn applies to the names containing “… acid(s), salts” which appear in the lists, if the corresponding free acid(s) is (are) not mentioned.

    (39)

    Migration limit might be exceeded at very high temperature.

    (40)

    SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 38940 and 40020.