ANNEX II
Annex III to Directive 2002/72/EC is amended as follows:
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. 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. 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. substances whose name contains “… acid(s), salts” which appear in the lists, if the corresponding free acid(s) is (are) not mentioned,
    2. substances referred to in note 38 of Annex VI.
;
2. section A is amended as follows:
  1. 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, C 16-C 18 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 C 12-C 22 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. 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. 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. section B is amended as follows:
  1. 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. 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(C 10-C 16) 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. 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)’