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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:

(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;

(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:

(i)

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

(ii)

substances referred to in note 38 of Annex VI.’;

2.

section A is amended as follows:

(a)

the following lines are inserted in numerical order:

Reference NoCAS NoNameRestrictions and/or specifications
(1)(2)(3)(4)
‘30340330198-91-912-(Acetoxy)stearic acid, 2,3-bis(acetoxy)propyl ester
30401—Acetylated mono- and diglycerides of fatty acids
31542174254-23-0Acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl estersQM = 0,5 % (w/w) in FP
43480064365-11-3Charcoal, activatedIn compliance with the specifications laid down in Annex V, Part B
62245012751-22-3Iron phosphideFor PET polymers and copolymers only
64990025736-61-2Maleic anhydride-styrene, copolymer, sodium saltIn compliance with specifications laid down in Annex V
66905000872-50-4N-Methylpyrrolidone
66930068554-70-1MethylsilsesquioxaneResidual 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
76415019455-79-9Pimelic acid, calcium salt
76815—Polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acidsIn compliance with the specifications laid down in Annex V
76845031831-53-5Polyester of 1,4-butanediol with caprolactoneIn compliance with the specifications laid down in Annex V
77370070142-34-6Polyethyleneglycol-30 dipolyhydroxystearate
79600009046-01-9Polyethyleneglycol tridecyl ether phosphateSML = 5 mg/kg. For materials and articles intended for contact with aqueous foods only. In compliance with the specification laid down in Annex V
80000009002-88-4Polyethylene wax
81060009003-07-0Polypropylene wax’
(b)

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

Reference NoCAS NoNameRestrictions and/or specifications
(1)(2)(3)(4)
‘30080004180-12-5Acetic acid, copper saltSML(T) = 5 mg/kg (7) (expressed as Copper)
35760001309-64-4Antimony trioxideSML = 0,04 mg/kg (39) (expressed as Antimony)
40580000110-63-41,4-ButanediolSML(T) = 5 mg/kg (24)
42320007492-68-4Carbonic acid, copper saltSML(T) = 5 mg/kg (7) (expressed as Copper)
45195007787-70-4Copper bromideSML(T) = 5 mg/kg (7) (expressed as Copper)
45200001335-23-5Copper iodideSML(T) = 5 mg/kg (7) (expressed as Copper)
53610054453-03-1Ethylenediaminetetraacetic acid, copper saltSML(T) = 5 mg/kg (7) (expressed as Copper)
81515087189-25-1Poly(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 ironSML(T) = 5 mg/kg (7) (expressed as Copper)
88640008013-07-08Soybean oil, epoxidisedSML = 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
89200007617-31-4Stearic acid, copper saltSML(T) = 5 mg/kg (7) (expressed as Copper)
92030010124-44-4Sulphuric acid, copper saltSML(T) = 5 mg/kg (7) (expressed as Copper)
96190020427-58-1Zinc hydroxideSML(T) = 25 mg/kg (38) (as Zinc)
96240001314-13-2Zinc oxideSML(T) = 25 mg/kg (38) (as Zinc)
96320001314-98-3Zinc sulphideSML(T) = 25 mg/kg (38) (as Zinc)’
(c)

the following lines are deleted:

Reference NoCAS NoNameRestrictions and/or specifications
(1)(2)(3)(4)
‘30400—Acetylated glycerides
38320005242-49-94-(2-Benzoxazolyl)-4′-(5-methyl-2-benzoxazolyl)stilbeneIn compliance with the specifications laid down in Annex V’
3.

section B is amended as follows:

(a)

the following lines are inserted in numerical order:

Reference NoCAS NoNameRestrictions and/or specifications
(1)(2)(3)(4)
‘31500025134-51-4Acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymerSML(T) = 6 mg/kg (36) (expressed as acrylic acid) and SML = 0,05 mg/kg (expressed as acrylic acid, 2-ethylhexyl ester)
38505351870-33-2cis-endo-Bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, disodium saltSML = 5 mg/kg. Not to be used with polyethylene in contact with acidic foods. Purity ≥ 96 %
38940110675-26-82,4-Bis(dodecylthiomethyl)-6-methylphenolSML(T) = 5 mg/kg (40)
49595057583-35-4Dimethyltin bis(ethylhexyl mercaptoacetate)SML(T) = 0,18 mg/kg (16) (expressed as Tin)
63940008062-15-5Lignosulphonic acidSML = 0,24 mg/kg and to be used only as dispersant for plastics dispersions
66350085209-93-42,2′-Methylenebis(4,6-di-tert-butylphenyl) lithium phosphateSML = 5 mg/kg and SML(T) = 0,6 (8) (expressed as Lithium)
67515057583-34-3Monomethyltin tris(ethylhexyl mercaptoacetate)SML(T) = 0,18 mg/kg (16) (expressed as Tin)
69160014666-94-5Oleic acid, cobalt saltSML(T) = 0,05 mg/kg (14) (expressed as Cobalt)
76681—Polycyclopentadiene, hydrogenatedSML = 5 mg/kg (1)
85950037296-97-2Silicic acid, magnesium-sodium-fluoride saltSML = 0,15 mg/kg (expressed as fluoride). Only to be used in layers of multilayers materials not coming into direct contact with food
95265227099-60-71,3,5-Tris(4-benzoylphenyl) benzeneSML = 0,05 mg/kg’
(b)

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

Reference NoCAS NoNameRestrictions and/or specifications
(1)(2)(3)(4)
‘40020110553-27-02,4-Bis(octylthiomethyl)-6-methylphenolSML(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)
50240010039-33-5Di-n-octyltin bis(2-ethylhexyl maleate)SML(T) = 0,006 mg/kg (17) (expressed as Tin)
50320015571-58-1Di-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)
50400033568-99-9Di-n-octyltin bis(isooctyl maleate)SML(T) = 0,006 mg/kg (17) (expressed as Tin)
50480026401-97-8Di-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)
50640003648-18-8Di-n-octyltin dilaurateSML(T) = 0,006 mg/kg (17) (expressed as Tin)
50720015571-60-5Di-n-octyltin dimaleateSML(T) = 0,006 mg/kg (17) (expressed as Tin)
50800—Di-n-octyltin dimaleate, esterifiedSML(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)
50960069226-44-4Di-n-octyltin ethyleneglycol bis(mercaptoacetate)SML(T) = 0,006 mg/kg (17) (expressed as Tin)
51040015535-79-2Di-n-octyltin mercaptoacetateSML(T) = 0,006 mg/kg (17) (expressed as Tin)
51120—Di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetateSML(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 esterSML = 5 mg/kg (1)’
(c)

The following line is deleted:

Reference NoCAS NoNameRestrictions and/or specifications
(1)(2)(3)(4)
‘76680068132-00-3Polycyclopentadiene, hydrogenatedSML = 5 mg/kg (1)’