Commission Directive 2005/79/ECShow full title

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 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’

(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)’

(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.

section B is amended as follows:

(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’

(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)’

(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)’