# Commission Directive 2005/79/EC of 18 November 2005 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food (Text with EEA relevance), Annex II

Extent: E+W+S+N.I.

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)’

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Source: https://www.legislation.gov.uk/eudr/2005/79/annex/II (the official version)
Page: https://openlegislation.uk/eu-directive-2005-79/annex-II
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.