# Commission Directive 2007/19/EC of 2 April 2007 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food and Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance), Annex III

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

Annex III to Directive 2002/72/EC is amended as follows:
(1) Section A is amended as follows:
(a) the following additives are inserted in the appropriate numerical order:
Ref. No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
‘ 38885
002725-22-6
2,4-Bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine
SML = 0,05 mg/kg. For aqueous foods only.
42080
001333-86-4
Carbon black
In compliance with the specifications laid down in Annex V.
45705
166412-78-8
1,2-cyclohexanedicarboxylic acid, diisononyl ester
62020
007620-77-1
12-Hydroxystearic acid, lithium salt
SML(T) = 0,6 mg/kg ( 8 ) (expressed as lithium)
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 )
71960
003825-26-1
Perfluorooctanoic acid, ammonium salt
Only to be used in repeated use articles, sintered at high temperatures.
74560
000085-68-7
Phthalic acid, benzyl butyl ester
To be used only as:
(a) plasticizer in repeated use materials and articles;
(b) plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 91/321/EEC and products according to Directive 96/5/EC;
(c) technical support agent in concentrations up to 0,1 % in the final product.
SML = 30 mg/kg food simulant.
74640
000117-81-7
Phthalic acid, bis (2-ethylhexyl) ester
To be used only as:
(a) plasticizer in repeated use materials and articles contacting non-fatty foods;
(b) technical support agent in concentrations up to 0,1 % in the final product.
SML = 1,5 mg/kg food simulant.
74880
000084-74-2
Phthalic acid, dibutyl ester
To be used only as:
(a) plasticizer in repeated use materials and articles contacting non-fatty foods;
(b) technical support agent in polyolefines in concentrations up to 0,05 % in the final product.
SML = 0,3 mg/kg food simulant.
75100
068515-48-0
028553-12-0
Phthalic acid, diesters with primary, saturated C 8 -C 10 branched alcohols, more than 60 % C 9 .
To be used only as:
(a) plasticizer in repeated use materials and articles;
(b) plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 91/321/EEC and products according to Directive 96/5/EC;
(c) technical support agent in concentrations up to 0,1 % in the final product.
SML(T) = 9 mg/kg food simulant ( 42 ).
75105
068515-49-1
026761-40-0
Phthalic acid, diesters with primary, saturated C 9 -C 11 alcohols more than 90 % C 10
To be used only as:
(a) plasticizer in repeated use materials and articles;
(b) plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 91/321/EEC and products according to Directive 96/5/EC;
(c) technical support agent in concentrations up to 0,1 % in the final product.
SML(T) = 9 mg/kg food simulant ( 42 ).
79920
009003-11-6
106392-12-5
Poly(ethylene propylene) glycol
81500
9003-39-8
Polyvinylpyrrolidone
In compliance with the specifications laid down in Annex V.
93760
000077-90-7
Tri-n-butyl acetyl citrate
95020
6846-50-0
2,2,4-Trimethyl-1,3-pentanediol diisobutyrate
SML = 5 mg/kg food. To be used in single-use gloves only.
95420
745070-61-5
1,3,5-tris (2,2-dimethylpropanamido)benzene
SML = 0,05 mg/kg food. ’
(b) for the following additives, the entries in columns 3 ‘ Name ’ and 4 ‘ Restrictions and/or specifications ’ are replaced by the following:
Ref. No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
‘ 43480
064365-11-3
Charcoal, activated
In compliance with the specifications laid down in Annex V.
45200
001335-23-5
Copper iodide
SML(T) = 5 mg/kg ( 7 ) (expressed as copper) and SML = 1 mg/kg ( 11 ) (expressed as iodine)
76845
031831-53-5
Polyester of 1,4-butanediol with caprolactone
The restriction for Ref. No 14260 and Ref. No 13720 shall be respected.
In compliance with the specifications laid down in Annex V.
81760
—
Powders, flakes and fibres of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and iron
SML(T) = 5 mg/kg ( 7 ) (expressed as copper);
SML = 48 mg/kg (expressed as iron)
88640
008013-07-8
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 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.
In compliance with the specifications laid down in Annex V. ’
(c) the following additive is deleted:
Ref. No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
‘ 35760
001309-64-4
Antimony trioxide
SML = 0,04 mg/kg ( 39 ) (expressed as antimony).’
(2) Section B is amended as follows:
(a) the following additives are inserted, in the appropriate numerical order:
Ref. No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
‘ 35760
001309-64-4
antimony trioxide
SML = 0,04 mg/kg ( 39 ) (expressed as antimony)
47500
153250-52-3
N,N′-Dicyclohexyl-2,6-naphthalene dicarboxamide
SML = 5 mg/kg.
72081/10
—
Petroleum hydrocarbon resins (hydrogenated)
SML = 5 mg/kg ( 1 ) and in compliance with the specifications laid down in Annex V
93970
—
Tricyclodecanedimethanol bis(hexahydrophthalate)
SML = 0,05 mg/kg. ’
(b) for the following additives, the entries in columns 3 ‘ Name ’ and 4 ‘ Restrictions and/or specifications ’ are replaced by the following:
Ref. No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
‘ 47600
084030-61-5
Di-n-dodecyltin bis(isooctyl mercaptoacetate)
SML(T) = 0,05 mg/kg food ( 41 ) (as sum of mono-n-dodecyltin tris(isooctyl mercaptoacetate), di-n- dodecyltin bis(isooctyl mercaptoacetate), mono-dodecyltin trichloride and di-dodecyltin dichloride) expressed as the sum of mono- and di-dodecyltin chloride
67360
067649-65-4
Mono-n-dodecyltin tris(isooctyl mercaptoacetate)
SML(T) = 0,05 mg/kg food ( 41 ) (as sum of mono-n-dodecyltin tris(isooctyl mercaptoacetate), di-n- dodecyltin bis(isooctyl mercaptoacetate), mono-dodecyltin trichloride and di-dodecyltin dichloride) expressed as the sum of mono- and di-dodecyltin chloride’
(c) The following additives are deleted:
Ref. No
CAS No
Name
Restrictions and/or specifications
(1)
(2)
(3)
(4)
‘ 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 )
76681
—
Polycyclopentadiene, hydrogenated
SML = 5 mg/kg ( 1 )’

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Source: https://www.legislation.gov.uk/eudr/2007/19/annex/III (the official version)
Page: https://openlegislation.uk/eu-directive-2007-19/annex-III
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.