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Commission Directive 2008/39/EC (repealed)Show full title

Commission Directive 2008/39/EC of 6 March 2008 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food (Text with EEA relevance) (repealed)

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EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.

ANNEX IU.K.

Section A of Annex II to Directive 2002/72/EC is amended as follows:

(a)

the following monomers and other starting substances are inserted, in the appropriate numerical order:

Ref. NoCAS NoNameRestrictions and/or specifications
(1)(2)(3)(4)
‘15404000652-67-51,4:3,6-DianhydrosorbitolSML = 5 mg/kg. Only for use as a co-monomer in poly(ethylene-co-isosorbide terephthalate)
19180000099-63-8Isophthalic acid dichlorideSML(T) = 5 mg/kg (43) (expressed as isophthalic acid)
26305000078-08-0VinyltriethoxysilaneSML = 0,05 mg/kg. Only to be used as a surface treatment agent’
(b)

for the following monomers and starting substances, the content of the column ‘Restrictions and/or specifications’ is replaced by the following:

Ref. NoCAS NoNameRestrictions and/or specifications
(1)(2)(3)(4)
‘19150000121-91-5Isophthalic acidSML(T) = 5 mg/kg (43)’

ANNEX IIU.K.

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. NoCAS NoNameRestrictions and/or specifications
(1)(2)(3)(4)
‘38875002162-74-5Bis(2,6-diisopropylphenyl) carbodiimideSML = 0,05 mg/kg. For use behind a PET layer
45703491589-22-1cis-1,2-Cyclohexanedicarboxylic acid, calcium saltSML = 5 mg/kg
489609,10-dihydroxy stearic acid and its oligomersSML = 5 mg/kg
55910736150-63-3Glycerides, castor-oil mono-, hydrogenated, acetates
60025Hydrogenated homopolymers and/or copolymers made of 1-decene and/or 1-dodecene and/or 1-octeneIn compliance with the specifications laid down in Annex V. Not to be used for articles in contact with fatty foods.
62280009044-17-1Isobutylene-butene copolymer
70480000111-06-8Palmitic acid, butyl ester
76463Polyacrylic acid, saltsSML(T) = 6 mg/kg (36) (for acrylic acid)
76723167883-16-1Polydimethylsiloxane, 3-aminopropyl terminated, polymer with dicyclohexylmethane-4,4′-diisocyanateIn compliance with the specifications laid down in Annex V
76725661476-41-1Polydimethylsiloxane, 3-aminopropyl terminated, polymer with 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexaneIn compliance with the specifications laid down in Annex V
77732Polyethylene glycol (EO = 1-30, typically 5) ether of butyl 2-cyano 3-(4-hydroxy-3-methoxyphenyl) acrylateSML = 0,05 mg/kg. Only for use in PET
77733Polyethyleneglycol (EO = 1-30, typically 5) ether of butyl-2-cyano-3-(4-hydroxyphenyl) acrylateSML = 0,05 mg/kg. Only for use in PET
77897Polyethyleneglycol (EO = 1-50) monoalkylether (linear and branched, C8-C20) sulphate, saltsSML = 5 mg/kg
89120000123-95-5Stearic acid, butyl ester
95858Waxes, paraffinic, refined, derived from petroleum based or synthetic hydrocarbon feedstocksSML = 0,05 mg/kg and in compliance with the specifications laid down in Annex V. Not to be used for articles in contact with fatty foods.’
(b)

for the following additives, the content of the column ‘Restrictions and/or specifications’ of the table is replaced by the following:

Ref. NoCAS NoNameRestrictions and/or specifications
(1)(2)(3)(4)
‘39815182121-12-69,9-Bis(methoxymethyl)fluoreneSML = 0,05 mg/kg
66755002682-20-42-Methyl-4-isothiazolin-3-oneSML = 0,5 mg/kg. Only to be used in aqueous polymer dispersions and emulsions and at concentrations which do not result in an anti-microbial effect at the surface of the polymer or on the food itself.’
(c)

the following additives are deleted:

Ref. NoCAS NoNameRestrictions and/or specifications
(1)(2)(3)(4)
‘30340330198-91-912-(Acetoxy)stearic acid, 2,3-bis (acetoxy)propyl ester’
(2)

Section B is amended as follows:

(a)

the following additives are inserted in the appropriate numerical order:

Ref. NoCAS NoNameRestrictions and/or specifications
(1)(2)(3)(4)
‘34130Alkyl, linear with even number of carbon atoms (C12-C20) dimethylaminesSML = 30 mg/kg
53670032509-66-3Ethylene glycol bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]SML = 6 mg/kg’
(b)

for the following additives, the content of the column ‘Restrictions and/or specifications’ of the table is replaced by the following:

Ref. NoCAS NoNameRestrictions and/or specifications
(1)(2)(3)(4)
‘72081/10Petroleum Hydrocarbon Resins (hydrogenated)In compliance with the specifications laid down in Annex V’

ANNEX IIIU.K.

In Annex IVa to Directive 2002/72/EC the following substances are inserted in the appropriate numerical order:

Ref. NoCAS NoName
‘34130Alkyl, linear with even number of carbon atoms (C12-C20) dimethylamines
39815182121-12-69,9-Bis(methoxymethyl)fluorene
53670032509-66-3Ethylene glycol bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]’

ANNEX IVU.K.

In Part B of Annex V to Directive 2002/72/EC the following new specifications are inserted, in the appropriate numerical order:

Ref. NoOther specifications
‘60025

Specifications:

  • Minimum viscosity (at 100 °C) = 3,8 cSt

  • Average Mw > 450

76723

Specifications:

The fraction with molecular weight below 1 000 should not exceed 1,5 % w/w

76725

Specifications:

The fraction with molecular weight below 1 000 should not exceed 1 % w/w

95858

Specifications:

  • Average molecular weight not less than 350

  • Viscosity at 100 °C min 2,5 cSt

  • Content of hydrocarbons with carbon number less than 25, not more than 40 % w/w’

ANNEX VU.K.

Annex VI to Directive 2002/72/EC is amended as follows:

(1)

Note (36) is replaced by the following:

(36)SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 10690, 10750, 10780, 10810, 10840, 11470, 11590, 11680, 11710, 11830, 11890, 11980, 31500 and 76463.

(2)

Note (43) is added:

(43)SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Reference Nos 19150 and 19180.

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