
Article 1 
Directive 2002/72/EC is amended as follows:

1.. In Article 4, paragraph 1 is replaced by the following:
'
1. A Community list of additives which may be used for the manufacture of plastic materials and articles, together with the restrictions and/or specifications on their use, is set out in Annex III.Until 31 December 2009, additives which are not included in the Community list of additives may continue to be used subject to national law.As from 1 January 2010, only additives included in the Community list of additives may be used for the manufacture of plastic materials and articles (positive list).'
2.. Article 4a is amended as follows:

((a)) Paragraphs 3 and 4 are replaced by the following:
'
3. A provisional list of additives that are under evaluation by the Authority shall be made public by the Commission by 11 April 2008 at the latest. It shall be kept updated.
4. By derogation from the third subparagraph of Article 4(1), additives not included in the Community list referred to in that Article may continue to be used subject to national law after 1 January 2010 for as long as they are included in the provisional list.'
((b)) Paragraph 6 is added:
'
6. An additive shall be removed from the provisional list:
(a) when it is included in the Community list of additives; or
(b) when a decision is taken by the Commission not to include it in the Community list of additives; or
(c) if during the examination of the data, the Authority calls for supplementary information and that information is not submitted within the time limits specified by the Authority.'
3.. Annexes II, III, IVa, V and VI are amended in accordance with Annexes I, II, III, IV and V to this Directive.
Article 2 

1. Member States shall adopt and publish, by 7 March 2009 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.They shall apply those provisions in such a way as to:
(a) permit the trade in and use of plastic materials and articles intended to come into contact with food and complying with Directive 2002/72/EC, as amended by this Directive, from 7 March 2009;
(b) prohibit the manufacture and importation into the Community of plastic materials and articles intended to come into contact with food and which do not comply with Directive 2002/72/EC, as amended by this Directive, from 7 March 2010.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3 
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 4 
This Directive is addressed to the Member States.
Done at Brussels, 6 March 2008.
For the Commission
Androulla VASSILIOU
Member of the Commission
ANNEX I

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. No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
‘15404 000652-67-5 1,4:3,6-Dianhydrosorbitol SML = 5 mg/kg. Only for use as a co-monomer in poly(ethylene-co-isosorbide terephthalate)
19180 000099-63-8 Isophthalic acid dichloride SML(T) = 5 mg/kg (43) (expressed as isophthalic acid)
26305 000078-08-0 Vinyltriethoxysilane SML = 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. No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
‘19150 000121-91-5 Isophthalic acid SML(T) = 5 mg/kg (43)’

ANNEX II

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)
‘38875 002162-74-5 Bis(2,6-diisopropylphenyl) carbodiimide SML = 0,05 mg/kg. For use behind a PET layer
45703 491589-22-1 cis-1,2-Cyclohexanedicarboxylic acid, calcium salt SML = 5 mg/kg
48960 — 9,10-dihydroxy stearic acid and its oligomers SML = 5 mg/kg
55910 736150-63-3 Glycerides, castor-oil mono-, hydrogenated, acetates 
60025 — Hydrogenated homopolymers and/or copolymers made of 1-decene and/or 1-dodecene and/or 1-octene In compliance with the specifications laid down in Annex V. Not to be used for articles in contact with fatty foods.
62280 009044-17-1 Isobutylene-butene copolymer 
70480 000111-06-8 Palmitic acid, butyl ester 
76463 — Polyacrylic acid, salts SML(T) = 6 mg/kg (36) (for acrylic acid)
76723 167883-16-1 Polydimethylsiloxane, 3-aminopropyl terminated, polymer with dicyclohexylmethane-4,4′-diisocyanate In compliance with the specifications laid down in Annex V
76725 661476-41-1 Polydimethylsiloxane, 3-aminopropyl terminated, polymer with 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane In compliance with the specifications laid down in Annex V
77732 — Polyethylene glycol (EO = 1-30, typically 5) ether of butyl 2-cyano 3-(4-hydroxy-3-methoxyphenyl) acrylate SML = 0,05 mg/kg. Only for use in PET
77733 — Polyethyleneglycol (EO = 1-30, typically 5) ether of butyl-2-cyano-3-(4-hydroxyphenyl) acrylate SML = 0,05 mg/kg. Only for use in PET
77897 — Polyethyleneglycol (EO = 1-50) monoalkylether (linear and branched, C8-C20) sulphate, salts SML = 5 mg/kg
89120 000123-95-5 Stearic acid, butyl ester 
95858 — Waxes, paraffinic, refined, derived from petroleum based or synthetic hydrocarbon feedstocks SML = 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. No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
‘39815 182121-12-6 9,9-Bis(methoxymethyl)fluorene SML = 0,05 mg/kg
66755 002682-20-4 2-Methyl-4-isothiazolin-3-one SML = 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. 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’ 
((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)
‘34130 — Alkyl, linear with even number of carbon atoms (C12-C20) dimethylamines SML = 30 mg/kg
53670 032509-66-3 Ethylene 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. No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
‘72081/10 — Petroleum Hydrocarbon Resins (hydrogenated) In compliance with the specifications laid down in Annex V’

ANNEX III

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

Ref. No CAS No Name
‘34130 — Alkyl, linear with even number of carbon atoms (C12-C20) dimethylamines
39815 182121-12-6 9,9-Bis(methoxymethyl)fluorene
53670 032509-66-3 Ethylene glycol bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]’

ANNEX IV

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

Ref. No Other 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 V

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.
'
