DIRECTIVES
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)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European
Community,
Having regard to Regulation (EC) No 1935/2004 of the
European Parliament and of the Council of 27 October 2004on materials and articles intended to come into contact withfood and repealing Directives 80/590/EEC and 89/109/EEC (
1),
and in particular Article 5(2) thereof,
Whereas:
(1) Commission Directive 2002/72/EC (2) is a specific
Directive within the meaning of Regulation (EC) No1935/2004 and harmonises the rules on the authori-sation of plastic materials and articles intended to comeinto contact with food.
(2) Directive 2002/72/EC establishes lists of authorisedsubstances for the manufacture of these materials andarticles, in particular additives and monomers, restrictionson their use, as well as rules on labelling and on theinformation to be given to consumers or food businessoperators for the correct use of these materials andarticles.
(3) The current list of additives contained in Directive2002/72/EC is an incomplete list inasmuch as it doesnot contain all substances currently accepted in one ormore Member States.
(4) According to Article 4(1) of Directive 2002/72/EC as it
stands, the list of additives is considered to be an
incomplete list until the Commission decides, inaccordance with Article 4a, that it becomes a positiveCommunity list of authorised additives.
(5) For those additives which are currently permitted in theMember States, the time limit for the submission of datafor their safety evaluation by the European Food SafetyAuthority (hereinafter the Authority) with a view to their
inclusion in the Community list expired on 31 December
2006. Therefore the date when the Community list ofadditives becomes a positive list can now be set. Takinginto account the time the Authority will need to evaluateall valid applications submitted on time this date shouldbe January 2010.
(6) It is also appropriate to clarify the role of the provisionallist referred to in Article 4a (4) and (5) of Directive2002/72/EC as it stands and how it will be updated.The provisional list contains those additives for whichthe necessary data were supplied on time and in
accordance with the Authority ’s requirements, but
where no decision on their inclusion in the positive listhas yet been taken.
(7) This provisional list provides information to the publicon the additives that are under evaluation in view of theirpossible inclusion in the Community list of additives. Asit is impossible to know if the evaluations for all theadditives included in the provisional list will becompleted by the date when the list of additivesbecomes a positive list, it should be possible tocontinue to use those additives, in accordance withnational law, until their evaluation is completed and a
decision is taken on their inclusion in the positive list of
additives.
(8) When an additive included in the provisional list isinserted in the Community list of additives or when itis decided not to include it in the Community list, thatadditive should be removed from the provisional list ofadditives.
(9) If, during the examination of the data on an additiveincluded in the provisional list, the Authority calls forsupplementary information, that additive should bemaintained in the provisional list until a decision istaken in relation to it, provided that the information issubmitted within the time limits specified by theAuthority.EN L 63/6 Official Journal of the European Union 7.3.2008
(1) OJ L 338, 13.11.2004, p. 4.
(2) OJ L 220, 15.8.2002, p. 18. Directive as last amended by Directive
2007/19/EC (OJ L 97, 12.4.2007, p. 50).(10) On the basis of new information related to the risk
assessment of monomers and additives evaluated by theAuthority (
1), certain additives admitted at national level
as well as new monomers and additives should beincluded in the respective Community lists of authorisedsubstances. For other substances, the restrictions and/orspecifications already established at Community levelshould be amended on the basis of this new information.
Therefore, Annexes II, III, IVa, V and VI of Directive
2002/72/EC should be amended accordingly.
(11) Commission Directive 2005/79/EC (2) introduced in the
list of additives the additive Ref. No 30340 with thename 12-(Acetoxy)stearic acid, 2,3-bis(acetoxy)propyl ester
and CAS number 330198-91-9. The name and CAS
number introduced in that Directive reflect only the
main component of the application. However theopinion delivered by the Authority covers the mixtureof substances referred to in the application and notonly its main component. The mixture of substances isnow registered in the CAS register under CAS number736150-63-3 with the name Glycerides, castor-oil mono-,
hydrogenated, acetates . For this reason it is now appropriate
to change the name and CAS number to update theauthorisation to all substances in the mixture. Takinginto account the change of name a new Ref. No55910 is assigned. As the substance is now covered byRef. No 55910, Ref. No 30340 should be deleted.
(12) As a consequence, Directive 2002/72/EC should beupdated to take account of new information related tothe risk assessment of substances evaluated by theAuthority, to establish the date when the list ofadditives becomes a positive list and to clarify the roleof the provisional list of additives.
(13) The measures provided for in this Directive are inaccordance with the opinion of the StandingCommittee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
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, togetherwith the restrictions and/or specifications on their use, isset out in Annex III.Until 31 December 2009, additives which are not included
in the Community list of additives may continue to be usedsubject to national law.
As from 1 January 2010, only additives included in the
Community list of additives may be used for the manu-facture 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 bythe Commission by 11 April 2008 at the latest. Itshall be kept updated.
4. By derogation from the third subparagraph of
Article 4(1), additives not included in the Communitylist referred to in that Article may continue to be usedsubject to national law after 1 January 2010 for as longas 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 infor-mation is not submitted within the time limitsspecified 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 provisionsnecessary to comply with this Directive. They shall forthwithcommunicate to the Commission the text of those provisionsand a correlation table between those provisions and thisDirective.EN 7.3.2008 Official Journal of the European Union L 63/7
(1) The EFSA Journal (2007) 555 to 563, 1-32.
The EFSA Journal (2007) 516 to 518, 1-12.
The EFSA Journal (2007) 452 to 454, 1-10.The EFSA Journal (2006) 418 to 427, 1-25.
(
2) OJ L 302, 19.11.2005, p. 35.When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such areference on the occasion of their official publication. MemberStates 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 complyingwith 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 tocome into contact with food and which do not complywith 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 inthe 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 CommissionEN L 63/8 Official Journal of the European Union 7.3.2008ANNEX 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-isosorbideterephthalate)
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) ’EN 7.3.2008 Official Journal of the European Union L 63/9ANNEX 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)
carbodiimideSML = 0,05 mg/kg. For use behind a
PET layer
45703 491589-22-1 cis-1,2-Cyclohexanedicarboxylic acid,
calcium saltSML = 5 mg/kg
48960 — 9,10-dihydroxy stearic acid and its
oligomersSML = 5 mg/kg
55910 736150-63-3 Glycerides, castor-oil mono-,
hydrogenated, acetates
60025 — Hydrogenated homopolymers and/or
copolymers made of 1-decene and/or1-dodecene and/or 1-octeneIn compliance with the specifications
laid down in Annex V. Not to be usedfor articles in contact with fatty foods.
62280 009044-17-1 Isobutylene-butene copolymer
70480 000111-06-8 Palmitic acid, butyl ester76463 — Polyacrylic acid, salts SML(T) = 6 mg/kg (36) (for acrylic acid)
76723 167883-16-1 Polydimethylsiloxane, 3-aminopropyl
terminated, polymer with dicyclo-
hexylmethane-4,4 ′-diisocyanateIn 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-trimethylcyclohexaneIn 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)acrylateSML = 0,05 mg/kg. Only for use in PET
77733 — Polyethyleneglycol (EO = 1-30,
typically 5) ether of butyl-2-cyano-3-
(4-hydroxyphenyl) acrylateSML = 0,05 mg/kg. Only for use in PET
77897 — Polyethyleneglycol (EO = 1-50)
monoalkylether (linear and branched,
C
8-C20) sulphate, saltsSML = 5 mg/kg
89120 000123-95-5 Stearic acid, butyl ester
95858 — Waxes, 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. ’EN L 63/10 Official Journal of the European Union 7.3.2008(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 whichdo not result in an anti-microbial effectat 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)
dimethylaminesSML = 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 ’EN 7.3.2008 Official Journal of the European Union L 63/11ANNEX 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)fluorene53670 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 ’EN L 63/12 Official Journal of the European Union 7.3.2008ANNEX 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. ’EN 7.3.2008 Official Journal of the European Union L 63/13