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)
Date: 2008-03-06
Institutions: European Commission
Subjects: analytical chemistry, food safety, foodstuff, foodstuffs legislation, packaging product, plastics

L 63/6

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Official Journal of the European Union

7.3.2008

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
Community,

establishing the European

Having regard to Regulation (EC) No 1935/2004 of
the
European Parliament and of the Council of 27 October 2004
on materials and articles intended to come into contact with
food and repealing Directives 80/590/EEC and 89/109/EEC (1),
and in particular Article 5(2) thereof,

Whereas:

Commission Directive 2002/72/EC (2)
specific
Directive within the meaning of Regulation (EC) No
1935/2004 and harmonises the rules on the authori-
sation of plastic materials and articles intended to come
into contact with food.

is

a

lists of authorised
Directive 2002/72/EC establishes
substances for the manufacture of these materials and
articles, in particular additives and monomers, restrictions
on their use, as well as rules on labelling and on the
information to be given to consumers or food business
operators for the correct use of
these materials and
articles.

list of additives contained in Directive
The current
2002/72/EC is an incomplete list inasmuch as it does
not contain all substances currently accepted in one or
more Member States.

According to Article 4(1) of Directive 2002/72/EC as it
the list of additives is considered to be an
stands,
incomplete
in
accordance with Article 4a, that it becomes a positive
Community list of authorised additives.

the Commission decides,

list until

(1)

(2)

(3)

(4)

(5)

(6)

(7)

Authority (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 of
additives becomes a positive list can now be set. Taking
into account the time the Authority will need to evaluate
all valid applications submitted on time this date should
be January 2010.

It is also appropriate to clarify the role of the provisional
list referred to in Article 4a (4) and (5) of Directive
2002/72/EC as it stands and how it will be updated.
list contains those additives for which
The provisional
the necessary data were supplied on time and in
accordance with the Authority’s
requirements, but
where no decision on their inclusion in the positive list
has yet been taken.

included in the provisional

This provisional list provides information to the public
on the additives that are under evaluation in view of their
possible inclusion in the Community list of additives. As
it is impossible to know if the evaluations for all the
additives
list will be
completed by the date when the list of additives
to
it
becomes a positive
continue to use those additives,
in accordance with
national
law, until their evaluation is completed and a
decision is taken on their inclusion in the positive list of
additives.

should be possible

list,

(8) When an additive included in the provisional

is
inserted in the Community list of additives or when it
is decided not to include it in the Community list, that
additive should be removed from the provisional list of
additives.

list

For those additives which are currently permitted in the
Member States, the time limit for the submission of data
for their safety evaluation by the European Food Safety

(9)

(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).

If, during the examination of the data on an additive
list, the Authority calls for
included in the provisional
supplementary information,
should be
maintained in the provisional
list until a decision is
taken in relation to it, provided that the information is
submitted within the
specified by the
time
Authority.

that additive

limits

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(10) On the basis of new information related to the risk
assessment of monomers and additives evaluated by the
Authority (1), certain additives admitted at national level
as well as new monomers and additives should be
included in the respective Community lists of authorised
substances. For other substances, the restrictions and/or
specifications already established at Community level
should be amended on the basis of this new information.
Therefore, Annexes II,
IVa, V and VI of Directive
2002/72/EC should be amended accordingly.

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 manu-
facture of plastic materials and articles (positive list).’

(11)

the

application. However

Commission Directive 2005/79/EC (2) introduced in the
list of additives the additive Ref. No 30340 with the
name 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
opinion delivered by the Authority covers the mixture
of substances referred to in the application and not
only its main component. The mixture of substances is
now registered in the CAS register under CAS number
736150-63-3 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 the
authorisation to all substances in the mixture. Taking
into account
the change of name a new Ref. No
55910 is assigned. As the substance is now covered by
Ref. No 55910, Ref. No 30340 should be deleted.

(12) As a consequence, Directive 2002/72/EC should be
updated to take account of new information related to
substances evaluated by the
the risk assessment of
Authority,
list of
additives becomes a positive list and to clarify the role
of the provisional list of additives.

to establish the date when the

(13)

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DIRECTIVE:

Directive 2002/72/EC is amended as follows:

Article 1

2. Article 4a is amended as follows:

(a) Paragraphs 3 and 4 are replaced by the following:

A provisional

list of additives

‘3.
that are under
evaluation by the Authority shall be made public by
the Commission by 11 April 2008 at
It
shall be kept updated.

the latest.

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:

An additive shall be removed from the provisional

‘6.
list:

(a) when it

is
additives; or

included in the Community list of

(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 limits
specified by the Authority.’

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.

(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.

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.

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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.

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.

They shall apply those provisions in such a way as to:

This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

Article 3

(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;

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 6 March 2008.

(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.

For the Commission

Androulla VASSILIOU
Member of the Commission

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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

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘15404

000652-67-5

1,4:3,6-Dianhydrosorbitol

19180

000099-63-8

Isophthalic acid dichloride

26305

000078-08-0

Vinyltriethoxysilane

SML = 5 mg/kg. Only for use as a co-
monomer in poly(ethylene-co-isosorbide
terephthalate)

SML(T) = 5 mg/kg (43) (expressed as
isophthalic acid)

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

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘19150

000121-91-5

Isophthalic acid

SML(T) = 5 mg/kg (43)’

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Official Journal of the European Union

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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

(1)

(2)

‘38875

002162-74-5

Name

(3)

Restrictions and/or specifications

(4)

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 dicyclo-
hexylmethane-4,4′-diisocyanate

In compliance with the specifications
laid down in Annex V

76725

661476-41-1

77732

77733

77897

—

—

—

Polydimethylsiloxane, 3-aminopropyl
terminated, polymer with
1-isocyanato-3-isocyanatomethyl-
3,5,5-trimethylcyclohexane

Polyethylene glycol (EO = 1-30,
typically 5) ether of butyl 2-cyano
3-(4-hydroxy-3-methoxyphenyl)
acrylate

Polyethyleneglycol (EO = 1-30,
typically 5) ether of butyl-2-cyano-3-
(4-hydroxyphenyl) acrylate

In compliance with the specifications
laid down in Annex V

SML = 0,05 mg/kg. Only for use in PET

SML = 0,05 mg/kg. Only for use in PET

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.’

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(b) for the following additives, the content of the column ‘Restrictions and/or specifications’ of the table is replaced

(2)

(2)

by the following:

Ref. No

CAS No

(1)

‘39815

Name

(3)

Restrictions and/or specifications

(4)

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

(1)

‘30340

330198-91-9

12-(Acetoxy)stearic acid, 2,3-bis
(acetoxy)propyl ester’

Name

(3)

Restrictions and/or specifications

(4)

(2) Section B is amended as follows:

(a)

the following additives are inserted in the appropriate numerical order:

Ref. No

CAS No

(1)

‘34130

(2)

—

Name

(3)

Alkyl, linear with even number of
carbon atoms (C12-C20)
dimethylamines

Restrictions and/or specifications

(4)

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

(1)

‘72081/10

(2)

—

Name

(3)

Restrictions and/or specifications

(4)

Petroleum Hydrocarbon Resins
(hydrogenated)

In compliance with the specifications
laid down in Annex V’

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ANNEX III

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

Ref. No

CAS No

‘34130

—

Alkyl, linear with even number of carbon atoms (C12-C20) dimethylamines

Name

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

‘60025

Other specifications

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’

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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.’