Commission Directive 2002/17/EC of 21 February 2002 amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance)
Date: 2002-02-21
Institutions: European Commission
Subjects: analytical chemistry, approximation of laws, foodstuff, packaging product, plastics

28.2.2002

EN

Official Journal of the European Communities

L 58/19

COMMISSION DIRECTIVE 2002/17/EC

of 21 February 2002

amending Directive 90/128/EEC relating to plastic materials and articles intended to come into
contact with foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

by national laws only pending a decision at Community
level.

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 89/109/EEC of 21
December 1988 on the approximation of the laws of the
Member States relating to materials and articles intended to
come into contact with foodstuffs (1), and in particular Article
3 thereof,

(6)

(7)

Directive 90/128/EEC should therefore be amended
accordingly.

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on Foodstuffs,

After consulting the Scientific Committee on Food,

HAS ADOPTED THIS DIRECTIVE:

Whereas:

(1)

(2)

(3)

(4)

(5)

On the basis of the new information available to the
Scientific Committee on Food, certain monomers provi-
sionally permitted at national
level as well as other
monomers requested for use following the adoption of
Commission Directive 90/128/EEC of 23 February 1990
relating to plastic materials and articles intended to
come into contact with foodstuffs (2), as last amended by
Directive 2001/62/EC (3), may be included in the
Community list of permitted substances in Annex II to
Directive 90/128/EEC.

Article 1

Annexes II, III, V and VI to Directive 90/128/EEC are amended
as set out in the Annex to this Directive.

Article 2

Member States shall adopt and publish, by 28 February 2003
at the latest, the provisions necessary to comply with this
Directive. They shall forthwith inform the Commission thereof.

Annex III to Directive 90/128/EEC contains an incom-
plete list of additives which may be used in the manufac-
ture of plastics materials and articles. That list should be
amended so as to include other additives evaluated by
the Scientific Committee on Food.

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 foodstuffs and
complying with this Directive, from 1 March 2003;

For certain substances, the restrictions already estab-
lished at Community level should be amended on the
basis of the information available.

The current list of additives is an incomplete list inas-
much as it does not contain all the substances, which are
currently accepted in one or more Member States.
Accordingly, these substances continue to be regulated
by national laws only pending a decision on inclusion in
the Community list.

This Directive establishes specifications for only a few
substances. The other substances, which may require
specifications, therefore remain regulated in this respect

(b) prohibit

the manufacture

and importation into the
Community of plastic materials and articles intended to
come into contact with foodstuffs and which do not
comply with this Directive, from 1 March 2004. However,
for materials and articles which contain divinylbenzene and
do not comply with the restriction set in this Directive,
Member States
their manufacture and
importation into the Community as from 1 March 2003.

shall prohibit

When Member States adopt these 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.

Article 3

(1) OJ L 40, 11.2.1989, p. 38.
(2) OJ L 75, 21.3.1990, p. 19.
(3) OJ L 221, 17.8.2001, p. 18.

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

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Official Journal of the European Communities

28.2.2002

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 21 February 2002.

For the Commission

David BYRNE

Member of the Commission

28.2.2002

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Official Journal of the European Communities

L 58/21

ANNEX

The Annexes to Directive 90/128/EEC are amended as follows:

1. Annex II is amended as follows:

(a) In point 8:

(i) The definition of QM(T) is replaced by the following:

‘QM(T) =

Maximum permitted quantity of the “residual” substance in the material or article expressed as
total of moiety or substance(s) indicated. For the purpose of this Directive the quantity of the
substance in the material or article should be determined by a validated method of analysis. If
such a method does not currently exist, an analytical method with appropriate performance
characteristics at the specified limit may be used, pending the development of a validated
method;’

(ii) the following text is inserted after QM(T):

‘QMA =

Maximum permitted quantity of the “residual” substance in the finished material or article
expressed as mg per 6 dm2 of the surface in contact with foodstuffs. For the purpose of this
Directive the quantity of the substance in the surface of the material or article should be
determined by a validated method of analysis. If such a method does not currently exist, an
analytical method with appropriate performance characteristics at the specified limit may be
used, pending the development of a validated method;

QMA(T) = Maximum permitted quantity of the “residual” substance in the material or article expressed as
indicated per 6 dm2 of the surface in contact with
mg of total of moiety or substance(s)
foodstuffs. For the purpose of this Directive the quantity of the substance in the surface of the
material or article should be determined by a validated method of analysis. If such a method does
not currently exist, an analytical method with appropriate performance characteristics at the
specified limit may be used, pending the development of a validated method;’

(iii) The definitions of SML and SML(T) are replaced by the following:

‘SML =

SML(T) =

Specific migration limit in food or in food simulant, unless it is specified otherwise. For the
purpose of this Directive the specific migration of the substance should be determined by a
validated method of analysis. If such a method does not currently exist, an analytical method
with appropriate performance characteristics at the specified limit may be used, pending the
development of a validated method;

Specific migration limit in food or in food simulant expressed as total of moiety or substance(s)
indicated. For the purpose of this Directive the specific migration of the substances should be
determined by a validated method of analysis. If such a method does not currently exist, an
analytical method with appropriate performance characteristics at the specified limit may be
used, pending the development of a validated method.’

(b) Section A is amended as follows:

(i) The following monomers and other starting substances are inserted:

REF. No

CAS No

Name

Restrictions and/or specifications

13620

10043-35-3

Boric acid

(expressed as boron) without
SML(T) = 6 mg/kg (23)
prejudice to the provisions of Council Directive 98/
83/EC of 3 November 1998 on the quality of water
intended
L 330,
5.12.1998, p.32)

human consumption (OJ

for

16650

00127-63-9

Diphenyl sulphone

SML(T) = 3 mg/kg (25)

18897

16712-64-4

6-Hydroxy-2-naphtalenecarboxylic acid

SML = 0,05 mg/kg

18898

103-90-2

N-(4-Hydroxyphenyl) acetamide

Only to be used in liquid crysstals and behind a barrier
layer in multilayered plastics

22332

28679-16-5

Mixture of (40 % w/w) 2,2,4-trimethylhexane-1,6-
diisocyanate and (60 % w/w) 2,4,4-trimethylhexane-
1,6-diisocyanate

QM(T) = 1 mg/kg (expressed as NCO) (26)

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Official Journal of the European Communities

28.2.2002

(ii) For the following monomers and other 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

13510

01675-54-3

2,2-Bis(4-hydroxyphenyl)propane bis(2,3epoxypropyl)
ether (= Badge)

According to Commission Directive 2002/16/EC of 20
February 2002 on the use of certain epoxy derivatives
in materials and articles intended to come into contact
with foodstuffs (OJ L 51, 22.2.2002, p. 27)

13560

14650

14950

15700

16240

16570

16600

16630

18640

19110

22420

22570

25210

25240

25270

05124-30-1

Bis(4-isocyanatocyclohexyl)methane

See ‘Dicyclohexylmethane-4,4(cid:1)-diisocyanate’

00079-38-9

Chlorotrifluoroethylene

QMA = 0,5 mg/6 dm2

03173-53-3

Cyclohexyl isocyanate

QM(T) = 1 mg/kg (expressed as NCO) (26)

05124-30-1

Dicyclohexylmethane-4,4(cid:1)-diisocyanate

QM(T) = 1 mg/kg (expressed as NCO) (26)

00091-97-4

3,3(cid:1)-Dimethyl-4,4(cid:1)-diisocyanatobiphenyl

QM(T) = 1 mg/kg (expressed as NCO) (26)

04128-73-8

Diphenylether-4,4(cid:1)-diisocyanate

QM(T) = 1 mg/kg (expressed as NCO) (26)

05873-54-1

Diphenylmethane-2,4(cid:1)-diisocyanate

QM(T) = 1 mg/kg (expressed as NCO) (26)

00101-68-8

Diphenylmethane-4,4(cid:1)-diisocyanate

QM(T) = 1 mg/kg (expressed as NCO) (26)

00822-06-0

Hexamethylene diisocyanate

QM(T) = 1 mg/kg (expressed as NCO) (26)

04098-71-9

1-Isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclo-
hexane

QM(T) = 1 mg/kg (expressed as NCO) (26)

03173-72-6

1,5-Napthalene diisocyanate

QM(T) = 1 mg/kg (expressed as NCO) (26)

00112-96-9

Octadecyl isocyanate

QM(T) = 1 mg/kg (expressed as NCO) (26)

00584-84-9

2,4-Toluene diisocyanate

QM(T) = 1 mg/kg (expressed as NCO) (26)

00091-08-7

2,6-Toluene diisocyanate

QM(T) = 1 mg/kg (expressed as NCO) (26)

26747-90-0

2,4-Toluene diisocyanate dimer

QM(T) = 1 mg/kg (expressed as NCO) (26)

(iii) The following monomers and other starting substances are transferred from Section B to Section A:

REF. No

CAS No

Name

Restrictions and/or specifications

13075

13720

15310

16690

16697

25840

00091-76-9

Benzoguanamine

See ‘2,4-Diamino-6-phenyl-1,3,5-triazine’

00110-63-4

1,4-Butanediol

SML(T) = 0,05 mg/kg (24)

00091-76-9

2,4-Diamino-6-phenyl-1,3,5-triazine

QMA = 5 mg/6 dm2

01321-74-0

Divinylbenzene

or

(DL
QMA = 0,01 mg/6 dm2
= 0,02 mg/kg, analytical
for the
sum of Divinylbenzene and Ethylvinylbenzene and in
compliance with the specifications laid down in Annex
V

SML = ND
tolerance included)

00693-23-2

n-Dodecanedioic acid

03290-92-4

1,1,1-Trimethylolpropane trimethacrylate

SML = 0,05 mg/kg

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2. Annex III is amended as follows:

(a) The table of Section A is amended as follows:
(i) The following additives are inserted:

REF. No

CAS No

Name

Restrictions and/or specifications

36840

12007-55-5

Barium tetraborate

40320

10043-35-3

Boric acid

and
SML(T) = 1 mg/kg expressed as barium (12)
SML(T) = 6 mg/kg (23)
(expressed as boron) without
prejudice to the provisions of Council Directive 98/83/
EC of 3 November 1998 on the quality of water
intended
L 330,
5.12.1998, p. 32)

human consumption (OJ

for

(expressed as boron) without
SML(T) = 6 mg/kg (23)
prejudice to the provisions of Council Directive 98/
83/EC of 3 November 1998 on the quality of water
intended
L 330,
5.12.1998, p. 32)

human consumption (OJ

for

40580

00110-63-4

1,4-Butanediol

SML(T) = 0,05 mg/kg (24)

71670

178671-58-4

Pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)

SML = 0,05 mg/kg

87040

01330-43-4

Sodium tetraborate

SML(T) = 6 mg/kg (23)
(expressed as boron) without
prejudice to the provisions of Council Directive 98/
83/EC of 3 November 1998 on the quality of water
intended
L 330,
5.12.1998, p. 32)

human consumption (OJ

for

(ii) For the following additives the content of column ‘Restriction and/or specifications’

is replaced by the

following:

REF. No

CAS No

Name

Restrictions and/or specifications

37360

000100-52-7

Benzaldehyde

In compliance with note 9 in Annex VI

40120

68951-50-8

Bis(polyethyleneglycol)hydroxymethylphosphonate

SML = 0,6 mg/kg

41680

000076-22-2

Camphor

In compliance with note 9 in Annex VI

(iii) The following additive is deleted

REF. No

CAS No

Name

Restrictions and/or specifications

40020

110553-27-0

2,4-Bis(octylthiomethyl)-6-methylphenol

SML = 6 mg/kg

(b) The table of Section B is amended as follows:

(i) The following additives are inserted:

REF. No

CAS No

Name

Restrictions and/or specifications

45650

6197-30-4

2-Cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester

SML = 0,05 mg/kg

68860

04724-48-5

n-Octylphosphonic acid

SML = 0,05 mg/kg

95000

28931-67-1

Trimethylolpropane trimethacrylate-methyl methacry-
late copolymer

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(ii) For the following additives the content of column ‘Restriction and/or specifications’

is replaced by the

following:

REF. No

CAS No

Name

Restrictions and/or specifications

39120

—

N,N-Bis(2-Hydroxyethyl)alkyl(C8-C18)amine hydro-
chlorides

SML(T) = 1,2 mg/kg (13) expressed as tertiary amine
(expressed excluding HCl)

51570

00127-63-9

Diphenyl sulphone

SML(T) = 3 mg/kg (25)

3. Annex V is amended as follows:

The following specifications are inserted in the table of Part B:

PM/REF. No

Other specifications

16690

Divinylbenzene

It may contain up to 40 % of Ethylvinylbenzene

4. Annex VI is amended as follows:

(a) The notes (12) and (13) are replaced by the following:

‘(12) 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 PM/REF. Nos: 36720, 36800, 36840 and 92000.

(13) 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 PM/REF. Nos: 39090 and 39120.’

(b) The following notes are added:

‘(23) 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 PM/REF. Nos: 13620, 36840, 40320 and 87040.

(24) 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 PM/REF. Nos: 13720 and 40580.

(25) 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 PM/REF. Nos: 16650 and 51570.

(26) QM(T) in this specific case means that the restriction shall not be exceeded by the sum of the residual
quantities of the following substances mentioned as PM/REF. Nos: 14950, 15700, 16240, 16570, 16600,
16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240, 25270.’