Commission Directive 2004/14/EC of 29 January 2004 amending Directive 93/10/EEC relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs (Text with EEA relevance)
Date: 2004-01-29
Institutions: European Commission
Subjects: approximation of laws, cellulose, foodstuff, labelling, public health, toxic substance

L 27/48

EN

Official Journal of the European Union

30.1.2004

COMMISSION DIRECTIVE 2004/14/EC

of 29 January 2004

amending Directive 93/10/EEC relating to materials and articles made of regenerated cellulose film
intended to come into contact with foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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
Member States relating to materials and articles intended to
come into contact with foodstuffs (1), as amended by Regu-
lation (EC) No 1882/2003 of the European Parliament and of
the Council (2), and in particular Article 3 thereof,

the laws of

After consulting the Scientific Committee on Food,

Whereas:

(1)

(2)

(3)

Commission Directive 93/10/EEC of 15 March 1993
relating to materials and articles made of regenerated
cellulose film intended to come into contact with food-
stuffs (3), as amended by Directive 93/111/EC (4), applies
to regenerated cellulose film and establishes a list of
authorised substances together with restrictions on their
use. That Directive covers regenerated cellulose films
uncoated or coated with coatings manufactured only
with substances listed therein.

Further to technological developments, it is necessary to
authorise a new type of regenerated cellulose film with a
coating consisting of plastics, which is compostable and
biodegradable. This new type of regenerated cellulose
film is consistent with the environmental requirements
of Directive 94/62/EC of the European Parliament and of
the Council of 20 December 1994 on packaging and
packaging waste (5), as amended by Regulation (EC) No
1882/2003. Accordingly, such authorisation is in the
interest of consistency of Community legislation.

The rules to be applied to the regenerated cellulose films
should be specific to the nature of the layer in contact
with the foodstuff. Accordingly, the requirements for
regenerated
coatings
films
consisting of plastics should be different
from those
provided for regenerated cellulose films uncoated or
coated with coatings derived from cellulose.

coated with

cellulose

(4)

(5)

(6)

(7)

(8)

Only authorised substances should be used in the manu-
facture of all the types of regenerated cellulose films,
including regenerated cellulose films coated with plas-
tics.

In the case of regenerated cellulose films coated with
coatings consisting of plastics, the layer in contact with
foodstuffs consists of a material similar to plastic mate-
rials and articles intended to come into contact with
foodstuffs. Therefore it
the rules
provided for in Commission Directive 2002/72/EC of 6
August 2002 relating to plastic materials and articles
intended to come into contact with foodstuffs (6) should
be applicable also to such films.

is appropriate that

In the interest of consistency of Community legislation,
the verification of compliance of plastic-coated regener-
ated cellulose films with the migration limits set by
Directive 2002/72/EC should be carried out according to
the rules laid down in Council Directive 82/711/EEC of
18 October 1982 laying down the basic rules necessary
for testing migration of the constituents of plastic mate-
rials and articles intended to come into contact with
foodstuffs (7), as last amended by Commission Directive
97/48/EC (8), and Council Directive 85/572/EEC of 19
December 1985 laying down the list of simulants to be
used for testing migration of constituents of plastic
materials and articles intended to come into contact with
foodstuffs (9).

A number of polymers used as coatings should be
deleted from the list of authorised substances set out in
Directive 93/10/EEC as they are covered by the rules set
out in Directive 2002/72/EC which apply to plastic-
coated regenerated cellulose films.

Four solvents should also be deleted from the list of
authorised substances set out in Directive 93/10/EEC as
new data are available showing a risk for reproduction
and because they are no longer used in the manufacture
of regenerated cellulose films. In addition, some plastici-
sers, which are no longer used, should also be deleted
from that list.

(1) OJ L 40, 11.2.1989, p. 38.
(2) OJ L 284, 31.10.2003, p. 1.
(3) OJ L 93, 17.4.1993, p. 27.
(4) OJ L 310, 14.12.1993, p. 41.
(5) OJ L 365, 31.12.1994, p. 10.

(6) OJ L 220, 15.8.2002, p. 18.
(7) OJ L 297, 23.10.1982, p. 26.
(8) OJ L 222, 12.8.1997, p. 10.
(9) OJ L 372, 31.12.1985, p. 14.

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Official Journal of the European Union

L 27/49

(9)

In addition, the restriction on the use of 2-ethylhexyl
diphenyl phosphate (synonym: phosphoric acid diphenyl
2-ethylhexyl ester) set out in Directive 93/10/EEC should
be amended to take into account the opinion of the
Scientific Committee on Food of 19 March 1998.

3. Without prejudice to paragraph 1, materials and arti-
cles made of regenerated cellulose film referred to in Article
1a(c) shall comply with Articles 2, 7 and 8 of Directive
2002/72/EC.’

5. Annex II is amended in accordance with the Annex to this

(10) Directive 93/10/EEC should therefore be

amended

Directive.

accordingly.

(11)

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 93/10/EEC is amended as follows:

1. In Article 1(3), point (a) is deleted.

2. The following Article 1a is inserted:

‘Article 1a

The regenerated cellulose films referred to in Article 1(2)
shall belong to one of the following types:
(a) uncoated regenerated cellulose film;

(b) coated regenerated cellulose film with coating derived

from cellulose;

or

(c) coated regenerated cellulose film with coating consisting

of plastics.’

3. Article 2(1) is replaced by the following:

‘1.
Regenerated cellulose films referred to in points (a)
and (b) of Article 1a shall be manufactured using only
substances or groups of substances listed in Annex II subject
to the restrictions set out therein.’

4. The following Article 2a is inserted:

‘Article 2a

Regenerated cellulose film referred to in Article 1a(c)
1.
to coating, using only
shall be manufactured, prior
substances or groups of substances listed in the first part of
Annex II, subject to the restrictions set out therein.

2.
The coating to be applied to the regenerated cellulose
film referred to in paragraph 1 shall be manufactured using
only substances or groups of substances listed in Annexes II
to VI to Directive 2002/72/EC, subject to the restrictions set
out therein.

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 29 July 2005 at the latest. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this Direc-
tive.

Member States shall apply those provisions in such a way as to:

(a) permit the trade in and use of regenerated cellulose film
which is intended to come into contact with foodstuffs
complying with this Directive, from 29 July 2005;

(b) prohibit the manufacture and importation into the Com-
munity of regenerated cellulose film which is intended to
come into contact with foodstuffs and which does not
comply with the provisions of this Directive as from 29
January 2006. When Member States adopt those provi-
sions, 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.

Article 3

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

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 29 January 2004.

For the Commission

David BYRNE

Member of the Commission

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Official Journal of the European Union

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ANNEX

The second part of Annex II to Directive 93/10/EEC is amended as follows:

1. In the third line (C. Coating) of the second column (Restrictions) of the table: ‘Not more than 50 mg of coating/dm2

of film on the side in contact with foodstuffs’ is deleted.

2. The following polymers and their restrictions are deleted from the table:

Denominations

Restrictions

‘— Polymers, copolymers and their mixtures made with

the following monomers:

vinyl acetals derived from saturated aldehydes (C1 to
C6)

vinyl acetate

alkyl (C1 to C4) vinyl ethers

acrylic, crotonic, itaconic, maleic, methacrylic acids
and their esters

butadiene

styrene

methylstyrene

vinylidene chloride

acrylonitrile

methacrylonitrile

ethylene, propylene, 1- and 2-butylene

vinyl chloride

9

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>=
>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>;

In accordance with Community directives, and,
in
their absence, with national legislation pending the
adoption of Community directives

According to Directive 78/142/EEC (OJ L 44, 15.2.1978,
p. 15)’

3. For resins, the content of the column ‘Restrictions’ of the table is replaced by the following:

‘2. Resins

total quantity of

The
substances may not exceed
12,5 mg/dm2 of the coating on the side in contact with
foodstuffs and solely for the preparation of regenerated
cellulose films with cellulose nitrate based coatings’

4. The following plasticisers and their restrictions are deleted from the table:

Denominations

Restrictions

‘— Butylbenzylphthalate

— Di-n-butyl phthalate

— Di(2-ethylhexyl) sebacate [= dioctylsebacate]’

Not more than 2,0 mg/dm2 of the coating on the side in
contact with foodstuffs

Not more than 3,0 mg/dm2 of the coating on the side in
contact with foodstuffs

5. For the following plasticiser, the content of the column ‘Restrictions’ of the table is replaced by the following:

Denominations

Restrictions

‘— 2-ethylhexyl diphenyl phosphate (synonym: phos-

phoric acid diphenyl 2-ethylhexyl ester)

The amount of 2-ethylhexyl diphenyl phosphate shall
not exceed:
(a) 2,4 mg/kg of the foodstuff in contact with this type

of film, or

(b) 0.4 mg/dm2 in the coating on the side in contact

with foodstuffs’

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6. The following solvents are deleted from the table:

Denominations

Restrictions

‘— Ethyleneglycol monoethyl ether

— Ethyleneglycol monoethyl ether acetate

— Ethyleneglycol monomethyl ether

— Ethyleneglycol monomethyl ether acetate’