Commission Directive 2007/42/EC of 29 June 2007 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs (Codified version) (Text with EEA relevance)
Date: 2007-06-29
Institutions: European Commission
Subjects: adjuvant, cellulose, dangerous substance, food safety, foodstuff, foodstuffs legislation

30.6.2007

EN

Official Journal of the European Union

L 172/71

DIRECTIVES

COMMISSION DIRECTIVE 2007/42/EC

of 29 June 2007

relating to materials and articles made of regenerated cellulose film intended to come into contact
with foodstuffs

(Text with EEA relevance)

(Codified version)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1935/2004 of
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 thereof,

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 (2) has been substantially amended several times (3).
In the interests of clarity and rationality the said Directive
should be codified.

The Community measures envisaged by this Directive are
not only necessary but also indispensable for
the
attainment of
the internal market.
the objectives of
These objectives cannot be achieved by Member States
individually. Furthermore, their attainment at Community
level
already provided for by Regulation (EC)
is
No 1935/2004.

In order to achieve the objective laid down in Article 3(1)
of Regulation (EC) No 1935/2004 in the case of regen-
erated cellulose film,
the suitable instrument was a
specific directive within the meaning of Article 5 of
that Regulation.

(4)

Synthetic casings of regenerated cellulose should be the
subject of specific provisions.

(1) OJ L 338, 13.11.2004, p. 4.
(2) OJ L 93, 17.4.1993, p. 27. Directive as last amended by Directive

2004/14/EC (OJ L 27, 30.1.2004, p. 48).

(3) See Annex III, Part A.

(5)

(6)

(7)

(8)

The method for determining the absence of migration of
colouring matters should be established at a later stage.

Until criteria of purity and methods of analysis have been
drawn up, national provisions should remain in force.

The establishment of a list of approved substances,
accompanied by limits to the quantities to be used,
is
sufficient in principle in this specific case to achieve the
objective laid down in Article 3(1) of Regulation (EC)
No 1935/2004.

the

and

ethanediol

(= monoethyleneglycol)

bis(2-hydroxyethyl)ether

(= diethylene-
However,
glycol)
can
migrate extensively to certain foodstuffs and therefore
in order
to avoid this possibility, as a preventive
measure, it is more appropriate to lay down definitively
the maximum authorised quantity of such substances in
foodstuffs which have been in contact with regenerated
cellulose film.

(9)

To protect the health of the consumer, direct contact
between foodstuffs and the printed surfaces of regen-
erated cellulose film should be avoided.

(10)

(11)

The written declaration referred to in Article 16(1) of
Regulation (EC) No 1935/2004 should be provided for
in the event of professional use of regenerated cellulose
film for materials and articles intended to come into
contact with foodstuffs, except
those which are, by
their nature, intended for this use.

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

coated with

cellulose

films

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(12) Only authorised substances should be used in the manu-
facture of all the types of regenerated cellulose films,
including regenerated cellulose films coated with plastics.

(a) constitutes a finished product in itself; or

(13)

(14)

(15)

(16)

In the case of regenerated cellulose films coated with
coatings consisting of plastics, the layer in contact with
foodstuffs consists of a material
to plastic
materials and articles intended to come into contact
the
with foodstuffs. Therefore it
rules
Directive
in
2002/72/EC of 6 August 2002 relating to plastic
materials and articles intended to come into contact
with foodstuffs (1) apply also to such films.

is appropriate that
Commission

provided

similar

for

In the interest of consistency of Community legislation,
the verification of compliance of plastic-coated regen-
erated 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
the constituents of
necessary for testing migration of
plastic materials and articles intended to come into
and Council Directive
contact with
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 (3).

foodstuffs (2)

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

in this Directive are in
Standing
the

opinion

the

of

This Directive should be without prejudice to the obli-
gations of the Member States relating to the time-limits
for transposition into national law and application of the
Directives set out in Annex III, Part B,

HAS ADOPTED THIS DIRECTIVE:

Article 1

This Directive is a specific directive within the meaning of

1.
Article 5 of Regulation (EC) No 1935/2004.

2.
This Directive shall apply to regenerated cellulose film
the description given in Annex I
within the meaning of
which is intended to come into contact with foodstuffs or
which, by virtue of its purpose, does come into such contact
and which either:

(b) forms part of a finished product containing other materials.

This Directive shall not apply to synthetic casings of

3.
regenerated cellulose.

Article 2

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.

Article 3

1.
Regenerated cellulose films referred to in Article 2(a) and
(b) shall be manufactured using only substances or groups of
substances listed in Annex II subject to the restrictions set out
therein.

2.
By way of derogation from paragraph 1, substances other
than those listed in Annex II may be used when these
substances
and
pigments) or as adhesives, provided that there is no trace of
migration of the substances into or onto foodstuffs, detectable
by a validated method.

colouring matter

employed as

(dyes

are

Article 4

1.
Regenerated cellulose film referred to in Article 2(c) shall
be manufactured, prior to coating, using only substances or
groups of substances listed in the first part of Annex II,
subject to the restrictions set out therein.

(1) OJ L 220, 15.8.2002, p. 18. Directive as last amended by Directive

2007/19/EC (OJ L 91, 31.3.2007, p. 17).

(2) OJ L 297, 23.10.1982, p. 26. Directive as last amended by
Commission Directive 97/48/EC (OJ L 222, 12.8.1997, p. 10).
(3) OJ L 372, 31.12.1985, p. 14. Directive as last amended by

Commission Directive 2007/19/EC.

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.

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

Article 5

Printed surfaces of regenerated cellulose film shall not come
into contact with the foodstuffs.

Article 6

At

the marketing stages other

than the retail stages,
1.
materials and articles made of
regenerated cellulose film
intended to come into contact with foodstuffs shall be accom-
panied by a written declaration in accordance with Article 16(1)
of Regulation (EC) No 1935/2004.

Article 7

Directive 93/10/EEC, as amended by the Directives listed in
Annex III, Part A,
is repealed, without prejudice to the obli-
gations of the Member States relating to the time-limits for
transposition into national law and application of the Directives
set out in Annex III, Part B.

References to the repealed Directive shall be construed as
references to this Directive and shall be read in accordance
with the correlation table in Annex IV.

Article 8

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

Article 9

This Directive is addressed to the Member States.

2.
Paragraph 1 shall not apply to materials and articles made
of regenerated cellulose film which by their nature are clearly
intended to come into contact with foodstuffs.

Done at Brussels, 29 June 2007.

3. Where special conditions of use are indicated, the material
or article made of regenerated cellulose film shall be labelled
accordingly.

For the Commission
The President

José Manuel BARROSO

ANNEX I

DESCRIPTION OF REGENERATED CELLULOSE FILM

Regenerated cellulose film is a thin sheet material obtained from a refined cellulose derived from unrecycled wood or
cotton. To meet technical requirements, suitable substances may be added either in the mass or on the surface.
Regenerated cellulose film may be coated on one or both sides.

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ANNEX II

LIST OF SUBSTANCES AUTHORISED IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM

NB:

— The percentages in this Annex, first and second parts, are expressed in weight/weight (w/w) and are calculated in

relation to the quantity of anhydrous uncoated regenerated cellulose film.

— The usual technical denominations are given in square brackets.

— The substances used shall be of good technical quality as regards the purity criteria.

FIRST PART

Uncoated regenerated cellulose film

Denominations

Restrictions

A. Regenerated cellulose

Not less than 72 % (w/w)

B. Additives

1. Softeners

— Bis (2-hydroxyethyl) ether [= diethyleneglycol]

— Ethanediol [= monoethyleneglycol]

— 1,3-butanediol

— Glycerol

— 1,2-propanediol [= 1,2 propyleneglycol]

Not more than 27 % (w/w) in total

9

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

Only for films intended to be coated and then used for
foodstuffs which are not moist, namely which do not
contain water which is physically free at the surface.
The total amount of bis(2-hydroxyethyl)ether and etha-
nediol present in foodstuffs that have been in contact
with film of this type may not exceed 30 mg/kg of the
foodstuff.

— Polyethylene oxide [= polyethyleneglycol]

Average molecular weight between 250 and 1 200.

Average molecular weight not greater than 400 and free
in
1,3-propanediol content not greater than 1 % (w/w)
substance.

Not more than 1 % (w/w) in total.

The quantity of the substance or group of substances in
each indent may not exceed 2 mg/dm2 of the uncoated
film.

— 1,2-polypropylene oxide [= 1,2 polypropylene-

glycol]

— Sorbitol

— Tetraethyleneglycol

— Triethyleneglycol

— Urea

2. Other additives

F i r s t c l a s s

— Acetic acid and its NH4, Ca, Mg, K and Na salts

— Ascorbic acid and its NH4, Ca, Mg, K and Na

salts

— Benzoic acid and sodium benzoate

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Denominations

Restrictions

— Formic acid and its NH4, Ca, Mg, K and Na salts

— Linear fatty acids, saturated or unsaturated, with
an even number of carbon atoms from 8 to 20
inclusive and also behenic and ricinoleic acids
and the NH4, Ca, Mg, K, Na, Al, Zn salts of
these acids

— Citric, d- and l-lactic, maleic, l-tartaric acids and

their Na and K salts

— Sorbic acid and its NH4, Ca, Mg, K and Na salts

— Amides of linear fatty acids, saturated or unsa-
turated, with an even number of carbon atoms
from 8 to 20 inclusive and also the amides of
behenic and ricinoleic acids

— Natural edible starches and flours

— Edible starches and flours modified by chemical

treatment

— Amylose

— Calcium and magnesium carbonates

and

chlorides

— Esters of glycerol with linear fatty acids, saturated
or unsaturated, with an even number of carbon
atoms from 8 to 20 inclusive and/or with adipic,
ricinoleic
citric, 12-hydroxystearic (oxystearin),
acids

— Esters of polyoxyethylene (8 to 14 oxyethylene
groups) with linear fatty acids, saturated or unsa-
turated, with an even number of carbon atoms
from 8 to 20 inclusive

— Esters of sorbitol with linear fatty acids, saturated
or unsaturated, with an even number of carbon
atoms from 8 to 20 inclusive

— Mono-and/or di-esters of stearic acid with etha-
nediol and/or bis (2-hydroxyethyl) ether and/or
triethylene glycol

— Oxides and hydroxides of aluminium, calcium,
and
silicon
calcium,
of

magnesium and
hydrated
magnesium and potassium

aluminium,

silicates

silicates

and

— Polyethylene oxide [= polyethyleneglycol]

Average molecular weight between 1 200 and 4 000.

— Sodium propionate

S e c o n d c l a s s

— Sodium alkyl (C8-C18) benzene sulphonate

— Sodium isopropyl naphthalene sulphonate

The total quantity of
the substances may not exceed
1 mg/dm2 of the uncoated film and the quantity of the
substance or group of substances in each indent may not
exceed 0,2 mg/dm2 (or a lower
limit where one is
specified) of the uncoated film.

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Denominations

Restrictions

— Sodium alkyl (C8-C18) sulphate

— Sodium alkyl (C8-C18) sulphonate

— Sodium dioctylsulphosuccinate

— Distearate of dihydroxyethyl diethylene triamine

Not more than 0,05 mg/dm2 of the uncoated film.

monoacetate

— Ammonium, magnesium and potassium lauryl

sulphates

— N,N′-distearoyl diaminoethane, N,N′-dipalmitoyl
diaminoethane and N,N′-dioleoyl diaminoethane

— 2-heptadecyl-4,4-bis(methylene-stearate)

oxazoline

— Polyethylene-aminostearamide ethylsulphate

Not more than 0,1 mg/dm2 of the uncoated film.

T h i r d c l a s s — A n c h o r i n g a g e n t

The total quantity of substances may not exceed 1 mg/dm2
of the uncoated film.

— Condensation

product

of melamine-formal-
dehyde unmodified, or which may be modified
with one or more of the following products:

butanol, diethylenetriamine, ethanol, triethylene-
tetraethylenepentamine,
tetramine,
tri-(2-hydro-
3,3′-diaminodipropylamine,
xyethyl)
amine,
4,4′-diaminodibutylamine

— Condensation product of melamine-urea-formal-
dehyde modified with tris-(2-hydroxyethyl)amine

— Cross-linked cationic polyalkyleneamines:

(a) polyamide-epichlorhydrin resin based on
epichlor-

and

diaminopropylmethylamine
hydrin;

Free formaldehyde content not greater than 0,5 mg/dm2 of
the uncoated film.
Free melamine content not greater than 0,3 mg/dm2 of the
uncoated film.

Free formaldehyde content not greater than 0,5 mg/dm2 of
the uncoated film.
Free melamine content not greater than 0,3 mg/dm2 of the
uncoated film.

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

(b) polyamide-epichlorhydrin resin based on
epichlorhydrin,
caprolactam,
adipic
diethylenetriamine and/or ethylenediamine;

acid,

(c) polyamide-epichlorhydrin resin based on
adipic acid, diethylenetriamine and epichlor-
hydrin, or a mixture of epichlorhydrin and
ammonia;

(d) polyamide-polyamine-epichlorhydrin

resin
based on epichlorhydrin, dimethyl adipate
and diethylenetriamine;

(e) polyamide-polyamine-epichlorhydrin

based on epichlorhydrin,
diaminopropylmethylamine

adipamide

resin
and

— Polyethyleneamines and polyethyleneimines

Not more than 0,75 mg/dm2 of the uncoated film.

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Denominations

Restrictions

— Condensation product of urea-formaldehyde
unmodified, or which may be modified with
one or of the following products:

Free formaldehyde content not greater than 0,5 mg/dm2 of
the uncoated film.

acid,

sulphanilic

aminomethylsulphonic
acid,
butanol, diaminobutane, diaminodiethylamine,
diaminodipropylamine, diaminopropane, diethy-
lenetriamine, ethanol, guanidine, methanol, tetra-
ethylenepentamine, triethylenetetramine, sodium
sulphite

F o u r t h c l a s s

The total quantity of substances may not exceed
0,01 mg/dm2 of the uncoated film.

— Products

resulting from the reaction of

the

amines of edible oils with polyethylene oxide

— Monoethanolamine lauryl sulphate

SECOND PART

Coated regenerated cellulose film

Denominations

Restrictions

A. Regenerated cellulose

B. Additives

C. Coating

1.

Polymers

See first part.

See first part.

total quantity of

The
exceed
50 mg/dm2 of the coating on the side in contact with
foodstuffs.

substances may not

— Ethyl, hydroxyethyl, hydroxypropyl and methyl

ethers of cellulose

— Cellulose nitrate

Not more than 20 mg/dm2 of the coating on the side in
contact with foodstuffs; nitrogen content between 10,8 %
(w/w) and 12,2 % (w/w) in the cellulose nitrate.

total quantity of

exceed
The
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.

substances may not

2.

Resins

— Casein

— Colophony and/or its products of polymeri-
zation, hydrogenation, or disproportionation
and their esters of methyl, ethyl or C2 to C6
these
polyvalent
alcohols

alcohols, or mixtures of

— Colophony and/or its products of polymeri-
zation, hydrogenation, or disproportionation
condensed with acrylic, maleic, citric, fumaric
and/or phthalic acids and/or 2,2 bis (4-hydro-
xyphenyl) propane formaldehyde and esterified
with methyl ethyl or C2 to C6 polyvalent
alcohols or mixtures of these alcohols

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Denominations

Restrictions

— Esters derived from bis(2-hydroxyethyl) ether
with addition products of betapinene and/or
and maleic
dipentene
anhydride

diterpene

and/or

— Edible gelatine

— Castor oil and its products of dehydration or
hydrogenation and its condensation products
with
citric, maleic,
polyglycerol,
phthalic and sebacic acids

adipic,

— Natural gum [= damar]

— Poly-beta-pinene [= terpenic resins]

— Urea-formaldehyde

resins

(see

anchoring

agents)

3.

Plasticisers

— Acetyl tributyl citrate

— Acetyl tri(2-ethylhexyl) citrate

— Di-isobutyl adipate

— Di-n-butyl adipate

— Di-n-hexyl azelate

— Dicyclohexyl phthalate

The total quantity of substances may not exceed 6 mg/dm2
of the coating on the side in contact with foodstuffs.

Not more than 4,0 mg/dm2 of the coating on the side in
contact with foodstuffs.

— 2-ethylhexyl diphenyl phosphate

(synonym:

phosphoric 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.

— Glycerol monoacetate [= monoacetin]

— Glycerol diacetate [= diacetin]

— Glycerol triacetate [= triacetin]

— Di-butyl sebacate

— Di-n-butyl tartrate

— Di-isobutyl tartrate

4. Other additives

4.1. A d d i t i v e s l i s t e d i n t h e f i r s t p a r t

The total quantity of substances may not exceed 6 mg/dm2
in the uncoated regenerated cellulose film, inclusive of the
coating on the side in contact with foodstuffs.

Same restrictions as in the first part (however the quantities
in mg/dm2 refer to the uncoated regenerated cellulose film,
inclusive of the coating on the side in contact with food-
stuffs).

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Denominations

Restrictions

4.2. S p e c i f i c c o a t i n g a d d i t i v e s

The quantity of the substance or group of substances in
each indent may not exceed 2 mg/dm2 (or a lower limit
where one is specified) of the coating on the side in contact
with foodstuffs.

— 1-hexadecanol and 1-octadecanol

— Esters of linear fatty acids, saturated or unsa-
turated, with an even number of carbon atoms
from 8 to 20 inclusive and of ricinoleic acid
with ethyl, butyl, amyl and oleyl linear alcohols

— Montan waxes, comprising purified montanic
(C26 to C32) acids and/or their esters with etha-
nediol and/or 1,3 butanediol and/or
their
calcium and potassium salts

— Carnauba wax

— Beeswax

— Esparto wax

— Candelilla wax

— Dimethylpolysiloxane

Not more than 1 mg/dm2 of the coating on the side in
contact with foodstuffs.

— Epoxidised soya-bean oil (oxirane content 6 to

8 %)

— Refined paraffin and microcrystalline waxes

— Pentaerythritol tetrastearate

— Mono and bis(octadecyldiethyleneoxide)-phos-

phates

— Aliphatic acids

mono- or di-(2-hydroxyethyl)amine

(C8 to C20) esterified with

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

— 2- and 3-tert.butyl-4-hydroxyanisole
[= butylated hydroxyanisole — BHA]

Not more than 0,06 mg/dm2 of the coating on the side in
contact with foodstuffs.

— 2,6-di-tert.butyl-4-methylphenol

hydroxytoluene — BHT]

[= butylated

Not more than 0,06 mg/dm2 of the coating on the side in
contact with foodstuffs.

— Di-n-octyltin-bis(2-ethylhexyl) maleate

Not more than 0,06 mg/dm2 of the coating on the side in
contact with foodstuffs.

total quantity of

exceed
The
0,6 mg/dm2 of the coating on the side in contact with
foodstuffs.

substances may not

5.

Solvents

— Butyl acetate

— Ethyl acetate

— Isobutyl acetate

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Denominations

Restrictions

— Isopropyl acetate

— Propyl acetate

— Acetone

— 1-butanol

— Ethanol

— 2-butanol

— 2-propanol

— 1-propanol

— Cyclohexane

— Ethyleneglycol monobutyl ether

— Ethyleneglycol monobutyl ether acetate

— Methyl ethyl ketone

— Methyl isobutyl ketone

— Tetrahydrofuran

— Toluene

Not more than 0,06 mg/dm2 of the coating on the side in
contact with foodstuffs.

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ANNEX III

PART A

Repealed Directive with list of its successive amendments

(referred to in Article 7)

Commission Directive 93/10/EEC

(OJ L 93, 17.4.1993, p. 27).

Commission Directive 93/111/EC

(OJ L 310, 14.12.1993, p. 41).

Commission Directive 2004/14/EC

(OJ L 27, 30.1.2004, p. 48).

PART B

List of time-limits for transposition into national law and application

(referred to in Article 7)

Directive

Time-limit for transposition

Date of application

93/10/EEC

1 January 1994

93/111/EC

2004/14/EC

—

29 July 2005

1 January 1994 (1)

1 January 1994 (2)

1 January 1995 (3)

—

29 July 2005 (4)

29 January 2006 (5)

(1) In accordance with the first indent of Article 5(1) of Directive 93/10/EEC: ‘Member States shall permit, as from 1 January 1994, the
trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs complying with this Directive.’
(2) In accordance with the second indent of Article 5(1) of Directive 93/10/EEC: ‘Member States shall prohibit, as from 1 January 1994,
the trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs and which complies with
neither this Directive nor Directive 83/229/EEC, other than film which Directive 92/15/EEC prohibits as from 1 July 1994.’

(3) In accordance with the third indent of Article 5(1) of Directive 93/10/EEC: ‘Member States shall prohibit, as from 1 January 1995, the
trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs and which does not comply with
this Directive but did comply with Directive 83/229/EEC.’

(4) In accordance with Article 2(1)(a) of Directive 2004/14/EC: ‘Member States shall apply those provisions in such a way as to 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.’

(5) In accordance with Article 2(1)(b) of Directive 2004/14/EC: ‘Member States shall apply those provisions in such a way as to prohibit
the manufacture and importation into the Community 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.’

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ANNEX IV

Correlation table

Directive 93/10/EEC

This Directive

Article 1(1) and (2)

Article 1(1) and (2)

Article 1(3), introductory wording, point (b)

Article 1(3)

Article 1a

Article 2

Article 2a

Article 3

Article 4

Article 5

Article 6

—

—

Article 7

Annex I

Annex II

Annex III

—

—

Article 2

Article 3

Article 4

Article 5

Article 6

—

—

Article 7

Article 8

Article 9

Annex I

Annex II

—

Annex III

Annex IV