1993L0010 — EN — 19.02.2004 — 002.001 — 1
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►B COMMISSIONDIRECTIVE93/10/EEC
of15March1993
relatingtomaterialsandarticlesmadeofregeneratedcellulosefilmintendedtocomeintocontact
withfoodstuffs
(OJ L 93, 17.4.1993, p. 27)
Amended by:
Official Journal
No page date
►M1Commission Directive 93/111/EC of 10 December 1993 L 310 41 14.12.1993
►M2Commission Directive 2004/14/EC of 29 January 2004 L 27 48 30.1.2004
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COMMISSIONDIRECTIVE93/10/EEC
of15March1993
relatingtomaterialsandarticlesmadeofregeneratedcellulosefilm
intendedtocomeintocontactwithfoodstuffs
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community,
Having regard to Council Directive 89/109/EEC of 21 December 1988
on the approximation of the laws of the Member States relating tomaterials and articles intended to come into contact with foodstuffs (
1),
and in particular Article 3 thereof,
After consulting the Scientific Committee for Food,
Whereas the number and nature of the changes that have had to be
made and should now be made to Council Directive 83/229/EEC of25 April 1993 on the approximation of the laws of the Member States
relating to materials and articles made of regenerated cellulose film
intended to come into contact with foodstuffs(
2), as last amended by
Commission Directive 92/15/EEC (3), indicate the need for the said
Directive to be replaced;
Whereas the Community measures envisaged by this Directive are not
only necessary but also indispensable for the attainment of the objec-
tives of the internal market; whereas these objectives cannot beachieved by Member States individually; whereas, furthermore, theirattainment at Community level is already provided for by Directive89/109/EEC;
Whereas Article 2 of Directive 89/109/EEC lays down that materials
and articles, in their finished state, must not transfer their constituentsto foodstuffs in quantities which could endanger human health or bringabout an unacceptable change in the composition of the foodstuffs;
Whereas, in order to achieve this objective in the case of regenerated
cellulose film, the suitable instrument is a specific directive within the
meaning of Article 3 of Directive 89/109/EEC;
Whereas synthetic casings of regenerated cellulose should be the
subject of specific provisions;
Whereas the method for determining the absence of migration of
colouring matters should be established at a later stage;
Whereas, until criteria of purity and methods of analysis have been
drawn up, national provisions should remain in force;
Whereas the establishment of a list of approved substances, accompa-
nied by limits to the quantities to be used, is sufficient in principle inthis specific case to achieve the objective laid down in Article 2 ofDirective 89/109/EEC;
Whereas, however, the bis(2-hydroxyethyl)ether (= diethyleneglycol)
and ethanediol (= monoethyleneglycol), can migrate extensively to
certain foodstuffs and therefore in order to avoid this possibility, as apreventive measure, it is more appropriate to lay down definitively themaximum authorized quantity of such substances in foodstuffs whichhave been in contact with regenerated cellulose film;
Whereas, to protect the health of the consumer, direct contact between
foodstuffs and the printed surfaces of regenerated cellulose film shouldbe avoided;
Whereas the written declaration referred to in Article 6 (5) of Directive
89/109/EEC should be provided for in the event of professional use of1993L0010 — EN — 19.02.2004 — 002.001 — 2
(1) OJ No L 40, 11. 2. 1989, p. 38.
(2) OJ No L 123, 11. 5. 1983, p. 31.
(3) OJ No L 102, 16. 4. 1992, p. 44.
▼B
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;
Whereas the measures provided for in this Directive are in accordance
with the opinion of the Standing Committee on Foodstuffs,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive is a specific directive within the meaning of
Article 3 of Directive 89/109/EEC.
2. This Directive shall apply to regenerated cellulose film within the
meaning of the description given in Annex I which either:
(a) constitutes a finished product in itself; or
(b) forms part of a finished product containing other materials,
and which is intended to come into contact with foodstuffs or which,
by virtue of its purpose, does come into such contact.
3. This Directive does not apply to:
(b) synthetic casings of regenerated cellulose.
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 cellu-
lose;
or
(c) coated regenerated cellulose film with coating consisting of plas-
tics.
Article 2
1. Regenerated cellulose films referred to in points (a) and (b) of
Article 1a shall be manufactured using only substances or groups ofsubstances 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 are
employed as colouring matter (dyes and pigments) or as adhesives,
provided that there is no trace of migration of the substances into oronto foodstuffs, detectable by a validated method.
Article 2a
1. Regenerated cellulose film referred to in Article 1a(c) shall be
manufactured, prior to coating, using only substances or groups ofsubstances listed in the first part of Annex II, subject to the restrictionsset out therein.
2. The coating to be applied to the regenerated cellulose film
referred to in paragraph 1 shall be manufactured using only substancesor groups of substances listed in Annexes II to VI to Directive 2002/72/EC, subject to the restrictions set out therein.1993L0010 — EN — 19.02.2004 — 002.001 — 3
▼M2
▼B
▼M2
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▼M2
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▼M2
▼M2
3. Without prejudice to paragraph 1, materials and articles made of
regenerated cellulose film referred to in Article 1a(c) shall comply withArticles 2, 7 and 8 of Directive 2002/72/EC.
Article 3
Printed surfaces of regenerated cellulose film shall not come into
contact with the foodstuffs.
Article 4
1. At the marketing stages other than the retail stages, materials and
articles made of regenerated cellulose film intended to come intocontact with foodstuffs shall be accompanied by a written declarationin accordance with Article 6 (5) of Directive 89/109/EEC.
2. Paragraph 1 does not apply to materials and articles made of
regenerated cellulose film which by their nature are clearly intended
to come into contact with foodstuffs.
3. Where special conditions of use are indicated, the material or
article made of regenerated cellulose film shall be labelled accordingly.
Article 5
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive asfrom 1 January 1994. They shall immediately inform the Commissionthereof.
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 food-stuffs complying with this Directive,
— prohibit, as from 1 January 1994, the trade in and use of regener-
ated cellulose film which is intended to come into contact withfoodstuffs and which complies with neither this Directive norDirective 83/229/EEC, other than film which Directive 92/15/EEC
prohibits as from 1 July 1994,
— prohibit, as from 1 January 1995, the trade in and use of regener-
ated cellulose film which is intended to come into contact withfoodstuffs and which does not comply with this Directive but didcomply with Directive 83/229/EEC.
2. When Member States adopt the measures referred to in paragraph
1, these shall contain a reference to this Directive or shall be accompa-nied by such reference at the time of their official publication. The
procedure for such reference shall be adopted by Member States.
Article 6
1. Directive 83/229/EEC is hereby repealed as from 1 January 1994.
2. References to Directive 83/229/EEC shall be construed as refer-
ences to this Directive and should be read in accordance with thecorrelation table appearing in Annex III.
Article 7
This Directive is addressed to the Member States.1993L0010 — EN — 19.02.2004 — 002.001 — 4
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▼M1
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ANNEX I
DESCRIPTIONOFREGENERATEDCELLULOSEFILM
Regenerated cellulose film is a thin sheet material obtained from a refined cellu-
lose derived from unrecycled wood or cotton. To meet technical requirements,
suitable substances may be added either in the mass or on the surface. Regener-
ated cellulose film may be coated on one or both sides.1993L0010 — EN — 19.02.2004 — 002.001 — 5
▼B
ANNEX II
LIST OF SUBSTANCES AUTHORIZEDIN THE MANUFACTURE OF
REGENERATEDCELLULOSEFILM
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 anhy-
drous 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
UNCOATEDREGENERATEDCELLULOSEFILM
Denominations Restrictions
A. Regeneratedcellulose Not less than 72 % (w/w)
B. Additives
1.Softeners Not more than 27 % (w/w) in total
— Bis (2-hydroxyethyl) ether
[= diethyleneglycol])Only for films intended to be coated
and then used for foodstuffs which
are not moist, i.e. which do not
contain water which is physicallyfree 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./C148/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C150— Ethanediol [= monoethyle-
neglycol]
— 1,3-butanediol
— Glycerol
— 1,2-propanediol [= 1,2
propyleneglycol]
— Polyethylene oxide [=
polyethyleneglycol]Average molecular weight between
250 and 1 200
— 1,2-polypropylene oxide [=
1,2 polypropyleneglycol]Average molecular weight not
greater than 400 and free 1,3-propa-
nediol content not greater than 1 %
(w/w) in substance
— Sorbitol
— Tetraethyleneglycol
— Triethyleneglycol
— Urea
2.Otheradditives Not more than 1 % (w/w) in total
First class The quantity of the substance or
groupof substances in each indent
may not exceed 2 mg/dm
2of the
uncoated film
— 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
— Formic acid and its NH4,
Ca, Mg, K and Na salts1993L0010 — EN — 19.02.2004 — 002.001 — 6
▼B
Denominations Restrictions
— Linear fatty acids, satu-
rated or unsaturated, with
an even number of carbo
atoms from 8 to 20 inclu-
sive 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 unsatu-
rated, with an even number
of carbon atoms from 8 to
20 inclusive and also the
amides of behenic and rici-
noleic acids
— Natural edible starches and
flours
— Edible starches and flours
modified by chemical
treatment
— Amylose— Calcium and magnesium
carbonates and chlorides
— Esters of glycrol with
linear fatty acids, saturated
or unsaturated, with an
even number of carbon
atoms from 8 to 20 inclu-
sive and/or with adipic,
citric, 12-hydroxystearic
(oxystearin), ricinoleic
acids
— Esters of polyoxyethylene
(8 to 14 oxyethylene
groups) with linear fatty
acids, saturated or unsatu-
rated, 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 carton
atoms from 8 to 20 inclu-
sive
— Mono-and/or di-esters of
stearic acid with ethanediol
and/or bis (2-hydroxyethyl)
ether and/or triethylene
glycol
— Oxides and hydroxides of
aluminium, calcium,
magnesium and silicon
and silicates and hydrated
silicates of aluminium,
calcium, magnesium and
potassium
— Polyethylene oxide [=
polyethyleneglycol]Average molecular weight between
1 200 and 4 000
— Sodium propionate1993L0010 — EN — 19.02.2004 — 002.001 — 7
▼B
Denominations Restrictions
Second class The total quantity of the substances
may not exceed 1 mg/dm2of the
uncoated film and the quantity of
the substance or groupof substances
in each indent may not exceed 0,2
mg/dm2(or a lower limit where one
is specified) of the uncoated film
— Sodium alkyl (C8to C18)
benzene sulphonate
— Sodium isopropyl naphtha-
lene sulphonate
— Sodium alkyl (C8-C18)
sulphate
— Sodium alkyl (C8-C18)
sulphonate
— Sodium dioctylsulphosuc-
cinate
— Distearate of dihydrox-
yethyl diethylene triamine
monoacetateNot more than 0,05 mg/dm2of the
uncoated film
— Ammonium, magnesium
and potassium lauryl
sulphates
— N,N ′-distearoyl diami-
noethane, N,N ′-dipalmitoyl
diaminoethane and N,N ′-
dioleoyl diaminoethane
— 2-heptadecyl—4,4-
bis(methylene-stearate)
oxazoline
— Polyethylene-aminosteara-
mide ethylsulphateNot more than 0,1 mg/dm2of the
uncoated film
Third class — Anchoring
agentThe total quantity of substances may
not exceed 1 mg/dm2of the uncoated
film
— Condensation product of
melamine-formaldehyde
unmodified, or which may
be modified with one or
more of the following
products:
butanol, diethylenetria-
mine, ethanol, triethylene-
tetramine, tetraethylene-
pentamine, tri-(2-
hydroxyethyl) amine, 3,3 ′-
diaminodipropylamine,
4,4′-diaminodibutylamineFree formaldehyde content not
greater than 0,5 mg/dm2of the
uncoated film
Free melamine content not greater
than 0,3 mg/dm2of the uncoated
film
— Condensation product of
melamine-urea-formalde-
hyde modified with tris-(2-
hydroxyethyl)amineFree formaldehyde content not
greater than 0,5 mg/dm2of the
uncoated film.
Free melamine content not greater
than 0,3 mg/dm2of the uncoated
film1993L0010 — EN — 19.02.2004 — 002.001 — 8
▼B
Denominations Restrictions
— Cross-linked cationic poly-
alkyleneamines:
(a) polyamide-epichlorhy-
drin resin based on
diaminopropylmethyla-
mine and epichlorhy-
drin
(b) polyamide-epichlorhy-
drin resin based on
epichlorhydrin, adipic
acid, caprolactam,
diethylenetriamine
and/or ethylenediamine
(c) polyamide-epichlorhy-
drin resin based on
adipic acid, diethylene-
triamine and epichlor-
hydrin, or a mixture of
epichlorhydrin and
ammonia
(d) polyamide-polyamine-
epichlorhydrin resin
based on epichlorhy-
drin, dimethyl adipate
and diethylenetriamine
(e) polyamide-polyamine-
epichlorhydrin resin
based on epichlorhy-
drin, adipamide and
diaminopropylmethyla-
mineIn accordance with Community
directives and in their absence, with
national legislation, pending the
adoption of Community directives
— Polyethyleneamines and
polyethyleneiminesNot more than 0,75 mg/dm2of the
uncoated film
— Condensation product of
urea-formaldehyde unmo-
dified, or which may be
modified with one or of
the following products:
aminomethylsulphonic
acid, sulphanilic acid,
butanol, diaminobutane,
diaminodiethylamine,diaminodipropylamine,
diaminopropane, diethyle-
netriamine, ethanol, guani-
dine, methanol,
tetraethylenepentamine,
triethylenetetramine,
sodium sulphiteFree formaldehyde content not
greater than 0,5 mg/dm
2of the
uncoated film
Fourth class The total quantity of substances may
not exceed 0,01 mg/dm2of the
uncoated film
— Products resulting from the
reaction of the amines ofedible oils with polyethy-
lene oxide
— Monoethanolamine lauryl
sulphate1993L0010 — EN — 19.02.2004 — 002.001 — 9
▼B
SECOND PART
COATEDREGENERATEDCELLULOSEFILM
Denominations Restrictions
A. Regeneratedcellulose See first part
B. Additives See first part
C. Coating ►M2 ◄
1.Polymers The total quantity of substances may
not exceed 50 mg/dm2of the coating
on the side in contact with foodstuffs
— Ethyl, hydroxyethyl,
hydroxypropyl and methyl
ethers of cellulose
— Cellulose nitrate Not more than 20 mg/dm2of the
coating on the side in contact with
foodstuffs; nitrogen content between10,8 % (w/w) and 12,2 % (w/w) in
the cellulose nitrate
2.Resins The total quantity of substances may
not exceed 12,5 mg/dm2of the
coating on the side in contact with
foodstuffs and solely for the prepara-
tion of regenerated cellulose films
with cellulose nitrate based coatings
— Casein
— Colophony and/or its
products of polymeriza-
tion, hydrogenation, or
disproportionation and
their esters of methyl,
ethyl or C2to C6polyva-
lent alcohols, or mixtures
of these alcohols
— Colophony and/or its
products of polymeriza-
tion, hydrogenation, or
disproportionation
condensed with acrylic,
maleic, citric, fumaric and/
or phthalic acids and/or 2,2
bis (4-hydroxyphenyl)
propane formaldehyde and
esterified with methylethyl or C
2to C6polyva-
lent alcohols or mixtures
of these alcohols
— Esters derived from bis(2-
hydroxyethyl) ether with
addition products of beta-pinene and/or dipentene
and/or diterpene and
maleic anhydride
— Edible gelatine— Castor oil and its products
of dehydration or hydroge-
nation and its condensation
products with polyglycerol,
adipic, citric, maleic,
phthalic and sebacic acids
— Natural gum [= damar]
— Poly-beta-pinene [=
terpenic resins]
— Urea-formaldehyde resins1993L0010 — EN — 19.02.2004 — 002.001 — 10
▼M2
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Denominations Restrictions
(see anchoring agents)
3.Plasticizers The total quantity of substances may
not exceed 6 mg/dm2of the coating
on the side in contact with foodstuffs
— Acetyl tributyl citrate— Acetyl tri(2-ethylhexyl)
citrate
— Di-isobutyl adipate— Di-n-butyl adipate— Di-n-hexyl azelate
— Dicyclohexyl phthalate Not more than 4,0 mg/dm2of the
coating on the side in contact with
foodstuffs
— 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/dm2in the coating on the
side in contact with foodstuffs
— Glycerol monoacetate [=
monoacetin]
— Glycerol diacetate [=
diacetin]
— Glycerol triacetate [= tria-
cetin]
— Di-butyl sebacate
— Di-n-butyl tartrate— Di-isobutyl tartrate
4.Otheradditives The total quantity of substances may
not exceed 6 mg/dm
2in the uncoated
regenerated cellulose film, inclusive
of the coating on the side in contact
with foodstuffs
4.1.Additives listed in the first
partSame restrictions as in the first part
(however the quantities in mg/dm2
refer to the uncoated regeneratedcellulose film, inclusive of the coating
on the side in contact with foodstuffs)
4.2.Specific coatingadditives: The quantity of the substance or
groupof substances in each indent
may not exceed 2 mg/dm
2(or a lower
limit where one is specified) of the
coating on the side in contact with
foodstuffs
— 1-hexadecanol and 1-octa-
decanol
— Esters of linear fatty acids,
saturated or unsaturated,
with an even number of
carbon atoms from 8 to 20
inclusive and of ricinoleic
acid with ethyl, butyl,
amyl and oleyl linear alco-
hols1993L0010 — EN — 19.02.2004 — 002.001 — 11
▼M2
▼B
▼M2
▼B
▼M2
▼B
▼B
Denominations Restrictions
— Montan waxes, comprising
purified montanic (C26to
C32) acids and/or their
esters with ethanediol and/
or 1,3 butanediol and/or
their calcium and potas-
sium salts
— Carnauba wax— Beeswax— Esparto wax— Candelilla wax— Dimethylpolysiloxane Not more than 1 mg/dm
2of the
coating on the side in contact with
foodstuffs
— Epoxidized soya-bean oil
(oxirane content 6 to 8 %)
— Refined paraffin and
microcrystalline waxes
— Pentaerythritol tetrastearate— Mono and bis(octadecyl-
diethyleneoxide)-phos-
phatesNot more than 0,2 mg/dm
2of the
coating on the side in contact with
foodstuffs
— Aliphatic acids (C8to C20)
esterified with mono- or
di-(2-hydroxyethyl)amine
— 2- and 3-tert.butyl-4-
hydroxyanisole [= buty-
lated hydroxyanisole —
BHA]Not more than 0,06 mg/dm2of the
coating on the side in contact with
foodstuffs
— 2,6-di-tert.butyl-4-methyl-
phenol [= butylated hydro-
xytoluene — BHT]Not more than 0,06 mg/dm2of the
coating on the side in contact with
foodstuffs
— Di-n-octyltin-bis(2-ethyl-
hexyl) maleateNot more than 0,06 mg/dm2of the
coating on the side in contact with
foodstuffs
5.Solvents The total quantity of substances may
not exceed 0,6 mg/dm2of the coating
on the side in contact with foodstuffs
— Butyl acetate— Ethyl acetate— Isobutyl acetate— Isopropyl acetate— Propyl acetate— Acetone— 1-butanol
— Ethanol
— 2-butanol— 2-propanol— 1-propanol— Cyclohexane
— Ethyleneglycol mono-
methyl ether
— Ethyleneglycol mono-
methyl ether acetate
— Methyl ethyl ketone1993L0010 — EN — 19.02.2004 — 002.001 — 12
▼M2
▼B
▼B
Denominations Restrictions
— Methyl isobutyl ketone
— Tetrahydrofuran
— Toluene Not more than 0,06 mg/dm2of the
coating on the side in contact with
foodstuffs.1993L0010 — EN — 19.02.2004 — 002.001 — 13
▼B
ANNEX III
CORRELATIONTABLE
Directive 83/229/EEC Present Directive
Article 1 Article 1
Article 2 Article 2
Article 3 Article 3
Article — Article 4
Article 4 (1) Article 5
Article 4 (2) Article —
Article — Article 6
Article 5 Article 71993L0010 — EN — 19.02.2004 — 002.001 — 14