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"B 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
foodstuffs
(OJ L 93, 17.4.1993, p. 27)
Amended by:
Official Journal
No page date
"M1 Commission Directive 93/111/EC of 10 December 1993 L 310 41 14.12.19931993L0010 — EN — 17.12.1993 — 001.001 — 1
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 foodstuffs
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 to materials 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 of 25 April 1993 onthe approximation of the laws of the Member States relating to materials andarticles 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 objectives of theinternal market; whereas these objectives cannot be achieved by Member
States individually; whereas, furthermore, their attainment at Community
level is already provided for by Directive 89/109/EEC;
Whereas Article 2 of Directive 89/109/EEC lays down that materials and
articles, in their finished state, must not transfer their constituents tofoodstuffs in quantities which could endanger human health or bring about anunacceptable 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, accompanied by
limits to the quantities to be used, is sufficient in principle in this specific caseto achieve the objective laid down in Article 2 of Directive 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 a preventive
measure, it is more appropriate to lay down definitively the maximumauthorized quantity of such substances in foodstuffs which have been incontact with regenerated cellulose film;
Whereas, to protect the health of the consumer, direct contact between
foodstuffs and the printed surfaces of regenerated cellulose film should be
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 ofregenerated cellulose film for materials and articles intended to come intocontact 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,!B
(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. 44.1993L0010 — EN — 17.12.1993 — 001.001 — 2
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:(a) regenerated cellulose film which, on the side intended to come into
contact with foodstuffs or which, by virtue of its purpose does come into
such contact, has a coating exceeding 50 mg/dm
2;
(b) synthetic casings of regenerated cellulose.
Article 2
1. Only those substances or groups of substances listed in Annex II may be
used for the manufacture of regenerated cellulose film and only under theconditions laid down 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 ascolouring matter (dyes 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.
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 into contact withfoodstuffs shall be accompanied by a written declaration in 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 as from 1
January 1994. They shall immediately inform the Commission thereof.
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,
— prohibit, as from 1 January 1994, the trade in and use of regenerated
cellulose film which is intended to come into contact with foodstuffs andwhich complies with neither this Directive nor Directive 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 regenerated
cellulose film which is intended to come into contact with foodstuffs and!B
!M1
!B1993L0010 — EN — 17.12.1993 — 001.001 — 3
which does not comply with this Directive but did comply 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 accompanied bysuch reference at the time of their official publication. The procedure for suchreference 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 references to
this Directive and should be read in accordance with the correlation table
appearing in Annex III.
Article 7
This Directive is addressed to the Member States.!B1993L0010 — EN — 17.12.1993 — 001.001 — 4
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, suitablesubstances may be added either in the mass or on the surface. Regenerated cellulosefilm may be coated on one or both sides.!
B1993L0010 — EN — 17.12.1993 — 001.001 — 5
ANNEX II
LIST OF SUBSTANCES AUTHORIZED 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 uncoatedregenerated 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.!
B1993L0010 — EN — 17.12.1993 — 001.001 — 6
FIRST PART
UNCOATED REGENERATED CELLULOSE FILM
Denominations Restrictions
A. Regenerated cellulose Not less than 72 % (w/w)
B. Additives
1.Softeners Not more than 27 % (w/w) in total
— Bis (2-hydroxyethyl) ether [= diethylenegly-
col])Only for films intended to be coated and then used for
foodstuffs which are not moist, i.e. which do notcontain water which is physically free at the surface.The total amount of bis(2 hydroxyethyl)ether andethanediol present in foodstuffs that have been incontact with film of this type may not exceed 30 mg/
kg of the foodstuff.9
>>>>>>>>=
>>>>>>>>;— Ethanediol [= monoethyleneglycol]
— 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 polypropyle-
neglycol]Average molecular weight not greater than 400 and
free 1,3-propanediol content not greater than 1 % (w/w) in substance
— Sorbitol
— Tetraethyleneglycol— Triethyleneglycol
— Urea
2.Other additives Not more than 1 % (w/w) in total
F i r s t c l a s s The quantity of the substance or group of substances
in each indent may not exceed 2 mg/dm
2of the
uncoated film
— Acetic acid and its NH 4, Ca, Mg, K and Na
salts
— Ascorbic acid and its NH 4, Ca, Mg, K and Na
salts
— Benzoic acid and sodium benzoate— Formic acid and its NH
4, Ca, Mg, K and Na
salts
— Linear fatty acids, saturated or unsaturated,
with an even number of carbo atoms from 8 to20 inclusive and also behenic and ricinoleicacids and the NH
4, 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 NH 4, Ca, Mg, K and Na
salts
— Amides of linear fatty acids, saturated or
unsaturated, with an even number of carbonatoms from 8 to 20 inclusive and also theamides of behenic and ricinoleic acids
— Natural edible starches and flours!
B1993L0010 — EN — 17.12.1993 — 001.001 — 7
Denominations Restrictions
— 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 inclusive and/or
with adipic, citric, 12-hydroxystearic (oxy-stearin), ricinoleic acids
— Esters of polyoxyethylene (8 to 14 oxyethy-
lene groups) with linear fatty acids, saturated
or unsaturated, 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 numberof carton atoms from 8 to 20 inclusive
— Mono-and/or di-esters of stearic acid with
ethanediol and/or bis (2-hydroxyethyl) etherand/or triethylene glycol
— Oxides and hydroxides of aluminium, cal-
cium, 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 propionate
S e c o n d c l a s s The total quantity of the substances may not exceed 1
mg/dm
2of the uncoated film and the quantity of the
substance or group of substances in each indent maynot exceed 0,2 mg/dm
2(or a lower limit where one is
specified) of the uncoated film
— Sodium alkyl (C 8to C 18) benzene sulphonate
— Sodium isopropyl naphthalene sulphonate— Sodium alkyl (C
8-C18) sulphate
— Sodium alkyl (C 8-C18) sulphonate
— Sodium dioctylsulphosuccinate— Distearate of dihydroxyethyl diethylene tria-
mine monoacetateNot more than 0,05 mg/dm
2of the uncoated film
— Ammonium, magnesium and potassium lauryl
sulphates
—N , N ’-distearoyl diaminoethane, N,N ’-dipalmi-
toyl diaminoethane and N,N ’-dioleoyl diami-
noethane
— 2-heptadecyl—4,4-bis (methylene-stearate)
oxazoline
— Polyethylene-aminostearamide ethylsulphate Not more than 0,1 mg/dm2of the uncoated film!B1993L0010 — EN — 17.12.1993 — 001.001 — 8
Denominations Restrictions
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/
dm2of the uncoated film
— Condensation product of melamine-formalde-
hyde unmodified, or which may be modified
with one or more of the following products:
butanol, diethylenetriamine, ethanol, triethy-
lenetetramine, tetraethylenepentamine, tri-(2-
hydroxyethyl) amine, 3,3 ’-diaminodipropyla-
mine, 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-for-
maldehyde modified with tris-(2-hydro-
xyethyl)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 film
— Cross-linked cationic polyalkyleneamines:
(a) polyamide-epichlorhydrin resin based on
diaminopropylmethylamine and epichlor-
hydrin
(b) polyamide-epichlorhydrin resin based on
epichlorhydrin, adipic acid, caprolactam,
diethylenetriamine and/or ethylenedia-
mine
(c) polyamide-epichlorhydrin resin based on
adipic acid, diethylenetriamine and epi-
chlorhydrin, or a mixture of epichlorhy-
drin and ammonia
(d) polyamide-polyamine-epichlorhydrin re-
sin based on epichlorhydrin, dimethyl
adipate and diethylenetriamine
(e) polyamide-polyamine-epichlorhydrin re-
sin based on epichlorhydrin, adipamide
and diaminopropylmethylamineIn accordance with Community directives and in their
absence, with national legislation, pending the adop-tion of Community directives
— Polyethyleneamines and polyethyleneimines Not more than 0,75 mg/dm
2of the uncoated film
— Condensation product of urea-formaldehyde
unmodified, or which may be modified with
one or of the following products:
aminomethylsulphonic acid, sulphanilic acid,
butanol, diaminobutane, diaminodiethyla-
mine, diaminodipropylamine, diaminopro-
pane, diethylenetriamine, ethanol, guanidine,methanol, tetraethylenepentamine, triethyle-netetramine, sodium sulphiteFree formaldehyde content not greater than 0,5 mg/
dm
2of the uncoated film
Fo u r t h c l a s s The total quantity of substances may not exceed 0,01
mg/dm2of the uncoated film
— Products resulting from the reaction of the
amines of edible oils with polyethylene oxide
— Monoethanolamine lauryl sulphate!B1993L0010 — EN — 17.12.1993 — 001.001 — 9
SECOND PART
COATED REGENERATED CELLULOSE FILM
Denominations Restrictions
A. Regenerated cellulose See first part
B. Additives See first part
C. Coating Not more than 50 mg of coating/dm2of film on the
side in contact with foodstuffs
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 between 10,8% (w/w) and 12,2 % (w/w) in the cellulose nitrate
— Polymers, copolymers and their mixtures
made with the following monomers:
vinyl acetals derived from saturated aldehydes
(C
1to C 6)
vinyl acetate
alkyl (C 1to C 4) vinyl ethers
acrylic, crotonic, itaconic, maleic, methacry-
lic acids and their esters
butadiene
styrenemethylstyrene
vinylidene chloride
acrylonitrilemethacrylonitrile
ethylene, propylene, 1- and 2-butyleneIn accordance with Community directives, and, in
their absence, with national legislation pending theadoption of Community directives9
>>>>>>>>>>>>>>>>>>>>>>>>>>>>=
>>>>>>>>>>>>>>>>>>>>>>>>>>>>;
vinyl chloride According to Directive 78/142/EEC
(OJ No L 44, 15. 2. 1978, p. 15)
2.Resins The total quantity of substances may not exceed 12,5
mg/dm
2of the coating on the side in contact with
foodstuffs and solely for the preparation of regener-ated cellulose films with cellulose nitrate or vinylchloride and vinyl acetate copolymer based coatings
— Casein
— Colophony and/or its products of polymeriza-
tion, hydrogenation, or disproportionation andtheir esters of methyl, ethyl or C
2to C 6
polyvalent alcohols, or mixtures of thesealcohols
— Colophony and/or its products of polymeriza-
tion, hydrogenation, or disproportionationcondensed with acrylic, maleic, citric, fumaricand/or phthalic acids and/or 2,2 bis (4-hydroxyphenyl) propane formaldehyde and
esterified with methyl ethyl or C
2to C 6
polyvalent alcohols or mixtures of these
alcohols
— Esters derived from bis(2-hydroxyethyl) ether
with addition products of betapinene and/ordipentene and/or diterpene and maleic anhy-
dride
— Edible gelatine— Castor oil and its products of dehydration or
hydrogenation and its condensation products
with polyglycerol, adipic, citric, maleic,
phthalic and sebacic acids!
B1993L0010 — EN — 17.12.1993 — 001.001 — 10
Denominations Restrictions
— Natural gum [= damar]
— Poly-beta-pinene [= terpenic resins]
— Urea-formaldehyde resins (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— Butylbenzylphthalate Not more than 2,0 mg/dm
2of the coating on the side
in contact with foodstuffs
— Di-n-butyl phthalate Not more than 3,0 mg/dm2of the coating on the side
in contact with foodstuffs
— Dicyclohexyl phthalate Not more than 4,0 mg/dm2of the coating on the side
in contact with foodstuffs
— 2-ethylhexyl diphenyl phosphate Not more than 2,5 mg/dm2of the coating on the side
in contact with foodstuffs
— Glycerol monoacetate [= monoacetin]
— Glycerol diacetate [= diacetin]
— Glycerol triacetate [= triacetin]— Di-butyl sebacate— Di (2-ethylhexal) sebacate [= dioctylsebacate]
— Di-n-butyl tartrate
— Di-isobutyl tartrate
4.Other additives 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 withfoodstuffs
4.1. Additives listed in the first part Same restrictions as in the first part (however the
quantities in mg/dm
2refer to the uncoated regenerated
cellulose film, inclusive of the coating on the side in
contact with foodstuffs)
4.2. Specific coating additives: 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 sidein contact with foodstuffs
— 1-hexadecanol and 1-octadecanol
— Esters of linear fatty acids, saturated or
unsaturated, with an even number of carbonatoms from 8 to 20 inclusive and of ricinoleic
acid with ethyl, butyl, amyl and oleyl linear
alcohols
— Montan waxes, comprising purified montanic
(C
26to C 32) acids and/or their esters with
ethanediol and/or 1,3 butanediol and/or theircalcium and potassium salts
— Carnauba wax
— Beeswax!
B1993L0010 — EN — 17.12.1993 — 001.001 — 11
Denominations Restrictions
— Esparto wax
— Candelilla wax
— Dimethylpolysiloxane Not more than 1 mg/dm2of 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(octadecyldiethyleneoxide)-
phosphatesNot more than 0,2 mg/dm
2of the coating on the side
in contact with foodstuffs
— Aliphatic acids (C 8to C 20) 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-methylphenol [= butylated
hydroxytoluene — BHT]Not more than 0,06 mg/dm2of the coating on the side
in contact with foodstuffs
— Di-n-octyltin-bis(2-ethylhexyl)
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 monobutyl ether— Ethyleneglycol monobutyl ether acetate
— Ethyleneglycol monoethyl ether
— Ethyleneglycol monoethyl ether acetate— Ethyleneglycol monomethyl ether
— Ethyleneglycol monomethyl ether acetate
— Methyl ethyl ketone— Methyl isobutyl ketone— Tetrahydrofuran
— Toluene Not more than 0,06 mg/dm
2of the coating on the side
in contact with foodstuffs.!B1993L0010 — EN — 17.12.1993 — 001.001 — 12
ANNEX III
CORRELATION TABLE
Directive 83/229/EEC Present Directive
Article 1 Article 1
Article 2 Article 2Article 3 Article 3
Article — Article 4
Article 4 (1) Article 5Article 4 (2) Article —
Article — Article 6
Article 5 Article 7!
B1993L0010 — EN — 17.12.1993 — 001.001 — 13