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Regulation 6(3)

SCHEDULE 1SUBSTANCES PERMITTED FOR USE IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM

PART ISubstances Permitted For Use In The Manufacture Of Uncoated Regenerated Cellulose Film

Column 1Column 2
SubstancesConditions and restrictions

1.  Regenerated cellulose

Not less than 72%

2.  Additives

SoftenersNot more than 27% in total

— 1,3-butanediol

— glycerol

— 1,2-propanediol [=1,2-propylene glycol]

— polyethylene oxide [=polyethylene glycol]Average molecular weight between 250 and 1,200

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

— sorbitol

— triethylene glycol

— urea

Average molecular weight shall not exceed 400, free 1,3-propanediol content shall not exceed 1%
Other additivesNot more than 1% in total
First classThe quantity of the substance or group of substances in each entry shall not exceed 2 mg/dm2

— 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 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, dl-lactic, maleic, 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 unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and also the amides of behenic acid and ricinoleic acid

— 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, citric, 12-hydroxystearic (oxystearin) and ricinoleic acid

— esters of polyoxyethylene (8—14 oxyethylene 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 number of carbon atoms from 8 to 20 inclusive

— 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 [=polyethylene glycol]

Average molecular weight between 1,200 and 4,000
— sodium propionate
Second classNot more than 1 mg/dm2 in total; the quantity of the substance or group of substances in each entry shall not exceed 0.2 mg/dm2 (or a lower limit where one is specified)

— sodium alkyl (C8 to C18) benzene sulphonate

— sodium isopropyl naphthalene sulphonate

— sodium alkyl (C8 to C18) sulphate

— sodium alkyl (C8 to C18) sulphonate

— sodium dioctylsulphosuccinate

— distearate of dihydroxyethyldiethylene-triamine monoacetate

Not more than 0.05 mg/dm2 in total on the side for contact with food

— ammonium, magnesium and potassium lauryl sulphates

— N,N'-distearoyl diaminoethane [=N,N'-distearoyl ethylenediamine] and N,N'-dipalmitoyl diaminoethane [=N,N'-dipalmitoyl ethylenediamine] and N,N'-dioleoyl diaminoethane [=N,N'-dioleoyl ethylenediamine]-2-heptadecyl-4,4'-bis-(methylenestearate) oxazoline

— polyethylene aminostearamide ethyl sulphate

Not more than 0.1 mg/dm2 in total on the side for contact with food
Third class—Anchoring AgentsNot more than 1 mg/dm2 in total

— condensation product of melamine-formaldehyde unmodified, or modified with one or more of the following products:

  • butanol, diethylenetriamine, ethanol, triethylenetetramine, tetraethylenepentamine, tris(2-hydroxyethyl)amine, 3,3'-diaminodipropylamine, 4,4'-diaminodibutylamine

Free formaldehyde content on the side for contact with food shall not exceed 0.5 mg/dm2; free melamine content on the side for contact with food shall not exceed 0.3 mg/dm2
— condensation product of melamine-urea-formaldehyde modified with tris(2-hydroxyethyl)amineFree formaldehyde content on the side for contact with food shall not exceed 0.5 mg/dm2; free melamine content on the side for contact with food shall not exceed 0.3 mg/dm2

— cross-linked cationic polyalkyleneamines:

(a)

olyamide-epichlorohydrin resin based on diaminopropylmethylamine and epichlorohydrin

(b)

olyamide-epichlorohydrin resin based on epichlorohydrin, adipic acid, caprolactam, diethylenetriamine and/or ethylenediamine

(c)

olyamide-epichlorohydrin resin based on adipic acid, diethylenetriamine and epichlorohydrin, or a mixture of epichlorohydrin and ammonia

(d)

olyamide-polyamine-epichlorohydrin resin based on epichlorohydrin, dimethyl adipate and diethylenetriamine

(e)

olyamide-polyamine-epichlorohydrin resin based on epichlorohydrin, adipamide and diaminopropylmethylamine

— polyethyleneamines and polyethyleneiminesNot more than 0.75 mg/dm2 in total

— condensation product of urea-formaldehyde unmodified, or modified with one or more of the following products:

  • aminomethyl sulphonic acid, sulphanilic acid, butanol, diaminobutane, diaminodipropylamine, diaminopropane, diethylenetriamine, ethanol, guanidine, methanol, tetraethylenepentamine, triethylenetetramine, sodium sulphite

Free formaldehyde content on the side for contact with food shall not exceed 0.5 mg/dm2
Fourth classNot more than 0.01 mg/dm2 in total

— products resulting from the reaction of the amines of edible oils with polyethylene oxide

— monoethanolamine lauryl sulphate

3.  Adhesives and colourants

In accordance with regulation 6(4)

PART IISubstances Permitted For Use In The Manufacture Of Coated Regenerated Cellulose Film

Column 1Column 2
SubstancesConditions and restrictions
(1)

All percentages specified in this Schedule are by weight and are to be calculated in relation to the total quantity of anhydrous regenerated cellulose film.

(2)

Substances named or described in this Schedule shall be of good commercial quality.

1.  Regenerated cellulose

For that part of the film other than the coating

Not less than 72%

2.  Additives

For that part of the film other than the coating
SoftenersNot more than 27% in total

(a)Any softener specified in item 2 of Part I

Any condition or restriction specified in relation to that additive

(b)bis(2-hydroxyethyl)ether }

  • [=diethylene glycol] — ethanediol [=monoethylene glycol] }

In accordance with regulation 6(5)
Other additivesNot more than 1% in total
Any other additive specified in item 2 of Part IAny condition or restriction specified in relation to that additive

3.  Coating substances

Polymers

— ethyl, hydroxyethyl, hydroxypropyl and methyl ethers of cellulose

— cellulose nitrateNot more than 20 mg/dm2 on the side for contact with food; nitrogen content between 10.8 and 12.2%

— 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 chlorideIn accordance with regulation 5
ResinsNot more than 12.5 mg/dm2 in total on the side for contact with food and solely for the preparation of regenerated cellulose films with coatings based on nitrocellulose or polymers or copolymers of vinyl chloride and vinyl acetate

— casein

— colophony and/or its products of polymerization, hydrogenation, or disproportionation, and their esters of methyl, ethyl or C2 to C6 polyhydric alcohols, or mixtures of these alcohols

— colophony and/or its products of polymerization, hydrogenation, or disproportionation, condensed with acrylic, maleic, citric, fumaric and/or phthalic acid and/or bisphenol formaldehyde and esterified with methyl, ethyl or C2 to C6 polyhydric alcohols or mixtures of these alcohols

— esters derived from bis-(2-hydroxyethyl) ether with addition products of β-pinene and/or dipentene and/or diterpene and maleic anhydride

— edible gelatine

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

— natural gum [=damar]

— poly-β-pinene [=terpenic resins]

— urea-formaldehyde resin (see Anchoring agents in item 2 of Part I)

PlasticisersNot more than 12.5 mg/dm2 in total on the side for contact with food and, except as specified below, solely for the preparation of regenerated cellulose films with coatings based on nitrocellulose or polymers or copolymers of vinyl chloride and vinyl acetate

— di-isobutyl and di-n-butyl adipate

— di-n-hexyl azelate

— butyl benzyl phthalate

— butyl methylcarboxybutyl phthalate [=butylphthalyl butyl glycolate]

— di-n-butyl phthalate and di-isobutyl phthalate

— dicyclohexyl phthalate

— di(methylcyclohexyl) phthalate and its isomers [=sextolphthalate]

— 2-ethylhexyl diphenyl phosphateNot more than 2.5 mg/dm2 on the side for contact with food

— glycerol monoacetate [=monoacetin]

— glycerol diacetate [=diacetin]

— glycerol triacetate [=triacetin]

— methylmethylcarboxyethyl phthalate [=methylphthalyl ethyl glycolate]

— bis(2-ethylhexyl) sebacate [=dioctyl sebacate]

— dibutyl sebacate

— di-n-butyl tartrate and di-isobutyl tartrate

— tributyl acetyl citrate

— tris(2-ethylhexyl) acetyl citrate

Also for the preparation of regenerated cellulose films with coatings based on vinylidene chloride provided that they bear a distinctive indication that the film coating is based on vinylidene chloride and contains tributyl acetyl citrate or tris-(2-ethylhexyl) acetyl citrate, as the case may be
Other coating additivesNot more than 6 mg/dm2 in total on the side for contact with food

(a)Any additive specified in item 2 of Part I

Any condition or restriction specified in relation to that additive

(b)Specific coating additives

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

— hexadecan-1-ol and octadecan-1-ol

— 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 oleoyl linear alcohols

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

— carnauba wax

— beeswax

— esparto wax

— candelilla wax

— dimethylpolysiloxaneNot more than 1 mg/dm2 on the side for contact with food

— epoxidized soya-bean oil (oxirane content 6 to 8%)

— refined paraffin and microcrystalline waxes

— pentaerythritol tetrastearate

— mono-and bis(octadecyldiethyleneoxide) phosphates

Not more than 0.2 mg/dm2 on the side for contact with food
— aliphatic acids (C8 to C20) esterified with mono-or bis(2-hydroxyethyl) amine
— 2-and 3—tert. butyl-4-hydroxyanisole [=butylated hydroxyanisole-BHA]Not more than 0.06 mg/dm2 on the side for contact with food
— 2,6-di—tert. butyl-4-methylphenol [=butylated hydroxytoluene-BHT]Not more than 0.06 mg/dm2 on the side for contact with food
— di-n-octyltin-bis(2-ethylhexyl) maleateNot more than 0.06 mg/dm2 on the side for contact with food

4.  Solvents for coating substances

Total quantity of all solvents may not exceed 0.6 mg/dm2 on the side for contact with food

— n-butyl acetate

— ethyl acetate

— isobutyl acetate

— isopropyl acetate

— propyl acetate

— butan-l-ol [=butyl alcohol]

— ethanol [=ethyl alcohol]

— butan-2-ol [=isobutyl alcohol]

— propan-2-ol [=isopropyl alcohol]

— propan-1-ol [=propyl alcohol]

— cyclohexane

— ethanediol monobutyl ether [=ethylene glycol monobutyl ether]

— ethanediol monobutyl ether acetate [=ethylene glycol monobutyl ether acetate]

— ethanediol monoethyl ether [=ethylene glycol monoethyl ether]

— ethanediol monoethyl ether acetate [=ethylene glycol monoethyl ether acetate]

— ethanediol monomethyl ether [=ethylene glycol monomethyl ether]

— ethanediol monomethyl ether acetate [=ethylene glycol monomethyl ether acetate]

— acetone

— butanone [=methyl ethyl ketone]

— 4-methylpentan-2-one [=methyl isobutyl ketone]

— tetrahydrofuran

— toluene

5.  Adhesives and colourants

In accordance with regulation 6(4)