{
  "url": "https://openlegislation.uk/eu-directive-2007-42/annex-II",
  "json_url": "https://openlegislation.uk/eu-directive-2007-42/annex-II.json",
  "legislation": "eudr/2007/42",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2007-42",
  "path": "annex/II",
  "kind": "annex",
  "number": "II",
  "heading": "LIST OF SUBSTANCES AUTHORISED IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM",
  "text": "FIRST PART\nUncoated regenerated cellulose film\nDenominations\nRestrictions\nA.\nRegenerated cellulose\nNot less than 72 % (w/w)\nB. Additives\n1.\nSofteners\nNot more than 27 % (w/w) in total\n—\nBis (2-hydroxyethyl) ether [= diethyleneglycol]\nOnly 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 ethanediol present in foodstuffs that have been in contact with film of this type may not exceed 30 mg/kg of the foodstuff.\n—\nEthanediol [= monoethyleneglycol]\n—\n1,3-butanediol\n—\nGlycerol\n—\n1,2-propanediol [= 1,2 propyleneglycol]\n—\nPolyethylene oxide [= polyethyleneglycol]\nAverage molecular weight between 250 and 1 200.\n—\n1,2-polypropylene oxide [= 1,2 polypropyleneglycol]\nAverage molecular weight not greater than 400 and free 1,3-propanediol content not greater than 1 % (w/w) in substance.\n—\nSorbitol\n—\nTetraethyleneglycol\n—\nTriethyleneglycol\n—\nUrea\n2.\nOther additives\nNot more than 1 % (w/w) in total.\nFirst class\nThe quantity of the substance or group of substances in each indent may not exceed 2 mg/dm2 of the uncoated film.\n—\nAcetic acid and its NH4, Ca, Mg, K and Na salts\n—\nAscorbic acid and its NH4, Ca, Mg, K and Na salts\n—\nBenzoic acid and sodium benzoate\n—\nFormic acid and its NH4, Ca, Mg, K and Na salts\n—\nLinear 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\n—\nCitric, d- and l-lactic, maleic, l-tartaric acids and their Na and K salts\n—\nSorbic acid and its NH4, Ca, Mg, K and Na salts\n—\nAmides 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 and ricinoleic acids\n—\nNatural edible starches and flours\n—\nEdible starches and flours modified by chemical treatment\n—\nAmylose\n—\nCalcium and magnesium carbonates and chlorides\n—\nEsters 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), ricinoleic acids\n—\nEsters of polyoxyethylene (8 to 14 oxyethylene groups) with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive\n—\nEsters of sorbitol with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive\n—\nMono-and/or di-esters of stearic acid with ethanediol and/or bis (2-hydroxyethyl) ether and/or triethylene glycol\n—\nOxides and hydroxides of aluminium, calcium, magnesium and silicon and silicates and hydrated silicates of aluminium, calcium, magnesium and potassium\n—\nPolyethylene oxide [= polyethyleneglycol]\nAverage molecular weight between 1 200 and 4 000.\n—\nSodium propionate\nSecond class\nThe 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.\n—\nSodium alkyl (C8-C18) benzene sulphonate\n—\nSodium isopropyl naphthalene sulphonate\n—\nSodium alkyl (C8-C18) sulphate\n—\nSodium alkyl (C8-C18) sulphonate\n—\nSodium dioctylsulphosuccinate\n—\nDistearate of dihydroxyethyl diethylene triamine monoacetate\nNot more than 0,05 mg/dm2 of the uncoated film.\n—\nAmmonium, magnesium and potassium lauryl sulphates\n—\nN,N′-distearoyl diaminoethane, N,N′-dipalmitoyl diaminoethane and N,N′-dioleoyl diaminoethane\n—\n2-heptadecyl-4,4-bis(methylene-stearate) oxazoline\n—\nPolyethylene-aminostearamide ethylsulphate\nNot more than 0,1 mg/dm2 of the uncoated film.\nThird class — Anchoring agent\nThe total quantity of substances may not exceed 1 mg/dm2 of the uncoated film.\n—\nCondensation product of melamine-formaldehyde unmodified, or which may be modified with one or more of the following products:\nbutanol, diethylenetriamine, ethanol, triethylenetetramine, tetraethylenepentamine, tri-(2-hydroxyethyl) amine, 3,3′-diaminodipropylamine, 4,4′-diaminodibutylamine\nFree formaldehyde content not greater than 0,5 mg/dm2 of the uncoated film.\nFree melamine content not greater than 0,3 mg/dm2 of the uncoated film.\n—\nCondensation product of melamine-urea-formaldehyde modified with tris-(2-hydroxyethyl)amine\nFree formaldehyde content not greater than 0,5 mg/dm2 of the uncoated film.\nFree melamine content not greater than 0,3 mg/dm2 of the uncoated film.\n—\nCross-linked cationic polyalkyleneamines:\n(a) polyamide-epichlorhydrin resin based on diaminopropylmethylamine and epichlorhydrin;\n(b) polyamide-epichlorhydrin resin based on epichlorhydrin, adipic acid, caprolactam, diethylenetriamine and/or ethylenediamine;\n(c) polyamide-epichlorhydrin resin based on adipic acid, diethylenetriamine and epichlorhydrin, or a mixture of epichlorhydrin and ammonia;\n(d) polyamide-polyamine-epichlorhydrin resin based on epichlorhydrin, dimethyl adipate and diethylenetriamine;\n(e) polyamide-polyamine-epichlorhydrin resin based on epichlorhydrin, adipamide and diaminopropylmethylamine\nIn accordance with Community directives and in their absence, with national legislation, pending the adoption of Community directives.\n—\nPolyethyleneamines and polyethyleneimines\nNot more than 0,75 mg/dm2 of the uncoated film.\n—\nCondensation product of urea-formaldehyde unmodified, or which may be modified with one or of the following products:\naminomethylsulphonic acid, sulphanilic acid, butanol, diaminobutane, diaminodiethylamine, diaminodipropylamine, diaminopropane, diethylenetriamine, ethanol, guanidine, methanol, tetraethylenepentamine, triethylenetetramine, sodium sulphite\nFree formaldehyde content not greater than 0,5 mg/dm2 of the uncoated film.\nFourth class\nThe total quantity of substances may not exceed 0,01 mg/dm2 of the uncoated film.\n—\nProducts resulting from the reaction of the amines of edible oils with polyethylene oxide\n—\nMonoethanolamine lauryl sulphate\nSECOND PART\nCoated regenerated cellulose film\nDenominations\nRestrictions\nA.\nRegenerated cellulose\nSee first part.\nB.\nAdditives\nSee first part.\nC. Coating\n1.\nPolymers\nThe total quantity of substances may not exceed 50 mg/dm2 of the coating on the side in contact with foodstuffs.\n—\nEthyl, hydroxyethyl, hydroxypropyl and methyl ethers of cellulose\n—\nCellulose nitrate\nNot 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.\n2.\nResins\nThe total quantity of 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.\n—\nCasein\n—\nColophony and/or its products of polymerization, hydrogenation, or disproportionation and their esters of methyl, ethyl or C2 to C6 polyvalent alcohols, or mixtures of these alcohols\n—\nColophony and/or its products of polymerization, 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 methyl ethyl or C2 to C6 polyvalent alcohols or mixtures of these alcohols\n—\nEsters derived from bis(2-hydroxyethyl) ether with addition products of betapinene and/or dipentene and/or diterpene and maleic anhydride\n—\nEdible gelatine\n—\nCastor oil and its products of dehydration or hydrogenation and its condensation products with polyglycerol, adipic, citric, maleic, phthalic and sebacic acids\n—\nNatural gum [= damar]\n—\nPoly-beta-pinene [= terpenic resins]\n—\nUrea-formaldehyde resins (see anchoring agents)\n3.\nPlasticisers\nThe total quantity of substances may not exceed 6 mg/dm2 of the coating on the side in contact with foodstuffs.\n—\nAcetyl tributyl citrate\n—\nAcetyl tri(2-ethylhexyl) citrate\n—\nDi-isobutyl adipate\n—\nDi-n-butyl adipate\n—\nDi-n-hexyl azelate\n—\nDicyclohexyl phthalate\nNot more than 4,0 mg/dm2 of the coating on the side in contact with foodstuffs.\n—\n2-ethylhexyl diphenyl phosphate (synonym: phosphoric acid diphenyl 2 ethylhexyl ester)\nThe amount of 2-ethylhexyl diphenyl phosphate shall not exceed:\n(a) 2,4 mg/kg of the foodstuff in contact with this type of film; or\n(b) 0,4 mg/dm2 in the coating on the side in contact with foodstuffs.\n—\nGlycerol monoacetate [= monoacetin]\n—\nGlycerol diacetate [= diacetin]\n—\nGlycerol triacetate [= triacetin]\n—\nDi-butyl sebacate\n—\nDi-n-butyl tartrate\n—\nDi-isobutyl tartrate\n4.\nOther additives\nThe 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.\n4.1.\nAdditives listed in the first part\nSame 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 foodstuffs).\n4.2.\nSpecific coating additives\nThe 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.\n—\n1-hexadecanol and 1-octadecanol\n—\nEsters 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 alcohols\n—\nMontan 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\n—\nCarnauba wax\n—\nBeeswax\n—\nEsparto wax\n—\nCandelilla wax\n—\nDimethylpolysiloxane\nNot more than 1 mg/dm2 of the coating on the side in contact with foodstuffs.\n—\nEpoxidised soya-bean oil (oxirane content 6 to 8 %)\n—\nRefined paraffin and microcrystalline waxes\n—\nPentaerythritol tetrastearate\n—\nMono and bis(octadecyldiethyleneoxide)-phosphates\nNot more than 0,2 mg/dm2 of the coating on the side in contact with foodstuffs.\n—\nAliphatic acids (C8 to C20) esterified with mono- or di-(2-hydroxyethyl)amine\n—\n2- and 3-tert.butyl-4-hydroxyanisole [= butylated hydroxyanisole — BHA]\nNot more than 0,06 mg/dm2 of the coating on the side in contact with foodstuffs.\n—\n2,6-di-tert.butyl-4-methylphenol [= butylated hydroxytoluene — BHT]\nNot more than 0,06 mg/dm2 of the coating on the side in contact with foodstuffs.\n—\nDi-n-octyltin-bis(2-ethylhexyl) maleate\nNot more than 0,06 mg/dm2 of the coating on the side in contact with foodstuffs.\n5.\nSolvents\nThe total quantity of substances may not exceed 0,6 mg/dm2 of the coating on the side in contact with foodstuffs.\n—\nButyl acetate\n—\nEthyl acetate\n—\nIsobutyl acetate\n—\nIsopropyl acetate\n—\nPropyl acetate\n—\nAcetone\n—\n1-butanol\n—\nEthanol\n—\n2-butanol\n—\n2-propanol\n—\n1-propanol\n—\nCyclohexane\n—\nEthyleneglycol monobutyl ether\n—\nEthyleneglycol monobutyl ether acetate\n—\nMethyl ethyl ketone\n—\nMethyl isobutyl ketone\n—\nTetrahydrofuran\n—\nToluene\nNot more than 0,06 mg/dm2 of the coating on the side in contact with foodstuffs.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2007/42/annex/II",
    "retrieved_at": "2026-11-01T15:22:26.860896+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}