360-english

Federal Institute for Risk Assessment
This is an unofficial translation. Only the German version is binding.
XXXVI. Paper and board for food contact

As of 01.06.2007

Preamble

1. This Recommendation is valid for single and multi-layered commodities (articles, materials)
made of paper or paperboard which are intended to come into contact with or affect food-stuffs. 2. This Recommendation does not appy to paper and board for use in microwave ovens. 3. In a composite, multi-layered or coated material, if the layer which comes into contact with the foodstuff is made of paper or paperboard it must comply with this Recommendation. Also, except for traces that are harmless to health and have no effect on taste or smell of the foodstuff, there must be no migration of substances from other layers into foodstuffs or on their surface. 4. If plastics or other polymers are used to coat paper or paperboard on the side that will come into contact with the foodstuff, only substances in compliance with the corresponding BfR Recommendations and the conditions stipulated therein may be used. 5. Paper or filter layers that will be subject, for example, to hot extraction (tea bags, boil-in-bag packages, hot filter papers), and paper that will come into contact with and affect food in baking, must comply with the special requirements laid down in Recommendation XXXVI/1 "Cooking paper, hot filter papers and filter layers" and Recommendation XXXVI/2 "Paper and paperboard for baking purposes". 6. Methods for testing commodities (articles and materials) made of paper or paperboard are published in a continuously up-dated loose-leaf edition by the German Pulp and Paper Association (Verband Deutscher Papierfabriken e. V. - VDP), Bonn, under the title "Unter-suchung von Papieren, Kartons und Pappen für den Lebensmittelkontakt", Erich Goltze Verlag, Göttingen. 7. To the extent that this and the Recommendations mentioned above under 4. restrict the use of certain production aids and refining agents, the maximum quantities given, if not applied to surface area or otherwise stated, refer to the dry finished product. 8. If in the production of a certain paper or paperboard a particular production aid, on account of its wide spectrum of use, is listed more than once in the Recommendation, the largest maximum amount given is to be taken as the “in total” maximum. Adding the different maximum amounts together is not permissible. 9. The finished paper must not contain more than 0.15 mg/kg pentachlorophenol. 10. It is assumed that under normal conditions of use there is no transfer of metal ions to food- stuffs when their concentration (determined in cold water extract) does not exceed A µg per gram paper, whereby “A“ has the following values: cadmium, 0.5, lead, 3 and mercury, 0.3 µg per gram paper. Testing is not necessary for paper or paperboard intended for Federal Institute for Risk Assessment

11. Azo dyes after Annex 1, No. 7 (§ 3) of the Commodities Regulation (Bedarfsgegenstände- verordnung), must not be used in the manufacture of food-contact paper or paper board1. 12. The finished paper or paperboard must have no preserving effect on the foodstuffs with 13. Paper and board may contain Diisopropylnaphthalene (DIPN) as a consequence of the use of recycled fibres as raw material. DIPN is used as a solvent in carbonless copy paper. Such paper may be contained in recovered paper. A transfer of DIPN to foodstuffs may take place by direct contact or via the gas phase. The DIPN content in paper and board must be as low as technologically possible in order to minimise its transfer to foodstuffs. Experiments have shown that fat-containing foodstuffs and foodstuffs with a large surface like rice, pasta with egg, chocolate-coated biscuits, nut biscuits, egg biscuits, breakfast cereals containing chocolate or nuts, baking mixtures, and cocoa can take up DIPN in especially high proportions. Therefore, in the packaging of such foods with paper and board manufactured from recy-cled fibres, special precautionary measures should be taken, e.g. by the use of additional intermediate packagings. There are no objections to the use of paper or paperboard in the manufacture of commodities
in the sense of § 2, Para. 6, No. 1 of the Food and Feed Code (Lebensmittel- und Futtermittel-
gesetzbuch (LFGB)), provided they are suitable for their intended purpose and comply also with
the following conditions:
A. Raw materials

The following raw materials may be used:
I. Fibrous materials:

1. Natural and synthetic cellulose fibres, bleached or unbleached.
2. Fibres of synthetic high polymers, provided they comply with the corresponding BfR
3. Wood pulp, bleached or unbleached. 4. Recycled fibres from the manufacture and processing of paper or paperboard3 and from returned paper3, provided that the products manufactured from these fibres comply with the requirements of this Recommendation. For contact with dry, non-fatty foodstuffs (e.g. flour, semolina, rice, sugar, salt, peas, lentils and the like) and with foodstuffs that are normally washed and/or peeled before being eaten (e.g. fruit, vegetables), other raw materials may also be used as a source of fibre, provided that the requirements of this Recommendation are otherwise complied with4. 1 Detecting the use of prohibited azo dyes according to "Amtliche Sammlung von Untersuchungsverfahren nach 2 DIN EN 1104: “Determination of the transfer of antimicrobial constituents” 3 Only rejects from manufacturing and processing, or recycled paper of equivalent quality, may be used. The sorts of paper that are suitable are listed in "Wiedergewinnung von Papierfasern; Beschreibung des Verfahrens" publis-hed by the German Pulp and Paper Association (Verband Deutscher Papierfabriken e. V. - VDP) in its loose-leaf collection, "Untersuchung von Papieren, Kartons und Pappen für den Lebensmittelkontakt", Erich Goltze Verlag, Göttingen. 4 What must not be used are sort A 00 in the German Pulp and Paper Association’s "Liste der Deutschen Standard- sorten und ihre Qualitäten", and paper and paperboard from sorting plants for general or mixed component waste. Federal Institute for Risk Assessment

II. Additives to raw materials

1. Anthraquinone as an accelerator for separating lignin and cellulose from wood pulp,
max. 0.15 %, based on the finished paper. 1 kg of dry paper must not contain more than 30 mg anthraquinone5. 2. Xylanase6. 3. Diethylene triamine pentamethylene phosphonic acid, max. 0.22 %, based on dry 4. Potassium sulfite, max. 0.01 %.
5. Tetrasodium iminodisuccinate, max. 0.17 %, based on dry fibres weight.
III. Fillers:

Natural and synthetically produced, insoluble minerals that are harmless to health, such as
carbonates of calcium and magnesium, silicon dioxide, silicates, or mixed silicates of sodium,
potassium, magnesium, calcium, aluminium and iron, calcium sulfate, calcium sulfoaluminate
(satin white), barium sulfate (free of soluble barium compounds), titanium oxide.
B. Production aids

The following production aids may be used:
I. Sizing agents:

1. Colophony, addition products of maleic and fumaric acid and/or of formaldehyde with colo-
phony. No more than 1.0 mg formaldehyde/ dm2 must be detectable in the extract of the finished product. 2. Casein and glue of animal origin 3. Starch7 Native8 starch, physically modified starch, enzymatically modified starch and acid-treated starch, as well as the chemically modified starches listed in Annex 2, List B, Part I of the Regulation on Food Additives (Zusatzstoff-Verkehrsverordnung) Bleached starch, also treated with sodium, potassium or ammonium peroxy- disulfate, as well as with peroxyacetic acid and/or hydrogen peroxide Oxidatively degraded starch, also treated with hydrogen peroxide, sodium, potassium or ammonium peroxydisulfate, including dialdehyde starch produced from oxidised starch with an aldehyde content of at least 90 %9 Monostarch phosphate, also treated with ammonium phosphate or orthophos-phoric acid in the presence of urea Starch acetate, also treated with vinyl acetate (specification of starch: 5 Most of the anthraquinone is washed out during manufacture. 6 There must be no detectable residual activity of this enzyme in the finished product. 7 The general and specific purity requirements after Annex 2, List A, Part II of the Regulation on Food Additives 8 Native food starch is a carbohydrate polymer consisting almost entirely of alpha-D-glucose units. It occurs in granular form in the organs of certain plants, from which it is extracted. 9 See method for analysing tobacco additives, "Bestimmung der Dialdehydeinheiten in Oxi- bzw. Dialdehydstärke" in Bundesgesundheitsbl. 8 (1965) 110.
Federal Institute for Risk Assessment

Treated with propylene oxide to produce neutral starch ethers (specification of starch: propylene chlorohydrin, max. 1 mg/kg; degree of substitution (DS), max. 0.2). Treated with monochloroacetate to produce anionic starch ethers (specification of starch: sodium glycolate, max. 0.4 %; degree of substitution, max. 0.08). Treated with 3-chloro-2-hydroxypropyl trimethyl ammonium chloride or glycidyl trimethyl ammonium chloride (specification of starch: epichlorohydrin, max. 1 mg/kg; nitrogen, max. 4.0 %). Treated with 3-chloro-2-hydroxypropyl trimethyl ammonium chloride and succinic anhydride (specification of starch: epichlorohydrin, max. 1 mg/kg; nitrogen, max. 1.6 %). Starch, crosslinked with epichlorohydrine and treated with 3-chloro-2-hydroxypropyl trimethyl ammonium chloride (specification of starch: epichloro-hydrin, max. 1mg/kg; nitrogen, max. 0.5 %). Monostarch phosphate, treated with 3-chloro-2-hydroxypropyl trimethyl ammo-nium chloride (specification of starch: epichlorohydrin, max. 1 mg/kg; nitrogen, max. 0.5 %). 4. Cellulose ether 5. Sodium salt of carboxymethyl cellulose, technically pure10 6. Alginates7, xanthan gum7, mannogalactanes7 7. Galactomannane ethers Carboxymethylgalactomannane, residual content in sodium glycolate Galactomannane, treated with 3-chloro-2-hydroxypropyl-trimethylammonium chloride or glycidyl-trimethylammonium chloride (specification: epichlorohydrine max.1 mg/kg, nitrogen max. 4.0 %) 8. Water-glass and alumina gel 9. Dispersions of wax and paraffin, provided the waxes and paraffins comply with amended Recommendation XXV, Part I11, in total max. 2.0 %. 10. Plastics dispersions, provided they comply with amended Recommendation XIV. In addition, N-[3-(dimethylamino) propyl] methacrylic amide and 2-(N,N,N-trimethyl-ammonium)ethylmethacrylat chloride may also be used as a monomer. 11. Reemulsifiable polyvinyl chloride, provided it complies with amended Recommendation II12. 12. Di-alkyl(C10-C22)diketenes, which can contain up to 65 % isoalkyl groups, max. 1.0 % 13. Condensation products of melamine, formaldehyde and ω-aminocaproic acid, max. 1.0 %. No more than1.0 mg formaldehyde/dm2 must be detectable in the extract of the finished product. 14. Sodium and ammonium salts of copolymers of maleic acid monoisopropyl hemiester (approx. 29 %), acrylic acid (approx. 16 %) and styrene (approx. 59 %), in total, max. 0.5 %, based on weight of the dry paper. 15. A mixture consisting of the ammonium salt of a copolymer of styrene and maleic acid anhydride (50 : 50) with a copolymer of acrylic acid n-butyl ester and acrylonitrile (70 : 30) in the ratio of 1 : 2, max. 0.6 %, based on weight of the dry paper. 16. Ammonium salt of a copolymer of maleic acid anhydride, maleic acid monoisopropyl ester and diisobutylene, max. 0.5 %, based on weight of the dry paper. 17. Ammonium salt of a copolymer of styrene (approx. 60 %), acrylic acid (approx. 23 %) and maleic acid (approx. 17 %), max. 0.5 %, based on weight of the dry paper. 10 The Sodium glycolate content may not exceed 12 %. 11 Recommendation XXV. " Hard paraffins, microcrystalline waxes and mixtures of these with waxes, resins and 12 Recommendation II. "Plasticizer-free polyvinyl chloride ." Federal Institute for Risk Assessment

18. Di-sodium salt of a copolymer of styrene (approx. 50 %) and maleic acid (approx. 50 %), max. 0.7 %, based on weight of the dry paper. 19. Cationic, water-soluble polyurethane, cross-linked with epichlorohydrin13, made from glycerol monostearate, toluylene diisocyanate and N-methyl diethanol amine (mean mol. wt. 100 000), max. 0.6 %, based on the dry fibres weight Cationic, water-soluble polyurethanes, made from glycerol monostearate, toluylene diisocy-anate and N-methyl diethanol amine (mean mol. wt. 10 000), max. 0.15 %, based on the fi-bres weight or Anionic, water-soluble polyurethanes, made from glycerol monostearate, toluylene diisocy-anate, dimethylol propionic acid and N-methyl diethanol amine (mean mol. wt. 10 000), max. 0.15 %, based on the dry fibres weight. In producing the aforementioned polyurethanes, in each case a maximum of 0.03 % dibutyl tin diacetate, based on the sizing agent, may be used; 1 dm2 of sized paper must not con-tain more than 0.3 µg dibutyl tin diacetate. Primary aromatic amines must not be detectable in extract of the finished product.14 As preservative for the aforementioned polyurethanes, max. 0.5 % formaldehyde, based on the sizing agent, may be used. 20. Copolymer of maleic acid and dicyclopentadiene (ammonium salt), max. 2.0 mg/dm2. 21. 3-Alkenyl(C15-C21)-dihydrofuran-2,5-dione, max. 1.0 %. 22. Cereal flour 1. treated with acids 2. treated with monochloroacetic acid to produce anionic cereal flour ethers (specification: sodium glycolate, max. 0.4 %; degree of substitution, max. 0.08) 3. treated with glycidyl trimethyl ammonium chloride (specification: epichlorohydrin, 23. Copolymer of acrylamide and acrylic acid, cross-linked with N-methylene-bis(acrylamide), 24. Copolymer of acrylamide, 2-[(methacryloyloxy)ethyl]trimethyl ammonium chloride, N,N'-methylene bisacrylamide and itaconic acid, max. 1.0 %, based on the dry fibres weight. 25. Copolymer of acrylamide, 2-[(methacryloyloxy)ethyl]trimethyl ammonium chloride, N,N'-methylene bisacrylamide, itaconic acid and glyoxal, max. 1.0 %, based on the dry fibres weight. 26. Addition product of fumaric acid with colophony, cross-linked with triethanol amine, max. 4.0 %, based on the dry fibres weight. 27. Hydroxyethyl starch 28. Anhydrides of natural fatty acids, max. 0.2 %, based on the dry fibres weight As emulsifier for the sizing agents, max. 0.02 % sodium-2-stearoyllactylate may be used. II. Precipitating, fixing and parchmentisation agents:
1. Aluminium salts such as aluminium sulfate, aluminium chloride hydroxide, aluminium 13 No ethyleneimine must be detectable in the resin (detection limit 0.1 mg/kg). 1,3-Dichloro-2-propanol must not be detectable in water extract of the finished product (detection limit 2 µg/l). The transfer of 3-monochloro-1,2-propanediol into the water extract of the finished products must be as low as technically achievable, a limit of 12 µg/l must not be exceeded in any case. For compliance with the requirement in respect to chloropropanols, a transitional period has been granted until the 31.03.2002. 14 On the determination of primary aromatic amines in aqueous extracts see: Amtliche Sammlung von Unter- suchungsverfahren nach § 64 LFGB, Method L. No. 00.00-6, "Untersuchung von Lebensmitteln - Bestimmung von primären aromatischen Aminen in wäßrigen Prüflebensmitteln". Federal Institute for Risk Assessment

2. Sulfuric acid 3. Ammonia 4. Sodium carbonate, sodium hydrogen carbonate, sodium phosphate 5. Tannin 6. Condensation products of urea, dicyandiamide, melamine with formaldehyde. Extract of the finished products must contain no more than 1.0 mg formaldehyde per dm2 (compare C I 2 and 3) 7. Condensation products of aromatic sulfonic acids with formaldehyde, max. 1.0 %. Extract of the finished products must contain no more than 1.0 mg formaldehyde per dm2 (compare B V 7) 8. Sodium salts of ethylenediamine tetraacetic acid and diethylenetriamine pentaacetic acid and N-(2-Hydroxyethyl)ethylenediamine-triacetic acid 9. Gluconic acid 10. Vinylformamide-vinylamine copolymer, max. 0.4 % 11. Polycondensate of dicyandiamide and diethylenetriamine, max. 0.45 % 12. Polyethyleneimine, modified with polyethyleneglycol and epichlorohydrin, max. 0.2 % 13. Choline and its salts 14. Copolymer of vinylformamide, vinylamine and acrylic acid, max. 1 %, based on the dry fi- III. Retention agents:
a) Acrylamide b) Acrylic acid c) 3-(N,N,N-Trimethylammonium)propylacrylamide, chloride d) 2-(N,N,N-Trimethylammonium)ethylacrylate, chloride e) 2-(N,N,N-Trimethylammonium)ethylmethacrylate, chloride f) 2-(N,N-Dimethyl-N-benzylammonium)ethylacrylate, chloride max. 0.1 %, provided that the polymers contain no more than 0.1 % monomeric acrylamide and 0.5 % of the monomers listed under b) - f). 2. Polyethyleneimine, max. 0.5 %15 (compare B. IV. l and B. V. 10). 3. Cross-linked, cationic polyalkylene amines14 (compare C. I. 4) i.e.: in total max. 4.0 %: a) Polyamine-epichlorohydrin resin, produced from epichlorohydrin and diaminopropyl- b) Polyamide-epichlorohydrin resin, produced from epichlorohydrin, adipic acid, capro- lac- tam, diethylenetriamine and/or ethylenediamine13 c) Polyamide-epichlorohydrin resin, produced from adipic acid, diethylenetriamine and epichlorohydrin or a mixture of epichlorohydrin with ammonia13 d) Polyamide-polyamine-epichlorohydrin resin, produced from epichlorohydrin, adipic acid d) Polyamide-polyamine-dichloroethane resin, produced from dichloroethane and an amide of adipic acid, caprolactam and diethylenetriamine f) Polyamide-epichlorohydrin resin, produced from epichlorohydrin, diethylenetriamine, adipic acid and ethyleneimine13, max. 0.5 % g) Polyamide-epichlorohydrin resin, produced from adipic acid, diethylenetriamine and a mixture of epichlorohydrin and dimethylamine13, max. 0.2 % 15 This production aid becomes firmly attached to the cellulose fibre. However, if under certain conditions of use, significant amounts of it, or its conversion products, may migrate out of the paper, appropriate testing instructions will be published at a future date. Federal Institute for Risk Assessment

h) Polyamide-epichlorohydrin resin, produced from polyepichlorohydrin, diethylenetriamine and a mixture of epichlorohydrin and dimethylamine13, max. 0.2 % i) Polyamide-epichlorohydrin resin, produced from epichlorohydrin, diethylenetriamine, adipic acid, ethyleneimine and polyethyleneglycol13, max. 0.2 % j) Polyamide-polyamine-epichlorohydrin resin, produced from epichlorohydrin, adipic acid dimethyl ester, glutaric acid dimethyl ester and diethylenetriamine13, max. 2.0 % k) Polyamide-polyamine-dichloroethane resin, produced from adipic acid, diethylenetriamine l) Polyamide-polyamine-dichloroethane resin, produced from adipic acid, diethylenetriamine, and a mixture of ethylenediamine, diethylenetriamine, triethylenetetramine, tetraethylene-pentamine, pentaethylenehexamine, aminomethylpiperazine and 1,2-dichloroethane, m Polyamine-dichloroethane resin, produced from bis-(3-aminopropyl)-methylamine and n) Polyamideamine-polyetheramine-epichlorohydrin resin, produced from diethylenetri- amine, caprolactam, adipic acid, polyethyleneglycol and epichlorohydrin13, max. 0.2 % o) Polyamidoamine-ethyleneimine resin, produced from adipic acid, a mixture of ethyl- enediamine and N-(2-aminoethyl)-1,3-propylenediamine, N,N’-[bis-(3-aminopropyl)]-1,2-ethylenediamine, ethyleneimine, epichlorohydrin and polyethyleneglycol13, max. 0.2 % 4. High-molecular, cationic polyamide amine, produced from triethylenetetramine and adipic acid with a content of 15 % diethyleneglycol monomethyl ether (as diluting agent) or a mix-ture of 70 parts of this polyamide amine solution with 30 parts of sulfatised sperm oil, in each case no more than 0.2 % (calculated as polyamide amine in dry the fibre). Polyamide-epichlorohydrin resin, produced from adipic acid, diethylenetriamine and a mixture of epichlorohydrin and dimethylamine13, max. 0.05 %, linear, high-molecular polyethylene oxide, max. 0.015 % and a condensation product of xylene sulfonic acid, dihydroxydiphenylsulfone and form aldehyde (sodium and ammonium salt), max. 0.1 % Polyamide-epichlorohydrin resin, produced from adipic acid, diethylenetriamine and a mixture of epichlorohydrin and dimethylamine13, max. 0.05 %, linear, high-molecular polyethylene oxide, max. 0.015 % and a condensation product of β-naphtholsulfonic acid, phenol and formaldehyde as sodium salt, max. 0.06 % The limits given above under a) and b) for individual components are based on dry fibres weight of the particular paper. 6. Reaction product of polyacrylamide with formaldehyde and dimethylamine16, max. 0.06 %, based on weight of the dry paper. Extract of the finished products must not contain more than 1.0 mg formaldehyde per dm2. 7. Copolymer of dimethylamine and epichlorohydrin13, max. 0.25 % 8. Copolymer of dimethylamine ethylenediamine and epichlorohydrin13, max. 3 % 9. Homopolymers and copolymers of vinylformamide and vinylamine, max. 0.2 % 10. Copolymer of acrylamide and diallyldimethyl ammonium chloride, max. 0.02 %, based on 11. Polydimethyldiallyl ammonium chloride, max. 0.15 % 16 Dimethylamine must not be detectable in the aqueous extract (detection limit: 0.002 mg/dm2). Residual monomeric acrylamide, based on the reaction product of polyacrylamide with formaldehyde and dimethylamine, must not exceed 0.1 %. Federal Institute for Risk Assessment

IV. Dewatering accelerators:
1. Polyethyleneimine, max. 0.5 %15 (compare B. III. 2 and B. V. 10). 2. Alkyl-aryl sulfonates, max. 1.0 %17. 3. Silicone-containing paraffin dispersions, provided that the silicones and paraffins comply with amended Recommendations XV18 and XXV, Part I11, max. 0.5 % (based on dispersion dry substance) 4. Lignosulfonic acid, as well as its calcium, magnesium, sodium and ammonium salts, in total, 5. Cellulase6 6. Water-glass, stabilised with 0.42 % sodium tetraborate, based on the formulation. V. Dispersion and flotation agents:
1. Polyvinylpyrrolidone (mol. wt. min. 11 000) 2. Alkyl (C10-C20) sulfonates 3. Alkyl-aryl sulfonates (compare B. IV. 2) 4. Alkali salts of mainly linear-condensed polyphosphates. The content of cyclic-condensed 5. Alkyl polyglycol ether and/or alkylphenol polyglycol ether with 6-12 ethylene oxide groups 6. Sulfonated castor oil 7. Condensation products of aromatic sulfonic acids with formaldehyde. Extract of the finished products must contain no more than 1.0 mg formaldehyde per dm2 (compare B. II. 7) 8. Lignosulfonic acid, as well as its calcium, magnesium, sodium and ammonium salts 9. Sodium lauryl sulfate Of the production aids listed under 1. - 9. up to 1 % of each may be used, but in total no more than 3.0 %. 10. Polyethyleneimine, max. 0.5 %15 (compare B. III. 2 and B. IV. l) 11. Polymer of acrylic acid, sodium salt, max. 0.5 % 12. Alkyl (C13) polyglycol ether with 5-7 ethylene oxide groups and 1-2 terminal propylene oxide 13. Citric acid 14. 1,2-Dihydroxy-C12-C14-alkyloxethylates , max. 1.0 %, based on the dry fibres weight 15. 2-Amino-2-methyl-1-propanol; no more than 0.25 mg/dm² must be detectable in extract of 16. 2-Phosphonobutane-1,2,4-tricarboxylic acid, max. 0.01 %, based on the dry fibres weight.
17. Polyaspartic acid, max. 0.5 %
VI. Defoamers:

1. Organopolysiloxanes with methyl and/or phenyl groups (silicone oil) according to Section I of
Recommendation XV18. Kinematic viscosity of the silicone oils, determined according to DIN 51 562 at 20 °C, min. 100 mm2 s-1. 2. Triisobutylphosphate 3. Higher aliphatic alcohols (C8-C26), also in emulsified form19 4. Fatty acid esters of mono and polyhydric aliphatic alcohols (C1-C18), and esters of fatty acids with polyethyleneglycol and polypropyleneglycol 17This production aid is washed out to the paper during manufacture. 18 Recommendation XV. "Silicones" 19 Max. 2 % liquid paraffin, sodium monoalkyl-dialkylphenoxybenzene-disulfonate, max. 2 %, and a total of max. 2 % alkyl and alkyaryloxethylates and their esters with sulfuric acid (as emulsifiers) may be added to 20-25 % aqueous
solutions of this antifoam agent. The liquid paraffins must comply with the "Purity requirements for liquid paraffins"
in the 155th Communication of Bundesgesundheitsbl. 25 (1982) 192).
Federal Institute for Risk Assessment

5. Alkylsulfonamides (C10-C20) 6. Liquid paraffins, max. 0.1 % (for purity requirements see 155th Communication). 7. Gelatine Of each of the production aids listed under 1. to 7. no more than 0.1 % may be used. 8. Copolymer of glycerol with ethylene oxide and propylene oxide, esterified with coconut fatty acid or oleic acid, of each max. 0.075 %. 9. N,N’-Ethylene-bis-stearamide. 10. Sorbitan monostearate, polyoxyethylene sorbitan monostearate, polyoxyethylene sorbitan monooleate with 20 ethylene oxide end groups, each max. 0.01 % 11. Sorbitan monooleate, max. 0.1 %
12. Edible oil.
VII. Slimicides:

a) Enzymatic agents
1. Fructose polysaccharide (levan)-hydrolase, 12.5 mg dry substance per kg paper. No more than one unit of levanase activity must be detectable. 1. Sodium chlorite, hydrogen peroxide, sodium peroxide, sodium hydrogen sulfite, as well as peroxyacetic acid, max. 0.1 %, based on dry fibres weight. 2. 1,4-Bis(bromoacetoxy)butene. Extract of the finished products must contain no more than 3. Tetramethyl thiuram disulfide. This substance must not be detectable in extract of the 4. 3,5-Dimethyl-tetrahydro-1,3,5-thiadiazine-2-thione. This substance must not be detec- table in extract of the finished products. 5. Bromohydroxyacetophenone. This substance must not be detectable in extract of the 6. Di-sodium-cyano-dithioimidocarbonate and/or Potassium-N-methyl-dithiocarbamate. Neither substance must not be detectable in extract of the finished products. 7. N-(2-p-chlorobenzoylethyl)-hexaminium chloride. Extract of the finished products must contain no more than 1.0 mg formaldehyde per dm2. The breakdown product, 2-(p-chlorobenzoyl)-ethylamine must not be detectable in methanol extract. 8. Methylene-bis-thiocyanate. This substance must not be detectable in extract of the 9. Potassium-N-hydroxymethyl-N'-methyl-dithiocarbamate and sodiummercaptobenzo- thiazole. Neither substance, nor their conversion products (mainly methylthiourea, N,N'-dimethylthiourea and dithiocarbamates) must be detectable in extract of the 10. 2-Oxo-2(4-hydroxy-phenyl)-acethydroxamic acid chloride. This substance must not be detectable in extract of the finished product. 11. 2-Bromo-2-nitro-1,3-propanediol, max. 0.003 %, based on dry fibres weight. This sub- stance must not be detectable in extract of the finished product 12. a) Mixture of 5-chloro-2-methyl-4-isothiazoline-3-one (approx. 3 parts) and 2-methyl-4- isothiazoline-3-one (approx. l part), in total, max. 0.0004 %, based on dry fibres weight or b) Mixture of N,N'-bis(hydroxymethyl)urea, max. 0.0125 %, 1,6-dihydroxy-2,5-dioxahexane, max. 0.029 %, 5-Chloro-2-methyl-4-isothiazoline-3-one, max. 0.00045 % and 2-methyl-4-isothiazoline-3-one, max. 0.00015 %, based on dry fibres weight Extract of the finished product must not contain more than 1.0 mg formaldehyde or 0.0005 mg isothiazolinones per dm2. Federal Institute for Risk Assessment

13. 2,2-Dibromo-3-nitrilopropionamide, max. 0.0045 %, based on dry fibres weight. This substance must not be detectable in the extract of the finished products. Phenyl-(2-chloro-2-cyan-vinyl)sulfone (approx. 80 %), phenyl-(1,2-dichloro-2-cyan- vinyl)sulfone (approx. 10 %) and 2-phenyl-sulfonylpropionitrile (approx. 10 %), in total, max. 0.001 %, based on dry fibres weight. These substances and the degradation product, phenylsulfonyl acetonitrile, must not be detectable in the extract of the finished product 15. 1,2-Benzisothiazoline-3-one, max. 0.15 mg/dm2. This substance must not be detectable in the extract of the finished product (detection limit: 5 µg/dm2). 16. 1,2-Dibromo-2,4-dicyanobutane, max. 0.005 %, based on dry fibres weight. This sub- stance must not be detectable in extract of the finished product (detection limit of method of analysis: 0.6 µg/dm2). 17. 4,5-Dichloro-(3 H)-1,2-dithiol-3-one, max. 0.004 %, based on dry fibres weight. Extract of finished products must not contain more than 2.0 mg of this substance per kg dry fibres. 18. beta-Bromo-beta-nitrostyrene, max. 0.045 %, based on dry fibres weight20. This sub- stance must not be detectable in the extract of the finished product (detection limit: 19. Glutaraldehyde, max. 2.5 %, based on dry fibres weight. No more than 2 mg glutaralde- hyde must be detectable in 1 kg of finished product. 20. 1-Bromo-3-chloro-5,5-dimethylhydantoin, max. 0.04 % based on dry fibres weight. No hypochlorite and hypobromite must be detectable in the extract of the finished product. 21. Didecyl dimethyl ammonium chloride, max. 0.05 %, based on the dry fibres weight. 22. 2-Methyl-4,5-trimethylene-4-isothiazoline-3-one, max. 0.034 %, based on dry fibres 23. 2-(Thiocyanatomethylthio)-benzothiazole, max. 0.00045 %, based on dry fibres weight. 24. Tetrakis(hydroxymethyl)phosponium sulfate. The extract of the finished products must contain no more than 0.15 ppm of this sub-stance. 25. Mixture of 1,3-dichloro-5-ethyl-5-methylhydantoin, 1,3-dichloro-5,5-dimethylhydantoin and 1-bromo-3-chloro-5,5-dimethylhydantoin in the ratio of 1:3:6, max. 0.04 %, based on the dry fibres weigth. No hypochlorite or hypobromite must be detectable in the extract of the finished product. 26. Mixture of 1,3-dichloro-5-ethyl-5-methylhydantoin and 1,3-dichloro-5,5- dimethylhydantoin in the ratio of 1:5, max. 0.04 %, based on the dry fibres weight. 27. Ammonium bromide/sodium hypochlorite adduct, max. 0.02 % (active substance deter- mined as chlorine), based on the dry fibres weight 28. 4,5-Dichloro-2-n-octyl-2H-isothiazol-3one, the content in the finished paper must not 29. Mixture of 2-methyl-4-isothiazilin-3-one and 1,2-benzisothiazolin-3-one in the ratio of 1:1. No more than 1 µg 2-Methyl-4-isothiazolin-3-one and 10 µg 1,2-Benzisothiazolin-3-one per dm² must be detectable in the extract of the finished products. 30. Dodecylguanidine hydrochloride, max. 0.02 %, based on the dry fibres weight. 31. Alkali-stabilised solution of hypobromite, max. 0.07 %, based on the dry fibres weight. The sodium hypobromite content of the solution is max. 10 % and the sodium sulfamate content is max. 12 %. 32. 1,3-Dimethylol-5,5-dimethylhydantoine, max. 0,04 %, based on the dry fibres weight 33. Chlorine dioxide. 20 Experiments have shown that following cold extraction with n-heptane, the conversion products, benzaldehyde and bromonitromethane are not detectable in the finished product (detection limits for benzaldehyde and bromoni-tromethane = 0.04 and 2.0 mg/kg, respectively). Federal Institute for Risk Assessment

34. Tetrahydro-1,3,4,6-tetrakis-(hydroxymethyl)-imidazo(4,5-d)imidazole-2,5(1H,3H)-dione as formaldehyde donator system with an average ratio of formaldehyde: acetylene diurea of 3.1:1 to 3.5:1. In the extract of the finished products not more than 0.3 mg/dm², corre-sponding to 0.1 mg formaldehyde/dm², must be detectable.21 35. Sodium hypochlorite, max. 0.028 %, based on the dry fibres weight
VIII. Preservatives:

1. Sorbic acid
2. p-Hydroxybenzoic acid ethyl and/or propyl ester22
3. Formic acid
4. Benzoic acid
5. Adduct of 70 % benzyl alcohol and 30 % formaldehyde
Extract of the finished products must contain no more than 1.0 mg formaldehyde/dm2. 5-Chloro-2-methyl-isothiazoline-3-one, max. 0.001 % 2-Methyl-4-isothiazoline-3-one, max. 0.0004 % Formaldehyde, max. 0.022 % Ethyleneglycol, max. 0.03 % The above limits are all based on the weight of the dry fibres. Extract of finished product must contain no more than 1.0 mg formaldehyde and 0.0005 mg isothiazolinones per dm2. 7. Sodium hydroxide. 8. Methylene-bis(thiocyanate); this substance must not be detectable in extract of the finished 9. o-Phenyl phenol and its sodium and potassium salts, max. 0.01 % 10. Sodium tetraborate, max. 0.005 %, based on the dry fibres weight. 11. Mixture of 2-methyl-4-isothiazolin-3-one and 1,2-benzisothiazolin-3-one in the ratio of 1:1. No more than 1 µg 2-Methyl-4-isothiazolin-3-one and 10 µg 1,2-Benzisothiazolin-3-one per dm² must be detectable in the extract of the finished products. The preservatives listed above must only be used in the amounts necessary to protect the raw
materials (Section A), processing aids (Section B), and paper refining agents (Section C) from
deterioration and decay.
C. Special Paper refining agents

The following paper refining agents may be used:
I. Wet-strength agents:
1. Glyoxal. Extract of the finished product must not contain more than 1.5 mg glyoxal 2. Urea-formaldehyde resins. Extract of the finished product must not contain more than 3. Melamine- formaldehyde resins. Extract of the finished product must not contain more than 4. Cross-linked, cationic polyalkylene amines13, 15 (compare B. III. 3.), in total max. 4.0 %: 21 brief description: Tetramethylolacetylenediurea (tetramethylolglycoluril) in chemical equilibrium with trimethylolace- tylenediurea, dimethylolacetylenediurea, monomethylolacetylenediurea and formaldehyde. 22 A 0.15 % aqueous solution of p-hydroxybenzoic acid ester (methyl, ethyl and n-propyl ester of p-hydroxybenzoic acid, as well as their sodium salts) in hydrogen peroxide (35 %) may be used, provided no more than 15 mg p-hydroxybenzoic acid ester are contained in 1 kg of packaging material. Federal Institute for Risk Assessment

a) Polyamine-epichlorohydrin resin, produced from epichlorohydrin and diaminopropyl me- b) Polyamide-epichlorohydrin resin, produced from epichlorohydrin, adipic acid, capro- lactam, diethylenetriamine and/or ethylenediamine (compare B. III. 3. b) c) Polyamide-epichlorohydrin resin, produced from adipic acid, diethylenetriamine and epichlorohydrin or a mixture of epichlorohydrin with ammonia d) Polyamide-polyamine-epichlorohydrin resin, produced from epichlorohydrin, adipic acid dimethyl ester and diethylenetriamine (compare B. III. 3. d) e) Polyamide-polyamine-epichlorohydrin resin produced from epichlorohydrin, an adipic f) Polyamide-epichlorohydrin resin, produced from epichlorohydrin, diethylenetriamine, adipic acid, ethyleneimine and polyethyleneglycol, max. 0.2 % g) Polyamide-epichlorohydrin resin, produced from bis-(3-aminopropyl)methylamine, adipic h) Polyamide-epichlorohydrin resin, produced from bis-(3-aminopropyl)methylamine, epichlorohydrin, urea and oxalic acid, max. 1.0 % i) Polyamide-epichlorohydrin resin, produced from diethylenetriamine, adipic acid, glutaric j) Polyamide-epichlorohydrin resin, produced from diethylenetriamine, triethylene- tetramine, adipic acid and epichlorohydrin. 5. Vinylformamide-vinylamine copolymer, max. 1.0 %. 6. Polyhexamethylene-1,6-diisocyanate, modified with polyethyleneglycol monomethyl ether, 7. Polyhexamethylene-1,6-diisocyanate, modified with polyethyleneglycol monomethyl ether and N,N-dimethylaminoethanol, max. 1.2 %. 8. Terpolymer of acrylamide, diallyldimethyl ammonium chloride and glyoxal, max. 2 %, based on the dry fibres weight. Extract of the finished product must not contain more than 1.5 mg glyoxal per dm². 9. Copolymer of hexamethylenediamine and epichlorohydrine, max. 0.2 % 10. Copolymer of diethylenetriamine, adipic acid, 2-aminoethanol and epichlorohydrin13, max. 0.1 %, based on the dry fibres weight 11. Copolymer of diethylenetriamine, adipic acid, acetic acid and epichlorohydrin13, max. 2 %, This copolymer must only be used in the manufacture of kitchen rolls. 12. Copolymer of vinylformamide and acrylic acid, max. 1 %, based on the dry fibres weight II. Humectants:
1. Glycerol 2. Polyethyleneglycols which contain no more than 0.2 % monoethyleneglycol. 3. Urea. 4. Sorbitol. 5. Saccharose, glucose, glucose syrup. 6. Sodium chloride, calcium chloride. 7. Sodium nitrate, but only together with urea. In total max 7.0 % of the substances listed above may be used. Federal Institute for Risk Assessment

III. Colorants and optical brighteners
1. There must be no migration of colorants to the foodstuff. Testing is conducted according to DIN EN 64623, whereby grade 5 on the so-called grey scale must be reached. 2. Sulfonated stilbene derivates, max. 0.3 %. Optical brighteners must not migrate to the food- stuff. Testing is conducted according to DIN EN 64823, whereby a value of 5 on the evalua-tion scale must be reached.
IV. Surface refining and coating agents:
1. Plastics (films, melts, solutions, laquers, dispersions), provided they comply with the corre- sponding BfR Recommendations. Plastic coated paper or paperboard, in which from normal use only the layer of plastic comes into contact with the foodstuff and in which there can be no migration of substances from the paper or paperboard to the foodstuff, should not be evaluated after this Recommendation, but after the BfR Recommendation for the corre-sponding plastic. 2. Paraffins, microcrystalline waxes, low-molecular polyolefins and polyterpenes, provided they comply with amended Recommendation XXV11. The second sentence of No. 1 above applies here likewise. 3. Polyvinyl alcohol (viscosity of 4 % aqueous solution at 20 °C, min. 5 cP). 4. Silicone oils with special additives after Section I, No. 3 of Recommendation XV and/or silicone resins or silicone elastomers (silicone rubber) in compliance with Sections II and III of Recommendation XV18. 5. Chromium(III)chloride complexes with saturated straight-chain fatty acids of chain length C14 and longer, max. 0.4 mg/dm2, based on chromium. Cold water extract of the finished product must contain no more than 0.004 mg chromium(III)/dm2, while chromium (VI) must not be detectable. 6. Aluminium, calcium, sodium, potassium and ammonium salts of straight-chain aliphatic car- boxylic acids of chain length C12-C20. These must comply with the general purity require-ments (Annex l, No. 2) of the Regulation on Food Additives (Zusatzstoffverkehrs-verordnung). 7. Casein7 (compare B I No. 2) and vegetable proteins 8. The product list under B I No. 3 9. Mannogalactanes7 10. Galactomannane ethers 10.1 Carboxymethylgalactomannane, residual content in sodium glycolate max. 0.5 % 10.2 Galactomannane, treated with 3-chloro-2-hydroxypropyl-trimethylammonium chloride or glycidyl-trimethylammonium chloride (specification: epichlorohydrine max.1 mg/kg, nitrogen max. 4.0 %) 11. Sodium salt of carboxymethyl cellulose, technically pure10 12. Methyl cellulose7 13. Hydroxyethyl cellulose7 14. Natural and synthetically produced, insoluble mineral compounds that are harmless to 15. Alginates7 16. Xanthane7 17. Ammonium zirconium carbonate, max. 1.0 mg/dm2 (based on zirconium dioxide, ZrO2) 18. Ammonium salts of perfluoroalkyl-substituted phosphoric acid esters, formed as reaction products of 2,2-bis(α,ω-perfluoro-C4-C20-alkylthio)methyl]-1,3-propanediol, polyphosphoric acid and ammonium hydroxide, max. 0.44 %. Paper and paperboard treated with this coat-ing agent must not come into contact with foodstuffs that contain alcohol. 23 Testing is not necessary for paper and paperboard intended for contact with dry, non-fatty foodstuffs. Federal Institute for Risk Assessment

19. Copolymer of vinyl alcohol and isopropenyl alcohol. Viscosity of 4 % aqueous solution at 20. Copolymer of perfluoroalkylethyl acrylate, vinylacetate and N,N-dimethylamino-ethyl meth- 21. Basic potassium zirconium carbonate, max. 1.25 mg/dm2, expressed as ZrO2. 22. Mixture of bis-(diethanol ammonium)-mono-1H-1H, 2H-2H-perfluoroalkylortho-phosphate and diethanol ammonium-bis-(1H-1H, 2H-2H-perfluoroalkyl)orthophosphate, max. 5 mg/dm². Paper and paperboard treated with this coating agent must not come into contact with foodstuffs that contain alcohol. 23. Di(hydrogenated tallow fatty acids-2-hydroxyethyl ester)dimethyl ammonium chloride, 24. Imidazolium compounds, 2-(C17- and C17-unsaturated alkyl)-1-[2-(C18- and C18- unsaturated amido)ethyl]-4,5-dihydro-1-methyl-, methylsulfates, max. 0.5 %, based on the dry fibres weight 25. Phosphoric acid ester of ethoxylated perfluoropolyetherdiol, max. 1.5 %, based on the dry 26. Modified polyethylene terephthalates, manufactured from polyethylene terephthalate and one or more of the following substances or substance classes: Ethylene glycol, tri-methylolpropane, pentaerythritol, C16-C22 fatty acids and triglycerides thereof, isophthalic acid and trimellitic acid anhydride, max. 0.1 g/dm² 27. Copolymer of Acrylic acid-2-methyl-2-(dimethylamino)ethyl ester and gamma, omega- perfluoro-(C8-C14)alkyl-acrylate, N-oxide, acetate, max. 5 mg/dm². 28. Copolymer of acrylic acid-2-methyl-2-(dimethylamino)ethylester and γ,ω-perfluoro-(C8- C14)alkyl-acrylate, N-oxide, max. 3.8 mg/dm2. 29. Copolymer of Perfluoralkyl(C4-C18)-ethylacrylate, 2-(Diethylamino)ethyl methacrylate and 2,3-Epoxypropyl methacrylate with a fluorine content of 54 %, max. 0.48 %, based on the dry fibres weight. 30. Perfluoropolyetherdicarbonic acid, ammonium salt, max. 0.5 %, based on the dry fibres weight. The correspondingly treated papers may not come into contact with aqueous and alcoholic foodstuff. 31. Copolymer with 2-diethylaminoethylmethacrylate, 2,2'-ethylendioxydiethyldimethacrylate, 2- hydroxyethylmethacrylate and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctylmethacrylate, ace-tate, max. 1.2 %, based on the dry fibres weight.

Source: http://www.international.offset.at/uploads/tmce_templates/pdf_downloads/reliability_01.pdf