150-english

This is an unofficial translation. Only the German version is binding.
XV. Silicones

As of 01.01.2012

There are no objections to the use of silicones (organopolysiloxanes) in the manufacture of
commodities in the sense of § 2, Para. 6, No. 1 of the Food and Feed Code (Lebensmittel- und
Futtermittelgesetzbuch), provided they are suitable for their intended purpose and comply with
the following conditions. The same applies for commodities in the sense of § 2, Para.6, No. 3 of
the same act, which are dealt with in Section III (Silicone elastomers) No. 4 of this Recommen-
dation:
I. Silicone oils1
1. The following starting materials may be used:
a) Linear or branched and/or cyclic2 organopolysiloxanes with methyl groups alone or with n-alkyl(C2-C32), phenyl2 and/or hydroxyl groups attached to the silicon atom, and their condensation products with polyethylene and/or polypropyleneglykol. b) Linear or branched organopolysiloxanes as mentioned under a) but in addition with up to max. 5 % hydrogen and/or alkoxy(C2-C4) and/or carboalkoxyalkyl (-(CH2)2-17-C(O)-O-(CH2)0-17CH3)- and/or hydroxyalkyl(C1-C3) groups attached to the silicon atom. 2. Finished products may contain only the following production aids, used in manufacturing the raw polymer, in the maximum amounts given: Residues of condensation accelerators and their conversion products: Conversion products of phosphonitrile chloride, max. 0,001 % Calcium salts of straight-chain aliphatic saturated monocarboxylic acids C10-C20 12-Hydroxystearic acid, calcium salt Carboxymethylcellulose Pulped Starch3 c) Emulsifying agents, provided that the oils are used as aqueous emulsions4, in total max. 10 %, based on the silicone content: 1 Silicone fats or pastes are silicone oils to which fillers or extenders (see Section I. No. 2 b) with a thickening effect have been added, and for which the same requirements apply. 2 There must be no cyclic polysiloxanes included, which besides a phenyl group also have a hydrogen atom or a methyl group attached to the same silicon atom. 3 Because the viscosity of natural starch is too high, it is partially broken down through dextrinisation (treatment with acids at moderate temperature, or without acid, at elevated temperature), through oxidation (with hypochlorite in alkaline medium) or with the help of enzymes. 4 Silicone emulsions are used to produce coatings and films. As a result of heat treatment (e.g. the hydrophobing of glass at 280 °C) or of strong dilution of the aqueous phase prior to use (e.g. as slip agent for corks, artificial guts (sausage casings), or as release agent for rubber stoppers and seals), as a rule, they only contain a fraction of the emulsifying agents present in the emulsion. Federal Institute for Risk Assessment

Alkyl(C8-C18) dimethylbenzyl ammonium chloride, max. 1.5 %, but only for coating paper Sodium dodecyl sulfate, max. 0.5 % Polyethyleneglycol ethers of monohydric aliphatic alcohols C12-C20 and of C2-C9 alkyl Polyethyleneglycol esters of natural fatty acids C8-C22 and vegetable oils Semi-acetylated polyvinyl alcohol with less than 20 % acetyl groups and a K-value The following preserving agents may be added to silicone oil emulsions: 1 ml extract from the finished products may contain no more than 3 µg formaldehyde5. 4. Kinematic viscosity of the silicone oils, measured according to DIN 51 562 at 20 °C, must
II. Silicone resins

1. The following starting materials may be used:
Linear and branched organopolysiloxanes with methyl groups alone and/or n-alkyl(C2-C32)-, and/or phenyl-2, and/or vinyl-, and/or hydroxyl-, and/or alkoxy(C1-C4)-, and/or hydrogen-, and/or carboalkoxyalkyl(-(CH2)2-17-C(O)-O-(CH2)0-17CH3)-, and/or hydroxyalkyl(C1-C3)-groups attached to the silicon atom also in combination with polycondensation products (es-ters) of: Isophthalic acid Terephthalic acid Ethandiol Trimethylol propane 4,4'-Dioxydiphenyl-2,2-propane (bisphenol A) Glycerol Pentaerythrite 2. Finished products may contain only the following production aids, used in manufacturing and processing the raw polymer, in the maximum amounts given: a) Condensation agents: Residues of hydrochloric acid and its conversion products with fillers and hardeners, in total max. 0.1 % β) Conversion products6 of hardeners named under α), plus the following: Butyltitanate and/or butylpolytitanate, as necessary, with the monoethyl ether of ethanediol (ethyleneglycol) in the ratio 1:1 7 5 61st Communication on testing of plastics in Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz 6 The conversion products are either incorporated into the resin or occur as oxides. Thus, a quantitative limit is not 7 To be used at temperatures of at least 180 °C. Federal Institute for Risk Assessment

In so far as the resins are used in the form of aqueous emulsions4, the substances listed above under 1, No. 2 c may be used, however, max. 7.0 %, based on silicone content. 3. The following substances may be added to silicone resins used for coating paper: Carboxymethyl cellulose Pulped starch3 Alginates Casein Dispersions of hard paraffin and wax8 Dispersions based on copolymers of acrylic and methacrylic acid esters, butadiene and styrene, provided they comply with Recommendation XIV9. Polyvinyl alcohol (viscosity of 4 % aqueous solution at 20 °C min. 5 cP). Hydroxyethyl cellulose, max. 2 % in the resin.
III. Silicone elastomers (Silicone rubber)
1. The following starting materials may be used:
Polymers complying with Section I, No.1 of this Recommendation Organopolysiloxanes with vinyl groups attached to the silicon atom Addition products of trivinyl cyclohexane and α,ω-Dihydrogenpolyhydrogen- 1-Dodecene, max. 20 % Polydimethyl- siloxanes and -silicones, 3-aminopropyl-group terminated, polymers with 1- isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane10 Polydimethyl- siloxanes and -silicones, 3-aminopropyl-group terminated, polymers with 2. Finished products may contain only the following production aids, used in manufacturing and processing the raw polymer, in the maximum amounts given: a) Residues of condensation accelerators and their neutralising agents: Sodium hydroxide Potassium hydroxide Hydrochloric acid Phosphoric acid Acetic acid Conversion products of phosphorus nitrile chloride, max. 0.001 % 8 The waxes and paraffins must comply with Recommendation XXV. "Hard paraffins, microcrystalline waxes and mixtures of these with waxes, resins and plastics", Part I. 9 Recommendation XIV. "Plastics dispersions" 10 Specifical restrictions for 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane and 1-amino-3- aminomethyl-3,5,5-trimethylcyclohexane, laid down in the Commission Regulation (EU) No 10/2011, must be complied with. 11 Specifical restrictions for bis(4-isocyanatocyclohexyl)methane and bis(4-aminocyclohexyl)methane, laid down in the Commission Regulation (EU) No 10/2011, must be complied with. Federal Institute for Risk Assessment

b) Conversion products of following cross-linking agents: Benzoyl peroxide Bis-(2,4-Dichlorobenzoyl) peroxide12 Dicumyl peroxide tert-Butyl-cumyl peroxide 2,5-Bis(tert-butylperoxy)-2,5-dimethylhexane Methyl-tris-sec-butylaminosilane13 Methyl-tris-acetoxysilane Ethyl-tris-acetoxysilane Methyl-tris-butanoximosilane13 Di-(4-methyl-benzoyl)peroxide Esters of alkyl-C1-C8-silicic acid or orthosilicic acid with aliphatic monohydric alcohols C2-C4 and the monomethyl ether of ethanediol (methylglycol) and their condensation products14, in total max. 3 %. c) Hardener or catalysts and their conversion products: Di-n-octyl-tin-dimaleinate Di-n-octyl-tin-dilaurate Esters of titanic acid with isobutyl alcohol, n-butanol Amides of aliphatic carboxylic acids, C8-C22 Coordination compounds of platinum, max. 50 mg platinum per kg finished product15. The following substances may be used as inhibitors for these coordination com-pounds: 1-ethinyl-cyclohexanol and 2-methylbutine-3-ol-2, in total max. 0.1 %. Apart from the emulsifying agents4 listed above under Section I, No. 2 c, the following may be used only in silicone elastomers for coating paper: Sodium alkyl(C8-C22)-sulfates The total amount of emulsifying agents used must not exceed 10 %. e) Reclaimed silicone rubber, provided it complies with this Recommendation. 3. To the extent that the silicone elastomers are intended for coating paper or plastic films, the a) the substances listed above under Section II, No. 3 b) as hardener or catalyst – departing from No. 2, c) of this Section -, coordination com- pounds of platinum, max. 120 mg platinum per kg finished coating c) 1,2-dibromo-2,4-dicyanobutane, max. 2.7 µg/dm2 of finished coating, as preservative. d) 2-Bromo-2-nitropropane-1,3-diol, max. 1,25 µg/dm2 of finished coating, as preservative. 4. To the extent that silicone elastomers in compliance with this recommendation are used in the manufacture of bottle teats, dummies (pacifiers), nipple caps, teething rings or dental 12 The migration of 2,4-dichloro benzoic acid formed as decomposition product must not exceed 5 mg/kg food resp. 13 The reaction products, cyclohexylamine, sec-butylamine or Butanonoxime and their conversion products must not be detectable in the finished products. For method of analysis, see 43rd Communication on the testing of plastics in Bundesgesundheitsblatt 22 (1979) 339 14 The conversion products are incorporated into the elastomers or hydrolysed to silicic acid. 15 Hexachloroplatinic acid and its conversion products with vinyl-containing siloxanes are the catalysts of choice. Federal Institute for Risk Assessment

guards, the finished products may only contain the following production aids, used during manufacture and processing of the raw polymer, in the maximum amounts given: a) Conversion products of the following cross-linking agents: b) Hardener or catalysts and their conversion products: Coordination compounds of platinum, max. 50 mg platinum c) The following may be used as inhibitors: 1-Ethinyl-cyclohexanol and 2-methylbutine-3-ol-2, in total max. 0.1 % Dummies (pacifiers) and bottle teats made of silicone elastomers must comply with the requirements laid down in the Commodities Regulation (Bedarfsgegenständeverordnung). 5. The silicone elastomers must release no more than 0.5 % volatile organic and no more than 6. The finished products must not test positively for peroxides.17 16 Recommendation LII. "Fillers (extenders) for commodities made of plastic " 17 58th Communication on testing of plastics in Bundesgesundheitsblatt 40 (1997) 412

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