This is an unofficial translation. Only the German version is binding.
XV. Silicones
As of 01.10.2014
There are no objections to the u of silicones (organopolysiloxanes) in the manufacture of commodities in the n of § 2, Para. 6, No. 1 of the Food and Feed Code (Lebensmittel- und Futtermittelgetzbuch), provided they are suitable for their intended purpo and comply with the following conditions. The same applies for commodities in the n 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 ud:
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, ud in manufacturing
the raw polymer, in the maximum amounts given:
a) Condensation agents:
Residues of condensation accelerators and their conversion products:
Sodium hydroxide
Potassium hydroxide
Hydrochloric acid in total
Sulfuric acid max. 0.01 %
micromediaPhosphoric acid
Acetic acid
Conversion products of phosphonitrile chloride, max. 0,001 %
b) Thickening agents:
Calcium salts of straight-chain aliphatic saturated monocarboxylic acids C10-C20
12-Hydroxystearic acid, calcium salt
Carboxymethylcellulo
Pulped Starch3
c) Emulsifying agents, provided that the oils are ud as aqueous emulsions4, in total
max. 10 %, bad on the silicone content:
1Silicone fats or pastes are silicone oils to which fillers or extenders (e Section I. No. 2 b) with a thickening effect have been added, and for which the same requirements apply.
2There 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 Becau 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.
4Silicone emulsions are ud 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 pha prior to u (e.g. as slip
agent for corks, artificial guts (sausage casings), or as relea agent for rubber stoppers and als), as a rule, they only contain a fraction of the emulsifying agents prent in the emulsion.
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 phenols
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 greater than 40
3. Prerving agents:
The following prerving agents may be added to silicone oil emulsions:
Sorbic acid, max. 0.1 %.
4. Kinematic viscosity of the silicone oils, measured according to DIN 51 562 at 20 °C, must
be min. 100 mm2 • s-1.
II. Silicone resins
1. The following starting materials may be ud:
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, ud 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 %
b) Hardeners:
α) Zinc-di-2-ethylhexoate in total
Di-n-octyl-tin-maleinate max. 1.5 %
β) Conversion products5 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 6
Aluminium acetylacetonate
Zirconium acetylacetonate
c) Emulsifying agents:
In so far as the resins are ud in the form of aqueous emulsions4, the substances listed above under 1, No. 2 c may be ud, however, max. 7.0 %, bad on silicone content.
5The conversion products are either incorporated into the resin or occur as oxides. Thus, a quantitative limit is not deemed necessary.
6To be ud at temperatures of at least 180 °C.
3. The following substances may be added to silicone resins ud for coating paper:
Carboxymethyl cellulo
Pulped starch3
Alginates
Cain
Dispersions of hard paraffin and wax7
如何快速提高记忆力Dispersions bad on copolymers of acrylic and methacrylic acid esters, butadiene and styrene, provided they comply with Recommendation XIV8.
Polyvinyl alcohol (viscosity of 4 % aqueous solution at 20 °C min. 5 cP).
Hydroxyethyl cellulo, max. 2 % in the resin.
III. Silicone elastomers (Silicone rubber)
1. The following starting materials may be ud:
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- methyldimethyl-siloxanes, max. 10 %
1-Dodecene, max. 20 %
Polydimethyl- siloxanes and -silicones, 3-aminopropyl-group terminated, polymers with 1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane9ingredient
Polydimethyl- siloxanes and -silicones, 3-aminopropyl-group terminated, polymers with bis(4-isocyan
atocyclohexyl)methane10
2. Finished products may contain only the following production aids, ud 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 in total
Sulfuric acid max. 0.1 %
Phosphoric acid
Acetic acid
Conversion products of phosphorus nitrile chloride, max. 0.001 %
7The waxes and paraffins must comply with Recommendation XXV. "Hard paraffins, microcrystalline waxes and mixtures of the with waxes, resins and plastics", Part I.
8Recommendation XIV. "Plastics dispersions"
const
美国第一夫人米歇尔9 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.
10 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.
b) Conversion products of following cross-linking agents:
Benzoyl peroxide
Bis-(2,4-Dichlorobenzoyl) peroxide11
Dicumyl peroxide
tert-Butyl-cumyl peroxide
2,5-Bis(tert-butylperoxy)-2,5-dimethylhexane in total
Methyl-tris-cyclohexyl-aminosilane12 max. 0.2 %
Methyl-tris-c-butylaminosilane12
Methyl-tris-acetoxysilane
Ethyl-tris-acetoxysilane
wanbangMethyl-tris-butanoximosilane12
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 products13, in total max. 3 %.
c) Hardener or catalysts and their conversion products:
Di-n-octyl-tin-dimaleinate
Di-n-octyl-tin-dilaurate max. 1.5 %,
Esters of titanic acid with isobutyl alcohol, n-butanol bad on
and the enolate of acetoacetic ester finished product Amides of aliphatic carboxylic acids, C8-C22
Coordination compounds of platinum, max. 50 mg platinum per kg finished product14.
The following substances may be ud as inhibitors for the coordination com-
pounds:
1-ethinyl-cyclohexanol and 2-methylbutine-3-ol-2, in total max. 0.1 %.
d) Emulsifying agents:
Apart from the emulsifying agents4 listed above under Section I, No. 2 c, the following
may be ud only in silicone elastomers for coating paper:
Sodium alkyl(C8-C22)-sulfates in total max. 4 %
Sodium alkyl(C8-C22)-sulfonates bad ondeport
Sodium alkylaryl sulfonates silicone content
The total amount of emulsifying agents ud 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
following may be ud:
a) the substances listed above under Section II, No. 3
browb) 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 prervative.
d) 2-Bromo-2-nitropropane-1,3-diol, max. 1,25 µg/dm2of finished coating, as prervative.
4. To the extent that silicone elastomers in compliance with this recommendation are ud in
the manufacture of bottle teats, dummies (pacifiers), nipple caps, teething rings or dental guards, the
finished products may only contain the following production aids, ud during manufacture and processing of the raw polymer, in the maximum amounts given:
11 The migration of 2,4-dichloro benzoic acid formed as decomposition product must not exceed 5 mg/kg food resp. food simulant.
12 The reaction products, cyclohexylamine, c-butylamine or Butanonoxime and their conversion products must not be detectable in the finished products. For method of analysis, e 43rd Communication on the testing of plastics in Bundesgesundheitsblatt 22 (1979) 339
13 The conversion products are incorporated into the elastomers or hydrolyd to silicic acid.
14 Hexachloroplatinic acid and its conversion products with vinyl-containing siloxanes are the catalysts of choice.
a) Conversion products of the following cross-linking agents:
Dicumyl peroxide
Benzoyl peroxide in total max. 0.2 %
tert-Butyl-cumyl peroxide
b) Hardener or catalysts and their conversion products:
Coordination compounds of platinum, max. 50 mg platinum
per kg of finished product14提出索赔 英文
奥巴马就职演讲mp3c) The following may be ud as inhibitors:
1-Ethinyl-cyclohexanol and 2-methylbutine-3-ol-2, in total max. 0.1 %
d) Fillers:
Silicic acid15.
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 relea no more than 0.5 % volatile organic and no more than
0.5 % extractable components.16
6. The finished products must not test positively for peroxides.17
15 Recommendation LII. "Fillers (extenders) for commodities made of plastic"
16 61st Communication on testing of plastics in Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz 46 (2003) 362
17 58th Communication on testing of plastics in Bundesgesundheitsblatt40 (1997) 412
