This is an unofficial translation. Only the German version is binding.
XV. Silicones
As of 01.02.2005
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:
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I. Silicone oils1
1.The following starting materials may be ud:
a)Linear or branched and/or cyclic 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%
Phosphoric 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.
3Becau 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.
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Alkyl(C8 - C18) dimethylbenzyl ammonium chloride, max.1.5%, but only for coating paper Sodium d
odecyl 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:
Formaldehyde, max. 0.1%.
1 ml extract from the finished products may contain no more than 3 µg formaldehyde5.
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 or branched organopolysiloxanes with methyl groups and/or n-alkyl(C2-C32), phenyl2, and/or vinyl, and/or hydroxyl, and/or alkoxy (C1-C4), and/or hydrogen, and/or carboalkoxy-alkyl (-(CH2)2-17-C(O)-O-(CH2)0-17CH3)-, and/or hydroxyalkyl(C1 - C3) groups attached to the silicon atom and their condensation products with polyethylene and/or polypropyleneglykol., alone or in combination with polycondensation products (esters) of:
Isophthalic acid
Terephthalic acid
Ethandiol
Trimethylol propane
williams4,4'-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:
a)Zinc-di-2-ethylhexoate in total
Di-n-octyl-tin-maleinate max. 1.5%
ß)Conversion products6α), plus the following:
Butyltitanate and/or butylpolytitanate, as necessary, with the monoethyl ether of
ethanediol (ethyleneglycol) in the ratio 1:1 7
Aluminium acetylacetonate
Zirconium acetylacetonate
5See 61st Communication on testing of plastics in Bundesgesundheitsbl 46 (2003) 362.
6The conversion products are either incorporated into the resin or occur as oxides. Thus, a quantitative limit is not deemed necessary.
下终南山过斟斯山人宿置酒7To be ud at temperatures of at least 180°C.
超越自我演讲稿
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. 3.The following substances may be added to silicone oils ud for coating paper:
Carboxymethyl cellulo
Pulped starch3
消失英文Alginates
Cain
初中英语被动语态
Dispersions of hard paraffin and wax8
Dispersions bad on copolymers of acrylic and methacrylic acid esters, butadiene and styrene, provided they comply with Recommendation XIV9.除此之外英文
Polyvinyl alcohol (viscosity of 4% aqueous solution at 20°C min. 5 cP).
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 trivinylcyclohexane and α,ω-dihydrogen-polyhydrogen-
methyldimethyl-siloxanes, max. 10%
1-Dodecene, max. 20%
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%
b)Conversion products of following cross-linking agents:
Benzoyl peroxide
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2,4-Dichlorobenzoyl peroxide10
Dicumyl peroxide
tert-Butyl-cumyl peroxide
2,5-Bis(tert-butylperoxy)-2,5-dimethylhexane in total
Methyl-tris-cyclohexyl-aminosilane11max. 0.2%
Methyl-tris-c.-butylaminosilane11
Methyl-tris-acetoxysilane
Ethyl-tris-acetoxysilane
尖叫的女妖Methyl-tris-butanoximosilane11
Di-(4-methyl-benzoyl)peroxide
8The waxes and paraffins must comply with Recommendation XXV. "Hard paraffins, microcrystalline waxes and mixtures of the with waxes, resins and plastics", Part I.
9Recommendation XIV. "Plastics dispersions"
10The migration of 2,4-dichloro benzoic acid formed as decomposition product must not exceed 5 mg/kg food resp. food simulant.
11The reaction products, cyclohexylamine, c-butylamine or Butanonoxime and their conversion pr
oducts must not be detectable in the finished products. For method of analysis, e 43rd Communication on the testing of plastics
in Bundesgesundheitsbl. 22 (1979) 339
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 products12, 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 product13.
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 on
Sodium alkylaryl sulfonates silicone content
The total amount of emulsifying agents ud must not exceed10%.
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
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 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:
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 product13
c)The following may be ud as inhibitors:
1-Ethinyl-cyclohexanol and 2-methylbutine-3-ol-2, in total max. 0.1%
d)Fillers:
Silicic acid14.
Dummies (pacifiers) and bottle teats made of silicone elastomers must comply with the requirements
laid down in the Commodities Regulation (Bedarfsgegenständeverordnung). 12The conversion products are incorporated into the elastomers or hydrolyd to silicic acid.
13Hexachloroplatinic acid and its conversion products with vinyl-containing s iloxanes are the catalysts of choice.
14 See Recommendation LII. "Fillers (extenders) for commodities made of plastic "
5.The silicone elastomers must relea no more than 0.5% volatile organic and no more than
0.5% extractable components.5
6.The finished products must not test positively for peroxides.15
15 See 58th Communication on testing of plastics in Bundesgesundheitsbl. 40 (1997) 412
