ＦＤＡ認可のゴム材料（サンプル版）

加藤事務所作成データ

FDA 2004年版
　ＦＤＡ認可済みのゴム原材料　（サンプル版です。リストの一部のみ表示しています）
作成：㈱加藤事務所

(i)　エラストマー、ポリマー Elastomers.

Acrylonitrile-butadiene copolymer.　（ＮＢＲ）
Brominated isobutylene-isoprene copolymers　complying with Sec. 177.1210.　（臭化ブチルゴム）
Butadiene-acrylonitrile-ethylene glycol dimethacrylate　copolymers containing not more than 5 weight percent of polymer units　
derived from ethylene glycol dimethacrylate.
Butadiene-acrylonitrile-methacrylic　acid copolymer.
Butadiene-styrene-methacrylic acid copolymer.
Chloroprene　polymers.（ＣＲ）
Chlorotrifluoroethylene-vinylidene fluoride copolymer.
Ethylene-propylene　copolymer elastomers which may contain not more than 5 weight-percent　of total polymer units
derived from 5-methylene-2-　norbornene and/or 5-ethylidine-2-norbornene.（ＥＮＢ５％以下のＥＰＤＭ）
Ethylene-propylene-dicyclopentadiene copolymer.　（ＤＣＰ系のＥＰＤＭ）
Ethylene-propylene-1,4-hexadiene　copolymers containing no more than 8 weight percent of total polymer units　derived
from 1,4-hexadiene.
Hydrogenated butadiene/acrylonitrile copolymers　(CAS Reg. No. 88254-10-8) produced when acrylonitrile/butadiene
copolymers　are modified by hydrogenation of the olefinic unsaturation to leave not　more than 10 percent
trans olefinic unsaturation and no α,β-olefinic　unsaturation as determined by a method entitled
``Determination of 　Residual　α,β-Olefinic and Trans Olefinic Unsaturation
Levels in HNBR,'' developed　October 1, 1991, by Polysar Rubber Corp., 1256 South Vidal St., Sarnia,
　Ontario, Canada N7T 7MI, which is incorporated by reference in accordance　with 5 U.S.C. 552(a)
and 1 CFR 　part 51. Copies may be obtained from the Center for Food Safety and Applied Nutrition
(HFS-200), Food and Drug　Administration, 200 C St. SW., Washington, DC 20204, or may be examined
　at the Office of the Federal Register, 800 North Capitol St. NW., suite　700, Washington, DC.
Isobutylene-isoprene copolymer　（ブチルゴム）
Polyamide/polyether　block copolymers (CAS Reg. No. 77402-38-1 prepared by reacting a copolymer　
of omega-laurolactam and adipic acid with poly(tetramethylene ether glycol).The polyamide and polyether
components are reacted in ratios such that the polyamide component constitutes a minimum of 30 weight-percent of
total polymer　units. The copolymers may be used in contact with foods of
Types I, II, III, IV, V, VI, VII, VIII, and IX identified in table 1 of　Sec. 176.170(c) of this chapter at temperatures not
to exceed 150 deg.F　except that those copolymers prepared with less than 50 weight-percent　of polyamide are
limited to use in contact with such foods at temperatures　not to exceed 100 deg.F.
Polybutadiene.　（ＢＲ）
Polyester elastomers derived from　the reaction of dimethyl terephthalate, 1,4-butanediol, and
α-hydro-omega-hydroxypoly　(oxytetramethylene). Additionally, trimethyl trimellitate may be used　
as a reactant. The polyester elastomers may be used only in contact with　foods containing not more than
8 percent alcohol and limited to use in　contact with food at temperatures not exceeding 150 deg.F.
Polyisoprene.　（ＩＲ）
Polyurethane resins (CAS Reg. Nos. 37383-28-1 or 9018-04-6) derived from　the reaction of diphenylmethane
diisocyanate with 1,4-butanediol and polytetramethylene ether glycol.（ウレタンゴム）
Polyurethane resins derived from reactions　of diphenylmethane diisocyanate with adipic acid and 1,4-butanediol.
Rubber,　natural.（ＮＲ）
Silicone basic polymer as described in ASTM method D1418-81, ``Standard　Practice for Rubber and Rubber Latices--
Nomenclature,'' which is incorporated　by reference. Copies may be obtained from the American Society for Testing
　Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at　the Office of the Federal Register, 800
North Capitol Street, NW., suite　700, Washington, DC 20408.

Silicone (Si) elastomers containing methyl　groups.
Silicone (Psi) elastomers containing methyl and phenyl groups.
Silicone (Vsi) elastomers containing methyl and vinyl groups.
Silicone　(Fsi) elastomers containing methyl and fluorine groups.
Silicone (PVsi)　elastomers containing phenyl, methyl, and vinyl groups.
　　（シリコンゴムの一部）

Styrene-butadiene　copolymer.（ＳＢＲ）
Vinylidene fluoride-hexafluoropropylene copolymers (minimum　number average molecular weight 70,000 as determined
by osmotic pressure　in methyl ethyl ketone).
Vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene　copolymers (minimum number average molecular weight
100,000 as determined　　by osmotic pressure in methyl ethyl ketone).　（フッ素ゴムの一部）

(ii)加硫材料　 Vulcanization materials-
(a)加硫剤 Vulcanizing agents.

4,4'-Bis(aminocyclohexyl)methane carbamate for use only as cross-linking
　agent in the vulcanization of vinylidene fluoridehexafluoropropylene
　copolymer and vinylidene fluoride-hexafluoropropylene-
　tetrafluoroethylene copolymer elastomers identified under paragraph
　(c)(4)(i) of this section and limited to use at levels not to exceed 2.4
　percent by weight of such copolymers.
Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-
　methylethyl)trithio-bis-thioformate, O,O-di(1-methylethyl)tetrathio-bis-
　thioformate, and O,O-di(1-methylethyl)pentathio-bis-thioformate) for use
　as a cross linking agent in the vulcanization of natural rubber,
　styrene-butadiene copolymer, acrylonitrile-butadiene copolymer, and
　ethylene-propylene terpolymers identified under paragraph (c)(4)(i) of
　this section and limited to use at levels not to exceed 2.4 percent by
　weight of such copolymers.
Hexamethylenediamine carbamate for use only as cross-linking agent in
　the vulcanization of vinylidene fluoride-hexafluoropropylene copolymer
　and vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene
　copolymer elastomers identified under paragraph (c)(4)(i) of this
　section and limited to use at levels not to exceed 1.5 percent by weight
　of such copolymers.
Sulfur, ground.

(b) 加硫促進剤　合計で1.5ｗｔ％を越さないこと
　Accelerators (total not to exceed 1.5 percent by weight of
　rubber product).

2-Benzothiazyl-N,N-diethylthiocarbamyl-sulfide.
Benzoyl peroxide.
1,3-Bis(2-benzothiazolylmercaptomethyl) urea.
N-tert-Butyl-2-benzothiazole sulfenamide.
Butyraldehyde-aniline resin (iodine number 670-705).
Carbon disulfide-1,1'-methylenedipiperidine reaction product.
Copper dimethyldithiocarbamate.
N-Cyclohexyl-2-benzothiazole sulfenamide.
Dibenzoyl-p-quinone dioxime.
Dibenzylamine.
Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-
　methylethyl)trithio-bis-thioformate, O,O-di(1-methylethyl)tetrathio-bis-
　thioformate, and O,O-di(1-methylethyl)pentathio-bis-thioformate).
　Di(4-methylbenzoyl) peroxide (CAS Reg. No. 895-85-2) for use only as a
　crosslinking agent in silicone polymers and elastomers identified under
　paragraph (c)(4)(i) of this section at levels not to exceed 1 percent by
　weight of such polymers and elastomers where the total of all
　accelerators does not exceed 1.5 percent by weight of rubber product.
Di-tert-butyl peroxide.
Dibutyl xanthogen disulfide.
2,4-Dichlorobenzoyl peroxide.
Dicumyl peroxide.
N,N-Dimethylcyclohexylamine salt of dibutyldithiocarbamic acid.
2,6-Dimethylmorpholine thiobenzothiazol.
Dipentamethylenethiuram hexasulfide (CAS Reg. No. 971-15-3).
Diphenylguanidine.
Diphenylguanidine phthalate.
1,3-Diphenyl-2-thiourea.
2,2'-Dithiobis[benzothiazole].
4,4'-Dithiodimorpholine.
N,N'-Di-o-tolylguanidine.
Di-o-tolylguanidine salt of pyrocatecholborate.
Ethylenediamine carbamate.
Heptaldehyde-aniline resin (iodine number 430-445).
Hexamethylenetetramine.
2-Mercaptobenzothiazole.
2-Mercaptothiazoline.
N-Oxydiethylene-benzothiazole-2-sulfenamide.
Piperidinium pentamethylenedithiocarba-mate.
Potassium pentamethylenedithiocarbamate.
p-Quinone dioxime.
Sodium dibutyldithiocarbamate.
Sodium dimethyldithiocarbamate.
Stannous oleate for use only as an accelerator for silicone elastomers.
Tetrabutylthiuram monosulfide.
Tetraethylthiuram disulfide.
(1,1,4,4-Tetramethyltetramethylene)bis [tert-butyl peroxide].
Tetramethylthiuram monosulfide.
Thiram (tetramethylthiuram disulfide).
Triallyl cyanurate.
Triethylenetetramine.
1,3,5-Triethyl-hexahydro-s-triazine (triethyltrimethylenetriamine).
Triphenylguanidine.
Zinc butyl xanathate.
Zinc dibenzyl dithiocarbamate.
Zinc dibutyldithiocarbamate.
Zinc diethyldithiocarbamate.
Zinc 2-mercaptobenzothiazole.
Ziram (zinc dimethyldithiocarbamate).

(c)リターダー　合計で1.5ｗｔ％を越さないこと
Retarders (total not to exceed 10 percent of weight of rubber
　product).
Cyanoguanidine.
Phthalic anhydride.
Salicylic acid.

以下　老化防止剤、補強充填剤、軟化剤、その他の項目
とその制限、水、オイルへの溶解度の制限等の項目が続きます。