美国食品接触材料法规清单 (FCM)
发布机构:食品药品监督管理局(FDA)
发布时间:1977-03-15
美国的食品接触材料法规主要由美国食品药品监督管理局(FDA)依据《联邦食品、药品和化妆品法案》(FD&C Act)制定和执行,属于食品接触材料的部分具体列于联邦规章法典第 21条(21CFR)174-186章节。其中包含用于粘合剂,涂层,纸添加剂,聚合物,聚合物助剂,前批准物质,GRAS(一般认为安全的物质)等的食品接触物质清单
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  • 1497
    2-oxiranone, 3-methylene, homopolymer (CAS Reg. No. 56385-15-0).
    Kemira Oyj
    Kemira Oyj
    名录数据
    FCN编号

    1497

    英文名称

    2-oxiranone, 3-methylene, homopolymer (CAS Reg. No. 56385-15-0).

    通告人

    Kemira Oyj

    生产商

    Kemira Oyj

    预期用途

    For use as a peroxide stabilizer in the mechanical bleaching process of pulp used to manufacture food-contact paper and paperboard, except for use in contact with infant formula and breast milk (see Limitations/Specifications).

    使用限制和规格

    The paper and paperboard containing the FCS may contact all food types under Conditions of Use B through H, as described in Tables 1 and 2. The finished product is not for use in contact with infant formula and breast milk. Such uses are not included as part of the intended use of the substance in the FCN.

    生效日期

    04/04/2015

  • 56
    Petroleum hydrocarbon resins (cyclopentadiene-type), hydrogenated (CAS Reg. Name Naptha (petroleum), light steam-cracked, debenzenized, polymers, hydrogenated (CAS Reg. No. 68132-00-3).
    ExxonMobil Chemical Company
    ExxonMobil Product Solutions Company
    名录数据
    FCN编号

    56

    英文名称

    Petroleum hydrocarbon resins (cyclopentadiene-type), hydrogenated (CAS Reg. Name Naptha (petroleum), light steam-cracked, debenzenized, polymers, hydrogenated (CAS Reg. No. 68132-00-3).

    通告人

    ExxonMobil Chemical Company

    生产商

    ExxonMobil Product Solutions Company

    预期用途

    1. As a component of adhesive formulations complying with 21 CFR 175.125; 2. As a component of resinous and polymeric coatings complying with 21 CFR 175.320; 3. As a component of can-end cement formulations complying with 21 CFR 175.300(b)(3)(xxxi); 4. As a component of coatings for paper and paperboard complying with 21 CFR 176.170 and 21 CFR 176.180; 5. As a component of adhesives for seals of food-contact, glass containers complying with 21 CFR 177.1210.

    使用限制和规格

    At levels not to exceed 60 percent by weight of total polymer/formulation weight in contact with all types of food under Conditions of Use B throught H, as described in Table 2. The average thickness of polyolefin films containing the food contact substance should not exceed 1.25 mils (0.00125 inch).

    生效日期

    08/24/2000

  • 1498
    Copolymer of ethylene glycol dimethacrylate, butyl methacrylate, and glycidyl methacrylate (CAS Reg. No. 133396-60-8).
    Alcresta Inc.
    Alcresta Inc.
    名录数据
    FCN编号

    1498

    英文名称

    Copolymer of ethylene glycol dimethacrylate, butyl methacrylate, and glycidyl methacrylate (CAS Reg. No. 133396-60-8).

    通告人

    Alcresta Inc.

    生产商

    Alcresta Inc.

    预期用途

    As a fixing agent for the immobilization of lipase enzyme preparations.

    使用限制和规格

    The FCS-enzyme complex will be used at a level not to exceed 3.0 g of FCS-enzyme complex/person/day in contact with food type IV-B under Condition of Use E as described in Tables 1 and 2. The use is limited to supplemental enteral nutrition applications only. The FCS-enzyme complex is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.

    生效日期

    01/20/2015

  • 57
    Aromatic modified aliphatic hydrocarbon resin. The FCS is also known as aromatic modified petroleum hydrocarbon resin. (CAS Reg. No. 68527-25-3).
    ExxonMobil Chemical Company
    ExxonMobil Product Solutions Company
    名录数据
    FCN编号

    57

    英文名称

    Aromatic modified aliphatic hydrocarbon resin. The FCS is also known as aromatic modified petroleum hydrocarbon resin. (CAS Reg. No. 68527-25-3).

    通告人

    ExxonMobil Chemical Company

    生产商

    ExxonMobil Product Solutions Company

    预期用途

    1. As a component of adhesive formulations complying with 21 CFR 175.105 and 21 CFR 175.125; 2. As a component of resinous and polymeric coatings complying with 21 CFR 175.320 applied to polyolefin films complying with 21 CFR 175.1520(c); 3. As a component of can-end cement formulations complying with 21 CFR 175.300(b)(3)(xxxi); 4. As a component of coatings for paper and paperboard complying with 21 CFR 176.170 and 21 CFR 176.180; 5. As a component of adhesives for seals of food-contact, glass containers complying with 21 CFR 177.1210 and 21 CFR 175.105.

    使用限制和规格

    At levels not to exceed 60 percent by weight of total polymer/formulation weight in contact with all types of food under Conditions of Use B through H, as described in Table 2.

    生效日期

    08/24/2000

  • 1499
    2-Propenoic acid, 2-methyl-, methyl ester, polymer with 1,3-butadiene, diethenylbenzene, ethenylbenzene and ethyl 2-propenoate (CAS Reg. No. 59858-50-3).
    The Dow Chemical Company
    The Dow Chemical Company
    名录数据
    FCN编号

    1499

    英文名称

    2-Propenoic acid, 2-methyl-, methyl ester, polymer with 1,3-butadiene, diethenylbenzene, ethenylbenzene and ethyl 2-propenoate (CAS Reg. No. 59858-50-3).

    通告人

    The Dow Chemical Company

    生产商

    The Dow Chemical Company

    预期用途

    As articles or components of articles intended for repeat use in contact with food, except for use in contact with infant formula and breast milk (see Limitations and Specifications).

    使用限制和规格

    The FCS is composed of a minimum of 60 weight percent of the polymer consisting of styrene and butadiene with the balance of the polymer consisting of one or more of the following monomers: Dinvinylbenzene <3%; Ethyl acrylate 0-5%; and Methyl methacrylate <25%. The FCS may be used in contact with all food types under Conditions of Use E through G as described in Tables 1 and 2, respectively. The FCS is not for use in contact with infant formula and breast milk. Such use was not included as part of the intended use of the substance in the FCN.

    生效日期

    04/02/2015

  • 58
    2,2'-Methylenebis(4,6-di-tert-butylphenyl) 2-ethylhexyl phosphite (CAS Reg. No. 126050-54-2).
    Asahi Denka Kogyo K.K.
    Asahi Denka Kogyo K.K.
    名录数据
    FCN编号

    58

    英文名称

    2,2'-Methylenebis(4,6-di-tert-butylphenyl) 2-ethylhexyl phosphite (CAS Reg. No. 126050-54-2).

    通告人

    Asahi Denka Kogyo K.K.

    生产商

    Asahi Denka Kogyo K.K.

    预期用途

    As an antioxidant and/or stabilizer in styrene-butadiene block polymers.

    使用限制和规格

    The food contact substance shall be used at levels not to exceed 0.20 percent by weight of styrene-butadiene block polymers complying with the specifications in 21 CFR 177.1810(b), item 1(i), when tested by the methods described in 21 CFR 177.1810(c). The finished copolymers may only be used in contact with food typesI, II, IV-B, VI, VII-B and VIII under conditions of use D through G as described in Tables 1 and 2.

    生效日期

    06/29/2000

  • 1500
    2-Propenoic acid, polymer with butyl 2-propenoate, ethenylbenzene, N-(hydroxymethyl)-2-methyl-2-propenamide and 2-methyl-2-propenamide (CAS Reg. No. 71477-85-5)
    BASF SE
    BASF SE
    名录数据
    FCN编号

    1500

    英文名称

    2-Propenoic acid, polymer with butyl 2-propenoate, ethenylbenzene, N-(hydroxymethyl)-2-methyl-2-propenamide and 2-methyl-2-propenamide (CAS Reg. No. 71477-85-5)

    通告人

    BASF SE

    生产商

    BASF SE

    预期用途

    As a pigment binder in coatings on paper and paperboard intended to contact food, except for use in contact with infant formula and breast milk (see Limitations/Specifications).

    使用限制和规格

    The FCS may be used at a level not to exceed 6 percent by weight of the final food contact paper and paperboard. Paper containing the FCS may be used in contact with all food types, excepting VI (beverages), under Conditions of Use C through G, as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.

    生效日期

    05/05/2015

  • 60
    GENOXTM EP, chemically identified as amines, bis(hydrogenated rape-oil alkyl)methyl, N-oxides (CAS Reg. No. 204933-93-7).
    Addivant
    Addivant
    名录数据
    FCN编号

    60

    英文名称

    GENOXTM EP, chemically identified as amines, bis(hydrogenated rape-oil alkyl)methyl, N-oxides (CAS Reg. No. 204933-93-7).

    通告人

    Addivant

    生产商

    Addivant

    预期用途

    As an antioxidant in the manufacture of polypropylene homopolymer and copolymers complying with 21 CFR 177.1520.

    使用限制和规格

    The FCS will be used at levels not to exceed 0.1 weight percent in polypropylene homopolymers and copolymers. The finished homopolymers and copolymers may be used in contact with food types III, IV-A, V, VII-A, and IX (i.e., fatty foods) and VI-C (foods containing up to 15 percent alcohol), under Conditions of Use B through H as described in Tables 1 and 2, respectively.

    生效日期

    07/15/2000

  • 1501
    An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidine-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).
    Arkema Inc.
    Arkema Inc. and Biosafe Systems
    名录数据
    FCN编号

    1501

    英文名称

    An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidine-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).

    通告人

    Arkema Inc.

    生产商

    Arkema Inc. and Biosafe Systems

    预期用途

    As an antimicrobial to control microorganisms in process water and ice used in the production and preparation of poultry, shell eggs, meat, processed and pre-formed meat and poultry, fish and seafood, and fruits and vegetables.

    使用限制和规格

    The components of the FCS mixture will not exceed: (1) 2000 ppm peroxyacetic acid (PAA), 933 ppm hydrogen peroxide (HP), and 120 ppm 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) in spray, wash, rinse, dip, chiller water, low-temperature (e.g., less than 40°F) immersion baths, scald water for whole or cut poultry carcasses, parts, trim, skin on or off, and organs, and shell egg washes; (2) 400 ppm PAA, 187 ppm HP, and 24 ppm HEDP in process water or ice used for washing, rinsing, storing, or cooling whole or cut meat, including carcasses, parts, trim, and organs; (3) 230 ppm PAA, 107 ppm HP, and 14 ppm HEDP in process water, ice, or brine used for washing, rinsing, storing, or cooling of processed and pre-formed meat as defined in 21 CFR 170.3(n)(29) and poultry as defined in 21 CFR 170.3(n)(34); (4) 230 ppm PAA, 107 ppm HP, and 14 ppm HEDP in process water or ice used during commercial preparation of fish and seafood; and (5) 80 ppm PAA, 37 ppm HP, and 5 ppm HEDP in process water for washing or chilling fruits and vegetables in food processing facilities.

    生效日期

    03/21/2015

  • 62
    Amorphous hydrogenated carbon coating produced from acetylene as the carbon source in a microwave plasma. The coating is formed at reduced pressure with 0.1 mbar acetylene using microwave energy, followed by an air rinse.
    Sidel S.A. (ACTIS Technology)
    Sidel S.A. (ACTIS Technology)
    名录数据
    FCN编号

    62

    英文名称

    Amorphous hydrogenated carbon coating produced from acetylene as the carbon source in a microwave plasma. The coating is formed at reduced pressure with 0.1 mbar acetylene using microwave energy, followed by an air rinse.

    通告人

    Sidel S.A. (ACTIS Technology)

    生产商

    Sidel S.A. (ACTIS Technology)

    预期用途

    A technology used to produce an amorphous hydrogenated carbon coating for food-contact containers to provide an improved barrier to permeation of the polyethylene terephthalate (PET) bottle by oxygen, carbon dioxide, and other substances.

    使用限制和规格

    The amorphous hydrongenated carbon coating is intended for use at a level not to exceed approximately 0.15 microns thick (0.006 mil) and may be used in contact with food types I through IX, under Conditions of Use A through H, as described in Tables 1 and 2.

    生效日期

    07/19/2000

所有类型的食品接触材料都需要列入 21 CFR对应用途的法规清单中,并符合相应的规格和测试要求。
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