fda21cfr法规全文

A. 谁有FDA 21CFR123法规的资料信息

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION PART 123 FISH AND FISHERY PRODUCTS

Subpart A--General Provisions
§ 123.3 - Definitions.
§ 123.5 - Current good manufacturing practice.
§ 123.6 - Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
§ 123.7 - Corrective actions.
§ 123.8 - Verification.
§ 123.9 - Records.
§ 123.10 - Training.
§ 123.11 - Sanitation control proceres.
§ 123.12 - Special requirements for imported procts.

Subpart B--Smoked and Smoke-Flavored Fishery Procts
§ 123.15 - General.
§ 123.16 - Process controls.

Subpart C--Raw Molluscan Shellfish
§ 123.20 - General.
§ 123.28 - Source controls.

B. 美国法规21CFR,174-179的内容

您好，我只有英文版的。
§174 General provisions applicable to indirect food additives.
(a) Regulations prescribing conditions under which food additive substances may be safely used predicate usage under conditions of good manufacturing practice. For the purpose of this part and parts 175, 176, and 177 of this chapter, good manufacturing practice shall be defined to include the following restrictions:
(1) The quantity of any food additive substance that may be added to food as a result of use in articles that contact food shall not exceed, where no limits are specified, that which results from use of the substance in an amount not more than reasonably required to accomplish the intended physical or technical effect in the food-contact article; shall not exceed any prescribed limitations; and shall not be intended to accomplish any physical or technical effect in the food itself, except as such may be permitted by regulations in parts 170 through 189 of this chapter.
(2) Any substance used as a component of articles that contact food shall be of a purity suitable for its intended use.
(b) The existence in the subchapter B of a regulation prescribing safe conditions for the use of a substance as an article or component of articles that contact food shall not be construed to relieve such use of the substance or article from compliance with any other provision of the Federal Food, Drug, and Cosmetic Act. For example, if a regulated food-packaging material were found on appropriate test to impart odor or taste to a specific food proct such as to render it unfit within the meaning of section 402(a)(3) of the Act, the regulation would not be construed to relieve such use from compliance with section 402(a)(3).
(c) The existence in this subchapter B of a regulation prescribing safe conditions for the use of a substance as an article or component of articles that contact food shall not be construed as implying that such substance may be safely used as a direct additive in food.
(d) Substances that under conditions of good manufacturing practice may be safely used as components of articles that contact food include the following, subject to any prescribed limitations:
(1) Substances generally recognized as safe in or on food.
(2) Substances generally recognized as safe for their intended use in food packaging.
(3) Substances used in accordance with a prior sanction or approval.
(4) Substances permitted for use by regulations in this part and parts 175, 176, 177, 178 and §179.45 of this chapter.
(5) Food contact substances used in accordance with an effective premarket notification for a food contact substance (FCN) submitted under section 409(h) of the act.
[42 FR 14534, Mar. 15, 1977, as amended at 67 FR 35731, May 21, 2002]

§174.6 Threshold of regulation for substances used in food-contact articles.
Substances used in food-contact articles (e.g., food-packaging or food-processing equipment) that migrate, or that may be expected to migrate, into food at negligible levels may be reviewed under §170.39 of this chapter. The Food and Drug Administration will exempt substances whose uses it determines meet the criteria in §170.39 of this chapter from regulation as food additives and, therefore, a food additive petition will not be required for the exempted use.
[60 FR 36596, July 17, 1995]

§175.105 Adhesives.
(a) Adhesives may be safely used as components of articles intended for use in packaging, transporting, or holding food in accordance with the following prescribed conditions:
(1) The adhesive is prepared from one or more of the optional substances named in paragraph (c) of this section, subject to any prescribed limitations.
(2) The adhesive is either separated from the food by a functional barrier or used subject to the following additional limitations:
(i) In dry foods. The quantity of adhesive that contacts packaged dry food shall not exceed the limits of good manufacturing practice.
(ii) In fatty and aqueous foods. (a) The quantity of adhesive that contacts packaged fatty and aqueous foods shall not exceed the trace amount at seams and at the edge exposure between packaging laminates that may occur within the limits of good manufacturing practice.
(b) Under normal conditions of use the packaging seams or laminates will remain firmly bonded without visible separation.
(b) To assure safe usage of adhesives, the label of the finished adhesive container shall bear the statement “food-packaging adhesive”.
(c) Subject to any limitation prescribed in this section and in any other regulation promulgated under section 409 of the Act which prescribes safe conditions of use for substances that may be employed as constituents of adhesives, the optional substances used in the formulation of adhesives may include the following:
(1) Substances generally recognized as safe for use in food or food packaging.
(2) Substances permitted for use in adhesives by prior sanction or approval and employed under the specific conditions of use prescribed by such sanction or approval.
(3) Flavoring substances permitted for use in food by regulations in this part, provided that such flavoring substances are volatilized from the adhesives ring the packaging fabrication process.
(4) Color additives approved for use in food.
(5) Substances permitted for use in adhesives by other regulations in this subchapter and substances named in this subparagraph: Provided, however, That any substance named in this paragraph and covered by a specific regulation in this subchapter, must meet any specifications in such regulation.

Substances
Limitations

Abietic acid
Acetone
Acetone-formaldehyde condensate (CAS Reg. No. 25619-09-4)
Acetone-urea-formaldehyde resin
N-Acetyl ethanolamine
Acetyl tributyl citrate
Acetyl triethyl citrate
2-Acrylamido-2-methyl-propanesulfonic acid, homopolymer, sodium salt (CAS Reg. No. 35641-59-9)
Albumin, blood
(2-Alkenyl) succinic anhydrides in which the alkenyl groups are derived from olefins which contain not less than 78 percent C30 and higher groups (CAS Reg. No. 70983-55-0)
4-[2-[2-2-(Alkoxy (C12-C15) ethoxy) ethoxy]ethyl] disodium sulfosuccinate
1-Alkyl (C6-C18) amino-3-amino-propane monoacetate
Alkylated (C4 and/or C8) phenols
Alkyl (C7-C12) benzene
Alkyl (C10-C20) dimethylbenzyl ammonium chloride
n-Alkyl(C12, C14, C16, or C18) dimethyl (ethylbenzyl) ammonium cyclohexylsulfamate For use as preservative only.
Alkyl ketene dimers as described in §176.120 of this chapter
Alkyl (C7-C12) naphthalene
alpha Olefin sulfonate [alkyl group is in the range of C10-C18 with not less than 50 percent C14-C16], ammonium, calcium, magnesium, potassium, and sodium salts
2-[(2-aminoethyl)amino]ethanol (CAS Reg. No. 111-41-1)
3-Aminopropanediol For use only in the preparation of polyurethane resins.

C. 什么是 FDA 21 CFR PART 11

FDA 《联邦法规21章》第11款，主要规定内容涉及电子记录和电子签名
CFR--Code of Federal Regulations ;
PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES 。详细内容请查看FDA官方网站。

D. FDA 21 CFR 177.1520

FDA 21 CFR 177.1520 FOR PP 这是FDA里，与食品接触材料安全指令的PP材料检测标准；测试熔点、密度、正已烷浸取、二甲苯浸取。

产品有复有OPP膜，那与食品接触的就是PP，做PDA的话，是按照标准FDA 21 CFR 177.1520 没错；如果测试没过的话，那就是PP达不到要求。

E. FDA cfr21 和制药相关的部分 求 下载地址

你这个问题也太广了，制药相关，范围有点大唉~
CFR跟食品药品相关的部分在FDA网站上都可以查到：
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
你想要看哪一节的内容，在中间的框中输入相应数字，点下面的search即可。其中，200开始是跟药品有关的章节，GMP是210，211和212，在网上也很容易能找到翻译版的~
内容相当多，希望你能找到你想要的~

F. FDA的21CFR是什么意思，和CGMP有什么关系

CFR是Code federal regulation,美国联邦法律，21指第二十一部分，这一部分是有关食品药品法律。CGMP也是属于这一部分的。

G. 请问FDA CFR21 是什么意思

FDA是指美国食品药品管理局。是专门从事食品与药品管理的最高执法机关，也是一个由医生、律师、微生物学家、化学家和统计学家等专业人士组成的致力于保护、促进和提高国民健康的政府卫生管制的监控机构。

CFR21是美国联邦法规第21条，有关食品、药品的认证标准。

(7)fda21cfr法规全文扩展阅读：

按照《美国第107-188公共法》 必须向FDA登记的外国食品生产加工企业如下：

1、 酒和含酒类饮料；

2、婴儿及儿童食品；

3、 面包糕点类；

4、 饮料；

5、 糖果类（包括口香糖）；

6、 麦片和即食麦片类；

7、 奶酪和奶酪制品；

8、 巧克力和可可类食品；

9、 咖啡和茶叶产品；

10、 食品用色素；

11、 减肥常规食品和药用食品、肉替代品；

12、 补充食品（即国内的健康食品、维生素类药品以及中草药制品）；

13、 调味品；

14、 鱼类和海产品；

15、 往食品里置放和直接与食品接触的材料物质及制品；

16、 食品添加剂和安全的配料类食用品；

17、 食品代糖；

18、 水果和水果产品；

19、 食用胶、乳酶、布丁和馅；

20、 冰激淋和相关食品；

21、 仿奶制品；

22、 通心粉和面条；

23、 肉、肉制品和家禽产品；

24、 奶、黄油和干奶制品；

25、 正餐食品和卤汁、酱类和特色制品；

26、 干果和果仁；

27、 带壳蛋和蛋制品；

28、 点心（面粉、肉和蔬菜类）；

29、 辣椒、特味品和盐等；

30、 汤类；

31、 软饮料和罐装水；

32、 蔬菜和蔬菜制品；

33、 菜油（包括橄榄油）；

34、 蔬菜蛋白产品（方肉类食品）；

35、 全麦食品和面粉加工的食品、淀粉等；

36、 主要或全部供人食用的产品。

H. FDA CFR 21 175-189

美国具体对与食品接触容器及材料的通用要求：
－ 厂家能够依照GMP体系（卫生生产质量管理程序及规范）运作
－ 使用符合法规中批准的材料(U.S. FDA CFR 21 Part 170－189)
－ 批准的材料应符合规范中的技术指标(U.S. FDA CFR Part 170－189)
－ 任何进入市场的新材料必须经U.S. FDA审核及认可(与欧盟新的食品级法规2004/1935/EC相类似)

I. 如何进行 fda 21 cfr part 11 认证

实际应用常以 符合FDA 21 CFR Part 11 方式表达。食品、医药制造行业多遵照此标准。只有遵照此标准，其厂商生产的产品才可以正常销往国外市场，并且遵照此标准而保留的数据才可以作为通过检验或者今后追溯的有效数据来源。现在很多大型自动化控制系统已经符合此标准规定。此法规确保了电子数据的有效性和可靠性。

J. 美国FDACFR21规定指的是什么

1、FDA，全称 Food and Drug Administration ，也就是美国食品和药物管理局。

2、CFR21，是美国FDA的食品法规，也就是《美国联邦管理法规》的第21篇，其内容规定了食品级材料的标准，不同的产品依据该标准的不同部分：
*食品级聚丙烯(PP).FDA 21CFR 177.1520
*食品级聚乙烯(PE)FDA 21CFR 177.1520.
*食品级烯烃聚合物(OP)FDA 21CFR 177.1520
*食品级聚苯乙烯.(PS)FDA 21 CFR 177.1640
*与食品接触的树酯和聚合体涂层FDA 21CFR 175.300
*有封垫圈的食物容器盖FDA 21CFR 177.1210
*食品级乙烯-乙酸乙烯酯共聚物(EVA) FDA 21CFR 177.1350
*食品级三聚氰胺甲醛树脂FDA 21CFR 177.1460
*食品级尼龙树脂FDA 21CFR 177.1500
*食品级聚对苯二甲酸乙二脂(PET). FDA 21CFR 177.1630.
*食品级聚碳酸酯(PC) FDA 21CFR 177.1580
*食品级橡胶.FDA 21CFR 177.2600
*与食品接触的纸张及纸板之组件.FDA 21CFR 176.170
*食品级聚酯树脂FDA 21CFR 177.2420
*食品级丙烯腈/丁二烯/苯乙烯共聚物(ABS) FDA 21 CFR 177.1020
*食品级氯乙烯/月桂基乙烯基醚共聚物FDA 21 CFR 177.1970
*食品级聚醚砜树脂 FDA 21 CFR 177.2440.
*食品级聚酰胺/亚胺树脂.FDA 21 CFR 177.2450.
*食品级丙烯腈-苯乙烯树脂(AS) FDA 21 CFR 177.1040
*食品级聚氧亚甲基共聚物(POM聚甲醛)FDA 21 CFR 177.2470.
* 食品级丙烯腈-丁二烯-苯乙烯FDA 21 CFR 188.22 & 181.32等：
其他食品容器 CPG
- 7117.05：银/镀银器皿;
- 7117.06 & 7117.07：玻璃器皿/陶瓷制品/搪瓷器皿;
- 加利福尼亚提案65：玻璃器皿/陶瓷制品/搪瓷器皿

3、更多详细内容，请参阅网络文库：
http://wenku..com/view/fae27fd20508763231121274.html