fda21cfr法規全文

A. 誰有FDA 21CFR123法規的資料信息

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. 美國法規21CFR,174-179的內容

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. 什麼是 FDA 21 CFR PART 11

FDA 《聯邦法規21章》第11款，主要規定內容涉及電子記錄和電子簽名
CFR--Code of Federal Regulations ;
PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES 。詳細內容請查看FDA官方網站。

D. FDA 21 CFR 177.1520

FDA 21 CFR 177.1520 FOR PP 這是FDA里，與食品接觸材料安全指令的PP材料檢測標准；測試熔點、密度、正已烷浸取、二甲苯浸取。

產品有復有OPP膜，那與食品接觸的就是PP，做PDA的話，是按照標准FDA 21 CFR 177.1520 沒錯；如果測試沒過的話，那就是PP達不到要求。

E. FDA cfr21 和制葯相關的部分 求 下載地址

你這個問題也太廣了，制葯相關，范圍有點大唉~
CFR跟食品葯品相關的部分在FDA網站上都可以查到：
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
你想要看哪一節的內容，在中間的框中輸入相應數字，點下面的search即可。其中，200開始是跟葯品有關的章節，GMP是210，211和212，在網上也很容易能找到翻譯版的~
內容相當多，希望你能找到你想要的~

F. FDA的21CFR是什麼意思，和CGMP有什麼關系

CFR是Code federal regulation,美國聯邦法律，21指第二十一部分，這一部分是有關食品葯品法律。CGMP也是屬於這一部分的。

G. 請問FDA CFR21 是什麼意思

FDA是指美國食品葯品管理局。是專門從事食品與葯品管理的最高執法機關，也是一個由醫生、律師、微生物學家、化學家和統計學家等專業人士組成的致力於保護、促進和提高國民健康的政府衛生管制的監控機構。

CFR21是美國聯邦法規第21條，有關食品、葯品的認證標准。

(7)fda21cfr法規全文擴展閱讀：

按照《美國第107-188公共法》 必須向FDA登記的外國食品生產加工企業如下：

1、 酒和含酒類飲料；

2、嬰兒及兒童食品；

3、 麵包糕點類；

4、 飲料；

5、 糖果類（包括口香糖）；

6、 麥片和即食麥片類；

7、 乳酪和乳酪製品；

8、 巧克力和可可類食品；

9、 咖啡和茶葉產品；

10、 食品用色素；

11、 減肥常規食品和葯用食品、肉替代品；

12、 補充食品（即國內的健康食品、維生素類葯品以及中草葯製品）；

13、 調味品；

14、 魚類和海產品；

15、 往食品里置放和直接與食品接觸的材料物質及製品；

16、 食品添加劑和安全的配料類食用品；

17、 食品代糖；

18、 水果和水果產品；

19、 食用膠、乳酶、布丁和餡；

20、 冰激淋和相關食品；

21、 仿奶製品；

22、 通心粉和面條；

23、 肉、肉製品和家禽產品；

24、 奶、黃油和干奶製品；

25、 正餐食品和鹵汁、醬類和特色製品；

26、 乾果和果仁；

27、 帶殼蛋和蛋製品；

28、 點心（麵粉、肉和蔬菜類）；

29、 辣椒、特味品和鹽等；

30、 湯類；

31、 軟飲料和罐裝水；

32、 蔬菜和蔬菜製品；

33、 菜油（包括橄欖油）；

34、 蔬菜蛋白產品（方肉類食品）；

35、 全麥食品和麵粉加工的食品、澱粉等；

36、 主要或全部供人食用的產品。

H. FDA CFR 21 175-189

美國具體對與食品接觸容器及材料的通用要求：
－ 廠家能夠依照GMP體系（衛生生產質量管理程序及規范）運作
－ 使用符合法規中批準的材料(U.S. FDA CFR 21 Part 170－189)
－ 批準的材料應符合規范中的技術指標(U.S. FDA CFR Part 170－189)
－ 任何進入市場的新材料必須經U.S. FDA審核及認可(與歐盟新的食品級法規2004/1935/EC相類似)

I. 如何進行 fda 21 cfr part 11 認證

實際應用常以 符合FDA 21 CFR Part 11 方式表達。食品、醫葯製造行業多遵照此標准。只有遵照此標准，其廠商生產的產品才可以正常銷往國外市場，並且遵照此標准而保留的數據才可以作為通過檢驗或者今後追溯的有效數據來源。現在很多大型自動化控制系統已經符合此標准規定。此法規確保了電子數據的有效性和可靠性。

J. 美國FDACFR21規定指的是什麼

1、FDA，全稱 Food and Drug Administration ，也就是美國食品和葯物管理局。

2、CFR21，是美國FDA的食品法規，也就是《美國聯邦管理法規》的第21篇，其內容規定了食品級材料的標准，不同的產品依據該標準的不同部分：
*食品級聚丙烯(PP).FDA 21CFR 177.1520
*食品級聚乙烯(PE)FDA 21CFR 177.1520.
*食品級烯烴聚合物(OP)FDA 21CFR 177.1520
*食品級聚苯乙烯.(PS)FDA 21 CFR 177.1640
*與食品接觸的樹酯和聚合體塗層FDA 21CFR 175.300
*有封墊圈的食物容器蓋FDA 21CFR 177.1210
*食品級乙烯-乙酸乙烯酯共聚物(EVA) FDA 21CFR 177.1350
*食品級三聚氰胺甲醛樹脂FDA 21CFR 177.1460
*食品級尼龍樹脂FDA 21CFR 177.1500
*食品級聚對苯二甲酸乙二脂(PET). FDA 21CFR 177.1630.
*食品級聚碳酸酯(PC) FDA 21CFR 177.1580
*食品級橡膠.FDA 21CFR 177.2600
*與食品接觸的紙張及紙板之組件.FDA 21CFR 176.170
*食品級聚酯樹脂FDA 21CFR 177.2420
*食品級丙烯腈/丁二烯/苯乙烯共聚物(ABS) FDA 21 CFR 177.1020
*食品級氯乙烯/月桂基乙烯基醚共聚物FDA 21 CFR 177.1970
*食品級聚醚碸樹脂 FDA 21 CFR 177.2440.
*食品級聚醯胺/亞胺樹脂.FDA 21 CFR 177.2450.
*食品級丙烯腈-苯乙烯樹脂(AS) FDA 21 CFR 177.1040
*食品級聚氧亞甲基共聚物(POM聚甲醛)FDA 21 CFR 177.2470.
* 食品級丙烯腈-丁二烯-苯乙烯FDA 21 CFR 188.22 & 181.32等：
其他食品容器 CPG
- 7117.05：銀/鍍銀器皿;
- 7117.06 & 7117.07：玻璃器皿/陶瓷製品/搪瓷器皿;
- 加利福尼亞提案65：玻璃器皿/陶瓷製品/搪瓷器皿

3、更多詳細內容，請參閱網路文庫：
http://wenku..com/view/fae27fd20508763231121274.html