美国FDA的食品添加剂使用卫生标准.doc

[Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2006] [CITE: 21CFR171] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED) PART 171 FOOD ADDITIVE PETITIONS Subpart A--General Provisions Sec. 171.1 Petitions. (a) Petitions to be filed with the Commissioner under the provisions of section 409(b) of the Federal Food, Drug, and Cosmetic Act (the act) shall be submitted in triplicate (quadruplicate, if intended uses include use in meat, meat food product, or poultry product). If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall state petitioners post office address to which published notices or orders issued or objections filed pursuant to section 409 of the Act may be sent. (b) Pertinent information may be incorporated in, and will be considered as part of, a petition on the basis of specific reference to such information submitted to and retained in the files of the Food and Drug Administration. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized in a written statement signed by the person who submitted it. Any reference to published information offered in support of a food additive petition should be accompanied by reprints or photostatic copies of such references. (c) Petitions shall include the following data and be submitted in the following form: (Date) Name of petitioner Post-office address Date Name of food additive and proposed use ______________________________________________________________ Petitions Control Branch Food and Drug Administration Department of Health and Human Services Washington, DC 20204. Dear Sirs: The undersigned, _____ submits this petition pursuant to section 409(b)(1) of the