美国FDA的食品添加剂使用卫生标准Word格式.docx

1、 21CFR171 TITLE 21-FOOD AND DRUGSCHAPTER I-FOOD AND DRUG ADMINISTRATIONDEPARTMENT 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

2、 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 accompani

3、ed 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

4、 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 However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is

5、 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 i

6、n the following form:（Date）Name of petitionerPost-office addressDateName of food additive and proposed use_Petitions Control BranchFood and Drug AdministrationDepartment of Health and Human ServicesWashington, DC 20204.Dear Sirs:The undersigned, _ submits this petition pursuant to section 409（b）（1）

7、of the Federal Food, Drug, and Cosmetic Act with respect to _（Name of the food additive and proposed use）Attached hereto, in triplicate （quadruplicate, if intended uses include use in meat, meat food product, or poultry product）, and constituting a part of this petition are the following:A. The name

8、 and all pertinent information concerning the food additive, including chemical identity and composition of the food additive, its physical, chemical, and biological properties, and specifications prescribing the minimum content of the desired component（s） and identifying and limiting the reaction b

9、yproducts and other impurities. Where such information is not available, a statement as to the reasons why it is not should be submitted.When the chemical identity and composition of the food additive is not known, the petition shall contain information in sufficient detail to permit evaluation rega

10、rding the method of manufacture and the analytical controls used during the various stages of manufacturing, processing, or packing of the food additive which are relied upon to establish that it is a substance of reproducible composition. Alternative methods and controls and variations in methods a

11、nd controls within reasonable limits that do not affect the characteristics of the substance or the reliability of the controls may be specified.If the food additive is a mixture of chemicals, the petition shall supply a list of all substances used in the synthesis, extraction, or other method of pr

12、eparation, regardless of whether they undergo chemical change in the process. Each substance should be identified by its common English name and complete chemical name, using structural formulas when necessary for specific identification. If any proprietary preparation is used as a component, the pr

13、oprietary name should be followed by a complete quantitative statement of composition. Reasonable alternatives for any listed substance may be specified.If the petitioner does not himself perform all the manufacturing, processing, and packing operations for a food additive, the petition shall identi

14、fy each person who will perform a part of such operations and designate the part.The petition shall include stability data, and, if the data indicate that it is needed to insure the identity, strength, quality, or purity of the additive, the expiration date that will be employed.B. The amount of the

15、 food additive proposed for use and the purposes for which it is proposed, together with all directions, recommendations, and suggestions regarding the proposed use, as well as specimens of the labeling proposed for the food additive and any labeling that will be required by applicable provisions of

16、 the Federal Food, Drug, and Cosmetic Act on the finished food by reason of the use of the food additive. If the additive results or may reasonably be expected to result from the use of packaging material, the petitioner shall show how this may occur and what residues may reasonably be anticipated.（

17、Typewritten or other draft-labeling copy will be accepted for consideration of the petition, provided a statement is made that final printed labeling identical in content to the draft copy will be submitted as soon as available and prior to the marketing of the food additive.）（If the food additive i

18、s one for which a tolerance limitation is required to assure its safety, the level of use proposed should be no higher than the amount reasonably required to accomplish the intended physical or other technical effect, even though the safety data may support a higher tolerance.）C. Data establishing t

19、hat the food additive will have the intended physical or other technical effect or that it may reasonably be expected to become a component, or to affect the characteristics, directly or indirectly, of food and the amount necessary to accomplish this. These data should include information in suffici

20、ent detail to permit evaluation with control data.D. A description of practicable methods to determine the amount of the food additive in the raw, processed, and/or finished food and of any substance formed in or on such food because of its use. The test proposed shall be one that can be used for fo

21、od-control purposes and that can be applied with consistent results by any properly equipped and trained laboratory personnel.E. Full reports of investigations made with respect to the safety of the food additive.（A petition may be regarded as incomplete unless it includes full reports of adequate t

22、ests reasonably applicable to show whether or not the food additive will be safe for its intended use. The reports ordinarily should include detailed data derived from appropriate animal and other biological experiments in which the methods used and the results obtained are clearly set forth. The pe

23、tition shall not omit without explanation any reports of investigations that would bias an evaluation of the safety of the food additive.）F. Proposed tolerances for the food additive, if tolerances are required in order to insure its safety. A petitioner may include a proposed regulation.G. If submi

24、tting petition to modify an existing regulation issued pursuant to section 409（c）（1）（A） of the Act, full information on each proposed change that is to be made in the original regulation must be submitted. The petition may omit statements made in the original petition concerning which no change is p

25、roposed. A supplemental petition must be submitted for any change beyond the variations provided for in the original petition and the regulation issued on the basis of the original petition.H. The petitioner is required to submit either a claim for categorical exclusion under 25.30 or 25.32 of this

26、chapter or an environmental assessment under 25.40 of this chapter.Yours very truly,PetitionerBy（Indicate authority）（d） The petitioner will be notified of the date on which his petition is filed; and an incomplete petition, or one that has not been submitted in triplicate, will usually be retained b

27、ut not filed as a petition under section 409 of the Act. The petitioner will be notified in what respects his petition is incomplete.（e） The petition must be signed by the petitioner or by his attorney or agent, or （if a corporation） by an authorized official.（f） The data specified under the several

28、 lettered headings should be submitted on separate sheets or sets of sheets, suitably identified. If such data have already been submitted with an earlier application, the present petition may incorporate it by specific reference to the earlier. If part of the data have been submitted by the manufac

29、turer of the food additive as a master file, the petitioner may refer to the master file if and to the extent he obtains the manufacturers written permission to do so. The manufacturer may authorize specific reference to the data without disclosure to the petitioner. Nothing herein shall prevent ref

30、erence to published data.（g） A petition shall be retained but shall not be filed if any of the data prescribed by section 409（b） of the Act are lacking or are not set forth so as to be readily understood.（h）（1） The following data and information in a food additive petition are available for public d

31、isclosure, unless extraordinary circumstances are shown, after the notice of filing of the petition is published in the Federal Register or, if the petition is not promptly filed because of deficiencies in it, after the petitioner is informed that it will not be filed because of the deficiencies inv

32、olved:（i） All safety and functionality data and information submitted with or incorporated by reference in the petition.（ii） A protocol for a test or study, unless it is shown to fall within the exemption established for trade secrets and confidential commercial information in 20.61 of this chapter.（iii） Adverse reaction reports, product experience reports, consumer complaints, and other similar data