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2021年1月19日发(作者：bag是什么意思)
[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
petitioner's 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 However, any reference to unpublished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 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 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 byproducts 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 regarding 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 and 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 preparation, 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 proprietary 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 identify 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 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 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.

(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 is 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 that 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 sufficient 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 food- 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 tests
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 petition 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 submitting 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 proposed. 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 chapter or an environmental assessment under 25.40 of this chapter.

Yours very truly,

Petitioner

By

(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 but 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 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 manufacturer of the food additive as
a master file, the petitioner may refer to the master file if and to the extent he obtains the
manufacturer's written permission to do so. The manufacturer may authorize specific
reference to the data without disclosure to the petitioner. Nothing herein shall prevent
reference 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 disclosure, 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 involved:

(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 and information, after deletion of:

(a) Names and any information that would identify the person using the product.

(b) Names and any information that would identify any third party involved with the
report, such as a physician or hospital or other institution.

(iv) A list of all ingredients contained in a food additive, whether or not it is in
descending order of predominance. A particular ingredient or group of ingredients shall
be deleted from any such list prior to public disclosure if it is shown to fall within the
exemption established in 20.61 of this chapter, and a notation shall be made that any such
ingredient list is incomplete.

(v) An assay method or other analytical method, unless it serves no regulatory or
compliance purpose and is shown to fall within the exemption established in 20.61 of this
chapter.

(2) The following data and information in a food additive petition are not available for
public disclosure unless they have been previously disclosed to the public as defined in
20.81 of this chapter or they relate to a product or ingredient that has been abandoned and
they no longer represent a trade secret or confidential commercial or financial
information as defined in 20.61 of this chapter:

(i) Manufacturing methods or processes, including quality control procedures.

(ii) Production, sales, distribution, and similar data and information, except that any
compilation of such data and information aggregated and prepared in a way that does not
reveal data or information which is not available for public disclosure under this
provision is available for public disclosure.

(iii) Quantitative or semiquantitative formulas.

(3) All correspondence and written summaries of oral discussions relating to a food
additive petition are available for public disclosure in accordance with the provisions of