[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR720.8]

[Page 159-160]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 720_VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION 
 
Sec. 720.8  Confidentiality of statements.

    (a) Data and information contained in, attached to, or included with 
Forms FDA 2512 and FDA 2514, and amendments thereto are submitted 
voluntarily to the Food and Drug Administration (FDA). Any request for 
confidentiality of a cosmetic ingredient submitted with such forms or 
separately will be handled in accordance with the procedure set forth in 
this section. The request for confidentiality will also be subject to 
the provisions of Sec. 20.111 of this chapter, as well as to the 
exemptions in subpart D of part 20 of this chapter and to the 
limitations on exemption in subpart E of part 20 of this chapter.
    (b) Any request for confidentiality of the identity of a cosmetic 
ingredient should contain a full statement, in a well-organized format, 
of the factual and legal grounds for that request, including all data 
and other information on which the petitioner relies, as well as 
representative information known to the petitioner that is unfavorable 
to

[[Page 160]]

the petitioner's position. The statement of the factual grounds should 
include, but should not be limited to, scientific or technical data, 
reports, tests, and other relevant information addressing the following 
factors that FDA will consider in determining whether the identity of an 
ingredient qualifies as a trade secret:
    (1) The extent to which the identity of the ingredient is known 
outside petitioner's business;
    (2) The extent to which the identity of the ingredient is known by 
employees and others involved in petitioner's business;
    (3) The extent of measures taken by the petitioner to guard the 
secrecy of the information;
    (4) The value of the information about the identity of the claimed 
trade secret ingredient to the petitioner and to its competitors;
    (5) The amount of effort or money expended by petitioner in 
developing the ingredient; and
    (6) The ease or difficulty with which the identity of the ingredient 
could be properly acquired or duplicated by others.
    (c) The request for confidentiality should also be accompanied by a 
statement that the identity of the ingredient for which confidentiality 
is requested has not previously been published or disclosed to anyone 
other than as provided in Sec. 20.81(a) of this chapter.
    (d) FDA will return to the petitioner any request for 
confidentiality that contains insufficient data to permit a review of 
the merits of the request. FDA will also advise the petitioner about the 
additional information that is necessary to enable the agency to proceed 
with its review of the request.
    (e) If, after receiving all of the data that are necessary to make a 
determination about whether the identity of an ingredient is a trade 
secret, FDA tentatively decides to deny the request, the agency will 
inform the person requesting trade secrecy of its tentative 
determination in writing. FDA will set forth the grounds upon which it 
relied in making this tentative determination. The petitioner may 
withdraw the records for which FDA has tentatively denied a request for 
confidentiality or may submit, within 60 days from the date of receipt 
of the written notice of the tentative denial, additional relevant 
information and arguments and request that the agency reconsider its 
decision in light of both the additional material and the information 
that it originally submitted.
    (f) If the petitioner submits new data in response to FDA's 
tentative denial of trade secret status, the agency will consider that 
material together with the information that was submitted initially 
before making its final determination.
    (g) A final determination that an ingredient is not a trade secret 
within the meaning of Sec. 20.61 of this chapter constitutes final 
agency action that is subject to judicial review under 5 U.S.C. Chapter 
7. If suit is brought within 30 calendar days after such a 
determination, FDA will not disclose the records involved or require 
that the disputed ingredient or ingredients be disclosed in labeling 
until the matter is finally determined in the courts. If suit is not 
brought within 30 calendar days after a final determination that an 
ingredient is not a trade secret within the meaning of 21 CFR 20.61, and 
the petitioner does not withdraw the records for which a request for 
confidentiality has been denied, the records involved will be made a 
part of FDA files and will be available for public disclosure upon 
request.

[51 FR 11444, Apr. 3, 1986, as amended at 57 FR 3130, Jan. 28, 1992; 68 
FR 25288, May 12, 2003]