Sec. 10. Special rules
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Chapter VI ( 21 U.S.C. 361 et seq. ), as amended by sections 3, 4, 5, 6, 7, 8, and 9, is further amended by adding at the end the following: The person described in section 607(f) with respect to a cosmetic (referred to in this section as the responsible party ) may, by agreement, authorize a manufacturer, distributor, or packer of the cosmetic or a third-party contractor to submit any required report of a serious and unexpected adverse event (as such term is used in section 607) so long as the responsible party directs to the manufacturer, distributor, packer, or third-party contractor all such adverse events associated with such cosmetic that are reported to the responsible party through the address or telephone number described in section 607(f).
The Secretary, on the Secretary’s own initiative or in response to a petition, may establish exemptions from the requirements of sections 601(f), 605, 606, 607, and 608— for the efficient and cost-effective implementation of such requirements; or where the cost of compliance exceeds the safety benefit to the public. . Section 201(i) ( 21 U.S.C. 321(i) ) is amended by adding at the end the following: An article described in subparagraph
(1)that is intended only for topical external use to alter the appearance by temporarily affecting the structure or any function of the human skin, and that is not the subject of an approved new drug application under section 505, shall, for purposes of this Act, be treated only as a cosmetic and not a drug. . Section 721(f) ( 21 U.S.C. 379e(f) ) is amended— by striking
(f)The Secretary shall and inserting (f)(1) The Secretary shall ; and by adding at the end the following: A color additive, including mixtures thereof, intended for use in externally applied cosmetics and not in the area of the eye is exempt from the requirements of this section if it is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been shown through scientific procedures to be safe under the conditions of its intended use. Notwithstanding the preceding sentence, the Secretary may by regulation require certification of batches under subsection
(c)for any such color additive. .
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