determinations under chapter VI, the Poison Preven-
tion Packaging Act of 1970, or the Fair Packaging 
and Labeling Act; or 
‘‘(2) relating directly or indirectly to registra-
tion or listing of cosmetic facilities, establishments, 
cosmetics, or cosmetic ingredients, reporting of any 
information relating to cosmetics including adverse 
event reporting, cosmetic manufacturing processes 
or standards including good manufacturing practice, 
cosmetic labels or labeling including any general or 
health related warnings or public statement, or the 
requirement of any fees on cosmetic establishments, 
cosmetics, ingredients, or nonfunctional constitu-
ents.’’; and 
(4) by repealing subsection (e). 
SEC. 13. IMPORTATION. 
Section 801(a) (21 U.S.C. 381(a)) is amended by 
adding at the end the following: ‘‘If a cosmetic is being 
imported or offered for import into the United States and 
the importer does not present both the unique cosmetic 
establishment registration number required under section 
605 for the establishment that performs the final portion 
of the manufacturing operation and the unique cosmetic 
and ingredient statement number required under section 
606 for the cosmetic, or the registration or statement 
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number is not correct and accurate, the cosmetic shall be 
denied entry.’’. 
SEC. 14. EFFECTIVE DATES. 
(a)(1) The amendments made by sections 4, 5, 6, and 
13 of this Act apply beginning on the later date of— 
(A) the date that is one year after the Sec-
retary of Health and Human Services promulgates 
final regulations implementing such amendments; or 
(B) the date that is one year after the Sec-
retary of Health and Human Services publishes a 
notice in the Federal Register determining that an 
effective electronic system has been established and 
is fully operational for— 
(i) the submission of cosmetic manufac-
turing establishment registrations, cosmetic and 
ingredient statements, and reports of serious 
cosmetic adverse events; and 
(ii) the National Cosmetic Regulatory 
Databank. 
(2) Until the date applicable under paragraph (1), 
the voluntary establishment registration and voluntary in-
gredient listing programs established in parts 710 and 720 
of title 21, Code of Federal Regulations (as in effect on 
the date of enactment of this Act), shall remain effective 
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and shall be fully implemented by the Secretary of Health 
and Human Services. 
(b) The amendments made by sections 7 and 8 apply 
beginning on the date that is two years after the date of 
enactment of this Act. 
(c) Notwithstanding subsections (a) and (b), the 
amendments made by sections 5 and 7 shall not apply with 
respect to a cosmetic manufacturer with less than 
$5,000,000 of annual net sales of cosmetics until the later 
of— 
(1)(A) with respect to the amendment made by 
section 5, the date that is 36 months after the date 
otherwise applicable under subsection (a); and 
(B) with respect to the amendments made by 
section 7, the date that is 36 months after the date 
otherwise applicable under subsection (b); and 
(2) such later date as may be determined by the 
Secretary of Health and Human Services. 
(d) Except as provided in subsections (a) through (c), 
this Act takes effect on the date of enactment of this Act. 
Æ 
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