I 
112TH CONGRESS 
2D SESSION 
H. R. 4395 
To amend the Federal Food, Drug, and Cosmetic Act to establish new 
procedures and requirements for the registration of cosmetic product 
manufacturing establishments, the submission of cosmetic product and 
ingredient statements, and the reporting of serious and unexpected cos-
metic product adverse events, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 18, 2012 
Mr. LANCE introduced the following bill; which was referred to the Committee 
on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
establish new procedures and requirements for the reg-
istration of cosmetic product manufacturing establish-
ments, the submission of cosmetic product and ingredient 
statements, and the reporting of serious and unexpected 
cosmetic product adverse events, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE AND REFERENCES. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Cosmetic Safety Amendments Act of 2012’’. 
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(b) REFERENCES TO THE FEDERAL FOOD, DRUG, 
AND COSMETIC ACT.—Except as otherwise specified, 
whenever in this Act an amendment is expressed in terms 
of an amendment to a section or other provision, the ref-
erence shall be considered to be made to a section or other 
provision of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.). 
SEC. 2. TABLE OF CONTENTS. 
Sec. 1. Short title and references. 
Sec. 2. Table of contents. 
Sec. 3. Registration of cosmetic manufacturing establishments. 
Sec. 4. Cosmetic and ingredient statement. 
Sec. 5. Serious and unexpected adverse event reporting for cosmetics. 
Sec. 6. Good manufacturing practice for cosmetics. 
Sec. 7. Tolerances for nonfunctional constituents in cosmetics. 
Sec. 8. Cosmetic ingredient review. 
Sec. 9. Cosmetic ingredient safety. 
Sec. 10. National cosmetic regulatory databank. 
Sec. 11. Cosmetic records inspection. 
Sec. 12. Rules of construction. 
Sec. 13. Conforming amendments. 
Sec. 14. National uniformity for cosmetics. 
Sec. 15. Importation. 
Sec. 16. Authorization of appropriations. 
Sec. 17. Effective dates. 
SEC. 3. REGISTRATION OF COSMETIC MANUFACTURING ES-
TABLISHMENTS. 
Chapter VI is amended by adding at the end the fol-
lowing: 
‘‘SEC. 604. REGISTRATION OF COSMETIC MANUFACTURING 
ESTABLISHMENTS. 
‘‘(a) IN GENERAL.— 
‘‘(1) The Secretary shall by regulation require 
that every domestic and foreign establishment en-
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gaged in the manufacture of a cosmetic intended to 
be marketed in the United States be registered with 
the Secretary within 60 days after beginning such 
manufacture. If a cosmetic is processed in more 
than one establishment, registration shall be re-
quired only for the establishment that performs the 
final portion of the manufacturing operation. The 
registration shall state the name of the company or 
other organization, the city, street address, State, 
and country of the establishment, and the title, 
email address, and telephone number for the office 
within the establishment that is responsible for sub-
mitting and maintaining the registration. 
‘‘(2) The Secretary shall establish and provide 
to the registrant a unique cosmetic establishment 
registration number within 15 business days after 
receiving the registration. Where more than one per-
son registers the same manufacturing establishment, 
the Secretary shall provide only one unique estab-
lishment registration number for the establishment. 
‘‘(b) MAINTENANCE.—The information required in a 
registration under subsection (a) or in an existing reg-
istration under subsection (e) shall be maintained as cur-
rent and accurate by the registrant by withdrawing or 
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amending the registration within 60 days after the infor-
mation becomes no longer current and accurate. 
‘‘(c) LIST.—The Secretary shall compile and main-
tain an up-to-date and publicly available electronic list of 
establishments that are registered under this section. 
‘‘(d) DEFINITIONS.—For purposes of this chapter the 
following definitions apply: 
‘‘(1) The term ‘establishment’ is a place of 
business where a cosmetic is manufactured, without 
further processing outside or within the United 
States. 
‘‘(2)(A) The term ‘domestic establishment’ 
means an establishment location in any State. 
‘‘(B) The term ‘foreign establishment’ means 
an establishment location outside the States from 
which a cosmetic is exported to the United States. 
‘‘(3) A cosmetic shall not be considered to have 
undergone further processing for purposes of para-
graph (1) solely on the basis that packaging or other 
labeling was added or that any similar activity of a 
de minimis nature was carried out with respect to 
the cosmetic. 
‘‘(e) EXEMPTIONS.—Registration under subsection 
(a) shall not be required for any establishment that as of 
the date of enactment of this section is registered as a 
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‘‘(4) requires more information in order to 
make a determination whether the ingredient is safe 
for use in a cosmetic product under any conditions 
of use; or 
‘‘(5) is the subject of any other type of deter-
mination by the Cosmetic Ingredient Review Expert 
Panel, shall be deemed to constitute a recommenda-
tion that the Secretary accept that determination for 
purposes of implementing and enforcing this chapter 
in accordance with the effective dates established 
under subsection (d). 
‘‘(b) SECRETARY’S DETERMINATION.—The Secretary 
shall be deemed to accept that determination and rec-
ommendation unless the Secretary at any time determines, 
by regulation or guidance, after public notice and an op-
portunity for public comment, to make a different deter-
mination. A determination and recommendation described 
in subsection (a) that is deemed to be accepted by the Sec-
retary shall be implemented and enforced by the Secretary 
by banning any use of any ingredient that does not con-
form to the specified safe conditions of use under sub-
section (a)(2) and any ingredient described under sub-
section (a)(3) or (4). 
‘‘(c) PROPRIETARY DATA.—The determination de-
scribed in subsection (a)(4) shall not apply to a person 
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