3.0.0 4395 2022-02-03T05:53:22Z 2022-02-03T05:53:22Z House H HR 2012-04-18 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. LANCE:H.R. 4395.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8 of the Constitution of the UnitedStates.[Page H1977]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2012-04-20T18:52:19Z Referred to 2012-04-18T14:01:05Z 2012-04-20 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2012-04-18 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2012-04-18 Introduced in House IntroReferral Intro-H 9 Library of Congress 2012-04-18 Introduced in House IntroReferral 1000 9 Library of Congress L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 N Commerce Administrative law and regulatory procedures Business records Consumer affairs Department of Health and Human Services Federal preemption Food and Drug Administration (FDA) Government information and archives Health information and medical records Health programs administration and funding Licensing and registrations Manufacturing Product safety and quality Trade restrictions Commerce 00 2012-04-18 Introduced in House 2012-08-03T15:23:31Z Cosmetic Safety Amendments Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require the registration of every domestic and foreign establishment engaged in the manufacture of a cosmetic intended to be marketed in the United States with the Secretary of Health and Human Services (HHS). Requires such manufacturers to submit to the Secretary: (1) a cosmetic and ingredient statement for each manufactured cosmetic containing a unique registration number for the manufacturing establishment where the cosmetic is manufactured, the brand name for the cosmetic, the ingredients in the cosmetic, and contact information for individuals responsible for filing and maintaining the cosmetic and ingredient statement; and (2) a report on any serious and unexpected adverse event allegedly associated with the use of a cosmetic product.

Requires the Secretary to: (1) establish good manufacturing practices for the manufacture, processing, filling, or packaging of cosmetics; and (2) establish and maintain in the Center for Food Safety and Applied Nutrition of the Food and Drug Administration (FDA) an electronic National Cosmetic Regulatory Databank to hold information pertaining to the regulation of cosmetics.

Grants the Secretary authority to review the findings of the Cosmetic Ingredient Review Expert Panel with respect to any cosmetic products.

Authorizes the Secretary to: (1) establish a tolerance level for a nonfunctional constituent in a cosmetic product, (2) evaluate the safety of any ingredient in a cosmetic product, and (3) obtain access to and copy records for determining whether a cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans.

Denies entry into the United States of a cosmetic product if: (1) the importer does not present the unique cosmetic establishment registration number and the unique cosmetic and ingredient statement number, or (2) either of such numbers is not correct.

]]> Cosmetic Safety Amendments Act of 2012 Short Titles as Introduced Cosmetic Safety Amendments Act of 2012 Display Title Cosmetic Safety Amendments Act of 2012 Official Title as Introduced 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 cosmetic product adverse events, and for other purposes. Introduced in House 2012-04-18T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr4395ih/xml/BILLS-112hr4395ih.xml 2012-04-20 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.