,i #aadth ,,congress #ast ,session ,h4 ,r4 #djge ,,in ,,the ,,house ,,of ,,representatives ,november #ah1 #bjae ,mr4 ,sessions introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to establish new procedures and requirements for the registration of cosmetic manufacturing establishments1 the submission of cosmetic and ingredient statements1 and the reporting of serious cosmetic adverse events1 and for other purposes4 #a4 ,short title and references 7a7 ,short title ,this ,act may be cited as the ,cosmetic ,modernization ,amendments of #bjae4 7b7 ,references to the ,federal ,food1 ,drug1 and ,cosmetic ,act ,except as otherwise specified1 whenever in this ,act an amendment is expressed in terms of an amendment to a section or other provision1 the reference shall be considered to be made to a section or other provision of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 #b4 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title and references4 ,sec4 #b4 ,table of contents4 ,sec4 #c4 ,definitions4 ,sec4 #d4 ,registration of cosmetic manufacturing establishments4 ,sec4 #e4 ,cosmetic and ingredient statement4 ,sec4 #f4 ,serious and unexpected adverse event reporting for cosmetics4 ,sec4 #g4 ,good manufacturing practice4 ,sec4 #h4 ,safety substantiation for cosmetic ingredients and nonfunctional constituents4 ,sec4 #i4 ,national ,cosmetic ,regulatory ,databank4 ,sec4 #aj4 ,special rules4 ,sec4 #aa4 ,prohibited acts4 ,sec4 #ab4 ,national uniformity for cosmetics4 ,sec4 #ac4 ,importation4 ,sec4 #ad4 ,effective dates4 #c4 ,definitions ,chapter ,,vi 7#ba ,u4,s4,c4 #cfa et seq47 is amended by adding at the end the following3 #fjd4 ,definitions ,in this chapter3 7#a7 ,cosmetic ,notwithstanding section #bja7;i71 for purposes of this section and sections #fja7;f71 #fje1 #fjf1 #fjg1 #fjh1 and #hja7;a71 the term cosmetic includes only articles described in section #bja7;i77#a74 7#b7 ,establishment 7,a7 ,the term establishment means a place of business where a cosmetic is manufactured1 without further processing outside or within the ,united ,states4 7,b7 ,a cosmetic shall not be considered to have undergone further processing for purposes of subparagraph 7,a7 solely on the basis that packaging or other labeling was added or changed or that any similar activity of a de minimis nature was carried out with respect to the cosmetic4 7,c7 ,the term domestic establishment means an establishment location in any ,state4 7,d7 ,the term foreign establishment means an establishment location outside the ,united ,states4 7#c7 ,safe2 safety 7,a7 ,the terms safe and safety1 with respect to a cosmetic1 mean the cosmetic does not present a significant risk of serious illness or injury to humans under the conditions of use recommended or suggested in the labeling of the cosmetic1 including the limitation of for professional use only4 7,b7 ,for purposes of subparagraph 7,a71 the term professional means an individual who-- 7i7 is licensed by an official ,state authority to practice in the field of cosmetology1 nail care1 barbering1 and or esthetics2 and 7ii7 is in compliance with all requirements of the ,state for such licensing4 4 #d4 ,registration of cosmetic manufacturing establishments ,chapter ,,vi 7#ba ,u4,s4,c4 #cfa et seq471 as amended by section #c1 is further amended by adding at the end the following3 #fje4 ,registration of cosmetic manufacturing establishments 7a7 ,in general 7#a7 ,registration ,the ,secretary shall by regulation require that every domestic and foreign establishment engaged in the manufacture of a cosmetic intended to be sold in the ,united ,states that is not exempt under subsection 7e7 be registered with the ,secretary within #fj business days after the first commercial sale of a cosmetic in the ,united ,states4 ,if a cosmetic is processed in more than one establishment1 registration shall be required under this section only for the establishment that performs the final portion of the manufacturing operation4 ,the single registration shall cover all such cosmetics manufactured by the establishment4 ,the registration shall state only the name of the company or other organization name of the establishment1 the city1 street address1 ,state1 and country of the establishment1 and the title1 email address1 and telephone number for the office within the establishment that is responsible for submitting and maintaining the registration4 ,for a foreign establishment1 the registration shall include the contact information for the initial ,united ,states agent of the establishment4 7#b7 ,unique number ,the ,secretary shall establish and provide to each registrant under this section a unique cosmetic establishment registration number within #ae business days after receiving the registration4 ,if the ,secretary does not provide a unique cosmetic establishment registration number within such #ae business days1 any requirement under this ,act for such number shall be deemed to be inapplicable until #cj business days after such number is received by the person who submitted the registration4 ,where more than one person registers the same establishment1 the ,secretary shall provide only one unique establishment registration number for the establishment4 ,the unique cosmetic establishment number shall not be required to be included in cosmetic labeling4 7b7 ,maintenance ,the information required in a registration under subsection 7a7 or in an existing registration under subsection 7e77#a77;,a7 shall be maintained as current and accurate by the registrant by withdrawing or amending the registration within #fj business days after the information becomes no longer current and accurate4 7c7 ,enforcement ,the ,secretary shall enforce this section under section #cja7;ddd7 and shall not suspend or revoke a registration under this section4 7d7 ,list ,the ,secretary shall compile and maintain an up-to-date and publicly available electronic list of establishments that are registered under this section4 7e7 ,exemptions 7#a7 ,in general ,registration under subsection 7a7 shall not be required for any entity based on such entity operating as-- 7,a7 an establishment that as of the date of enactment of this section is registered as a cosmetic establishment under part #gaj of title #ba1 ,code of ,federal ,regulations 7as in effect on such date72 7,b7 a beauty shop or salon or spa2 7,c7 a cosmetic retailer1 including any such retailer that is-- 7i7 an individual sales representative2 7ii7 a wholesale or retail distribution or sales facility2 or 7iii7 a pharmacy or other person or organization that-- 7,i7 compounds cosmetics at a single location and administers1 dispenses1 or distributes such cosmetics at retail from that location2 and 7,,ii7 does not otherwise manufacture or package cosmetics from that location2 7,d7 a health care provider1 including a hospital or clinic2 7,e7 a public health agency or other nonprofit entity2 7,f7 a hotel or other entity that provides complimentary cosmetics2 7,g7 a trade show or other venue where cosmetic samples are provided2 7,h7 an establishment that manufactures1 prepares1 compounds1 or processes cosmetics for use in research1 teaching1 or chemical analysis or pilot plant production2 7,i7 a handcrafted soap or cosmetic made in a home1 a community facility1 or a similar establishment2 or 7,j7 a business with less than #a1jjj1jjj annual net sales of cosmetics4 7#b7 ,additional exemptions ,the ,secretary may supplement the list of exemptions under paragraph 7#a7 with additional exemptions for persons and activities where the cost of compliance exceeds the safety benefit to the public4 4 #e4 ,cosmetic and ingredient statement ,chapter ,,vi 7#ba ,u4,s4,c4 #cfa et seq471 as amended by sections #c and #d1 is further amended by adding at the end the following3 #fjf4 ,cosmetic and ingredient statement 7a7 ,in general ,the ,secretary shall by regulation require that every domestic establishment and foreign establishment engaged in the manufacture of a cosmetic intended to be sold in the ,united ,states submit to the ,secretary1 for each cosmetic so manufactured in the establishment1 except such cosmetics manufactured by entities exempted by section #fje7;e7 from registration under section #fje1 within #fj business days after the first commercial sale of the cosmetic1 a cosmetic and ingredient statement4 ,the ,secretary shall require the statement to contain only-- 7#a7 the unique establishment registration number of the manufacturing establishment where the cosmetic is manufactured or1 if the same cosmetic is manufactured in more than one establishment1 the unique establishment registration number of each establishment where it is manufactured2 7#b7 the brand name or names for the cosmetic2 7#c7 the applicable cosmetic category or categories for the cosmetic2 7#d7 the ingredients in the cosmetic 7in accordance with section #gja4c of title #ba1 ,code of ,federal ,regulations 7as in effect on the date of enactment of the ,cosmetic ,modernization ,amendments of #bjae and including any successor regulations71 and using the name of each ingredient established under subsection 7d71 if any71 in descending order of predominance by weight1 except that-- 7,a7 flavors and fragrances may be designated as such2 and 7,b7 all variations in color1 flavor1 or fragrance may be included in one statement2 and 7#e7 the title1 email address1 and telephone number for the office within the establishment that is responsible for submitting and maintaining the statement4 7b7 ,unique number ,the ,secretary shall establish and provide to the office submitting a statement required by subsection 7a7 a unique cosmetic and ingredient statement number within #ae business days after receiving the statement4 ,if the ,secretary does not provide a unique cosmetic and ingredient statement number within such #ae-;business-day period1 any requirement under this ,act for such number shall be deemed to be inapplicable until the date that is #cj business days after such number is received by the office that submitted the statement4 ,the unique cosmetic and ingredient statement number shall not be required to be included in cosmetic labeling4 7c7 ,change in labeling ,an establishment shall not be required to submit a new or revised statement under subsection 7a7 because of a change in labeling except to the extent necessary to maintain the accuracy of the information included in a statement under subsection 7a74 7d7 ,name of ingredient ,for purposes of this section and cosmetic ingredient labeling under section #gja4c of title #ba1 ,code of ,federal ,regulations 7as in effect on the date of enactment of the ,cosmetic ,modernization ,amendments of #bjae and including any successor regulations71 the name of a cosmetic ingredient shall be the name1 if any1 in the most recent edition of the ,international ,cosmetic ,ingredient ,dictionary1 unless the ,secretary by regulation establishes a different name for the ingredient4 7e7 ,maintenance ,the information required in a statement submitted to the ,secretary under subsection 7a7 or in an existing statement under subsection 7g77#a7 shall be maintained as current and accurate by the office that filed the statement by withdrawing or amending the statement within #fj business days after the information becomes no longer current and accurate1 except that no amendment shall be required for a change in the order of predominance of the ingredients or for any other type or category of change for which the costs of amending the statement exceed the safety benefit to the public4 7f7 ,enforcement ,the ,secretary shall enforce subsections 7a7 and 7e7 under section #cja7;eee7 and shall not suspend or revoke a cosmetic and ingredient statement4 7g7 ,list ,the ,secretary shall compile and maintain an up-to-date and publicly available electronic list of cosmetics and ingredients for which statements are submitted under this section4 ,a statement submitted pursuant to this section shall not be subject to disclosure under section #eeb of title #e1 ,united ,states ,code4 ,the ,secretary may make publicly available information derived from such statements that discloses the names of ingredients used in cosmetics and the number of cosmetics in which a specific ingredient is used1 but may not make publicly available any information that relates to any ingredient that is exempt from public disclosure under section #gbj4h of title #ba1 ,code of ,federal ,regulations 7as in effect on the date of enactment of the ,cosmetic ,modernization ,amendments of #bjae and including any successor regulations71 or that discloses at what establishment a cosmetic is manufactured4 ,at the written request of the director of a ,state agency responsible for regulating the safety of cosmetics stating good cause therefor1 the ,secretary may disclose to such official confidential business and trade secret information contained in a statement and such official and other ,state employees who have access to such information shall then be subject to the provisions of section #cja7;j7 of this ,act1 section #eeb7;b7 of title #e1 ,united ,states ,code1 and section #aije of title #ah1 ,united ,states ,code1 with respect to such information4 7h7 ,exemptions ,submission of a statement under subsection 7a7 shall not be required-- 7#a7 for a cosmetic for which as of the date of enactment of this section a cosmetic ingredient statement has been submitted to the ,secretary under part #gaj of title #ba1 ,code of ,federal ,regulations 7as in effect on the date of enactment of the ,cosmetic ,modernization ,amendments of #bjae72 7#b7 for a cosmetic ingredient exempt from public disclosure under section #gbj4h of title #ba1 ,code of ,federal ,regulations 7as in effect on the date of enactment of the ,cosmetic ,modernization ,amendments of #bjae and including any successor regulations72 or 7#c7 by an entity to the extent such entity is exempted by section #fje7;e7 from registration under section #fje4 4 #f4 ,serious and unexpected adverse event reporting for cosmetics 7a7 ,in general ,chapter ,,vi 7#ba ,u4,s4,c4 #cfa et seq471 as amended by sections #c1 #d1 and #e1 is further amended by adding at the end the following3 #fjg4 ,serious and unexpected adverse event reporting for cosmetics 7a7 ,in general ,the ,secretary shall by regulation require that a domestic or foreign manufacturer1 packer1 or distributor whose name appears on the label pursuant to section #fjb7;b77#a7 of a cosmetic marketed in the ,united ,states submit to the ,secretary under subsection 7b7 a report containing-- 7#a7 information received concerning any serious and unexpected adverse event in the ,united ,states allegedly associated with the use of the cosmetic for which it is reasonably likely that the adverse event was caused by the cosmetic when used as recommended or suggested in the labeling2 and 7#b7 a copy of the label for the cosmetic4 7b7 ,submission of reports ,a report on an adverse event under subsection 7a7 shall be submitted to the ,secretary not later than #ae business days after information concerning the adverse event is received at the place of business labeled on the cosmetic pursuant to section #fjb7;b77#a74 7c7 ,required contents ,a report under subsection 7a7 shall include all of the following information3 7#a7 ,an identifiable patient4 7#b7 ,an identifiable reporter4 7#c7 ,a suspect cosmetic or component thereof4 7#d7 ,a serious adverse event4 7d7 ,additional contents2 supplemental reporting ,the person submitting a report under subsection 7a7 may-- 7#a7 include pertinent information in addition to the information listed in subsection 7c72 and 7#b7 after submitting the initial report1 supplement the report with additional information4 7e7 ,special rules 7#a7 ,protected information ,a serious and unexpected adverse event report 7including all information submitted in the initial report or added later7 submitted under subsection 7a7-- 7,a7 shall be considered to be a safety report under section #gef that is subject to the provisions of that section2 and 7,b7 shall be considered to be a record about an individual under section #eeb;a of title #e1 ,united ,states ,code1 and a medical or similar file the disclosure of which would constitute a violation of section #eeb of such title #e1 and shall not be publicly disclosed unless all personally identifiable information is redacted4 7#b7 ,no treatment as admission ,the submission of a serious and unexpected adverse event report in compliance with subsection 7a7-- 7,a7 shall not be construed as an admission that the cosmetic involved caused or contributed to the adverse event2 and 7,b7 may be accompanied by a statement that denies that the report constitutes an admission that the cosmetic involved caused or contributed to the adverse event4 7#c7 ,inclusion of statement in public disclosure ,in releasing any report under subsection 7a7 or portion thereof for public disclosure1 the ,secretary shall include any statement under paragraph 7#b77;,b74 7f7 ,labeling ,the label of a cosmetic shall bear the domestic telephone number1 email address1 or mailing address through which the person whose name and place of business appear on the label may receive a report of a serious adverse event4 7g7 ,exemption ,the ,secretary may1 by regulation1 establish an exemption to the requirements under subsections 7b7 and 7d7 if the ,secretary determines that such exemption would have no adverse effect on public health4 7h7 ,definitions ,in this section3 7#a7 ,the term serious1 with respect to an adverse event1 means-- 7,a7 resulting in-- 7i7 death2 7ii7 a life-threatening experience2 7iii7 inpatient hospitalization2 7iv7 a persistent and significant disability or incapacity2 7v7 a congenital anomaly or birth defect2 or 7vi7 permanent disfiguration2 or 7,b7 requiring1 based on reasonable medical judgment1 a medical or surgical intervention to prevent an outcome described under subparagraph 7,a74 7#b7 ,the term unexpected1 with respect to an adverse event1 means not identified on the cosmetic label4 4 7b7 ,misbranding ,section #fjb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfb7 is amended by adding at the end the following3 7g7 ,if it is a cosmetic that is marketed in the ,united ,states1 unless the label of such cosmetic includes a domestic address or domestic phone number through which a report of a serious and unexpected adverse event 7as such term is used in section #fjg7 associated with the use of such cosmetic may be submitted to the person described in section #fjg7;f74 4 #g4 ,good manufacturing practice 7a7 ,prohibition ,section #fja 7#ba ,u4,s4,c4 #cfa7 is amended by adding at the end the following3 7f7 ,if it has been manufactured under conditions that do not satisfy the principles and standards for good manufacturing practice established under section #fjh and as a result presents a significant risk of serious adverse health consequences or death to humans4 4 7b7 ,principles and standards ,chapter ,,vi 7#ba ,u4,s4,c4 #cfa et seq471 as amended by sections #c1 #d1 #e1 and #f1 is further amended by adding at the end the following3 #fjh4 ,good manufacturing practice 7a7 ,in general ,the ,secretary may by regulation establish principles and standards for good manufacturing practice for the manufacture of cosmetics in accordance with paragraphs 7a7 and 7d7 of section #fja4 7b7 ,notice and comment ,a regulation under subsection 7a7 shall be promulgated only after providing notice and an opportunity for comment in accordance with chapter #e of title #e1 ,united ,states ,code4 7c7 ,good manufacturing practices of other parties ,a manufacturer shall not be responsible under section #fja7;f7 or this section for the good manufacturing practice of its suppliers4 ,a distributor shall not be responsible under section #fja7;f7 or this section for the good manufacturing practice of its manufacturers4 4 #h4 ,safety substantiation for cosmetic ingredients and nonfunctional constituents ,chapter ,,vi 7#ba ,u4,s4,c4 #cfa et seq471 as amended by sections #c1 #d1 #e1 #f1 and #g1 is further amended by adding at the end the following3 #fji4 ,cosmetic ingredients and nonfunctional constituents that are safe for use in cosmetics 7a7 ,in general ,a manufacturer or distributor of a cosmetic may rely on this section to substantiate the safety of such cosmetic4 7b7 ,safe ingredients ,unless and until prohibited or limited by the ,secretary by regulation1 the following ingredients are deemed to be adequately substantiated for safe use in cosmetics subject to the requirements of good manufacturing practice3 7#a7 ,color additives approved by the ,secretary for use in cosmetics1 within any limits established in such approval4 7#b7 ,food additives approved by the ,secretary for direct addition to food for human consumption1 within any limits established in such approval4 7#c7 ,food ingredients that have been determined by the ,secretary to be generally recognized as safe for direct addition to food for human consumption1 within any limits established in such determination4 7#d7 ,food ingredients for which monographs have been included in the ,food ,chemicals ,codex for direct addition to food for human consumption1 within any limits established in such monographs4 7#e7 ,pharmaceutical excipients and inactive ingredients approved or permitted by the ,secretary1 listed on a ,food and ,drug ,administration website for use in drugs for human consumption or for which monographs have been included in the ,handbook of ,pharmaceutical ,excipients1 within any limits established in such lists or monographs4 7#f7 ,cosmetic ingredients that have been reviewed for safety by a qualified nongovernmental or governmental expert scientific body1 including the ,cosmetic ,ingredient ,review ,expert ,panel1 and that are the subject of a monograph published in a peer-reviewed scientific journal1 within any limits established in such monographs4 7#g7 ,fragrance ingredients that have been reviewed for safety by a qualified nongovernmental or governmental expert scientific body1 including the ,research ,institute of ,fragrance ,materials ,expert ,panel1 and that are the subject of a monograph published in a peer-reviewed scientific journal1 within any limits established in such monographs4 7#h7 ,cosmetic ingredients approved or permitted for use in cosmetics by any of the countries listed in section #hjb7;b77#a77;,a7 as having an adequate regulatory authority1 within any limits established by such regulatory authority4 7c7 ,safe nonfunctional constituents 7#a7 ,definition ,a nonfunctional constituent in a cosmetic is any substance that-- 7,a7 has not been intentionally added as a separate substance2 and 7,b7 serves no technical or cosmetic function in the cosmetic4 7#b7 ,adequate substantiation ,the following nonfunctional constituents are deemed to be adequately substantiated for safe use in cosmetics1 subject to the requirements of good manufacturing practice and any limits or bans established by the ,secretary by regulation3 7,a7 ,the levels approved or permitted for nonfunctional constituents by the ,secretary for color additives for cosmetic use and for food additives and generally recognized as safe food ingredients for direct human consumption4 7,b7 ,the levels approved or permitted for nonfunctional constituents by the ,secretary for cosmetics and for food and food ingredients for direct human consumption in compliance policy guides1 guidance1 and website statements4 7,c7 ,the levels approved or permitted for nonfunctional constituents by the ,secretary or the ,united ,states ,pharmacopeia for oral nonprescription drugs4 7,d7 ,the levels approved or permitted for nonfunctional constituents by the ,environmental ,protection ,agency for direct human consumption in drinking water4 7,e7 ,the levels for nonfunctional constituents approved or permitted in cosmetics and human food and food ingredients by any of the countries listed in section #hjb7;b77#a77;,a7 as having an adequate regulatory authority4 7d7 ,center ,the ,secretary shall establish a program within the center of the ,food and ,drug ,administration with primary responsibility for regulating cosmetics to evaluate and make determinations1 by regulation1 on the safe use of cosmetics and ingredients and nonfunctional constituents thereof4 7e7 ,application2 preemption ,a safety determination accepted or made by the ,secretary or established under this section shall apply in every ,state4 ,no ,state may establish or enforce a safety determination for a cosmetic or an ingredient or nonfunctional constituent of a cosmetic 7f7 ,effective date of regulations ,any regulation or guidance by the ,secretary pursuant to this section concerning the safety of a cosmetic or an ingredient or nonfunctional constituent of a cosmetic shall apply beginning no earlier than the date that is #b years after the date on which such regulation or guidance is issued as final1 unless the ,secretary determines1 after public notice and an opportunity for public comment1 that an earlier date of applicability is required to prevent serious adverse health consequences or death to humans4 4 #i4 ,national ,cosmetic ,regulatory ,databank ,chapter ,,vi 7#ba ,u4,s4,c4 #cfa et seq471 as amended by sections #c1 #d1 #e1 #f1 #g1 and #h1 is further amended by adding at the end the following3 #faj4 ,national ,cosmetic ,regulatory ,databank 7a7 ,in general ,for the purpose of consolidating information pertaining to the regulation of cosmetic safety1 the ,secretary shall establish and maintain in the center of the ,food and ,drug ,administration with primary responsibility for regulating cosmetics a database1 to be known as the ,national ,cosmetic ,regulatory ,databank1 containing-- 7#a7 the information submitted to the ,secretary under sections #fje1 #fjf1 #fjg1 and #fji2 and 7#b7 such other information pertaining to the regulation of cosmetics as the ,secretary deems appropriate4 7b7 ,availability ,in the case of information in the ,national ,cosmetic ,regulatory ,databank that is not subject to public disclosure under section #eeb of title #e1 ,united ,states ,code1 the ,secretary may nonetheless disclose such information to the director of a ,state agency on written request by such director demonstrating good cause for the disclosure4 ,a director receiving information pursuant to the preceding sentence shall agree to limit to the disclosure of such information by ,state officials and employees to the same extent such disclosure is limited with respect to ,federal officials and employees under section #cja7;j7 of this ,act1 section #eeb7;b7 of title #e1 ,united ,states ,code1 and section #aije of title #ah1 ,united ,states ,code1 with respect to such information4 7c7 ,preemption ,no ,state or political subdivision thereof may require submission of information that is available in the ,national ,cosmetic ,regulatory ,databank1 whether in the same or a different format4 4 #aj4 ,special rules 7a7 ,certain rules ,chapter ,,vi 7#ba ,u4,s4,c4 #cfa et seq471 as amended by sections #c1 #d1 #e1 #f1 #g1 #h1 and #i1 is further amended by adding at the end the following3 #faa4 ,special rules 7a7 ,contractors ,the person described in section #fjg7;f7 with respect to a cosmetic 7referred to in this section as the responsible party7 may1 by agreement1 authorize a manufacturer1 distributor1 or packer of the cosmetic or a third-party contractor to submit any required report of a serious and unexpected adverse event 7as such term is used in section #fjg7 so long as the responsible party directs to the manufacturer1 distributor1 packer1 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 #fjg7;f74 7b7 ,exemptions ,the ,secretary1 on the ,secretary's own initiative or in response to a petition1 may establish exemptions from the requirements of sections #fja7;f71 #fje1 #fjf1 #fjg1 and #fjh-- 7#a7 for the efficient and cost-effective implementation of such requirements2 or 7#b7 where the cost of compliance exceeds the safety benefit to the public4 4 7b7 ,cosmetic definition ,section #bja7;i7 7#ba ,u4,s4,c4 #cba7;i77 is amended by adding at the end the following3 ,an article described in subparagraph 7#a7 that is intended only for topical external use to alter the appearance by temporarily affecting the structure or any function of the human skin1 and that is not the subject of an approved new drug application under section #eje1 shall1 for purposes of this ,act1 be treated only as a cosmetic and not a drug44 7c7 ,color ,additives ,section #gba7;f7 7#ba ,u4,s4,c4 #cgi;e7f77 is amended-- 7#a7 by striking 7f7 ,the ,secretary shall and inserting 7f77#a7 ,the ,secretary shall2 and 7#b7 by adding at the end the following3 7#b7 ,a color additive1 including mixtures thereof1 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 recognized1 among experts qualified by scientific training and experience to evaluate its safety1 as having been shown through scientific procedures to be safe under the conditions of its intended use4 ,notwithstanding the preceding sentence1 the ,secretary may by regulation require certification of batches under subsection 7c7 for any such color additive4 4 #aa4 ,prohibited acts 7a7 ,in general ,section #cja 7#ba ,u4,s4,c4 #cca7 is amended by adding at the end the following3 7ddd7 ,the failure to register a cosmetic establishment as required under section #fje or to maintain the registration current and accurate4 7eee7 ,the failure to submit a cosmetic and ingredient statement as required under section #fjf or to maintain the statement current and accurate4 7fff7 ,the failure to submit a serious and unexpected adverse event report1 or to include on the label of a cosmetic the domestic telephone number1 email address1 or mailing address through which a report of a serious adverse event may be received1 as required under section #fjg4 4 7b7 ,information security ,section #cja7;j7 7#ba ,u4,s4,c4 #cca7;j77 is amended by inserting #fje1 #fjf1 #fji1 after #egc14 #ab4 ,national uniformity for cosmetics ,section #geb 7#ba ,u4,s4,c4 #cgis7 is amended-- 7#a7 by amending the section heading to read as follows3 ,national uniformity for cosmetics2 7#b7 by amending subsection 7a7 to read as follows3 7a7 ,in general ,except as provided in subsection 7b7 or 7d7 of this section1 no ,state or political subdivision of a ,state may establish or continue in effect any requirement for labeling or packaging of a cosmetic4 2 7#c7 by amending subsection 7c7 to read as follows3 7c7 ,cosmetic safety ,no ,state or political subdivision of a ,state may establish or continue in effect any law1 regulation1 order1 or other requirement-- 7#a7 relating directly or indirectly to1 or relying upon1 a human health or safety evaluation of a nonfunctional cosmetic constituent1 cosmetic ingredient1 or cosmetic 7as defined in section #bja7;i77#a771 or relating in any way to the safety standard and the human health-based requirements1 evaluations1 and determinations under chapter ,,vi1 the ,poison ,prevention ,packaging ,act of #aigj1 or the ,fair ,packaging and ,labeling ,act2 or 7#b7 relating directly or indirectly to registration or listing of cosmetic facilities1 establishments1 cosmetics1 or cosmetic ingredients1 reporting of any information relating to cosmetics including adverse event reporting1 cosmetic manufacturing processes or standards including good manufacturing practice1 cosmetic labels or labeling including any general or health related warnings or public statement1 or the requirement of any fees on cosmetic establishments1 cosmetics1 ingredients1 or nonfunctional constituents4 2 and 7#d7 by repealing subsection 7e74 #ac4 ,importation ,section #hja7;a7 7#ba ,u4,s4,c4 #cha7;a77 is amended by adding at the end the following3 ,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 #fje for the establishment that performs the final portion of the manufacturing operation and the unique cosmetic and ingredient statement number required under section #fjf for the cosmetic1 or the registration or statement number is not correct and accurate1 the cosmetic shall be denied entry44 #ad4 ,effective dates 7a7 7#a7 ,the amendments made by sections #d1 #e1 #f1 and #ac of this ,act apply beginning on the later date of-- 7,a7 the date that is one year after the ,secretary of ,health and ,human ,services promulgates final regulations implementing such amendments2 or 7,b7 the date that is one year after the ,secretary 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-- 7i7 the submission of cosmetic manufacturing establishment registrations1 cosmetic and ingredient statements1 and reports of serious cosmetic adverse events2 and 7ii7 the ,national ,cosmetic ,regulatory ,databank4 7#b7 ,until the date applicable under paragraph 7#a71 the voluntary establishment registration and voluntary ingredient listing programs established in parts #gaj and #gbj of title #ba1 ,code of ,federal ,regulations 7as in effect on the date of enactment of this ,act71 shall remain effective and shall be fully implemented by the ,secretary of ,health and ,human ,services4 7b7 ,the amendments made by sections #g and #h apply beginning on the date that is two years after the date of enactment of this ,act4 7c7 ,notwithstanding subsections 7a7 and 7b71 the amendments made by sections #e and #g shall not apply with respect to a cosmetic manufacturer with less than #e1jjj1jjj of annual net sales of cosmetics until the later of-- 7#a7 7,a7 with respect to the amendment made by section #e1 the date that is #cf months after the date otherwise applicable under subsection 7a72 and 7,b7 with respect to the amendments made by section #g1 the date that is #cf months after the date otherwise applicable under subsection 7b72 and 7#b7 such later date as may be determined by the ,secretary of ,health and ,human ,services4 7d7 ,except as provided in subsections 7a7 through 7c71 this ,act takes effect on the date of enactment of this ,act4