,i #aagth ,,congress #ast ,session ,h4 ,r4 #eeci ,,in ,,the ,,house ,,of ,,representatives ,october #h1 #bjba,ms4 ,schakowsky introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend title ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act to ensure the supply chain transparency needed for companies to make safe cosmetics1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,cosmetic ,supply ,chain ,transparency ,act of #bjba4 #b4 ,cosmetic regulation ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq47 is amended-- 7#a7 by inserting before section #fja the following3 ,a ,adulterated and ,misbranded ,cosmetics 2 and 7#b7 by adding at the end the following3 ,b ,supply chain transparency #faa4 ,definitions ,in this subchapter3 7#a7 ,brand owner ,the term brand owner means the entity responsible for bringing a cosmetic to market4 7#b7 ,flavor or fragrance company ,the term flavor or fragrance company means an entity that makes or supplies fragrance or flavor ingredients or fragrance or flavor formulations4 7#c7 ,formulating laboratory ,the term formulating laboratory means an entity that supplies a finished cosmetic product to a retailer or cosmetic company to sell under the retailer or cosmetic company's brand name4 7#d7 ,harmful to human health or the environment ,the phrase harmful to human health or the environment means1 with respect to a nonfunctional constituent-- 7,a7 being-- 7i7 a reproductive or developmental toxicant2 7ii7 persistent1 bioaccumulative1 and toxic2 7iii7 an allergen2 or 7iv7 an endocrine disruptor1 carcinogen1 or mutagen2 and 7,b7 present on the most recent version in effect of any of the following lists3 7i7 ,chapter #f4f of the ,california ,safe ,drinking ,water and ,toxic ,enforcement ,act of #aihf 7sections #bebdi4e through #bebdi4ad of the ,california ,health and ,safety ,code71 ,list of ,reproductive and ,developmental ,toxicants and ,carcinogens4 7ii7 ,chemicals classified as ,persistent1 ,bioaccumulative and ,toxic by the ,toxics ,release ,inventory published by the ,environmental ,protection ,agency pursuant to section #cac of the ,emergency ,planning and ,community ,right-to-,know ,act of #aihf4 7iii7 ,european ,union ,regulation #abbc_/bjji_/;,,ec on ,cosmetic ,products1 as amended by ,regulation 7,,eu7 #bjbj_/afhc1 ,annex ,,ii-,prohibited ,substances4 7iv7 ,annex ,,iii of ,european ,union ,cosmetics ,regulation ,no4 #abbc_/bjji1 as required to be disclosed pursuant to ,european ,union ,detergents ,regulation ,no4 #bafdh_/bjjd4 7v7 ,chemicals included in the ,european ,union ,candidate ,list of ,substances of ,very ,high ,concern in accordance with ,article #ei of the ,,reach ,regulation 7,,ec7 ,no4 #aijg_/bjjf on the basis of fulfilling the criteria defined in ,article #eg7;f7 for endocrine-disrupting properties4 7vi7 ,substances classified as carcinogens1 mutagens1 or reproductive toxicants in ,appendices #a-f of ,annex ,,xvii to ,regulation 7,,ec7 ,no4 #aijg_/bjjf of the ,european ,union's ,registration1 ,evaluation1 ,authorisation1 and ,restriction of ,chemicals 7,,reach7 law1 as revised by the ,commission ,regulation 7,,eu7 #bjbj_/bjif of ,december #ae1 #bjbj4 7vii7 ,group #a1 #b;,a1 or #b;,b carcinogens identified by the ,international ,agency for ,research on ,cancer of the ,world ,health ,organization4 7viii7 ,any other list the ,secretary determines appropriate for purposes of this subchapter4 7#e7 ,ingredient ,the term ingredient means an intentionally added chemical in a cosmetic that has a technical or functional effect1 including-- 7,a7 the breakdown products of an intentionally added chemical that also have a functional or technical effect in the cosmetic2 7,b7 a fragrance1 flavor1 preservative1 or colorant 7and the components thereof72 and 7,c7 any individual component that the ,secretary deems to be an ingredient for purposes of this subchapter4 7#f7 ,incidental component ,the term incidental component means-- 7,a7 a chemical added during the manufacturing process at any point in a cosmetic's1 or an ingredient's1 supply chain1 but which has no functional or technical effect in the finished cosmetic2 or 7,b7 a chemical present in the environment which was introduced into a cosmetic1 or into an ingredient1 at any point in the supply chain for the cosmetic or ingredient4 7#g7 ,manufacturer ,the term manufacturer means any entity that-- 7,a7 produces an ingredient2 or 7,b7 combines one or more ingredients to produce a cosmetic4 7#h7 ,nonfunctional constituent ,the term nonfunctional constituent means a chemical that has no functional or technical effect on the product or ingredient and is present-- 7,a7 as an incidental component of an intentionally added ingredient2 7,b7 as a breakdown product of an intentionally added ingredient2 7,c7 as a byproduct of the manufacturing process2 7,d7 due to storage of primary substances2 or 7,e7 due to instability of the packaging4 7#i7 ,raw material ,the term raw material means a substance or mixture of substances that-- 7,a7 is used in the manufacture of a cosmetic for commercial distribution2 and 7,b7 is supplied to a cosmetic manufacturer1 packer1 or distributor by a cosmetic raw material manufacturer or supplier4 7#aj7 ,supplier ,the term supplier-- 7,a7 means an entity that supplies a cosmetic1 cosmetic packaging1 or an ingredient or raw material of a cosmetic or cosmetic packaging2 and 7,b7 includes any such entity that is a manufacturer1 a formulating laboratory1 or a fragrance or flavor company4 #fab4 ,cosmetic and ingredient safety information ,at the request of a brand owner of a cosmetic1 a supplier of the cosmetic or any ingredient therein shall1 not later than #ij days after receipt of such request1 provide to the brand owner1 with respect to the cosmetic or ingredient1 any of the following information3 7#a7 7,a7 ,functions and uses4 7,b7 ,the human health and environmental hazards4 7,c7 ,the physical and chemical properties4 7,d7 ,the ,chemical ,abstracts ,services ,registry number of any such ingredient4 7,e7 ,environmental exposure and fate information4 7,f7 ,any other information used to substantiate the safety of such ingredient4 7#b7 ,a full and complete listing of ingredients in fragrance or flavor formulations1 preservative systems1 or other ingredient formulations1 including the presence of any allergens4 7#c7 ,a full and complete listing of ingredients in a finished cosmetic presented in descending order of predominance by weight1 except that ingredients present in amounts of #a percent or less by weight can be placed in any order at the end of the ingredient statement4 7#d7 ,a certificate of analysis for the ingredient4 #fac4 ,process for establishing an ,,fda list of nonfunctional constituents known or reasonably expected to be present in cosmetics and ingredients 7a7 ,in general ,the ,secretary shall create and maintain a list of nonfunctional constituents to guide testing under this subchapter conducted by suppliers of cosmetics and ingredients4 7b7 ,contents ,the list under subsection 7a7 shall consist of nonfunctional constituents that are-- 7#a7 known or reasonably expected to be present in cosmetics or ingredients2 and 7#b7 subject to subsection 7e77#b71 harmful to human health or the environment4 7c7 ,identification of ingredients and cosmetics ,for each nonfunctional constituent on the list under subsection 7a71 the ,secretary shall identify the specific ingredient or cosmetic1 or category of ingredients or cosmetics1 in which the nonfunctional constituent is known or reasonably expected to be present4 7d7 ,initial list 7#a7 ,in general ,in creating the initial list under subsection 7a71 the ,secretary shall-- 7,a7 publish a proposed list and provide an opportunity for public comment on such proposed list for a period of #fj days2 and 7,b7 not later than #ah months after the date of enactment of the ,cosmetic ,supply ,chain ,transparency ,act of #bjba1 finalize and publish the list4 7#b7 ,advisory committee 7,a7 ,in general ,not later than #i months after the date of enactment of the ,cosmetic ,supply ,chain ,transparency ,act of #bjba1 the ,secretary shall convene an advisory committee to advise the ,secretary on-- 7i7 creating the initial list under subsection 7a72 and 7ii7 best practices related to analytical testing for nonfunctional constituents in cosmetics and ingredients4 7,b7 ,membership ,the membership of the advisory committee convened under subparagraph 7,a7 shall consist of an equal number of-- 7i7 representatives from industry2 7ii7 representatives from the nonprofit community2 7iii7 representatives from the scientific community2 and 7iv7 representatives from the medical and public health community4 7,c7 ,termination ,the ,secretary shall terminate the advisory committee convened under this paragraph upon the finalization of the initial list pursuant to paragraph 7#a74 7e7 ,updates ,not less than annually after the finalization pursuant to subsection 7d7 of the initial list under subsection 7a71 and not less than annually thereafter1 the ,secretary shall-- 7#a7 review the list under subsection 7a72 7#b7 after providing a period of at least #cj days for public comment1 update the list by adding nonfunctional constituents that are known or reasonably expected to be present in a cosmetic or ingredient as specified in subsection 7b77#a7 and-- 7,a7 are determined by the ,secretary to meet the standard specified in section #faa7d77;,a7 based on existing and emerging science2 or 7,b7 have been added to one of the lists in section #faa7d77;,b72 and 7#c7 update the list by adding any nonfunctional constituent whose addition was approved pursuant to a petition under subsection 7f74 7f7 ,petition process for adding nonfunctional constituents or new lists 7#a7 ,in general ,any person may petition1 in accordance with paragraph 7#c71 to add-- 7,a7 a nonfunctional constituent to the list under subsection 7a72 or 7,b7 a new list to the lists specified in section #faa7d77;,b74 7#b7 ,development of process ,the ,secretary-- 7,a7 not later than #bd months after the date of enactment of the ,cosmetic ,supply ,chain ,transparency ,act of #bjba1 shall develop and publish the process for submitting a petition under this subsection2 and 7,b7 may periodically review and update such process4 7#c7 ,requirements for process ,the process developed and updated by the ,secretary under paragraph 7#b7 shall be consistent with the following3 7,a7 ,such process shall specify the necessary scientific justification that must be included in a petition4 7,b7 ,the ,secretary shall-- 7i7 provide a #cj-;day period for public comment on a petition2 and 7ii7 not later than #ij days after the close of such public comment period1 approve or deny the petition4 7,c7 ,if the ,secretary approves a petition1 the ,secretary shall provide notice in the ,federal ,register of each addition made pursuant to such approval4 7,d7 ,in denying a petition1 the ,secretary shall provide a written justification to the petitioner for the denial4 7g7 ,guidance ,the ,secretary-- 7#a7 shall1 concurrently with the publication of the initial list under subsection 7a71 and upon adding any nonfunctional constituent pursuant to subsection 7e7 or 7f7 to the list under subsection 7a71 issue guidance for industry on best practices related to-- 7,a7 analytical testing for nonfunctional constituents in cosmetics and ingredients2 and 7,b7 detection limits2 and 7#b7 may periodically review and update such guidance4 #fad4 ,treatment of nonfunctional constituents ,a supplier of an ingredient or cosmetic shall-- 7#a7 not later than #a year after a nonfunctional constituent is added to the list under section #fac7;a7 pursuant to subsection 7d71 7e71 or 7f7 of section #fac1 conduct testing for such nonfunctional constituent2 and 7#b7 prior to the sale of the ingredient or cosmetic to the brand owner1 provide the brand owner a certificate of analysis that includes-- 7,a7 the levels of each such nonfunctional constituent present2 7,b7 any analytical test used2 and 7,c7 the detection limits of any analytical test used to detect each such nonfunctional constituent4 #fae4 ,notification1 nondistribution1 and recall of adulterated or misbranded cosmetics 7a7 ,supply chain information ,in the case of a cosmetic that the ,secretary has reason to believe is adulterated1 misbranded1 or otherwise in violation of this ,act1 the ,secretary shall request that the brand owner named on the label of such cosmetic submit to the ,secretary all of the following information3 7#a7 ,the name and place of business of the manufacturer of the cosmetic and any supplier of an ingredient or raw material used in the manufacture of the cosmetic4 7#b7 ,the name and place of business of any entity 7including any retailer7 to which the brand owner provided the cosmetic4 7b7 ,collection of additional supply chain information ,in the case of a cosmetic that the ,secretary has reason to believe is adulterated1 misbranded1 or otherwise in violation of this ,act1 to the extent necessary to protect the safety of the public1 the ,secretary may request that any entity in the supply chain of such cosmetic submit to the ,secretary information that is similar to the information described in paragraphs 7#a7 and 7#b7 of subsection 7a74 7c7 ,maintenance of records ,any entity in the supply chain of a cosmetic 7including the brand owner named on the label of a cosmetic7 shall-- 7#a7 maintain records sufficient to provide the information described in paragraphs 7#a7 and 7#b7 of subsection 7a72 and 7#b7 provide such information to the ,secretary upon the request of the ,secretary4 #faf4 ,civil penalties ,any person that violates section #fab1 #fad1 or #fae shall be liable to the ,united ,states for a civil penalty in an amount not to exceed #a1ejj for each day on which such violation continues4 4