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HR 2359 IHCommentsClose CommentsPermalink

112th CONGRESSCommentsClose CommentsPermalink

1st SessionCommentsClose CommentsPermalink

H. R. 2359CommentsClose CommentsPermalink

To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the safe use of cosmetics, and for other purposes.CommentsClose CommentsPermalink

IN THE HOUSE OF REPRESENTATIVESCommentsClose CommentsPermalink

June 24, 2011CommentsClose CommentsPermalink

Ms. SCHAKOWSKY (for herself, Mr. MARKEY, Ms. BALDWIN, Mr. MORAN, Ms. WOOLSEY, Mr. BLUMENAUER, Ms. CHU, Mr. GUTIERREZ, Ms. LEE of California, Mr. FRANK of Massachusetts, and Ms. WASSERMAN SCHULTZ) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and the Workforce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concernedCommentsClose CommentsPermalink

A BILLCommentsClose CommentsPermalink

To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the safe use of cosmetics, and for other purposes.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title- This Act may be cited as the ‘Safe Cosmetics Act of 2011’.CommentsClose CommentsPermalink





(b) Table of Contents- The table of contents of this Act is as follows:CommentsClose CommentsPermalink





Sec. 1. Short title; table of contents.CommentsClose CommentsPermalink





Sec. 2. Cosmetic regulation.CommentsClose CommentsPermalink

‘subchapter a--adulterated and misbranded cosmetics

‘subchapter b--regulation of cosmetics

‘Sec. 611. Definitions.CommentsClose CommentsPermalink

‘Sec. 612. Registration of establishments and registration fees.CommentsClose CommentsPermalink

‘Sec. 613. Ingredients labels on cosmetics.CommentsClose CommentsPermalink

‘Sec. 614. Safety standard and good manufacturing practices.CommentsClose CommentsPermalink

‘Sec. 615. Cosmetic and ingredient safety information.CommentsClose CommentsPermalink

‘Sec. 616. Lists of ingredients and required responses.CommentsClose CommentsPermalink

‘Sec. 617. Treatment of cosmetics based on ingredient lists.CommentsClose CommentsPermalink

‘Sec. 618. Treatment of contaminants.CommentsClose CommentsPermalink

‘Sec. 619. Cosmetic and ingredient statements.CommentsClose CommentsPermalink

‘Sec. 620. Notification, nondistribution, and recall of adulterated or misbranded cosmetics.CommentsClose CommentsPermalink

‘Sec. 621. Petitions.CommentsClose CommentsPermalink

‘Sec. 622. Mandatory reporting of adverse health effects.CommentsClose CommentsPermalink

‘Sec. 623. Nonconfidential information.CommentsClose CommentsPermalink

‘Sec. 624. Animal testing alternatives.CommentsClose CommentsPermalink

‘Sec. 625. Product Testing and Review Audit.CommentsClose CommentsPermalink

‘Sec. 626. Resources for small businesses.CommentsClose CommentsPermalink

‘Sec. 627. Interagency cooperation.CommentsClose CommentsPermalink

‘Sec. 628. Savings clause.CommentsClose CommentsPermalink

‘Sec. 629. Authorization of appropriations.CommentsClose CommentsPermalink

Sec. 3. Worker issues.CommentsClose CommentsPermalink

SEC. 2. COSMETIC REGULATION.

(a) In General- Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361 et seq.) is amended--CommentsClose CommentsPermalink





(1) by inserting before section 601 the following:CommentsClose CommentsPermalink

‘Subchapter A--Adulterated and Misbranded Cosmetics’;

andCommentsClose CommentsPermalink





(2) by adding at the end the following:CommentsClose CommentsPermalink

‘Subchapter B--Regulation of Cosmetics

‘SEC. 611. DEFINITIONS.

‘In this subchapter:CommentsClose CommentsPermalink





‘(1) DOMESTIC ESTABLISHMENT- The term ‘domestic establishment’ means an establishment located in any State that manufactures or packages cosmetics.CommentsClose CommentsPermalink





‘(2) FOREIGN ESTABLISHMENT- The term ‘foreign establishment’ means an establishment that manufactures or packages cosmetics that are exported to the United States.CommentsClose CommentsPermalink





‘(3) MANUFACTURER- The term ‘manufacturer’ only includes manufacturers that determine the final formulation of a cosmetic.CommentsClose CommentsPermalink





‘(4) INGREDIENT-CommentsClose CommentsPermalink





‘(A) IN GENERAL- The term ‘ingredient’ means a chemical in a cosmetic, including--CommentsClose CommentsPermalink





‘(i) chemicals that provide a technical or functional effect;CommentsClose CommentsPermalink





‘(ii) chemicals that have no technical or functional effect in the cosmetic but are present by reason of having been incorporated into the cosmetic as an ingredient of another cosmetic ingredient;CommentsClose CommentsPermalink





‘(iii) processing aids that are present by reason of having been added to a cosmetic during the processing of such cosmetic;CommentsClose CommentsPermalink





‘(iv) substances that are present by reason of having been added to a cosmetic during processing for their technical or functional effect;CommentsClose CommentsPermalink





‘(v) the components of a fragrance, flavor, or preservative; andCommentsClose CommentsPermalink





‘(vi) any individual component of a petroleum-derived, animal-derived, or other ingredient that the Secretary deems an ingredient for purposes of this chapter.CommentsClose CommentsPermalink





‘(B) TREATMENT OF CONTAMINANTS- For purposes of sections 614 through 617, the term ‘ingredient’ also includes--CommentsClose CommentsPermalink





‘(i) contaminants present at levels above technically feasible detection limits; andCommentsClose CommentsPermalink





‘(ii) contaminants that may leach from container materials or form via reactions over the shelf life of a cosmetic and that may be present at levels above technically feasible detection limits.CommentsClose CommentsPermalink





‘(5) MICROBUSINESS- The term ‘microbusiness’ means a business--CommentsClose CommentsPermalink





‘(A) that is engaged in the manufacturing or packaging of cosmetics; andCommentsClose CommentsPermalink





‘(B) that has annual sales receipts for cosmetic products that do not exceed $2,000,000.CommentsClose CommentsPermalink





‘(6) PROFESSIONAL USE- The term ‘professional use’ means the use of any cosmetic--CommentsClose CommentsPermalink





‘(A) by an employee (within the scope of the employment of such employee) of; orCommentsClose CommentsPermalink





‘(B) purchased by a consumer in,CommentsClose CommentsPermalink





a hair salon, nail salon, beauty salon, spa, or other establishment that provides cosmetic treatment services for humans.CommentsClose CommentsPermalink





‘(7) REASONABLE CERTAINTY OF NO HARM- With respect to an ingredient or cosmetic, the term ‘reasonable certainty of no harm’ means that no harm will be caused to members of the general population or any vulnerable population by aggregate exposure to the cosmetic or ingredient, taking into account possible harmful effects from--CommentsClose CommentsPermalink





‘(A) low-dose exposures to the cosmetic or ingredient; orCommentsClose CommentsPermalink





‘(B) additive effects resulting from repeated exposure to the cosmetic or ingredient over time; orCommentsClose CommentsPermalink





‘(C) cumulative exposure resulting from all sources, including both the cosmetic or ingredient and environmental sources.CommentsClose CommentsPermalink





‘(8) REPRODUCTIVE OR DEVELOPMENTAL TOXICITY- With respect to an ingredient or cosmetic, the term ‘reproductive or developmental toxicity’ means that the ingredient or cosmetic can contribute to biologically adverse effects on the development of humans or animals, including effects on the female or male reproductive system, the endocrine system, fertility, pregnancy, pregnancy outcomes, or modifications in other functions of the body that are dependent on the integrity of the reproductive system as well normal fetal development.CommentsClose CommentsPermalink





‘(9) VULNERABLE POPULATIONS- The term ‘vulnerable populations’ includes pregnant women, infants, children, the elderly, people with compromised immune systems, and highly exposed populations, including workers employed by hair salons, nail salons, beauty salons, spas, other establishments that provide cosmetic treatment services for humans, and cosmetic manufacturing plants.CommentsClose CommentsPermalink

‘SEC. 612. REGISTRATION OF ESTABLISHMENTS AND REGISTRATION FEES.

‘(a) Registration-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Beginning 1 year after the date of the enactment of this subchapter, and annually thereafter, any establishment (except for microbusinesses) engaged in manufacturing or packaging cosmetics for use in the United States shall register with the Secretary and pay to the Secretary the applicable fee, as established under the fee schedule in subsection (e).CommentsClose CommentsPermalink





‘(2) RULES FOR DOMESTIC AND FOREIGN ESTABLISHMENTS- To be registered under paragraph (1)--CommentsClose CommentsPermalink





‘(A) as a domestic establishment, the owner, operator, or agent in charge of the domestic establishment shall submit a registration to the Secretary; orCommentsClose CommentsPermalink





‘(B) as a foreign establishment, the owner, operator, or agent in charge of the foreign establishment shall--CommentsClose CommentsPermalink





‘(i) submit a registration to the Secretary; andCommentsClose CommentsPermalink





‘(ii) include with the registration the name of the United States agent for the foreign establishment.CommentsClose CommentsPermalink





‘(3) NEW ESTABLISHMENTS- Any establishment that begins to manufacture or package a cosmetic after the date on which the requirements of paragraph (1) apply shall, not later than 60 days after the date on which the establishment began to manufacture or package such cosmetic, register with the Secretary and pay the applicable fee, as required under paragraph (1).CommentsClose CommentsPermalink





‘(b) Submission of Registration-CommentsClose CommentsPermalink





‘(1) IN GENERAL- In order to register under subsection (a), an establishment (referred to in this section as the ‘registrant’) shall submit to the Secretary, with respect to any cosmetics that the establishment manufactures or package, all of the following:CommentsClose CommentsPermalink





‘(A) Any information necessary to notify the Secretary of the name, address, and legal status of each establishment at which, and all trade names under which, the registrant manufactures or package cosmetics.CommentsClose CommentsPermalink





‘(B) A description of the establishment’s activities with respect to cosmetics, including a list of all cosmetic products manufactured or packaged by the establishment and the functions of such cosmetics.CommentsClose CommentsPermalink





‘(C) The gross receipts or sales for the establishment from cosmetics.CommentsClose CommentsPermalink





‘(D) The name and address of any company that supplies the establishment, if the establishment manufactures cosmetics, with any ingredient and the name of the ingredient supplied to such establishment by such supplier.CommentsClose CommentsPermalink





‘(2) NOTIFICATION OF CHANGES- When submitting the annual registration, the registrant shall notify the Secretary of changes to the information described in paragraph (1).CommentsClose CommentsPermalink





‘(c) Procedure- Upon receipt of a completed registration submitted under subsection (a), the Secretary shall notify the registrant of the receipt of such registration and assign a registration number to each registered establishment.CommentsClose CommentsPermalink





‘(d) List of Registered Establishments-CommentsClose CommentsPermalink





‘(1) MAINTENANCE OF LIST- The Secretary shall--CommentsClose CommentsPermalink





‘(A) compile, maintain, and update as appropriate, a list of establishments that are registered under this section;CommentsClose CommentsPermalink





‘(B) make such list publically available; andCommentsClose CommentsPermalink





‘(C) remove from such list the name of any establishment that fails to register in accordance with this section.CommentsClose CommentsPermalink





‘(2) APPLICATION OF FOIA-CommentsClose CommentsPermalink





‘(A) REGISTRATION DOCUMENTS- Any registration documents submitted pursuant to this section shall not be subject to disclosure under section 552 of title 5, United States Code.CommentsClose CommentsPermalink





‘(B) OTHER INFORMATION- Information derived from--CommentsClose CommentsPermalink





‘(i) the list under paragraph (1); orCommentsClose CommentsPermalink





‘(ii) registration documents submitted pursuant to this section,CommentsClose CommentsPermalink





shall not be subject to disclosure under section 552 of title 5, United States Code, except to the extent that such information discloses the identity or location of a specific registrant.CommentsClose CommentsPermalink





‘(e) Fee Schedule- A schedule of fees shall be developed by the Secretary to provide for oversight and enforcement of this subchapter. The fee structure shall--CommentsClose CommentsPermalink





‘(1) be prorated based on the establishment’s gross receipts or sales; andCommentsClose CommentsPermalink





‘(2) only be assessed on companies with annual gross receipts or sales of cosmetics that exceed $10,000,000.CommentsClose CommentsPermalink





‘(f) Suspension and Cancellation of Registration-CommentsClose CommentsPermalink





‘(1) CRITERIA FOR SUSPENSION- Registration under this section is subject to suspension if the Secretary finds--CommentsClose CommentsPermalink





‘(A) the information submitted by the establishment for registration under subsection (a) is incomplete, inaccurate, or out of date;CommentsClose CommentsPermalink





‘(B) the establishment fails to notify the Secretary of changes required under subsection (b)(2);CommentsClose CommentsPermalink





‘(C) the establishment fails to pay registration fees, as required under subsection (a), in a timely manner; orCommentsClose CommentsPermalink





‘(D) the establishment violates any portion of this chapter.CommentsClose CommentsPermalink





‘(2) SUSPENSION OF REGISTRATION- If the Secretary determines that an establishment is subject to suspension under subsection (f) and that it is appropriate to suspend the registration of such establishment, the Secretary shall--CommentsClose CommentsPermalink





‘(A) suspend the registration of such establishment; andCommentsClose CommentsPermalink





‘(B) provide a notice of suspension to such establishment.CommentsClose CommentsPermalink





‘(3) CANCELLATION- If the establishment fails to correct the issue that resulted in the suspension under paragraph (2) before the last day of the 30-day period beginning on the date that the establishment receives notice under such paragraph, the Secretary may cancel the registration of such establishment.CommentsClose CommentsPermalink

‘SEC. 613. INGREDIENTS LABELS ON COSMETICS.

‘(a) In General- Subject to subsections (b) and (c), the Secretary shall require that the label on each package of cosmetics (including cosmetics distributed for retail sale and professional use) bears a declaration of the name of each ingredient in such cosmetic in descending order of predominance.CommentsClose CommentsPermalink





‘(b) Adjustments for Label Size-CommentsClose CommentsPermalink





‘(1) RULES FOR SMALL PRODUCTS- Not later than 6 months after the date of the enactment of this subchapter, the Secretary shall issue regulations that apply to any cosmetic for which the product packaging is not of sufficient size to bear or contain a label that meets the requirements of subsection (a).CommentsClose CommentsPermalink





‘(2) REQUIREMENTS FOR PUBLIC DISCLOSURE- Such regulations shall establish requirements for listing ingredients on the label of such cosmetics and additional requirements for public disclosure of the ingredients in such cosmetics.CommentsClose CommentsPermalink





‘(c) Special Rule for Contaminants- The Secretary shall require, in the case of a contaminant, that a contaminant be declared on the label of a cosmetic, in the same manner as an ingredient under subsection (a), if the contaminant is present at the lower of the following levels:CommentsClose CommentsPermalink





‘(1) A level that is greater than one part-per-billion by weight of product formation.CommentsClose CommentsPermalink





‘(2) A level that is greater than one percent of the restriction on the concentration for such contaminant for such use, as determined by the Secretary under section 616(a)(2).CommentsClose CommentsPermalink





‘(d) Labeling of Nanomaterials in Cosmetics- The Secretary may require that--CommentsClose CommentsPermalink





‘(1) minerals and other particulate ingredients be labeled as ‘nano-scale’ on a cosmetic ingredient label or list if not less than 1 percent of the ingredient particles in the cosmetic are 100 nanometers or smaller in not less than 1 dimension; andCommentsClose CommentsPermalink





‘(2) other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties.CommentsClose CommentsPermalink





‘(e) Labeling of Ingredients in Cosmetics Sold Through Internet Commerce- The Secretary shall require--CommentsClose CommentsPermalink





‘(1) in the case of a cosmetic sold on the Web site of an Internet vendor, that the manufacturers and distributors of such cosmetic provide to such Internet vendor a list of the ingredients of the cosmetic; andCommentsClose CommentsPermalink





‘(2) that each Internet vendor display the list of ingredients of a cosmetic sold by such vendor on the Web page that is the primary Web page providing information relating to the sale of such cosmetic on the Web site of the vendor.CommentsClose CommentsPermalink





‘(f) Trade Secrets- Notwithstanding any other provision of law, an ingredient required to be listed on a label under this section shall not be treated as a trade secret.CommentsClose CommentsPermalink





‘(g) Application- Beginning 18 months after the date of the enactment of this subchapter, the requirements of this section shall apply to--CommentsClose CommentsPermalink





‘(1) all cosmetics that are available for retail sale; andCommentsClose CommentsPermalink





‘(2) manufacturers, distributors, and Internet vendors of such cosmetics.CommentsClose CommentsPermalink

‘SEC. 614. SAFETY STANDARD AND GOOD MANUFACTURING PRACTICES.

‘(a) Safety Standard-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Taking into account the expected use of a cosmetic, the Secretary shall establish a safety standard that, with respect to a cosmetic or an ingredient in a cosmetic provides a reasonable certainty of no harm (as such term is defined in section 611(7)) from exposure to the cosmetic or ingredient and protects the public from any known or anticipated adverse health effects associated with the cosmetic or ingredient.CommentsClose CommentsPermalink





‘(2) STANDARDS FOR ESTABLISHING SAFETY STANDARD- In establishing the safety standard under paragraph (1), the Secretary shall ensure that--CommentsClose CommentsPermalink





‘(A) the likely level of exposure to all sources of the ingredient or cosmetic (including environmental sources) that will result under the safety standard presents not more than a 1 in a million risk for any adverse health effect in any vulnerable population at the lower 95th percentile confidence interval; orCommentsClose CommentsPermalink





‘(B) the safety standard results in exposure to the amount or concentration of an ingredient or cosmetic that is shown to produce no adverse health effects, incorporating an margin of safety of at least 1,000 and considering the impact of cumulative exposure from all sources (including environmental sources).CommentsClose CommentsPermalink





‘(3) USE OF OTHER FEDERAL STANDARDS- If any Federal agency has promulgated a standard for an ingredient that satisfies the requirements under paragraph (1), the Secretary may treat such standard as the safety standard under paragraph (1) for purposes of such ingredient.CommentsClose CommentsPermalink





‘(4) APPLICATION OF SAFETY STANDARD- The Secretary may only determine that an ingredient or a cosmetic meets the safety standard under paragraph (1) if there is a reasonable certainty of no harm from exposure to the ingredient or cosmetic.CommentsClose CommentsPermalink





‘(b) Good Manufacturing Practices-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Secretary shall issue guidance prescribing good manufacturing practices for cosmetics and ingredients, including quality control procedures that the Secretary determines are necessary, and shall update such regulations as necessary.CommentsClose CommentsPermalink





‘(2) CONSIDERATION OF SMALL BUSINESS- In developing the guidance under paragraph (1), the Secretary shall consider how such practices will impact small businesses.CommentsClose CommentsPermalink

‘SEC. 615. COSMETIC AND INGREDIENT SAFETY INFORMATION.

‘(a) Required Submission of All Safety Information-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Manufacturers of cosmetics and ingredients shall submit to the Secretary (in an electronic format that the Secretary shall determine) all data and information that the manufacturer can access regarding the safety of the--CommentsClose CommentsPermalink





‘(A) ingredients listed on the cosmetic label under section 613 for a cosmetic; andCommentsClose CommentsPermalink





‘(B) cosmetic itself.CommentsClose CommentsPermalink





‘(2) REQUIRED INFORMATION- The required data and information under paragraph (1) shall include, for each ingredient in a cosmetic and for the cosmetic, the following:CommentsClose CommentsPermalink





‘(A) Functions and uses.CommentsClose CommentsPermalink





‘(B) Data and information on the physical, chemical, and toxicological properties of each such ingredient or cosmetic.CommentsClose CommentsPermalink





‘(C) Exposure and fate information.CommentsClose CommentsPermalink





‘(D) Results of all safety tests that the manufacturer can access or has conducted.CommentsClose CommentsPermalink





‘(E) Any other information used to substantiate the safety of such ingredient and cosmetic.CommentsClose CommentsPermalink





‘(3) DEADLINES-CommentsClose CommentsPermalink





‘(A) INITIAL SUBMISSION- A manufacturer shall submit the data and information required under paragraph (1)--CommentsClose CommentsPermalink





‘(i) in the case of an ingredient or cosmetic which is marketed for sale in interstate commerce on or before the date of the enactment of this subchapter, not later than 1 year after such date; andCommentsClose CommentsPermalink





‘(ii) in the case of an ingredient or cosmetic which is not marketed for sale on or before such date--CommentsClose CommentsPermalink





‘(I) not later than the end of the 14-month period beginning on the date of the enactment of this subchapter; orCommentsClose CommentsPermalink





‘(II) if the ingredient or cosmetic is first marketed for sale in interstate commerce after the end of the period described in subclause (I), not later than 60 days after the date on which such ingredient or cosmetic is first marketed for sale.CommentsClose CommentsPermalink





‘(B) UPDATES-CommentsClose CommentsPermalink





‘(i) IN GENERAL- Subject to clause (ii), a manufacturer shall update the data and information submitted under subparagraph (A) annually.CommentsClose CommentsPermalink





‘(ii) ADVERSE HEALTH EFFECTS- In the case of information related to an adverse health effect that is suspected to be caused by an ingredient or a cosmetic, a manufacturer shall update the information not later than 60 days after receiving such information.CommentsClose CommentsPermalink





‘(4) SUPPLIER INFORMATION-CommentsClose CommentsPermalink





‘(A) USE OF SUPPLIER INFORMATION- In order to meet the requirements of paragraph (1) with respect to an ingredient, a manufacturer may submit safety data and information provided by the supplier of the ingredient.CommentsClose CommentsPermalink





‘(B) SUPPLIER PROVISION OF INFORMATION- If a manufacturer requests that a supplier of an ingredient provide to such manufacturer any of the data and information described under paragraph (2), such supplier shall provide such data and information to such manufacturer not later than 90 days after receiving such request.CommentsClose CommentsPermalink





‘(b) Database-CommentsClose CommentsPermalink





‘(1) INITIAL PUBLICATION- Not later than 1 year after the date of the enactment of this subchapter, the Secretary shall publish a comprehensive, publicly accessible database containing all nonconfidential information (as such term is used under section 623) submitted under subsection (a)(1).CommentsClose CommentsPermalink





‘(2) UPDATES- Not later than 90 days after the Secretary receives new or updated information under subsection (a)(3)(B), the Secretary shall update the database under paragraph (1) with such information.CommentsClose CommentsPermalink





‘(c) Review and Evaluation of Information-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Based on the data and information submitted under subsection (a)(1), available from an authoritative source (as such term is defined in paragraph (3), including data described under section 627(b)), and such other information as the Secretary may have available, the Secretary shall review and evaluate the safety of cosmetics and ingredients of cosmetics that are marketed in interstate commerce.CommentsClose CommentsPermalink





‘(2) CONSIDERATION OF NANOMATERIALS- The Secretary shall--CommentsClose CommentsPermalink





‘(A) monitor developments in the scientific understanding from any adverse health effects related to the use of nanotechnology in the formulation of cosmetic (including progress in the standardization of testing methods and specific size definitions for nanomaterials); andCommentsClose CommentsPermalink





‘(B) consider scale specific hazard properties of ingredients when reviewing and evaluating the safety of cosmetics and ingredients under paragraph (1).CommentsClose CommentsPermalink





‘(3) AUTHORITATIVE SOURCE DEFINED- For purposes of this paragraph, the term ‘authoritative source’ means--CommentsClose CommentsPermalink





‘(A) the Environmental Protection Agency;CommentsClose CommentsPermalink





‘(B) the International Agency for Research on Cancer;CommentsClose CommentsPermalink





‘(C) the National Toxicity Program through the National Institutes of Health;CommentsClose CommentsPermalink





‘(D) the California Environmental Protection Agency; andCommentsClose CommentsPermalink





‘(E) any other authoritative international, Federal, and State entity, as determined by the Secretary.CommentsClose CommentsPermalink

‘SEC. 616. LISTS OF INGREDIENTS AND REQUIRED RESPONSES.

‘(a) Placement on List-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Based on an initial review and evaluation of an ingredient under subsection (c), the Secretary shall place the ingredient on one of the following lists:CommentsClose CommentsPermalink





‘(A) The prohibited and restricted list under subsection (b).CommentsClose CommentsPermalink





‘(B) The safe without limits list under subsection (c).CommentsClose CommentsPermalink





‘(C) The priority assessment list under subsection (d).CommentsClose CommentsPermalink





‘(2) CONSIDERATIONS- In determining the placement of an ingredient on a list under subsection (a), the Secretary shall consider whether the ingredient--CommentsClose CommentsPermalink





‘(A) reacts with other substances to form harmful contaminants;CommentsClose CommentsPermalink





‘(B) is found to be present in the body through biomonitoring;CommentsClose CommentsPermalink





‘(C) is found in drinking water or air;CommentsClose CommentsPermalink





‘(D) is a known or suspected neurological or immunological toxicant, respiratory asthmagen, carcinogen, teratogen, or endocrine disruptor, or have other toxicological concerns (including reproductive or developmental toxicity); orCommentsClose CommentsPermalink





‘(E) is known to persist in the environment or bioaccumulate.CommentsClose CommentsPermalink





‘(3) PRIORITIZIATION OF INGREDIENTS THAT ARE FOOD- In placing ingredients on the lists under paragraph (1), the Secretary shall prioritize the placement of ingredients that are food (as such term is defined under section 201(f)) on such lists.CommentsClose CommentsPermalink





‘(b) Prohibited and Restricted List-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Not later than 2 years after the date of the enactment of this subchapter, the Secretary shall issue, by regulation, a list of ingredients that are identified by the Secretary--CommentsClose CommentsPermalink





‘(A) as prohibited for use because the Secretary determines that such ingredients are unsafe for use in cosmetics in any amount because such ingredients fail to meet the safety standard under section 614(a); orCommentsClose CommentsPermalink





‘(B) as being subject to necessary restrictions in use or concentration to allow the use of the ingredient in a cosmetic to satisfy the safety standard.CommentsClose CommentsPermalink





‘(2) SPECIFICATION OF RESTRICTIONS- In the case of any ingredient listed under paragraph (1)(B), the Secretary shall specify the restrictions on use or concentration that are necessary to satisfy the safety standard for such ingredient.CommentsClose CommentsPermalink





‘(3) UPDATES- The Secretary shall, at a minimum, annually update the list under paragraph (1), including any--CommentsClose CommentsPermalink





‘(A) determinations under subsection (d)(3); orCommentsClose CommentsPermalink





‘(B) new information that demonstrates that an ingredient fails to meet the safety standard, or requires restrictions on use to meet such standard.CommentsClose CommentsPermalink





‘(4) MANUFACTURER REQUIREMENTS- Not later than 1 year after the date that an ingredient is placed on a list under subsection (b), any manufacturer using such ingredient in a cosmetic shall reformulate such cosmetic to--CommentsClose CommentsPermalink





‘(A) eliminate the use of the ingredient, if it is listed under paragraph (1)(A); orCommentsClose CommentsPermalink





‘(B) modify the use of the ingredient if it is listed under paragraph (1)(B), to meet the restrictions specified under paragraph (2).CommentsClose CommentsPermalink





‘(c) Safe Without Limits List-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Not later than 2 years after the date of the enactment of this subchapter, the Secretary shall issue, by regulation, a list of ingredients that the Secretary has determined are safe for use in cosmetics, without limits or restrictions.CommentsClose CommentsPermalink





‘(2) STANDARD FOR INCLUSION IN LIST- The Secretary may only include an ingredient on the list under paragraph (1) if the Secretary determines that the ingredient meets the safety standard under section 614(a), regardless of--CommentsClose CommentsPermalink





‘(A) the type and form of cosmetic the ingredient is used in; andCommentsClose CommentsPermalink





‘(B) the concentration of the ingredient that is used in a cosmetic.CommentsClose CommentsPermalink





‘(3) UPDATES AND REDETERMINATIONS- The Secretary shall annually update the list under paragraph (1) and may redetermine whether an ingredient distributed in commerce meets the safety standard if, in the judgment of the Secretary, new information raises a credible question as to whether the ingredient continues to meet the safety standard.CommentsClose CommentsPermalink





‘(d) Priority Assessment List and Related Safety Determinations-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Not later than 2 years after the date of the enactment of this subchapter, the Secretary shall develop and publish a priority assessment list of not less than 300 ingredients--CommentsClose CommentsPermalink





‘(A) which, because of a lack of authoritative information on the safety of the ingredient, cannot be included on--CommentsClose CommentsPermalink





‘(i) the list under subsection (b) (relating to prohibited and restricted ingredients); orCommentsClose CommentsPermalink





‘(ii) the list under subsection (c) (relating to ingredients that are safe without limits); andCommentsClose CommentsPermalink





‘(B) for which the Secretary has determined it is a priority to conduct a safety determination under paragraph (3).CommentsClose CommentsPermalink





‘(2) ANNUAL ADDITION OF INGREDIENTS- After the list is developed under paragraph (1), the Secretary shall annually add at least 100 additional ingredients to such list until all ingredients that are used in the formulation or manufacture of cosmetics have been added--CommentsClose CommentsPermalink





‘(A) to such list;CommentsClose CommentsPermalink





‘(B) to the list under subsection (b); orCommentsClose CommentsPermalink





‘(C) to the list under subsection (c).CommentsClose CommentsPermalink





‘(3) DETERMINATION OF WHETHER INGREDIENT MEETS SAFETY STANDARD-CommentsClose CommentsPermalink





‘(A) REVIEW OF PRIORITY INGREDIENTS- During the 2-year period following the date on which an ingredient is placed on the list under paragraph (1), the Secretary shall--CommentsClose CommentsPermalink





‘(i) collect data and information on such ingredient; andCommentsClose CommentsPermalink





‘(ii) review and evaluate the safety of such ingredient.CommentsClose CommentsPermalink





‘(B) DETERMINATION OF LIST PLACEMENT- Not later than the end of the period under subparagraph (A), the Secretary shall issue a determination, based on the review and evaluation under such clause, that--CommentsClose CommentsPermalink





‘(i) the ingredient meets the requirements for inclusion on a list under subsection (b) (relating to prohibited and restricted ingredients) or subsection (c) (relating to ingredients that are safe without limits); orCommentsClose CommentsPermalink





‘(ii) insufficient information exists to place the ingredient on either such list.CommentsClose CommentsPermalink





‘(C) GUIDANCE IN THE CASE OF INSUFFICIENT INFORMATION- If the Secretary determines under subparagraph (B) that, with respect to an ingredient, insufficient information exists to place such ingredient on either of the lists under subsection (b) or subsection (c), the Secretary shall provide guidance to manufacturers on the data and information (including minimum data requirements and safety testing protocols) that the Secretary requires to evaluate whether the ingredient meets the safety standard under section 614(a) for purposes of placing such ingredient on such a list.CommentsClose CommentsPermalink





‘(D) COMMENT PERIOD- Upon issuing the determination under subparagraph (B), and, if applicable, the guidance under subparagraph (C), the Secretary shall provide a period of not less than 60 days for public comment on the determination before applying such determination to an ingredient, except that a shorter period for comment may be provided if the Secretary--CommentsClose CommentsPermalink





‘(i) finds that it would be in the public interest to have a shorter period; andCommentsClose CommentsPermalink





‘(ii) publically declares the reasons for such finding.CommentsClose CommentsPermalink





‘(4) MANUFACTURER RESPONSE TO INADEQUATE INFORMATION- Not later than 18 months after the date that the Secretary issues guidance under paragraph (3)(C) with respect to an ingredient subject to a determination under paragraph (3)(B), a manufacturer using such ingredient in a cosmetic shall--CommentsClose CommentsPermalink





‘(A) reformulate such cosmetic to eliminate the use of the ingredient; orCommentsClose CommentsPermalink





‘(B) provide the Secretary with the data and information specified in such guidance.CommentsClose CommentsPermalink





‘(5) EVALUATION OF ADDITIONAL DATA AND INFORMATION- With respect to an ingredient, not later than 6 months after a manufacturer provides the Secretary with the data and information under paragraph (4)(B) the Secretary shall review such data and information and shall make a redetermination under paragraph (3)(B) for such ingredient, subject to the comment period under paragraph (3)(D).CommentsClose CommentsPermalink





‘(6) LIMITATION- If the Secretary has not placed an ingredient on either of the lists under subsection (b) and subsection (c) by the end of the 5-year period beginning on the date that such ingredient is first placed on the list under subsection (d), beginning on the first day after such period such ingredient may not be--CommentsClose CommentsPermalink





‘(A) used in a cosmetic; andCommentsClose CommentsPermalink





‘(B) manufactured, imported, distributed, or marketed for use in cosmetics.CommentsClose CommentsPermalink

‘SEC. 617. TREATMENT OF COSMETICS BASED ON INGREDIENT LISTS.

‘(a) In General- Subject to subsections (b)(4) and (d)(4) of section 616, a manufacturer may only manufacture a cosmetic for distribution in interstate commerce if such cosmetic meets the safety standard under section 614(a).CommentsClose CommentsPermalink





‘(b) Presumption Related to the Safety of Cosmetics-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Subject to paragraph (2), for purposes of subsection (a), the Secretary shall presume that the following cosmetics meet the safety standard under section 614(a):CommentsClose CommentsPermalink





‘(A) A cosmetic that is made solely of ingredients on the list under section 616(c)(1) (relating to ingredients that are safe without limits).CommentsClose CommentsPermalink





‘(B) A cosmetic that is made solely of ingredients on the list under section 616(b)(1)(B) (relating to ingredients subject to restrictions) and the use of each of such ingredients in such cosmetic is in compliance with the restrictions on the use of such ingredients specified under section 616(b)(2).CommentsClose CommentsPermalink





‘(C) A cosmetic that is made solely of ingredients described under subparagraph (A) and subparagraph (B).CommentsClose CommentsPermalink





‘(2) EXCEPTIONS- The Secretary may require that a manufacturer demonstrate that a cosmetic meets the safety standard under section 614(a) (including by requiring that the manufacturer conduct safety testing of a cosmetic described under paragraph (1)) if the cosmetic--CommentsClose CommentsPermalink





‘(A) contains penetration enhancers, sensitizers, estrogenic chemicals, or other similar ingredients;CommentsClose CommentsPermalink





‘(B) contains ingredients that react with each other or with other substances to form harmful byproducts; orCommentsClose CommentsPermalink





‘(C) the Secretary has any additional reason to believe that such cosmetic does not meet the safety standard under section 614(a).CommentsClose CommentsPermalink





‘(3) GUIDANCE- If, under paragraph (2), the Secretary requires that a manufacturer demonstrate that a cosmetic meets the safety standard under section 614(a), the Secretary shall provide the manufacturer with guidance on the data and information that the Secretary requires to evaluate whether the cosmetic meets the safety standard under such section.CommentsClose CommentsPermalink





‘(c) Notification of Failure of Secretary To Act- If the Secretary fails to act by an applicable deadline under section 616 or this section, a manufacturer of an ingredient or a cosmetic affected by such failure of the Secretary to act shall issue to the Secretary, the public, and each known customer of the ingredient or cosmetic, a written notice that a determination by the Secretary of the safety of the ingredient for use in cosmetics is pending.CommentsClose CommentsPermalink

‘SEC. 618. TREATMENT OF CONTAMINANTS.

‘(a) Publication of List- Not later than 1 year after the date of the enactment of this subchapter, and annually thereafter, the Secretary shall publish a list of--CommentsClose CommentsPermalink





‘(1) ingredients used in cosmetics that may contain contaminants;CommentsClose CommentsPermalink





‘(2) combinations of ingredients that may create contaminants when such ingredients interact;CommentsClose CommentsPermalink





‘(3) contaminants that may leech from product packaging into a cosmetic; andCommentsClose CommentsPermalink





‘(4) any other contaminant of cosmetics identified by the Secretary.CommentsClose CommentsPermalink





‘(b) Requirements for Testing-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Not later than 1 year after the date of enactment of this subchapter, the Secretary shall establish, by rule, requirements for testing ingredients and cosmetics for contaminants listed under subsection (a).CommentsClose CommentsPermalink





‘(2) CONTENTS- The requirements under paragraph (1) shall include--CommentsClose CommentsPermalink





‘(A) testing methods and applicable protocols; andCommentsClose CommentsPermalink





‘(B) maximum allowable detection limits for each contaminant in an ingredient.CommentsClose CommentsPermalink





‘(3) UPDATE- The Secretary shall annually update the requirements under paragraph (1).CommentsClose CommentsPermalink





‘(c) Supplier Requirements- Not later than 1 year after the promulgation of the rule under subsection (b)(1), a supplier of an ingredient that is used in a cosmetic shall, with respect to such ingredient--CommentsClose CommentsPermalink





‘(1) comply with the requirements under subsection (b)(1) for any ingredient listed under subsection (a);CommentsClose CommentsPermalink





‘(2) conduct similar testing on any ingredient that--CommentsClose CommentsPermalink





‘(A) the supplier expects may be used in a cosmetic;CommentsClose CommentsPermalink





‘(B) the supplier suspects may contain a contaminant; andCommentsClose CommentsPermalink





‘(C) is not listed under subsection (a); andCommentsClose CommentsPermalink





‘(3) upon the sale of an ingredient to the manufacturer, provide to the manufacturer specifications for the ingredient that--CommentsClose CommentsPermalink





‘(A) include the levels of contaminants present in such ingredient; andCommentsClose CommentsPermalink





‘(B) are based on the results of the tests under paragraph (1) and paragraph (2).CommentsClose CommentsPermalink





‘(d) Manufacturer Requirements- Not later than 1 year after the promulgation of the rule under subsection (b)(1), a manufacturer of a cosmetic shall, with respect to each ingredient that the manufacturer uses in a cosmetic--CommentsClose CommentsPermalink





‘(1) obtain, from each supplier of the ingredient, specifications for the ingredient that include--CommentsClose CommentsPermalink





‘(A) the level of each contaminant present in the ingredient; andCommentsClose CommentsPermalink





‘(B) the detection limits of the analytical test used to detect the contaminant; orCommentsClose CommentsPermalink





‘(2) comply with the requirements under paragraphs (1) and (2) of subsection (c) for the ingredient, in the same manner as if the manufacturer were a supplier.CommentsClose CommentsPermalink

‘SEC. 619. COSMETIC AND INGREDIENT STATEMENTS.

‘(a) In General- Beginning 1 year after the date of the enactment of this subchapter, each establishment engaged in the manufacture of a cosmetic intended to be marketed in the United States shall submit electronically to the Secretary, for each cosmetic manufactured in the establishment that is intended to be marketed in the United States, a statement containing--CommentsClose CommentsPermalink





‘(1) the registration number of the manufacturing establishment where the cosmetic is manufactured or, if the same cosmetic is manufactured in more than 1 establishment, the registration number of each establishment where it is manufactured;CommentsClose CommentsPermalink





‘(2) the registration number of the establishment responsible for distributing the cosmetic;CommentsClose CommentsPermalink





‘(3) the brand name and the product name for the cosmetic;CommentsClose CommentsPermalink





‘(4) the applicable use for the cosmetic;CommentsClose CommentsPermalink





‘(5) the ingredient list as it appears on the cosmetic label or insert, including the particle size range of any nanoscale cosmetic ingredients;CommentsClose CommentsPermalink





‘(6) any warnings and directions for use from the cosmetic label or insert; andCommentsClose CommentsPermalink





‘(7) the title and full contact information for the individual responsible for submitting and maintaining such statement.CommentsClose CommentsPermalink





‘(b) New Cosmetics- Any establishment that begins to manufacture a cosmetic after the date of the enactment of this subchapter shall comply with the requirements of subsection (a) beginning on the later of the following:CommentsClose CommentsPermalink





‘(1) The end of the 18-month period beginning on the date of the enactment of this subchapter.CommentsClose CommentsPermalink





‘(2) The 6-month period after the date on which the establishment begins to manufacture such cosmetic.CommentsClose CommentsPermalink





‘(c) Notification of Changes- The establishment shall notify the Secretary annually of any change to the information required under subsection (a).CommentsClose CommentsPermalink





‘(d) Procedure- Upon receipt of a completed statement described under subsection (a), the Secretary shall notify the establishment of the receipt of such statement and assign a cosmetic statement number.CommentsClose CommentsPermalink





‘(e) List- The Secretary shall compile, maintain, and update as appropriate, a list of cosmetics for which statements are submitted under this section.CommentsClose CommentsPermalink





‘(f) Access to Safety Information- The cosmetic and ingredient statements collected under this section shall be added to the publicly accessible database created by the Secretary under section 615(b).CommentsClose CommentsPermalink

‘SEC. 620. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED COSMETICS.

‘(a) Notification of Adulterated or Misbranded Cosmetics-CommentsClose CommentsPermalink





‘(1) IN GENERAL- A responsible party that has reason to believe that a cosmetic, when introduced into or while in interstate commerce, or while held for sale (regardless of whether such sale is the first sale of such cosmetic) after shipment in interstate commerce, is adulterated or misbranded in a manner that presents a reasonable probability that the use or exposure to the cosmetic (or an ingredient or component used in any such cosmetic) will cause a threat of serious adverse health effects or death to humans shall notify the Secretary of the identity and location of the cosmetic.CommentsClose CommentsPermalink





‘(2) MANNER OF NOTIFICATION- Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation or guidance.CommentsClose CommentsPermalink





‘(3) RESPONSIBLE PARTY DEFINED- For purposes of this subsection, the term ‘responsible party’ means a manufacturer, packager, retailer, or distributor of the cosmetic.CommentsClose CommentsPermalink





‘(b) Voluntary Recall- The Secretary may request that any person who distributes a cosmetic that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act voluntarily--CommentsClose CommentsPermalink





‘(1) recall such cosmetic; andCommentsClose CommentsPermalink





‘(2) provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.CommentsClose CommentsPermalink





‘(c) Order To Cease Distribution-CommentsClose CommentsPermalink





‘(1) IN GENERAL- If the Secretary has reason to believe that--CommentsClose CommentsPermalink





‘(A) the use of, or exposure to, a cosmetic may cause serious adverse health effects or death to humans;CommentsClose CommentsPermalink





‘(B) the cosmetic is misbranded; orCommentsClose CommentsPermalink





‘(C) the cosmetic is manufactured, packaged, or distributed by an unregistered facility;CommentsClose CommentsPermalink





the Secretary shall have the authority to issue an order requiring any person who distributes such cosmetic to immediately cease distribution of such cosmetic.CommentsClose CommentsPermalink





‘(2) CEASE DISTRIBUTION AND NOTICE- Any person who is subject to an order under paragraph (1) shall immediately cease distribution of such cosmetic and provide notification as required by such order.CommentsClose CommentsPermalink





‘(3) APPEAL-CommentsClose CommentsPermalink





‘(A) 24 HOURS- A person subject to an order under paragraph (1) may appeal such order to the Secretary within 24 hours of the issuance of such order.CommentsClose CommentsPermalink





‘(B) CONTENTS OF APPEAL- Such appeal may include a request for an informal hearing and a description of any efforts to recall such cosmetic undertaken voluntarily by the person, including after a request under subsection (b).CommentsClose CommentsPermalink





‘(C) INFORMAL HEARING- Except as provided in subsection (e), an informal hearing shall be held as soon as practicable, but not later than 5 calendar days (or less as determined by the Secretary) after such an appeal is filed, unless the parties jointly agree to an extension.CommentsClose CommentsPermalink





‘(D) IMPACT ON RECALL- If an appeal is filed under subparagraph (A), the Secretary may not amend the order to require a recall under subsection (d) until after the conclusion of the hearing under subparagraph (C).CommentsClose CommentsPermalink





‘(4) VACATION OF ORDER- If the Secretary determines that inadequate grounds exist to support the actions required by the order under paragraph (1), the Secretary shall vacate the order.CommentsClose CommentsPermalink





‘(d) Order To Recall-CommentsClose CommentsPermalink





‘(1) AMENDMENT- Except as provided under subsection (e) and subject to subsection (c)(3)(D), if the Secretary determines that a recall of a cosmetic subject to an order under subsection (c) is appropriate, the Secretary shall amend the order to require a recall.CommentsClose CommentsPermalink





‘(2) CONTENTS- An amended order under paragraph (1) shall--CommentsClose CommentsPermalink





‘(A) specify a timetable in which the recall will occur;CommentsClose CommentsPermalink





‘(B) require periodic reports to the Secretary describing the progress of the recall; andCommentsClose CommentsPermalink





‘(C) provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.CommentsClose CommentsPermalink





In providing for such notice, the Secretary may allow for the assistance of health professionals, State or local officials, or other individuals designated by the Secretary.CommentsClose CommentsPermalink





‘(3) NONDELEGATION- An amended order under this subsection may only be issued by the Secretary or an official designated by the Secretary, and may not be delegated to another official or employee.CommentsClose CommentsPermalink





‘(4) DETERMINATION- If the Secretary determines that inadequate grounds exist to support the amendment made to the order under paragraph (1), the Secretary shall remove such amendment from such order.CommentsClose CommentsPermalink





‘(e) Emergency Recall Order-CommentsClose CommentsPermalink





‘(1) IN GENERAL- If the Secretary has credible evidence or information that a cosmetic subject to an order under subsection (c) presents an imminent threat of serious adverse health effects or death to humans, the Secretary may issue an order requiring any person who distributes such cosmetic--CommentsClose CommentsPermalink





‘(A) to immediately recall such cosmetic; andCommentsClose CommentsPermalink





‘(B) to provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.CommentsClose CommentsPermalink





‘(2) RECALL AND NOTICE- Any person who is subject to an emergency recall order under this subsection shall immediately recall such cosmetic and provide notification as required by such order.CommentsClose CommentsPermalink





‘(3) APPEAL-CommentsClose CommentsPermalink





‘(A) 24 HOURS- Any person subject to such an order may appeal such order to the Secretary within 24 hours of the issuance of such order.CommentsClose CommentsPermalink





‘(B) CONTENTS OF APPEAL- Such appeal may include a request for an informal hearing and a description of any efforts to recall such cosmetic undertaken voluntarily by the person, including after a request under subsection (b).CommentsClose CommentsPermalink





‘(C) INFORMAL HEARING- An informal hearing shall be held as soon as practicable after the appeal is filed under subparagraph (A), but not later than 5 calendar days after such an appeal is filed, or fewer days (as determined by the Secretary), unless the parties jointly agree to an extension.CommentsClose CommentsPermalink





‘(4) VACATION OF ORDER- If the Secretary determines that inadequate grounds exist to support the actions required by the order under paragraph (1), the Secretary shall vacate the order.CommentsClose CommentsPermalink





‘(5) NONDELEGATION- An order under this subsection may only be issued by the Secretary or an official designated by the Secretary, and may not be delegated to another official or employee.CommentsClose CommentsPermalink





‘(f) Notice to Consumers and Health Officials- The Secretary shall, as the Secretary determines to be necessary, provide notice of a recall order under this section to consumers to whom the cosmetic was, or may have been, distributed and to appropriate State and local health officials.CommentsClose CommentsPermalink





‘(g) Supply Chain Information-CommentsClose CommentsPermalink





‘(1) IN GENERAL- In the case of a cosmetic that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act, the Secretary shall request that the entity named on the label of such cosmetic (as required under section 602(b)(1)) submit all of the following information:CommentsClose CommentsPermalink





‘(A) The name and place of business of the manufacturer, packer, or distributor from which such entity received the cosmetic or ingredients for manufacturing such cosmetic.CommentsClose CommentsPermalink





‘(B) The name and place of business of any entity (including any retailer) that was provided with such cosmetic by the entity named on the label.CommentsClose CommentsPermalink





‘(2) COLLECTION OF ADDITIONAL SUPPLY CHAIN INFORMATION- In the case of a cosmetic that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act, to the extent necessary to protect the safety of the public, the Secretary may request that any entity (including a supplier of an ingredient, manufacturer, packer, distributor, or retailer) in the supply chain of such cosmetic submit to the Secretary information that is similar to the information described under subparagraphs (A) and (B) of paragraph (1).CommentsClose CommentsPermalink





‘(3) MAINTENANCE OF RECORDS- Any entity in supply chain of a cosmetic (including the entity named on the label of a cosmetic) shall--CommentsClose CommentsPermalink





‘(A) maintain records sufficient to provide the information described in subparagraphs (A) and (B) of paragraph (1); andCommentsClose CommentsPermalink





‘(B) provide such information to the Secretary upon the request of the Secretary.CommentsClose CommentsPermalink





‘(h) Savings Clause- Nothing contained in this section shall be construed as limiting the authority of the Secretary to issue an order to cease distribution of, or to recall, a cosmetic under any other provision of this Act.CommentsClose CommentsPermalink

‘SEC. 621. PETITIONS.

‘(a) In General- The Secretary shall complete and publish a review, and, if appropriate, immediately revise related, relevant information, including ingredient lists, ingredient restrictions or prohibitions, or ingredient or cosmetic safety determinations, not later than 6 months after the date on which the Secretary receives from any individual or entity a reasonable petition--CommentsClose CommentsPermalink





‘(1) to prohibit or restrict an ingredient for use in cosmetics and list such ingredient on the list under section 616(b);CommentsClose CommentsPermalink





‘(2) to remove an ingredient from the list of ingredients that are safe without limits under section 616(c);CommentsClose CommentsPermalink





‘(3) to add an ingredient to the priority assessment list under section 616(d); orCommentsClose CommentsPermalink





‘(4) to add an ingredient to the list of contaminants under section 618.CommentsClose CommentsPermalink





‘(b) Reasonable Petition- Not later than 1 year after the date of the enactment of this Act, the Secretary shall issue rules specifying the criteria which the Secretary will use to determine if a petition submitted under this section is a reasonable petition.CommentsClose CommentsPermalink

‘SEC. 622. MANDATORY REPORTING OF ADVERSE HEALTH EFFECTS.

‘(a) Submission of Report on Adverse Health Effects- The Secretary shall require that the manufacturer, packager, or distributor of a cosmetic whose name appears on the label of a cosmetic marketed in the United States submit to the Secretary a report containing information received concerning any adverse health effect associated with the use of the cosmetic.CommentsClose CommentsPermalink





‘(b) Timing of Report- A report under subsection (a) shall be submitted to the Secretary not later than 15 business days after information concerning the adverse health effect is received at the place of business of the manufacturer, packager, or distributor.CommentsClose CommentsPermalink





‘(c) Content of Report- A report under subsection (a) shall include the following information, to the extent to which the manufacturer, packager, or distributor submitting the report has been able to verify the information:CommentsClose CommentsPermalink





‘(1) The identity of the individual experiencing the adverse health effect.CommentsClose CommentsPermalink





‘(2) An identifiable report of such effect.CommentsClose CommentsPermalink





‘(3) The name of the cosmetic suspected of causing such effect.CommentsClose CommentsPermalink





‘(4) A description of the adverse health effect.CommentsClose CommentsPermalink





‘(d) Public Availability and Privacy-CommentsClose CommentsPermalink





‘(1) PUBLIC AVAILABILITY- Subject to paragraph (2), the adverse health effect reports collected by the Secretary under this section shall be submitted electronically and shall be made accessible to the public.CommentsClose CommentsPermalink





‘(2) PRIVACY-CommentsClose CommentsPermalink





‘(A) PERSONALLY IDENTIFIABLE INFORMATION- Notwithstanding any other provision of law, personally identifiable information in adverse health effect reports provided to the Secretary under this section, shall not--CommentsClose CommentsPermalink





‘(i) be made publicly available pursuant to any State or other law requiring disclosure of information or records; orCommentsClose CommentsPermalink





‘(ii) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary.CommentsClose CommentsPermalink





‘(B) TREATMENT OF INFORMATION UNDER PRIVACY ACT AND FOIA- An adverse health effect report submitted to the Secretary under this section, shall be considered to be a record about an individual under section 552a of title 5, United States Code (commonly referred to as the ‘Privacy Act of 1974’) and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5 (commonly referred to as the ‘Freedom of Information Act’), and shall not be publicly disclosed unless all personally identifiable information is redacted.CommentsClose CommentsPermalink

‘SEC. 623. NONCONFIDENTIAL INFORMATION.

‘(a) Information Available to Public- Subject to subsection (c) and section 622(d)(2), all nonconfidential information submitted pursuant to this subchapter shall be made available to the public, including the following types of information:CommentsClose CommentsPermalink





‘(1) The name, identity, and structure of a chemical substance, contaminant, or impurity that is an ingredient.CommentsClose CommentsPermalink





‘(2) All information concerning function, exposure, health hazards, and environmental hazards for a cosmetic., andCommentsClose CommentsPermalink





‘(3) The functions of ingredients in cosmetics.CommentsClose CommentsPermalink





‘(4) Fragrance, flavor, and colorants in a cosmeticCommentsClose CommentsPermalink





‘(b) Confidential Information- The concentration of cosmetic ingredients used in a finished cosmetic shall be considered confidential business information and may not be made available to the public under subsection (a).CommentsClose CommentsPermalink





‘(c) Petition for Information To Remain Confidential-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Secretary shall create a process for an entity to petition for nonconfidential information described in subsection (a) to remain confidential if the entity shows that there would be a serious negative impact to the entity’s commercial interests if such information were disclosed to the public.CommentsClose CommentsPermalink





‘(2) LIMITATION- The Secretary may not approve a petition under paragraph (1) to the extent that such petition would prevent the public disclosure of--CommentsClose CommentsPermalink





‘(A) the name, identity, and structure of any chemical substance, contaminant, or impurity that is an ingredient;CommentsClose CommentsPermalink





‘(B) all health and safety data related to that substance, contaminant, or impurity; orCommentsClose CommentsPermalink





‘(C) any data used to substantiate the safety of that substance, contaminant, or impurity.CommentsClose CommentsPermalink

‘SEC. 624. ANIMAL TESTING ALTERNATIVES.

‘(a) In General- To minimize the use of animal testing of ingredients and cosmetics, the Secretary shall--CommentsClose CommentsPermalink





‘(1) require, where practicable, alternative testing methods that--CommentsClose CommentsPermalink





‘(A) do not involve the use of an animal to test the chemical substance;CommentsClose CommentsPermalink





‘(B) provide information that is equivalent or superior in scientific quality to the animal testing method; andCommentsClose CommentsPermalink





‘(C) use fewer animals than conventional animal-based tests when nonanimal methods are impracticable, including the use of tests that combine multiple endpoints; andCommentsClose CommentsPermalink





‘(2) encourage, where practicable--CommentsClose CommentsPermalink





‘(A) estimation of toxicological properties of a chemical through the use of testing information for 1 or more structurally similar chemicals where such estimates provide information of sufficient scientific quality;CommentsClose CommentsPermalink





‘(B) the formation of industry consortia to conduct testing to avoid duplication of tests; andCommentsClose CommentsPermalink





‘(C) funding for research and validation of alternative test methods, in accordance with this subsection.CommentsClose CommentsPermalink





‘(b) List of Alternative Testing Methods- Not later than 1 year after the date of the enactment of this subchapter, and triennially thereafter, the Secretary shall publish a list of the alternative testing methods described in subsection (a).CommentsClose CommentsPermalink

‘SEC. 625. PRODUCT TESTING AND REVIEW AUDIT.

‘The Secretary shall conduct annual audits of random samples of cosmetics to assess or test for acute negative reactions, pathogen hazards, contaminants, leaching of packaging additives, mislabeling, or other relevant issues of concern (as determined by the Secretary).CommentsClose CommentsPermalink

‘SEC. 626. RESOURCES FOR SMALL BUSINESSES.

‘The Secretary shall provide technical support to assist small businesses in carrying out the requirements of this subchapter.CommentsClose CommentsPermalink

‘SEC. 627. INTERAGENCY COOPERATION.

‘(a) Interagency Council on Cosmetic Safety- There is established an Interagency Council on Cosmetic Safety for the purpose of sharing data and promoting collaboration on cosmetic safety between the Food and Drug Administration, the National Institute of Environmental Health Sciences, the Centers for Disease Control and Prevention, the Occupational Safety and Health Administration, and the Environmental Protection Agency.CommentsClose CommentsPermalink





‘(b) Use of Data From Federal Sources- For purposes of this subchapter, the Secretary, as appropriate, shall request and utilize ingredient and cosmetic toxicity, use, and exposure data from other Federal agencies.CommentsClose CommentsPermalink

‘SEC. 628. SAVINGS CLAUSE.

‘Nothing in this subchapter shall affect the right of a State, political subdivision of a State, or tribe to adopt or enforce any regulation, requirement, liability, or standard of performance that is more stringent than a regulation, requirement, liability, or standard of performance established by this subchapter, including requiring the provision of a warning of risk, illness, or injury.CommentsClose CommentsPermalink

‘SEC. 629. AUTHORIZATION OF APPROPRIATIONS.

‘There are authorized to be appropriated such sums as may be necessary to carry out this subchapter for each of the fiscal years 2012 through 2016.’.CommentsClose CommentsPermalink





(b) Adulterated and Misbranded Cosmetics-CommentsClose CommentsPermalink





(1) ADULTERATED COSMETICS- Section 601 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361) is amended in paragraph (a)--CommentsClose CommentsPermalink





(A) by striking ‘, except that this provision shall not apply to coal-tar hair dye’ and all that follows through ‘or eyebrow dyes’; andCommentsClose CommentsPermalink





(B) by adding at the end the following:CommentsClose CommentsPermalink





‘(f) If it is manufactured in a manner that fails to comply with section 617(a).CommentsClose CommentsPermalink





‘(g) If it is imported, distributed, or marketed and--CommentsClose CommentsPermalink





‘(1) it contains an ingredient on the list under section 616(b)(1)(A), and the manufacturer has not complied with section 616(b)(4) with respect to such ingredient and such cosmetic; orCommentsClose CommentsPermalink





‘(2) it contains an ingredient on the list under section 616(b)(1)(B), such ingredient is being used in a manner that violates the limit on use or concentration of such ingredient under section 616(b)(2), and the manufacturer has not complied with section 616(b)(4) with respect to such ingredient and such cosmetic.CommentsClose CommentsPermalink





‘(h) If it is manufactured by a manufacturer that, with respect to such cosmetic, is required to demonstrate, under section 617(b)(2), that the cosmetic meets the safety standard and the manufacturer has not yet submitted the required data under section 617(b)(3).’.CommentsClose CommentsPermalink





(2) MISBRANDED COSMETICS- Section 602 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amended--CommentsClose CommentsPermalink





(A) in paragraph (a), by inserting ‘ or fails to meet the requirements of section 613’ before the period; andCommentsClose CommentsPermalink





(B) by adding at the end the following:CommentsClose CommentsPermalink





‘(g) If it--CommentsClose CommentsPermalink





‘(1) was manufactured, packaged, or distributed by an entity that failed to register and pay the applicable fee as required under section 612;CommentsClose CommentsPermalink





‘(2) is manufactured, packaged, distributed, or sold in retail by a manufacturer, packager, distributor, or retailer, respectively, who fails to notify the Secretary as required under section 620(a)(1);CommentsClose CommentsPermalink





‘(3) is distributed in violation of an order under section 620(c);CommentsClose CommentsPermalink





‘(4) is not recalled as required by an order under subsection (d) or (e) of section 620;CommentsClose CommentsPermalink





‘(5) is manufactured in a manner that fails to comply with good manufacturing practices prescribed by the Secretary under section 614(b); orCommentsClose CommentsPermalink





‘(6) is manufactured by a manufacturer who fails--CommentsClose CommentsPermalink





‘(A) to submit the statement required under section 619; orCommentsClose CommentsPermalink





‘(B) notify the Secretary of changes to information contained in such report, as required by such section.’.CommentsClose CommentsPermalink





(3) ADDITIONAL PROHIBITIONS- Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(aaa) The failure of a manufacturer of a cosmetic or an ingredient for use in a cosmetic to submit and update data and information as required under section 615(a).CommentsClose CommentsPermalink





‘(bbb) The manufacture, importation, distribution, or marketing of an ingredient for use in a cosmetic that is on the list under section 616(b)(1)(A).CommentsClose CommentsPermalink





‘(ccc) The failure of a supplier of an ingredient for use in a cosmetic--CommentsClose CommentsPermalink





‘(1) to provide data and information as required by section 615(a)(4)(B); orCommentsClose CommentsPermalink





‘(2) comply with the testing requirements under section 618(c).CommentsClose CommentsPermalink





‘(ddd) The failure of a manufacturer to comply with the requirements of section 618(d).CommentsClose CommentsPermalink





‘(eee) The failure of a manufacturer, packager, or distributor of a cosmetic to comply with the requirement of reporting adverse health effects under section 622.’.CommentsClose CommentsPermalink

SEC. 3. WORKER ISSUES.

(a) In General- The Secretary of Labor shall promulgate an occupational safety and health standard under section 6 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655) that requires the following:CommentsClose CommentsPermalink





(1) MANUFACTURERS AND IMPORTERS- Each manufacturer or importer selling any cosmetic for professional use shall--CommentsClose CommentsPermalink





(A) obtain or develop a material safety data sheet described in subsection (b) for each such cosmetic or personal care product that--CommentsClose CommentsPermalink





(i) the manufacturer or importer produces or imports; andCommentsClose CommentsPermalink





(ii) includes a hazardous chemical, or a product ingredient associated with any chemical hazard, that is classified as a health hazard in accordance with the criteria found in section 1910.1200(d) of title 29 of the Code of Federal Regulations, and any successor regulations; andCommentsClose CommentsPermalink





(B) make the material safety data sheet available to distributors and employers, including salon owners, in English and, upon request, in other languages, including Spanish and Vietnamese.CommentsClose CommentsPermalink





(2) DISTRIBUTORS- Each distributor of a cosmetic or personal care product for professional use shall distribute and provide material safety data sheets described in subsection (b) in the same manner as a distributor of a chemical hazard is required to distribute and provide material safety data sheets under section 1910.1200(g) of title 29, Code of Federal Regulations, or any successor regulations.CommentsClose CommentsPermalink





(3) EMPLOYERS- Each employer, including any operator of a salon, shall--CommentsClose CommentsPermalink





(A) have a material safety data sheet in the workplace for each cosmetic or personal care product for professional use that is used in the course of the employer’s business;CommentsClose CommentsPermalink





(B) make such material safety data sheet available to all employees of the employer who are exposed or use the product to the same extent and in the same manner as material safety data sheets are required to be made available under section 1910.1200(g) of title 29, Code of Federal Regulations, or any successor regulations; andCommentsClose CommentsPermalink





(C) upon request, provide employees with translations of such material safety data sheet in other languages, including Spanish and Vietnamese.CommentsClose CommentsPermalink





(b) Contents of Material Safety Data Sheet- A material safety data sheet for a cosmetic or personal care product for professional use described in this section shall--CommentsClose CommentsPermalink





(1) contain the information required in a material safety data sheet under section 1910.1200(g) of title 29, Code of Federal Regulations, or any successor regulations, for each hazardous chemical, or product ingredient associated with any chemical hazard, described in subsection (a)(1)(A)(ii); andCommentsClose CommentsPermalink





(2) include the following statement: ‘This material safety data sheet is also available in multiple languages by contacting the manufacturer, using the contact information provided on this sheet.’.CommentsClose CommentsPermalink





(c) Professional Use Defined- In this section, the term ‘professional use’ has the meaning given such term in section 611(6) of the Federal Food, Drug, and Cosmetic Act, except to the extent that such term applies to a product that is sold as a retail product in any of the establishments listed under such definition.CommentsClose CommentsPermalink