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Code · BILL · 115th Congress · H.R. 575 (Introduced in House) — To amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the registration o... · Sec. 5

Sec. 5. Cosmetic and ingredient statement

941 words·~4 min read·/bill/115/hr/575/ih/section-5

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Chapter VI ( 21 U.S.C. 361 et seq.), as amended by sections 3 and 4, is further amended by adding at the end the following: 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 Secretary, for each cosmetic so manufactured in the establishment, except such cosmetics manufactured by entities exempted by section 605(e) from registration under section 605, within 60 business days after the first commercial sale of the cosmetic, a cosmetic and ingredient statement.
The Secretary shall require the statement to contain only— the unique establishment registration number of the manufacturing establishment where the cosmetic is manufactured or, if the same cosmetic is manufactured in more than one establishment, the unique establishment registration number of each establishment where it is manufactured; the brand name or names for the cosmetic; the applicable cosmetic category or categories for the cosmetic; the ingredients in the cosmetic (in accordance with section 701.3 of title 21, Code of Federal Regulations (as in effect on the date of enactment of the Cosmetic Modernization Amendments of 2017 and including any successor regulations), and using the name of each ingredient established under subsection (d), if any), in descending order of predominance by weight, except that— flavors and fragrances may be designated as such; and all variations in color, flavor, or fragrance may be included in one statement; and the title, email address, and telephone number for the office within the establishment that is responsible for submitting and maintaining the statement.
The Secretary shall establish and provide to the office submitting a statement required by subsection
(a)a unique cosmetic and ingredient statement number within 15 business days after receiving the statement. If the Secretary does not provide a unique cosmetic and ingredient statement number within such 15-business-day period, any requirement under this Act for such number shall be deemed to be inapplicable until the date that is 30 business days after such number is received by the office that submitted the statement. The unique cosmetic and ingredient statement number shall not be required to be included in cosmetic labeling. An establishment shall not be required to submit a new or revised statement under subsection
(a)because of a change in labeling except to the extent necessary to maintain the accuracy of the information included in a statement under subsection (a). For purposes of this section and cosmetic ingredient labeling under section 701.3 of title 21, Code of Federal Regulations (as in effect on the date of enactment of the Cosmetic Modernization Amendments of 2017 and including any successor regulations), the name of a cosmetic ingredient shall be the name, if any, in the most recent edition of the International Cosmetic Ingredient Dictionary, unless the Secretary by regulation establishes a different name for the ingredient. The information required in a statement submitted to the Secretary under subsection
(a)or in an existing statement under subsection (g)(1) shall be maintained as current and accurate by the office that filed the statement by withdrawing or amending the statement within 60 business days after the information becomes no longer current and accurate, 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 public. The Secretary shall enforce subsections
(a)and
(e)under section 301(fff) and shall not suspend or revoke a cosmetic and ingredient statement. 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 section. A statement submitted pursuant to this section shall not be subject to disclosure under section 552 of title 5, United States Code. 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 used, but may not make publicly available any information that relates to any ingredient that is exempt from public disclosure under section 720.8 of title 21, Code of Federal Regulations (as in effect on the date of enactment of the Cosmetic Modernization Amendments of 2017 and including any successor regulations), or that discloses at what establishment a cosmetic is manufactured. At the written request of the director of a State agency responsible for regulating the safety of cosmetics stating good cause therefor, 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 301(j) of this Act, section 552(b) of title 5, United States Code, and section 1905 of title 18, United States Code, with respect to such information. Submission of a statement under subsection
(a)shall not be required— 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 710 of title 21, Code of Federal Regulations (as in effect on the date of enactment of the Cosmetic Modernization Amendments of 2017 ); for a cosmetic ingredient exempt from public disclosure under section 720.8 of title 21, Code of Federal Regulations (as in effect on the date of enactment of the Cosmetic Modernization Amendments of 2017 and including any successor regulations); or by an entity to the extent such entity is exempted by section 605(e) from registration under section 605. .
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Sec. 5
Cosmetic and ingredient statement
U.S.C.§ 361
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