Sec. 4. Registration of cosmetic manufacturing establishments
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Chapter VI ( 21 U.S.C. 361 et seq.), as amended by section 3, is further amended by adding at the end the following: The Secretary shall by regulation require that every domestic and foreign establishment engaged in the manufacture of a cosmetic intended to be sold in the United States that is not exempt under subsection
(e)be registered with the Secretary within 60 business days after the first commercial sale of a cosmetic in the United States. If a cosmetic is processed in more than one establishment, registration shall be required under this section only for the establishment that performs the final portion of the manufacturing operation. The single registration shall cover all such cosmetics manufactured by the establishment. The registration shall state only the name of the company or other organization name of the establishment, the city, street address, State, and country of the establishment, and the title, email address, and telephone number for the office within the establishment that is responsible for submitting and maintaining the registration. For a foreign establishment, the registration shall include the contact information for the initial United States agent of the establishment. The Secretary shall establish and provide to each registrant under this section a unique cosmetic establishment registration number within 15 business days after receiving the registration. If the Secretary does not provide a unique cosmetic establishment registration number within such 15 business days, any requirement under this Act for such number shall be deemed to be inapplicable until 30 business days after such number is received by the person who submitted the registration. Where more than one person registers the same establishment, the Secretary shall provide only one unique establishment registration number for the establishment. The unique cosmetic establishment number shall not be required to be included in cosmetic labeling. The information required in a registration under subsection
(a)or in an existing registration under subsection (e)(1)(A) shall be maintained as current and accurate by the registrant by withdrawing or amending the registration within 60 business days after the information becomes no longer current and accurate. The Secretary shall enforce this section under section 301(eee) and shall not suspend or revoke a registration under this section. The Secretary shall compile and maintain an up-to-date and publicly available electronic list of establishments that are registered under this section. Registration under subsection
(a)shall not be required for any entity based on such entity operating as— an establishment that as of the date of enactment of this section is registered as a cosmetic establishment under part 710 of title 21, Code of Federal Regulations (as in effect on such date); a beauty shop or salon or spa; a cosmetic retailer, including any such retailer that is— an individual sales representative; a wholesale or retail distribution or sales facility; or a pharmacy or other person or organization that— compounds cosmetics at a single location and administers, dispenses, or distributes such cosmetics at retail from that location; and does not otherwise manufacture or package cosmetics from that location; a health care provider, including a hospital or clinic; a public health agency or other nonprofit entity; a hotel or other entity that provides complimentary cosmetics; a trade show or other venue where cosmetic samples are provided; an establishment that manufactures, prepares, compounds, or processes cosmetics for use in research, teaching, or chemical analysis or pilot plant production; a handcrafted soap or cosmetic made in a home, a community facility, or a similar establishment; or a business with less than $1,000,000 of annual net revenue from cosmetics. The Secretary may supplement the list of exemptions under paragraph
(1)with additional exemptions for persons and activities where the cost of compliance exceeds the safety benefit to the public. .
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Sec. 4
Registration of cosmetic manufacturing establishments
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