21 USC 364c - Registration and product listing

U.S Code last checked for updates: Apr 29, 2024

§ 364c.

Registration and product listing

(a)

Submission of registration

(1)

Initial registration

(A)

Existing facilities

(B)

New facilities

(2)

Biennial renewal of registration

(3)

Contract manufacturers

(4)

Updates to content

(5)

Abbreviated renewal registrations

(b)

Format; contents of registration

(1)

In general

(2)

Contents

The registration under subsection (a) shall contain—

(A)

the facility’s name, physical address, email address, and telephone number;

(B)

with respect to any foreign facility, the contact for the United States agent of the facility, and, if available, the electronic contact information;

(C)

the facility registration number, if any, previously assigned by the Secretary under subsection (d);

(D)

all brand names under which cosmetic products manufactured or processed in the facility are sold; and

(E)

the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility.

(c)

Cosmetic product listing

(1)

In general

(2)

Cosmetic product listing

(3)

Abbreviated renewal

(4)

Contents of listing

(A)

In general

Each such cosmetic product listing shall include—

(i)

the facility registration number of each facility where the cosmetic product is manufactured or processed;

(ii)

the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;

(iii)

the applicable cosmetic category or categories for the cosmetic product;

(iv)

a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient; and

(v)

the product listing number, if any previously assigned by the Secretary under subsection (d).

(B)

Flexible listings

(5)

Updates to content

(6)

Submission

(d)

Facility registration and product listing numbers

(e)

Confidentiality

(f)

Suspensions

(1)

Suspension of registration of a facility

(2)

Notice of suspension

Before suspending a facility registration under this section, the Secretary shall provide—

(A)

notice to the facility registrant of the cosmetic product or other responsible person, as appropriate, of the intent to suspend the facility registration, which shall specify the basis of the determination by the Secretary that the facility registration should be suspended; and

(B)

an opportunity, within 5 business days of the notice provided under subparagraph (A), for the responsible person to provide a plan for addressing the reasons for possible suspension of the facility registration.

(3)

Hearing on suspension

(4)

Post-hearing corrective action plan

(5)

Vacating of order; reinstatement

(6)

Effect of suspension

(7)

No delegation

(June 25, 1938, ch. 675, § 607, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5851.)

cite as: 21 USC 364c