Code of Federal Regulations

  Title 21, Volume 7, Parts 600 to 799

  Revised as of April 1, 1996

 From the U.S. Government Printing Office via GPO Access

  CITE: 21CFR710

 

  Page 192-194

 

         TITLE 21--FOOD AND DRUGS

 

 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)

 

 PART 710--VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS

 

 Sec.

 710.1  Who should register.

 710.2  Time for registration.

 710.3  How and where to register.

 710.4  Information requested.

 710.5  Amendments to registration.

 710.6  Notification of registrant; cosmetic product establishment

           registration number.

 710.7  Inspection of registrations.

 710.8  Misbranding by reference to registration or to registration

           number.

 710.9  Exemptions.

 

     Authority: Secs. 201, 301, 601, 602, 701, 704 of the Federal Food,

 Drug, and Cosmetic Act (21 U.S.C. 321, 331, 361, 362, 371, 374).

 

     Source: 39 FR 10059, Mar. 15, 1974, unless otherwise noted.

 

 Sec. 710.1   Who should register.

 

     The owner or operator of a cosmetic product establishment which is

 not

 

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 exempt under Sec. 710.9 and engages in the manufacture or packaging of a

 cosmetic product is requested to register for each such establishment,

 whether or not the product enters interstate commerce. This request

 extends to any foreign cosmetic product establishment whose products are

 exported for sale in any State as defined in section 201(a)(1) of the

 act. No registration fee is required.

 

 Sec. 710.2   Time for registration.

 

     The owner or operator of an establishment entering into the

 manufacture or packaging of a cosmetic product should register his

 establishment within 30 days after the operation begins.

 

 Sec. 710.3   How and where to register.

 

     Form FD-2511 (``Registration of Cosmetic Product Establishment'') is

 obtainable on request from the Food and Drug Administration, Department

 of Health and Human Services, Washington, DC 20204, or at any Food and

 Drug Administration district office. The completed form should be mailed

 to Cosmetic Product Establishment Registration, Food and Drug

 Administration, Department of Health and Human Services, Washington, DC

 20204.

 

 Sec. 710.4   Information requested.

 

     Form FD-2511 requests information on the name and address of the

 cosmetic product establishment, including post office ZIP code; all

 business trading names used by the establishment; and the type of

 business (manufacturer and/or packer). The information requested should

 be given separately for each establishment as defined in Sec. 700.3(j)

 of this chapter.

 

  39 FR 10059, Mar. 15, 1974, as amended at 46 FR 38073, July 24, 1981;

 54 FR 39640, Sept. 27, 1989

 

 Sec. 710.5  Amendments to registration.

 

     Within 30 days after a change in any of the information contained on

 a submitted Form FD-2511, a new Form FD-2511 should be submitted to

 amend the registration. This amendment is also necessary when a

 registration is to be canceled because an establishment has changed its

 name and no longer conducts business under the original name.

 

 Sec. 710.6  Notification of registrant; cosmetic product establishment

           registration number.

 

     The Commissioner of Food and Drugs will provide the registrant with

 a validated copy of Form FD-2511 as evidence of registration. This

 validated copy will be sent only to the location shown for the

 registering establishment. A permanent registration number will be

 assigned to each cosmetic product establishment registered in accordance

 with the regulations in this part.

 

 Sec. 710.7   Inspection of registrations.

 

     A copy of the Form FD-2511 filed by the registrant will be available

 for inspection at the Food and Drug Administration, Department of Health

 and Human Services, Washington, DC 20204.

 

 Sec. 710.8   Misbranding by reference to registration or to registration

           number.

 

     Registration of a cosmetic product establishment or assignment of a

 registration number does not in any way denote approval of the firm or

 its products by the Food and Drug Administration. Any representation in

 labeling or advertising that creates an impression of official approval

 because of registration or possession of a registration number will be

 considered misleading.

 

 Sec. 710.9   Exemptions.

 

     The following classes of persons are not requested to register in

 accordance with this part 710 because the Commissioner has found that

 such registration is not justified:

     (a) Beauty shops, cosmetologists, retailers, pharmacies, and other

 persons and organizations that compound cosmetic products at a single

 location and administer, dispense, or distribute them at retail from

 that location and who do not otherwise manufacture or package cosmetic

 products at that location.

     (b) Physicians, hospitals, clinics, and public health agencies.

     (c) Persons who manufacture, prepare, compound, or process cosmetic

 products solely for use in research,

 

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 pilot plant production, teaching, or chemical analysis, and who do not

 sell these products.